| Over a week ago | ||||
Sees FY23 adjusted EBITDA… Sees FY23 adjusted EBITDA $74M-$80M. Sees FY23 adjusted R&D expense $41M-$45M. "Our path to achieving our projected earnings per share range of $4.20 to $4.53 for 2023 is based on several key drivers. First, we anticipate higher PEMFEXY sales in 2023 than we had last year, and we also reduced future royalties related to PEMFEXY profits from 25% to a range of 0% to 12.5% based on aggregate profits achieved in exchange for a one-time payment of $15 million. In addition, we expect the 2023 decline in bendamustine to be manageable, and the 10% royalty on bendamustine products no longer applies. We also remain enthusiastic about the commercial potential of our two newest hospital-based products, Barhemsys and Byfavo. These efforts, together with our intention to further expand the Company, including M&A, lead us to believe that Eagle is poised for another year of strong earnings growth and profitability in 2023," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. | ||||
| Over a month ago | ||||
Eagle Pharmaceuticals… Eagle Pharmaceuticals announced that the U.S. FDA has approved an additional indication for PEMFEXY in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Eagle's approved PEMFEXY is a ready-to-dilute novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug, ALIMTA. "With this fifth indication, PEMFEXY is now approved for all of the same indications as ALIMTA, and we believe it allows for key advantages such as eliminating the need for reconstitution. Since its initial launch in February 2022, PEMFEXY has been an important addition to Eagle's hospital and acute care product portfolio, and we are pleased to bring this treatment option to patients undergoing chemotherapy. At the same time, we also believe that Eagle is well positioned to capture the commercial opportunity that PEMFEXY represents," stated Scott Tarriff, President and CEO of Eagle Pharmaceuticals. Effective October 1, 2022, the company amended its agreement to reduce future royalties related to PEMFEXY profits from 25% to a range of 0% to 12.5% based on aggregate profits achieved in exchange for a one-time payment of $15M. | ||||
Eagle Pharmaceuticals… Eagle Pharmaceuticals announced that it has reached a settlement agreement with Accord Healthcare. Eagle had asserted its Orange Book-listed patents against Accord related to Accord's new drug application referencing BENDEKA. The settlement agreement provides that Accord has the right to market its product beginning January 17, 2028, or earlier based on certain circumstances. The settlement agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. The settlement with Accord follows Eagle's previously announced settlement with Hospira, Inc. regarding two Orange Book-listed patents, which granted Hospira the right to market its product beginning January 17, 2028, or earlier based on certain circumstances. | ||||
Investor Day to be held… Investor Day to be held in New York on December 6 at 8 am. Webcast Link | ||||
Investor Day to be held… Investor Day to be held in New York on December 6 at 8 am. Webcast Link | ||||
Investor Day to be held… Investor Day to be held in New York on December 6 at 8 am. Webcast Link | ||||
As compared to $32.5M in… As compared to $32.5M in 2021. Adjusted non-GAAP SG&A expense for the full year 2022 is expected to be in the range of $64M-$68M, as compared to $54.9M in 2021. | ||||
Reports Q3 revenue… Reports Q3 revenue $65.9M, consensus $62.08M. "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 CEO 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. | ||||
| Over a quarter ago | ||||
Eagle Pharmaceuticals… Eagle Pharmaceuticals announced that it has submitted an investigational new drug application to the U.S. Food and Drug Administration for CAL02, a novel first-in-class broad-spectrum anti-virulence agent for the treatment of severe community-acquired bacterial pneumonia. 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. The design, entry criteria, and endpoints for the proposed Phase 2 study have been discussed with the FDA in a pre-IND meeting held on September 19, 2022. The Phase 2 study plans to enroll approximately 276 patients with SCABP at 120 sites worldwide. Patient enrollment is expected as early as the beginning of 2023. Eagle anticipates filing for ten years of regulatory exclusivity, including five years as a new chemical entity and five years as a qualified infectious disease product under the Generating Antibiotic Incentives Now Act. Eagle believes that CAL02 could be eligible for fast track and breakthrough therapy designations. In addition, Eagle believes a CAL02 new drug application for the treatment of SCABP may qualify for priority review. The Company expects to strengthen the patent portfolio for this asset. In August 2021, Eagle entered into a worldwide licensing agreement with Combioxin SA, a clinical-stage biotechnology company based in Epalinges, Switzerland, for the commercial rights to CAL02. As previously announced, the Company expects to invest $35 million to achieve interim results from the Phase 2 study expected in late 2023/early 2024. | ||||
