ARS Pharmaceuticals, Inc. · NASDAQ:SPRY
ARS Pharmaceuticals — Q4 2022 Earnings Presentation
28 slides from ARS Pharmaceuticals's earnings presentation, Nov 1, 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 expected timing, completion, effects and potential benefits of the proposed merger with Silverback Therapeutics Inc.’s (“Silverback”); the expected cash of the
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, and latex (e.g., 2+ organ systems involved) 10+ million people with
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 with FDA
neffy clinical program supports NDA filed with 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) Type I allergy
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 Mean Study Study Tmax Mean Study TREATMENT N Cmax Tmax range • FDA stated neffy should be (pg/mL) (min) (min) bracketed by PK of approved products Epinephrine 0.3 m
Slide 12: neffy meets FDA-confirmed endpoints in 3 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 Maximum 100 Maximum 360 240 150 360 120 2250 1820 1590 1560 1550 outlier value outlier value 1000 pAUC pAUC Tre
Slide 13: neffy meets FDA-confirmed endpoints in 3 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 14: 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 15: neffy NDA accepted with potential FDA approval in 2023
neffy NDA accepted with potential FDA approval in 2023 • Successful pre-NDA • Pediatric program to • NDA accepted in Q4 2022: meeting completed support label expansion Adults and Pediatric with FDA mid-2021 • Pediatric data to be Patients (30kg or greater) • Engagements support included in NDA, at F
Slide 16: 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 17: Significant existing US market opportunity for neffy penetration
Significant existing US market opportunity for neffy penetration CURRENT ~$1 BILLION1 ANNUAL EPINEPHRINE MULTIPLE LEVERS OF MARKET IS THE IMMEDIATE OPPORTUNITY CURRENT MARKET GROWTH Consistent market growth ~16M +5% y/y in the last ~15 years diagnosed patients with Promotional responsiveness severe
Slide 18: neffy has the potential to transform the treatment of Type I allergies
neffy has the potential to transform the treatment of Type I allergies 18
Slide 19: neffy has the opportunity to address a significant unmet need
neffy has the opportunity to address a significant unmet need LIFE-THREATENING ALLERGIES • Severe allergic reactions involve more than $24.8 Billion one system (e.g., skin and respiratory) have 1 in 12 children have food allergies annual cost of the potential to progress to anaphylaxis and food alle
Slide 20: ~25M patients with Type I Severe Allergic Reactions represent a significant therapeutic opportunity
~25M patients with Type I Severe Allergic Reactions (SAR) represent a significant therapeutic opportunity at launch and beyond SAR Patients With Epinephrine Injectable Rx Primary Launch Target 3.3 M Patients seeking care who have filled their Rx (13%) SAR Patients Actively Managed by HCP 13.1 M Pati
Slide 21: neffy poised to be the first epinephrine product enabling treatment of all serious systemic allergic reactions
neffy poised to be the first epinephrine product enabling the treatment of all serious systemic allergic reactions without hesitation, regardless of severity AVERAGE TIME TO RESPIRATORY OR • First-line treatment for severe Type I allergic CARDIAC ARREST DUE TO ANAPHYLAXIS reactions is epinephrine -
Slide 22: 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 22
Slide 23: Significant pent-up patient demand for neffy (Market Research)
Significant pent-up patient demand for neffy (Market Research) OF PATIENTS STATED THEY 80% WOULD PREFER TO GET 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% 88% OF PEOPLE OF PEOPLE OF PEOPLE WHO USE AN W
Slide 24: Physicians responded very positively to neffy with high interest in switching patients
Physicians responded very positively to neffy with high interest in switching patients within the first year Physicians viewed neffy as a completely new category of epinephrine device that eliminates “ “ most reasons why a patient doesn’t carry today’s epinephrine delivery device This product is not
Slide 25: Caregivers are enthusiastic about neffy and its benefits
Caregivers are enthusiastic about neffy and its benefits “ “ “ Motivation to Use neffy Sooner If I could trade in I want this. Is it This is fantastic. available yet? Let me my EpiPen for this n = 200 subjects Much easier than know when it is, I will without it costing me a jabbing the thigh. litera
Slide 26: 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 27: US commercial preparedness efforts underway for potential 2023 launch
US commercial preparedness efforts underway for potential 2023 launch 3.3M patients prescribed today, majority of patients and physicians responded favorably to neffy over auto-injectors, and 22M untreated patients with the potential to be activated BUILD HEALTHCARE DRIVE CONSUMER SECURE MARKET PROF
Slide 28: 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