Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) announced results of operations for the second quarter and six months ended June 30, 2015.
“We have reported significant progress across our late stage pipeline,” stated Mark Baker, CEO of Progenics. “Our ultra-orphan drug, Azedra, received Breakthrough Therapy Designation from the FDA for malignant pheochromocytoma and paraganglioma, providing for an expedited development and review process. We are encouraged by the progress with our ongoing pivotal Phase 2b trial and we remain on track to complete enrollment in this trial by year-end.”
Mr. Baker continued, “We have solidified our leadership position in prostate cancer imaging, announcing plans to advance 1404 into a Phase 3 trial later this year and acquiring PyL, a complementary imaging agent candidate used in conjunction with PET imaging. With these two programs, we have established a premier development portfolio of prostate cancer imaging agents, with the potential to transform how we detect and monitor the full spectrum of prostate cancer, from initial diagnosis to recurrent and advanced disease.”
“Important progress was also made with our RELISTOR® franchise in the second quarter, with Valeant’s New Drug Application submission for RELISTOR Oral and EU approval of RELISTOR Subcutaneous Injection for the treatment of opioid induced constipation,” concluded Mr. Baker.
Net loss for the quarter was $11.7 million or $0.17 diluted per share, compared to net loss of $11.1 million or $0.16 diluted per share in the second quarter of 2014. Net loss for the current six months was $22.0 million, or $0.32 diluted per share, compared to $20.4 million or $0.31 diluted per share in the first half of 2014. Progenics ended the quarter with cash and cash equivalents of $99.3 million, a decrease of $9.1 million in the quarter and $20.0 million from 2014 year-end.
Second quarter revenue totaled $1.9 million, up from $1.5 million in the second quarter of 2014, reflecting RELISTOR® (methylnaltrexone bromide) royalty income of $1.8 million compared to $1.4 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 increase in royalty revenue is primarily due to higher net sales of $11.9 million for the three months ended June 30, 2015, compared to $9.1 million for the corresponding period in 2014. Collaboration revenue for the second quarter remained unchanged at $0.1 million compared to the corresponding period in 2014. Current year first half revenues were $2.2 million, down from $3.3 million in the first half of 2014, reflecting royalty income of $1.9 million compared to $2.1 million and collaboration revenue of$0.2 million compared to $1.1 million in the corresponding period in 2014.
Second quarter research and development expenses decreased by $1.5 million compared to the second quarter of 2014, reflecting lower clinical trial expenses for PSMA ADC and 1404, resulting from completion of these Phase 2 trials in 2014, and lower compensation expenses, partially offset by higher contract manufacturing and clinical trial expenses for Azedra. Year-to-date research and development expenses decreased by $2.1 millioncompared to the corresponding period in 2014. Second quarter general and administrative expenses increased by $2.1 million from the corresponding period in 2014. Year-to-date general and administrative expenses increased by $2.3 million compared to prior year period. Both increases are primarily due to charges accrued in the second quarter of 2015 related to an action brought by a former employee who was terminated by the Company in 2008. The non-cash item for the quarter and year-to-date periods resulted from increased estimates for fair value of contingent consideration liability.
Second Quarter and Recent Events
- In August, Progenics 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.
- In July, Progenics announced that the FDA designated Azedra as a Breakthrough Therapy for the treatment of patients with malignant pheochromocytoma and paraganglioma. Azedra is currently being evaluated in a pivotal Phase 2b trial, which is being conducted under a Special Protocol Assessment Agreement (SPA), and has received Orphan Drug and Fast Track designations from the FDA.
- In July, the Company also announced details of its planned Phase 3 clinical trial for 1404, a developmental stage small molecule designed to help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA). The Phase 3 clinical trial is expected to enroll approximately 450 patients with biopsy-proven low-grade prostate cancer who are candidates for active surveillance but have planned to undergo radical prostatectomy, and will evaluate the specificity and sensitivity of 1404 to identify clinically significant prostate cancer. Progenics expects to commence the Phase 3 trial by the end of this year.
- In July, Sheldon Hirt joined Progenics as Executive Vice President and General Counsel. Mr. Hirt previously served as Senior Vice President, Legal Affairs and Assistant General Counsel at Actavis plc.
- In June, Progenics and Valeant announced that Valeant had submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for RELISTOR® Tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
- Also in June, Progenics and Valeant announced that the European Commission had approved RELISTOR® Subcutaneous Injection for the treatment of OIC when response to laxative therapy has not been sufficient in adult patients. The decision is applicable to all 28 European Unionmember states plus Iceland and Norway and includes an additional one year of marketing protection. (Original Source)
Shares of Progenics closed yesterday at $8.64. PGNX has a 1-year high of $11.15 and a 1-year low of $4.26. The stock’s 50-day moving average is $7.88 and its 200-day moving average is $6.48.
On the ratings front, Progenics has been the subject of a number of recent research reports. In a report issued on July 23, Brean Murray Carret analyst Jonathan Aschoff maintained a Buy rating on PGNX, with a price target of $11, which represents a potential upside of 27.3% from where the stock is currently trading. Separately, on May 26, BTIG’s Hartaj Singh initiated coverage with a Buy rating on the stock and has a price target of $12.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jonathan Aschoff and Hartaj Singh have a total average return of 11.9% and 18.6% respectively. Aschoff has a success rate of 52.3% and is ranked #216 out of 3727 analysts, while Singh has a success rate of 69.2% and is ranked #930.
Progenics Pharmaceuticals Inc is engaged in the development of medicines for oncology. The Company develops products for the treatment of prostate cancer, opioid-induced constipation, or OIC, as well as OIC for non-cancer pain.