Get Cash Back and $0 Commissions
+ The Power of TradeStation
Globe Newswire 14-Mar-2019 7:45 AM
NEW YORK, March 14, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) today announced financial results for the fourth quarter and full-year 2018 and provided a business update.
"2018 was an extremely productive year for the advancement of our portfolio of radiopharmaceuticals, highlighted by the FDA's approval of AZEDRA for the treatment of advanced or metastatic pheochromocytoma and paraganglioma. As part of our ongoing U.S. commercial launch efforts, patient scheduling is ongoing at eight activated treatment centers across the country. We recently acquired the launch manufacturing facility for AZEDRA, allowing us to become a fully-integrated operation," said Mark Baker, Chief Executive Officer of Progenics.
Mr. Baker continued, "In parallel with our AZEDRA launch, we have made significant progress across our entire prostate cancer and AI portfolio, including the initiation of patient dosing in our Phase 3 CONDOR trial, which is evaluating the diagnostic potential and clinical impact of PyL in patients with suspected biochemical recurrence of prostate cancer. We have extended the reach of our PSMA-targeted portfolio with our collaboration with Curium for the development and commercialization of PyL in Europe, which validates the potential of our PET/CT imaging agent. We look forward to providing further updates on our PSMA-targeted programs during the year with the initiation of the Phase 2 trial of 1095 planned in the second quarter of 2019 and data presentations of deep convolutional neural network algorithms from our cutting-edge AI technology."
Fourth Quarter and Recent Key Business Highlights
AZEDRA (iobenguane I 131) 555 MBq/mL injection for intravenous use, Ultra-orphan Radiotherapeutic
PSMA-Targeted Prostate Cancer Pipeline
Digital Technology
RELISTOR, Treatment for Opioid-Induced Constipation (partnered with Bausch Health Companies Inc.)
Leronlimab (PRO 140), Monoclonal Antibody for HIV (owned and developed by CytoDyn)
Fourth Quarter and Full-Year 2018 Financial Results
Fourth quarter 2018 revenue totaled $3.2 million, down from $3.9 million in the fourth quarter of 2017. Revenue for the 2018 period reflects RELISTOR royalty income of $3.2 million compared to $3.7 million in the corresponding period of 2017. The full-year 2018 revenue totaled $15.6 million, up from $11.7 million for the full-year of 2017, resulting primarily from higher royalty income of $14.9 million in 2018 compared to $11.0 million in 2017.
Research and development expenses decreased by $1.3 million and $7.4 million in the fourth quarter and full-year 2018, respectively, compared to the corresponding periods in 2017, resulting primarily from lower external costs associated with the completion of the Phase 2 pivotal trial for AZEDRA and the Phase 3 trial for 1404. Fourth quarter and full-year selling, general and administrative expenses increased by $1.2 million and $4.5 million, respectively, compared to the corresponding periods in 2017, primarily attributable to higher costs associated with the commercial launch of AZEDRA. Progenics also recorded a net non-cash charge of $17.4 million in 2018, resulting from changes in the estimated fair values of intangible assets and contingent consideration liability, primarily related to 1404, following the decision not to invest in additional 1404 clinical trials.
For the three months and full-year ended December 31, 2018, Progenics recognized interest expense of $1.1 million and $4.7 million, respectively, related to the RELISTOR royalty-backed loan, compared to $1.2 million and $4.8 million recognized in the corresponding periods in 2017. For the three months and full-year ended December 31, 2018, Progenics recorded $0.1 million and $1.6 million, respectively, in income tax benefit. The primary driver of this tax benefit is related to the impairment and reclassification of the indefinite-lived intangibles for in process research and development assets. In the fourth quarter of 2017, Progenics recorded $11.7 million income tax benefit, primarily related to the reduction in the federal tax rate and the use of the Company's deferred tax liability related to indefinite-lived intangible assets (naked tax credit) as a source of income to release a portion of its valuation allowance recorded against deferred tax assets.
Net loss attributable to Progenics for the fourth quarter was $14.7 million or $0.17 per diluted share, compared to a net loss of $2.7 million or $0.04 per diluted share in the corresponding 2017 period. Net loss for the full-year 2018 was $67.7 million or $0.87 per diluted share, compared to net loss of $51.0 million or $0.73 per diluted share for the full-year 2017.
Progenics ended the year with cash and cash equivalents of $137.7 million, reflecting a decrease of $11.2 million in the quarter and an increase of $47.0 million from 2017 year-end. During the year ended December 31, 2018, the Company raised net proceeds of $70.0 million in an underwritten public offering and an additional $27.5 million in at-the-market transactions.
Conference Call and Webcast
Progenics will review fourth quarter and year-end financial results in a conference call today at 8:30 a.m. EDT. To participate, please dial (877) 250-8889 (domestic) or (720) 545-0001 (international) and reference conference ID 7764968. A live webcast will be available in the Media Center of the Progenics website, www.progenics.com, and a replay will be available there for two weeks.
- Financial Tables follow -
PROGENICS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) |
|||||||||||||
For the Three Months Ended December 31, |
For the Year Ended December 31, |
||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||
(Unaudited) | |||||||||||||
Revenues: | |||||||||||||
Royalty income | $ | 3,151 | $ | 3,683 | $ | 14,908 | $ | 10,965 | |||||
Other revenues | 87 | 206 | 714 | 733 | |||||||||
Total revenues | 3,238 | 3,889 | 15,622 | 11,698 | |||||||||
Operating expenses: | |||||||||||||
Research and development | 9,600 | 10,948 | 35,147 | 42,589 | |||||||||
Selling, general and administrative | 8,090 | 6,923 | 29,431 | 24,909 | |||||||||
Intangible impairment charge | - | - | 23,200 | - | |||||||||
Change in contingent consideration liability | 100 | (700 | ) | (5,800 | ) | 2,600 | |||||||
Total operating expenses | 17,790 | 17,171 | 81,978 | 70,098 | |||||||||
Operating loss | (14,552 | ) | (13,282 | ) | (66,356 | ) | (58,400 | ) | |||||
Other (expense) income: | |||||||||||||
Interest (expense) income and other income, net | (235 | ) | (1,055 | ) | (2,933 | ) | (4,285 | ) | |||||
Total other (expense) income | (235 | ) | (1,055 | ) | (2,933 | ) | (4,285 | ) | |||||
Loss before income tax benefit | (14,787 | ) | (14,337 | ) | (69,289 | ) | (62,685 | ) | |||||
Income tax benefit | 83 | 11,672 | 1,632 | 11,672 | |||||||||
Net loss | $ | (14,704 | ) | $ | (2,665 | ) | $ | (67,657 | ) | $ | (51,013 | ) | |
Net loss per share - basic and diluted | $ | (0.17 | ) | $ | (0.04 | ) | $ | (0.87 | ) | $ | (0.73 | ) | |
Weighted average shares outstanding – basic and diluted | 84,543 | 70,437 | 77,890 | 70,284 | |||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) |
||||
December 31, 2018 |
December 31, 2017 |
|||
Cash and cash equivalents | $ | 137,686 | $ | 90,642 |
Accounts receivable, net | 3,803 | 3,972 | ||
Property and equipment, net | 3,944 | 4,122 | ||
Intangible assets, net and goodwill | 19,740 | 43,443 | ||
Other assets | 4,324 | 3,778 | ||
Total assets | $ | 169,497 | $ | 145,957 |
Current liabilities | $ | 23,446 | $ | 15,359 |
Contingent consideration liability | 3,950 | 16,800 | ||
Long-term debt, deferred tax and other liabilities | 41,026 | 50,345 | ||
Total liabilities | 68,422 | 82,504 | ||
Total stockholders' equity | 101,075 | 63,453 | ||
Total liabilities and stockholders' equity | $ | 169,497 | $ | 145,957 |
Indication
AZEDRA® (iobenguane I 131) is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.
Important Safety Information
Warnings and Precautions:
Adverse Reactions:
The most common severe (Grade 3–4) adverse reactions observed in AZEDRA clinical trials (= 10%) were lymphopenia (78%), neutropenia (59%), thrombocytopenia (50%), fatigue (26%), anemia (24%), increased international normalized ratio (18%), nausea (16%), dizziness (13%), hypertension (11%), and vomiting (10%). Twelve percent of patients discontinued treatment due to adverse reactions (thrombocytopenia, anemia, lymphopenia, nausea and vomiting, multiple hematologic adverse reactions).
Drug Interactions:
Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells and therefore interfere with dosimetry calculations or the efficacy of AZEDRA. These drugs were not permitted in clinical trials that assessed the safety and efficacy of AZEDRA. Discontinue the drugs listed in the prescribing information for at least 5 half-lives before administration of either the dosimetry dose or a therapeutic dose of AZEDRA. Do not administer these drugs until at least 7 days after each AZEDRA dose.
For important risk and use information about AZEDRA, please see Full Prescribing Information.
To report suspected adverse reactions, contact Progenics Pharmaceuticals, Inc. at 844-668-3950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference:
AZEDRA® prescribing information. New York, NY: Progenics Pharmaceuticals, Inc.; 08 2018 and 07 2018.
About RELISTOR®
Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Bausch Health Companies, Inc. RELISTOR Tablets (450 mg once daily) are approved in the United States for the treatment of opioid-induced constipation (OIC) in patients with chronic non-cancer pain. RELISTOR Subcutaneous Injection (12 mg and 8 mg) is a treatment for OIC approved in the United States and worldwide for patients with advanced illness and chronic non-cancer pain.
IMPORTANT SAFETY INFORMATION - RELISTOR (methylnaltrexone bromide) tablets, for oral use and RELISTOR (methylnaltrexone bromide) injection, for subcutaneous use
RELISTOR tablets and injection are contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie's syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn's disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.
If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.
Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.
A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions.
In the clinical studies, the most common adverse reactions were:
OIC in adult patients with chronic non-cancer pain
OIC in adult patients with advanced illness
Please see complete Prescribing Information for RELISTOR at www.bauschhealth.com. For more information about RELISTOR, please visit www.RELISTOR.com.
About PROGENICS
Progenics is an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer, including: therapeutic agents designed to treat cancer (AZEDRA®, 1095, and PSMA TTC); prostate-specific membrane antigen ("PSMA") targeted imaging agent for prostate cancer (PyL™); and imaging analysis technology (aBSI and PSMA AI). Progenics has two commercial products, AZEDRA, for the treatment of patients with unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (rare neuroendocrine tumors of neural crest origin) who require systemic anticancer therapy; and RELISTOR® (methylnaltrexone bromide) for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies Inc.
This press release contains projections and other "forward-looking statements" regarding future events. Statements contained in this communication that refer to Progenics' estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Progenics' current perspective of existing trends and information as of the date of this communication. Forward looking statements generally will be accompanied by words such as "anticipate," "believe," "plan," "could," "should," "estimate," "expect," "forecast," "outlook," "guidance," "intend," "may," "might," "will," "possible," "potential," "predict," "project," or other similar words, phrases or expressions. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, market acceptance for approved products; the risk that the commercial launch of AZEDRA may not meet revenue and income expectations; the cost, timing and unpredictability of results of clinical trials and other development activities and collaborations; the unpredictability of the duration and results of regulatory review of New Drug Applications (NDA) and Investigational NDAs; the inherent uncertainty of outcomes in the intellectual property disputes such as the dispute with the University of Heidelberg regarding PSMA-617; our ability to successfully develop and commercialize products that incorporate licensed intellectual property; the effectiveness of the efforts of our partners to market and sell products on which we collaborate and the royalty revenue generated thereby; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; possible product safety or efficacy concerns, general business, financial, regulatory and accounting matters, litigation and other risks. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission, including those risk factors included in its Annual Report on Form 10-K for the year ended December 31, 2018, as updated in its subsequent Quarterly Reports on Form 10-Q. Progenics is providing the information in this press release as of its date and, except as expressly required by law, Progenics disclaims any intent or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.
Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this release. For more information, please visit www.progenics.com. Information on or accessed through our website or social media sites is not included in the company's SEC filings.
(PGNX-F)
Contact
Melissa Downs
Investor Relations
(646) 975-2533
mdowns@progenics.com