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]

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].

Financial Position - Cash, cash equivalents, and marketable securities totaled $583.3 million as of September 30, 2024, up from $341.6 million as of December 31, 2023, indicating a strong cash position[7] - Working capital increased to $432,191 thousand as of September 30, 2024, compared to $334,303 thousand at the end of 2023, indicating a 29% growth[18] - Total assets reached $603,857 thousand as of September 30, 2024, up from $357,951 thousand at the end of 2023, marking a 68% increase[18] - The accumulated deficit improved to $(472,196) thousand as of September 30, 2024, from $(615,710) thousand at the end of 2023, showing a reduction of approximately 23%[18] - Total stockholders' equity increased to $531,915 thousand as of September 30, 2024, compared to $336,677 thousand at the end of 2023, reflecting a 58% rise[18] Revenue and Collaboration - License and collaboration revenue for the nine months ended September 30, 2024, was $263.8 million, primarily from a $300 million upfront payment from the Takeda Collaboration Agreement[9] - The company recognized $4.7 million of deferred revenue during the third quarter of 2024 based on costs incurred[9] - Deferred revenue stood at $36,205 thousand as of September 30, 2024, with no deferred revenue reported at the end of 2023[18] Expenses - Research and development expenses increased by $5.3 million for the three months ended September 30, 2024, compared to the prior year, driven by higher drug discovery and pre-clinical research costs[10] - General and administrative expenses rose by $2.5 million for the three months ended September 30, 2024, primarily due to increases in stock-based compensation and personnel-related expenses[11] - Research and development stock-based compensation for the three months ended September 30, 2024, was $5,212 thousand, up from $3,780 thousand for the same period in 2023, representing a 38% increase[17] - Total stock-based compensation expense for the nine months ended September 30, 2024, was $28,461 thousand, compared to $22,692 thousand for the same period in 2023, reflecting a 25% increase[17] Net Loss - The net loss for the three months ended September 30, 2024, was $33.2 million, or $0.54 per share, compared to a net loss of $34.1 million, or $0.58 per share, for the same period in 2023[12] Clinical Trials and Development - Top line results for JNJ-2113 Phase 3 ICONIC-LEAD and ICONIC-TOTAL clinical trials in psoriasis are expected in Q4 2024[1] - Top line results for rusfertide Phase 3 VERIFY clinical trial in polycythemia vera are anticipated in Q1 2025[3] - The company expects to nominate a development candidate for an oral IL-17 peptide antagonist in Q4 2024[5] - The company is pursuing the discovery of novel oral peptides targeting various diseases, with additional candidates expected to be nominated in 2025[5]

Clinical Trials and Drug Development - Rusfertide is in a Phase 3 trial (VERIFY) for polycythemia vera with 250 patients enrolled, expecting top-line data in Q1 2025 and potential NDA filing in Q4 2025[78]. - The Phase 2 REVIVE trial showed rusfertide significantly reduced the need for phlebotomy, with 69.2% of subjects responding compared to 18.5% for placebo (p=0.0003)[81]. - Long-term follow-up from the REVIVE trial indicated durable hematocrit control and no new safety signals in patients with polycythemia vera[83]. - The VERIFY trial for rusfertide has completed enrollment, with results from a two-year carcinogenicity study expected by the end of 2024[78]. - The PACIFIC Phase 2 trial for rusfertide indicated improvements in iron deficiency markers in patients with polycythemia vera[83]. - JNJ-2113, an oral IL-23 receptor antagonist, is undergoing multiple Phase 3 trials for plaque psoriasis, with a peak sales projection exceeding $5 billion[89]. - The Phase 2b FRONTIER 1 trial for JNJ-2113 achieved primary and secondary endpoints, showing significant improvement in skin lesions compared to placebo[87]. - JNJ-2113's potential across multiple indications includes plaque psoriasis, psoriatic arthritis, and inflammatory bowel disease, with significant market potential[89]. Financial Performance and Revenue - Cumulative net losses from inception through June 30, 2024, amounted to $439.0 million, primarily due to research and development costs[95]. - License and collaboration revenue increased from $0 for the three months ended June 30, 2023, to $4.2 million for the three months ended June 30, 2024[111]. - The company earned a $50.0 million milestone payment upon dosing the third patient in the ICONIC-TOTAL Phase 3 trial in late October 2023, received in December 2023[90]. - The company is eligible for up to approximately $795.0 million in future development and sales milestone payments from JNJ[90]. - License and collaboration revenue surged to $259.1 million for the six months ended June 30, 2024, compared to $0 for the same period in 2023, primarily due to the Takeda Collaboration Agreement[118]. - Net income for the six months ended June 30, 2024, was $176.7 million, a significant increase from a net loss of $72.2 million for the same period in 2023[120]. - Cash provided by operating activities for the six months ended June 30, 2024, was $241.2 million, primarily due to a net income of $176.7 million and a $300.0 million upfront payment from Takeda[140]. Research and Development Expenses - Research and development expenses for the three months ended June 30, 2024, were $33.5 million, a slight increase from $33.2 million in the same period of 2023[109]. - Research and development expenses increased by $0.3 million, or 1%, from $33.2 million for the three months ended June 30, 2023, to $33.5 million for the three months ended June 30, 2024[112]. - Total research and development expenses for the six months ended June 30, 2024, were $67.3 million, an increase of $6.7 million, or 11%, compared to $60.6 million for the same period in 2023[120]. - The company anticipates an increase in research and development expenses in the near term as it progresses its rusfertide program and pre-clinical research[106]. - Research and development personnel-related expenses increased by $1.3 million for the three months ended June 30, 2024, compared to the same period in 2023[114]. Cash and Funding - The company had $595.4 million in cash, cash equivalents, and marketable securities as of June 30, 2024, compared to $341.6 million at the end of 2023[125]. - The company expects its existing cash and marketable securities to be sufficient to fund operations for at least the next twelve months[136]. - The company may require additional funding to advance its early discovery pipeline and develop new product candidates[136][138]. - Cash used in investing activities for the six months ended June 30, 2024, was $82.0 million, mainly due to purchases of marketable securities[141]. - An immediate 100 basis point increase in interest rates would increase the company's annual interest income by approximately $4.7 million[146]. Collaborations and Milestones - A collaboration with Takeda for rusfertide includes a $300 million upfront payment and potential milestone payments up to $330 million, with royalties of 10% to 17% on ex-U.S. net sales[84][85]. - The company is eligible for additional milestones under the Takeda Collaboration Agreement, including $25.0 million for achieving the primary endpoint in the Phase 3 VERIFY trial and up to $75.0 million upon FDA approval of rusfertide[132][134]. - The company has received $172.5 million in nonrefundable payments from JNJ to date[90]. - Upcoming potential milestones under the JNJ License and Collaboration Agreement include $115.0 million for a Phase 3 trial and $50.0 million upon FDA approval of a second-generation compound[134].

Core Insights - Protagonist Therapeutics reported a quarterly loss of $0.50 per share, which aligns with the Zacks Consensus Estimate, showing an improvement from a loss of $0.68 per share a year ago [1] - The company posted revenues of $4.17 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 89.58%, compared to zero revenues a year ago [2] - Protagonist Therapeutics shares have increased approximately 56.1% since the beginning of the year, significantly outperforming the S&P 500's gain of 8.7% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.64 on $5 million in revenues, while for the current fiscal year, it is $2.24 on $303.73 million in revenues [7] - The estimate revisions trend for Protagonist Therapeutics is mixed, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance 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 in the top 37% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]