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SECURITIES AND EXCHANGE
    COMMISSION
 Washington, D.C.
    20549
  Form 10-K
   (Mark One)þ

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
    OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended
    September 30,
    2010oro

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

90-0136863(State or Other Jurisdiction
    of
    Incorporation or Organization)

(I.R.S. Employer
    Identification No.)100 Saw Mill Road
    Danbury, CT(Address of Principal
    Executive Offices)

06810(Zip
    Code)   Registrants
    telephone number, including area code(203) 796-5000
 Securities registered pursuant to Section 12(b) of the
    Act:
  Title of Each Class

Name of Each Exchange on Which RegisteredCommon Stock, par value $0.01 per share

The NASDAQ Global Market   Securities registered pursuant to Section 12(g) of the
    Act:
 None
  o þ
  o þ
  þ o
  Regulation S-T o o
  Regulation S-K Form 10-K Form 10-K. o
  Rule 12b-2
  Large accelerated filer o



Accelerated filer þNon-accelerated filer o



Smaller reporting company o(Do not check if a smaller reporting company)   o þ
      Form 10-K Form 10-K.




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BIODEL
    INC.
  INDEX TO
    REPORT ON
    FORM 10-K
   
 PagePART IItem 1:


Business


3Item 1A:


Risk Factors


18Item 1B:


Unresolved Staff Comments


36Item 2:


Properties


36Item 3:


Legal Proceedings


37Item 4:


Removed and Reserved


37PART IIItem 5:


Market for Registrants Common Equity,
    Related Stockholder Matters and Issuer Purchases of Equity
    Securities


37Item 6:


Selected Financial Data


38Item 7:


Managements Discussion and Analysis of
    Financial Condition and Results of Operations


39Item 7A:


Quantitative and Qualitative Disclosures About
    Market Risk


53Item 8:


Financial Statements and Supplementary Data


53Item 9:


Changes in and Disagreements With Accountants on
    Accounting and Financial Disclosures


53Item 9A:


Controls and Procedures


53Item 9B:


Other InformationPART IIIItem 10:


Directors, Executive Officers and Corporate
    Governance


56Item 11:


Executive Compensation


56Item 12:


Security Ownership of Certain Beneficial Owners
    and Management and Related Stockholder Matters


56Item 13:


Certain Relationships and Related Transactions,
    and Director Independence


56Item 14:


Principal Accountant Fees and Services


56PART IVItem 15:


Exhibits and Financial Statement Schedules


56EX-10.23EX-10.24EX-21.1EX-23.1EX-31.01EX-31.02EX-32.01   i




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FORWARD-LOOKING
    STATEMENTS
  Form 10-K tm Form 10-K
  Form 10-K
  
    our ability to respond to the complete response letter regarding
    our NDA for
    Linjetatm

    (formerly known as
    VIAject®)

    in a timely manner and the possibility that information we
    provide in response to the letter may not be sufficient for the
    approval of
    Linjetatm

    or another rapid-acting insulin or insulin analog by the
    U.S. Food and Drug Administration, or FDA;
    our ability to secure approval by the FDA for our product
    candidates under Section 505(b)(2) of the Federal Food, Drug and
    Cosmetic Act, or FFDCA, and the degree to which we are able to
    clarify with the FDA related regulatory requirements;
    our ability to conduct the additional pivotal clinical trials
    the FDA requested in the complete response letter or other tests
    or analyses required by the FDA to secure approval to
    commercialize
    Linjetatm;
    our ability to develop and commercialize formulations of
    Linjetatm

    or other rapid-acting insulin or insulin analog formulations
    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 progress, timing or success of our product candidates,
    particularly
    Linjetatm,

    and that of our research, development and clinical programs,
    including any resulting data analyses;
    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 patent for
    Linjetatm

    and our ability to secure additional patents for
    Linjetatm

    and for our other 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, including suppliers of
    insulin, to produce our product or 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.   1




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Form 10-K
 2




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PART I  ITEM 1:
    BUSINESS  Overview
  tm ® tm tm
      LinjetatmDevelopment
    Status. tm tm tm ® tm ®
  tm tm tm tm
  tm tm
 3




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tm
  Other Corporate Developments. tm
      tm ®
  tm tm
  Fiscal Year 2011 Strategic Focus. tm
  
    Determine Whether to Advance our Current Formulation of
    Linjetatm

    through Pivotal Phase 3 Clinical Trials.  In light
    of the extensive nature of the FDAs comments regarding our
    NDA, we do not anticipate commencing new pivotal Phase 3
    clinical trials with our current formulation of
    Linjetatm

    prior to meeting with the FDA and, separately, determining
    whether one of our other proprietary rapid-acting insulin or
    insulin analog formulations should be advanced in its place.
    These alternate formulations generally use the same or similar
    excipients as
    Linjetatm,

    but may present improvements with regard to injection site
    discomfort. In fiscal year 2011, we intend to conduct
    preclinical studies and Phase 1 clinical trials studies to
    determine whether one or more of our newer insulin formulations
    is likely to offer a combination of pharmacokinetic, stability
    and tolerability characteristics that is preferable to
    Linjetatm.

    Following our meeting with the FDA regarding
    Linjetatm,

    and based on our analysis of the preclinical and Phase 1
    clinical data for our alternate formulations, we will determine
    the number, type and duration of additional trials we intend to
    conduct prior to initiating Phase 3 clinical trials with a
    proprietary rapid-acting insulin.
    Advance
    Proof-of-Concept
    Formulations.  We intend to make limited
    investments in our
    VIAtabtm,

    glucagon, extended glargine and glucose-sensing basal insulin
    development programs. Our goal is to advance
    proof-of-concept
    formulations that we can discuss with potential corporate
    partners. Because we are focusing on therapeutic indications in
    large markets, we believe that these larger companies have the
    marketing, sales and financial resources to maximize the
    commercial potential of our technologies and products. 4




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Diabetes
    and the Insulin Market
  Diabetes
    Overview
            New
    England Journal of Medicine,
 5




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First
    Phase Insulin Release
  
  Current
    Treatments for Diabetes and their Limitations
          ® ® ®
 6




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A More
    Rapid-Acting Mealtime Insulin
  tm tm tm tm
  Clinical
    Trials of
    Linjetatm
  Phase 1 and Phase 2 Clinical Trials. tm ® ® tm
  Pivotal Phase 3 Clinical Trials. tm tm ® tm tm ® tm ®
  tm
  tm ® ® ®
  tm tm
 7




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tm tm tm
  Complete Response Letter. tm intent-to-treat tm
  Tolerability. tm tm tm
  tm tm ® tm tm ® tm tm tm ®
  tm tm tm tm
 8




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tm tm
  Use of
    Linjetatm

    in Insulin Pumps. tm ® tm ® tm ® tm ® tm
  Development status. tm tm tm tm
  Government
    Regulation
    United
    States Government Regulation
    
    completion of extensive nonclinical laboratory tests, animal
    studies and formulation studies, all performed in accordance
    with the FDAs Good Laboratory Practice, or GLP,
    regulations;
    submission to the FDA of an IND which must become effective
    before human clinical trials may begin; 9




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
    for some products, performance of adequate and well-controlled
    human clinical trials in accordance with the FDAs
    regulations, including Good Clinical Practices, to establish the
    safety and efficacy of the product candidate for each proposed
    indication;
    submission to the FDA of an NDA;
    satisfactory completion of an FDA preapproval inspection of the
    manufacturing facilities at which the product is produced to
    assess compliance with current Good Manufacturing Practice, or
    cGMP, regulations; and
    FDA review and approval of the NDA prior to any commercial
    marketing, sale or shipment of the drug.    30-day
  Clinical Trials.
    
    Phase 1 clinical trials typically involve the initial
    introduction of the product candidate into healthy human
    volunteers. In Phase 1 clinical trials, the product candidate is
    typically tested for safety, dosage tolerance, absorption,
    metabolism, distribution, excretion and pharmacodynamics.
    Phase 2 clinical trials are conducted in a limited patient
    population to gather evidence about the efficacy of the product
    candidate for specific, targeted indications; to determine
    dosage tolerance and optimal dosage; and to identify possible
    adverse effects and safety risks.
    Phase 3 clinical trials are undertaken to evaluate clinical
    efficacy and to test for safety in an expanded patient
    population at geographically dispersed clinical trial sites. The
    size of Phase 3 clinical trials depends upon clinical and
    statistical considerations for the product candidate and
    disease, but sometimes can include several thousand patients.
    Phase 3 clinical trials are intended to establish the overall
    risk-benefit ratio of the product candidate and provide an
    adequate basis for product labeling.   10




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New Drug Applications.
    Section 505(b)(2) NDAs.
   11




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Patent Protections.
      Marketing Exclusivity.
 12




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Other Regulatory Requirements.
  
    record-keeping requirements;
    reporting of adverse experiences with the drug;
    providing the FDA with updated safety and efficacy information;
    reporting on advertisements and promotional labeling;
    drug sampling and distribution requirements; and
    complying with electronic record and signature requirements.   13




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Regulations
    Outside the United States
      Competition
    tm ® ® ®
  tm
 14




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® ® ® ®
      ® ® ® ® ® tm
  Intellectual
    Property and Proprietary Technology
    tm tm
  tm tm
    
    one granted United States patent, three foreign patents, and
    several pending United States patent applications and
    corresponding foreign and international patent applications
    relating to our
    Linjetatm

    and
    VIAtabtm

    technology;
    one foreign patent and one pending foreign patent application
    relating to our technology for enhancing delivery of drugs in a
    form for absorption through the skin into the blood, a process
    known as transdermal drug delivery;
    one granted United States patent, one foreign patent, one
    pending United States patent application and corresponding
    foreign patent applications relating to sublingual
    and/or oral
    delivery devices that can be used to deliver the certain insulin
    based products; and
    two granted United States patents, several United States patent
    applications and a corresponding foreign and international
    patent applications relating to other early stage product
    candidates.    tm tm
 15




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Manufacturing
  tm tm
  tm
  Sales and
    Marketing
    Employees
    Additional
    Information
  www.biodel.com. Form 10-K. Form 10-K, Form 10-Q, Form 8-K www.sec.gov.
 16




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Executive
    Officers of the Registrant
    Name

Age

PositionDr. Errol B. De Souza


57


President and Chief Executive OfficerDr. Solomon S. Steiner


73


Chief Scientific OfficerGerard Michel


47


Chief Financial Officer, Vice President, Corporate Development
    and TreasurerDr. Alan Krasner


47


Chief Medical OfficerPaul Bavier


38


General Counsel and SecretaryErik Steiner


44


Vice President, Operations   Dr. De Souza
  Dr. Solomon S. Steiner
  Mr. Gerard Michel
  Dr. Alan Krasner
 17




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Mr. Paul Bavier
  Mr. Erik Steiner
  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.
  tm tm tm tm tm tm tm
  
    conduct pre-clinical studies and Phase 1 clinical trials to
    study formulations of
    Linjetatm

    and other related rapid-acting insulin and insulin analog
    formulations that 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;
    commence a stability program to determine whether any of our
    alternate formulations of rapid-acting insulins or insulin
    analogs are likely to present a commercially acceptable
    stability profile;
    conduct additional clinical trials of
    Linjetatm,

    including two potential pivotal Phase 3 clinical trials
    requested by the FDA to support approval; 18




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
    produce additional validation batches of
    Linjetatm

    vials, cartridges, and disposable pens to support our NDA for
    Linjetatm;
    purchase recombinant human insulin and other materials
    consistent with our existing contractual obligations; and
    conduct additional clinical development of our other product
    candidates.    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.
  tm tm tm
    
    our ability to respond to the complete response letter regarding
    our NDA for
    Linjetatm

    in a timely manner and the possibility that information we
    provide in response to the letter may not be sufficient for the
    approval of
    Linjetatm

    or another rapid-acting insulin or insulin analog by the FDA;
    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 the additional pivotal clinical trials
    that the FDA requested in the complete response letter or other
    tests or analyses required by the FDA to secure approval to
    commercialize
    Linjetatm;
    our ability to develop and commercialize formulations of
    Linjetatm

    or other rapid-acting insulin or insulin analog formulations
    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; 19




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
    the progress, timing or success of our product candidates,
    particularly
    Linjetatm,

    and that of our research, development and clinical programs,
    including any resulting data analyses;
    the cost to develop an insulin pen for use with
    Linjetatm

    and a formulation of
    Linjetatm

    for use 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 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.    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.
      Risks
    Related to the Development and Commercialization of Our Product
    Candidates
  We
    have depended heavily on the success of our most advanced
    product candidate,
    Linjetatm .
  tm tm tm tm
 20




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Our
    development of alternate formulations of
    Linjetatmor other rapid-acting mealtime insulins or insulin analogs may
    not be successful; some formulations may have different
    regulatory requirements to obtain marketing approval from the
    FDA.
  tm tm tm tm
  We may
    never reinitiate significant expenditures on our earlier stage
    product candidates.
  tm
  The
    results of clinical trials do not ensure success in future
    clinical trials or commercial success.
  tm tm tm tm tm
    
    successful completion of preclinical development and clinical
    trials;
    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 to
    Linjetatm

    or any rapid or long-acting insulin or insulin analog, 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. 21




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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.
  tm
  
    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.    
    be delayed in obtaining marketing approval for our product
    candidates;
    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.    If our
    product candidates are found to cause undesirable side effects
    we may need to delay or abandon our development and
    commercialization efforts.
   22




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
    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
    the need to conduct additional clinical trials.    tm tm tm ®
  The
    commercial success of any product candidates that we may
    develop, including
    Linjetatm,

    will depend upon the degree of market acceptance by physicians,
    patients, healthcare payors and others in the medical
    community.
  tm tm
    
    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
    Linjetatm,

    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. 23




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If we
    fail to enter into strategic collaborations for the
    commercialization of our product candidates or if our
    collaborations are unsuccessful, 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.
      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.
    
    a covered benefit under its health plan;
    safe, effective and medically necessary;
    appropriate for the specific patient;
    cost-effective; and
    neither experimental nor investigational.   24




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We may
    be subject to pricing pressures and uncertainties regarding
    Medicare reimbursement and reform.
    Governments
    outside the United States tend to impose strict price controls,
    which may adversely affect our revenues, if any.
      Product
    liability lawsuits against us could cause us to incur
    substantial liabilities and to limit commercialization of any
    products that we may develop.
    
    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
    the inability to commercialize any products that we may develop.  tm
 25




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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.
  ® ® ® tm ® ® ® ®
      ® ® ® ® ® tm
      
    significantly greater financial, technical and human resources
    than we have and may be better equipped to discover, develop,
    manufacture and commercialize product candidates;
    more extensive experience in preclinical testing and clinical
    trials, obtaining regulatory approvals and manufacturing and
    marketing pharmaceutical products;
    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. 26




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Our
    product candidates may be rendered obsolete by technological
    change.
    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.
    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.
  tm
  tm
 27




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
    reliance on the third party for regulatory compliance and
    quality assurance;
    the possible breach of the manufacturing agreement by the third
    party because of factors beyond our control; and
    the possible refusal by the third party to support our
    manufacturing programs, based on its own business priorities, at
    a time that is costly or inconvenient for us.        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.
   28




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If our
    suppliers, principally our sole insulin supplier, fail to
    deliver materials and provide services needed for the production
    of
    Linjetatmor any alternative rapid-acting insulin or insulin analog in a
    timely and sufficient manner, or if they fail to comply with
    applicable regulations, clinical development or regulatory
    approval of our product candidates or commercialization of our
    products could be delayed, producing additional losses and
    depriving us of potential product revenue.
    tm
  tm tm tm
  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.
    
    receiving patent protection for our product candidates;
    maintaining our trade secrets;
    not infringing on the proprietary rights of others; and
    preventing others from infringing our proprietary rights.   29




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tm tm
  tm tm
      We may
    become involved in lawsuits and administrative proceedings to
    protect, defend or enforce our patents that would be expensive
    and time-consuming.
     30




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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.
          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
    Linjetatmunder 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.
  tm
 31




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tm
  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.
      
    restrictions on such products manufacturers or
    manufacturing processes;
    restrictions on the marketing or distribution of a product;
    requirements that we conduct new studies, make labeling changes,
    and implement Risk Evaluation and Mitigation Strategies;
    warning letters; 32




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
    withdrawal of the products from the market;
    refusal to approve pending applications or supplements to
    approved applications that we submit;
    recall of products;
    fines, restitution or disgorgement of profits or revenue;
    suspension or withdrawal of regulatory approvals;
    refusal to permit the import or export of our products;
    product embargo
    and/or
    seizure;
    injunctions; or
    imposition of civil or criminal penalties.  Changes
    in law, regulations, and policies legislation 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.
      Failure
    to obtain regulatory approval in international jurisdictions
    would prevent us from marketing our products
    abroad.
   33




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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.
    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 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.
    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.
   34




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##### Table of Contents




    establish a classified board of directors such that not all
    members of the board are elected at one time;
    allow the authorized number of our directors to be changed only
    by resolution of our board of directors;
    limit the manner in which stockholders can remove directors from
    the board;
    establish advance notice requirements for stockholder proposals
    that can be acted on at stockholder meetings and nominations to
    our board of directors;
    require that stockholder actions must be effected at a duly
    called stockholder meeting and prohibit actions by our
    stockholders by written consent;
    limit who may call stockholder meetings;
    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
    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.    If our
    stock price is volatile, purchasers of our common stock could
    incur substantial losses.
    
    results of clinical trials of our product candidates or those of
    our competitors;
    regulatory or legal developments in the United States and other
    countries;
    variations in our financial results or those of companies that
    are perceived to be similar to us;
    developments or disputes concerning patents or other proprietary
    rights;
    the recruitment or departure of key personnel;
    changes in the structure of healthcare payment systems;
    market conditions in the pharmaceutical and biotechnology
    sectors and issuance of new or changed securities analysts
    reports or recommendations;
    general economic, industry and market conditions; and
    the other factors described in this Risk Factors
    section. 35




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##### Table of Contents



Our
    outstanding warrants may be exercised in the future, which would
    increase the number of shares in the public market and result in
    dilution to our stockholders.
  tm
  We
    have never paid any cash dividends on our capital stock and we
    do not anticipate paying any cash dividends in the foreseeable
    future.
    A
    significant portion of our total outstanding shares are
    restricted from immediate resale but may be sold into the market
    in the near future. This could cause the market price of our
    common stock to drop significantly, even if our business is
    doing well.
    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.
    ITEM 1B.
    UNRESOLVED
    STAFF COMMENTS    ITEM 2.
    PROPERTIES   36




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##### Table of Contents



ITEM 3.
    LEGAL
    PROCEEDINGS    ITEM 4.
    REMOVED
    AND RESERVED PART II-OTHER
    INFORMATION  ITEM 5.
    MARKET
    FOR REGISTRANTS COMMON EQUITY, RELATED STOCKHOLDER MATTERS
    AND ISSUER PURCHASES OF EQUITY SECURITIES  Market
    Information
      Quarter Ended

High

LowDecember 31, 2008

$
4.99


$
1.62March 31, 2009

$
6.00


$
3.29June 30, 2009

$
6.02


$
3.64September 30, 2009

$
5.48


$
4.46December 31, 2009

$
5.39


$
3.29March 31, 2010

$
5.30


$
3.22June 30, 2010

$
6.25


$
3.74September 30, 2010

$
6.08


$
3.25     Holders
    Dividends
    Equity
    Compensation Plan Information
    Issuer
    Purchases of Equity Securities
   37




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##### Table of Contents



ITEM 6.
    SELECTED
    FINANCIAL DATA    Year Ended September 30,2006


2007


2008


2009


2010(In thousands, except share and per share amounts)Statement of operations data:Revenue

$



$



$



$



$
Operating expenses:Research and development


5,987



15,939



32,554



32,325



26,177General and administrative


1,548



8,386



14,800



10,994



10,980Total operating expenses


7,535



24,325



47,354



43,319



37,157Other (income) and expense:Interest and other income


(182
)


(1,902
)


(3,010
)


(386
)


(17
)Interest expense


78















Adjustment to fair value of common stock warrant liability


















1,254Loss on settlement of debt


627















Loss before tax provision (benefit)


(8,058
)


(22,423
)


(44,344
)


(42,933
)


(38,394
)Tax provision (benefit)


10



125



(983
)


337



(104
)Net loss


(8,068
)


(22,548
)


(43,361
)


(43,270
)


(38,290
)Charge for accretion of beneficial conversion rights


(603
)














Deemed dividend  warrants






(4,457
)










Net loss applicable to common stockholders

$
(8,671
)

$
(27,005
)

$
(43,361
)

$
(43,270
)

$
(38,290
)Net loss per share  basic and diluted

$
(1.05
)

$
(1.76
)

$
(1.94
)

$
(1.82
)

$
(1.58
)Weighted average shares outstanding  basic and diluted


8,252,113



15,354,898



22,390,434



23,746,598



24,161,866   As of September 30,2006

2007

2008

2009

2010(In thousands)Balance sheet data:Cash, cash equivalents, and marketable securities

$
17,539


$
80,022


$
90,283


$
54,640


$
28,923Working capital (deficit)


(15,307
)


75,244



84,377



46,787



25,178Total assets


18,659



82,506



97,511



59,625



32,616Deficit accumulated during the development stage


(12,828
)


(39,833
)


(83,194
)


(126,464
)


(164,754
)Total stockholders equity


16,348



77,223



88,487



50,538



24,060  38




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##### Table of Contents



ITEM 7
    MANAGEMENT
    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 and other financial
    information included elsewhere in this
    Form 10-K.
    Some of the information in this discussion and analysis or set
    forth elsewhere in this
    Form 10-K,
    including our plans and strategies for our business, includes
    forward-looking statements which involve risks and
    uncertainties. Please review the Forward-Looking
    Statements and the Risk Factors sections of
    this
    Form 10-K
    for a discussion of important factors that could cause actual
    results to materially differ from those anticipated or implied
    by the forward-looking statements contained in the following
    discussion and analysis.
  Overview
  tm ® tm tm
  tm tm tm ® tm
  tm tm tm
   39




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##### Table of Contents



tm
  and/or and/or
  Financial
    Operations Overview
  Revenues
    Research
    and Development Expenses
    
    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.    
    conduct preclinical studies and Phase 1 clinical trials to
    determine whether one or more of our newer insulin formulations
    is likely to offer a combination of pharmacokinetic, stability
    and tolerability characteristics that is preferable to
    Linjetatm;
    determine our preferred development, clinical and regulatory
    program for a proprietary rapid-acting insulin or insulin analog
    formulation following our meeting with the FDA regarding
    Linjetatm,

    and based on our analysis of the preclinical and Phase 1
    clinical data for our alternate insulin formulations;
    conduct preclinical studies with earlier stage product
    candidates and make limited investments in order to advance
    proof-of-concept
    formulations; and
    purchase recombinant human insulin and other materials as
    required under existing contractual commitments.  tm
 40




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##### Table of Contents



tm
    December 3,2003(Inception) toYear Ended September 30,


September 30,2008


2009


2010


2010(In thousands)Research and development expenses:Preclinical expenses

$
4,230


$
2,709


$
2,746


$
15,000Manufacturing expenses


6,728



11,674



8,894



30,955Clinical/regulatory expenses


21,596



17,942



14,537



70,273Total

$
32,554


$
32,325


$
26,177


$
116,228     
    our ability to respond to the complete response letter regarding
    our NDA for
    Linjetatm

    in a timely manner and the possibility that information we
    provide in response to the letter may not be sufficient for the
    approval of
    Linjetatm

    or another rapid-acting insulin or insulin analog by the FDA;
    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 the additional pivotal clinical trials
    the FDA requested in the complete response letter or other tests
    or analyses required by the FDA to secure approval to
    commercialize
    Linjetatm;
    our ability to develop and commercialize formulations of
    Linjetatm

    or other rapid-acting insulin or insulin analog formulations
    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 progress, timing or success of our product candidates,
    particularly
    Linjetatm,

    and that of our research, development and clinical programs,
    including any resulting data analyses;
    the cost to develop an insulin pen for use with
    Linjetatm

    and a formulation of
    Linjetatm

    for use 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 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. 41




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##### Table of Contents



tm
  General
    and Administrative Expenses
    tm
  Restricted
    Cash
    Marketable
    Securities
  available-for-sale. other-than-temporary,
  Pre-Launch
    Inventory
  tm tm
  Warrant
    Liability
   42




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##### Table of Contents



Comprehensive
    Loss
    Interest
    Income
    short-to-intermediate-term
  Exercise
    of Warrants
      tm
  Critical
    Accounting Policies and Significant Judgments and
    Estimates
   43




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##### Table of Contents



Form 10-K,
  Preclinical
    Study and Clinical Trial Accruals
    
    fees paid to contract research organizations in connection with
    preclinical and toxicology studies and clinical trials;
    fees paid to investigative sites in connection with clinical
    trials;
    fees paid to contract manufacturers in connection with the
    production of clinical trial materials; and
    professional service fees.  Share-Based
    Compensation
       44




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##### Table of Contents



718-10-55-37(c)
  non-directors,
    Income
    Taxes
       45




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##### Table of Contents



Results
    of Operations
  Year
    Ended September 30, 2010 Compared to Year Ended
    September 30, 2009
  Revenue.
  Research
    and Development Expenses.
  Year Ended September 30,


Decrease2009


2010


$


%In thousands, except per share amountsResearch and Development

$
32,325


$
26,177


$
6,148



19.0
%Percentage of net loss


74.7
%


68.4
%   tm share-based share-based
  tm
 46




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##### Table of Contents



General
    and Administrative Expenses.
  Year EndedSeptember 30,


Decrease2009


2010


$


%In thousands, except per share amountsGeneral and Administrative

$
10,994


$
10,980


$
14



0.1
%Percentage of net loss


25.5
%


28.7
%   share-based share-based
  tm
  Interest
    and Other Income.
  Year EndedSeptember 30,


Decrease2009


2010


$


%In thousands, except per share amountsInterest and Other Income

$
386


$
17


$
369



95.6
%Percentage of net loss


0.9
%


0.04
%     Interest Expense.
  Adjustments
    to Fair Value of Common Stock Warrant Liability.
  Year EndedSeptember 30,


Increase2009


2010


$


%In thousands, except per share amountsAdjustments to fair value of common stock warrant liability

$



$
1,254


$
1,254



100
%Percentage of net loss



%


3.3
%    47




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##### Table of Contents



Net Loss
    and Net Loss per Share.
  Year EndedSeptember 30,


Decrease2009


2010


$


%In thousands, except per share amountsNet loss

$
(43,270
)

$
(38,290
)

$
4,980



11.5
%Net loss per share

$
(1.82
)

$
(1.58
)     Year
    Ended September 30, 2009 Compared to Year Ended
    September 30, 2008
  Revenue.
  Research
    and Development Expenses.
  Year EndedSeptember 30,


Decrease2008


2009


$


%In thousands, except per share amountsResearch and Development

$
32,554


$
32,325


$
229



0.7
%Percentage of net loss


75.1
%


74.7
%   tm share-based
  General
    and Administrative Expenses.
  Year EndedSeptember 30,


Decrease2008


2009


$


%In thousands, except per share amountsGeneral and Administrative

$
14,800


$
10,994


$
3,806



25.7
%Percentage of net loss


33.1
%


25.5
%   share-based
 48




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##### Table of Contents



Interest
    and Other Income.
  Year EndedSeptember 30,


Decrease2008


2009


$


%In thousands, except per share amountsInterest and Other Income

$
3,010


$
386


$
2,624



87.2
%Percentage of net loss


6.8
%


0.9
%     Interest Expense.
  Net Loss
    and Net Loss per Share.
  Year EndedSeptember 30,


Decrease2008


2009


$


%In thousands, except per share amountsNet loss

$
(43,361
)

$
(43,270
)

$
91



0.2
%Net loss per share

$
(1.94
)

$
(1.82
)     Liquidity
    and Capital Resources
  Sources
    of Liquidity and Cash Flows
       49




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##### Table of Contents



tm
  re-set
    Funding
    Requirements
  tm
 50




---



##### Table of Contents




    our ability to respond to the complete response letter regarding
    our NDA for
    Linjetatm

    in a timely manner and the possibility that information we
    provide in response to the letter may not be sufficient for the
    approval of
    Linjetatm

    or another rapid-acting insulin or insulin analog by the FDA;
    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 the additional pivotal clinical trials
    the FDA requested in the complete response letter or other tests
    or analyses required by the FDA to secure approval to
    commercialize
    Linjetatm;
    our ability to develop and commercialize formulations of
    Linjetatm

    or other rapid-acting insulin or insulin analog formulations
    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 progress, timing or success of our product candidates,
    particularly
    Linjetatm,

    and that of our research, development and clinical programs,
    including any resulting data analyses;
    the cost to develop an insulin pen for use with
    Linjetatm

    and a formulation of
    Linjetatm

    for use 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 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; and
    our ability to accurately estimate anticipated operating losses,
    future revenues, capital requirements and our needs for
    additional financing.    No. 333-153167)
  re-set
   51




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##### Table of Contents



Off-Balance
    Sheet Arrangements
    Contractual
    Obligations
    Less Than








More ThanTotal


1 Year


1-3 Years


3-5 Years


5 YearsOperating lease obligations

$
2,347


$
635


$
1,712


$



$
Purchase commitments


6,740



4,155



2,585







Total fixed contractual obligations

$
9,087


$
4,790


$
4,297


$



$
   Adopted
    Accounting Pronouncements
  Subsequent
    Events
    Fair
    Value Measurement
  2009-5 2009-5). 2009-5 820-10, 2009-5
  Participating
    Securities
  ASC 260-10-55 03-6-1, 260-10-55). ASC 260-10-55 260-10-55
 52




---



##### Table of Contents



ASC 260-10-55.
  ASC 260-10-55.
  ASC 260-10-55.
  Recent
    Accounting Pronouncements
    ITEM 7A.
    QUANTITATIVE
    AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK      ITEM 8.
    FINANCIAL
    STATEMENTS AND SUPPLEMENTARY DATA  page F-1.
  ITEM 9.
    CHANGES
    IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
    FINANCIAL DISCLOSURES    ITEM 9A.
    CONTROLS
    AND PROCEDURES  Managements
    Evaluation of Disclosure Controls and Procedures
  Rules 13a-15(e) 15d-15(e)
 53




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##### Table of Contents



Managements
    Annual Report on Internal Control over Financial
    Reporting
  Rule 13a-15(f) 15d-15(f)
  
    pertain to the maintenance of records that in reasonable detail
    accurately and fairly reflect the transactions and dispositions
    of the assets of the company;
    provide reasonable assurance that transactions are recorded as
    necessary to permit preparation of financial statements in
    accordance with generally accepted accounting principles, and
    that receipts and expenditures of the company are being made
    only in accordance with authorizations of management and
    directors of the company; and
    provide reasonable assurance regarding prevention or timely
    detection of unauthorized acquisition, use or disposition of the
    companys assets that could have a material effect on the
    financial statements.          Report of
    Independent Registered Public Accounting Firm
      Internal Control  Integrated Framework
 54




---



##### Table of Contents



Changes
    in Internal Control over Financial Reporting
   55




---



##### Table of Contents



PART III  Form 10-K
  ITEM 10.
    DIRECTORS,
    EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE  Form 10-K.
  www.biodel.com
  ITEM 11.
    EXECUTIVE
    COMPENSATION    ITEM 12.
    SECURITY
    OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
    RELATED STOCKHOLDER MATTERS    ITEM 13.
    CERTAIN
    RELATIONSHIP AND RELATED TRANSACTIONS, AND DIRECTOR
    INDEPENDENCE    ITEM 14.
    PRINCIPAL
    ACCOUNTANT FEES AND SERVICES   PART IV  ITEM 15.
    EXHIBITS AND
    FINANCIAL STATEMENT SCHEDULES       56




---



##### Table of Contents



SIGNATURES
      By:
    /s/  Errol
    De Souza        Signature

Title

Date/s/  Errol
    De SouzaErrol
    De Souza

President and Chief Executive Officer (Principal Executive
    Officer), Director

December 14, 2010/s/  Gerard
    MichelGerard
    Michel

Chief Financial Officer, Vice President, Corporate Development
    and Treasurer (Principal Financial and Accounting Officer)

December 14, 2010/s/  Donald
    CaseyDonald
    Casey

Director

December 14, 2010/s/  Barry
    GinsbergBarry
    Ginsberg

Director

December 14, 2010/s/  Ira
    W. LiebermanIra
    W. Lieberman

Director

December 14, 2010/s/  Daniel
    LorberDaniel
    Lorber

Director

December 14, 2010/s/  Brian
    J.G. PereiraBrian
    J.G. Pereira

Director

December 14, 2010/s/  Solomon
    S. SteinerSolomon
    S. Steiner

Director

December 14, 2010/s/  Arthur
    UrciuoliArthur
    Urciuoli

Director

December 14, 2010  57




---



##### Table of Contents



Exhibits Index
  ExhibitNumber

Description of Document3
.1

Registrants Second Amended and Restated Certificate of
    Incorporation (Incorporated by reference to the exhibits to the
    Registrants Registration Statement on Form S-1
    (333-140504)).3
.2

Registrants Amended and Restated Bylaws (Incorporated by
    reference to the exhibits to the Registrants Registration
    Statement on Form S-1 (333-140504)).4
.1

Specimen Common Stock Certificate (Incorporated by reference to
    the exhibits to the Registrants Registration Statement on
    Form S-1 (333-140504)).4
.2

Form of Warrant issued to Scott Weisman and McGinn Smith
    Holdings LLC to Purchase Shares of Series A convertible
    preferred stock (Incorporated by reference to the exhibits to
    the Registrants Registration Statement on Form S-1
    (333-140504)).4
.3

Form of Warrant to Purchase Shares of Common stock (Incorporated
    by reference to exhibit 10.2 to the Registrants Current
    Report on Form 8-K filed on August 25, 2010).4
.4

Form of Subscription and Rights Agreement by and among the
    Registrant and the holders of the Series A convertible preferred
    stock (Incorporated by reference to the exhibits to the
    Registrants Registration Statement on Form S-1
    (333-140504)).4
.5

Amended and Restated Registration Rights Agreement, dated
    September 19, 2006, by and among the Registrant and other
    parties named therein (Incorporated by reference to the exhibits
    to the Registrants Registration Statement on Form S-1
    (333-140504)).10
.1

2010 Stock Incentive Plan (Incorporated by reference to the
    exhibits to the Registrants Quarterly Report on Form 10-Q
    filed on May 7, 2010).10
.2

2010 Incentive Stock Option Agreement (Incorporated by reference
    to the exhibits to the Registrants Quarterly Report on
    Form 10-Q filed on May 7, 2010).10
.3

2010 Non Statutory Stock Option Agreement (Incorporated by
    reference to the exhibits to the Registrants Quarterly
    Report on Form 10-Q filed on May 7, 2010).10
.4

2010 Restricted Stock Unit Agreement (Incorporated by reference
    to the exhibits to the Registrants Quarterly Report on
    Form 10-Q filed on May 7, 2010).10
.5

Form of Indemnity Agreement entered into between the Registrant
    and its directors and certain of its executive officers
    (Incorporated by reference to the exhibits to the
    Registrants Registration Statement on Form S-1
    (333-140504)).10
.6

Amended and Restated 2004 Stock Incentive Plan (Incorporated by
    reference to the exhibits to the Registrants Registration
    Statement on Form S-1 (333-140504)).10
.7

2005 Employee Stock Purchase Plan (Incorporated by reference to
    the exhibits to the Registrants Registration Statement on
    Form S-1 (333-140504)).10
.8

2005 Non-Employee Directors Stock Option Plan
    (Incorporated by reference to the exhibits to the
    Registrants Registration Statement on Form S-1
    (333-140504)).10
.9

Employment Agreement, dated March 26, 2010, between the
    Registrant and Solomon S. Steiner (Incorporated by reference to
    the Registrants Current Report on Form 8-K filed on April
    1, 2010).10
.10

Employment Agreement, dated March 26, 2010, between the
    Registrant and Errol B. De Souza (Incorporated by reference to
    the Registrants Current Report on Form 8-K filed on April
    1, 2010).10
.11

Letter agreement, dated October 1, 2010, between the Registrant.
    and Errol B. De Souza (Incorporated by reference to the
    Registrants Current Report on Form 8-K filed on October 6,
    2010).10
.12

Amended and Restated Consulting Agreement entered into on
    November 13, 2007, effective June 5, 2007, between the
    Registrant and Dr. Andreas Pfützner (Incorporated by
    reference to the Registrants Current Report on Form 8-K
    filed on November 14, 2007).10
.13

Manufacturing Agreement, dated December 20, 2005 between the
    Registrant and Cardinal Health  PTS, LLC
    (Incorporated by reference to the exhibits to the
    Registrants Registration Statement on Form S-1
    (333-140504)).10
.14

Change of Control Agreement entered into between the Registrant
    and certain of its executive officers (Incorporated by reference
    to the exhibits to the Registrants Registration Statement
    on Form S-1 (333-140504)). 58




---



##### Table of Contents



ExhibitNumber

Description of Document10
.15

Executive Severance Agreement entered into between the
    Registrant and certain of its executive officers (Incorporated
    by reference to the exhibits to the Registrants
    Registration Statement on Form S-1 (333-140504)).10
.16

Lease Agreement, dated February 2, 2004, between the Registrant
    and Mulvaney Properties, LLC and amendment thereto dated
    September 29, 2006 (Incorporated by reference to the exhibits to
    the Registrants Registration Statement on Form S-1
    (333-140504)).10
.17

Commercial Lease, dated July 23, 2007, by and between the
    Registrant and Mulvaney Properties LLC. (Incorporated by
    reference to the Registrants Current Report on Form 8-K
    filed on July 27, 2007).10
.18

Lease Amendment, dated October 1, 2007, between the Registrant
    and Mulvaney Properties LLC (Incorporated by reference to the
    Registrants Current Report on Form 8-K filed on October 4,
    2007).10
.19

Amendment to Lease Agreement, dated February 2, 2004, as
    amended, by and between the Registrant and Mulvaney Properties
    LLC. (Incorporated by reference to the Registrants Current
    Report on Form 8-K filed on July 27, 2007).10
.20

Offer Letter, dated November 12, 2007, by and between the
    Registrant and Gerard J. Michel. (Incorporated by reference to
    the Registrants Current Report on Form 8-K filed on
    November 14, 2007).10
.21

Form of Incentive Stock Option Agreement for 2004 Amended and
    Restated Stock Incentive Plan. (Incorporated by reference to the
    Registrants Annual Report on Form 10-K filed on December
    21, 2007).10
.22

Form of Option Agreement for 2005 Non-Employee Directors
    Stock Option Plan. (Incorporated by reference to the
    Registrants Annual Report on Form 10-K filed on December
    21, 2007).10
.23

Base salaries of Executive Officers of the Registrant.10
.24

Summary of the Registrants Non-Employee Director
    Compensation.10
.25

Supply Agreement, dated July 7, 2008, between the Registrant and
    N.V. Organon (Incorporated by reference to the Registrants
    Quarterly Report on Form 10-Q filed on August 11, 2008).10
.26*

Letter Agreement, dated November 12, 2009, between the
    Registrant and N.V. Organon, amending the Supply Agreement,
    dated July 7, 2008, between the parties. (Incorporated by
    reference to Registrants Annual Report on Form 10-K
    filed on December 14, 2009).21
.1

Subsidiaries of the Registrant.23
.1

Consent of BDO USA, LLP, Independent Registered Public
    Accounting Firm.24
.1

Powers of Attorney (included on signature page).31
.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.     
    
    Confidential treatment granted with respect to certain portions
    of this exhibit. Omitted portions have been filed separately
    with the Securities and Exchange Commission.*
    
    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. 59




---



##### Table of Contents



BIODEL
    INC.
  INDEX TO
    FINANCIAL STATEMENTS
 PageReport of independent registered public
    accounting firm


F-2Balance sheets


F-3Statements of operations


F-4Statements of stockholders equity


F-5Statements of comprehensive loss


F-6Statements of cash flows


F-7Notes to financial statements


F-8  F-1




---



##### Table of Contents



Report of
    Independent Registered Public Accounting Firm          ,
  Internal Control  Integrated Framework
  
    F-2




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Balance Sheets
    (In thousands, except share and per share amounts)
  September 30,2009


2010ASSETSCurrent:Cash and cash equivalents

$
54,640


$
22,922Restricted cash






150Marketable securities, available for sale






6,001Taxes receivable


752



116Other receivable






11Prepaid and other assets


482



365Total current assets


55,874



29,565Property and equipment, net


3,695



2,998Intellectual property, net


56



53Total assets

$
59,625


$
32,616Current:Accounts payable

$
1,007


$
1,989Accrued expenses:Clinical trial expenses


5,647



1,362Payroll and related


1,117



357Accounting and legal fees


325



300Severance


183



Other


643



334Income taxes payable


165



45Total current liabilities


9,087



4,387Common stock warrant liability






4,169CommitmentsStockholders equity:Preferred stock, $.01 par value; 50,000,000 shares
    authorized, none outstanding






Common stock, $.01 par value; 100,000,000 shares
    authorized; 23,803,672 and 26,399,764 issued and outstanding


238



264Additional paid-in capital


176,764



188,549Accumulated other comprehensive loss






1Deficit accumulated during the development stage


(126,464
)


(164,754
)Total stockholders equity


50,538



24,060Total liabilities and stockholders equity

$
59,625


$
32,616    F-3




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Statements of Operations
    (In thousands, except share and per share amounts)
  December 3,2003(Inception) toYear Ended September 30,


September 30,2008


2009


2010


2010Revenue

$



$



$



$
Operating expenses:Research and development


32,554



32,325



26,177



116,228General and administrative


14,800



10,994



10,980



47,625Total operating expenses


47,354



43,319



37,157



163,853Other (income) and expense:Interest and other income


(3,010
)


(386
)


(17
)


(5,506
)Interest expense














78Adjustments to fair value of common stock warrant liability










1,254



1,254Loss on settlement of debt














627Loss before tax provision (benefit)


(44,344
)


(42,933
)


(38,394
)


(160,306
)Tax provision (benefit)


(983
)


337



(104
)


(612
)Net loss


(43,361
)


(43,270
)


(38,290
)


(159,694
)Charge for accretion of beneficial conversion rights














(603
)Deemed dividend  warrants














(4,457
)Net loss applicable to common stockholders

$
(43,361
)

$
(43,270
)

$
(38,290
)

$
(164,754
)Net loss per share  basic and diluted

$
(1.94
)

$
(1.82
)

$
(1.58
)Weighted average shares outstanding  basic and diluted


22,390,434



23,746,598



24,161,866    F-4




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Statements of
    Stockholders Equity
    (In thousands, except share and per share amounts)
  Series B








DeficitSeries A Preferred


Preferred





Accumulated


AccumulatedCommon Stock


stock


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


EquityShares issued to employees


732,504


$
7






$







$



$
(7
)

$



$



$
January 2004 Proceeds from sale of common stock


4,581,240



46



















1,308











1,354Net loss


































(774
)


(774
)Balance, September 30, 2004


5,313,744



53



















1,301







(774
)


580Additional stockholder contributions


























514











514Share-based compensation


























353











353Shares issued to employees and directors for services


42,656



1



















60











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


5,356,400



54



569,000



6











4,751







(4,157
)


654Share-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


4,030























23











23Accretion of fair value of beneficial conversion charge


























603







(603
)


Net loss


































(8,068
)


(8,068
)Balance, September 30, 2006


5,360,430



54



569,000



6



6,198,179



62



29,054







(12,828
)


16,348May 2007 Proceeds from sale of common stock


5,750,000



58



















78,697











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


6,407,008



64



(569,000
)


(6
)


(6,198,179
)


(62
)


4











Share-based compensation


























4,224











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


2,949























16











16Stock options exercised


3,542























5











5March 2007 Warrants exercised


2,636,907



26



















397











423Deemed dividend  warrants


























4,457







(4,457
)


Net loss


































(22,548
)


(22,548
)Balance, September 30, 2007


20,160,836



202



















116,854







(39,833
)


77,223Proceeds from sale of common stock


3,260,000



32



















46,785











46,817Issuance of restricted stock


9,714























172











172Share-based compensation


























6,503











6,503Stock options exercised


174,410



1



















901











902Warrants exercised


79,210



1



















111











112Net unrealized (loss) on Marketable Securities






























(62
)






(62
)Proceeds from sale of stock  ESPP


14,388



1



















180











181Net loss


































(43,361
)


(43,361
)Balance, September 30, 2008


23,698,558


$
237






$







$



$
171,506


$
(62
)

$
(83,194
)

$
88,487Balance, September 30, 2008


23,698,558


$
237






$







$



$
171,506


$
(62
)

$
(83,194
)

$
88,487Share-based compensation


























5,064











5,064Stock options exercised


17,661























25











25Net unrealized gain on Marketable Securities






























62







62Proceeds from sale of stock  ESPP


87,453



1



















169











170Net loss


































(43,270
)


(43,270
)Balance, September 30, 2009


23,803,672


$
238






$







$



$
176,764


$



$
(126,464
)

$
50,538Registered direct offering


2,398,200



24



















8,688











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


























(2,915
)










(2,915
)Share-based compensation


























5,621











5,621Stock options exercised


32,320























68











68Net unrealized gain on Marketable Securities






























1







1Proceeds from sale of stock  ESPP


165,572



2



















323











325Net loss


































(38,290
)


(38,290
)Balance, September 30, 2010


26,399,764


$
264






$







$



$
188,549


$
1


$
(164,754
)

$
24,060    F-5




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Statements of Comprehensive
    Loss(In thousands)
  Year Ended September 30,2008


2009


2010Net loss

$
(43,361
)

$
(43,270
)

$
(38,290
)Unrealized holding gains (losses) arising during the period


(62
)


62



1Comprehensive loss

$
(43,423
)

$
(43,208
)

$
(38,289
)  F-6




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Statements of Cash Flows(In thousands, except share and per share
    amounts)
  December 3,2003(Inception) toYear Ended September 30,


September 30,2008


2009


2010


2010Cash flows from operating activities:Net loss

$
(43,361
)

$
(43,270
)

$
(38,290
)

$
(159,694
)Adjustments to reconcile net loss to net cash used in operating
    activities:Depreciation and amortization


567



877



991



3,140Founders compensation contributed to capital














271Share-based compensation for employees and directors


6,434



4,970



5,628



20,832Share-based compensation for non-employees


241



94



(7
)


2,318Loss on settlement of debt














627Write-off of capitalized patent expense


208











208Write-off of loan to related party














41Adjustment to fair value of common stock warrant liability










1,254



1,254(Increase) decrease in:Prepaid expenses and other assets


(745
)


768



117



(365
)Income taxes receivable


(1,988
)


1,236



636



(116
)Other receivable










(11
)


(11
)Increase (decrease) in:Accounts payable


(1,374
)


194



982



1,989Income tax payable


917



(847
)


(120
)


45Accrued expenses and other liabilities


4,198



715



(5,561
)


2,572Total adjustments


8,458



8,007



3,909



32,805Net cash used in operating activities


(34,903
)


(35,263
)


(34,381
)


(126,889
)Cash flows from investing activities:Purchase of property and equipment


(2,769
)


(637
)


(292
)


(6,101
)Purchase of marketable securities


(25,614
)






(6,000
)


(31,614
)Sale of marketable securities






25,614







25,614Capitalized intellectual properties


(17
)










(298
)Loan to related party














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


(28,400
)


24,977



(6,292
)


(12,440
)Cash flows from financing activities:Restricted cash










(150
)


(150
)Options exercised


902



25



68



1,000Warrants exercised


112











535Deferred public offering costs














(1,458
)Stockholder contribution














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














2,466Net proceeds from employee stock purchase plan


181



170



325



676Net proceeds from sale of common stock


46,817







8,712



135,742Proceeds from bridge financing














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














19,205Net cash provided by financing activities


48,012



194



8,955



162,251Net increase (decrease) in cash and cash equivalents


(15,291
)


(10,091
)


(31,718
)


22,922Cash and cash equivalents, beginning of period


80,022



64,731



54,640



Cash and cash equivalents, end of period

$
64,731


$
54,640


$
22,922


$
22,922Cash paid for interest and income taxes was:Interest

$



$



$



$
9Income taxes


88



111



60



306Non-cash financing and investing activities:Warrants issued in connection with registered direct offering

$



$



$
2,915


$
2,915Settlement 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














68    F-7




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement
    (In thousands, except share and per share amounts)
  1.
    Business
    and Basis of Presentation  Business
  tm ® tm tm
  Basis
    of Presentation
      2.
    Summary
    of Significant Accounting Policies  Research
    and Development Costs
    Use of
    Estimates
    Cash
    and Cash Equivalents
   F-8




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
  Restricted
    Cash
    Marketable
    securities
  available-for-sale other-than-temporary,
  Fair
    Value of Financial Instruments
    Pre-Launch
    Inventory
  tm tm
  Intellectual
    Property
  tm
 F-9




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
  Property
    and Equipment
    Impairment
    of Long-Lived Assets
    Warrant
    Liability
  FSP 150-5,
  Comprehensive
    Income (Loss)
    Income
    Taxes
   F-10




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
      Concentration
    of Risks and Uncertainties
    tm
      Share-Based
    Compensation
   F-11




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
            Year Ended September 30,2008


2009


2010Expected life (in years)


5.25



5.25



2.72 - 5.25Expected volatility


57 - 60%



59 - 68%



64 - 77%Expected dividend yield


0%



0%



0%Risk-free interest rate


2.36% - 4.42%



1.00% - 3.19%



0.77 - 2.69%Weighted-average grant date fair value

$
13.92


$
2.69


$
4.09  F-12




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
  Subsequent
    Events
  Form 10-Q
  Fair
    Value Measurement
  2009-5 2009-5). 2009-5 820-10, 2009-5
  Participating
    Securities
  ASC 260-10-55 03-6-1, 260-10-55). ASC 260-10-55
  ASC 260-10-55.
  ASC 260-10-55.
  Codification
    Standard
  No. 2009-01,
 F-13




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
    Recent
    Accounting Pronouncements
    3.
    Marketable
    Securities    short-to-intermediate-term available-for-sale.
    September 30, 2010Amortized


Gross Unrealized


FairCost


Gains


Losses


ValueShort term marketable securitiesUS government agency securities

$
6,000


$
1


$



$
6,001Total

$
6,000


$
1


$



$
6,001   4.
    Fair
    Value Measurement   F-14




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
              SignificantQuoted Prices in


Other


SignificantFair Value at


Active Markets for


Observable


UnobservableSeptember 30,


Identical Assets


Market Inputs


InputsDescription

2010


(Level 1)


(Level 2)


(Level 3)Assets:Cash and cash equivalents

$
22,922


$
22,922


$



$
Restricted cash


150



150







Marketable securities:US government agency securities (short-term securities)


6,001



6,001







Subtotal


29,073



29,073







Liabilities:Common stock warrant liability


(4,169
)










(4,169
)Subtotal


(4,169
)










(4,169
)Total

$
24,904


$
29,073


$



$
(4,169
)     5.
    Net Loss
    per Share   F-15




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
        Year Ended September 30,2008


2009


2010Common shares underlying warrants for Series A Preferred
    Stock


118,815



118,815



118,815Common shares underlying warrants issued in registered direct
    offering










2,398,200Stock options


3,135,390



3,407,633



4,635,532   6.
    Property
    and Equipment    September 30,2009


2010Furniture and fixtures

$
318


$
324Leasehold improvements


1,549



1,549Construction-in-progress


15



63Laboratory equipment


1,612



1,756Manufacturing equipment


529



587Facility equipment


50



65Computer equipment and other


1,270



1,291Sub-Total


5,343



5,635Less: Accumulated depreciation and amortization


1,648



2,637Total

$
3,695


$
2,998     7.
    Related
    Party Transactions   F-16




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
    Consulting
    and Clinical Research Services
    Issuance
    of Series A Convertible Preferred Stock
          Bridge
    Financing
     F-17




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
    Issuance
    of Series B Convertible Preferred Stock
      Deferred
    Compensation
     F-18




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
  8.
    Commitments  Chief
    Executive Officer Employment Agreement
      
    two times his then current salary, plus two times his target
    annual bonus for the fiscal year in which he is terminated, plus
    the pro rata amount of his target annual bonus for the fiscal
    year in which he is terminated;
    COBRA benefits until the earlier of the end of the
    24th month after the date his employment with the Company
    ends or the date his COBRA coverage expires;
    24 months of acceleration of his outstanding equity
    compensation awards; and
    full vesting of his outstanding equity compensation awards, if
    the Company terminates his employment without cause, or he
    resigns within 12 months following a change in control, as
    defined in the agreement.  Chief
    Scientific Officer Employment Agreement
      
    two times his then current salary, plus two times his target
    annual bonus for the fiscal year in which he is terminated, plus
    the pro rata amount of his target annual bonus for the fiscal
    year in which he is terminated; F-19




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##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
   
    COBRA benefits until the earlier of the end of the
    24th month after the date his employment with the Company
    ends or the date his COBRA coverage expires;
    24 months of acceleration of his outstanding equity
    compensation awards; and
    full vesting of his outstanding equity compensation awards, if
    the Company terminates his employment without cause, or he
    resigns within 12 months following a change in control, as
    defined in the agreement.  Leases
              Years Ending September 30,2011


6352012


6622013


5882014


462Total

$
2,347   Purchase
    Commitments
    F-20




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
  Years Ending September 30,2011

$
4,1552012


2,585Total

$
6,740   9.
    Income
    Taxes        Year Ended September 30,2008


2009


2010Balance, beginning of year

$
75


$
988


$
188Increase related to current year tax position


913



6



5Increase related to prior years tax position






107Decrease related to prior years tax position






(913
)


(107
)Balance, at end of year

$
988


$
188


$
86       Year EndedSeptember 30,2008


2009


2010Current expenseFederal

$



$



$
State


(983
)


337



(104
)Actual tax provision (benefit)

$
(983
)

$
337


$
(104
)  F-21




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
        September 30,2009


2010Deferred Tax AssetsNet operating losses

$
39,959


$
46,917Research and development credits


2,149



2,800Depreciation of fixed assets


284



166Other


802



176Total deferred tax asset


43,195



50,059Valuation Allowance


(43,195
)


(50,059
)Net Deferred Tax Assets

$



$
      F-22




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
    Year Ended September 30,2008


2009


2010Federal statutory rate


34.00
%


34.00
%


34.00
%Federal taxes at statutory rate

$
(15,077
)

$
(14,597
)

$
(13,054
)Tax expense on permanent differences


2,293



1,741



2,296Tax benefit on research and business credits


(325
)


(325
)


(425
)State taxes, net of federal tax effect


61



43



23State benefit, net operating loss


(2,784
)


(1,249
)


(2,990
)Valuation allowance increase


14,972



14,432



14,156Connecticut research and development refund


(1,988
)


(40
)


(30
)Reserve for uncertain tax positions


913



6



4Other


952



326



84Actual tax provision (benefits)

$
(983
)

$
337


$
(104
)   10.
    August
    2010 Financing  tm tm
      marked-to-market
 F-23




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
          Balance at September 30, 2009

$
Initial fair value


2,915Increase in fair value


1,254Balance at September 30, 2010

$
4,169   Fair
    Value Assumptions Used in Accounting for Warrant
    Liability
        September 30,2010Risk-free interest rate


.25%Expected remaining term


1.17 yearsExpected volatility


100%Dividend yield


0%   Risk-Free Interest Rate.
  Expected Remaining Term.
 F-24




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
    Expected Volatility.
  Dividend Yield.
  Change of Control.
  Participating
    Securities
    ASC 260-10-55
  11.
    Stockholders
    Equity  Common
    Stock
         F-25




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
    Preferred
    Stock
    Series A
    Convertible Preferred Stock
    3 4
       F-26




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
    Series B
    Convertible Preferred Stock
               F-27




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
  Shares Reserved
    for Future Issuance
    2010 stock incentive plan


8,807,6332005 employee stock purchase plan


1,600,000Exercise of warrants issued to placement agent


118,815Exercise of warrants issued in connection with August 2010
    registered direct offering


2,398,200Total


12,924,648   2010
    Stock Incentive Plan
    2004
    Stock Incentive Plan
        2005
    Employee Stock Purchase Plan
   F-28




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
      2005
    Non-Employee Directors Stock Option Plan
       F-29




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
    WeightedAverage


AggregateOptions

Number


Exercise Price


Intrinsic ValueBalance, September 30, 2004





$




Granted


385,432



1.41


$
1,499Outstanding balance, September 30, 2005


385,432



1.41


$
1,499Granted


461,602



5.65



55Forfeited, expired


60,222



3.40



144Outstanding balance, September 30, 2006


786,812



3.23


$
1,330Granted


955,842



13.96



Exercised


3,542



1.41


$
14Forfeited, expired


53,138



5.65



Outstanding balance, September 30, 2007


1,685,974



6.80


$
1,316Granted


1,727,397



16.88



Exercised


174,410



5.18



33Forfeited, expired


103,571



11.04



Outstanding balance, September 30, 2008


3,135,390


$
13.92


$
1,283Granted


611,500



2.69


$
1,570Exercised


17,661



1.41


$
69Forfeited, expired


321,596



13.88



Outstanding balance, September 30, 2009


3,407,633


$
11.81


$
2,784Granted


1,314,100



4.09



1,564Exercised


32,321



2.11



103Forfeited, expired


53,880



13.04



Outstanding balance, September 30, 2010


4,635,532



9.68



4,245Exercisable shares, September 30, 2010


2,285,867


$
11.22


$
1,457   Restricted
    Stock Units
     F-30




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
  paid-in-capital
  WeightedAverage


AggregateGrant Date


IntrinsicOptions

Number


Fair Value


ValueRSUsGranted


250,000


$
3.95



Vested










Forfeited, expired


980



3.95



Outstanding and unvested balance, September 30, 2010


249,020



3.95



1,319,806     12.
    Employee
    Benefit Plan    13.
    Reverse
    Split  and/or
  14.
    Summary
    Selected Quarterly Financial Data (Unaudited)   F-31




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
    Quarter
    Ended
    (in thousands, except share and per share amounts)
  December 31,


March 31,


June 30,


September 30,2009


2010


2010


2010Revenue

$



$



$



$
Net loss

$
(11,148
)

$
(10,409
)

$
(8,629
)

$
(8,104
)Basic and diluted net loss per common share

$
(0.47
)

$
(0.44
)

$
(0.36
)

$
(0.31
)Weighted average common shares basic and diluted


23,848,855



23,885,856



23,944,386



24,961,083   Quarter
    Ended
    (in thousands, except share and per share amounts)
  December 31,


March 31,


June 30,


September 30,2008


2009


2009


2009Revenue

$



$



$



$
Net loss

$
(10,024
)

$
(11,629
)

$
(11,148
)

$
(10,469
)Basic and diluted net loss per common share

$
(0.42
)

$
(0.49
)

$
(0.47
)

$
(0.44
)Weighted average common shares basic and diluted


23,706,148



23,717,800



23,759,675



23,802,286   15.
    Subsequent
    Event    and/or and/or
 F-32




---



##### Table of Contents



Biodel
    Inc.
    (A Development Stage Company)
  Notes to Financial Statement  (Continued)
    (In thousands, except share and per share amounts)
    tm tm
      tm tm
  re-set
 F-33