Actionable news
All posts from Actionable news
Actionable news in PGNX: Progenics Pharmaceuticals Inc.,

Progenics Pharmaceuticals: 777 Old Saw Mill River Road

The following excerpt is from the company's SEC filing.

Tarrytown, New York 10591

Fax: (914) 789-2817

(914) 789-2800





TARRYTOWN, N.Y., November 9, 2015

– Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced results of operations for the quarter and nine months ended September 30, 2015.

"We had a highly productive quarter, with positive regulatory developments, key additions to our pipeline and continued clinical progress," stated Mark Baker, CEO of Progenics. "The Breakthrough Therapy Designation for ultra-orphan candidate Azedra

provides for an expedited development and review process, while the April 2016 PDUFA date for Oral RELISTOR establishes a pivotal near-term catalyst for our RELISTOR franchise. We acquired PyL, an imaging agent which is highly complementary with our 1404 program, establishing the leading portfolio of prostate cancer imaging agent candidates. In addition, our acquisition of EXINI will provide us with software development expertise to help further build our imaging toolkit for prostate cancer. We are well-positioned as we approach critical clinical milestones in the fourth quarter, including the completion of enrollment in our pivotal Phase 2b trial for Azedra and the launch of our Phase 3 program for 1404."

Net loss for the quarter was $10.0 million or $0.14 per diluted share, compared to net income of $37.0 million or $0.51 per diluted share in the third quarter of 2014. Net loss for the current nine months was $32.0 million, or $0.46 per diluted share, compared to net income of $16.6 million or $0.24 per diluted share in 2014. Progenics ended the quarter with cash and cash equivalents of $90.4 million, a decrease of $8.9 million in the quarter and $28.9 million from 2014 year-end.

Third quarter revenue totaled $1.4 million, down from $41.7 million in the third quarter of 2014, reflecting a decrease in collaboration revenue for RELISTOR

(methylnaltrexone bromide) of $39.8 million, primarily resulting from the recognition of $40.0 million milestone from Salix and royalty income of $1.2 million compared to $1.6 million in the corresponding period in 2014, based on net sales reported to Progenics by our commercialization partner, Valeant Pharmaceuticals International, Inc. The current quarter decrease in royalty revenue is primarily due to lower net sales of $8.0 million for the three months ended September 30, 2015, compared to $10.8 million for the corresponding period in 2014. Current year first nine months revenues were $3.6 million, down from $44.9 million in the first nine months of 2014, reflecting royalty income of $3.2 million compared to $3.7 million and collaboration revenue of $0.4 million compared to $41.1 million in the corresponding period in 2014.

Third quarter research and development expenses were flat compared to the third quarter of 2014, reflecting higher expenses for the Azedra clinical trial, 1404 and consulting expenses, offset by lower contract manufacturing and compensation expenses. Year-to-date research and development expenses decreased by $2.1 million compared to the corresponding period in 2014 primarily due to lower clinical trial expenses for PSMA ADC and 1404 and compensation expenses, partially offset by higher Azedra-related expenses. Third quarter general and administrative expenses increased by $0.5 million from the corresponding period in 2014 primarily due to higher compensation, consulting and professional fees. Year-to-date general and administrative expenses increased by $2.9 million compared to prior year period primarily due to an action brought by a former employee. The change in the contingent consideration liability for the quarter and year-to-date periods is a non-cash item and resulted from changes in estimates for fair value of contingent consideration liability.

Page 2

Progenics Announces Third Quarter Financial Results

Third Quarter and Recent Events

In October, the Company announced an offer to acquire EXINI Diagnostics AB, a leader in the development of software solutions for medical decision support based on advanced image analysis. The Company reported today that over 90 percent of the outstanding shares of EXINI have been tendered, and Progenics expects the settlement of the Offer to occur on or about November 12, 2015. EXINI is expected to complement Progenics's strategy to support its imaging and therapeutic agents with sophisticated software and other technologies that help physicians and patients visualize, understand, target and treat cancer. The planned acquisition would provide Progenics with in-house development capabilities in these areas that it can apply to its own pipeline, including its prostate cancer imaging agents 1404 and PyL.

Also in October, Dr. Thomas Strack joined Progenics as Vice President of Clinical Affairs. Prior to joining Progenics, he was the Vice President of Research and Development at Asubio Pharmaceuticals where he led clinical research programs as well as R&D portfolio strategies. Prior to joining Asubio, Dr. Strack held a number of key positions at Eli Lilly, Pfizer, and Takeda Pharmaceuticals, where he led global clinical programs in multiple therapeutic areas, including endocrinology, ophthalmology, and oncology. Dr. Strack is board certified in internal medicine and endocrinology.

In September, Valeant Pharmaceuticals International, Inc. and Progenics announced that the...