CAMBRIDGE, Mass., Feb. 7 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today reported 2007 non-GAAP net income of $86.9 million and GAAP net income of $14.9 million.(1) These results exceeded the Company’s 2007 financial guidance, driven by strong worldwide sales of VELCADE, the global market leader for the treatment of patients with relapsed multiple myeloma.
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“Millennium over-delivered on high expectations in 2007, including the achievement of record financial results,” said Deborah Dunsire, M.D., President and Chief Executive Officer. “Millennium is uniquely situated for growth with a blockbuster oncology product, a pipeline of innovative product candidates and strong financials.”
“We remain committed to positioning the Company to deliver sustainable earnings growth,” stated Marsha Fanucci, Chief Financial Officer. “In 2008, the Company is focused on elevating its success by maximizing the launch of VELCADE in newly diagnosed multiple myeloma, initiating a pivotal trial program with MLN0002 in inflammatory bowel disease and achieving our financial guidance.”
Recent Development Pipeline Highlights
The Company is advancing a pipeline of innovative molecules in cancer and inflammatory diseases. In 2007, the Company achieved important milestones within its inflammatory bowel disease and protein homeostasis oncology programs:
2008 Financial Guidance
On January 4, 2008, the Company announced its financial guidance for 2008, as follows:
Presentation Reminder
Dr. Dunsire and Ms. Fanucci will present additional detail on 2007 financial results and 2008 goals and financial guidance on February 7, 2008, at the Merrill Lynch 2008 Global Pharmaceutical, Biotechnology & Medical Device Conference. The presentation will be webcast live at 8:00 a.m. ET and may be accessed by visiting the Investors section of the Company’s website at: http://www.millennium.com.
About VELCADE
VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and J&JPRD. Millennium is responsible for commercialization of VELCADE in the U.S. and Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. For a limited period of time, Millennium and Ortho Biotech Inc. are co-promoting VELCADE in the U.S. VELCADE is approved in 85 countries worldwide. More than 85,000 patients have been treated with VELCADE globally.
In the U.S., VELCADE is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. VELCADE is also indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. In the European Union and many other countries worldwide, VELCADE is approved for patients with multiple myeloma after first relapse.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension observed throughout therapy, cardiac and pulmonary disorders, gastrointestinal adverse events, thrombocytopenia, neutropenia and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE. Cases of severe sensory and motor peripheral neuropathy have been reported. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported, including reports in patients with few or no risk factors for decreased left ventricular ejection fraction. There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of these events have been fatal. A higher proportion of these events have been reported in Japan. There have been rare reports of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. VELCADE is associated with thrombocytopenia and neutropenia. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. Complete blood counts (CBC) should be frequently monitored during treatment with VELCADE. Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.
Integrated Safety Data: Safety data from Phase 2 and 3 studies of single-agent VELCADE 1.3 mg/m2/dose twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with multiple myeloma (N=1008) and mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma. In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%), and anemia (29%). Twenty percent (20%) of patients experienced at least 1 episode of >/= Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%). Adverse events thought by the investigator to be drug-related and leading to discontinuation occurred in 22% of patients. The reasons for discontinuation included peripheral neuropathy (8%), asthenic conditions (3%) and thrombocytopenia and diarrhea (each 2%). In total, 2% of the patients died and the cause of death was considered by the investigator to be possibly related to study drug: including reports of cardiac arrest, congestive heart failure, respiratory failure, renal failure, pneumonia and sepsis. This integrated analysis does not include the Phase 3, VELCADE plus DOXIL study.
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has a robust clinical development pipeline of product candidates. Millennium’s research, development and commercialization activities are focused in two therapeutic areas: oncology and inflammation. By applying its knowledge of the human genome, understanding of disease mechanisms and industrialized drug discovery platform, Millennium is developing an exciting pipeline of innovative product candidates. Millennium’s website is http://www.millennium.com.
This press release contains “forward-looking statements,” including statements about the Company’s growth, future operating results, discovery, development of products and strategic alliances. Various important risks may cause the Company’s actual results to differ materially from the results indicated by these forward-looking statements, including: adverse results in its drug discovery and clinical development programs; failure to obtain patent protection for its discoveries; commercial limitations imposed by patents owned or controlled by third parties; the Company’s dependence upon strategic alliance partners to develop and commercialize products and services based on its work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from its development efforts; product withdrawals; competitive factors; difficulties or delays in manufacturing the Company’s products; government and third-party reimbursement rates; the commercial success of VELCADE and INTEGRILIN(R) (eptifibatide) Injection; achieving revenue consistent with internal forecasts; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties the Company faces, see the reports it has filed with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Editors’ Note: This press release is also available under the Media section of the Company’s website at: http://www.millennium.com.
(1) Non-GAAP net income, non-GAAP earnings per share, non-GAAP R&D expenses and non-GAAP SG&A expenses are financial measures that are not prepared in accordance with U.S. generally accepted accounting principles (GAAP). Please see the Form 8-K, furnished on February 7, 2008, by the Company to the Securities and Exchange Commission for a discussion of why the Company believes these non-GAAP measures are useful to investors and the additional purposes for which management uses these measures.
(2) The Company adopted Statement of Financial Accounting Standards No. 123R (SFAS 123R) as of January 1, 2006 and records stock-based compensation expense in its statement of operations. Although this expense is a significant ongoing expense affecting the Company’s results of operations, the Company excludes this charge from its non-GAAP R&D, non-GAAP SG&A and non-GAAP net income because: (1) the Company’s management excludes this expense from the Company’s budget and planning process used to allocate resources in the Company’s ongoing portfolio prioritization efforts, (2) the Company believes that excluding this expense could be helpful in comparing the Company’s financial results to periods prior to January 1, 2006 because stock-based compensation charges are excluded in the various operating expense categories and (3) as a result of varying available valuation methodologies, subjective assumptions and the variety of award types, the Company believes that excluding stock-based compensation may enable useful comparisons of the Company’s operating results to its competitors. Non-GAAP net income and other non-GAAP financial measures disclosed by the Company should not be considered in isolation or as a substitute for GAAP.
(3) In 2007, non-GAAP and GAAP net income included a non-recurring milestone of $40 million. The Company does not expect to achieve any material milestones in 2008.
(4) GAAP net income for 2008 is expected to include stock-based compensation expense of approximately $30 million, amortization of intangibles of $34 million, and restructuring charges of less than $5 million. There could be additional charges excluded from the Company’s GAAP net income, to arrive at non-GAAP net income, which are dependent on unknown future events and are difficult to predict and estimate at this time.
(1) In accordance with SFAS 123R, stock-based compensation expense is allocated between research and development and selling, general and administrative expense as follows:
(2) Certain prior year amounts have been reclassified between research and development and selling, general and administrative expenses to conform to the current year presentation. This reclassification has no impact on previously reported results.
(3) During the year ended December 31, 2006, the Company recognized a $3.4 million deferred gain from the sale of assets to Gene Logic, Inc. and a $19.5 million gain upon receipt of a termination fee as a result of the termination of the support agreement with AnorMED in October 2006.
(4) When the assumed conversion of convertible notes into 16.2 million shares of common stock has a dilutive effect, earnings per share is computed by dividing (i) net income, after adding back interest expense associated with convertible notes outstanding by (ii) basic shares plus additional common equivalent shares including the assumed conversion of convertible notes. The dilutive income adjustment was $1.8 million for the three months ended December 31, 2007.
(1) Certain prior year amounts have been reclassified between research and development and selling, general and administrative expenses to conform to the current year presentation. This reclassification has no impact on previously reported results.
(2) When the assumed conversion of convertible notes into 16.2 million shares of common stock has a dilutive effect, earnings per share is computed by dividing (i) net income, after adding back interest expense associated with convertible notes outstanding by (ii) basic shares plus additional common equivalent shares including the assumed conversion of convertible notes. The dilutive income adjustment was $1.8 million for the three months ended December 31, 2007 on a GAAP and non-GAAP basis and $0.9 million for the three months ended December 31, 2006 on a non-GAAP basis.
(3) During the three months ended December 31, 2006, the Company recognized a $19.5 million gain upon receipt of a termination fee as a result of the termination of the support agreement with AnorMED in October 2006, net of transaction costs of approximately $5.5 million. Transaction costs are included in selling, general and administrative expenses.
(1) Certain prior year amounts have been reclassified between research and development and selling, general and administrative expenses to conform to the current year presentation. This reclassification has no impact on previously reported results.
(2) When the assumed conversion of convertible notes into 16.2 million shares of common stock has a dilutive effect, earnings per share is computed by dividing (i) net income, after adding back interest expense associated with convertible notes outstanding by (ii) basic shares plus additional common equivalent shares including the assumed conversion of convertible notes. The dilutive income adjustment was $0.9 million for the year ended December 31, 2006 on a non-GAAP basis.
(3) During the year ended December 31, 2006, the Company recognized a $19.5 million gain upon receipt of a termination fee as a result of the termination of the support agreement with AnorMED in October 2006, net of transaction costs of approximately $5.5 million. Transaction costs are included in selling, general and administrative expenses.
CONTACT: Investors, Kyle Kuvalanka, +1-617-761-4734, or Media, Jennifer
Snyder, +1-617-444-1439
Web site: http://www.millennium.com/
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