Form 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): August 7, 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 (908) 617-1309

 

 

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 August 7, 2018, Melinta Therapeutics, Inc. (the “Company”) issued a press release announcing its results for its second quarter ended June 30, 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 August 7, 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 Second Quarter 2018 Financial Results,” dated August 7, 2018
99.2    Investor presentation, dated August 7, 2018

 

2


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: August 7, 2018

 

3

EX-99.1

Exhibit 99.1

 

LOGO

Melinta Therapeutics Reports Second Quarter 2018 Financial Results

Solid Performance from New Product Launches

Vabomere™ Granted NTAP Status by CMS

Strengthened Financial Position Supports Continued Growth

Completed Expansion and Cross-Training of Experienced Anti-infective Sales Force

NEW HAVEN, Conn., August 7, 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 June 30, 2018. Melinta continued to make progress this quarter in its mission to save lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new therapeutic solutions.

Q2 2018 and Recent Business Highlights

 

   

Completed the hiring of 71 additional field sales personnel bringing total sales representatives to 170

 

   

Completed realignment and cross-training of experienced anti-infective sales force across all four products, including Baxdela™ (delafloxacin), Vabomere™ (meropenem and vaborbactam), Orbactiv® (oritavancin) and Minocin® (minocycline) for Injection

 

   

Made strong progress on hospital approval process of new launches, Vabomere and Baxdela

 

   

Vabomere granted New Technology Add-On Payment (NTAP) by Centers for Medicare & Medicaid Services (CMS), effective Oct. 1, 2018

 

   

Continued growth in retail market for Baxdela, driven by specialty retail focus of our sales force

 

   

Completed enrollment ahead of schedule for Baxdela Phase III trial for treatment of adults with community acquired bacterial pneumonia (“CABP”)

 

   

Entered into partnership with CARB-X, receiving up to approximately $6 million to help advance pre-clinical and clinical development of a novel antibiotic class

 

   

Launched new antibiotic stewardship program designed to address the growing threat of antimicrobial resistance

 

   

Completed follow-on public offering of shares of common stock, raising approximately $115 million in net proceeds

 

   

Demonstrated breadth of commercial and clinical programs with 20 presentations at the American Society of Microbiology’s ASM Microbe 2018 meeting


“Melinta took important steps forward during the second quarter, with solid sales performance from our new launches of Baxdela and Vabomere and the completion of a public follow-on offering of common shares that significantly strengthened our long-term financial position,” said Dan Wechsler, President and CEO of Melinta. “Product sales remained steady during the quarter and we continued to make excellent progress on our recent launches. We expect our sales trajectory to increase in the second half of the year, powered by our significantly increased presence in the marketplace and our expanded and now fully cross-trained sales force of 170 highly experienced sales representatives, with average hospital expertise of 15 years.”

“We also continued to make advancements within our pipeline during the quarter. Our Phase III trial of Baxdela for the treatment of adults with CABP completed enrollment ahead of schedule and is on track for top-line data by the end of 2018. Our discovery organization also continued to advance their important work following the announcement of our agreement with CARB-X that will provide us funding to advance the development of a novel antimicrobial from our ESKAPE pathogen program.”

“With the completion of our public offering, we are now in a strong financial position to support our continued growth.”

2018 Upcoming Potential Catalysts

 

   

Pivotal Phase 3 data for Baxdela in CABP

 

   

Vabomere EMA regulatory approval decision

 

   

Vabomere Medicare NTAP status effective Oct. 1, 2018

 

   

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

 

   

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

 

   

Additional data and publications at ID Week

 

   

IND-enabling studies for the lead ESKAPE compound

Q2 2018 Financial Results

Melinta reported revenue of $12.0 million for the quarter ended June 30, 2018. In addition, the company earned $2.1 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), which it recorded as other income.

During the quarter, as part of the final stages of the integration of the Infectious Disease business acquired from The Medicines Company, Melinta implemented a new, direct-to-wholesaler distribution process that will shorten the Company’s overall supply chain cycle, reduce inventory levels at wholesalers and save fees paid to wholesalers. The change resulted in a one-time negative impact on second quarter revenues of $2.7 million, primarily impacting Orbactiv.


Second quarter of 2018 total net revenue of $12.0 million compares to total net revenue of $4.0 million for the same period in 2017, prior to the acquisition of The Medicines Company ID business and the launch of Baxdela. In the second quarters of 2018 and 2017, we recognized contract research revenue totaling $2.8 million and $4.0 million, respectively. In the second quarter of 2018, net product sales were $9.2 million. The net product sales reflect solid performance of new launches and include the impact described above of the implementation of the new, direct-to-wholesaler distribution process, which occurred during the quarter and resulted in a one-time negative impact of $2.7 million, primarily impacting Orbactiv.

 

in USD millions

   Q2 2018      Q2 2017  

Product sales, net

   $ 9.2      $ —    

Contract revenue

     2.8        4.0  

Total net revenue *

   $ 12.0    $ 4.0  

 

*

Excludes BARDA grant funding included in Other Income of $2.1 million

Cost of goods sold (“COGS”) was $11.0 million for the quarter ended June 30, 2018, of which $6.7 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. Cost of goods sold also included charges of $2.4 million for Baxdela and Vabomere inventory that is approaching shelf life. Adjusted COGS was $2.0 million, excluding these non-cash charges, resulting in an Adjusted Gross Margin of 84% for the second quarter. There were no product sales and therefore no costs of goods sold in the prior year period.

Research and development (“R&D”) expenses were $15.8 million for the quarter ended June 30, 2018, compared to $14.1 million for the same period in 2017. The increase was driven by additional headcount and development activities resulting from the acquisition of the infectious disease business from The Medicines Company and the recent merger with Cempra. Adjusted R&D expenses were $15.6 million, which reflects the adjustment for non-cash expenses of $0.2 million.

Selling, general and administrative (“SG&A”) expenses were $34.9 million for the quarter ended June 30, 2018, compared to $7.7 million for the same period in 2017. The increase was driven by additional expenses associated with being a larger, public, commercial organization, including the operational impact of both the acquisition of the infectious disease business from The Medicines Company and the Cempra merger, consisting of additional headcount, facilities and commercial infrastructure. Approximately $1.7 million of SG&A expenses were a result of acquisition-related costs and lease exit costs, resulting in Adjusted SG&A expenses of $32.7 million.


Net loss was $55.8 million, or $1.38 per share, for the quarter ended June 30, 2018 compared to a net loss of $20.4 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.

On May 29, 2018, Melinta completed a follow-on public offering of 21.9 million shares of its common stock. The underwriters of the public offering also exercised in full their option to purchase an additional 2.6 million shares of Melinta’s common stock. Net proceeds from the offering were approximately $115.1 million after deducting underwriting discounts and commissions and expenses paid. As of June 30, 2018, Melinta had cash and cash equivalents of $150.1 million.

Q2 2018 and Recent Pipeline and Publication Highlights

 

   

20 presentations at ASM Microbe 2018, including pharmacoeconomic analyses of Vabomere and Orbactiv® (oritavancin), and analyses showing the rising incidence of Gram-negative pathogens in skin and skin structure infections (SSSIs) and the changes to empiric therapy that may be considered to improve outcomes

 

   

12 presentations at the MAD-ID 2018 Annual Meeting, including detailed safety and efficacy findings from the Phase 3 PROCEED studies of Baxdela in patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

 

   

Findings from the Orbactiv real-world registry demonstrating efficacy and safety consistent with the Phase 3 SOLO program published in Open Forum Infectious Diseases

 

   

12 Presentations at the European Congress of Clinical Microbiology and Infectious Diseases (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 (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species and Escherichia coli) at ECCMID 2018

 

   

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

 

   

Discovery Platform Oral Presentations at ECCMID 2018 and ASM Microbe 2018 Highlighting Progress Towards Leads for Drug-resistant Neisseria gonorrhoeae and Multidrug- and Extremely Drug-resistant ESKAPE Pathogens


Conference Call and Webcast

Melinta’s earnings conference call for the quarter ended June 30, 2018 will be broadcast at 8:30 a.m. ET on August 7, 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 9594878. Investors can also access the call at http://ir.melinta.com/events/event-details/melinta-therapeutics-q2-2018-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 # 9594878.

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 second 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 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 one-time, extraordinary inventory charges. 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, 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; 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 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 number 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

 

     June 30,
2018
    December 31,
2017
 
     (in 000s)  

Assets

    

Cash and cash equivalents

   $ 150,087     $ 128,387  

Trade receivables

     8,064       —    

Other receivables

     12,546       7,564  

Inventory

     33,960       10,825  

Prepaid expenses and other current assets

     5,510       2,988  
  

 

 

   

 

 

 

Total current assets

     210,167       149,764  

Property and equipment, net

     2,459       1,596  

In-process research and development

     19,859       —    

Other intangible assets

     221,877       7,500  

Goodwill

     17,614       —    

Other assets

     42,671       1,413  
  

 

 

   

 

 

 

Total assets

   $ 514,647     $ 160,273  
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Accounts payable and accrued expenses

   $ 44,738     $ 31,446  

Warrant liability

     6,790       —    

Current deferred purchase price and contingent consideration

     23,925       —    

Contingent milestone paymentss

     27,052       —    

Accrued interest on notes payable

     4,389       284  
  

 

 

   

 

 

 

Total current liabilities

     106,894       31,730  

Notes payable, net of debt discount

     107,463       39,555  

Deferred revenues

     —         10,008  

Deferred purchase price and contingent consideration

     31,289       —    

Other long-term liabilities

     8,027       6,644  
  

 

 

   

 

 

 

Total liabilities

     253,673       87,937  

Stockholders’ equity

    

Common stock

     56       22  

Additional paid-in capital

     908,781       644,973  

Accumulated deficit

     (647,863     (572,659
  

 

 

   

 

 

 

Total stockholders’ equity

     260,974       72,336  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 514,647     $ 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
June 30,
 
     2018     2017  
     (in 000s)  

Revenue

    

Product sales, net

   $ 9,152     $ —    

License revenue

     —         —    

Contract revenue

     2,870       3,978  
  

 

 

   

 

 

 

Total revenue

     12,022       3,978  

Operating expenses

    

Cost of goods sold

     10,989       —    

Research and development

     15,813       14,073  

Selling, general and administrative

     34,946       7,698  
  

 

 

   

 

 

 

Total operating expenses

     61,748       21,771  
  

 

 

   

 

 

 

Loss from operations

     (49,726     (17,793

Other income (expense):

    

Interest income

     63       12  

Interest expense

     (10,659     (1,762

Change in fair value of warrant liability

     2,389       (311

Loss on extinguishment of debt

     —         (607

Other income

     32       36  

Grant income

     2,121       —    
  

 

 

   

 

 

 

Total other income (expense), net

     (6,054     (2,632
  

 

 

   

 

 

 

Net loss

   $ (55,780   $ (20,425
  

 

 

   

 

 

 

Accretion of convertible preferred stock dividends

     —         (5,721
  

 

 

   

 

 

 

Net loss available to common shareholders

   $ (55,780   $ (26,146
  

 

 

   

 

 

 

Basic and diluted net loss per share

   $ (1.38   $ (884.06
  

 

 

   

 

 

 

Basic and diluted weighted-average shares outstanding

     40,297,364       29,575  
  

 

 

   

 

 

 


Melinta Therapeutics

Condensed Consolidated Statement of Cash Flows

 

     Three Months Ended
June 30,
 
     2018     2017  
     (in 000s)  

Net loss

   $ (55,780   $ (20,425

Adjustments to reconcile net loss to net cash used in operations:

    

Depreciation and amortization

     3,689       107  

Non-cash interest expense

     6,271       1,335  

Share-based compensation

     1,545       508  

Change in fair value of warrants

     (2,390     311  

Loss on disposal of assets

     —         33  

Loss on extinguishment of debt

     —         607  

Changes in operating assets and liabilities:

    

Receivables

     2,699       (1,202

Inventory

     (221     (551

Prepaids and other assets/liabilities

     (18,675     (879

Accounts payable and accrued expenses

     8,531       3,656  
  

 

 

   

 

 

 

Net cash used in operating activities

     (54,331     (16,500

Cash flows from investing activities:

    

Purchases of intangible assets

     (2,000     (3,500

Purchases of property, plant and equipment

     (423     (484
  

 

 

   

 

 

 

Net cash used in investing activities

     (2,423     (3,984

Cash flows from financing activities:

    

Proceeds from the issuance of common stock, net

     115,759       —    

Proceeds from the issuance of debt instruments

     —         21,990  

Proceeds from issuance of convertible notes payable

     —         24,526  

Principal payments on notes payable

     —         (21,659

IDB acquisition deferred payments

     (398     —    

Debt extinguishment costs

     —         (1,240
  

 

 

   

 

 

 

Net cash provided by financing activities

     115,361       23,617  

Net change in cash and cash equivalents

     58,607       3,133  

Cash and cash equivalents and restricted cash at beginning of period

     91,680       20,126  
  

 

 

   

 

 

 

Cash and cash equivalents and restricted cash at end of period

   $ 150,287     $ 23,259  
  

 

 

   

 

 

 


Melinta Therapeutics

Reconciliation of Reported Net Loss to Adjusted EBITDA

 

     Three Months Ended
June 30,
 
     2018      2017  
     (in 000s)  

Net loss

   $ (55,780    $ (20,425

EBITDA adjustments:

     

Interest expense

     10,659        1,762  

Interest income

     (63      (12

Depreciation and amortization

     6,814        135  
  

 

 

    

 

 

 

Total EBITDA adjustments

     17,410        1,885  

EBITDA

   $ (38,370    $ (18,540

Other adjustments:

     

Stock-based compensation

     1,545        508  

Changes in fair value of warrant liability

     (2,389      311  

Loss on extinguishment of debt

     —          607  

Acquisition-related costs

     229        —    

Other*

     2,907        —    
  

 

 

    

 

 

 

Total other adjustments

     2,292        1,426  

Adjusted EBITDA

   $ (36,078    $ (17,114

 

*

“Other” reflects charges that we recorded for certain inventory approaching shelf life as well as lease exit charges for one of our vacated facilities.

Melinta Therapeutics

Reconciliation of Reported Gross Margin to Adjusted Gross Margin

 

Three Months Ended June 30, 2018

   (in 000s)  

As reported under GAAP:

  

Revenue

   $ 12,022  

Cost of products sold (COGS)

     (10,989
  

 

 

 

Gross Margin

   $ 1,033  

Gross Margin (% of revenue)

     9

Adjustments to COGS:

  

Depreciation and amortization

   $ 6,675  

Other*

     2,352  
  

 

 

 

Adjusted COGS

   $ (1,962

Adjusted Gross Margin

   $ 10,060  

Adjusted Gross Margin (% of revenue)

     84

 

*

“Other” reflects charges that we recorded for certain inventory approaching shelf life.


Melinta Therapeutics

GAAP to Non-GAAP Adjustments

for the Three Months Ended June 30, 2018 and June 30, 2017

 

            Cost of                 Other Income        

Three Months Ended June 30, 2018

   Revenue      Product Sales     R&D     SG&A     (Expense), Net     Total  

As reported under GAAP

   $ 12,022      $ (10,989   $ (15,813   $ (34,946   $ (6,054   $ (55,780

Adjustments:

             

Interest expense

     —          —         —         —         10,659       10,659  

Interest income

     —          —         —         —         (63     (63

Depreciation and amortization

     —          6,675       54       85       —         6,814  

Stock-based compensation

     —          —         173       1,372       —         1,545  

Change in fair value of warrant liability

     —          —         —         —         (2,389     (2,389

Acquisition-related costs

     —          —         —         229       —         229  

Other*

     —          2,352       —         555       —         2,907  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total adjustments

   $ —        $ 9,027     $ 227     $ 2,241     $ 8,207     $ 19,702  

Adjusted EBITDA

   $ 12,022      $ (1,962   $ (15,586   $ (32,705   $ 2,153     $ (36,078

 

                        Other Income        

Three Months Ended June 30, 2017

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

As reported under GAAP

   $ 3,978      $ (14,073   $ (7,698   $ (2,632   $ (20,425

Adjustments:

           

Interest expense

     —          —         —         1,762       1,762  

Interest income

     —          —         —         (12     (12

Depreciation and amortization

     —          95       40       —         135  

Stock-based compensation

     —          124       384       —         508  

Change in fair value of warrant liability

     —          —         —         311       311  

Loss on extinguishment of debt

     —          —         —         607       607  
  

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total adjustments

   $ —        $ 219     $ 424     $ 2,061     $ 3,311  

Adjusted EBITDA

   $ 3,978      $ (13,854   $ (7,274   $ (571   $ (17,114

 

*

“Other” reflects charges that we recorded for certain inventory approaching shelf life as well as lease exit charges for one of our vacated facilities.

 

For More Information:   
Media Inquiries:    Investor Inquiries:
David Belian    Lisa DeFrancesco
(203) 848-6276    (908) 617-1358
EX-99.2

Slide 1

Melinta Therapeutics The Antibiotics Company . Q2 2018 Earnings Conference Call August 7, 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

Q2 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

Q2 and YTD Business Highlights $12.0 million of net revenue* in Q2 $9.2 million of net product sales Includes $2.7 million negative impact for one-time change in distribution to direct to wholesaler - primarily impacting Orbactiv Strengthened balance sheet following May offering Strong sales force presence of 170 representatives as of August 2-3x share of voice Realignment, hiring and training complete Continuing to identify opportunities for cost savings Vabomere granted NTAP status by CMS, effective Oct. 1, 2018 Vabomere EU marketing application review on target Baxdela CABP trial enrollment complete; focused on database lock and initiating process for sNDA filing Submissions of delafloxacin ongoing in Europe and Latin America Revenue Growth Operational Strength Clinical and Regulatory Progress . * Excludes $2.1 million BARDA grant funding included in Other Income


Slide 5

Vabomere™: Launch Momentum Continues Cumulative Ordering Accounts Tripled Since February 2018 Cumulative Ordering Accounts Source: Company data . ~3x Over 200 formulary approvals to-date > 98 % formulary acceptance rate 81% growth from Q1 to Q2 59% of accounts reordering Medicare NTAP status effective Oct. 1, 2018


Slide 6

Baxdela™: Increasing Momentum in Q2 Source: Company data . 200 million lives have access Accessible or on formulary at 138 hospitals Week-over-week Prescribing Has More than Doubled Over Q1 (Last 4 weeks Q1 vs. Last 4 weeks Q2) Cumulative Health Care Professionals (HCPs) Prescribing Cumulative Hospital Accounts Ordering 11 different specialties prescribing for ABSSSI Retail prescriptions more than double since Q1 3x >2x


Slide 7

. Baxdela Prescriptions Continue to Expand Breadth and Depth of Specialties Percent of Prescriptions by Specialty Early signs show that Podiatry and ID are leading the way Hospital avoidance strategy is a key focus


Slide 8

Orbactiv®: Continuing Growth ~10% Year-on-year Growth in Accounts ordering multiple units # of Accounts Ordering Multiple Units Source: Company data . 49 new accounts in June 70% of volume purchased by the hospital ~10% Continue year over year growth in units and number of accounts ordering


Slide 9

Minocin®: Sales Reinvigorated with Vabomere Source: Company data . Consistent Quarter-over-quarter Gains; Continued Synergies Reported Alongside Vabomere Double-digit growth vs. Q2 2017 on a pro forma basis Increased level of product growth YTD correlation with launch of Vabomere >20% Boxes Sold By Quarter


Slide 10

All Products Receiving Full Sales Force Support . Beginning to see impact in third quarter. Full impact anticipated fourth quarter. Jan - April May - June July à 170 Sales Reps Cross-Trained With ALL Products ~46 Reps ~66 Reps 112 Reps 170 Reps Realignment + Cross Training + New Hires


Slide 11

Significant Progress Made on Business Development Efforts Ex-US out-licensing Strategic acquisitions / partnerships Non-core portfolio optimization Government / non-dilutive partnerships 1 OUS rights for Vabomere, Orbactiv, Minocin Late stage discussions ongoing 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 CARB-X Announced .


Slide 12

Pipeline and Publications Update Vabomere Orbactiv Radezolid (partnered) Baxdela . Discovery Phase 3 CABP enrollment completed ahead of schedule; Data estimated end 2018 Pediatric formulation work underway EMA centralized review in process; LATAM NDA submissions underway Pediatric study ongoing EMA regulatory approval: Expected Q4 2018 TANGO-1 published; TANGO-2 data in the public domain ongoing Pediatric study ongoing Initial work to support updated formulation in US has begun Phase 2 topical acne vulgaris trial ongoing Formulation development initiated for bacterial vaginosis, received QIDP Announced CARB-X funding for ESKAPE program


Slide 13

Q2 Financial Results & Guidance Paul Estrem, Chief Financial Officer .


Slide 14

Q2 2018 Financial Highlights . Metrics (in millions) GAAP Adjustment Non-GAAP Comments Total Net Revenue $12.0 $12.0 Excludes BARDA grant funding - Product 9.2 9.2 - Contract 2.8 2.8 COGS 11.0 (9.0) 2.0 Deal-related amortization and inventory dating charges Total Operating Expenses $50.7 (2.4) $48.3 - R&D 15.8 (0.2) 15.6 Stock comp and depreciation - SG&A 34.9 (2.2) 32.7 Stock comp, M&A-related Cash & Cash Equivalents $150.1 $150.1 Gross Long-term Debt $147.8 $147.8 Common Shares Outstanding 40.3 40.3 Options, RSUs and Warrants Outstanding 8.6 8.6 Anticipate Orbactiv and Minocin to Achieve Net Sales of $36-$40 Million for FY 2018


Slide 15

Key Financial Information Key Metrics (unaudited) As of 6/30/18 Total Cash, Cash Equivalents and Marketable Securities $150.1 million Gross Long-term Debt Obligation $147.8 million Basic Shares Outstanding* 56,010,254 Stock Options, Restricted Stock Units and Warrants Outstanding 8,596,744 . *Full year projected weighted average share count expected to be 45,905,589


Slide 16

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


Slide 17

Strong first half 2018 performance from four brands with growing momentum $1 Billion Peak Sales Potential Achieved key development milestones on or ahead of schedule Baxdela CABP study enrollment complete 170 Fully Trained Reps to Impact Products Beginning September Fully funded balance sheet to support growth Continued focus on partnerships to support discovery efforts CARB-X awarded Melinta Therapeutics, The Antibiotics Company . Products Pipeline Discovery Operational Strength


Slide 18

2018 Future Catalysts Progress ESKAPE Program in partnership with CARB-X Baxdela Vabomere Discovery Corporate/ BD Medicare NTAP status effective Oct. 1, 2018 Provide launch updates EMA regulatory approval, including TANGO-2 data 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 Top line CABP data anticipated in 2018 EMA Centralized Review progress for ABSSSI Receive country approvals in South & Central America .