##### Table of Contents



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
 Washington, D.C. 20549
 FORM 10-Q
  þ
    
    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
 For the quarterly period ended March 31, 2009
 or
 o
    
    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
 For the transition period from ___________to _________
 Commission file number: 001-15281
 REPROS THERAPEUTICS INC.
  Delaware
    
    2408 Timberloch Place, Suite B-7
    
    76-0233274(State or other
jurisdiction of
incorporation or
organization)
    
    The Woodlands, Texas 77380
(Address of principal executive
offices and zip code)
(281) 719-3400
(Registrants telephone number,
including area code)
    
    (IRS Employer
Identification No.)
 þ o
 o o
  Large accelerated filer o
    
    Accelerated filer þ
    
    Non-accelerated filer  o
(Do not check if a smaller reporting company)
    
    Smaller reporting company o
 o þ




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##### 



REPROS THERAPEUTICS INC.
  INDEX
 PageFACTORS AFFECTING FORWARD-LOOKING STATEMENTS
    
    
    3PART I. FINANCIAL INFORMATIONItem 1. Financial Statements (unaudited)
    
    
    4Unaudited Condensed Consolidated Balance Sheets as of March 31, 2009 and December 31, 2008.
    
    
    5Unaudited Condensed Consolidated Statements of Operations for the three months ended March
31, 2009 and 2008 and from Inception (August 20, 1987) through March 31, 2009
    
    
    6Unaudited Condensed Consolidated Statements of Stockholders Equity for the three months
ended March 31, 2009
    
    
    7Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March
31, 2009 and 2008 and from Inception (August 20, 1987) through March 31, 2009
    
    
    8Notes to Unaudited Condensed Consolidated Financial Statements
    
    
    9Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
    
    
    14Item 3. Quantitative and Qualitative Disclosures About Market Risk
    
    
    25Item 4. Controls and Procedures
    
    
    25PART II. OTHER INFORMATIONItem 1. Legal Proceedings
    
    
    26Item 1A. Risk Factors
    
    
    26Item 5. Other Information
    
    
    26Item 6. Exhibits
    
    
    26SIGNATURES
    
    
    28EX-31.1EX-31.2EX-32.1EX-32.2
  2




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FACTORS AFFECTING FORWARD-LOOKING STATEMENTS
 ® ®
 3




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PART I. FINANCIAL INFORMATION
 
 Item 1. Financial Statements
  4




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REPROS THERAPEUTICS INC. AND SUBSIDIARY
 
 CONDENSED CONSOLIDATED BALANCE SHEETS
 March 31,
    
    
    December 31,2009
    
    
    2008ASSETSCurrent AssetsCash and cash equivalents
    
    $
    12,402
    
    
    $
    19,470Prepaid expenses and other current assets
    
    
    2,240
    
    
    
    1,392Total current assets
    
    
    14,642
    
    
    
    20,862Fixed assets,net
    
    
    23
    
    
    
    28Other assets,net
    
    
    1,840
    
    
    
    1,713Total assets
    
    $
    16,505
    
    
    $
    22,603LIABILITIES AND STOCKHOLDERS EQUITYCurrent LiabilitiesAccounts payable
    
    $
    5,790
    
    
    $
    5,132Accrued expenses
    
    
    1,522
    
    
    
    1,857Total current liabilities
    
    
    7,312
    
    
    
    6,989Commitments & Contingencies (note 6)Stockholders EquityUndesignated Preferred Stock, $.001 par value, 5,000,000
shares authorized, none issued and outstanding
    
    
    
    
    
    
    Common Stock, $.001 par value, 30,000,000 shares
authorized, 17,111,939 shares issued;
15,174,904 shares outstanding
    
    
    17
    
    
    
    17Additional paid-in capital
    
    
    169,121
    
    
    
    168,787Cost of treasury stock, 1,937,035 shares
    
    
    (5,948
    )
    
    
    (5,948
    )Deficit accumulated during the development stage
    
    
    (153,997
    )
    
    
    (147,242
    )Total stockholders equity
    
    
    9,193
    
    
    
    15,614Total liabilities and stockholders equity
    
    $
    16,505
    
    
    $
    22,603
  5




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REPROS THERAPEUTICS INC. AND SUBSIDIARY
 
 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
 From Inception(August 20, 1987)throughThree Months Ended March 31,
    
    
    March 31,2009
    
    
    2008
    
    
    2009Revenues and other incomeLicensing fees
    
    $
    
    
    
    $
    
    
    
    $
    28,755Product royalties
    
    
    
    
    
    
    
    
    
    
    627Research and development grants
    
    
    
    
    
    
    
    
    
    
    1,219Interest income
    
    
    3
    
    
    
    269
    
    
    
    16,296Gain on disposal of fixed assets
    
    
    
    
    
    
    
    
    
    
    102Other Income
    
    
    
    
    
    
    
    
    
    
    35Total revenues and
other income
    
    
    3
    
    
    
    269
    
    
    
    47,034ExpensesResearch and development
    
    
    5,698
    
    
    
    6,166
    
    
    
    152,966General and administrative
    
    
    1,060
    
    
    
    797
    
    
    
    38,334Interest expense and amortization
of intangibles
    
    
    
    
    
    
    
    
    
    
    388Total expenses
    
    
    6,758
    
    
    
    6,963
    
    
    
    191,688Loss from continuing operations
    
    
    (6,755
    )
    
    
    (6,694
    )
    
    
    (144,654
    )Loss from discontinued operations
    
    
    
    
    
    
    
    
    
    
    (1,828
    )Gain on disposal of discontinued operation
    
    
    
    
    
    
    
    
    
    
    939Net loss before cumulative effect of
change in accounting principle
    
    
    (6,755
    )
    
    
    (6,694
    )
    
    
    (145,543
    )Cumulative effect of change in accounting
principle
    
    
    
    
    
    
    
    
    
    
    (8,454
    )Net loss
    
    $
    (6,755
    )
    
    $
    (6,694
    )
    
    $
    (153,997
    )Loss per share  basic and diluted
    
    $
    (0.45
    )
    
    $
    (0.52
    )Shares used in loss per share calculation:Basic
    
    
    15,175
    
    
    
    12,775Diluted
    
    
    15,175
    
    
    
    12,775
  6




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Repros Therapeutics, Inc. and Subsidiary
 
 CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
 DeficitAccumulatedAdditional
    
    
    
    
    
    
    
    
    
    
    During the
    
    
    TotalCommon Stock
    
    
    Paid-in
    
    
    Treasury Stock
    
    
    Development
    
    
    StockholdersShares
    
    
    Amount
    
    
    Capital
    
    
    Shares
    
    
    Amount
    
    
    Stage
    
    
    EquityBalance at December 31, 2008
    
    
    17,111,939
    
    
    $
    17
    
    
    $
    168,787
    
    
    
    1,937,035
    
    
    $
    (5,948
    )
    
    $
    (147,242
    )
    
    $
    15,614Stock based option compensation
    
    
    
    
    
    
    
    
    
    
    334
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    334Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (6,755
    )
    
    
    (6,755
    )Balance at March 31, 2009
    
    
    17,111,939
    
    
    $
    17
    
    
    $
    169,121
    
    
    
    1,937,035
    
    
    $
    (5,948
    )
    
    $
    (153,997
    )
    
    $
    9,193
  7




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REPROS THERAPEUTICS INC. AND SUBSIDIARY
 
 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
 From Inception(August 20, 1987)throughThree Months Ended March 31,
    
    
    March 31,2009
    
    
    2008
    
    
    2009Cash Flows from Operating ActivitiesNet loss
    
    $
    (6,755
    )
    
    $
    (6,694
    )
    
    $
    (153,997
    )Gain on disposal of discontinued operations
    
    
    
    
    
    
    
    
    
    
    (939
    )Gain on disposal of assets
    
    
    
    
    
    
    
    
    
    
    (102
    )Adjustments to reconcile net loss to net cash
used in operating activities:Noncash financing costs
    
    
    
    
    
    
    
    
    
    
    316Noncash inventory impairment
    
    
    
    
    
    
    
    
    
    
    4,417Noncash patent impairment
    
    
    
    
    
    
    
    
    
    
    1,339Noncash decrease in accounts payable
    
    
    
    
    
    
    
    
    
    
    (1,308
    )Depreciation and amortization
    
    
    17
    
    
    
    9
    
    
    
    3,899Noncash expenses related to stock-based
transactions
    
    
    334
    
    
    
    192
    
    
    
    5,691Common stock issued for agreement not to
compete
    
    
    
    
    
    
    
    
    
    
    200Series B Preferred Stock issued for consulting
services
    
    
    
    
    
    
    
    
    
    
    18Changes in operating assets and liabilities
(net effects of purchase of businesses in 1988 and 1994):Increase in receivables
    
    
    
    
    
    
    
    
    
    
    (199
    )Increase in inventory
    
    
    
    
    
    
    
    
    
    
    (4,447
    )Increase in prepaid expenses and other
current assets
    
    
    (848
    )
    
    
    (387
    )
    
    
    (1,938
    )Increase (decrease) in accounts payable and
accrued expenses
    
    
    323
    
    
    
    723
    
    
    
    8,507Net cash used in operating activities
    
    
    (6,929
    )
    
    
    (6,157
    )
    
    
    (138,543
    )Cash Flows from Investing ActivitiesChange in trading marketable securities
    
    
    
    
    
    
    16,087
    
    
    
    (191
    )Capital expenditures
    
    
    
    
    
    
    (2
    )
    
    
    (2,371
    )Purchase of technology rights and other assets
    
    
    (139
    )
    
    
    (137
    )
    
    
    (3,909
    )Proceeds from sale of PP&E
    
    
    
    
    
    
    
    
    
    
    225Cash acquired in purchase of FTI
    
    
    
    
    
    
    
    
    
    
    3Proceeds from sale of subsidiary, less
$12,345 for operating losses during
1990 phase-out period
    
    
    
    
    
    
    
    
    
    
    138Proceeds from sale of the assets of FTI
    
    
    
    
    
    
    
    
    
    
    2,250Increase in net assets held for disposal
    
    
    
    
    
    
    
    
    
    
    (213
    )Net cash (used in) provided by investing activities
    
    
    (139
    )
    
    
    15,948
    
    
    
    (4,068
    )Cash Flows from Financing ActivitiesProceeds from issuance of common stock, net of
offering costs
    
    
    
    
    
    
    
    
    
    
    151,015Exercise of stock options
    
    
    
    
    
    
    
    
    
    
    363Proceeds from a shareholder transaction
    
    
    
    
    
    
    
    
    
    
    327Proceeds from issuance of preferred stock
    
    
    
    
    
    
    
    
    
    
    23,688Purchase of treasury stock
    
    
    
    
    
    
    
    
    
    
    (21,487
    )Proceeds from issuance of notes payable
    
    
    
    
    
    
    
    
    
    
    2,839Principal payments on notes payable
    
    
    
    
    
    
    
    
    
    
    (1,732
    )Net cash provided by financing activities
    
    
    
    
    
    
    
    
    
    
    155,013Net increase (decrease) in cash and cash equivalents
    
    
    (7,068
    )
    
    
    9,791
    
    
    
    12,402Cash and cash equivalents at beginning of period
    
    
    19,470
    
    
    
    1,779
    
    
    
    Cash and cash equivalents at end of period
    
    $
    12,402
    
    
    $
    11,570
    
    
    $
    12,402
  8




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REPROS THERAPEUTICS INC. AND SUBSIDIARY
 
 NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2009
 NOTE 1  Organization, Operations and Liquidity
  ®
 ®
     9




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10




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NOTE 2  Marketable Securities
  NOTE 3  Patents
  NOTE 4  Accrued Expenses
  March 31, 2009
    
    
    December 31, 2008Research and development costs
    
    $
    1,438
    
    
    $
    1,573Payroll
    
    
    
    
    
    
    123Patent costs
    
    
    8
    
    
    
    81Other
    
    
    76
    
    
    
    80Total
    
    $
    1,522
    
    
    $
    1,857
 NOTE 5  Loss Per Share
  11




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Three Months Ended March 31,2009
    
    2008Net loss
    
    $
    (6,755
    )
    
    $
    (6,694
    )Average common shares outstanding
    
    
    15,175
    
    
    
    12,775Basic and diluted loss per share
    
    $
    (0.45
    )
    
    $
    (0.52
    )
  NOTE 6  Commitments and Contingencies
     12




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13




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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
 The following discussion contains forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. Such statements reflect the Companys current views with respect to future events and
financial performance and are subject to certain risks, uncertainties and assumptions. Should one
or more of these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated in such forward-looking
statements. The following discussion of financial condition should be read in conjunction with the
accompanying consolidated financial statements and related notes.
 Overview
   Proellex®
 
    
    Phase 3  three-month pre-surgical treatment for women with anemia due to excessive
menstrual bleeding associated with uterine fibroids (anemia associated with uterine
fibroids) who may consider having a subsequent hysterectomy
 o
    
    Currently conducting two 65-patient, 3-month duration, registration
Pivotal Phase 3 clinical trials (ZPU-301 and ZPU-302).o
    
    In addition to our Pivotal Phase 3 clinical trials, the FDA will
require data from 100 patients that have been exposed to Proellex for a six-month
period. We will also have to provide the FDA with data accumulated from our other
Proellex indications as well as other clinical data.
 
    
    Phase 3  chronic treatment of symptoms associated with uterine fibroids
 o
    
    Currently conducting two 75-patient, 4-month duration, registration
Pivotal Phase 3 clinical trials (ZPU-303 and ZPU-304).o
    
    In addition to our two Pivotal Phase 3 clinical trials, the FDA will
require data from 200 patients that have been exposed to Proellex for one year with
the final duration of drug exposure to be determined as data from ongoing trials
continues to evolve. We will also need to provide the FDA with data from
approximately 300 to 600 patients that have been on Proellex for six months. The
FDA has suggested a total safety data base of 1,500 patients which may be derived
from all of our trials and studies of Proellex for all indications, doses and
durations of exposure.
 
    
    Phase 2  chronic treatment of symptoms associated with endometriosis
 o
    
    Finalizing activities associated with our 4-month duration, Phase 2 clinical trial (ZPE-201).
 o
    
    We are preparing to request an end of Phase 2 meeting with the FDA that
we anticipate could occur mid-year 2009. Pending positive FDA outcome from that
meeting and acceptance of clinical protocols, we plan to initiate registration
Phase 3 pivotal trials as soon as practicable.
 14




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Androxal®
 
    
    Phase 2b  men being treated for low testosterone levels who want to improve or maintain
their fertility and/or sperm number and function
 o
    
    Currently conducting a Phase 2b (ZA-201) proof-of-concept
clinical trial.
 
    
    We intend to file an Investigational New Drug Application, or
IND, in the second half of
2009 for Androxal as a treatment for diabetes type 2.
   Available Information
  Proellex
 ®
   o
    
    Currently conducting one uterine fibroid 400-patient, 12-month drug
treatment
duration,
 15




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Open Label Safety Trial (ZPU-305) and continuing preparation requirements
to conduct a second 400-patient, 8-month drug treatment duration, Open Label Safety
Trial (ZPU-306) immediately after ZPU-305 patient randomization is completed.o
    
    Proellex 12-month uterine fibroid Open Label Safety Trial (ZPU-003ext)
completed with patients that rolled over from our prior Phase 2 clinical trial
(ZPU-003). Currently conducting a second small 12-month uterine fibroid Open Label
Safety Trial (ZPU-003ext2) with rollover patients from (ZPU-003ext).o
    
    Currently conducting one endometriosis 12-month Open Label Safety Trial
(ZPE-201ext) with rollover patients from our U.S. Phase 2 clinical trial (ZPE-201).o
    
    Proellex Phase 1 clinical trials completed and also ongoing.o
    
    Proellex animal safety studies completed and also ongoing.o
    
    Continuing scale-up activities related to manufacturing and production.
  Pre-surgical treatment of anemia associated with uterine fibroids
    
    2010Treatment of symptoms associated with uterine fibroids
    
    Late 2010-2011Treatment of symptoms associated with endometriosis
    
    2011
  Androxal
 ®
 ®
 16




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® ® ®
  General
     17




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18




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Critical Accounting Policies and the Use of Estimates
  Investments
  Capitalized Patent Costs
   Accrued Expenses
  19




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R&D Expense
  Share-Based Compensation
  Income Taxes
  RECENT ACCOUNTING PRONOUNCEMENTS
  20




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Results of Operations
 Comparison of the three-month periods ended March 31, 2009 and 2008
 Revenues and Other Income
  Research and Development Expenses
  Three-months
    
    
    Three-monthsMarch 31,
    
    
    March 31,
    
    
    
    
    
    
    ChangeResearch and Development
    
    2009
    
    
    2008
    
    
    Variance
    
    
    (%)Proellex clinical development
    
    $
    4,717
    
    
    $
    4,640
    
    
    $
    77
    
    
    
    2
    %Androxal clinical development
    
    
    347
    
    
    
    970
    
    
    
    (623
    )
    
    
    (64
    )%Payroll and benefits
    
    
    416
    
    
    
    235
    
    
    
    181
    
    
    
    77
    %Operating and occupancy
    
    
    218
    
    
    
    321
    
    
    
    (103
    )
    
    
    (32
    )%Total
    
    $
    5,698
    
    
    $
    6,166
    
    
    $
    (468
    )
    
    
    (8
    )%
  21




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Proellex
  Three-months
    
    
    Three-monthsProellex Clinical
    
    March 31,
    
    
    March 31,
    
    
    
    
    
    
    ChangeDevelopment
    
    2009
    
    
    2008
    
    
    Variance
    
    
    (%)Clinical trials
    
    $
    4,063
    
    
    $
    3,658
    
    
    $
    405
    
    
    
    11
    %Preclinical studies
    
    
    222
    
    
    
    743
    
    
    
    (521
    )
    
    
    (70
    )%Formulation and dosage
    
    
    343
    
    
    
    111
    
    
    
    232
    
    
    
    209
    %Other
    
    
    89
    
    
    
    128
    
    
    
    (39
    )
    
    
    (30
    )%Total
    
    $
    4,717
    
    
    $
    4,640
    
    
    $
    77
    
    
    
    2
    %
   Androxal
  Three-months
    
    
    Three-monthsAndroxal Clinical
    
    March 31,
    
    
    March 31,
    
    
    
    
    
    
    ChangeDevelopment
    
    2009
    
    
    2008
    
    
    Variance
    
    
    (%)Clinical trials
    
    $
    59
    
    
    $
    236
    
    
    $
    (177
    )
    
    
    (75
    )%Preclinical studies
    
    
    258
    
    
    
    718
    
    
    
    (460
    )
    
    
    (64
    )%Formulation and dosage
    
    
    
    
    
    
    14
    
    
    
    (14
    )
    
    
    (100
    )%Other
    
    
    30
    
    
    
    2
    
    
    
    28
    
    
    
    1400
    %Total
    
    $
    347
    
    
    $
    970
    
    
    $
    (623
    )
    
    
    (64
    )%
  22




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Payroll and Benefits
  Operating and Occupancy
  General and Administrative Expenses
  Three-
    
    
    Three-months
    
    
    monthsMarch 31,
    
    
    March 31,
    
    
    
    
    
    
    ChangeGeneral and Administrative
    
    2009
    
    
    2008
    
    
    Variance
    
    
    (%)Payroll and benefits
    
    $
    475
    
    
    $
    346
    
    
    $
    129
    
    
    
    37
    %Operating and occupancy
    
    
    585
    
    
    
    451
    
    
    
    134
    
    
    
    30
    %Total
    
    $
    1,060
    
    
    $
    797
    
    
    $
    263
    
    
    
    33
    %
   23




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Off-Balance Sheet Arrangements
  Liquidity and Capital Resources
        24




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Item 3. Quantitative and Qualitative Disclosures About Market Risk
 Interest Rate Risk.
 
 Item 4. Controls and Procedures
 Disclosure Controls and Procedures
  Changes in Internal Control over Financial Reporting
  25




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PART II  OTHER INFORMATION
 
 Item 1. Legal Proceedings
   
 Item 1A. Risk Factors
  
 Item 5. Other Information
  
 Item 6. Exhibits
 3.1
    (a)
    
    Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.3 to
the Companys Registration Statement on Form SB-2 (No. 33-57728-FW), as amended
(Registration Statement)).3.1
    (b)
    
    Certificate of Amendment to the Companys Restated Certificate of Incorporation,
dated as of May 2, 2006 (incorporated by reference to Exhibit 3.1 to the Companys
Current Report on Form 8-K as filed with the Securities and Exchange Commission (the
Commission) on May 2, 2006).3.1
    (c)
    
    Certificate of Amendment to the Companys Restated Certificate of Incorporation, as
amended, dated as of December 16, 2008 (incorporated by reference to Exhibit 3.1(d) to
the Companys Current Report on Form 8-K as filed with the Commission on December 23,
2008).
 26




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##### Table of Contents



3.1
    (d)
    
    Certificate of Designation of Series One Junior Participating Preferred Stock dated
September 2, 1999 (incorporated by reference to Exhibit A to Exhibit 4.1 to the
Companys Registration Statement on Form 8-A as filed with the Commission on September
3, 1999).3.2
    
    
    Restated Bylaws of the Company (incorporated by reference to Exhibit 3.4 to the
Registration Statement).10.1
    
    
    Employment Agreement dated February 18, 2009 between the Company and Paul
Lammers, M.D., M.Sc. (incorporated by reference to Exhibit 10.1 to the Companys
Current Report on Form 8-K as filed with the Commission on February 24, 2009).10.2
    
    
    Third Amendment to Employment Agreement dated effective March 11, 2009 between
the Company and Joseph S. Podolski (incorporated by reference to Exhibit 10.1 to the
Companys Current Report on Form 8-K as filed with the Commission on March 17, 2009).31.1*
    
    
    Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 (Chief Executive Officer).31.2*
    
    
    Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 (Chief Financial Officer).32.1*
    
    
    Certification furnished pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Executive Officer).32.2*
    
    
    Certification furnished pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chief Financial Officer).
 
 *
    
    Filed herewith.
 27




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##### Table of Contents



SIGNATURES
  REPROS THERAPEUTICS INC.Date: May 11, 2009By:
    
    /s/ Joseph S. PodolskiJoseph S. PodolskiChief Executive Officer and Director(Principal Executive Officer)Date: May 11, 2009By:
    
    /s/ Louis Ploth, Jr.Louis Ploth, Jr.Chief Financial Officer, Director and Secretary(Principal Financial and Accounting Officer)
 28