8-K

 

 

UNITED 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): May 8, 2018

 

 

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.)

 

300 George Street, Suite 301, New Haven, CT   06511
(Address of principal executive offices)   (Zip Code)

 

 

Registrant’s telephone number, including area code (312) 767-0291

 

 

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:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

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    ☐

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.    ☐

 

 

 


 

Item 2.02. Results of Operations and Financial Condition.

On May 8, 2018, Melinta Therapeutics, Inc. (the “Company”) issued a press release announcing its results for its first quarter ended March 31, 2018. 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 7.01. Regulation FD Disclosure.

On May 8, 2018, in connection with the Company’s quarterly earnings call, the Company made available the investor presentation furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K on the Company’s investor website, ir.melinta.com.

The information in this Item 7.01 (including Exhibit 99.2) shall not be deemed “filed” for purposes of Section 18 of 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, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by reference in such filing. The information contained in, or that can be accessed through the Company’s website, is not a part of this filing.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit  No.    Description
99.1    Press Release titled “Melinta Therapeutics Reports First Quarter 2018 Financial Results,” dated May 8, 2018
99.2    Investor presentation, dated May 8, 2018


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/ Paul Estrem

  Paul Estrem
  Chief Financial Officer

Dated: May 8, 2018

EX-99.1

Exhibit 99.1

 

LOGO

Melinta Therapeutics Reports First Quarter 2018 Financial Results

Strong Product Sales Performance Across Entire Portfolio

Continuing to Optimize Operations to Achieve Cost Synergies

Important Achievements for Development and Discovery Efforts Including CARB-X Funding Award

NEW HAVEN, Conn., May 8, 2018 – Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, today reported financial results and provided an update on commercial activities for the quarter ended March 31, 2018. Melinta reported revenue of $14.8 million for the quarter ended March 31, 2018, which includes product sales of $11.8 million and contract revenue of $3.0 million. In addition, the company earned $2.7 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), which it recorded as other income. This quarter was the first including sales from all four of the company’s antibiotic brands.

“The new Melinta is off to a strong start in 2018, as we completed our first quarter as a combined company following the close of our acquisition of The Medicines Company’s infectious disease business on January 5, 2018,” said Dan Wechsler, President and CEO of Melinta. “During the quarter we launched Baxdela™ (delafloxacin) in the U.S. and continued our launch of Vabomere™ (meropenem and vaborbactam) in the U.S., and generated strong sales performance across all four of our brands, powered by our experienced antibiotics-focused salesforce. Our salesforce is now fully cross-trained with all reps selling all products beginning in May, significantly expanding our share of voice.

“Within our pipeline we saw continued advancement, with our partners Menarini Group and Eurofarma Laboratórios submitting Marketing Authorization Applications for delafloxacin in the E.U. and Argentina, respectively. We also announced an agreement with CARB-X, one of the world’s largest public-private partnerships devoted to early development antibacterial R&D, that will provide us funding to advance the development of a novel antimicrobial from our ESKAPE pathogen program.

“From a financial perspective, we have received significant interest to partner outside of the U.S. on our products. In addition, we have strong support from shareholders and others to provide a foundation for the continued growth of our company.”

Q1 2018 and Recent Business Highlights

 

    January 5, 2018 - acquired the infectious disease business of The Medicines Company, including approved products Vabomere, Orbactiv® (oritavancin) and Minocin® (minocycline) for Injection


    In Q1:

 

    added well-experienced talent across the entire organization, including sales and marketing, medical affairs and other expertise

 

    completed integration

 

    had no disruption to product launches or performance

 

    February 6, 2018 – launched Baxdela in the United States

 

    February 20, 2018 – partner Eurofarma Laboratórios submitted the first of many anticipated marketing authorization applications (MAA) in Latin America, in Argentina, for delafloxacin for treatment of adult patients with acute bacterial skin and skin structure infection (ABSSSI)

 

    additional MAA submitted in Peru on May 4, 2018

 

    March 6, 2018 – partner Menarini submitted an MAA to the European Medicines Agency (EMA) for delafloxacin (Quofenix) for treatment of adult patients with ABSSSI

Q1 2018 Financial Results

Melinta reported product sales for the first time in the first quarter of 2018 totaling $11.8 million, which included the addition of Vabomere, Minocin and Orbactiv as of January 5, 2018, the close of The Medicines Company acquisition, as well as the launch of Baxdela in February.

For the quarter, total net revenue was $14.8 million compared to total net revenue of $22.5 million for the same period in 2017, when Melinta was a private company. The composition of revenue in the first quarter of 2018 was significantly different than that recognized in the first quarter of 2017. In the first quarters of 2018 and 2017, we recognized contract research revenue totaling $3.0 million and $2.6 million, respectively. In the first quarter of 2017, we also recognized $19.9 million in upfront consideration from Menarini in connection with the execution of our ex-U.S. Baxdela licensing arrangement.

 

in USD millions

   2018      2017  

Product sales

   $ 11.8        0.0  

Contract revenue

     3.0        2.6  

Licensing revenue

     0.0        19.9  

Total net revenue *

   $ 14.8      $ 22.5  

 

* Excludes BARDA grant funding included in Other Income

Cost of goods sold was $7.7 million for the quarter ended March 31, 2018. Notably, $4.7 million of the $7.7 million was comprised of non-cash, amortization of intangible assets. There were no product sales and therefore no costs of goods sold in the prior year period.


Research and development (“R&D”) expenses were $16.1 million for the quarter ended March 31, 2018, compared to $12.9 million for the same period in 2017. The increase was driven by additional headcount and development activities resulting from the recent merger with Cempra, the acquisition of the infectious disease business from The Medicines Company and accelerated patient enrollment for our ongoing community-acquired bacterial pneumonia (CABP) registration trial for Baxdela.

Selling, general and administrative (“SG&A”) expenses were $34.6 million for the quarter ended March 31, 2018, compared to $8.0 million for the same period in 2017. The increase was driven by costs to support a larger, public, commercial organization after the Cempra merger and the acquisition of the infectious disease business from The Medicines Company, including additional headcount and commercial infrastructure, and acquisition-related severance and other non-recurring expenses. Approximately $4.3 million was a result of acquisition-related costs and other non-GAAP adjustments.

Net loss available to shareholders was $29.4 million, or $0.95 per share, for the quarter ended March 31, 2018 compared to a net loss of $5.8 million 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 infectious disease business from The Medicines Company.

As of March 31, 2018, Melinta had cash and cash equivalents of $91.5 million. Cash and cash equivalents for this quarter was negatively impacted by the timing of certain payments and receipts of reimbursement expenses of approximately $10 million.

Q1 2018 and Recent Pipeline and Publication Highlights

 

    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

 

    12 Presentations at ECCMID 2018 including six from Vabomere TANGO-2 trial, as well as new in vitro and in vivo findings for Baxdela and a pyrrolocytosine lead molecule

 

    Pyrrolocytosine compound RX-P2382 against ESKAPE pathogens at ECCMID 2018

 

    TANGO-2 Trial at ECCMID 2018, highlighting outcomes in vulnerable patient populations

 

    Discovery Platform Oral Presentations at ECCMID 2018 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 CABP

 

    Vabomere EMA regulatory approval decision

 

    TANGO-2 additional data and potential publication

 

    Additional ex-U.S. submissions for Baxdela in Central and South America

 

    Ex-U.S. partnership opportunities for Vabomere, Orbactiv and Minocin for Injection

 

    IND-enabling studies for the lead ESKAPE compound

Conference Call and Webcast

Melinta’s earnings conference call for the quarter ended March 31, 2018 will be broadcast at 4:30pm EDT on May 8, 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 6689334. Investors can also access the call at http://ir.melinta.com/events/event-details/melinta-therapeutics-q1-2018-earnings-call.

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 # 6689334.

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. It also has an extensive pipeline of preclinical and clinical-stage products representing many important classes of antibiotics, each targeted at a different segment of the anti-infective market. Together, 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.

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 first 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.

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 these non-GAAP financial measures, 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. These non-GAAP measures closely align with the way management measures and evaluates the Company’s performance. These non-GAAP financial measures 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) 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. 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. 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. 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 or strategies 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; uncertainties of cash flows and inability to meet working capital needs as well as other milestone, royalty and payment obligations; the fact that our independent registered public accounting firm’s report on the Company’s 2016 and 2017 financial statements contains an explanatory paragraph that states that the our recurring losses from operations and our need to obtain additional capital raises substantial doubt about our ability to continue as a going concern; our substantial indebtedness; risks related to our 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 amount of shares of common stock may be sold into the public markets by one or more of our large shareholders 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, 2017, 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

Condensed Consolidated Balance Sheets

 

     March 31,
2018
    December 31,
2017
 
     (Unaudited)        
     (in 000s)  

Assets

    

Cash and cash equivalents

   $ 91,479     $ 128,387  

Trade receivables, net

     10,455       —    

Other receivables

     11,619       7,564  

Inventory

     28,220       10,825  

Prepaid expenses and other current assets

     7,322       2,988  
  

 

 

   

 

 

 

Total current assets

     149,095       149,764  

Property and equipment, net

     2,276       1,596  

Goodwill

     13,059       —    

Intangible assets

     260,825       7,500  

Other assets

     22,678       1,413  
  

 

 

   

 

 

 

Total assets

   $ 447,933     $ 160,273  
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Accounts payable and accrued expenses

   $ 41,084     $ 31,446  

Warrant liability

     9,179       —    

Deferred and contingent purchase price

     22,830       —    

Contingent milestones

     27,184       —    

Other current liabilities

     —         284  
  

 

 

   

 

 

 

Total current liabilities

     100,277       31,730  

Debt facilities, net of discounts

     106,090       39,555  

Deferred revenues

     —         10,008  

Deferred and contingent purchase price

     33,393       —    

Other long-term liabilities

     8,340       6,644  
  

 

 

   

 

 

 

Total liabilities

     248,100       87,937  

Convertible preferred stock

     —         —    

Stockholders’ equity

    

Common stock

     31       22  

Additional paid in capital

     791,885       644,973  

Accumulated deficit

     (592,083     (572,659
  

 

 

   

 

 

 

Total stockholders’ equity

     199,833       72,336  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 447,933     $ 160,273  
  

 

 

   

 

 

 

The Company has recorded goodwill and intangible assets, as well as deferred and contingent consideration, in connection with the acquisition of the infectious disease business from The Medicines Company on a preliminary basis and based on its best estimates. The Company will


record adjustments as necessary as it completes the valuation process, which may impact the value of intangible assets and related amortization expense included in our financial statements. Under GAAP, the Company has one year to finalize the purchase accounting for the acquisition.

Melinta Therapeutics

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

 

     Three Months Ended
March 31,
 
     2018     2017  
     (Unaudited)        
     (in 000s)  

Revenue

    

Product sales, net

   $ 11,846     $ —    

License revenue

     —         19,905  

Contract revenue

     2,995       2,558  
  

 

 

   

 

 

 

Total revenue

     14,841       22,463  

Operating expenses

    

Cost of product sales

     7,686       —    

Research and development

     16,129       12,917  

Selling, general and administrative

     34,624       7,973  
  

 

 

   

 

 

 

Total operating expenses

     58,439       20,890  
  

 

 

   

 

 

 

Income (loss) from operations

     (43,598     1,573  

Other income (expense), net

    

Grant income

     2,658       —    

Interest expense

     (10,196     (1,622

Change in fair value of warrant liability

     24,085       (55

Loss on extinguishment of debt

     (2,595     —    

Interest and other income, net

     214       30  
  

 

 

   

 

 

 

Total other income (expense), net

     14,166       (1,647
  

 

 

   

 

 

 

Net loss

   $ (29,432   $ (74
  

 

 

   

 

 

 

Accretion of convertible preferred stock dividends

     —         (5,720
  

 

 

   

 

 

 

Net loss available to common shareholders

   $ (29,432   $ (5,794
  

 

 

   

 

 

 

Basic and diluted net loss per share

   $ (0.95   $ (208.16
  

 

 

   

 

 

 

Basic and diluted weighted-average shares outstanding

     30,918       28  
  

 

 

   

 

 

 


Melinta Therapeutics

Condensed Consolidated Statement of Cash Flows

 

     Three Months Ended
March 31,
 
     2018     2017  
     (Unaudited)        
     (in 000s)  

Net loss

   $ (29,432   $ (74

Adjustments to reconcile net income (loss) to net cash used in operations:

    

Depreciation and amortization

     4,805       123  

Change in fair value of warrants

     (24,085     56  

Loss on extinguishment of debt

     2,595       —    

Non-cash interest expense

     5,954       1,155  

Stock-based compensation

     955       572  

Changes in operating assets and liabilities:

    

Receivables

     (5,052     (2,623

Inventory

     (2,002     —    

Prepaids and other assets/liabilities

     (3,508     992  

Accounts payable and accrued expenses

     (1,650     3,364  
  

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     (51,420     3,565  

Cash flows from investing activities:

    

Cash acquired from acquisition of IDB

     (166,383     —    

Purchases of property, plant and equipment

     (504     (109
  

 

 

   

 

 

 

Net cash used in investing activities

     (166,887     (109

Cash flows from financing activities:

    

Proceeds from the issuance of common stock, net

     40,003       95  

Proceeds from the issuance of debt instruments

     190,000       8,010  

Principal payments on notes payable

     (40,000     (2,844

Debt extinguishment costs

     (2,150     —    

Debt issuance costs

     (6,454     —    
  

 

 

   

 

 

 

Net cash provided by financing activities

     181,399       5,261  

Net increase (decrease) in cash and cash equivalents

     (36,908     8,717  

Cash and cash equivalents at beginning of period, including restricted cash

     128,587       11,409  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period, including restricted cash

   $ 91,679     $ 20,126  
  

 

 

   

 

 

 


Melinta Therapeutics

Reconciliation of Reported Net Loss to Adjusted EBITDA

 

     Three Months Ended
March 31,
 
     2018     2017  
     (Unaudited)        
     (in 000s)  

Net loss

   $ (29,432   $ (74 )  

EBITDA adjustments:

    

Interest expense

     10,196       1,622  

Interest income

     (210     (5

Depreciation and amortization

     4,805       114  
  

 

 

   

 

 

 

Total EBITDA adjustments

     14,791       1,731  

EBITDA

   $ (14,641   $ 1,657  

Other adjustments:

    

Stock-based compensation

     955       572  

Changes in fair value of warrant liability

     (24,085     55  

Loss on extinguishment of debt

     2,595       —    

Acquisition-related costs

     2,069       —    

Other

     1,532       —    
  

 

 

   

 

 

 

Total other adjustments

     (16,934     627  

Adjusted EBITDA

   $ (31,575   $ 2,284  


Melinta Therapeutics

GAAP to Non-GAAP Adjustments

for the Three Months Ended March 31, 2018 and March 31, 2017

 

Three Months Ended March 31, 2018 (Unaudited)

   Revenue      Cost of
Product Sales
    R&D     SG&A     Other Income
(Expense), Net
    Total  

As reported under GAAP

   $ 14,841      $ (7,686   $ (16,129   $ (34,624   $ 14,166     $ (29,432

Adjustments:

             

Interest expense

     —          —         —         —         10,196       10,196  

Interest income

     —          —         —         —         (210     (210

Depreciation and amortization

     —          4,683       53       69       —         4,805  

Stock-based compensation

     —          37       217       701       —         955  

Change in fair value of warrant liability

     —          —         —         —         (24,085     (24,085

Loss on extinguishment of debt

     —          —         —         —         2,595       2,595  

Acquisition-related costs

     —          —         —         2,069       —         2,069  

Other

     —          —         —         1,532       —         1,532  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total adjustments

   $ —        $ 4,720     $ 270     $ 4,371     $ (11,504   $ (2,143

Adjusted EBITDA

   $ 14,841      $ (2,966   $ (15,859   $ (30,253   $ 2,662     $ (31,575  

Three Months Ended March 31, 2017

   Revenue      R&D     SG&A     Other Income
(Expense), Net
    Total        

As reported under GAAP

   $ 22,463      $ (12,917   $ (7,973   $ (1,647   $ (74  

Adjustments:

             

Interest expense

     —          —         —         1,622       1,622    

Interest income

     —          —         —         (5     (5  

Depreciation and amortization

     —          82       32       —         114    

Stock-based compensation

     —          140       432       —         572    

Change in fair value of warrant liability

     —          —         —         55       55    
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

Total adjustments

   $ —        $ 222     $ 464     $ 1,672     $ 2,358    

Adjusted EBITDA

   $ 22,463      $ (12,695   $ (7,509   $ 25     $ 2,284    

For More Information:

 

Media Inquiries:    Investor Inquiries:
David Belian    Lisa DeFrancesco
(203) 848-6276    (847) 681-3217
dbelian@melinta.com    ldefrancesco@melinta.com
EX-99.2

Slide 1

Melinta Therapeutics The Antibiotics Company . Q1 2018 Earnings Conference Call May 8, 2018 Exhibit 99.2


Slide 2

Cautionary Note Regarding Forward-looking Statements This presentation contains forward-looking statements that involve a number of risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our strategy, future operations, future financial position, future cash flows, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. We are under no obligation (and expressly disclaim any such obligation) to update or revise any forward-looking statement that may be made from time to time, whether as a result of new information, future developments or otherwise. Risks and uncertainties for Melinta Therapeutics, Inc. (the “Company”) are more fully described in the Company’s recent filings with the SEC, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2017. .


Slide 3

Q1 2018 Earnings Conference Call - Agenda 1. Business Update Dan Wechsler, President and CEO 2. Financial Results and Outlook Paul Estrem, CFO 3. Conclusion and 2018 Catalysts Dan Wechsler, President and CEO .


Slide 4

Q1 and YTD Business Highlights $14.8 million of net revenue* in Q1 $11.8 million of net product sales in Q1 Sales force cross training complete – new incentive plan in place Cost synergies to be achieved earlier than anticipated Evaluating BD opportunities to monetize valued portfolio ex-US Strong support from existing shareholders to support growth of the company Baxdela CABP trial enrollment ahead of schedule Vabomere EU application on target CARB-X funding received to support advancement of new antibiotic class Strong ECCMID presence with 12 posters & presentations Submissions of delafloxacin ongoing in Europe and Latin America Revenue Growth Operational Strength R&D Progress . * Excludes $2.7 million BARDA grant funding included in Other Income


Slide 5

Vabomere™: Launch Momentum Continues Cumulative Ordering Accounts Tripled Year to Date Cumulative Ordering Accounts Source: Company data . ~3x 97 formulary approvals to-date 0 formulary rejections to-date >35% month-over-month ordering growth YTD 50% of accounts reordering


Slide 6

Baxdela™: Off to a Terrific Start Source: Company data . 115 million patient lives have access 90 formulary approvals to-date Week-over-week Prescribing Doubled Over Last 8 Weeks Cumulative Health Care Professionals (HCPs) Prescribing Cumulative Hospital Accounts Ordering 11 different specialties prescribing for ABSSSI >30 additional formulary meetings scheduled ~2x ~2x


Slide 7

Orbactiv®: Accelerating Growth Quarter-on-quarter >30% Quarter-on-quarter Growth # of Hospital Accounts Ordering # of New Accounts Ordering 5 or More Boxes/Quarter Source: Company data . ~50% Quarter-on-quarter Growth 54 new accounts in March 70% of volume purchased by the hospital >50% demand over Q1 2017 ~50% >30%


Slide 8

Minocin®: Sales Reinvigorated with Vabomere Source: Company data . Consistent Quarter-over-quarter Gains; Early Synergies Reported Alongside Vabomere Double-digit growth vs. Q1 2017 on a pro forma basis Increased level of product growth YTD correlation with launch of Vabomere >10% Boxes Sold By Quarter


Slide 9

Commercial Efficiency and Optimization Underway Expands Share of Voice for All Products by 2-3x Step 1: Launch Step 2: Optimize . Incentive Plan 1 Incentive Plan 2 New Incentive Plan


Slide 10

Focused on Accelerating Growth and Cash Flows Through Business Development Ex-US out-licensing Strategic acquisitions / partnerships Non-core portfolio optimization Government / non-dilutive partnerships 1 Support existing partnerships OUS rights for Vabomere, Orbactiv, Minocin Japan rights for Baxdela Accretive, differentiated anti-infective products Leveragable within established commercial infrastructure 2 3 Paths to derive value from non-core assets 4 Government contracts, grants, other non-dilutive arrangements .


Slide 11

Melinta is Now Powered by CARB-X . . Agreement supporting development of new antibiotic class called the pyrrolocytosine to treat ESKAPE pathogens Melinta will receive initial grant of up to $2.3 million with potential to receive additional $3.9 million to support existing discovery efforts Initial goal of selecting lead candidate & completing IND-enabling program


Slide 12

Pipeline and Publications Update Pediatric formulation work underway EMA centralized review in process; LATAM NDA submissions underway Phase 3 CABP enrollment completion: Expected by Q4 2018 Baxdela Vabomere Fusidic Acid * Solithromycin * Radezolid (partnered) ESKAPE Pediatric study ongoing EMA regulatory approval: Expected Q4 2018 TANGO-1 published; TANGO-2 additional data and potentially publication First ABSSSI Phase 3 met primary endpoint Japan partner Toyama completed enrollment in four studies US pediatric trial winding down after evaluation and discussions with BARDA Phase 2 topical acne vulgaris trial ongoing Formulation development initiated for bacterial vaginosis, received QIDP Announced CARB-X funding Pediatric study ongoing Pre-clinical studies to support IV reformulation - under discussion Orbactiv Minocin Ongoing discussions with EMA related to regulatory approval pathways * Non-core assets .


Slide 13

Q1 Financial Results & Guidance Paul Estrem, Chief Financial Officer .


Slide 14

Q1 2018 Financial Highlights – Strong Start to 2018 . Metrics (in millions) GAAP Adjustment Non-GAAP Comments Total Net Revenue $14.8 $14.8 Excludes BARDA grant funding - Product 11.8 11.8 - Contract 3.0 3.0 COGS 7.7 (4.7) 3.0 Deal-related amortization Total Operating Expenses $50.8 (4.6) $46.1 - R&D 16.1 (0.3) 15.8 Stock comp - SG&A 34.6 (4.3) 30.3 Stock comp, M&A-related Cash & Cash Equivalents $91.5 $91.5 Long-term Debt $147.8 $147.8 Common Shares Outstanding 31.4 31.4 Options, RSUs and Warrants Outstanding 6.1 6.1 Anticipate Orbactiv and Minocin to Achieve Net Sales of $36-40 Million for FY 2018


Slide 15

Closing and Catalysts Dan Wechsler, President & Chief Executive Officer .


Slide 16

Strong Q1 performance from four brands with growing momentum Achieved key development milestones on or ahead of schedule Compelling progress on cost savings and sales cross-training Focused on enhancing cash position Secured important partnership with CARB-X to support research initiatives Melinta Therapeutics, The Antibiotics Company . Products Pipeline Discovery Operational Strength


Slide 17

2018 Future Catalysts Progress ESKAPE Program in partnership with CARB-X Baxdela Vabomere Discovery Corporate/ BD Provide launch updates EMA regulatory approval, including TANGO-2 data TANGO-2 data potential publications Execute ex-US partnerships for balance of portfolio Execute accretive business development opportunities Drive focused publication strategy with 30+ planned Continue to drive revenue and cost synergies in 2018 and beyond Provide launch updates Complete enrollment for Phase 3 CABP study Receive country approvals in South & Central America .