PARSIPPANY, NJ--(Marketwire - February 18, 2009) - The Medicines Company (NASDAQ: MDCO) today announced its financial results for the full year and fourth quarter of 2008.
Financial highlights for the full year of 2008:
-- Net revenue increased by 35% to $348.2 million for 2008 from $257.5
million for 2007.
- Angiomax® (bivalirudin) U.S. net revenue increased by 31% to
$334.2 million for 2008 from $255.0 million for 2007.
- Angiomax/Angiox ex-U.S. net revenue in 2008 increased by 444% to
$13.6 million compared to $2.5 million in 2007.
- Cleviprex® (clevidipine butyrate) net revenue for 2008 was $0.4
million. Cleviprex was launched in the U.S. on September 15, 2008.
Initial gross orders from the sole source distributor totaled $10.0
million and were recorded as deferred revenue.
-- Net loss for 2008, primarily related to the Curacyte Discovery
acquisition in the third quarter of 2008, was $8.5 million, or $0.16
per share, compared to net loss of $18.3 million, or $0.35 per share,
for 2007 primarily due to the Nycomed transaction in the third quarter
of 2007.
-- Non-GAAP net income for 2008 was $37.2 million, or $0.72 per share,
compared to non-GAAP net income of $25.2 million, or $0.49 per share,
for 2007. Non-GAAP net income excludes the Curacyte Discovery
acquisition, the non-recurring Nycomed transaction charges, stock-based
compensation expense and non-cash income taxes.
Clive Meanwell, Chief Executive Officer, stated, "2008 was another important year of building a global organization with a substantial portfolio of hospital critical care products. Strong revenue growth year on year continues to provide cash flow for us to invest in our future and we believe we are poised for further sustainable growth."
Summary of 2008 Accomplishments
-- Angiomax U.S. top-line growth of 31%
-- Angiomax/Angiox ex-U.S. top-line growth of 444%; completed transition
of distribution of all European countries previously serviced by Nycomed
-- Publication of HORIZONS AMI 30-day results and presentation of one-
year data follow-up
-- Approval of Angiox ACS indication in Europe
-- Cleviprex approval and launch in the United States
-- Initial ex-US Cleviprex regulatory filings
-- Enrollment of approximately 5,300 patients in cangrelor Phase 3
program
-- Completed the acquisition of Curacyte Discovery
-- Continued global expansion
John Kelley, President and Chief Operating Officer, stated, "Our operating results in 2008 once again demonstrate the dedication and excellence of our associates as they serve the needs of critical care providers and their patients. We look forward to more progress in 2009 as we continue to build our global organization."
Financial highlights for the fourth quarter of 2008:
-- Net revenue increased by 30% to $93.9 million for the fourth quarter of
2008 from $72.3 million for the same period in 2007.
- Angiomax U.S. net revenue increased by 21% to $87.9 million for the
fourth quarter of 2008 from $72.8 million for the fourth quarter of
2007.
- Angiomax/Angiox ex-U.S. net revenue in the fourth quarter of 2008
increased $6.1 million to $5.6 million compared to ($0.5 million)
in the fourth quarter 2007.
- Cleviprex net revenue for the fourth quarter of 2008 was $0.4
million.
-- Net loss for the fourth quarter of 2008, was $4.2 million, or $0.08 per
share, compared to net income of $1.5 million, or $0.03 per share for
the fourth quarter of 2007.
-- Non-GAAP net income for the fourth quarter of 2008 was $1.8 million, or
$0.03 per share, compared to non-GAAP net income of $5.6 million, or
$0.11 per share, for the fourth quarter of 2007. Non-GAAP net income
excludes stock-based compensation expense and non-cash income taxes.
The following table provides reconciliations between GAAP and non-GAAP net (loss) income for the full year (FY) and fourth quarter (Q4) of 2008 and 2007. Non-GAAP net income excludes the Curacyte Discovery acquisition, non-recurring Nycomed transaction charges, stock-based compensation expense and the non-cash provision (benefit) for income taxes:
Non-Cash
Provision
Reported FAS 123R (Benefit)
GAAP Net Curacyte Stock-Based for Non-GAAP
(in (Loss) Discovery Nycomed Compensation Income Net
millions) Income Acquisition Transaction Expense Taxes Income (1)
-------- ---------- ---------- ---------- ---------- ----------
FY 2008 $ (8.5) $ 13.2 - $ 22.8 $ 9.7 $ 37.2
-------- ---------- ---------- ---------- ---------- ----------
FY 2007 $ (18.3) - $ 28.1 $ 15.4 - $ 25.2
-------- ---------- ---------- ---------- ---------- ----------
Q4 2008 $ (4.2) - - $ 5.4 $ 0.6 $ 1.8
-------- ---------- ---------- ---------- ---------- ----------
Q4 2007 $ 1.5 - - $ 4.1 - $ 5.6
-------- ---------- ---------- ---------- ---------- ----------
Note: Amounts may not sum due to rounding.
(1) Excluding the Curacyte Discovery acquisition costs, non-recurring
Nycomed transaction charges, stock-based compensation expense and the
non-cash provision (benefit) for income taxes.
Reconciliations between GAAP and non-GAAP fully diluted (loss) earnings per share (EPS) for the full year (FY) and fourth quarter (Q4) of 2008 and 2007 are provided in the following table:
Non-Cash
Provision
FAS 123R (Benefit)
Reported Curacyte Stock-Based for
GAAP Discovery Nycomed Compensation Income Non-GAAP
(per share) EPS Acquisition Transaction Expense Taxes EPS (1)
-------- ---------- ---------- ---------- ---------- ----------
FY 2008 $ (0.16) $ 0.25 - $ 0.44 $ 0.19 $ 0.72
-------- ---------- ---------- ---------- ---------- ----------
FY 2007 $ (0.35) - $ 0.54 $ 0.30 - $ 0.49
-------- ---------- ---------- ---------- ---------- ----------
Q4 2008 $ (0.08) - - $ 0.10 $ 0.01 $ 0.03
-------- ---------- ---------- ---------- ---------- ----------
Q4 2007 $ 0.03 - - $ 0.08 - $ 0.11
-------- ---------- ---------- ---------- ---------- ----------
Note: Amounts may not sum due to rounding.
(1) Excluding the Curacyte Discovery acquisition costs, non-recurring
Nycomed transaction charges, stock-based compensation expense and the
non-cash provision (benefit) for income taxes.
The Company believes that presenting the non-GAAP information contained in the financial tables and in this press release assists investors and others in gaining a better understanding of the Company's core operating results and future prospects, expected growth rates or forecasted guidance, particularly as related to the Curacyte Discovery acquisition costs, non-recurring Nycomed transaction charges, stock-based compensation expense and non-cash income taxes. Management uses this non-GAAP information, in addition to the GAAP information, as the basis for measuring the Company's core operating performance and comparing such performance to that of prior periods and to the performance of its competitors. Such measures are also used by management in its financial and operating decision-making. Non-GAAP information is not meant to be considered superior to or a substitute for the Company's results of operations prepared in accordance with GAAP. A reconciliation of GAAP results with non-GAAP results may also be found in the attached financial tables.
2009 Guidance (in millions, except percentages and per share data)
Targanta
Acquisition
2009 Guidance Impact (2)
--------------- ---------------
Net Sales
US Angiomax $ 395-$ 405
International Angiox $ 30-$ 40
US Cleviprex $ 10-$ 19
Total $ 435-$ 464
Cost of Revenue 28%
R&D (GAAP) $ 79-$ 84 $ 15-$ 20 (3)
--------------- ---------------
(w/o 123R) $ 75-$ 80
--------------- ---------------
SG&A (GAAP) $ 186-$ 193 $ 10-$ 12 (3)
--------------- ---------------
(w/o 123R) $ 170-$ 175
--------------- ---------------
Stock Based Comp -123R (1) $ 20-$ 22
Investment Income $ 3-$ 5
Effective Tax Rate 45%-50%
Net Income (loss) - GAAP $ 26-$ 31 (4)
--------------- ---------------
- Non GAAP $ 66-$ 78 (4)
--------------- ---------------
EPS - GAAP $ 0.47-$ 0.57 (4)
--------------- ---------------
EPS - Non GAAP $ 1.22-$ 1.44 (4)
--------------- ---------------
(1) Note that GAAP reporting of R&D and SG&A include stock based
compensation expense
(2) Amounts contingent upon Targanta close in first quarter of 2009
presented on January 13, 2009 MDCO conference call
(3) $10 million to $12 million in infrastructure costs including
employees, one time transaction costs plus an additional $15 million
to $20 million costs for a Phase 3 trial for oritavancin
(4) Impact of Targanta acquisition to GAAP and non-GAAP net income and
earnings per share will be provided subsequent to the close and
completion of the valuation
There will be a conference call with management today at 8:30 a.m. Eastern Time to discuss full year and fourth quarter 2008 financial results, operational developments, guidance and outlook for 2009. The conference call will be available via phone and webcast. The webcast can be accessed at The Medicines Company website at www.themedicinescompany.com.
The dial in information is listed below:
Domestic dial in: 800-901-5226 International dial in: 617-786-4513 Passcode for both dial in numbers: 24685928
Replay is available from 11:30 a.m. Eastern Time following the conference call through March 4, 2009. To hear a replay of the call dial 888-286-8010 (domestic) and 617-801-6888 (international). Passcode for both dial in numbers is 28543782.
MDCO-G
About The Medicines Company: The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, and Cleviprex® (clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Company also has an investigational antiplatelet agent, cangrelor, in late-stage development and a serine protease inhibitor, CU-2010, in early-stage development. The Company's website is www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company that are not purely historical, 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" and "expects" and similar expressions, including our 2009 guidance, 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, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, risks associated with the establishment of international operations, 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 November 10, 2008, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
Consolidated Statements of Operations
(unaudited)
(in thousands, except per share data) Year to Date December 31,
2008 2007
Net revenue $ 348,157 $ 257,534
Operating expenses:
Cost of revenue 88,355 66,502
Research and development 105,720 77,255
Selling, general and administrative 164,903 141,807
------------ ------------
Total operating expenses 358,978 285,564
------------ ------------
Loss from operations (10,821) (28,030)
Other income 5,235 10,653
------------ ------------
Loss before income taxes (5,586) (17,377)
Provision for income taxes (2,918) (895)
------------ ------------
Net loss $ (8,504) $ (18,272)
============ ============
Basic loss per common share $ (0.16) $ (0.35)
============ ============
Shares used in computing basic loss per common
share 51,904 51,624
============ ============
Diluted loss per common share $ (0.16) $ (0.35)
============ ============
Shares used in computing diluted loss per
common share 51,904 51,624
============ ============
The Medicines Company
Consolidated Statements of Operations
(unaudited)
Three Months Ended
(in thousands, except per share data) December 31,
2008 2007
Net revenue $ 93,873 $ 72,297
Operating expenses:
Cost of revenue 25,234 17,471
Research and development 23,202 23,307
Selling, general and administrative 47,900 32,350
------------ ------------
Total operating expenses 96,336 73,128
------------ ------------
Loss from operations (2,463) (831)
Other (loss) income (22) 2,688
------------ ------------
(Loss) income before income taxes (2,485) 1,857
Provision for income taxes (1,713) (350)
------------ ------------
Net (loss) income $ (4,198) $ 1,507
============ ============
Basic (loss) income per common share $ (0.08) $ 0.03
============ ============
Shares used in computing basic (loss) income
per common share 52,089 51,706
============ ============
Diluted (loss) income per common share $ (0.08) $ 0.03
============ ============
Shares used in computing diluted (loss) income
per common share 52,089 52,182
============ ============
The Medicines Company
Condensed Consolidated Balance Sheets
(unaudited)
December 31, December 31,
(in thousands) 2008 2007
------------- -------------
ASSETS
Cash, cash equivalents and available for sales
securities $ 216,206 $ 222,113
Accrued interest receivable 1,336 1,598
Accounts receivable, net 33,657 25,584
Inventory 28,229 35,468
Prepaid expenses and other current assets 16,402 7,425
------------- -------------
Total current assets 295,830 292,188
------------- -------------
Fixed assets, net 27,331 3,245
Intangible assets, net 16,349 14,929
Restricted cash 5,000 5,000
Deferred tax assets 37,657 46,018
Other assets 5,237 136
------------- -------------
Total assets $ 387,404 $ 361,516
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities $ 89,379 $ 83,620
Stockholders' equity 298,025 277,896
------------- -------------
Total liabilities and stockholders' equity $ 387,404 $ 361,516
============= =============
The Medicines Company
Reconciliation of GAAP to non-GAAP Measures
(Amounts in thousands, except per share data)
(Unaudited)
Year to Date December 31,
-----------------------------------------------------
2008
-----------------------------------------------------
GAAP Non-GAAP
Reported Curacyte SFAS 123R Non-Cash Adjusted
(1) (2) (3) Taxes (4) (5)
--------- --------- --------- ---------- ---------
Net revenue $ 348,157 $ - $ - $ - $ 348,157
Operating expenses:
Cost of revenue 88,355 - (803) - 87,552
Research and
development 105,720 (21,373) (3,750) - 80,597
Selling, general
and
administrative 164,903 - (18,245) - 146,658
--------- --------- --------- ---------- ---------
Total
operating
expenses 358,978 (21,373) (22,798) - 314,807
(Loss) income from
operations (10,821) 21,373 22,798 - 33,350
Other income 5,235 - - - 5,235
--------- --------- --------- ---------- ---------
(Loss) income before
income taxes (5,586) 21,373 22,798 - 38,585
(Provision)
benefit for
income taxes (2,918) (8,154) - 9,674 (1,398)
--------- --------- --------- ---------- ---------
Net (loss) income (8,504) 13,219 22,798 9,674 37,187
========= ========= ========= ========== =========
Basic and diluted
(loss) earnings
per common share $ (0.16) $ 0.25 $ 0.44 $ 0.19 $ 0.72
========= ========= ========= ========== =========
Shares used in
computing basic
and diluted (loss)
earnings per common
share 51,904 51,904 51,904 51,904 51,904
========= ========= ========= ========== =========
(1) GAAP results
(2) Curacyte Discovery acquisition costs
(3) Non-cash stock compensation expense
(4) Non-cash tax provision
(5) Non-GAAP results
The Medicines Company
Reconciliation of GAAP to non-GAAP Measures
(Amounts in thousands, except per share data)
(Unaudited)
Three Months Ended December 31,
-----------------------------------------------------
2008
-----------------------------------------------------
GAAP Non-GAAP
Reported Curacyte SFAS 123R Non-Cash Adjusted
(1) (2) (3) Taxes (4) (5)
--------- ---------- --------- ---------- ---------
Net revenue $ 93,873 $ - $ - $ - $ 93,873
Operating expenses:
Cost of revenue 25,234 - (226) - 25,008
Research and
development 23,202 - (883) - 22,319
Selling, general
and
administrative 47,900 - (4,315) - 43,585
--------- ---------- --------- ---------- ---------
Total
operating
expenses 96,336 - (5,424) - 90,912
(Loss) income from
operations (2,463) - 5,424 - 2,961
Other (loss)
income (22) - - - (22)
--------- ---------- --------- ---------- ---------
(Loss) income before
income taxes (2,485) - 5,424 - 2,939
(Provision)
benefit for
income taxes (1,713) - - 573 (1,140)
--------- ---------- --------- ---------- ---------
Net (loss) income (4,198) - 5,424 573 1,799
========= ========== ========= ========== =========
Basic and diluted
(loss) earnings
per common share $ (0.08) $ - $ 0.10 $ 0.01 $ 0.03
========= ========== ========= ========== =========
Shares used in
computing basic
and diluted (loss)
earnings per common
share 52,089 52,089 52,089 52,089 52,089
========= ========== ========= ========== =========
(1) GAAP results
(2) Curacyte Discovery acquisition costs
(3) Non-cash stock compensation expense
(4) Non-cash tax provision
(5) Non-GAAP results
