PARSIPPANY, N.J.--(BUSINESS WIRE)--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.

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.

(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.

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.

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.

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.comand follow us on Twitter@MDCONews.