Ars Pharmaceuticals, Inc. · NASDAQ:SPRY
Ars Pharmaceuticals — Investor Presentation (May 2023)
36 slides from Ars Pharmaceuticals's investor presentation, May 16, 2023
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 Q2 2023 Exhibit 99.1
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 for neffy; the timing of regulatory approval for and th
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 hesitation
Slide 4: Proven leadership team with track record in intranasal and consumer-driven medicines
Proven leadership team with track record developing and commercializing intranasal and consumer-driven medicines Richard Lowenthal, M.S. Chief Executive Officer, Co-Founder Led FDA approvals for multiple nasal spray products 25+ years of experience Robert Bell, Ph.D. Chief Scientific Officer, Co-Fou
Slide 5: Top-tier board of directors
Top-tier board of directors Pratik Shah, Ph.D. Chairman of Board of Directors Executive Chairman at Design, Former Chairman of Synthorx (acq. $2.5B), Former CEO at Auspex (acq. $3.5B) Peter Kolchinsky, Ph.D. Managing Partner and Founder at RA Capital Rajeev Dadoo, Ph.D. Managing Partner at SR One Ri
Slide 6: Type I allergic reactions: a life-threatening hypersensitivity reaction
Type I allergic reactions: a life-threatening hypersensitivity reaction Carrillo-Martin et al. J Allergy Clin Immunol Pract (2020), BlueCross BlueShield of America. Childhood Allergies in America (2018) Images Reproduced with permission from Allergy & Anaphylaxis Australia Caused by exposure to a sp
Slide 7: Epinephrine is the only first-line therapy, but device limitations exist
Epinephrine recognized as the only first-line therapy by allergy society treatment guidelines1, but… Epinephrine is effective, but significant device limitations exist Anaphylaxis – a 2020 practice parameter update, systematic review and Grading Recommendations, Assessment, Development and Evaluatio
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 FIRST 15 MINUTES TYPE I SEVERE ALLERGIC REACTION ANTIGEN EXPOSURE 1. Emergency treatment of anaphylactic reactions: guidelines for healthcare providers. Resuscitation Council (UK); 2016, 2. JF Philips et al. Allergy Asthma
Slide 9: Limitations of injection lead to hesitation; neffy may address these limitations
FAILURE OF TREATMENT 23 - 35%4 fail to dose correctly Limitations of injection lead to hesitation and decreased or ineffective usage neffy may address these limitations to transform the treatment paradigm Rapid administration without a needle No risk of needle-related injuries; lacerations2 or cardi
Slide 10: neffy Designed for Needle-free, Easier Carriage
neffy Designed for Needle-free, Easier Carriage
Slide 11: Approved injection products have a range of PK profiles, all deemed efficacious
Approved injection products have a range of PK profiles, but are all deemed efficacious (no known difference across products) 0.3 mg IM (needle & syringe) is considered to be the gold standard, and autoinjectors were approved based on literature support from 0.3 mg IM for efficacy and safety1, 2 Aut
Slide 12: Differences in PK do not translate to meaningful differences in efficacy
Differences in PK (including tmax - time to max concentration) do not translate to any meaningful difference in efficacy among injection products Analysis of 12 studies with 100% autoinjector (≥ 80% EpiPen) or 100% IM-needle-and-syringe use in community or emergency room or hospital setting, respect
Slide 13: Systolic blood pressure and heart rate are surrogates for efficacy
Systolic blood pressure and heart rate are surrogates for efficacy, and most important to clinicians given the high variability of PK Adrenergic Receptor Pharmacological Effect of Epinephrine Clinical Effect of Epinephrine a1 Increases systolic blood pressure Causes blood vessel constriction Decreas
Slide 14: neffy clinical program under NDA review; FDA Advisory Committee vote
neffy clinical program under NDA review; FDA Advisory Committee voted that data supports favorable benefit-risk for allergic reactions (type I) Target PDUFA action date anticipated in mid-2023 FDA Advisory Committee / PADAC (May 11) voted 16:6 and 17:5 in favor of adults and children <18 years of ag
Slide 15: Notable PD response observed with neffy even at 1 minute after dosing
Notable PD response observed with neffy even at 1 minute after dosing, and comparable to or significantly higher than 0.3 mg IM injection Mean Change HR (BPM) Time (Minutes) Heart Rate Response Mean Change SBP (mmHg) Time (Minutes) Systolic Blood Pressure Response First PD 1 minute First PD 1 minute
Slide 16: PD response comparable to EpiPen on single dose, higher on second dose
PD response is comparable to EpiPen on single dose, with significantly higher response on second dose neffy 2 mg n = 78 EpiPen 0.3 mg n = 77 IM 0.3 mg n = 178 p < 0.0001 p = 0.0787 (ns) Emax (mmHg) 2 mg x 2 neffy (L/R) n = 39 0.3 mg EpiPen n = 78 0.3 mg IM n = 70 p = 0.947 (ns) p = 0.01 Emax (mmHg)
Slide 17: neffy meets PK endpoints agreed with FDA in primary studies
neffy meets PK endpoints agreed with FDA in 3 primary studies* Integrated PK data summary for neffy and comparators Plasma Epinephrine Cmax (pg/mL) Median tmax (minutes) Mean Early Partial AUCs 0.3 mg IM (n = 178) 2 mg neffy HCP-admin (n = 78) 0.3 mg EpiPen (n = 77) 0.5 mg IM (n = 123) 2 mg neffy Se
Slide 18: neffy PK is Bracketed by EpiPen Studies
neffy PK is Bracketed by EpiPen Studies (high variability) Treatment Study Reference N Mean Study Cmax (pg/mL) Median Study Tmax (min) EpiPen (0.3 mg) AQST-109 EPIPHAST II Results (2022) 22 869 22 ARS EPI-JP01 Data (2020) 30 676 10 ARS EPI-15 (2022) 35 612 8 Tal et al. EAACI (2022) 12 550 9 ARS EPI-
Slide 19: Dosing neffy after nasal allergen challenge shows no meaningful impact on PK or PD
Dosing neffy immediately following nasal allergen challenge (worst-case conditions) shows no clinically meaningful impact on PK or PD ~2 to 11% of patients experience nasal symptoms during an allergic reaction1 Congestion accelerates absorption, and rhinorrhea accelerates drainage neffy during moder
Slide 20: Dosing neffy during congestion from upper respiratory tract infection
Dosing neffy during congestion/rhinitis due to an upper respiratory tract infection (e.g. cold or flu) has no clinically meaningful impact on PK or PD Mean Epinephrine Plasma Mean Systolic Blood Pressure Change Mean Epinephrine Concentration (pg / mL) ±SE Time (Minutes) Mean SBP Change from Baseline
Slide 21: neffy well-tolerated across 600+ individuals dosed
neffy well-tolerated across 600+ individuals dosed in clinical program Well-tolerated at all single-doses (0.5 mg to 2 mg) and repeat doses up to 4 mg within 10 minutes Mostly grade 1 events and comparable to injection products Low Pain Scores: recorded by VAS (100mm scale) with mean scores between
Slide 22: 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 provides foundational exclusivity blocking any generic products. Method of treatment patents (US11,173,209; US11,191,838) block other alkyl glycosides. Issued method
Slide 23: Commercial Opportunity and Strategy
Commercial Opportunity and Strategy
Slide 24: Multiple levers of current market growth
MULTIPLE LEVERS OF CURRENT MARKET GROWTH Significant existing US market opportunity for neffy penetration CURRENT ~$1 BILLION1 ANNUAL EPINEPHRINE MARKET IS THE IMMEDIATE OPPORTUNITY 1. SEC filings, IQVIA data and ARS payer research data on file ARS market research data on file (n = 75 physicians, n
Slide 25: Physicians supportive of adopting neffy into practice
Physicians supportive of adopting neffy into practice Would prescribe neffy if their patients asked for it 100% 10 = MAJOR ADVANCE / 1 = NOT AN ADVANCE AT ALL 8.5 out of 10 rating viewed as a major advance in therapy n = 75 Physicians No difference in uptake of neffy by physician specialty
Slide 26: neffy addresses the unmet need and aligns with what HCPs, patients and parents want
neffy addresses the unmet need and is better aligned with what healthcare providers, patients and parents want 65% to 72% OF THE TIME, PEOPLE WHO USE AN OTC WOULD USE neffy FIRST 69% OF PEOPLE WOULD USE neffy SOONER THAN CURRENT AUTOINJECTOR OF NON-FILLING PATIENTS STATED THEY WOULD ASK THEIR PHYSIC
Slide 27: Caregivers are enthusiastic about neffy and its benefits
Caregivers are enthusiastic about neffy and its benefits Source: ARS Consumer Quant Research, 2022 This is fantastic. Much easier than jabbing the thigh. – Father We are talking about someone’s life and lifestyle here. Great improvement. – Mother I don’t have a co-pay, but I’d get this for my daught
Slide 28: By addressing needle injector deficiencies neffy can become the standard in treatment
Propensity of Current SAR Patients Prescribed a Needle Injector 50% Don’t Keep On Hand2 42% Don’t Use Properly1 By Addressing Needle Injector Deficiencies neffy can Become the Standard in Treatment 60% Delay Treatment3 86% Would Keep On Hand3 neffy Patient Research Shows… 100% Used Device Correctly4
Slide 29: 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 treatm
Slide 30: Commercial strategy and imperatives
Commercial strategy and imperatives Ensure broad and rapid neffy coverage as well as affordable access for patients Change HCP habits and switch prescribing from needle to neffy Drive neffy awareness and new patient growth (into and back into) the market 3 1 2 From needle to neffy: Convert the exist
Slide 31: Strategic Imperatives and Critical Success Factors
Drive neffy awareness and new patient growth (into and back into) the market Ensure broad and rapid neffy coverage as well as affordable access for patients Strategic Imperatives and CSFs: From Needle to neffy Change HCP habits and switch prescribing from needle to neffy 1 2 3 Payers recognize the v
Slide 32: Integrated HCP Promotion to Drive Awareness and Reach
Integrated HCP Promotion to Drive Awareness and Reach with Current Epinephrine Prescribers Representing >40% of Prescriptions* Specialty Salesforce Virtual Salesforce Non-Personal Promotion FTEs ~125 FTEs 40 - 50 Top 50,000 Decile 5 to 10 HCP Reach ~ 15,000 HCPs ~3,000 Top 12,000 HCP promotion will
Slide 33: neffy is positioned potentially to transform the treatment of serious allergic reactions
neffy is positioned potentially to transform the treatment of serious allergic reactions Less Hesitation to Dose Effective Compact Safe Easy to Use No Needle PK comparable or superior to IM (reference listed drug) and less than EpiPen (upper limit for safety) offers therapeutic exposures and makes i
Slide 34: Supplemental Slides
Supplemental Slides
Slide 35: Many patients/caregivers do not administer treatment or delay use during reaction
Many patients/caregivers do not administer treatment or delay use during reaction Did not fill or re-fill their Rx in last 3 years1 ~50% do not carry2 Patients (millions) Rx’ed Epinephrine in Last 3 Years1 40-60% delay 9 to 18 min6 25-50% refuse to inject and go to ER2-5 23-35% fail to dose correctl
Slide 36: Basis of Approval for Community Use Products
Basis of Approval for Community Use Products Approved community use products include IM and SC dosing (FDA briefing book) Almost all approved without PK data Device Approval Basis Pharmacokinetics (any data including literature) FDA Approved Route and Dose EpiPen® (1987) No PK Data Significant diffe
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