Form 8-K MELINTA THERAPEUTICS, For: Aug 09
Tweet
Share
E-mailUNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): August 9, 2019
MELINTA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE | 001-35405 | 45-4440364 | ||
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||
44 Whippany Rd, Ste 280, Morristown, NJ | 07960 | |
(Address of principal executive offices) | (Zip Code) | |
Registrant’s telephone number, including area code (908) 617-1309
Title of Each Class | Trading Symbol | Name of Exchange on which Registered |
Common Stock, $0.001 Par Value | MLNT | Nasdaq Global Market |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 2.02. Results of Operations and Financial Condition.
On August 9, 2019, Melinta Therapeutics, Inc. (the “Company”) issued a press release announcing its results for its second quarter ended June 30, 2019. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by reference in such filing.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Kevin Ferro resigned from the Board of Directors (the “Board”) and all committees of the Board of the Company effective August 5, 2019. Mr. Ferro’s resignation did not involve any disagreement with the Company on any matter relating to the Company's operations, policies or practices. The Company and the Board wish to thank Mr. Ferro for his many years of dedicated service.
John H. Johnson resigned from his position as chief executive officer (“CEO”) of the Company effective August 5, 2019. Mr. Johnson will serve as acting CEO for at least thirty days to work through the transition, including the search process and appointment of a permanent successor. Mr. Johnson also resigned from the Board and all committees of the Board effective August 5, 2019. Mr. Johnson’s decision to resign is due to changes in the Company’s circumstances and in order to pursue other opportunities and not because of a disagreement with the Company on any matter relating to the Company's operations, policies or practices.
In connection with Mr. Johnson's resignation, the Company expects to enter into a separation and release agreement with Mr. Johnson that will include the provision of consulting services by Mr. Johnson to the Company for a period of at least six months and such other terms as may be mutually agreed upon between the Board and Mr. Johnson. A copy of any such separation and release agreement will be filed as an exhibit in a subsequent filing.
David Gill, a current member of the Board of the Company, has been named chairman of the Board, effective August 5, 2019.
On August 9, 2019, the Company issued a press release announcing the changes to the composition of the Board and executive management team. A copy of the Company’s press release is attached as Exhibit 99.2 hereto.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Melinta Therapeutics, Inc.. | |||
By: | /s/ Peter J. Milligan | ||
Peter J. Milligan | |||
Chief Financial Officer | |||
Dated: August 9, 2019
Melinta Therapeutics Reports Second Quarter 2019 Financial Results and Provides Business Update
~ Revenue of $16.0 million, Including Net Product Sales of $13.8 million, for the Second Quarter 2019 ~
~ Reduction of Operating Expenses of 32 Percent, or $16.3 million, Year-Over-Year ~
~ Commenced Enrollment in Clinical Trial Evaluating Orbactiv® (oritavancin) Shorter Infusion Time Formulation in Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ~
~ First Commercial Sale of Baxdela® (delafloxacin) Outside of the United States ~
Morristown, N.J., August 9, 2019 - 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 second quarter ended June 30, 2019.
“Melinta’s second quarter 2019 results were driven by accelerating product sales, disciplined financial stewardship, and improved operational efficiencies. We continue to make strides towards expanding the market for our product portfolio with the potential approval of Baxdela® (delafloxacin) for community-acquired bacterial pneumonia (CABP) and have enrolled more than half of the target study population in a clinical study evaluating a shorter infusion time formulation of Orbactiv® (oritavancin) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI),” said John H. Johnson, chief executive officer of Melinta. “We also applaud the recent and final ruling from the Centers for Medicare & Medicaid Services (CMS) to increase the new technology add-on payment, or NTAP, for Vabomere® (meropenem and vaborbactam) from 50 to 75 percent for the fiscal year 2020, which will be effective October 1, 2019,” Johnson added.
"We are encouraged with the progress we have made toward our financial stewardship goals and product sales revenue growth. However, we continue to face significant risk relative to near-term compliance with the Company’s financial commitments and covenants under its credit and convertible notes facilities. We are working diligently to negotiate with our creditors to navigate a path forward to continue executing against our strategy to provide effective antibiotics for patients in need,” said Peter Milligan, chief financial officer of Melinta.
Second Quarter 2019 Financial Results
Melinta reported revenue of $16.0 million and $12.0 million, respectively, for the three-month periods ended June 30, 2019 and 2018. Revenue from product sales was $13.8 million in the second quarter of 2019, up 51 percent1 from the second quarter of 2018. Revenue from product sales was $25.6 million for the six-month period ended June 30, 2019, up 22 percent1 from $21.0 million reported in the six-month period ended June 30, 2018.
in USD millions | Q2 2019 | Q2 2018 | YTD 2019 | YTD 2018 | |||||||||
Product sales, net | $ | 13,825 | $ | 9,152 | $ | 25,600 | $ | 20,998 | |||||
Contract research | 2,130 | 2,870 | 3,539 | 5,865 | |||||||||
License | — | — | 900 | — | |||||||||
Total revenue * | $ | 15,955 | $ | 12,022 | $ | 30,039 | $ | 26,863 | |||||
Cost of goods sold (COGS) was $8.6 million and $11.0 million, respectively, for the three-month periods ended June 30, 2019 and 2018, respectively, including $4.1 million and $3.5 million of non-cash amortization of intangible assets. For the six-month periods ending June 30, 2019 and 2018, COGS was $16.0 million and $18.7 million, respectively, including $8.2 million of non-cash amortization of intangible assets in each period.
Research and development (R&D) expenses were $3.5 million and $15.8 million, respectively, for the three-month periods ended June 30, 2019 and 2018, and $8.9 million and $31.9 million, respectively, for the six-month periods ended June 30, 2019 and 2018. For both the three- and six-month periods ended June 30, 2019, R&D expenses decreased year-over-year primarily as a result of the completion of the Company's Phase 3 study for Baxdela in CABP as well as winding down its early research and discovery programs, which was completed in March 2019.
1 In connection with its second quarter 2018 earnings release, Melinta disclosed that in the second quarter of 2018, net product sales were negatively impacted by approximately $2.7 million related to the integration of distribution channels in connection with the acquisition of the infectious disease business of The Medicines Company. Absent this integration activity in the second quarter of 2018, net product sales for the three- and six-month periods ended June 30, 2019 would have increased 17 percent and 8 percent, respectively, year-over-year.
Selling, general and administrative (SG&A) expenses were $30.9 million and $34.9 million, respectively, for the three-month periods ended June 30, 2019 and 2018, and $56.9 million and $69.6 million, respectively, for the six-month periods ended June 30, 2019 and 2018. For both the three- and six-month periods ended June 30, 2019, SG&A expenses decreased year-over-year primarily as a result of the cost-cutting measures the Company initiated in the fourth quarter of 2018.
Net loss was $36.2 million, or $3.07 per share, for the three-month period ended June 30, 2019, compared to a net loss of $55.8 million, or $6.92 per share, for the three-month period ended June 30, 2018. Net loss was $62.7 million, or $5.42 per share, for the six-month period ended June 30, 2019, compared to a net loss of $85.2 million, or $11.96 per share, for the six-month period ended June 30, 2018. Net loss per share year-over-year reflects changes in share count as a result of the one-for-five reverse stock split effective on February 22, 2019.
The Company ended the quarter with $90.3 million of cash and cash equivalents.
The Company is not providing any financial guidance for the full-year 2019.
Recent Portfolio Updates
• | CMS released the final rule for the 2020 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and has increased the NTAP for Vabomere, from 50 to 75 percent for the fiscal year 2020, which is effective October 1, 2019 |
• | The U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental New Drug Application (sNDA) for Baxdela seeking to expand the current indication to include adult patients with community-acquired bacterial pneumonia (CABP); the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of October 24, 2019 |
• | In July, the Company commenced enrollment in a Phase 1 study to evaluate the pharmacokinetics and safety of a new formulation of Orbactiv versus the approved formulation in subjects with ABSSSI; the new formulation aims to reduce infusion time from three hours to one hour |
• | The World Health Organization (WHO) added Vabomere (meropenem and vaborbactam) to its Essential Medicines List for its ability to target multidrug-resistant infections caused by pathogens deemed a "critical priority" by the WHO, including carbapenem-resistant Enterobacteriaceae |
• | Our partners in Latin America sold the first commercial product of Baxdela outside of the United States in Uruguay |
Upcoming Potential Catalysts
• | FDA approval for Baxdela for the treatment of CABP in adults by October 24, 2019 |
• | European Commission approval decision for delafloxacin (to be marketed under the brand name Quofenix) for ABSSSI |
• | Country approvals for Baxdela in South America and Central America |
About Melinta Therapeutics
Melinta Therapeutics, Inc. is the largest pure-play antibiotics company, dedicated to saving lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new therapeutic solutions. Its four marketed products include Baxdela (delafloxacin), Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin), and Minocin® (minocycline) for Injection. This portfolio provides Melinta with the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit www.melinta.com for more information.
Non-GAAP Financial Measures
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, gains or losses on extinguishment of debt and other liabilities, and acquisition-related costs. 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.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this communication constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions, including statements related to guidance. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made and include statements regarding: expectations with respect to our financial position, results and performance, compliance with our debt facilities and discussions with our creditors. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations, strategies or prospects will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control.
Risks and uncertainties for Melinta include, but are not limited to, the fact that we have incurred significant operating losses since inception and will incur continued losses for the foreseeable future; our limited operating history; our need for future capital and risks related to our ability to obtain additional capital to fund future operations; risks related to our failure to close on the full amount of the two disbursements under the Vatera loan financing and risks related to the satisfaction of the closing conditions for the remaining disbursement amount, including the inability to close on such disbursement; risks related to our ability to borrow additional amounts under the Deerfield facility agreement; risks related to compliance with the covenants under our facilities with Vatera and Deerfield; risks related to our future liquidity, including uncertainties of cash flows and inability to meet working capital needs as well as other milestone, royalty and payment obligations, including as a result of the outcome of the pending litigation with respect to, and any requirement to make, payments potentially due under our purchase agreement with to The Medicines Company; risks that may arise from the Vatera loan financing and the Deerfield facility agreement, including potential dilution to our stockholders and the fact that Vatera beneficially owns a substantial portion of our common stock; risks related to our ability to continue as a going concern unless we can secure additional sources of liquidity; our substantial indebtedness; risks related to potential strategic transactions; risks related to the commercial launches of our products and our inexperience as a company in marketing drug products; the degree of market acceptance of our products among physicians, patients, health care payors and the medical community; the pricing we are able to achieve for our products; failure to obtain and sustain an adequate level of reimbursement for our products by third-party payors; inaccuracies in our estimates of the market for and commercialization potential of our products; failure to maintain optimal inventory levels to meet commercial demand for any of our products; risks that our competitors are able to develop and market products that are preferred over our products; our dependence upon third parties for the manufacture and supply of our marketed products; failure to achieve the benefits of our recently completed transactions with Cempra and The Medicines Company; failure to establish and maintain development and commercialization collaborations; uncertainty in the outcome or timing of clinical trials and/or receipt of regulatory approvals for our product candidates; undesirable side effects of our products; failure of third parties to conduct clinical trials in accordance with their contractual obligations; our ability to identify, develop, acquire or in-license products; difficulties in managing the growth of our company; the effects of recent comprehensive tax reform; risks related to failure to comply with extensive laws and regulations; product liability risks related to our products; failure to retain key personnel; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; risks relating to third party infringement of intellectual property rights; our ability to maintain effective internal control over financial reporting; unfavorable outcomes in any of the class action and shareholder derivative lawsuits currently pending against the Company; and the fact that a substantial number of shares of common stock may be sold into the public markets by one or more of our large stockholders in the near future. Many of these factors that will determine actual results are beyond Melinta’s ability to control or predict.
Other risks and uncertainties are more fully described in our Annual Report on Form 10-K for the year ended December 31, 2018, our Revised Definitive Proxy Statement filed January 29, 2019, and in other filings that Melinta makes and will make with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as
of the date stated herein, and subsequent events and developments may cause our expectations and beliefs to change. While we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date after the date stated herein.
Melinta Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
June 30, 2019 | December 31, 2018 | |||||
Assets | ||||||
Cash and cash equivalents | $ | 90,343 | $ | 81,808 | ||
Receivables | 19,081 | 22,485 | ||||
Inventory | 42,043 | 41,341 | ||||
Prepaid expenses and other current assets | 5,292 | 3,848 | ||||
Total current assets | 156,759 | 149,482 | ||||
Property and equipment, net | 1,309 | 1,586 | ||||
Intangible assets, net | 220,949 | 229,196 | ||||
Other assets | 61,355 | 61,326 | ||||
Total assets | $ | 440,372 | $ | 441,590 | ||
Liabilities | ||||||
Accounts payable | $ | 5,792 | $ | 16,765 | ||
Accrued expenses | 27,260 | 33,924 | ||||
Deferred purchase price and other liabilities | 83,031 | 78,394 | ||||
Accrued interest on notes payable | 4,305 | 4,485 | ||||
Warrant liability | 129 | 38 | ||||
Conversion liability | 11,869 | — | ||||
Total current liabilities | 132,386 | 133,606 | ||||
Notes payable, net of debt discount and costs | 93,821 | 110,476 | ||||
Convertible notes payable to related parties, net of debt discount and costs | 63,239 | — | ||||
Other long-term liabilities | 9,259 | 7,444 | ||||
Total long-term liabilities | 166,319 | 117,920 | ||||
Total liabilities | $ | 298,705 | $ | 251,526 | ||
Commitments and Contingencies | ||||||
Shareholders' Equity | ||||||
Common stock | 12 | 11 | ||||
Additional paid-in capital | 926,152 | 909,896 | ||||
Accumulated deficit | (784,497 | ) | (719,843 | ) | ||
Total shareholders’ equity | $ | 141,667 | $ | 190,064 | ||
Total liabilities and shareholders’ equity | $ | 440,372 | $ | 441,590 | ||
Melinta Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three Month Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Revenue | ||||||||||||||||
Product sales, net | $ | 13,825 | $ | 9,152 | $ | 25,600 | $ | 20,998 | ||||||||
Contract research | 2,130 | 2,870 | 3,539 | 5,865 | ||||||||||||
License | — | — | 900 | — | ||||||||||||
Total revenue | 15,955 | 12,022 | 30,039 | 26,863 | ||||||||||||
Operating expenses | ||||||||||||||||
Cost of goods sold | 8,639 | 10,989 | 16,004 | 18,675 | ||||||||||||
Research and development | 3,527 | 15,813 | 8,891 | 31,942 | ||||||||||||
Selling, general and administrative | 30,932 | 34,946 | 56,873 | 69,570 | ||||||||||||
Total operating expenses | 43,098 | 61,748 | 81,768 | 120,187 | ||||||||||||
Loss from operations | (27,143 | ) | (49,726 | ) | (51,729 | ) | (93,324 | ) | ||||||||
Other income (expenses) | ||||||||||||||||
Interest income | 210 | 63 | 397 | 273 | ||||||||||||
Interest expense | (8,176 | ) | (10,659 | ) | (15,279 | ) | (20,855 | ) | ||||||||
Interest expense (related party) | (1,365 | ) | — | (1,929 | ) | — | ||||||||||
Change in fair value of warrant & conversion liabilities | 261 | 2,389 | 6,276 | 26,474 | ||||||||||||
Loss on extinguishment of debt | — | — | (346 | ) | (2,595 | ) | ||||||||||
Other income (expense) | 25 | 2,121 | (37 | ) | 4,779 | |||||||||||
Grant income (expense) | 8 | 32 | (65 | ) | 36 | |||||||||||
Total other income (expense), net | (9,037 | ) | (6,054 | ) | (10,983 | ) | 8,112 | |||||||||
Net loss | $ | (36,180 | ) | $ | (55,780 | ) | $ | (62,712 | ) | $ | (85,212 | ) | ||||
Basic and diluted net loss per share | $ | (3.07 | ) | $ | (6.92 | ) | $ | (5.42 | ) | $ | (11.96 | ) | ||||
Basic and diluted weighted-average shares outstanding | 11,801,874 | 8,059,471 | 11,567,250 | 7,126,687 | ||||||||||||
Melinta Therapeutics, Inc.
Condensed Consolidated Statement of Cash Flows
(In thousands)
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Operating activities | |||||||||||||||
Net loss | $ | (36,180 | ) | $ | (55,780 | ) | $ | (62,712 | ) | $ | (85,212 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||||||
Depreciation and amortization | 3,947 | 3,689 | 8,421 | 8,494 | |||||||||||
Non-cash interest expense | 4,679 | 6,271 | 7,909 | 12,225 | |||||||||||
Share-based compensation | 1,315 | 1,418 | 2,207 | 2,373 | |||||||||||
Change in fair value of warrant & conversion liabilities | (261 | ) | (2,389 | ) | (6,276 | ) | (26,474 | ) | |||||||
Loss on extinguishment of debt | — | — | 346 | 2,595 | |||||||||||
Gain on extinguishment of lease liabilities | (122 | ) | — | (914 | ) | — | |||||||||
Provision for inventory obsolescence | 392 | 2,532 | 392 | 2,532 | |||||||||||
Changes in operating assets and liabilities: | |||||||||||||||
Receivables | (4,189 | ) | 2,699 | 3,404 | (3,169 | ) | |||||||||
Inventory | 2,033 | (2,626 | ) | (1,060 | ) | (4,628 | ) | ||||||||
Prepaid expenses and other current assets and liabilities | 970 | 1,812 | (581 | ) | 519 | ||||||||||
Accounts payable | (2,529 | ) | 649 | (10,901 | ) | 4,632 | |||||||||
Accrued expenses | 5,106 | 3,494 | (4,605 | ) | (1,323 | ) | |||||||||
Accrued interest on notes payable | (135 | ) | 4,389 | (181 | ) | 4,105 | |||||||||
Deposits on inventory | — | (22,983 | ) | — | (22,983 | ) | |||||||||
Other non-current assets and liabilities | (702 | ) | 2,495 | 1,554 | 565 | ||||||||||
Net cash used in operating activities | (25,676 | ) | (54,330 | ) | (62,997 | ) | (105,749 | ) | |||||||
Investing activities | |||||||||||||||
IDB acquisition | — | — | — | (166,383 | ) | ||||||||||
Purchases of intangible assets | — | (2,000 | ) | (1,209 | ) | (2,000 | ) | ||||||||
Purchases of property and equipment | — | (423 | ) | (12 | ) | (927 | ) | ||||||||
Net cash provided by (used in) investing activities | — | (2,423 | ) | (1,221 | ) | (169,310 | ) | ||||||||
Financing activities | |||||||||||||||
Proceeds from the issuance of notes payable | — | — | — | 111,421 | |||||||||||
Proceeds from the issuance of convertible notes payable | — | — | 75,000 | — | |||||||||||
Costs associated with the issuance of notes payable | (882 | ) | — | (2,183 | ) | (6,455 | ) | ||||||||
Proceeds from the issuance of warrants | — | — | — | 33,264 | |||||||||||
Proceeds from the issuance of royalty agreement | — | — | — | 1,472 | |||||||||||
Purchase of notes payable disbursement option | — | — | — | (7,609 | ) | ||||||||||
Proceeds from issuance of common stock, net, to lender | — | — | — | 51,452 | |||||||||||
Proceeds from issuance of common stock, net | — | 115,759 | 8 | 155,759 | |||||||||||
Debt extinguishment | — | — | — | (2,150 | ) | ||||||||||
IDB acquisition contingent payments | — | (398 | ) | (72 | ) | (398 | ) | ||||||||
Proceeds from the exercise of stock options, net of cancellations | — | — | — | 3 | |||||||||||
Principal payments on notes payable | — | — | — | (40,000 | ) | ||||||||||
Net cash provided by (used in) financing activities | (882 | ) | 115,361 | 72,753 | 296,759 | ||||||||||
Net change in cash and equivalents | (26,558 | ) | 58,608 | 8,535 | 21,700 | ||||||||||
Cash, cash equivalents and restricted cash at beginning of the period | 117,101 | 91,679 | 82,008 | 128,587 | |||||||||||
Cash, cash equivalents and restricted cash at end of the period | $ | 90,543 | $ | 150,287 | $ | 90,543 | $ | 150,287 | |||||||
Melinta Therapeutics
GAAP to Non-GAAP Adjustments
for the Three and Six Months Ended June 30, 2019 and 2018
(In thousands)
Three Months Ended June 30, 2019 | Revenue | Cost of Product Sales | R&D | SG&A | Other Income (Expense), Net | Total | |||||||||||||
Net loss, as reported under GAAP | $ | 15,955 | $ | (8,639 | ) | $ | (3,527 | ) | $ | (30,932 | ) | $ | (9,037 | ) | $ | (36,180 | ) | ||
EBITDA adjustments: | |||||||||||||||||||
Interest expense | — | — | — | — | 9,541 | 9,541 | |||||||||||||
Interest income | — | — | — | — | (210 | ) | (210 | ) | |||||||||||
Depreciation and amortization | — | 4,136 | 9 | (198 | ) | — | 3,947 | ||||||||||||
Total EBITDA adjustments | — | 4,136 | 9 | (198 | ) | 9,331 | 13,278 | ||||||||||||
EBITDA | $ | 15,955 | $ | (4,503 | ) | $ | (3,518 | ) | $ | (31,130 | ) | $ | 294 | $ | (22,902 | ) | |||
Other adjustments: | |||||||||||||||||||
Stock-based compensation | — | — | 179 | 1,136 | — | 1,315 | |||||||||||||
Change in fair value of warrant & conversion liabilities | — | — | — | — | (261 | ) | (261 | ) | |||||||||||
Gain on extinguishment of lease liabilities | — | — | — | (122 | ) | — | (122 | ) | |||||||||||
Total adjustments | — | — | 179 | 1,014 | (261 | ) | 932 | ||||||||||||
Adjusted EBITDA | $ | 15,955 | $ | (4,503 | ) | $ | (3,339 | ) | $ | (30,116 | ) | $ | 33 | $ | (21,970 | ) | |||
Three Months Ended June 30, 2018 | Revenue | Cost of Product Sales | R&D | SG&A | Other Income (Expense), Net | Total | |||||||||||||
Net loss, as reported under GAAP | $ | 12,022 | $ | (10,989 | ) | $ | (15,813 | ) | $ | (34,946 | ) | $ | (6,054 | ) | $ | (55,780 | ) | ||
EBITDA adjustments: | |||||||||||||||||||
Interest expense | — | — | — | — | 10,659 | 10,659 | |||||||||||||
Interest income | — | — | — | — | (63 | ) | (63 | ) | |||||||||||
Depreciation and amortization | — | 3,550 | 54 | 85 | — | 3,689 | |||||||||||||
Total EBITDA adjustments | — | 3,550 | 54 | 85 | 10,596 | 14,285 | |||||||||||||
EBITDA | $ | 12,022 | $ | (7,439 | ) | $ | (15,759 | ) | $ | (34,861 | ) | $ | 4,542 | $ | (41,495 | ) | |||
Other adjustments: | |||||||||||||||||||
Stock-based compensation | — | — | 166 | 1,379 | — | 1,545 | |||||||||||||
Change in fair value of warrant liability | — | — | — | — | (2,389 | ) | (2,389 | ) | |||||||||||
Launch-related E&O inventory charges | — | 2,352 | — | — | — | 2,352 | |||||||||||||
Acquisition-related costs | — | — | — | 229 | — | 229 | |||||||||||||
Total adjustments | — | 2,352 | 166 | 1,608 | (2,389 | ) | 1,737 | ||||||||||||
Adjusted EBITDA | $ | 12,022 | $ | (5,087 | ) | $ | (15,593 | ) | $ | (33,253 | ) | $ | 2,153 | $ | (39,758 | ) | |||
Six Months Ended June 30, 2019 | Revenue | Cost of Product Sales | R&D | SG&A | Other Income (Expense), Net | Total | |||||||||||||
Net loss, as reported under GAAP | $ | 30,039 | $ | (16,004 | ) | $ | (8,891 | ) | $ | (56,873 | ) | $ | (10,983 | ) | $ | (62,712 | ) | ||
EBITDA adjustments: | |||||||||||||||||||
Interest expense | — | — | — | — | 17,208 | 17,208 | |||||||||||||
Interest income | — | — | — | — | (397 | ) | (397 | ) | |||||||||||
Depreciation and amortization | — | 8,259 | 38 | 124 | — | 8,421 | |||||||||||||
Total EBITDA adjustments | — | 8,259 | 38 | 124 | 16,811 | 25,232 | |||||||||||||
EBITDA | $ | 30,039 | $ | (7,745 | ) | $ | (8,853 | ) | $ | (56,749 | ) | $ | 5,828 | $ | (37,480 | ) | |||
Other adjustments: | |||||||||||||||||||
Stock-based compensation | — | — | 258 | 1,949 | — | 2,207 | |||||||||||||
Change in fair value of warrant & conversion liabilities | — | — | — | — | (6,276 | ) | (6,276 | ) | |||||||||||
Gain on extinguishment of lease liabilities | — | — | — | (914 | ) | — | (914 | ) | |||||||||||
Loss on extinguishment of debt | — | — | — | — | 346 | 346 | |||||||||||||
Total adjustments | — | — | 258 | 1,035 | (5,930 | ) | (4,637 | ) | |||||||||||
Adjusted EBITDA | $ | 30,039 | $ | (7,745 | ) | $ | (8,595 | ) | $ | (55,714 | ) | $ | (102 | ) | $ | (42,117 | ) | ||
Six Months Ended June 30, 2018 | Revenue | Cost of Product Sales | R&D | SG&A | Other Income (Expense), Net | Total | |||||||||||||
Net loss, as reported under GAAP | $ | 26,863 | $ | (18,675 | ) | $ | (31,942 | ) | $ | (69,570 | ) | $ | 8,112 | $ | (85,212 | ) | |||
EBITDA adjustments: | |||||||||||||||||||
Interest expense | — | — | — | — | 20,855 | 20,855 | |||||||||||||
Interest income | — | — | — | — | (273 | ) | (273 | ) | |||||||||||
Depreciation and amortization | — | 8,218 | 123 | 153 | — | 8,494 | |||||||||||||
Total EBITDA adjustments | — | 8,218 | 123 | 153 | 20,582 | 29,076 | |||||||||||||
EBITDA | $ | 26,863 | $ | (10,457 | ) | $ | (31,819 | ) | $ | (69,417 | ) | $ | 28,694 | $ | (56,136 | ) | |||
Other adjustments: | |||||||||||||||||||
Stock-based compensation | — | — | 295 | 2,078 | — | 2,373 | |||||||||||||
Change in fair value of warrant liability | — | — | — | — | (26,474 | ) | (26,474 | ) | |||||||||||
Launch-related E&O inventory charges | 2,352 | 2,352 | |||||||||||||||||
Loss on extinguishment of debt | — | — | — | — | 2,595 | 2,595 | |||||||||||||
Acquisition-related costs | — | — | — | 2,069 | — | 2,069 | |||||||||||||
Total adjustments | — | 2,352 | 295 | 4,147 | (23,879 | ) | (17,085 | ) | |||||||||||
Adjusted EBITDA | $ | 26,863 | $ | (8,105 | ) | $ | (31,524 | ) | $ | (65,270 | ) | $ | 4,815 | $ | (73,221 | ) | |||
For More Information:
Media Inquiries:
Lindsay Rocco
Elixir Health Public Relations
+1 862-596-1304
Investor Inquiries:
Susan Blum
(312) 767-0296
Melinta Therapeutics Names David Gill as Chairman and Announces CEO Succession Plan
~ Company Initiates Search for New Chief Executive Officer ~
MORRISTOWN, N.J., August 9, 2019 - Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, today announced changes to its board of directors and executive management team.
David Gill, a current Melinta board member, has been named chairman of the board of directors, effective immediately, succeeding Kevin Ferro, who voluntarily resigned from the position and the board of directors.
John H. Johnson voluntarily resigned from his position as chief executive officer (CEO) due to changes in the Company’s circumstances and in order to pursue other opportunities. Mr. Johnson will serve as acting CEO for at least 30 days to work through the transition, including the search process and appointment of a permanent successor. Mr. Johnson also resigned from his position as director, effective immediately. Additionally, and at the request of the board of directors, Mr. Johnson will remain a strategic advisor to Melinta for at least six months.
“On behalf of the Board, I would like to thank Kevin for his contributions to the Company,” said David Gill, chairman of Melinta. “The Board and I also want to thank John for his dedication and service as a long-standing board member and most recently for his leadership and stepping into the CEO position during a very challenging time for the Company and antibiotics industry as a whole. John made many significant contributions to further advance the Company’s mission to provide life-saving therapeutic solutions that address the evolving global threat of bacterial infections and antibiotic resistance. We look forward to continuing to work closely with John on the process to select a successor and as a strategic advisor during Melinta’s next phase,” Gill added.
“It has been an honor to work with such a talented team that is truly dedicated to providing critical and potentially life-saving antibiotics to patients in need. Since joining Melinta as CEO, the organization has made tremendous strides towards enhancing operational efficiencies, increasing product sales, working with stakeholders to improve the reimbursement landscape, securing a Prescription Drug User Fee Act (PDUFA) action date of October 24, 2019 for the supplemental new drug application (sNDA) to expand the current indication for Baxdela® (delafloxacin) for community-acquired bacterial pneumonia (CABP), and enrolling more than half of the target study population in a clinical study evaluating a shorter infusion time formulation of Orbactiv® (oritavancin) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI),” said John H. Johnson, chief executive officer of Melinta. “I look forward to working with the board and management team to continue executing against Melinta’s strategy to deliver antibiotics solutions to both patients and providers,” Johnson added.
Mr. Gill joined the Company’s board of directors in April 2012. Mr. Gill served as chief financial officer of EndoChoice Holdings, Inc., a publicly-traded medical device company from August 2014 to November 2016, and as president and chief financial officer from March 2016 to November 2016, when the company was acquired. He served as the chief financial officer of INC Research Holdings Inc. (now known as Syneos), a clinical research organization, from February 2011 to August 2013, after having served as a board member and its audit committee chairman from 2007 to 2010. Mr. Gill currently serves as a director of Evolus, Inc., an aesthetics company, YmAbs Therapeutics, an immuno-oncology company and Strata Skins Sciences, a dermatology company. Earlier in his career, Mr. Gill served in a variety of senior executive leadership roles for several medical device companies, including TramsEnterix, NxStage Medical, CTI Molecular Imaging, Inc., Novoste Corporation and Dornier Medical. Mr. Gill holds a B.S. degree, cum laude, in Accounting from
Wake Forest University and an M.B.A. degree, with honors, from Emory University, and was formerly a certified public accountant.
About Melinta Therapeutics
Melinta Therapeutics, Inc. is the largest pure-play antibiotics company, dedicated to saving lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new therapeutic solutions. Its four marketed products include Baxdela® (delafloxacin), Vabomere® (meropenem and vaborbactam), Orbactiv® (oritavancin), and Minocin® (minocycline) for Injection. This portfolio provides Melinta with the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit www.melinta.com for more information.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this communication constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions, including statements related to guidance. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made and include statements regarding: expectations with respect to our financial position, results and performance, compliance with our debt facilities and discussions with our creditors. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations, strategies or prospects will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control.
Risks and uncertainties for Melinta include, but are not limited to, the fact that we have incurred significant operating losses since inception and will incur continued losses for the foreseeable future; our limited operating history; our need for future capital and risks related to our ability to obtain additional capital to fund future operations; risks related to our failure to close on the full amount of the two disbursements under the Vatera loan financing and risks related to the satisfaction of the closing conditions for the remaining disbursement amount, including the inability to close on such disbursement; risks related to our ability to borrow additional amounts under the Deerfield facility agreement; risks related to compliance with the covenants under our facilities with Vatera and Deerfield; risks related to our future liquidity, including uncertainties of cash flows and inability to meet working capital needs as well as other milestones, royalty and payment obligations, including as a result of the outcome of the pending litigation with respect to, and any requirement to make, payments potentially due under our purchase agreement with to The Medicines Company; risks that may arise from the Vatera loan financing and the Deerfield facility agreement, including potential dilution to our stockholders and the fact that Vatera beneficially owns a substantial portion of our common stock; risks related to our ability to continue as a going concern unless we can secure additional sources of liquidity; our substantial indebtedness; risks related to potential strategic transactions; risks related to the commercial launches of our products and our inexperience as a company in marketing drug products; the degree of market acceptance of our products among physicians, patients, health care payors and the medical community; the pricing we are able to achieve for our products; failure to obtain and sustain an adequate level of reimbursement for our products by third-party payors; inaccuracies in our estimates of
the market for and commercialization potential of our products; failure to maintain optimal inventory levels to meet commercial demand for any of our products; risks that our competitors are able to develop and market products that are preferred over our products; our dependence upon third parties for the manufacture and supply of our marketed products; failure to achieve the benefits of our recently completed transactions with Cempra and The Medicines Company; failure to establish and maintain development and commercialization collaborations; uncertainty in the outcome or timing of clinical trials and/or receipt of regulatory approvals for our product candidates; undesirable side effects of our products; failure of third parties to conduct clinical trials in accordance with their contractual obligations; our ability to identify, develop, acquire or in-license products; difficulties in managing the growth of our company; the effects of recent comprehensive tax reform; risks related to failure to comply with extensive laws and regulations; product liability risks related to our products; failure to retain key personnel; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; risks relating to third party infringement of intellectual property rights; our ability to maintain effective internal control over financial reporting; unfavorable outcomes in any of the class action and shareholder derivative lawsuits currently pending against the Company; and the fact that a substantial number of shares of common stock may be sold into the public markets by one or more of our large stockholders in the near future. Many of these factors that will determine actual results are beyond Melinta’s ability to control or predict.
Other risks and uncertainties are more fully described in our Annual Report on Form 10-K for the year ended December 31, 2018, our Revised Definitive Proxy Statement filed January 29, 2019, and in other filings that Melinta makes and will make with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cause our expectations and beliefs to change. While we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date after the date stated herein.
For More Information:
Media Inquiries:
Lindsay Rocco
Elixir Health Public Relations
+1 862-596-1304
Investor Inquiries:
Susan Blum
(312) 767-0296
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- LTIMindtree Closes FY24 with a Strong Order Inflow of $5.6 Bn; up 15.7% YoY
- Meet Terrand, the Inspiring Leader Behind the FedEx E-Commerce Learning Lab
- The Partners Group Selects Reperio Health as Their Exclusive Biometric Health Screening Partner
Create E-mail Alert Related Categories
SEC FilingsSign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
