On March 9, 2017 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported financial results and provided a business update for the fourth quarter and full-year 2016 (Press release, Progenics Pharmaceuticals, MAR 9, 2017, View Source [SID1234518050]). Schedule your 30 min Free 1stOncology Demo! "Since the beginning of 2016, we have made tremendous progress in advancing our robust pipeline of innovative cancer treatments and executing against our strategic corporate goals," said Mark Baker, CEO of Progenics. "2017 has the potential to be a transformational year for Progenics, with AZEDRA topline data from our registrational trial in pheochromocytoma and paraganglioma expected in the coming weeks. Should we report positive data and meet the requirements of the Special Protocol Assessment, we will move quickly toward an NDA as we strive to introduce a promising treatment to patients with these rare and difficult-to-treat cancers."
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Mr. Baker continued, "We also continued to advance our novel portfolio of prostate cancer imaging agents and therapeutics in 2016, including 1404, PyL and 1095, which could transform how physicians and patients find, fight and followTM prostate cancer. We are encouraged by the significant investigator interest in our PSMA-targeted candidates, and with our strong cash position, we look forward to progressing these programs through key trials this year."
Fourth Quarter and Recent Key Business Highlights
AZEDRA, Ultra-orphan radiotherapeutic candidate
AZEDRA Topline Results Expected First Quarter 2017. Progenics expects to report topline results from its ongoing registrational trial of AZEDRA by the end of March 2017. With positive data (AZEDRA trial meets the primary endpoint of the Special Protocol Assessment (SPA)), the Company expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in mid-2017.
PSMA-Targeted Prostate Cancer Pipeline
Positive DMC Recommendation for Continuation of Phase 3 Study of 1404. In December 2016, an independent Data Monitoring Committee (DMC) completed its review of an interim analysis of the Company’s ongoing Phase 3 clinical trial of its PSMA-targeted SPECT/CT imaging agent candidate 1404, and recommended that the trial continue. The study is designed to evaluate the specificity of 1404 imaging to identify patients without clinically significant prostate cancer and sensitivity to identify patients with clinically significant disease.
Initiated Phase 2/3 Trial of PSMA-Targeted PET/CT Imaging Agent PyL. Also in December 2016, Progenics announced that the first patient had been dosed in a Phase 2/3 trial of PyL. The study is designed to evaluate the diagnostic accuracy of PyL PET/CT imaging in patients with metastatic prostate cancer.
Launched PyL Research Access ProgramTM. In November 2016, Progenics announced a research access program making limited doses of PyL available to researchers. Progenics plans to use data generated from the access program to support its registration efforts for PyL and advance the development of algorithms designed to analyze and interpret the scans.
Initiated Phase 1 Trial of 1095 for the Treatment of Metastatic Prostate Cancer. The trial, which is being conducted at Memorial Sloan Kettering Cancer Center, is expected to include approximately 30 patients with mCRPC who have demonstrated tumor avidity to 1095. The objectives of this trial are to determine the maximum tolerated dose, safety and tolerability, biodistribution, and efficacy — results that will guide the decision of an optimal dose for a potential Phase 2 study.
RELISTOR, treatment for OIC (partnered with Valeant Pharmaceuticals International, Inc.)
RELISTOR (SC and Oral) Net Sales for the Fourth Quarter of 2016 Totaled $16 million. Full-year 2016 net sales totaled $70.6 million as reported by our partner, Valeant.
Announced $50 Million RELISTOR Royalty-Backed Non-Dilutive Debt Financing with HealthCare Royalty Partners. In November 2016, Progenics announced a $50 million non-recourse, term loan agreement at a per annum interest rate of 9.50 percent, to be secured by and repaid from royalties on future sales of RELISTOR. Any future sales milestones received under Valeant agreement are excluded from the transaction and would not be used to repay interest or principal on the loan.
Fourth Quarter and Full-Year 2016 Financial Results
Total revenue decreased $0.4 million for the fourth quarter and increased $60.8 million for the full-year, over the fourth quarter and full-year of 2015, respectively. The full-year increase was due primarily to milestone revenue of $50 million for the July 19 FDA approval of RELISTOR Tablets, higher RELISTOR royalty income, and the recognition of $7 million in upfront and development milestone payments from Bayer for the collaboration of our PSMA antibody technology in combination with Bayer’s alpha-emitting radionuclides.
Fourth quarter and full-year research and development expenses increased by $2.7 million and $9.4 million, respectively, compared to the corresponding periods in 2015, resulting primarily from higher clinical trial expenses for 1404 and PyL and higher contract manufacturing expenses for 1095, PyL and AZEDRA. Fourth quarter and full-year general and administrative expenses increased by $1 million and $5.2 million, respectively, compared to the corresponding prior year periods, primarily attributable to higher depreciation expense as a result of a reduction in the remaining useful lives of our leasehold improvements at our Tarrytown, NY former location and higher compensation and market research expenses. Progenics also recorded non-cash adjustments of $6 million and $4.6 million in the fourth quarter and full-year 2016, respectively, related to a decrease in the fair value estimate of the contingent consideration liability.
Net loss attributable to Progenics for the quarter was $7.2 million or $0.10 per diluted share, compared to a net loss of $7.1 million or $0.10 per diluted share in the corresponding 2015 period. Net income attributable to Progenics for the full-year 2016 was $10.8 million or $0.15 per basic and diluted share, compared to net loss of $39.1 million or $0.56 per diluted share for the full-year 2015.
Progenics ended the year with cash and cash equivalents of $138.9 million, reflecting increases of $40 million in the quarter and $64.8 million from 2015 year-end.