Ars Pharmaceuticals, Inc. · NASDAQ:SPRY
Ars Pharmaceuticals — Investor Presentation (May 2024)
41 slides from Ars Pharmaceuticals's investor presentation, May 10, 2024
Slide 1: ARS Corporate Presentation Q2 2024
ARS Corporate Presentation Q2 2024 Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements Statements in this presentation that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this presentation include, without limitation, statements reg
Slide 3: Potential to Transform the Treatment of Type I Allergic Reactions
Potential to Transform the Treatment of Type I Allergic Reactions neffy®: first potential “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
Slide 4: Anaphylaxis is Accompanied by Many Frequent Symptoms
Anaphylaxis is Accompanied by Many Frequent Symptoms References: 1. Shaker MS, et al. J Allergy Clin Immunol. 2020. 2. Pistiner M, et al. J Allergy Clin Immunol Pract. 2021. 3. Jalil M, et al. Abstract at AAAAI 2020 Virtual Meeting. 4. Gonzelez-Estrada A, et al. Ann Allergy Asthma Immunol. 2018. 5.
Slide 5: Epinephrine: The First Line of Defense Against Anaphylaxis
Epinephrine: The First Line of Defense Against Anaphylaxis Patients with Type 1 Severe Allergic Reactions are prescribed epinephrine to use at symptom onset Used for over 100 years Well-known mechanism of action, and only drug known to reverse a systemic allergic reaction Well-established efficacy a
Slide 6: Rapid administration without a needle
Rapid administration without a needle No risk of needle-related injuries; lacerations2 or cardiotoxic blood vessel injections Less hesitation to dose NO NEEDLE NO INJECTION Fits in your pocket; easy to carry the recommended 2 devices ~10% of cases require repeat doses of epinephrine1 EASIER AND MORE
Slide 7: neffy Designed for Ease of Use and Easy Carry
neffy Designed for Ease of Use and Easy Carry For epinephrine to be effective, patients must: neffy has a simple place and press administration (no hold time) 100% of adults and children able to use neffy successfully without any training Relative Size of neffy two pack Compared to iPhone 15 and Epi
Slide 8: Development Program Centers on Pharmacology Studies
Development Program Centers on Pharmacology Studies Efficacy studies not ethical / feasible in severe Type I allergy patients neffy clinical studies developed in agreement with FDA and EMA to allow reference to historic efficacy and safety data of epinephrine injection Bracketed pharmacokinetic (PK)
Slide 9: Registrational studies demonstrate comparability on PD surrogates and PK
Registrational studies demonstrate comparability on both PD surrogates for efficacy and PK with neffy Safety Data 2 mg neffy met all clinical endpoints PD surrogates for efficacy comparable to approved products (SBP/HR approved injection products) Rapid and significant response on PD surrogates for
Slide 10: Pharmacokinetic Results Satisfy Bracketing Approach
Pharmacokinetic Results from neffy 2 mg Studies Satisfies Bracketing Approach agreed with by FDA Mean Epinephrine Concentration (pg/mL) Time (Minutes) neffy 2 mg (HCP) (n=78)* EpiPen 0.3 mg (n=77) SC 0.3 mg (n=35) neffy 2 mg (self-administration) (n=42) IM 0.3 mg (n=178) Upper bracket for safety Low
Slide 11: Second Dose Frequency Demonstrates Similar Efficacy Between IM and Autoinjectors
Second Dose Frequency Demonstrates Similar Efficacy Between IM and Autoinjectors (the only FDA approved products today) Autoinjector reactions n = 79911 IM Needle-in-Syringe reactions n = 570 Treated Reactions Requiring Second Epinephrine Dose (%) ~90% resolution on first dose Analysis of 12 studies
Slide 12: Robust response on PD surrogate markers for efficacy
Robust response on PD surrogate markers for efficacy shows engagement of receptors that reverse anaphylaxis symptoms 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 neffy 2 mg IM 0.3 mg
Slide 13: Exposures of repeat doses of neffy in healthy subjects
Exposures of repeat doses of neffy in healthy subjects are also in the range of FDA approved epinephrine injection products Geometric Mean Plasma Concentration (pg/mL) Time (mins) 1.65x Integrated data from ARS clinical studies, FDA Briefing Document May 2023 PADAC for NDA/BLA# 214697 (neffy) neffy
Slide 14: PK/PD profile may be influenced by anaphylaxis itself
PK/PD profile and ability to dose may be influenced by anaphylaxis itself, so FDA asked ARS to evaluate rhinitis in clinical studies Anaphylaxis Symptom US % Intranasal Sublingual Oral* Inhalation* Nasal symptoms or rhinitis 4% X X Oropharyngeal edema 10% X X X Vomiting / Emesis 20% X X X Dysphagia
Slide 15: NAC-Induced Rhinitis Does Not Negatively Impact neffy's PK Profile
Experimental Nasal Allergen Challenge (NAC)-Induced Rhinitis Does Not Negatively Impact neffy’s PK Profile (allergic rhinitis subjects) NAC-induced rhinitis accelerates absorption of single dose neffy, but within the range of injection Repeat doses of neffy under NAC-induced rhinitis supports simila
Slide 16: NAC-Induced Rhinitis Does Not Negatively Impact neffy's PD Profile
Experimental NAC-Induced Rhinitis Does Not Negatively Impact neffy’s PD Profile (Repeat Doses 10 min Apart) Mean Change in Systolic Blood Pressure (mmHg) Mean Change in Heart Rate (bpm) Response to FDA’s CRL submitted April 2, 2024 followed by up to 6-month FDA review
Slide 17: neffy on track for potential US launch in H2 2024 with exclusivity until 2038
neffy on track for potential US launch in H2 2024 with 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,
Slide 18: Commercialization Strategy
Commercialization Strategy
Slide 19: Significant Opportunity to Address Unmet Needs in US Severe Allergic Reaction Market
Significant Opportunity to Address Unmet Needs in Current US Severe Allergic Reaction Market Promotional Responsiveness ~20M diagnosed and under physician care over the last 3 years11 Epidemiology prevalence data estimates ~40M patients with type 1 allergic reactions2-10 ~50% increase over market gr
Slide 20: neffy addresses the unmet need aligned with what HCPs, patients and parents want
neffy has the ability to address the unmet need and is aligned with what healthcare providers, patients and parents want1 72% OF THE TIME, PEOPLE WHO USE AN OTC WOULD USE neffy FIRST2 81% OF PEOPLE WOULD USE neffy SOONER THAN CURRENT NEEDLE INJECTORS3 OF NON-FILLING PATIENTS STATED THEY WOULD ASK TH
Slide 21: Physicians supportive of adopting neffy into practice
PHYSICIAN Physicians supportive of adopting neffy into practice Would prescribe neffy if their patients asked for it1 99% 10 = MAJOR ADVANCE / 1 = NOT AN ADVANCE AT ALL 8.5 out of 10 rating1 viewed as a major advance in therapy n = 75 Physicians n = 185 Physicians References: 1. ARS market research
Slide 22: Two-Thirds of Allergists and Half of GPs Ready to Prescribe neffy
PHYSICIAN Two-Thirds of Allergists and Half of GPs Ready to Prescribe neffy as Soon as Possible; Majority of Pediatricians Expected to Prescribe within One Year Timeline for Prescribing neffy – % of physicians References: ARS market research on file. Allergists (n=98) General Practitioners (n=48) Pe
Slide 23: Innovative Treatment to Overcome Known Challenges with Needle-Injectors
neffy: Innovative Treatment to Overcome Known Challenges with Needle-Injectors for SAR Patients Carry 55% N = 9172 Would Carry 85% N = 1503 % of Time Carrying at least One Epinephrine Device2,3 More allergy patients and caregivers are likely to carry neffy compared to current needle-bearing options
Slide 24: ~72% of Respondents would Make a Special Appointment to Discuss neffy
~ 72% of Respondents would Make a Special Appointment to Discuss neffy with their HCP References: ARS market research on file. PATIENT Action Taken to Discuss neffy with HCP Respondents who may ask their HCP about neffy, Aug-23: Total (n=476), Patient (n=244), Caregiver (n=232) % of respondents
Slide 25: neffy Strategic Objectives
neffy Strategic Objectives ACTIVATE PATIENTS Create awareness and motivate patients and caregivers to seek neffy FACILITATE ACCESS neffy access, affordability and support services EDUCATE PRESCRIBERS Drive adoption within specialty and high decile prescribers on the compelling value-proposition of n
Slide 26: Drive Adoption within Specialty and High Decile Prescribers
Drive Adoption within Specialty and High Decile Prescribers EDUCATE Healthcare Provider Launch Objectives Commercial force of 110 Sales and Virtual Representatives and Area Sales Managers Education, awareness, and resources to drive adoption (neffy Experience) Calling on 12,500 Allergy Specialists a
Slide 27: 100% of patients responded to a single dose of neffy in first 15 minutes
EDUCATE 100% of patients responded to a single dose of neffy in the first 15 minutes, and did not require a second dose of epinephrine per treatment guidelines 100% of patients experienced complete resolution of the anaphylaxis symptoms with single dose of neffy2 16 min median time to complete resol
Slide 28: Committed to ensuring neffy access for all patients
Committed to ensuring neffy access for all patients FACILITATE Key findings from discussions with the major payers and PBMs: High degree of interest in neffy and positive receptivity in early conversations; proactively requesting clinical presentations prior to approval Epinephrine is covered as a p
Slide 29: Create Awareness & Motivate Patients and Caregivers to Request neffy
Create Awareness & Motivate Patients and Caregivers to Request neffy ACTIVATE Consumer Launch Objectives Drive awareness & motivate patients and caregivers to request neffy by name Enable patients and caregivers to feel fully prepared to act during a potential crisis moment Activate patients and car
Slide 30: Intranasal Analog Comparison: Seizure Rescue Market
Intranasal Analog Comparison: Seizure Rescue Market Valtoco and Nayzilam Share Growth VALTOCO® NAYZILAM® References: 1. IQVIA prescription data (2023) 75% market share at 50 months post-launch On track for ~90% market share with 72 to 84 months post-launch
Slide 31: US Epinephrine Market Evolution Supports Significant Revenue Opportunity
US Epinephrine Market Evolution Due to the Availability of neffy Supports Significant Revenue Opportunity1 References: 1. ARS company estimates and market research on file. 2. Market estimates based only on prescription volume from community use epinephrine autoinjector products, not intramuscular i
Slide 32: neffy Shows Rapid Clinical Responses in Treatment-Resistant Urticaria
neffy Shows Robust and Rapid Clinical Responses in Treatment-Resistant Urticaria; Phase 2 outpatient study to initiate in 2024 Randomized, Placebo-Controlled Efficacy Data in Treatment Refractory Chronic Urticaria (EPI-U01)1 Study Design randomized, placebo-controlled crossover trial study 18 chroni
Slide 33: Significant Ex-US opportunity for neffy
Significant Ex-US opportunity for neffy Europe EAI Market: ~$219M TODAY Japan EAI Market: ~$12M TODAY China EAI market: no approved products Significant Potential References:: 2023 IQVIA MIDAS (USD MNF) Canada EAI Market: ~$67M TODAY AUS/NZ EAI market: ~$18M TODAY <10% TYPE I ALLERGY MARKET PENETRAT
Slide 34: Multiple Attributes Contribute to neffy's Potential Best-in-Class Profile
Multiple Attributes Contribute to neffy’s Potential Best-in-Class Epinephrine Product Profile Will patients use it? Benign safety profile – mild nasal discomfort and headache Palatable – no meaningful pain/irritation, no taste/smell Small – fits in pocket Easy to use – 100% of adults and children ca
Slide 35: neffy: the first needle-free way to administer epinephrine
neffy: the first needle-free way to administer epinephrine Rapid, reliable delivery Small and easy to carry Place and Press administration Well-tolerated in extensive trials AVOIDS ALL NEEDLE-RELATED ADVERSE EVENTS
Slide 36: Appendix
Appendix AiR?
Slide 37: EPI-18 Repeat Dose NAC Study Design
EPI-18 Repeat Dose NAC Study Design Rationale: Study designed together with FDA to generate data on neffy’s PK/PD profile if NAC-like conditions occurred during the 10% of anaphylaxis events that require a second dose Comparator: FDA explicitly requested ARS include 0.3 mg intramuscular (IM) injecti
Slide 38: PD response (SBP) with repeat doses of neffy with or without NAC
PD response (SBP) with repeat doses of neffy with or without NAC greater or similar to repeat doses of injection Dosing 10 min apart
Slide 39: PD response (HR) with repeat doses of neffy with or without NAC
PD response (HR) with repeat doses of neffy with or without NAC greater or similar to repeat doses of injection Dosing 10 min apart
Slide 40: Exposures with repeat doses of neffy with or without NAC
Exposures with repeat doses of neffy with or without NAC greater or similar to repeat doses of injection Dosing 10 min apart
Slide 41: Exposures with repeat doses of neffy (first 60 min)
Exposures with repeat doses of neffy with or without NAC greater or similar to repeat doses of injection (first 60 min) Dosing 10 min apart
ARS Pharmaceuticals — Investor Presentation (May 2024) on 6ix