Melinta Therapeutics The Antibiotics Company

Transcription

1 Melinta Therapeutics The Antibiotics Company January 10, 2018 Dan Wechsler, CEO

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 definitive proxy statements filed with the SEC in October and December

3 Presentation Overview Company Overview Who is Melinta? Where We Are Going The New Melinta Product Launch Update Integration Update Key Priorities Next 12 Months 3

4 Creating a Pure-play Antibiotics Leader Founded on Nobel Prizewinning discovery Received 1 st FDA approval (Baxdela) Reverse merged in 2017 to list on Nasdaq (MLNT) with >$150 million of capital Acquired three marketed antibiotics and pipeline Added strong IDfocused team Leading Pure-play Antibiotics Pipeline from Discovery to Commercial; Significant Antibiotics-focused Talent Within Single Organization; >$1 Billion US Peak Sales Potential From 4 Currently Approved Products 4

5 The New Melinta Products Pipeline Operational Strength Discovery 5

6 Significant Commercial Opportunity >$1 Billion US Sales Potential for Current Indications Products For ABSSSI patients at risk for mixed infections in the hospital, community or ED For cutiin the hospital For Gram (+) ABSSSI in the ED or community For Acinetobacter in the hospital Unique Market Value for Each Approved Product Optimized by Company Infrastructure and Commitment to Antibiotics 6

7 Industry Leading Portfolio and Pipeline 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 >$1 Billion US Sales Potential Minocin IV Serious infections due to select organisms including Acinetobacter Baxdela Community-acquired Bacterial Pneumonia (CABP) Fusidic Acid ABSSSI Solithromycin CABP Radezolid Dermatology Industry Leading Pipeline to Fuel Future Growth ESKAPE Superbugs 7

8 Successful Out-licensing Offers Potential to Expand Partnerships Across Full Portfolio of Assets Pipeline Out-licensed Territory Global rights to products acquired from The Medicines Company present strong future partnership opportunities 8

9 Nobel Prize-winning Discovery Platform Discovery We own the 3D structure of ribosome (home to >50% of commercial antibiotic classes) We created the tools and developed the know-how to exploit the ribosome structure This technology platform enables us to: 1 Engineer improvements in 2 existing classes Create novel classes of antibiotics to overcome multidrug-resistant bacteria Discovered Radezolid, Currently in Clinical Development for Dermatology; >10,000 Compounds Created, with 3 Completely New Classes 9

10 Strong Commercial and Medical Affairs Capabilities Operational Strength Commercial Approx 135 sales representatives selling today Significant experience: ~15 years hospital + antibiotics A portfolio of products that allows HCPs to address serious infections across continuum of care Medical Affairs More than 3x increase in field-based medical support from ID specialists Commitment to antibiotic stewardship Appropriate capital to generate and publish data for appropriate access Leveraging Best Practices and Talent From All Organizations 10

11 Experienced, Leading Combined Management Team Operational Strength 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, MD CMO >20 years; development of Cubicin and Zyvox Erin Duffy, PhD 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 11

12 Solid Financial Profile Operational Strength Sufficient capital to execute key priorities Significant value inflection points on near-term horizon Ability to leverage industry-leading infrastructure across multiple assets Fiscally responsible organization with multiple levers Sustainable platform for shareholder value generation 12

13 Well-positioned to Meet Critical Unmet Needs Company Multiple Late-stage Indications Gramnegative Pipeline Successful Phase 3 Program Multiple Approved Products Sustainable Discovery Capabilities Melinta (MLNT) Achaogen (AKAO) Paratek (PRTK) Tetraphase (TTPH) Nabriva (NBRV) Source: Company estimates 13

14 Strategy for Long-term Growth and Expansion DRIVE DEVELOP DISCOVER EXPAND Sales of >$1 billion from four US-approved antibiotics Additional indications during 10+ years of market exclusivity for key assets afforded by GAIN Act Completely novel anti-infectives leveraging our proprietary, Nobel Prize-winning discovery platform Ex-US partnerships across entire product portfolio to enhance company value Continue to Execute Growth-accelerating Business Development Activities 14

15 Business Update Products Integration Planning / Execution Near-term Priorities 15

16 Significant Commercial Opportunity >$1 Billion US Sales Potential for Current Indications For ABSSSI patients at risk for mixed infections in the hospital, community or ED For cutiin the hospital For Gram (+) ABSSSI in the ED or community For Acinetobacter in the hospital Unique Market Value for Each Approved Product Optimized by Company Infrastructure and Commitment to Antibiotics 16

17 Baxdela Differentiates in ABSSSI US Market: 28 Million Annual Hospitalizations Leading Brands Leading Generics Baxdela Teflaro Sivextro Cubicin Zyvox Vancomycin Quinolone Broad Spectrum Incl MRSA IV and Oral Fixed Dose Limited Drug Interactions Promoted Inpatient Hospital Source: Company estimates 17

18 Baxdela Launch Preparations Complete Product supply chain established; Baxdela now available through full line wholesalers servicing hospitals, institutional pharmacies and retail pharmacies MelintAssist patient access program operational as of Jan 1 Baxdela commercial presence established at major medical meetings as of Q Direct to HCP professional promotion and peer-to-peer programs ready for execution Launch First Week in February 18

19 Baxdela Launch Strategy Commercial Strategy to Enable Patient and Provider Access 1 Commercialize in all areas of unmet need In-patient Emergency Department Community 2 Create product access and ensure continuity of care Four antimicrobial susceptibility testing devices commercially available at launch WAC: $135/day; $265/day 3 Promote key product attributes Pathogen coverage: Gram (+), Gram (-), MRSA IV or oral initiation of therapy Fixed dose Limited drug or disease interactions Favorable safety profile relative to drug class 19

20 Exciting New Asset in Gram-negative Space Hospital-treated Gram-negative infections Carbapenemresistant Gramnegative infections Extended-spectrum cephalosporinresistant Gramnegative infections Confirmed or suspected KPCmediated CRE 20

21 Vabomere Product Launch Update Commercial testing available 2 months after launch WAC: $990/day Active discussions ongoing with high priority accounts Favorable early read on hospital orders/re-orders Formulary approval progress constructive Positive customer feedback on differentiation and comfort with utilization vs alternative therapies 21

22 Integration Objectives Building the Leading Antibiotics Company 1 Create the Best Combined Team Hired new Commercial, Med Affairs and HR leaders from MDCO ID 2 Commercialize Baxdela and Vabomere Took inventory of existing programs and initiatives Expanded sales and MSL teams to increase commercial potential 3 Continue Development of Highest Value Programs Forming Pharmaceutical Development Committee to assess and prioritize full portfolio and pipeline 22

23 Integration Planning Complete; Execution Underway Stabilized organization Offers made to >150 employees with high rate of job acceptance 100% of employees at both organizations know where they stand Field force, including management, undisrupted to ensure seamless commercial focus on product launches and established products No disruptions on all four product marketing/product management teams Baxdela launch on track with no delays to original timelines Efficient Integration With Meaningful Accomplishment in Impressive Timeframe; Building High Performance Culture 23

24 Key Immediate Priorities 1 Commercialize approved products in the US 2 Continue to develop pipeline 3 Advance discovery platform 4 Expand ex-us partnership opportunities 5 Seamlessly complete integration activities When Strategy is Clear, EXECUTION is the Strategy 24

25 The New Melinta Four approved antibiotic assets with >$1 billion sales potential Robust drug development pipeline to fuel future growth 2 on market; 2 launches underway Products Pipeline Global footprint with significant expansion potential Strong combined experienced talent, processes and capabilities Operational Strength Discovery Nobel prize-winning technology Proprietary discovery know-how to address emerging resistance Attractive Growth Equity Story; Robust Antibiotics Pipeline from Discovery to Commercial; World-class Capabilities 25