XML 15 R9.htm IDEA: XBRL DOCUMENT v3.3.0.814
Interim Financial Statements
9 Months Ended
Sep. 30, 2015
Interim Financial Statements [Abstract]  
Interim Financial Statements
1.  Interim Financial Statements

Progenics Pharmaceuticals, Inc. (the Company, Progenics, we or us) develops innovative medicines for oncology. Our clinical development efforts center on later-stage oncology assets. We have completed phase 2 clinical trials of 1404 (trofolastat), an imaging agent candidate for prostate cancer, and our therapeutic candidate also for prostate cancer, PSMA ADC, a fully human monoclonal antibody-drug conjugate (ADC). We resumed a pivotal phase 2 clinical trial of Azedra™, our ultra-orphan radiotherapy candidate for malignant pheochromocytoma and paraganglioma. We are moving forward with MIP-1095 into clinical development and plan to file an Investigational New Drug (IND) application in the U.S. We have entered into an exclusive worldwide licensing agreement for [18F]DCFPyL ("PyL"), a clinical-stage prostate specific membrane antigen (PSMA)-targeted imaging agent for prostate cancer, with Johns Hopkins University. Under this agreement, we are obligated to pay milestone payments aggregating approximately $2.25 million, low single-digit royalties, patent costs and minimum annual royalties which are creditable against royalties.

On April 1, 2015, Valeant Pharmaceuticals International, Inc. acquired Salix Pharmaceuticals, Ltd. (Salix), and Salix became a wholly-owned subsidiary of Valeant (references hereinafter to "Valeant" refer to Salix and Valeant as a consolidated entity as a result of the acquisition). We have licensed to Valeant our first commercial drug, RELISTOR® (methylnaltrexone bromide) subcutaneous injection for the treatment of opioid induced constipation (OIC), which in May of this year received an approval from the Committee for Medicinal Products for Human Use of the European Medicines Agency for the treatment of OIC when response to laxative therapy has not been sufficient in adult patients, aged 18 years and older. In June of this year, a New Drug Application for RELISTOR® (methylnaltrexone bromide) Tablets was submitted by Valeant to the U.S. Food and Drug Administration (FDA) for the treatment of OIC in adult patients with chronic non-cancer pain. In September of this year, the FDA assigned this NDA for oral Relistor a Prescription Drug User Fee Act (PDUFA) action date of April 19, 2016. In September 2014 RELISTOR received an expanded approval from the FDA for the treatment of OIC in patients taking opioids for chronic non-cancer pain. We have partnered other internally-developed or acquired compounds and technologies with third parties. We continue to consider opportunities for strategic collaborations, out-licenses and other arrangements with biopharmaceutical companies involving proprietary research, development and clinical programs, and may in the future also in-license or acquire additional oncology compounds and/or programs.

On October 13, 2015 we announced an offer to acquire EXINI Diagnostics AB, ("Exini") a leader in the development of software solutions for medical decision support based on advanced image analysis, through a public offer to the shareholders of Exini (the "Offer"). Exini is headquartered in Lund, Sweden, and is listed on the Nasdaq First North stock exchange, Stockholm.  Under the terms of the Offer, Progenics is offering to pay a total aggregate purchase price for all of the equity of Exini of approximately $7 million, funded from Progenics' cash on hand.  The purchase price implies a price per share of approximately SEK 3.15. The acquisition has been approved by the board of directors of Progenics, and unanimously recommended by the board of directors of Exini. The estate of Bo Håkansson, the largest shareholder, which holds approximately 30.74 percent of the total shares and voting rights in Exini, has undertaken to accept the Offer, subject to certain conditions.  As of November 5, 2015, the end of the initial acceptance period for the Offer, the Offer had been accepted by shareholders representing approximately 92 percent of the outstanding shares and votes in Exini.  The settlement of the Offer is expected to occur on or about November 12, 2015. In order to give the remaining Exini shareholders who have not yet tendered their shares additional time in which to take advantage of the Offer, Progenics will extend the offer acceptance period until November 20, 2015.

Our current principal sources of revenue from operations are royalty, development milestone and revenue-sharing payments from Valeant's RELISTOR operations. Royalty and milestone payments from RELISTOR depend on success in development and commercialization, which is dependent on many factors, such as Valeant's efforts, decisions by the FDA and other regulatory bodies, competition from drugs for the same or similar indications, and the outcome of clinical and other testing of RELISTOR.

Progenics commenced principal operations in 1988, became publicly traded in 1997 and throughout has been engaged primarily in research and development efforts, establishing corporate collaborations and related activities. Certain of our intellectual property rights are held by wholly owned subsidiaries. All of our operations are conducted at our facilities in Tarrytown, New York. We operate under a single research and development segment.

Funding and Financial Matters. At September 30, 2015 we held $90.4 million in cash and cash equivalents, an $8.9 million decrease from the second quarter-end, and a $28.9 million decrease from $119.3 million at 2014 year-end. We expect that this amount will be sufficient to fund operations as currently anticipated beyond one year. We expect to require additional funding in the future, the availability of which is uncertain and not guaranteed. We expect that we may continue to incur operating losses for the foreseeable future.

We fund our operations to a significant extent from capital-raising. In the first quarter of 2014, we raised $37.5 million in an underwritten public offering of 8.75 million shares of common stock at a public offering price of $4.60 per share, and entered into an agreement with an investment bank under which we may sell from time to time up to an additional $50 million of our common stock.

Our interim Consolidated Financial Statements have been prepared in accordance with applicable presentation requirements, and accordingly do not include all information and disclosures necessary for a presentation of our financial position, results of operations and cash flows in conformity with accounting principles generally accepted in the United States of America (GAAP). In the opinion of management, these financial statements reflect all adjustments, consisting primarily of normal recurring accruals necessary for a fair statement of results for the periods presented. The results of operations for interim periods are not necessarily indicative of the results for the full year. Our interim financial statements should be read in conjunction with the financial statements and notes thereto contained in our 2014 Annual Report on Form 10-K. The year-end consolidated balance sheet data in these financial statements were derived from audited financial statements but do not include all disclosures required by GAAP.