Financial Position - As of December 31, 2024, the company had $216.7 million in cash, cash equivalents, and short-term marketable securities, expected to fund operations into fiscal 2028[72]. - The company received a $200 million cash payment in April 2023 from a royalty sale agreement, which will impact future royalty payments[81][100]. - The company has funded operations primarily through royalty payments from AbbVie and the $200 million received from the royalty sale agreement, enabling funding into fiscal 2028[85]. - Cash used in operating activities was $16.8 million for the three months ended December 31, 2024, a decrease of $8.2 million compared to $25.0 million for the same period in 2023[110]. - Cash provided by investing activities was $68.9 million for the three months ended December 31, 2024, an increase of $82.0 million compared to cash used in investing activities of $13.1 million for the same period in 2023[112]. - Cash used in financing activities decreased by $2.4 million to $5.0 million for the three months ended December 31, 2024, compared to $7.4 million for the same period in 2023[113]. - Total estimated minimum lease payments for the next five years are projected to be $6.7 million for 2025, $8.5 million for 2026, $8.7 million for 2027, $9.0 million for 2028, and $9.3 million for 2029[120]. Research and Development - The company is developing two clinical stage product candidates for RSV: zelicapavir and EDP-323, both of which have received Fast Track designation from the FDA[74]. - Zelicapavir demonstrated a viral load decline of 1.0 log at Day 3 and 1.4 log at Day 5 in a Phase 2 study, with a favorable safety profile observed across all age groups[75]. - EDP-323 achieved statistically significant reductions in viral load and clinical symptoms in a Phase 2a challenge study, with a p-value of <0.0001 compared to placebo[76]. - EDP-235, an oral inhibitor targeting SARS-CoV-2, showed a dose-dependent improvement in total symptom score, achieving statistical significance (p<0.05) in the 400 mg treatment group[76]. - The company plans to select a lead development candidate for oral STAT6 inhibitors in the second half of 2025, focusing on type 2 immune-driven diseases[76]. - The company has ongoing development programs targeting chronic spontaneous urticaria (CSU) and atopic dermatitis (AD), with CSU affecting approximately 1.75-3.5 million people in the U.S.[70][71]. - The company expects to complete enrollment for a Phase 2b study of zelicapavir in high-risk adults by the end of the current Northern Hemisphere RSV season, with topline data expected in Q3 2025[75]. - The company is focusing on collaborations to progress EDP-235 into Phase 3 studies, as it will not advance this candidate independently[77]. - The company has identified novel oral KIT inhibitors for preclinical development, with a lead candidate selected in Q4 2024[77]. - The company plans to expand its presence in immunology with the introduction of a third program in 2025[78]. - The company is conducting a Phase 2b study of zelicapavir in high-risk adults and has completed a Phase 2b study in pediatric patients[83]. Expenses and Revenue - Royalty revenue for the three months ended December 31, 2024, was $16.96 million, a decrease of $1.04 million from $18.00 million in the same period of 2023[86][98]. - Research and development expenses for the three months ended December 31, 2024, decreased by $8.7 million to $27.66 million compared to $36.37 million in the same period of 2023[101]. - The company expects a reduction in external research and development expenses in the next 12 months, primarily due to the completion of key studies[84][91]. - The total revenue recognized for the three months ended December 31, 2024, was $16.96 million, attributed to AbbVie's lower reported HCV sales compared to the previous year[98]. - Research and development expenses in the virology program decreased by $9 million, mainly due to the timing of clinical trials[102]. - Immunology program costs increased by $2.5 million due to scale-up and IND-enabling activities related to the KIT program and initiation of preclinical studies for the STAT6 program[103]. - Other program costs decreased by $2.2 million due to the completion of discovery and optimization activities related to the STAT6 program[104]. - General and administrative expenses decreased by $3.7 million for the three months ended December 31, 2024, primarily due to a decrease in legal expenses related to a patent infringement suit against Pfizer[105]. - Interest expense decreased by $1.5 million for the three months ended December 31, 2024, due to the paydown of obligations associated with a royalty sale agreement[106].

Financial Performance - Enanta Pharmaceuticals reported a quarterly loss of $1.05 per share, which was better than the Zacks Consensus Estimate of a loss of $1.16, representing an earnings surprise of 9.48% [1] - The company posted revenues of $16.96 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 5.93%, although this is a decrease from $18 million in the same quarter last year [2] - Over the last four quarters, Enanta has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Performance - Enanta Pharmaceuticals shares have declined approximately 14.8% since the beginning of the year, contrasting with the S&P 500's gain of 2.5% [3] - The current Zacks Rank for Enanta is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Future Outlook - The consensus EPS estimate for the upcoming quarter is -$1.37 on revenues of $15.6 million, and for the current fiscal year, it is -$5.05 on revenues of $64.77 million [7] - The outlook for the Medical - Drugs industry, to which Enanta belongs, is currently in the top 34% of over 250 Zacks industries, suggesting a favorable environment for stock performance [8]

Financial Performance - Total revenue for the fiscal first quarter ended December 31, 2024, was $17.0 million, a decrease from $18.0 million in the same period of 2023, primarily due to a decline in AbbVie's sales of MAVYRET®/MAVIRET®[4] - Net loss for the three months ended December 31, 2024, was $22.3 million, or a loss of $1.05 per diluted common share, compared to a net loss of $33.4 million, or a loss of $1.58 per diluted common share, for the same period in 2023[10] Expenses - Research and development expenses decreased to $27.7 million for the three months ended December 31, 2024, from $36.4 million in the same period of 2023, attributed to timing of clinical trials in the RSV program[6] - General and administrative expenses were $12.8 million for the three months ended December 31, 2024, down from $16.5 million in the same period of 2023, due to reduced legal expenses related to a patent infringement lawsuit[7] - Interest expense for the three months ended December 31, 2024, was $2.0 million, down from $3.4 million in the same period of 2023[5] Cash and Assets - Cash, cash equivalents, and short-term marketable securities totaled $216.7 million at December 31, 2024, expected to support operations into fiscal year 2028[11] - Cash and cash equivalents increased significantly from $37,233 million in September 2024 to $84,349 million in December 2024, representing a growth of 126.5%[22] - Total current assets decreased from $299,852 million in September 2024 to $268,145 million in December 2024, a decline of approximately 10.6%[22] - Property and equipment, net increased from $32,688 million in September 2024 to $37,368 million in December 2024, a growth of about 14.0%[22] - Short-term marketable securities decreased from $210,953 million in September 2024 to $132,342 million in December 2024, a decline of approximately 37.3%[22] Liabilities - Total liabilities decreased from $247,838 million in September 2024 to $236,826 million in December 2024, a reduction of about 4.5%[22] - Accounts payable decreased from $8,002 million in September 2024 to $4,726 million in December 2024, a decrease of about 41.4%[22] - Accrued expenses and other current liabilities decreased from $13,547 million in September 2024 to $10,575 million in December 2024, a decline of approximately 22.8%[22] - Liability related to the sale of future royalties decreased from $34,462 million in September 2024 to $32,743 million in December 2024, a reduction of about 5.0%[22] - Operating lease liabilities increased slightly from $1,524 million in September 2024 to $1,006 million in December 2024, a decrease of approximately 34.0%[22] Future Developments - Enanta is on track to report topline results for RSVHR, a Phase 2 study of zelicapavir, in the third quarter of 2025[3] - The company plans to announce a lead development candidate for its STAT6 program in the second half of 2025[3] - Enanta aims to develop a first-in-disease and best-in-class RSV antiviral treatment portfolio, with both zelicapavir and EDP-323 in clinical development[13] Royalty Revenue - A portion (54.5%) of ongoing royalty revenue from AbbVie's net sales of MAVYRET®/MAVIRET® is paid to OMERS, with a liability of $200.0 million recorded for the royalty sale transaction[5]

Company Overview - Enanta Pharmaceuticals is a biotechnology company focused on developing small-molecule drugs for viral infections, with its lead candidate being zelicapavir, an oral N-protein inhibitor currently in midstage studies for treating respiratory syncytial virus infection in both pediatric and adult patients [1][5]. Stock Performance - Enanta Pharmaceuticals' shares experienced a rally of 7.2% in the last trading session, closing at $6.28, which is notable given the stock's 37.1% loss over the previous four weeks [4]. - The stock currently holds a Zacks Rank of 3 (Hold), indicating a neutral outlook [1][7]. Earnings Expectations - The company is expected to report a quarterly loss of $1.15 per share, reflecting a year-over-year change of +27.2%, while revenues are projected to be $17.51 million, down 2.7% from the same quarter last year [5]. - The consensus EPS estimate for the upcoming quarter has been revised 7.3% higher over the last 30 days, suggesting a positive trend that may lead to price appreciation [6]. Industry Context - Enanta Pharmaceuticals is part of the Zacks Medical - Drugs industry, which includes other companies such as Neurocrine Biosciences, whose stock has shown a return of 8% over the past month [3].

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]

The stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> Enanta Pharmaceuticals (ENTA) shares rallied 6.7% in the last trading session to close at $16. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 11.6% gain over the past four weeks. Enanta Pharmaceuticals is a member of the Zacks Medical - Drugs industry. One other stock in th ...

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]