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 27, 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 7.01. Regulation FD Disclosure.

As previously announced, Melinta Therapeutics, Inc. (the “Company”) will present information regarding the Company at 12:45 pm ET on Tuesday, March 27, 2018 at Needham & Company’s 17th Annual Healthcare Conference. The presentation slides to be used during the event are attached hereto as Exhibit 99.1. A live and archived webcast of the presentation will be accessible from the “Investors” section on the Company’s website (ir.melinta.com) under the “Events & Presentations” tab.

The information in this Item 7.01 (including Exhibit 99.1) 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    Needham Presentation

 

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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 27, 2018

 

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EX-99.1

Slide 1

Melinta Therapeutics The Antibiotics Company Needham Healthcare Conference March 27, 2018 . Exhibit 99.1


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 most recently filed Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q and its Current Reports on Form 8-K. .


Slide 3

Strategy for Near- and Long-term Growth and Expansion Strong sales growth from four US-approved antibiotics with potential to achieve >$1 billion in peak sales Additional indications and publications to maximize potential during long market exclusivity period Ex-US partnerships across entire product portfolio to enhance company value Novel anti-infectives leveraging our proprietary, Nobel Prize-winning discovery platform DRIVE DEVELOP DISCOVER EXPAND Continue to Execute Growth-accelerating Business Development Activities .


Slide 4

Creating the Pure Play Antibiotics Leader NASDAQ: MLNT Jun 2017 Nov 2017 FDA approval for ABSSSI Jan 2018 acquires (ID Business) Transformed into Largest Pure-play Antibiotics Company .


Slide 5

Integration Nearing Completion Experienced, combined team executing well on product launches Unified sales force and messaging driving continued product growth trajectory Strong product performance during period of transition Pharmaceutical Development Committee evaluating pipeline priorities Opportunities for additional cost savings and potential revenue synergies as we complete integration – focus on bringing them forward through 2018 .


Slide 6

Resident Expertise Capable of Driving Execution . Products (Infectious Disease Business) Fully-integrated Anti-infectives Company Offering Multiple Therapies to Payors, Providers and the Patients they Serve Strong Operating Infrastructure 4 Approved Brands 18 2 Out of 3 Employees 17 Years Average Field Experience 135 Medical Science Liaisons Key Account Manager Territories Customer Facing / Revenue Generating


Slide 7

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 8

Industry Leading Portfolio of Branded Antibiotics Assets Products Well established quinolone drug class Only approved fluoroquinolone for treatment of ABSSSI that covers MRSA Broad spectrum, IV/oral, fixed dose Rx IP/Exclusivity into 2027 Single dose treatment of ABSSSI, incl. those caused by MRSA Allows for treatment in lower cost settings Single dose regimen ensures patient adherence IP/Exclusivity into 2024 One of a limited number of options for Acinetobacter infections Established drug class and well understood utilization patterns IP/Exclusivity into 2031 Antibiotics for Serious Infections Gram-positive Gram-negative Developed to address KPC-mediated resistance Combines meropenem with novel BLI vaborbactam for treatment of cUTI CRE-specific clinical data (TANGO-2) IP/Exclusivity into 2031 .


Slide 9

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


Slide 10

Commercial Overview Products Launch meeting occurred on February 6, 2018 Favorable early uptake in acute & community settings 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

Early Launch Signals Positive Cumulative HCPs Prescribing Tripled Since Feb Cumulative Hospital Accounts Ordering Doubled Since Feb Cumulative Health Care Professionals (HCPs) Prescribing Cumulative Hospital Accounts Ordering 3x 2x Source: Company data .


Slide 12

Early Launch Signals Positive Cumulative Ordering Accounts Cumulative Ordering Accounts Doubled Year-to-date 2x Source: Company data .


Slide 13

Building Momentum 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 14

2018 Key Catalysts Acquired Infectious Disease Business of The Medicines Company Executed transaction with Deerfield Capital Strengthened team with ID-focused talent Completed initial portfolio optimization decisions 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 Partner Menarini submitted regulatory filing in EU Partner Eurofarma submitted marketing authorization in Argentina Provide launch updates Complete enrollment for Phase 3 CABP study Receive country approvals in South & Central America Provide launch updates Upcoming FDA meeting in Q2 and evaluate sNDA Receive EMA regulatory approval Present additional TANGO-2 data and potential publications Progress ESKAPE Program Baxdela Vabomere Other When Strategy is Clear, EXECUTION Becomes the Strategy Corporate/ BD ü ü ü ü


Slide 15

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


Slide 16

Backup .


Slide 17

Industry Leading Portfolio and Pipeline PRODUCT / INDICATION PRE CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA Submitted FDA Approved EMA Submitted EMA Approved Baxdela Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Vabomere Complicated Urinary Tract Infections (cUTI) Orbactiv ABSSSI Minocin IV Serious infections due to select organisms including Acinetobacter Baxdela Community-acquired Bacterial Pneumonia (CABP) Radezolid Dermatology ESKAPE “Superbugs” Pipeline NON-CORE ASSETS PRE CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA Submitted FDA Approved EMA Submitted EMA Approved Fusidic Acid ABSSSI Solithromycin CABP Development ongoing in Japan through partner. Potential to evaluate additional indications One positive Phase 3 complete