Health & Fitness
Health and Fitness
Health and Fitness
Fri, October 30, 2009
Thu, October 29, 2009
Wed, October 28, 2009 The Medicines Company Reports Third Quarter 2009 Financial Results
PARSIPPANY, NJ--(Marketwire - October 28, 2009) - The Medicines Company (
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. -- 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. -- 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. -- 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. -- 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 equals 0.005), improved overall survival by 27 percent (p equals 0.037) and reduced major bleeding complications by 39 percent (p is less than 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 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. -- 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. -- 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. -- 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 $0.68 per share, for the first nine months of 2008. Non-GAAP net income excludes the Targanta and Curacyte acquisitions, stock-based compensation expense and non-cash income taxes.
The following table provides reconciliations between GAAP and non-GAAP net (loss) income for the third quarter (Q3) and first nine months (9M) of 2009 and 2008. Non-GAAP net income excludes the transaction charges related to the Targanta and Curacyte acquisitions, stock-based compensation expense and non-cash income taxes:
FAS 123R Non-Cash Stock- (Benefit) Reported Targanta Curacyte Based Provision GAAP Net Trans- Acquisi- Compen- for Non-GAAP (Loss) action tion sation Income Net (in millions) Income Costs Costs Expense Taxes Income(1) -------- --------- --------- --------- --------- --------- Q3 2009 ($ 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:
FAS 123R Non-Cash Reported Stock- (Benefit) GAAP Targanta Curacyte Based Provision (Loss) Trans- Acquisi- Compen- for Earnings action tion sation Income Non-GAAP (in millions) Per Share Costs Costs Expense Taxes EPS(1) -------- --------- --------- --------- --------- --------- 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 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:
April 28, 2009 July 29, 2009 October 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 ---------------- ----------------- ---------------- (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 (
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 Condensed Consolidated Statements of Operations (unaudited) (in thousands, except per share data) Three Months Ended September 30, -------------------------------- 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 Condensed Consolidated Statements of Operations (unaudited) (in thousands, except per share data) Nine Months Ended September 30, -------------------------------- 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 =============== =============== 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 ============= ============= The Medicines Company 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 admini- strative 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 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 admini- strative 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
