Report of unscheduled material events or corporate event

Document - velhartice.info


    


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): February 28, 2017


The Medicines Company
(Exact Name of Registrant as Specified in Charter)


Delaware
 
000-31191
 
04-3324394
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
                       

8 Sylvan Way
Parsippany, New Jersey
 
07054
(Address of Principal Executive Offices)
 
(Zip Code)

Registrant's telephone number, including area code: (973) 290-6000

 
(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 February 28, 2017 The Medicines Company (the “Company”) announced financial results for the three months and year ended December 31, 2016. 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 February 28, 2017 entitled “The Medicines Company Reports Fourth-Quarter and Full-Year 2016 Business and Financial Results”








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:  February 28, 2017        
By:    /s/ Stephen M. Rodin        
Stephen M. Rodin
Executive Vice President and General Counsel







Exhibit Index


Exhibit No.
Description
99.1
Press release dated February 28, 2017 entitled “The Medicines Company Reports Fourth-Quarter and Full-Year 2016 Business and Financial Results”


 
    





Exhibit - velhartice.info


Exhibit 99.1

Contacts:

Media
Meg Langan
Vice President
(973) 290-6319

Investor Relations
Krishna Gorti, M.D.
Vice President, Investor Relations
(973) 290-6122

FOR IMMEDIATE RELEASE
The Medicines Company Reports Fourth-Quarter and Full-Year 2016 Financial Results
PARSIPPANY, N.J.—February 28, 2017 —The Medicines Company (NASDAQ: MDCO) today announced its financial results for the fourth-quarter and full-year ended December 31, 2016.

“Driven by strong execution against our strategic priorities, 2016 was a transformative year for the Company,” said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. “We announced positive top-line results from the ORION-1 Phase II study of inclisiran, which continued to demonstrate compelling safety and efficacy data, reinforcing our belief in its highly-differentiated and competitive profile and providing a strong basis for advancing inclisiran into Phase III. We look forward to presenting full safety and efficacy data from the ORION-1 study, with six- to nine-month follow-up for all study patients, in the Late-Breaking Clinical Trials session at the American College of Cardiology’s 66th Annual Scientific Session.”

Dr. Meanwell continued, “During the year, we also announced impressive results from the TANGO 1 Phase III clinical trial of Carbavance® (meropenem-vaborbactam) in patients with complicated urinary tract infection. Our new drug application filing for Carbavance was recently accepted by the U.S. Food and Drug Administration for priority review. Carbavance has the potential to be a promising and highly-differentiated treatment option for patients with the most serious drug-resistant infections. Finally, during 2016, we took decisive actions to significantly strengthen the Company’s financial position, including generating non-dilutive capital through the disposition of non-core products, refinancing approximately 80% of our 2017 convertible notes and implementing a restructuring to streamline our infrastructure and reduce operating expenses and R&D. Importantly, these actions have provided the Company with substantial strategic and operational flexibility and positioned us to further unlock the value of our key development programs. We look forward to continuing our momentum in 2017.”

Fourth-Quarter 2016 Financial Summary from Continuing Operations

Worldwide net revenue was $25.2 million in the fourth-quarter of 2016 compared to $67.2 million in the fourth-quarter of 2015. Included in total net revenue for the fourth-quarter of 2016 and 2015 were $9.1 million and $29.4 million, respectively, of royalty revenues derived from the gross profit on authorized generic sales of Angiomax® (bivalirudin) by Sandoz, Inc. Worldwide Angiomax®/Angiox® (bivalirudin) net

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product sales were $7.8 million in the fourth-quarter of 2016, compared to $23.2 million in the fourth-quarter of 2015, with net product sales in the United States decreasing to $5.5 million in the fourth-quarter of 2016 from $18.7 million in the fourth-quarter of 2015. Other products, including Ionsys® (fentanyl iontophoretic transdermal system), Minocin® (minocycline) for Injection, and Orbactiv® (oritavancin), and including the divested non-core cardiovascular products in the fourth-quarter of 2015, recorded sales of $8.3 million in the fourth-quarter of 2016 compared to $14.6 million in the fourth-quarter of 2015.
Net loss from continuing operations in the fourth-quarter of 2016 was $124.4 million, or $1.77 per share, compared to $68.2 million, or $0.99 per share, in the fourth-quarter of 2015. Adjusted net loss (1) from continuing operations in the fourth-quarter of 2016 was $84.1 million, or $1.19(1) per share, compared to $59.3 million, or $0.86(1) per share, in the fourth-quarter of 2015.
Fourth-Quarter 2016 Financial Summary from Discontinued Operations
In the first-quarter of 2016, the Company completed the sale of its hemostasis products. Net income from discontinued operations in the fourth-quarter of 2016 was $1.6 million, or $0.02 per share, compared to net loss from discontinued operations of $137.8 million, or $2.00 per share, in the fourth-quarter of 2015. Net loss from discontinued operations in the fourth-quarter of 2015 included an impairment charge of $133.3 million.
Full-Year 2016 Financial Summary from Continuing Operations
Worldwide net revenue was $167.8 million in the full-year 2016 compared to $309.0 million in the full-year 2015. Included in total net revenue in the full-year 2016 and 2015 were $71.2 million and $53.9 million, respectively, of royalty revenues derived from the gross profit on authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. Worldwide Angiomax/Angiox (bivalirudin) net product sales were $50.6 million in the full-year 2016 compared to $212.0 million in the full-year 2015, with net product sales in the United States decreasing to $39.7 million in the full-year 2016 from $193.2 million in the full-year 2015, driven by the loss of Angiomax exclusivity in July 2015. Other products, including Ionsys, Minocin for Injection, and Orbactiv, along with the divested non-core cardiovascular products, recorded sales of $46.0 million in the full-year 2016 compared to $43.2 million in the full-year 2015.
The sale of the Company’s non-core cardiovascular products resulted in a gain of $288.3 million, which was recorded in the second-quarter of 2016.
Net loss from continuing operations in the full-year 2016 was $119.4 million, or $1.71 per share, compared to $221.9 million, or $3.32 per share, in the full-year 2016. Adjusted net loss (1) from continuing operations in the full-year 2016 was $248.3 million, or $3.55(1) per share, compared to $152.3 million, or $2.28 (1) per share in the full-year 2015.

Full-Year 2016 Financial Summary from Discontinued Operations
Net income from discontinued operations in the full-year 2016 was $0.2 million, compared to net loss from discontinued operations of $130.8 million, or $1.96 per share, in the full-year 2015. Net loss from discontinued operations in the fourth-quarter of 2015 included an impairment charge of $133.3 million.
(1)Adjusted net loss and adjusted loss per share from continuing operations are non-GAAP financial performance measures with no standardized definitions under U.S. GAAP. For further information and a detailed reconciliation, refer to the “Non-GAAP Financial Performance Measures” and “Reconciliations of GAAP to Adjusted Net Loss and Adjusted Loss per Share” sections of this press release.
At December 31, 2016, the Company had $541.8 million in cash and cash equivalents compared to $373.2 million at the end of 2015.

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Fourth-Quarter and Full-Year 2016 Conference Call and Webcast Information
The Company will host a conference call and webcast today, February 28, 2017, at 8:30 a.m., Eastern Time, to discuss fourth-quarter and full-year 2016 financial results. The dial-in information to access the call is as follows:

U.S./Canada:    (877) 359-9508
International:    (224) 357-2393
Conference ID:    66296847

The live webcast can be accessed in the “Investors - Events/Presentations” section of The Medicines Company’s website at velhartice.info/investors/events.

A taped replay of the conference call will be available from 11:30 a.m., Eastern Time, today until 11:30 a.m., Eastern Time, on March 7, 2017. The replay may be accessed as follows:

U.S./Canada:    (855) 859-2056
International:    (404) 537-3406
Conference ID:    66296847

A replay of the webcast will also be available.
About The Medicines Company
The Medicines Company is a biopharmaceutical company driven by an overriding purpose - to save lives, alleviate suffering and contribute to the economics of healthcare. The Company’s mission is to create transformational solutions to address the most pressing healthcare needs facing patients, physicians and providers in three critical therapeutic areas: serious infectious disease care, cardiovascular care and surgery and perioperative care. The Company is headquartered in Parsippany, New Jersey, with global innovation centers in California and Switzerland.
Forward Looking Statements
Statements contained in this press release 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," "plans," "expects," "potential" and similar expressions, including the Company's preliminary financial 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 the Company’s products; 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, or succeed in achieving their specified endpoints; 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; whether the Company can protect its intellectual property; whether the Company will be able to raise additional capital on favorable terms or at all when needed; 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 with the SEC on October 27, 2016, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.


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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 loss and adjusted loss per share from continuing operations attributable to The Medicines Company. The Company believes these measures 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 loss from continuing operations excludes share-based compensation expense, amortization of acquired intangible assets, inventory adjustments, restructuring charges, milestone payments, changes in contingent purchase price, expenses incurred for certain transactions, non-cash interest expense, gain on sale of investment, gain on remeasurement of equity investment, gain on sale of assets, loss on extinguishment of debt, legal settlement and net loss tax adjustments. The Company believes these non-GAAP financial measures help indicate underlying trends in the Company’s business and are important in comparing current results with prior period results and understanding projected operating performance. Non-GAAP financial measures provide the Company and its investors with an indication of the Company’s baseline performance before items that are considered by the Company not to be reflective of the Company’s ongoing results. See the attached Reconciliations of GAAP to Adjusted Net Loss and Adjusted Loss per Share for explanations of the amounts excluded and included to arrive at adjusted net loss and adjusted loss per share amounts for the three month periods and years ended December 31, 2016 and 2015.
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. The Company strongly encourages investors to review its consolidated financial statements and publicly-filed reports in their entirety and cautions investors that the non-GAAP measures used by the Company may differ from similar measures used by other companies, even when similar terms are used to identify such measures.


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THE MEDICINES COMPANY
CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED
(In thousands, except per share amounts)
 
Three Months Ended
December 31,
 
Year Ended
December 31,
 
2016
 
2015
 
2016
 
2015
Net product revenues
$
16,088

 
$
37,811

 
$
96,630

 
$
255,148

Royalty revenues
9,111

 
29,356

 
71,205

 
53,859

Total net revenues
25,199

 
67,167

 
167,835

 
309,007

Operating expenses:
 
 
 
 
 
 
 
Cost of product revenues
16,543

 
25,449

 
71,347

 
119,931

Research and development
44,667

 
40,186

 
139,262

 
123,606

Selling, general and administrative
76,673

 
76,959

 
319,151

 
337,943

Total operating expenses
137,883

 
142,594

 
529,760

 
581,480

Loss from operations
(112,684
)
 
(75,427
)
 
(361,925
)
 
(272,473
)
Legal settlement

 

 

 
5,000

Co-promotion and license income
781

 
121

 
3,854

 
10,132

Gain on remeasurement of equity investment

 

 

 
22,597

Gain on sale of investment

 

 

 
19,773

Gain on sale of assets

 

 
288,301

 

Loss on extinguishment of debt

 

 
(5,380
)
 

Interest expense
(12,265
)
 
(9,590
)
 
(44,463
)
 
(37,092
)
Other (loss) income
(414
)
 
(204
)
 
327

 
400

Loss from continuing operations before income taxes
(124,582
)
 
(85,100
)
 
(119,286
)
 
(251,663
)
Benefit (provision) for income taxes
150

 
16,853

 
(70
)
 
29,743

Net loss from continuing operations
(124,432
)
 
(68,247
)
 
(119,356
)
 
(221,920
)
Income (loss) from discontinued operations, net of tax
1,574

 
(137,825
)
 
184

 
(130,826
)
Net loss
(122,858
)
 
(206,072
)
 
(119,172
)
 
(352,746
)
Net loss (income) attributable to non-controlling interest
4

 
6

 
54

 
(10
)
Net loss attributable to The Medicines Company
$
(122,854
)
 
$
(206,066
)
 
$
(119,118
)
 
$
(352,756
)
 
 
 
 
 
 
 
 
Amounts attributable to The Medicines Company:
 
 
 
 
 
 
 
Net loss from continuing operations
$
(124,428
)
 
$
(68,241
)
 
$
(119,302
)
 
$
(221,930
)
Income (loss) from discontinued operations, net of tax
1,574

 
(137,825
)
 
184

 
(130,826
)
Net loss attributable to The Medicines Company
$
(122,854
)
 
$
(206,066
)
 
$
(119,118
)
 
$
(352,756
)
 
 
 
 
 
 
 
 
Basic (loss) income per common share attributable to The Medicines Company:
 
 
 
 
 
 
 
Loss from continuing operations
$
(1.77
)
 
$
(0.99
)
 
$
(1.71
)
 
$
(3.32
)
Income (loss) from discontinued operations
0.02

 
(2.00
)
 

 
(1.96
)
Basic loss per share
$
(1.75
)
 
$
(2.99
)
 
$
(1.71
)
 
$
(5.28
)
 
 
 
 
 
 
 
 
Diluted (loss) income per common share attributable to The Medicines Company:
 
 
 
 
 
 
 
Loss from continuing operations
$
(1.77
)
 
$
(0.99
)
 
$
(1.71
)
 
$
(3.32
)
Income (loss) from discontinued operations
0.02

 
(2.00
)
 

 
(1.96
)
Diluted loss per share
$
(1.75
)
 
$
(2.99
)
 
$
(1.71
)
 
$
(5.28
)
 
 
 
 
 
 
 
 
Weighted average number of common shares outstanding:
 
 
 
 
 
 
 
Basic
70,492

 
68,976

 
69,909

 
66,809

Diluted
70,492

 
68,976

 
69,909

 
66,809

    

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THE MEDICINES COMPANY
BALANCE SHEET ITEMS
UNAUDITED
(In thousands)

 
December 31, 2016
 
December 31, 2015
Cash and cash equivalents
$
541,835

 
$
373,173

Total assets*
$
1,705,211

 
$
1,795,516

Convertible senior notes (due 2017, 2022 and 2023)*
$
677,333

 
$
567,580

The Medicines Company stockholders' equity
$
652,501

 
$
732,238

* Reclassified debt issuance costs of $2.4 million and $9.0 million as of December 31, 2015 from Total assets and Convertible senior notes
(due 2017 and due 2022) in connection with the adoption of ASU 2015-03.




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THE MEDICINES COMPANY
RECONCILIATIONS OF GAAP TO ADJUSTED NET LOSS AND ADJUSTED LOSS PER SHARE
UNAUDITED
(In thousands, except per share amounts)

 
 
Three Months Ended
December 31,
 
Year Ended
December 31,
 
 
2016
 
2015
 
2016
 
2015
Net loss from continuing operations attributable to The Medicines Company - GAAP
 
$
(124,428
)
 
$
(68,241
)
 
$
(119,302
)
 
$
(221,930
)
Before tax adjustments:
 
 
 
 
 
 
 
 
 Cost of product revenues:
 
 
 
 
 
 
 
 
      Share-based compensation expense
(1) 
247

 
398

 
938

 
987

      Amortization of acquired intangible assets
(2) 
6,469

 
6,267

 
25,788

 
17,281

      Inventory adjustments
(3) 
(714
)
 
1,528

 
533

 
41,678

      Restructuring charges
(4) 
383

 

 
767

 

 Research and development:
 
 
 
 
 
 
 
 
      Share-based compensation expense
(1) 
861

 
697

 
3,784

 
3,513

      Restructuring charges
(4) 
4

 

 
1,455

 

      Milestone payments
(5) 
2,924

 
1,007

 
13,924

 
6,359

 Selling, general and administrative:
 
 
 
 
 
 
 
 
      Share-based compensation expense
(1) 
5,440

 
5,380

 
25,994

 
25,677

      Amortization of acquired intangible assets
(2) 

 

 

 
164

      Restructuring charges
(4) 
750

 

 
15,194

 

      Changes in contingent purchase price
(6) 
9,634

 
4,704

 
23,980

 
27,812

      Expenses incurred for certain transactions
(7) 
7,500

 

 
15,387

 

 Other:
 
 
 
 
 
 
 
 
     Non-cash interest expense
(8) 
6,789

 
6,144

 
26,182

 
23,676

Gain on sale of investment
(9) 

 

 

 
(19,773
)
Gain on remeasurement of equity investment
(10) 

 

 

 
(22,597
)
Gain on sale of assets
(11) 

 

 
(288,301
)
 

Loss on extinguishment of debt
(12) 

 

 
5,380

 

Legal settlement
(13) 

 

 

 
(5,000
)
Net loss tax adjustments
(14) 

 
(17,145
)
 
(1
)
 
(30,182
)
Net loss attributable to The Medicines Company - Adjusted
 
$
(84,141
)
 
$
(59,261
)
 
$
(248,298
)
 
$
(152,335
)
 
 
 
 
 
 
 
 
 
Net loss per share attributable to The Medicines Company - Adjusted
 
 
 
 
 
 
 
 
   Basic
 
$
(1.19
)
 
$
(0.86
)
 
$
(3.55
)
 
$
(2.28
)
   Diluted
 
$
(1.19
)
 
$
(0.86
)
 
$
(3.55
)
 
$
(2.28
)
Weighted average number of common shares outstanding:
 
 
 
 
 
 
 
 
   Basic
 
70,492

 
68,976

 
69,909

 
66,809

   Diluted
 
70,492

 
68,976

 
69,909

 
66,809


Page 7 of 8




Explanation of Adjustments:
(1)
Excludes share-based compensation of $6,548 and $6,475 for the three-months ended December 31, 2016 and 2015 and $30,716 and $30,177 for the year ended December 31, 2016 and 2015 because these expenses are substantially dependent on changes in the market price of the Company's common stock.
(2)
Excludes amortization of intangible assets resulting from transactions with CSL, Teva, Targanta, Incline Therapeutics and Rempex.
(3)
Excludes all non-cash inventory adjustments. Year to date balances reflect all non-cash inventory adjustments for the respective periods.
(4) Excludes restructuring charges for the workforce reorganization related to the sale of the non-core cardiovascular products.
(5)
Excludes upfront and milestone payments for research and development collaboration arrangements and manufacturing scale up for MDCO-216.
(6)
Excludes changes in fair value of the contingent price related to the acquisitions of Targanta, Incline Therapeutics, Rempex and Annovation.
(7)
Excludes transaction and one-time costs related to the sale of the non-core cardiovascular products.
(8)
Excludes non-cash interest expense which is in excess of the actual interest expense paid on the Convertible Senior Notes.
(9)
Excludes gain on sale of investment in a specialty pharmaceutical company.
(10)
Excludes gain on remeasurement of the Company's equity investment in Annovation.
(11)
Excludes gain on the sale of the non-core cardiovascular products.
(12)
Excludes loss on the repurchase of $220,000 of 2017 Notes.
(13)
Excludes gain from legal settlement in which the Company was the beneficiary.
(14)
Net loss tax adjustments reflect the estimated tax effect of the above adjustments and the impact of certain other non-operating tax adjustments.


In addition to the financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted financial measures that the Company believes 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. The Company strongly encourages investors to review its consolidated financial statements and publicly filed reports in their entirety and cautions investors that the non-GAAP measures used by the Company may differ from similar measures used by other companies, even when similar terms are used to identify such measures.




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