- VELCADE(R) (bortezomib) for Injection U.S. net sales increase 10%
year-over- year -
- New molecule advances to oncology development pipeline -
- Company achieves non-GAAP profitability and reduces GAAP net loss for
fifth consecutive quarter(1)-
CAMBRIDGE, Mass., April 26 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today provided an update on its
financial and operational performance for the first quarter of 2007.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"We had an excellent start to 2007, executing well on all fronts -
commercial, clinical and financial," said Deborah Dunsire, M.D., President
and Chief Executive Officer, Millennium. "We continue to realize the
benefits of the actions we have taken to position Millennium for success,
aligned with the vision of building an innovation-driven company to
continuously deliver medicines that fundamentally change the lives of
patients with cancer and inflammatory diseases."
"Financially, we delivered strong first-quarter results which reflect
both global VELCADE revenue growth and continued expense management,"
commented Marsha Fanucci, Chief Financial Officer, Millennium. "These
results were once again achieved as we continued to invest in VELCADE, the
clinical pipeline and our innovative discovery organization to enable
achievement of our goals."
First-Quarter 2007 Financial Results Compared to First-Quarter 2006
Results
-- The Company achieved non-GAAP net income of $12.7 million compared to
non-GAAP net income of $1.0 million in the first quarter of 2006. This
significant improvement was primarily due to:
-- VELCADE U.S. net sales of $58.6 million, a 10 percent increase,
-- Royalties of $36.4 million, a 19 percent increase,
-- Net investment income of $15.5 million, a $10.9 million increase,
-- A nine percent planned reduction in non-GAAP research and
development expense (R&D) resulting in $69.2 million (corresponding
GAAP R&D, including stock-based compensation, decreased 14 percent
to $71.2 million),(2) offset in part by
-- Enhanced sales and marketing investment for VELCADE which increased
non-GAAP selling, general and administrative expense (SG&A) by 16
percent to $36.2 million (corresponding GAAP SG&A, including stock-
based compensation, increased 11 percent to $39.5 million).(2)
-- The Company narrowed GAAP net loss to $6.8 million from $20.8 million
in the first quarter of 2006. This result was driven by:
-- The items listed above, and
-- A $5.1 million decrease in stock-based compensation expense, offset
by a $2.8 million increase in restructuring charges, both of which
are excluded from non-GAAP income.
-- As of March 31, 2007, the Company had $819.2 million in cash, cash
equivalents and marketable securities. The outstanding principal amount
of convertible debt was $250.0 million. During the first quarter of
2007, the Company retired $99.6 million in convertible debt.
VELCADE Highlights
In January 2007, Millennium and Ortho Biotech Inc. began jointly
promoting VELCADE for its approved indications in the U.S. This
co-promotion arrangement, coupled with the Company's sales force expansion
in 2006, is expected to enhance the reach and frequency of the promotional
effort for VELCADE. The Company believes that these efforts will have
increasing impact throughout the year.
"VELCADE showed significant growth driven by our enhanced sales and
marketing effort including the co-promotion arrangement with Ortho Biotech
Inc.," said Christophe Bianchi, M.D., Executive Vice President, Commercial
Operations, Millennium. "Our market research shows that demand growth was
the result of an increase in the number of cycles administered to patients
and an increase in the number of relapsed mantle cell lymphoma patients
using VELCADE. At the same time, we maintained our market-leading position
among patients with previously treated multiple myeloma and experienced
unsolicited use in patients with newly diagnosed multiple myeloma and
follicular non-Hodgkin's lymphoma."
Development Pipeline Highlights
In April 2007, the Company announced the advancement of a new small
molecule, MLN4924, a novel inhibitor of Nedd 8 Activating Enzyme (NAE),
from discovery to the development pipeline. NAE is an unprecedented target
in the protein homeostasis pathway that acts upstream of the proteasome,
the target of VELCADE. NAE regulates a subset of proteins that controls the
regulation and survival of cancer cells. In xenograft models, MLN4924 has
demonstrated significant anti-tumor activity in several solid and liquid
tumors. IND- enabling work is ongoing, and a Phase I trial with the
molecule is planned for 2008. MLN4924 is the seventh molecule to advance
from the Millennium discovery organization to the development pipeline in
the past three years.
Findings published in the April 15, 2007 issue of Blood showed that a
team of researchers, led by Millennium, discovered biomarkers that may lead
to identifying multiple myeloma patients likely to respond to VELCADE. The
analyses of tumor samples taken from multiple myeloma patients in VELCADE
clinical trials showed that patients with an increased expression of genes
in the NFkappa-B and adhesion-molecule pathways may be more sensitive to
VELCADE therapy. Additionally, these findings showed that the biomarkers
did not predict sensitivity to dexamethasone therapy, indicating that the
biomarkers may be specific to VELCADE. These results add to the body of
evidence supporting the role of VELCADE as the foundation of therapy for a
broad range of multiple myeloma patients. This research, in combination
with similar ongoing studies of VELCADE based combinations, may ultimately
lead to improved outcomes for patients.
2007 Financial Guidance
The Company is reiterating its financial guidance for 2007 as
originally provided on January 4, 2007.
-- 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 include stock-
based compensation expenses, in the range of $455 million to $465
million,
-- Non-GAAP net income in 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 (3), and
-- Cash, cash equivalents and marketable securities greater than $800
million on December 31, 2007.
Conference Call and Presentation Reminder
Dr. Dunsire and members of the Millennium leadership team will present
additional detail on these financial and operational results this morning,
April 26, 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. 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. will
co-promote 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, 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 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.
Safety Data: In 1163 patients in multiple myeloma and mantle cell
lymphoma studies, the most commonly reported adverse events were asthenic
conditions (64%), nausea (55%), diarrhea (52%), constipation (41%),
peripheral neuropathy (39%), thrombocytopenia (36%), appetite decrease,
including reports of anorexia (36%), pyrexia (34%), vomiting (33%) and
anemia (29%). Twenty percent of patients reported at least one episode of
grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia
(5%) and neutropenia (3%). Fifty percent of patients reported serious
adverse events. The most commonly reported serious adverse events were
pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea,
dehydration, dyspnea and thrombocytopenia (each 3%).
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.
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 March 31,
2007 2006
(in thousands, except per share amounts)
Revenues:
Net product sales $58,640 $53,373
Revenue under strategic alliances 15,714 38,629
Royalties 36,370 30,473
Total revenues 110,724 122,475
Costs and expenses:
Cost of sales 5,358 15,828
Research and development (Note 1) 71,229 82,598
Selling, general and administrative (Note 1) 39,525 35,465
Restructuring 5,611 2,831
Amortization of intangibles 8,487 8,487
Total costs and expenses 130,210 145,209
Loss from operations (19,486) (22,734)
Other income (expense):
Investment income, net 15,495 4,625
Interest expense (2,787) (2,732)
Net loss $(6,778) $(20,841)
Amounts per common share:
Net loss per share, basic and diluted $(0.02) $(0.07)
Weighted average shares, basic and diluted 316,072 311,823
Note 1: In accordance with SFAS 123R, stock-based compensation expense of
$5,402 and $10,500 for the three months ended March 31, 2007 and March 31,
2006, respectively, is allocated between research and development and
selling, general and administrative expense lines as follows:
Three Months Ended March 31,
2007 2006
Research and development $2,055 $6,334
Selling, general and administrative 3,347 4,166
$5,402 $10,500
Millennium Pharmaceuticals, Inc.
Reconciliation of Non-GAAP to GAAP (Note 1)
(unaudited)
Three Months Ended Three Months Ended
March 31, 2006 March 31, 2007
Non-GAAP (Note 2) Non-GAAP
(in thousands, except per share amounts)
Revenues:
Net product sales $53,373 $58,640
Revenue under strategic
alliances 38,629 15,714
Royalties 30,473 36,370
Total revenues 122,475 110,724
Costs and expenses:
Cost of sales 15,828 5,358
Research and development 76,264 69,174
Selling, general and administrative 31,299 36,178
Restructuring - -
Amortization of intangibles - -
Total costs and expenses 123,391 110,710
Income (loss) from operations (916) 14
Other income (expense):
Investment income, net 4,625 15,495
Interest expense (2,732) (2,787)
Net income (loss) $977 $12,722
Amounts per common share:
Net income (loss) per share, basic
and diluted $0.00 $0.04
Weighted average shares, basic 311,823 316,072
Weighted average shares, diluted 314,025 319,484
Note 1: Stock-based compensation, amortization of intangibles and
restructuring charges are deducted in accordance with generally accepted
accounting principles in the United States (GAAP) to arrive at GAAP
reported net loss for the periods presented.
Note 2: Excludes stock-based compensation of $10,500, restructuring
charges of $2,831 and amortization of intangibles of $8,487 for the three
months ended March 31, 2006.
Millennium Pharmaceuticals, Inc.
Reconciliation of Non-GAAP to GAAP (Note 1)
(unaudited)
Stock-based Amortization of
Compensation Restructuring Intangibles GAAP
(in thousands, except per
share amounts)
Revenues:
Net product sales $- $- $- $58,640
Revenue under
strategic alliances - - - 15,714
Royalties - - - 36,370
Total revenues - - - 110,724
Costs and expenses:
Cost of sales - - - 5,358
Research and
development 2,055 - - 71,229
Selling, general and
administrative 3,347 - - 39,525
Restructuring - 5,611 - 5,611
Amortization of
intangibles - - 8,487 8,487
Total costs and
expenses 5,402 5,611 8,487 130,210
Income (loss) from
operations (5,402) (5,611) (8,487) (19,486)
Other income (expense):
Investment income,
net - - - 15,495
Interest expense - - - (2,787)
Net income (loss) $(5,402) $(5,611) $(8,487) $(6,778)
Amounts per common share:
Net income (loss) per
share, basic and diluted $(0.01) $(0.02) $(0.03) $(0.02)
Weighted average shares,
basic 316,072 316,072 316,072 316,072
Weighted average shares,
diluted 316,072 316,072 316,072 316,072
Note 1: Stock-based compensation, amortization of intangibles and
restructuring charges are deducted in accordance with generally accepted
accounting principles in the United States (GAAP) to arrive at GAAP
reported net loss for the periods presented.
Note 2: Excludes stock-based compensation of $10,500, restructuring
charges of $2,831 and amortization of intangibles of $8,487 for the three
months ended March 31, 2006.
Millennium Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
March 31, December 31,
2007 2006
(in thousands)
Cash, cash equivalents and marketable
securities $819,169 $894,349
Other current assets 95,018 121,305
Property and equipment, net 145,796 153,349
Restricted cash and other assets 38,985 35,500
Goodwill and intangible assets, net 1,539,623 1,547,309
Total assets $2,638,591 $2,751,812
Current liabilities $103,422 $125,948
Current portion of long term debt - 99,571
Other long term liabilities 57,242 56,075
Capital lease obligations, net of
current portion 74,735 75,041
Long term debt, net of current
portion 250,000 250,000
Stockholders' equity 2,153,192 2,145,177
Total liabilities and
stockholders' equity $2,638,591 $2,751,812
(1)Non-GAAP net income, non-GAAP profitability, 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 April 26, 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 now 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 (loss) 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 (loss) 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 in 2007, restructuring charges of between $15
million and $25 million in 2007 and stock-based compensation expense of
between $30 million and $40 million. There could be additional charges
excluded from the Company's GAAP net loss to arrive at non-GAAP net income
and that are dependent on unknown future events and are difficult to
predict and estimate at this time.
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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