Emmaus Life Sciences, Inc. · OTC:EMMA
Emmaus Life Sciences — Investor Presentation (November 2021)
30 slides from Emmaus Life Sciences's investor presentation, November 2021
Slide 1: Hope Delivered: Changing Lives For the Better
Hope Delivered: Changing Lives For the Better Discovering, developing, and commercializing innovative therapies to improve the quality of life for underserved patients and their communities Corporate Presentation | November 2021 Corporate Presentation | November 2021
Slide 2: Forward-looking statements
This presentation contains forward-looking statements regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or ch
Slide 3: Our Mission
Our Mission: Corporate Corporate Presentation Presentation || November November 2021 2021
Slide 4: Why invest in Emmaus?
A highly experienced management team with proven success in pharmaceutical research, development and commercialization led by CEO and principal inventor of Endari®, Yutaka Niihara, M.D., M.P.H. Significant domestic and global opportunities targeting underserved sickle cell disease patient population
Slide 5: Leadership team
Willis Lee, MS Vice Chairman & Chief Operating Officer Lead by George Sekulich Distinguished Clinician and Senior Vice President of Global Commercialization & Chief Information Officer Principal Inventor of Endari® Charles Stark, Pharm.D. Yutaka Niihara, Senior Vice President of Medical Affairs, Res
Slide 6: Product pipeline
Product ID Preclinical Phase 1 Phase 2 Phase 3 Commercial Description ELS001 Pharmaceutical grade L-glutamine to treat SCD (Endari®) ELS004 Pharmaceutical grade L-glutamine to treat diverticulosis ELS003 Lab device/research tool to measure transmittance cell sheet ELS005 Cancer treatment targeting I
Slide 7: Cause and Effect
Cause and Effect Normal Sickled cells blood cells causing clumping Sickle cell disease (SCD) is an autosomal recessive disorder, meaning each parent carries one copy of mutated gene. Blood smear of a sickle cell disease patient The most prevalent symptom of SCD is pain. SCD affects an estimated 20M
Slide 8: Cause and Effect: NAD
Cause and Effect NAD is nicotinamide NAD exists in two forms: The higher levels of oxidants adenine dinucleotide, an oxidized and reduced form, experienced by SCD patients tilts a critical coenzyme found in abbreviated as the NAD+/NADH equilibrium every cell in your body, and towards NAD+ production
Slide 9: A domino effect
A domino effect Devastating mortality expectancy, reduced life expectancy Patients experience pain and acute symptoms with increasing severity Patients’ quality of as chronic damage accumulates. life suffers, as they endure excruciating The severe pain pain and subsequent experienced by SCD negative
Slide 10: A reduction in sickle cell crises extends lives
A reduction in sickle cell crises extends lives 45% p = 0.022 Endari® reduces instances of sickle cell crises Corporate Presentation | November 2021
Slide 11: Potential savings on treatment costs of over $2B annually (U.S.)
Potential savings on treatment costs of over $2B annually (U.S.)¹ Driving down SCD Breaking the SCD hospital hospitalization costs readmittance cycle 33% 41% 56% 59% 63% p = 0.005 p = 0.02 p = 0.02 p = 0.03 p = 0.003 Lower frequency Fewer days Delay in the onset of Delay in the onset of Fewer cases
Slide 12: Results for an early clinical trial patient after 12 weeks
The results for an Emmaus early clinical trial patient after 12 weeks of treatment Endari® E N D A R I ® C AU S E S P RO D U C T I O N O F N A D, WHICH “MOPS UP” OXIDANTS REDUCTION REDUCTION NAD+ + H+ + 2e- NADH NAD+ + H+ + 2e- NADH OXIDATION OXIDATION Corporate Presentation | November 2021
Slide 13: Endari versus Siklos, Oxbryta, Adakveo
Siklos Oxbryta Endari® Hydroxyurea (Hydroxyurea) (Global Blood Adakveo (L-glutamine) (Amedica) Therapeutics) Broad indication YES NO NO NO NO Black box warning NONE YES YES NONE NONE Lab tests required NONE YES YES YES YES Patient age range 18+ years old, 5+ 2+ 12+ 16+ used off label years old years
Slide 14: Income Statement Summary
Six Months Ended – June 30, 2021 Income Statement Summary Year Ended – December 31, 2020 (unaudited) ($ in Thousands) Revenues, net $ 23,167 $ 11,824 Gross Profit 20,919 10,958 Operating Expenses 20,951 12,090 Loss from Operations (32) (1,132) Net Income (Loss) 1,354 (5,933) Earnings (Loss) Per Comm
Slide 15: EMMA share data
Ticker Symbol Shares Outstanding Fully Diluted Shares Insider Ownership EMMA 49,311,864 73,338,458 28.9% (OTCQX)* (As of 10/30/2021) *With plans to up list to a national exchange Corporate Presentation | November 2021
Slide 16: L-glutamine
No preliminary bloodwork or follow up testing needed High potential to be first L-glutamine choice medication for Can be delivered to telemedicine services is a key SCD a patient’s door and treatment that can taken at home be used alone or alongside other treatments Can be administered mixed into fo
Slide 17: Endari commercial milestones 2017-2020
COVID19 & entry of competitors 2017 2018 2019 2020 FDA approval for ages 5+ $16.5M Net Revenue $22.8M Net Revenue $23.2M Net Revenue Indicated to reduce the Endari’s January launch was Launch of Commercial APCER Life Sciences acute complications of the first new SCD treatment Co-Payment Assistance c
Slide 18: 86% of patients reside in major metropolitan areas in 18 states
WA 86% of patients reside OR MT ND in major metropolitan ME MN ID NH SD WI areas in 18 states WY VT NY MA MI NV RI NE IA PA CT CA UT IL OH NJ CO IN DE WV MD KS VA MO KY Our 19-person field AZ TN NC NM OK AR SC team is well deployed MS AL GA LA AK TX to serve this market FL HI Corporate Presentation
Slide 19: U.S. and EU market opportunity and international focus
Europe $480M Focus on early access programs EMA and UK approval process U.S. and EU Middle East & North Africa (MENA) Distribution partners in place $3.4B Opened Dubai office in 2020 Latin America Rest of World With a focus on Brazil and Colombia Corporate Presentation | November 2021
Slide 20: Commercial strategy: target, support, expand
$30K annual wholesale acquisition cost per adult patient Expand Network of over 600 pharmacies and growing Support Big 3 distributors: AmerisourceBergen, Cardinal Involvement with local and and McKesson national SCD foundations RXs filled in 44 states, Puerto Excellent payer coverage Rico and Washin
Slide 21: Current approvals and submissions
Current Approvals United States FDA Israeli Ministry of Health Submitted Kingdom of Saudi Arabia Kuwait Bahrain United Arab Emirates In process Gulf Cooperation Council (GCC) Countries Early Access program in the U.K., France, and Turkey SCD affects an estimated 20M - 25M patients worldwide, predomi
Slide 22: Ongoing research in new applications
L-GLUTAMINE IRAK4 Inhibitor Anti-Cancer Drug Ongoing research in new applications For solid cancers, blood-cancers, and lymphoma Diverticulosis Type 2 Diabetes: Partnership with Kainos Medicine, Inc. Phase 1 — trial using Endari® Emmaus responsibilities: investigation and proof of target disease sel
Slide 23: L-glutamine for diverticulosis
In the U.S., this affects an estimated Giant 40% diverticulum of whom 10% - 20% will develop into of 60-year-olds1 diverticulitis, resulting Sigmoid in abdominal pain, 70% colon nausea, vomiting, Rectum constipation, diarrhea, Diverticula of 80-year-olds fever, and leukocytosis Anus L-glutamine Prev
Slide 24: Large potential markets, patents, early results
Large potential Internationally Promising markets approved patents early results $8B-$20B U.S. market U.S., EU, Australia, China, Two initial patients showed $14B-$35B EU market Russia, Japan, South Korea, 100% and 50% reductions Mexico, Indonesia, and India in number of diverticula over 6 months Co
Slide 25: Initial focus on rare and orphan diseases
Initial focus and success on rare and orphan diseases with unmet needs. We are now extending our efforts to include conditions and diseases affecting larger populations, also with unmet needs. Xyndari launch For Europe and Cell Sheets – Commercial Commercial Latin America Regenerative launch of laun
Slide 26: EJ Holdings, Inc. manufacturing facility
Location EJ Holdings, Inc. Ube, Yamaguchi Prefecture, Japan Product: USP grade L- Glutamine & Endari® Area: 95.1 acers Purpose: Additional API cGMP facility to meet the captive source of API for Endari® and product candidates Capability: Fermentation process Crude purification process L-Glutamine ma
Slide 27: EJ Holdings acquisition and ownership
Date of acquisition of Purchase price: Ownership: the manufacturing plant: JPY 1,100M Dec. 25, 2019 (~USD 10.4M) Emmaus Life Japan Industrial Sciences, Inc. Partners, Inc. 40% interest accounted for as a Variable Interest Entity (VIE) 40% 60% Fair Market Value (Dec. 2019): USD 53.5M (Appraisal by Ma
Slide 28: Investment highlights
Commercial stage company marketing Endari® – a safe and efficacious therapy for sickle cell disease Targeting large addressable markets in underserved patient populations Experiencing year-over-year revenue growth Investment highlights Clinical pipeline with multiple shots on goal Experienced leader
Slide 29: Developed Endari through Phase 3 and FDA approval
Developed Launched and Built and deployed Created a pipeline Endari® through commercialized an internal sales with multiple Phase 3 and FDA Endari® team product candidates approval Corporate Presentation | November 2021
Slide 30: Contact
Company: Investor Relations: Emmaus Life Sciences, Inc. Rx Communications Group Willis Lee Michael Miller (917)-633-6086 Chief Operating Officer [email protected] (310) 214-0065 x1130 [email protected] Corporate Presentation | October 2021 Corporate Presentation | November 2021
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