Enanta Pharmaceuticals(ENTA)

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Does Enanta Pharmaceuticals (ENTA) Have the Potential to Rally 189.58% as Wall Street Analysts Expect?
ZACKS· 2025-05-15 15:00
Shares of Enanta Pharmaceuticals (ENTA) have gained 5.1% over the past four weeks to close the last trading session at $5.18, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $15 indicates a potential upside of 189.6%.The mean estimate comprises six short-term price targets with a standard deviation of $7.27. While the lowest estimate of $5 indicates a 3.5% decline from the curre ...
Enanta Pharmaceuticals(ENTA) - 2025 Q2 - Quarterly Report
2025-05-14 20:00
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, 2025 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. (Exact name of registrant as specified in its charter) DELAWARE 04-3205099 (State or other jurisdiction of incorporation or organization) ...
Enanta Pharmaceuticals (ENTA) Reports Q2 Loss, Misses Revenue Estimates
ZACKS· 2025-05-12 22:10
Group 1 - Enanta Pharmaceuticals reported a quarterly loss of $1.06 per share, slightly worse than the Zacks Consensus Estimate of a loss of $1.04, but an improvement from a loss of $1.47 per share a year ago, indicating an earnings surprise of -1.92% [1] - The company posted revenues of $14.93 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 8.71%, and down from $17.05 million in the same quarter last year [2] - Enanta Pharmaceuticals shares have declined approximately 8.4% since the beginning of the year, compared to a decline of 3.8% for the S&P 500 [3] Group 2 - The earnings outlook for Enanta Pharmaceuticals is mixed, with the current consensus EPS estimate for the upcoming quarter at -$1.15 on revenues of $16.34 million, and for the current fiscal year at -$3.90 on revenues of $64.44 million [7] - The Zacks Industry Rank for Medical - Drugs is currently in the top 27% of over 250 Zacks industries, suggesting that the industry outlook can significantly impact stock performance [8] - Plus Therapeutics, another company in the same industry, is expected to report a quarterly loss of $0.17 per share, reflecting a year-over-year change of +77.3%, with revenues projected to be $1.85 million, up 10.1% from the previous year [9]
Enanta Pharmaceuticals(ENTA) - 2025 Q2 - Quarterly Results
2025-05-12 20:05
Exhibit 99.1 Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2025 WATERTOWN, Mass., May 12, 2025 – Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today reported financial results for its fiscal second quarter ended March 31, 2025. "Throughout the fiscal second quarter, Enanta remained squarely focused on executing across our virology a ...
Enanta Pharmaceuticals (ENTA) Moves to Buy: Rationale Behind the Upgrade
ZACKS· 2025-02-14 18:06
Core Viewpoint - Enanta Pharmaceuticals (ENTA) has received an upgrade to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are closely correlated with near-term stock price movements [4][6]. - Institutional investors often rely on earnings estimates to determine the fair value of a company's shares, leading to buying or selling actions that affect stock prices [4]. Recent Performance of Enanta Pharmaceuticals - Enanta Pharmaceuticals is projected to earn -$4.65 per share for the fiscal year ending September 2025, reflecting a year-over-year change of 15.2% [8]. - Over the past three months, the Zacks Consensus Estimate for Enanta has increased by 7.3%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - The upgrade of Enanta Pharmaceuticals to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].
Enanta Pharmaceuticals(ENTA) - 2025 Q1 - Quarterly Report
2025-02-12 21:00
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].
Enanta Pharmaceuticals (ENTA) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-02-10 23:11
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]
Enanta Pharmaceuticals(ENTA) - 2025 Q1 - Quarterly Results
2025-02-10 21:05
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]
Enanta Pharmaceuticals (ENTA) Moves 7.2% Higher: Will This Strength Last?
ZACKS· 2024-12-23 15:46
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].
Enanta Pharmaceuticals(ENTA) - 2024 Q4 - Annual Report
2024-11-27 13:35
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].