On March 13, 2018 Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, reported financial results and an update on commercial and regulatory activities for the quarter ended December 31, 2017 (Press release, Cempra, MAR 13, 2018, View Source [SID1234524729]). During the quarter, the Company completed its reverse merger with Cempra, Inc. (Cempra) to become a publicly traded company. Fourth quarter and full year 2017 results include the addition of the Cempra business as of the merger date of November 3, 2017. Immediately following the quarter, the Company acquired the infectious disease business of The Medicines Company, including products Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin) and Minocin (minocycline) for Injection. This press release includes highlights from The Medicines Company infectious disease business as of acquisition close on January 5, 2018.
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"Following Melinta becoming a public company on November 3, we swiftly acquired the infectious disease business from The Medicines Company, transforming Melinta into the largest global, pure-play antibiotics company. Today, we have a strong portfolio of products including Vabomere, Orbactiv and Minocin for Injection, together with our first drug Baxdela that we launched just this quarter," said Dan Wechsler, president and CEO of Melinta.
"We have a strong combined team, including the addition of over 150 seasoned professionals at the time of The Medicines Company transaction, and a leading pipeline of development and discovery assets including those from our own Nobel Prize-winning discovery platform. 2018 will be an exciting year for Melinta, and we look forward to launching our products, furthering our pipeline and telling our story focused on bringing life-saving anti-infective products to areas of unmet need and, in turn, building strong shareholder value over the long-term," Mr. Wechsler concluded.
Full Year 2017 and Recent Business Highlights
• March 2, 2017 – entered into commercial and co-development agreement with Menarini Group for delafloxacin in 68 countries outside of the United States
• >$100 million of upfront and potential milestone payments and double-digit royalties on sales in partnered territories
• Menarini pays 50% of future delafloxacin indication-expansion efforts
LOGO
• June 19, 2017 – the U.S. Food and Drug Administration (FDA) approved Baxdela indicated in adults for treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria
• A fluoroquinolone that exhibits activity against both Gram-positive and Gram-negative pathogens, including the distinction of being the only approved drug in its class that covers methicillin-resistant Staphylococcus aureus (MRSA)
• A fixed-dose therapy with limited disease or drug interactions and is available in interchangeable intravenous and oral formulations
• September 26, 2017 – announced the expansion of agreement with Eurofarma Laboratorios S.A. (Eurofarma) to include 19 countries in South and Central America and the Caribbean
• Eurofarma has submitted a marketing authorization for delafloxacin in Argentina
• November 3, 2017 – completed the reverse merger with Cempra to become a publicly traded company
• January 5, 2018 – acquired the infectious disease business of The Medicines Company, including approved products Vabomere, Orbactiv and Minocin for Injection
• Added a well-experienced commercial, medical affairs and commercial support organization
• Integration nearing completion
• Minimal disruption to product launches or performance, including Vabomere, which was recently launched
• February 6, 2018 – launched Baxdela in the United States
• March 8, 2018 – partner Menarini submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for delafloxacin for treatment of adults with ABSSSI
Q4 and Full Year 2017 Financial Results
Melinta reported a net loss available to shareholders of $20.9 million, or $1.48 per share, for the quarter ended December 31, 2017 compared to a net loss of $27.7 million for the same period in 2016. For the full year ended December 31, 2017, the Company reported net loss available to shareholders of $78.2 million.
Research and development expenses were $11.6 million for the quarter ended December 31, 2017, compared to $16.3 million for the same period in 2016. The decrease was driven primarily by fourth quarter 2016 New Drug Application (NDA)-related fees and milestone payments and lower manufacturing costs. For the full year ended December 31, 2017, the Company reported R&D expenses of $49.5 million.
LOGO
Selling, general and administrative expenses were $37.3 million for the quarter ended December 31, 2017, compared to $4.6 million for the same period in 2016. The increase was driven primarily by commercial launch preparation activities for Baxdela and transaction- and integration-related costs, including severance and stock-based compensation, due to the merger. For the full year ended December 31, 2017, the Company reported selling, general and administrative expenses of $63.3 million.
As of December 31, 2017, Melinta had cash and cash equivalents of $128.4 million. In addition, the Company has available debt capacity under the Deerfield agreement. It is anticipated that Melinta may strengthen its cash position through the completion of business development activities, similar to the transaction completed with Menarini. The Company also recently filed a universal shelf registration statement on Form S-3 with the SEC, which will allow the Company to provide more timely and efficient access to the capital markets should the Company decide to issue securities in the future, subject to market conditions.
2017 and Recent Pipeline and Publication Highlights
Includes highlights from The Medicines Company infectious disease business as of acquisition close on January 5, 2018.
• Publication of Baxdela Outcomes in ABSSSI Patients with Fluoroquinolone-resistant S. aureus Isolates
• Presented Outcomes of Baxdela Treatment of Gram-Positive and Gram-Negative Pathogens at IDWeek 2017
• Announced Topical Radezolid (partnered product) Well Tolerated in Phase 1 Study for Treatment of Acne, Initiation of Program in Patients with Bacterial Vaginosis, and Qualified Infectious Disease Product (QIDP) Designation for Bacterial Vaginosis
• Publication in Journal of Antimicrobial Chemotherapy of 1st Pivotal Phase 3 Baxdela Trial Data in ABSSSI
• Complete Results from the Phase 3 TANGO-1 Data for Vabomere Published in The Journal of the American Medical Association (JAMA)
• 2nd Pivotal Phase 3 Baxdela ABSSSI Trial Data Published in Clinical Infectious Diseases
• Discovery Platform Oral Presentations at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) and American Society for Microbiology (ASM Microbe) Highlighting Progress Towards Leads for Drug-resistant Neisseria gonorrhoeae and Multidrug- and Extremely Drug-resistant ESKAPE Pathogens
2018 Upcoming Potential Catalysts
• Pivotal Phase 3 data for Baxdela in community-acquired bacterial pneumonia (CABP)
• Vabomere EMA regulatory approval decision
• TANGO-2 additional data and potential publications
• Additional ex-US approvals for Baxdela in Central and South America
• Ex-US partnership opportunities for Vabomere, Orbactiv and Minocin for Injection
• IND-enabling studies for lead ESKAPE compound
Conference Call and Webcast
Melinta’s earnings conference call for the quarter ended December 31, 2017 will be broadcast at 8:30am EDT on March 13, 2018. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Melinta’s website at www.melinta.com.
Investors wishing to participate in the call should dial: 877-377-7553 and international investors should dial: 253-237-1151. The conference ID is 7787858. Investors can also access the call at View Source
A live webcast of the call will be available online from the investor relations section of the company website at www.melinta.com and will be archived there for 30 days. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 7787858.