-- VELCADE third-quarter U.S. net sales increased 32% year-over-year to
$70.4 million --
-- Full-year financial guidance raised for second time in 2007 --
-- Phase III VISTA trial in newly diagnosed multiple myeloma stopped early
due to positive interim analysis; sNDA filing now expected in December 2007
--
-- VELCADE listed in national compendia for use in newly diagnosed multiple
myeloma --
-- VELCADE label broadened by FDA providing further differentiation as
leading multiple myeloma therapy --
CAMBRIDGE, Mass., Nov. 1 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced its financial and
operational results for the third quarter of 2007. The Company raised its
full-year 2007 financial guidance for the second time this year.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"Millennium delivered outstanding results for the quarter. U.S. net
sales of VELCADE grew 32 percent over the same period last year as we
fortified our leading position in relapsed multiple myeloma. The strength
of our Phase III VISTA data clearly demonstrates that VELCADE has the
potential to expand this leadership position into the front-line setting,"
said Deborah Dunsire, M.D., President and Chief Executive Officer,
Millennium. "We are raising our full- year 2007 financial guidance for the
second time this year, validating the success of our strategic initiatives
to accelerate growth."
"We continue to outperform financial expectations driven by
acceleration of worldwide VELCADE sales growth. Year-to-date, we have
approximately tripled our non-GAAP net income and reduced GAAP net loss by
50 percent, compared to the same period last year," (1) commented Marsha
Fanucci, Chief Financial Officer, Millennium. "Our increased financial
guidance now projects that VELCADE U.S. net sales will grow 20 percent in
2007 to approximately $265 million."
Third Quarter 2007 Financial Results
-- The Company achieved non-GAAP net income of $15.3 million in the third
quarter of 2007 compared to $6.4 million in the third quarter of 2006.
This significant improvement resulted from an increase in VELCADE U.S.
net sales and royalties. These improvements were partially offset by
an increase in investments to support the continued growth of VELCADE.
Key financial results for the quarter, as compared to the third quarter
of 2006, included:
-- VELCADE U.S. net sales of $70.4 million, a 32 percent increase;
-- Royalties of $41.3 million, a 23 percent increase;
-- Net investment income of $8.6 million, a 31 percent increase;
-- Non-GAAP research and development (R&D) expense of $69.5 million
(corresponding GAAP R&D expense, including stock-based compensation,
of $72.6 million); (2) and
-- Non-GAAP selling, general and administrative (SG&A) expense of $39.2
million (corresponding GAAP SG&A expense, including stock-based
compensation, of $42.9 million). (2)
Year-to-date, the Company achieved $31.3 million in non-GAAP net
income compared to $11.2 million for the same period of 2006.
-- The Company narrowed GAAP net loss to $1.7 million for the third
quarter of 2007 from $13.7 million in the third quarter of 2006. The
improvement in the Company's GAAP net loss reflected a $3.4 million
decrease in stock-based compensation expense, which is excluded from
non-GAAP net income. Year-to-date, the Company reduced GAAP net loss
to $26.2 million from $52.2 million for the same period of 2006.
-- As of September 30, 2007, the Company had $876.3 million in cash,
cash equivalents and marketable securities. The outstanding
principal amount of convertible debt was $250.0 million.
Full-Year 2007 Financial Guidance
The Company is raising its full-year 2007 financial guidance for the
second time, having also raised its guidance in July 2007. Full-year 2007
financial guidance as of January 4, July 26, and November 1 of this year, is
as follows:
2007 Financial Guidance as of as of as of
(dollars in millions) Jan 4, 2007 Jul 26, 2007 Nov 1, 2007
VELCADE U.S. net sales $240 - 260 $250 - 260 $~265
Royalties $140 - 150 $150 - 155 $~160
Non-GAAP R&D, SG&A
expense $~425 $440 - 450 $440 - 450
GAAP R&D, SG&A expense $455 - 465 $465 - 480 $465 - 475
Non-GAAP net income $10 - 20 $20 - 30 $40 - 45
GAAP net loss (3) $60 - 90 $50 - 60 $30 - 35
Amortization $~34 $~34 $~34
Stock-based compensation $30 - 40 $25 - 30 $~25
Restructuring $15 - 25 $15 - 20 $~15
Cash, cash equivalents,
and marketable
securities $ > 800 $ > 800 $ > 800
VELCADE Highlights
"VELCADE sales showed considerable strength this quarter resulting from
the convergence of a number of growth drivers. In multiple myeloma, VELCADE
use increased significantly with expanded use of VELCADE based combinations
and re-treatment. In mantle cell lymphoma, our launch continues
successfully with more physicians prescribing VELCADE," said Christophe
Bianchi, M.D., Executive Vice President, Commercial, Millennium. "The
future of VELCADE is even more exciting as we look to expand into
front-line multiple myeloma with several combinations that have the
potential to deliver the strongest long- term survival for patients."
-- Phase III VISTA Trial in Front-Line Multiple Myeloma (MM) -- The
Company announced that the results of the large, randomized, Phase III
VISTA trial in patients with newly diagnosed MM showed that the therapy
of VELCADE, melphalan and prednisone demonstrated a highly
statistically significant improvement, compared with melphalan and
prednisone alone, across all efficacy endpoints, including time to
progression, complete remission rate, progression free survival and
overall survival. Side effects were manageable and included those seen
in previous VELCADE trials. Based on these positive data, the control
arm of the trial was stopped early to allow patients still being
treated with melphalan and prednisone to have VELCADE added to their
therapy. The Company now expects to file a supplementary new drug
application (sNDA) for use of VELCADE in patients with newly diagnosed
MM in December 2007.
-- Compendia Listing in Front-Line MM -- In October 2007, the national
compendia organization DrugPoints Systems included VELCADE as a
recommended therapy for use in newly diagnosed multiple myeloma
patients.
-- Label Expansion in MM -- In October 2007, the U.S. Food and Drug
Administration (FDA) granted approval for VELCADE use, without dose
adjustments, in patients with impaired kidney function, including those
requiring dialysis. Impaired kidney function is a common complication
related to MM, affecting approximately 30 percent of patients at
diagnosis and a growing percentage throughout the course of the
disease.
-- American Society of Hematology (ASH) Meeting -- Numerous VELCADE
abstracts are expected to be featured at the ASH meeting in December
2007. These abstracts may include data from two large, randomized
Phase III trials in patients with newly diagnosed MM. Data may also be
presented on additional VELCADE based combinations in front-line MM and
Non-Hodgkin's Lymphoma (NHL).
Clinical Pipeline Highlights
In addition to VELCADE, the Company continues to advance ten novel
molecules in the areas of cancer and inflammatory diseases. Recent progress
included the following:
-- MLN0002 - The Company completed enrollment in the bridging trials
designed to evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of this novel antibody to the target alpha 4 beta 7,
derived from a new commercially scalable cell line. The Company is
tracking toward pivotal trials with MLN0002 in ulcerative colitis and
Crohn's disease.
-- MLN3897 - The Company is on track to announce top-line results for this
novel CCR1 inhibitor by year end from a 191-patient Phase II proof-of-
concept trial in rheumatoid arthritis.
-- MLN4924 - In October 2007, the Company presented data on this
Millennium-discovered molecule and target at the European Organization
for Research and Treatment of Cancer (EORTC) meeting. Data for this
inhibitor of the Nedd8-activating enzyme showed the molecule
significantly inhibited tumor growth in xenograft models for colorectal
cancer and several types of lymphoma. MLN4924 is expected to enter
Phase I trials in early 2008.
Conference Call and Presentation Reminder
Dr. Dunsire and members of the Millennium leadership team will present
additional details on these results this morning, November 1, 2007. A
conference call and accompanying slides 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
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (JJPRD).
Millennium is responsible for commercialization of VELCADE in the U.S.,
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 more than 80 countries worldwide.
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
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 net income per share, non-GAAP research
and development expenses and non-GAAP selling, general and
administrative 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 November 1, 2007, 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, non-GAAP net income and non-GAAP net income
per share 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) GAAP net loss for 2007 includes amortization of intangibles of
approximately $34 million, stock-based compensation expense of
approximately $25 million and restructuring charges of approximately
$15 million. There could be additional charges excluded from the
Company's GAAP net loss, to arrive at non-GAAP net income, which are
dependent on unknown future events and are difficult to predict and
estimate at this time.
Contacts:
Kyle Kuvalanka (investors) Jennifer Snyder (media)
(617) 761-4734 (617) 444-1439
Millennium Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2007 2006 2007 2006
(in thousands, except per share
amounts)
Revenues:
Net product sales $70,360 $53,161 $191,550 $165,320
Revenue under strategic
alliances 10,628 17,196 38,168 82,990
Royalties 41,344 33,737 116,617 98,382
Total revenues 122,332 104,094 346,335 346,692
Costs and expenses:
Cost of sales 6,931 6,730 17,668 36,660
Research and development (Note 1) 72,551 73,436 217,162 235,343
Selling, general and
administrative (Note 1) 42,949 34,365 129,506 107,221
Restructuring 1,667 1,352 13,050 5,737
Amortization of intangibles 8,488 8,488 25,462 25,462
Total costs and expenses 132,586 124,371 402,848 410,423
Loss from operations (10,254) (20,277) (56,513) (63,731)
Other income (expense):
Investment income, net 10,995 5,635 38,057 16,037
Interest expense (2,434) (2,478) (7,696) (7,934)
Other income - 3,403 - 3,403
Net loss $(1,693) $(13,717) $(26,152) $(52,225)
Amounts per common share:
Net loss per share, basic and
diluted $(0.01) $(0.04) $(0.08) $(0.17)
Weighted average shares, basic and
diluted 318,871 314,228 317,591 313,132
Note 1: In accordance with SFAS 123R, stock-based compensation expense
is allocated between research and development and selling, general and
administrative expense as follows:
Three Months Ended Nine Months Ended
September 30, September 30,
2007 2006 2007 2006
Research and development $3,090 $5,603 $8,235 $17,935
Selling, general and
administrative 3,792 4,642 10,748 14,291
Millennium Pharmaceuticals, Inc.
Reconciliation of GAAP to Non-GAAP
(unaudited)
(in thousands, except per share amounts)
Three Months Ended September 30, 2007
Costs and Expenses
Net Income
(Loss)per
Share, Basic
Research and Selling, General Net Income and
Development and Administrative (Loss) Diluted
GAAP $72,551 $42,949 $(1,693) $(0.01)
Adjustments
to reconcile
to Non-GAAP:
Stock-based
Compensation (1) (3,090) (3,792) 6,882 0.02
Restructuring (2) - - 1,667 0.01
Amortization of
Intangibles (3) - - 8,488 0.03
Non-GAAP $69,461 $39,157 $15,344 $0.05
Weighted average
shares, basic
(GAAP and Non-GAAP)
and diluted (GAAP) 318,871
Weighted average
shares, diluted
(Non-GAAP) 321,546
Nine Months Ended September 30, 2007
Costs and Expenses
Net Income
(Loss) per
Share, Basic
Research and Selling, General Net Income and
Development and Administrative (Loss) Diluted
GAAP $217,162 $129,506 $(26,152 $(0.08)
Adjustments to
reconcile to
Non-GAAP:
Stock-based
Compensation (1) (8,235) (10,748) 18,983 0.06
Restructuring (2) - - 13,050 0.04
Amortization of
Intangibles (3) - - 25,462 0.08
Non-GAAP $208,927 $118,758 $31,343 $0.10
Weighted average
shares, basic
(GAAP and Non-GAAP)
and diluted (GAAP) 317,591
Weighted average
shares, diluted
(Non-GAAP) 320,666
Three Months Ended September 30, 2006
Costs and Expenses
Net Income
(Loss) per
Share, Basic
Research and Selling, General Net Income and
Development and Administrative (Loss) Diluted
GAAP $73,436 $34,365 $(13,717) $(0.04)
Adjustments to
reconcile to
Non-GAAP:
Stock-based
Compensation (1) (5,603) (4,642) 10,245 0.03
Restructuring (2) - - 1,352 0.00
Amortization of
Intangibles (3) - - 8,488 0.03
Non-GAAP $67,833 $29,723 $6,368 $0.02
Weighted average
shares, basic
(GAAP and Non-GAAP)
and diluted (GAAP) 314,228
Weighted average
shares, diluted
(Non-GAAP) 316,206
Nine Months Ended September 30, 2006
Costs and Expenses
Net Income
(Loss) per
Share, Basic
Research and Selling, General Net Income and
Development and Administrative (Loss) Diluted
GAAP $235,343 $107,221 $(52,225) $(0.17)
Adjustments to
reconcile to
Non-GAAP:
Stock-based
Compensation (1) (17,935) (14,291) 32,226 0.11
Restructuring (2) - - 5,737 0.02
Amortization
of Intangibles (3) - - 25,462 0.08
Non-GAAP $217,408 $92,930 $11,200 $0.04
Weighted average
shares, basic
(GAAP and Non-GAAP)
and diluted (GAAP) 313,132
Weighted average
shares, diluted
(Non-GAAP 314,586
(1) Represents expense associated with stock-based compensation related
to stock options, the Company's employee stock purchase plan and
restricted stock.
(2) Represents costs associated with the Company's restructuring efforts.
(3) Represents expense associated with the amortization of acquisition-
related intangible assets.
Millennium Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
September 30, December 31,
2007 2006
(in thousands)
Cash, cash equivalents and marketable
securities $876,312 $894,349
Other current assets 78,076 121,305
Property and equipment, net 146,305 153,349
Restricted cash and other assets 36,401 35,500
Goodwill and intangible assets, net 1,524,440 1,547,309
Total assets $2,661,534 $2,751,812
Current liabilities $124,061 $125,948
Current portion of long term debt - 99,571
Other long term liabilities 47,626 56,075
Capital lease obligations, net of
current portion 74,112 75,041
Long term debt, net of current
portion 250,000 250,000
Stockholders' equity 2,165,735 2,145,177
Total liabilities and
stockholders' equity $2,661,534 $2,751,812
SOURCE Millennium Pharmaceuticals, Inc.
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Related links:
http://www.millennium.com
Photo Notes:Newscom:
http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO
AP Archive: http://photoarchive.ap.org PRN Photo Desk
photodesk@prnewswire.com
http://www.prnewswire.com/comp/114562.html /
CONTACT:
Investors, Kyle Kuvalanka, +1-617-761-4734,
or Media, Jennifer Snyder, +1-617-444-1439, both of Millennium
Pharmaceuticals, Inc.
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