WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) today announced its financial results for the three and nine months ended September 30, 2018. Highlights of and subsequent to the third quarter of 2018 include:

Business and Recent Highlights:

• Commenced a $50.0 million accelerated share repurchase (the “ASR”) as part of a new $150.0 million share repurchase authorization;
• Announced that the Company’s fulvestrant formulation did not meet the primary bioequivalence endpoints evaluating Eagle’s formulation compared to FASLODEX® in its open label, randomized, pharmacokinetic (“PK”) and safety study conducted in 600 healthy female volunteers across multiple U.S. sites;
• Entered into an agreement with the United States Army Medical Research Institute of Chemical Defense (“USAMRICD”), the nation's leading science and technology laboratory in the area of medical chemical countermeasures research and development, to conduct a study to evaluate the neuroprotective effects of RYANODEX® (dantrolene sodium);
• Appointed David Pernock to the position of Chief Operating Officer;
• Completed enrollment of the Company’s second clinical study to further evaluate the safety and efficacy of RYANODEX for the treatment of exertional heat stroke (“EHS”), an investigational new indication for the product;
• Named to the Fortune 100 List of Fastest-Growing Companies, ranking 16th overall, including achieving the #1 positions for EPS 3-year growth of 392% and revenue 3-year growth of 109%; and
• United States Patent and Trademark Office (“USPTO”) issued patent number 10,052,385 for BENDEKA. The USPTO has now issued or allowed a total of 16 patents in the BENDEKA family of patents expiring from 2026 to 2033.

Financial Highlights:

Third Quarter 2018

• Total revenue for the third quarter of 2018 was $51.3 million, compared to $63.0 million in the third quarter of 2017, which included a $12.5 million milestone payment for BENDEKA;
• Eagle launched bendamustine hydrochloride 500ml solution (“Big Bag”) on May 15, 2018 and Big Bag product sales were $8.0 million in the third quarter of 2018; for the week ending October 19, 2018, the Company achieved market share of 5% according to IMS Health;
• Q3 2018 RYANODEX product sales were $3.5 million, up 9% compared to Q3 2017;
• Q3 2018 net income was $14.0 million, or $0.94 per basic and $0.91 per diluted share, compared to net income of $15.4 million, or $1.03 per basic and $0.98 per diluted share in Q3 2017;
• Q3 2018 Adjusted Non-GAAP net income was $18.3 million, or $1.22 per basic and $1.18 per diluted share, compared to Adjusted Non-GAAP net income of $19.2 million, or $1.27 per basic and $1.22 per diluted share in Q3 2017; and
• Cash and cash equivalents were $91.2 million, accounts receivable was $78.5 million, and debt was $45.0 million as of September 30, 2018.
• Reiterating 2018 Expense Guidance:
  • R&D expense is expected to be in the range of $46.0 - $50.0 million ($40.0 – $44.0 million on a non-GAAP basis)
  • SG&A expense is expected to be in the range of $61.0 - $64.0 million ($44.0 – $47.0 million on a non-GAAP basis)

“While we were disappointed in the outcome of the fulvestrant trial, we believe in the strength of the remaining products in our pipeline and our ability to generate long-term meaningful earnings. We are conducting a confirmatory study with the U.S. military to evaluate RYANODEX as a treatment for nerve agent exposure and continue to make progress on an intramuscular formulation. And, we maintain a positive view of a potential exertional heat stroke application. We are also advancing our vasopressin and pemetrexed assets. Consequently, we have decided to expand our share repurchase program to $150 million,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

“The $50 million of Eagle stock we purchased as part of an ASR represents the confidence of management and the Board of Directors in the value we are building at Eagle. As a publicly traded company, Eagle has raised an aggregate $110 million of equity capital. With the ASR completed, as of November 1, 2018, we have now repurchased $154 million of Eagle stock, without levering the balance sheet. With a strong base business, an exciting pipeline and growing cash position, we expect to continue building long-term value for shareholders,” concluded Tarriff.

About Eagle Pharmaceuticals, Inc.

Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle’s main strategy is to utilize the FDA's 505(b)(2) regulatory pathway. Additional information is available on the Company’s website at www.eagleus.com.