Slides
Page 1
ATEA Corporate Presentation January 2025
Page 2
DISCLAIMERS Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future conditions including without limitation the future of the HCV landscape and related commercial market opportunities. All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements by Atea Pharmaceuticals, Inc. (the “Company”) regarding future results of operations and financial position, including our anticipated cash runway; business strategy; current and prospective product candidates; anticipated milestone events; potential benefits of our product candidates and market opportunity; clinical trials, including, without limitation, anticipated initiation, enrollment, regulatory submission and data readout timelines; preclinical activities; product approvals; manufacturing availability; degree of market acceptance of any products that may be approved; research and development costs; current and prospective collaborations; and prospects and opportunities for investors. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. The information in this presentation, including without limitation the forward-looking statements contained herein, represent our views as of the date of this presentation. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any anticipated results, performance or achievements expressed or implied by the forward-looking statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug discovery and development process and the regulatory submission or approval process, unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts; delays in or disruptions to clinical trials or our business; our reliance on third parties over which we may not always have full control, our ability to manufacture sufficient commercial pr oduct, competition from approved treatments for HCV, and other important risks and uncertainties that are described in our Annual Report on Form 10-K filed for the year ended December 31, 2023 and our most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) and our other filings with the SEC. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Industry Information Market data and industry information used throughout this presentation are based on management’s knowledge of the industry and the good faith estimates of management. We also relied, to the extent available, upon management’s review of independent industry surveys and publications and other publicly available information prepared by a number of third-party sources. All of the market data and industry information used in this presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimat es. Although we believe that these sources are reliable, we cannot guarantee the accuracy or completeness of this information, and we have not independently verified this information. While we believe the estimated mar ket position, market opportunity and market size information included in this presentation are generally reliable, such information, which is derived in part from management’s estimates and beliefs, is inherently uncertain and imprecise. No representations or warranties are made by the Company or any of its affiliates as to the accuracy of any such statements or projections. Projections, assumptions and estimates of our future performance an d the future performance of the industry in which we operate are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described above. These and other factors could ca use results to differ materially from those expressed in our estimates and beliefs and in the estimates prepared by independent parties. 2
Page 3
Broad Antiviral Pipeline with De-risked Phase 3 Program 3 Program Therapeutic/ Indication Preclinical Phase 1 Phase 2 Phase 3 Upcoming Milestone Flaviviridae Hepatitis C Fixed Dose Combination: Bemnifosbuvir (BEM) Nucleotide +Ruzasvir (RZR) NS5A Inhibitor End-of-Phase 2 meeting with FDA planned for January 2025 Phase 3 initiation planned for Q1 2025 RNA Viruses Respiratory Protease Inhibitor RNA Viruses Other RNA viruses Nucleotide AT587, AT2490 Cash, cash equivalents & marketable securities: $454.7 M at 12/31/24 Cash runway anticipated into 2028
Page 4
BEM+RZR Regimen De-risked Phase 3 HCV Program for Multibillion-Dollar Market • Robust Phase 2 results for antiviral therapies have historically led to high probability of success in Phase 3 studies • High rate of regimen efficacy in the Phase 2 trial de-risks global Phase 3 program Potential Best-In- Class Treatment Robust Phase 2 Results Ready for Commercial-scale Manufacturing Large Market Opportunity Long Patent Life 4
Page 5
WHO Worldwide Numbers Global HCV: Large Market with Undertreatment of Infections - 20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000 180,000 200,000 2017 2018 2019 2020 2021 2022 Newly Reported US HCV Infections New Epclusa® /Mavyret® US Treated Patients CDC US: 2.4 – 4 Million Untreated, >160K Newly Reported Annual Infections * Exceed Annual Cures 3,4 1 WHO April 2024 2 www.cancer.gov/types/liver 3 CDC 2022 Viral Hepatitis Surveillance Report 4 IQVIA National Prescription Audit December 2024 *Newly repo rted chronic and acute HCV infectio ns in US 5 Number of US Patients 50 Million People Infected1 1 Million New Infections Annually1 Chronic HCV is Leading Cause of Liver Cancer in US, EU & Japan2 242,000 Annual Deaths1
Page 6
US HCV: Major Commercial Opportunity Poised for Growth 6 US Treatment 2022 2023 9 months 2024 Total US HCV Market Net Revenues 1 $1.6B $1.5B $1.2B Net revenue per patient treated $17K $15K $17K 1 Based on Global Net Revenues from Gilead and AbbVie’s year end 2022 and 2023 and nine months 2024 financial reports 2 Assumes treatment of 2.2 million chronically infected HCV patients at $10,000 net revenue per patient. Poised for Growth Optimal product profile with potential to expand HCV treatment Removal of HCV prescribing barriers by payors Potential US government initiatives to eradicate HCV Attractive Near-Term Opportunity Primarily 2 product market No competitors in clinical development $3B global net sales in 20231 $1.5B US net sales in 20231 >$20B+ Potential US Market Opportunity 2
Page 7
94% of US Prescribers Want Improvements to Current HCV Therapies 38% 29%26% 6% 53%51% 25% 0% Shorter Length of Treatment Higher Treatment Efficacy Fewer Contraindications (e.g., DDIs) No Unmet Needs Overall 1 Atea Custom Market Research, IQVIA 2024 2 Atea Custom Market Research, PharmaValue Partners 2023 HCV Prescribers and Patients Need Improved Therapy 7 Bemnifosbuvir (BEM) + Ruzasvir (RZR) best-in-class profile meets the need of HCV patients and prescribersBEM+RZR best-in-class profile more closely meets the needs of HCV patients and prescribers HCPs Report ~20% of Patients Are Not Compliant with DAA Therapy 1 Co-Infected HIV / HCV Patients Unmet Needs from Physician Survey (N = 157 US Healthcare Providers) 2 19% 17% Estimated Percent Not Completing DAA Treatment Estimated Percent Who Missed Doses DAA = Direct Acting Antiviral
Page 8
BEM+RZR: Potential Best-in-Class Profile • BEM+RZR: Next generation, pan-genotypic, fixed dose combination of BEM, most potent HCV nucleotide and RZR, highly potent HCV NS5A inhibitor • Targeted Indications: Treatment of adult patients 18 years+ with chronic HCV infection, with and without compensated cirrhosis Treatment Duration Treatment Duration Non-Cirrhotic 8 Weeks 8 Weeks 12 Weeks 12 Weeks Short Duration Profile Patient Population MAVYRET® 8 Weeks 12 Weeks BEM+RZR EPCLUSA® Protease-Inhibitor Free No Food Effect Low Potential for Drug-Drug Interactions Compensated Cirrhosis (<10% of US cases) 8
Page 9
Drug-Drug Interaction Profile of BEM+RZR Regimen is a Key Differentiator for HCV Treatment -- ~80% of HCV Patients Take Concomitant Medications 1 9 Drug BEM+RZR MAVYRET® Oral Contraceptives2 Protease Inhibitor-Containing HIV Drugs Statins Immunosuppressants 3 Antiarrhythmics 4 EPCLUSA® Healthcare Providers Prefer Therapies Convenient to Prescribe Proton Pump Inhibitors 5 Permitted No clinically meaningful DDI expected; confirming data pending Contraindicated Permitted but require dose modification/TDM Certain drugs (doses) in the class are contraindicated while others are permitted Certain drugs (doses) in the class are contraindicated while others are permitted but require dose modification/TDM 1Atea Custom Market Research, IQVIA 2024, Atea clinical/in vitro DDI data 2 Ethinyl estradiol > 20 g - containing product 3 Cyclosporin > 100 mg/d4 Digoxin 5 Omeprazole
Page 10
BEM+RZR Potential Best-in-Class Pan-Genotypic Regimen Global Phase 2 Results Global Phase 3 Program 10
Page 11
Phase 2 Open Label Study of BEM+RZR in HCV Patients (N=275) 11 Per-Protocol Treatment Adherent Population Efficacy Primary Endpoint (N=213) Per-Protocol Population Regardless of Adherence* (N = 256) Total Enrolled (N=275) ~17% of Patients Non- Adherent as Measured by Pill Count & Pharmacokinetics Primary Endpoints: SVR at Week 12 post-treatment (SVR12) in per-protocol treatment adherent population Safety Secondary & Other E ndpoints: SVR12 in per-protocol population regardless of treatment adherence (efficacy evaluable population) Additional Data to Follow: SVR at Week 24 post-treatment (SVR24) Virologic failure Resistance Patient Population: HCV-infected patients including compensated cirrhosis, d irect- acting antiviral naïve, all genotypes BEM 550 mg QD RZR 180 mg QD 8 weeks dosing w/combination
Page 12
Efficacy Primary Endpoint: High SVR12 Rates with 98% SVR12 12 98% 95% 0% 20% 40% 60% 80% 100% Overall SVR12 (%) 208/213 242/256 Treatment adherent patients: 98% SVR12 (primary endpoint analysis) 95% SVR12 Regardless of Adherence Robust potency and drug forgiveness Treatment viral kinetics in hard - to-treat cirrhotic patients • Cirrhotic adherent patients: 88% SVR12 • 100% viral clearance at Week 8 in cirrhotic patients, should lead to very high SVR rates with a 12-Week treatment duration 85% 100% 0% 20% 40% 60% 80% 100% Week 4 Week 8 HCV RNA <LLOQ (%) 34/3429/34 Patients regardless of treatment adherence: 95% SVR12
Page 13
99% SVR12 in Non-Cirrhotic Treatment Adherent Patients Across Genotypes 13 97% SVR12 Non-cirrhotic patients regardless of treatment adherence 98% SVR12 Non-cirrhotic genotype 3 patients regardless of adherence 212/219 99% 99% 100% 100% 100% 0% 20% 40% 60% 80% 100% Overall GT 1 GT 2 GT 3 GT 4 SVR12 (%) 178/179 119/120 4/4 2/253/53 Overall: 99% SVR12 Non-cirrhotic treatment adherent patients with a short 8- week treatment 100% Efficacy Non-cirrhotic treatment adherent genotype 3 Very high SVR12 cure rates in non -cirrhotic patients across genotypes 97% SVR12 Regardless of Adherence Robust potency and drug forgiveness 97% 98% 0% 20% 40% 60% 80% 100% Overall GT 3 SVR12 (%) 212/219 62/63
Page 14
No drug-related SAEs or treatment discontinuations due to drug-related adverse events (AEs) AEs were generally mild to moderate No trends observed in AEs or safety laboratory parameters Regimen was generally safe and well tolerated in HCV-infected patients with and without cirrhosis Safety Primary Endpoint: BEM+RZR Regimen Generally Safe and Well Tolerated 14 Phase 2 Open Label Study of BEM+RZR for 8 Weeks End-of-Phase 2 meeting with US FDA planned for January 2025 to support global Phase 3 program
Page 15
Anticipated* Global HCV Phase 3 Program 1 Trial US / Canada & 1 Trial Outside North America Open-label: BEM+RZR Regimen vs Active Comparator in Chronic HCV Patients Randomized (1:1) Primary Endpoint SVR at Week 12 Post Treatment • No Cirrhosis: 8 weeks of BEM+RZR vs 12 weeks of active comparator • Compensated Cirrhosis: 12 weeks of BEM+RZR vs active comparator 12 1:1 = Study Primary Endpoint SVR = Sustained Virologic Response FDC = Fixed Dose Combination 15 Non-Cirrhotic US / Canada Trial ~N=680 Outside North America Trial ~N=640 Cirrhotic US / Canada ~N=120 Outside North America ~N=160 8 weeks BEM+RZR FDC 12 weeks SOF/VEL FDC 12 weeks BEM+RZR FDC 12 weeks SOF/VEL FDC Week 1:1 Chronic HCV , patients stratified by cirrhosis and genotype, HIV co - infected allowed, prior DAA excluded Two Phase 3 Trials: 1) N=800 trial US / Canada 2) N=800 trial Outside North America N=1,600 total patients *Pending meeting with regulators
Page 16
Potential Best-in-Class Pan-Genotypic Regimen Prescriber & Payor Reaction to Profile 16
Page 17
Highly Positive Reaction to BEM+RZR Profile by US Prescribers Neutral 1% Negative Positive89% 10% Overall Impression of BEM+RZR Profile Favorable 1 89% 93% 90% 85% 0% 20% 40% 60% 80% 100% HEPs IDs GIs PCPs ◼ Top 10 Clinics Account for ~6% of NRx’s 2 ◼ Top 10 Integrated Delivery Networks Account for ~10% of NRx’s 2 Majority of US healthcare providers indicate a high likelihood of prescribing BEM+RZR Regimen 1 Atea Custom Market Research, PharmaValue Partners 2023 2 Atea Custom Market Research, IQVIA 202217 Positive Impression of BEM+RZR Profile Regardless of Specialty Limited Competition with Concentrated Prescriber Base ~6000 Prescribers Write ~80% Direct Acting Antiviral Prescriptions2
Page 18
Majority US Payors Receptive to Inclusion of BEM+RZR Regimen on Formulary Key insights regarding BEM+RZR regimen and payor access • Majority of payors have > one DAA on formulary • Formulary inclusion assumes competitive contract pricing • Ability to move market share and educate providers will be an important factor Payors covering >130M lives rated BEM+RZR profile either superior or comparable to Epclusa® or Mavyret® 16% 53% 26% 0% 5% 28% 55% 15% 0% 3% Extremely willing Somewhat willing Neither willing or unwilling Somewhat unwilling Extremely unwilling By Payor By Lives Source: Atea Custom Market Research, Formulary Insights 202418 High willingness to add BEM+RZR regimen onto formulary By Lives By Payor
Page 19
BEM+RZR Regimen Has Potential to Become Most Prescribed Treatment in Multibillion-Dollar HCV Market 3rd entrants with differentiated profile have been highly successful Therapeutic Class 3rd Entrant Time Lag Peak Share GLP-1 (Type 2 Diabetes, Pre- weight loss) Ozempic® Launched in 2018, 4 years after the 2nd product 33% CGRP mAbs (Migraine) Emgality® Launched in 2018, the same year as other products 38% IL-5 antagonist mAbs (Asthma) Fasenra® Launched in 2017, 2 years after the first product 41% 52% 30% 48% 29% 41% Current Predicted Post BEM+RZR Launch 49% 31% 51% 32% 37% Current Predicted Post BEM+RZR Launch 46% 30% 54% 36% 34% Current Predicted Post BEM+RZR Launch PWID2 with or without compensated cirrhosis Non - PWID with or without compensated cirrhosis EPCLUSA® MAVYRET® BEM+RZR HIV Co-Infected 1 Atea Custom Market Research, PharmaValue Partners 2023 2 IQVIA National Prescription Audit 2024 3 LEK Consulting, First vs Best In Class 19 BEM+RZR Projected to be the Most Preferred DAA 1 3rd Entrants in Highly Entrenched Class with Limited Competitors Have Captured 30%+ Share 2,3 PWID=People Who Inject Drugs
Page 20
De-risked Phase 3 Program with Blockbuster Potential 20
Page 21
BEM+RZR Regimen De-Risked Phase 3 HCV Program for Multibillion-Dollar Market Potential best-in-class profile of regimen supports opportunity to disrupt global HCV market of approximately $3B in annual net sales Potential Best-In- Class Treatment Robust Phase 2 Results Ready for Commercial-scale Manufacturing Large Market Opportunity Long Patent Life Demonstrated very high efficacy, low risk of DDIs, short treatment duration and no food effect 98% cure rate after short eight-week treatment duration for primary endpoint analysis Fixed dose regimen tablet ready for Ph 3 Commercial-scale production ready >$3B global net sales market with treatment expansion potential Atea IP for regimen until at least 2042 21
Page 22
22 225 Franklin Street Suite 2100 Boston MA USA 02110 www.ateapharma.com