-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, R7guhxWdVXLkSgCX7pwksFOoLMrNchpuM8ZNWMNO2pKoRrG0Bdm4c0VCOP2NJkMj +5ObeDMcwjJXTAT4ycucXw== 0001193125-05-156289.txt : 20050803 0001193125-05-156289.hdr.sgml : 20050803 20050803162341 ACCESSION NUMBER: 0001193125-05-156289 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050802 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050803 DATE AS OF CHANGE: 20050803 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OSCIENT PHARMACEUTICALS CORP CENTRAL INDEX KEY: 0000356830 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 042297484 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-10824 FILM NUMBER: 05995951 BUSINESS ADDRESS: STREET 1: 1000 WINTER STREET STREET 2: SUITE 2200 CITY: WALTHAM STATE: MA ZIP: 02451 BUSINESS PHONE: 7813982300 MAIL ADDRESS: STREET 1: 1000 WINTER STREET STREET 2: SUITE 2200 CITY: WALTHAM STATE: MA ZIP: 02451 FORMER COMPANY: FORMER CONFORMED NAME: GENOME THERAPEUTICS CORP DATE OF NAME CHANGE: 19941215 FORMER COMPANY: FORMER CONFORMED NAME: COLLABORATIVE RESEARCH INC DATE OF NAME CHANGE: 19920703 8-K 1 d8k.htm FORM 8-K FORM 8-K

 

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 2, 2005

 


 

OSCIENT PHARMACEUTICALS CORPORATION

(Exact name of registrant as specified in its charter)

 

Massachusetts   0-10824   04-2297484

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(I.R.S. Employer

Identification Number)

 

1000 Winter Street, Suite 2200

Waltham, Massachusetts 02451

(Address of principal executive offices, including zip code)

 

(781) 398-2300

(Registrant’s telephone number, including area code)

 


 

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 (see General Instruction A.2. below):

 

¨ 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))

 


 

Page 1 of 4 pages.


ITEM 2.02.  RESULTS OF OPERATIONS AND FINANCIAL CONDITION.

 

On August 2, 2005, Oscient Pharmaceuticals Corporation issued a press release announcing its financial results for its second fiscal quarter ended June 30, 2005. A copy of that press release is furnished with this Current Report on Form 8-K as Exhibit 99.1.

 

The information in this Current Report on Form 8-K and the Exhibit attached hereto 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, regardless of any general incorporation language in such filing.

 

ITEM 9.01.  FINANCIAL STATEMENTS AND EXHIBITS.

 

(c) Exhibits

 

99.1    Press Release issued by Oscient Pharmaceuticals Corporation on August 2, 2005.

 

2


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 hereunto duly authorized.

 

OSCIENT PHARMACEUTICALS CORPORATION

By:

 

/s/ Stephen Cohen

   

Name: Stephen Cohen

   

Title: Senior Vice President and Chief Financial

          Officer

 

Date: August 3, 2005

 

3


EXHIBIT INDEX

 

Exhibit Number

  

Description


99.1    Press Release issued by Oscient Pharmaceuticals Corporation on August 2, 2005.

 

4

EX-99.1 2 dex991.htm PRESS RELEASE PRESS RELEASE

Exhibit 99.1

 

Investor Relations:

Christopher Taylor

781-398-2466

 

Media Relations:

Sarah Emond

781-398-2544

 

For Immediate Release

 

Oscient Pharmaceuticals Reports Financial Results for Second Quarter of 2005

- Conference call with senior management scheduled for 8:30 AM ET today -

 

Waltham, Mass., August 2, 2005 – Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) today reported financial results for the second quarter ended June 30, 2005. During this period, the Company recorded $4.2 million in total revenue, with $3.8 million from sales of the Company’s lead product, FACTIVE ® (gemifloxacin mesylate) tablets, FDA-approved for the treatment of acute bacterial exacerbations of chronic bronchitis (AECB) and mild to moderate community-acquired pneumonia (CAP). The Company also recorded $0.4 million in revenue related to the Company’s co-promotion agreement with Auxilium Pharmaceuticals for TESTIM® 1% testosterone gel.

 

“During the second quarter we took an important step toward leveraging the value of our sales force through our agreement to co-promote TESTIM with Auxilium Pharmaceuticals – and the initial response from physicians to this product has been quite favorable,” stated Steven M. Rauscher, President and CEO. “By utilizing our experienced sales team to introduce this testosterone replacement therapy to our target physicians across the country, we expect to translate our previous investment into increased revenue.”

 

For the second quarter ended June 30, 2005, the Company reported a net loss of ($21,744,000), or ($0.28) per basic and diluted share. This compares to a net loss of ($17,266,000), or ($0.23) per basic and diluted share, for the second quarter of 2004. Included in the results for the second quarter of 2005 are approximately $1.2 million in non-cash charges which consist primarily of amortization of intangible assets (included in cost of product revenue) and amortization of stock-based compensation. Cash used in operations during the quarter ended June 30, 2005 was $22.8 million, including $1.9 million in net inventory purchases to support anticipated order demand. Also during the second quarter, the Company recorded a $2.0 million gain, recorded as other income, related to the sale of an equity stake in Agencourt Bioscience, which was recently acquired by Beckman Coulter. The Company’s total cash, restricted cash and investments balance at June 30, 2005 was approximately $123 million.

 

Management noted that research and development expenses for the second quarter of 2005 of $4,192,000 primarily reflect investment in FACTIVE development related to the recently completed Phase III trial of FACTIVE for the potential five-day treatment of CAP and the on-going Phase IV post-marketing trial. For the second quarter of 2004, research and development expenses were $6,166,000. Selling, general and administrative expenses were $20,261,000 in the second quarter of 2005, reflecting expenses related to building the FACTIVE commercial organization, the full effect of the expanded Oscient sales force and initial marketing expenses related to the TESTIM co-promotion agreement. This compares with $9,266,000 in selling, general and administrative expenses in the second quarter of 2004, prior to the launch of FACTIVE.

 

For the six months ended June 30, 2005, the Company reported revenues of $8,182,000 and a net loss of ($49,580,000) or ($0.65) per basic and diluted share. This compares to a net loss of ($36,746,000), or ($0.56) per basic and diluted share, on revenues of $2,371,000 for the first half of 2004. Included in the 2005 results are

 

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8.2.05

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approximately $3.4 million in non-cash charges. Non-cash charges for the 2004 six-month period were $16.1 million related to the merger with GeneSoft Pharmaceuticals completed in February 2004. Cash used in operations during the six months ended June 30, 2005 was $53.2 million, including $4.9 million in inventory investment.

 

Second Quarter Highlights

 

    Prescription Growth: During the second quarter, approximately 45,500 prescriptions for FACTIVE were written, down slightly from the 56,000 written in the first quarter, due to seasonal patterns for respiratory tract infections. Since launch, 129,000 scripts have been written through July 15, 2005.
    Physician Acceptance: At the end of the second quarter, over 12,600 physicians had prescribed FACTIVE, more than a 37% increase from the 9,200 prescribing physicians at the end of the first quarter.
    Market Share: Comparing prescribing patterns of physicians who have written a prescription for FACTIVE since launch, using the most recent available data, FACTIVE attained approximately a 7.4% share of prescriptions among fluoroquinolones used for respiratory tract infections. Among all prescriptions for fluoroquinolones used to treat respiratory tract infections, FACTIVE obtained a 2% market share.
    Five-Day Treatment of Community-Acquired Pneumonia: During the second quarter, Oscient announced preliminary results in the Phase III study of FACTIVE for the potential five-day treatment of CAP of mild to moderate severity. The study, which compared the five-day dosing (320 mg once-daily) to the FDA-approved seven-day dosing (320 mg once-daily), achieved its primary endpoint, illustrating the potential to utilize a short-course of FACTIVE to treat CAP. The Company has submitted abstracts on these results to the fall infectious diseases conferences and expects to file a supplemental New Drug Application (sNDA) for the five-day treatment of CAP by the end of 2005.
    Acute Bacterial Sinusitis: The Company has maintained a dialogue with the FDA related to ABS and expects to file a sNDA for this indication by year end. The ABS filing may be integrated with the sNDA submission to the FDA for the FACTIVE five-day treatment of CAP.
    LG Life Sciences Licensing Agreement: The Company announced an amendment to its licensing agreement with LG Life Sciences to reduce product royalties at higher sales levels, making FACTIVE a potentially more attractive opportunity for increased investment by Oscient and a co-promotion partner.
    TESTIM 1% Testosterone Gel: As part of a co-promotion agreement with Auxilium Pharmaceuticals, Oscient sales representatives began promoting TESTIM during the second quarter. Oscient is promoting TESTIM to primary care physicians, while Auxilium continues to promote TESTIM to urologists, endocrinologists and select primary care physicians. Both companies will share profits from primary care sales above a pre-determined baseline after marketing expenses are reimbursed.

 

Expansion to 300-Person Sales Effort

 

In order to capitalize on the promotional sensitivity of FACTIVE and TESTIM, Oscient is adding approximately 50 contract sales representatives in targeted, high volume territories. The expansion to 300 representatives will allow the Company to grow share of voice among high fluoroquinolone prescribing physicians while increasing primary care calls for TESTIM. The Company plans to have the new team members trained and in place at the beginning of the fourth quarter.

 

“During our first year in the marketplace, we confirmed that frequency of physician calls by our representatives directly impacts prescription volume, and this move helps achieve a competitive share of voice. The new representatives will augment our existing sales force’s efforts by doubling the call frequency on target physicians. Specifically, we are placing additional representatives in each of our five highest potential districts,” stated Mr. Rauscher. “Separately, we continue to pursue a co-promotion partnership that would maximize the long-term potential of FACTIVE for our shareholders.”

 

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About Oscient Pharmaceuticals

 

Oscient Pharmaceuticals Corporation is a biopharmaceutical company committed to the clinical development and commercialization of novel therapeutics to address unmet medical needs. The Company is marketing FACTIVE® (gemifloxacin mesylate) tablets, approved by the FDA for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. In addition to the oral tablet form, Oscient is developing an investigational FACTIVE intravenous formulation for use in hospitalized patients. The Company is also promoting Auxilium Pharmaceuticals’ TESTIM® 1% testosterone gel to primary care physicians in the U.S. Oscient has a novel antibiotic candidate, Ramoplanin, in advanced clinical development for the treatment of Clostridium difficile-associated diarrhea (CDAD).

 

For important information regarding the safety and use of FACTIVE, please see the prescribing information available at www.factive.com. For important information regarding the safety and use of TESTIM, please see the prescribing information available at www.testim.com.

 

Forward-Looking Statement

 

This press release may contain forward-looking statements, as defined by the Private Securities Litigation Reform Act of 1995, including statements about (i) the Company’s growth and future operating results, (ii) its plans to expand its sales force and such expansion’s effect on FACTIVE’s prescribing base and prescription growth, (iii) the Company’s ability to leverage the value of its sales force to increase revenue, (iv) the potential to utilize a five-day course of FACTIVE to treat CAP, (v) the Company’s expectation of filing a supplemental New Drug Application with the FDA for the five-day treatment of CAP and for the indication of acute bacterial sinusitis by the end of 2005, (vi) the Company’s ability to enter into a co-promotion agreement with respect to FACTIVE and (vii) the fact that the LG Life Sciences Licensing Amendment may make FACTIVE a potentially more attractive opportunity for investment by Oscient or a co-promotion partne , as well as other statements related to the progress and timing of product development, present or future licensing, collaborative or financing arrangements or that otherwise relate to future periods. These statements represent, among other things, the expectations, beliefs, plans and objectives of management and/or assumptions underlying or judgments concerning matters discussed in this document. Forward-looking statements typically are identified by use of terms such as “may,” “will,” “should,” “plan,” “expect,” “intend,” “anticipate,” “estimate,” and similar words, although some forward-looking statements are expressed differently. We do not plan to update these forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements due to a number of risks affecting our business. These risks include, but are not limited to, (i) whether we will be able to successfully expand the indications for which FACTIVE is approved, (ii) the delay in or inability to obtain additional regulatory approvals of our products and product candidates due to negative, inconclusive or insufficient results in ongoing or future clinical trials, the FDA requiring additional information or data, delays in the progress of ongoing clinical trials, safety concerns arising with respect to our products or product candidates and disputes with the third parties from whom we license our products or product candidates and (iii) our inability to successfully commercialize FACTIVE or promote TESTIM due to: the limitations on our resources and experience in the commercialization of products; lack of acceptance by physicians, patients and third party payors; unanticipated safety, product liability, efficacy, or other regulatory issues; delays in recruiting and training sales personnel; problems relating to manufacturing or supply; inadequate distribution of the products by wholesalers, pharmacies, hospitals and other customer; and competition from other products. In addition, there is no assurance that the Company will enter into a co-promotion agreement with respect to FACTIVE on terms that are favorable to the Company or at all. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement are described under the heading “Factors Affecting Future Operating Results” in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Quarterly Report on Form 10-Q for the quarter ending March 31, 2005 and in other filings that we may make with the Securities and Exchange Commission from time to time.

 

Conference Call & Webcast Information

 

A conference call will be held today at 8:30 AM ET with Steven Rauscher, President and CEO, and other members of Oscient’s management team. Participants can access the call by dialing 1-888-634-4009. International participants are asked to dial 1-706-634-2285. The call will also be available via webcast on the Company’s website at www.oscient.com. A replay will be available two hours after the conclusion of the call until August 9, 2005. Domestic participants can access the replay by dialing 1-800-642-1687, while international participants are asked to dial 1-706-645-9291. The conference ID number for the replay is 7953198. A replay of the webcast will also be available on the Company’s website.

 

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OSCIENT PHARMACEUTICALS CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts) (unaudited)

 

     Three Months Ended     Six Months Ended  
     June 30, 2005

    June 26, 2004

    June 30, 2005

    June 26, 2004

 

Revenues:

                                

Product revenue, net

   $ 3,806     $ —       $ 7,717     $ —    

Co-promotion revenue

     370       —         370       —    

Biopharmaceutical revenue

     60       710       95       2,371  
    


 


 


 


Total revenues

     4,236       710       8,182       2,371  

Costs and expenses:

                                

Cost of product revenue

     2,308       —         4,374       —    

Research and development

     4,192       6,166       9,360       11,361  

Write-off of in-process technology

     —         —         —         11,704  

Restructuring charge

     —         —         —         99  

Stock-based compensation

     45       1,882       994       2,446  

Selling, general and administrative

     20,261       9,266       45,285       12,891  
    


 


 


 


Total costs and expenses

     26,806       17,314       60,013       38,501  
    


 


 


 


Loss from operations

     (22,570 )     (16,604 )     (51,831 )     (36,130 )
    


 


 


 


Other income (expense):

                                

Interest income

     881       498       1,751       690  

Interest expense

     (2,097 )     (1,245 )     (4,141 )     (1,541 )

Gain on sale of fixed assets

     5       85       43       135  

Other income

     2,024       —         4,563       —    
    


 


 


 


Net other income (expense)

     813       (662 )     2,216       (716 )
    


 


 


 


Net loss before discontinued operations

     (21,757 )     (17,266 )     (49,615 )     (36,846 )

Income (loss) from discontinued operations

     13       —         35       100  
    


 


 


 


Net loss:

   $ (21,744 )   $ (17,266 )   $ (49,580 )   $ (36,746 )
    


 


 


 


Basic/diluted net loss per common share

   $ (0.28 )   $ (0.23 )   $ (0.65 )   $ (0.56 )

Basic/diluted weighted average

common shares outstanding

     76,347,529       74,325,687       76,127,901       65,237,885  
    


 


 


 


 

SELECTED BALANCE SHEET DATA

(in thousands) (unaudited)

 

     June 30,
2005


   Dec. 31,
2004


Cash, cash equivalents, marketable securities and restricted cash

   $ 122,982    $ 176,628

Total assets

     285,935      340,560

Deferred revenue

Long-term liabilities

    
 
885
192,403
    
 
1,302
193,397

Shareholders’ equity

     66,754      114,400

 

###

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