On August 1, 2018 The Medicines Company (NASDAQ:MDCO) reported its financial results for the second quarter ended June 30, 2018 (Press release, Medicines Company, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361238 [SID1234528394]).

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"During the second quarter of 2018, we continued to advance inclisiran’s development programs, including the accumulation of further promising safety data from 3,660 patients in Phase III trials," said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. "We were also able to present consistent phase II subset efficacy data in various demographic and disease populations for LDL-C and other atherogenic lipoproteins. We look forward to further progress in 2018 and Phase III data read-outs in 2019."

Second quarter 2018 highlights included the following:

In April, the Company presented new data and analyses from multiple studies in the ORION development program for inclisiran at the National Lipid Association 2018 Scientific Sessions. The data demonstrated that inclisiran likely has a "one-size-fits-all" dosing regimen, without the necessity of dose adjustments, across a wide range of dyslipidemia patient populations, including those hard-to-treat patients with homozygous familial hypercholesterolemia (HoFH) and other sub-groups, such as patients with renal impairment and diabetes. The data showed that inclisiran lowered low-density lipoproteins cholesterol (LDL-C) by more than 50% for a wide range of dyslipidemia patient populations and sub-groups, and by up to 44% in HoFH patients.
In May, the Company presented the results of a pre-specified analysis of secondary endpoints from the ORION-1 Phase II trial at the 86thEuropean Atherosclerosis Society Congress. The results, which were published in Circulation, the journal of the American Heart Association, showed that, beyond its powerful effect on LDL-C, inclisiran also reduced atherogenic lipoproteins in a profound and sustained manner. Atherogenic lipoproteins – non-HDL-C, ApoB, VLDL-C and Lp(a) – have been associated with an increased risk of heart attacks and strokes, particularly in high-risk patients. The reductions, which were generally dose-dependent, were achieved most clearly with a 300 mg dose of inclisiran given on Day-1 and Day-90, and were sustained to the pre-specified time of assessment (180 days) and beyond (at least 210 days). This is the same starting dose of inclisiran being utilized in the Phase III trials (the Phase III dose of inclisiran is 300 mg given on Day-1 and Day-90, and then every six months thereafter).
In June, the Company presented new data from a pre-specified, subgroup analysis of dosing, efficacy and safety of inclisiran in patients with diabetes from the ORION-1 Phase II trial at the American Diabetes Association 78th Scientific Sessions. The data demonstrated that a subcutaneous injection of 300 mg of inclisiran given at Day-1 and Day-90 lowered LDL-C at Day-180 by more than 50% in patients with atherosclerotic cardiovascular disease (ASCVD) and those considered ASCVD-risk equivalents, regardless of whether those patients had diabetes. Importantly, the data showed that patients with and without diabetes experienced similar adverse event profiles, including no effects on control of blood glucose levels over six months.
In June, the Independent Data Monitoring Committee (IDMC) for the ongoing inclisiran Phase III clinical trials conducted its third, planned review of safety and efficacy data from the trials and recommended that they continue without modification. At the time of the review, substantially all patients in trials had received two doses of inclisiran or placebo, and more than 1,550 patient-years of safety data for inclisiran had been accumulated – with an additional 5 patient-years of safety data continuing to accumulate every day.
During the second quarter, the Company substantially completed the implementation of its previously-announced restructuring, as anticipated.
Commenting further, Dr. Meanwell said, "We continued to deliver against our 2018 objectives during the second quarter, demonstrating strong execution on all fronts. We remain sharply focused on tightening expense management and advancing the inclisiran development program efficiently."

Second-Quarter 2018 Financial Summary from Continuing Operations

On a GAAP basis, loss from continuing operations in the second quarter of 2018 was $54.5 million, or $0.74 per share, compared to a loss of $370.1 million, or $5.15 per share, in the second quarter of 2017. Included in loss from continuing operations for the second quarter of 2018 were restructuring charges of $6.1 million. On a non-GAAP basis, adjusted loss(1) from continuing operations in the second quarter of 2018 was $46.3 million, or $0.63(1) per share, compared to a loss of $52.0 million, or $0.72(1) per share, in the second quarter of 2017.

First Half 2018 Financial Summary from Continuing Operations

On a GAAP basis, loss from continuing operations in the first half of 2018 was $139.3 million, or $1.89 per share, compared to a loss of $441.1 million, or $6.17 per share, in the first half of 2017. Included in loss from continuing operations for the first half of 2018 was a non-cash, mark-to-market change in fair value of approximately $31.1 million associated with the Company’s common stock ownership in Melinta, guaranteed repayments and restructuring charges of $11.4 million. On a non-GAAP basis, adjusted loss(1) from continuing operations in the first half of 2018 was $102.6 million, or $1.40(1) per share, compared to a loss of $105.3 million, or $1.47(1) per share, in the first half of 2017.

First Half 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 and guaranteed payments, tiered royalty payments of between 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.

(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.

Net income from discontinued operations in the first half of 2018 was $114.2 million, compared to a net loss of $58.9 million in 2017. Net income from discontinued operations in the first half of 2018 included a pre-tax gain of approximately $169.0 million from the sale of the Company’s infectious disease business to Melinta.

At June 30, 2018, the Company had $162.5 million in cash and cash equivalents, compared to $151.4 million at the end of 2017.

Second-Quarter 2018 Conference Call and Webcast Information

The Company will host a conference call and webcast today, August 1, 2018, at 8:30 a.m., Eastern Daylight Time, to discuss its second-quarter 2018 financial results and provide clinical and operational updates. The dial-in information to access the call is as follows:

U.S./Canada: (877) 359-9508
International: (224) 357-2393
Conference ID: 5847059
A taped replay of the conference call will be available from 11:30 a.m., Eastern Daylight Time, today until 11:30 p.m., Eastern Daylight Time, on August 8, 2018. The replay may be accessed as follows:

U.S./Canada: (855) 859-2056
International: (404) 537-3406
Conference ID: 5847059
The webcast can be accessed in the "Investors" section of The Medicines Company website. A replay of the webcast will also be available.

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. 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.