Atea Pharmaceuticals(AVIR)

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Atea Pharmaceuticals(AVIR) - 2024 Q2 - Earnings Call Presentation
2024-08-11 16:57
Second Quarter Financial and Business Update August 7, 2024 June 2020 NASDAQ: AVIR 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 ...
Atea Pharmaceuticals(AVIR) - 2024 Q2 - Earnings Call Transcript
2024-08-11 16:13
Financial Data and Key Metrics Changes - The company reported a significant increase in research and development expenses in Q2 2024 compared to the prior year, attributed to the advancement of the Phase 3 SUNRISE-3 COVID-19 trial and the Phase 2 HCV trial [25] - General and administrative expenses decreased in Q2 2024 compared to the same period in 2023 due to lower professional fees [25] - Interest income decreased in Q2 2024 compared to Q2 2023 due to lower investment balances [26] - The company ended Q2 2024 with $502.2 million in cash, cash equivalents, and marketable securities, projecting a cash runway into 2027 [8][26] Business Line Data and Key Metrics Changes - The Phase 3 SUNRISE-3 study for COVID-19 has completed patient enrollment, with results expected in the second half of 2024 [6][19] - The Phase 2 study for HCV showcased a potential best-in-class profile for the combination of bemnifosbuvir and ruzasvir, with full results expected in Q4 2024 [7][18] Market Data and Key Metrics Changes - The U.S. prescription demand for oral antivirals to treat COVID-19 increased by 32% in June 2024 compared to June 2023, correlating with the summer wave of infections [23] - The U.S. HCV treatment demand grew approximately 5% in 2023 based on the number of patients treated [10] Company Strategy and Development Direction - The company aims to deliver bemnifosbuvir to millions of patients, addressing the unmet needs of vulnerable populations [6][7] - A fixed-dose combination tablet has been selected to reduce the daily pill burden from four tablets to two, enhancing patient convenience [8][13] - The company is preparing to initiate the Phase 3 program for HCV by the end of 2024, pending discussions with regulatory agencies [18] Management's Comments on Operating Environment and Future Outlook - Management highlighted the ongoing unmet medical need for effective COVID-19 treatments, especially among high-risk populations [19] - The company expressed confidence in the potential of bemnifosbuvir to improve the COVID-19 treatment paradigm and address limitations of current therapies [24] - Management is optimistic about the significant clinical progress made and the potential for key milestones to drive shareholder value in the remainder of 2024 [27][28] Other Important Information - The company is focused on maintaining financial discipline while pursuing strategic investments [26] - The demographic of HCV patients has shifted, with a higher proportion of younger patients and those taking multiple concomitant medications [11][12] Q&A Session Summary Question: Can you walk me through the payer dynamic for Hep C? - The majority of chronic Hep C patients are covered by government programs like Medicaid and Medicare, with both brand and authorized copies of Epclusa being prescribed [31][32] Question: How does the company view competition from Pfizer's next-gen Paxlovid? - Management believes that having multiple mechanisms of action is important and is confident in the profile of bemnifosbuvir, which may offer advantages over Paxlovid [34][36] - The company plans to co-promote its COVID-19 programs with a pharmaceutical partner that has primary care and managed care capabilities [38]
Atea Pharmaceuticals(AVIR) - 2024 Q2 - Quarterly Report
2024-08-07 20:45
Financial Position - The company has $502.2 million in cash, cash equivalents, and marketable securities as of June 30, 2024, which is expected to fund operations into 2027[76]. - The company recorded a net loss of $40.5 million for the three months ended June 30, 2024, compared to a net loss of $28.2 million for the same period in 2023, indicating a worsening financial position[88]. - The net loss for the six months ended June 30, 2024 was $103.7 million, while the net loss for the same period in 2023 was $63.7 million[99]. - Net cash used in operating activities for the six months ended June 30, 2024 was $82.1 million, compared to $46.0 million for the same period in 2023[98]. - The company experienced a net increase in cash, cash equivalents, and restricted cash of $99.6 million for the six months ended June 30, 2024[98]. - Cash, cash equivalents, and marketable securities totaled $502.2 million as of June 30, 2024[105]. - The company may require additional capital to meet operational needs and capital requirements associated with future operating plans[96]. - Market volatility, inflation, and interest rate fluctuations may significantly impact the availability of funding sources[96]. - Future debt financing may impose additional covenants that restrict operations, including limitations on incurring additional debt[96]. Clinical Trials - The SUNRISE-3 clinical trial for bemnifosbuvir has fully enrolled 2,295 patients, with results anticipated in the second half of 2024[73][74]. - The ongoing Phase 2 clinical trial for bemnifosbuvir in combination with ruzasvir has enrolled 275 treatment-naïve HCV-infected patients, with final SVR12 results expected in Q4 2024[75]. - The lead-in cohort of the HCV trial showed a 97% SVR12 rate after eight weeks of treatment[75]. - The primary endpoint of the SUNRISE-3 study is all-cause hospitalization or death through Day 29 in the supportive care monotherapy cohort[73]. Revenue and Expenses - The company has not generated any product revenue since inception and does not anticipate revenue from product sales in the foreseeable future[76][80]. - The company does not expect to generate any product revenue until regulatory approval and commercialization of its product candidates are achieved[95]. - Research and development expenses increased by $12.6 million from $22.1 million for the three months ended June 30, 2023, to $34.7 million for the three months ended June 30, 2024, primarily due to higher external spend related to clinical trials[89]. - Total research and development costs for the three months ended June 30, 2024, were $34.7 million, compared to $22.1 million for the same period in 2023, reflecting a significant increase in external costs[85]. - Research and development expenses for the six months ended June 30, 2024, were $92.3 million, up from $51.0 million for the same period in 2023, driven by increased external spending on clinical trials[93]. - The company recorded a net reduction in research and development expenses of $1.3 million for the six months ended June 30, 2024, related to credits received from Roche, down from $8.9 million for the same period in 2023[84]. - General and administrative expenses decreased by $1.0 million from $13.2 million for the three months ended June 30, 2023, to $12.2 million for the three months ended June 30, 2024, mainly due to lower professional fees[90]. - Stock-based compensation expense for the six months ended June 30, 2024 was $25.3 million, compared to $24.9 million for the same period in 2023[99]. Licensing Agreements - The Roche License Agreement for bemnifosbuvir was terminated in February 2022, granting the company exclusive rights to develop and commercialize the product[78]. - The Merck License Agreement for ruzasvir includes milestone payments and tiered royalties based on net sales, with the first milestone of $5 million due upon starting a Phase 3 trial[79]. Operational Plans - The company plans to continue using third-party service providers for clinical development and manufacturing[81]. - The company expects to incur significant expenses as it advances clinical development and prepares for potential commercialization of its product candidates[81]. - The company anticipates continued significant operating expenditures as it seeks regulatory approvals and prepares for potential commercialization of its product candidates[95]. - Interest income and other, net, decreased by $0.7 million for the three months ended June 30, 2024, compared to the same period in 2023, primarily due to lower investment balances[90].
Atea Pharmaceuticals(AVIR) - 2024 Q2 - Quarterly Results
2024-08-07 20:15
Exhibit 99.1 Atea Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Business Update Full Enrollment Achieved in Global Phase 2 Hepatitis C Virus (HCV) Study; Complete SVR12 Results Expected 4Q'24 Bemnifosbuvir and Ruzasvir HCV Data Presented at EASL: Support Best-in-Class Potential with High Antiviral Potency, Low Risk of Drug Interaction, Short Treatment Duration and High Barrier to Resistance Results from COVID-19 Global Phase 3 SUNRISE-3 Trial Expected 2H'24 Conference Call at 4: ...
Atea Pharmaceuticals to Present at the Jefferies Healthcare Conference
globenewswire.com· 2024-05-29 11:00
BOSTON, May 29, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea, will present a business update at the Jefferies Healthcare Conference on Wednesday, June 5, 2024 at 10:30 a.m. ET in New York. A live webcast of the presentation will be available h ...
Atea Pharmaceuticals Presents New Data Showcasing Potential Best-in-Class Combination Profile of Bemnifosbuvir and Ruzasvir for Treatment of Hepatitis C Virus at EASL Congress 2024
Newsfilter· 2024-05-22 11:00
Presentations to Include New Antiviral Efficacy Results, Including SVR12 Data, from Lead-In Cohort of Ongoing Phase 2 HCV Trial Data Also Highlight the High Prevalence of Pre-Existing NS5A Resistance-Associated Substitutions (RAS) Detected in HCV-infected Patients BOSTON, May 22, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today annou ...
Atea Pharmaceuticals Presents New Data Showcasing Potential Best-in-Class Combination Profile of Bemnifosbuvir and Ruzasvir for Treatment of Hepatitis C Virus at EASL Congress 2024
globenewswire.com· 2024-05-22 11:00
Presentations to Include New Antiviral Efficacy Results, Including SVR12 Data, from Lead-In Cohort of Ongoing Phase 2 HCV Trial Data Also Highlight the High Prevalence of Pre-Existing NS5A Resistance-Associated Substitutions (RAS) Detected in HCV-infected Patients BOSTON, May 22, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today anno ...
Atea Pharmaceuticals(AVIR) - 2024 Q1 - Earnings Call Transcript
2024-05-15 02:00
Financial Data and Key Metrics Changes - The company reported a cash, cash equivalents, and marketable securities balance of $541.5 million as of March 31, 2024, with a projected runway into 2027 based on strong operational execution and financial discipline [10][22][23] - Research and development expenses increased in Q1 2024 compared to Q1 2023, primarily due to higher external spending related to clinical trials [22] Business Line Data and Key Metrics Changes - The Bemnifosbuvir program for COVID-19 is progressing with a completed enrollment of 2,221 patients in the SUNRISE-3 Phase 3 trial, focusing on high-risk patients [6][18] - The Phase 2 program for hepatitis C (HCV) reported a 98% sustained virologic response (SVR4) rate from the leading cohort of 60 patients, with plans to present new efficacy data at the upcoming EASL conference [8][12][15] Market Data and Key Metrics Changes - The U.S. HCV market demand grew approximately 5% in 2023, with over 2 million individuals estimated to be infected, indicating a significant patient pool for treatment [12] - The market opportunity for oral antiviral therapeutics for COVID-19 is projected to remain a multibillion-dollar opportunity, with annual revenues estimated between $4 billion and $5 billion for the two approved oral antiviral products [21] Company Strategy and Development Direction - The company aims to address unmet medical needs in COVID-19 and HCV treatment through innovative therapies, with a focus on the combination of Bemnifosbuvir and ruzasvir for HCV [11][17] - The company plans to initiate a Phase 3 study for HCV around the end of 2024, following the completion of the current Phase 2 study [9][26] Management's Comments on Operating Environment and Future Outlook - Management highlighted the ongoing evolution of COVID-19 variants and the need for effective treatments, emphasizing the potential of Bemnifosbuvir to meet this demand [6][16] - The company expressed optimism about upcoming data presentations and the potential for significant shareholder value driven by key milestones in both COVID-19 and HCV programs [24][26] Other Important Information - The company is preparing for a Phase 3 study for HCV, with a focus on a fixed-dose combination tablet that aims to minimize pill burden [9][48] - Management indicated that the current cash runway includes plans for potential partnerships in the COVID-19 program while also engaging in initial commercialization activities [58] Q&A Session Summary Question: What percentage of the 220 patients in the HCV trial will be rolling patients? - The target is to enroll at least 10% to 20% of the 220 patients [30] Question: What is the pathway for registration for the HCV trial? - The company anticipates needing two Phase 3 trials, likely one against a comparator, and plans to execute the Phase 3 program independently [32][41] Question: Thoughts on Shionogi's recent Phase 3 update? - Management noted the importance of focusing on hospitalization as a primary endpoint, contrasting it with Shionogi's approach [36] Question: Will the EASL data include long-term SVR results? - New Phase 2 efficacy data will be presented, but specifics on SVR12 cannot be disclosed due to embargo [40] Question: How large of a safety database is needed for registration? - A safety database of around 1,000 patients is typically required for a combination antiviral like this [55]
Atea Pharmaceuticals(AVIR) - 2024 Q1 - Earnings Call Presentation
2024-05-14 22:29
First Quarter Results and Business Update May 14, 2024 NASDAQ: AVIR June 2020 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 ...
Atea Pharmaceuticals(AVIR) - 2024 Q1 - Quarterly Report
2024-05-14 20:43
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q1 2024 financials report a net loss of $63.2 million, with $541.5 million in cash and equivalents [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Account | March 31, 2024 ($ thousands) | December 31, 2023 ($ thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 160,910 | 143,823 | | Marketable securities | 380,581 | 434,283 | | Total current assets | 548,764 | 590,455 | | **Total assets** | **553,029** | **594,968** | | **Liabilities & Equity** | | | | Total current liabilities | 41,311 | 32,376 | | **Total liabilities** | **48,658** | **39,776** | | **Total stockholders' equity** | **504,371** | **555,192** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric | Three Months Ended March 31, 2024 ($ thousands) | Three Months Ended March 31, 2023 ($ thousands) | | :--- | :--- | :--- | | Research and development | 57,575 | 28,954 | | General and administrative | 12,231 | 12,615 | | **Total operating expenses** | **69,806** | **41,569** | | Loss from operations | (69,806) | (41,569) | | Interest income and other, net | 6,868 | 6,299 | | **Net loss** | **(63,169)** | **(35,467)** | | Net loss per share - basic and diluted | $(0.75) | $(0.43) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity | Three Months Ended March 31, 2024 ($ thousands) | Three Months Ended March 31, 2023 ($ thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (39,865) | (29,850) | | Net cash provided by investing activities | 56,802 | 24,480 | | Net cash provided by financing activities | 150 | 165 | | **Net increase (decrease) in cash** | **17,087** | **(5,205)** | | Cash at end of period | 160,910 | 183,453 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company is a clinical-stage biopharmaceutical firm focused on antiviral therapeutics, currently conducting a Phase 3 trial (SUNRISE-3) for bemnifosbuvir for COVID-19 and a Phase 2 trial for a bemnifosbuvir/ruzasvir combination for Hepatitis C (HCV)[26](index=26&type=chunk) - As of March 31, 2024, the company had **$541.5 million** in cash, cash equivalents, and marketable securities, which is believed to be sufficient to fund operations for at least the next twelve months[27](index=27&type=chunk) - Under a license agreement with Merck, Atea is developing ruzasvir in combination with bemnifosbuvir for HCV. The company is obligated to pay future milestone payments, with the first potential milestone of **$5.0 million** payable upon commencing a Phase 3 trial[63](index=63&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses bemnifosbuvir development, noting increased R&D expenses and $541.5 million cash expected to fund operations into 2027 - The company is conducting the SUNRISE-3 Phase 3 trial for bemnifosbuvir in high-risk COVID-19 outpatients, with enrollment completed in March 2024 and results expected in the second half of 2024[72](index=72&type=chunk) - For HCV, a Phase 2 trial of bemnifosbuvir combined with ruzasvir is ongoing. The lead-in cohort showed a **98% SVR4 rate**, meeting the efficacy criteria to continue the study. Final SVR12 results are anticipated in the second half of 2024, with a potential Phase 3 start in the same period[73](index=73&type=chunk) Expense Category | Expense Category | Q1 2024 ($ thousands) | Q1 2023 ($ thousands) | Change ($ thousands) | | :--- | :--- | :--- | :--- | | Research and development | 57,575 | 28,954 | 28,621 | | General and administrative | 12,231 | 12,615 | (384) | | **Total operating expenses** | **69,806** | **41,569** | **28,237** | - The **$28.6 million** increase in R&D expenses was primarily driven by higher external spending on the Phase 3 COVID-19 SUNRISE-3 trial and the Phase 2 HCV combination trial[87](index=87&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Market risk is interest rate sensitivity on $541.5 million cash, with no material impact from a 10% rate change - As of March 31, 2024, the company held **$541.5 million** in cash, cash equivalents, and marketable securities, primarily in interest-bearing money market funds[101](index=101&type=chunk) - The company does not believe that inflation, interest rate changes, or foreign currency fluctuations have had a material impact on its results of operations[101](index=101&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls effective March 31, 2024, with no material changes in internal control - The principal executive officer and principal financial officer concluded that as of March 31, 2024, the company's disclosure controls and procedures were effective[103](index=103&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2024, that have materially affected, or are reasonably likely to materially affect, internal controls[104](index=104&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not subject to any material legal proceedings[105](index=105&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including clinical trial uncertainties, competition, regulatory hurdles, manufacturing, intellectual property, and financing - **COVID-19 Development Risks:** There is significant uncertainty around the development of bemnifosbuvir for COVID-19, which faces substantial competition from approved oral antivirals like Pfizer's Paxlovid™ and Merck's Lagevrio™[107](index=107&type=chunk)[109](index=109&type=chunk) - **Financial Risks:** The company has a history of significant operating expenses (**$69.8 million** for Q1 2024) and an accumulated deficit of **$259.0 million**. It will require substantial additional financing to continue its development and commercialization efforts[114](index=114&type=chunk)[116](index=116&type=chunk) - **Clinical and Regulatory Risks:** The business is highly dependent on the success of its most advanced product candidates. The regulatory approval process is lengthy, expensive, and unpredictable, and there is no guarantee of success for its COVID-19 or HCV programs[120](index=120&type=chunk) - **Intellectual Property Risks:** The company faces a patent challenge from Gilead Sciences, which was issued a patent ('361 patent) in May 2023 with a claim that purports to cover bemnifosbuvir. While the company believes the claim is invalid, an adverse legal outcome could require obtaining a license from Gilead, which may not be available on reasonable terms[172](index=172&type=chunk) - **Third-Party Reliance Risks:** The company relies on third parties for manufacturing (CMOs) and conducting clinical trials (CROs). This dependency creates risks related to supply chain disruptions, quality control, and adherence to regulatory standards like cGMP and GCP[162](index=162&type=chunk)[164](index=164&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=93&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales reported; $317.6 million net IPO proceeds invested with no material change - The company completed its IPO on November 3, 2020, raising net proceeds of approximately **$317.6 million**[203](index=203&type=chunk) - There has been no material change in the expected use of the net proceeds from the IPO[204](index=204&type=chunk) [Item 5. Other Information](index=94&type=section&id=Item%205.%20Other%20Information) CEO Jean-Pierre Sommadossi adopted a Rule 10b5-1 trading plan for selling up to 1.2M shares until June 2025 - On March 4, 2024, CEO Jean-Pierre Sommadossi adopted a Rule 10b5-1 trading plan for the sale of up to **1,200,000** shares of common stock, valid until June 4, 2025[205](index=205&type=chunk) [Item 6. Exhibits](index=95&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including CEO/CFO certifications and Inline XBRL