Royalty Pharma 10-Q 10 May 16 2016 Q1 Quarterly report Financial data

Document And Entity Information

Document And Entity Information - shares	3 Months Ended
	Mar. 31, 2016	May. 03, 2016
Document Information [Line Items]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2016
Document Fiscal Year Focus	2,016
Document Fiscal Period Focus	Q1
Entity Registrant Name	REPROS THERAPEUTICS INC.
Entity Central Index Key	897,075
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Trading Symbol	RPRX
Entity Common Stock, Shares Outstanding		24,318,111

CONDENSED CONSOLIDATED BALANCE

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Current Assets
Cash and cash equivalents	$ 16,046	$ 21,393
Prepaid expenses and other current assets	293	84
Total current assets	16,339	21,477
Fixed assets, net	6	8
Total assets	16,345	21,485
Current Liabilities
Accounts payable	1,623	1,969
Accrued expenses	483	949
Total current liabilities	$ 2,106	$ 2,918
Commitments & Contingencies (note 5)
Stockholders' Equity
Undesignated Preferred Stock, $.001 par value, 5,000,000 shares authorized, none issued and outstanding	$ 0	$ 0
Common Stock, $.001 par value, 75,000,000 shares authorized, 24,430,461 shares issued; 24,318,111 shares outstanding	24	24
Additional paid-in capital	322,695	322,179
Cost of treasury stock, 112,350 shares	(1,380)	(1,380)
Accumulated deficit	(307,100)	(302,256)
Total stockholders' equity	14,239	18,567
Total liabilities and stockholders' equity	$ 16,345	$ 21,485

CONDENSED CONSOLIDATED BALANCE3

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 2016	Dec. 31, 2015
Common Stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common Stock, shares authorized	75,000,000	75,000,000
Common Stock, shares issued	24,430,461	24,430,461
Common Stock, shares outstanding	24,318,111	24,318,111
Treasury stock, shares	112,350	112,350
Undesignated Preferred Stock [Member]
Preferred Stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred Stock, shares authorized	5,000,000	5,000,000
Preferred Stock, issued	0	0
Preferred Stock, outstanding	0	0

CONDENSED CONSOLIDATED STATEMEN

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Revenues and other income
Interest income	$ 17	$ 1
Total revenues and other income	17	1
Expenses
Research and development	3,765	7,321
General and administrative	1,096	1,205
Total expenses	4,861	8,526
Net loss	$ (4,844)	$ (8,525)
Loss per share - basic and diluted (in dollars per share)	$ (0.20)	$ (0.35)
Shares used in loss per share calculation:
Basic (in shares)	24,318	24,276
Diluted (in shares)	24,318	24,276

CONSOLIDATED STATEMENTS OF STOC

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Common Stock [Member]	Additional Paid-in Capital [Member]	Treasury Stock [Member]	Accumulated Deficit [Member]
Balance at Dec. 31, 2014	$ 44,017	$ 24	$ 318,437	$ (1,380)	$ (273,064)
Balance (in shares) at Dec. 31, 2014		24,388,523		112,350
Stock based compensation	1,022	$ 0	1,022	$ 0	0
Net loss	(8,525)	0	0	0	(8,525)
Balance at Mar. 31, 2015	36,514	$ 24	319,459	$ (1,380)	(281,589)
Balance (in shares) at Mar. 31, 2015		24,388,523		112,350
Balance at Dec. 31, 2015	18,567	$ 24	322,179	$ (1,380)	(302,256)
Balance (in shares) at Dec. 31, 2015		24,430,461		112,350
Stock based compensation	516	$ 0	516	$ 0	0
Net loss	(4,844)	0	0	0	(4,844)
Balance at Mar. 31, 2016	$ 14,239	$ 24	$ 322,695	$ (1,380)	$ (307,100)
Balance (in shares) at Mar. 31, 2016		24,430,461		112,350

CONDENSED CONSOLIDATED STATEME6

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Cash Flows from Operating Activities
Net loss	$ (4,844)	$ (8,525)
Depreciation	2	10
Noncash stock-based compensation	516	1,022
Increase in prepaid expenses and other current assets	(209)	(382)
Decrease in accounts payable and accrued expenses	(812)	(972)
Net cash used in operating activities	(5,347)	(8,847)
Cash Flows from Investing Activities
Capital expenditures	0	0
Net cash used in investing activities	0	0
Cash Flows from Financing Activities
Exercise of stock options & warrants	0	0
Proceeds from a shareholder transaction	0	102
Net cash provided by financing activities	0	102
Net decrease in cash and cash equivalents	(5,347)	(8,745)
Cash and cash equivalents at beginning of period	21,393	46,620
Cash and cash equivalents at end of period	$ 16,046	$ 37,875

Organization, Operations and Li

Organization, Operations and Liquidity	3 Months Ended
	Mar. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization, Operations and Liquidity	NOTE 1 — Organization, Operations and Liquidity Repros Therapeutics Inc. (the “Company,” “RPRX,” “Repros,” or “we,” “us” or “our”) was organized on August 20, 1987. We are a biopharmaceutical company focused on the development of new drugs to treat hormonal and reproductive system disorders. Our enclomiphene product candidate, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound. We are developing enclomiphene for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Men with secondary hypogonadism exhibit low testosterone levels due to under stimulated testes but they are generally fertile. Enclomiphene is designed to treat the underlying mechanism, insufficient stimulation of the testes by the pituitary, which causes secondary hypogonadism. Secondary hypogonadism due to being overweight or obese is the single greatest cause of hypogonadism in general. On February 2, 2015, we announced that we electronically submitted our New Drug Application (“NDA”) to the Food and Drug Administration (“FDA”) for enclomiphene. The FDA accepted the NDA for review on April 1, 2015 and later assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2015. In addition, the Division of Bone, Reproductive and Urologic Products (the Division) of the FDA scheduled an advisory committee meeting to review the NDA for November 3, 2015. However, the Division subsequently cancelled the scheduled advisory committee meeting due to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data. On December 1, 2015, we announced that we had received a Complete Response Letter (CRL) from the FDA. A CRL informs companies that an NDA cannot be approved in its present form. In the CRL, the FDA stated that, based on recent scientific developments, the design of the enclomiphene Phase 3 studies is no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an additional Phase 3 study or studies to support approval in the target population. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase 3 program. Subsequently, on February 4, 2016, the Company attended a meeting with the FDA reviewers and senior leaders to discuss resolution of issues identified during the NDA review. The meeting covered a broad range of topics surrounding the NDA data as well as emerging agency and expert thinking regarding the treatment of hypogonadism. The Company believes based on the meeting that the FDA is not closed to considering secondary hypogonadism as an indication. Additionally, in January 2016, the Company initiated a Phase 2 double-blind, placebo controlled, proof of concept study, ZA-205, in obese secondary hypogonadal men to assess the impact of enclomiphene on metabolic parameters and quality of life under a diet and exercise regimen. This study was fully enrolled in February 2016 and six month data is expected in the third quarter of 2016. Proellex®, our product candidate for female reproductive health, is a new chemical entity that acts as a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. On December 29, 2014, we announced that we have initiated two Phase 2B studies for low dose Proellex® in the treatment of uterine fibroids and are currently conducting a Phase 2 study in the treatment of endometriosis. All three of these Proellex® studies were fully enrolled in January 2016. On April 12, 2016, we announced positive clinical data for the vaginal application of Proellex® in women with severe menstrual bleeding due to uterine fibroids. Product Candidate (Indication) Enclomiphene Status Next Expected Milestone(s) Secondary Hypogonadism NDA submitted/Complete Response Letter received Proellex® Uterine Fibroids Phase 2 Complete second course of treatment in a Phase 2B study (oral delivery) (H2 2016) Complete second course of treatment in a Phase 2B study (vaginal delivery) (H2 2016) Endometriosis Phase 2 Topline data Phase 2 study (oral delivery) (H2 2016) As of March 31, 2016, we had accumulated losses of $ 307.1 16.0 2.1

Accrued Expenses

Accrued Expenses	3 Months Ended
	Mar. 31, 2016
Accrued Expenses [Abstract]
Accrued Expenses	NOTE 2 — Accrued Expenses March 31, 2016 December 31, 2015 Research and development costs $ 330 $ 300 Personnel related costs 66 544 Other 87 105 Total $ 483 $ 949

Loss Per Share

Loss Per Share	3 Months Ended
	Mar. 31, 2016
Earnings Per Share [Abstract]
Loss Per Share	NOTE 3 — Loss Per Share Basic loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share is computed using the average shares outstanding for the period and applying the treasury stock method to potentially dilutive outstanding options. In all applicable periods, all potential common stock equivalents were anti-dilutive and, accordingly, were not included in the computation of diluted loss per share. Three Months Ended March 31, 2016 2015 Net loss $ (4,844) $ (8,525) Average common shares outstanding 24,318 24,276 Basic and diluted loss per share $ (0.20) $ (0.35) Potential common stock of 2,554,857 3,274,157 39,595 0.01 429,704 2.49

Stock-Based Compensation

Stock-Based Compensation	3 Months Ended
	Mar. 31, 2016
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Stock-Based Compensation	NOTE 4 – Stock-Based Compensation During the three month period ended March 31, 2016, the Compensation Committee of the Company’s Board of Directors approved grants of options to purchase 35,000 135,000

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Mar. 31, 2016
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	NOTE 5 — Commitments and Contingencies Therapeutic uses of our enclomiphene product candidate are covered in the United States by nine issued U.S. patents and eight pending patent applications. Foreign coverage of therapeutic uses of our enclomiphene product candidate includes 84 106 On July 19, 2013, we received a letter from Dr. Harry Fisch threatening to file a lawsuit against us and two of our executive officers (Joseph S. Podolski, President and Chief Executive Officer and Ron Wiehle, Executive Vice President), seeking addition of Dr. Harry Fisch as an inventor on three of our patents, U.S. Patent Nos. 7,173,064 7,737,185 7,759,360

Organization, Operations and 12

Organization, Operations and Liquidity (Tables)	3 Months Ended
	Mar. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Product Development Pipeline	Our product development pipeline, with dates as expected as of the date of this report, is summarized in the table below: Product Candidate (Indication) Enclomiphene Status Next Expected Milestone(s) Secondary Hypogonadism NDA submitted/Complete Response Letter received Proellex® Uterine Fibroids Phase 2 Complete second course of treatment in a Phase 2B study (oral delivery) (H2 2016) Complete second course of treatment in a Phase 2B study (vaginal delivery) (H2 2016) Endometriosis Phase 2 Topline data Phase 2 study (oral delivery) (H2 2016)

Accrued Expenses (Tables)

Accrued Expenses (Tables)	3 Months Ended
	Mar. 31, 2016
Accrued Expenses [Abstract]
Accrued Expenses	Accrued expenses consist of the following (in thousands): March 31, 2016 December 31, 2015 Research and development costs $ 330 $ 300 Personnel related costs 66 544 Other 87 105 Total $ 483 $ 949

Loss Per Share (Tables)

Loss Per Share (Tables)	3 Months Ended
	Mar. 31, 2016
Earnings Per Share [Abstract]
Calculation of Loss Per Share	The following table presents information necessary to calculate loss per share for the three month periods ended March 31, 2016 and 2015 (in thousands, except per share amounts): Three Months Ended March 31, 2016 2015 Net loss $ (4,844) $ (8,525) Average common shares outstanding 24,318 24,276 Basic and diluted loss per share $ (0.20) $ (0.35)

Organization, Operations and 15

Organization, Operations and Liquidity (Product Development Pipeline) (Details)	3 Months Ended
	Mar. 31, 2016
Enclomiphene [Member] | Secondary Hypogonadism [Member]
Product Information [Line Items]
Status	NDA submitted/Complete Response Letter received
Proellex [Member] | Uterine Fibroids [Member]
Product Information [Line Items]
Status	Phase 2
Next Expected Milestone(s)	Complete second course of treatment in a Phase 2B study (oral delivery) (H2 2016) Complete second course of treatment in a Phase 2B study (vaginal delivery) (H2 2016)
Proellex [Member] | Endometriosis [Member]
Product Information [Line Items]
Status	Phase 2
Next Expected Milestone(s)	Topline data Phase 2 study (oral delivery) (H2 2016)

Organization, Operations and 16

Organization, Operations and Liquidity (Additional Information) (Details) - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015	Mar. 31, 2015	Dec. 31, 2014
Product Information [Line Items]
Deficit accumulated during the development stage	$ 307,100
Cash and cash equivalents	16,046	$ 21,393	$ 37,875	$ 46,620
Accounts payable and accrued expenses	$ 2,100

Accrued Expenses (Details)

Accrued Expenses (Details) - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Schedule Of Accrued Liabilities [Line Items]
Research and development costs	$ 330	$ 300
Personnel related costs	66	544
Other	87	105
Total	$ 483	$ 949

Loss Per Share (Calculation of

Loss Per Share (Calculation of Loss Per Share) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Net loss	$ (4,844)	$ (8,525)
Average common shares outstanding (in shares)	24,318	24,276
Basic and diluted loss per share (in dollars per share)	$ (0.20)	$ (0.35)

Loss Per Share (Additional Info

Loss Per Share (Additional Information) (Details) - $ / shares	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Earnings Per Share Disclosure [Line Items]
Class of Stock Warrants or Right, Warrants Expiration Date	Feb. 8, 2016
Maximum [Member]
Earnings Per Share Disclosure [Line Items]
Anti-dilutive shares of common stock excluded from computation of earning per share	2,554,857	3,274,157
Series A Warrants [Member]
Earnings Per Share Disclosure [Line Items]
Anti-dilutive shares of common stock excluded from computation of earning per share		39,595
Warrants, exercise price per share		$ 0.01
Series B Warrants [Member]
Earnings Per Share Disclosure [Line Items]
Anti-dilutive shares of common stock excluded from computation of earning per share		429,704
Warrants, exercise price per share		$ 2.49

Stock-Based Compensation (Addit

Stock-Based Compensation (Additional Information) (Details) - 2011 Equity Incentive Plan [Member]	3 Months Ended
	Mar. 31, 2016shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross	35,000
Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures in Period	135,000

Commitments and Contingencies (

Commitments and Contingencies (Additional Information) (Details)	3 Months Ended
	Mar. 31, 2016
Joseph S. Podolski
Commitments and Contingencies [Line Items]
Issued Patent Number	7,173,064
Ron Wiehle
Commitments and Contingencies [Line Items]
Issued Patent Number	7,737,185
Dr. Harry Fisch
Commitments and Contingencies [Line Items]
Issued Patent Number	7,759,360
Foreign [Member]
Commitments and Contingencies [Line Items]
Number of patents	84
Number of pending patent applications	106
Third Party [Member]
Commitments and Contingencies [Line Items]
Number of patents	2