Eagle Pharmaceuticals total revenue increases by $2.5 million for Q2 2014

May 14 2014

Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) today announced its financial results for the three-month period ended March 31, 2014. This marks the first period for which Eagle is reporting financial results as a public company. Second quarter 2014 highlights include:

• PDUFA ("Prescription Drug User Fee Act") date of July 6, 2014 set for bendamustine Ready-to-Dilute ("RTD") for the treatment of Chronic Lymphocytic Leukemia ("CLL") and indolent B-cell Non-Hodgkin's Lymphoma ("NHL").
• Enrollment continues in the clinical trial of our bendamustine low-volume, shorter infusion time product. To date, Eagle has dosed over 40 patients and anticipates the last patient will receive their last dose in August.
• The U.S. Food and Drug Administration ("FDA") granted priority review to our New Drug Application ("NDA") for Ryanodex^®, our enhanced formulation of dantrolene sodium for injectable suspension ("dantrolene") for use in malignant hypothermia ("MH"); the PDUFA date is July 22, 2014.
• The U.S. Patent and Trademark Office ("USPTO") issued a patent for Ryanodex for treatment of heat stroke.
• The Company expects to begin dosing exertional heat stroke ("EHS") patients later this year, in a pilot study.
• Successfully completed three registration batches of Ready-to-Use ("RTU") liquid bivalirudin required for our NDA submission.
• Filed an additional patent for RTU bivalirudin.
• Argatroban market share increased to 30% during the quarter.
• Total revenue increased to $5.0 million compared to $2.5 million for the second quarter of 2013.
• Net loss improved to $3.2 million compared to a net loss of $5.6 million for the second quarter of 2013.
• Strengthened the balance sheet with $46.1 million in aggregate net proceeds from our initial public offering, (including subsequent exercise of the underwriter's over-allotment option (less the underwriter discount) and exercise of Series C preferred stock warrants). As of March 31, 2014 the Company had $54.9 million in cash and cash equivalents and a working capital surplus of $44.3 million.

"We significantly advanced the development of multiple core product candidates during the second quarter of 2014, and look forward to PDUFA dates for two of our products, Ryanodex and bendamustine RTD, in July," said Scott Tarriff, President and Chief Executive Officer. "If approved, we believe these novel products will offer significant benefits to patients and healthcare providers over currently available injectable forms of these drugs.

In addition to these important regulatory events, upcoming milestones enabled by our progress include completion of the treatment portion of the ongoing clinical trial evaluating lower-volume, shorter-infusion bendamustine this summer, and dosing the first exertional heat stroke patient with Ryanodex in the fourth quarter of this year. We plan to submit an NDA for our novel RTU bivalirudin liquid and to file for approvals of Ryanodex with the European Medicines Agency by mid-2015.

We are developing products that address the shortcomings of existing injectable products in proven markets. Ultimately, we believe utilizing the 505(b)(2) pathway will allow our products to reach critical care and oncology patients sooner," concluded Tarriff.

Second Quarter 2014 Financial Results

Total revenue increased by $2.5 million for the three months ended March 31, 2014 to $5.0 million, as compared to $2.5 million for the three months ended March 31, 2013. A summary of total revenue is outlined below (in millions except share and per share data):

Our product sales and royalty income are derived from the sale of argatroban to, and the resale of this product by, two commercial partners. The increase in total revenue was due to greater market penetration by one of our partners and higher royalty income from the end use sales of argatroban by our commercial partners.

Cost of net revenues increased by $2.0 million to $3.4 million in the three months ended March 31, 2014 from $1.3 million in the three months ended March 31, 2013 as a result of the increase in product sales of argatroban and royalty expense associated with our commercial and development partners.

Research and development expenses increased by $1.3 million for the three months ended March 31, 2014 to $3.8 million, compared to $2.5 million in the three months ended March 31, 2013. The increase was a result of a net increase in project spending specifically for RTU bivalirudin and the bendamustine projects, offset by a reduction in spending on Ryanodex for MH.

Selling, general and administrative expenses decreased by $1.5 million for the three months ended March 31, 2014 to $1.5 million as compared to $3.0 million for the three months ended March 31, 2013. This decrease is primarily related to a $2.0 million decrease in legal and arbitration expenses, offset by a $0.5 million increase in salaries and benefits, professional fees and insurance expense.

Income tax benefit was $1.3 million for the three months ended March 31, 2014. There was no benefit for the three months ended March 31, 2013. Income tax benefit increased due to the timing of sales of our New Jersey State net operating loss carryforwards.

Net loss for the second quarter of 2014 improved to $3.2 million, or ($0.36) per basic and diluted share, compared to a net loss of $5.6 million, or ($1.84) per basic and diluted share, for the second quarter of 2013.

In connection with the initial public offering, the Company's Board of Directors approved a one-for-6.41 reverse stock split of the Company's common stock, all outstanding shares of preferred stock converted into 7,487,928 million shares of common stock. Additionally, all Series C preferred stock warrants outstanding prior to the initial public offering were exercised for 34,074 shares of common stock. Following these transactions, the Company's total issued common stock as of March 31, 2014 was 14,020,133 shares.

Pipeline Developments

The USPTO granted Patent No. 8,685,460 for the treatment of heat stroke with Eagle's dantrolene formulation. The patent expires in 2023. Eagle's dantrolene formulation for the treatment of exertional heat stroke was granted Orphan Drug designation by the FDA on September 25, 2012.

SOURCE Eagle Pharmaceutical, Inc.