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Actionable news in PGNX: Progenics Pharmaceuticals Inc.,

Progenics Pharmaceuticals Announces First Quarter 2016 Financial and Business Results

  • On May 2nd, the Company Announced It Had Granted Exclusive World-Wide Rights to Bayer to Develop and Commercialize Products Using Progenics' PSMA Antibody Technology In Combination with Alpha-Emitting Radionuclides
  • Enrollment in Pivotal Phase 3 Study of PSMA-Targeted SPECT/CT Imaging Agent 1404 Ongoing in the U.S. and Canada
  • PyL Study Data to be Presented at the 2016 American Urological Association
  • AZEDRA(R) Pivotal Phase 2b Trial Topline Results Expected Between December 2016 and March 2017
  • On April 4 [th] , Oral RELISTOR(R) PDUFA Date Was Set for July 19, 2016; Approval to Trigger $50 Million Milestone Payment from Valeant plus Royalties and Sales Milestones
  • First Quarter 2016 RELISTOR Net Sales of $16.6 Million

Progenics Pharmaceuticals, Inc. PGNX, -3.35% today announced financial and business results for the first quarter 2016.

Key Business Highlights

PSMA-Targeted Prostate Cancer Pipeline

  • On May 2nd, the Company Announced It Had Granted Exclusive World-Wide Rights to Bayer to Develop and Commercialize Products Using Progenics' PSMA Antibody Technology In Combination with Alpha-Emitting Radionuclides. The transaction combines Bayer's expertise in alpha emitter radiopharmaceuticals with Progenics' validated PSMA antibody technology to develop a new therapeutic approach for prostate cancer. Under the terms of the agreement, Progenics will receive an upfront payment of $4 million and could receive up to an additional $49 million in potential clinical and regulatory development milestones. The Company is also entitled to single digit royalties on net sales, and potential net sales milestone payments up to an aggregate total of $130 million.

  • Advancing Pivotal Phase 3 Study of PSMA-Targeted SPEC/CT Imaging Agent 1404 in the U.S. and Canada. The study will enroll approximately 450 patients with newly-diagnosed or low-grade prostate cancer who are candidates for active surveillance who have decided to undergo a radical prostatectomy. Progenics is planning an interim analysis during the second half of 2016 to assess futility and evaluate the need for a sample size re-estimation.

  • Johns Hopkins University Study Evaluating the Utility of PyL in Men with Elevated PSA Following Radical Prostatectomy to be Presented at the 2016 American Urological Association Annual Meeting, which is being held May 6-10 in San Diego. PSMA-targeted [18] F-DCFPyL PET/CT (PyL) appears to be a sensitive imaging modality for detecting prostate cancer recurrence. Progenics plans to meet with the FDA in the second quarter to discuss a phase 2 study design.

  • Company Remains On-Track to Initiate a Phase 1 Trial of 1095 in the Second Half of 2016. The Phase 1 Study of 1095, a PSMA-Targeted Therapeutic for Metastatic Prostate Cancer, will be conducted at Memorial Sloan Kettering Cancer Center.

AZEDRA, Ultra-orphan radiotherapeutic candidate

  • AZEDRA Topline Results Expected Between December 2016 and March 2017. In late 2016 or early 2017, Progenics expects to report topline results from its ongoing pivotal Phase 2b study of AZEDRA. If positive, the Company expects to submit an NDA to the FDA during the first half of 2017.

RELISTOR, treatment for opioid-induced constipation (partnered with Valeant Pharmaceuticals International, Inc.)

  • RELISTOR Net Sales for the First Quarter 2016 Total $16.6 Million. The first quarter 2016 sales, as reported to us by our partner Valeant, translated to $2.2 million in royalty revenue, net of prior year adjustments.

  • PDUFA Date for Oral RELISTOR Extended to July 19, 2016. The FDA extended the action date to allow for a full review of Valeant's responses to recent information requests from the FDA. If approved, Progenics would be entitled to a $50 million milestone payment and subsequent royalties and sales milestones from Valeant.

"The Progenics' portfolio features multiple value-creating opportunities, and we are continuing to drive development of high-priority internal programs while leveraging the potential of our technology through strategic transactions, such as the recent Bayer license agreement," said Mark Baker, Chief Executive Officer of Progenics. "AZEDRA represents a near-term commercial candidate in an ultra-orphan indication, while our portfolio of imaging agents and therapeutics has the potential to transform how prostate cancer is detected, managed and treated. We look forward to progressing toward key milestones over the next several quarters."

First Quarter 2016 Financial Results

Net loss attributable to Progenics for the quarter was $12.7 million or $0.18 per basic and diluted share, compared to a net loss of $10.3 million or $0.15 per basic and diluted share in the 2015 period. Progenics ended the quarter with cash and cash equivalents of $65.7 million, a decrease of $8.4 million in the quarter.

First quarter revenue totaled $2.5 million, up from $0.2 million in the 2015 period, reflecting RELISTOR royalty income of $2.2 million (net of prior year adjustments) compared to $0.1 million in the prior year period, based on net sales reported by Valeant. Net sales in the first quarter of the prior year were impacted by a wholesaler inventory reduction initiative implemented in the fourth quarter of 2014 by Salix Pharmaceuticals, Inc., which was subsequently acquired by Valeant.

First quarter 2016 research and development expenses increased by $2.7 million compared to the prior year period, primarily attributable to higher clinical trial and contract manufacturing expenses for AZEDRA and 1404 and higher compensation expenses, partially offset by clinical trial expenses for PSMA ADC which were incurred in the prior year but not the current period. First quarter 2016 general and administrative expenses increased by $2.1 million compared to the prior year period, primarily attributable to incremental depreciation, which is expected to continue through August 1, 2016, as a result of a reduction in the remaining useful lives of the Company's leasehold improvements at its Tarrytown, NY location, and higher compensation, consulting, and...


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