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): March 13, 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 March 13, 2018, Melinta Therapeutics, Inc. (the “Company”) issued a press release announcing its results for its fourth quarter and fiscal year ended December 31, 2017. 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 March 13, 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 Fourth Quarter and Full Year 2017 Financial Results,” dated March 13, 2018
99.2    Investor presentation, dated March 13, 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: March 13, 2018

 

- 3 -

EX-99.1

Exhibit 99.1

 

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Melinta Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results

Baxdela(delafloxacin) Launched February 6, 2018, in U.S. for Adults with ABSSSI

Acquired Infectious Disease Business from The Medicines Company on January 5, 2018

First Earnings Report as a Public Company

NEW HAVEN, Conn., March 13, 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 and regulatory activities for the quarter ended December 31, 2017. During the quarter, the Company completed its reverse merger with Cempra, Inc. (Cempra) to become a publicly traded company. Fourth quarter and full year 2017 results include the addition of the Cempra business as of the merger date of November 3, 2017. Immediately following the quarter, the Company acquired the infectious disease business of The Medicines Company, including products Vabomere (meropenem and vaborbactam), Orbactiv® (oritavancin) and Minocin® (minocycline) for Injection. This press release includes highlights from The Medicines Company infectious disease business as of acquisition close on January 5, 2018.

“Following Melinta becoming a public company on November 3, we swiftly acquired the infectious disease business from The Medicines Company, transforming Melinta into the largest global, pure-play antibiotics company. Today, we have a strong portfolio of products including Vabomere, Orbactiv and Minocin for Injection, together with our first drug Baxdela that we launched just this quarter,” said Dan Wechsler, president and CEO of Melinta.

“We have a strong combined team, including the addition of over 150 seasoned professionals at the time of The Medicines Company transaction, and a leading pipeline of development and discovery assets including those from our own Nobel Prize-winning discovery platform. 2018 will be an exciting year for Melinta, and we look forward to launching our products, furthering our pipeline and telling our story focused on bringing life-saving anti-infective products to areas of unmet need and, in turn, building strong shareholder value over the long-term,” Mr. Wechsler concluded.

Full Year 2017 and Recent Business Highlights

 

    March 2, 2017 - entered into commercial and co-development agreement with Menarini Group for delafloxacin in 68 countries outside of the United States

 

    >$100 million of upfront and potential milestone payments and double-digit royalties on sales in partnered territories

 

    Menarini pays 50% of future delafloxacin indication-expansion efforts


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    June 19, 2017 - the U.S. Food and Drug Administration (FDA) approved Baxdela indicated in adults for treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria

 

    A fluoroquinolone that exhibits activity against both Gram-positive and Gram-negative pathogens, including the distinction of being the only approved drug in its class that covers methicillin-resistant Staphylococcus aureus (MRSA)

 

    A fixed-dose therapy with limited disease or drug interactions and is available in interchangeable intravenous and oral formulations

 

    September 26, 2017 - announced the expansion of agreement with Eurofarma Laboratorios S.A. (Eurofarma) to include 19 countries in South and Central America and the Caribbean

 

    Eurofarma has submitted a marketing authorization for delafloxacin in Argentina

 

    November 3, 2017 - completed the reverse merger with Cempra to become a publicly traded company

 

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

 

    Added a well-experienced commercial, medical affairs and commercial support organization

 

    Integration nearing completion

 

    Minimal disruption to product launches or performance, including Vabomere, which was recently launched

 

    February 6, 2018 - launched Baxdela in the United States

 

    March 8, 2018 - partner Menarini submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for delafloxacin for treatment of adults with ABSSSI

Q4 and Full Year 2017 Financial Results

Melinta reported a net loss available to shareholders of $20.9 million, or $1.48 per share, for the quarter ended December 31, 2017 compared to a net loss of $27.7 million for the same period in 2016. For the full year ended December 31, 2017, the Company reported net loss available to shareholders of $78.2 million.

Research and development expenses were $11.6 million for the quarter ended December 31, 2017, compared to $16.3 million for the same period in 2016. The decrease was driven primarily by fourth quarter 2016 New Drug Application (NDA)-related fees and milestone payments and lower manufacturing costs. For the full year ended December 31, 2017, the Company reported R&D expenses of $49.5 million.

 


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Selling, general and administrative expenses were $37.3 million for the quarter ended December 31, 2017, compared to $4.6 million for the same period in 2016. The increase was driven primarily by commercial launch preparation activities for Baxdela and transaction- and integration-related costs, including severance and stock-based compensation, due to the merger. For the full year ended December 31, 2017, the Company reported selling, general and administrative expenses of $63.3 million.

As of December 31, 2017, Melinta had cash and cash equivalents of $128.4 million. In addition, the Company has available debt capacity under the Deerfield agreement. It is anticipated that Melinta may strengthen its cash position through the completion of business development activities, similar to the transaction completed with Menarini. The Company also recently filed a universal shelf registration statement on Form S-3 with the SEC, which will allow the Company to provide more timely and efficient access to the capital markets should the Company decide to issue securities in the future, subject to market conditions.

2017 and Recent Pipeline and Publication Highlights

Includes highlights from The Medicines Company infectious disease business as of acquisition close on January 5, 2018.

 

    Publication of Baxdela Outcomes in ABSSSI Patients with Fluoroquinolone-resistant S. aureus Isolates

 

    Presented Outcomes of Baxdela Treatment of Gram-Positive and Gram-Negative Pathogens at IDWeek 2017

 

    Announced Topical Radezolid (partnered product) Well Tolerated in Phase 1 Study for Treatment of Acne, Initiation of Program in Patients with Bacterial Vaginosis, and Qualified Infectious Disease Product (QIDP) Designation for Bacterial Vaginosis

 

    Publication in Journal of Antimicrobial Chemotherapy of 1st Pivotal Phase 3 Baxdela Trial Data in ABSSSI

 

    Complete Results from the Phase 3 TANGO-1 Data for Vabomere Published in The Journal of the American Medical Association (JAMA)

 

    2nd Pivotal Phase 3 Baxdela ABSSSI Trial Data Published in Clinical Infectious Diseases

 

    Discovery Platform Oral Presentations at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) and American Society for Microbiology (ASM Microbe) Highlighting Progress Towards Leads for Drug-resistant Neisseria gonorrhoeae and Multidrug- and Extremely Drug-resistant ESKAPE Pathogens

 


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2018 Upcoming Potential Catalysts

 

    Pivotal Phase 3 data for Baxdela in community-acquired bacterial pneumonia (CABP)

 

    Vabomere EMA regulatory approval decision

 

    TANGO-2 additional data and potential publications

 

    Additional ex-US approvals for Baxdela in Central and South America

 

    Ex-US partnership opportunities for Vabomere, Orbactiv and Minocin for Injection

 

    IND-enabling studies for lead ESKAPE compound

Conference Call and Webcast

Melinta’s earnings conference call for the quarter ended December 31, 2017 will be broadcast at 8:30am EDT on March 13, 2018. The live webcast can be accessed under “Events and Presentations” in the Investor Relations section of Melinta’s website at www.melinta.com.

Investors wishing to participate in the call should dial: 877-377-7553 and international investors should dial: 253-237-1151. The conference ID is 7787858. Investors can also access the call at http://ir.melinta.com/events/event-details/melinta-therapeutics-q4-2017-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 # 7787858.

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 and better 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.

 


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About Baxdela (delafloxacin)

For more information about Baxdela, including the Medication Guide and important safety information, including the Boxed Warning, see www.baxdela.com.

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; 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

 


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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, which we expect to file promptly with the SEC, 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.

 

     December 31,     December 31,  
     2017     2016  
     (in 000s)  

Assets

    

Cash and cash equivalents

   $ 128,387     $ 11,409  

Receivables

     7,564       454  

Inventory

     10,825       —    

Prepaid expenses and other current assets

     2,988       3,226  
  

 

 

   

 

 

 

Total current assets

     149,764       15,089  

Property and equipment, net

     1,596       1,101  

Intangible assets

     7,500       —    

Other assets

     1,413       444  
  

 

 

   

 

 

 

Total assets

   $ 160,273     $ 16,634  
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Accounts payable and accrued expenses

   $ 31,446     $ 11,496  

Notes payable, net

     —         11,075  

Other current liabilities

     284       848  
  

 

 

   

 

 

 

Total current liabilities

     31,730       23,419  

Notes payable, net of current and debt discount

     39,555       12,647  

Convertible promissory notes

     —         45,127  

Deferred revenue

     10,008       9,008  

Other long-term liabilities

     6,644       1,541  
  

 

 

   

 

 

 

Total liabilities

     87,937       91,742  

Convertible preferred stock

     —         218,343  

Stockholders’ equity

    

Common stock

     22       —    

Additional paid in capital

     644,973       220,292  

Accumulated deficit

     (572,659     (513,743
  

 

 

   

 

 

 

Total stockholders’ equity

     72,336       (293,451
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 160,273     $ 16,634  
  

 

 

   

 

 

 

 


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     Three Months Ended     Twelve Months Ended  
     December 31,     December 31,  
     2017     2016     2017     2016  
           (in 000s)        

Revenue

        

Contract revenue

   $ 4,231     $ —       $ 13,959     $ —    

License

     —         —         19,905       —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     4,231       —         33,864       —    

Operating expenses

        

Research and development

     11,599       16,302       49,475       49,791  

Selling, general and administrative

     37,349       4,586       63,325       19,410  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     48,948       20,888       112,800       69,201  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (44,717     (20,888     (78,936     (69,201

Other income (expense), net

        

Interest income

     130       6       155       30  

Interest expense

     (1,859     (1,478     (7,624     (4,406

Change in fair value of tranche assets and liabilities

     —         —         —         (1,313

Change in fair value of warrant liability

     —         (64     335       781  

Loss on extinguishment of debt

     —         —         (607     —    

Other income

     3       42       98       177  

Bargain purchase gain

     27,663         27,663       —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     25,937       (1,494     20,020       (4,731
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (18,780   $ (22,382   $ (58,916   $ (73,932
  

 

 

   

 

 

   

 

 

   

 

 

 

Accretion of convertible preferred stock dividends

     (2,098     (5,334     (19,259     (21,117
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss available to common shareholders

   $ (20,878   $ (27,716   $ (78,175   $ (95,049
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted net loss per share

   $ (1.48   $ (1,186.17   $ (21.86   $ (4,119.67
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted weighted-average shares outstanding

     14,105       23       3,577       23  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

For More Information:   

Media Inquiries:

Amra Maynard

(917) 302-2702

Amra.maynard@inventivhealth.com

  

Investor Inquiries:

Lisa DeFrancesco

(847) 681-3217

ldefrancesco@melinta.com

  

Raj Mistry

(312) 801-2051

rmistry@melinta.com

 

EX-99.2

Slide 1

Melinta Therapeutics The Antibiotics Company Q4 2017 Earnings Conference Call March 13, 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 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 filings with the SEC, including in its Annual Report on Form 10-K for the year ended December 31, 2017, which the Company expects to file promptly with the SEC and, its Quarterly Reports on Form 10-Q. .


Slide 3

Q4 2017 Earnings Conference Call - Agenda 1. Business Overview Dan Wechsler, President and CEO Q4 2017 Highlights and Recent Events Integration Update Commercial Overview Pipeline and Publication Highlights 2. Financial Results and Outlook Paul Estrem, CFO 3. Conclusion and 2018 Catalysts Dan Wechsler, President and CEO .


Slide 4

Q4 Highlights and Recent Events Merged with Cempra to become a publicly-traded company Acquired The Medicines Company ID Business including three approved products and strong ID-focused organization Integration nearing completion with strong, combined team Vabomere launched Oct. 28, 2017 Baxdela launched Feb. 6, 2018 Baxdela ABSSSI EMA regulatory filing submitted by partner Menarini Ex-US MA filed for Baxdela in Argentina with partner Eurofarma Discovery asset Radezolid Entered Phase 2 for acne vulgaris Received FDA QIDP designation for bacterial vaginosis Business Product Transformed into Largest Pure-play Antibiotics Company >$1 Billion US Peak Sales Potential From 4 Approved Products .


Slide 5

Integration Nearing Completion Strong, experienced, combined team executing on product launches, assessing pipeline and developing New Melinta culture Products performing during period of transition Vabomere and Baxdela launches underway with early favorable trends Minocin and Orbactiv combined experiencing double-digit growth Pharmaceutical Development Committee established to evaluate pipeline priorities All key milestones & deadlines met during period of integration .


Slide 6

Robust and Complementary Product Portfolio of Four Approved Assets with Significant Commercial Potential . cUTI including KPC-mediated CRE Acinetobacter in the Hospital Setting ABSSSI Patients with Comorbidities in the Hospital, Emergency and Outpatient Setting Gram (+) ABSSSI in the Emergency and Outpatient Setting Unique Market Value for Each Approved Product Optimized By Company Infrastructure and Commitment to Antibiotics


Slide 7

Industry Leading Organization with Deep Expertise . Strong Operating Infrastructure 4 Approved Brands 18 300+ Employees 17 Years Average Sales Experience 135+ (Infectious Disease Business) Medical Science Liaisons Key Account Manager Territories


Slide 8

Dan Wechsler CEO >25 years; led Zyvox at Pharmacia; led pharma, generics and OTC at Bausch & Lomb; CEO at Smile Brands Paul Estrem CFO >25 years; CFO of multiple business units at Baxter Sue Cammarata, M.D. CMO >20 years; development of Cubicin and Zyvox Erin Duffy, Ph.D. CSO >20 years; leading expert in structure & function of bacterial ribosome Juliet Agranoff SVP, HR >20 years; head of HR for The Medicines Company ID franchise Lisa DeFrancesco SVP, IR >15 years; VP investor relations at Allergan Peter Di Roma SVP, QA/RA >20 years; regulatory approval of Zyvox and Baxdela Michael McGuire SVP, Comm’l >25 years of pharma marketing and anti-infectives Kevin Conway VP, Tech Ops >30 years; operational management of Humira and Kaletra launches Kate Farrington VP, Compliance >20 years of pharma industry compliance/officer roles Experienced Combined Management Team .


Slide 9

Organization Dedicated to Antibiotic Stewardship Antibiotic Stewardship Right Patient, Right Product, Right Length of Time .


Slide 10

Commercial Overview . Products Launched February 6, 2018 Favorable early uptake Launched October 28, 2017 Formulary approvals and uptake trends positive 50% of high priority target accounts have access Q4 2017 strongest quarter since 2014 launch Experienced double-digit growth Renewed focus supports continued sales growth Complementary product offering to Vabomere


Slide 11

Vabomere: Fixed Dose, IV Monotherapy Targeting KPC-producing, Carbapenem-resistant Enterobacteriaceae Indications: cUTI (approved) Acute pyelonephritis (approved) Attributes / Differentiation: Product for serious Gram-negative pathogens, an area of significant need Fixed dose, no requirement for plasma monitoring Meropenem “backbone” with safety profile similar to meropenem alone Conducted first & only supportive study as monotherapy in CRE infections versus a range of “best available therapy” regimens $990/day WAC 2g meropenem / 2g vaborbactam TID dosing Fixed dose .


Slide 12

Vabomere Reporting Positive Initial Adoption Trends >150 Accounts with Product Available >150 Accounts with Upcoming P&T or Sub-committee Review 50% Accounts Already Placed Re-orders 100% of Susceptibility Testing Devices* Currently Available * Semi-automated testing devices .


Slide 13

Baxdela: Fixed Dose, IV/Oral Monotherapy Targeting Serious Mixed Pathogen Infections Indications: ABSSSI (approved) CABP (single Phase 3, >75% enrolled) Attributes / Differentiation: Gram-positive, Gram-negative, MRSA (only approved FQ with coverage) Interchangeable IV and Oral administration Fixed dose, no food effect, no drug interactions (other than antacids) <1% discontinuation due to treatment-related AEs in ABSSSI Phase 3s Large database of co-morbid patients studied $135/day WAC 450mg tablet BID dosing Fixed dose $265/day WAC 300mg vial BID dosing Fixed dose .


Slide 14

Large ABSSSI Market Opportunity for Baxdela in Hospital, Emergency and Selected Outpatient Areas . 3 Million Hospitalized Cases 2 Million Emergency Department Cases Selected Outpatient, i.e. Peri- and Post-acute Care 10 Million Community Cases ü ü ü


Slide 15

First Month of Baxdela Commercial Indicators Promising >50M Commercial Lives Have Product Access (Tier 3, No Prior Authorization) 71 Accounts Allowing Product Access 34 Hospital Formulary Reviews Scheduled in Next Quarter 100% of Susceptibility Testing Devices* Currently Available . * Semi-automated testing devices


Slide 16

Focus on Newly Accessible Opportunities, e.g. Outpatient Clinics Surrounding Hospitals Leverage Power of 100% Dedicated Anti-infectives Business Drive Value from Reinvigorated Salesforce Orbactiv & Minocin Strategy Demonstrating Consistent Growth Since Launch . 1 2 3 $34 Million FY 2017 Sales; Anticipate Steady Growth


Slide 17

Attractive Product Portfolio for Multiple Sites of Care . Hospital Avoidance Hospital Transition of Care (Post-Discharge) Specialty Outpatient POD / ID / Surg Wound / Burn Urgent Care LTC High Value PCP


Slide 18

Company Pipeline Update . EU partner Menarini submitted EMA regulatory submission for ABSSSI: Q1 2018 LATAM partner Eurofarma submitted MA for Argentina for ABSSSI: Q1 2018 Phase 3 CABP enrollment completion: Expected Q4 2018 Baxdela Vabomere Fusidic Acid Solithromycin Radezolid (partnered) ESKAPE EMA regulatory approval: Expected Q4 2018 TANGO-1 published; TANGO-2 data available Phase 2 Bone & Joint study: 6 month primary endpoint data ABSSSI Phase 3 met primary endpoint Continuing to evaluate options Meeting scheduled with BARDA Japan partner Toyama completed enrollment in four studies Phase 2 topical acne vulgaris trial ongoing Formulation development initiated for bacterial vaginosis, received QIDP Evaluating efficacy and safety credentials of >100 compounds that focus on multiple target product profiles in anticipation of IND-enabling studies in 2018 IV reformulation under evaluation Orbactiv Minocin EMA approval pathway under evaluation


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Financial Results & Guidance Paul Estrem, Chief Financial Officer .


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Financial Highlights . 12 months ended Metrics (in millions) 12/31/2017 01/05/2018 Full Year Revenue* $33.9 N.A. Cash & Cash Equivalents $128.4 N.A. Long-term Debt $40.0 $148.0 Common Shares Outstanding 22.0 31.3 Options, RSUs and Warrants Outstanding 2.4 6.2 * Includes one-time license revenue of $19.9 million 2018 Cash Supports Execution of Near-term Strategic Objectives


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2018 Key Financial Items Revenue Vabomere and Baxdela in early launch phase Continued combined growth of Orbactiv and Minocin (full year 2017 generated $34 million) Cost reimbursement and milestone achievements from collaborations and partnerships Key Financial Items Operating expenses (R&D and SG&A): $175-$200 million Interest expense: $18 million . Opportunity to Achieve Cash Flow Positive During 2020


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


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Attractive Growth Equity Story; Robust Antibiotics Pipeline from Discovery to Commercial; World-class Capabilities Four approved antibiotic assets with >$1 billion sales potential 4 marketed products incl. 2 launches underway Robust drug development pipeline to fuel future growth Strong combined experienced talent, processes and capabilities Nobel Prize-winning technology Proprietary discovery know-how to address emerging resistance Global footprint* with significant expansion potential Melinta Therapeutics, The Antibiotics Company * Including partnership agreements . Products Pipeline Discovery Operational Strength


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2018 Key Catalysts . Launch updates Phase 3 CABP study enrollment completion Country approvals in South & Central America Launch updates EMA regulatory approval TANGO-2 additional data and potential publications Ex-US partnerships for balance of portfolio Business development opportunities Progress on ESKAPE program Focused publication strategy; 30+ planned Baxdela Vabomere Other When Strategy is Clear, EXECUTION Becomes the Strategy