0001113481-19-000002.txt : 20190227 0001113481-19-000002.hdr.sgml : 20190227 20190227075801 ACCESSION NUMBER: 0001113481-19-000002 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20190227 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190227 DATE AS OF CHANGE: 20190227 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: 19635840 BUSINESS ADDRESS: STREET 1: 8 SYLVAN WAY CITY: PARSIPPANY STATE: NJ ZIP: 07054 BUSINESS PHONE: 973-290-6000 MAIL ADDRESS: STREET 1: 8 SYLVAN WAY CITY: PARSIPPANY STATE: NJ ZIP: 07054 FORMER COMPANY: FORMER CONFORMED NAME: MEDICINES CO/ MA DATE OF NAME CHANGE: 20000504 8-K 1 form8-k12312018xq42018.htm 8-K Document


    


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 27, 2019

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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company    o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.                                                     o






Item 2.02. Results of Operations and Financial Condition.
On February 27, 2019 The Medicines Company (the “Company”) announced financial results for the three months and year ended December 31, 2018. 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 27, 2019 entitled “The Medicines Company Reports Fourth-Quarter and Full-Year 2018 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 27, 2019        
By:    /s/ Stephen M. Rodin        
Stephen M. Rodin
Executive Vice President and General Counsel







Exhibit Index


Exhibit No.
Description
Press release dated February 27, 2019 entitled “The Medicines Company Reports Fourth-Quarter and Full-Year 2018 Business and Financial Results”

 
    





EX-99.1 2 pressreleaseq42018.htm EXHIBIT 99.1 Exhibit


The Medicines Company                                     Exhibit 99.1
8 Sylvan Way
Parsippany, NJ 07054

Contacts:

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

FOR IMMEDIATE RELEASE
The Medicines Company Reports Fourth-Quarter and Full Year 2018 Business and Financial Results
Continued progress in inclisiran’s development, with no material safety issues to date, paves the way for topline pivotal trial readouts expected in 3Q
Inclisiran’s unique profile, vast global market opportunity and long-dated exclusivity set the stage for significant shareholder value creation

PARSIPPANY, N.J. - February 27, 2019 - The Medicines Company (NASDAQ: MDCO) today reported its financial results for the fourth quarter and full year ended December 31, 2018.

“During 2018 we successfully restructured our business and executed on our development plan for inclisiran, a first-in-class drug candidate with the potential to deliver potent, durable, and consistent lowering of LDL-C levels via twice-a-year dosing. 2019 is an exciting year for the Medicines Company, as we count down to topline Phase 3 ORION program results in the third quarter and subsequent NDA and MAA submissions,” said Mark Timney, Chief Executive Officer of The Medicines Company.
Fourth quarter 2018 highlights and recent developments include the following:
In January 2019, the Independent Data Monitoring Committee (IDMC) for the ongoing inclisiran Phase III clinical trials conducted its fifth planned review of un-blinded safety and efficacy data from the trials, and recommended that they continue as designed and conducted, without modification. At the time of the IDMC’s review, more than 2,450 patient years of safety data had been accumulated, with substantially all randomized patients having received three doses of inclisiran or placebo, and more than 2,000 patients having completed their 60-day follow up after the third dose of study medication.

In December 2018, the Company announced and subsequently completed its offering of $172.5 million aggregate principal amount of 3.50% convertible senior notes due 2024 (inclusive of the over-allotment option). The net proceeds from the offering (inclusive of the full exercise of the over-allotment option) were $166.7 million, after deducting the commissions and the Company’s offering expenses, significantly enhancing the company’s capital position.

Page 1 of 9




Fourth-Quarter 2018 Financial Summary from Continuing Operations
On a GAAP basis, loss from continuing operations in the fourth quarter of 2018 was $44.3 million, or $0.60 per share, compared to a loss of $159.4 million, or $2.19 per share, in the fourth quarter of 2017. Included in loss from continuing operations for the fourth quarter of 2018 was a non-cash, mark-to-market reduction in fair value of approximately $10.5 million associated with the Company's common stock ownership in Melinta Therapeutics, Inc. (Melinta), offset by a $21.6 million gain from the sale of pre-clinical products associated with our infectious disease business. On a non-GAAP basis, adjusted loss (1) from continuing operations in the fourth quarter of 2018 was $45.6 million, or $0.62(1) per share, compared to a loss of $44.4 million, or $0.61(1) per share, in the fourth quarter of 2017.

Full Year 2018 Financial Summary from Continuing Operations
On a GAAP basis, loss from continuing operations for the full year 2018 was $235.2 million, or $3.20 per share, compared to a loss of $607.7 million, or $8.40 per share, for the full year 2017. Included in loss from continuing operations for 2018 were non-cash, mark-to-market reduction in fair value of approximately $51.9 million associated with the Company's common stock ownership in Melinta; restructuring charges of $11 million; and a $5.1 million non-cash impairment charge related to fixed assets associated with the early-stage infectious disease products; partially offset by a $21.6 million gain from the sale of pre-clinical products associated with our infectious disease business, and a $7.0 million gain from the sale of the Company's rights to branded Angiomax in the United States to Sandoz Inc. On a non-GAAP basis, adjusted loss (1) from continuing operations for 2018 was $199.8 million, or $2.72(1) per share, compared to a loss of $142.4 million, or $1.97(1) per share, for 2017.

Full Year 2018 Financial Summary from Discontinued Operations
In the first quarter of 2018 the Company completed the sale of its infectious disease business, consisting of the products Vabomere™, Orbactiv® and Minocin® IV as well as line extensions of those products, for $270 million in upfront consideration (including Melinta common stock then valued at $55 million) and deferred payments, tiered royalty payments of 5% to 25% on worldwide net sales of Vabomere, Orbactiv and Minocin IV, and the assumption by Melinta of all royalty, milestone and other payment obligations relating to those products.
Net income from discontinued operations for the full year 2018 was $112.1 million, compared to a net loss of $100.7 million for the full year 2017. Net income from discontinued operations for 2018 included a pre-tax gain of approximately $169.0 million from the sale of the Company's infectious disease business to Melinta.
At December 31, 2018, the Company had $238.3 million in cash and cash equivalents, compared to $151.4 million at the end of 2017.
(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 Loss From Continuing Operations and Adjusted Loss per Share” sections of this press release.


Page 2 of 9




Fourth-Quarter 2018 Conference Call and Webcast Information

The Company will host a conference call and webcast today, February 27, 2019 at 8:30 a.m., Eastern Standard Time, to discuss its fourth-quarter and full year 2018 financial results and provide clinical and operational updates. The dial-in information to access the call is as follows:

U.S./Canada:    (877) 407-0312
International:    (201) 389-0899
Conference ID:    13687492

A taped replay of the conference call will be available after the call concludes, and may be accessed by telephone as follows:

U.S./Canada:    (877) 660-6853
International:    (201) 612-7415
Conference ID:    13687492

A live audio webcast of the conference call may be accessed in the "Investors" section of The Medicines Company website. An archived webcast will be available after the call concludes.


About Inclisiran
Inclisiran is an investigational GalNAc-conjugated RNA interference therapeutic, which inhibits the synthesis of PCSK9 protein in liver cells, thereby reducing liver cell LDL receptor turnover, and lowering plasma LDL-C.

The Medicines Company and Alnylam Pharmaceuticals, Inc. (Alnylam) are collaborating in the advancement of inclisiran pursuant to their 2013 agreement. Under the terms of the agreement, Alnylam completed certain pre-clinical studies and the Phase I clinical study, with The Medicines Company leading and funding the development of inclisiran from Phase II forward, as well as potential commercialization.

Commercial opportunity
In the US alone, 67.5 million individuals are estimated to have sufficient cardiovascular risk to warrant lipid-lowering therapy. 27.5 million of these individuals are at a significantly elevated risk, either because of confirmed cardiovascular disease or LDL-C levels above 190 mg/dl. Of this higher risk group, 15.1 million are currently treated with lipid-lowering therapies, but only one out of five (or 2.4 million) is successfully reaching LDL-C targets with current therapies. This implies a population of at least 12.7 million Americans who could benefit from inclisiran, a first in class therapy with the potential to deliver potent, durable and consistent lowering of LDL-C levels via twice-a-year dosing.

Page 3 of 9




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 goal is to create transformational solutions to address the most pressing healthcare needs facing patients, physicians, and providers in cardiovascular care. The Company is headquartered in Parsippany, New Jersey. For more information, please visit www.themedicinescompany.com and follow us on Twitter @MDCONews.


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," "plans," "expects," "should," and "potential" 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 the ability of the Company to effectively develop inclisiran; whether inclisiran will advance in the clinical trials process on a timely basis or at all, or succeed in achieving its specified endpoints; whether the Company will make regulatory submissions for inclisiran on a timely basis; whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all; the extent of the commercial success of inclisiran, if approved; the strength, durability and life of the Company's patent protection for inclisiran and whether the Company will be successful in extending exclusivity; 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 (SEC), including, without limitation, the risk factors detailed in the Company's Current Report on Form 8-K filed with the SEC on December 12, 2018, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.


NON-GAAP FINANCIAL PERFORMANCE MEASURES
In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted loss from continuing operations 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 loss from continuing operations excludes share-based compensation expense, amortization of acquired intangible assets, asset impairment charges, inventory adjustments, restructuring charges, charges and gains associated with product discontinuance, changes in contingent purchase price, milestone payments, legal settlements, changes in short-term investments and non-cash interest expense. 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 Loss from Continuing Operations 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- and twelve-months ended December 31, 2018 and 2017.


Page 4 of 9



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.

Page 5 of 9



THE MEDICINES COMPANY
CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED
(In thousands, except per share amounts)
 
Three Months Ended
December 31,
 
Year Ended
December 31,
 
2018
 
2017
 
2018
 
2017
Net revenues
$

 
$
8,595

 
$
6,138

 
$
44,789

Operating expenses:
 
 
 

 
 
 
 
Cost of revenues
697

 
20,438

 
7,255

 
47,193

Asset impairment charges

 
63,000

 
5,073

 
392,097

Research and development
29,611

 
55,600

 
133,007

 
138,370

Selling, general and administrative
(4,576
)
 
29,644

 
52,214

 
132,225

Total operating expenses
25,732

 
168,682

 
197,549

 
709,885

Loss from operations
(25,732
)
 
(160,087
)
 
(191,411
)
 
(665,096
)
Co-promotion and license income
266

 
5,266

 
1,019

 
7,549

Loss on short-term investment
(10,465
)
 

 
(51,881
)
 

Interest expense
(12,913
)
 
(11,811
)
 
(49,411
)
 
(48,564
)
Other income
1,039

 
248

 
5,580

 
1,840

Loss from continuing operations before income taxes
(47,805
)
 
(166,384
)
 
(286,104
)
 
(704,271
)
Benefit from income taxes
3,513

 
6,968

 
50,888

 
96,576

Loss from continuing operations
(44,292
)
 
(159,416
)
 
(235,216
)
 
(607,695
)
Income (loss) from discontinued operations, net of tax
1,818

 
(18,846
)
 
112,060

 
(100,678
)
Net loss
$
(42,474
)
 
$
(178,262
)
 
$
(123,156
)
 
$
(708,373
)
 
 
 
 
 
 
 
 
Basic (loss) earnings per common share:
 
 
 
 
 
 
 
Loss from continuing operations
$
(0.60
)
 
$
(2.19
)
 
$
(3.20
)
 
$
(8.40
)
Earnings (loss) from discontinued operations
0.02

 
(0.26
)
 
1.52

 
(1.39
)
Basic loss per share
$
(0.58
)
 
$
(2.45
)
 
$
(1.68
)
 
$
(9.79
)
 
 
 
 
 
 
 
 
Diluted (loss) earnings per common share:
 
 
 
 
 
 
 
Loss from continuing operations
$
(0.60
)
 
$
(2.19
)
 
$
(3.20
)
 
$
(8.40
)
Earnings (loss) from discontinued operations
0.02

 
(0.26
)
 
1.52

 
(1.39
)
Diluted loss per share
$
(0.58
)
 
$
(2.45
)
 
$
(1.68
)
 
$
(9.79
)
 
 
 
 
 
 
 
 
Weighted average number of common shares outstanding:
 
 
 
 
 
 
 
Basic
73,593

 
72,950

 
73,571

 
72,356

Diluted
73,593

 
72,950

 
73,571

 
72,356

    

Page 6 of 9



THE MEDICINES COMPANY
BALANCE SHEET ITEMS
UNAUDITED
(In thousands)

 
December 31, 2018
 
December 31, 2017
Cash and cash equivalents
$
238,310

 
$
151,359

Short-term investment
$
2,627

 
$

Total assets
$
841,686

 
$
872,983

Convertible senior notes (due 2022, 2023 and 2024)
$
792,752

 
$
649,198

The Medicines Company stockholders' (deficit) equity
$
(22,264
)
 
$
24,914




Page 7 of 9



THE MEDICINES COMPANY
RECONCILIATIONS OF GAAP TO ADJUSTED LOSS FROM CONTINUING OPERATIONS AND ADJUSTED LOSS PER SHARE
UNAUDITED
(In thousands, except per share amounts)
 
 
Three Months Ended
December 31,
 
Year Ended
December 31,
 
 
2018
 
2017
 
2018
 
2017
Loss from continuing operations
 
$
(44,292
)
 
$
(159,416
)
 
$
(235,216
)
 
$
(607,695
)
Before tax adjustments:
 
 
 
 
 
 
 
 
 Cost of product revenues:
 
 
 
 
 
 
 
 
      Share-based compensation expense
(1) 
67

 
110

 
178

 
722

      Amortization of acquired intangible assets
(2) 

 

 

 
4,486

      Inventory adjustments
(3) 

 
14,661

 
(407
)
 
11,348

      Restructuring charges
(4) 

 
(7
)
 
565

 
(55
)
      Market withdrawal of Ionsys
(5) 

 

 

 
8,458

Asset impairment charges
 
 
 
 
 
 
 
 
 Asset Impairment
(6) 

 

 
5,073

 

      Market withdrawal of Ionsys
(5) 

 

 

 
264,097

      Discontinuance of MDCO 700
(7) 

 

 

 
65,000

      Impairment of contingent purchase price
(8) 

 
63,000

 

 
63,000

 Research and development:
 
 
 
 
 
 
 
 
      Share-based compensation expense
(1) 
841

 
556

 
4,409

 
2,906

      Restructuring charges
(4) 
(20
)
 
1,435

 
3,080

 
1,794

      Milestone charges
(9) 

 
20,000

 

 
20,000

      Market withdrawal of Ionsys
(5) 

 

 

 
1,032

 Selling, general and administrative:
 
 
 
 
 
 
 
 
      Share-based compensation expense
(1) 
3,806

 
6,332

 
13,375

 
25,886

      Restructuring charges
(4) 
223

 
2,341

 
7,355

 
3,348

      Additional severance charges
(10) 
854

 
 
 
854

 
 
      Changes in contingent purchase price
(11) 

 

 
(258
)
 
692

      Gain on sale of pre-clinical ID products
(12) 
(21,556
)
 

 
(21,556
)
 

 Gain on sale of assets
(13) 

 

 
(7,025
)
 

One-time facility charges
(14) 
685

 

 
685

 

      Legal settlements
(15) 

 

 
3,550

 

      Market withdrawal of Ionsys
(5) 

 

 

 
3,434

      Discontinuance of MDCO 700
(7) 

 

 

 
(14,701
)
 Other:
 
 
 
 
 
 
 
 
     Non-cash interest expense
(16) 
7,389

 
6,543

 
27,915

 
26,868

Change in short-term investments
(17) 
10,010

 

 
48,652

 

Net loss tax adjustments
(18) 
(3,623
)
 

 
(51,030
)
 
(22,988
)
Loss from continuing operations - Adjusted
 
$
(45,616
)
 
$
(44,445
)
 
$
(199,801
)
 
$
(142,368
)
 
 
 
 
 
 
 
 
 
Loss from continuing operations per share - Adjusted
 
 
 
 
 
 
 
 
   Basic
 
$
(0.62
)
 
$
(0.61
)
 
$
(2.72
)
 
$
(1.97
)
   Diluted
 
$
(0.62
)
 
$
(0.61
)
 
$
(2.72
)
 
$
(1.97
)
Weighted average number of common shares outstanding:
 
 
 
 
 
 
 
 
   Basic
 
73,593

 
72,950

 
73,571

 
72,356

   Diluted
 
73,593

 
72,950

 
73,571

 
72,356


Page 8 of 9




Explanation of Adjustments:
(1)
Excludes share-based compensation of $4,714 and $6,998 for the three months ended December 31, 2018 and 2017 and $17,962 and $29,514 for the year ended December 31, 2018 and 2017 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 the Incline Therapeutics transaction.
(3)
Excludes all non-cash inventory adjustments.
(4) Excludes restructuring charges related to workforce reorganization initiated in the first quarter 2018 and the sale of the non-core cardiovascular products to Chiesi USA, Inc.
(5)
Excludes charges associated with the voluntary discontinuation and withdrawal of Ionsys from the market in the United States and cessation of related commercial activities in 2017.
(6)
Excludes non-cash asset impairment charges associated with the pre-clinical infectious disease products.
(7)
Excludes costs associated with the decision to discontinue the MDCO-700 program.
(8)
Excludes impairment of fair value of the contingent purchase price related to the discontinuation of Raplixa by Mallinckrodt plc.
(9)
Excludes upfront milestone payment for the first patient dosing in a pivotal study of inclisiran.
(10)
Excludes additional severance costs for employees excluded from the initial restructuring plan.
(11)
Excludes changes in fair value of the contingent price related to the acquisition of Rempex Pharmaceuticals, Inc. that were not included in the sale to Melinta.
(12)
Excludes gain from the sale of pre-clinical infectious disease products.
(13)
Excludes gain from the sale of the Angiomax business in the United States.
(14)
Excludes one-time non cash charges associated with the Parsippany facility.
(15)
Excludes net loss from one-time legal settlements in 2018.
(16)
Excludes non-cash interest expense which is in excess of the actual interest expense paid on the convertible senior notes.
(17)
Excludes changes in fair value with our investment in Melinta net of guaranteed payment accretion associated with the sale of our infectious disease business.
(18)
Excludes the estimated non-cash tax effect related to adjustments above.


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.




Page 9 of 9