Millennium Achieves 2006 Non-GAAP Profitability, Reduces GAAP Net Loss
Thursday January 4, 4:01 pm ET
--Announces 2007 plan, building on 2006 success--
CAMBRIDGE, Mass., Jan. 4 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced 2007 goals and financial guidance, which build on a successful 2006. In 2006, the Company achieved non-GAAP profitability and substantially reduced its GAAP net loss while accomplishing significant goals.(1) These results and the 2007 goals and financial guidance will be presented at the 25th Annual JPMorgan Healthcare Conference on January 8, 2007, in San Francisco, Calif.
"The past year was extremely productive as we executed successfully against our goals," said Deborah Dunsire, M.D., President and Chief Executive Officer, Millennium. "VELCADE received full regulatory approval in relapsed mantle cell lymphoma -- the first indication beyond multiple myeloma, and we maintained our market-leading position in relapsed multiple myeloma. We over- delivered on our original non-GAAP profitability guidance and substantially reduced our GAAP net loss. We also announced positive Phase II data of MLN1202 in patients with high C-Reactive Protein at high risk for atherosclerosis and brought forward two new molecules from discovery to the development pipeline. We are heading into 2007 with a solid foundation for continued success."
VELCADE® (bortezomib) for Injection
VELCADE is the market leader in the relapsed multiple myeloma treatment setting with an unmatched single-agent median survival of 29.8 months. The Company is focused on maximizing the potential of VELCADE in multiple myeloma and non-Hodgkin's lymphoma as well as other hematological and solid tumors.
- 2006 achievements
- Achieved $220 million in U.S. net product sales, a 15 percent increase over 2005
- Gained full regulatory approval from the U.S. Food and Drug Administration for use of VELCADE in patients with mantle cell lymphoma who have received at least one prior therapy
- Expanded the Millennium sales force and entered into a two-year U.S. based co-promotion with Ortho Biotech Inc. to increase share of voice in the marketplace
- Advanced three Phase III registration-enabling trials in the front-line multiple myeloma setting with patient enrollment completed in the VISTA trial and positive preliminary data presented from the IFM trial
- Initiated a Phase III registration-enabling trial in relapsed indolent non-Hodgkin's lymphoma
- Continued to explore the potential of VELCADE in additional hematological and solid tumors with over 330 Company-, investigator- or cooperative group-sponsored trials ongoing or planned
- 2007 goals
- Grow VELCADE and execute effectively on the U.S. co-promotion with Ortho Biotech Inc.
- Advance the three Phase III multiple myeloma front-line trials and the Phase III relapsed indolent non-Hodgkin's lymphoma trial toward the goal of supplementary new drug application filings
- Outline next set of indications and development timelines
Development Pipeline
The Millennium pipeline consists of nine novel molecules in oncology and inflammation including six discovered in-house at Millennium.
- 2006 achievements
- Accelerated the development of assets with clinical or biomarker activity
- MLN0002 (alpha 4 beta 7 antagonist) in ulcerative colitis - Engineered a new commercially scaleable cell line and completed preclinical studies keeping the molecule on track to enter clinical trials in 2007. As previously reported, in a Phase II trial MLN0002 showed a statistically significant benefit in clinical remission compared to placebo
- MLN1202 (CCR2 antagonist) in patients at high risk of atherosclerosis - Announced that in a Phase II study, MLN1202 met the primary endpoint of a statistically significant reduction in C Reactive Protein, an inflammatory biomarker associated with atherosclerosis, relative to placebo. No serious adverse events were observed. These data are believed to be the first public data on CCR2 antagonism to show significant and sustained activity
- MLN518 (RTK FLT-3 inhibitor) in acute myelogenous leukemia - In a Phase I/II trial, the Company successfully established a treatment dose and schedule. The National Cancer Institute (NCI) initiated Phase I/II trials in prostate and renal cancers
- Advanced two early molecules to key milestones - MLN3897 (CCR1 inhibitor) - Initiated a randomized, double-blind Phase II proof-of-concept trial in rheumatoid arthritis in partnership with sanofi-aventis - MLN0415 (IKKbeta inhibitor) - Initiated a Phase I trial with MLN0415, to the Company's knowledge, the first IKKbeta inhibitor to enter human clinical trials
- Advanced two new development candidates from discovery to the development pipeline - MLN6095 (CrTH2 inhibitor) and MLN8237 (Aurora A kinase inhibitor)
- 2007 goals
- MLN0002 - Initiate bridging studies with material derived from the new cell line to demonstrate comparability with the original cell line; prepare for start of a pivotal trial
- MLN1202 - Present data from Phase II trials in patients at high risk of atherosclerosis and in patients with relapsed and remitting multiple sclerosis; outline plans for further development and/or a collaboration
- MLN3897 - Complete Phase II proof-of-concept trial in rheumatoid arthritis
- Earlier stage pipeline
- Advance at least two clinical programs to key milestones
- Advance at least one new development candidate from discovery to the development pipeline
Strategic Business Relationships
Strategic business relationships remain a key component of the Company's strategy. While not required to achieve the outlined financial objectives, the right one could enhance the growth profile of the Company. In 2007, the Company will continue to evaluate strategic in-licensing and acquisition opportunities. The Company will also explore out-licensing and collaborations for pipeline assets, where appropriate.
Financial Guidance
The Company is on track to achieve its revised 2006 financial guidance outlined during its third-quarter 2006 earnings call on October 26, 2006. Financial results for 2006 will be issued in the Company's year-end earnings release on February 8, 2007, in conjunction with the Merrill Lynch Eighteenth Annual Global Pharmaceutical, Biotechnology and Medical Device Conference in New York, NY.
The Company's financial guidance for 2007 includes:
- VELCADE U.S. net product sales in the range of $240 million to $260 million
- Royalties in the range of $140 million to $150 million
- Non-GAAP R&D and non-GAAP SG&A expenses of approximately $425 million; the corresponding GAAP R&D and GAAP SG&A expenses, which includes stock-based compensation expenses, in the range of $455 million to $465 million
- Non-GAAP net income within the range of $10 million to $20 million
- GAAP net loss in the range of $60 million to $90 million, with the difference between the GAAP net loss and non-GAAP net income attributable to stock-based compensation expense, amortization of intangibles and restructuring(2)
- Stock-based compensation expense of $30 million to $40 million
- Amortization of intangibles of approximately $34 million
- Restructuring charges of $15 million to $25 million
- Cash, cash equivalents and marketable securities greater than $800 million on December 31, 2007 |
