World News: 12:00 GMT Wednesday 7th November 2018. [Melinta Therapeutics via Globe Newswire via SPi World News]
NEW HAVEN, Conn., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company, developing and commercializing novel antibiotics to treat serious bacterial infections, today reported financial results and provided a business update for the quarter ended September 30, 2018. Melinta made continued progress during the quarter driven by the achievement of several key milestones within its commercial, R&D and business development operations critical to positioning the company for long-term growth.
“We are taking deliberate and decisive steps to accelerate sales, lower costs and optimize cash,” said John Johnson, Interim CEO and Director of Melinta. “We have undertaken an optimization of our organization to refine our strategic focus on the critical needs of the business, while supporting the momentum of our ongoing launches. This includes initiatives to reduce or eliminate spending within our operations. As a result of these changes, we now expect more than $50 million in operating expense savings for 2019 from our current spending levels.”
“At the same time, we are making progress on our initiatives to drive growth with product sales demonstrating signs of recent acceleration that we are working hard to build upon especially in the outpatient setting. Importantly, we achieved several key milestones, including the agreement with Menarini Group to market Vabomere, Orbactiv and Minocin in 68 countries outside of the U.S., and the reporting of positive results from our Phase III trial of Baxdela for the treatment of adult patients with CABP. In addition, the recommendation by the CHMP for approval of Vabomere by the EMA for five indications was highly encouraging and brings us one step closer to providing access to this important treatment option for patients in Europe. We have much work ahead, but we are moving forward with urgency to drive profitable growth and shareholder value,” continued Johnson.
“From a financial perspective, we have received a funding commitment from Vatera Healthcare Partners, our largest shareholder, of up to $75.0 million in equity,” said Peter Milligan, Chief Financial Officer of Melinta. “Drawing on this option will help support the company as we enter 2019 and approach a number of contractual obligations and payments related to the acquisition of The Medicines Company’s infectious disease business earlier this year.”
Cost of goods sold (“COGS”) was $13.4 million for the quarter ended September 30, 2018, of which $10.4 million was comprised of non-cash amortization of intangible assets and the step-up basis in inventory acquired from The Medicines Company in January 2018 and charges for inventory that is approaching shelf life. There were no product sales and therefore no costs of goods sold in the prior year period.
Research and development (“R&D”) expenses were $13.1 million for the quarter ended September 30, 2018, compared to $10.9 million for the same period in 2017. Selling, general and administrative (“SG&A”) expenses were $34.3 million for the quarter ended September 30, 2018, compared to $10.3 million for the same period in 2017. R&D and SG&A expenses increased primarily as a result of the additional costs associated with the acquisition of The Medicines Company infectious disease business and the Cempra merger.
Net loss was $27.9 million, or $0.50 per share, for the quarter ended September 30, 2018 compared to a net loss of $19.6 million, or $857.35 per share, for the same period in 2017. Net loss per share is impacted by changes in our share count as a result of the Cempra merger and financing related to the acquisition of The Medicines Company infectious disease business.
Investors wishing to participate in the call should dial: 877-377-7553 and international investors should dial: 253-237-1151. The conference ID is 2096564. Investors can also access the call at .
A live webcast of the call will be available online from the Investor Relations section of the company website at 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 # 2096564.
As more fully described in our Annual Report on Form 10-K for the year ended December 31, 2017, the former private company Melinta was determined to be the accounting acquirer in our November 2017 reverse merger with Cempra and, accordingly, historical financial information for the third quarter of 2017 presented in this press release reflects the standalone former private company Melinta and, therefore, period-over-period comparisons may not be meaningful.
To supplement our financial results presented on a U.S. generally accepted accounting principles, or GAAP, basis, we have included information about non-GAAP adjusted EBITDA, a non‑GAAP financial measure, as a useful operating metric. We believe that the presentation of this non‑GAAP financial measure, when viewed with our results under GAAP and the accompanying reconciliation, provides supplementary information to analysts, investors, lenders, and our management in assessing the Company’s performance and results from period to period. This non‑GAAP measure closely aligns with the way management measures and evaluates the Company’s performance. This non‑GAAP financial measure should be considered in addition to, and not a substitute for, or superior to, net income or other financial measures calculated in accordance with GAAP. Non‑GAAP Adjusted EBITDA is not based on any standardized methodology prescribed by GAAP and represents GAAP net income (loss), which the Company believes is the most directly comparable GAAP measure, adjusted to exclude interest income, interest expense, depreciation and amortization, stock‑based compensation expense, changes in the fair value of our warrant liability, gain or loss on extinguishment of debt, acquisition-related costs, and other adjustments, including severance, lease exit costs and gain on the reversal of a loss contract. Non‑GAAP financial measures used by us may be calculated differently from, and therefore may not be comparable to, non‑GAAP measures used by other companies.
* “Other” reflects charges that we recorded for certain inventory approaching shelf life as well as lease exit charges for one of our vacated facilities.
Globe Newswire: 12:00 GMT Wednesday 7th November 2018
SPi News is published by Sector Publishing Intelligence Ltd.
© Sector Publishing Intelligence Ltd 2018. [Admin Only]
Sector Publishing Intelligence Ltd.
Agriculture House, Acland Road, DORCHESTER, Dorset DT1 1EF United Kingdom
Registered in England and Wales number 0751938.