Jaguar Health, Inc. · NASDAQ:JAGX
Jaguar Health — IPO Roadshow (September 2017)
32 slides from Jaguar Health's IPO roadshow presentation, Sep 18, 2017
Slide 1: Forward-looking statements
2 This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding the merger between Jaguar and Napo, the combined company’s ability to benefit from economies of scale, access efficiencies,
Slide 2: Free Writing Prospectus Statement
3 Free Writing Prospectus Statement This presentation highlights basic information about us and the offering to which this communication relates. Because it is a summary, it does not contain all of the information that you should consider before investing in our common stock. We have filed a registr
Slide 3: Offering Summary
4 Offering Summary Issuer: Jaguar Health, Inc. Exchange/Symbol: NASDAQ: JAGX Offering Type: Follow-on Offering Securities To Be Issued: Common Stock Use of Proceeds: Commercialization of Mytesi; general corporate purposes and working capital Sole Book-Running Manager: Maxim Group LLC Co-Manager: Wes
Slide 4: Crofelemer was Discovered Through the Science of Ethnobotany
5 Crofelemer was Discovered Through the Science of Ethnobotany
Slide 5: Mytesi approved by the FDA for symptomatic relief of noninfectious diarrhea in HIV/AIDS
6 Mytesi® (crofelemer 125mg delayed-release tablets) is approved by the FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.
Slide 6: About Jaguar Health
7 About Jaguar Health Human Health Animal Health FDA Approved Product: Mytesi® (crofelemer) Mytesi® (crofelemer 125mg delayed-release tablets) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Canalevia
Slide 7: Mytesi Overview
Mytesi® Overview 8 The Company recently hired 6 additional experienced sales representatives in key U.S. markets to promote Mytesi® to an estimated 1,000+ prescribers considered ‘high potential’ for HIV (prescribers who write the majority of total prescriptions for ART drugs) as well as to gastroent
Slide 8: Mytesi - Forward Momentum
Mytesi® - Forward Momentum 9 Hired a national sales director Additional 6x sales representation effort: Sales reps have been hired for coverage of Atlanta, Houston, Chicago, St. Louis, Dallas, San Francisco, Florida, New York, Los Angeles Additional 6x advertising, medical education, publications an
Slide 9: Total Specialty Market Forecasted Sales Opportunity of ~$100 Million
Initiation on a new ART still causes diarrhea 18% of the time1 A growing percentage of HIV patients have lived with the virus in their gut for 10+ years, causing chronic diarrhea. By 2020, more than 70% of Americans with HIV are expected to be 50 and older.3 10 Total Specialty Market Forecasted Sale
Slide 10: Mytesi Coverage and Reimbursement
Mytesi® Coverage and Reimbursement 11 Mytesi® is covered by all of the top 10 commercial insurance plans, representing >245 million US lives. Mytesi is covered on ~2.4 million lives of the top 10 Managed Medicare plans Mytesi® is covered on Medicaid in all 50 states The Company has a copay coupon pr
Slide 11: Mytesi Coverage and Reimbursement
Mytesi® Coverage and Reimbursement * Mytesi® is covered by all of the top 10 commercial insurance plans, representing >245 million US lives. + Mytesi is covered on ~2.4 million lives of the top 10 Managed Medicare plans + Mytesi® is covered on Medicaid in all 50 states + The Company has a copay coup
Slide 12: Anti-Secretory Mechanism of Action in Mammals
13 Anti-Secretory Mechanism of Action (MOA) in Mammals Crofelemer acts at the common last step in a physiological pathway, regardless of cause, thereby normalizing defective secretion, specifically mitigating dehydration Acts locally in the gut and is minimally absorbed systemically P P Intestinal L
Slide 13: Human Indications of Mytesi - A Pipeline within a Product
Human Indications of Mytesi®—A Pipeline within a Product Preclinical Phase 1 Phase 2 Phase 3 NDA Near-Term Milestones HIV-D Diarrhea in HIV/AIDS patients on antiretrovirals Expanding marketing & sales efforts 6x CID Chemotherapy-induced diarrhea Ongoing II Trials; SAB Protocol Design IBD Inflammator
Slide 14: HIV Physicians and Patient Advocacy Advisors
15 HIV Physicians Gary Blick, MD, AAHIVS, Chief Medical Officer at Health Care Advocates International; Co-Founder, HIV EQUAL David Asmuth, MD (tentative), Infectious diseases specialist, UC Davis Health Patrick Clay, Pharm. D, HIV management and treatment specialist, UNT Health Science Center Peter
Slide 15: Size of Target Markets
16 Size of Target Markets 16 Number of Competitors for Mytesi’s Approved/Anticipated Labelled Indication Market Size/Potential HIV-D 0 Jaguar estimates the U.S. market revenue potential for Mytesi® to be ~$100mm in gross annual sales CID 0 ~650,000 U.S. cancer patients receive chemotherapy in an out
Slide 16: Chemotherapy-induced Diarrhea (CID)
17 Chemotherapy-induced Diarrhea (CID) Diarrhea is the most common adverse event reported “All-grade” diarrhea rates are 50-80% Tyrosine kinase inhibitors (TKI’s) and EGFR monoclonal antibodies (i.e. Herceptin) worse offenders Chronic adjuvant therapy Puma‘s Neratinib Receives FDA Approval In one st
Slide 17: Two Ongoing Investigator Initiated Studies in CID
18 Two Ongoing Investigator Initiated Studies in CID Crofelemer as salvage anti-diarrheal therapy with investigational breast cancer agent, neratinib TITLE: An open label study to characterize the incidence and severity of diarrhea in patients with early stage HER2+ breast cancer treated with adjuva
Slide 18: IBS Market Evolution: Mytesi Opportunity in 2017
19 IBS Market Evolution: Mytesi® Opportunity in 2017 IBS has several new entrants Most new IBS market introductions have estimated revenue potential >$1.0 bn1 Continual pain severity is an unmet need, as reflected in Rome 4 criteria (May 2016, DDW) The Rome IV criteria established that recurrent abd
Slide 19: Two Significant Phase Crofelemer Studies in IBS-D Patients
20 Two Significant Phase 2 Crofelemer Studies in IBS-D Patients A successful dose-ranging study and confirmation of benefit for abdominal pain reduction A statistically significant difference in reduction in composite abdominal pain/stool consistency, regulatory endpoint (FDA guidance): ~15%/11% dif
Slide 20: Congenital Diarrheal Disease and Short Bowel Syndrome
21 Congenital Diarrheal Disease (CDD) and Short Bowel Syndrome (SBS) Filed for orphan-drug status in US Received orphan status for SBS Consanguineous increased prevalence Gut ion (chloride) channels continuously open Orphan-drug advantages Exclusivity Relief from filing fees Tax advantages Need for
Slide 21: Inflammatory Bowel Diseases (IBD)
22 Inflammatory Bowel Diseases (IBD) KOLs identified an unmet need to treat diarrhea in IBD patients, particularly in specific subsets of patients IBD patients after ileal pouch-anal anastomosis (IPAA) surgery all suffer chronic severe diarrhea Highly motivated patient population with low placebo re
Slide 22: Study of Crofelemer for Diarrhea Caused by Cholera
23 Study of Crofelemer for Diarrhea Caused by Cholera: Potentially Lifesaving Benefit Study evaluating crofelemer vs. placebo 1 hour after Azithromycin in cholera1 Reducing amount of watery stool, 25-30%, 0-12 hour time periods (p=0.07) Indian patient study in adults with severe watery diarrhea2 N=9
Slide 23: Global Partnering Driving Pipeline
24 Global Partnering Driving Pipeline Multiple indications Multiple geographies Second generation anti-secretory Strategically sequence indication development priorities, second-generation product pipeline development, and partnering goals on a global basis Global partnering for a tremendous pipelin
Slide 24: Combination Results in Tremendous Synergies
25 Combination Results in Tremendous Synergies Centralized management Manufacturing economies of scale “Weaving” synergies of R&D Common messaging in commercialization
Slide 25: Portfolio Management: Animal Pipeline
26 Portfolio Management: Animal Pipeline Goal No cash-impact activities: Our business partner Elanco funds companion animal prescription product development and distribution through commercial launch Equilevia and acute colitis prescription program: Personalized non-prescription product based on cus
Slide 26: Equilevia: Equine Personalized Product for Total Gut Health
27 Equilevia™: Equine Personalized Product for Total Gut Health ~4 million high performance horses in US ~7 million worldwide 87% of high performance horses have gastric ulcers1 Clinical data from Jaguar’s POC studies supports Equilevia’s safety and efficacy Additional targeted benefit: No withdrawa
Slide 27: Management Team
28 Management Team Name / Title Experience Lisa Conte Founder & CEO 28+ years of industry experience Obtained first anti-secretory human product FDA approval Board of directors of Healing Forest Conservancy, Dickey Center for International Understanding (Dartmouth College) Karen Wright CFO & Treasur
Slide 28: Board of Directors
29 Board of Directors Name / Title Experience James Bochnowski Chairman Founder of Delphi Ventures, one of the first VC firms to focus exclusively on investing in life sciences companies Co-founded Technology Venture Investors Lisa Conte Founder, CEO & President 25+ years of industry experience Obta
Slide 29: Pro Forma and Cap Table
30 Pro Forma and Cap Table 1Includes outstanding shares of voting common stock and non-voting common stock. Approximately 43% of fully diluted shares of common stock are non-voting common stock with restrictions on trading for one year 2Board has approved stock option grants in the amount of 13,635,
Slide 30: Anticipated Milestones
31 Mytesi® 2017: 6-fold commercial expansion; expand to gastroenterologist offices 2017/18: Geographical partnerships 2017 and beyond: Indication expansion 2017/18: Publish IBS results 2017: KOL meeting scheduled for November: Advances in IBD 2018: File INDs and initiate clinical trials for follow-o
Slide 31: Investment Highlights
Investment Highlights Only FDA-approved diarrhea treatment that’s been studied specifically in adults with HIV / AIDS The Company recently hired 6 additional experienced sales reps in key U.S. markets to promote Mytesi® 6x advertising, medical education, publications and promotion Ability to track p
Slide 32: Investment Highlights
Investment Highlights Mytesi: FDA- Approved Human Drug Broad Human Product Pipeline Product Rights Risk-Mitigated Product Development Animal Health Pipeline Synergy & cash conservation Strong Management Team Proprietary Position * Only FDA-approved diarrhea treatment that’s been studied specifically