CAMBRIDGE, Mass., Feb. 8 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today reported non-GAAP net income of
$38.6 million for 2006, which marks the Company's first full year of
non-GAAP profitability since becoming a fully integrated biopharmaceutical
organization and exceeds the Company's financial guidance for 2006. This
achievement represents a substantial improvement over the non-GAAP net loss
of $87.2 million in 2005 primarily as a result of an increase in U.S. net
sales of VELCADE(R) (bortezomib) for Injection, the market leader for the
treatment of relapsed multiple myeloma, and lower expenses. GAAP net loss
narrowed 78 percent to $44.0 million in 2006 from $198.2 million in 2005.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO)
"In 2006, we continued to strengthen the business by driving VELCADE,
advancing our clinical pipeline and bringing forward two new molecules from
discovery to development, all while streamlining our infrastructure," said
Deborah Dunsire, M.D., president and chief executive officer. "These moves
align us with our vision of building an innovation-based company to
continuously deliver medicines that fundamentally change the lives of
patients with cancer and inflammatory diseases."
"Financially, we had an outstanding year in 2006 as we achieved the
significant milestone of non-GAAP profitability and exceeded our
bottom-line financial guidance for the fourth consecutive year," said
Marsha Fanucci, chief financial officer. "As we enter 2007, we continue to
position the Company for long-term growth by investing in VELCADE and our
promising pipeline while continuing to focus on achieving our annual
financial goals."
2006 Financial Results
- The Company achieved non-GAAP net income of $38.6 million. This result
represents a significant improvement over the non-GAAP net loss of $87.2
million in 2005 due primarily to:
- A 15 percent increase in VELCADE U.S. net sales to $220.5 million,
- An 18 percent decrease in combined non-GAAP research and development
(R&D) expense and non-GAAP selling, general and administrative (SG&A)
expense as a result of the Company's restructuring initiatives to
focus investment on the key near-term growth drivers of the business,
including VELCADE, the development pipeline and oncology discovery,
and to reduce expenses. This reduction consists of:
- A 14 percent decrease in non-GAAP R&D expense to $294.9 million
(with the corresponding GAAP R&D expense, including stock-based
compensation, of $318.2 million)(2) and
- A 27 percent decrease in non-GAAP SG&A expense to $131.2 million
(with the corresponding GAAP SG&A expense, including stock-based
compensation and transaction costs associated with the AnorMED
support agreement, of $155.6 million).(2)
- The Company achieved GAAP net loss of $44.0 million, a substantial
improvement over the GAAP net loss of $198.2 million for 2005
primarily as a result of:
- The increase in VELCADE U.S. net sales and
- The decrease in operating expenses outlined above, as well as a
$56.7 million reduction in restructuring charges resulting in $20.4
million in 2006.
- As of December 31, 2006, the Company had $894.3 million in cash, cash
equivalents and marketable securities. The outstanding principal amount
of convertible debt was $349.6 million of which $99.6 million is
included in current liabilities.
VELCADE Commercial Update
In the U.S., VELCADE is the market leader in the relapsed multiple
myeloma setting, despite new competition, and has experienced unsolicited
market-share growth in the front-line multiple myeloma setting. Outside of
the U.S., VELCADE is marketed by Ortho Biotech Products, L.P., a member of
the Johnson & Johnson Family Of Companies, and is approved in more than 75
countries. Ex- U.S. sales increased consistently throughout 2006 as a
result of several new approvals and launches. In October 2006, VELCADE was
approved for marketing in Japan for relapsed or refractory multiple myeloma
in patients who have received at least one prior therapy. Millennium
received an $8.0 million payment from Ortho Biotech for the achievement of
this significant regulatory milestone. In addition, in the fourth quarter
of 2006, VELCADE sales outside of the U.S. reached a pre-specified
threshold which triggered a $25.0 million milestone payment from Ortho
Biotech to Millennium.
In December 2006, the U.S. Food and Drug Administration (FDA) granted
full approval of VELCADE for the treatment of patients with mantle cell
lymphoma who have received at least one prior therapy. VELCADE is the first
therapy to be approved by the FDA for the treatment of this disease. Mantle
cell lymphoma is an aggressive form of non-Hodgkin's lymphoma (NHL) with a
U.S. prevalence of 10,000 patients. The approval marks the first indication
for VELCADE in NHL, the most common blood cancer.
In January 2007, the Company and Ortho Biotech Inc. launched their two-
year U.S. co-promotion efforts, announced in October 2006, to jointly
promote VELCADE for its approved indications. This arrangement is expected
to increase the share of voice around the promotional and educational
effort for VELCADE by leveraging the Ortho Biotech oncology sales force,
which is one of the largest in the industry. Millennium will continue to be
responsible for commercialization, manufacturing and distribution of
VELCADE in the U.S.
VELCADE Clinical Update
In January 2007, the Intergroupe Francophone du Myelome (IFM)
cooperative group completed the enrollment of 480 patients in the Phase III
trial evaluating VELCADE in combination with dexamethasone compared to the
vincristine, adriamycin and dexamethasone (VAD) triplet, a commonly used
therapy, as induction therapy prior to stem cell transplantation in newly
diagnosed multiple myeloma patients. The trial conducted by the IFM is part
of a comprehensive Phase III program evaluating VELCADE in the treatment of
newly diagnosed multiple myeloma patients in the transplant and
non-transplant settings.
In December 2006, VELCADE was added to the updated National
Comprehensive Cancer Network treatment protocol for newly diagnosed
multiple myeloma patients. These practice guidelines are a benchmark for
clinical policy in the oncology community.
At the 48th Annual Meeting of the American Society of Hematology (ASH)
in December 2006, VELCADE was featured in over 150 abstracts, demonstrating
significant and continued interest in the product by the hematology
oncology community. The data further underscored the unparalleled strength
of VELCADE as a single agent and demonstrated the product's power in
combination with other agents with a well-characterized and predictable
safety profile.
- In relapsed multiple myeloma, VELCADE based combinations showed high
response rates and improvement in time to disease progression.
- Results from a randomized Phase III trial announced by Johnson &
Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) showed
a statistically significant improvement in median time to progression
(p < 0.0001) in patients receiving VELCADE in combination with
DOXIL(R) (pegylated liposomal doxorubicin) compared to in patients
receiving VELCADE alone. Ortho Biotech Products, L.P. announced on
January 22, 2007 that the FDA accepted an application for priority
review of DOXIL as combination therapy with VELCADE to treat patients
with multiple myeloma who have received at least one prior therapy.
- Results of Phase I and Phase II trials showed overall response rates
as high as 93 percent and complete and near-complete response rates as
high as 43 percent, some of the highest known response rates in this
treatment setting.
- In front-line multiple myeloma, VELCADE based combinations showed
improvement in pre- and post-transplant outcomes.
- Jean-Luc Harousseau, M.D., of Hospital Hotel-Dieu, Nantes, France
presented preliminary data from the Phase III IFM trial showing that
the VELCADE and dexamethasone combination achieved a complete and
near-complete response rate of 20 percent, a greater than two-fold
improvement over the complete and near-complete response rate produced
by VAD. The preliminary investigator-assessed data also showed that
the higher complete and near-complete response rate achieved by the
VELCADE and dexamethasone combination potentially translated to
improved post-transplant outcomes for patients.
- Results of Phase II studies showed overall response rates as high as
89 percent and very good partial response and complete response rates
as high as 53 percent. This very good partial response and complete
response rate improved to 79 percent following stem cell transplant.
- As retreatment, VELCADE produced high response rates. VELCADE either as
a single agent or in combination showed overall response rates (complete
and partial responses) as high as 60 percent among patients who had an
initial response to VELCADE treatment.
- In the relapsed NHL setting, VELCADE based combinations demonstrated
high response rates. Results showed overall response rates as high as 75
percent across four subtypes of the disease (follicular, marginal zone,
mantle cell lymphoma and T-cell lymphoma). These data include positive
results from the Phase II study of VELCADE in combination with rituximab
in follicular and marginal zone lymphoma which served as the basis for
the Company-sponsored Phase III registration-enabling trial of once-
weekly VELCADE plus rituximab versus rituximab alone.
- Side effects observed in each of the VELCADE studies outlined above were
similar to those seen in previous studies with VELCADE.
Pipeline Update
- MLN0415 - In January 2007, the Company initiated a Phase I multiple
ascending dose trial of MLN0415, an oral, highly selective, small
molecule inhibitor of IKKbeta which targets a key inflammatory pathway.
- MLN0518 - In the fourth quarter of 2006, the National Cancer Institute
(NCI) initiated Phase I/II trials of MLN0518, a RTK FLT-3, PDGF
inhibitor, in prostate and renal cancers.
- MLN3897 - Also in the fourth quarter of 2006, the Company initiated a
randomized, double-blind, placebo-controlled Phase II study of MLN3897
in patients with rheumatoid arthritis (RA). MLN3897 is an oral small
molecule designed to block CCR1, a chemokine receptor believed to play a
role in a number of inflammatory disorders. The multicenter study will
assess the efficacy, safety and tolerability of MLN3897 in combination
with methotrexate, a standard therapy for RA.
2007 Guidance and Strategic Goals
The Company provided its strategic goals and guidance for 2007 on
January 4, 2007.
2007 Financial Guidance
- 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)
- Cash, cash equivalents and marketable securities greater than $800
million on December 31, 2007
2007 Strategic Goals
The Company outlined 2007 goals focused on three key strategic drivers
of the business: VELCADE, the development pipeline and strategic business
relationships.
- VELCADE
- Grow VELCADE and execute effectively on the U.S. co-promotion
arrangement 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
- Prioritize the next set of indications in hematological and solid
tumors with development timelines
- Development Pipeline
- MLN0002 - Initiate bridging studies and prepare for the 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 - Millennium will continue to evaluate
strategic in-licensing, acquisition and partnering opportunities. The
Company will also explore out-licensing and collaborations for pipeline
assets, where appropriate.
Presentation Reminder
Dr. Dunsire and Ms. Fanucci will present additional detail on these
financial results on February 8, 2007, at the Merrill Lynch 2007 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
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 75
countries worldwide. VELCADE also is approved in the European Union after
first relapse.
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.
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.
(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 February 8, 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
previous periods 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.
Millennium Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
Prepared According to Generally Accepted Accounting Principles (GAAP)
(unaudited)
Three Months Ended Year Ended
December 31, December 31,
2006 2005 2006 2005
(in thousands, except per share
amounts)
Revenues:
Net product sales $55,132 $52,444 $220,452 $192,073
Co-promotion revenue - - - 123,524
Revenue under strategic
alliances 48,685 44,151 131,675 204,519
Royalties 36,321 25,678 134,703 38,192
Total revenues 140,138 122,273 486,830 558,308
Costs and expenses:
Cost of sales 8,785 21,046 45,445 141,327
Research and development
(Note 1) 82,827 88,459 318,170 342,184
Selling, general and
administrative (Note 1) 48,412 36,279 155,633 180,599
Restructuring 14,656 14,213 20,393 77,110
Amortization of intangibles 8,488 8,487 33,950 33,987
Total costs and expenses 163,168 168,484 573,591 775,207
Loss from operations (23,030) (46,211) (86,761) (216,899)
Other income (expense):
Investment income, net 14,936 5,002 30,973 29,083
Interest expense (3,134) (2,710) (11,068) (10,433)
Other income (Note 2) 19,500 - 22,903 -
Total other income 31,302 2,292 42,808 18,650
Net income/(loss) $8,272 $(43,919) $(43,953) $(198,249)
Amounts per common share:
Net income/(loss) per share, basic
and diluted $0.03 $(0.14) $(0.14) $(0.64)
Weighted average shares, basic 315,481 310,096 313,724 308,284
Weighted average shares, diluted 318,468 310,096 313,724 308,284
Note 1: As of January 1, 2006, the Company adopted SFAS 123R under the
modified prospective method, which requires the Company to record stock-
based compensation expense based upon fair value in the Company's
statements of operations. Stock-based compensation expense relates to
stock options, the Company's employee stock purchase plan and restricted
stock. No stock-based compensation expense was recognized under SFAS 123R
in any prior period presented. Stock-based compensation expense is
allocated between research and development and selling, general and
administrative expense lines as follows:
Three Months Ended Year Ended
December 31, December 31,
2006 2005 2006 2005
Research and development $5,345 $- $23,280 $-
Selling, general and
administrative 4,570 - 18,861 -
$9,915 $- $42,141 $-
Note 2: 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.
Millennium Pharmaceuticals, Inc.
Reconciliation of Non-GAAP to GAAP (Note 1)
(unaudited)
Three Months
Ended December Three Months Ended
31, 2005 December 31, 2006
Stock-
based
Non-GAAP Compen- Restruc-
(Note 2) Non-GAAP sation turing
(in thousands, except per share
amounts)
Revenues:
Net product sales $52,444 $55,132 $- $-
Co-promotion revenue - - - -
Revenue under strategic
alliances 44,151 48,685 - -
Royalties 25,678 36,321 - -
Total revenues 122,273 140,138 - -
Costs and expenses:
Cost of sales 21,046 8,785 - -
Research and development 88,459 77,482 5,345 -
Selling, general and
administrative 36,279 38,304 4,570 -
Restructuring - - - 14,656
Amortization of intangibles - - - -
Total costs and expenses 145,784 124,571 9,915 14,656
(Loss)/income from operations (23,511) 15,567 (9,915) (14,656)
Other income (expense):
Investment income, net 5,002 14,936 - -
Interest expense (2,710) (3,134) - -
Other income - - - -
Total other income 2,292 11,802 - -
Net (loss)/income $(21,219) $27,369 $(9,915) $(14,656)
Amounts per common share:
Net (loss)/income per share, basic
and diluted $(0.07) $0.09 $(0.03) $(0.04)
Weighted average shares, basic 310,096 315,481 315,481 315,481
Weighted average shares, diluted 310,096 318,468 315,481 315,481
Millennium Pharmaceuticals, Inc.
Reconciliation of Non-GAAP to GAAP (Note 1)
(unaudited)
Three Months Ended December 31, 2006
Termination fee,
Amorti- net of trans-
zation of action costs
Intangibles (Note 3) GAAP
(in thousands, except per share
amounts)
Revenues:
Net product sales $- $- $55,132
Co-promotion revenue - - -
Revenue under strategic alliances - - 48,685
Royalties - - 36,321
Total revenues - - 140,138
Costs and expenses:
Cost of sales - - 8,785
Research and development - - 82,827
Selling, general and administrative - 5,538 48,412
Restructuring - - 14,656
Amortization of intangibles 8,488 - 8,488
Total costs and expenses 8,488 5,538 163,168
(Loss)/income from operations (8,488) (5,538) (23,030)
Other income (expense):
Investment income, net - - 14,936
Interest expense - - (3,134)
Other income - 19,500 19,500
Total other income - 19,500 31,302
Net (loss)/income $(8,488) $13,962 $8,272
Amounts per common share:
Net (loss)/income per share, basic
and diluted $(0.03) $0.04 $0.03
Weighted average shares, basic 315,481 315,481 315,481
Weighted average shares, diluted 315,481 318,468 318,468
Note 1: Stock-based compensation, amortization of intangibles,
restructuring charges and termination fee, net of transaction costs are
included in the appropriate financial statement category to arrive at GAAP
reported net (loss)/income for the periods presented.
Note 2: Excludes restructuring charges of $14,213 and amortization of
intangibles of $8,487 for the three months ended December 31, 2005.
Note 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.
Millennium Pharmaceuticals, Inc.
Reconciliation of Non-GAAP to GAAP (Note 1)
(unaudited)
Year Ended
December 31, Year Ended
2005 December 31, 2006
Stock-
based
Non-GAAP Compen- Restruc-
(Note 2) Non-GAAP sation turing
(in thousands, except per share
amounts)
Revenues:
Net product sales $192,073 $220,452 $- $-
Co-promotion revenue (Note 4) 123,524 - - -
Revenue under strategic alliances 204,519 131,675 - -
Royalties 38,192 134,703 - -
Total revenues 558,308 486,830 - -
Costs and expenses:
Cost of sales 141,327 45,445 - -
Research and development 342,184 294,890 23,280 -
Selling, general and
administrative 180,599 131,234 18,861 -
Restructuring - - - 20,393
Amortization of intangibles - - - -
Total costs and expenses 664,110 471,569 42,141 20,393
(Loss)/income from operations (105,802) 15,261 (42,141) (20,393)
Other income (expense):
Investment income, net 29,083 30,973 - -
Interest expense (10,433) (11,068) - -
Other income - 3,403 - -
Total other income 18,650 23,308 - -
Net (loss)/income $(87,152) $38,569 $(42,141) $(20,393)
Amounts per common share:
Net (loss)/income per share, basic
and diluted $(0.28) $0.12 $(0.13) $(0.06)
Weighted average shares, basic 308,284 313,724 313,724 313,724
Weighted average shares, diluted 308,284 315,626 313,724 313,724
Millennium Pharmaceuticals, Inc.
Reconciliation of Non-GAAP to GAAP (Note 1)
(unaudited)
Year Ended December 31, 2006
Termination fee,
Amorti- net of trans-
zation of action costs
Intangibles (Note 3) GAAP
(in thousands, except per share
amounts)
Revenues:
Net product sales $- $- $220,452
Co-promotion revenue (Note 4) - - -
Revenue under strategic alliances - - 131,675
Royalties - - 134,703
Total revenues - - 486,830
Costs and expenses:
Cost of sales - - 45,445
Research and development - - 318,170
Selling, general and administrative - 5,538 155,633
Restructuring - - 20,393
Amortization of intangibles 33,950 - 33,950
Total costs and expenses 33,950 5,538 573,591
(Loss)/income from operations (33,950) (5,538) (86,761)
Other income (expense):
Investment income, net - - 30,973
Interest expense - - (11,068)
Other income - 19,500 22,903
Total other income - 19,500 42,808
Net (loss)/income $(33,950) $13,962 $(43,953)
Amounts per common share:
Net (loss)/income per share, basic
and diluted $(0.11) $0.04 $(0.14)
Weighted average shares, basic 313,724 313,724 313,724
Weighted average shares, diluted 313,724 315,626 313,724
Note 1: Stock-based compensation, amortization of intangibles,
restructuring charges and termination fee, net of transaction costs are
included in the appropriate financial statement category to arrive at GAAP
reported net (loss)/income for the periods presented.
Note 2: Excludes restructuring charges of $77,110 and amortization of
intangibles of $33,987 for the year ended December 31, 2005.
Note 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.
Note 4: Beginning September 1, 2005, in connection with the closing of the
Company's transaction with Schering-Plough for INTEGRILIN, the Company no
longer reports co-promotion revenue and began reporting royalty revenue as
a separate line item.
Condensed Consolidated Balance Sheets
(unaudited)
December 31, December 31,
2006 2005
(in thousands)
Cash, cash equivalents and marketable
securities $894,349 $645,588
Other current assets 121,305 95,508
Property and equipment, net 153,349 183,059
Restricted cash and other assets 35,500 25,202
Goodwill and intangible assets, net 1,547,309 1,578,275
Total assets $2,751,812 $2,527,632
Other current liabilities $125,948 $158,705
Current portion of long term debt 99,571 5,890
Other long term liabilities 56,075 85,562
Capital lease obligations, net of
current portion 75,041 76,226
Long term debt, net of current portion 250,000 99,571
Stockholders' equity 2,145,177 2,101,678
Total liabilities and
stockholders' equity $2,751,812 $2,527,632
Contacts:
Kyle Kuvalanka (investors) Lisa Adler (media)
(617) 761-4734 (617) 444-3285
Editors' Note: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com.
SOURCE Millennium Pharmaceuticals, Inc.
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Related links:
http://www.millennium.com
Photo Notes: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, Lisa Adler, +1-617-444-3285, both of Millennium
Pharmaceuticals, Inc.
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