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8-K - 8-K - MEDICINES CO /DEform8-kq42014.htm


Exhibit 99.1

Contacts:

Investor Relations:
Neera Dahiya Ravindran, MD
Vice President, Investor Relations & Strategic Planning
Neera.Ravindran@themedco.com
+1 973-290-6044

Media:
Bob Laverty
Vice President, Communications
Robert.Laverty@themedco.com
+1 973-290-6162

FOR IMMEDIATE RELEASE:
The Medicines Company Reports Fourth Quarter and Full Year 2014 Financial Results
Fourth Quarter Net Revenue Rise 3.2%; Full Year Net Revenue Rise 5.3%

PARSIPPANY, NJ -- (MARKETWIRE) -- 02/18/2015 --The Medicines Company (NASDAQ: MDCO) today announced fourth quarter and full year financial results for 2014.

Financial highlights for the fourth quarter of 2014:

Worldwide net revenue increased by 3.2% to $191.0 million for the fourth quarter of 2014 from $185.0 million in the fourth quarter of 2013:

Worldwide Angiomax® (bivalirudin)/Angiox® (bivalirudin) revenue, was up 3.1% to $165.9 million in the fourth quarter of 2014 compared to $160.9 million in the fourth quarter of 2013, with revenue in the United States increasing to $157.5 million in the fourth quarter of 2014 from $142.4 million in the fourth quarter of 2013.

Recothrom® Thrombin, topical (recombinant) sales were $17.9 million in the United States in the fourth quarter of 2014, as compared to $19.7 million in the fourth quarter of 2013.

Other products including Argatroban RTU, Cleviprex® (clevidipine), Minocin® (minocycline) for injection, OrbactivTM and PreveLeakTM recorded sales of $7.2 million during fourth quarter of 2014.


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Net loss for the fourth quarter of 2014 was $5.3 million, or ($0.08) per share, compared with net income of $1.2 million, or $0.02 per share for the fourth quarter of 2013.

Adjusted net income(1) for the fourth quarter of 2014 was $13.5 million, or $0.20 per share(1), compared to adjusted net income(1) of $15.4 million, or $0.23 per share(1) for the fourth quarter 2013.

Financial highlights for the full year of 2014:

Worldwide net revenue increased by 5.3% to $724.4 million in 2014, from $687.9 million in 2013:

Worldwide Angiomax/Angiox revenue, was up 4.5% to $635.7 million in 2014 from $608.6 million in 2013, with revenue in the United States increased to $599.5 million in 2014 from $550.2 million in 2013.

Recothrom sales were $64.4 million in the United States in 2014. Sales during 2013 were $63.3 million, after the Company began selling Recothrom in the US in February 2013.

Other products including Argatroban RTU, Cleviprex, Minocin (minocycline) for injection, Orbactiv and PreveLeak recorded sales in 2014 of $24.3 million.

Net loss for the full year 2014 was $32.2 million, or ($0.50) per share, compared with net income of $15.5 million, or $0.25 per share in 2013.

Adjusted net income(1) for the full year 2014 was $67.8 million, or $1.02 per share (1), compared to adjusted net income(1) of $91.9 million, or $1.50 per share(1) in 2013.

Glenn Sblendorio, President and Chief Financial Officer, stated, "We showed solid financial performance in 2014, progressing our product portfolio through a series of commercial, regulatory and developmental successes that will contribute to prolonged growth through 2018 and beyond. With the completion of the acquisition of Annovation Biopharma, we expanded our surgery and perioperative care portfolio with what we believe is an exciting new anesthetic, ABP-700, which could be the first new development in this area in the last 30 years.”


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Clive Meanwell, Chairman and Chief Executive Officer, added, "We continue to build a leading acute and intensive care hospital portfolio of innovative products. We have seven regulatory applications under review with approvals expected in 2015. Three of these applications have already received positive opinions recommending marketing authorization from the Committee for Medicinal Products for Human Use of the European Medicines Agency. We expect strong news flow throughout 2015 with new product growth, regulatory approvals, and clinical advances for our key pipeline products; it is a very exciting time at The Medicines Company.”

(1) Adjusted net income and adjusted earnings per share are non-GAAP financial performance measures with no standardized definitions under US GAAP. For further information and a detailed reconciliation, refer to the Non-GAAP Financial Performance Measures and Reconciliations of GAAP to Adjusted Net income sections of this release for explanations of the amounts excluded and included to arrive at adjusted net income and adjusted earnings per share amounts.

Conference Call Information
There will be a conference call with management today at 8:30 a.m. Eastern Time to discuss 2014 financial results and operational developments.

Domestic Dial In: + 1 (888) 201-7255
International Dial In: + 1 (253) 642-1007    
Passcode for both dial-in numbers: 80672834

Replay is available from 1:30 p.m. Eastern Time following the conference call through February 25, 2015. To hear a replay of the call, dial +1 (855) 859-2056 (domestic) and +1 (404) 537-3406 (international). Passcode for both dial in numbers is 80672834.

This call is being webcast and can be accessed via The Medicines Company website at www.themedicinescompany.com.

About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3,000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.



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NON-GAAP FINANCIAL PERFORMANCE MEASURES
In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted net income and adjusted earnings per share measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information.
Adjusted net income excludes upfront collaboration payments, amortization of acquired intangible assets and other charges, deal related charges, restructuring charges, stock-based compensation expense, changes in contingent consideration, arbitration award, milestone payments, non-cash interest, impairment charges, gain on settlement, loss on equity investment, and net income tax adjustments. See the attached Reconciliations of GAAP to Adjusted Net Income and Adjusted Earnings Per Share for explanations of the amounts excluded and included to arrive at adjusted net income and adjusted earnings per share amounts for the three month periods and year ended December 31, 2014 and December 31, 2013.
These adjusted measures are non-GAAP and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways.


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Forward Looking Statements
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 financial results, are intended to identify forward-looking statements. These forward-looking statements involve important 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 product candidates 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 the Company’s ongoing and planned commercial launches will be successful; 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 November 7, 2014, 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
 Consolidated Statements of Income
(Unaudited)
(in thousands, except per share data)
 
Three months ended December 31,
 
 
2014
 
2013
 
 
 
 
 
Net revenue
 
$
190,998

 
$
185,003

Operating expenses:
 
 
 
 
 Cost of revenue
 
66,000

 
76,339

 Research and development
 
53,543

 
38,522

 Selling, general and administrative
 
106,236

 
86,004

 Total operating expenses
 
225,779

 
200,865

 
 
 
 
 
Loss from operations
 
(34,781
)
 
(15,862
)
 Co-promotion and profit share income
 
8,026

 
5,142

 Loss in equity investment
 
(527
)
 

 Settlement
 
25,736

 

 Interest expense
 
(3,991
)
 
(4,388
)
 Other income
 
345

 
391

Loss before income taxes
 
(5,192
)
 
(14,717
)
(Provision) benefit for income taxes
 
(190
)
 
15,803

 
 
 
 
 
Net (loss) income
 
(5,382
)
 
1,086

Net loss attributable to non-controlling interest
 
59

 
112

Net (loss) income attributable to The Medicines Company
 
$
(5,323
)
 
$
1,198

 
 
 
 
 
(Loss) earnings per common share attributable to The Medicines Company:
 
 
 
 
Basic
 
$
(0.08
)
 
$
0.02

Diluted
 
$
(0.08
)
 
$
0.02

Weighted average number of common shares outstanding:
 
 
 
 
Basic
 
64,800

 
63,437

Diluted
 
64,800

 
69,019

 
 
 
 
 

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The Medicines Company
Consolidated Statements of Income
 
(in thousands, except per share data)
 
Year ended December 31,
 
 
2014
 
2013
 
 
 
 
 
Net revenue
 
$
724,408

 
$
687,864

Operating expenses:
 
 
 
 
 Cost of revenue
 
287,630

 
262,785

 Research and development
 
159,181

 
146,930

 Selling, general and administrative
 
342,164

 
264,958

 Total operating expenses
 
788,975

 
674,673

 
 
 
 
 
Income (loss) from operations
 
(64,567
)
 
13,191

 Co-promotion and profit share income
 
24,236

 
17,383

 Loss in equity investment
 
(1,711
)
 

 Settlement
 
25,736

 

 Interest expense
 
(15,701
)
 
(15,531
)
 Investment Impairment
 
(7,500
)
 

 Other income
 
322

 
1,577

(Loss) Income before income taxes
 
(39,185
)
 
16,620

Benefit (provision) for income taxes
 
6,837

 
(1,360
)
 
 
 
 
 
Net (loss) income
 
(32,348
)
 
15,260

Net loss attributable to non-controlling interest
 
138

 
252

Net (loss) income attributable to The Medicines Company
 
$
(32,210
)
 
$
15,512

 
 
 
 
 
(Loss) earnings per common share attributable to The Medicines Company:
 
 
 
 
Basic
 
$
(0.50
)
 
$
0.27

Diluted
 
$
(0.50
)
 
$
0.25

Weighted average number of common shares outstanding:
 
 
 
 
Basic
 
64,473

 
58,096

Diluted
 
64,473

 
62,652


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Balance Sheet Items
(in thousands)
 
December 31,
 
 
2014
 
2013
 
 
 
 
 
 
 
 
 
 
Cash and cash equivalents
 
$
370,741

 
$
376,727

Total assets
 
$
1,885,705

 
$
1,741,282

Convertible senior notes (due 2017)
 
$
246,676

 
$
236,088

The Medicines Company stockholders' equity
 
$
920,565

 
$
892,497


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The Medicines Company
Reconciliation of GAAP to Adjusted Net Income and Adjusted Earnings Per Share
(unaudited)
 
 
 
 
 
 
 
 
 
 
 
Three months ended December 31,
 
Year ended December 31,
(in thousands)
 
2014
 
2013
 
2014
 
2013
 
 
 
 
 
 
 
 
 
Net (loss) income attributable to The Medicines Company - GAAP
 
$
(5,323
)
 
$
1,198

 
$
(32,210
)
 
$
15,512

Before tax adjustments:
 
 
 
 
 
 
 
 
 Cost of revenue:
 
 
 
 
 
 
 
 
      Share-based compensation expense
(1) 
103

 
84

 
454

 
231

      Restructuring charges
(2) 

 

 

 
581

      Amortization of acquired intangible assets
(3) 
14,001

 
10,075

 
46,853

 
23,969

 Research and development:
 
 
 
 
 
 
 
 
      Share-based compensation expense
(1) 
1,136

 
1,423

 
5,578

 
4,053

      Restructuring charges
(2) 
550

 

 
550

 
1,252

      Milestone payments
(4) 
10,000

 

 
18,429

 
25,000

 Selling, general and administrative:
 
 
 
 
 
 
 
 
      Share-based compensation expense
(1) 
7,942

 
5,705

 
27,885

 
18,555

      Restructuring charges
(2) 
8,457

 

 
8,457

 
4,525

      Amortization of acquired intangible assets
(3) 
1,415

 
1,136

 
5,657

 
4,544

      Change in contingent purchase price
(5) 
7,698

 
17,110

 
36,429

 
16,942

      Expenses incurred for certain transactions
(6) 

 
2,644

 
566

 
9,720

      Arbitration award
(7) 

 

 

 
5,000

      Milestone payment
(4) 

 

 
2,500

 

 Other:
 
 
 
 
 
 
 
 
      Non-cash interest expense
(8) 
3,046

 
2,851

 
11,920

 
11,158

      Investment impairment
(9) 

 

 
7,500

 

      Loss in equity investment
(10) 
527

 

 
1,711

 

      Settlement
(11) 
(25,736
)
 

 
(25,736
)
 

Net income tax adjustments
(12) 
(10,269
)
 
(26,846
)
 
(48,723
)
 
(49,165
)
Net income attributable to The Medicines Company - Adjusted
 
$
13,547

 
$
15,380

 
$
67,820

 
$
91,877

 
 
 
 
 
 
 
 
 
Net income per share attributable to The Medicines Company - Adjusted
 
 
 
 
 
 
 
 
   Basic
 
$
0.21

 
$
0.24

 
$
1.05

 
$
1.58

   Diluted
(13) 
$
0.20

 
$
0.23

 
$
1.02

 
$
1.50

Weighted average number of common shares outstanding:
 
 
 
 
 
 
 
 
   Basic
 
64,799

 
63,437

 
64,473

 
58,096

   Diluted - Adjusted
(13) 
66,347

 
66,864

 
66,284

 
61,184


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Explanation of Adjustments:
(1) Excludes share-based compensation of $9,181 and $7,212 for three months ended December 31, 2014 and December 31, 2013, respectively and $33,917 and $22,839 for the year ended December 31, 2014 and December 31, 2013, respectively.
(2) Excludes restructuring charges relating to the reorganization of our European operations of $9,007 in 2014 and excludes workforce reduction charges relating to workforce reduction of $6,358 during 2013.
(3) Excludes amortization of intangible assets and other charges resulting from transactions with Nycomed, CSL, APP, Teva, Targanta, BMS, Rempex and Tenaxis.
(4) Excludes upfront and milestone payments for research and development collaboration arrangements.
(5) Excludes changes in contingent purchase price due to shareholders of Targanta, Incline Therapeutics, ProFibrix, Rempex and Tenaxis.
(6) Excludes charges related to the acquisition of Incline, ProFibrix, Rempex and license of Recothrom during 2013 and acquisition of Tenaxis during 2014.
(7) Excludes one time arbitration award to Eagle.
(8) Excludes non-cash interest expense related to convertible senior notes.
(9) Excludes write off of impaired investment.
(10) Excludes loss in equity investment.
(11) Reflects impact of one-time income in connection with the settlement with the former equity holders of Incline.
(12) Net income tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating tax adjustments.
(13) Reflects impact of note hedge transactions on outstanding diluted share amounts and net income per share associated with convertible senior notes.



In addition to the financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted financial measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. These adjusted measures should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways.

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