Progenics Pharmaceuticals Announces Second Quarter 2019 Financial Results and Business Update

August 9, 2019 7:30 AM

NEW YORK, Aug. 09, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced financial results for the second quarter 2019 and provided a business update.

“We are excited to report significant progress across our entire portfolio, with commercial, clinical, and business development achievements forming a strong foundation for near-term growth,” said Mark Baker, Chief Executive Officer of Progenics. “AZEDRA commercial dosing is underway and we are now focused on converting our growing number of treatment requests into treated patients. We are on our way to unlocking the significant value of this drug for both patients and our shareholders.”

Mr. Baker continued, “We also continued to drive the development of our PSMA-targeted prostate cancer pipeline of diagnostics and therapeutics. Strong interest in our PyL imaging agent resulted in rapid enrollment in our Phase 3 CONDOR study, and we are now looking ahead to a topline data readout by year end. We commenced dosing in our Phase 2 trial of 1095 and, assuming early positive data from this open-label trial, see potential to advance 1095 into a pivotal trial in 2020 following agreement from the FDA. Our recent partnerships with ROTOP and FUJIFILM, together with our established partnerships with Bayer and Curium, provide additional validation for our PSMA-targeted approach and expand the reach of our pipeline across the globe. As we continue to grow our pipeline and operations, we remain focused on delivering our life-saving treatments for cancer to the patients who need them while creating significant value for our shareholders.”

Second 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.)

Corporate Update

Second Quarter 2019 Financial Results

Second quarter revenue totaled $10.0 million, up from $3.9 million in the second quarter of 2018, primarily due to the achievement of a $2.0 million milestone under the Bayer agreement for initiation of a Phase 1 trial of PSMA TTC and a $4.0 million upfront payment from FUJIFILM under the aBSI transfer agreement.

Second quarter research and development expenses increased by $3.7 million compared to the corresponding prior year period, primarily resulting from higher clinical trial costs and contract manufacturing costs for clinical trial materials for 1095 and PyL, as well as higher costs associated with the transition costs for the AZEDRA manufacturing site and additional production capacity for iodine-based products. Second quarter selling, general and administrative expenses increased by $7.0 million compared to the corresponding prior year period, primarily due to increases in legal and advisory fees of $5.5 million associated with the contested election at our 2019 Annual Meeting of Shareholders, PSMA-617 litigation costs of $1.0 million, and costs associated with the build out of commercial infrastructure to support the launch and distribution of AZEDRA. Progenics also recorded non-cash adjustments of $0.9 million in the second quarter 2019, related to changes in the fair value estimate of the contingent consideration liability. For the three months ended June 30, 2019, Progenics recognized interest expense of $1.1 million related to the RELISTOR royalty-backed loan.

Net loss for the second quarter was $19.7 million, or $0.23 per diluted share, compared to net loss of $15.2 million, or $0.20 per diluted share, in the corresponding 2018 period.

Progenics ended the second quarter with cash and cash equivalents of $84.8 million, a decrease of $52.9 million compared to cash and cash equivalents as of December 31, 2018, reflecting primarily cash used for operating expenses and for the acquisition of the Somerset manufacturing site for the AZEDRA launch.

Conference Call and Webcast

Progenics will review second quarter 2019 results in a conference call today at 8:30 a.m. EST. To participate, please dial (877) 250-8889 (domestic) or (720) 545-0001 (international) and reference conference ID 9149197. 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.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(In thousands, except per share data)

For the Three Months EndedJune 30,For the Six Months EndedJune 30,
2019 2018 2019 2018
Revenues: (unaudited)
AZEDRA product sales$270 $- $270 $-
Royalty income 3,593 3,530 7,754 6,588
License and other revenue 6,103 348 6,223 479
Total revenues 9,966 3,878 14,247 7,067
Operating expenses:
Cost of goods sold 493 - 493 -
Research and development 13,080 9,347 25,472 17,457
Selling, general and administrative (1) 14,570 7,569 23,794 14,266
Change in contingent consideration liability 916 1,300 1,816 2,100
Total operating expenses 29,059 18,216 51,575 33,823
Operating loss (19,093) (14,338) (37,328) (26,756)
Other (expense) income:
Interest (expense) income, net (607) (930) (1,107) (1,936)
Total other (expense) income (607) (930) (1,107) (1,936)
Loss before income tax benefit (19,700) (15,268) (38,435) (28,692)
Income tax benefit - 96 - 96
Net loss $(19,700)$(15,172)$(38,435)$(28,596)
Net loss per share - basic and diluted$(0.23)$(0.20)$(0.45)$(0.39)
Weighted average shares outstanding – basic and diluted 85,000 74,017 84,772 73,271
(1) Included in the selling, general and administrative expenses for the three and six months ended June 30, 2019 are $5.5 million and $5.9 million, respectively of legal and advisory fees associated with the contested election at our 2019 Annual Meeting of Shareholders and $1.0 million and $1.8 million, respectively associated with PSMA-617 litigation.

CONDENSED CONSOLIDATED BALANCE SHEETS(In thousands)
June 30, 2019 December 31, 2018
(unaudited) (audited)
Cash and cash equivalents$84,823$137,686
Accounts receivable, net 10,569 3,803
Property and equipment, net 7,008 3,944
Intangible assets, net and goodwill 25,222 19,740
Operating right-of-use lease assets 13,889 -
Other assets 11,270 4,324
Total assets$152,781$169,497
Current liabilities$23,571$23,446
Contingent consideration liability 4,800 3,950
Operating lease liability 15,312 -
Long-term debt, deferred tax and other liabilities 36,370 41,026
Total liabilities 80,053 68,422
Total stockholders’ equity 72,728 101,075
Total liabilities and stockholders’ equity$152,781$169,497

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:

20 mmHg or an increase in diastolic blood pressure to ≥ 100 mmHg with an increase of 10 mmHg. All changes in blood pressure occurred within the first 24 hours post infusion. Monitor blood pressure frequently during the first 24 hours after each therapeutic dose of AZEDRA.

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 PROGENICSProgenics 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 agents for prostate cancer (PyL™ and 1404); 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.

Forward Looking StatementsThis 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 and include statements regarding Progenics’ strategic and operational plans and delivering value for shareholders. 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 ; the costs and management distraction attendant to activist shareholder campaigns; and risks related to changes in the composition of our Board of Directors following our 2019 Annual Meeting of Shareholders. 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 Securities and Exchange Commission (the “SEC”), 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 press 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)

ContactMelissa DownsInvestor Relations(646) 975-2533mdowns@progenics.com

PGNX Logo (Vector)-FFF.png

Source: Progenics Pharmaceuticals Inc.

Categories

Globe Newswire Press Releases