Exhibit 99.1
The Medicines Company Reports Third Quarter Financial Results;
Third Quarter Net Revenue of $37.7 Million -
up 77% Compared to 2003 Period
PARSIPPANY, N.J.--(BUSINESS WIRE)--Oct. 19, 2004--
Third Quarter Earnings of $5.3 Million; Company Raises Guidance Again
for 2004; Phase III Programs Expected to Deliver Results in 2004 and
Early 2005
The Medicines Company (Nasdaq: MDCO) today announced its financial
results for the third quarter and first nine months of 2004.
Financial highlights include:
-- Year-on-year revenue growth exceeds 75%. Net revenue of $37.7
million for the third quarter 2004, compared to $21.2 million
for the third quarter 2003; for the first nine months of 2004,
net revenue was $103.4 million, compared to $56.7 million for
the first nine months of 2003.
-- Sustained and growing earnings.
-- Net income of $5.3 million for the third quarter 2004,
compared to a net loss of $6.2 million for the third
quarter 2003; for the first nine months of 2004, net
income was $12.3 million, compared to a net loss of $19.2
million for the first nine months of 2003.
-- Net income per share of $0.11 (diluted) for the third
quarter 2004, compared to a net loss per share of $0.13
for the third quarter 2003; for the first nine months of
2004, net income per share was $0.25 (diluted), compared
to a net loss per share of $0.43 for the first nine months
of 2003.
Clive Meanwell, Chairman, President and Chief Executive Officer of
The Medicines Company stated, "Strong Angiomax(R) sales in the summer,
which has historically been the lowest volume period in our market,
drove our continued growth. We are increasing our 2004 revenue
guidance to an anticipated $139-141 million, from $134-139 million. We
are also revising our earnings guidance, from $12-19 million to $15-19
million."
Operational developments in the third quarter include:
-- European approval - the Company received marketing
authorization for European sales of Angiomax(R) (bivalirudin)
(under the tradename Angiox(TM)) for use as an anticoagulant
in patients undergoing percutaneous coronary interventions. We
anticipate launch in European countries during the fourth
quarter. The Medicines Company recorded European pipeline
stocking sales in the third quarter 2004.
-- Important new published data on Angiomax(R) - JAMA publication
of 1-year data from the REPLACE-2 clinical trial. The paper
reported long-term efficacy of Angiomax in patients undergoing
coronary angioplasty with stenting and included analyses
suggesting lower mortality in high risk patients treated with
Angiomax than among high risk patients treated with heparin
plus GP IIb/IIIa inhibitors.
-- Springboard for 4th quarter sales - a major presence at the
Transcatheter Cardiovascular Therapeutics meeting in
Washington during October.
-- Progress with three Phase III clinical programs - continued
recruitment of patients for trials of Angiomax in coronary
artery bypass surgery (EVOLUTION, CHOOSE), Angiomax in acute
coronary syndromes (ACUITY) and Clevelox(TM) in coronary
surgery (ESCAPE).
-- Progress with Cangrelor - manufacturing progress and
significant steps in clinical trial protocol planning.
-- New organizational structure - creation of fully integrated
business units in (1) Interventional and Emergency Medicines
and (2) Surgery Therapeutics to continue our concentrated and
customer-oriented stance.
Brent Furse, Vice President and General Manager of the
Interventional and Emergency Medicines business unit, said, "Release
of the 1-year REPLACE-2 data in JAMA and our experiences at TCT -
where we had our strongest presence to date - strengthened our belief
in the substantial growth potential of Angiomax in the cath lab in
coronary angioplasty. We are delivering intensive development,
marketing and sales programs in the cath lab and look forward to
strong 4th quarter and 2005 results."
Bob Weiland, Vice President and General Manager of the Surgery
Therapeutics business unit, said, "We have made excellent progress
with our surgery Phase III programs for both Clevelox and Angiomax. We
are approaching the point of release of Phase III data - we expect
that some data will be ready as soon as the 4th quarter 2004 - and we
are planning NDA submissions and pre-launch activities for 2005."
There will be a conference call with management today at 5:00 P.M.
to discuss 2004 financial and operations results, as well as guidance.
To listen live, webcast login is available at
http://www.themedicinescompany.com. Alternatively, the call dial-in is
800-472-8325 (request The Medicines Company call). From outside U.S.:
dial 1-706-679-0816. Replay available for two weeks following call:
1-800-642-1687. Replay outside the U.S.: 1-706-645-9291. Replay
passcode: 1527805.
The Medicines Company meets the demands of the world's most
advanced medical practitioners by developing products that improve
acute hospital care. The Company markets Angiomax(R) (bivalirudin), an
anticoagulant approved in the U.S. and other countries for use in
patients undergoing percutaneous transluminal coronary angioplasty
(PTCA) procedures. The Medicines Company creates value using its range
of clinical and commercial skills to develop products acquired from
leading life science innovators.
Statements contained in this press release about The Medicines
Company, the Company's projected revenues and financial results,
Angiomax, the timing of clinical trial results, and all other
statements that are not purely historical, may be deemed to be
forward-looking statements for purposes of the safe harbor provisions
under The Private Securities Litigation Reform Act of 1995. Without
limiting the foregoing, the words "believes", "anticipates", "plans",
"expects", "intends", "potential", "estimates" and similar expressions
are intended to identify forward-looking statements. These
forward-looking statements involve known and unknown risks and
uncertainties that may cause the Company's actual results, levels of
activity, performance or achievements to be materially different from
those expressed or implied by these forward-looking statements.
Important factors that may cause or contribute to such differences
include the extent of the commercial success of Angiomax, the
Company's dependence on third-party distributors for sales of Angiomax
or Angiox in foreign countries, physicians' acceptance of Angiomax
clinical trial results, such as the results referred to above, whether
the Company will be able to obtain regulatory approval for additional
indications of Angiomax, whether the Company's products will receive
approvals from regulatory agencies, including pricing and
reimbursement approvals in certain European countries, whether the
Company's products will advance in the clinical trials process,
whether the clinical trial results will warrant submission of
applications for regulatory approval, and such other factors as are
set forth in the risk factors detailed from time to time in the
Company's periodic reports and registration statements filed with the
Securities and Exchange Commission including, without limitation, the
risk factors detailed in the Company's Quarterly Report on Form 10-Q
filed on August 6, 2004, which are incorporated herein by reference.
The Company specifically disclaims any obligation to update these
forward-looking statements.
The Medicines Company
Condensed Consolidated Statements of Operations
Three months ended September 30,
--------------------------------
(in thousands, except per share data) (unaudited)
--------------------------------
2004 2003
-------- --------
Net revenue $37,715 $21,248
Operating expenses:
Cost of revenue 9,148 6,602
Research and development 12,332 9,383
Selling, general and administrative 11,353 11,835
-------- --------
Total operating expenses 32,833 27,820
-------- --------
Income/(loss) from operations 4,882 (6,572)
Other income 516 410
-------- --------
Income/(loss) before income taxes 5,398 (6,162)
Provision for income taxes (137) -
-------- --------
Net income/(loss) $5,261 $(6,162)
======== ========
Basic earnings/(loss) per common share $0.11 $(0.13)
======== ========
Shares used in computing basic
earnings/(loss) per common share 47,885 47,130
======== ========
Diluted earnings/(loss) per common
share $0.11 $(0.13)
======== ========
Shares used in computing diluted
earnings/(loss) per common share 49,666 47,130
======== ========
The Medicines Company
Condensed Consolidated Statements of Operations
Nine months ended September 30,
--------------------------------
(in thousands, except per share data) (unaudited)
--------------------------------
2004 2003
-------- --------
Net revenue $103,386 $56,703
Operating expenses:
Cost of revenue 20,329 19,835
Research and development 34,183 24,836
Selling, general and administrative 37,599 32,191
-------- --------
Total operating expenses 92,111 76,862
-------- --------
Income/(loss) from operations 11,275 (20,159)
Other income 1,475 994
-------- --------
Income/(loss) before income taxes 12,750 (19,165)
Provision for income taxes (418) -
-------- --------
Net income/(loss) $12,332 $(19,165)
======== ========
Basic earnings/(loss) per common share $0.26 $(0.43)
======== ========
Shares used in computing basic
earnings/(loss) per common share 47,715 45,036
======== ========
Diluted earnings/(loss) per common
share $0.25 $(0.43)
======== ========
Shares used in computing diluted
earnings/(loss) per common share 49,697 45,036
======== ========
The Medicines Company
Condensed Consolidated Balance Sheets
(Unaudited)
September 30, December 31,
(in thousands) 2004 2003
------------- ------------
ASSETS
Cash, cash equivalents, available for sales
securities $136,929 $135,864
Accrued interest receivable 673 991
Accounts receivable, net 29,068 15,660
Inventories 20,356 11,460
Prepaid expenses and other current assets 1,539 976
--------- ---------
Total current assets 188,565 164,951
--------- ---------
Fixed assets, net 1,537 1,511
Other assets 160 200
--------- ---------
Total assets $190,262 $166,662
========= =========
LIABILITIES AND STOCKHOLDER'S EQUITY
Current liabilities $27,271 $25,227
Deferred revenue 3,612 1,270
Stockholders' equity 159,379 140,165
--------- ---------
Total liabilities and stockholders'
equity $190,262 $166,662
========= =========
CONTACT: The Medicines Company
Michael Mitchell, 973-656-1616
investor.relations@themedco.com