Cv Therapeutics Inc 8-k (events Or Changes Between Quarterly Reports) 2009-02-20
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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): 02/20/2009
CV THERAPEUTICS, INC. (Exact n am e of re gistran t as spe cifie d in its ch arte r)
Commission File Number: 0-21643 Delaware
43-1570294
(State or oth e r jurisdiction of in corporation )
(IRS Em ploye r Ide n tification No.)
3172 Porter Drive, Palo Alto, CA 94304 (Addre ss of prin cipal e xe cu tive office s, inclu ding z ip code )
650-384-8500 (Re gistran t’s te le ph on e n u m be r, inclu ding are a code )
Not Applicable (Form e r n am e or form e r addre ss, if ch an ge d since last re port)
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))
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Item 7.01.
Regulation FD Disclosure
(a) On February 20, 2009, CV Therapeutics, Inc. (the “Company”) publicly disseminated a press release announcing that the Company’s board of directors has again reviewed and rejected the previously announced unsolicited proposal from Astellas Pharma Inc. (“Astellas”) to acquire the Company at a price of $16.00 per share. After consideration of the Astellas proposal with its independent financial and legal advisors, the Company’s board of directors concluded that the proposal significantly undervalues the Company and is not in the best interests of the Company and its stockholders. Louis G. Lange, the Company’s chairman and chief executive officer, sent a letter to that effect to Masafumi Nogimori, president and chief executive officer of Astellas, on February 20, 2009. A copy of the Company’s press release, dated February 20, 2009, including the full text of the letter, is furnished with this Form 8-K and attached hereto as Exhibit 99.1. Exhibit 99.1 of this Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise be subject to the liabilities under that Section of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act. The Astellas proposal is further described in the Company’s Current Report on Form 8-K filed on January 30, 2009 and the press release attached as Exhibit 99.1 thereto. The Company’s board of directors had previously rejected the same proposal on November 21, 2008. (b) In addition, as relates to the Lexiscan® (regadenson injection) product being sold in the United States by the Company’s collaborative partner Astellas US LLC (a U.S. subsidiary of Astellas Pharma Inc.), the Company believes that the product should expand the overall market for pharmacologic stress imaging agents in the United States, that the product could capture a significant portion of the market for such agents in the United States in 2009 and become a multi-hundred million dollar product as well this year, and that the product may ultimately achieve more than $500 million in total worldwide sales over time assuming future regulatory approvals and launches. The matters set forth in this report are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including operating losses and fluctuations in operating results; capital requirements; regulatory review and approval of CV Therapeutics’ products; the conduct and timing of clinical trials; commercialization of products; market acceptance of products; product labeling; concentrated customer base; reliance on strategic partnerships and collaborations; uncertainties in drug development; uncertainties regarding intellectual property; and other risks detailed from time to time in CV Therapeutics SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2008. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements. ***** Item 9.01. Financial Statements and Exhibits (d) Exhibits. 99.1
Press Release dated February 20, 2009.
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Signature(s) 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. CV THERAPEUTICS, INC. Date: February 20, 2009
By: /s/ TRICIA BORGA SUVARI TRICIA BORGA SUVARI Senior Vice President and General Counsel
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Exhibit Index Exh ibit No.
EX-99.1
De scription
Press Release dated February 20, 2009. Exhibit 99.1
LOGO
FOR IMMEDIATE RELEASE Contacts: John Bluth Executive Director, Corporate Communications & Investor Relations CV Therapeutics, Inc. (650) 384-8850 Joele Frank/Jeremy Jacobs Joele Frank, Wilkinson Brimmer Katcher 212-355-4449 CV THERAPEUTICS’ BOARD OF DIRECTORS REJECTS ASTELLAS UNSOLICITED PROPOSAL PALO ALTO, Calif., February 20, 2009 – CV Therapeutics, Inc. (Nasdaq: CVTX) today announced that its board of directors has thoroughly reviewed and rejected the previously announced unsolicited proposal from Astellas Pharma Inc. to acquire CV Therapeutics at a price of $16.00 per share. After careful consideration of the proposal with its independent financial and legal advisors, the CV Therapeutics board concluded that the Astellas proposal significantly undervalues the company and is not in the best interests of CV Therapeutics and its stockholders. The board had previously rejected the same proposal on November 21, 2008, when Astellas approached the company privately. “CV Therapeutics has a strategic plan in place which we believe will enhance shareholder value. Moreover, we have always been, and remain, receptive to opportunities to further enhance shareholder value. Executing on our strategic plan enabled us to achieve outstanding results in 2008, with multiple regulatory approvals, record revenues and two exceptional strategic transactions. This strong record of product approvals, which exceeds that of many pharma companies over the last several years, has allowed the company to establish a solid cash position. The full promotional launch of the improved U.S. Ranexa labeling is just beginning, the introduction of Ranexa in Europe is imminent, and Lexiscan is showing real growth in the marketplace. Accordingly, we expect 2009 to be another outstanding year, highlighted by increasing revenues and pipeline advancement, for example with CVT-3619,” said Louis G. Lange, chairman and chief executive officer of CV Therapeutics. —more—
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LOGO
Following is the text of the letter being sent by CV Therapeutics today to Masafumi Nogimori, president and chief executive officer of Astellas Pharma: Dear Mr. Nogimori: The CV Therapeutics board of directors is committed to enhancing value for our stockholders. The board, with the assistance of its financial and legal advisors, has carefully considered your proposal to acquire our company in the context of our strategic plans and the best interests of our stockholders. We concluded that your proposal significantly undervalues CV Therapeutics and its potential growth opportunities and we decline to accept it. CV Therapeutics has a strategic plan in place which we believe will enhance shareholder value. Moreover, as we stated in our press release, we have always been, and remain, receptive to opportunities to further enhance shareholder value. Sincerely, Dr. Louis Lange Chairman and Chief Executive Officer As previously announced, CV Therapeutics received a letter dated November 13, 2008 from Astellas setting forth an unsolicited proposal by Astellas to acquire the company at a price of $16.00 per share, subject to due diligence, Astellas board approval and other conditions. On November 21, 2008, after careful deliberation, with the assistance of its financial and legal advisors, the CV Therapeutics board of directors concluded that the Astellas proposal was not in the best interests of CV Therapeutics and its stockholders. Dr. Louis Lange, chairman and chief executive officer of CV Therapeutics, sent a letter dated November 21, 2008 to that effect to Astellas on behalf of the board of directors of CV Therapeutics. Barclays Capital and Goldman Sachs are serving as financial advisors, and Latham & Watkins LLP is serving as legal counsel, to CV Therapeutics. About CV Therapeutics CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company primarily focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics Europe Ltd. is the company’s European subsidiary based in the United Kingdom. CV Therapeutics’ approved products in the United States include Ranexa® (ranolazine extended-release tablets), indicated for the treatment of chronic angina, and Lexiscan® (regadenoson) injection for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. Ranexa® (ranolazine prolonged-release tablets) is approved for use in the European Union as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to firstline anti anginal therapies. CV Therapeutics also has other clinical and preclinical drug development candidates and programs.
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LOGO
Except for the historical information contained herein, the matters set forth in this press release, including statements as to research and development and commercialization of products, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including operating losses and fluctuations in operating results; capital requirements; regulatory review and approval of our products; the conduct and timing of clinical trials; commercialization of products; market acceptance of products; product labeling; concentrated customer base; reliance on strategic partnerships and collaborations; uncertainties in drug development; uncertainties regarding intellectual property and other risks detailed from time to time in CV Therapeutics’ SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2008. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements. ###
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): 02/20/2009
CV THERAPEUTICS, INC. (Exact n am e of re gistran t as spe cifie d in its ch arte r)
Commission File Number: 0-21643 Delaware
43-1570294
(State or oth e r jurisdiction of in corporation )
(IRS Em ploye r Ide n tification No.)
3172 Porter Drive, Palo Alto, CA 94304 (Addre ss of prin cipal e xe cu tive office s, inclu ding z ip code )
650-384-8500 (Re gistran t’s te le ph on e n u m be r, inclu ding are a code )
Not Applicable (Form e r n am e or form e r addre ss, if ch an ge d since last re port)
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))
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Item 7.01.
Regulation FD Disclosure
(a) On February 20, 2009, CV Therapeutics, Inc. (the “Company”) publicly disseminated a press release announcing that the Company’s board of directors has again reviewed and rejected the previously announced unsolicited proposal from Astellas Pharma Inc. (“Astellas”) to acquire the Company at a price of $16.00 per share. After consideration of the Astellas proposal with its independent financial and legal advisors, the Company’s board of directors concluded that the proposal significantly undervalues the Company and is not in the best interests of the Company and its stockholders. Louis G. Lange, the Company’s chairman and chief executive officer, sent a letter to that effect to Masafumi Nogimori, president and chief executive officer of Astellas, on February 20, 2009. A copy of the Company’s press release, dated February 20, 2009, including the full text of the letter, is furnished with this Form 8-K and attached hereto as Exhibit 99.1. Exhibit 99.1 of this Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise be subject to the liabilities under that Section of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act. The Astellas proposal is further described in the Company’s Current Report on Form 8-K filed on January 30, 2009 and the press release attached as Exhibit 99.1 thereto. The Company’s board of directors had previously rejected the same proposal on November 21, 2008. (b) In addition, as relates to the Lexiscan® (regadenson injection) product being sold in the United States by the Company’s collaborative partner Astellas US LLC (a U.S. subsidiary of Astellas Pharma Inc.), the Company believes that the product should expand the overall market for pharmacologic stress imaging agents in the United States, that the product could capture a significant portion of the market for such agents in the United States in 2009 and become a multi-hundred million dollar product as well this year, and that the product may ultimately achieve more than $500 million in total worldwide sales over time assuming future regulatory approvals and launches. The matters set forth in this report are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including operating losses and fluctuations in operating results; capital requirements; regulatory review and approval of CV Therapeutics’ products; the conduct and timing of clinical trials; commercialization of products; market acceptance of products; product labeling; concentrated customer base; reliance on strategic partnerships and collaborations; uncertainties in drug development; uncertainties regarding intellectual property; and other risks detailed from time to time in CV Therapeutics SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2008. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements. ***** Item 9.01. Financial Statements and Exhibits (d) Exhibits. 99.1
Press Release dated February 20, 2009.
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Signature(s) 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. CV THERAPEUTICS, INC. Date: February 20, 2009
By: /s/ TRICIA BORGA SUVARI TRICIA BORGA SUVARI Senior Vice President and General Counsel
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Exhibit Index Exh ibit No.
EX-99.1
De scription
Press Release dated February 20, 2009. Exhibit 99.1
LOGO
FOR IMMEDIATE RELEASE Contacts: John Bluth Executive Director, Corporate Communications & Investor Relations CV Therapeutics, Inc. (650) 384-8850 Joele Frank/Jeremy Jacobs Joele Frank, Wilkinson Brimmer Katcher 212-355-4449 CV THERAPEUTICS’ BOARD OF DIRECTORS REJECTS ASTELLAS UNSOLICITED PROPOSAL PALO ALTO, Calif., February 20, 2009 – CV Therapeutics, Inc. (Nasdaq: CVTX) today announced that its board of directors has thoroughly reviewed and rejected the previously announced unsolicited proposal from Astellas Pharma Inc. to acquire CV Therapeutics at a price of $16.00 per share. After careful consideration of the proposal with its independent financial and legal advisors, the CV Therapeutics board concluded that the Astellas proposal significantly undervalues the company and is not in the best interests of CV Therapeutics and its stockholders. The board had previously rejected the same proposal on November 21, 2008, when Astellas approached the company privately. “CV Therapeutics has a strategic plan in place which we believe will enhance shareholder value. Moreover, we have always been, and remain, receptive to opportunities to further enhance shareholder value. Executing on our strategic plan enabled us to achieve outstanding results in 2008, with multiple regulatory approvals, record revenues and two exceptional strategic transactions. This strong record of product approvals, which exceeds that of many pharma companies over the last several years, has allowed the company to establish a solid cash position. The full promotional launch of the improved U.S. Ranexa labeling is just beginning, the introduction of Ranexa in Europe is imminent, and Lexiscan is showing real growth in the marketplace. Accordingly, we expect 2009 to be another outstanding year, highlighted by increasing revenues and pipeline advancement, for example with CVT-3619,” said Louis G. Lange, chairman and chief executive officer of CV Therapeutics. —more—
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LOGO
Following is the text of the letter being sent by CV Therapeutics today to Masafumi Nogimori, president and chief executive officer of Astellas Pharma: Dear Mr. Nogimori: The CV Therapeutics board of directors is committed to enhancing value for our stockholders. The board, with the assistance of its financial and legal advisors, has carefully considered your proposal to acquire our company in the context of our strategic plans and the best interests of our stockholders. We concluded that your proposal significantly undervalues CV Therapeutics and its potential growth opportunities and we decline to accept it. CV Therapeutics has a strategic plan in place which we believe will enhance shareholder value. Moreover, as we stated in our press release, we have always been, and remain, receptive to opportunities to further enhance shareholder value. Sincerely, Dr. Louis Lange Chairman and Chief Executive Officer As previously announced, CV Therapeutics received a letter dated November 13, 2008 from Astellas setting forth an unsolicited proposal by Astellas to acquire the company at a price of $16.00 per share, subject to due diligence, Astellas board approval and other conditions. On November 21, 2008, after careful deliberation, with the assistance of its financial and legal advisors, the CV Therapeutics board of directors concluded that the Astellas proposal was not in the best interests of CV Therapeutics and its stockholders. Dr. Louis Lange, chairman and chief executive officer of CV Therapeutics, sent a letter dated November 21, 2008 to that effect to Astellas on behalf of the board of directors of CV Therapeutics. Barclays Capital and Goldman Sachs are serving as financial advisors, and Latham & Watkins LLP is serving as legal counsel, to CV Therapeutics. About CV Therapeutics CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company primarily focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics Europe Ltd. is the company’s European subsidiary based in the United Kingdom. CV Therapeutics’ approved products in the United States include Ranexa® (ranolazine extended-release tablets), indicated for the treatment of chronic angina, and Lexiscan® (regadenoson) injection for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. Ranexa® (ranolazine prolonged-release tablets) is approved for use in the European Union as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to firstline anti anginal therapies. CV Therapeutics also has other clinical and preclinical drug development candidates and programs.
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LOGO
Except for the historical information contained herein, the matters set forth in this press release, including statements as to research and development and commercialization of products, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including operating losses and fluctuations in operating results; capital requirements; regulatory review and approval of our products; the conduct and timing of clinical trials; commercialization of products; market acceptance of products; product labeling; concentrated customer base; reliance on strategic partnerships and collaborations; uncertainties in drug development; uncertainties regarding intellectual property and other risks detailed from time to time in CV Therapeutics’ SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2008. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements. ###
