PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company (NASDAQ:MDCO) today reported its financial results for the second quarter ended June 30, 2017, and provided an update on its clinical and operational activities.
Second Quarter 2017 Highlights and Projected Milestones
Meropenem-Vaborbactam
- The Company announced positive results from a planned, interim analysis of the TANGO-2 trial of its fixed-dose, investigational antibiotic combination, meropenem-vaborbactam, versus best available therapy. Randomization in the trial was stopped early, following a recommendation by the TANGO-2 independent Data and Safety Monitoring Board (DSMB) based on an analysis of 72 patients, including 43 patients with microbiologically evaluable carbapenem-resistant Enterobacteriaceae (CRE) infections of blood, lung, urinary tract and abdominal organs. The DSMB concluded that a risk-benefit analysis of available data no longer supported randomization of additional patients to the best available therapy comparator arm. In the interim analysis, when compared to best available therapy, meropenem-vaborbactam demonstrated higher clinical cure rates at test-of-cure and end-of-therapy among microbiologically evaluable CRE patients; higher clinical cure rates across all infection types; lower all-cause mortality, particularly in high-risk situations (e.g., HABP-VABP and bacteremia); and a superior safety profile, including fewer serious treatment emergent adverse events and lower rates of renal toxicity. The Company will continue to enroll patients into an amended, single-arm study protocol for treatment with meropenem-vaborbactam at selected study centers.
- The Company announced that it selected, and both U.S. and European regulatory authorities accepted, Vabomere™ as the U.S. and European trade name for meropenem-vaborbactam, assuming marketing applications are approved.
- The PDUFA action date for meropenem-vaborbactam is August 29, 2017. The Company is currently completing pre-launch activities and, if Vabomere is approved by the U.S. Food and Drug Administration (FDA), will leverage its fully-integrated, dedicated sales and marketing infrastructure to launch Vabomere in the United States.
- The European Medicines Agency (EMA) has validated the Company’s Marketing Authorization Application (MAA) for meropenem-vaborbactam, which confirms that the MAA submission is complete and initiates the Centralized Review process by the EMA’s Committee for Medicinal Products for Human Use. The MAA submission will be reviewed under the Centralized Procedure and, if authorized, will provide a marketing authorization for Vabomere which is valid in all European Economic Area member states.
Inclisiran (PCSK9 synthesis inhibitor)
- The Company came to agreement with the FDA and received Scientific Advice from the EMA on plans for the Phase III clinical program for inclisiran, which is designed to support the submission of an initial New Drug Application (NDA) and a MAA for an LDL-C lowering indication. The Phase III program will comprise clinical trials in patients with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk-equivalent and familial hypercholesterolemia (FH), and will collectively enroll a total of 3,400 subjects – 1,700 subjects randomized to inclisiran and 1,700 subjects randomized to placebo. The primary endpoint will be percentage change in LDL-C from baseline at Day-510 and the studies will have an 18-month observation period.
- The Company announced that, although not part of the initial NDA, it will perform a cardiovascular outcomes trial in approximately 14,000 patients with ASCVD and/or risk equivalents, such as diabetes, to determine the effects of inclisiran on reducing cardiovascular outcomes. The Company also came to agreement with the FDA and received Scientific Advice from the EMA on the design of the outcomes trial. The primary efficacy endpoint of the trial will be a composite, including coronary heart disease, death, non-fatal myocardial infarction and fatal and non-fatal ischemic stroke. As has been demonstrated in previous, similar outcomes trials, these endpoints are modifiable by LDL-C lowering.
- Significant preparation work for the inclisiran Phase III LDL-C lowering program and the cardiovascular outcomes trial has been completed. All Phase III LDL-C lowering trials are expected to commence before year-end. The Company expects to read out final data from the Phase III LDL-C lowering trials in the second half of 2019. The cardiovascular outcomes trial will commence concurrently with the Phase III LDL-C lowering program. The duration of the outcomes trial will be long enough to maximize the clinical effect size associated with LDL-C lowering and to minimize the number-needed-to-treat (NNT) result.
- The Company will present new, one-year follow-up data on inclisiran from the ORION-1 study at the upcoming ESC Congress 2017, organized by the European Society of Cardiology, being held August 26 through August 30 in Barcelona, Spain.
MDCO-700
- The Company recently completed studies to characterize the central nervous system effects of our investigational anesthetic agent, MDCO-700, in dogs. During those studies, we observed seizures in some animals, although the mechanism remains unclear. Seizures have not been observed in humans and these dog findings may be species-specific. Nevertheless, these findings do not support the target profile required to initiate Phase III development of MDCO-700. Therefore, the Company has discontinued development of, and ceased all further investment in, the product.
Second Quarter 2017 Financial Summary from Continuing Operations
Worldwide net revenue was $18.7 million in the second quarter of 2017 compared to $54.7 million in the second quarter of 2016. Included in total net revenue for the second quarter of 2017 and 2016 were $10.7 million and $40.2 million, respectively, of total Angiomax revenue, including both royalty revenues derived from the gross profit on authorized generic sales of Angiomax® (bivalirudin) by Sandoz, Inc. and worldwide Angiomax®/Angiox® (bivalirudin) net product sales. Other products, including Minocin® (minocycline) for Injection and Orbactiv® (oritavancin), recorded aggregate sales of $8.0 million in the second quarter of 2017 compared to $6.3 million in the second quarter of 2016. The second quarter of 2016 also included $8.2 million of sales related to the divested non-core cardiovascular products.
On a GAAP basis, net loss from continuing operations in the second quarter of 2017 was $397.3 million, or $5.52 per share, compared to net income from continuing operations of $181.8 million, or $2.51 per share, in the second quarter of 2016. Included in the net loss from continuing operations for the second quarter of 2017 were net charges of approximately $277.0 million ($268.1 million non-cash) associated with the discontinuation and market withdrawal of Ionsys® (fentanyl iontophoretic transdermal system) in the U.S. market, and $27.3 million (non-cash) associated with the discontinuation of the clinical development program for MDCO-700, our investigational anesthetic agent. On a non-GAAP basis, adjusted net loss (1) from continuing operations in the second quarter of 2017 was $73.5 million, or $1.02(1) per share, compared to $48.2 million, or $0.69(1) per share, in the second quarter of 2016.
Second Quarter 2016 Financial Summary from Discontinued Operations
In the first quarter of 2016, the Company completed the divestiture of its hemostasis products for an upfront payment of $174.1 million, and potential milestone payments of up to an additional $235.0 million in the aggregate following the achievement of certain specified net sales milestones. Net income from discontinued operations in the second quarter of 2016 was $0.6 million, or $0.01 per share.
First Half 2017 Financial Summary from Continuing Operations
Worldwide net revenue was $43.0 million in the first half of 2017 compared to $105.0 million in the first half of 2016. Included in total net revenue for the first half of 2017 and 2016 were $28 million and $76 million, respectively, of total Angiomax revenue, including both royalty revenues derived from the gross profit on authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. and worldwide Angiomax/Angiox (bivalirudin) net product sales. Other products, including Minocin (minocycline) for Injection and Orbactiv (oritavancin), recorded aggregate sales of $15.0 million in the first half of 2017 compared to $10.6 million in the first half of 2016. The first half of 2016 also included $18.4 million of sales related to the divested non-core cardiovascular products.
