Jaguar Health, Inc. · NASDAQ:JAGX
Jaguar Health — Jaguar Animal Health — Merger or Acquisition (June 2017)
36 slides from Jaguar Health's merger presentation, Jun 7, 2017
Slide 1: Forward-looking statements
This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding the proposed merger between Jaguar and Napo and the expectation that the merger will close, the combined company’s ability to
Slide 2: Crofelemer was Discovered Through the Science of Ethnobotany
Crofelemer was Discovered Through the Science of Ethnobotany 2
Slide 3: Human Health FDA Approved Product: Mytesi (crofelemer)
Human 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). Essentially Unencumbered Worldwide Rights Mul
Slide 4: Comp of a Combined Jaguar/Napo: Heron Therapeutics
Comp of a Combined Jaguar/Napo Heron Therapeutics, Inc. SUSTOL® (granisetron): Approved August 2016 for the prevention of chemotherapy-induced nausea and vomiting. Pipeline: Pain product NASDAQ: HRTX Market Cap: $781.3M (June 6, 2017) Heron has an approved product for supportive care as well as a pi
Slide 5: GI Product Development Strategy
GI Product Development Strategy Approved for use in humans Mytesi®1 (crofelemer) Intellectual property applies globally to all products across species 1Mytesi® (formerly known as Fulyzaq) was approved by the FDA in 2012 for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on
Slide 6: GI Product Development Strategy
GI Product Development Strategy Approved for use in humans Mytesi®1 (crofelemer) Intellectual property applies globally to all products across species 1Mytesi® (formerly known as Fulyzaq) was approved by the FDA in 2012 for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on
Slide 7: Jaguar Animal Health and Napo Have Entered a Definitive Merger Agreement
Jaguar Animal Health and Napo Pharmaceuticals Have Entered a Definitive Merger Agreement 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 adul
Slide 8: Napo Launched Mytesi October 2016
Napo Launched Mytesi® October 2016 and Estimates Potential U.S. Market to be Approximately $100 Million in Gross Annual Sales 1Orange Book, www.accessdata.fda.gov/scripts/cder/ob/, accessed October 2016 Napo has deployed a direct sales effort in Q2 2017 with 8 field sales representatives and telesal
Slide 9: Total Specialty Market Opportunity of ~$100 Million
Total Specialty Market Opportunity of ~$100 Million Initiation on a new ART still causes diarrhea 15% of the time >50% of the U.S. HIV population is aging, and living with the virus in their gut for 10+ years, causing chronic diarrhea Commercial manufacturing in place with brand new facility We beli
Slide 10: First-Generation Pipeline: Human Indications of Mytesi
First-Generation Pipeline: Human Indications of Mytesi® (Crofelemer) Phase 3 2018-2019 Phase 3 2019-2020 Phase 1 Two significant Phase 2’s completed sNDA 2021 Phase 2a 2018 Dose & Formulation Selection Phase 2-3 2019-2021 sNDA 2022 Proof-of-Concept 2017 Pivotal Trial 2018 sNDA 2019 Phase 1 2018 Phas
Slide 11: Mytesi Future: Chemotherapy-induced Diarrhea
Diarrhea is the most common adverse event reported “All-grade” diarrhea rates are 50-80% Epidermal growth factor receptor (EGFR) Tyrosine kinase inhibitors (TKI’s) and EGFR monoclonal antibodies (i.e. Herceptin) Chronic maintenance therapy Source: Wadler S, Treatment Guidelines for CID. Gastroentero
Slide 12: Two Ongoing Investigator Initiated Studies in CID
Crofelemer as salvage anti-diarrheal therapy with investigational breast cancer agent, neratinib TITLE: An open label study to characterize the incidence and severity of diarrhea in patients with early stage HER2+ breast cancer treated with adjuvant trastuzumab and neratinib followed by neratinib mo
Slide 13: Orphan Drug: Congenital Diarrheal Disease and Short Bowel Syndrome
Filed for Orphan drug status in US Consanguineous increased prevalence Gut ion (chloride) channels continuously open Diagnosed patients lifespan typically into the teens Immediate investigator initiated trials and orphan drug advantages Exclusivity Relief from filing fees Tax advantages Pediatric re
Slide 14: IBS Market Evolution: Mytesi Opportunity in 2017
IBS has several new entrants Largest market opportunity: All new agents have guidance >$billion Continual pain severity is an unmet need, as reflected in Rome 4 criteria (May 2016, DDW) The Rome IV criteria established that recurrent abdominal pain is the hallmark of IBS, with the associated symptom
Slide 15: Two Significant Phase 2 Studies in IBS-D Patients
Address the unmet medical need that persists with current therapy A successful dose-ranging study and confirmation of benefit for abdominal pain reduction A statistically significant difference in reduction of abdominal pain favoring crofelemer was observed-- ~13% difference Stool consistency improv
Slide 16: 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 and those with microscopic colitis all suffer chronic severe diarrhea Highly motivated patient population with low placebo resp
Slide 17: Evaluation of Crofelemer in Diarrhea from Cholera
Study evaluating crofelemer at 125 or 250 mg QID vs. placebo 1 hour after Azithromycin in confirmed cholera cases with watery diarrhea (Bardhan, et.al., ‘08 US-Japan Cholera Conf.) N=100; randomized 1:2:2 (placebo, 125 QID, 250 QID) Reducing amount of watery stool, 25-30%, 0-12 hour time periods (p=
Slide 18: Long-term Pipeline Human Indications of Mytesi
Long-term Pipeline Human Indications of Mytesi® (Crofelemer) Tropical Disease Priority Review Voucher* First-Generation Pipeline Second generation lower COGS botanical product: SB-300 Multiple Targeted Follow-on Indications Backed by Strong Phase 2 Evidence Brings Mytesi® to Blockbuster Potential Ex
Slide 19: Mytesi Future: A Blockbuster Pipeline within a Product
Cholera PRV/SB-300 offer long-term pipeline opportunity for anti-secretory novel mechanism of action Mytesi® Future: A Blockbuster Pipeline within a Product Expanded manufacturing will lower cost of goods 19 HIV-D (diarrhea in HIV/AIDS patients on antiretrovirals) IBS-D (Irritable Bowel Syndrome – d
Slide 20: Global partnering for a pipeline
Global partnering for a tremendous pipeline provides opportunity for non-dilutive funding and global access to Mytesi® and novel anti-secretory agents Multiple indications Multiple geographies Second generation anti-secretory Strategically sequence indication development priorities, second-generatio
Slide 21: Combination Results in Tremendous Synergies
Combination Results in Tremendous Synergies Centralized management Manufacturing economies of scale “Weaving” synergies of R&D Common messaging in commercialization 21
Slide 22: Animal Health Development Programs
LA Acute Diarrhea in Dogs Target animal Safety NADA 2017 Field study CID (MUMS) Target Animal Safety Conditional NADA 2017 Reasonable Expectation of Efficacy MUMS Designation Diarrhea Associated with Acute Equine Colitis Investigate MUMS Potential Target Animal Safety Reasonable Expectation of Effic
Slide 23: MUMS Strategy: Canalevia for CID in Dogs
MUMS Strategy: Canalevia: Chemotherapy-Induced Diarrhea (CID) in Dogs 23 Develop second-generation “chew” for ease of chronic administration Commercial launch expected late 2017/early 2018 Received MUMS designation MUMS designation is similar to ‘‘orphan drug’’ status Termed “conditional approval” b
Slide 24: Jaguar and Elanco Enter Global Collaboration for Canalevia
Food and companionship enriching life. At Elanco, we provide those who raise and care for animals with solutions that empower them to advance a vision of food and companionship enriching life. Elanco US Inc. is a division of Eli Lilly and Company. Up-front and milestone payment of $61 mm Canalevia™
Slide 25: Equine Athlete Ulcer Opportunity: Equilevia
Equine Athlete Ulcer Opportunity: Equilevia™ ~4 million high performance horses in US ~7 million worldwide 87% of high performance horses have gastric ulcers* (squamous and glandular) No marketed FDA-approved treatments effective for glandular ulcers Chronic treatment cost omeprazole: ~$50/day Posit
Slide 26: Equilevia: Positive Effect on Racing Results
Horses on treatment with Equilevia™ had higher average winnings as a percent of purse in races. Horses on placebo or on the positive control (Merial’s GASTROGARD® product) had a reduction in their average winnings. Horses on treatment with Equilevia™ had higher average total dollar winnings. Horses
Slide 27: R&D/GI Expertise: First-in-class products
R&D/GI Expertise First-in-class products Pivotal Trial: Canalevia-Dogs- Acute Diarrhea LAUNCH: Neonorm Calf LAUNCH:* Canalevia – CID in Dogs INITIATE DEVELOPMENT: Acute Diarrhea Cats 2015 2017 2016 *Contingent upon FDA approval POC Data, Ulcers in Horses LAUNCH: Biogenesis Bagó Neonorm Calf Safety D
Slide 28: Product launch and development timeline
Pivotal Trial: Canalevia-Dogs- Acute Diarrhea LAUNCH: Neonorm Calf LAUNCH:* Canalevia – CID in Dogs LAUNCH:* Acute Diarrhea Canalevia INITIATE DEVELOPMENT: Acute Diarrhea Cats 2015 2017 2016 POC Data, Ulcers in Horses LAUNCH: Biogenesis Bagó Neonorm Calf Safety Data, Diarrhea Associated with Acute C
Slide 29: Management Team of Combined Company
Management Team of Combined Company Lisa Conte Founder & CEO 25+ years of industry experience Obtained first anti-secretory human product FDA approval Karen Wright Chief Financial Officer & Treasurer 30+ years of financial experience with biotech companies Former Head of Finance for Clene Nanomedici
Slide 30: Board of Directors
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 Obtained first anti-secretory human product FDA ap
Slide 31: Market Cap: Jaguar Animal Health to be renamed Jaguar Health
Market Cap: Jaguar Animal Health to be renamed Jaguar Health, of which Napo will be a wholly-owned subsidiary Current outstanding shares at Jaguar Animal Health (JAGX): ~14.4 mm Approximate number of outstanding shares post merger, Jaguar Health with wholly-owned subsidiary Napo Pharmaceuticals (sam
Slide 32: Comp of a Combined Jaguar/Napo: Heron Therapeutics
Comp of a Combined Jaguar/Napo Heron Therapeutics, Inc. SUSTOL® (granisetron): Approved August 2016 for the prevention of chemotherapy-induced nausea and vomiting. Pipeline: pain product NASDAQ: HRTX Market Cap: $781.3M (June 6, 2017) Heron has an approved product for supportive care as well as a pi
Slide 33: Investment Highlights
Investment Highlights Mytesi® forecasted net sales of $7.0 mm, 2017 Ability to track performance Forward integration to prescription revenue generating company Important manufacturing economies of scale Efficiencies of shared skillset Weaving of R&D and commercial common assets Synergies of merger M
Slide 34: The team that discovered and developed crofelemer
The team that discovered and developed crofelemer Enthusiasm: Anyone familiar with Malcom Gladwell’s book, Outlier, is familiar with the 10,000-hour rule to excel; our team at this combined company breaks through that barrier with 40,000 hours—20 plus years—to change the standard of care for gastroi
Slide 35: Common Pathway and MOA in Mammals
Common Pathway and MOA in Mammals Canalevia and Neonorm are distinct products that act at the same last step in a physiological pathway generally present in mammals, regardless of cause Acts locally in the gut and is minimally absorbed systemically P P Intestinal Lumen Intestinal Epithelial Cell Cl-
Slide 36: Common Pathway and MOA in Mammals
Common Pathway and MOA in Mammals Intestinal Lumen Intestinal Lumen Intestinal Lumen Drugs! Toxins! actertum Views Quel Tenn Me Hs \o-fropnf ‘/ Acts locally in the gut and is minimally absorbed systemically
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