Exhibit 99.1
Contact: | Robyn Brown Vice President, Investor Relations The Medicines Company 973-290-6000 investor.relations@themedco.com |
FOR IMMEDIATE RELEASE:
THE MEDICINES COMPANY REPORTS THIRD QUARTER 2009
FINANCIAL RESULTS
FINANCIAL RESULTS
Total sales in third quarter up 12%, year to date up 19%, despite economic
pressures on U.S. hospitals and reduced PCI volume
pressures on U.S. hospitals and reduced PCI volume
PARSIPPANY, NJ, October 28, 2009— The Medicines Company (NASDAQ: MDCO) today announced its financial results for the third quarter of 2009.
Financial highlights for the third quarter of 2009:
• | Net revenue increased by 12% to $98.8 million for the third quarter of 2009 from $88.1 million for the third quarter of 2008. |
o | Angiomax U.S. sales increased by 9% to $92.2 million in the third quarter of 2009 compared to $85.0 million in the third quarter of 2008. | ||
o | Angiomax/Angiox international net revenue in the third quarter of 2009 increased by 74% to $5.5 million compared to $3.1 million in the third quarter of 2008. | ||
o | Cleviprex has now been accepted by more than 345 hospital formularies and has been purchased by more than 400 hospitals in the United States. Net revenue in the third quarter of 2009 was $1.1 million, up from $0.9 million in the second quarter. |
• | Net loss for the third quarter of 2009 was ($3.2) million, or ($0.06) per share, compared to a net loss of ($13.2) million, or ($0.25) per share, for the third quarter of 2008. |
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973)290-6000 Fax: (973)656-9898
IRCC-PPR-066-01
• | Non-GAAP net income for the third quarter of 2009 was $5.1 million, or $0.10 per share, compared to non-GAAP net income of $8.5 million, or $0.16 per share, for the third quarter of 2008. Non-GAAP net income excludes the transaction costs associated with the Targanta and Curacyte acquisitions, stock-based compensation expense and non-cash income taxes. |
Clive Meanwell, Chairman and Chief Executive Officer, stated, “This was a challenging quarter in terms of market dynamics. We estimate that inpatient PCI volume declined 9% year on year, including a dramatic 17 % reduction in elective PCIs, set against a 4% increase in emergent or urgent procedures. Despite this, we grew U.S. Angiomax volume and year on year, net sales worldwide are up 19%. Angiox and Cleviprex are beginning to make meaningful contributions to our top line. Our development programs are making progress.”
Recent operational highlights:
• | HORIZONS-AMI one-year trial results were published in The Lancet. The trial showed that Angiomax reduced cardiac-related death by 43 percent (p=0.005), improved overall survival by 27 percent (p=0.037) and reduced major bleeding complications by 39 percent (p<0.0001) compared with heparin plus a GP IIb/IIIa inhibitor. Angiomax showed an absolute reduction of 1.7 percent in cardiac-related death and 1.3 percent in all-cause death at one year. | ||
• | The United States Patent and Trademark Office issued 2 new patents relating to a more consistent and improved Angiomax drug product, which were listed in the U.S. Food and Drug Administration’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is commonly known as the Orange Book, for Angiomax. | ||
• | The Company entered into a license agreement with Eagle Pharmaceuticals, Inc. under which The Medicines Company will have rights in the United States and Canada to an innovative, ready-to-use formulation of Argatroban, which is currently under review by the U.S. Food and Drug Administration (FDA). |
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973)290-6000 Fax: (973)656-9898
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• | The Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion applicable to all Member States of the European Union/European Economic Area that will extend the use of Angiox to include patients with heart attacks (so-called ST segment elevation myocardial infarction (STEMI)) undergoing emergency heart procedures called primary percutaneous coronary intervention (PCI). |
Financial highlights for the first nine months of 2009:
• | Net revenue increased by 19% to $302.2 million for the first nine months of 2009 from $254.3 million for the same period in 2008. |
o | Angiomax U.S. sales increased by 16% to $286.6 million for the first nine months of 2009 from $246.3 million for the first nine months of 2008. | ||
o | Angiomax/Angiox international net revenue in the first nine months of 2009 increased by 64% to $13.1 million compared to $8.0 million in the first nine months of 2008. | ||
o | Cleviprex net revenue in the first nine months of 2009 was $2.5 million. |
• | Net loss for the first nine months of 2009 was ($2.7) million, or ($0.05) per share, and includes costs for the Targanta acquisition, compared to net loss of ($4.3) million, or ($0.08) per share, in the first nine months of 2008. | ||
• | The Company reported non-GAAP net income of $20.9 million, or $0.40 per share, for the first nine months of 2009, compared to non-GAAP net income of $35.4 million, or $0.68 per share, for the first nine months of 2008. Non-GAAP net income excludes the Targanta and Curacyte acquisitions, stock-based compensation expense and non-cash income taxes. |
The following table provides reconciliations between GAAP and non-GAAP net (loss) income for the third quarter (Q3) and first nine months (9M) of 2009 and 2008. Non-GAAP net income excludes the transaction charges related to the
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973)290-6000 Fax: (973)656-9898
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Targanta and Curacyte acquisitions, stock-based compensation expense and non-cash income taxes:
Non-Cash | ||||||||||||||||||||||||
Reported | FAS 123R | (Benefit) | ||||||||||||||||||||||
GAAP Net | Targanta | Curacyte | Stock-Based | Provision | ||||||||||||||||||||
(Loss) | Transaction | Acquisition | Compensation | for Income | Non-GAAP | |||||||||||||||||||
(in millions) | Income | Costs | Costs | Expense | Taxes | Net Income1 | ||||||||||||||||||
Q3 2009 | ($3.2 | ) | — | — | $ | 4.4 | $ | 3.8 | $ | 5.1 | ||||||||||||||
Q3 2008 | ($13.2 | ) | — | $ | 13.2 | $ | 6.0 | $ | 2.5 | $ | 8.5 | |||||||||||||
9M 2009 | ($2.7 | ) | $ | 4.3 | — | $ | 15.3 | $ | 4.0 | $ | 20.9 | |||||||||||||
9M 2008 | ($4.3 | ) | — | $ | 13.2 | $ | 17.4 | $ | 9.1 | $ | 35.4 |
Note: Amounts may not sum due to rounding. |
1 | Excluding the transaction charges related to the Targanta and Curacyte acquisitions, stock-based compensation expense and non-cash income taxes. |
Reconciliations between GAAP and non-GAAP fully diluted (loss) earnings per share (EPS) for the third quarter (Q3) and first nine months (9M) of 2009 and 2008 are provided in the following table:
Reported | Non-Cash | |||||||||||||||||||||||
GAAP | FAS 123R | (Benefit) | ||||||||||||||||||||||
(Loss) | Targanta | Curacyte | Stock-Based | Provision | ||||||||||||||||||||
Earnings | Transaction | Acquisition | Compensation | for Income | Non-GAAP | |||||||||||||||||||
(in millions) | Per Share | Costs | Costs | Expense | Taxes | EPS1 | ||||||||||||||||||
Q3 2009 | ($0.06 | ) | — | — | $ | 0.09 | $ | 0.07 | $ | 0.10 | ||||||||||||||
Q3 2008 | ($0.25 | ) | — | $ | 0.25 | $ | 0.11 | $ | 0.05 | $ | 0.16 | |||||||||||||
9M 2009 | ($0.05 | ) | $ | 0.08 | — | $ | 0.29 | $ | 0.08 | $ | 0.40 | |||||||||||||
9M 2008 | ($0.08 | ) | — | $ | 0.25 | $ | 0.34 | $ | 0.18 | $ | 0.68 |
Note: Amounts may not sum due to rounding. |
1 | Excluding the transaction charges related to the Targanta and Curacyte acquisitions, 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
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973)290-6000 Fax: (973)656-9898
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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)
The Medicines Company is changing guidance for fiscal year 2009 as follows:
July 29, 2009 | October 28, 2009 | |||||||||||
April 28, 2009 | Guidance | Guidance | ||||||||||
Guidance | Changes(1) | Changes(1) | ||||||||||
Net Sales | ||||||||||||
US Angiomax | $ | 395-$405 | ||||||||||
International Angiox | $ | 30-$40 | ||||||||||
Total Angiomax / Angiox | $ | 425-$445 | $ | 425-$445 | ||||||||
US Cleviprex | $ | 10-$19 | $ | 5-$10 | ||||||||
Total Net Sales | $ | 435-$464 | $ | 430-$455 | $ | 395-$405 | (3) | |||||
Cost of Revenue | 28 | % | ||||||||||
R&D (GAAP) | $ | 97-$102 | $ | 102-$105 | ||||||||
(w/o 123R) | $ | 93-$98 | $ | 98-$101 | ||||||||
SG&A (GAAP) | $ | 194-$201 | ||||||||||
(w/o 123R) | $ | 178-$183 | ||||||||||
Stock Based Comp -123R(2) | $ | 20-$22 | $ | 19-$20 | ||||||||
Investment Income | $ | 3-$5 | $ | 2-$4 | ||||||||
Effective Tax Rate | 45%-50 | % | 15%-25 | %(4) | ||||||||
Net Income (loss) — GAAP | $ | 13-$18 | ($13)-($10 | ) | ||||||||
— Non GAAP | $ | 47-$59 | $ | 8-$13 | ||||||||
EPS — GAAP | $ | 0.24-$0.34 | ($0.25)-($0.19 | ) | ||||||||
EPS — Non GAAP | $ | 0.88-$1.10 | $ | 0.14-$0.24 |
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973)290-6000 Fax: (973)656-9898
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(1) | Where no changes are indicated, previous guidance is reiterated. | |
(2) | Note that GAAP reporting of R&D and SG&A include stock based compensation expense | |
(3) | Updated guidance is provided for combined sales globally only. | |
(4) | Rate represents a benefit. |
Non-GAAP net income (loss) and non-GAAP EPS each exclude expense from the Targanta acquisition, compensation expense relating to SFAS 123R, and non-cash tax provision.
There will be a conference call with management today at 8:30 a.m. Eastern Time to discuss third 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: | 866-515-2915 | |||
International Dial In: | 617-399-5129 | |||
Passcode for both dial in numbers: | 71064969 |
Replay is available from 11:30 a.m. Eastern Time following the conference call through November 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 57422848.
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 recently licensed rights in the United States and Canada to an innovative formulation of Argatroban, which is currently under regulatory review in the United States. The Company also has two products in late stage development, cangrelor, an investigational antiplatelet agent and oritavancin, a semi-synthetic lipoglycopeptide antibiotic. The Company’s pipeline also includes a serine protease inhibitor, CU2010, in early-stage development. The Medicines Company’s website iswww.themedicinescompany.com.
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973)290-6000 Fax: (973)656-9898
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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 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 whether we receive regulatory approval for additional indications, whether the Company’s products will advance in the clinical trials process on a timely basis or at all, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers will accept clinical trial results, 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 10, 2009, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973)290-6000 Fax: (973)656-9898
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The Medicines Company
Condensed Consolidated Statements of Operations
(unaudited)
Three Months Ended September 30, | ||||||||
(in thousands, except per share data) | 2009 | 2008 | ||||||
Net revenue | $ | 98,789 | $ | 88,126 | ||||
Operating expenses: | ||||||||
Cost of revenue | 28,308 | 22,089 | ||||||
Research and development | 22,464 | 44,075 | ||||||
Selling, general and administrative | 47,358 | 42,865 | ||||||
Total operating expenses | 98,130 | 109,029 | ||||||
Income (loss) from operations | 659 | (20,903 | ) | |||||
Other income | 151 | 1,070 | ||||||
Income (loss) before income taxes | 810 | (19,833 | ) | |||||
(Provision) benefit for income taxes | (4,007 | ) | 6,616 | |||||
Net (loss) income | $ | (3,197 | ) | $ | (13,217 | ) | ||
Basic (loss) per common share | $ | ( 0.06 | ) | $ | (0.25 | ) | ||
Shares used in computing basic (loss) per common share | 52,298 | 51,941 | ||||||
Diluted (loss) per common share | $ | (0.06 | ) | $ | (0.25 | ) | ||
Shares used in computing diluted (loss) per common share | 52,298 | 51,941 | ||||||
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973)290-6000 Fax: (973)656-9898
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The Medicines Company
Condensed Consolidated Statements of Operations
(unaudited)
Nine Months Ended September 30, | ||||||||
(in thousands, except per share data) | 2009 | 2008 | ||||||
Net revenue | $ | 302,181 | $ | 254,285 | ||||
Operating expenses: | ||||||||
Cost of revenue | 86,958 | 63,121 | ||||||
Research and development | 68,685 | 82,518 | ||||||
Selling, general and administrative | 146,863 | 117,004 | ||||||
Total operating expenses | 302,506 | 262,643 | ||||||
(Loss) from operations | (325 | ) | (8,358 | ) | ||||
Other income | 2,055 | 5,256 | ||||||
Income (loss) before income taxes | 1,730 | (3,102 | ) | |||||
Provision for income taxes | (4,465 | ) | (1,205 | ) | ||||
Net (loss) | $ | (2,735 | ) | $ | (4,307 | ) | ||
Basic (loss) per common share | $ | (0.05 | ) | $ | (0.08 | ) | ||
Shares used in computing basic (loss) per common share | 52,225 | 51,842 | ||||||
Diluted (loss) per common share | $ | (0.05 | ) | $ | (0.08 | ) | ||
Shares used in computing diluted (loss) per common share | 52,225 | 51,842 | ||||||
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The Medicines Company
Condensed Consolidated Balance Sheets
September 30, | December 31, | |||||||
(in thousands) | 2009 | 2008 | ||||||
ASSETS | ||||||||
Cash, cash equivalents and available for sales securities | $ | 172,020 | $ | 216,206 | ||||
Accrued interest receivable | 868 | 1,336 | ||||||
Accounts receivable, net | 44,717 | 33,657 | ||||||
Inventory | 19,440 | 28,229 | ||||||
Prepaid expenses and other current assets | 15,712 | 16,402 | ||||||
Total current assets | 252,757 | 295,830 | ||||||
Fixed assets, net | 26,210 | 27,331 | ||||||
Intangible assets, net | 15,471 | 16,349 | ||||||
Restricted cash | 7,169 | 5,000 | ||||||
Deferred tax assets | 4,958 | 37,657 | ||||||
In process research & development | 69,500 | — | ||||||
Goodwill | 26,035 | — | ||||||
Other assets | 7,325 | 5,237 | ||||||
Total assets | $ | 409,425 | $ | 387,404 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities | $ | 70,697 | $ | 83,608 | ||||
Contingent purchase price | 22,741 | — | ||||||
Other long term liabilities | 5,667 | 5,771 | ||||||
Stockholders’ equity | 310,320 | 298,025 | ||||||
Total liabilities and stockholders’ equity | $ | 409,425 | $ | 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)
Reconciliation of GAAP to non-GAAP Measures
(All amounts in thousands, except per share amounts)
(Unaudited)
Three Months Ended September 30, 2009 | ||||||||||||||||||||
Targanta | Non-cash | Non-GAAP(5) | ||||||||||||||||||
GAAP(1) | Acquisition | SFAS 123R | Tax Provision | As Adjusted | ||||||||||||||||
Net revenue | $ | 98,789 | $ | — | $ | — | $ | — | $ | 98,789 | ||||||||||
Operating expenses: | ||||||||||||||||||||
Cost of revenue | 28,308 | — | (223 | )(3) | — | 28,085 | ||||||||||||||
Research and development | 22,464 | — | (823 | )(3) | — | 21,641 | ||||||||||||||
Selling, general and administrative | 47,358 | — | (2) | (3,394 | )(3) | — | 43,964 | |||||||||||||
Total operating expenses | 98,130 | — | (4,440 | ) | — | 93,690 | ||||||||||||||
Income from operations | 659 | — | 4,440 | — | 5,099 | |||||||||||||||
Other income | 151 | — | — | — | 151 | |||||||||||||||
Income before income taxes | 810 | — | 4,440 | — | 5,250 | |||||||||||||||
(Provision) benefit for income taxes | (4,007 | ) | — | (2) | — | 3,829 | (4) | (178 | ) | |||||||||||
Net income | (3,197 | ) | — | 4,440 | 3,829 | 5,072 | ||||||||||||||
Basic (loss) earnings per common share | $ | (0.06 | ) | $ | — | $ | 0.09 | $ | 0.07 | $ | 0.10 | |||||||||
Shares used in computing basic (loss) earnings per common share | 52,298 | 52,298 | 52,298 | 52,298 | 52,298 | |||||||||||||||
Diluted (loss) earnings per common share | $ | (0.06 | ) | $ | — | $ | 0.09 | $ | 0.07 | $ | 0.10 | |||||||||
Shares used in computing diluted (loss) earnings per common share | 52,298 | 52,298 | 52,298 | 52,298 | 52,298 | |||||||||||||||
(1) | GAAP results | |
(2) | Targanta aquisition | |
(3) | Non-cash stock compensation expense | |
(4) | Non-cash income taxes | |
(5) | Non-GAAP results |
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973)290-6000 Fax: (973)656-9898
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The Medicines Company
Reconciliation of GAAP to non-GAAP Measures
(All amounts in thousands, except per share amounts)
(Unaudited)
Reconciliation of GAAP to non-GAAP Measures
(All amounts in thousands, except per share amounts)
(Unaudited)
Nine Months Ended September 30, 2009 | ||||||||||||||||||||
Targanta | Non-cash | Non-GAAP(5) | ||||||||||||||||||
GAAP(1) | Acquisition | SFAS 123R | Tax Provision | As Adjusted | ||||||||||||||||
Net revenue | $ | 302,181 | $ | — | $ | — | $ | — | $ | 302,181 | ||||||||||
Operating expenses: | ||||||||||||||||||||
Cost of revenue | 86,958 | — | (697 | )(3) | — | 86,261 | ||||||||||||||
Research and development | 68,685 | (2,762 | )(3) | — | 65,923 | |||||||||||||||
Selling, general and administrative | 146,863 | (4,281 | )(2) | (11,888 | )(3) | — | 130,694 | |||||||||||||
Total operating expenses | 302,506 | (4,281 | ) | (15,347 | ) | — | 282,878 | |||||||||||||
(Loss) income from operations | (325 | ) | 4,281 | 15,347 | — | 19,303 | ||||||||||||||
Other income | 2,055 | — | — | — | 2,055 | |||||||||||||||
Income before income taxes | 1,730 | 4,281 | 15,347 | — | 21,358 | |||||||||||||||
(Provision) benefit for income taxes | (4,465 | ) | — | (2) | — | 3,972 | (4) | (493 | ) | |||||||||||
Net (loss) income | (2,735 | ) | 4,281 | 15,347 | 3,972 | 20,865 | ||||||||||||||
Basic (loss) earnings per common share | $ | (0.05 | ) | $ | 0.08 | $ | 0.29 | $ | 0.08 | $ | 0.40 | |||||||||
Shares used in computing basic (loss) earnings per common share | 52,225 | 52,225 | 52,225 | 52,225 | 52,225 | |||||||||||||||
Diluted (loss) earnings per common share | $ | (0.05 | ) | $ | 0.08 | $ | 0.29 | $ | 0.08 | $ | 0.40 | |||||||||
Shares used in computing diluted (loss) earnings per common share | 52,225 | 52,225 | 52,225 | 52,225 | 52,225 | |||||||||||||||
(1) | GAAP results | |
(2) | Targanta aquisition | |
(3) | Non-cash stock compensation expense | |
(4) | Non-cash income taxes | |
(5) | Non-GAAP results |
The Medicines Company 8 Sylvan Way Parsippany, New Jersey 07054 Tel: (973)290-6000 Fax: (973)656-9898
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