Core Viewpoint - Kiniksa Pharmaceuticals International, plc will host a conference call on October 28, 2025, to discuss its third quarter 2025 financial results and recent portfolio execution [1]. Group 1: Conference Call Details - The conference call is scheduled for 8:30 a.m. Eastern Time on October 28, 2025 [1]. - A live webcast will be available on the company's website, and participants can register for telephone access [2]. - A replay of the event will be accessible on Kiniksa's website approximately 48 hours after the call [2]. Group 2: Company Overview - Kiniksa is a biopharmaceutical company focused on developing therapies for debilitating diseases, particularly in cardiovascular indications [3]. - The company aims to address unmet medical needs through its portfolio, which is based on strong biological rationale and validated mechanisms [3].

Core Viewpoint - Kiniksa Pharmaceuticals has received Orphan Drug Designation from the FDA for KPL-387, aimed at treating pericarditis, including recurrent cases, which highlights the company's commitment to addressing unmet medical needs in rare diseases [1][2]. Company Overview - Kiniksa Pharmaceuticals is focused on developing and commercializing novel therapies for diseases with unmet needs, particularly in cardiovascular indications [4]. - The company aims to improve the lives of patients suffering from debilitating diseases through innovative treatments [4]. Product Information - KPL-387 is a fully human IgG2 monoclonal antibody that targets human IL-1R1, inhibiting the activity of cytokines IL-1α and IL-1β [5]. - The drug is expected to offer a convenient treatment option for recurrent pericarditis patients, potentially allowing for a single monthly subcutaneous self-injection [2][5]. - Data from the Phase 2 dose-focusing portion of the KPL-387 Phase 2/3 trial is anticipated in the second half of 2026 [2]. Orphan Drug Designation - The FDA's Orphan Drug Designation is granted to products treating rare diseases, which includes those affecting fewer than 200,000 people in the U.S. [3]. - This designation provides financial incentives such as grant funding for clinical trials, tax advantages, and waivers for user fees [3].

Core Insights - Kiniksa Pharmaceuticals International, plc (KNSA) has a strong history of exceeding earnings estimates and is well-positioned for future earnings beats [1][2]. Earnings Performance - The company has achieved an average surprise of 238.89% over the past two quarters, indicating a consistent ability to outperform expectations [2]. - In the most recent quarter, Kiniksa reported earnings of $0.23 per share against an expectation of $0.18, resulting in a surprise of 27.78%. In the previous quarter, the earnings were $0.11 per share compared to an estimate of $0.02, leading to a surprise of 450.00% [3]. Earnings Estimates and Predictions - Estimates for Kiniksa have been trending upward, supported by its history of earnings surprises. The stock currently has a positive Zacks Earnings ESP of +8.95%, suggesting analysts are optimistic about its earnings prospects [6][9]. - The combination of a positive Earnings ESP and a Zacks Rank of 1 (Strong Buy) indicates a high likelihood of another earnings beat [9]. Statistical Insights - Research indicates that stocks with a positive Earnings ESP and a Zacks Rank of 3 (Hold) or better have a nearly 70% chance of producing a positive surprise [7]. - The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate, with the Most Accurate Estimate reflecting the latest analyst revisions [8].

Core Viewpoint - Kiniksa Pharmaceuticals International, plc (KNSA) has shown a 1.3% increase in share price over the past four weeks, closing at $37.03, with analysts suggesting a potential upside of 29.3% based on a mean price target of $47.88 [1][11]. Price Targets and Analyst Consensus - The average price target for KNSA is derived from eight short-term estimates, ranging from a low of $35.00 to a high of $60.00, with a standard deviation of $7.94, indicating variability in analyst predictions [2]. - The lowest estimate suggests a decline of 5.5%, while the highest indicates a potential upside of 62% [2]. - A low standard deviation signifies a strong agreement among analysts regarding the stock's price movement direction [9]. Earnings Estimates and Analyst Optimism - Analysts have shown increasing optimism about KNSA's earnings prospects, as evidenced by a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [11]. - Over the past 30 days, one estimate has increased with no negative revisions, leading to a 0.7% rise in the Zacks Consensus Estimate for the current year [12]. Zacks Rank and Investment Potential - KNSA holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13]. - While the consensus price target may not be entirely reliable, the implied direction of price movement appears to be a useful guide for investors [14].

Industry Overview - The biotech industry has shown resilience in 2025 despite ongoing geopolitical tensions and tariff threats, with significant investments in U.S. manufacturing by major pharma and biotech companies [1] - The Zacks Biomedical and Genetics industry includes biopharmaceutical and biotechnology firms that develop innovative drugs using advanced technology [4] - The industry is currently ranked 102 by Zacks, placing it in the top 41% of over 246 Zacks industries, indicating a decent outlook driven by consistent demand for medical treatments [15] Mergers and Acquisitions - 2025 has experienced a surge in mergers and acquisitions, particularly focused on AI-driven drug discovery, as companies seek to expand their product portfolios [2][9] - Notable acquisitions include Roche's purchase of 89bio, Inc. for $3.5 billion and Novartis's acquisition of Tourmaline Bio for $1.4 billion, highlighting a trend towards portfolio expansion in response to changing market dynamics [10] Company Performance - Biotech companies such as Halozyme Therapeutics, Akero Therapeutics, Kiniska Pharmaceuticals, ANI Pharmaceuticals, and Twist BioScience are positioned to outperform the sector [3] - Halozyme Therapeutics has seen a 63.8% increase in shares year-to-date, with a Zacks Consensus Estimate for 2025 EPS rising to $6.18 [25] - Kiniska Pharmaceuticals has experienced an 82.4% share increase, with the Zacks Consensus Estimate for 2025 EPS rising to $1.03 [28] - ANI Pharmaceuticals shares have gained 73.6% this year, with earnings estimates for 2025 increasing by 84 cents [33] - Akero Therapeutics has seen a 66.8% increase in shares, focusing on treatments for metabolic diseases [36] - Twist Bioscience is expanding its technology to include synthetic RNA and antibody proteins, collaborating with Synthetic Design Lab for cancer treatments [41] Market Trends - The focus on innovation and execution is critical, with companies investing heavily in research and development to create breakthrough treatments [6] - The use of AI technology in drug discovery is expected to attract further investment in the biotech sector [11] - New drug approvals have accelerated in 2025, contributing to positive market momentum despite a challenging macro environment [11] Financial Metrics - The Zacks Biomedical and Genetics industry is trading at a trailing 12-month price-to-sales ratio of 2.16X, compared to the S&P 500's 5.95X and the Zacks Medical sector's 2.40X [20] - The industry's stock performance has gained 6% year-to-date, outperforming the Zacks Medical sector, which declined by 0.5% [17]

Core Viewpoint - The article emphasizes the importance of identifying and sustaining trends in short-term investing, highlighting that sound fundamentals and positive earnings estimates are crucial for maintaining momentum in stock prices [1]. Group 1: Investment Strategy - Investors can utilize the "Recent Price Strength" screen to identify stocks that are trending upwards, supported by strong fundamentals and trading near their 52-week high [2]. - Kiniksa Pharmaceuticals International, plc (KNSA) is highlighted as a strong candidate for trend investors, having increased by 26.1% over the past 12 weeks, indicating investor confidence in its potential [3]. - A recent price increase of 7% over the last four weeks suggests that KNSA's upward trend is still intact, and it is currently trading at 92.7% of its 52-week high-low range, indicating a potential breakout [4]. Group 2: Fundamental Analysis - KNSA holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, which are critical for short-term price movements [5]. - The Zacks Rank system has a strong historical performance, with Rank 1 stocks averaging a +25% annual return since 1988, reinforcing the potential for KNSA's continued success [6]. - The Average Broker Recommendation for KNSA is also 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [6]. Group 3: Additional Opportunities - Besides KNSA, there are other stocks that meet the criteria of the "Recent Price Strength" screen, suggesting a broader opportunity for investors to explore [7]. - The article encourages investors to consider various Zacks Premium Screens tailored to different investing styles to identify potential winning stocks [7].

Company Highlights - Aurinia Pharmaceuticals Inc. (AUPH) has seen solid growth for its product LUPKYNIS, with expected net product sales for 2025 ranging from $250 million to $260 million, up from $216.2 million last year [2][3] - Arrowhead Pharmaceuticals Inc. (ARWR) is preparing for its first commercial launch in 2025, with its lead drug candidate Plozasiran under FDA review, decision expected on November 18, 2025 [4][5] - Beta Bionics Inc. (BBNX) reported a 54% growth in second-quarter net sales, with expectations for full-year 2025 net sales to range between $88 million and $93 million, compared to $65.1 million last year [7][8] - Kiniksa Pharmaceuticals International plc (KNSA) anticipates net product revenue for its drug Arcalyst to be between $625 million and $640 million for 2025, up from $417 million in 2024 [10][11] - Ionis Pharmaceuticals Inc. (IONS) generated net product sales of $19 million in Q2 2025, with a supplemental new drug application expected by year-end [12][14] - Stoke Therapeutics Inc. (STOK) is developing Zorevunersen for Dravet syndrome, with a 52-week high of $24.60 reached recently, representing an 82% gain in less than two months [16][17] - Fortress Biotech Inc. (FBIO) is awaiting an FDA decision on its investigational drug CUTX-101 for Menkes disease, expected on September 30, 2025 [18][21] Stock Performance - AUPH stock increased by 168% over 1.5 years, reaching a 52-week high of $12.87 [3] - ARWR stock gained 65% in less than 9 months, hitting a 52-week high of $31.13 [5] - BBNX stock rose nearly 55% in less than 4 months, reaching a 52-week high of $26.66 [8] - KNSA stock saw a 46% increase in less than four months, touching a 52-week high of $37.34 [11] - IONS stock gained 52% in less than two months, reaching a 52-week high of $64.72 [15] - STOK stock increased by 82% in less than two months, achieving a 52-week high of $24.60 [17] - FBIO stock rose by 61% in less than a month, reaching a 52-week high of $3.97 [21]

Financial Data and Key Metrics Changes - Kiniksa Pharmaceuticals reported Q2 revenue of $156.8 million, with a revised full-year revenue guidance for 2025 between $625 million and $640 million, up from a previous estimate of $590 million to $605 million [4][5][11] Business Line Data and Key Metrics Changes - The company has achieved approximately 15% penetration into its target patient population for Arclis, which is aimed at recurrent pericarditis, indicating significant growth potential [5][11][31] - The prescriber base for Arclis has expanded significantly, with over 3,475 prescribers by the end of Q2, marking a substantial increase in new patient enrollments [15][18] Market Data and Key Metrics Changes - The company noted that the recurrent pericarditis patient population is approximately 40,000 annually, with a significant opportunity remaining given the current 15% market penetration [31] - The introduction of the Inflation Reduction Act has made Arclis more affordable for Medicare Part D patients, leading to a one-time bolus of patients switching from free goods to paid therapy [20][21] Company Strategy and Development Direction - Kiniksa is focused on value creation and expanding its commercialization efforts for Arclis, with plans to enhance education among healthcare professionals regarding recurrent pericarditis [4][19] - The company is also developing KPL-387, a potential monthly liquid formulation for recurrent pericarditis, with expectations to enter the market around 2028-2029 [6][43] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory of Arclis, emphasizing the need for continued education and awareness among physicians to improve diagnosis and treatment of recurrent pericarditis [17][30] - The company remains committed to being cash flow positive annually while pursuing new indication opportunities for its pipeline products [58] Other Important Information - Kiniksa is collaborating with Mayo Clinic and Johns Hopkins on a clinical trial for cardiac sarcoidosis, which may provide insights into myocardial inflammation and potential new treatment avenues [33][34] - The company is also advancing its development of KPL-161, a quarterly IL-1 antagonist, with ongoing preclinical studies [56] Q&A Session Summary Question: What are the drivers for the significant expansion in the prescriber base? - The expansion is attributed to increased education and understanding of recurrent pericarditis among healthcare professionals, as well as initiatives to establish centers of excellence for treatment [16][17] Question: How does the company view the impact of Medicare Part D on patient treatment? - The changes in Medicare Part D have made therapy more affordable, leading to a one-time increase in patients transitioning to paid therapy, although this is not expected to repeat [20][21] Question: What is the average treatment duration for Arclis and what drives the increase? - The average treatment duration is currently 30 months, with many patients restarting therapy within eight weeks if symptoms return [24][25] Question: What is the rationale for exploring Arclis in cardiac sarcoidosis? - The exploration is based on the inflammatory nature of cardiac sarcoidosis and the potential for IL-1 pathway blockade to reduce inflammation in this condition [32][33] Question: What are the expectations for KPL-387 and its market potential? - KPL-387 is anticipated to provide a more convenient monthly dosing option, with strong interest from both healthcare professionals and patients, potentially expanding the market for IL-1 therapies [38][39]

Financial Data and Key Metrics Changes - The company reported Q2 revenue of $156.8 million and raised its full-year 2025 revenue guidance to between $625 million and $640 million, up from a previous estimate of $590 million to $600 million [4][5][11]. Business Line Data and Key Metrics Changes - The company has achieved approximately 15% penetration into its target patient population for Arclis, which is focused on recurrent pericarditis, indicating significant room for growth [5][11][34]. - The average treatment duration for Arclis is reported to be 30 months, with 45% of patients who stop therapy restarting within eight weeks due to symptom recurrence [26][27]. Market Data and Key Metrics Changes - The prescriber base for Arclis has expanded significantly, with over 3,475 prescribers by the end of Q2, reflecting a strong educational push and increased awareness of recurrent pericarditis [15][19]. - The company noted that patients often receive multiple misdiagnoses before being correctly identified as having recurrent pericarditis, highlighting the need for better education and awareness in the healthcare system [18]. Company Strategy and Development Direction - The company is focused on value creation and expanding its market presence, particularly for Arclis, which has only begun to penetrate the market [4][5]. - The development pipeline includes KPL-387, a potential monthly liquid formulation for recurrent pericarditis, expected to enter the market around 2028-2029 [6][46]. - The company is also exploring the use of Arclis in cardiac sarcoidosis, aiming to understand myocardial inflammation better through collaborations with leading medical institutions [35][36]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory of Arclis, emphasizing the importance of education and awareness in increasing prescriber confidence and patient access [19][33]. - The company remains committed to being cash flow positive annually while pursuing new indication opportunities for its pipeline products [59]. Other Important Information - The company has implemented a patient assistance program to help Medicare Part D patients afford their co-pays, which has positively impacted patient enrollment and therapy initiation [22][23]. - The company is leveraging AI and digital approaches to enhance its educational outreach to healthcare professionals and patients [20][19]. Q&A Session Summary Question: What are the growth drivers for Arclis? - The growth is driven by increased education and understanding of recurrent pericarditis among healthcare providers, leading to a broader prescriber base and higher patient enrollments [18][19]. Question: How does Medicare Part D impact patient treatment? - The changes in Medicare Part D have made therapy more affordable for patients, resulting in a one-time bolus of patients transitioning from free goods to paid therapy [22][23]. Question: What is the average treatment duration for Arclis? - The average treatment duration is reported to be 30 months, with many patients restarting therapy quickly if symptoms return [26][27]. Question: What is the strategy for KPL-387? - KPL-387 is being developed as a monthly auto-injector formulation, with strong interest from both healthcare professionals and patients, indicating a potential expansion of the market for interleukin inhibitors [40][42]. Question: What are the benefits of the Fc modified IL-1 antagonist, eleven sixty one? - The Fc modification allows for longer circulation times and potentially quarterly dosing, which could be beneficial for chronic diseases requiring long-term management [56][57].

Group 1 - The Citi Biopharma and Back-to-school Conference is in its 20th annual iteration, having skipped last year and integrated biotech companies into the Global Healthcare Conference in Miami [1] - Kiniksa is participating in the conference, with key executives including CEO Sanj Patel, CCO Ross Moat, and Chief Medical Officer John Paolini present [2]