UNITED STATES 
SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) þ

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the quarterly period ended June 30, 2012 OR o

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from   to  . Commission File Number 001-33451  BIODEL INC. (Exact name of registrant as specified in its charter) Delaware(State or other jurisdiction of incorporation or organization)

90-0136863(IRS Employer Identification No.)100 Saw Mill Road 
Danbury, Connecticut(Address of principal executive offices)

06810(Zip code) (203) 796-5000(Registrants telephone number, including area code) Not Applicable (Former Name, Former Address, and Former Fiscal Year, if Changed Since Last Report) Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. þYes oNo Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). þYes oNo Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):   Large accelerated filer o

Accelerated filer o

Non-accelerated filer o

Smaller reporting company þ(Do not check if a smaller reporting company) Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). oYes þNo Indicate the number of shares outstanding of the issuers common stock as of the latest practicable date: As of July 31, 2012 there were 13,982,826 shares of the registrants common stock outstanding.  -i-   BIODEL INC.

PagePART I  FINANCIAL INFORMATIONItem 1. Consolidated Condensed Financial Statements


1Consolidated Condensed Balance Sheets at September 30, 2011 and June 30, 2012 (unaudited)


1Consolidated Condensed Statements of Operations and Comprehensive Loss (unaudited) for the Three and Nine Months Ended June 30, 2011 and 2012 and for the period from December 3, 2003 (inception) to June 30, 2012


2Consolidated Condensed Statements of Stockholders Equity (period from October 1, 2011 to June 30, 2012, unaudited) for the period from December 3, 2003 (inception) to June 30, 2012


3Consolidated Condensed Statements of Cash Flows (unaudited) for the Nine Months Ended June 30, 2011 and 2012 and for the period from December 3, 2003 (inception) to June 30, 2012


6Notes to Consolidated Condensed Financial Statements


8Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations


20Item 3. Quantitative and Qualitative Disclosure About Market Risk


29Item 4. Controls and Procedures


29PART II  OTHER INFORMATIONItem 1. Legal Proceeding


30Item 1A. Risk Factors


30Item 6. Exhibits


45Signatures


46EX-3.01EX-3.02EX-3.03EX-3.04EX-4.01EX-10.01EX-10.02EX-12.01EX-31.01EX-31.02EX-32.01


-ii-




PART I  FINANCIAL INFORMATION
Item 1.
Consolidated Condensed Financial Statements
Biodel Inc. 
(A Development Stage Company) 
Consolidated Condensed Balance Sheets 
(in thousands, except share and per share amounts)
September 30,

    June 30,2011

    2012(unaudited)ASSETSCurrent:Cash and cash equivalents

    $
38,701


    $
43,691Restricted cash

    
60


    
1,060Taxes receivable

    
35


    
34Other receivables

    
1


    
—Prepaid and other assets

    
399


    
416Total current assets

    
39,196


    
45,201Property and equipment, net

    
2,253


    
1,662Intellectual property, net

    
49


    
47Long term other assets

    
7


    
—Total assets

    $
41,505


    $
46,910LIABILITIES AND STOCKHOLDERS’ EQUITYCurrent:Accounts payable

    $
222


    $
180Accrued expenses:Clinical trial expenses

    
763


    
427Payroll and related

    
1,118


    
1,113Accounting and legal fees

    
191


    
287Severance

    
688


    
306Other

    
204


    
382Income taxes payable

    
103


    
73Total current liabilities

    
3,289


    
2,768Common stock warrant liability

    
996


    
7,182Other long term liabilities

    
142


    
—Total liabilities

    
4,427


    
9,950CommitmentsStockholders’ equity:Preferred stock, $.01 par value; 50,000,000 shares authorized, 1,813,944 and 5,419,551 issued and outstanding

    
18


    
54Common stock, $.01 par value; 25,000,000 shares authorized; 9,661,868 and 13,982,826 issued and outstanding

    
96


    
140Additional paid-in capital

    
212,310


    
226,980Deficit accumulated during the development stage

    
(175,346
)

    
(190,214
)Total stockholders’ equity

    
37,078


    
36,960Total liabilities and stockholders’ equity

    $
41,505


    $
46,910See accompanying notes to consolidated condensed financial statements.

-1-




Biodel Inc. 
(A Development Stage Company)
Consolidated Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
December 3,2003Three Months Ended

    Nine Months Ended

    (inception) toJune 30,

    June 30,

    June 30,2011

    2012

    2011

    2012

    2012Revenue

    $
—


    $
—


    $
—


    $
—


    $
—Operating expenses:Research and development

    
2,941


    
2,956


    
11,349


    
7,952


    
138,081General and administrative

    
2,382


    
1,776


    
7,264


    
5,626


    
62,572Total operating expenses

    
5,323


    
4,732


    
18,613


    
13,578


    
200,653Other (income) and expense:Interest and other income

    
(20
)

    
(15
)

    
(30
)

    
(56
)

    
(5,622
)Interest expense

    
—


    
—


    
—


    
—


    
78Adjustment to fair value of common stock warrant liability

    
(1,355
)

    
1,355


    
(3,890
)

    
1,354


    
(10,003
)Loss on settlement of debt

    
—


    
—


    
—


    
—


    
627Operating loss before tax provision (benefit)

    
(3,948
)

    
(6,072
)

    
(14,693
)

    
(14,876
)

    
(185,733
)Tax provision (benefit)

    
26


    
(21
)

    
32


    
(8
)

    
(579
)Net loss and other comprehensive loss

    
(3,974
)

    
(6,051
)

    
(14,725
)

    
(14,868
)

    
(185,154
)Charge for accretion of beneficial conversion rights

    
—


    
—


    
—


    
—


    
(603
)Deemed dividend — warrants

    
—


    
—


    
—


    
—


    
(4,457
)Net loss and other comprehensive loss applicable to common stockholders

    $
(3,974
)

    $
(6,051
)

    $
(14,725
)

    $
(14,868
)

    $
(190,214
)Net loss and other comprehensive loss per share — basic and diluted

    $
(0.48
)

    $
(0.52
)

    $
(2.06
)

    $
(1.44
)Weighted average shares outstanding — basic and diluted

    
8,254,413


    
11,600,003


    
7,158,806


    
10,320,558See accompanying notes to consolidated condensed financial statements.

-2-




Biodel Inc. 
(A Development Stage Company) 
Consolidated Condensed Statements of Stockholders Equity 
(in thousands, except share and per share amounts)


DeficitAccumulated

    AccumulatedCommon Stock

    Series A Preferred stock

    Series B Preferred stock

    Additional

    Other

    During the

    Total$01 Par Value

    $.01 Par Value

    $.01 Par Value

    Paid in

    Comprehensive

    Development

    Stockholders’Shares

    Amount

    Shares

    Amount

    Shares

    Amount

    Capital

    Income (loss)

    Stage

    EquityBalance at Inception (December 3, 2003)

    —

    $—

    —

    $—

    —

    $—

    $—

    $—

    $—

    $—Shares issued to employees

    
183,126


    
2


    
—


    
—


    
—


    
—


    
(2
)

    
—


    
—


    $
—January 2004 Proceeds from sale of common stock

    
1,145,306


    
11


    
—


    
—


    
—


    
—


    
1,343


    
—


    
—


    
1,354Net loss

    
—


    
—


    
—


    
—


    
—


    
—


    
—


    



    
(774
)

    
(774
)Balance, September 30, 2004

    
1,328,432


    
13


    
—


    
—


    
—


    
—


    
1,341


    
—


    
(774
)

    
580Additional stockholder contributions

    
—


    
—


    
—


    
—


    
—


    
—


    
514


    
—


    
—


    
514Stock-based compensation

    
—


    
—


    
—


    
—


    
—


    
—


    
353


    
—


    
—


    
353Shares issued to employees and directors for services

    
10,658


    
—


    
—


    
—


    
—


    
—


    
61


    
—


    
—


    
61July 2005 Private placement — Sale of Series A preferred stock, net of issuance costs of $379

    
—


    
—


    
569,000


    
6


    
—


    
—


    
2,460


    
—


    
—


    
2,466Founder’s compensation contributed to capital

    
—


    
—


    
—


    
—


    
—


    
—


    
63


    
—


    
—


    
63Net loss

    
—


    
—


    
—


    
—


    
—


    
—


    
—


    
—


    
(3,383
)

    
(3,383
)Balance, September 30, 2005

    
1,339,090


    
13


    
569,000


    
6


    
—


    
—


    
4,792


    
—


    
(4,157
)

    
654Stock-based compensation

    
—


    
—


    
—


    
—


    
—


    
—


    
1,132


    
—


    
—


    
1,132July 2006 Private placement — Sale of Series B preferred stock, net of issuance costs of $1,795

    
—


    
—


    
—


    
—


    
5,380,711


    
54


    
19,351


    
—


    
—


    
19,405July 2006 — Series B preferred stock units issued July 2006 to settle debt

    
—


    
—


    
—


    
—


    
817,468


    
8


    
3,194


    
—


    
—


    
3,202Shares issued to employees and directors for services

    
988


    
—


    
—


    
—


    
—


    
—


    
23


    
—


    
—


    
23Accretion of fair value of beneficial conversion charge

    
—


    
—


    
—


    
—


    
—


    
—


    
603


    
—


    
(603
)

    
—Net loss

    
—


    
—


    
—


    
—


    
—


    
—


    
—


    
—


    
(8,068
)

    
(8,068
)Balance, September 30, 2006

    
1,340,078


    $
13


    
569,000


    $
6


    
6,198,179


    $
62


    $
29,095


    $
—


    $
(12,828
)

    $
16,348

-3-




Biodel Inc. 
(A Development Stage Company) 
Consolidated Condensed Statements of Stockholders Equity 
(in thousands, except share and per share amounts)


DeficitSeries A Preferred

    

    

    

    Accumulated

    AccumulatedCommon Stock

    stock

    Series B Preferred stock

    Additional

    Other

    During the

    Total$01 Par Value

    $.01 Par Value

    $.01 Par Value

    Paid in

    Comprehensive

    Development

    Stockholders’Shares

    Amount

    Shares

    Amount

    Shares

    Amount

    Capital

    Income (loss)

    Stage

    EquityBalance, September 30, 2006

    
1,340,078


    $
13


    
569,000


    $
6


    
6,198,179


    $
62


    $
29,095


    $
—


    $
(12,828
)

    $
16,348May 2007 Proceeds from sale of common stock

    
1,437,500


    
14


    
—


    
—


    
—


    
—


    
78,741


    
—


    
—


    
78,755Conversion of preferred stock on May 16, 2007

    
1,601,749


    
16


    
(569,000
)

    
(6
)

    
(6,198,179
)

    
(62
)

    
52


    
—


    
—


    
—Stock-based compensation

    
—


    
—


    
—


    
—


    
—


    
—


    
4,224


    
—


    
—


    
4,224Shares issued to employees, non-employees and directors for services

    
732


    
—


    
—


    
—


    
—


    
—


    
16


    
—


    
—


    
16Stock options exercised

    
885


    
—


    
—


    
—


    
—


    
—


    
5


    
—


    
—


    
5March 2007 Warrants exercised

    
659,226


    
7


    
—


    
—


    
—


    
—


    
416


    
—


    
—


    
423Deemed dividend — warrants

    
—


    
—


    
—


    
—


    
—


    
—


    
4,457


    
—


    
(4,457
)

    
—Net loss

    
—


    
—


    
—


    
—


    
—


    
—


    
—


    
—


    
(22,548
)

    
(22,548
)Balance, September 30, 2007

    
5,040,170


    
50


    
—


    
—


    
—


    
—


    
117,006


    
—


    
(39,833
)

    
77,223Proceeds from sale of common stock

    
815,000


    
8


    
—


    
—


    
—


    
—


    
46,809


    
—


    
—


    
46,817Issuance of restricted stock

    
2,428


    
—


    
—


    
—


    
—


    
—


    
172


    
—


    
—


    
172Stock-based compensation

    
—


    
—


    
—


    
—


    
—


    
—


    
6,503


    
—


    
—


    
6,503Stock options exercised

    
43,600


    
1


    
—


    
—


    
—


    
—


    
901


    
—


    
—


    
902Warrants exercised

    
19,802


    
—


    
—


    
—


    
—


    
—


    
112


    
—


    
—


    
112Net unrealized loss on Marketable Securities

    
—


    
—


    
—


    
—


    
—


    
—


    
—


    
(62
)

    
—


    
(62
)Proceeds from sale of stock — ESPP

    
3,596


    
—


    
—


    
—


    
—


    
—


    
181


    
—


    
—


    
181Net loss

    
—


    
—


    
—


    
—


    
—


    
—


    
—


    
—


    
(43,361
)

    
(43,361
)Balance, September 30, 2008

    
5,924,596


    $
59


    
—


    $
—


    
—


    
—


    $
171,684


    $
(62
)

    $
(83,194
)

    $
88,487

-4-




Biodel Inc. 
(A Development Stage Company) 
Consolidated Condensed Statements of Stockholders Equity 
(in thousands, except share and per share amounts)

DeficitSeries A Preferred

    

    

    



    Accumulated

    AccumulatedCommon Stock

    stock

    Series B Preferred stock

    Additional

    Other

    During the

    Total$01 Par Value

    $.01 Par Value

    $.01 Par Value

    Paid in

    Comprehensive

    Development

    Stockholders’Shares

    Amount

    Shares

    Amount

    Shares

    Amount

    Capital

    Income (loss)

    Stage

    EquityBalance, September 30, 2008

    
5,924,596


    $
59


    
—



    $
—


    
—



    
—


    $
171,684


    $
(62
)

    $(83,194)

    $88,487Stock-based compensation

    
—


    
—


    
—



    
—


    
—



    
—


    
5,064


    
—


    —

    5,064Stock options exercised

    
4,413


    
—


    
—



    
—


    
—



    
—


    
25


    
—


    —

    25Net unrealized gain on Marketable Securities

    
—


    
—


    
—



    
—


    
—



    
—


    
—


    
62


    —

    62Proceeds from the sale of stock - ESPP

    
21,863


    
—


    
—



    
—


    
—



    
—


    
170


    
—


    —

    170Net loss

    



    



    




    



    




    



    



    



    (43,270)

    (43,270)Balance, September 30, 2009

    
5,950,872


    $
59


    
—



    $
—


    
—



    $
—


    $
176,943


    $
—


    $(126,464)

    $50,538Registered direct financing

    
599,550


    
6


    
—



    
—


    
—



    
—


    
8,706


    
—


    —

    8,712Initial value of warrants issued in a registered direct

    
—


    
—


    
—



    
—


    
—



    
—


    
(2,915
)

    
—


    —

    (2,915)Stock-based compensation

    
—


    
—


    
—



    
—


    
—



    
—


    
5,621


    
—


    —

    5,621Stock options exercised

    
8,076


    
—


    
—



    
—


    
—



    
—


    
68


    
—


    —

    68Net unrealized gain on marketable securities

    
—


    
—


    
—



    
—


    
—



    
—


    
—


    
1


    —

    1Proceeds from the sale of stock - ESPP

    
41,393


    
1


    
—



    
—


    
—



    
—


    
324


    
—


    —

    325Net loss

    
—


    
—


    
—



    
—


    
—



    
—


    
—


    
—


    (38,290)

    (38,290)Balance, September 30, 2010

    
6,599,891


    $
66


    
—



    
—


    
—



    



    $
188,747


    $
1


    $(164,754)

    $24,060Registered direct financing

    
3,018,736


    
30


    
1,813,944



    
18


    
—



    
—


    
27,913


    
—


    —

    27,961Initial value of warrants issued in a registered direct offering

    
—


    
—


    
—



    
—


    
—



    
—


    
(9,438
)

    
—


    —

    (9,438)Stock-based compensation

    
—


    
—


    
—



    
—


    
—



    
—


    
4,920


    
—


    —

    4,920Stock options exercised

    
104


    
—


    
—



    
—


    
—



    
—


    
—


    
—


    —

    —Warrants exercised

    
10,549


    
—


    
—



    
—


    
—



    
—


    
50


    
—


    —

    50RSU’s granted

    
15,537


    
—


    
—



    
—


    
—



    
—


    
—


    
—


    —

    —Net unrealized loss on marketable securities

    
—


    
—


    
—



    
—


    
—



    
—


    
—


    
(1
)

    —

    (1)Proceeds from the sale of stock - ESPP

    
17,051


    
—


    
—



    
—


    
—



    
—


    
118


    
—


    —

    118Net loss

    
—


    
—


    
—



    
—


    
—



    
—


    
—


    
—


    (10,592)

    (10,592)Balance, September 30, 2011

    
9,661,868


    $
96


    
1,813,944



    $
18


    
—



    $
—


    $
212,310


    $
—


    $(175,346)

    $37,078Proceeds from the sale of unregistered securities

    
4,250,020


    
43


    
—



    
—


    
3,605,607



    
36


    
17,142


    
—


    —

    17,221Initial value of warrants issued in private placement financing

    
—


    
—


    
—



    
—


    
—



    
—


    
(4,832
)

    
—


    —

    (4,832)Stock-based compensation

    
—


    
—


    
—



    
—


    
—



    
—


    
1,511


    
—


    —

    1,511Proceeds from the sale of stock - ESPP

    
10,776


    
—


    
—



    
—


    
—



    
—


    
27


    
—


    —

    27RSUs issued to settle bonus liability

    
—


    
—


    
—



    
—


    
—



    
—


    
823


    
—


    —

    823RSUs granted

    
60,409


    
1


    
—



    
—


    
—



    
—


    
(1
)

    
—


    —

    —Net loss

    
—


    
—


    
—



    
—


    
—



    
—


    
—


    
—


    (14,868)

    (14,868)Company re-purchase of fractional shares from the reverse stock split

    
(247
)

    
—


    
—



    
—


    
—



    
—


    
—


    
—


    —

    —Balance, June 30, 2012 (unaudited)

    
13,982,826


    $
140


    
1,813,944



    $
18


    
3,605,607



    $
36


    $
226,980


    $
—


    $(190,214)

    $36,960
See accompanying notes to consolidated condensed financial statements.

-5-




Biodel Inc. 
(A Development Stage Company) 
Consolidated Condensed Statements of Cash Flows 
(in thousands, except share and per share amounts) 
(unaudited)


December 3,2003Nine months ended

    (inception) toJune 30,

    June 30,2011

    2012

    2012Cash flows from operating activities:Net loss

    $
(14,725
)

    $
(14,868
)

    $
(185,154
)Adjustments to reconcile net loss to net cash used in operating activities:Depreciation and amortization

    
732


    
555


    
4,633Founder’s compensation contributed to capital

    
—


    
—


    
271Share-based compensation for employees and directors

    
3,948


    
1,511


    
27,307Share-based compensation for non-employees

    
(43
)

    
—


    
2,274Loss on settlement of debt

    
—


    
—


    
627Write-off of loan to related party

    
—


    
—


    
41Write-off of capitalized equipment and patent expense

    
—


    
38


    
246Adjustment to fair value of common stock warrant liability

    
(3,890
)

    
1,354


    
(10,003
)(Increase) decrease in:Taxes receivable

    
30


    
1


    
(34
)Other receivables

    
2


    
1


    
—Prepaid expenses and other assets

    
(141
)

    
(10
)

    
(416
)Increase (decrease) in:Accounts payable

    
(1,887
)

    
(42
)

    
180Income taxes payable

    
2


    
(28
)

    
75Accrued expenses and long term liabilities

    
1,043


    
230


    
3,555Total adjustments

    
(204
)

    
3,610


    
28,756Net cash used in operating activities

    
(14,929
)

    
(11,258
)

    
(156,398
)Cash flows from investing activities:Purchase of property and equipment

    
(163
)

    
—


    
(6,290
)Purchase of marketable securities

    
—


    
—


    
(31,614
)Sale of marketable securities

    
6,000


    
—


    
31,614Acquisition of intellectual property

    
—


    
—


    
(298
)Loan to related party

    
—


    
—


    
(41
)Net cash provided by (used in) investing activities

    
5,837


    
—


    
(6,629
)Cash flows from financing activities:Restricted cash

    
90


    
(1,000
)

    
(1,060
)Options exercised

    
0


    
—


    
1,000Warrants exercised

    
—


    
—


    
585Employee stock purchase plan

    
118


    
27


    
821Deferred public offering costs

    
—


    
—


    
(1,458
)Stockholder contribution

    
—


    
—


    
1,660Net proceeds from sale of Series A preferred stock 2005

    
—


    
—


    
2,466Net proceeds from sale of Series A preferred stock 2011

    
2,685


    
—


    
2,685Net proceeds from sale of unregistered common stock – private placement

    



    
8,730


    
8,730Net proceeds from sale of common stock

    
25,276


    
—


    
161,018Proceeds from bridge financing

    
—


    
—


    
2,575Net proceeds from sale of Series B preferred stock 2006

    
—


    
—


    
19,205Net proceeds from sale of Series B preferred stock 2012

    
—


    
8,491


    
8,491Net cash provided by financing activities

    
28,169


    
16,248


    
206,718Net increase in cash and cash equivalents

    
19,077


    
4,990


    
43,691Cash and cash equivalents, beginning of period

    
22,922


    
38,701


    
—Cash and cash equivalents, end of period

    $
41,999


    $
43,691


    $
43,691
-6-




Biodel Inc. 
(A Development Stage Company) 
Consolidated Condensed Statements of Cash Flows 
(in thousands, except share and per share amounts) 
(unaudited)


Nine months ended 
June 30,


December 3,2003 
(inception) to 
June 30,2011


2012


2012Supplemental disclosures of cash flow information:Cash paid for interest and income taxes was:Interest



$



$



$
9Income taxes








20



326Non-cash financing and investing activities:Warrants issued in connection with registered direct financing



$
9,438


$



$
12,353Warrants issued in connection with private placement financing








4,832



4,832Settlement of employee bonus payment with Restricted Stock Units








823



823Settlement of debt with Series B preferred stock












3,202Accrued expenses settled with Series B preferred stock












150Deemed dividend  warrants












4,457Accretion of fair value of beneficial charge on preferred stock












603Conversion of convertible preferred stock to common stock












68See accompanying notes to consolidated condensed financial statements.

-7-




Biodel Inc. 
(A Development Stage Company)
Notes to Consolidated Condensed Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
1. Business and Basis of Presentation
Business
Biodel Inc. and its wholly owned subsidiary (collectively, Biodel or the Company, and formerly Global Positioning Group Ltd.) is a development stage specialty pharmaceutical company located in Danbury, Connecticut. The Company was incorporated in the State of Delaware on December 3, 2003 and commenced operations in January 2004. The Company formed a wholly owned subsidiary in the United Kingdom in October 2011 (Biodel UK Limited). This subsidiary has been inactive since its inception.
The Company focuses on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. The Company's most advanced program involves developing proprietary formulations of injectable recombinant human insulin, or RHI, designed to be more rapid-acting than the rapid-acting mealtime insulin analogs presently used to treat patients with Type 1 and Type 2 diabetes. The Company, therefore, refers to these formulations as its ultra-rapid-acting insulin formulations. In addition to the Companys RHI-based formulations, the Company is using its formulation technologies to develop new ultra-rapid-acting formulations of insulin analogs. These insulin analog-based formulations generally use the same or similar excipients as the Companys RHI-based formulations and are designed to be more rapid-acting than the rapid-acting
mealtime insulin analogs, but they may present characteristics that are different from those offered by the Companys RHI-based formulations.
In April 2012, the Company announced top-line results from a Phase 1 clinical trial of two RHI-based formulations, BIOD-123 and BIOD-125. In this clinical trial, BIOD-123 and BIOD-125 achieved the Companys target pharmacokinetic, pharmacodynamic and toleration profiles. The Company now intends to study BIOD-123 in a Phase 2 clinical trial projected to begin in the third calendar quarter of 2012.
The Company is also developing a liquid formulation of glucagon for use as a rescue treatment for diabetes patients experiencing hypoglycemia. In March 2012, the Company announced that it had received feedback from the U.S. Food and Drug Administration (the FDA) regarding regulatory requirements for this product candidate as such a rescue treatment. Subject to successful completion of its formulation development work and subsequent completion of clinical trials, the Company intends to submit a New Drug Application (NDA) for its liquid formulation of glucagon in the first calendar quarter of 2014.
Basis of Presentation
The consolidated financial statements have been prepared by the Company and are unaudited. These consolidated financial statements include Biodel UK Limited. This subsidiary has been inactive since its inception. All intercompany balances and transactions have been eliminated. In the opinion of management, the Company has made all adjustments (consisting of normal recurring accruals) necessary to fairly present the financial position and results of operations for the interim periods presented. Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with generally accepted accounting principles in the United States of America (US GAAP) have been consolidated or omitted. These consolidated financial statements should be read in conjunction with the September 30, 2011 audited financial statements and accompanying notes included in the Companys Annual
Report on Form 10-K for the fiscal year ended September 30, 2011, filed with the Securities and Exchange Commission on December 15, 2011. The results of operations for the nine months ended June 30, 2012 are not necessarily indicative of the operating results for the full fiscal year or any other interim period.
The Company is in the development stage, as defined by Financial Accounting Standards Board (FASB) ASC 915 (prior authoritative literature: Statement of Financial Accounting Standards No. 7), Accounting and Reporting by Development Stage Enterprises, as its primary activities since incorporation have been establishing its facilities, recruiting personnel, conducting research and development, business development, business and financial planning and raising capital.
On June 11, 2012, the Company effected a one-for-four reverse split of its outstanding common stock. All references in these financial statements and accompanying notes to units of common stock or per share amounts are reflective of the reverse split for all periods reported. (See Note 7.)
Adopted Accounting Pronouncements
Comprehensive Income
In June 2011, the FASB issued ASU 2011-05 Presentation of Comprehensive Income (ASU 2011-05). ASU 2011-05 allows an entity to present components of net income and other comprehensive income in one continuous statement, referred to as the statement of comprehensive income, or in two separate, but consecutive statements. The new guidance eliminates the current option to report other comprehensive income and its components in the statement of changes in equity. While ASU 2011-05 changes the presentation of comprehensive income, there are no changes to the components that are recognized in net income or other comprehensive income under current accounting guidance. In December 2011, the FASB issued ASU 2011-12 Comprehensive Income (Topic 220): Deferral of the Effective Date for Amendments to the Presentation of Reclassifications of Items Out of Accumulated Other Comprehensive Income in Accounting Standards Update No. 2011-05
(ASU 2011-12). ASU 2011-12 deferred certain aspects of ASU 2011-05 pertaining only to the presentation of reclassification adjustments out of accumulated other comprehensive income and reinstates the previous requirements to

-8-




Biodel Inc. 
(A Development Stage Company)
Notes to Consolidated Condensed Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
present reclassification adjustments either on the face of the statement in which other comprehensive income is reported or to disclose them in a note to the financial statements. The new guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2011. The Company adopted this guidance in the first quarter of the fiscal year ending September 30, 2012. The adoption of ASU 2011-05 and the deferrals in ASU 2011-12 had no impact on the Companys consolidated financial statements.
2. Restricted Cash
Restricted cash as of September 30, 2011 and June 30, 2012 was $60 and $1,060, respectively. The $60 is kept in a money market account held with a bank to secure a credit card purchasing agreement utilized to facilitate employee travel and certain ordinary purchases. The $1,000 is kept in an escrow account as part of an arbitration stipulation relating to disputed fees charged to the Company for inventory storage. On July 30, 2012, the Company received a judgment from the arbitrator stating that the Company is required to only pay the vendor a balance of $55, after deducting legal fees. The Company expects the remaining escrow balance of $945 to be returned to it by the end of the fiscal year. (See Note 11.)
3. Fair Value of Financial Instruments
The carrying amounts of the Companys financial instruments, which include cash and cash equivalents, and accounts payable, approximate their fair values due to their short term maturities.
ASC Topic 820 (ASC 820, originally issued as SFAS No. 157, Fair Value Measurements) applies under other accounting pronouncements that require or permit fair value measurements, the FASB having previously concluded in those accounting pronouncements that fair value is the relevant measurement attribute. Accordingly, ASC 820 does not require any new fair value measurements. The fair value framework requires the categorization of assets and liabilities into three levels based upon the assumptions (inputs) used to price the assets or liabilities. The three levels of inputs used are as follows:
Level 1  Quoted prices in active markets for identical assets or liabilities.
Level 2  Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.
Level 3  Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs.
As of September 30, 2011 and June 30, 2012, the Company had assets and liabilities that fell under the scope of ASC 820. The Company used the Black-Scholes valuation model to determine the fair value of the Companys warrant liability (i) as of September 30, 2011 and June 30, 2012 for the warrants issued in the May 2011 Offering (as defined in Note 10) and (ii) as of June 30, 2012 for the warrants issued in the 2012 Private Placement (as defined in Note 10). The Black-Scholes valuation model takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the underlying stock and its expected volatility, expected dividends on the stock, and the risk-free interest rate for the term of the warrant. The Company used the Monte Carlo simulation model to determine the fair value of the Companys warrant liability as of September 30, 2011 for the warrants issued in the
Companys August 2010 registered direct offering. The Monte Carlo simulation method is a generally accepted statistical method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of future expected stock prices of the Company and its peer group and minimizes standard error. Accordingly, the Companys fair value measurements of its cash and cash equivalents and restricted cash are classified as a Level 1 input and the warrant liability as a Level 3 input. On December 1, 2011, the unexercised warrants issued in the August 2010 offering expired. The Company revalued the liability from September 30, 2011 through the date of expiration and there was no material impact on the statement of operations. The common stock warrant liability associated with these warrants no longer exists.


-9-




Biodel Inc. 
(A Development Stage Company)
Notes to Consolidated Condensed Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
The fair value of the Companys financial assets and liabilities carried at fair value and measured on a recurring basis are as follows:

Description

    Fair Value at  June 30, 2012

    Quoted Prices in  Active Markets for  Identical Assets  (Level 1)

    Significant Other  Observable  MarketInputs  (Level 2)

    Significant  Unobservable  Inputs  (Level 3)Assets:Cash and cash equivalents

    $
43,691


    $
43,691


    $
—


    $
—Restricted cash (see Note 2)

    
1,060


    
1,060


    
—


    
—Subtotal

    
44,751


    
44,751


    
—


    
—Liabilities:Common stock warrant liability (see Note 10)

    
(7,182
)

    



    
—


    
(7,182
)Subtotal

    
(7,182
)

    



    
—


    
(7,182
)Total

    $
37,569


    $
44,751


    $
—


    $
(7,182
)
Description

    Fair Value at  September 30, 2011

    Quoted Prices in  Active Markets for  Identical Assets  (Level 1)

    Significant Other  Observable  Market Inputs  (Level 2)

    Significant  Unobservable  Inputs  (Level 3)Assets:Cash and cash equivalents

    $
38,701


    $
38,701


    $
—


    $
—Restricted cash (see Note 2)

    
60


    
60


    
—


    
—Subtotal

    
38,761


    
38,761


    
—


    
—Liabilities:Common stock warrant liability (see Note 10)

    
(996
)

    
—


    
—


    
(996
)Subtotal

    
(996
)

    
—


    
—


    
(996
)Total

    $
37,765


    $
38,761


    $
—


    $
(996
)The Company recognizes transfers into and out of the levels indicated above on the actual date of the event or change in circumstances that caused the transfer of change. All changes within Level 3 can be found in the following Level 3 reconciliation table below:
Balance at September 30, 2011
    $(996)Initial fair value at date of issuance
    (4,832)Increase in fair value of common stock warrant liability
    (1,354)Balance at June 30, 2012
    $(7,182)


-10-




Biodel Inc. 
(A Development Stage Company)
Notes to Consolidated Condensed Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
5. Pre-Launch Inventory
Inventory costs associated with product candidates that have not yet received regulatory approval are capitalized if the Company believes there is probable future commercial use and future economic benefit. If the probability of future commercial use and future economic benefit of a product candidate cannot be reasonably determined, then pre-launch inventory costs associated with such product candidates are expensed as research and development expense during the period the costs are incurred. Because all of its product candidates are in early stages of preclinical or clinical development, the Company currently expenses all purchases of pre-launch inventory as research and development, and expects to continue to do so until it can determine the probability of regulatory approval for the applicable product candidate.
The Company did not make any purchases of pre-launch inventory for the three months and nine months ended June 30, 2012. For the nine months ended June 30, 2011, the Company expensed approximately $2,400 of costs associated with the purchase of recombinant human insulin as research and development expense after the material passed quality control inspection by the Company and transfer of title occurred.
6. Stock-Based Compensation
Under the Companys 2010 Stock Incentive Plan (the "2010 Plan"), up to 1,624,192 shares of the Companys common stock may be issued pursuant to awards granted under the 2010 Plan, plus shares of common stock underlying already outstanding awards under the Companys prior plans. In addition, on March 8, 2012, the Companys stockholders approved an amendment to the 2010 Plan to increase the number of shares of common stock authorized for issuance thereunder solely for the purpose of allowing the Company to issue an aggregate of 274,192 restricted stock units to certain of the Companys employees in place of an aggregate of $823 in discretionary cash bonuses in connection with the fiscal year ended September 30, 2011 (the 2011 Bonus RSUs). The contractual life of options granted under the 2010 Plan may not exceed seven years. The 2010 Plan uses a fungible share concept under which
the 2011 Bonus RSUs and any awards that are not a full-value award will be counted against the share limit as one (1) share for each share of common stock and any award that is a full-value award will be counted against the share limit as 1.6 shares for each one share of common stock. The Company has not made any new awards under any prior equity plans after March 2, 2010  the date the 2010 Plan was approved by stockholders.
The Company recognizes stock-based compensation arising from compensatory stock-based transactions using the fair value at the grant date of the award. The Company uses an option-pricing model (Black-Scholes pricing model) to assist in the calculation of fair value. The expected life for these grants was calculated in accordance with the simplified method described in the Securities and Exchange Commission Staff Accounting Bulletin (SAB) Topic 14.D.2 in accordance with SAB No. 110. Due to its limited history, the Company uses the simplified method that uses the average of (1) the weighted average vesting period and (2) the contractual life of the option  seven or eight years, as applicable  to determine the estimated term of the option. The risk free rate of interest for periods within the contractual life of the stock option is based on the yield of a U.S. Treasury strip on the date the award is granted with a maturity equal
to the expected term of the award. The Company bases its estimates of expected volatility on the median historical volatility of a group of publicly traded companies that it believes are comparable to the Company based on the line of business, stage of development, size and financial leverage. Additionally, the Company has assumed that dividends will not be paid.
The Company estimates forfeitures based on actual forfeitures during its limited history. Based on historical experience of option cancellations, the Company has estimated an annualized forfeiture rate of 9% for employee and director options. Forfeiture rates will be adjusted over the requisite service period when actual forfeitures differ, or are expected to differ, from the estimate.
The Company expenses the cost of the stock options granted to employees and directors ratably over the vesting period of the stock options. For the three months ended June 30, 2011 and 2012 and the nine months ended June 30, 2011 and 2012, total compensation charges, which included stock-based compensation charges related to the Company's 2005 Employee Stock Purchase Plan and to restricted stock unit awards , were $1,274, $332, $3,948 and $1,511, respectively. At June 30, 2012, the total compensation charge related to non-vested options and not yet recognized was $1,465. This charge will be recognized over the remaining vesting periods of the options over the next four years as the employees complete their service period for vesting of the options.
For stock options granted to non-employees, the Company measures fair value of the equity instruments utilizing the Black-Scholes pricing model if that value is more reliably measurable than the fair value of the consideration or service received. The fair value of these instruments is periodically revalued as the options vest, and is recognized as expense over the related period of service or vesting period, whichever is longer. The December 4, 2007 stock options granted to non-employees vested fully on December 4, 2011 and were the last group of non-employee stock option grants subject to the quarterly revaluation. The total compensation charge or credit for options granted to non-employees for the three months ended June 30, 2011 and 2012 and the nine months ended June 30, 2011 and 2012 were $0, $0, $(43), and $0, respectively.

-11-




Biodel Inc. 
(A Development Stage Company)
Notes to Consolidated Condensed Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
The following table summarizes the stock option activity during the nine months ended June 2012:
Number


Weighted 
Average 
Exercise 
Price


Weighted 
Average 
Remaining 
Contractual 
Life in Years

Aggregate 
Intrinsic 
ValueOutstanding options, September 30, 2011




1,365,350


$
32.68






$
Granted




215,877



2.54






$
Forfeited, expired




34,773



32.09






$
Outstanding options, June 30, 2012




1,546,454


$
27.80




5

$
Exercisable options, June 30, 2012




1,176,605


$
33.79




3

$
The Black-Scholes pricing model assumptions for the six and nine months ended June 30, 2011 and 2012 are determined as discussed below:
Three Months Ended 
June 30,



Nine Months Ended 
June 30,2011



2012



2011



2012Expected life (in years)



3.77  5.25



3.77  4.75



3.77  5.25



3.00  4.75Expected volatility



66  70
%


59  72
%


34  72
%


58  76
%Expected dividend yield



0
%


0
%


0
%


0
%Risk-free interest rate



0.75  1.97
%


0.40  0.79
%


0.75  2.24
%


0.39  0.91
%Weighted average grant date fair value


$
8.00


$
2.96


$
6.64


$
2.54Restricted Stock Units
The Company grants restricted stock units (RSUs) to executive officers and employees pursuant to the 2010 Plan from time to time. There is no direct cost to the recipients of RSUs, except for any applicable taxes. Each RSU represents one share of common stock. Awards vest per the terms of the applicable grant. If the Company declares a dividend, RSU recipients will receive payment based upon the percentage of RSUs that have vested prior to the date of declaration.
Based on historical experience of option cancellations, the Company has estimated an annualized forfeiture rate of 9% for employee RSUs. Forfeiture rates will be adjusted over the requisite service period when actual forfeitures differ, or are expected to differ, from the estimate.
In March 2012, the Company granted 274,192 2011 Bonus RSUs in place of an aggregate of $823 in discretionary cash bonuses to the Companys employees in connection with the fiscal year ended September 30, 2011. The Company had previously accrued and expensed the $823 in the fiscal year ended September 30, 2011. The 2011 Bonus RSUs will vest in full and be distributed on September 30, 2012. Since the total fair value of the 2011 Bonus RSUs did not exceed the discretionary aggregate cash bonus value of $823, the Company did not record any additional stock-based compensation expense in the period ended June 30, 2012. The accrued bonus liability was settled in March 2012 and, accordingly, the liability was reversed into additional paid-in-capital.
In December 2010, the Company granted 83,750 RSUs to the Companys executive officers and employees. Each year following the annual vesting date, between January 1st and March 15th, the Company will issue common stock for each such RSU that has vested. During the period when the RSU is vested but not distributed, the RSUs cannot be transferred and the grantee has no voting rights. The costs of the awards, determined as the fair market value of the shares on the grant date, are expensed per the vesting schedule outlined in the award.
As of June 30, 2012, a total of 75,959 RSUs were vested as follows:: (i) 53,524 RSUs held by employees vested on December 14 and 15, 2011 and the resulting common stock was distributed on March 12, 2012; (ii) 15,546 RSUs held by employees vested on December 15, 2010 and the resulting common stock was distributed on February 7, 2011; (iii) 4,428 RSUs held by directors vested on September 30, 2011 and the resulting common stock was distributed on the same date; and (iii) 2,461 RSUs granted to the Company's chief executive in connection with a one-time $50,000 reduction in his base salary vested on September 30, 2011 and the resulting common stock was distributed on the same date.

-12-




Biodel Inc. 
(A Development Stage Company)
Notes to Consolidated Condensed Financial Statements
(in thousands, except share and per share amounts)
(unaudited)
The stock-based compensation expense associated with the RSUs has been recorded in the statement of operations and in additional paid-in-capital on the balance sheets is as follows:
Three Months Ended 
June 30,


Nine Months Ended 
June 30,2011


2012


2011


2012Stock compensation expense  RSUs



$
164


$
90


$
446


$
1,112At June 30, 2012, there was $507 of total unrecognized stock-based compensation expense related to RSU awards granted under the 2004 Stock Incentive Plan and the 2010 Plan. This expense is expected to be recognized over the remaining vesting periods.
The following table summarizes RSU activity from October 1, 2011 through June 30, 2012:
Shares


Weighted 
Average 
Grant-Date 
Fair ValueNon-vested and outstanding balance at October 1, 2011




121,677


$
9.40Changes during the period:Shares granted




274,192


$
2.36Issued and distributed




(53,524
)

$
9.06Non-vested and outstanding balance at June 30, 2012




342,345


$
4.492005 Employee Stock Purchase Plan
The Companys 2005 Employee Stock Purchase Plan (the Purchase Plan) was adopted by its board of directors and approved by its stockholders on March 20, 2007. The Purchase Plan became effective upon the closing of the Companys initial public offering. The Purchase Plan is intended to qualify as an employee stock purchase plan within the meaning of Section 423 of the Internal Revenue Code.
Under the Purchase Plan, eligible employees may contribute up to 15% of their eligible earnings for the period of that offering withheld for the purchase of common stock under the Purchase Plan. The employees purchase price is equal to the lower of: 85% of the fair market value per share on the start date of the offering period in which the employee is enrolled or 85% of the fair market value per share on the semi-annual purchase date. The Purchase Plan imposes a limitation upon a participants right to acquire common stock if immediately after the purchase the employee would own 5% or more of the total combined voting power or value of the Companys common stock or of any of its affiliates. The Purchase Plan provides for an automatic rollover when the purchase price for a new offering period is lower than previously established purchase price(s). The Purchase Plan also provides for a one-time election that allows an
employee the opportunity to enroll into a new offering period when the new offering is higher than their current offering price. This election must be made within 30 days from the start of a new offering period. Offering periods are twenty-seven months in length. The compensation cost in connection with the Purchase Plan for the three months ended June 30, 2011 and 2012 and nine months ended June 30, 2011 and 2012 were $22, $(1), $42, and $7, respectively.
As of September 30, 2011 and June 30, 2012, an aggregate of 425,000 and 450,000 shares of common stock, respectively, are reserved for issuance pursuant to purchase rights to be granted to the Companys eligible employees under the Purchase Plan. The Purchase Plan shares are replenished annually on the first day of each calendar year by virtue of an evergreen provision. The provision allows for share replenishment equal to the lesser of 1% of the total number of shares of common stock outstanding on that date or 25,000 shares. As of September 30, 2011 and June 30, 2012, a total of 341,095 and 355,319 shares, respectively were reserved and available for issuance under the Purchase Plan. As of September 30, 2011 and June 30, 2012, the Company has issued 83,903 and 94,679 shares, respectively, under the Purchase Plan.
7. Reverse Stock Split
On June 11, 2012, the Company amended its certificate of incorporation in order to effect a one-for-four reverse split of its outstanding common stock and to fix on a post-split basis the number of authorized shares of its common stock at 25,000,000 (reduced from 100,000,000 authorized shares). As a result of the reverse stock split, each share of Company common stock outstanding at the effective time was automatically changed into one-quarter of a share of common stock. No fractional shares were issued in connection with the reverse stock split, and cash of $0.3 was paid in lieu of fractional shares. Also as a result of the reverse stock split, the number of shares of common stock subject to outstanding options, restricted stock units and warrants issued by the Company and the number of shares reserved for future issuance under the Companys stock plans have been reduced by a factor of four. There was no alteration to the par value
of the common stock or any modification of the voting rights or other terms thereof. All references in these financial statements and accompanying notes to units of common stock or per share amounts are reflective of the reverse stock split for all periods reported.

-13-




Biodel Inc. 
(A Development Stage Company) 
Notes to Consolidated Condensed Financial Statements 
(in thousands, except share and per share amounts) 
(unaudited)
8. Income Taxes
The Company accounts for income taxes under FASB ASC 740-10-25 (ASC 740-10-25), Accounting for Income Taxes. Under ASC 740-10-25, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Under ASC 740-10-25, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company files U.S. federal and state tax returns and has determined that its major tax jurisdictions are the United States and Connecticut. The tax years ended in 2004 through 2010 remain open and subject to
examination by the appropriate governmental agencies in the United States and Connecticut.
Section 382 of the Internal Revenue Code imposes limitations on the use of U.S. federal net operating losses (NOLs) upon a 50% or more change in ownership in the Company within a three-year period. As a result of the May 2011 Offering (as defined in Note 10), a significant change in the ownership of the Company occurred, which limits on an annual basis the Companys ability to utilize its federal NOLs. The Companys NOLs will continue to be available to offset taxable income (until such NOLs are either used or expire) subject to the Section 382 annual limitation. If the Section 382 annual limitation amount is not fully utilized in a particular tax year, then the unused portion from that particular tax year will be added to the Section 382 annual limitation in subsequent years. The Company completed a formal Section 382 analysis and believes that approximately $55,890 of the $104,689 federal
losses (prior to the Section 382 limitation) will expire unused due to Section 382 limitations. The maximum annual limitation under Section 382 is approximately $2,496 for twenty (20) years. The limitation could be further restricted if ownership changes occur in future years. To the extent the Companys use of NOL carryforwards is limited, future income could be subject to corporate income tax earlier than it would if the Company was able to use NOL carryforwards, which could result in decreased net income. In addition to the NOL limitation, the 382 limitation also limited approximately $1,815 of federal research and development credit carryovers.
The Company will analyze the effect, if any, of the 2012 Private Placement (as defined in Note 10) on the use of U.S. Federal net operating losses, following §Section 382 of the Internal Revenue Code.
The Companys effective tax rate for the three and nine months ended June 30, 2011 and 2012 was 0% and differs from the federal statutory rate of 34% primarily due to the effects of state income taxes and valuation allowance.
9. Net Loss per Share
Basic and diluted net loss per share has been calculated by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. All potentially dilutive common shares have been excluded from the calculation of weighted average common shares outstanding, as their inclusion would be anti-dilutive.
The amount of options, warrants, preferred stock and RSUs excluded are as follows:
Three Months Ended 
June 30,

Nine Months Ended 
June 30,2011

2012

2011

2012Common shares underlying warrants issued for common stock




2,886,197



3,213,284



2,886,197



3,213,284Common shares issuable upon conversion of Series A Preferred Stock








453,486







453,486Common shares issuable upon conversion of Series B Preferred Stock








3,605,607







3,605,607Stock options




1,393,243



1,547,480



1,393,243



1,547,480Restricted stock units




136,433



68,167



136,433



68,16710. Financings
June 2012 Private Placement
In June 2012, the Company completed a private placement (the 2012 Private Placement) of an aggregate of 4,250,020 shares of the Companys common stock, 3,605,607 shares of the Companys Series B Convertible Preferred Stock and warrants to purchase an aggregate of 2,749,469 shares of common stock at an exercise price of $2.66 per share. For each unit consisting of either a share of common stock or Series B Preferred Stock and a warrant to purchase 0.35 of a share of common stock, the purchasers in the June 2012 Private Placement paid a negotiated price of $2.355. The warrants are immediately exercisable and will expire on June 26, 2017, five years from the original issuance date of June 27, 2012. The Company received net proceeds, after deducting placement agents fees and other transaction expenses, of approximately $17,200 from the 2012 Private Placement.

-14-




Biodel Inc. 
(A Development Stage Company) 
Notes to Consolidated Condensed Financial Statements 
(in thousands, except share and per share amounts) 
(unaudited)
Each share of Series B Preferred Stock is convertible into one share of the Companys common stock at any time at the option of the holder, except that the securities purchase agreement that the Company entered into in connection with the 2012 Private Placement (the Securities Purchase Agreement) provides that a holder will be prohibited from converting shares of Series B Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of common stock then issued and outstanding. In the event of the Companys liquidation, dissolution or winding up, holders of the Series B Preferred Stock will receive a payment equal to $0.01 per share of Series B Preferred Stock before any proceeds are distributed to the holders of common stock. After the payment of this preferential amount, and subject to
the rights of holders of any class or series of capital stock specifically ranking by its terms senior to the Series B Preferred Stock, holders of Series B Preferred Stock and holders of the Companys Series A Preferred Stock will participate ratably in the distribution of any remaining assets with the common stock and any other class or series of capital stock that participates with the common stock in such distributions. Shares of Series B Preferred Stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series B Preferred Stock will be required to amend the terms of the Series B Preferred Stock. Holders of Series B Preferred Stock are entitled to receive, and the Company is required to pay, dividends on shares of the Series B Preferred Stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the
common stock when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock.
As required by the Securities Purchase Agreement, the Company filed a Registration Statement on Form S-3 (the Registration Statement)
with the Securities and Exchange Commission (the SEC) on July 27, 2012, which was within 30 days after the closing of the 2012 Private Placement. The Registration Statement, which was declared effective on
August 13, 2012, registers the resale of the shares of common stock and Series B Preferred Stock issued and sold in the 2012 Private Placement, the shares of common stock issuable upon conversion of the Series B Preferred
Stock issued and sold in the 2012 Private Placement, and the shares of common stock issuable upon exercise of the warrants issued and sold in the 2012 Private Placement. Pursuant to the terms of the Securities Purchase
Agreement, the Company agreed to pay liquidated damages to the purchasers in the 2012 Private Placement if, after effectiveness of the Registration Statement and subject to certain specified exceptions, the Company suspends
the use of the Registration Statement or the Registration Statement ceases to remain continuously effective as to all the securities for which it is required to be effective (each such event, a Registration Default).
Subject to specified exceptions, for each 30-day period or portion thereof during which a Registration Default remains uncured, the Company is obligated to pay liquidated damages to each purchaser in cash in an
amount equal to 1.0% of the aggregate purchase price paid by each such purchaser in the 2012 Private Placement, up to a maximum of 8.0% of such aggregate purchase price. As of the date of these financial statements, the Company
does not believe that it is probable that it will be obligated to pay any such liquidated damages. Accordingly, the Company has not established an accrual for liquidated damages.
In the event that the Company enters into a merger or change of control transaction, the holders of the warrants issued in the 2012 Private Placement will be entitled to receive consideration as if they had exercised the warrants immediately prior to such transaction, or they may require the Company to purchase the unexercised warrants at the Black-Scholes value (as defined in the warrant) of the warrant on the date of such transaction. The holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, the Company recognizes the warrants as liabilities at their fair value on each reporting date.
At June 30, 2012, the fair value of the warrant liability determined utilizing the Black-Scholes valuation model was approximately $4,759.
During the three months and nine months ended June 30, 2012, the Company recorded an Adjustment to fair value of common stock warrant liability of $(73), within Other (income) expense, to reflect a decrease in the valuation of the warrants from date of issuance to June 30, 2012.
The following summarizes the changes in value of the warrant liability from the date of issuance through June 30, 2011:
Balance at September 30, 2011

$
Initial fair value, at the date of issuance


4,832Decrease in fair value


(73
)Balance at June 30, 2012

$
4,759
-15-




Biodel Inc. 
(A Development Stage Company) 
Notes to Consolidated Condensed Financial Statements 
(in thousands, except share and per share amounts) 
(unaudited)
May 2011 Registered Direct Offering
In May 2011, the Company completed a registered direct offering (the May 2011 Offering) of an aggregate of 3,018,736 shares of the Companys common stock, 1,813,944 shares of the Companys Series A Preferred Stock and warrants to purchase 2,256,929 shares of the Companys common stock. The shares and warrants were sold in units consisting of (i) one share of common stock and (ii) one warrant to purchase 0.65 of a share of common stock, at an exercise price of $9.92 per share of the Companys common stock. However, one investor also purchased units consisting of one share of Series A Preferred Stock and a warrant to purchase 0.65 of a share of common stock. No fractional warrants were issued. Each unit was sold at a price of $8.64 per unit. These units were not issued or certificated. The shares and warrants were immediately separated. The warrants will expire on May 17, 2016, five years from
the original issuance date of May 18, 2011. The Company received net proceeds, after deducting placement agents fees and other offering expenses, of approximately $28,000 from the May 2011 Offering.
Each share of Series A Preferred Stock is convertible into 0.25 share of the Companys common stock at any time at the option of the holder, provided that the holder will be prohibited from converting the shares of Series A Preferred Stock into shares of the Companys common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of the Companys common stock then issued and outstanding. In the event of the Companys liquidation, dissolution or winding up, holders of the Series A Preferred Stock will receive a payment equal to $0.01 per share of Series A Preferred Stock before any proceeds are distributed to the holders of the Companys common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock specifically ranking by its terms senior to
the Series A Preferred Stock, holders of Series A Preferred Stock will participate ratably in the distribution of any remaining assets with the Companys common stock and any other class or series of capital stock that participates with the common stock in such distributions. Shares of Series A Preferred Stock will generally have no voting rights, except as required by law and except that the consent of the holders of a majority of the outstanding Series A Preferred Stock will be required to amend the terms of the Series A Preferred Stock. The Series A Preferred Stock will not be entitled to receive any dividends, unless and until specifically declared by the Companys board of directors.
In the event that the Company enters into a merger or change of control transaction, the holders of the warrants issued in the May 2011 Offering will be entitled to receive consideration as if they had exercised the warrants immediately prior to such transaction, or they may require the Company to purchase the unexercised warrants at the Black-Scholes value (as defined in the warrant) of the warrant on the date of such transaction. The holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, the Company recognizes the warrants as liabilities at their fair value on each reporting date.
At June 30, 2012, the fair value of the warrant liability determined utilizing the Black-Scholes valuation model was approximately $2,423.
During the three and nine months ended June 30, 2012, the Company recorded an Adjustment to fair value of common stock warrant liability of $(1,428) and $(1,427), respectively, within Other (income) expense, to reflect an increase in the valuation of the warrants from September 30, 2011 to June 30, 2012.
The following summarizes the changes in value of the warrant liability from September 30, 2011 through June 30, 2012:
Balance at September 30, 2011



$
996Increase in fair value of common stock warrant liability




1,427Balance at June 30, 2012



$
2,423August 2010 Registered Direct Offering
In August 2010, the Company completed a registered direct offering of an aggregate of 599,550 shares of common stock and warrants to purchase 599,500 shares of common stock. The warrants had an initial exercise price of $18.864 per share, subject to re-pricing following the Company’s receipt of the complete response letter for its LinjetaTM product candidate. On December 1, 2010, the exercise price of the warrants was reset to $6.24 per share. On May 12, 2011, the exercise price of the warrants was further reset to $4.70 per share. The Company received net proceeds, after deducting placement agents fees and other offering expenses, of approximately $8,700 from this offering.
In August 2011, one of the warrant holders exercised warrants to purchase 10,550 shares of common stock, at $4.70 per share, and the Company received proceeds totaling approximately $50. On December 1, 2011, the unexercised warrants to purchase 589,000 shares of common stock expired. The Company revalued the liability associated with these warrants from September 30, 2011 through the date of expiration and there was no material impact on the statement of operations. The common stock warrant liability associated with these warrants no longer exists.
Fair Value Assumptions Used in Accounting for Warrant Liability
The Company has determined its warrant liability to be a Level 3 fair value measurement and used the Black-Scholes valuation model to calculate, as of June 30, 2012, the fair value of the warrants issued in the 2012 Private Placement and the May 2011 Offering.

-16-




Biodel Inc. 
(A Development Stage Company) 
Notes to Consolidated Condensed Financial Statements 
(in thousands, except share and per share amounts) 
(unaudited)
As of June 30, 2012, the Company estimated such fair value using the following assumptions:
2012 Private Placement

June 30,2012Stock price

$
2.58Exercise price

$
2.66Risk-free interest rate


0.72%Expected remaining term


4.99Expected volatility


96%Dividend yield


0%Warrants outstanding


2,749,469Common stock outstanding


13,982,826
May 2011 Offering

June 30,2012Stock price

$
2.58Exercise price

$
9.92Risk-free interest rate


0.41%Expected remaining term


3.88Expected volatility


104%Dividend yield


0%Warrants outstanding


2,256,929Common stock outstanding


13,982,826
Risk-Free Interest Rate.This is the United States Treasury rate for the measurement date having a term equal to the expected remaining term of the warrant. An increase in the risk-free interest rate will increase the fair value and the associated derivative liability.
Term of Warrants.This is the period of time over which the warrant is expected to remain outstanding and is based on managements estimate, taking into consideration the remaining contractual life, and historical experience. An increase in the expected remaining term will increase the fair value and the associated derivative liability.
Expected Volatility.This is a measure of the amount by which the stock price has fluctuated or is expected to fluctuate. The Company uses a weighted-average of its historic volatility over the retrospective period corresponding to the expected remaining term of the warrants on the measurement date. An increase in the expected volatility will increase the fair value and the associated derivative liability.
Dividend Yield.The Company has not made any dividend payments nor does it have plans to pay dividends in the foreseeable future. An increase in the dividend yield will decrease the fair value and the associated derivative liability.
Participating Securities
If at any time the Company grants, issues or sells securities or other property to holders of any class of common stock, the holders of the warrants are entitled to also acquire those same securities as if they held the number of shares of common stock acquirable upon complete exercise of the warrants.
As such, given that the warrant holders will participate fully on any dividends or dividend equivalents, the Company determined that the warrants are participating securities and therefore are subject to ASC 260-10-55 earnings per share. These securities were excluded from the three and nine months ended June 30, 2011 and June 30, 2012 loss per share calculation since their inclusion would be anti-dilutive.

-17-




Biodel Inc. and Subsidiary 
(A Development Stage Company) 
Notes to Consolidated Condensed Financial Statements 
(in thousands, except share and per share amounts) 
(unaudited)
11. Commitments
Former Chief Scientific Officer General Release
Effective December 14, 2010, Dr. Solomon Steiner, the Companys former Chief Scientific Officer, retired from all his management positions with the Company. On the same date, the Company and Dr. Steiner executed a general release agreement. Dr. Steiner is therefore entitled to receive the severance benefits set forth in his employment agreement (the employment agreement) with the Company that were conditioned upon his signing the release. Pursuant to the employment agreement, Dr. Steiner will receive payments in the amount of two times his base salary in effect on the date of his retirement, two times his target annual bonus, plus a pro rata portion of his 2011 target bonus, as defined in the employment agreement, for the fiscal year in which he is terminated. Furthermore, the employment agreement provides that any outstanding equity compensation awards will fully and immediately vest with respect to any amounts that
would have vested if he had remained employed for an additional 24 months, which totals options to purchase 58,636 shares of common stock at exercise prices between $9.16 and $72.64. The options remain exercisable until the earlier of the second anniversary of Dr. Steiner ceasing to be a board member or their date of expiration. The Company recorded a charge of $1,360 for salary, bonus and benefits continuation for twenty-four months and an option acceleration modification charge of $7 in the fiscal quarter ended December 31, 2010. As of June 30, 2012, the Company has paid $1,029 in salary, bonus and benefits continuation per the terms of the agreement; reduced medical accrual by $25; and classified $306 in short term obligation.
Leases
As of June 30, 2012, the Company leased three facilities in Danbury, Connecticut.
The Company entered into its first lease for laboratory space in February 2004, which was subsequently renewed in January 2010 for an additional three years. The lease will expire in January 2013. This lease provides for annual basic lease payments of $66, plus operating expenses.
In July 2007 the Company entered into a second lease for its corporate office, which was subsequently amended in October 2007. The October 2007 amendment increased the term from five years to seven years beginning on August 1, 2007 and ending on July 31, 2014. The renewal option was also amended from a five year to a seven year term. This lease provides for annual basic lease payments of $357, plus operating expenses.
In December 2008, the Company entered into a third lease for additional office space adjacent to its laboratory space, which was subsequently renewed in January 2010 for an additional three years. The Company has agreed to use the leased premises only for offices, laboratories, research, development and light manufacturing. This lease provides for annual basic lease payments of $29, plus operating expenses.
Lease expense for the three months ended June 30, 2011 and 2012 and nine months ended June 30, 2011 and 2012 were $160, $164, $476, and $489, respectively.
Legal
In February 2012, the Company brought action against one of its vendors before the American Arbitration Association in New York relating to disputed fees charged to the Company for inventory storage. As part of an arbitration stipulation, the Company established a $1,500 escrow account and paid $500 during the quarter ended June 30, 2012, leaving an escrow balance of $1,000. The disputed fees were recorded in the prior year in accrued liabilities. On July 30, 2012, the Company received a judgment from the arbitrator stating that the Company is required to only pay the vendor a balance of $55, after deducting legal fees. The Company expects the remaining escrow balance of $945 to be returned to it by the end of the fiscal year.

12. Subsequent event

NIH Grant to Develop Concentrated Ultra-Rapid-Acting Insulin

In July 2012, the Company announced that the Small Business Innovation Research program of the National Institutes of Health has awarded the
Company a grant for the development of concentrated ultra-rapid-acting insulin formulations for use in an artificial pancreas, also known as a closed loop pump system.  The two-year grant, totaling $582, is intended
to fund research to develop the Company's proprietary ultra-rapid-acting insulin product candidate at high concentrations.  The Company anticipates receiving these funds in fiscal years 2013 and 2014.



-18-




FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this Quarterly Report on Form 10-Q regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words anticipates, believes, could, estimates, expects, intends, may, plans, potential, predicts, projects, should, will, would and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Our forward-looking statements in this Quarterly Report on Form 10-Q are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including:
·
the progress, timing or success of our research and development and clinical programs for our product candidates, including data analyses of any clinical trials of an ultra-rapid-acting insulin formulation or a liquid formulation of glucagon;
·
our ability to advance a proprietary RHI-based insulin formulation into a Phase 2 clinical trial in a timely manner and the outcome of that trial;
·
our ability to secure approval by the U.S. Food and Drug Administration, or FDA, for our product candidates under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, or FFDCA;
·
our ability to conduct pivotal clinical trials and other tests or analyses required by the FDA to secure approval to commercialize an ultra-rapid-acting insulin formulation or a liquid formulation of glucagon;
·
our ability to develop and commercialize a proprietary formulation of injectable insulin that may be associated with less injection site discomfort than LinjetaTM (formerly referred to as VIAject®), which is the subject of a complete response letter we received from the FDA;
·
our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves;
·
our ability to enforce our patents for our product candidates and our ability to secure additional patents for our product candidates;
·
our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
·
the degree of clinical utility of our products;
·
the ability of our major suppliers to produce our products in our final dosage form;
·
our commercialization, marketing and manufacturing capabilities and strategies; and
·
our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report, particularly in Part II-Item 1A of this Quarterly Report, and in our other public filings with the Securities and Exchange Commission that could cause actual results or events to differ materially from the forward-looking statements that we make.
You should read this Quarterly Report and the documents that we have filed as exhibits to the Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. It is routine for internal projections and expectations to change as the year, or each quarter in the year, progresses, and therefore it should be clearly understood that the internal projections and beliefs upon which we base our expectations are made as of the date of this Quarterly Report on Form 10-Q and may change prior to the end of each quarter or the year. While we may elect to update forward-looking statements at some point in the future, we do not undertake any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise.


-19-




Item 2.
Managements Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q . Some of the information contained in this discussion and analysis or set forth elsewhere in this Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. You should read the Risk Factors section of this Form 10-Q (see Part II-Item 1A below) for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
We are a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. Our most advanced program involves developing proprietary formulations of injectable recombinant human insulin, or RHI, designed to be more rapid-acting than the rapid-acting mealtime insulin analogs currently used to treat patients with Type 1 and Type 2 diabetes. We, therefore, refer to these formulations as our ultra-rapid-acting insulin formulations. In addition to our RHI-based formulations, we are using our formulation technologies to develop new ultra-rapid-acting formulations of insulin analogs. These insulin analog-based formulations generally use the same or
similar excipients as our RHI-based formulations and are designed to be more rapid-acting than the rapid-acting mealtime insulin analogs, but they may present characteristics that are different from those offered by our RHI-based formulations. We are also developing a liquid formulation of glucagon for use as a rescue treatment for diabetes patients experiencing hypoglycemia, and we have prototype formulations of a basal insulin and a glucose-responsive insulin.
An earlier RHI-based formulation known as LinjetaTM (and previously referred to as VIAject®) was the subject of a New Drug Application, or NDA, that we submitted to the FDA in December 2009. In October 2010, the FDA issued a complete response letter stating that the NDA for LinjetaTM could not be approved in its submitted form and that we should conduct two pivotal Phase 3 clinical trials with our preferred commercial formulation of LinjetaTM prior to re-submitting the NDA. The complete response letter included comments related to clinical trials, statistical analysis and chemistry, manufacturing and controls and tolerability issues relating to localized discomfort upon injection.
Based upon the complete response letter and subsequent feedback from the FDA provided to us at a meeting in January 2011, we decided to study newer RHI-based formulations in earlier stage clinical trials. Clinical trials of two newer formulations, BIOD-105 and BIOD-107, did not demonstrate our target product profile. We subsequently conducted a Phase 1 clinical trial of two additional formulations, BIOD-123 and BIOD-125. In April 2012, we announced top-line results from this Phase 1 clinical trial of BIOD-123 and BIOD-125. In this clinical trial, BIOD-123 and BIOD-125 achieved our target pharmacokinetic, pharmacodynamic and toleration profiles. We now intend to study BIOD-123 in a Phase 2 clinical trial that we expect to begin in the third calendar quarter of 2012. The Phase 2 clinical trial will be conducted at investigative centers in the United States and is expected to enroll approximately 130 randomized patients with Type 1 diabetes.
The Phase 1 clinical trial of BIOD-123 and BIOD-125 evaluated the pharmacokinetic, pharmacodynamic and injection site toleration profiles of these product candidates relative to Humalog®, a rapid-acting insulin analog. The objective of the clinical trial was to identify an RHI-based formulation with pharmacokinetic and pharmacodynamic profiles similar to the LinjetaTM formulation, but with improved injection site toleration characteristics. The clinical trial was a single-center, randomized, double-blind, three-period crossover trial in 12 patients with Type 1 diabetes. Each study drug was administered subcutaneously on separate days with a washout period between injections.
In the Phase 1 clinical trial, absorption rates of BIOD-123 and BIOD-125 were significantly faster than that of Humalog® as indicated by 64% and 54% reductions, respectively, in mean times to half maximal insulin concentrations (p < 0.001 for both BIOD-123 and BIOD-125 compared to Humalog®). Both RHI-based formulations and Humalog®were well tolerated, with injection site tolerability generally perceived by patients to be similar to that of their usual mealtime injections used at home. As measured on a 100 mm visual analog scale, or VAS, in which 100 mm is defined as the worst possible injection discomfort, local toleration was not significantly different for BIOD-123 compared to Humalog® (BIOD-123 mean VAS 3.6 +/- 2.1 mm, Humalog® 1.8 +/- 1.1 mm, p=NS). The VAS score for BIOD-125 was slightly higher as compared to Humalog® (mean VAS 6.8 +/- 2.9 mm, p < 0.05).
In March 2012, we announced that we had received feedback from the FDA regarding regulatory requirements for the development of a liquid formulation of glucagon for use as a rescue treatment for diabetes patients experiencing hypoglycemia. Subject to successful completion of our formulation development work and subsequent clinical trials, we intend to submit an NDA for this product candidate in the first calendar quarter of 2014.
In June 2012, we completed the private placement of an aggregate of 4,250,020 shares of our common stock, 3,605,607 shares of our series B convertible preferred stock and warrants to purchase an aggregate of 2,749,469 shares of common stock at an exercise price of $2.66 per share. We refer to this transaction as our 2012 private placement. We received net proceeds, after deducting placement agents fees and other transaction expenses, of approximately $17.2 million from the 2012 private placement. We intend to use these net proceeds to further develop our ultra-rapid-acting insulin product candidates and our liquid formulation of glucagon, as well as for other general corporate purposes. Each share of series B preferred stock is convertible into one share of our common stock at any time at the option of the holder, except that the securities purchase agreement that we entered into in connection with the 2012 private placement
provides that a holder will be prohibited from converting shares of series B preferred stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of our common stock then issued and outstanding. The warrants are immediately exercisable and will expire on June 26, 2017. Warrant holders will be prohibited from exercising

-20-




a warrant if, as a result of such exercise the holder, together with its affiliates, would beneficially own more than 9.98% of the total number of shares of our common stock then issued and outstanding. Pursuant to the securities purchase agreement, we have filed with the Securities and Exchange Commission a registration statement covering the resale of the securities issued in the 2012 private placement. We may be required to pay liquidated damages to the purchasers in the 2012 private placement if, subject to exceptions, we suspend the use of the registration statement or if the registration statement ceases to remain effective for specified periods.
We are a development stage company. We were incorporated in December 2003 and commenced active operations in January 2004. To date, we have generated no revenues and have incurred significant losses. We expect to continue to incur operating losses as we continue our efforts to develop and commercialize our product candidates. We have financed our operations and internal growth through various financing transactions, including our initial public offering in May 2007 and several subsequent transactions, including, most recently, our June 2012 private placement. We have devoted substantially all of our efforts to research and development activities, including clinical trials. Our net loss was $6.1 million and $14.9 million respectively for the three and nine months ended June 30, 2012. As of June 30, 2012, we had a deficit accumulated during the development stage of $190.2 million. Research
and development and general and administrative expenses, as a percentage of net loss applicable to common stockholders, represent approximately 69% and 31%, respectively, of the expenses that we have incurred since our inception.
As of June 30, 2012, we had approximately $43.7 million in cash and cash equivalents compared to $38.7 million in cash and cash equivalents as of September 30, 2011. We believe that our existing cash, cash equivalents and restricted cash will be sufficient to fund our anticipated operating expenses and capital expenditures at least until we file our NDA for a liquid formulation of glucagon, which we expect to occur in the first quarter of the 2014 calendar year. We believe that future cash expenditures will be partially offset by raising additional capital from research grants, capital markets, proceeds derived from collaborations, including, but not limited to, upfront fees, research and development funding, milestone payments and royalties. We can give no assurances that such funding will, in fact, be realized in the time frames we expect, or at all. We may be required to secure alternative financing arrangements and/or defer or limit some or all of our
research, development and/or clinical projects.
Financial Operations Overview
Revenues
To date, we have generated no revenues. We do not expect to begin generating any revenues unless any of our product candidates receive marketing approval, or if we receive payments in connection with strategic collaborations that we may enter into for the commercialization of our product candidates.
Research and Development Expenses
Research and development expenses consist of the costs associated with our basic research activities, as well as the costs associated with our drug development efforts, conducting preclinical studies and clinical trials, manufacturing development efforts and activities related to regulatory filings. Our research and development expenses consist of:
·
external research and development expenses incurred under agreements with third-party contract research organizations and investigative sites, third-party manufacturing organizations and consultants;
·
employee-related expenses, which include salaries and benefits for the personnel involved in our preclinical and clinical drug development and manufacturing activities; and
·
facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment and laboratory and other supplies.
We intend to focus our research and development efforts on conducting preclinical studies and Phase 1 and Phase 2 clinical trials to study new formulations of RHI or insulin analogs in order to determine our preferred development, clinical and regulatory program for our ultra-rapid-acting formulations. We also are conducting the formulation development work required to meet our goal of submitting an NDA for a liquid formulation of glucagon in the first calendar quarter of 2014. We anticipate that our research and development expenses for the fiscal year ending September 30, 2012 will increase moderately as compared to the 2011 fiscal year. Over the longer term, we anticipate that these expenses will increase further as we:
·
conduct preclinical studies and clinical trials to determine whether and how to advance the clinical development of and seek regulatory approval for an ultra-rapid-acting insulin product candidate and a liquid formulation of glucagon;
·
make limited investments in order to advance proof-of-concept formulations; and
·
purchase active pharmaceutical ingredients and other materials to support our research and development activities.
We have used our employee and infrastructure resources across multiple research projects and our drug development program for our ultra-rapid-acting RHI- and insulin analog-based formulations, including the original LinjetaTMformulations and BIOD-105, BIOD-107, BIOD-123 and BIOD-125. To date, we have not tracked expenses related to our product development activities on a project or program basis. Accordingly, we cannot reasonably estimate the amount of research and development expenses that we incurred with respect to each of our clinical and preclinical product candidates. However, substantially all of our research and development expenses incurred to date are attributable to our ultra-rapid-acting insulin program.

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The following table illustrates, for each period presented, our research and development costs by nature of the cost.





















December 3,2003Three Months Ended

    Nine Months Ended

    (inception) toJune 30,

    June 30,

    June 30,2011

    2012

    2011

    2012

    2012(in thousands)Research and development expenses:Preclinical expenses

$
782

$
996

$
2,715

$
2,879

$
21,543Manufacturing expenses


663


824


4,697


2,048


38,335Clinical/regulatory expenses


1,496


1,136


3,937


3,025


78,203Total

$
2,941

$
2,956

$
11,349

$
7,952

$
138,081The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, specific timing or estimated costs of the efforts that will be necessary to complete the remainder of the development of, or the period, if any, in which material net cash inflows may commence from our product candidates. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:
·
our ability to advance a proprietary RHI-based insulin formulation into a Phase 2 clinical trial in a timely manner and the outcome of that trial;
·
the success of our formulation development work to improve the stability or other characteristics of our analog-based ultra-rapid-acting insulin formulations and liquid formulations of glucagon;
·
the results of our real-time stability programs for our insulin and glucagon product candidates;
·
our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the FFDCA;
·
our ability to conduct pivotal clinical trials and other tests or analyses required by the FDA to secure approval to commercialize an ultra-rapid-acting insulin formulation or a liquid formulation of glucagon;
·
our ability to develop and commercialize a proprietary formulation of injectable insulin that may be associated with less injection site discomfort than the formulation that is the subject of the complete response letter we received from the FDA;
·
the cost to develop devices for use with our product candidates, such as insulin pen injectors and glucagon auto-injectors, and the clinical development program required to support use of an ultra-rapid-acting insulin formulation in insulin pumps;
·
the costs of pre-commercialization activities, if any;
·
the costs associated with qualifying and obtaining regulatory approval of suppliers of insulin and manufacturers of our product candidates;
·
the costs of preparing, filing and prosecuting patent applications;
·
the emergence of competing technologies and products and other adverse market developments; and
·
our ability to establish and maintain collaborations and the terms and success of the collaborations, including the timing and amount of payments that we might receive from potential strategic collaborators.
A change in the outcome of any of these variables with respect to the development of an ultra-rapid-acting insulin formulation or any of our other product candidates, including our liquid formulation of glucagon, could mean a significant change in the costs and timing associated with product development.
Restricted Cash
Restricted cash as of September 30, 2011 and June 30, 2012 was $60 thousand and $1.06 million, respectively. We keep $60 thousand in a money market account held with a bank to secure a credit card purchasing agreement utilized to facilitate employee travel and certain ordinary purchases. In February 2012, we brought action against one of our vendors, before the American Arbitration Association in New York, relating to disputed fees charged to us for inventory storage. As part of an arbitration stipulation, we established a $1.5 million escrow account and paid $0.5 million during the quarter ended June 30, 2012, leaving an escrow balance of $1.0 million. On July 30, 2012, we received a judgment from the arbitrator stating that we are required to only pay the vendor a balance of $55 thousand, after deducting legal fees. We expect the remaining escrow balance of $945 thousand to be returned to us by the end of the September 30, 2012 fiscal year.

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General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related expenses for personnel, including stock-based compensation expenses, in our executive, legal, accounting, finance and information technology functions. Other general and administrative expenses include facility-related costs not otherwise allocated to research and development expense, travel expenses, costs associated with industry conventions and professional fees, such as legal and accounting fees and consulting costs.
We anticipate that our general and administrative expenses for the fiscal year ending September 30, 2012 will remain substantially the same as in the 2011 fiscal year as we continue to focus our product development efforts on preclinical studies and Phase 1 and Phase 2 clinical trials. Over the longer term, however, these expenses could increase if we are successful in advancing our product candidates into later stage clinical trials including Phase 3 pivotal trials.
Pre-Launch Inventory
Inventory costs associated with product candidates that have not yet received regulatory approval are capitalized if we believe there is probable future commercial use and future economic benefit. If the probability of future commercial use and future economic benefit of a product candidate cannot be reasonably determined, then pre-launch inventory costs associated with such product candidates are expensed as research and development expense during the period the costs are incurred. Because all of our product candidates are in early stages of preclinical or clinical development, we currently expense all purchases of pre-launch inventory as research and development, and expect to continue to do so until we can determine the probability of regulatory approval for the applicable product candidate.
We did not make any purchases of pre-launch inventory for the three months and nine months ended June 30, 2012. For the nine months ended June 30, 2011, we expensed approximately $2,400 of costs associated with the purchase of recombinant human insulin as research and development expense after the material passed quality control inspection by us and transfer of title occurred.
Restricted Stock Units
In March 2012, we granted an aggregate of 274,192 restricted stock units, or RSUs, to our employees in place of discretionary cash bonuses in connection with the fiscal year ended September 30, 2011. Each RSU represents one share of common stock. The RSUs will vest and the underlying shares will be distributed on September 30, 2012. If we declare a dividend, RSU recipients will receive payment based upon the percentage of RSUs that have vested prior to the date of declaration. The costs of the awards, determined by the value of the discretionary cash bonus, are expensed per the vesting schedule outlined in the award. As of the award date, the discretionary cash bonus value exceeded the total fair market value of the RSUs.
In the quarter ended December 31, 2010, we granted RSUs to executive officers and employees pursuant to our 2010 Stock Incentive Plan. There is no direct cost to the recipients of the RSUs, except for any applicable personal taxes. Each RSU represents one share of common stock and each award vests per the terms of the grant. Each year following the annual vesting date, between January 1st and March 15th, we will issue common stock for each vested RSU. During the vesting period, the RSUs cannot be transferred and the grantee has no voting rights. If we declare a dividend, RSU recipients will receive payment based upon the percentage of RSUs that have vested prior to the date of declaration. The costs of the awards, determined as the fair value of the shares on the grant date, are expensed per the vesting schedule outlined in the award.
Warrant Liability
In May 2011, we issued warrants to purchase 2,256,929 shares of our common stock at an exercise price of $9.92 per share in connection with our May 2011 registered direct offering. These warrants will expire on May 17, 2016, five years from the original issuance date of May 18, 2011. In June 2012, we issued warrants to purchase 2,749,469 shares of our common stock at an exercise price of $2.66 per share in connection with our June 2012 Private Placement. These warrants will expire on June 26, 2017, five years from the original issuance date of June 27, 2012. Under the terms of both the 2011 warrants and the 2012 warrants, if we enter into a merger or change of control transaction, the holders of the warrants will be entitled to receive consideration as if they had exercised the warrants immediately prior to such transaction, or they may require us to purchase the unexercised warrants at the Black-Scholes value (as defined in the
applicable warrant) of the warrant on the date of such transaction. The holders have up to 30 days following any such transaction to exercise this right. As a result of this provision, we recognize the 2011 and 2012 warrants as liabilities at their fair value on each reporting date.
We use the Black-Scholes valuation model to estimate the fair value of the warrants. The Black-Scholes valuation model takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the underlying stock and its expected volatility, expected dividends on the stock, and the risk-free interest rate for the term of the warrant. Using this model, we recorded an initial warrant liability of $9.4 million for the 2011 warrants and $4.8 million for the 2012 warrants, in each case as of the initial warrant issuance date. The significant assumptions for the model for the 2011 warrants were warrants and common stock outstanding, remaining terms of the warrants, the common stock price of $8.24 per share, the warrant exercise price of $9.92 per share, a risk-free interest rate of 1.89% and an expected volatility rate of 104%. The significant assumptions for the model
for the 2012 warrants were warrants and common stock outstanding, remaining terms of the warrants, the common stock price of $2.61 per share, the warrant exercise price of $2.66 per share, a risk-free interest rate of 0.73% and an expected volatility rate of 96%. The liability for both the 2011 and 2012 warrants is revalued at each reporting period and changes in fair value are recognized currently in the statements of operations under the caption Adjustment to fair value of common stock warrant liability.

-23-




In August 2010, we issued warrants to purchase 599,550 shares of our common stock in connection with our August 2010 registered direct offering. On December 1, 2011, the unexercised warrants to purchase 589,000 shares of common stock expired. We revalued the liability from September 30, 2011 through the date of expiration and there was no impact on the statement of operations. The common stock warrant liability associated with these warrants no longer exists.
In addition to the 2011 and 2012 warrants, as of June 30, 2012, we had outstanding warrants to purchase 10,415 shares of our common stock at an exercise price of $5.64. These warrants expired unexercised in July 2012.
Critical Accounting Policies and Significant Judgments and Estimates
Our managements discussion and analysis of our financial condition and results of operations is based on our unaudited financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and assumptions. We base our estimates on historical experience and on various assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from
these estimates under different assumptions or conditions.
Our significant accounting policies are described in Note 2 to our audited financial statements included in our Annual Report on Form 10-K for the fiscal year ended September 30, 2011 and in the notes to our consolidated financial statements included in this Quarterly Report on Form 10-Q. We believe that our accounting policies relating to preclinical study and clinical trial accruals, stock-based compensation and income taxes are the most critical to aid you in fully understanding and evaluating our financial condition and results of operations. These policies are described under Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies and Significant Judgments and Estimates in our Annual Report on Form 10-K for the fiscal year ended September 30, 2011. There have been no material changes to such policies since the filing of such Annual
Report.
Adopted Accounting Pronouncements
Comprehensive Income
In June 2011, the Financial Accounting Standards Board, or the FASB, issued ASU 2011-05 Presentation of Comprehensive Income or ASU 2011-05. ASU 2011-05 allows an entity to present components of net income and other comprehensive income in one continuous statement, referred to as the statement of comprehensive income, or in two separate, but consecutive statements. The new guidance eliminates the current option to report other comprehensive income and its components in the statement of changes in equity. While ASU 2011-05 changes the presentation of comprehensive income, there are no changes to the components that are recognized in net income or other comprehensive income under current accounting guidance. In December 2011, the FASB issued ASU 2011-12 Comprehensive Income (Topic 220): Deferral of the Effective Date for Amendments to the Presentation of Reclassifications of Items Out of Accumulated Other Comprehensive Income in Accounting
Standards Update No. 2011-05, or ASU 2011-12. ASU 2011-12 deferred certain aspects of ASU 2011-05 pertaining only to the presentation of reclassification adjustments out of accumulated other comprehensive income and reinstates the previous requirements to present reclassification adjustments either on the face of the statement in which other comprehensive income is reported or to disclose them in a note to the financial statements. The new guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2011. We adopted this guidance in the first quarter of the fiscal year ending September 30, 2012. The adoption of ASU 2011-05 and the deferrals in ASU 2011-12 had no impact on our consolidated financial statements.
Results of Operations
Three Months Ended June 30, 2011 Compared to Three Months Ended June 30, 2012
Revenue. We did not recognize any revenue during the three months ended June 30, 2011 or 2012.
Research and Development Expenses.
Three Months Ended 
June 30,


Increase2011


2012


$


%(in thousands)Research and Development



$
2,941


$
2,956


$
15



1
%Percentage of net loss




74
%


49
%Research and development expenses were $3.0 million for the three months ended June 30, 2012, an increase of $15 thousand, or 1%, from $2.9 million for the three months ended June 30, 2011. This increase is primarily due to an increase of $0.5 million to purchase active pharmaceutical ingredients, manufacture clinical supplies of our upcoming ultra-rapid acting insulin Phase 2 study and perform toxicology studies on our glucagon formulation. This increase was offset by lower stock-based compensation charge of $0.4 million due to having fewer employees than previous quarter, last year.
Research and development expenses for the quarter ended June 30, 2011 and 2012 include $0.5 million and $0.1 million, respectively, in stock-based compensation expense related to options and RSUs granted to employees.

-24-




General and Administrative Expenses.
Three Months Ended 
June 30,


Decrease2011


2012


$


%(in thousands)General and Administrative



$
2,382


$
1,776


$
606



25
%Percentage of net loss




60
%


29
%General and administrative expenses were approximately $1.8 million for the three months ended June 30, 2012, a decrease of $0.6 million, or 25%, from $2.4 million for the three months ended June 30, 2011. This decrease is primarily attributable to decreased stock-based compensation costs of $0.6 million and a decrease of $58 thousand in depreciation expense, offset by an increase in professional and consulting fees of $0.1 million. General and administrative expenses for the three months ended June 30, 2011 and 2012 include $0.8 million and $0.2 million, respectively, in stock-based compensation expense related to options and RSUs granted to employees.
Interest and Other Income.
Three Months Ended 
June 30,


Decrease2011


2012


$


%(in thousands)Interest and Other Income



$
20


$
15


$
5



25
%Percentage of net loss





%



%Interest and other income was $15 thousand for the three months ended June 30, 2012, compared to $20 thousand for the three months ended June 30, 2011. The decrease was primarily due to lower cash balances for most of the quarter. On June 27, 2012, we completed our 2012 private placement, resulting in net proceeds to us, after deducting placement agents fees and other transaction expenses, of approximately $17.2 million.
Adjustments to Fair Value of Common Stock Warrant Liability
Three Months Ended 
June 30,


Increase2011


2012


$


%(in thousands)Adjustments to fair value of common stock warrant liability



$
(1,355
)

$
1,355


$
2,710



200
%Percentage of net loss




35
%


22
%Adjustments to fair value of common stock warrant liability was $1,355 thousand for the quarter ended June 30, 2012 as compared to $(1,355) for the quarter ended June 30, 2011. The June 2012 adjustment of $1,355 thousand is comprised of an increase in common stock warrant liability of $1,428 for the May 2011 warrants and a decrease in common stock warrant liability of $73 for the June 2012 warrants. We used the Black-Scholes valuation model to calculate the fair value of the May 2011 and the June 2012 warrants. For the three months ended June 30, 2011, we used the Monte Carlo simulation method to calculate the fair value of the August 2010 warrants. Because the closing price of our common stock on June 30, 2011 of $2.10 per share was lower than the September 30, 2010 closing price of $21.20, we decreased the fair value of the August 2010 warrant liability by $237 thousand. On December 1, 2011, the remaining outstanding August 2010
warrants expired unexercised. The revaluation of the liability, from September 30, 2011 through the date of expiration, had no impact on the statement of operations and the common stock warrant liability associated with these warrants no longer exists.
Net Loss and Net Loss per Share

Three Months Ended 
June 30,


Increase2011


2012


$


%(in thousands)Net loss



$
(3,974
)

$
(6,051
)

$
2,077



52
%Net loss per share



$
(0.48
)

$
(0.52
)Net loss was $6.1 million, or $(0.52) per share, for the three months ended June 30, 2012 compared to $4.0 million, or $(0.48) per share, for the three months ended June 30, 2011. The increase in net loss was primarily attributable to the increased expenses, described. We expect our losses to continue for the foreseeable future as we continue our development efforts.

-25-




Nine Months Ended June 30, 2011 Compared to Nine Months Ended June 30, 2012
Revenue.We did not recognize any revenue during the nine months ended June 30, 2011 or 2012.
Research and Development Expenses
Nine Months Ended 
June 30,


Decrease2011


2012


$


%(in thousands)Research and Development



$
11,349


$
7,952


$
3,397



30
%Percentage of net loss




77
%


53
%Research and development expenses were $8.0 million for the nine months ended June 30, 2012, a decrease of $3.4 million, or 30%, from $11.3 million for the nine months ended June 30, 2011. The decrease was principally the result of the net effect of the following:
·
we purchased $2.4 million of RHI in the nine months ended June 30, 2011 but none in the nine months ended June 30, 2012, as a result of renegotiating our supply agreement;
·
we incurred a one-time severance charge of $1.4 million in the nine months ended June 30, 2011 as a result of the retirement of our Chief Scientific Officer, a charge that did not recur in the nine months ended June 30, 2012;
·
personnel expenses declined by $0.7 million primarily as a result of a reduction in force implemented in January 2011; and
·
in December 2010, we were awarded a one-time grant of $1.2 million under the Internal Revenue Services therapeutic discovery tax credit program, which we treated as a reduction in research and development expenses for the nine months ended June 30, 2011.
Research and development expenses for the nine months ended June 30, 2011 and 2012 include $1.6 million and $0.6 million, respectively, in stock-based compensation expense related to options and RSUs granted to employees.
General and Administrative Expenses
Nine Months Ended 
June 30,


Decrease2011


2012


$


%(in thousands)General and Administrative



$
7,264


$
5,626


$
1,638



23
%Percentage of net loss




49
%


38
%General and administrative expenses were approximately $5.6 million for the nine months ended June 30, 2012, a decrease of $1.6 million, or 23%, from $7.3 million for the nine months ended June 30, 2011. This decrease is principally attributable to decreased personnel and stock-based compensation expenses of $1.4 million, as a result of the reduction in force implemented in January 2011, and a decrease of $0.2 million in depreciation, as a result of assets becoming fully depreciated. General and administrative expenses for the nine months ended June 30, 2011 and 2012 include $2.3 million and $0.9 million, respectively, in stock-based compensation expense related to options and RSUs granted to employees.
Interest and Other Income
Nine Months Ended 
June 30,


Increase2011


2012


$


%(in thousands)Interest and Other Income



$
30


$
56


$
26



87
%Percentage of net loss





%



%Interest and other income was $56 thousand for the nine months ended June 30, 2012, compared to $30 thousand for the nine months ended June 30, 2011.
Adjustments to Fair Value of Common Stock Warrant Liability.
Nine Months Ended 
June 30,


Increase2011


2012


$


%(in thousands)Adjustments to fair value of common stock warrant liability



$
(3,890
)

$
1,354


$
5,244



135
%Percentage of net loss




26
%


9
%Adjustments to fair value of common stock warrant liability was $1,354 thousand for the nine months ended June 30, 2012 as compared to ($3.9) million for the nine months ended June 30, 2011. The June 2012 adjustment of $1,354 thousand is comprised of a $1,427 increase to

-26-




the May 2011 warrants and the reduction of $73 thousand to the June 2012 warrants. We used the Black-Scholes valuation model to calculate the fair value of the May 2011 and June 2012 warrants. For the nine months ended June 30, 2011, we used the Monte Carlo simulation method to calculate the fair value of the August 2010 warrants. Because the closing price of our common stock on June 30, 2011 of $2.10 per share was lower than the September 30, 2010 closing price of $21.20, we decreased the fair value of the August 2010 warrant liability by $2.5 million. On December 1, 2011, the remaining outstanding August 2010 warrants expired unexercised. The revaluation of the liability, from September 30, 2011 through the date of expiration, had no impact on the statement of operations and the common stock warrant liability associated with these warrants no longer exists.
Net Loss and Net Loss per Share
Nine Months Ended 
June 30,


Decrease2011


2012


$


%(in thousands)Net Loss



$
(14,725
)

$
(14,868
)

$
1.172



1.31
%Net loss per share



$
(2.06
)

$
(1.44
)Net loss was $14.9 million, or $(1.44) per share, for the nine months ended June 30, 2012 compared to $14.7 million, or $(2.06) per share, for the nine months ended June 30, 2011. The decrease in net loss was primarily attributable to the decreases in expenses described above.
Liquidity and Capital Resources
Sources of Liquidity and Cash Flows
As a result of our significant research and development expenditures and the lack of any approved products or other sources of revenue, we have not been profitable and have generated significant operating losses since we were incorporated in 2003. We initially funded our research and development operations through aggregate gross proceeds of $26.6 million from our private financing transactions that we completed prior to our initial public offering. We received an aggregate of approximately $184 million from our initial public offering in May 2007, our follow-on offering in February 2008, our registered direct offerings in August 2010 and May 2011 and our private placement in June 2012.
At June 30, 2012, we had cash and cash equivalents totaling approximately $43.7 million. We currently invest our excess funds in a premium commercial money market fund with one major financial institution. We plan to continue to invest our cash and cash equivalents in accordance with our approved investment policy guidelines, which set forth our policy to hold investment securities to maturity.
Net cash used in operating activities was $11.3 million for the nine months ended June 30, 2012 and $14.9 million for the nine months ended June 30, 2011. Net cash used in operating activities for the nine months ended June 30, 2012 primarily reflects the net loss for the period, offset in part by stock-based compensation, adjustments to the fair value of warrant liability, depreciation and amortization expenses, increases in prepaid and accrued expenses and decreases in income taxes payable and accounts payable. Net cash used in operating activities for the nine months ended June 30, 2011 primarily reflects the net loss for the period, offset in part by stock-based compensation warrant liability fair value adjustment, depreciation and amortization expenses, increases in accrued expenses, prepaid expenses and income taxes payable and decreases in tax receivables and accounts payable.
Net cash provided by investing activities was $0 for the nine months ended June 30, 2012 and $5.8 million for the nine months ended June 30, 2011. Net cash provided by investing activities for the nine months ended June 30, 2011 primarily reflects the sale of marketable securities.
Net cash provided by financing activities was $16.2 million for the nine months ended June 30, 2012 and $28.2 million for the nine months ended June 30, 2011. Net cash provided by financing activities in the nine months ended June 30, 2012 primarily reflects the net proceeds of our June 2012 private placement financing. Net cash provided by financing activities in the nine months ended June 30, 2011 primarily reflects the net proceeds of the registered direct offering that we completed in May 2011.
Funding Requirements
We believe that our existing cash, cash equivalents and restricted cash will be sufficient to fund our anticipated operating expenses and capital expenditures at least until we file our NDA for a liquid formulation of glucagon, which we expect to occur in the first quarter of the 2014 calendar year. We have based this estimate upon assumptions that may prove to be wrong and we could use our available capital resources sooner than we currently expect. Our existing capital resources are not sufficient to complete our clinical development program for an ultra-rapid-acting insulin product candidate or a liquid formulation of glucagon. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, and to the extent that we may or may not enter into collaborations with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased
capital outlays and operating expenditures associated with our current anticipated clinical trials.
Our future capital requirements will depend on many factors, including:
·
the success of our product candidates, particularly our proprietary formulations of injectable insulin and our liquid formulation of glucagon;
·
the results of our real-time stability programs for our insulin and glucagon product candidates;

-27-




·
our ability to advance a proprietary insulin formulation into a Phase 2 clinical trial in a timely manner;
·
our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the FFDCA;
·
the progress, timing or success of our research and development and clinical programs for our product candidates, including data analyses of any clinical trials of an ultra-rapid-acting insulin formulation or a liquid formulation of glucagon;
·
our ability to conduct pivotal clinical trials and other tests or analyses required by the FDA to secure approval to commercialize an ultra-rapid-acting insulin formulation or a liquid formulation of glucagon;
·
our ability to develop and commercialize a proprietary formulation of injectable insulin that may be associated with less injection site discomfort than the formulation that is the subject of the complete response letter we received from the FDA;
·
our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves;
·
our ability to enforce our patents for our product candidates and our ability to secure additional patents for our product candidates;
·
our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
·
the degree of clinical utility of our products;
·
the ability of our major suppliers to produce our products in our final dosage form;
·
our commercialization, marketing and manufacturing capabilities and strategies; and
·
our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing.
We do not anticipate generating product revenue for the next few years. In the absence of additional funding, we expect our continuing operating losses to result in increases in our cash used in operations over the next several years. To the extent our capital resources are insufficient to meet our future capital requirements, we will need to finance our future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. We do not currently have any commitments for future external funding.
We may receive additional proceeds from the exercise of the warrants that we issued in connection with our May 2011 registered direct offering and our June 2012 private placement, if any of those warrants are exercised for cash. Whether the warrants are exercised for cash will depend on decisions made by the warrant holders and on whether the market price of our common stock exceeds the per share warrant exercise price. The warrants issued in May 2011, with an exercise price of $9.92, and June 2012, with an exercise price of $2.66, will expire on May 17, 2016 and June 26, 2017, respectively.
We have achieved cost saving initiatives to reduce operating expenses, including the reduction of employees and we continue to seek additional areas for cost reductions. However, we will also need to raise additional funds and periodically explore sources of equity or debt financing. We may seek to raise such capital through public or private equity financings, partnerships, joint ventures, debt financings, bank borrowings or other sources. However, additional funding may not be available on favorable terms or at all. If additional funds are raised by issuing equity securities, substantial dilution to existing stockholders may result. If we fail to obtain additional capital when needed, we may be required to delay, scale back, or eliminate some or all of our research and development programs. The accompanying financial statements do not include any adjustments that may result from the outcome of this uncertainty.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
Contractual Obligations
The following table summarizes our significant contractual obligations and commercial commitments as of June 30, 2012 (in thousands):

Total

Less 
Than 
1 Year

1-3 Years

3-5 Years

More 
Than 
5 YearsOperating lease obligations



$
1,228


$
626


$
602


$



$
Purchase commitments




17,050







4,122



8,522



4,406Total fixed contractual obligations



$
18,278


$
626


$
4,724


$
8,522


$
4,406

-28-




Item 3.
Quantitative and Qualitative Disclosures About Market Risk
Our exposure to market risk is limited to our cash, cash equivalents and marketable securities. We invest in high-quality financial instruments, as permitted by the terms of our investment policy guidelines. Currently, our excess funds are invested in a premium commercial money market fund with one major financial institution. We do not hedge interest rate exposure. A portion of our investments may be subject to interest rate risk and could fall in value if interest rates were to increase. The effective duration of our portfolio is currently less than one year, which we believe limits interest rate and credit risk.
Because most of our transactions are denominated in United States dollars, we do not have any material exposure to fluctuations in currency exchange rates.
Item 4.
Controls and Procedures
Managements Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2012. The term disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SECs rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our
management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2012, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in internal controls
No change in our internal control over financial reporting (defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended June 30, 2012 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

-29-




PART II-OTHER INFORMATION
Item 1.
Legal Proceedings
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. Management believes that the resolution of such matters will not have a material adverse effect on the financial position, results of operations or cash flows of the Company.
In February 2012, the Company brought action against one of its vendors, before the American Arbitration Association in New York relating to
disputed fees charged to the Company for inventory storage. As part of an arbitration stipulation, the Company established a $1.5 million escrow account and paid $0.5 million during the quarter ended June 30, 2012,
leaving an escrow balance of $1.0 million. On July 30, 2012, the Company received a judgment from the arbitrator stating that the Company is required to only pay the vendor a balance of $55 thousand, after deducting
legal fees. The Company expects the remaining escrow balance of $945 thousand to be returned to it by the end of the September 30, 2012 fiscal year.
Item 1A.
Risk Factors.
Risks Related to Our Financial Position and Need for Additional Capital
We have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
Since our inception in December 2003, we have incurred significant operating losses. Our net losses were approximately $6.1 million and $14.9 million, respectively, for the three and nine months ended June 30, 2012. As of June 30, 2012, we had a deficit accumulated during the development stage of approximately $190.2 million. We have invested a significant portion of our efforts and financial resources in the development of our ultra-rapid-acting insulin product candidates. In October 2010, the FDA notified us that it would not approve our NDA for the LinjetaTMformulation unless and until we conduct two new Phase 3 clinical trials, one in Type 1 diabetes and the other in Type 2 diabetes, using the final commercial formulation of LinjetaTM, we address deficiencies with the chemistry, manufacturing and controls section of the NDA, and our primary third-party manufacturers adequately remediate facility inspection
observations. In light of the extensive nature of the FDAs comments and their feedback at a subsequent meeting in January 2011, we decided not to initiate new pivotal Phase 3 clinical trials with the formulation of LinjetaTMsubmitted in our NDA. We have instead commenced clinical development of new RHI-based ultra-rapid-acting insulin formulations. These alternate formulations, which include BIOD-123, generally use the same or similar excipients as the formulation of LinjetaTMsubmitted in our NDA, but we believe they may present improvements with regard to injection site discomfort. We have also commenced preclinical testing of ultra-rapid-acting insulin analog-based formulations and liquid formulations of glucagon that may require additional formulation development prior to moving into later stage clinical trials. We expect to continue to incur significant operating losses for at least the next several years as we may:
·
conduct preclinical studies and clinical trials to study formulations of RHI- and insulin analog-based formulations that may be associated with less injection site discomfort than the LinjetaTMformulation;
·
conduct additional formulation development work to improve the stability or other characteristics of our analog-based ultra-rapid-acting insulin formulations and liquid formulations of glucagon;
·
conduct later stage clinical trials of our ultra-rapid-acting insulin formulations and our liquid formulations of glucagon, including one or more pivotal clinical trials required for FDA approval;
·
produce validation batches of our product candidates to support one or more NDAs;
·
conduct the required stability, preclinical and human factors and user acceptability studies to support the approval of one or more insulin pen and glucagon auto-injector devices intended for use with our product candidates;
·
purchase active pharmaceutical ingredients and other materials consistent with our existing contractual obligations; and
·
conduct clinical development of our other product candidates.
To become and remain profitable, we must succeed in developing and eventually commercializing drugs with significant market potential. This will require us to be successful in a range of challenging activities, including developing proprietary insulin and glucagon formulations with desirable pharmacokinetic, pharmacodynamic, stability and injection site tolerability characteristics and then successfully completing preclinical testing and clinical trials for those formulations, obtaining regulatory approval for these formulations and manufacturing, marketing and selling those products for which we may obtain regulatory approval. We may never succeed in these activities and may never generate revenues that are significant or large enough to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable could
depress the market price of our common stock and could impair our ability to raise capital, expand our business or continue our operations. A decline in the market price of our common stock could also cause you to lose all or a part of your investment.

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We will need substantial additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts.
We are a development stage company with no commercial products. All of our product candidates are in early stages of development. Our product candidates will require significant additional clinical development, regulatory approvals and related investment before they can be commercialized. We expect to continue to incur significant research and development expenses as we continue our formulation work and advance these programs through clinical trials. Unless we are successful in consummating a strategic partnership to develop and commercialize an ultra-rapid-acting insulin formulation or a liquid formulation of glucagon, we may need to raise substantial additional capital to develop and commercialize competitive products. Such financing may not be available on terms acceptable to us, or at all. If we are unable to obtain financing on favorable terms, our business, results of operations and financial condition may be materially adversely
affected.
Based upon our current plans, we believe that our existing cash, cash equivalents and restricted cash will be sufficient to fund our anticipated operating expenses and capital expenditures at least until we file our NDA for a liquid formulation of glucagon, which we expect to occur in the first quarter of the 2014 calendar year. We cannot assure you that our plans will not change or that changed circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate. Our future capital requirements will depend on many factors, including:
·
our ability to advance a proprietary RHI-based insulin formulation into a Phase 2 clinical trial in a timely manner, and the outcome of that trial;
·
the success of our formulation development work with an analog-based ultra-rapid-acting insulin formulation and a liquid formulation of glucagon;
·
the results of our real-time stability programs for our insulin and glucagon product candidates;
·
our ability to secure approval by the FDA for our product candidates under Section 505(b)(2) of the FFDCA and the degree to which we are able to clarify with the FDA related regulatory requirements;
·
our ability to conduct pivotal clinical trials or other tests or analyses required by the FDA to secure approval to commercialize an ultra-rapid-acting insulin formulation or a liquid formulation of glucagon;
·
the cost to develop devices for use with our product candidates, such as insulin pen injectors and glucagon auto-injectors, and the clinical development program required to support use of an ultra-rapid-acting insulin formulation in insulin pumps;
·
the costs of pre-commercialization activities, if any;
·
the costs associated with qualifying and obtaining regulatory approval of suppliers of insulin or other active pharmaceutical ingredients and manufacturers of our product candidates;
·
the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims;
·
the emergence of competing technologies and products and other adverse market developments; and
·
our ability to establish and maintain collaborations and the terms and success of the collaborations, including the timing and amount of payments that we might receive from potential strategic collaborators.
Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through public or private equity offerings and debt financings, strategic collaborations and licensing arrangements. If we raise additional funds by issuing additional equity securities, our stockholders will experience dilution. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt financing or additional equity that we raise may contain terms, such as liquidation and other preferences, which are not favorable to us or our stockholders. If we raise additional funds through collaboration, strategic alliance or licensing arrangements with third parties, it may be necessary to relinquish valuable rights to our technologies or product candidates, future
revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.
Our short operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
We commenced active operations in January 2004. Our operations to date have been limited to organizing and staffing our company, developing and securing our technology and undertaking preclinical studies and clinical trials of our product candidates. We have limited experience completing large-scale, pivotal clinical trials and we have not yet demonstrated our ability to obtain regulatory approval to market a product, manufacture a commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.
In addition, as a new business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We may need to transition from a company with a research focus to a company capable of supporting commercial activities. We may not be successful in such a transition.

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Risks Related to the Development and Commercialization of Our Product Candidates
We have depended heavily on the success of our ultra-rapid-acting mealtime insulin development program.
We have invested a significant portion of our efforts and financial resources in the development of our ultra-rapid-acting insulin product candidates. The FDA concluded that the results from our completed pivotal Phase 3 clinical trials of LinjetaTMare not sufficient to obtain marketing approval for LinjetaTM, and we chose to advance new formulations into the clinic. Clinical trials of our first two new formulations, BIOD-105 and BIOD-107, did not achieve satisfactory results. If we are not able to develop alternative RHI- or insulin-analog based formulations with desirable pharmacokinetic, pharmacodynamic, stability and injection site tolerability characteristics, or experience significant delays in doing so, then our business may be materially harmed. For example, while BIOD-123, our lead candidate for an ultra-rapid-acting RHI-based formulation demonstrated pharmacokinetic, pharmacodynamic and injection site
tolerability characteristics consistent with our target product profile in a Phase 1 clinical trial, we have generated limited real-time stability data with this formulation. If the stability profile of this product candidate is unfavorable from a commercial perspective, we may choose not to market our product, even if we are approved by the FDA to do so, or we may never generate revenues that are significant or large enough to achieve profitability.
Our development of an RHI- or insulin analog-based formulation may not be successful; some formulations may have different regulatory requirements to obtain marketing approval from the FDA.
While we have significant experience with the technology we use to develop ultra-rapid-acting insulin formulations, we cannot assure you that our program to advance RHI- or insulin analog-based formulations will be successful or will offer improvements over the LinjetaTMformulation that we submitted to the FDA in our NDA. Some of our formulations under development appear to be absorbed as rapidly as LinjetaTM, but are less stable in accelerated testing. Some of our formulations offer advantages in terms of injection site discomfort, but may not perform as well as LinjetaTMin terms of the overall pharmacokinetic and pharmacodynamic profile. We may be unable to develop a new formulation with pharmacokinetic, pharmacodynamic, stability and injection site tolerability characteristics that are acceptable to us, a potential strategic partner or the FDA. Furthermore, the regulatory requirements for any
alternate formulation may not meet our expectations or may be different from those applicable to the formulation of LinjetaTMsubmitted in our NDA. For example, advancing any formulation based on an insulin analog may necessitate our conducting additional toxicology work prior to initiation of Phase 1 clinical trials.
We have limited experience with developing pharmaceutical preparations of glucagon.
Our experience with the manufacture, testing and analysis of pharmaceutical preparations of glucagon in preclinical studies is limited, and we have not yet conducted any clinical trials using glucagon as an active pharmaceutical ingredient. We based our product development timelines for a glucagon rescue product on our assumption that we can generate the clinical data necessary to submit an NDA for such a product in a single pivotal clinical trial. As a result, although we intend to conduct at least one proof of concept clinical trial with our intended commercial formulation of a glucagon rescue product, we may not have a significant amount of additional experience working with glucagon prior to initiating a pivotal clinical trial. Additionally, we have limited experience with some of the technologies we use to stabilize our liquid glucagon formulations. Because of our limited experience, we may be unable to accurately anticipate
technical challenges we may face in the development of a glucagon rescue product, and our development timelines could be delayed.
We may be unable to allocate significant resources to all of our development programs.
Our expenditures on our preclinical development programs, other than our ultra-rapid-acting insulins and our formulations of glucagon, have been limited to date and may be insufficient to develop product candidates for clinical testing. We cannot guarantee that we will have sufficient resources to continue these programs.
The results of clinical trials do not ensure success in future clinical trials or commercial success.
We have completed and released the results of our two pivotal Phase 3 clinical trials of LinjetaTM. We have not completed the development of any products through commercialization. In October 2010, the FDA notified us that it would not approve our NDA for the LinjetaTMformulation, and we subsequently decided to advance alternate formulations, including BIOD-105, BIOD-107, BIOD-123 and BIOD-125 into the clinic and discontinued development of earlier formulations of LinjetaTM. The outcomes of preclinical testing and clinical trials of prior formulations of LinjetaTMmay not be predictive of the success of clinical trials with current or future formulations of our RHI- or insulin analog-based formulations. For example, despite promising preclinical data, BIOD-105 and BIOD-107 did not meet our preferred target product profile in Phase 1 clinical trials, and we discontinued development of these
formulations. In addition, interim or preliminary results of a clinical trial do not necessarily predict final results. We cannot assure you that the clinical trials of any of our RHI- or insulin analog-based formulations will ultimately be successful. New information regarding the safety, efficacy tolerability and stability of our RHI- or insulin analog-based formulations may arise that may be less favorable than the data observed to date. Furthermore, much of the clinical data we have generated to date has compared one or more of our ultra-rapid-acting formulations to recombinant human insulin, which is known to have a slower onset of action than the currently marketed insulin analogs. In the future, we plan to conduct all of our clinical trials using an insulin analog as the comparator. We have limited ability to predict how our RHI- or insulin analog-based formulations will perform when compared to an insulin analog.
If we are not successful in commercializing any of our product candidates, or are significantly delayed in doing so, our business will be materially harmed. The commercial success of our product candidates will depend on several factors, including the following:
·
successful completion of preclinical development and clinical trials;

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·
our ability to identify and enroll patients who meet clinical trial eligibility criteria;
·
receipt of marketing approvals from the FDA and similar regulatory authorities outside the United States;
·
establishing that, with regard an RHI- or insulin analog based-formulation, the formulation is well-tolerated in chronic use;
·
establishing commercial manufacturing capabilities through arrangements with third-party manufacturers;
·
launching commercial sales of the products, whether alone or in collaboration with others;
·
competition from other products; and
·
continued acceptable safety and tolerability profiles of the products following approval.
If our clinical trials are delayed or do not produce positive results, we may incur additional costs and ultimately be unable to commercialize our product candidates.
Before obtaining regulatory approval for the sale of our product candidates, we must conduct, at our own expense, extensive preclinical tests to demonstrate the safety of our product candidates in animals and clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Preclinical and clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more of our clinical trials of ultra-rapid-acting insulin formulations or liquid glucagon formulations can occur at any stage of testing. We may experience numerous unforeseen events during our clinical trials that could delay or prevent our ability to receive regulatory approval or commercialize our product candidates, including:
·
the number of patients required for our clinical trials may be larger than we anticipate, enrollment in our clinical trials may be slower than we currently anticipate, or participants may drop out of our clinical trials at a higher rate than we anticipate, any of which would result in significant delays;
·
our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner;
·
we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks;
·
regulators or institutional review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;
·
the cost of our clinical trials may be greater than we anticipate;
·
the supply or quality of our product candidates or other materials necessary to conduct our clinical trials may be insufficient or inadequate; and
·
the effects of our product candidates may not be the desired effects, may include undesirable side effects or the product candidates may have other unexpected characteristics.
If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete our clinical trials or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:
·
be delayed in obtaining or discontinue our efforts to obtain marketing approval;
·
not be able to obtain marketing approval;
·
obtain approval for indications that are not as broad as intended; or
·
have the product removed from the market after obtaining marketing approval.
Our product development costs will also increase if we experience delays in testing or approvals. We do not know whether any preclinical tests or clinical trials will begin as planned, will need to be redesigned or will be completed on schedule, if at all. Significant preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to commercialize our products or product candidates and may harm our business and results of operations.
If our product candidates are found to cause undesirable side effects we may need to delay or abandon our development and commercialization efforts.
Any undesirable side effects that might be caused by our product candidates could interrupt, delay or halt clinical trials and could result in the denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications. In addition, if any of our product candidates receive marketing approval and we or others later identify undesirable side effects caused by the product, we could face one or more of the following:
·
a change in the labeling statements or withdrawal of FDA or other regulatory approval of the product;
·
a change in the way the product is administered; or

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·
the need to conduct additional clinical trials.
Any of these events could prevent us from achieving or maintaining market acceptance of the affected product or could substantially increase the costs and expenses of commercializing the product, which in turn could delay or prevent us from generating significant revenues from its sale.
The commercial success of any product candidates that we may develop will depend upon the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community.
Any products that we bring to the market may not gain market acceptance by physicians, patients, healthcare payors and others in the medical community. If these products do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. Physicians will not recommend our product candidates until clinical data or other factors demonstrate the safety and efficacy of our product candidates as compared to other treatments. Even if the clinical safety and efficacy of our product candidates is established, physicians may elect not to recommend these product candidates for a variety of reasons including the reimbursement policies of government and third-party payors, the effectiveness of our competitors in marketing their products and the possibility that patients may experience more injection site discomfort than they experience with competing products.
The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:
·
the willingness and ability of patients and the healthcare community to adopt our products;
·
the ability to manufacture our product candidates in sufficient quantities with acceptable quality and to offer our product candidates for sale at competitive prices;
·
the perception of patients and the healthcare community, including third-party payors, regarding the safety, efficacy and benefits of our product candidates compared to those of competing products or therapies;
·
the convenience and ease of administration of our product candidates relative to existing treatment methods;
·
the label and promotional claims allowed by the FDA, such as, in the case of an RHI- or insulin analog-based formulation, claims relating to glycemic control, hypoglycemia, weight gain, injection site discomfort, expiry dating and required handling conditions;
·
the pricing and reimbursement of our product candidates relative to existing treatments; and
·
marketing and distribution support for our product candidates.
The successful development of our product candidates may depend upon our ability to collaborate with or license technology from third parties.
Our glucagon rescue product candidate is at an early stage of development. In order for us to meet our projected milestones for this program, we must obtain reliable sources of active pharmaceutical ingredient and other related materials and supplies, such as stabilizing agents, pre-filled syringes and auto-injector devices. Additionally, one of our leading candidates for a liquid formulation of glucagon uses proprietary stabilization technology supplied by a third party pursuant to a license agreement. If we do not maintain a commercial license to this technology, our efforts to commercialize a glucagon rescue product may be materially harmed.
If we fail to enter into strategic collaborations for the commercialization of our product candidates or if our collaborations are unsuccessful, we may be delayed in our commercialization efforts; we may be required to establish our own sales, marketing, manufacturing and distribution capabilities which will be expensive, require additional capital we do not currently have, and could delay the commercialization of our product candidates and have a material and adverse effect on our business; we cannot commercialize our insulin analog-based formulations until all applicable third-party patents have expired.
A broad base of physicians, including primary care physicians, internists and endocrinologists, treat patients with diabetes. A large sales force may be required to educate and support these physicians. In addition, we cannot commercialize on our own any insulin analog-based formulation in the United States until 2014 at the earliest, when the patents covering the currently marketed insulin analogs first begin to expire. Therefore, our current strategy for developing, manufacturing and commercializing our product candidates includes securing collaborations with leading pharmaceutical and biotechnology companies, including those that hold patents covering the currently marketed insulin analogs, for the commercialization of our product candidates. To date, we have not entered into any collaborations with pharmaceutical or biotechnology companies. We face significant competition in seeking appropriate collaborators. In addition,
collaboration agreements are complex and time-consuming to negotiate, document and implement. For all these reasons, it may be difficult for us to find third parties that are willing to enter into collaborations on economic terms that are favorable to us, or at all. Even if we do enter into any such collaboration, the collaboration may not be successful. The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. It is likely that our collaborators will have significant discretion in determining the efforts and resources that they will apply to these collaborations.
If we fail to enter into collaborations, or if our collaborations are unsuccessful, we may be required to establish our own direct sales, marketing, manufacturing and distribution capabilities. Establishing these capabilities can be time-consuming and expensive and we have little experience in doing so. Because of our size, we would be at a disadvantage to our potential competitors to the extent they collaborate with large pharmaceutical companies that have substantially more resources than we do. As a result, we would not initially be able to field a

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sales force as large as our competitors or provide the same degree of market research or marketing support. In addition, our competitors would have a greater ability to devote research and development resources toward expansion of the indications for their products. We cannot assure our investors that we will succeed in entering into acceptable collaborations, that any such collaboration will be successful or, if not, that we will successfully develop our own sales, marketing and distribution capabilities.
If we are unable to obtain adequate reimbursement from governments or third-party payors for any products that we may develop or if we are unable to obtain acceptable prices for those products, they may not be purchased or used and our revenues and prospects for profitability will suffer.
Our future revenues and profits will depend heavily upon the availability of adequate reimbursement for the use of our approved product candidates from governmental and other third-party payors, both in the United States and in other markets. Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payors determination that use of a product is:
·
a covered benefit under its health plan;
·
safe, effective and medically necessary;
·
appropriate for the specific patient;
·
cost-effective; and
·
neither experimental nor investigational.
Obtaining reimbursement approval for a product from each government or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to each payor. We may not be able to provide data sufficient to gain acceptance with respect to reimbursement. Even when a payor determines that a product is eligible for reimbursement, the payor may impose coverage limitations that preclude payment for some uses that are approved by the FDA or comparable authorities. In addition, eligibility for coverage does not imply that any product will be reimbursed in all cases or at a rate that allows us to make a profit or even cover our costs.
Interim payments for new products, if applicable, may also not be sufficient to cover our costs and may not be made permanent.
We may be subject to pricing pressures and uncertainties regarding Medicare reimbursement and reform.
Reforms in Medicare added a prescription drug reimbursement benefit beginning in 2006 for all Medicare beneficiaries. Although we cannot predict the full effects on our business of the implementation of this legislation, it is possible that the new benefit, which will be managed by private health insurers, pharmacy benefit managers, and other managed care organizations, will result in decreased reimbursement for prescription drugs, which may further exacerbate industry-wide pressure to reduce the prices charged for prescription drugs. This could harm our ability to generate revenues.
Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
In some countries, particularly the countries of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be adversely affected.
Legislation has been introduced in Congress that, if enacted, would permit more widespread re-importation of drugs from foreign countries into the United States, which may include re-importation from foreign countries where the drugs are sold at lower prices than in the United States. Such legislation, or similar regulatory changes, could decrease the price we receive for any approved products which, in turn, could adversely affect our operating results and our overall financial condition.
Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercially sell any products that we may develop. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
·
decreased demand for any product candidates or products that we may develop;
·
injury to our reputation;
·
withdrawal of clinical trial participants;
·
costs to defend the related litigation;
·
substantial monetary awards to trial participants or patients;
·
loss of revenue; and

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·
the inability to commercialize any products that we may develop.
We currently carry global liability insurance that we believe is sufficient to cover us from potential damages arising from past or future clinical trials of our ultra-rapid-acting insulin formulations and other product candidates that we may advance into the clinic. We also carry local insurance policies per clinical trial of our product candidates. The amount of insurance that we currently hold may not be adequate to cover all liabilities that we may incur. We intend to expand our insurance coverage to include the sale of commercial products if we obtain marketing approval for any products. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost. If losses from product liability claims exceed our liability insurance coverage, we may ourselves incur substantial liabilities. If we are required to pay a product liability claim, we may not have sufficient financial resources to
complete development or commercialization of any of our product candidates and, if so, our business and results of operations would be harmed.
We face substantial competition in the development of our product candidates which may result in others developing or commercializing products before or more successfully than we do.
We are engaged in segments of the pharmaceutical industry that are characterized by intense competition and rapidly evolving technology. Many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies and other public and private research organizations are pursuing the development of novel drugs that target endocrine disorders. We face, and expect to continue to face, intense and increasing competition as new products enter the market and advanced technologies become available. There are several approved injectable rapid-acting mealtime insulin analogs currently on the market including Humalog®, marketed by Eli Lilly and Company, NovoLog®, marketed by Novo Nordisk, and aspart, marketed by Sanofi-Aventis. These rapid-acting insulin analogs provide improvement over regular forms of short-acting insulin, including faster subcutaneous absorption, an earlier and greater
insulin peak and more rapid post-peak decrease. In addition, other development stage insulin formulations may be approved and compete with ours. Halozyme Therapeutics, Inc. has conducted a Phase 1 and multiple Phase 2 clinical trials of RHI, lispro (the insulin analog in Humalog®) and aspart (the insulin analog in NovoLog®) in combination with a recombinant human hyaluronidase enzyme and has reported that in each case the combination yielded pharmacokinetics and glucodynamics that better mimicked physiologic mealtime insulin release and activity than RHI, Humalog®or NovoLog®alone. Novo Nordisk has reported that they have initiated clinical development of an insulin analog intended to provide faster onset of action than the currently available rapid-acting insulin analogs.
Several companies are also developing alternative insulin systems for diabetes, including MannKind Corporation, which has an inhalable insulin product candidate for which an NDA was submitted in early 2009. Although currently the subject of a complete response letter from the FDA, which requested significant additional clinical development, the approval and acceptance of an inhaled insulin such as MannKinds inhaled insulin could reduce the overall market for injectable prandial insulin.
Treatment practices can also change with the introduction of new classes of therapy. Currently glucagon-like peptide analogs such as Exanatide and Exanatide LAR, marketed by Amylin Pharmaceuticals in the United States and Eli Lilly in Europe, and Liraglutide, marketed by Novo Nordisk, are growing in usage and could delay the start of insulin usage in some patients therefore decreasing the size of the prandial insulin market.
While at this time there are no approved generic or biosimilar insulin analogs in the market in the United States or Europe, in other countries such as India there are multiple approved manufacturers of insulin analogs such has Humalog®. Both Humalog®and NovoLog®have limited remaining patent protection in the United States and Europe. The possible introduction of lower priced brands or substitutable generic versions of these products could negatively impact the revenue potential of our ultra-rapid-acting product candidates.
Our liquid formulation of glucagon that is intended as rescue treatment for diabetes patients experiencing severe hypoglycemia would also face significant competition if it were to be commercialized. There are two approved injectable glucagon rescue kit products marketed by Eli Lilly and Company and Novo Nordisk. In addition, other development stage glucagon rescue formulations and injectors may be approved. Enject Inc. is developing an auto-injection pen that integrates glucagon powder and a diluent into a dual chamber cartridge within the pen. Xeris Inc. is developing an auto-injection pen utilizing a highly concentrated, non aqueous glucagon formulation. Additionally, Latitude Pharmaceuticals, Inc. has announced that it has developed a stable liquid glucagon formulation using FDA-approved injectable ingredients, and AMG Medical Inc. is believed to be studying a novel formulation of glucagon in one or more clinical trials. All of these
programs utilize the same active ingredient as our liquid formulation of glucagon and offer, or may offer, presentations allowing for room temperature storage. In addition, Eli Lilly and Company is developing a glucagon analog, which may also offer advantages over our liquid formulation of glucagon.
Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization. Our competitors may develop products that are more effective, safer, more convenient or less costly than any that we are developing or that would render our product candidates obsolete or non-competitive. Our competitors may also obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours.
·
Many of our potential competitors have:
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significantly greater financial, technical and human resources than we have and may be better equipped to discover, develop, manufacture and commercialize product candidates;
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more extensive experience in preclinical testing and clinical trials, obtaining regulatory approvals and manufacturing and marketing pharmaceutical products;

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·
product candidates that have been approved or are in late-stage clinical development; or
·
collaborative arrangements in our target markets with leading companies and research institutions.
Our product candidates may be rendered obsolete by technological change.
The rapid rate of scientific discoveries and technological changes could result in one or more of our product candidates becoming obsolete or noncompetitive. For several decades, scientists have attempted to improve the bioavailability of injected formulations and to devise alternative non-invasive delivery systems for the delivery of drugs such as insulin. Our product candidates will compete against many products with similar indications. In addition to the currently marketed rapid-acting insulin analogs, our competitors are developing insulin formulations delivered by oral pills, pulmonary devices and oral spray devices. Our future success will depend not only on our ability to develop our product candidates, but also on our ability to maintain market acceptance against emerging industry developments. We cannot assure present or prospective stockholders that we will be able to do so.
Our business activities involve the storage and use of hazardous materials, which require compliance with environmental and occupational safety laws regulating the use of such materials. If we violate these laws, we could be subject to significant fines, liabilities or other adverse consequences.
Our research and development work and manufacturing processes involve the controlled storage and use of hazardous materials, including chemical and biological materials. Our operations also produce hazardous waste products. We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these materials. Although we believe that our safety procedures for handling and disposing of such materials and waste products comply in all material respects with the standards prescribed by federal, state and local laws and regulations, the risk of accidental contamination or injury from hazardous materials cannot be completely eliminated. In the event of an accident or failure to comply with environmental laws, we could be held liable for any damages that may result, and any such liability could fall outside the coverage or exceed the limits of our insurance. In addition, we could be
required to incur significant costs to comply with environmental laws and regulations in the future or pay substantial fines or penalties if we violate any of these laws or regulations. Finally, current or future environmental laws and regulations may impair our research, development or production efforts.
Risks Related to Our Dependence on Third Parties
Use of third parties to manufacture our product candidates may increase the risks that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost, or that our suppliers will not be able to manufacture our products in their final dosage form. In any such case, clinical development and commercialization of our product candidates could be delayed, prevented or impaired.
We do not currently own or operate manufacturing facilities for commercial production of our product candidates. We have limited experience in drug manufacturing and we lack the resources and the capabilities to manufacture any of our product candidates on a clinical or commercial scale. Our current strategy is to outsource to third parties a significant portion of the manufacturing required for our product candidates. We also expect to rely upon third parties to produce materials required for the commercial production of our product candidates if we succeed in obtaining necessary regulatory approvals. We have recently relied on the University of Iowa to manufacture our product candidates, but we do not have any commercial manufacturing agreements in place with third parties.
Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured product candidates or products ourselves, including:
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reliance on the third party for regulatory compliance and quality assurance;
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the possible breach of the manufacturing agreement by the third party because of factors beyond our control; and
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the possible refusal by or inability of the third party to support our manufacturing programs in a time frame that we would otherwise prefer.
Our manufacturers may not be able to comply with current good manufacturing practice, or cGMP, regulations or other regulatory requirements or similar regulatory requirements outside the United States. Our manufacturers are subject to unannounced inspections by the FDA, state regulators and similar regulators outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our product candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidates.
Our product candidates and any products that we may develop may compete with other product candidates and products for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that are both capable of manufacturing for us and willing to do so. If the third parties that we engage to manufacture product for our clinical trials should cease to continue to do so for any reason, we likely would experience delays in advancing these trials while we identify and qualify replacement suppliers and we may be unable to obtain replacement supplies on terms that are favorable to us. In addition, if we are not able to obtain adequate supplies of our product candidates or the drug substances used to manufacture them, it will be more difficult for us to develop our product candidates and compete effectively.

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Our current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to develop product candidates and commercialize any products that receive regulatory approval on a timely and competitive basis.
We rely on third parties to conduct our clinical trials and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such trials.
We do not independently conduct clinical trials of our product candidates. We rely on third parties, such as contract research organizations, clinical data management organizations, medical institutions and clinical investigators, to enroll qualified patients and conduct our clinical trials. Our reliance on these third parties for clinical development activities reduces our control over these activities. We are responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with standards, commonly referred to as Good Clinical Practices, for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance on third parties that we do not control
does not relieve us of these responsibilities and requirements. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, regulatory approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.
If our suppliers of active pharmaceutical ingredients and other production materials fail to deliver materials and provide services needed for the production of our ultra-rapid acting insulin formulations or our liquid formulation of glucagon in a timely and sufficient manner, or if they fail to comply with applicable regulations, clinical development or regulatory approval of our product candidates, commercialization of our products could be delayed, producing additional losses and depriving us of potential product revenue.
We need access to sufficient, reliable and affordable supplies of insulin, glucagon and other materials for which we rely on various suppliers. We also must rely on those suppliers to comply with relevant regulatory and other legal requirements, including the production of insulin in accordance with cGMP. We can make no assurances that our suppliers, particularly our insulin supplier, will comply with cGMP. In addition, we do not anticipate entering into any long-term agreements to secure a supply of one or more insulin analogs in the near future.
We have entered into an agreement with our existing RHI supplier from which we obtain all of the RHI that we use for testing and manufacturing our RHI-based formulations. In July 2011, we amended our agreement with this insulin supplier so that the agreement will terminate in June 2018.
We believe that our current supplies of RHI, together with the quantities of RHI called for under our existing supply agreement, will be sufficient to allow us to complete the full development program required by the FDA in order to receive approval to market an RHI-based formulation if we are successful in developing one. If we are unable to procure sufficient quantities of insulin from our current or any future supplier, if supply of RHI and other materials otherwise becomes limited, or if our suppliers do not meet relevant regulatory requirements, and if we were unable to obtain these materials in sufficient amounts, in a timely manner and at reasonable prices, we could be delayed in the manufacturing and possible commercialization of an ultra-rapid-acting insulin, which may have a material adverse effect on our business. We would incur substantial costs and manufacturing delays if our suppliers are unable to provide us with products
or services approved by the FDA or other regulatory agencies.
We have entered into a commercial supply agreement with a third party for the supply of glucagon that we intend to use in the manufacture of our glucagon rescue product candidate. However, we have not purchased significant quantities of glucagon from this third-party supplier and we do not anticipate doing so prior to the manufacture of validation batches of a proposed commercial product. Additionally, we have agreed to purchase an excipient used to stabilize one of our glucagon rescue candidate formulations from a third-party that has licensed its proprietary stabilization technologies to us. If this third-party is unable to supply us with sufficient quantities of the stabilizing excipient, our development program for a liquid formulation of glucagon may be materially harmed.
Risks Related to Our Intellectual Property
If we are unable to protect our intellectual property rights, our competitors may develop and market similar or identical products that may reduce demand for our products, and we may be prevented from establishing collaborative relationships on favorable terms.
The following factors are important to our success:
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receiving patent protection for our product candidates;
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maintaining our trade secrets;
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not infringing on the proprietary rights of others; and
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preventing others from infringing our proprietary rights.
We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary rights are covered by valid and enforceable patents or are effectively maintained as trade secrets. We try to protect our proprietary position by filing U.S. and foreign patent applications related to our proprietary technology, inventions and improvements that are important to the

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development of our business. Because the patent position of pharmaceutical companies involves complex legal and factual questions, the issuance, scope and enforceability of patents cannot be predicted with certainty. Patents, if issued, may be challenged, invalidated or circumvented. Thus, any patents that we own or license from others may not provide any protection against competitors.
We have been granted patents in the United States and Europe that encompass our ultra-rapid-acting formulations. In addition, we have several pending U.S. and corresponding foreign and international patent applications relating to ultra-rapid-acting insulin formulations and our other potential product candidates. These pending patent applications, those we may file in the future, or those we may license from third parties, may not result in patents being issued. If patents do not issue with claims encompassing our products, our competitors may develop and market similar or identical products that compete with ours. Even if patents are issued, they may not provide us with proprietary protection or competitive advantages against competitors with similar technology. Failure to obtain effective patent protection for our technology and products may reduce demand for our products and prevent us from establishing collaborative relationships on
favorable terms.
Certain of the active and inactive ingredients in our RHI- and insulin analog-based formulations have been known and used for many years and are not subject to patent protection. Accordingly, our granted U.S. and foreign patents and pending patent applications are directed to the particular formulations of these ingredients in our products, and their use. Although we believe our formulations and their use are patentable and provide a competitive advantage, even if issued our patents may not prevent others from marketing formulations using the same active and inactive ingredients in similar but different formulations.
We also rely on trade secrets, know-how and technology, which are not protected by patents, to maintain our competitive position. We try to protect this information by entering into confidentiality agreements with parties that have access to it, such as potential corporate partners, collaborators, employees and consultants. Any of these parties may breach the agreements and disclose our confidential information or our competitors may learn of the information in some other way. Furthermore, others may independently develop similar technologies or duplicate any technology that we have developed. If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed by a competitor, our business and financial condition could be materially adversely affected.
The laws of many foreign countries do not protect intellectual property rights to the same extent as do the laws of the United States. Accordingly, the fact that we have obtained certain patent rights in the United States does not guarantee that we will be able to obtain the same or similar rights elsewhere. Even if we are granted patents in foreign countries, we cannot guarantee that we will be able to enforce our rights effectively.
We may become involved in lawsuits and administrative proceedings to protect, defend or enforce our patents that would be expensive and time-consuming.
In order to protect or enforce our patent rights, we may initiate patent litigation against third parties in the United States or in foreign countries. In addition, we may be subject to certain opposition proceedings conducted in patent and trademark offices challenging the validity of our patents and may become involved in future opposition proceedings challenging the patents of others. The defense of intellectual property rights, including patent rights, through lawsuits, interference or opposition proceedings, and other legal and administrative proceedings can be costly and can divert our technical and management personnel from their normal responsibilities. Such costs increase our operating losses and reduce our resources available for development activities. An adverse determination of any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our
patent applications at risk of not issuing.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. For example, during the course of this kind of litigation and despite protective orders entered by the court, confidential information may be inadvertently disclosed in the form of documents or testimony in connection with discovery requests, depositions or trial testimony. This disclosure could materially adversely affect our business and financial results.
Claims by other parties that we infringe or have misappropriated their proprietary technology may result in liability for damages, royalties, or other payments, or stop our development and commercialization efforts.
Competitors and other third parties may initiate patent litigation against us in the United States or in foreign countries based on existing patents or patents that may be granted in the future. Many of our competitors may have obtained patents covering products and processes generally related to our products and processes, and they may assert these patents against us. Moreover, there can be no assurance that these competitors have not sought or will not seek additional patents that may cover aspects of our technology. As a result, there is a greater likelihood of a patent dispute than would be expected if our competitors were pursuing unrelated technologies.
While we conduct patent searches to determine whether the technologies used in our products infringe patents held by third parties, numerous patent applications are currently pending and may be filed in the future for technologies generally related to our technologies, including many patent applications that remain confidential after filing. Due to these factors and the inherent uncertainty in conducting patent searches, there can be no guarantee that we will not violate third-party patent rights that we have not yet identified.
There may be U.S. and foreign patents issued to third parties that relate to aspects of our product candidates. There may also be patent applications filed by these or other parties in the United States and various foreign jurisdictions that relate to some aspects of our product candidates, which, if issued, could subject us to infringement actions. The owners or licensees of these and other patents may file one or more infringement actions against us. In addition, a competitor may claim misappropriation of a trade secret by an employee hired from that competitor. Any such infringement or misappropriation action could cause us to incur substantial costs defending the lawsuit and could

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distract our management from our business, even if the allegations of infringement or misappropriation are unwarranted. A need to defend multiple actions or claims could have a disproportionately greater impact. In addition, either in response to or in anticipation of any such infringement or misappropriation claim, we may enter into commercial agreements with the owners or licensees of these rights. The terms of these commercial agreements may include substantial payments, including substantial royalty payments on revenues received by us in connection with the commercialization of our products.
Payments under such agreements could increase our operating losses and reduce our resources available for development activities. Furthermore, a party making this type of claim could secure a judgment that requires us to pay substantial damages, which would increase our operating losses and reduce our resources available for development activities. A judgment could also include an injunction or other court order that could prevent us from making, using, selling, offering for sale or importing our products or prevent our customers from using our products. If a court determined or if we independently concluded that any of our products or manufacturing processes violated third-party proprietary rights, our clinical trials could be delayed and there can be no assurance that we would be able to reengineer the product or processes to avoid those rights, or to obtain a license under those rights on commercially reasonable terms, if at all.
Risks Related to Regulatory Approval of Our Product Candidates
If the FDA does not believe that our product candidates satisfy the requirements for the Section 505(b)(2) approval procedure, or if the requirements for our product candidates under Section 505(b)(2) are not as we expect, the approval pathway will take longer and cost more than anticipated and in either case may not be successful.
We believe our ultra-rapid acting insulin formulations and our liquid formulation of glucagon for use as a rescue product qualify for approval under Section 505(b)(2) of the FFDCA. Because we are developing new formulations of previously approved chemical entities, such as insulin and glucagon, this may enable us to avoid having to submit certain types of data and studies that are required in full NDAs and instead submit an NDA under Section 505(b)(2). The FDA has not published any guidance that specifically addresses an NDA for an insulin or glucagon product candidate under Section 505(b)(2). We are not aware of any insulin product that has been approved pursuant to an NDA under Section 505(b)(2). If the FDA determines that NDAs under Section 505(b)(2) are not appropriate and that full NDAs are required for our product candidates, we would have to conduct additional studies, provide additional data and information, and meet additional
standards for approval. The time and financial resources required to obtain FDA approval for our product candidates could substantially and materially increase. This would require us to obtain substantially more funding than previously anticipated which could significantly dilute the ownership interests of our stockholders. Even with this investment, the prospect for FDA approval may be significantly lower. If the FDA requires full NDAs for our product candidates or requires more extensive testing and development for some other reason, our ability to compete with alternative products that arrive on the market more quickly than our product candidates would be adversely impacted.
Notwithstanding the approval of many products by the FDA under Section 505(b)(2) over the last few years, certain brand-name pharmaceutical companies and others have objected to the FDAs interpretation of Section 505(b)(2). If the FDAs interpretation of Section 505(b)(2) is successfully challenged, the FDA may be required to change its interpretation of Section 505(b)(2) which could delay or even prevent the FDA from approving any NDA that we submit under Section 505(b)(2). The pharmaceutical industry is highly competitive, and it is not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending competing products. If successful, such petitions can significantly delay, or even prevent, the approval of the new product. However, even if the FDA ultimately denies such a petition, the FDA may substantially delay
approval while it considers and responds to the petition.
Moreover, even if one of our product candidates is approved under Section 505(b)(2), the approval may be subject to limitations on the indicated uses for which the product may be marketed or to other conditions of approval, or may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product.
Any product for which we obtain marketing approval could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.
Any product for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other state and federal regulatory authorities. These requirements include, in the case of FDA, submissions of safety and other post-marketing information and reports, registration requirements, cGMP requirements relating to quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping. Even if regulatory approval of a product is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to other conditions of approval, or may contain requirements for costly post-marketing testing and surveillance to monitor the safety
or efficacy of the product. In addition, if any of our product candidates are approved, our product labeling, advertising and promotion would be subject to regulatory requirements and continuing regulatory review. The FDA strictly regulates the promotional claims that may be made about prescription drug products. In particular, a drug may not be promoted in a misleading manner or for uses that are not approved by the FDA as reflected in the products approved labeling. The FDA and other state and federal entities actively enforce the laws and regulations prohibiting misleading promotion and the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.
Discovery after approval of previously unknown problems with our products, manufacturers or manufacturing processes, or failure to comply with state or federal regulatory requirements, may result in actions such as:

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restrictions on such products manufacturers or manufacturing processes;
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restrictions on the marketing or distribution of a product;
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requirements that we conduct new studies, make labeling changes, and implement Risk Evaluation and Mitigation Strategies;
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warning letters;
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withdrawal of the products from the market;
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refusal to approve pending applications or supplements to approved applications that we submit;
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recall of products;
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fines, restitution or disgorgement of profits or revenue;
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suspension or withdrawal of regulatory approvals;
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refusal to permit the import or export of our products;
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product embargo and/or seizure;
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injunctions; or
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imposition of civil or criminal penalties.
Changes in law, regulations, and policies may preclude approval of our product under a 505(b)(2) or make it more difficult and costly for us to obtain regulatory approval of our product candidates and to produce, market and distribute our existing products.
In March 2010, the President signed into law legislation creating an abbreviated pathway for approval under the Public Health Service, or PHS Act, of biological products that are similar to other biological products that are approved under the PHS Act. This legislation also expanded the definition of biological product to include proteins such as insulin. The new law contains transitional provisions governing protein products such as insulin that, under certain circumstances, might permit companies to seek approval for their insulin products as biologics under the PHS Act and might require that Biodels product be approved under the PHS Act rather than in a 505(b)(2) NDA. We would be unlikely to pursue approval of our RHI- or insulin analog-based product candidates if we were required to seek approval under the PHS Act rather than in a 505(b)(2) NDA.
In addition, the federal and state laws, regulations, policies or guidance may change in a manner that could prevent or delay regulatory approval of our product candidates or further restrict or regulate post-approval activities. It is impossible to predict whether additional legislative changes will be enacted, or FDA regulations, guidance or interpretations implemented or modified, or what the impact of such changes, if any, may be.
Failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our products abroad.
We intend to have our products marketed outside the United States. In order to market our products in the European Union and many other jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy and governing, among other things, clinical trials and commercial sales and distribution of our products. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ from that required to obtain FDA approval. The regulatory approval processes outside the United States may include all of the risks associated with obtaining FDA approval, as well as additional risks. In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved for sale in that country. We may not obtain approvals
from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. We may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our products in any market.
Reports of side effects or safety concerns in related technology fields or in other companies clinical trials could delay or prevent us from obtaining regulatory approval or negatively impact public perception of our product candidates.
At present, there are a number of clinical trials being conducted by us and by other pharmaceutical companies involving insulin or insulin delivery systems. The major safety concern with patients taking insulin is the occurrence of hypoglycemic events. If we discover that our product is associated with a significantly increased frequency of hypoglycemic or other adverse events, or if other pharmaceutical companies announce that they observed frequent or significant adverse events in their trials involving insulin or insulin delivery systems, we could encounter delays in the commencement or completion of our clinical trials or difficulties in obtaining the approval of our product candidates. In addition, the public perception of our products might be adversely affected, which could harm our business and results of operations, even if the concern relates to another companys product.

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Risks Related to Employee Matters and Managing Growth
Our future success depends on our ability to retain our chief executive officer and other key executives and to attract, retain and motivate qualified personnel.
We are highly dependent on Errol De Souza, our President and Chief Executive Officer, Gerard Michel, our Chief Financial Officer and Dr. Alan Krasner, our Chief Medical Officer. The loss of the services of any of these persons might impede the achievement of our research, development and commercialization objectives. Replacing key employees may be difficult and time-consuming because of the limited number of individuals in our industry with the skills and experiences required to develop, gain regulatory approval of and commercialize our product candidates successfully. We generally do not maintain key person life insurance to cover the loss of any of our employees.
Recruiting and retaining qualified scientific personnel, clinical personnel and sales and marketing personnel will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms, if at all, given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from other companies, universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.
We may expand our development, regulatory and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
If our development and commercialization plans for any of our product candidates are successful, we may experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of manufacturing, clinical trials management, and regulatory affairs. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems and continue to recruit and train additional qualified personnel. Due to our limited financial resources we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.
Risks Related to Our Common Stock
Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
Provisions in our corporate charter and bylaws may discourage, delay or prevent a merger, acquisition or other change in control of us that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Because our board of directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team.
Among others, these provisions:
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establish a classified board of directors such that not all members of the board are elected at one time;
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allow the authorized number of our directors to be changed only by resolution of our board of directors;
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limit the manner in which stockholders can remove directors from the board;
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establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our board of directors;
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require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent;
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limit who may call stockholder meetings;
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authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a stockholder rights plan or poison pill that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; and
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require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws.
In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which generally prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

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If our stock price is volatile, purchasers of our common stock could incur substantial losses.
Our stock price has been and may continue to be volatile. The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The market price for our common stock may be influenced by many factors, including:
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results of clinical trials of our product candidates or those of our competitors;
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regulatory or legal developments in the United States and other countries;
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variations in our financial results or those of companies that are perceived to be similar to us;
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developments or disputes concerning patents or other proprietary rights;
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the recruitment or departure of key personnel;
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changes in the structure of healthcare payment systems;
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market conditions in the pharmaceutical and biotechnology sectors and issuance of new or changed securities analysts reports or recommendations;
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general economic, industry and market conditions; and
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the other factors described in this Risk Factors section.
If we fail to continue to meet all applicable Nasdaq Capital Market requirements and Nasdaq determines to delist our common stock, the delisting could adversely affect the market liquidity of our common stock, impair the value of your investment and harm our business.
In November 2011, we received notice from the Nasdaq Listing Qualifications Department that our common stock had not met the Nasdaq Global Markets $1.00 per share minimum bid price requirement for thirty consecutive business days and that, if we were unable to demonstrate compliance with this requirement during the applicable cure periods, our common stock would be delisted. As part of our steps to regain compliance with Nasdaq listing requirements, we transferred the listing of our common stock from the Nasdaq Global Market to the Nasdaq Capital Market on May 11, 2012. In addition, we effected a one-for-four reverse split of our common stock on June 11, 2012. On June 26, 2012, we were informed by the Nasdaq staff that we had regained compliance with the applicable listing requirements because the closing bid price of our common stock was at $1.00 per share or greater for at least 10 business days.
Following the reverse stock split, the lowest trading price for our common stock was $2.19 per share and the last reported sale
price of the common stock on August 13, 2012 was $2.97 per share. However, the reverse stock split may not prevent the price of our common stock from dropping below the Nasdaq minimum bid price requirement
in the future. If we fail to continue to meet all applicable Nasdaq Capital Market requirements in the future and Nasdaq determines to delist our common stock, the delisting could adversely affect the market
liquidity of our common stock, adversely affect our ability to obtain financing for the continuation of our operations and harm our business. This delisting could also impair the value of your investment.
Our outstanding warrants may be exercised, and our outstanding shares of preferred stock may be converted, in the future, which would increase the number of shares in the public market and result in dilution to our stockholders.
As a result of our May 2011 registered direct offering and June 2012 private placement, we have outstanding warrants to purchase 2,256,929 shares of our common stock at $9.92 per share and 2,749,469 shares of our common stock at $2.66 per share. The $9.92 per share warrants expire in May 2016 and the $2.66 per share warrants expire in June 2017. We also have outstanding shares of series A convertible preferred stock that are convertible into 453,486 shares of common stock and shares of series B preferred stock that are convertible into 3,605,607 shares of common stock. The exercise of these warrants for, or the conversion of shares of series A preferred stock or series B preferred stock into, shares of common stock would be substantially dilutive to the outstanding shares of common stock. Any dilution or potential dilution may cause our stockholders to sell their shares, which would contribute to a downward movement in the stock price of
our common stock.
We have never paid any cash dividends on our capital stock and we do not anticipate paying any cash dividends in the foreseeable future.
We have paid no cash dividends on our capital stock to date. We currently intend to retain our future earnings, if any, to fund the development and growth of our business. In addition, the terms of any future debt agreements may preclude us from paying dividends. As a result, we do not expect to pay any cash dividends in the foreseeable future, and payment of cash dividends, if any, will depend on our financial condition, results of operations, capital requirements and other factors and will be at the discretion of our board of directors. Furthermore, we may in the future become subject to contractual restrictions on, or prohibitions against, the payment of dividends. Capital appreciation, if any, of our common stock will be investors sole source of gain for the foreseeable future.

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We incur substantial costs as a result of operating as a public company, and our management is required to devote substantial time to comply with public company regulations.
We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act of 2002 as well as other federal and state laws. These requirements may place a strain on our people, systems and resources. The Exchange Act requires that we file annual, quarterly and current reports with respect to our business and financial condition. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal controls over financial reporting. In order to maintain and improve the effectiveness of our disclosure controls and procedures and internal controls over financial reporting, significant resources and management oversight will be required. This may divert managements attention from other business concerns, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Risks Related to our June 2012 Private Placement
The number of shares of our common stock outstanding has increased substantially as a result of our June 2012 private placement, and some of the purchasers in the private placement beneficially own significant blocks of our common stock; the securities that we issued in the private placement will be generally available for resale in the public market upon registration under the Securities Act of 1933, as amended, or the Securities Act.
In June 2012, we completed our 2012 private placement of an aggregate of 4,250,020 shares of our common stock, 3,605,607 shares of our series B preferred stock and warrants to purchase an aggregate of 2,749,469 shares of our common stock. The issuance of these shares and warrants resulted in substantial dilution to stockholders who held our common stock prior to the 2012 private placement. Some of the purchasers in the private placement will have significant influence over the outcome of any stockholder vote, including the election of directors and the approval of mergers or other business combination transactions.
Pursuant to the securities purchase agreement that we entered into with the purchasers in the 2012 private placement, we filed with the Securities and Exchange, or the SEC, a registration statement to register the resale of the shares of common stock and series B preferred stock issued and sold in the private placement, the shares of common stock issuable upon conversion of the series B preferred stock issued and sold in the private placement, and the shares of common stock issuable upon exercise of the warrants issued and sold in the private placement. Upon such registration, these securities will become generally available for immediate resale in the public market. The market price of our common stock could fall as a result of an increase in the number of shares available for sale in the public market.
If we do not obtain and maintain effectiveness of the registration statement, we will be required to pay certain liquidated damages, which could be material in amount.
Pursuant to the terms of the securities purchase agreement that we entered into with the purchasers in the 2012 private placement, we have agreed to pay
liquidated damages to such purchasers if the registration statement we filed with the SEC, which was declared effective on August 13, 2012, is suspended or ceases to remain continuously effective as to all the securities for
which it is required to be effective. We refer to such an event as a registration default. Subject to the specified exceptions, for each 30-day period or portion thereof
during which a registration default remains uncured, we are obligated to pay liquidated damages to each purchaser in cash in an amount equal to 1% of the aggregate purchase price
paid by each such purchaser in the private placement, up to a maximum of 8% of such aggregate purchase price. These amounts could be material, and any liquidated damages we are required to pay could have a material
adverse effect on our financial condition.



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Item 6.
Exhibits
Exhibit No.

Description3.01

Registrants Second Amended and Restated Certificate of Incorporation (Incorporated by reference to Exhibit 3.4 to the Registrants Registration Statement on Form S-1 (SEC File No. 333-140504))3.02

Certificate of Designation of Series A Convertible Preferred Stock of the Registrant (Incorporated by reference to exhibit 4.6 to the Registrants Current Report on Form 8-K filed on May 19, 2011)3.03

Certificate of Amendment to Registrants Second Amended and Restated Certificate of Incorporation, as amended (Incorporated by reference to Exhibit 3.1 to the Registrants Current Report on Form 8-K filed on June 11, 2012)3.04

Certificate of Designation of Series B Convertible Preferred Stock of the Registrant (Incorporated by reference to Exhibit 4.8 to the Registrants Current Report of Form 8-K filed on June 27, 2012)4.01

Form of Warrant issued in the Registrants June 2012 private placement (Incorporated by reference to Exhibit 4.9 to the Registrants Current Report on Form 8-K filed on June 21, 2012)10.01*

License Agreement, effective as of June 8, 2012, between Aegis Therapeutics, LLC and the Registrant10.02

Securities Purchase Agreement, dated as of June 21, 2012, among the Registrant and the purchasers named therein ((Incorporated by reference to Exhibit 10.1 to the Registrants Current Report on Form 8-K filed on June 21, 2012)12.01

Statement re: Calculation of Ratio of Earnings to Fixed Charges and Preference Dividends31.01

Chief Executive OfficerCertification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.31.02

Chief Financial OfficerCertification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.32.01

Chief Executive Officer and Chief Financial OfficerCertification pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.


__________

*
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.


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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
BIODEL INC.Dated: August 14, 2012
By:
/s/ Gerard MichelGerard Michel, Chief Financial Officer,VP Corporate Development, and Treasurer


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Exhibit No.

Description3.01

Registrants Second Amended and Restated Certificate of Incorporation (Incorporated by reference to Exhibit 3.4 to the Registrants Registration Statement on Form S-1 (SEC File No. 333-140504))3.02

Certificate of Designation of Series A Convertible Preferred Stock of the Registrant (Incorporated by reference to exhibit 4.6 to the Registrants Current Report on Form 8-K filed on May 19, 2011)3.03

Certificate of Amendment to Registrants Second Amended and Restated Certificate of Incorporation, as amended (Incorporated by reference to Exhibit 3.1 to the Registrants Current Report on Form 8-K filed on June 11, 2012)3.04

Certificate of Designation of Series B Convertible Preferred Stock of the Registrant (Incorporated by reference to Exhibit 4.8 to the Registrants Current Report of Form 8-K filed on June 27, 2012)4.01

Form of Warrant issued in the Registrants June 2012 private placement (Incorporated by reference to Exhibit 4.9 to the Registrants Current Report on Form 8-K filed on June 21, 2012)10.01*

License Agreement, effective as of June 8, 2012, between Aegis Therapeutics, LLC and the Registrant10.02

Securities Purchase Agreement, dated as of June 21, 2012, among the Registrant and the purchasers named therein ((Incorporated by reference to Exhibit 10.1 to the Registrants Current Report on Form 8-K filed on June 21, 2012)12.01

Statement re: Calculation of Ratio of Earnings to Fixed Charges and Preference Dividends31.01

Chief Executive OfficerCertification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.31.02

Chief Financial OfficerCertification pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.32.01

Chief Executive Officer and Chief Financial OfficerCertification pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.


__________

*
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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