Core Insights - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1: Service Offerings - Biotech Analysis Central offers a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - The service is available for $49 per month, with a discounted annual plan at $399, representing a 33.50% savings [1]. Group 2: Analyst Background - The author of the article runs the Biotech Analysis Central service and emphasizes the depth of analysis provided to help healthcare investors make informed decisions [2]. - The article does not indicate any personal investment positions in the companies mentioned, ensuring an unbiased perspective [3].

Core Insights - Protagonist Therapeutics, Inc. (PTGX) announced positive top-line data from the phase IIb ANTHEM-UC study for icotrokinra, a targeted oral peptide for treating moderately to severely active ulcerative colitis (UC) [1][2] - The study met its primary endpoint of clinical response across all icotrokinra dose groups, with significant improvements in secondary endpoints [2][4] - Following the announcement, PTGX shares surged by 45.9% on March 10, and the stock has increased by 87.4% over the past year, contrasting with an 8.5% decline in the industry [2][3] Study Details - The ANTHEM-UC study was a randomized, placebo-controlled trial evaluating three once-daily oral dosages of icotrokinra in patients with inadequate response or intolerance to conventional therapy [4] - The highest dose of icotrokinra achieved a response rate of 63.5% compared to 11.1% for placebo, with 30.2% of patients in the highest dose group showing clinical remission at week 12 [5] Partnership and Development - Icotrokinra was jointly discovered by Protagonist and Johnson & Johnson (JNJ), with JNJ holding exclusive worldwide rights for further development [6][7] - Icotrokinra is also being investigated in the pivotal phase III ICONIC clinical program for moderate-to-severe plaque psoriasis and active psoriatic arthritis [7] Additional Studies - Recent data from the phase III ICONIC-LEAD study indicated that nearly half of patients with moderate-to-severe psoriasis treated with icotrokinra achieved completely clear skin at week 24 [8] - In the phase III ICONIC-ADVANCE 1&2 studies, icotrokinra demonstrated superiority over Bristol Myers' Sotyktu, leading to plans for a head-to-head study against JNJ's Stelara [9][10]

Financial Performance - The company has no approved products and has incurred a cumulative net loss since inception, anticipating significant future losses [19] - The company ended fiscal 2024 with cash, cash equivalents, and marketable securities of approximately $559.2 million, up from $341.6 million as of December 31, 2023 [30] Collaborations and Agreements - A worldwide license and collaboration agreement for rusfertide with Takeda was announced, including an upfront cash payment of $300.0 million and potential total deal value of up to $630.0 million [26] - The company is eligible for up to $330.0 million in development, regulatory, and sales milestones under the agreement with Takeda [26] - The company earned $165.0 million in milestone payments under the icotrokinra license and collaboration agreement with J&J, with future potential payments of up to $630.0 million [30] - A worldwide collaboration agreement for rusfertide with Takeda includes a $300 million upfront payment and potential milestone payments up to $330 million [36] - A worldwide license and collaboration agreement for rusfertide development was entered into with Takeda in January 2024 [80] - The company entered into an Amended and Restated License and Collaboration Agreement with JNJ on July 27, 2021, for the development and commercialization of oral IL-23 receptor antagonist drug candidates [129] Clinical Development and Trials - Positive topline results from the Phase 3 ICONIC studies of icotrokinra showed that 64.7% of patients achieved IGA scores of 0 or 1 at week 16 compared to 8.3% on placebo [30] - The icotrokinra Phase 2b FRONTIER 1 trial results were published in the New England Journal of Medicine, indicating significant efficacy in treating moderate-to-severe plaque psoriasis [26] - The company has two novel peptides, rusfertide and icotrokinra, currently in advanced Phase 3 clinical development, with NDA submissions potentially in 2025 [22] - Rusfertide is in Phase 3 development for Polycythemia Vera (PV) with a global trial of approximately 250 patients, expecting top-line data in March 2025 [32] - In the REVIVE Phase 2 trial, 54% of PV patients achieved durable hematocrit control (<45%) over 2.5 years, indicating decreased phlebotomy use and improved patient-reported outcomes [33] - Icotrokinra, an IL-23R antagonist, has shown significant efficacy in Phase 3 trials, with 64.7% of patients achieving IGA scores of 0 or 1 at week 16 [41] - The company plans to initiate a Phase 1 study for PN-881, an oral peptide IL-17 antagonist, in Q4 2025, targeting immune-mediated skin diseases [45] - An oral hepcidin mimetic development candidate is expected to be nominated in Q4 2025, complementing rusfertide for treating PV and related disorders [49] - The company anticipates topline results for the ANTHEM trial in Q1 2025 and for the ICONIC-ADVANCE trials in Q2 2025 [42] - The Phase 3 VERIFY trial for rusfertide includes a milestone payment of $25 million upon achieving the primary endpoint [38] - In the Phase 2 REVIVE trial, 69.2% of subjects receiving rusfertide were responders compared to 18.5% in the placebo group (p=0.0003) [62] - 92.3% of subjects on rusfertide during the randomized withdrawal phase were not phlebotomized [62] - The estimated mean phlebotomy rate in patients enrolled in the trial was over 5 per year, reduced to less than 1 per year for those receiving rusfertide [71] - 69% of rusfertide patients achieved hematocrit control and remained phlebotomy-free at 12 weeks compared to 19% on placebo (p=0.0003) [65] - The FDA granted orphan drug designation for rusfertide for the treatment of PV in June 2020 [78] - The company expects to announce top-line data for the Phase 3 VERIFY trial in the first quarter of 2025, potentially leading to an NDA filing in the fourth quarter of 2025 [75] - Icotrokinra achieved the primary and secondary efficacy endpoints in the FRONTIER 1 trial, with a statistically significant greater proportion of patients achieving PASI-75 responses compared to placebo [99] - Icotrokinra is projected to have peak year sales greater than $5.0 billion, with JNJ's IL-23 monoclonal antibody drugs generating approximately $14.1 billion in revenues in 2024 [100] - In the ICONIC-LEAD trial, 64.7% of patients treated with icotrokinra achieved IGA scores of 0/1 at week 16, compared to 8.3% on placebo, and 49.6% achieved PASI 90, compared to 4.4% on placebo [103] - The ICONIC-TOTAL trial also showed that icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo [105] - PN-881, a potential best-in-class oral peptide IL-17 antagonist, is expected to begin Phase 1 clinical studies in Q4 2025 [112] - JNJ initiated six additional icotrokinra trials in psoriasis and one in ulcerative colitis (UC) [102] Market Opportunities - Approximately 155,000 diagnosed patients in the U.S. with an estimated market opportunity of $1.0 billion to $2.0 billion for PV treatments [53] - 78% of treated PV patients did not maintain hematocrit control below the recommended 45%, indicating a significant unmet need [52] - Global market sales for psoriasis therapies in 2023 were $24.9 billion, with U.S. market sales of $18.4 billion [84] - The global market forecast for psoriasis therapies anticipates sales of $32.0 billion by 2033, with U.S. market sales of $23.8 billion [84] - Global market sales for hidradenitis suppurativa (HS) therapies in 2024 were $1.5 billion, with U.S. market sales of $1.2 billion [88] - The global market forecast for HS therapies anticipates sales of $6.5 billion by 2034, with U.S. market sales of $5.4 billion [88] - Global market sales for axial spondyloarthritis (axSpA) therapies in 2024 were $7.5 million, with U.S. market sales of $6.0 million [89] - The global market forecast for axSpA therapies anticipates sales of $10.7 million by 2034, with U.S. market sales of $8.7 million [89] - In 2023, global sales for ulcerative colitis (UC) therapies were approximately $7.8 billion, expected to grow to $13.2 billion by 2030 [92] - In 2023, global sales for Crohn's disease (CD) therapies were estimated to be $15.2 billion, with anticipated growth to $18.1 billion by 2030 [92] - Stelara® generated $10.4 billion in sales in 2024, while Tremfya® generated $3.7 billion in sales in the same year [97] Regulatory Environment - The FDA has a target of ten months to review and act on a standard NDA for a new molecular entity, with a typical review taking twelve months from submission [150] - The FDA may issue a complete response letter requiring additional clinical or pre-clinical testing before reconsidering a new drug application (NDA) [158] - Orphan designation provides financial incentives such as grant funding opportunities and user-fee waivers for drugs intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S. [164] - The FDA may grant breakthrough therapy designation to drugs showing substantial improvement over existing therapies, allowing for accelerated approval and priority review [166] - Post-approval requirements may include mandatory Phase 4 clinical trials and ongoing compliance with cGMP regulations [168] - The FDA strictly regulates marketing and promotion of drugs, allowing promotion only for approved indications [172] - Coverage and reimbursement for drug products can vary significantly among third-party payors, affecting market acceptance and sales [174] - The FDA may withdraw approval if compliance with regulatory requirements is not maintained after a product reaches the market [171] - The FDA may require post-marketing studies to assess new safety risks, which can materially affect the product's market potential [159] - Federal and state legislatures are increasingly implementing regulations to control pharmaceutical pricing, which may limit revenue generation and profitability [181] - Future healthcare reform measures could impose price controls and cost-containment strategies, affecting the commercialization of product candidates [184] - The company is subject to various healthcare regulations, including HIPAA and anti-kickback statutes, which could lead to significant penalties for non-compliance [188] - The centralized procedure for drug marketing authorization in the EU requires a single application valid across all EU Member States, with a typical evaluation timeframe of 210 days [198] - Medicines authorized under the centralized procedure must meet quality, safety, and efficacy requirements, with the possibility of accelerated assessment in cases of major public health interest [198] - The company must submit a Risk Management Plan (RMP) for new marketing authorization applications, which is updated throughout the product's lifecycle [201] - Non-compliance with GDPR can result in fines up to €20 million or 4% of annual global revenues, whichever is greater [206] Corporate Governance and Ethics - The Board of Directors oversees strategic direction and risk management related to sustainability and corporate responsibility [207] - The company is committed to high standards of business conduct and ethics, including policies on bribery and corruption [208] - Environmental commitment includes protocols for handling biohazardous waste and promoting resource conservation [209] Workforce and Employee Relations - As of December 31, 2024, the total global workforce consisted of 126 full-time equivalent employees, with 98 in research and development [214] - The company has a good relationship with its employees, with none represented by a labor union or covered by a collective bargaining agreement [214] - The employee turnover rate for the year ended December 31, 2024, was approximately 11% [215] - The company covers 100% of its U.S. employees' monthly healthcare premiums [215] - Competitive compensation packages include performance-based incentives, equity awards, and robust benefits [215] - The company has 117 employees located in the United States and 9 in Australia [214] - The focus is on attracting, developing, and retaining talented employees to support business growth [215] - The company invests in fostering a supportive and inclusive workplace for its employees [213] - The recruitment and retention processes are designed to attract individuals with necessary expertise and innovative drive [215] - The company supports educational efforts related to therapeutic areas and life sciences education [211]

分组1 - Protagonist Therapeutics (PTGX) reported quarterly earnings of $1.98 per share, significantly exceeding the Zacks Consensus Estimate of $0.06 per share, and showing a substantial increase from $0.44 per share a year ago, resulting in an earnings surprise of 3,200% [1] - The company achieved revenues of $170.64 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 202.56%, compared to $60 million in the same quarter last year [2] - Protagonist Therapeutics has outperformed consensus EPS estimates three times over the last four quarters and has topped consensus revenue estimates two times during the same period [2] 分组2 - The stock has underperformed the market with a loss of about 0.3% since the beginning of the year, while the S&P 500 has gained 4% [3] - The current consensus EPS estimate for the upcoming quarter is $0.58 on revenues of $88.02 million, and for the current fiscal year, it is -$0.64 on revenues of $163.2 million [7] - The Medical - Biomedical and Genetics industry, to which Protagonist Therapeutics belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]

Financial Performance - Protagonist earned a $165.0 million milestone from icotrokinra in Q4 2024, received in January 2025[1] - Net income for Q4 2024 was $131.7 million, or $2.11 per basic share, compared to $27.3 million, or $0.45 per basic share in Q4 2023[17] - License and collaboration revenue increased from $60.0 million in 2023 to $434.4 million in 2024, a growth of $374.4 million[14] - Total revenue from the Takeda Agreement was $269.4 million for the year ended December 31, 2024[16] - License and collaboration revenue for Q4 2024 was $170.638 million, a significant increase from $60 million in Q4 2023[23] - Net income for Q4 2024 was $131.674 million, compared to a net income of $27.335 million in Q4 2023, representing a 382.5% increase[23] - The company reported a diluted net income per share of $4.23 for the twelve months ended December 31, 2024, compared to a loss of $(1.39) per share in 2023[23] Cash and Equity - Cash, cash equivalents, and marketable securities totaled $559.2 million as of December 31, 2024, up from $341.6 million the previous year[13] - Cash, cash equivalents, and marketable securities as of December 31, 2024, totaled $559.165 million, up from $341.617 million in 2023, indicating a 63.8% increase[27] - Total stockholders' equity increased to $675.295 million as of December 31, 2024, compared to $336.677 million in 2023, reflecting a 100.6% growth[27] - The accumulated deficit decreased to $(340.522) million in 2024 from $(615.710) million in 2023, showing an improvement of 44.6%[27] - Interest income for the twelve months ended December 31, 2024, was $26.315 million, compared to $14.898 million in 2023, a 76.5% increase[23] Research and Development - Protagonist's research and development expenses increased by $18.0 million for the full year 2024 compared to the previous year, primarily due to drug discovery and pre-clinical research[14] - Research and development expenses for the twelve months ended December 31, 2024, were $138.128 million, an increase from $120.161 million in 2023, marking a 14.9% rise[23] - Total stock-based compensation expense for the twelve months ended December 31, 2024, was $37.554 million, up from $29.293 million in 2023, representing a 28.2% increase[25] Clinical Trials and Development - The Phase 3 VERIFY trial results for rusfertide in polycythemia vera are expected in March 2025[2] - Topline results for the Phase 2b ANTHEM trial of icotrokinra in ulcerative colitis are also expected in March 2025[11] - PN-881, a potential best-in-class oral IL-17 receptor antagonist, was nominated as a development candidate in Q4 2024[1] - The company plans to nominate an oral peptide-based development candidate in the obesity program in Q2 2025[12] Operating Expenses - Total operating expenses for Q4 2024 were $43.858 million, up from $36.951 million in Q4 2023, reflecting a 18.5% increase[23]

Protagonist Therapeutics (PTGX) Update / Briefing February 06, 2025 10:30 AM ET Speaker0 Good morning, everybody. Thanks for joining us. I'm Corey Davis with LifeSci Advisors. Welcome to our PV Day with Protagonist Therapeutics to review the current PV market and set the stage for the upcoming Phase III data that are expected in March. We have got two KOLs and a number of company executives to walk through what I hope will be a scintillating presentation. We've got about 40 people in the room and over 100 p ...

Company Update - Protagonist Therapeutics (NASDAQ: PTGX) is preparing to report top-line results from its phase 3 VERIFY study for rusfertide (PTG-300), a subcutaneous injectable Hepcidin Mimetic, targeting Polycythemia Vera (PV) patients [1] Author Background - The article is authored by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace [4] - Biotech Analysis Central offers a library of 600+ biotech investing articles, a model portfolio of 10+ small and mid-cap stocks with deep analysis, live chat, and analysis/news reports for healthcare investors [1] Subscription Details - Biotech Analysis Central SA marketplace subscription costs $49 per month [4] - A yearly subscription plan offers a 33.50% discount, reducing the price to $399 per year [4] - A two-week free trial period is currently available for new subscribers [4]

Core Viewpoint - Protagonist Therapeutics (PTGX) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks rating system is primarily based on changes in a company's earnings picture, with the Zacks Consensus Estimate tracking EPS estimates from sell-side analysts [2]. - For the fiscal year ending December 2024, Protagonist Therapeutics is expected to earn $2.33 per share, reflecting a substantial increase of 267.6% from the previous year [9]. - Over the past three months, the Zacks Consensus Estimate for Protagonist Therapeutics has risen by 12.4%, indicating a positive trend in earnings estimates [9]. Impact of Institutional Investors - Changes in earnings estimates are strongly correlated with stock price movements, with institutional investors using these estimates to determine the fair value of shares [5]. - The buying and selling activities of institutional investors based on earnings estimates can lead to significant price movements in stocks [5]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [8]. - Protagonist Therapeutics' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [11].

Core Viewpoint - Protagonist Therapeutics reported a quarterly loss of $0.54 per share, which was better than the Zacks Consensus Estimate of a loss of $0.59, indicating an earnings surprise of 8.47% [1][2] Financial Performance - The company posted revenues of $4.68 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 3.89%, compared to zero revenues a year ago [2] - Over the last four quarters, Protagonist Therapeutics has exceeded consensus EPS estimates three times [2] Stock Performance - Protagonist Therapeutics shares have increased approximately 107.6% since the beginning of the year, significantly outperforming the S&P 500's gain of 24.3% [3] Future Outlook - The company's earnings outlook will be crucial for determining future stock movements, with current consensus EPS estimates at $0.09 on $60.2 million in revenues for the upcoming quarter and $2.80 on $308.15 million in revenues for the current fiscal year [7] - The estimate revisions trend for Protagonist Therapeutics is currently mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Protagonist Therapeutics belongs, is currently ranked in the top 36% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Drug Development - The company has two peptide-based new chemical entities, rusfertide and JNJ-2113, in advanced Phase 3 stages of development[86]. - Rusfertide is in a global Phase 3 trial (VERIFY) for polycythemia vera with approximately 250 patients, and top-line data is expected in Q1 2025[87]. - In the REVIVE trial, rusfertide showed a responder rate of 69.2% compared to 18.5% for placebo (p=0.0003) in maintaining hematocrit control without phlebotomy[90]. - JNJ-2113 is being evaluated in multiple Phase 3 trials for moderate-to-severe plaque psoriasis, with topline results expected in Q4 2024 and Q1 2025[96][97]. - JNJ-2113 Phase 2b FRONTIER trials demonstrated promising efficacy and safety for moderate-to-severe plaque psoriasis, maintaining high skin clearance rates through 52 weeks[101]. - The company expects to file a New Drug Application (NDA) for rusfertide in Q4 2025 following the VERIFY trial results[87]. - The ongoing two-year carcinogenicity study for rusfertide is expected to yield results by the end of 2024[87]. - The company expects to nominate a development candidate for a new oral IL-17 peptide antagonist program by the end of 2024[105]. - The company expects to nominate a development candidate from its discovery platform for IND-enabling studies by the end of 2024[130]. Financial Performance - The company incurred cumulative net losses of $472.2 million from inception through September 30, 2024, primarily due to research and development costs[108]. - The net loss for the three months ended September 30, 2024, was $33.21 million, a slight improvement from a net loss of $34.11 million in the previous year[125]. - License and collaboration revenue for the three months ended September 30, 2024, was $4.675 million, a significant increase compared to the previous period[125]. - License and collaboration revenue increased from $0 for the nine months ended September 30, 2023 to $263.8 million for the nine months ended September 30, 2024, primarily due to the Takeda Collaboration Agreement[139]. - Research and development expenses increased by 17% to $35.97 million for the three months ended September 30, 2024, compared to $30.66 million in the same period last year[125]. - Research and development expenses increased by $12.0 million, or 13%, from $91.3 million for the nine months ended September 30, 2023 to $103.2 million for the nine months ended September 30, 2024[141]. - General and administrative expenses rose by 33% to $10.16 million for the three months ended September 30, 2024, compared to $7.66 million in the prior year[125]. - General and administrative expenses increased by $9.1 million, or 36%, from $25.4 million for the nine months ended September 30, 2023 to $34.5 million for the nine months ended September 30, 2024[143]. - Interest income increased by 81% to $7.68 million for the three months ended September 30, 2024, compared to $4.25 million in the same period last year[125]. - Interest income increased by $8.8 million, or 83%, from $10.6 million for the nine months ended September 30, 2023 to $19.5 million for the nine months ended September 30, 2024, primarily due to higher invested balances[147]. - The effective tax rate was 1.53% for the nine months ended September 30, 2024, compared to 0% for the same period in 2023[148]. Collaboration and Milestones - The company received a one-time upfront payment of $300 million from Takeda for the rusfertide collaboration, with potential milestone payments of up to $330 million[93]. - The company shares profits and losses equally with Takeda for rusfertide in the U.S. market[94]. - The company received a $50 million milestone payment from JNJ upon dosing the third patient in the ICONIC-TOTAL Phase 3 trial in late October 2023, totaling $172.5 million in non-refundable payments earned to date[102]. - Future milestone payments from JNJ could reach approximately $795 million, including $115 million for meeting co-primary endpoints in ICONIC Phase 3 trials and $35 million upon NDA filing with the FDA[102]. - Upcoming potential milestones under the Takeda Collaboration Agreement include $25.0 million for achieving primary endpoints in the Phase 3 VERIFY trial and $50.0 million upon FDA approval of rusfertide[156]. - A milestone payment of $50.0 million was earned upon dosing the third patient in the ICONIC-TOTAL Phase 3 trial in October 2023, with total non-refundable payments from JNJ amounting to $172.5 million since 2017[157]. Cash and Funding - The company had $583.3 million in cash, cash equivalents, and marketable securities as of September 30, 2024, compared to $341.6 million as of December 31, 2023[149]. - Cash provided by operating activities for the nine months ended September 30, 2024 was $213.3 million, primarily due to a net income of $143.5 million and a $300.0 million payment from Takeda[164]. - Cash used in investing activities for the nine months ended September 30, 2024 was $290.8 million, mainly from purchases of marketable securities totaling $507.3 million[165]. - Cash provided by financing activities for the nine months ended September 30, 2024 was $21.8 million, a decrease of $148.1 million compared to the same period in 2023[166]. - The company may require additional funding to advance its early discovery pipeline and develop new product candidates, depending on various factors including clinical trial progress and commercialization success[160]. - An immediate 100 basis point increase in interest rates would increase the company's annual interest income by approximately $3.4 million[173].