Eton Pharmaceuticals, Inc. · NASDAQ:ETON
Eton Pharmaceuticals — IPO Roadshow (September 2018)
29 slides from Eton Pharmaceuticals's IPO roadshow presentation, Sep 28, 2018
Slide 1: Corporate Presentation October 2018
CORPORATE PRESENTATION OCTOBER 2018 Filed Pursuant to Rule 433 Registration Statement No. 333 - 226774 Issuer Free Writing Prospectus dated September 28, 2018 Relating to Preliminary Prospectus dated September 25, 2018
Slide 2: Special Note Regarding Forward-Looking Statements
2 SPECIAL NOTE REGARDING FORWARD - LOOKING STATEMENTS This document contains forward - looking statements concerning Eton Pharmaceuticals, Inc. (“Eton”, the “Company,” “we,” “us,” and “our”). The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,”
Slide 3: Company Overview
3 Focused on acquiring, developing, and commercializing innovative drug products • Building a diversified portfolio of low - risk, high - value 505(b)(2) products • Current portfolio contains eight product candidates with addressable market of > $4.4 Bn • Two products filed with the FDA and expected
Slide 4: Management
4 Management 100+ business development transactions completed by management* 100% of management and board plan to buy stock in the IPO * Full management and board bios available on page 23
Slide 5: 505(b)(2) Pathway
5 505(b)(2) Pathway FDA’s abbreviated system for products containing molecules that have been proven to be safe and effective ● Takes significantly less time, clinical requirement, and expense than the typical pathway Something of a hybrid between an New Chemical Entity and a generic ● Typically uti
Slide 6: 505(b)(2) Examples
6 505(b)(2) Examples Low - risk, low - cost, high - value 505(b)(2) drugs in the US market Note: All sales data from IQVIA except actual reported sales for Bloxiverz, Vazculep, and Akovaz. Development costs are manag eme nt estimates based on details of FDA review packages. Product Name Company Mole
Slide 7: Regulatory Capabilities
7 Regulatory Capabilities • In - house team handles FDA meetings, management of clinical programs, and NDA filings • Meets with the FDA prior to initiating development activities to understand regulatory pathway before committing capital • Products typically require a small phase III trial, a bioequ
Slide 8: Product Opportunities Eton Targets
8 Product Opportunities Eton Targets Low Development Costs • Typical total investment of $2 - 5 million per product $10 - 75 Million High - Margin Revenue Opportunities • Larger product opportunities tend to attract more competition and are less abundant Short Time to Market • ~36 months for new int
Slide 9: Business Development
9 ~100 • Opportunities reviewed ~25 • Proceeded to negotiations & advanced due diligence 9 • Agreed to terms and held Pre - IND meeting with FDA 5 • Successful FDA meeting, executed agreement & added product to pipeline Eton Business Development Activity Since Inception (June 2017) Value - creating
Slide 10: Project Life Cycle
10 Project Life Cycle Conserve capital by meeting with FDA before development activities
Slide 11: Eton's Constantly Evolving Portfolio
11 Eton’s Constantly Evolving Portfolio
Slide 12: Eton's Products
12 Eton’s Products Products where Eton is converting the market from a DESI or grandfathered product to a FDA - approved product Products approved pre - 1962 were not required to prove efficacy FDA has allowed these DESI or “grandfathered” products to remain on the market until another company recei
Slide 13: Our diversified portfolio of product opportunities
13 Our diversified portfolio of product opportunities Pipeline Product Type Product Dosage Form Clinical Requirement Estimated Filing Year Reference Product Sales* Innovative Formula Products EM - 100 Ophthalmic Bioequivalence Study Filed $55 Million + ET - 103 Oral Liquid Bioequivalence Study 2019
Slide 14: ET-103 (Levothyroxine Oral Solution)
14 ET - 103 (Levothyroxine Oral Solution) • Innovative liquid formulation of levothyroxine • With annual sales of $2.6 billion and 5.7 billion pills, Levothyroxine is one of the most prescribed medications in the United States • Liquid formulation will provide significant benefit to pediatric and ge
Slide 15: EM-100 (Ketotifen Ophthalmic Solution)
15 EM - 100 (Ketotifen Ophthalmic Solution) • Unique preservative - free formula of ketotifen ophthalmic solution • Currently approved preservative (multi - dose) product is widely used under the Zaditor, Alaway, and private - label brand names • EM - 100 would be the first preservative - free ophth
Slide 16: CT-100 (Corticotropin)
16 CT - 100 (Corticotropin) • Proprietary and patent - pending formulation of synthetic Corticotropin injection to compete with H.P. Acthar Gel® • H.P Acthar Gel® is an off - patent $1.1 billion+ product that has no generic or generic - like competition. • FDA has requested Eton run a Phase III clin
Slide 17: DESI Conversion Products
17 DESI Conversion Products • Three injectable product candidates where Eton is seeking formal FDA approval to replace DESI products • US market is currently reliant on DESI or grandfathered products with inconsistent supply • FDA guidance generally calls for DESI products to leave the market within
Slide 18: Product Pipeline
Product Pipeline PRODUCT DOSAGEFORM DS-300 INjecraste EM-100 OPHTHALMIC DS-100 IMjecraste DS-200 NjecrABLe £T-103 RAL QUID FT-101 ORAL LIQUID FT-102 ORAL UQUID 7-100 inpecrasue élon
Slide 19: Offering Details
19 Offering Details
Slide 20: Transformation Since Series A
20 Transformation Since Series A Since closing our Series A financing in June 2017, we have seen transformational change in our pipeline ● Added 5 new late - stage assets to portfolio. 2 of which have already been filed with FDA ● Drastically accelerated Eton’s path to profitability and increased co
Slide 21: Use of Proceeds
21 Use of Proceeds • Opportunistic business development • Commercial infrastructure for product launches • Continued product development activities • NDA application fees • Buildout of FDA - compliant R&D laboratory
Slide 22: Offering Details
22 Offering Details We expect the net proceeds of the offering , plus our current cash on hand, to take us to profitability Proposed Offering With Over - allotment Option Proposed Price per Share $6.00 $6.00 Shares Offered 3.0 million 3.45 million Net Proceeds $15.5 million $17.9 million Shares Outs
Slide 23: Summary
23 Focused on acquiring, developing, and commercializing innovative drug products • Building a diversified portfolio of low - risk, high - value 505(b)(2) products • Current portfolio contains eight product candidates with addressable market of > $4.4 Bn • Two products filed with the FDA and expecte
Slide 24: Appendix
24 Appendix
Slide 25: Management Team: Sean Brynjelsen
25 Sean Brynjelsen Chief Executive Officer & Director Management Team ● EVP of Business Development at Sagent Pharmaceuticals ● SVP of Global Business Development at Akorn, Inc ● Management and drug development roles at Baxter and Hospira ● MBA from University of Notre Dame; MS Chemistry from Univer
Slide 26: Management Team
26 Management Team PREVIOUS EXPERIENCE Wilson Troutman - Chief Financial Officer • CFO of Omeda Communications; Corporate Controller & Treasurer at Akorn, Inc • MBA from University of Chicago; BS in Commerce from University of Illinois - Urbana Bharathi Devarakonda - SVP of Regulatory Affairs & Prod
Slide 27: Board of Directors
27 Mark Baum ● Founder and current CEO of Imprimis Pharmaceuticals ● Current Board member of Imprimis Pharmaceuticals Dr. Norbert Riedel Chairman ● Current CEO of Aptinyx ● Previously CEO of Naurex (Acquired by Allergan for $560 million) ● Previously Corporate Vice President and Chief Science & Inno
Slide 28: Board of Directors (continued)
28 Board of Directors Charles Casamento ● Current Executive Director and Principal of The Sage Group, a healthcare advisory group ● Previously CEO of Questcor, which acquired H.P Acthar® Gel ● Previously CEO of Osteologix Paul Maier ● Chairman of Eton Audit Committee ● Previously CFO of Ligand Pharm
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