Ars Pharmaceuticals, Inc. · NASDAQ:SPRY
Ars Pharmaceuticals — Investor Day (March 2024)
72 slides from Ars Pharmaceuticals's investor day presentation, Mar 7, 2024
Slide 1: neffy Investor Day March 7, 2024
Exhibit 99.1 neffy Investor Day March 7, 2024
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: Today's Speakers
Today’s Speakers ARS Management Key Opinion Leaders Richard Lowenthal, M.S., MSEL Jonathan Spergel, M.D., Ph.D. Chief Executive Officer, Co-Founder Chief of Allergy Program Led FDA approvals for multiple Children’s Hospital of Philadelphia nasal spray products 25+ years of experience Eric Karas Thom
Slide 4: 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
Slide 5: What We Will Cover Today
What We Will Cover Today Unmet need in type I allergic reactions including anaphylaxis Dr. Jonathan Spergel neffy clinical profile, registrational studies Richard Lowenthal neffy benefit-risk for type I allergic reactions including anaphylaxis Dr. Thomas Casale US market opportunity and commercializ
Slide 6: Unmet Need / Current Challenges
Unmet Need / Current Challenges Vast Majority of Type I Allergy Patients Face Significant Limitations with Current Treatment Options NO TREATMENT REFUSAL OF DELAY IN USER ERROR PROBLEM AVAILABLE TREATMENT TREATMENT IN TREATMENT ONLY 10% - 20% of 1 ~40% - 60% of ~50% of patients carry ~25% - 60% do n
Slide 7: Significant Catalysts for neffy in 2024
Significant Catalysts for neffy in 2024 o US NDA response to CRL by early Q2 2024 FDA o PDUFA action date anticipated in H2 2024 o EMA decision (CHMP Opinion) expected by mid-2024 EMA o China NDA filing expected by YE 2024 o Japan NDA filing expected by YE 2024 o Planning in progress for filing in o
Slide 8: Type I Allergies & Unmet Needs
Type I Allergies & Unmet Needs Jonathan M. Spergel, M.D., Ph.D. Professor of Pediatrics Chief of the Allergy Program Children’s Hospital of Philadelphia
Slide 9: Type I Allergic Reactions: Systemic Hypersensitivity Reaction
Type I Allergic Reactions: Systemic Hypersensitivity Reaction More than 500,000 ER visits ~40 Million people in each year due to systemic Type I allergic US with systemic Type I allergic 1 2 reactions , costing an average of $1600+ per visit reaction to allergens Other Type I allergy indications Sig
Slide 10: Anaphylaxis Diagnosis Criteria and Symptoms
Mucosal Respiratory Cardiac GI Anaphylaxis Diagnosis Criteria and Symptoms 2-14 Symptoms (>2%) reported during US anaphylaxis events 0% 20% 40% 60% 80% 100% Urticaria or Angioedema Urticaria Flushing Pruritus Angioedema (e.g. face, lips, tongue or larynx) Intraoral Edema or Tongue Swelling Laryngeal
Slide 11: Most frequently reported symptoms of anaphylaxis
Most frequently reported symptoms are difficulty breathing, angioedema (face, lips, tongue, larynx) and urticaria (hives) References: 1. LoVerde D, et al. Chest. 2018. 2. Images reproduced with permission 11
Slide 12: Epinephrine: Well Known Mechanism of Action
Epinephrine: Well Known Mechanism of Action Adrenergic Pharmacological Effect Clinical Effect Receptor of Epinephrine of Epinephrine • Stabilizes mast cells and basophils - • Reverses pathological histamine cascade Inhibits inflammatory mediators • Increase in bronchial airflow β 2 • Relaxation of b
Slide 13: Second Dose Demonstrates Similar Efficacy Between IM and Autoinjectors
Second Dose Demonstrates Similar Efficacy Between IM and Autoinjectors (the only FDA approved products today) ~90% resolution on first dose 12% • Analysis of 12 studies with 100% autoinjector (≥ 80% EpiPen) or 10% 9.3% 100% IM-needle-and-syringe use in 1-11 community or ED setting 8% • Differences i
Slide 14: Prompt Treatment with Epinephrine is Critical
Prompt Treatment with Epinephrine is Critical ANTIGEN EXPOSURE Consequence of Delayed Treatment Risk Factor 1 Abnormal vitals (HR, SBP, Respiration) p<0.001 Patients / Caregivers wait 2 Repeat Epinephrine Doses OR = 5.0 up to 18 minutes 3 Hospitalization (500,000 ER visits / yr) HR = 4.0 to dose epi
Slide 15: Only ~40% of ER Anaphylaxis Patients Dosed Pre-Arrival
% dosed with epinephrine in b community setting (pre-ED) Only ~40% of ER Anaphylaxis Patients are Dosed with Epinephrine Pre-Arrival in the Community Setting Median Year of Study Period 15 References: 1. Mehta GD, et al. Expert Rev Clin Immunol. 2023. Percentage Treated with Epinephrine
Slide 16: Delays in Treatment Due to Autoinjector Limitations
Delays in Treatment with Epinephrine are Principally Due to Autoinjector Limitations and Accompanying Patient Reluctance ~40% of patients do not >40% of patients do not fill or refill 40% 2 1 40% administer epinephrine at all their epinephrine prescription >50% of parents are afraid or 55%-60% don’t
Slide 17: Needle-Related Safety Risks & Use Errors
Needle-Related Safety Risks & Use Errors Needle-related risks defined in labeling for all autoinjectors Ø Lacerations and bone injections Ø IV bolus injection (blood vessel injections) – likely result in most serious AEs Accidental self-injection into extremity by patient or caregiver 1 Ø ~ 3,500 ev
Slide 18: 2023 AAAAI guidelines updated for EMS activation
2023 AAAAI guidelines updated so that EMS activation not required for 90% of events that resolve with single dose Historic guidelines recommended ED visit following use of epinephrine for anaphylaxis, which may result in families not giving epinephrine to avoid ED visits Based on outcomes of anaphyl
Slide 19: neffy Can Fill Great Unmet Medical Need
neffy (epinephrine nasal spray) Can Fill Great Unmet Medical Need for Patients and Caregivers Epinephrine has a well-established efficacy and safety profile Ø Efficacy same across epinephrine injection products despite PK differences Immediate administration of epinephrine is critical Patients and c
Slide 20: neffy Profile
neffy Profile Richard Lowenthal CEO, ARS Pharma
Slide 21: neffy is a High Bioavailability, Low mg Dose Saline-Based Nasal Spray
neffy is a High Bioavailability, Low 2 mg Dose Saline-Based Nasal Spray: Proven Triad of FDA-Approved Components High bioavailability with low dose minimizes side effects that mimic anaphylaxis (GI symptoms) > 9 FDA Approvals in Allergy and risk of cardiotoxicity from overdosing (> 100 years of clin
Slide 22: Intravail Allows Injection-Like PK and Robust IP Protection
Intravail® Allows Injection-Like PK at a Low Intranasal Dose Without Irritation or Pain, and Robust IP Protection to 2038+ NCE-like exclusivity enabled by Intravail • No systemic absorption via nose without Intravail when epinephrine is put in water-based solution • Intravail allows systemic intrana
Slide 23: Designed for Easier Carry and Portability
Designed for Easier Carry and Portability 23 Case holds two neffy 2mg devices.
Slide 24: Basis of Approval for Community Use Products
Basis of Approval for Community Use Products Ø Approved community use products include IM and SC dosing (FDA briefing book) Ø Almost all approved without PK data Approval FDA Approved Route Device Pharmacokinetics (any data including literature) Basis and Dose ® EpiPen Significant differences (EpiPe
Slide 25: All Products Demonstrate Efficacy Despite Different PK
All Products Demonstrate Efficacy Despite Different PK Ø Despite PK differences no known difference in efficacy Ø All products 90% resolution on single dose Median or Mean Mean Study C Study T Range 1 max max Treatment Source N Study T max (pg/mL) (min) (min) EpiPen 0.3 mg Literature and ARS 507 288
Slide 26: Development Program Focused on PK / PD Comparison
Development Program Focused on Comparison to PK / PD Profile of Approved Epinephrine Products PK to ensure efficacious and safe exposures PD response to support effect at achieving within range of approved products - receptor response Bracketing Approach • Blood pressure (BP): α & β (β ) receptors 1
Slide 27: Registrational Studies Demonstrate Comparability on PD and PK
Registrational Studies Demonstrate Comparability on Both PD Surrogates for Efficacy and PK with neffy PD and PK Data Safety Data • 2 mg neffy met all clinical endpoints • Adverse events generally mild in nature with no meaningful nasal irritation or pain up to 4 mg dose • PD surrogates for efficacy
Slide 28: PK Results Satisfy Bracketing Approach
Pharmacokinetic Results from neffy 2 mg Studies Satisfies Bracketing Approach designed with FDA 450 neffy 2.0 mg (HCP) (n=78)* 400 neffy 2.0 mg (self-administration) (n=42) Upper bracket for safety 350 IM 0.3 mg (n=178) EpiPen 0.3 mg (n=77) 300 SC 0.3 mg (n=35) 250 Lower bracket for efficacy 200 150
Slide 29: neffy PK is Bracketed by EpiPen Studies
neffy PK is Bracketed by EpiPen Studies (Cmax or tmax) Mean Study C Median Study T max max Treatment Study Reference N (pg/mL) (min) AQST-109 EPIPHAST II Results (2022) 22 869 22 ARS EPI-JP01 Data (2020) 30 676 10 AQST-109 Pilot Results (2023) 27 628 10 ARS EPI-15 (2022) 35 612 8 Tal et al. EAACI (2
Slide 30: Robust Response on PD Surrogate Markers for Efficacy
Robust Response on PD Surrogate Markers for Efficacy Systolic Blood Pressure Response Heart Rate Response Epi 53 pg/mL neffy 2 mg Epi 53 pg/mL (2 min PK) **** neffy 2 mg (2 min PK) 12 12 **** 10 10 **** **** **** 8 8 ** ** 6 6 4 *** 4 IM 0.3 mg 2 IM 0.3 mg 2 0 0 0 5 10 15 20 -2 0 5 10 15 20 -2 -4 Ti
Slide 31: Positive FDA AdCom vote supports benefit-risk of neffy
Positive FDA AdCom vote supports benefit-risk of neffy FDA Advisory Committee (May 2023) voted that benefit-risk of neffy supported FDA approval Ø 17:5 and 16:6 voted in favor for approval in pediatric and adult populations, respectively Ø Advisory members who voted against approval desired comparat
Slide 32: Repeat Dose NAC Study per FDA's CRL Request
Completion of Repeat Dose neffy NAC study per FDA’s CRL Request Shows PK/PD Greater or Similar to IM Injection PD Response (Mean Change in SBP, HR) PK Profile (Mean Plasma Concentrations, pg/mL) neffy 2 mg twice (R/L) Normal (N=42) Mean Change in SBP (mmHg) Mean Change in HR (bpm) IM epinephrine 0.3
Slide 33: Risk-benefit assessment of neffy
Risk-benefit assessment of neffy Thomas B. Casale, M.D. Professor of Medicine & Pediatrics Chief, Allergy & Immunology University of South Florida
Slide 34: Ideal Properties of an Epinephrine Delivery Product
Ideal Properties of an Epinephrine Delivery Product Does it work? Is it safe? Will patients use it? Ø Consistent and reproducible PK/PD Ø No risk of injury and Ø Minimal side effects profiles (no to minimal outliers) and minimal side effects drug administration that is not Ø Palatable affected by an
Slide 35: Severe or Fatal Anaphylaxis Due to Laryngeal / Airway Edema
Severe or Fatal Anaphylaxis Due to Laryngeal / Airway Edema in Children; Presence of Hypotension in Adults 4 % hypotension in anaphylaxis EU Anaphylaxis Registry Both n = 7,217 Ø Most frequent symptom is laryngeal edema: 41% to Non-Venom 46% prevalence of upper air way edema (lips to Venom 1, 2 lary
Slide 36: neffy Shows Rapid and Robust PD Response
neffy Shows Rapid and Robust PD Response that Demonstrates Engagement of Receptors that Reverse Anaphylaxis Symptoms Systolic Blood Pressure Response Heart Rate Response neffy 2 mg Epi 53 pg/mL Epi 53 pg/mL (2 min PK) (2 min PK) **** neffy 2 mg 12 12 **** 10 10 **** **** **** 8 8 ** ** 6 6 4 *** 4 I
Slide 37: 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 Repeat dosing 10 min apart in healthy subjects neffy exposure similar to 500 neffy 2.0 mg IN twice (L/R) EpiPen to ensure safety neffy 2.0 mg IN twice (R/R) 450 Epinephrine 0.3
Slide 38: PD Response at Least as Good as EpiPen
PD Response as Shown to be at Least as Good as EpiPen, Supporting Engagement of Receptors that Reverse Anaphylaxis Symptoms Single Dose SBP Response Twice Dose SBP Response p = 0.947 (ns) 75 p < 0.0001 55 65 45 55 Mean: Mean: 35 Mean: 45 Mean: 22.3 mm 28.9 mm Mean: 29.1 … Mean: 18.2 mm Hg Hg 22.6 mm
Slide 39: Resolution of Oral Food Challenge Induced Anaphylaxis Symptoms
neffy Shows Robust and Rapid Clinical Resolution of Oral Food Challenge Induced Anaphylaxis Symptoms Efficacy Study of neffy in Oral Food Challenge Study Outcomes 1 Induced Anaphylaxis (EPI-JP-03) Clinical Response Rate (%) Study Design: single arm, open-label study neffy 100.0% Participants: 15 ped
Slide 40: Resolution of Oral Food Challenge Induced Anaphylaxis Symptoms
neffy shows Robust and Rapid Clinical Resolution of Oral Food Challenge Induced Anaphylaxis Symptoms References: 1. Ebisawa M, et al. Presentation at AAAAI 2024 (Washington DC). 40
Slide 41: Rapid Clinical Responses in Treatment-Resistant Urticaria
neffy Shows Robust and Rapid Clinical Responses in Treatment- Resistant Urticaria (Most Common Symptom of Anaphylaxis) Randomized, Placebo-Controlled Efficacy Data in 1 Treatment Refractory Chronic Urticaria (EPI-U01) Study Design randomized, placebo-controlled crossover trial study • 18 chronic urt
Slide 42: NAC-Induced Rhinitis Does Not Impact neffy's PK Profile
Experimental NAC-Induced Rhinitis Does Not Negatively Impact neffy’s PK Profile (Allergic Rhinitis Subjects) FDA Advisory Committee viewed neffy NAC data as “encouraging” and “favorable” Repeat dose under NAC-induced rhinitis supports similarity NAC-induced rhinitis accelerates absorption of single
Slide 43: NAC-Induced Rhinitis Does Not 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 Heart Rate (bpm) Mean Change in Systolic Blood Pressure (mmHg) neffy 2 mg twice (R/L) Normal (N=42) IM epinephrine 0.3 mg twice (R/L) Normal (N=42) neffy 2 mg twice (R/L) NAC (N
Slide 44: URTI-Induced Rhinitis Has No Meaningful Impact on PK/PD
Upper Respiratory Tract Infection (URTI)-Induced Rhinitis has no Clinically Meaningful Impact on the PK/PD Profile of neffy Mean Epinephrine Plasma Mean Systolic Blood Pressure Change 18 500 n ne ef ff fy y 2.0 mg neffy neffy 2.0 mg neffy neffy 2.0 mg with URTI 16 neffy neffy 2.0 mg with URTI 400 14
Slide 45: PK/PD Profile and Ability to Dose Influenced by Conditions
PK/PD Profile and Ability to Dose May Be Influenced By Varying Conditions Including Anaphylaxis Itself Headache Cardiac failure/arrest Oral/palatal pruritus/stinging Potential effect on ability to dose or absorption profile by Arrhythmia theoretical route of administration for epinephrine Nasal symp
Slide 46: Excellent Tolerability and Palatability
Excellent Tolerability and Palatability Adverse events generally mild in nature with no meaningful nasal irritation or pain up to 4 mg dose No serious adverse events in any clinical study No risk of needle-related injuries or blood vessel injections with neffy Most common adverse events (>5%) were m
Slide 47: Adverse Event Profile Compares Favorably to Autoinjectors
Adverse Event Profile Compares Favorably to Autoinjectors Incidence of adverse events in neffy, EpiPen and Auvi-Q studies (greater than 5% frequency) 1 2 2 Adverse Event 2 mg neffy 0.3 mg EpiPen 0.3 mg Auvi-Q Injection-site erythema 0% 32.6% 31.3% Injection-site pain 0% 24.4% 13.4% Tremors 0% 14.1%
Slide 48: Low Dose Minimizes Risk of Overdosing
Low Dose is an Important Benefit of neffy that Minimizes Risk of Overdosing, and Difficulty Monitoring Clinical Response Epinephrine has a therapeutic window and potential for overdose 1, 2 if too much is systemically absorbed too fast (e.g. IV bolus) – multiple cardiac events and fatalities 3, 4 re
Slide 49: Too Much Epinephrine, too Fast, can be Dangerous
Too Much Epinephrine, too Fast, can be Dangerous, without 1 More Benefit: Suspected IV Bolus Case-Study with EpiPen △104 mmHg SBP 5000 230 4500 210 PK DBP PR SBP 4000 190 3500 170 3000 150 2500 130 2000 110 1500 90 1000 70 500 0 50 0 10 20 30 40 50 60 Minutes References: 1. Ebisawa, et al. JACI: Glo
Slide 50: Children More Likely to Experience Vomiting and GI Symptoms
Children more likely to experience vomiting and GI symptoms than adult anaphylaxis patients with non-venom allergies ~40% rate of pediatric vomiting ~60% rate of pediatric GI symptoms Non-Venom in non-venom anaphylaxis in non-venom anaphylaxis Venom n = 7,217 n = 7,217 Age Age Important side effect
Slide 51: Human Factors Studies and Real-World Data
Human Factors Studies and Real-World Data Have Proven that neffy is Easy for Patients to Carry and Simple to Administer Proven ease of use in human factors studies and real-world emergency use settings 100% of adults (including passersby without allergies) able to use neffy successfully without trai
Slide 52: Patients Should be Carrying and Dosing Sooner with neffy
Patients Should be Carrying and Dosing Sooner with neffy’s Potential Best-in-Class Epinephrine Product Profile Does it work? Will patients use it? Is it safe? Ø PK/PD response shows onset within 1 Ø Benign safety profile – mild Ø Benign safety profile – mild minute after dosing nasal discomfort (9.7
Slide 53: Commercial Opportunity
Commercial Opportunity Eric Karas Chief Commercial Officer
Slide 54: Significant Opportunity in US Severe Allergic Reaction Market
Significant Opportunity to Address Unmet Needs in Current 1 US Severe Allergic Reaction Market (~$1B Net ) PHYSICIAN Epidemiology prevalence data estimates Consistent Market Growth (Units) 2-10 1 ~40M patients with type 1 allergic reactions +6.5% CAGR since 2010, +12.7% YoY in 2023 Promotional Respo
Slide 55: neffy Aligned with What HCPs, Patients and Parents Want
neffy has the Ability to Address the Unmet Need and is Aligned 1 with what Healthcare Providers, Patients and Parents Want PHYSICIAN OF PATIENTS LIKELY TO VERY LIKELY TO 88% 1 ASK THEIR PHYSICIAN ABOUT neffy Rx n = 392 Current Users OF NON-FILLING PATIENTS STATED THEY WOULD ASK THEIR 89% 1 PHYSICIAN
Slide 56: Physicians Supportive of Adopting neffy into Practice
Physicians Supportive of Adopting neffy into Practice PHYSICIAN 1 8.5 out of 10 rating viewed as a major advance in therapy 10 = MAJOR ADVANCE / 1 = NOT AN ADVANCE AT ALL n = 75 Physicians Would prescribe neffy if their 99% 1 patients asked for it n = 185 Physicians References: 1. ARS market researc
Slide 57: Allergists and GPs Ready to Prescribe neffy
Two-Thirds of Allergists and Half of GPs Ready to Prescribe neffy as Soon as Possible; Majority of Pediatricians Expected PHYSICIAN to Prescribe within One Year Timeline for Prescribing neffy – % of physicians As soon as possible 68% Within one year of its approval 54% 52% 43% 1-3 years of it being
Slide 58: Innovative Treatment to Overcome Challenges with Needle-Injectors
neffy: Innovative Treatment to Overcome Known Challenges with Needle-Injectors for SAR Patients PATIENT 45% REDUCTION IN TIME TO USE % of Time Carrying Average Time (minutes) at least One 1 from Symptom Start to Device Use 2,3 Epinephrine Device Benefits of needle-free 8.8 alternative to address maj
Slide 59: 72% of Respondents Would Make a Special Appointment
~ 72% of Respondents would Make a Special Appointment to Discuss neffy with their HCP PATIENT Action Taken to Discuss 49% neffy with HCP 45% 40% Make a special in-person appointment to discuss neffy 27% 27% 27% 26% Make a special telehealth 22% appointment to discuss neffy 18% Wait until my next reg
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Slide 61: neffy Strategic Objectives
neffy Strategic Objectives EDUCATE PRESCRIBERS Drive adoption within specialty and high decile prescribers on the compelling value-proposition of neffy FACILITATE ACCESS neffy access, affordability and support services ACTIVATE PATIENTS Create awareness and motivate patients and caregivers to seek n
Slide 62: Drive Adoption within Specialty and High Decile Prescribers
Drive Adoption within Specialty and High Decile Prescribers EDUCATE Healthcare Provider Launch Objectives Ø Commercial force of 110 Sales and Virtual Representatives and Area Sales Managers Ø Education, awareness, and resources to drive adoption (neffy Experience) Ø Calling on 12,500 Allergy Special
Slide 63: 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
Slide 64: Create Awareness & Motivate Patients and Caregivers
Create Awareness & Motivate Patients and Caregivers to Request neffy ACTIVATE Consumer Launch Objectives Ø Drive awareness & motivate patients and caregivers to request neffy by name Ø Enable patients and caregivers to feel fully prepared to act during a potential crisis moment Ø Activate patients a
Slide 65: Intranasal Analog Comparison: Seizure Rescue Market
Intranasal Analog Comparison: Seizure Rescue Market Valtoco and Nayzilam Share Growth Valtoco + Nayzilam TRx Share in Seizure Rescue Market VALTOCO® (Valtoco, Nayzilam, Diazepam Rectal, Diastat Rectal, Diastat Acudial Rectal) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% NAYZILAM® 0% Valtoco + Nayzilam T
Slide 66: US Epinephrine Market Evolution with neffy
US Epinephrine Market Evolution Due to the Availability of 1 neffy Supports Significant Revenue Opportunity Millions of epinephrine 2-pack devices sold in US ~$1+ billion net sales US epinephrine market in 2023 1 (~5M 2-packs, ~3.2M active patients) 14M 2 Natural population growth (~0.6% YoY growth)
Slide 67: 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 68: Financial Update
Financial Update *Post-Marketing Requirements/Post-Marketing Commitments
Slide 69: Financial highlights
Financial highlights Cash and short-term investments: $228M Debt: $0M Common Shares: 96.4M As of 12/31/2023 Estimated at least three years of operating runway including the anticipated launch and commercialization of neffy 69
Slide 70: Significant Ex-US opportunity for neffy
Significant Ex-US opportunity for neffy <10% TYPE I ALLERGY MARKET PENETRATION (LESS THAN HALF OF US Europe EAI Market: ADOPTION RATES) ~$219M TODAY Japan EAI Market: ~$12M TODAY Canada EAI Market: ~$67M TODAY China EAI market: no approved products Significant Potential AUS/NZ EAI market: ~$18M TODA
Slide 71: Significant Catalysts for neffy in 2024
Significant Catalysts for neffy in 2024 o US NDA response to CRL by early Q2 2024 FDA o PDUFA action date anticipated in H2 2024 o EMA decision (CHMP Opinion) expected by mid-2024 EMA o China NDA filing expected by YE 2024 o Japan NDA filing expected by YE 2024 o Planning in progress for filing in o
Slide 72: Q&A
Q&A AiR?