Shares of Eagle Pharmaceuticals Inc. (EGRX) are down 67% from their 52-week high of $40.85, recorded last November, and trade around $13.<\/p>\n
This commercial-stage pharmaceutical company specializes in oncology and acute care. Its marketed drugs include Belrapzo, Bendeka, Ryanodex, Treakisym, Pemfexy, Barhemsys and Byfavo.<\/p>\n
— Belrapzo is indicated for the treatment of patients with chronic lymphocytic leukemia.
— Bendeka for the treatment of Chronic Lymphocytic Leukemia, Non-Hodgkin’s Lymphoma
Ryanodex is a skeletal muscle relaxant in a concentrated formulation for the treatment of malignant hyperthermia.
— Pemfexy is approved for Non-Small Cell Lung Cancer and Malignant Pleural Mesothelioma.
— Byfavo (remimazolam) is an ultra-short-acting, intravenous benzodiazepine sedative\/anesthetic for the induction and maintenance of procedural sedation in adults.
— Barhemsys (amisulpride) is a dopamine-2 (D2) antagonist for the management of post-operative nausea and vomiting (PONV). The Centers for Medicare & Medicaid Services (CMS) granted Barhemsys transitional pass-through status, which became effective October 1, 2023, and J-code effective January 1, 2024.<\/p>\n
“Receiving pass-through status, as well as a J-code, is an ideal combination that will facilitate patient access to this important therapeutic,” according to Scott Tarriff, President and Chief Executive Officer of Eagle. <\/p>\n
The above 6 products are approved by the FDA.<\/p>\n
— Treakisym is approved for low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia in Japan.<\/p>\n
While Pemfexy, Ryanodex and Belrapzo, are marketed by the company, Bendeka is marketed by Teva Pharma through its subsidiary Cephalon Inc. Barhemsys and Byfavo are marketed to hospitals in the acute care space through Eagle Pharma’s internal direct sales force. Treakisym is marketed in Japan by SymBio Pharmaceuticals Ltd.<\/p>\n
Pipeline candidates<\/b><\/p>\n
CAL02, a first-in-class anti-toxin agent being developed for the treatment of severe community-acquired bacterial pneumonia; ENA-001, a new chemical entity being developed by Eagle’s partner, Enalare, as an agnostic respiratory stimulant for multiple patient populations experiencing respiratory depression; and EA-114, a novel and proprietary formulation of fulvestrant being developed for hormone-receptor-positive (HR+) metastatic breast cancer. <\/p>\n
Q2 in Retrospect<\/b><\/p>\n
For the second quarter ended June 30, 2023, the company reported a net income of $5.2 million or $0.39 per share, compared to net loss of $9.5 million or $0.74 per share, in the second quarter of 2022.<\/p>\n
On an adjusted basis, non-GAAP net income for the second quarter of 2023 declined to $15.5 million, or $1.18 per share from $20.3 million, or $1.56 per share, in the year-ago quarter.<\/p>\n
Total revenue, which includes product sales and royalty revenue, dropped to $64.6 million in the second quarter of 2023 from $74.1 million for the second quarter of 2022.<\/p>\n
In the second quarter of 2023, product sales accounted for $42.99 million and royalty revenue amounted to $21.65 million. This compared with product sales of $49.2 million and royalty revenue of $24.9 million in the year-ago period.<\/p>\n
Gross margin was 74% during the second quarter of 2023, compared to 68% in the second quarter of 2022.<\/p>\n
Perspectives – 2023 and Beyond<\/b><\/p>\n
Based on the strength of its business<\/span> and product pipeline, Eagle Pharma expects adjusted non-GAAP earnings per share to be in the range of $4.40 to $4.70 for full year 2023. The adjusted non-GAAP net income was $7.79 per share in 2022. <\/p>\n The company had a positive Type C meeting with the FDA in August of this year related to the path forward to advance the clinical development of EA-114.<\/p>\n Accordingly, the company expects to file a New Drug Application for EA-114 for the treatment of breast cancer in post-menopausal women in 2024.<\/p>\n Cash position<\/b><\/p>\n As of June 30, 2023, Eagle had $15.4 million in cash and cash equivalents, $115.1 million in accounts receivable, net, and $71.3 million in outstanding debt on its $150.0 million credit facility with JPMorgan.<\/p>\n Eagle Pharma shares began trading on the NASDAQ Global Market under the ticker symbol “EGRX” on February 12, 2014. <\/p>\n EGRX has traded in a range of $12.35 to $40.85 in the last 1 year. The stock closed Friday’s (Oct.20, 2023) trading at $13.40. <\/p>\n