Jaguar Health, Inc. · NASDAQ:JAGX
Jaguar Health — Jaguar Animal Health — IPO Roadshow (April 2015)
30 slides from Jaguar Health's IPO roadshow presentation, Apr 28, 2015
Slide 1: Jaguar Animal Health Corporate Presentation
es DHDiroguars ANIMAL HEALTH Corporate Presentation
Slide 2: Forward-Looking Statements
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 anticipated timing of commercial launch of Canalevia, obtaining MUMS designation, and timing o
Slide 3: Free Writing Prospectus Statement
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 registrat
Slide 4: Initial Public Offering Summary
Initial Public Offering Summary Aegis Capital Corp. Sole Book-runner 3,150,000 Shares of Common Stock (100% Primary) Shares Offered Jaguar Animal Health, Inc. Issuer Nasdaq /JAGX Exchange/Ticker 15% (100% Primary) Over-Allotment $7.00 Per Share Expected Price CRT Capital and Feltl and Company Co-Man
Slide 5: Jaguar GI Product Development Strategy
Jaguar GI Product Development Strategy Approved for use in humans Fulyzaq1 (crofelemer) Canalevia™ (Rx) Neonorm™ (non-Rx) Intellectual property applies globally to all products across species 4 1Fulyzaq was approved by the FDA in 2012 for the symptomatic relief of noninfectious diarrhea in adults wi
Slide 6: Investment Highlights
Investment Highlights The only FDA-approved human anti-secretory diarrhea product1 Significant animal and human data Natural products from Croton lechleri First-in-Class GI Products for Animals Species-specific Rx formulations and trial/endpoint design: dogs, horses and cats Non-Rx: Beef cattle, hor
Slide 7: 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 8: Rx Drug Product Candidates
Rx Drug Product Candidates Product Candidate Species Indication Anticipated Milestones 2015 2016 Canalevia CID NADA approval first quarter Commercial launch first quarter General Watery Diarrhea Concurrence meeting with FDA Initiate pivotal trial 1H, Initiate filing NADA Specific formulations of cro
Slide 9: Canalevia: Diarrhea in Dogs
Canalevia: Diarrhea in Dogs In the US, one of the most common reasons for vet and emergency visits for dogs 6 million cases annually of acute and chronic watery diarrhea No FDA-approved anti-secretory products for dogs Current treatments Rehydration Diet change Absorbents/binding agents (Pepto-Bismo
Slide 10: Canalevia: Rolling NADA Filing for CID in Dogs
Canalevia: Rolling NADA Filing in 2014 for Chemotherapy-induced Diarrhea (CID) in Dogs Canalevia: Oral, twice daily, canine-friendly formulation of crofelemer Over 230,000 dogs receive chemotherapy in the US Estimated that ~25% suffer from CID Applied for MUMS designation to shorten time to commerci
Slide 11: Proof of concept study: Expand indication to general watery diarrhea
Proof of concept study: Expand indication to general watery diarrhea Purpose: Gather data and exploratory analyses in support of concurrence meeting with FDA Design of pivotal trial and statistical analysis plan Demonstrate significance in support of common Mechanism of Action across humans, calves,
Slide 12: Canalevia: General Watery Diarrhea POC Study
Canalevia: General Watery Diarrhea POC Study Enrollment criteria: 4 or 5 stool formulation Bacterial Infection Pancreatitis Dietary Indiscretion Giardia Infection Dosing: 2-4 mg/kg of Canalevia or a placebo twice a day for 3 days Other treatment: All dogs will receive “standard of care” for diarrhea
Slide 13: Endpoints: Achieved significance with all-comer evaluable dogs
Endpoints: Achieved significance with 39 “all –comer” evaluable dogs - 23 Canalevia, 16 placebo Resolution: 91% vs. 50% (p=0.007) Fecal score of 1 or 2 Responder (at conclusion of treatment): 92% vs. 44% (p=0.046) Across all days: p=0.013 Responder is a dog who had formed stools with no follow up un
Slide 14: Clinical response stratified by day
Day Canalevia Placebo 1 17.4% 6.7% 2 50.0% 33.3% 3 69.6% 53.3% 4 91.7% 44.4% Clinical response stratified by day, p=0.013. Significant difference occurs on Day 4, p=0.046 Results Support Conclusion That Canalevia is Superior to Placebo Proportion of Responders 14
Slide 15: Canalevia: Next Steps
Canalevia: Next Steps Plan to expand labeled indication to general watery diarrhea, regardless of cause Concurrence meeting with FDA in 2015 Pivotal efficacy initiation in 2015 Commercial launch expected in early 2017 Expansion of promotion with initiation of filing of NADA general watery diarrhea 1
Slide 16: Equine Diarrhea, Gastric & Colonic Ulcer Product
Equine Diarrhea, Gastric & Colonic Ulcer Product 97% of high performance horses have either gastric or colonic ulcers* 63% of high performance horses have colonic ulcers* 87% of high performance horses have gastric ulcers* 54% of high performance horses have both colonic and gastric ulcers* Diarrhea
Slide 17: Intellectual Property: New and Current IP
New IP Prebiotic effect of polyphenols/Croton lechleri-derived products Rifaximin combination Current IP Exclusive worldwide veterinary license to all Napo IP Zero to low royalties Exclusive global license to library of 2,300+ medicinal plants for all veterinary uses 11 Jaguar provisional patent app
Slide 18: Non-Rx Products
Non-Rx Products Products Species Use Anticipated Milestones 2015 2016 Neonorm Calf Improve gut health and normalize stool formation in pre-weaned dairy calves with scours Field study results second quarter (studies have been ongoing since fourth quarter of 2014); includes evaluation of prebiotic eff
Slide 19: Neonorm Calf Commercial Strategy (non-Rx)
Neonorm Calf Commercial Strategy (non-Rx) “Promotes normal stool formation” September 2014 Geographical Launch: World Dairy Expo National launch in February 2015 Geographical markets: Shipped ~$450k of Neonorm Calf to distributors Targeted sales force supporting regional distributors and vet clinics
Slide 20: Neonorm E. coli Challenge Study
Neonorm E. coli Challenge Study Enrolled 39 calves randomized into 2 groups 20 calves received Neonorm 19 calves received placebo All calves challenged with E. coli on Day 1 First dose was administered to all calves at 12 hours Additional doses administered every 12 hours until hour 72 Total of 6 do
Slide 21: Neonorm E. coli Challenge Study: Calf Evaluation and Scoring
Calves evaluated twice-daily for 10 days as well as at days 15 and 25 Measurements Fecal consistency Weight Mortality Dehydration Appetite Attitude Other adverse health disorders Modified University of Wisconsin Calf Health Scoring Chart Calf Feces Description Potential Treatment Normal 0 Normal, fo
Slide 22: Average Daily Calf Fecal Scores
Average Daily Calf Fecal Scores Neonorm significantly decreased the severity of watery diarrhea over the course of the 25 days (p=0.0133) Neonorm E. coli Challenge Study 22
Slide 23: Health and Economic Impacts
Health and Economic Impacts # of calves Mortality Avg. daily weight gain after 25 days Neonorm 20 5% (1) 15.5 pounds (281g/day) Placebo 19 21% (4) 12.1 pounds (219g/day) Avg. Duration of Watery Diarrhea (Score ≥2) Avg. Duration of Severe Watery Diarrhea (Score 3 or 4) Neonorm 3.03 days 1.10 days Pla
Slide 24: Agreement with Biogenesis Bagó
Jaguar Animal Health Signs Agreement with Latin America’s Largest Veterinary Biotechnology Company: Biogenesis Bagó (“Bagó”), based in Argentina A region that contains 401 million dairy and beef cattle and produces 11% of the world’s milk supply. Bagó chosen as winner of the Animal Pharm award for “
Slide 25: US Market: Initial GI Products
US Market: Initial GI Products Canalevia Market Neonorm Market Rx Companion Animals US Population: 74 mm cats, 70 mm dogs Non-Rx Dairy, Beef, Horses Population Incidence >11 mm dairy calves 23.9%* ~22 mm beef calves 2.4%** 9.2 mm horses >10% *Incidence in dairy heifer calves **Beef calves < 3 weeks
Slide 26: Selected Milestones
Selected Milestones 2014 2015 2016 Companion Animals (Rx) Production Animals (non-Rx) Neonorm Field Study Data in Dairy Calves Neonorm Launch in Dairy Calves Canalevia CID in Dogs Rolling NADA Filing Horse Acute Colitis Safety Data & Apply for MUMS Designation Horse Foals Safety & Efficacy Data Comm
Slide 27: Jaguar Commercialization Horizon
Jaguar Commercialization Horizon R&D/GI Expertise First-in-class products ONGOING LAUNCH: Neonorm Non-Rx (Dairy Calves) Concurrence/ Pivotal Trial: Canalevia-Dogs- General Diarrhea Canalevia- CID in Dogs- Rolling NADA Filing LAUNCH: Neonorm Non-Rx (Foals) LAUNCH:* Canalevia – CID in Dogs LAUNCH:* MU
Slide 28: Use of Proceeds
Use of Proceeds (Offering size of $22.1 million) Amount ($ Mil.) % Canalevia clinical studies and regulatory approval costs 2.4. 10.9% Other Rx clinical studies and regulatory approval costs 2.1. 9.5% Commercial activities for Canalevia and Neonorm inside and outside the US 3.5. 15.9% Studies and fi
Slide 29: Investment Highlights
Investment Highlights The only FDA-approved human anti-secretory diarrhea product1 Significant animal and human data Natural products from Croton lechleri First-in-Class GI Products for Animals Species-specific Rx formulations and trial/endpoint design: dogs, horses and cats Non-Rx: Beef cattle, hor
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