On October 25, 2017 The Medicines Company (NASDAQ: MDCO) reported its financial results for the third quarter ended September 30, 2017, and provided an update on its clinical and operational activities (Press release, Medicines Company, OCT 25, 2017, View Source [SID1234521157]).
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"We made significant clinical and strategic progress during the third quarter," said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. "We aggressively advanced start-up work for the inclisiran Phase III clinical program, preparing investigational sites–which began screening patients in September–and manufacturing double-blind-packaged drug supply, and are pleased to announce that dosing of patients in the Phase III LDL-C lowering program will commence next week. We remain confident that all trials comprising the inclisiran LDL-C lowering program will commence before year-end. Turning to our process to monetize our Infectious Disease Business (ID Business), we continue to expect to announce a transaction to divest the business before the end of the year. In the meantime, independent of that transaction, we are finalizing plans to significantly restructure the remainder of The Medicines Company. We anticipate that the restructuring, which we intend to substantially implement within the next 45 days, will reduce headcount to less than 60 people at The Medicines Company (excluding the ID Business), significantly reducing go-forward annual operating expenses. As indicated in our strategic plans previously disclosed, we believe that the restructuring, when taken together with the anticipated disposition of our ID Business, will provide the Company with a strong financial position from which to aggressively advance the inclisiran development program to anticipated readout of final data from the Phase III LDL-C lowering trials in the second half of 2019. We expect to provide further information regarding the restructuring plan and its implementation in our third quarter Form 10-Q."
Third-Quarter 2017 Highlights
Inclisiran (PCSK9 synthesis inhibitor)
On August 28, 2017, new, one-year data from the ORION-1 Phase II study of inclisiran was presented in the "Hot Line – Late-Breaking Clinical Trials 2" session at the European Society of Cardiology (ESC) Congress 2017. Efficacy data presented reaffirmed inclisiran’s significant LDL-C lowering effects following a starting dose of 300 mg given on Day-1 and Day-90, after which the mean LDL-C reduction was 56% at Day-150 and 51% at Day-180. For the subsequent six-month period – from Day-90 to Day-270 – the time-averaged LDL-C reduction was 51%, with minimum intra-patient variability over time (all comparisons to placebo P <0.0001). These robust data underscore the selection of a six-monthly maintenance dose of 300 mg in the inclisiran Phase III clinical program. With completion of one-year follow-up, safety data for inclisiran from the Phase II ORION-1 study now include 370 subject-years of observation, including at least 300 subject-years of inclisiran effects. As in prior analyses, no material safety issues were observed on inclisiran, which continued to demonstrate an adverse event profile similar to placebo. There were no deaths or serious adverse events during the extended observation period. In particular, in spite of the prolonged LDL-C lowering effects of inclisiran, there were no investigational drug-related elevations of liver enzymes and no neuropathy, change in renal function, thrombocytopenia or anti-drug antibodies during extended follow-up, or at any earlier time periods in the ORION-1 study.
VABOMERE
On August 29, 2017, the U.S. Food and Drug Administration (FDA) approved VABOMERE (meropenem-vaborbactam) for injection for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Enterobacteriaceae – Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex.
At IDWeek 2017 in October, the Company presented new data on VABOMERE, including results from the landmark TANGO II study of VABOMERE versus "best available therapy" (BAT) in the treatment of suspected or documented infections due to carbapenem-resistant Enterobacteriaceae (CRE). Highlights from the posters on the TANGO II study included:
VABOMERE was associated with a higher clinical cure versus BAT in patients with a baseline organism that was CRE (mCRE-MITT population) at both end-of-therapy (EOT) (VABOMERE 64.3% vs. BAT 33.3%; p=0.04) and test-of-cure (TOC) (VABOMERE 57.1% vs. BAT 26.7%; p=0.04). In immunocompromised patients, VABOMERE was also associated with a higher clinical cure versus BAT at EOT (VABOMERE 60% vs. BAT 12.5%; p<0.01), and a relative mortality benefit of 46.7%.
In further exploratory analyses, VABOMERE was associated with a relative mortality benefit of 84% (p = 0.03) compared to BAT when excluding patients with previous antibiotic failures.
Sensitivity Analysis of Clinical Cure at TOC and All-Cause Mortality at Day 28 Across All
Infection Types (mCRE-MITT) Excluding Prior Antibiotic Failure
M-V
N=19
n (%) BAT
N=15
n (%)
Absolute Difference
(95% CI)
P value
Relative
Difference
Patients with All Infection Types
Clinical Cure at TOC 13 (68.4) 4 (26.7) 41.8 (11.1 to 72.4) 0.008 156.2
Day-28 All-cause Mortality 1 (5.3) 5 (33.3) -28.1 (-54.0 to -2.2) 0.03 -84.1
VABOMERE was associated with decreased nephrotoxicity and significantly fewer treatment-related adverse events versus BAT.
An analysis using the composite endpoints of clinical failure or nephrotoxicity demonstrated a risk-benefit profile favoring VABOMERE versus BAT (VABOMERE 32.1% vs BAT 80.0% (95% CI: −74.5 to −21.2; P< 0.001)).
In July 2017, the Company announced randomization in the TANGO II trial was stopped early following a recommendation by the TANGO II independent Data and Safety Monitoring Board (DSMB) based on an analysis of 72 patients, including 43 patients with microbiologically evaluable 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.
VABOMERE is now available for pharmacies to order through wholesalers and usual distribution channels.
Third-Quarter 2017 Financial Summary from Continuing Operations
Worldwide net revenue was $16.9 million in the third quarter of 2017 compared to $37.6 million in the third quarter of 2016. Included in total net revenue for the third quarter of 2017 and 2016 was $7.9 million and $28.9 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 recorded aggregate sales of $9.0 million in the third quarter of 2017 compared to $6.7 million in the third quarter of 2016. Among these other products, Minocin (minocycline) for Injection and Orbactiv (oritavancin) recorded sales of $9.0 million in the third quarter of 2017 compared to $6.5 million in the third quarter of 2016, an increase of 38%, predominantly driven by an increase in Orbactiv (oritavancin) revenue of 57%, from $4.3 million in the third quarter of 2016 to $6.8 million in the third quarter of 2017. The third quarter of 2016 also included $2.0 million of sales related to the divested non-core cardiovascular products.
On a GAAP basis, net loss from continuing operations in the third quarter of 2017 was $30.2 million, or $0.42 per share, compared to $86.4 million, or $1.23 per share, in the third quarter of 2016. On a non-GAAP basis, adjusted net loss (1) from continuing operations in the third quarter of 2017 was $86.3 million, or $1.19(1) per share, compared to $44.8 million, or $0.64(1) per share, in the third quarter of 2016.
Third-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 third quarter of 2016 was $0.1 million.
First Nine Months 2017 Financial Summary from Continuing Operations
Worldwide net revenue was $59.8 million in the first nine months of 2017 compared to $142.6 million in the first nine months of 2016. Included in total net revenue for the first nine months of 2017 and 2016 was $35.9 million and $104.9 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 $23.9 million in the first nine months of 2017 compared to $17.4 million in the first nine months of 2016. The first nine months of 2016 also included $20.3 million of sales related to the divested non-core cardiovascular products.
On a GAAP basis, net loss from continuing operations in the first nine months of 2017 was $530.1 million, or $7.39 per share, compared to net income from continuing operations of $5.1 million, or $0.07 per share, in the first nine months of 2016. Included in net loss from continuing operations for the first nine months of 2017 were net charges of approximately $277.0 million associated with the discontinuation and market withdrawal of Ionsys (fentanyl iontophoretic transdermal system) in the U.S. market, and $27.3 million 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 first nine months of 2017 was $234.5 million, or $3.27(1) per share, compared to $164.2 million, or $2.35(1) per share, in the first nine months of 2016.
First Nine Months 2016 Financial Summary from Discontinued Operations
Net loss from discontinued operations in the first nine months of 2016 was $1.4 million, or $0.02 per share.
(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 September 30, 2017, the Company had a total of $208.9 million in cash and cash equivalents and available for sale securities.
Third-Quarter 2017 Conference Call and Webcast Information
The Company will host a conference call and webcast today, October 25, 2017, at 8:30 a.m., Eastern Daylight Time, to discuss its third-quarter 2017 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: 9194649
A taped replay of the conference call will be available from 11:30 a.m., Eastern Daylight Time, today until 11:30 a.m., Eastern Daylight Time, on November 1, 2017. The replay may be accessed as follows:
U.S./Canada: (855) 859-2056
International: (404) 537-3406
Conference ID: 9194649
The webcast can be accessed in the Investors section of The Medicines Company website. A replay of the webcast will also be available.