Jaguar Health, Inc. · NASDAQ:JAGX
Jaguar Health — Noble Capital Markets conference (January 2019)
36 slides from Jaguar Health's conference presentation, Jan 28, 2019
Slide 1: 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 Company’s plan to file an IND in 2H 2019 for lechlemer for the possible indication of diarrhea
Slide 2: Our Story: From Tree to Bottle
Crofelemer was discovered through the science of ethnobotany Our Story: From Tree to Bottle
Slide 3: Jaguar Health: The Product Portfolio
Mytesi (crofelemer 125mg delayed-release tablets) is FDA-approved for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar Health: The Product Portfolio
Slide 4: Mytesi Gross & Net Sales Q4 2017 Through Q4 2018
Chart data on file in Jaguar Health General Ledger 1Non-GAAP measure A line-by-line reconciliation of gross sales to net sales is included in the appendix on page 36 of this presentation *Q4 2018 gross and net figures are estimates Estimated Q4 2018 Gross & Net Sales: Approximately $2.18 Million & $
Slide 5: Jaguar Health By The Numbers
Revenue-Generating Biopharma With an FDA-Approved Drug 19% Growth in Total Mytesi Prescriptions in Q4’18 Versus Q3’182 37% Anticipated Mytesi Gross Sales Growth in Q4’18 Versus Q3’18 36% Mytesi Gross Sales Growth in Q3’18 Versus Q2’181 1Data on file in Jaguar Health General Ledger 2Source: IQVIA Mon
Slide 6: Key Market Events and Prescription Trends
Data Source: IQVIA NPA (National Prescription Audit 12/18) Name Change Fulyzaq to Mytesi Pilot Sales Team (n=2) Phase I Sales Expansion (n=8) Digital Campaign Launched (8/26/18) Phase II Sales Expansion & Comprehensive S&M Effort (n=18) Mytesi US Total Prescriptions (TRx) Key Market Events and Presc
Slide 7: Our Dual Mission
Our Dual Mission Develop and commercialize proprietary novel GI products for the global marketplace Build value recognition in the company by all stakeholders Break even from Mytesi HIV sales Non-dilutive funding to progress pipeline Napo, a Wholly-owned Subsidiary of Jaguar Health (JAGX)
Slide 8: Pipeline Within the Brand for Diarrheal Disorders
Irritable Bowl Syndrome-D (under development) Cancer Therapy-Related-D (under development) Inflammatory Bowl Disease – Supportive Care (under development) Congenital Diarrheal Disorders / Short Bowl Syndrome (under development) Portfolio of current and potential diarrheal indications; Lechlemer offe
Slide 9: Distribution, License and Supply Agreement with Knight Therapeutics
On September 24, 2018, Jaguar signed a Distribution, License and Supply Agreement with Knight Therapeutics Inc. Agreement provides Knight Therapeutics with an exclusive right to commercialize current and future Jaguar human health products in Canada and Israel. In accordance with the agreement, the
Slide 10: Unique Anti-Secretory Mechanism of Action in Mammals
P P Intestinal Lumen Intestinal Epithelial Cell Cl- CFTR Channel CaCC Channel Cl- H20 H20 H20 H20 H20 Cl- Cl- Cl- Cl- Cl- Cl- Intestinal Lumen Intestinal Epithelial Cell Cl- CFTR Channel CaCC Channel Cl- H20 H20 H20 H20 H20 H20 H20 H20 H20 Bacterium Viruses Drugs/ Chemo Toxins/ Other cAMP cGMP Ca2+
Slide 11: Mytesi Addresses HIV-Associated Diarrhea
GI tract is profoundly affected by HIV infection HIV enteropathy is due to direct and indirect effects of HIV on the intestinal mucosa Gut inflammation and depletion of T cells continues even after viral load levels are managed Chronic diarrhea remains a significant complaint of people living with H
Slide 12: Results Over Time With Mytesi
1Based on a supplemental analysis of data from Napo’s ADVENT trial Poster Presentation at the 2017 International Aids Society Conference on HIV Science Results Over Time With Mytesi
Slide 13: Mytesi Growth Strategy
Bob Griffing, Chief Commercial Officer, started June 2018 Targeting high-potential HIV prescribers and GIs that actively treat HIV patients 17 strategically positioned reps target major urban areas and the highest-volume prescribers of antiretrovirals and antidiarrheals, such as internal medicine ph
Slide 14: The Three 'E's of Patient Focus: Engage, Empower, Educate
The Three ‘E’s” of Patient Focus: Engage Empower Educate
Slide 15: Recent Mytesi Media Coverage
Recent Mytesi Media Coverage
Slide 16: Mytesi Access and Coverage
Signed agreement with AIDS Drug Assistance Program (ADAP) in April 2018 Mytesi access available to greater than 90% of ADAP lives nationally Covered by all top 10 commercial insurers (>245 million lives) Covered by all top 10 Managed Medicare plans (>2.4 million lives) Covered by Medicaid in all 50
Slide 17: Global Growth Potential
“If approved for all indications in all countries, crofelemer could be the most utilized product in the world.” - Former Head of Global Health at Gates Foundation Hold global rights to FDA-approved product with: Chronic safety profile Commercial manufacturing in place Multiple potential follow-on in
Slide 18: Priority Review Vouchers
*Priority Review Vouchers are transferable. In recent transactions by other companies, Priority Review Vouchers have sold for $67M-$350M PRV Data Source: https://www.raps.org/regulatory-focus/news-articles/2017/12/regulatory-explainer-everything-you-need-to-know-about-fdas-priority-review-vouchers 1
Slide 19: Our 'Heroes' of Clinical Success
A product that is safe and effective, and a trial design that supports this to the statistical satisfaction of FDA Our “Heroes” of Clinical Success
Slide 20: Scientific Advisory Boards
Cancer Therapy-Related Diarrhea SAB Lee Schwartzberg, MD, FACP: Executive Director of the West Cancer Center, a multispecialty oncology practice affiliated with the University of Tennessee; Chief, Division of Hematology/Oncology, the University of Tennessee Health Science Center Eric Roeland, MD: At
Slide 21: Cancer Therapy-related Diarrhea (CTD)
Cancer Therapy-related Diarrhea (CTD) Diarrhea is a common adverse event reported with cancer treatments “All-grade” diarrhea rates are often 50-80% Dose-limiting toxicity for tyrosine kinase inhibitors (e.g., Neratinib) and EGFR mAbs (e.g., Herceptin) 1https://www.prnewswire.com/news-releases/chemo
Slide 22: Two Ongoing Investigator Initiated Studies in CTD
Two Ongoing Investigator Initiated Studies in CTD Crofelemer as salvage anti-diarrheal therapy with investigational breast cancer agent, neratinib Title: Open label study to characterize the incidence and severity of diarrhea in patients with early stage HER2+ breast cancer treated with adjuvant tra
Slide 23: Mytesi Pediatric Orphan-Drug Indications
Congenital Diarrheal Disease (CDD) Rare, congenital chronic intestinal channel diseases, occurring exclusively in early infancy Characterized by severe, lifelong diarrhea and a lifelong need for nutritional intake either parenterally or with a feeding tube Incidence much more prevalent in regions wh
Slide 24: Planned Investigator-Initiated Trial in CDD
Filed for orphan-drug status in US Received orphan status for SBS Principal investigator: Dr. Mohamad Miqdady, Chief of Pediatric Gastroenterology, Hepatology & Nutrition at Sheikh Khalifa Medical City in Abu Dhabi Jaguar has agreed to support investigator-initiated trial Napo intends to submit docu
Slide 25: Crofelemer for Diarrhea Caused by Cholera
Study evaluating crofelemer versus placebo 1 hour after Azithromycin in cholera1 Reducing amount of watery stool, 25-30%, 0-6 hour time periods (p=0.025) Indian patient study in adults with severe watery diarrhea2 Statistically significant benefits seen in seven prospectively defined clinical endpoi
Slide 26: Priority Review Voucher Sale Transactions
$350 Million August 2015: AbbVie (ABBV) purchased a PRV from United Therapeutics (UTHR) $125 Million February 2017: Gilead Sciences (GILD) purchased a PRV from Sarepta Therapeutics (SRPT) $67 Million July 2014: Sanofi(SNY) purchased PRV from BioMarin (BMRN) $81 Million July 2018: Ultragenyx (RARE) s
Slide 27: Global Partnering Driving Pipeline
Multiple indications Multiple geographies Second-generation anti-secretory (lechlemer) Strategically sequence indication development priorities, second-generation product pipeline development, and partnering goals on a global basis Global partnering for an expanding pipeline provides opportunity for
Slide 28: Upcoming Milestones
Q1 2019: Interim IIT results for CTD Q1 2019: First shipment of Equilevia Q1 2019: Meet FDA for CTD pivotal protocol agreement April 2019: File Q4 2018 earnings report as part of 2018 10-K on or before April 1 deadline Q2 2019: Complete filing of Canalevia NADA for CID in dogs Mid-May 2019: File Q1
Slide 29: 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 & Treasurer 30+ years of fin
Slide 30: 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 28+ years of industry experience Obtained first anti-secret
Slide 31: Capitalization Table – As of January 17, 2019
Common shares outstanding: 27,478,072 Non-voting common shares outstanding (as converted to voting common basis): 2,686,749 Preferred stock (as converted to common basis): 3,314,956 Total common and preferred stock: 33,479,777 Warrants: 119,994 warrants, expiration 5/2022; average exercise price of
Slide 32: Investment Highlights
Investment Highlights Only FDA-approved diarrhea treatment that’s been studied specifically in adults with HIV / AIDS Extensive global rights Commercial manufacturing in place Approved with chronic safety/locally acting in gut Mytesi: FDA-Approved Human Drug Potential multiple follow-on human indica
Slide 33: It’s a marathon, not a sprint Break the big problem up into little pieces
It’s a marathon, not a sprint Break the big problem up into little pieces to solve Walk before you run Plan solve recalculate refocus Don’t look at the rocks, find the way through Don’t just do your best, just do it Setting goals is the first step in turning the invisible into the visible
Slide 34: Investor Relations Contact
Jaguar Health, Inc. Investor Relations Contact Peter Hodge phodge@jaguar.health
Slide 35: Appendix A – GAAP and Non-GAAP Basis
*Q4 2018 figures are estimates Appendix A – GAAP and Non-GAAP Basis Q1 2017 Q2 2017 Q3 2017 Q4 2017 Mytesi Gross Sales $ (368,389) $ (461,267) $ (556,526) $ (923,507) Mytesi allowance for sales discounts $ 10,001 $ 53,351 $ 36,014 $ 73,767 Mytesi allowance for sales returns $ (159,746) $ 4,204 $ 3,1
Slide 36: Appendix A — GAAP and Non-GAAP Basis
Noble FON : @Nobleconference | @channelchek channelchek Appendix A — GAAP and Non-GAAP Basis Q1 2017 Q2 2017 Q3 2017 Q4 2017 Mytesi Gross Sales S _(368,389)| $ (461,267)| $ _(556,526)| $__ (923,507) Mytesi allowance for sales discounts | $ 10,001 | $ 53,351 | $ 36,014 | $ 73,767 Mytesi allowance for
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