PARSIPPANY, NJ--(Marketwire - April 29, 2009) - The Medicines Company (NASDAQ: MDCO) today announced its financial results for the first quarter of 2009.
Financial highlights for the first quarter of 2009:
-- Net revenue increased by 25% to $99.2 million for the first quarter of 2009 from $79.4 million for the first quarter of 2008. -- Including one-time transaction costs of $4.0 million related to the Targanta Therapeutics Corporation ("Targanta") acquisition, net loss for the first quarter of 2009, was $3.3 million, or $0.06 per share, compared to net income of $4.9 million, or $0.09 per share, for the first quarter of 2008. -- Non-GAAP net income for the first quarter of 2009 was $3.5 million, or $0.07 per share, compared to non-GAAP net income of $12.4 million, or $0.24 per share, for the first quarter of 2008. Non-GAAP net income excludes the transaction costs associated with the Targanta acquisition, stock-based compensation expense and non-cash income taxes.
Clive Meanwell, Chief Executive Officer, stated, "We continue to invest aggressively in the acquisition of new products such as oritavancin, and in the development of our global capabilities as evidenced by our European expansion. These investments will help us deliver sustainable growth far into the future."
Operating highlights for the first quarter of 2009:
-- Achieved 24% growth in Angiomax demand versus first quarter of 2008; market share in STEMI patients at an all time high of 22% -- Exceeded 170 cumulative formulary wins for Cleviprex; now growing at a rate of approximately 1 per day; submitted Cleviprex Marketing Authorization Application in Europe -- Deployed fully staffed teams of medical science, sales and marketing associates in the United Kingdom, France, and Scandinavia -- Continued to enroll patients in the Phase 3 cangrelor trials; projected to complete planned enrollment over the summer -- Completed the acquisition and integration of Targanta
John Kelley, President and Chief Operating Officer, stated, "Angiomax continues to grow in both volume and market share and we are making progress with Angiox in Europe. The Cleviprex launch is progressing, winning formularies, and beginning to see pull through from customers. This is a solid start to 2009 and we are on track to achieve our 2009 top line guidance."
The following table provides reconciliations between GAAP and non-GAAP net (loss) income for the first quarter (Q1) of 2009 and 2008. Non-GAAP net income excludes the transaction charges related to the Targanta acquisition, stock-based compensation expense and non-cash income taxes:
Non-Cash Reported FAS 123R (Benefit) GAAP Net Targanta Stock-Based Provision Non-GAAP (in (Loss) Transaction Compensation for Income Net millions) Income Costs Expense Taxes Income (1) ----------- ------------ ------------ ----------- ------------ Q1 2009 $ (3.3) $ 4.0 $ 5.5 $ (2.6) $ 3.5 ----------- ------------ ------------ ----------- ------------ Q1 2008 $ 4.9 - $ 4.6 $ 3.0 $ 12.4 ----------- ------------ ------------ ----------- ------------ Note: Amounts may not sum due to rounding. (1) Excluding the transaction charges related to the Targanta acquisition, stock-based compensation expense and non-cash income taxes.
Reconciliations between GAAP and non-GAAP fully diluted (loss) earnings per share (EPS) for the first quarter (Q1) of 2009 and 2008 are provided in the following table:
Reported GAAP (Loss) FAS 123R Non-Cash Earnings Targanta Stock-Based Provision Per Transaction Compensation for Income Non-GAAP (per share) Share Costs Expense Taxes EPS (1) ----------- ------------ ------------ ----------- ------------ Q1 2009 $ (0.06) $ 0.08 $ 0.10 $ (0.05) $ 0.07 ----------- ------------ ------------ ----------- ------------ Q1 2008 $ 0.09 - $ 0.09 $ 0.06 $ 0.24 ----------- ------------ ------------ ----------- ------------ Note: Amounts may not sum due to rounding. (1) Excluding the transaction charges related to the Targanta acquisition, stock-based compensation expense and non-cash 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 transaction charges associated with the Targanta acquisition, 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)
Following the completion of the Targanta acquisition, The Medicines Company is reissuing guidance as follows:
February 18, 2009 April 28, 2009 -------------------------------- -------------- Guidance Targanta Guidance Acquisition Including Impact Targanta --------------- --------------- --------------- Net Sales US Angiomax $ 395 - $ 405 International Angiox $ 30 - $ 40 US Cleviprex $ 10 - $ 19 Total Net Sales $ 435 - $ 464 Cost of Revenue 28% R&D (GAAP) $ 79 - $ 84 $ 15 - $ 20 $ 97 - $ 102 --------------- --------------- --------------- (w/o 123R) $ 75 - $ 80 $ 93 - $ 98 --------------- --------------- --------------- SG&A (GAAP) $ 186 - $ 193 $ 10 - $ 12 $ 194 - $ 201 --------------- --------------- --------------- (w/o 123R) $ 170 - $ 175 $ 178 - $ 183 --------------- --------------- --------------- Stock Based Comp - 123R (1) $ 20 - $ 22 Investment Income $ 3 - $ 5 Effective Tax Rate 45% - 50% Net Income (loss) - GAAP $ 26 - $ 31 $ 13 - $ 18 --------------- --------------- --------------- - Non GAAP $ 66 - $ 78 $ 47 - $ 59 --------------- --------------- --------------- EPS - GAAP $ 0.47 - $ 0.57 $ 0.24 - $ 0.34 --------------- --------------- --------------- EPS - Non GAAP $ 1.22 - $ 1.44 $ 0.88 - $ 1.10 --------------- --------------- --------------- (1) Note that GAAP reporting of R&D and SG&A include stock based compensation expense
There will be a conference call with management today at 8:30 a.m. Eastern Time to discuss first quarter 2009 financial results and operational developments. 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: 800-706-7745 International Dial In: 617-614-3472 Passcode for both dial in numbers: 34239136
Replay is available from 11:30 a.m. Eastern Time following the conference call through May 13, 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 33236910.
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. Through the acquisition of Targanta, The Medicines Company's pipeline also includes oritavancin, a semi-synthetic lipoglycopeptide antibiotic currently awaiting EU regulatory approval. The Medicines 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 Annual Report on Form 10-K filed on March 2, 2009, 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) Three Months Ended (in thousands, except per share data) March 31, 2009 2008 Net revenue $ 99,217 $ 79,427 Operating expenses: Cost of revenue 28,297 19,092 Research and development 24,436 18,663 Selling, general and administrative 53,595 35,350 --------- --------- Total operating expenses 106,328 73,105 --------- --------- (Loss) income from operations (7,111) 6,322 Other income 1,170 2,381 --------- --------- (Loss) income before income taxes (5,941) 8,703 Benefit (provision) for income taxes 2,593 (3,850) --------- --------- Net (loss) income $ (3,348) $ 4,853 ========= ========= Basic (loss) income per common share $ (0.06) $ 0.09 ========= ========= Shares used in computing basic (loss) income per common share 52,141 51,749 ========= ========= Diluted (loss) income per common share $ (0.06) $ 0.09 ========= ========= Shares used in computing diluted (loss) income per common share 52,141 52,274 ========= ========= The Medicines Company Condensed Consolidated Balance Sheets (unaudited) March 31, December 31, (in thousands) 2009 2008 ------------ ------------ ASSETS Cash, cash equivalents and available for sales securities $ 164,312 $ 216,206 Accrued interest receivable 1,241 1,336 Accounts receivable, net 34,976 33,657 Inventory 24,225 28,229 Prepaid expenses and other current assets 16,423 16,402 ------------ ------------ Total current assets 241,177 295,830 ------------ ------------ Fixed assets, net 27,537 27,331 Intangible assets, net 16,056 16,349 In-process research and development 67,200 -- Goodwill 27,154 -- Restricted cash 8,004 5,000 Deferred tax assets 12,428 37,657 Other assets 5,328 5,237 ------------ ------------ Total assets $ 404,884 $ 387,404 ============ ============ LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities $ 77,214 $ 83,608 Contingent purchase price 22,000 -- Other long-term liabilities 5,627 5,771 Stockholders' equity 300,043 298,025 ------------ ------------ Total liabilities and stockholders' equity $ 404,884 $ 387,404 ============ ============ The Medicines Company Reconciliation of GAAP to non-GAAP Measures (Amounts in thousands, except per share data) (Unaudited) Three Months Ended March 31, ---------------------------------------------------------- 2009 ---------------------------------------------------------- GAAP Targanta Non-GAAP Reported Transaction SFAS 123R Non-Cash Adjusted (1) Costs (2) (3) Taxes (4) (5) ---------- ----------- ----------- ---------- ----------- Net revenue $ 99,217 $ - $ - $ - $ 99,217 Operating expenses: Cost of revenue 28,297 - (221) - 28,076 Research and development 24,436 - (986) - 23,450 Selling, general and admini- strative 53,595 (3,995) (4,254) - 45,346 ---------- ----------- ----------- ---------- ----------- Total operating expenses 106,328 (3,995) (5,461) - 96,872 (Loss) income from operations (7,111) 3,995 5,461 - 2,345 Other income 1,170 - - - 1,170 ---------- ----------- ----------- ---------- ----------- (Loss) income before income taxes (5,941) 3,995 5,461 - 3,515 (Provision) benefit for income taxes 2,593 - - (2,633) (40) ---------- ----------- ----------- ---------- ----------- Net (loss) income (3,348) 3,995 5,461 (2,633) 3,475 ========== =========== =========== ========== =========== Basic (loss) earnings per common share $ (0.06) $ 0.08 $ 0.10 $ (0.05) $ 0.07 ========== =========== =========== ========== =========== Shares used in computing basic (loss) earnings per common share 52,141 52,141 52,141 52,141 52,141 ========== =========== =========== ========== =========== Diluted (loss) earnings per common share $ (0.06) $ 0.08 $ 0.10 $ (0.05) $ 0.07 ========== =========== =========== ========== =========== Shares used in computing diluted (loss) earnings per common share 52,141 52,496 52,496 52,496 52,496 ========== =========== =========== ========== =========== (1) GAAP results (2) Transaction charges associated with the Targanta acquisition (3) Non-cash stock compensation expense (4) Non-cash tax benefit (5) Non-GAAP results