-- VELCADE(R) (bortezomib) for Injection U.S. net sales increased to $62.6
million, 7 percent growth over first quarter --
-- Full-year 2007 financial guidance raised --
-- VELCADE front-line multiple myeloma data showed strongest ever reported
three-year survival rate --
-- Phase III front-line multiple myeloma interim analysis on track for
third quarter of 2007; potential sNDA filing --
-- Phase III pivotal NHL trial on track to complete enrollment in first
half of 2008 --
CAMBRIDGE, Mass., July 26 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced its financial and
operational results for the second quarter of 2007. The Company also
increased its financial guidance for full-year 2007.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"This is an exciting time at Millennium as we continue to build
momentum by executing against our commercial, development and operational
goals. With VELCADE, we drove strong U.S. sales performance and presented
new clinical data that support future expansion," said Deborah Dunsire,
M.D., President and Chief Executive Officer, Millennium. "We are quickly
approaching a key growth catalyst with an interim analysis for a VELCADE
Phase III front-line multiple myeloma trial scheduled for the third
quarter, offering the potential for an early sNDA filing."
"Financially, we had another outstanding quarter which led us to raise
our guidance for the year," commented Marsha Fanucci, Chief Financial
Officer, Millennium. "Year-to-date, we increased non-GAAP net income by
greater than 200 percent and reduced our GAAP net loss by greater than 35
percent, compared to the same period last year.(1) Very importantly, we
accomplished these results while advancing our development pipeline of ten
novel molecules in the areas of cancer and inflammatory diseases and
increasing the commercial investment to support short- and long-term growth
of VELCADE."
Second Quarter 2007 Financial Results
-- The Company achieved non-GAAP net income of $3.3 million in the second
quarter of 2007 compared to $3.9 million in the second quarter of 2006.
During the quarter, the Company recorded increases in VELCADE U.S. net
sales and royalties, which were offset by an increase in non-GAAP
selling, general and administrative (SG&A) expense as a result of
investments made to support VELCADE expansion. Key financial results
for the quarter as compared to the second quarter of 2006 included:
-- VELCADE U.S. net sales of $62.6 million, a 6 percent increase;
-- Royalties of $38.9 million, a 14 percent increase;
-- Net investment income of $9.1 million, a $6.0 million increase;
-- Lower non-GAAP research and development (R&D) expense of $70.3
million (corresponding GAAP R&D expense, including stock-based
compensation, of $73.4 million);(2)
-- Higher non-GAAP SG&A expense of $43.4 million (corresponding GAAP
SG&A expense, including stock-based compensation, of $47.0
million).(2)
Year-to-date, the Company achieved $16.0 million in non-GAAP net income
in 2007, a 231 percent improvement, compared to $4.8 million for the
same period of 2006.
-- The Company reported GAAP net loss of $17.7 million for both the second
quarters of 2007 and 2006. The Company's GAAP net loss for the second
quarter of 2007 reflected a $4.8 million decrease in stock-based
compensation expense, offset by a $4.2 million increase in
restructuring charges, both of which are excluded from non-GAAP net
income. Year-to-date, the Company reduced GAAP net loss to $24.5
million for 2007, a 36 percent decrease, compared to $38.5 million for
the same period of 2006.
-- As of June 30, 2007, the Company had $844.4 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 financial guidance for full-year 2007 as
follows:
-- VELCADE U.S. net product sales in the range of $250 million to $260
million, compared to the original range of $240 million to $260
million;
-- Royalties in the range of $150 million to $155 million, compared to the
original range of $140 million to $150 million;
-- Non-GAAP R&D and non-GAAP SG&A expenses in the range of $440 million to
$450 million, compared to the original guidance of approximately $425
million; corresponding GAAP R&D and GAAP SG&A expenses, which include
stock-based compensation expenses, in the range of $465 million to $480
million, compared to the original range of $455 million to $465
million;
-- Non-GAAP net income in the range of $20 million to $30 million,
compared to the original range of $10 million to $20 million;
-- GAAP net loss in the range of $50 million to $60 million, compared to
the original 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.
VELCADE Commercial Highlights
"Our enhanced marketing and sales initiatives led to strong growth in
VELCADE sales performance with a strengthening of our market-leading
position in previously treated multiple myeloma patients," said Christophe
Bianchi, M.D., Executive Vice President, Commercial, Millennium. "We expect
increased sales in the near term will be driven by the recent approval of
the VELCADE / DOXIL combination, repeated use of VELCADE by patients in
multiple lines of therapy and increased use by previously treated mantle
cell lymphoma patients."
In May 2007, the FDA granted marketing approval to Ortho Biotech Inc.
for the steroid-free therapy of VELCADE / DOXIL(R) (pegylated liposomal
doxorubicin) in multiple myeloma patients who have received at least one
prior therapy. The label includes the strongest complete remission /
complete response (CR)(4) rate and the longest time to progression of any
approved therapy in this disease setting.
VELCADE Clinical Highlights
"New clinical data presented at major medical meetings support future
VELCADE expansion," said Nancy Simonian, M.D., Chief Medical Officer,
Millennium. "In front-line multiple myeloma, VELCADE based therapies have
consistently demonstrated some of the highest recorded complete remission
and survival rates, which previously had been achieved only with stem-cell
transplantation. We also continue to see very positive data in NHL, and our
ongoing Phase III trial in relapsed patients is on track to complete
enrollment in the first half of 2008."
Front-line Multiple Myeloma (MM):
-- Clinical data presentations during the quarter showed that VELCADE
based therapies produced some of the highest recorded CR and overall
survival rates in front-line MM. Highlights included:
-- In the long-term follow-up of a Phase II trial conducted by the
PETHEMA cooperative group, VELCADE, melphalan and prednisone (VMP)
demonstrated a CR rate of 43 percent, the highest rate ever reported
for a melphalan prednisone (MP) combination therapy. At 38 months,
85 percent of patients were alive. This is the strongest reported
three-year survival rate in the front-line MM treatment setting.
-- In a Phase III trial conducted by the IFM cooperative group, VELCADE
and dexamethasone (VD) as induction therapy prior to stem cell
transplantation (SCT) produced a high CR rate of 20 percent, which
led to a post SCT CR rate of 43 percent, and a very good partial
response (VGPR) + CR rate of 75 percent. Compared to a commonly
used induction chemotherapy regimen vincristine, adriamycin and
dexamethasone (VAD), which served as the comparative therapy in the
trial, VD nearly doubled the CR rate as induction therapy which in
turn led to a greater than 60 percent improvement in VGPR + CR rate
following SCT. As previously presented, a greater percentage of
patients receiving the VD therapy were spared a second SCT compared
to patients on the VAD therapy.
-- An interim analysis for the 711-patient Phase III VISTA trial is
scheduled for the third quarter of 2007. The trial, sponsored by the
Company and its development partner Johnson & Johnson Pharmaceutical
Research & Development (JJPRD), is evaluating VMP compared to MP in
patients ineligible for SCT. Pending positive results of the interim
analysis, the Company would file a sNDA for front-line MM.
-- The Company launched new clinical trials to continue building evidence
for use of VELCADE based therapies in front-line MM, including:
-- The first patients were dosed in a Company-sponsored Phase III trial
combining VELCADE with currently approved therapies. The trial will
study VD, VMP, and VTD (VELCADE, thalidomide, and dexamethasone) and
will enroll up to 500 patients ineligible for SCT.
-- The Company activated clinical trial sites for a 100-patient
Company-sponsored Phase II trial evaluating the four-drug
combination of VELCADE, lenalidomide / dexamethasone, and
cyclophosphamide. In previous studies, VELCADE and
cyclophosphamide, an alkylating agent, have shown synergistic
activity.
Non-Hodgkin's Lymphoma (NHL):
-- Clinical data presentations during the quarter reported that VELCADE
based therapies produced high CR rates in NHL. Highlights included:
-- In a Phase II trial conducted by the GELA cooperative group of newly
diagnosed B-cell lymphoma patients, the combination of VELCADE and
R-CHOP produced a complete remission rate of 83 percent. This is a
superior result compared to an estimated historical comparison of 55
percent to 75 percent for R-CHOP given for six cycles.
-- The Company and JJPRD announced that more than half of the targeted
670 patients have been enrolled to date in the Company-sponsored
Phase III NHL trial. The trial is evaluating VELCADE in combination
with rituximab compared to rituximab alone in previously treated NHL
patients. Patient accrual is expected to be completed in the first
half of 2008.
Clinical Pipeline Highlights
The Company continues to advance ten novel molecules, in addition to
VELCADE, in the areas of cancer and inflammatory diseases. Recent progress
included:
-- MLN1202 - By the end of the third quarter, the Company expects to
report next steps for this CCR2 antagonist in multiple sclerosis (MS),
based on results from a Phase II study. The Company plans to present
data in MS at the American Neurological Association meeting in October
2007 and data in atherosclerosis from a Phase II trial at the American
Heart Association meeting in November 2007.
-- MLN3897 - The Company completed enrollment in a 191-patient Phase II
proof-of-concept trial for this CCR1 inhibitor in rheumatoid arthritis
and is on track to announce top-line results by year end.
-- MLN8054 - The Company announced preliminary results from the first 49
patients in a Phase I trial of this first-generation Aurora A kinase
inhibitor. Data showed that oral administration was well tolerated
with the only dose-limiting toxicity being off-target somnolence.
Analysis of actual skin biopsies showed evidence of mitotic arrest,
indicative of Aurora A kinase inhibition.
-- MLN8237 - The Company initiated a Phase I clinical trial for this
second-generation Aurora A kinase inhibitor. The open-label, dose-
escalation study is being conducted to determine the dose-limiting
toxicities and maximum tolerated dose as well as to assess the
pharmacokinetic and pharmacodynamic properties in advanced-stage cancer
patients.
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,
July 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. 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 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%) in single-agent VELCADE, 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.
(1) Non-GAAP net income, non-GAAP net income per share, 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
July 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 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 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 in 2007, restructuring charges of between
$15 million and $20 million in 2007 and stock-based compensation
expense of between $25 million and $30 million. There could be
additional charges excluded from the Company's GAAP net loss, to
arrive at non-GAAP net income, that are dependent on unknown future
events and are difficult to predict and estimate at this time.
(4) Complete remission / complete response includes both immunofixation
positive and negative readouts.
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 Six Months Ended
June 30, June 30,
2007 2006 2007 2006
(in thousands, except per share
amounts)
Revenues:
Net product sales $62,550 $58,786 $121,190 $112,159
Revenue under strategic
alliances 11,826 27,165 27,540 65,794
Royalties 38,903 34,172 75,273 64,645
Total revenues 113,279 120,123 224,003 242,598
Costs and expenses:
Cost of sales 5,379 14,102 10,737 29,930
Research and development
(Note 1) 73,382 79,309 144,611 161,907
Selling, general and
administrative (Note 1) 47,032 37,391 86,557 72,856
Restructuring 5,772 1,554 11,383 4,385
Amortization of intangibles 8,487 8,487 16,974 16,974
Total costs and expenses 140,052 140,843 270,262 286,052
Loss from operations (26,773) (20,720) (46,259) (43,454)
Other income (expense):
Investment income, net 11,567 5,777 27,062 10,402
Interest expense (2,475) (2,724) (5,262) (5,456)
Net loss $(17,681) $(17,667) $(24,459) $(38,508)
Amounts per common share:
Net loss per share, basic and
diluted $(0.06) $(0.06) $(0.08) $(0.12)
Weighted average shares, basic and
diluted 317,799 313,321 316,940 312,575
Note 1: In accordance with SFAS 123R, stock-based compensation expense is
allocated between research and development and selling, general and
administrative expense lines as follows:
Three Months Ended Six Months Ended
June 30, June 30,
2007 2006 2007 2006
Research and development $3,090 $5,998 $5,145 $12,332
Selling, general and administrative 3,609 5,483 6,956 9,649
Millennium Pharmaceuticals, Inc.
Reconciliation of GAAP to Non-GAAP
(unaudited)
(in thousands, except per share amounts)
Three Months Ended June 30, 2007
Costs and Expenses
Net
Income
Selling, (Loss)
Research General per
and and Net Share,
Develop- Admin- Income Basic and
ment istrative (Loss) Diluted
GAAP $73,382 $47,032 $(17,681) $(0.06)
Adjustments to reconcile to Non-
GAAP:
Stock-based Compensation (1) (3,090) (3,609) 6,699 0.02
Restructuring (2) - - 5,772 0.02
Amortization of Intangibles (3) - - 8,487 0.03
Non-GAAP $70,292 $43,423 $3,277 $0.01
Weighted average shares, basic
(GAAP and Non-GAAP) and
diluted (GAAP) 317,799
Weighted average shares,
diluted (Non-GAAP) 320,895
Three Months Ended June 30, 2006
Costs and Expenses
Net
Income
Selling, (Loss)
Research General per
and and Net Share,
Develop- Admin- Income Basic and
ment istrative (Loss) Diluted
GAAP $79,309 $37,391 $(17,667) $(0.06)
Adjustments to reconcile to Non-
GAAP:
Stock-based Compensation (1) (5,998) (5,483) 11,481 0.04
Restructuring (2) - - 1,554 0.00
Amortization of Intangibles (3) - - 8,487 0.03
Non-GAAP $73,311 $31,908 $3,855 $0.01
Weighted average shares, basic
(GAAP and Non-GAAP) and
diluted (GAAP) 313,321
Weighted average shares,
diluted (Non-GAAP) 314,289
Six Months Ended June 30, 2007
Costs and Expenses
Net
Income
Selling, (Loss)
Research General per
and and Net Share,
Develop- Admin- Income Basic and
ment istrative (Loss) Diluted
GAAP $144,611 $86,557 $(24,459) $(0.08)
Adjustments to reconcile to Non-
GAAP:
Stock-based Compensation (1) (5,145) (6,956) 12,101 0.04
Restructuring (2) - - 11,383 0.04
Amortization of Intangibles (3) - - 16,974 0.05
Non-GAAP $139,466 $79,601 $15,999 $0.05
Weighted average shares, basic
(GAAP and Non-GAAP) and
diluted (GAAP) 316,940
Weighted average shares,
diluted (Non-GAAP) 320,218
Six Months Ended June 30, 2006
Costs and Expenses
Net
Income
Selling, (Loss)
Research General per
and and Net Share,
Develop- Admin- Income Basic and
ment istrative (Loss) Diluted
GAAP $161,907 $72,856 $(38,508) $(0.12)
Adjustments to reconcile to Non-
GAAP:
Stock-based Compensation (1) (12,332) (9,649) 21,981 0.07
Restructuring (2) - - 4,385 0.02
Amortization of Intangibles (3) - - 16,974 0.05
Non-GAAP $149,575 $63,207 $4,832 $0.02
Weighted average shares, basic
(GAAP and Non-GAAP) and
diluted (GAAP) 312,575
Weighted average shares,
diluted (Non-GAAP) 313,892
(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)
June 30, December 31,
2007 2006
(in thousands)
Cash, cash equivalents and marketable
securities $844,364 $894,349
Other current assets 79,511 121,305
Property and equipment, net 145,417 153,349
Restricted cash and other assets 37,892 35,500
Goodwill and intangible assets, net 1,531,982 1,547,309
Total assets $2,639,166 $2,751,812
Current liabilities $111,301 $125,948
Current portion of long term debt - 99,571
Other long term liabilities 52,181 56,075
Capital lease obligations, net of
current portion 74,426 75,041
Long term debt, net of current
portion 250,000 250,000
Stockholders' equity 2,151,258 2,145,177
Total liabilities and
stockholders' equity $2,639,166 $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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