-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, MU6rXtF6vDyFuz1swYvF8gpXIoxDVoal6Fc9qDPpkqWoT+taf6a1p4pUgi8hJjAt D1LX+Pb2UYc3DMs4/Icd2Q== 0001104659-07-055876.txt : 20070725 0001104659-07-055876.hdr.sgml : 20070725 20070725080636 ACCESSION NUMBER: 0001104659-07-055876 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070725 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070725 DATE AS OF CHANGE: 20070725 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDICINES CO /DE CENTRAL INDEX KEY: 0001113481 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043324394 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31191 FILM NUMBER: 07997883 BUSINESS ADDRESS: STREET 1: 8 CAMPUS DRIVE CITY: PARSIPPANY STATE: NJ ZIP: 07054 BUSINESS PHONE: 973-656-1616 FORMER COMPANY: FORMER CONFORMED NAME: MEDICINES CO/ MA DATE OF NAME CHANGE: 20000504 8-K 1 a07-17941_48k.htm 8-K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549


FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of report (Date of earliest event reported):  July 25, 2007

The Medicines Company

(Exact Name of Registrant as Specified in Charter)

Delaware

 

000-31191

 

04-3324394

(State or Other Jurisdiction

 

(Commission

 

(IRS Employer

of Incorporation)

 

File Number)

 

Identification No.)

 

8 Campus Drive

 

 

Parsippany, New Jersey

 

07054

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (973) 656-1616

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 




 

Item 2.02.  Results of Operations and Financial Condition.

On July 25, 2007, The Medicines Company (the “Company”) announced financial results for the quarter and six month period ended June 30, 2007.  The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01.  Financial Statements and Exhibits

(d)           Exhibits

The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:

99.1                           Press release dated July 25, 2007 entitled “The Medicines Company Reports Second Quarter and First Half 2007 Financial Results”

2




 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

THE MEDICINES COMPANY

 

 

 

 

Date:  July 25, 2007

By:

 

/s/ Paul M. Antinori

 

 

 

 

Paul M. Antinori

 

 

 

Senior Vice President and General Counsel

 

3




 

Exhibit Index

Exhibit No.

 

Description

99.1

 

Press release dated July 25, 2007 entitled “The Medicines Company Reports Second Quarter and First Half 2007 Financial Results”

 

4



EX-99.1 2 a07-17941_4ex99d1.htm EX-99.1

Exhibit 99.1

Contact:

 

Michael Mitchell

 

 

Executive Director, Corporate Affairs

 

 

The Medicines Company

 

 

973-656-1616

 

 

investor.relations@themedco.com

FOR IMMEDIATE RELEASE

THE MEDICINES COMPANY REPORTS SECOND QUARTER AND FIRST HALF 2007 FINANCIAL RESULTS

PARSIPPANY, NJ — July 25, 2007 — The Medicines Company (NASDAQ: MDCO) today announced its financial results for the second quarter and first half of 2007. The Company reported second quarter net revenue of $56.4 million and first half net revenue of $123.0 million.  Second quarter net revenue is within the anticipated range of $56-58 million that the Company pre-announced on July 2, 2007.

Second quarter earnings highlights:

·                  Fully diluted earnings per share (EPS) as reported under U.S. generally accepted accounting principles (GAAP) were $0.02, which includes stock-based compensation expense and a provision for income taxes, a portion of which will be offset by available net operating loss (NOL) carryforwards.

·                  Excluding stock-based compensation expense, the Company reported fully diluted non-GAAP EPS of $0.09.

·                  Excluding both stock-based compensation expense and the non-cash portion of the income tax provision that will be offset by available NOL carryforwards, the Company reported fully diluted non-GAAP EPS of $0.10.

Additional financial highlights for second quarter and first half 2007:

·                  For the first half of 2007, net revenue increased to $123.0 million, compared to $94.0 million for the same period in 2006.

·                  Net revenue decreased to $56.4 million for the second quarter of 2007, compared with $59.4 million for the second quarter of 2006.

·                  Angiomax® (bivalirudin) U.S. sales increased to $55.2 million in the second quarter of 2007, compared to $53.4 million in the second quarter of 2006. Slow domestic growth was attributable to lower than anticipated percutaneous coronary intervention (PCI) procedure volumes in the United States in the second quarter of 2007.

·                  Angiomax international sales decreased to $1.2 million for the second quarter of 2007, compared to $5.8 million in the second quarter of 2006 due to the absence of European revenues in the second quarter of 2007.

“We estimate that the Angiomax share of the U.S. PCI market has grown to more than 40% through April 2007 which is gratifying; however, a substantial decline in the overall volume of U.S. PCI




 

procedures during the second quarter affected second quarter revenues,” said John Kelley, President and Chief Operating Officer. “In other parts of the business, we met our goal to submit a new drug application (NDA) to the FDA for Cleviprex(TM) (clevidipine), our novel blood pressure control agent, and we made progress toward our planned third quarter submission of a supplemental NDA with data from the ACUITY trial of Angiomax use in acute coronary syndromes patients. We also continued with patient enrollment of Phase III trials for cangrelor, our novel antiplatelet therapy.”

The following table provides reconciliations between GAAP and non-GAAP net income for the second quarters (Q2) of 2007 and 2006, as well as the first half (1H) of 2007 and 2006, excluding for each of these periods stock-based compensation expense and the non-cash portion of the provision for income taxes which will be offset by available NOL carryforwards:

(in millions)

 

Reported GAAP
Net Income/
(Loss)

 

FAS 123R Stock-
Based Compensation
Expense

 

Non-GAAP Net
Income Excluding
FAS 123R Stock-
Based Compensation
Expense

 

Non-Cash
Portion of 
Provision for
Income Taxes

 

Non-GAAP Net Income
(1)

 

Q2 2007

 

$

0.8

 

$

3.7

 

$

4.6

 

$

0.7

 

$

5.2

 

Q2 2006

 

$

10.9

 

$

2.0

 

$

12.9

 

$

(0.1

)

$

12.8

 

1H 2007

 

$

3.9

 

$

7.2

 

$

11.1

 

$

2.4

 

$

13.5

 

1H 2006

 

$

(1.2

)

$

3.5

 

$

2.3

 

$

(0.1

)

$

2.2

 


Note: Amounts may not sum due to rounding.

(1) Excluding FAS 123R Stock-Based Compensation Expense and Non-Cash Portion of Provision for Income Taxes which will be offset by available NOL carryforwards

Reconciliations between GAAP and non-GAAP fully diluted EPS for the second quarters (Q2) of 2007 and 2006, as well as the first half (1H) of 2007 and 2006 are provided in the following table:

(per share)

 

Reported GAAP 
Net Income/
(Loss)

 

FAS 123R Stock-
Based Compensation
Expense

 

Non-GAAP Net
Income Excluding
FAS 123R Stock-
Based Compensation
Expense

 

Non-Cash
Portion of
Provision for
Income Taxes

 

Non-GAAP Net Income(1)

 

Q2 2007

 

$

0.02

 

$

0.07

 

$

0.09

 

$

0.01

 

$

0.10

 

Q2 2006

 

$

0.22

 

$

0.04

 

$

0.26

 

$

0.00

 

$

0.25

 

1H 2007

 

$

0.07

 

$

0.14

 

$

0.21

 

$

0.05

 

$

0.26

 

1H 2006

 

$

(0.02

)

$

0.07

 

$

0.05

 

$

0.00

 

$

0.04

 


Note: Amounts may not sum due to rounding.

(1) Excluding FAS 123R Stock-Based Compensation Expense and Non-Cash Portion of Provision for Income Taxes which will be offset by available NOL carryforwards

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 both stock-based compensation expense and the portion of the provision for income taxes which will be offset by available NOL carryforwards.  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.

European Transaction

On July 2, The Medicines Company announced the termination of its distribution arrangements with Nycomed and the reacquisition of all development, commercial and distribution rights held by Nycomed for Angiox® (bivalirudin) in Europe.  In connection with the transaction, The Medicines Company paid Nycomed $20 million in July 2007 and agreed to pay Nycomed an additional $20 million in 2008. The Medicines Company agreed to pay an additional $5 million upon European health regulators approving an expanded Angiox product label to include findings of the ACUITY trial. Angiox is the name under which Angiomax is marketed in Europe.

“We believe the Angiox opportunity will enable The Medicines Company to grow into the next decade,” said Glenn Sblendorio, Executive Vice President and Chief Financial Officer of The Medicines Company. “We expect the investments we plan to make in 2007, 2008 and 2009 related to Angiox and our planned global expansion can add to our earnings in 2009 and beyond.”

The Medicines Company expects that in connection with the $40 million that it has committed to pay to Nycomed, it will recognize a one-time charge of between $30 and $34 million (unaudited estimate) in the third quarter of 2007 and that it will record the remaining $6 to $10 million as an intangible asset or assets which will likely be amortized through 2015.

Webcast

There will be a conference call with management today at 8:30 A.M. ET to discuss financial results, guidance, outlook 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:        866-575-6540

International Dial In:   913-312-1240

Replay is available from 11:30 a.m. Eastern Time following the conference call through August 15, 2007. To hear a replay of the call dial 888-203-1112 (domestic) and 719-457-0820 (international). Passcode for both dial in numbers is 8450715.

MDCO-F

About The Medicines Company: The Medicines Company is committed to delivering innovative, cost-effective acute care hospital products in the worldwide hospital marketplace.  The Company markets Angiomax® (bivalirudin) in the U.S. and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart.  The Company also has two products in late-stage development, Cleviprex™ (clevidipine) and cangrelor. The Company’s website is http://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 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 the Company is successful in extending the term of the principal patent covering Angiomax, 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, 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 May 9, 2007, 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

 

(in thousands, except per share data)

 

Three months ended June 30,

 

 

 

2007

 

2006

 

 

 

 

 

 

 

Net revenue

 

$

56,399

 

$

59,372

 

Operating expenses:

 

 

 

 

 

Cost of revenue

 

15,094

 

15,450

 

Research and development

 

15,729

 

13,978

 

Selling, general and administrative

 

26,819

 

20,618

 

Total operating expenses

 

57,642

 

50,046

 

Income/(loss) from operations

 

(1,243

)

9,326

 

Other income

 

2,719

 

1,511

 

Income/(loss) before income taxes

 

1,476

 

10,837

 

Provision for income taxes

 

(659

)

77

 

 

 

 

 

 

 

Net income/(loss)

 

$

817

 

$

10,914

 

 

 

 

 

 

 

Basic earnings/(loss) per common share

 

$

0.02

 

$

0.22

 

Shares used in computing basic earnings/(loss) per common share

 

51,638

 

49,951

 

 

 

 

 

 

 

Diluted earnings/(loss) per common share

 

$

0.02

 

$

0.22

 

Shares used in computing diluted earnings/(loss) per common share

 

52,294

 

50,546

 

 

 




 

The Medicines Company

Consolidated Statements of Operations

 

(in thousands, except per share data)

 

Six Months Ended June 30,

 

 

 

 

 

 

 

2007

 

2006

 

Net revenue

 

$

123,046

 

$

94,015

 

Operating expenses:

 

 

 

 

 

Cost of revenue

 

32,874

 

23,948

 

Research and development

 

35,208

 

28,526

 

Selling, general and administrative

 

53,957

 

45,654

 

Total operating expenses

 

122,039

 

98,128

 

Income/(loss) from operations

 

1,007

 

(4,113

)

Other income

 

5,302

 

2,862

 

Income/(loss) before income taxes

 

6,309

 

(1,251

)

Provision for income taxes

 

(2,444

)

51

 

Net income/(loss)

 

3,865

 

(1,200

)

 

 

 

 

 

 

Basic earnings/(loss) per common share

 

$

0.07

 

$

(0.02

)

Shares used in computing basic earnings/(loss) per common share

 

51,578

 

49,933

 

 

 

 

 

 

 

Diluted earnings/(loss) per common share

 

$

0.07

 

$

(0.02

)

Shares used in computing diluted earnings/(loss) per common share

 

52,587

 

49,933

 

 




 

The Medicines Company

Condensed Consolidated Balance Sheets

 

 

 

June 30,

 

December 31,

 

(in thousands)

 

2007

 

2006

 

ASSETS

 

 

 

 

 

Cash, cash equivalents and available for sale securities

 

$

216,505

 

$

196,817

 

Accrued interest receivable

 

1,868

 

1,414

 

Accounts receivable, net

 

27,040

 

21,504

 

Inventories

 

33,438

 

41,628

 

Prepaid expenses and other current assets

 

10,813

 

12,963

 

Total current assets

 

289,664

 

274,326

 

 

 

 

 

 

 

Fixed assets, net

 

2,774

 

3,071

 

Deferred tax assets

 

41,032

 

41,032

 

Other assets

 

139

 

139

 

Total assets

 

$

333,609

 

$

318,568

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDER’S EQUITY

 

 

 

 

 

Current liabilities

 

$

41,598

 

$

45,803

 

Deferred revenue

 

2,650

 

2,814

 

Stockholders’ equity

 

289,361

 

269,951

 

Total liabilities and stockholders’ equity

 

$

333,609

 

$

318,568

 

 




 

The Medicines Company

Reconciliation of GAAP to non-GAAP Measures

(All amounts in thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended June 30,

 

 

 

2007

 

 

 

Reported
GAAP Net
Income/
(Loss)

 

FAS 123R
Stock-Based
Compensation
Expense

 

Non-GAAP
Net Income
(Loss)
Excluding
FAS 123R
Stock-Based
Compensation
Expense

 

Non-Cash
Portion of
Provision
for Income
Taxes

 

Non-GAAP
Net
Income(1)

 

Net revenue

 

$

56,399

 

$

 

$

56,399

 

$

 

$

56,399

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

15,094

 

(94

)(2)

15,000

 

 

15,000

 

Research and development

 

15,729

 

(770

)(2)

14,959

 

 

14,959

 

Selling, general and administrative

 

26,819

 

(2,879

)(2)

23,940

 

 

23,940

 

Total costs and expenses

 

57,642

 

(3,743

)

53,899

 

 

53,899

 

 

 

 

 

 

 

 

 

 

 

 

 

Income/loss from operations

 

(1,243

)

3,743

 

2,500

 

 

2,500

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income

 

2,719

 

 

2,719

 

 

2,719

 

Income before income taxes

 

1,476

 

3,743

 

5,219

 

 

5,219

 

Provision for income taxes

 

(659

)

 

 

(659

)

569

(3)

(90

)

Net income

 

817

 

3,743

 

4,560

 

569

 

5,129

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic earnings per common share

 

$

0.02

 

$

0.07

 

$

0.09

 

$

0.01

 

$

0.10

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic earnings/(loss) per common share

 

51,638

 

51,638

 

51,638

 

51,638

 

51,638

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted earnings per common share

 

$

0.02

 

$

0.07

 

$

0.09

 

$

0.01

 

$

0.10

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic earnings/(loss) per common share

 

52,294

 

52,294

 

52,294

 

52,294

 

52,294

 


(1)             Excluding stock-based compensation expenses and non-cash portion of income tax provision to be offset by available NOL carry-forwards

(2)             Stock-based compensation expense

(3)             Non-cash portion of income tax provision to be offset by available NOL carryforwards




 

The Medicines Company

Reconciliation of GAAP to non-GAAP Measures

(All amounts in thousands, except per share amounts)

(Unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2007

 

 

 

Reported
GAAP Net
Income/
(Loss)

 

FAS 123R
Stock-Based
Compensation
Expense

 

Non-GAAP
Net Income
(Loss)
Excluding
FAS 123R
Stock-Based
Compensation
Expense

 

Non-Cash
Portion of
Provision for
Income Taxes

 

Non-GAAP
Net Income
(1)

 

Net revenue

 

$

123,046

 

$

 

$

123,046

 

$

 

$

123,046

 

 

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

32,874

 

(192

)(2)

32,682

 

 

32,682

 

Research and development

 

35,208

 

(1,525

)(2)

33,683

 

 

33,683

 

Selling, general and administrative

 

53,957

 

(5,508

)(2)

48,449

 

 

48,449

 

Total costs and expenses

 

122,039

 

(7,225

)

114,814

 

 

114,814

 

 

 

 

 

 

 

 

 

 

 

 

 

Income/loss from operations

 

1,007

 

7,225

 

8,232

 

 

8,232

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income

 

5,302

 

 

5,302

 

 

5,302

 

Income before income taxes

 

6,309

 

7,225

 

13,534

 

 

13,534

 

Provision for income taxes

 

(2,444

)

 

 

(2,444

)

2,217

(3)

(227

)

Net income

 

3,865

 

7,225

 

11,090

 

2,217

 

13,307

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic earnings per common share

 

$

0.07

 

$

0.14

 

$

0.21

 

$

0.04

 

$

0.26

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic earnings/(loss) per common share

 

51,578

 

51,578

 

51,578

 

51,578

 

51,578

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted earnings per common share

 

$

0.07

 

$

0.14

 

$

0.21

 

$

0.04

 

$

0.25

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares used in computing basic earnings/(loss) per common share

 

52,587

 

52,587

 

52,587

 

52,587

 

52,587

 


(1)             Excluding stock-based compensation expenses and non-cash portion of income tax provision to be offset by available NOL carry-forwards

(2)             Stock-based compensation expense

(3)             Non-cash portion of income tax provision to be offset by available NOL carryforwards

 



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