MORRISVILLE, N.C. -- (BUSINESS WIRE) -- Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today reported its financial and operating results for the quarter and year ended December 31, 2013.
For the year ended December 31, 2013, Furiex recorded total revenues of $71.0 million. This included milestone revenue of $45.0 million, consisting of a $25.0 million regulatory milestone from Takeda Pharmaceuticals Company Limited with respect to the U.S. Food and Drug Administration’s approval of three alogliptin-related products in January 2013, a $10.0 million milestone from Takeda upon the European Marketing Authorization of alogliptin and related products in September 2013, a $5.0 million milestone from Berlin-Chemie AG (Menarini Group) upon the launch of Priligy® in France in March 2013 and a $5.0 million milestone from Menarini upon the launch of Priligy in the United Kingdom in October 2013.
For the full year 2013, Furiex recorded royalty revenues of $26.0 million, compared to $20.5 million in the prior year. Royalty revenue included royalties related to sales of Nesina® and related combination products in Japan and the United States, and Priligy in various countries outside the United States. Furiex recorded fourth quarter royalty revenues of $8.1 million, compared to $9.2 million for the same period in the prior year and $5.6 million in the third quarter of 2013. Royalty revenue increased 47% in the fourth quarter of 2013 compared to the third quarter of 2013.
“Our 2013 was marked by multiple successes for our partnered products, including Takeda’s receipt of the FDA approval and European Marketing Authorization for three type-2 diabetes treatments, and Menarini’s launch of Priligy in France and the United Kingdom,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “This momentum continued in early 2014 with the reporting last month of positive top-line results of our two pivotal Phase III clinical trials of eluxadoline in patients with diarrhea-predominant irritable bowel syndrome.”
Fred Eshelman, Pharm.D., founding chairman of Furiex, added, “Looking ahead to the remainder of 2014, we will focus on submitting our new drug application for eluxadoline to the U.S. Food and Drug Administration by the end of the second quarter of 2014. In addition, we will continue to evaluate all of our strategic options, which include launching the drug ourselves or possibly securing a strategic partnership.”
Research and development expenses were $15.4 million for the quarter ended December 31, 2013, compared to $14.6 million for the same period in the prior year. For the full year 2013, Furiex recorded research and development expenses of $82.7 million, compared to $69.5 million in the prior year. The increase in research and development expense was due predominantly to eluxadoline Phase III costs.
Fourth quarter selling, general and administrative expenses were $2.4 million for 2013, compared to $2.5 million for the fourth quarter of 2012. For the full year 2013, Furiex recorded selling, general and administrative expenses of $12.7 million, compared to $11.3 million in the prior year. The slight increase in selling, general and administrative expense was due primarily to increases in non-cash stock compensation expense of $1.2 million, including additional restricted stock awards issued to employees and directors during 2013 and the mark-to-market adjustment for non-vested consultant options.
Interest expense was $1.7 million for the quarter ended December 31, 2013, compared to $1.1 million for the same period in the prior year. For the full year 2013, Furiex recorded interest expense of $5.0 million, compared to $2.5 million in the prior year. The increase in interest expense was due to increased borrowings under the first and second amended loan agreements entered into with MidCap Funding and Silicon Valley Bank in August 2012 and September 2013, respectively, and a new $15.0 million loan from Fred Eshelman as of September 2013.
Net loss was $6.5 million for the fourth quarter of 2013, compared to $9.1 million for the fourth quarter of 2012. For the year ended 2013, net loss was $29.7 million compared to $42.9 million in 2012.
Net loss per share for the fourth quarter of 2013 was $0.63, compared to $0.90 for the fourth quarter of 2012. For the year ended 2013, net loss per share was $2.92, compared to $4.29 for 2012.
Company to Host Conference Call
Furiex will conduct a live conference call and webcast Wednesday, March 12, 2014 at 9:00 a.m. ET to discuss fourth quarter and full year 2013 financial results. A Q&A session will follow. All interested parties can access the webcast through the Presentations and Events link in the Investors section of the Furiex website at www.furiex.com. The webcast will be archived shortly after the call for on-demand replay. The conference call will be broadcast live over the Internet and will also be available using the following direct dial numbers:
Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of drug development programs by advancing them through the drug discovery and development process in a cost-efficient manner. Our drug development programs are designed and driven by a core team with extensive drug development experience. The Company collaborates with pharmaceutical and biotechnology companies and has a diversified product portfolio and pipeline with multiple therapeutic candidates, including one Phase III-ready asset, two compounds in Phase III development, one of which is with a partner, and four products on the market. The Company's mission is to develop innovative medicines faster and at a lower cost, thereby improving profitability and accelerating time to market while providing life-improving therapies for patients. For more information, visit www.furiex.com.
Except for historical information, all of the statements, expectations and assumptions contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although Furiex attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause actual results to differ materially include the following: progress of compounds in clinical trials and regulatory approvals; potential changes to regulatory guidance by regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency; the risk of finding a collaborator for our late-stage compounds, or risks involved in our attempting to commercialize compounds ourselves; continuing losses and our potential need for additional financing; reliance on key personnel; inability of collaborators to effectively market approved products for which we receive royalty and sales-based milestone payments; changes in the safety and efficacy profile of our existing compounds as they progress through research and development; new collaborative agreements that we might enter into in the future; the costs of defending any patent opposition or litigation necessary to protect our proprietary technologies; and the other risk factors set forth from time to time in the SEC filings for Furiex, copies of which can be found on our website.
|FURIEX PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share data)|
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Research and development expenses||14,586||15,395||69,505||82,704|
|Selling, general and administrative expenses||2,529||2,370||11,261||12,676|
|Depreciation and amortization||22||7||86||57|
|Total operating expenses||17,137||17,772||80,852||95,437|
|Other income, net||1||1||1||93|
|Loss before provision for income taxes||(9,047)||(6,299)||(42,851)||(29,325)|
|Provision for income taxes||5||201||14||348|
|Net loss per basic and diluted share||$||(0.90)||$||(0.63)||$||(4.29)||$||(2.92)|
|Weighted-average shares used to compute net loss per basic and diluted share||10,015||10,260||9,984||10,148|
|FURIEX PHARMACEUTICALS, INC. AND SUBSIDIARIES|
|CONSOLIDATED BALANCE SHEETS|
|(In thousands, except share data)|
|Cash and cash equivalents||$||25,718||$||29,153|
|Accounts receivable, net||11,745||8,178|
|Total current assets||37,783||37,746|
|Property and equipment, net||118||87|
|Deferred financing costs, net||238||1,493|
|Liabilities and Shareholders’ Equity|
|Current portion of long-term debt, third party||—||10,080|
|Current portion of long-term debt, related party||5,405||500|
|Total current liabilities||22,239||22,954|
|Long-term debt, third party, net||34,595||31,920|
|Long-term debt, related party, net||—||14,500|
|Other long-term liabilities||324||627|
Common stock, $0.001 par value, 40,000,000 shares authorized; 10,015,297 and
10,459,233 shares issued and outstanding, respectively
Preferred stock, $0.001 par value, 10,000,000 shares authorized; no shares issued or
|Total shareholders’ equity||37,597||18,441|
|Total liabilities and shareholders’ equity||$||94,755||$||88,442|