Health & Fitness
Health and Fitness
Health and Fitness
Thu, February 19, 2009
Wed, February 18, 2009 The Medicines Company: The Medicines Company Reports Full Year and Fourth Quarter 2008 Financial Results
PARSIPPANY, NJ--(Marketwire - February 18, 2009) - The Medicines Company (
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 (
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
