Exhibit 99.1
| | |
| Contact: | | Michael Mitchell
The Medicines Company
973-290-6000
investor.relations@themedco.com |
FOR U.S. AUDIENCES ONLY
FOR IMMEDIATE RELEASE:
THE MEDICINES COMPANY REPORTS FULL YEAR AND FOURTH QUARTER 2009 FINANCIAL RESULTS
Revenue growth driven by Angiomax® (bivalirudin) market share gains
Product portfolio expanded from existing cash flow
PARSIPPANY, NJ, February 17, 2010— The Medicines Company (NASDAQ: MDCO) today announced its financial results for the full year and the fourth quarter of 2009.
Financial highlights for the full year of 2009:
| • | | Net revenue increased by $56 million or 16.1% to $404.2 million for 2009 from $348.2 million in 2008. |
| | • | | Angiomax U.S. sales increased by 14.6% to $382.9 million in 2009 compared to $334.2 million in 2008. |
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| | • | | Angiomax/Angiox international net revenue in 2009 increased by 34.6% to $18.3 million compared to $13.6 million in 2008. |
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| | • | | Cleviprex® (clevidipine butyrate) has now been accepted by more than 425 hospital formularies and has been purchased by 454 hospitals in the United States. Net revenue in the first full commercial year of 2009 was $3.0 million. |
| • | | Net loss for 2009 was ($76.2) million, or ($1.46) per share, compared to a net loss of ($8.5) million, or ($0.16) per share, for 2008. This loss was driven mainly by four items totaling $90.5 million: 1) the Company’s decision to fully reserve against its deferred tax assets ($48.1 million), 2) the acquisition of ApoA-1 Milano asset ($17.5 million), 3) milestone payments, license payments, and other costs, for three products (totaling $21.3 million), and 4) charges related to the Cleviprex recall ($3.6 million). |
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| • | | Non-GAAP net loss for 2009 was ($4.8 million), or ($0.09) per share, compared to non-GAAP net income of $37.2 million, or $0.72 per share for 2008. Non-GAAP net income excludes costs associated with the Targanta acquisition, stock-based compensation expense and non-cash income taxes. |
Clive Meanwell, Chairman and Chief Executive Officer, stated, “In 2009 we added oritavancin, argatroban and ApoA-1 Milano to create a sector-leading portfolio in intensive and critical care that is diversified by stage and indication. These assets were financed by existing cash flow. In addition, we were able to grow Angiomax/Angiox market share and revenues in a hospital PCI market that was significantly depressed by the global economic crisis.”
Financial highlights for the fourth quarter of 2009:
| • | | Net revenue increased by 8.7% to $102.1 million for the fourth quarter of 2009 from $ 93.9 million in the fourth quarter of 2008. |
| | • | | Angiomax U.S. sales increased by 9.6% to $96.3 million in the fourth quarter of 2009 compared to $87.9 million in the fourth quarter of 2008. |
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| | • | | Angiomax/Angiox international net revenue in the fourth quarter of 2009 decreased by 7.1% to $5.2 million compared to $5.6 million in the fourth quarter of 2008. |
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| | • | | Cleviprex U.S. sales in the fourth quarter of 2009 amounted to $0.6 million. |
| • | | Net loss for the fourth quarter of 2009 was ($73.5) million, or ($1.40) per share, compared to a net loss of ($4.2) million, or ($0.08) per share, for the fourth quarter of 2008. This loss was driven mainly by four items totaling $79.0 million: 1) the Company’s decision to fully reserve against its deferred tax assets ($43.6 million), 2) the acquisition of ApoA-1 Milano asset ($17.5 million), 3) milestone payments, license payments, and other costs for three products (totaling $14.3 million), and 4) charges related to the Cleviprex recall ($3.6 million). |
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| • | | Non-GAAP net loss for the fourth quarter of 2009 was ($25.6 million), or ($0.49) per share, compared to non-GAAP net income of $1.8 million, or $0.03 per share for the fourth quarter of 2008. Non-GAAP net income excludes costs associated with the Targanta acquisition, 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 2009 and 2008. Non-GAAP net income excludes the transaction charges related to the Targanta and Curacyte acquisitions, stock-based compensation expense and non-cash income taxes:
| | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | Non-cash | | |
| | | | | | | | | | | | | | | FAS 123R | | Provision | | |
| | | Reported | | Targanta | | Curacyte | | Stock-Based | | (Benefit) for | | Non-GAAP |
| | | GAAP Net | | Acquisition | | Acquisition | | Compensation | | Income | | Net (Loss) |
| (in millions) | | (Loss) Income | | Costs | | Costs | | Expense | | Taxes | | Income (1) |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| FY 2009 | | | ($76.2 | ) | | $ | 4.3 | | | | — | | | $ | 19.4 | | | $ | 47.7 | | | | ($4.8 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| FY 2008 | | | ($8.5 | ) | | | — | | | $ | 13.2 | | | $ | 22.8 | | | $ | 9.7 | | | $ | 37.2 | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Q4 2009 | | | ($73.5 | ) | | | — | | | | — | | | $ | 4.1 | | | $ | 43.8 | | | | ($25.6 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Q4 2008 | | | ($4.2 | ) | | | — | | | | — | | | $ | 5.4 | | | $ | 0.6 | | | $ | 1.8 | |
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| | | Note: Amounts may not sum due to rounding. |
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| (1) | | Excluding the Targanta acquisition costs, Curacyte Discovery acquistion costs, stock-based compensation expense and the non-cash provision (benefit) for income taxes. |
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Reconciliations between GAAP and non-GAAP fully diluted (loss) earnings per share (EPS) for the full year (FY) and fourth quarter (Q4) of 2009 and 2008 are provided in the following table:
| | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | Non-cash | | |
| | | | | | | | | | | | | | | FAS 123R | �� | Provision | | |
| | | Reported | | Targanta | | Curacyte | | Stock-Based | | (Benefit) for | | |
| | | GAAP | | Acquisition | | Acquisition | | Compensation | | Income | | Non-GAAP |
| (per share) | | EPS | | Costs | | Costs | | Expense | | Taxes | | EPS (1) |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| FY 2009 | | | ($1.46 | ) | | $ | 0.08 | | | | — | | | $ | 0.37 | | | $ | 0.91 | | | | ($0.09 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| FY 2008 | | | ($0.16 | ) | | | — | | | $ | 0.25 | | | $ | 0.44 | | | $ | 0.19 | | | $ | 0.72 | |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Q4 2009 | | | ($1.40 | ) | | | — | | | | — | | | $ | 0.08 | | | $ | 0.84 | | | | ($0.49 | ) |
| | | | | | | | | | | | | | | | | | | | | | | | | |
| Q4 2008 | | | ($0.08 | ) | | | — | | | | — | | | $ | 0.10 | | | $ | 0.01 | | | $ | 0.03 | |
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| Note: Amounts may not sum due to rounding. |
| |
| (1) | | Excluding the Targanta acquisition costs, Curacyte Discovery acquistion costs, 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 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.
There will be a conference call with management today at 8:30 a.m. Eastern Time to discuss full year and fourth quarter 2009 financial results and operational developments.
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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:
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| Domestic Dial In: | | 800.599.9829 |
| International Dial In: | | 617.847.8703 |
| Passcode for both dial in numbers: | | 95981334 |
Replay is available from 11:30 a.m. Eastern Time following the conference call through February 24, 2010. To hear a replay of the call dial 888-286-8010 (domestic) and 617-801-6888 (international). Passcode for both dial in numbers is 99158077.
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’s website iswww.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 the Company’s preliminary revenue results, 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 ability to develop its global operations and penetrate foreign markets, 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 9, 2009, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
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The Medicines Company
Condensed Consolidated Statements of Operations
(unaudited)
| | | | | | | | | |
| (in thousands, except per share data) | | Three months ended December 31, | |
| | | 2009 | | | 2008 | |
| | | | | | | | | |
| Net revenue | | $ | 102,060 | | | $ | 93,873 | |
| | | | | | | | | |
| Operating expenses: | | | | | | | | |
| Cost of revenue | | | 31,190 | | | | 25,234 | |
| Research and development | | | 48,925 | | | | 23,202 | |
| Selling, general and administrative | | | 46,969 | | | | 47,900 | |
| | | | | | | |
| Total operating expenses | | | 127,084 | | | | 96,336 | |
| | | | | | | |
| | | | | | | | | |
| Income (loss) from operations | | | (25,024 | ) | | | (2,463 | ) |
| | | | | | | | | |
| Other income (loss) | | | (4,873 | ) | | | (22 | ) |
| | | | | | | |
| | | | | | | | | |
| Income (loss) before income taxes | | | (29,897 | ) | | | (2,485 | ) |
| Provision for income taxes | | | (43,597 | ) | | | (1,713 | ) |
| | | | | | | |
| | | | | | | | | |
| Net income (loss) | | $ | (73,494 | ) | | $ | (4,198 | ) |
| | | | | | | |
| | | | | | | | | |
| Basic earnings (loss) per common share | | $ | (1.40 | ) | | $ | (0.08 | ) |
| | | | | | | |
| Shares used in computing basic earnings (loss) per common share | | | 52,395 | | | | 52,089 | |
| | | | | | | |
| | | | | | | | | |
| Diluted earnings (loss) per common share | | $ | (1.40 | ) | | $ | (0.08 | ) |
| | | | | | | |
| Shares used in computing diluted earnings (loss) per common share | | | 52,395 | | | | 52,089 | |
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The Medicines Company
Condensed Consolidated Statements of Operations
(unaudited)
| | | | | | | | | |
| (in thousands, except per share data) | | Year to Date December 31, | |
| | | 2009 | | | 2008 | |
| Net revenue | | $ | 404,241 | | | $ | 348,157 | |
| Operating expenses: | | | | | | | | |
| Cost of revenue | | | 118,148 | | | | 88,355 | |
| Research and development | | | 117,610 | | | | 105,720 | |
| Selling, general and administrative | | | 193,832 | | | | 164,903 | |
| | | | | | | |
| Total operating expenses | | | 429,590 | | | | 358,978 | |
| | | | | | | |
| Income (loss) from operations | | | (25,349 | ) | | | (10,821 | ) |
| | | | | | | | | |
| Other income (loss) | | | (2,818 | ) | | | 5,235 | |
| | | | | | | |
| Income (loss) before income taxes | | | (28,167 | ) | | | (5,586 | ) |
| Provision for income taxes | | | (48,062 | ) | | | (2,918 | ) |
| | | | | | | |
| Net income (loss) | | $ | (76,229 | ) | | $ | (8,504 | ) |
| | | | | | | | | |
| Basic earnings (loss) per common share | | $ | (1.46 | ) | | $ | (0.16 | ) |
| | | | | | | |
| Shares used in computing basic earnings (loss) per common share | | | 52,269 | | | | 51,904 | |
| | | | | | | |
| | | | | | | | | |
| Diluted earnings (loss) per common share | | $ | (1.46 | ) | | $ | (0.16 | ) |
| | | | | | | |
| Shares used in computing diluted earnings (loss) per common share | | | 52,269 | | | | 51,904 | |
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The Medicines Company
Condensed Consolidated Balance Sheets
| | | | | | | | | |
| | | December 31, | | | December 31, | |
| (in thousands) | | 2009 | | | 2008 | |
| | | | | | | | | |
ASSETS | | | | | | | | |
| Cash, cash equivalents and available for sales securities | | $ | 176,191 | | | $ | 216,206 | |
| Accrued interest receivable | | | 922 | | | | 1,336 | |
| Accounts receivable, net | | | 29,789 | | | | 33,657 | |
| Inventory | | | 25,836 | | | | 28,229 | |
| Prepaid expenses and other current assets | | | 9,984 | | | | 16,402 | |
| | | | | | | |
| Total current assets | | | 242,722 | | | | 295,830 | |
| | | | | | | |
| | | | | | | | | |
| Fixed assets, net | | | 25,072 | | | | 27,331 | |
| Intangible assets, net | | | 15,178 | | | | 16,349 | |
| Restricted cash | | | 7,049 | | | | 5,000 | |
| Deferred tax assets | | | — | | | | 37,657 | |
| In Process Research & Development | | | 69,500 | | | | — | |
| Goodwill | | | 14,934 | | | | — | |
| Other assets | | | 321 | | | | 5,237 | |
| | | | | | | |
| Total assets | | $ | 374,776 | | | $ | 387,404 | |
| | | | | | | |
| | | | | | | | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | | | |
| Current liabilities | | $ | 86,619 | | | $ | 83,608 | |
| Contingent purchase price | | | 23,667 | | | | — | |
| Other Long Term Liabilities | | | 24,101 | | | | 5,771 | |
| Stockholders’ equity | | | 240,389 | | | | 298,025 | |
| | | | | | | |
| Total liabilities and stockholders’ equity | | $ | 374,776 | | | $ | 387,404 | |
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The Medicines Company
Reconciliation of GAAP to non-GAAP Measures
(All amounts in thousands, except per share amounts)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | |
| | | Three Months Ended December 31, | |
| | | 2009 | |
| | | | | | | Targanta | | | | | | | Non-cash | | | Non-GAAP (5) | |
| | | GAAP(1) | | | Acquisition | | | SFAS 123R | | | Tax Provision | | | As Adjusted | |
| Net revenue | | $ | 102,060 | | | $ | — | | | $ | — | | | $ | — | | | $ | 102,060 | |
| | | | | | | | | | | | | | | | | | | | | |
| Operating expenses: | | | | | | | | | | | | | | | | | | | | |
| Cost of revenue | | | 31,190 | | | | — | | | | (187 | )(3) | | | — | | | | 31,003 | |
| Research and development | | | 48,925 | | | | | | | | (672 | )(3) | | | — | | | | 48,253 | |
| Selling, general and administrative | | | 46,969 | | | | — | (2) | | | (3,250 | )(3) | | | — | | | | 43,719 | |
| | | | | | | | | | | | | | | | |
| Total operating expenses | | | 127,084 | | | | — | | | | (4,109 | ) | | | — | | | | 122,975 | |
| | | | | | | | | | | | | | | | | | | | | |
| (Loss) income from operations | | | (25,024 | ) | | | — | | | | 4,109 | | | | — | | | | (20,915 | ) |
| | | | | | | | | | | | | | | | | | | | | |
| Other (loss)/income | | | (4,873 | ) | | | — | | | | — | | | | — | | | | (4,873 | ) |
| | | | | | | | | | | | | | | | |
| (Loss) income before income taxes | | | (29,897 | ) | | | — | | | | 4,109 | | | | — | | | | (25,788 | ) |
| Benefit (Provision) for income taxes | | | (43,597 | ) | | | — | (2) | | | — | | | | 43,764 | (4) | | | 167 | |
| | | | | | | | | | | | | | | | |
| Net (loss) income | | | (73,494 | ) | | | — | | | | 4,109 | | | | 43,764 | | | | (25,621 | ) |
| | | | | | | | | | | | | | | | | | | | | |
| Basic (loss) earnings per common share | | $ | (1.40 | ) | | $ | — | | | $ | 0.08 | | | $ | 0.84 | | | $ | (0.49 | ) |
| | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | |
| Shares used in computing basic earnings (loss) per common share | | | 52,395 | | | | 52,395 | | | | 52,395 | | | | 52,395 | | | | 52,395 | |
| | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | |
| Diluted (loss) earnings per common share | | $ | (1.40 | ) | | $ | — | | | $ | 0.08 | | | $ | 0.84 | | | $ | (0.49 | ) |
| | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | |
| Shares used in computing diluted (loss) earnings per common share | | | 52,395 | | | | 52,395 | | | | 52,395 | | | | 52,395 | | | | 52,395 | |
| | | | | | | | | | | | | | | | |
| | |
| (1) | | GAAP Results |
| |
| (2) | | Targanta Acquisition |
| |
| (3) | | Non-cash stock compensation expense |
| |
| (4) | | Non-cash income taxes |
| |
| (5) | | Non-GAAP Results |
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The Medicines Company
Reconciliation of GAAP to non-GAAP Measures
(All amounts in thousands, except per share amounts)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | |
| | | Twelve Months Ended December 31, | |
| | | 2009 | |
| | | GAAP (1) | | | Targanta | | | | | | | Non-cash | | | Non-GAAP (5) | |
| | | As Reported | | | Acquisition | | | SFAS 123R | | | Tax Provision | | | As Adjusted | |
| Net revenue | | $ | 404,241 | | | $ | — | | | $ | — | | | $ | — | | | $ | 404,241 | |
| | | | | | | | | | | | | | | | | | | | | |
| Costs and expenses: | | | | | | | | | | | | | | | | | | | | |
| Cost of revenue | | | 118,148 | | | | — | | | | (884 | )(3) | | | — | | | | 117,264 | |
| Research and development | | | 117,610 | | | | | | | | (3,438 | )(3) | | | — | | | | 114,172 | |
| Selling, general and administrative | | | 193,832 | | | | (4,281 | )(2) | | | (15,115 | )(3) | | | — | | | | 174,436 | |
| | | | | | | | | | | | | | | | |
| Total operating expenses | | | 429,590 | | | | (4,281 | ) | | | (19,437 | ) | | | — | | | | 405,872 | |
| | | | | | | | | | | | | | | | | | | | | |
| Income (loss) from operations | | | (25,349 | ) | | | 4,281 | | | | 19,437 | | | | — | | | | (1,631 | ) |
| | | | | | | | | | | | | | | | | | | | | |
| Other (loss)/income | | | (2,818 | ) | | | — | | | | — | | | | — | | | | (2,818 | ) |
| | | | | | | | | | | | | | | | |
| Income before income taxes | | | (28,167 | ) | | | 4,281 | | | | 19,437 | | | | — | | | | (4,449 | ) |
| (Provision) benefit for income taxes | | | (48,062 | ) | | | | (2) | | | — | | | | 47,736 | (4) | | | (326 | ) |
| | | | | | | | | | | | | | | | | |
| Net income (loss) | | | (76,229 | ) | | | 4,281 | | | | 19,437 | | | | 47,736 | | | | (4,775 | ) |
| | | | | | | | | | | | | | | | | | | | | |
| Basic (loss) earnings per common share | | $ | (1.46 | ) | | $ | 0.08 | | | $ | 0.37 | | | $ | 0.91 | | | $ | (0.09 | ) |
| | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | |
| Shares used in computing basic earnings (loss) per common share | | | 52,269 | | | | 52,269 | | | | 52,269 | | | | 52,269 | | | | 52,269 | |
| | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | |
| Diluted earnings per common share | | $ | (1.46 | ) | | $ | 0.08 | | | $ | 0.37 | | | $ | 0.91 | | | $ | (0.09 | ) |
| | | | | | | | | | | | | | | | |
| Shares used in computing diluted earnings (loss) per common share | | | 52,269 | | | | 52,269 | | | | 52,269 | | | | 52,269 | | | | 52,269 | |
| | | | | | | | | | | | | | | | |
| | |
| (1) | | GAAP Results |
| |
| (2) | | Targanta Acquisition |
| |
| (3) | | Non-cash stock compensation expense |
| |
| (4) | | Non-cash income taxes |
| |
| (5) | | Non-GAAP Results |
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