0001437749-13-010034.txt : 20130806 0001437749-13-010034.hdr.sgml : 20130806 20130806172425 ACCESSION NUMBER: 0001437749-13-010034 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20130806 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20130806 DATE AS OF CHANGE: 20130806 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Furiex Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001484478 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 271197863 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34641 FILM NUMBER: 131014479 BUSINESS ADDRESS: STREET 1: 3900 PARAMOUNT PARKWAY STREET 2: SUITE 150 CITY: MORRISVILLE STATE: NC ZIP: 27560 BUSINESS PHONE: 919-456-7800 MAIL ADDRESS: STREET 1: 3900 PARAMOUNT PARKWAY STREET 2: SUITE 150 CITY: MORRISVILLE STATE: NC ZIP: 27560 FORMER COMPANY: FORMER CONFORMED NAME: PPD Therapeutics, Inc. DATE OF NAME CHANGE: 20100218 8-K 1 furx20130806_8k.htm FORM 8-K furx20130806_8k.htm

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) August 6, 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 August 6, 2013, Furiex Pharmaceuticals, Inc. issued a press release announcing its operating results for the quarter ended June 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 August 6, 2013, announcing operating results for the quarter ended June 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: August 6, 2013       
  By: /s/ Marshall H. Woodworth  
    Marshall H. Woodworth  
    Chief Financial Officer  

 

 

 

        

 

 

 

 

 EX-99 2 ex99-1.htm EXHIBIT 99.1 ex99-1.htm

Exhibit 99.1

 

 

Contact

Media/Analysts/Investors:

Sailash Patel

919.456.7814

sailash.patel@furiex.com

 

 

Furiex Reports Second Quarter 2013 Financial Results

 

Recent Events:

 

 

● 

Completed patient enrollment in the two on-going Phase III clinical trials studying eluxadoline1 for the treatment of diarrhea-predominant irritable bowel syndrome.

 

 

● 

Takeda Pharmaceutical Company Limited (Takeda) received positive EU Committee for Medicinal Products for Human Use (CHMP) opinion for VIPIDIA™ (alogliptin) and fixed-dose combinations VIPDOMET™ (alogliptin and metformin) and INCRESYNC™ (alogliptin and pioglitazone).

     
 

● 

Takeda received Marketing Authorization from the People’s Republic of China’s Food and Drug Administration (CFDA) for Nesina®.

 

MORRISVILLE, N.C. (August 6, 2013) - Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today reported its financial and operating results for the quarter ended June 30, 2013.

 

Total revenues were $3.0 million for the quarter ended June 30, 2013, compared to $13.1 million for the same period in the prior year. The primary driver of the decrease was the fact that in May 2012 the Company recorded a $10.0 million regulatory milestone payment from Takeda with respect to the acceptance of the submission of a Marketing Authorization Application from the European Medicines Agency for alogliptin.

 

Furiex recorded second quarter royalty revenue of $3.0 million, compared to $3.1 million for the same period in the prior year. Royalty revenue included royalties related to Nesina and Liovel® sales in Japan, and Priligy sales in various countries outside of the United States.

 

Research and development expenses were $22.1 million for the quarter ended June 30, 2013, compared to $30.8 million for the same period in the prior year. The level of research and development expense during the current quarter relates primarily to the clinical trial and manufacturing costs associated with the continued development of eluxadoline. The level of quarterly research and development costs, including drug manufacture, patient recruitment, clinical monitoring and related pass-through costs, can vary significantly from quarter to quarter based on the timing of specific activities associated with the on-going Phase I and Phase III clinical trials for eluxadoline.

 

Second quarter selling, general and administrative expenses were $3.2 million for 2013, compared to $2.8 million for the same period in the prior year. The change in selling, general and administrative expenses for the quarter was due primarily to fluctuations in non-cash stock compensation expense, including the mark-to-market adjustment for non-vested consultant options.

 

                                                                                    

 1 United States Adopted Names Council (USAN) adopted, International Nonproprietary Names (INN) approval pending.

 

 
 
 

 

Interest expense of $1.1 million for the quarter ended June 30, 2013 related entirely to our loan agreement with MidCap Funding III, LLC, Midcap Funding RE Holdings, LLC and Silicon Valley Bank.

 

Net loss was $23.5 million for the second quarter of 2013, compared to net loss of $20.8 million for the second quarter of 2012. The changes in net loss during the second 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 second quarter of 2013 was $2.32, compared to net loss per basic and diluted share of $2.09 for the second quarter of 2012.

 

“We’re pleased to have completed enrollment of the Phase III program for eluxadoline in July and expect to have top line results of the efficacy endpoints for these studies in the first quarter of 2014,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex, “The Phase I studies and manufacturing work supporting the New Drug Application remain on schedule.”

 

Fred Eshelman, Pharm.D., chairman of Furiex, added, “The U.S. launch of Nesina, Kazano® and Oseni® on June 17, 2013, the positive CHMP opinion on the alogliptin family of products and the recent marketing authorization from the CFDA, we believe, will add value to the alogliptin franchise and continue to provide an important foundation for our business. We remain on track with the development of eluxadoline and we are one step closer to our goal of filing a New Drug Application with patient enrollment in the Phase III clinical trials now complete.”

 

Furiex will conduct a live conference call and webcast Wednesday, August 7, 2013, at 9:00 a.m. ET to discuss its second 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:

11013047

 

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

June 30,

   

Six Months Ended

June 30,

 
   

2012

    

2013

    

2012

    

2013

  

Revenue:

                                

Milestones

   $ 10,000     $ —     $ 10,000     $ 30,000  

Royalties

     3,075       2,990       5,720       12,315  

Total revenue

     13,075       2,990       15,720       42,315  

Research and development expenses

     30,753       22,050       40,121       47,414  

Selling, general and administrative expenses

     2,790       3,236       5,523       7,109  

Depreciation and amortization

     21       19       42       42  

Total operating expenses

     33,564       25,305       45,686       54,565  

Operating loss

     (20,489 )     (22,315 )     (29,966 )     (12,250 )

Interest expense

     274       1,111       549       2,211  

Other income, net

     —       2       —       93  

Loss before provision for income taxes

     (20,763 )     (23,424 )     (30,515 )     (14,368 )

Provision for income taxes

     6       29       12       121  

Net loss

   $ (20,769 )   $ (23,453 )   $ (30,527 )   $ (14,489 )
                                 

Net loss per basic and diluted share

   $ (2.09 )   $ (2.32 )   $ (3.07 )   $ (1.44 )
                                 

Weighted-average shares used to compute net loss per basic and diluted share

     9,957       10,119       9,953       10,078  

 

 
 
 

 

FURIEX PHARMACEUTICALS, INC. AND SUBSIDIARIES  

            

CONSOLIDATED BALANCE SHEETS  

            

(Unaudited)  

            

(In thousands, except share data)  

            
             

   

December 31,

2012

    

June 30,

2013

  

Assets

               

Current assets:

                

Cash and cash equivalents

   $ 25,718     $ 27,646  

Accounts receivable, net

     11,745       3,162  

Prepaid expenses

     320       79  

Total current assets

     37,783       30,887  

Property and equipment, net

     118       102  

Investments

     7,500       7,500  

Goodwill

     49,116       49,116  

Other assets

     238       163  

Total assets

   $ 94,755     $ 87,768  
                 

Liabilities and Shareholders’ Equity

                

Current liabilities:

                

Accounts payable

   $ 6,604     $ 11,655  

Accrued expenses

     10,230       7,049  

Current portion of long-term debt

     5,405       11,892  

Total current liabilities

     22,239       30,596  

Long-term debt, net

     34,595       28,108  

Other long-term liabilities

     324       460  

Total liabilities

     57,158       59,164  
                 

Common stock, $0.001 par value, 40,000,000 shares authorized; 10,015,297 and 10,273,224 shares issued and outstanding, respectively

     10       10  

Preferred stock, $0.001 par value, 10,000,000 shares authorized; no shares issued or outstanding

     —       —  

Paid-in capital

     164,577       170,073  

Accumulated deficit

     (126,990 )     (141,479 )

Total shareholders’ equity

     37,597       28,604  

Total liabilities and shareholders’ equity

   $ 94,755     $ 87,768  

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