On November 11, 2015 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three- and nine-month periods ended September 30, 2015 (Press release, Eagle Pharmaceuticals, NOV 11, 2015, View Source [SID:1234508203]). Highlights of and subsequent to the third quarter of 2015 include:
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Entered into a co-promotion agreement with Spectrum Pharmaceuticals, under which Spectrum’s 32-person Corporate Accounts Sales Team, focused in the hematology and oncology space, will dedicate 80% of its time to marketing up to six Eagle products over the next 18 months. The agreement facilitates Eagle’s transition into a fully-commercial pharmaceutical company with limited commercial risk and minimal financial obligation. Eagle will also hire up to 20 Direct Sales Representatives as part of its long-term commercialization strategy;
Entered into an exclusive U.S. licensing agreement with Teikoku Pharma USA Inc. to market, sell and distribute Docetaxel Injection Concentrate, Non-Alcohol Formula, an investigational product intended for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer (PDUFA Date: December 26, 2015);
Successfully completed the clinical portion of its safety and efficacy study in September 2015 to evaluate RYANODEX (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke (EHS). Based on preliminary study results, participants who received RYANODEX in combination with the Standard of Care1 showed no significant drug-related adverse events. Data analysis for the study is expected to be completed and released shortly;
The U. S. Patent and Trademark Office granted a new patent, expiring in March 2033, for the use of bendamustine hydrochloride (HCl) in a 50ml bag within ten minutes (the "rapid infusion" product). This new patent, along with three previously issued patents, further expands and protects Eagle’s bendamustine HCI intellectual property estate;
Product sales increased to $3.3 million compared to $0.9 million for the three months ended September 30, 2014;
Total revenue was $5.7 million compared to $2.8 million for the three months ended September 30, 2014;
Net loss was $10.2 million, or $0.65 per basic and diluted share, compared to a net loss of $9.1 million, or $0.65 per basic and diluted share, for the three months ended September 30, 2014; and
Cash, cash equivalents and short-term investments were $96.0 million at September 30, 2015.
"Eagle has accomplished a great deal already this year, and we remain focused on achieving our goals in the particularly exciting and important final weeks ahead," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "As we near the end of 2015 and enter 2016, there is the potential for us to have as many as four in-market products by May of next year."
"We are preparing for three important events at Eagle over the next several weeks, including reporting the results of our clinical study for RYANODEX in Exertional Heat Stroke shortly. Thereafter, we are awaiting approval of two products with December PDUFA dates: our rapidly infused bendamustine product, and our recently licensed Docetaxel Injection Concentrate, Non-Alcohol Formula, which has the potential to be the first alcohol-free docetaxel formulation approved in the US. Looking further ahead, we may receive approval of RTU bivalirudin in March 2016 and our tentatively approved liquid bendamustine in the 500ml bag on May 1st, 2016. Regarding rapidly infused bendamustine, we believe our commercial partner, Teva, will convert most or all of the market quickly in what we expect will be a promising launch in 2016. Regarding our other products, with a highly-talented commercial team now in place, we are able to capitalize on the exciting opportunities that lie ahead in order to deliver long term value to shareholders."
Third Quarter 2015 Financial Results
Total revenue for the three months ended September 30, 2015 was $5.7 million, as compared to $2.8 million for the three months ended September 30, 2014.
Product sales are primarily comprised of sales of RYANODEX, which was launched in August 2014, diclofenac-misoprostol, which was launched in January 2015, and sales of argatroban to two commercial partners. The latter also contributes royalty income. The $2.4 million increase in product sales in the third quarter of 2015 was driven by $0.7 million in net product sales of diclofenac-misoprostol (launched in January 2015), an increase of $1.0 million in net product sales of RYANODEX (launched in August 2014), and an increase in argatroban product sales of $0.7 million.
The $0.5 million increase in royalty income in the third quarter of 2015 reflects higher end-use sales of argatroban by our commercial partners.
Cost of revenues increased by $1.6 million to $3.8 million in the three months ended September 30, 2015 from $2.2 million in the three months ended September 30, 2014. This $1.6 million net increase resulted from $0.4 million in cost of revenue for diclofenac-misoprostol, an increase of $0.5 million in cost of revenue for RYANODEX due to increased product sales, and an increase of $0.7 million in argatroban cost of revenue due to increased product sales.
Research and development expenses were $6.9 million in the third quarter of 2015 as compared to $5.9 million in the three months ended September 30, 2014. The increase reflects an increase in project spending for the successful completion of the clinical treatment portion of the safety and efficacy study of RYANODEX (dantrolene sodium) for exertional heatstroke and an increase in project spending for Pemetrexed. The increased spending for these projects were offset by a decrease in project spending for bendamustine ready to dilute, 500ml and bendamustine rapid infusion due to the timing of research and development activities performed.
Selling, general and administrative expenses increased $1.6 million to $5.5 million in the third quarter of 2015, compared to $3.9 million in the three months ended September 30, 2014. This increase is related to a $0.4 million increase in professional fees, $1.4 million increase in selling, general and administrative salary and personnel related expenses, and $0.3 million increase in miscellaneous expenses offset by a $0.5 million decrease in marketing related to RYANODEX.
Net loss for the third quarter of 2015 was $10.2 million, compared to net loss of $9.1 million for the three months ended September 30, 2014, as a result of the factors discussed above.
Liquidity
As of September 30, 2015, the Company had $96.0 million in cash, cash equivalents and short-term investments; $196.0 million in additional paid in capital; and $87.6 million in stockholders’ equity.