Eagle Pharmaceuticals, Inc. Reports Second Quarter 2018 Results

Business and Recent Highlights:

• EHS clinical trial for RYANODEX^® will be conducted August 20 – 24, 2018 during the Hajj pilgrimage;
• Eagle received a favorable decision by the U.S. District Court for the District of Columbia granting seven years of orphan drug exclusivity (ODE) in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI) until December 2022 and denying the Food and Drug Administration’s (FDA’s) attempt to preemptively exclude TREANDA generics from the scope of exclusivity;
• Data from the fulvestrant clinical trial expected in the fourth quarter of 2018;
• Advancing discussions with U.S. military to formalize clinical and regulatory plans for RYANODEX in the treatment of nerve agent exposure;
• United States Patent and Trademark Office issued patent number 10,010,533 for BENDEKA. The USPTO has now issued or allowed a total of 15 U.S. patents in the BENDEKA family of patents expiring from 2021 to 2033;
• Eagle was first to file a vasopressin 1ml injection ANDA, which was accepted for filing by the FDA in April; and
• A second source manufacturing facility for Eagle’s bendamustine products has been approved by the FDA.

Financial Highlights:

Second quarter 2018

• Total revenue for the second quarter of 2018 was $59.3 million, compared to $50.1 million in the second quarter of 2017;
• Eagle launched bendamustine hydrochloride 500ml solution (“Big Bag”) on May 15, 2018 and Big Bag product sales were $8.1 million in the second quarter of 2018;
• Q2 2018 Ryanodex product sales were $7.2 million, up 38% compared to Q2 2017;
• Q2 2018 net income was $2.7 million, or $0.18 per basic and $0.17 per diluted share, compared to net income of $4.5 million, or $0.30 per basic and $0.28 per diluted share in Q2 2017;
• Q2 2018 Adjusted Non-GAAP net income was $14.7 million, or $0.99 per basic and $0.95 per diluted share, compared to Adjusted Non-GAAP net income of $7.9 million, or $0.52 per basic and $0.49 per diluted share in Q2 2017;
• During Q2 2018, Eagle purchased an additional $3.5 million of Eagle common stock as part of its share buyback program; since August 2016, Eagle has repurchased $91.3 million of Eagle common stock; and
• Cash and cash equivalents were $100.2 million, accounts receivable was $69.4 million, and debt was $47.5 million as of June 30, 2018.
• Reiterating 2018 Expense Guidance:
  • R&D expense is expected to be in the range of $46 – $50 million ($40 – $44 million on a non-GAAP basis)
  • SG&A expense is expected to be in the range of $61 – $64 million ($44 – $47 million on a non-GAAP basis)

“We believe 2018 will be another solid year of growth for Eagle, with continued near-term value creation, and strong upside potential with our advanced pipeline that could meaningfully contribute to the long-term value of the business. This includes protecting the value and longevity of our existing bendamustine franchise where we recently prevailed in litigation and received orphan drug exclusivity until December 2022 for BENDEKA, as well as having recently launched “Big Bag”, our 500 mL liquid form bendamustine solution that does not require reconstitution, filling an important need in the market for a lower-cost alternative. Our RYANODEX portfolio is advancing as we take advantage of product and label expansion opportunities for Exertional Heat Stroke and evaluate the neurological impact of nerve agent exposure in collaboration with the U.S. military,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

“As a result of the favorable court ruling requiring the FDA to grant BENDEKA orphan drug exclusivity, the FDA will not be able to approve any drug applications referencing BENDEKA until the ODE expires in December 2022. The court also denied the FDA’s attempt to preemptively exclude TREANDA generics from the scope of BENDEKA’s ODE. We continue to believe that an appropriate application of ODE would first allow generic TREANDA entrants in December 2022, rather than November 2019 and intend to vigorously pursue our position with the FDA and through additional litigation, if necessary,” added Tarriff.

“We look forward to completing our clinical study for RYANODEX for EHS scheduled during the Hajj Pilgrimage, to support the data we have previously collected. We anticipate reporting results for our fulvestrant study later this year, along with progress on other products under development. We look forward to sharing our continued progress to create value for patients and shareholders,” concluded Tarriff.

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