UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) November 5, 2013
FURIEX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
001-34641 27-1197863 (Commission File Number) (IRS Employer ID Number) 3900 Paramount Parkway, Suite 150, Morrisville, North Carolina 27560 (Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (919) 456-7800
__________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition.
On November 5, 2013, Furiex Pharmaceuticals, Inc. issued a press release announcing its operating results for the quarter ended September 30, 2013. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein in its entirety by reference.
The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
Description |
99.1 | Press release issued November 5, 2013, announcing operating results for the quarter ended September 30, 2013. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.
FURIEX PHARMACEUTICALS, INC. |
|||
Date: November 5, 2013 | |||
By: | /s/ Marshall H. Woodworth | ||
Marshall H. Woodworth
Chief Financial Officer |
Exhibit 99.1
Contact
Media/Analysts/Investors:
Sailash Patel
919.456.7814
sailash.patel@furiex.com
Furiex Reports Third Quarter 2013 Financial Results
Third Quarter 2013 Highlights:
● |
Milestone revenue of $10.0 million for third quarter 2013. |
● |
Royalty revenue of $5.6 million, an increase of $2.6 million (86%) from second quarter 2013. |
● |
Cash and cash equivalents balance of $34.7 million as of September 30, 2013. |
● |
Secured an additional $17.0 million in capital by restructuring our existing credit facility to provide $2.0 million in additional funding and entered into a new loan agreement with our chairman for $15.0 million. |
● |
Takeda Pharmaceutical Company Limited (Takeda) received European Marketing Authorization for VIPIDIA™ (alogliptin) and fixed-dose combinations VIPDOMET™ (alogliptin and metformin) and INCRESYNC™ (alogliptin and pioglitazone). |
Recent Events:
● |
In October 2013, the Menarini Group (Menarini) confirmed the launch of Priligy® in the United Kingdom. The Company is entitled to receive a $5.0 million milestone payment related to this launch. |
MORRISVILLE, N.C. (November 5, 2013) - Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today reported its financial and operating results for the quarter ended September 30, 2013.
Total revenues were $15.6 million for the quarters ended September 30, 2013 and 2012. Milestone revenue for the third quarter of 2013 related to a $10.0 million milestone from Takeda upon receipt of European marketing authorization for alogliptin and related products in September 2013. Milestone revenue for the third quarter of 2012 related to a $10.0 million milestone from Menarini upon the closing of the new license agreement related to Priligy in July 2012.
Furiex recorded third quarter royalty revenue of $5.6 million in both 2013 and 2012. Royalty revenue included royalties related to alogliptin and related product sales in Japan and the United States, and Priligy sales in various countries outside of the U.S.
Research and development expenses were $19.9 million for the quarter ended September 30, 2013, compared to $14.8 million for the same period in the prior year. The level of research and development expense during the current quarter relate primarily to the clinical trial and manufacturing costs associated with the continued development of eluxadoline.
Third quarter selling, general and administrative expenses were $3.2 million for both 2013 and 2012. Selling, general and administrative expenses relate to Company overhead costs, employee compensation and related benefit expenses, professional fees, public company costs and non-cash share based compensation expense, including the mark-to-market adjustment for non-vested consultant options.
Interest expense of $1.1 million for the quarter ended September 30, 2013 related entirely to our loan agreement with MidCap Financial LLC and Silicon Valley Bank.
Net loss was $8.7 million for the third quarter of 2013, compared to a net loss of $3.3 million for the third quarter of 2012. The changes in net loss during the third quarter of 2013, as compared to the same period in the prior year, relates primarily to the changes in revenues and expenses previously discussed.
Net loss per basic and diluted share for the third quarter of 2013 was $0.85, compared to net loss per basic and diluted share of $0.33 for the third quarter of 2012.
“We are pleased that our Phase III program for eluxadoline remains on track with top line results of the efficacy endpoints for these studies still expected in the first quarter of 2014,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “We have also recently completed the key Phase I and preclinical studies needed to support the NDA submission.”
Fred Eshelman, Pharm.D., chairman of Furiex, added, “We continue to make steady progress on several fronts, including the recent marketing approval of the alogliptin family of products in the EU and the associated $10.0 million milestone, a restructure of our existing debt, $15.0 million in new debt financing and new launches for Priligy. We believe we are well-positioned as we progress towards the topline data readout for eluxadoline Phase III studies.”
Furiex will conduct a live conference call and webcast Wednesday, November 6, 2013, at 9:00 a.m. ET to discuss its third quarter 2013 results and financial outlook for 2013 as well as provide an overview of its business and pipeline. A Q&A session will follow. All interested parties can access the webcast through the Presentations & 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:
Participant dial-in: |
+1.877.677.9122 (U.S./Canada) |
+1.708.290.1401 (International) | |
Conference ID: |
74974988 |
About Furiex
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: continuing losses and our potential need for additional financing; the risks and expense of continuing the research and development activities of our existing compounds; the risk of finding a collaborator for our late-stage compounds; progress of compounds in clinical trials and regulatory approvals as it relates to receiving future milestone payments; inability of our existing 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; potential changes to regulatory guidance by regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency; 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 (Unaudited) (In thousands, except per share data) Three Months Ended Nine Months Ended September 30, September 30, 2012 2013 2012 2013 Revenue: Milestones Royalties Total revenue Research and development expenses Selling, general and administrative expenses Depreciation and amortization Total operating expenses Operating loss Interest expense Other income, net Loss before provision for income taxes Provision for income taxes Net loss Net loss per basic and diluted share Weighted-average shares used to compute net loss per basic and diluted share
FURIEX PHARMACEUTICALS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (Unaudited) (In thousands, except share data) December 31, September 30, 2012 2013 Assets Current assets: Cash and cash equivalents Accounts receivable, net Prepaid expenses Total current assets Property and equipment, net Investments Deferred financing costs Goodwill Total assets Liabilities and Shareholders’ Equity Current liabilities: Accounts payable Accrued expenses Current portion of long-term debt Total current liabilities Long-term debt, net Long-term debt, related party, net Other long-term liabilities Total liabilities Common stock, $0.001 par value, 40,000,000 shares authorized; 10,015,297 and 10,371,155 shares issued and outstanding, respectively Preferred stock, $0.001 par value, 10,000,000 shares authorized; no shares issued or outstanding Paid-in capital Accumulated deficit Total shareholders’ equity Total liabilities and shareholders’ equity
$
10,000
$
10,000
$
20,000
$
40,000
5,577
5,550
11,297
17,865
15,577
15,550
31,297
57,865
14,798
19,895
54,919
67,309
3,209
3,197
8,732
10,306
22
8
64
50
18,029
23,100
63,715
77,665
(2,452
)
(7,550
)
(32,418
)
(19,800
)
837
1,107
1,386
3,319
—
—
—
93
(3,289
)
(8,657
)
(33,804
)
(23,026
)
(3
)
26
9
147
$
(3,286
)
$
(8,683
)
$
(33,813
)
$
(23,173
)
$
(0.33
)
$
(0.85
)
$
(3.39
)
$
(2.29
)
10,015
10,174
9,974
10,110
$
25,718
$
34,668
11,745
15,598
320
568
37,783
50,834
118
94
7,500
—
238
1,640
49,116
49,116
$
94,755
$
101,684
$
6,604
$
15,558
10,230
6,033
5,405
5,880
22,239
27,471
34,595
36,120
—
15,000
324
528
57,158
79,119
10
10
—
—
164,577
172,718
(126,990
)
(150,163
)
37,597
22,565
$
94,755
$
101,684