Ars Pharmaceuticals, Inc. · NASDAQ:SPRY
Ars Pharmaceuticals — Investor Presentation (December 2022)
25 slides from Ars Pharmaceuticals's investor presentation, December 2022
Slide 1: The First No-Needle, No-Injection Solution for Type I Allergic Reactions
THE FIRST NO-NEEDLE, NO-INJECTION SOLUTION for Type I Allergic Reactions Q4 2022 1
Slide 2: Forward looking statements
Forward looking statements This presentation contains forward-looking statements which include, but are not limited to, statements regarding the design and potential benefits of neffy; the anticipated Prescription Drug User Fee Act (PDUFA) date; ARS Pharmaceuticals Inc.’s (“ARS Pharma”) plans to sub
Slide 3: Potential to Transform the Treatment of Type I Allergic Reactions
Potential to Transform the Treatment of Type I Allergic Reactions • neffy: first “no needle, no injection” solution for Type I allergic reactions to address an unmet market need • Registration program demonstrates comparable PK and PD, without risk of needle-related safety concerns, fear and hesitat
Slide 4: Proven leadership team with track record developing and commercializing intranasal medicines
Proven leadership team with track record developing and commercializing intranasal and consumer-driven medicines Richard Lowenthal, M.S. Sarina Tanimoto, M.D. Eric Karas Chief Executive Officer, Co-Founder Chief Medical Officer, Co-Founder Chief Commercial Officer Led FDA approvals for Led FDA appro
Slide 5: Top-tier board of directors
Top-tier board of directors Peter Kolchinsky, Ph.D. Rajeev Dadoo, Ph.D. Managing Partner and Founder Managing Partner at SR One Pratik Shah, Ph.D. at RA Capital Chairman of Board of Directors Executive Chairman at Design, Former Chairman of Synthorx (acq. $2.5B), Former CEO at Auspex (acq. $3.5B) Br
Slide 6: Type I allergic reactions: a life-threatening hypersensitivity reaction
Type I allergic reactions: a life-threatening hypersensitivity reaction Caused by exposure to a ~25 to 40 million people in US specific allergen, with systemic Type I allergic most commonly food, reaction to allergens venom, drugs (e.g., 2+ organ systems involved) 10+ million people with other Type
Slide 7: Epinephrine is effective, but significant device limitations exist
Epinephrine is effective, but significant device limitations exist Epinephrine recognized as the only first-line therapy by allergy society treatment guidelines1, but… Apprehension to dose due to Safety concerns: lacerations, needle caregiver self-injection, blood vessel hits Lack of portability Lac
Slide 8: Early intervention with epinephrine is critical in a Type I allergic reaction
Early intervention with epinephrine is critical in a Type I allergic reaction REACTION SERIOUS PATIENT DISCOMFORT HIGHER RISK OF HOSPITALIZATION AND DISEASE PROGRESSION2,3,4 PROGRESSION 5 MINUTES 15 MINUTES 30 MINUTES TYPE I SEVERE LIKELIHOOD OF ANAPHYLAXIS ALLERGIC REACTION LIFE-THREATENING REACTIO
Slide 9: Limitations of injection lead to hesitation and decreased or ineffective usage
Limitations of injection lead to hesitation and decreased or ineffective usage neffy may address these limitations to transform the treatment paradigm 1 2 3 4 NO TREATMENT REFUSAL OF DELAY IN FAILURE OF PROBLEM AVAILABLE TREATMENT TREATMENT TREATMENT ~50% of ~25% - 50%1, 3, 5 ~40 - 60%2 of 23 - 35%4
Slide 10: neffy clinical program supports NDA filed and accepted by FDA
neffy clinical program supports NDA filed and accepted by FDA FDA confirmed three primary registration studies required for neffy approval EPI-15: Single dose and twice EPI-16: Nasal challenge in EPI-17: Self-administration in dosing in healthy volunteers (n=42) allergic rhinitis patients (n=36) Typ
Slide 11: Approved injection products have a range of PK profiles, but are all deemed efficacious
Approved injection products have a range of PK profiles, but are all deemed efficacious (no known difference across products) Median or • FDA stated neffy should be Mean Study Study Tmax bracketed by PK of approved products Mean Study TREATMENT N Cmax range Tmax (pg/mL) (min) (min) • 0.3 mg IM (need
Slide 12: neffy meets FDA-confirmed endpoints in primary studies
neffy meets FDA-confirmed endpoints in 3 primary studies* Integrated PK data summary for neffy and comparators Plasma Epinephrine Cmax (pg/mL) Median tmax (minutes) Mean Early Partial AUCs 100 Mean early partial AUCs Cmax bracketed bracketed by approved products by approved Tmax bracketed by approve
Slide 13: neffy well-tolerated across 500+ individuals dosed in clinical program
neffy well-tolerated across 500+ individuals dosed in clinical program Risk of blood vessel injection during self- administration that could lead to adverse events • Well-tolerated at all single-doses (0.5 mg to 2 mg) and repeat doses up to 4 mg within 10 minutes 13.8% • Mostly grade 1 events and co
Slide 14: neffy market exclusivity potential until at least 2038
neffy market exclusivity potential until at least 2038 Issued composition of matter patent (US10,576,156) on Intravail® + epinephrine Extensive studies in provides foundational exclusivity blocking any generic products. Method of the lab and clinic treatment patents (US11,173,209; US11,191,838) bl
Slide 15: Commercial Opportunity and Strategy
Commercial Opportunity and Strategy 15
Slide 16: Significant existing US market opportunity for neffy penetration
Significant existing US market opportunity for neffy penetration CURRENT ~$1 BILLION 1 ANNUAL EPINEPHRINE MARKET IS THE IMMEDIATE OPPORTUNITY MULTIPLE LEVERS OF CURRENT MARKET GROWTH ~16M Consistent market growth diagnosed patients with +5% y/y in the last ~15 years severe type I allergic reactions
Slide 17: Physicians supportive of adopting neffy into practice
Physicians supportive of adopting neffy into practice 8.5 out of 10 rating viewed as a major advance in therapy n = 75 10 = MAJOR ADVANCE / 1 = NOT AN ADVANCE AT ALL Physicians 100% Would prescribe neffy if their patients asked for it No difference in uptake of neffy by physician specialty 17
Slide 18: neffy addresses the unmet need and is better aligned with what HCPs, patients and parents want
neffy addresses the unmet need and is better aligned with what healthcare providers, patients and parents want ~80% OF PATIENTS EXPECTED TO SWITCH TO neffy n = 150 Current Users OF NON-FILLING PATIENTS 75% STATED THEY WOULD ASK THEIR PHYSICIAN ABOUT neffy RX n = 100 Non-fillers 65% to 72% 69% OF THE
Slide 19: Caregivers are enthusiastic about neffy and its benefits
Caregivers are enthusiastic about neffy and its benefits Time from Onset of Symptoms to Epinephrine Administration “ “ 10 9 9.3 I want this. Is it 8.8 This is fantastic. available yet? Let me 8 8.3 Much easier than know when it is, I will jabbing the thigh. literally call the doctor 7 from my car. B
Slide 20: neffy can Become the Standard in Treatment
By Addressing Needle Injector Deficiencies neffy can Become the Standard in Treatment Propensity of Current SAR Patients neffy Patient Research Shows… Prescribed a Needle Injector 42% Don’t Use Properly1 45% 47% Faster Treatment Time3 More Likely to Fill Rx3 50% Don’t Keep On Hand2 86% 100% Would Ke
Slide 21: Payer research supports positive reimbursement environment
Payer research supports positive reimbursement environment Key findings from discussions with ~50 decision-makers within the major payers and PBMs: • Category is generally not restricted, unlike biologics and orphan disease drugs with high WACs • Payers view neffy as a valuable and differentiated tr
Slide 22: Commercial strategy and imperatives
Commercial strategy and imperatives From needle to neffy: • Convert the existing market • Bring back patients that are lapsed • Bring in patients who should be carrying epinephrine now, but do not carry 1 Ensure broad and rapid neffy coverage as well as affordable access for patients 2 Change HCP ha
Slide 23: Strategic Imperatives and CSFs: From Needle to neffy
Strategic Imperatives and CSFs: From Needle to neffy 1 2 3 Ensure broad and Drive neffy Change HCP habits IMPERATIVES awareness and new STRATEGIC rapid neffy coverage as and switch prescribing well as affordable patient growth (into and from needle to neffy access for patients back into) the market
Slide 24: Integrated HCP Promotional Approach
Integrated HCP Promotional Approach*: Drive Awareness and Reach 45%+ Current Epinephrine Prescribers within Initial Launch Period Specialty CSO Virtual Non-Personal Salesforce Representatives Salesforce Promotion FTEs ~125 FTEs N/A HCP Greater than 7,500 Top 12,000 Reach *Opportunistic expansion ove
Slide 25: neffy is positioned potentially to transform the treatment of serious allergic reactions
neffy is positioned potentially to transform the treatment of serious allergic reactions PK superior to IM No needle, no fear, no wait (Reference listed drug & Less Easier to use and more reliable gold standard) Effective Hesitation delivery than with autoinjectors offers therapeutic exposures to Do
ARS Pharmaceuticals — Investor Presentation (December 2022) on 6ix