EAGLE PHARMACEUTICALS INC (EGRX) 34,75 + 10.16%
52w High: 56.43
TIME FOR A STRONG RECOVERY:
Total revenue for Q3 2022 was $65.9 million, compared to $39.9 million in Q3 2021
Nine-month 2022 net income was $2.41 per basic and $2.38 per diluted share
Nine-month 2022 adjusted non-GAAP earnings per diluted share1 more than doubled to $6.69 from full year 2021 adjusted non-GAAP earnings per diluted share, outperforming any full year in the Company’s history
Nine-month 2022 revenue of $255.9 million exceeds full year 2021 revenue of $171.5 million
Nine-month 2022 net sales of vasopressin and PEMFEXY combined totaled $114.9 million
BENDEKA®2 and BELRAPZO®3 - both ready-to-dilute (“RTD”) products — combined currently have 91% share of the bendamustine market, up from 85% at the beginning of the year. TREANDA®4, which is not an RTD product, has just 9%5
Q3 2022 gross profit from bendamustine franchise increased 9% compared to Q3 20216
Submitted an investigational new drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for CAL02, a novel first-in-class broad-spectrum anti-virulence agent for the treatment of severe community-acquired bacterial pneumonia
Strengthened hospital pipeline through equity stake in and an option to acquire Enalare Therapeutics Inc (“Enalare”)7. Enalare’s lead pipeline compound, ENA-001, a novel agnostic respiratory stimulant with strong patent protection, has three target indications: post-operative respiratory depression; community drug overdose; and Apnea of Prematurity, a common condition in preterm infants
Company to host Investor Day in New York City on December 6, 2022
WOODCLIFF LAKE, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and nine months ended September 30, 2022.
Business and Recent Highlights:
Submitted an IND application to FDA for CAL02, a novel first-in-class broad-spectrum anti-virulence agent for the treatment of severe community-acquired bacterial pneumonia (“SCABP”). The IND filing includes a protocol for an adequately powered global Phase 2 study to evaluate the efficacy and safety of CAL02 when added to standard of care therapy in patients with SCABP.
Acquired an equity stake in, with an option to purchase, Enalare Therapeutics Inc. (“Enalare”), adding a portfolio of novel NCEs with strong intellectual property protection, from the mid-2030s into the 2040s, including composition of matter patents. Enalare’s lead compound, ENA-001 is an investigational, one-of-a-kind NCE being developed as an agnostic respiratory stimulant for multiple patient populations experiencing acute respiratory depression. The initial targeted indications include post-operative respiratory depression; community drug overdose; and Apnea of Prematurity, a common condition in preterm infants. The Company believes this investment strengthens Eagle’s position as a diversified pharmaceutical company and a leader in hospital/anesthesia.
Enalare secured a contract for up to $50.3 million from the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services (contract number 75A50122C00072). In partnership with BARDA, ENA-001 is being developed in an intramuscular (“IM”) formulation for potential use in patients experiencing community drug overdose and as a potential medical countermeasure for mass casualty events.
FDA granted Orphan Drug Designation (“ODD”) to ENA-001 for the treatment of Apnea of Prematurity (“AoP”). AoP is a development disorder attributed to immaturity of the pulmonary system characterized by either cessation of breathing for more than 20 seconds or cessation of breathing that lasts less than 20 seconds but is accompanied by either bradycardia or hypoxemia.
Received favorable ruling in vasopressin litigation. The U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for the District of Delaware’s decision that Eagle’s vasopressin product does not infringe on any of the patents asserted by Par Pharmaceutical, Inc.
Appointed pharmaceutical industry veteran, Debra M. Hussain, as Senior Vice President, Head of Commercial, with responsibility for FDA-approved new chemical entities, BARHEMSYS® and BYFAVO®, acquired as part of the acquisition of Acacia Pharma Group plc (“Acacia”).
Amended and restated its credit agreement providing for a three-year $100 million revolving credit facility and $50 million term loan facility and repaid all other debt.
Financial Highlights
Third Quarter 2022
Total revenue for Q3 2022 was $65.9 million, compared to $39.9 million in Q3 2021.
Q3 2022 net loss was $(3.5) million, or $(0.27) per basic and diluted share, compared to net loss of $(5.6) million, or $(0.43) per basic and diluted share, in Q3 2021.
Q3 2022 adjusted non-GAAP net income was $14.9 million, or $1.13 per basic and $1.12 per diluted share, compared to adjusted non-GAAP net income of $7.5 million, or $0.57 per basic and $0.56 per diluted share, in Q3 2021.
Cash and cash equivalents were $15.4 million, net accounts receivable was $96.9 million, and debt was $59.3 million, as of September 30, 2022.
Recorded a $3.8 million milestone payment from SymBio on TREAKISYM® in Q3 2022, $1.2 million ($0.07 per basic and diluted share) less than anticipated due to currency declines of the Japanese Yen.
“It was another strong quarter for Eagle, and we are pleased that the earnings growth has continued. We are posting record earnings this year, as evidenced by the fact that in the first nine months of the year, we have already earned $6.69 per share, topping our previous best full year ever,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
“We expect another strong year in 2023 and anticipate deploying the cash from our earnings and strong balance sheet not only to fund our key clinical initiatives but also to potentially make an accretive acquisition to round out our portfolio. Between business development activities and our own R&D engine, we believe Eagle can grow significantly larger as it transitions into a branded pharmaceutical company with a diversified portfolio of assets,” concluded Tarriff.
Third Quarter 2022 Financial Results
Total revenue for the three months ended September 30, 2022 was $65.9 million, as compared to $39.9 million for the three months ended September 30, 2021.
Q3 2022 RYANODEX® net product sales were $7.6 million, compared to $4.5 million in the third quarter of 2021.
Q3 2022 BELRAPZO net product sales were $8.5 million, compared to $4.9 million in the third quarter of 2021.
Q3 2022 PEMFEXY® net product sales were $1.7 million and vasopressin net product sales were $13.8 million.
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