Financial Position - As of September 30, 2024, the company had $248.2 million in cash, cash equivalents, and short-term marketable securities, which is expected to fund operations into fiscal 2027[28]. - The company plans to use cash flows from its AbbVie collaboration to fund research and development activities through fiscal 2027[38]. - Research and development expenses for the fiscal years ended September 30 were $131.5 million in 2024, $163.5 million in 2023, and $164.5 million in 2022, indicating a decrease of approximately 19.6% from 2023 to 2024[143]. - The company does not anticipate paying cash dividends for the foreseeable future, focusing instead on retaining earnings to expand operations[207]. - The company may face limitations on utilizing future net operating loss carryforwards and research and development tax credit carryforwards due to ownership changes[207]. Clinical Development - The company is developing two clinical stage product candidates for RSV: zelicapavir and EDP-323, with zelicapavir currently in two Phase 2 studies targeting high-risk populations[30]. - EDP-323 achieved highly statistically significant reductions in both viral load and clinical symptoms in a Phase 2a challenge study, with a p-value of <0.0001[31]. - The company is conducting two Phase 2b studies of zelicapavir in high-risk populations, including 96 pediatric patients and approximately 180 high-risk adults[48][49]. - EDP-323, a novel oral antiviral targeting the RSV L-protein, has shown sub-nanomolar potency against RSV-A and RSV-B in vitro[50]. - EDP-235, an oral 3CL protease inhibitor, demonstrated a statistically significant improvement in total symptom score in a Phase 2 trial, with a p-value of <0.05 in the 400 mg treatment group[94]. Market Needs and Opportunities - The company aims to advance clinical development of novel virology product candidates for RSV, addressing a significant unmet medical need[38]. - The company estimates that RSV leads to approximately 3 million hospitalizations globally in children under 5 years old and 177,000 hospitalizations in the U.S. in adults over 65[19]. - The prevalence of chronic spontaneous urticaria (CSU) is estimated to affect 1.75-3.5 million people in the U.S. at any given time, indicating a significant unmet need for effective treatments[70]. - The moderate-severe atopic dermatitis (AD) treatment landscape is dominated by biologics, with a significant need for efficacious and safe oral agents due to the limitations of current therapies[74]. - Approximately 300 million people worldwide are chronically infected with HBV, with 15-40% at risk of developing severe liver disease[95]. Collaborations and Partnerships - The company plans to continue collaborations to progress EDP-235, as it will not advance this candidate into Phase 3 studies independently[33]. - The collaboration with AbbVie has generated $396 million in payments and $924 million in royalty payments through September 30, 2024[86][89]. - AbbVie has entered into a royalty-free licensing agreement to accelerate access to generic versions of MAVYRET/MAVIRET in low- and middle-income countries, which may impact royalty revenues[156]. - The joint steering committee established under the collaboration agreement has oversight responsibilities for all research, development, and commercialization activities[86]. Regulatory Environment - The FDA review process for a New Drug Application (NDA) typically takes ten months for standard reviews and six months for priority reviews, with no guarantee of approval[119]. - The FDA may require additional clinical data or other information before approving an NDA, and a "complete response" letter may outline specific deficiencies[121]. - The company must comply with extensive government regulations regarding drug development, which require substantial time and financial resources[114]. - The FDA has four programs to expedite drug development: fast track, breakthrough therapy, priority review, and accelerated approval, with priority review aiming to shorten the review period to six months from ten months[122]. - The company has not obtained regulatory approval for any wholly-owned product candidates, and future candidates may also fail to receive approval[172]. Competitive Landscape - The company faces significant competition in the HCV market, with Gilead's Epclusa and Harvoni posing substantial threats to MAVYRET/MAVIRET's market share[159]. - The company is competing in a highly competitive area of small-molecule drug development, with uncertain patent protection for its product candidates[188]. - The pharmaceutical industry is highly competitive, with established companies having greater resources and late-stage drug candidates, necessitating superior product development to compete effectively[102]. - The company faces intense competition in the biotechnology sector, which may hinder its ability to attract and retain qualified personnel necessary for development and commercialization efforts[163]. Intellectual Property Risks - The company may face significant risks related to intellectual property rights, including potential challenges to its patents and competitive advantage[192]. - The company’s ability to enforce its intellectual property rights may lead to counterclaims, increasing costs and potential damages[190]. - The company’s patent protection could be challenged, leading to loss of rights and adverse impacts on its product candidates[190]. - There is uncertainty regarding the future protection of intellectual property, which may not adequately safeguard the company's business interests[192]. Operational Challenges - The company relies on third-party manufacturers for active pharmaceutical ingredients and clinical trial supplies, with manufacturing for glecaprevir conducted by AbbVie[144]. - The company currently has no commercialization or sales and marketing capabilities and plans to partner with larger pharmaceutical companies for late-stage clinical development and potential commercialization[145]. - The company lacks its own sales and marketing infrastructure, which may hinder the commercialization of product candidates[179]. - The company must manage relationships with strategic partners and suppliers as it expands its pipeline, which adds complexity to its operational capabilities[163]. Cybersecurity and Compliance - The company has invested in a state-of-the-art cybersecurity framework, including regular network monitoring and advanced threat detection, to mitigate risks[216]. - The company conducts annual security reviews and hires third-party firms for network penetration testing to enhance security measures[216]. - Compliance with healthcare laws and regulations is essential, as violations could result in severe penalties and affect business operations[201]. - The company does not maintain insurance for environmental liability or toxic tort claims, exposing it to significant uninsured liabilities[210]. Stock Performance and Market Dynamics - The stock price has been volatile, posing risks for shareholders and potential financial losses[202]. - The stock price has fluctuated between $8.18 and $97.37 from October 1, 2019, to September 30, 2024, indicating significant volatility in the market[203]. - The trading market for the company's stock is influenced by analysts' reports, with inaccuracies potentially leading to stock price declines[205]. - The company qualifies as a "smaller reporting company," which may result in reduced reporting requirements and could make the stock less attractive to investors[207].

Company Performance - Enanta Pharmaceuticals reported a quarterly loss of $1.36 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.16, and compared to a loss of $1.33 per share a year ago, indicating a surprise of -17.24% [1] - The company posted revenues of $14.61 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 20.68%, and down from $18.93 million in the same quarter last year [2] - Over the last four quarters, Enanta Pharmaceuticals has surpassed consensus EPS estimates only once and has topped consensus revenue estimates two times [2] Future Outlook - The current consensus EPS estimate for the coming quarter is -$1.24 on revenues of $17.19 million, and for the current fiscal year, it is -$5.02 on revenues of $80.53 million [7] - The estimate revisions trend for Enanta Pharmaceuticals is mixed, leading to a Zacks Rank 3 (Hold), suggesting the shares are expected to perform in line with the market in the near future [6] - The sustainability of the stock's price movement will depend on management's commentary during the earnings call and future earnings expectations [3][4] Industry Context - The Medical - Drugs industry, to which Enanta Pharmaceuticals belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact the performance of stocks within the industry [5]

Company Overview - Enanta Pharmaceuticals (ENTA) shares increased by 5.6% to close at $10.94, following a period of 19.6% loss over the past four weeks, indicating a significant recovery in trading volume [1] - The company is a member of the Zacks Medical - Drugs industry, which includes other companies like BioCryst Pharmaceuticals (BCRX) [4] Recent Developments - Enanta Pharmaceuticals announced positive top-line data from a phase IIa human challenge study for its candidate EDP-323, showing significant reductions in viral load and clinical symptoms in healthy adults infected with respiratory syncytial virus [2] - The consensus EPS estimate for Enanta's upcoming quarterly report has been revised 5.3% higher over the last 30 days, suggesting a positive trend that may lead to further price appreciation [4] Financial Expectations - The company is expected to report a quarterly loss of $1.16 per share, reflecting a year-over-year change of +12.8%, with revenues projected at $18.73 million, down 1.1% from the previous year [3] - BioCryst Pharmaceuticals, a peer in the industry, has an unchanged EPS estimate of -$0.07, which represents a 63.2% improvement from the prior year [5]

Company Overview - Enanta Pharmaceuticals (ENTA) shares increased by 6.7% in the last trading session, closing at $16, with notable trading volume compared to typical sessions [1] - The stock has gained 11.6% over the past four weeks [1] Industry Context - Enanta Pharmaceuticals is part of the Zacks Medical - Drugs industry, where another stock, Ardelyx (ARDX), rose by 1.2% to $5.89 but has seen a decline of 10.3% over the past month [2] Financial Expectations - Enanta Pharmaceuticals is expected to report a quarterly loss of $1.49 per share, reflecting a year-over-year change of +19.9% [3] - Revenue for the upcoming report is anticipated to be $17.3 million, which is an 8.4% decrease from the same quarter last year [3] Product Development - The company's lead candidate, zelicapavir, is an oral N-protein inhibitor currently being evaluated in two mid-stage studies for treating respiratory syncytial virus (RSV) in both pediatric and adult patients [4] - Enanta also has a portfolio of small-molecule drugs targeting viral infections, contributing to positive sentiment around the stock [4] Earnings Estimate Trends - The consensus EPS estimate for Enanta Pharmaceuticals has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without earnings estimate revisions [6] - In contrast, Ardelyx's consensus EPS estimate has increased by 8.8% over the past month to -$0.10, representing a 25% decline compared to the previous year [7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35839 ENANTA PHARMACEUTICALS, INC. | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | --- | --- | --- | | Common Stock, par value $0.0 ...

Financial Data and Key Metrics Changes - Total revenue for Q2 2024 was $17.1 million, a decrease from $17.8 million in Q2 2023, primarily due to lower royalty rates [43][18] - Net loss for the quarter was $31.2 million, or a loss of $1.47 per diluted share, compared to a net loss of $37.7 million, or a loss of $1.79 per diluted share in the same period last year [20] - Research and development expenses decreased to $35.6 million from $43.5 million year-over-year, attributed to reduced costs associated with the COVID-19 program [44][19] - General and administrative expenses increased to $14.2 million from $13.8 million, mainly due to legal expenses related to a patent infringement lawsuit [45] Business Line Data and Key Metrics Changes - The RSV pipeline includes two main candidates: zelicapavir and EDP-323, with ongoing Phase 2 studies aimed at demonstrating safety and efficacy [5][37] - The company is also advancing its immunology program targeting chronic spontaneous urticaria (CSU), with plans to select a clinical candidate by Q4 2024 [41][16] Market Data and Key Metrics Changes - The company reported ongoing royalties from AbbVie's MAVYRET, with 54.5% of royalties being paid to OMERS due to a royalty sale transaction [18] - The company expects its current cash and marketable securities, along with retained royalties, to be sufficient to meet cash requirements through Q3 2027 [21] Company Strategy and Development Direction - Enanta is focused on advancing its virology and immunology pipeline to address high unmet medical needs, particularly in developing oral therapeutics for RSV and CSU [4][15] - The company aims to leverage its expertise in small-molecule drugs to develop best-in-disease therapies for CSU and is exploring additional immunology targets [15][41] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of developing effective treatments for RSV, noting the limitations of current pediatric monoclonal antibodies [10][4] - The company anticipates reporting data from ongoing studies in the second half of 2024, which will inform future clinical development strategies [16][62] Other Important Information - The company welcomed a new Chief Legal Officer, Matthew Kowalsky, who brings over 20 years of experience in the life sciences industry [42] - Enanta is updating its expense guidance, expecting R&D expenses to be between $125 million and $145 million for the fiscal year [46] Q&A Session Summary Question: What will you be looking at in terms of data to inform your design for Phase 3? - Management indicated that they will focus on safety and virology endpoints, with a need for clinically meaningful data to justify moving to Phase 3 [23][24] Question: Can you discuss your strategic plans for the immunology program? - Management stated they are exploring multiple approaches and are looking to broaden beyond the current KIT program [27][28] Question: How close are you to completing enrollment for the RSVPED study? - Management confirmed they are in the final stages of enrollment for the youngest age cohort and are actively recruiting [62] Question: What are your expectations for the EDP-323 challenge study? - Management expressed hope for strong data, aiming to replicate the best-in-class results seen with zelicapavir [60][64] Question: How do you plan to position your oral KIT inhibitor against other therapies? - Management emphasized the goal of achieving a potent and selective oral agent with a good safety profile, aiming for best-in-class status [91][92]

Enanta Pharmaceuticals (ENTA) came out with a quarterly loss of $1.47 per share versus the Zacks Consensus Estimate of a loss of $1.26. This compares to loss of $1.79 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -16.67%. A quarter ago, it was expected that this biotechnology company would post a loss of $1.18 per share when it actually produced a loss of $1.58, delivering a surprise of -33.90%.Over the last four quarters, t ...

Exhibit 99.1 Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter with Webcast and Conference Call Today at 4:30 p.m. ET WATERTOWN, Mass., May 6, 2024 – Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today reported financial results for its fiscal second quarter ended March 31, 2024. "At Enanta, we are committed to advancing the first antiviral treatment for RSV, ...

Financial Data and Key Metrics Changes - For the fiscal first quarter ended December 31, 2023, total revenue was $18 million, down from $23.6 million in the same period in 2022 [18] - Research and development expenses decreased to $36.4 million from $40.9 million year-over-year, primarily due to reduced costs associated with the COVID-19 program [20] - Net loss for the quarter was $33.4 million, or a loss of $1.58 per diluted common share, compared to a net loss of $29 million, or a loss of $1.39 per diluted common share for the same period in 2022 [21] - The company ended the quarter with approximately $337 million in cash and marketable securities [21] Business Line Data and Key Metrics Changes - The company is focused on developing treatments for RSV, with two key candidates: zelicapavir and EDP-323, both of which have fast-track designation from the FDA [7][10] - The RSVPEDs study is designed to demonstrate improved virology metrics for zelicapavir, while the RSVHR study aims to show clinically meaningful improvement in symptom resolution [10][34] Market Data and Key Metrics Changes - The current rate of adult RSV vaccine adoption is estimated at only 11% of the eligible population, indicating a significant unmet need in the market [30] - The company believes there is a $1 billion market opportunity for RSV treatments, particularly given the lack of established therapeutics in this area [66] Company Strategy and Development Direction - The company aims to advance its programs in both virology and immunology, focusing on small molecule treatments for high unmet medical needs [29] - The strategy includes leveraging drug discovery capabilities to bolster the pipeline for near and long-term value creation [29] - The company plans to announce a second immunology program in 2024, targeting chronic spontaneous urticaria (CSU) [39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their RSV portfolio, noting the absence of approved drugs for the unmet need [26] - The company anticipates reporting data from the RSVPEDs Phase 2 study in the third quarter of 2024 and aims to identify a clinical candidate for the CSU program this year [16][39] - Management highlighted the importance of understanding the competitive landscape for COVID treatments and how it may impact strategic decisions [57] Other Important Information - General and administrative expenses for the quarter increased to $16.5 million from $12.7 million in the same period in 2022, primarily due to higher stock compensation and legal expenses [62] - The company expects its current cash and marketable securities will be sufficient to meet anticipated cash requirements through fiscal 2027 [63] Q&A Session Summary Question: What is the expected outcome for the RSVPEDs study? - Management indicated that they are primarily looking for virology endpoints and numerical trends that would support moving into a Phase 3 study [76] Question: How does the company view the competitive landscape for COVID treatments? - Management noted that the recent developments simplify the COVID landscape and will help clarify future funding decisions [78] Question: What are the expectations for the new immunology program? - The company is targeting good markets with high unmet medical needs and plans to announce the program later this year [116] Question: What is the financial guidance for operating expenses? - The company confirmed that the operating expense guidance remains at $100 million to $120 million for R&D and $45 million to $50 million for G&A [118]

Enanta Pharmaceuticals (ENTA) came out with a quarterly loss of $1.58 per share versus the Zacks Consensus Estimate of a loss of $1.18. This compares to loss of $1.39 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -33.90%. A quarter ago, it was expected that this biotechnology company would post a loss of $2.11 per share when it actually produced a loss of $1.33, delivering a surprise of 36.97%.Over the last four quarters, th ...