KNSA
Kiniksa InternationalFDocument history
Earnings documents stored for KNSA.
Investor releaseQuarter not tagged2026-08-03KNSA Q2 Earnings Call Backs Higher ARCALYST Sales Outlook
Zacks
KNSA Q2 Earnings Call Backs Higher ARCALYST Sales Outlook
Kiniksa Pharmaceuticals International, plc KNSA used its second-quarter 2026 earnings call to emphasize accelerating ARCALYST adoption and a higher full-year sales outlook. Management also moved KPL-387 into pivotal testing, adding a second major execution priority. The quarter’s financial results supplied context rather than the central message. Earnings of 30 cents per share matched the Zacks Consensus Estimate, while revenue of $243.6 million topped the $227.5 million consensus. Kiniksa Pharmaceuticals International, plc price-consensus-eps-surprise-chart | Kiniksa Pharmaceuticals International, plc Quote Chief executive officer Sanj Patel said ARCALYST momentum supported raising 2026 net product revenue guidance to $980 million-$995 million from $930 million-$945 million. Second-quarter ARCALYST revenue rose 55% year over year and increased by more than $29 million from the first quarter. Patel framed the gain as evidence of broader IL-1 pathway adoption in recurrent pericarditis. Chief financial officer Mark Ragosa said operating income reached $27.2 million and net income was $25.4 million. Cash, cash equivalents and short-term investments totaled $525.9 million, with no debt. Chief operating officer Ross Moat attributed growth to gains in both new and repeat prescribing. About 450 health care professionals wrote their first ARCALYST prescription during the quarter, lifting the launch-to-date prescriber base above 5,000. Roughly 150 additional prescribers moved into the repeat category from the first quarter. About 29% of the prescriber base has now written ARCALYST for two or more patients. Moat also highlighted investments in machine learning, predictive alerts and the Heart’s Home direct-to-consumer campaign. He said dissemination of updated clinical guidance is helping physicians use ARCALYST earlier in the treatment sequence. Chief medical officer John Paolini said Phase 2 data supported selecting a 300-milligram monthly subcutaneous dose for the PASTORALE Phase 3 study. Median time to treatment response and pain response was four days, while median time to C-reactive protein normalization was eight days. Paolini said efficacy remained durable across the monthly interval and tolerability was consistent with IL-1 pathway inhibition. PASTORALE is enrolling up to about 85 participants in an event-driven randomized-withdrawal study. The primary endpoi…Read full documentShow less
Kiniksa Pharmaceuticals International, plc KNSA used its second-quarter 2026 earnings call to emphasize accelerating ARCALYST adoption and a higher full-year sales outlook. Management also moved KPL-387 into pivotal testing, adding a second major execution priority. The quarter’s financial results supplied context rather than the central message. Earnings of 30 cents per share matched the Zacks Consensus Estimate, while revenue of $243.6 million topped the $227.5 million consensus. Kiniksa Pharmaceuticals International, plc price-consensus-eps-surprise-chart | Kiniksa Pharmaceuticals International, plc Quote Chief executive officer Sanj Patel said ARCALYST momentum supported raising 2026 net product revenue guidance to $980 million-$995 million from $930 million-$945 million. Second-quarter ARCALYST revenue rose 55% year over year and increased by more than $29 million from the first quarter. Patel framed the gain as evidence of broader IL-1 pathway adoption in recurrent pericarditis. Chief financial officer Mark Ragosa said operating income reached $27.2 million and net income was $25.4 million. Cash, cash equivalents and short-term investments totaled $525.9 million, with no debt. Chief operating officer Ross Moat attributed growth to gains in both new and repeat prescribing. About 450 health care professionals wrote their first ARCALYST prescription during the quarter, lifting the launch-to-date prescriber base above 5,000. Roughly 150 additional prescribers moved into the repeat category from the first quarter. About 29% of the prescriber base has now written ARCALYST for two or more patients. Moat also highlighted investments in machine learning, predictive alerts and the Heart’s Home direct-to-consumer campaign. He said dissemination of updated clinical guidance is helping physicians use ARCALYST earlier in the treatment sequence. Chief medical officer John Paolini said Phase 2 data supported selecting a 300-milligram monthly subcutaneous dose for the PASTORALE Phase 3 study. Median time to treatment response and pain response was four days, while median time to C-reactive protein normalization was eight days. Paolini said efficacy remained durable across the monthly interval and tolerability was consistent with IL-1 pathway inhibition. PASTORALE is enrolling up to about 85 participants in an event-driven randomized-withdrawal study. The primary endpoint is time to first adjudicated pericarditis recurrence, and management continues to target a 2028-2029 commercial launch. A JPMorgan analyst asked whether the monthly KPL-387 profile could carry commercial significance. Chief operating officer Ross Moat cited prior market research showing about 75% of patients preferred the target profile over current commercial or investigational therapies. Moat added that about 92% of health care professionals indicated a high likelihood of prescribing the product to new patients. Management also said another IL-1 therapy could expand the overall treated population. A Wedbush analyst pressed for recurrence and follow-up details from the Phase 2 analysis. Chief Medical Officer John Paolini limited disclosure because the study remains ongoing, while emphasizing that 300-milligram monthly dosing maintained effect through the interval and biweekly dosing offered no incremental benefit. A Citi analyst asked whether first-recurrence patients contributed to ARCALYST demand. Chief Operating Officer Ross Moat said about 80% of new prescriptions came from patients with two or more recurrences, while about 20% came from the larger first-recurrence group. Management estimated that ARCALYST had reached about 21% of the 14,000-patient multiple-recurrence population. Chief executive officer Sanj Patel characterized that penetration level as evidence of remaining commercial runway. In response to Wells Fargo, Chief Financial Officer Mark Ragosa said year-to-date gross-to-net was 7.2%, down from 8.6% in the first quarter, mainly because of lower co-pay support. He expects the usual pattern of lower rates in the middle quarters and some increase in the fourth quarter. Management’s tone remained centered on disciplined commercial execution, continued patient penetration and timely delivery of KPL-387 milestones. The company also kept KPL-1161 on track for a Phase 1 study by year-end 2026, extending its IL-1 franchise toward a targeted quarterly dosing profile. KNSA carries a Zacks Rank #3 (Hold). Its Growth, Momentum and VGM Scores are all A, indicating strong characteristics in those styles, while the Value Score of D points to a weaker valuation profile.You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. The combination is less favorable than a Zacks Rank #1 or #2 (Buy) paired with A or B Style Scores, but the strong Growth, Momentum and VGM grades remain relevant for investors using those styles. The Zacks Rank can change as earnings estimates are revised after the reported results. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Kiniksa Pharmaceuticals International, plc (KNSA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-07-30Earnings Estimates Rising for Kiniksa Pharmaceuticals International, plc (KNSA): Will It Gain?
Zacks
Earnings Estimates Rising for Kiniksa Pharmaceuticals International, plc (KNSA): Will It Gain?
Kiniksa Pharmaceuticals International, plc (KNSA) appears an attractive pick given a noticeable improvement in the company's earnings outlook. The stock has been a strong performer lately, and the momentum might continue with analysts still raising their earnings estimates for the company. The upward trend in estimate revisions for this company reflects growing optimism of analysts on its earnings prospects, which should get reflected in its stock price. After all, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements. This insight is at the core of our stock rating tool -- the Zacks Rank. The five-grade Zacks Rank system, which ranges from a Zacks Rank #1 (Strong Buy) to a Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record of outperformance, with Zacks #1 Ranked stocks generating an average annual return of +25% since 2008. For Kiniksa Pharmaceuticals International, plc, strong agreement among the covering analysts in revising earnings estimates upward has resulted in meaningful improvement in consensus estimates for the next quarter and full year. The chart below shows the evolution of forward 12-month Zacks Consensus EPS estimate: For the current quarter, the company is expected to earn $0.44 per share, which is a change of +91.3% from the year-ago reported number. Over the last 30 days, the Zacks Consensus Estimate for Kiniksa Pharmaceuticals International, plc has increased 26.09% because one estimate has moved higher compared to no negative revisions. For the full year, the company is expected to earn $1.39 per share, representing a year-over-year change of +85.3%. There has been an encouraging trend in estimate revisions for the current year as well. Over the past month, one estimate has moved up for Kiniksa Pharmaceuticals International, plc versus no negative revisions. This has pushed the consensus estimate 10.9% higher. Thanks to promising estimate revisions, Kiniksa Pharmaceuticals International, plc currently carries a Zacks Rank #1 (Strong Buy). The Zacks Rank is a tried-and-tested rating tool that helps investors effectively harness the power of earnings estimate revisions and make the right investment decision.You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Our research shows that stocks with Zacks Rank #1 (St…Read full documentShow less
Kiniksa Pharmaceuticals International, plc (KNSA) appears an attractive pick given a noticeable improvement in the company's earnings outlook. The stock has been a strong performer lately, and the momentum might continue with analysts still raising their earnings estimates for the company. The upward trend in estimate revisions for this company reflects growing optimism of analysts on its earnings prospects, which should get reflected in its stock price. After all, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements. This insight is at the core of our stock rating tool -- the Zacks Rank. The five-grade Zacks Rank system, which ranges from a Zacks Rank #1 (Strong Buy) to a Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record of outperformance, with Zacks #1 Ranked stocks generating an average annual return of +25% since 2008. For Kiniksa Pharmaceuticals International, plc, strong agreement among the covering analysts in revising earnings estimates upward has resulted in meaningful improvement in consensus estimates for the next quarter and full year. The chart below shows the evolution of forward 12-month Zacks Consensus EPS estimate: For the current quarter, the company is expected to earn $0.44 per share, which is a change of +91.3% from the year-ago reported number. Over the last 30 days, the Zacks Consensus Estimate for Kiniksa Pharmaceuticals International, plc has increased 26.09% because one estimate has moved higher compared to no negative revisions. For the full year, the company is expected to earn $1.39 per share, representing a year-over-year change of +85.3%. There has been an encouraging trend in estimate revisions for the current year as well. Over the past month, one estimate has moved up for Kiniksa Pharmaceuticals International, plc versus no negative revisions. This has pushed the consensus estimate 10.9% higher. Thanks to promising estimate revisions, Kiniksa Pharmaceuticals International, plc currently carries a Zacks Rank #1 (Strong Buy). The Zacks Rank is a tried-and-tested rating tool that helps investors effectively harness the power of earnings estimate revisions and make the right investment decision.You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Our research shows that stocks with Zacks Rank #1 (Strong Buy) and 2 (Buy) significantly outperform the S&P 500. Kiniksa Pharmaceuticals International, plc shares have added 28.7% over the past four weeks, suggesting that investors are betting on its impressive estimate revisions. So, you may consider adding it to your portfolio right away to benefit from its earnings growth prospects. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Kiniksa Pharmaceuticals International, plc (KNSA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-07-28Kiniksa Pharmaceuticals International, plc (KNSA) Q2 Earnings Match Estimates
Zacks
Kiniksa Pharmaceuticals International, plc (KNSA) Q2 Earnings Match Estimates
Kiniksa Pharmaceuticals International, plc (KNSA) came out with quarterly earnings of $0.3 per share, in line with the Zacks Consensus Estimate . This compares to earnings of $0.23 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this company would post earnings of $0.18 per share when it actually produced earnings of $0.27, delivering a surprise of +50%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Kiniksa Pharmaceuticals International, plc, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $243.6 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 7.09%. This compares to year-ago revenues of $156.8 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Kiniksa Pharmaceuticals International, plc shares have added about 54% since the beginning of the year versus the S&P 500's gain of 8.3%. While Kiniksa Pharmaceuticals International, plc has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Kiniksa Pharmaceuticals International, plc was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #1 (Strong Buy) for the stock. So, the shares are expected to outperform the market in the n…Read full documentShow less
Kiniksa Pharmaceuticals International, plc (KNSA) came out with quarterly earnings of $0.3 per share, in line with the Zacks Consensus Estimate . This compares to earnings of $0.23 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this company would post earnings of $0.18 per share when it actually produced earnings of $0.27, delivering a surprise of +50%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Kiniksa Pharmaceuticals International, plc, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $243.6 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 7.09%. This compares to year-ago revenues of $156.8 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Kiniksa Pharmaceuticals International, plc shares have added about 54% since the beginning of the year versus the S&P 500's gain of 8.3%. While Kiniksa Pharmaceuticals International, plc has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Kiniksa Pharmaceuticals International, plc was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #1 (Strong Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.35 on $240.72 million in revenues for the coming quarter and $1.25 on $938.98 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Twist Bioscience (TWST), has yet to report results for the quarter ended June 2026. The results are expected to be released on August 3. This maker of synthetic DNA for the biotechnology industry is expected to post quarterly loss of $0.50 per share in its upcoming report, which represents a year-over-year change of -6.4%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Twist Bioscience's revenues are expected to be $114.5 million, up 19.2% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Kiniksa Pharmaceuticals International, plc (KNSA) : Free Stock Analysis Report Twist Bioscience Corporation (TWST) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-07-28Alkermes Q2 Earnings Break Even, Revenues Beat Estimates, Stock Down
Zacks
Alkermes Q2 Earnings Break Even, Revenues Beat Estimates, Stock Down
Alkermes plc ALKS reported break-even earnings for the second quarter of 2026 against the Zacks Consensus Estimate of a loss of 4 cents per share. The company had recorded earnings of 52 cents per share in the year-ago quarter. During the second quarter, the company recorded a change in the fair value of contingent consideration of $26.4 million related to the Avadel acquisition contingent value right (CVR) milestone. Alkermes reported total revenues of $496 million for the second quarter, up almost 27% from the year-ago quarter, driven by higher product sales. The top line beat the Zacks Consensus Estimate of $454 million. Shares of Alkermes were down in pre-market trading following the announcement of the earnings. The stock has rallied 88.5% so far this year compared with the industry’s rise of 2.6%. Image Source: Zacks Investment Research Alkermes derives revenues from the net sales of its proprietary products — Vivitrol (alcohol and opioid dependence), Aristada (schizophrenia), Lybalvi (schizophrenia and bipolar I disorder) and the newly acquired sleep disorder drug, Lumryz. The metric also includes manufacturing and/or royalty revenues on net sales of products commercialized by partners. Sales of the proprietary products portfolio grew 34% year over year to $411.7 million during the second quarter, driven by solid demand across the commercial portfolio. Sales of proprietary products were above management’s guided range of $385-$405 million. Vivitrol sales increased 2.3% year over year to $124.5 million in the reported quarter. The metric beat the Zacks Consensus Estimate of $117 million. Aristada sales decreased 4.5% year over year to $96.7 million. The figure, however, beat the Zacks Consensus Estimate of $95 million. Lybalvi generated sales of $94 million, up 11.5% year over year in the reported quarter, due to increased total prescriptions. Its sales, however, missed the Zacks Consensus Estimate of $98 million. Lybalvi’s total prescriptions grew 18% year over year in the quarter. Newly acquired sleep disorder drug Lumryz recorded revenues worth $96.6 million in the second quarter. The metric beat the Zacks Consensus Estimate of $89 million. In February 2026, Alkermes completed the previously announced acquisition of Ireland-based Avadel Pharmaceuticals, which added the latter’s FDA-approved product, Lumryz, to its commercial portfolio. Lumryz is app…Read full documentShow less
Alkermes plc ALKS reported break-even earnings for the second quarter of 2026 against the Zacks Consensus Estimate of a loss of 4 cents per share. The company had recorded earnings of 52 cents per share in the year-ago quarter. During the second quarter, the company recorded a change in the fair value of contingent consideration of $26.4 million related to the Avadel acquisition contingent value right (CVR) milestone. Alkermes reported total revenues of $496 million for the second quarter, up almost 27% from the year-ago quarter, driven by higher product sales. The top line beat the Zacks Consensus Estimate of $454 million. Shares of Alkermes were down in pre-market trading following the announcement of the earnings. The stock has rallied 88.5% so far this year compared with the industry’s rise of 2.6%. Image Source: Zacks Investment Research Alkermes derives revenues from the net sales of its proprietary products — Vivitrol (alcohol and opioid dependence), Aristada (schizophrenia), Lybalvi (schizophrenia and bipolar I disorder) and the newly acquired sleep disorder drug, Lumryz. The metric also includes manufacturing and/or royalty revenues on net sales of products commercialized by partners. Sales of the proprietary products portfolio grew 34% year over year to $411.7 million during the second quarter, driven by solid demand across the commercial portfolio. Sales of proprietary products were above management’s guided range of $385-$405 million. Vivitrol sales increased 2.3% year over year to $124.5 million in the reported quarter. The metric beat the Zacks Consensus Estimate of $117 million. Aristada sales decreased 4.5% year over year to $96.7 million. The figure, however, beat the Zacks Consensus Estimate of $95 million. Lybalvi generated sales of $94 million, up 11.5% year over year in the reported quarter, due to increased total prescriptions. Its sales, however, missed the Zacks Consensus Estimate of $98 million. Lybalvi’s total prescriptions grew 18% year over year in the quarter. Newly acquired sleep disorder drug Lumryz recorded revenues worth $96.6 million in the second quarter. The metric beat the Zacks Consensus Estimate of $89 million. In February 2026, Alkermes completed the previously announced acquisition of Ireland-based Avadel Pharmaceuticals, which added the latter’s FDA-approved product, Lumryz, to its commercial portfolio. Lumryz is approved as the first and only once-at-bedtime oxybate for extended-release oral suspension for the treatment of cataplexy or excessive daytime sleepiness in patients aged seven years and older with narcolepsy. Total manufacturing and royalty revenues increased 1.1% year over year to $84.3 million. Manufacturing and royalty revenues from Biogen’s multiple sclerosis drug, Vumerity, were $30.6 million. Royalty revenues from Xeplion and certain Invega products were $27.5 million in the second quarter. Research and development expenses totaled $112.9 million, up around 45.8% year over year. Selling, general and administrative expenses totaled $217.6 million, up around 27.4% year over year. As of June 30, 2026, Alkermes had cash and cash equivalents of $691.6 million compared with $538.2 million as of March 31, 2026. The company expects total revenues in the band of $1.73-$1.84 billion for 2026, unchanged from the previous expectation. Net sales of Vivitrol are expected to be in the range of $460-$480 million, while Aristada sales are anticipated in the range of $365-$385 million. Lybalvi’s net sales are expected in the $380-$400 million range. Net sales from Lumryz are expected to be in the range of $315-$335 million in 2026. Research and development expenses are anticipated in the range of $445-$485 million. Selling, general and administrative expenses are projected in the range of $890-$930 million. The company expects adjusted EBITDA to be in the range of $370-$410 million. Alkermes is developing alixorexton, a novel, investigational, oral, selective orexin 2 receptor agonist for the treatment of narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). In April 2026, the company initiated the phase III Brilliance studies, evaluating the safety and efficacy of alixorexton versus placebo in adults with NT1 and NT2. Alixorexton is also being evaluated in the phase II Vibrance-3 study for treating patients with IH. Top-line data from this study are expected by the end of 2026. In June 2026, the FDA granted an orphan drug designation (ODD) to alixorexton for the treatment of IH, and the European Commission granted ODD to alixorexton for the treatment of patients with narcolepsy. Alkermes plc price-consensus-eps-surprise-chart | Alkermes plc Quote Alkermes currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY, Kiniksa Pharmaceuticals KNSA and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.30, while estimates for 2027 have increased from $3.64 to $3.87 during the same time. HRMY shares have lost 3.8% year to date. Harmony Biosciences’ earnings missed estimates in each of the trailing four quarters, with the average negative surprise being 25.16%. Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 earnings per share have risen from $1.24 to $1.25, while estimates for 2027 have increased from $1.70 to $1.76 during the same time. KNSA shares have soared 54% year to date. Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 1.53%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 144.8% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alkermes plc (ALKS) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Kiniksa Pharmaceuticals International, plc (KNSA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-07-28Kiniksa Pharmaceuticals International Q2 Earnings Call Highlights
MarketBeat
Kiniksa Pharmaceuticals International Q2 Earnings Call Highlights
Interested in Kiniksa Pharmaceuticals International, plc? Here are five stocks we like better. ARCALYST revenue rose 55% year over year to $243.6 million in the second quarter, driven by growth in new and repeat prescribers. Kiniksa raised its 2026 revenue guidance to $980 million-$995 million from $930 million-$945 million. Kiniksa selected a 300-milligram monthly dose for KPL-387 after Phase II results showed rapid treatment and pain responses. The pivotal Phase III PASTEURAL trial is now enrolling and dosing patients, with a potential commercial launch projected for 2028-2029. The company reported $27.2 million in operating income and ended the quarter with $525.9 million in cash, generating approximately $58 million in net cash during the period. Kiniksa Pharmaceuticals Still Has Room to Run After 100% Rally Kiniksa Pharmaceuticals International (NASDAQ:KNSA) reported second-quarter ARCALYST revenue of $243.6 million, up 55% from a year earlier and more than $29 million from the first quarter, as the company cited continued expansion in both new and repeat prescribers for the recurrent pericarditis treatment. The company raised its full-year 2026 ARCALYST revenue guidance to a range of $980 million to $995 million, from its prior range of $930 million to $945 million. Kiniksa also announced dose-focusing data for KPL-387 and said the pivotal Phase III PASTEURAL trial is enrolling and dosing patients. → Volatility Is Back and These 3 Market Tollbooths Are Best Positioned to Profit “Kiniksa is in a strong position more than halfway through 2026 as we continue to execute across our portfolio,” CEO and Chairman Sanj Patel said. Patel said the company anticipates a potential commercial launch of KPL-387 in the 2028 to 2029 timeframe. Chief Operating Officer Ross Moat said the second quarter represented the largest quarterly increase in ARCALYST net revenue since the product’s launch more than five years ago. He attributed the performance to the company’s commercial strategy, including investments in sales infrastructure, machine learning and artificial intelligence tools, direct-to-consumer outreach, and dissemination of clinical guidance. → This Tiny AI Supplier Could Be More Important Than the Chipmakers Kiniksa launched its targeted direct-to-consumer campaign, called Heart’s Home, in April. The campaign is designed to educate patients with recurrent peric…Read full documentShow less
Interested in Kiniksa Pharmaceuticals International, plc? Here are five stocks we like better. ARCALYST revenue rose 55% year over year to $243.6 million in the second quarter, driven by growth in new and repeat prescribers. Kiniksa raised its 2026 revenue guidance to $980 million-$995 million from $930 million-$945 million. Kiniksa selected a 300-milligram monthly dose for KPL-387 after Phase II results showed rapid treatment and pain responses. The pivotal Phase III PASTEURAL trial is now enrolling and dosing patients, with a potential commercial launch projected for 2028-2029. The company reported $27.2 million in operating income and ended the quarter with $525.9 million in cash, generating approximately $58 million in net cash during the period. Kiniksa Pharmaceuticals Still Has Room to Run After 100% Rally Kiniksa Pharmaceuticals International (NASDAQ:KNSA) reported second-quarter ARCALYST revenue of $243.6 million, up 55% from a year earlier and more than $29 million from the first quarter, as the company cited continued expansion in both new and repeat prescribers for the recurrent pericarditis treatment. The company raised its full-year 2026 ARCALYST revenue guidance to a range of $980 million to $995 million, from its prior range of $930 million to $945 million. Kiniksa also announced dose-focusing data for KPL-387 and said the pivotal Phase III PASTEURAL trial is enrolling and dosing patients. → Volatility Is Back and These 3 Market Tollbooths Are Best Positioned to Profit “Kiniksa is in a strong position more than halfway through 2026 as we continue to execute across our portfolio,” CEO and Chairman Sanj Patel said. Patel said the company anticipates a potential commercial launch of KPL-387 in the 2028 to 2029 timeframe. Chief Operating Officer Ross Moat said the second quarter represented the largest quarterly increase in ARCALYST net revenue since the product’s launch more than five years ago. He attributed the performance to the company’s commercial strategy, including investments in sales infrastructure, machine learning and artificial intelligence tools, direct-to-consumer outreach, and dissemination of clinical guidance. → This Tiny AI Supplier Could Be More Important Than the Chipmakers Kiniksa launched its targeted direct-to-consumer campaign, called Heart’s Home, in April. The campaign is designed to educate patients with recurrent pericarditis and encourage them to discuss ARCALYST with their healthcare providers. Moat said the campaign had reached thousands of patients and was showing early signs of engagement. The company has also focused on communicating the 2025 American College of Cardiology concise clinical guidance for recurrent pericarditis. Moat said the guidance recommends moving ARCALYST earlier in treatment following nonsteroidal anti-inflammatory drugs and colchicine, and before corticosteroids. Penetration in the multiple-recurrence patient population reached approximately 21% at the end of the second quarter, compared with about 18% at the end of 2025. About 450 additional healthcare professionals wrote their first ARCALYST prescription during the quarter, bringing the total prescriber base to more than 5,000 since launch. The number of healthcare professionals who had written prescriptions for two or more patients increased by about 150 from the first quarter. Approximately 29% of the prescriber base had written ARCALYST prescriptions for at least two patients. → 2 Stocks Built to Thrive If Inflation Refuses to Fade Moat said more than 25,000 healthcare professionals nationwide manage recurrent pericarditis patients. During the question-and-answer session, he said roughly 80% of new ARCALYST prescriptions were for patients with two or more recurrences, a population Kiniksa estimates at about 14,000 patients. The remaining approximately 20% were for patients experiencing their first recurrence, a group the company estimated at about 26,000 patients. Moat said Kiniksa has not observed a meaningful change in the patient profile receiving ARCALYST. Rather, he pointed to broader recognition and diagnosis of recurrent pericarditis as contributing to growth. Kiniksa said its Phase II/III program for KPL-387, an investigational IL-1 alpha and beta inhibitor, has moved into the Phase III portion following dose-focusing results. The company selected a 300-milligram subcutaneous monthly dose for the pivotal PASTEURAL study. Chief Medical Officer Dr. John Paolini said Phase II data showed the selected dose produced a median time to treatment response of four days, with a 95% confidence interval of three to six days. The median time to pain response was also four days, while the median time to C-reactive protein normalization was eight days, with a confidence interval of seven to nine days. Paolini said the 300-milligram monthly regimen demonstrated rapid and sustained activity throughout the monthly dosing interval and was generally well tolerated, consistent with the established safety profile of IL-1 pathway inhibition. The 300-milligram biweekly dose was efficacious but did not show incremental benefit over the monthly regimen, while the 100-milligram dose levels showed effects that did not support further development, according to the company. PASTEURAL is a placebo-controlled, event-driven randomized-withdrawal study designed to evaluate reduction in the risk of pericarditis recurrence. The trial will enroll up to approximately 85 patients who experience a recurrence despite conventional oral therapies. Patients who respond during a single-blind run-in period will be randomized either to continue KPL-387 at 300 milligrams monthly or switch to placebo. Paolini said the primary endpoint is time to first adjudicated pericarditis recurrence during the randomized-withdrawal period. Kiniksa said the trial design follows the approach used in its prior RHAPSODY Phase III program for ARCALYST. Chief Financial Officer Mark Ragosa said operating income for the second quarter was $27.2 million and net income was $25.4 million. ARCALYST collaboration profit increased 68% year over year to $176.1 million, growing faster than sales, according to the company. Operating expenses increased from a year earlier due to higher cost of goods sold tied to ARCALYST revenue, increased collaboration expenses, KPL-387 clinical trial and manufacturing costs, preclinical investments, and commercialization-related selling, general and administrative expenses. Kiniksa ended the quarter with $525.9 million in cash, representing approximately $58 million in net cash generation during the period. Ragosa said year-to-date gross-to-net was 7.2%, down from 8.6% in the first quarter. He attributed the change primarily to lower co-pay expense following modifications to the company’s support program at the beginning of the year. Kiniksa Pharmaceuticals International, Inc is a biopharmaceutical company focused on discovering, acquiring and developing therapeutics for patients suffering from lifethreatening and debilitating immune-mediated diseases. Founded in 2013 and headquartered in Lexington, Massachusetts, Kiniksa applies a patient-centric approach to build a diversified portfolio of marketed medicines and clinical-stage candidates targeting inflammation and immunology. The company's core mission is to address complex conditions with significant unmet medical needs by advancing both novel and differentiated therapies. The company's lead marketed product is Ilaris (canakinumab), an interleukin-1β blocker licensed for the treatment of cryopyrin-associated periodic syndromes, systemic juvenile idiopathic arthritis, adult-onset Still's disease and Schnitzler syndrome. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Kiniksa Pharmaceuticals International Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.
Investor releaseQuarter not tagged2026-07-28Kiniksa Reports Strong Q2 Results, Raises 2026 ARCALYST Sales Guidance
InvestorsHub
Kiniksa Reports Strong Q2 Results, Raises 2026 ARCALYST Sales Guidance
Kiniksa Pharmaceuticals (NASDAQ:KNSA) reported strong second-quarter 2026 financial results, raised its full-year ARCALYST sales guidance, and advanced its cardiovascular pipeline with the Phase 3 launch of KPL-387 for recurrent pericarditis. Kiniksa increased its 2026 ARCALYST net sales guidance to $980 million-$995 million following strong prescription growth and higher patient adoption. Second-quarter revenue rose 55% year over year to $243.6 million, while net income increased to $25.4 million. Kiniksa (NASDAQ:KNSA) has initiated the pivotal Phase 3 PASTORALE trial for KPL-387 after positive Phase 2 results supported once-monthly dosing. The company ended the quarter with $525.9 million in cash, cash equivalents, and short-term investments and no debt. Management expects its current operating plan to remain cash flow positive on an annual basis. Kiniksa delivered second-quarter revenue of $243.6 million, up from $156.8 million in the prior-year period, driven by continued growth of ARCALYST for recurrent pericarditis. The company reported ARCALYST net product revenue of $243.6 million during the quarter and raised its full-year 2026 sales guidance to between $980 million and $995 million, up from its previous forecast of $930 million to $945 million. Management attributed the stronger outlook to continued growth in both new and repeat prescribers, resulting in a meaningful increase in patients receiving therapy. Kiniksa also announced positive progress for KPL-387. Interval data from the Phase 2 portion of its ongoing Phase 2/3 study showed rapid reductions in pain and inflammation with once-monthly subcutaneous dosing, supporting the launch of the pivotal Phase 3 PASTORALE trial, which is now enrolling and dosing patients. Financially, net income increased to $25.4 million from $17.8 million a year earlier despite higher investment in research, commercialization, and clinical development. The higher ARCALYST sales guidance reinforces the drug’s commercial momentum and suggests continued expansion within the recurrent pericarditis market. At the same time, advancing KPL-387 into Phase 3 provides Kiniksa with a potential next-generation therapy that management believes could offer convenient once-monthly dosing. If successful, the candidate could strengthen the company’s long-term growth strategy by expanding its cardiovascular inflammation franchise beyo…Read full documentShow less
Kiniksa Pharmaceuticals (NASDAQ:KNSA) reported strong second-quarter 2026 financial results, raised its full-year ARCALYST sales guidance, and advanced its cardiovascular pipeline with the Phase 3 launch of KPL-387 for recurrent pericarditis. Kiniksa increased its 2026 ARCALYST net sales guidance to $980 million-$995 million following strong prescription growth and higher patient adoption. Second-quarter revenue rose 55% year over year to $243.6 million, while net income increased to $25.4 million. Kiniksa (NASDAQ:KNSA) has initiated the pivotal Phase 3 PASTORALE trial for KPL-387 after positive Phase 2 results supported once-monthly dosing. The company ended the quarter with $525.9 million in cash, cash equivalents, and short-term investments and no debt. Management expects its current operating plan to remain cash flow positive on an annual basis. Kiniksa delivered second-quarter revenue of $243.6 million, up from $156.8 million in the prior-year period, driven by continued growth of ARCALYST for recurrent pericarditis. The company reported ARCALYST net product revenue of $243.6 million during the quarter and raised its full-year 2026 sales guidance to between $980 million and $995 million, up from its previous forecast of $930 million to $945 million. Management attributed the stronger outlook to continued growth in both new and repeat prescribers, resulting in a meaningful increase in patients receiving therapy. Kiniksa also announced positive progress for KPL-387. Interval data from the Phase 2 portion of its ongoing Phase 2/3 study showed rapid reductions in pain and inflammation with once-monthly subcutaneous dosing, supporting the launch of the pivotal Phase 3 PASTORALE trial, which is now enrolling and dosing patients. Financially, net income increased to $25.4 million from $17.8 million a year earlier despite higher investment in research, commercialization, and clinical development. The higher ARCALYST sales guidance reinforces the drug’s commercial momentum and suggests continued expansion within the recurrent pericarditis market. At the same time, advancing KPL-387 into Phase 3 provides Kiniksa with a potential next-generation therapy that management believes could offer convenient once-monthly dosing. If successful, the candidate could strengthen the company’s long-term growth strategy by expanding its cardiovascular inflammation franchise beyond ARCALYST. The company’s debt-free balance sheet and more than $525 million in cash also provide financial flexibility to continue investing in late-stage development programs, including KPL-387 and KPL-1161, while maintaining positive annual cash flow. Investors will likely monitor continued ARCALYST prescription growth, progress in the Phase 3 PASTORALE trial for KPL-387, and the planned initiation of the Phase 1 study for KPL-1161 by the end of 2026. Future updates on patient enrollment, clinical milestones, and commercial execution will be important indicators of the company’s long-term growth trajectory. Kiniksa Pharmaceuticals stock price
Investor releaseQuarter not tagged2026-07-28Kiniksa Pharmaceuticals, Ltd. Q2 2026 Earnings Call Summary
Moby
Kiniksa Pharmaceuticals, Ltd. Q2 2026 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved the largest quarterly net revenue increase since launch, driven by the execution of a multi-pronged commercial strategy and shifting treatment paradigms in recurrent pericarditis. Expanded ARCALYST market penetration to approximately 21% of the multiple recurrence population, up from around 18% at the end of 2025, highlighting significant remaining growth runway. Attributed commercial success to disciplined sales infrastructure investments and the deployment of machine learning and AI to optimize the timing and messaging of field team interactions. Leveraged the 2025 ACC concise clinical guidance to move ARCALYST earlier in the treatment sequence, successfully shifting physician behavior away from corticosteroids toward IL-1 inhibition. Reported a record number of new patient enrollments and a broadening prescriber base, with approximately 450 new health care professionals writing their first ARCALYST prescription in Q2. Affirmed the 300mg monthly subcutaneous dose for KPL-387 based on Phase II data showing rapid onset of action and durable efficacy, supporting its advancement into the pivotal PASTORALE trial. Raised full-year 2026 revenue guidance to between $980 million and $995 million, reflecting sustained commercial momentum and increased patient demand. Targeting a potential commercial launch for KPL-387 in the 2028 to 2029 timeframe to extend leadership in the recurrent pericarditis market with a monthly dosing profile. Initiated the Phase III PASTORALE study, an event-driven randomized withdrawal trial designed to measure the reduction in risk of pericarditis recurrence as the primary demonstration of efficacy. Progressing KPL-1161, an Fc-modified IL-1 alpha and beta inhibitor, with plans to initiate a Phase I study by the end of 2026 to target quarterly dosing. Anticipate that the operating plan and current cash balance of $525.9 million provide sufficient runway to execute on both commercial growth and pipeline advancement. Operating expenses increased year-over-year due to higher cost of goods sold, collaboration profit-sharing, and intensified R&D spending for the KPL-387 pivotal program. Gross-to-net adjustments reached 7.2% year-to-date, primarily influenced by strategic changes to pat…Read full documentShow less
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved the largest quarterly net revenue increase since launch, driven by the execution of a multi-pronged commercial strategy and shifting treatment paradigms in recurrent pericarditis. Expanded ARCALYST market penetration to approximately 21% of the multiple recurrence population, up from around 18% at the end of 2025, highlighting significant remaining growth runway. Attributed commercial success to disciplined sales infrastructure investments and the deployment of machine learning and AI to optimize the timing and messaging of field team interactions. Leveraged the 2025 ACC concise clinical guidance to move ARCALYST earlier in the treatment sequence, successfully shifting physician behavior away from corticosteroids toward IL-1 inhibition. Reported a record number of new patient enrollments and a broadening prescriber base, with approximately 450 new health care professionals writing their first ARCALYST prescription in Q2. Affirmed the 300mg monthly subcutaneous dose for KPL-387 based on Phase II data showing rapid onset of action and durable efficacy, supporting its advancement into the pivotal PASTORALE trial. Raised full-year 2026 revenue guidance to between $980 million and $995 million, reflecting sustained commercial momentum and increased patient demand. Targeting a potential commercial launch for KPL-387 in the 2028 to 2029 timeframe to extend leadership in the recurrent pericarditis market with a monthly dosing profile. Initiated the Phase III PASTORALE study, an event-driven randomized withdrawal trial designed to measure the reduction in risk of pericarditis recurrence as the primary demonstration of efficacy. Progressing KPL-1161, an Fc-modified IL-1 alpha and beta inhibitor, with plans to initiate a Phase I study by the end of 2026 to target quarterly dosing. Anticipate that the operating plan and current cash balance of $525.9 million provide sufficient runway to execute on both commercial growth and pipeline advancement. Operating expenses increased year-over-year due to higher cost of goods sold, collaboration profit-sharing, and intensified R&D spending for the KPL-387 pivotal program. Gross-to-net adjustments reached 7.2% year-to-date, primarily influenced by strategic changes to patient co-pay support programs implemented at the start of the year. Collaboration profit grew 68% year-over-year to $176.1 million, outpacing sales growth and demonstrating the operating leverage of the commercial model. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management attributed the growth to a culmination of flawless execution, including AI-driven predictive alerts for patient flares and the 'Heart's Home' DTC campaign. Confirmed that the 21% penetration rate in the multiple recurrence population represents a substantial opportunity for continued expansion into the broader 40,000-patient label. Noted no major changes in patient phenotype, but observed improved diagnosis rates as cardiologists better differentiate between index episodes and recurrent disease. Explained that gross-to-net is typically highest in Q1 and lower in Q2/Q3, with current favorability driven by optimized co-pay support structures. Stated that KPL-387's median time to treatment response of 4 days is consistent with the robust efficacy seen in the prior RHAPSODY trials for ARCALYST. Highlighted market research showing 75% of patients prefer the KPL-387 target profile (monthly dosing) over current commercial or other investigational therapies. The study is designed to provide supplemental label information to assist clinicians in transitioning patients from NSAIDs, corticosteroids, or other IL-1 inhibitors to KPL-387. Aims to establish clear dosing administration guidelines to facilitate transitioning patients who are experiencing disease recurrence despite conventional oral therapies.
Investor releaseQuarter not tagged2026-07-28Kiniksa Pharmaceuticals Reports Second Quarter 2026 Financial Results and Recent Portfolio Execution
GlobeNewswire
Kiniksa Pharmaceuticals Reports Second Quarter 2026 Financial Results and Recent Portfolio Execution
– ARCALYST® (rilonacept) Q2 2026 net product revenue of $243.6 million, representing ~55% year-over-year growth –– ARCALYST 2026 expected net product revenue increased to $980 - $995 million –– KPL-387 Phase 2 data demonstrated rapid and sustained reductions in pain and inflammation at 300 mg SC once-monthly, the dose level selected for Phase 3 –– KPL-387 pivotal Phase 3 trial in recurrent pericarditis now enrolling and dosing patients –– Conference call and webcast scheduled for 8:30 am ET today – LONDON, July 28, 2026 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, today reported second quarter 2026 financial results and recent portfolio execution. “In the second quarter, Kiniksa continued to drive growth in new and repeat prescribers of ARCALYST in recurrent pericarditis, which led to a meaningful increase in patients on therapy. As a result, we have raised our 2026 ARCALYST net sales guidance to between $980 and $995 million,” said Sanj K. Patel, Chairman & Chief Executive Officer of Kiniksa. “In our clinical portfolio, KPL-387 Phase 2 data supported initiation of the pivotal Phase 3 trial, PASTORALE, which is now enrolling and dosing patients. We are excited to advance KPL-387 with its target product profile of once-monthly subcutaneous dosing in a liquid formulation. We expect to bring this potential additional treatment option to patients in the 2028/2029 timeframe. Additionally, we continue to develop KPL-1161 with a target profile of once-quarterly dosing and are on track to initiate a Phase 1 trial by the end of this year.” Portfolio ExecutionARCALYST (IL-1α and IL-1β cytokine trap) ARCALYST net product revenue was $243.6 million for the second quarter of 2026. As of the end of the second quarter of 2026, approximately 21% of the 14,000 multiple-recurrence patients were actively on ARCALYST treatment. Since launch, more than 5,000 prescribers have written ARCALYST prescriptions for recurrent pericarditis. As of the end of the second quarter of 2026, average total duration of ARCALYST therapy in recurrent pericarditis was approximately 3 years, in line with the median duration of disease. KPL-387 (monoclonal antibody IL-1 receptor antagonist) Kiniksa today announ…Read full documentShow less
– ARCALYST® (rilonacept) Q2 2026 net product revenue of $243.6 million, representing ~55% year-over-year growth –– ARCALYST 2026 expected net product revenue increased to $980 - $995 million –– KPL-387 Phase 2 data demonstrated rapid and sustained reductions in pain and inflammation at 300 mg SC once-monthly, the dose level selected for Phase 3 –– KPL-387 pivotal Phase 3 trial in recurrent pericarditis now enrolling and dosing patients –– Conference call and webcast scheduled for 8:30 am ET today – LONDON, July 28, 2026 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, today reported second quarter 2026 financial results and recent portfolio execution. “In the second quarter, Kiniksa continued to drive growth in new and repeat prescribers of ARCALYST in recurrent pericarditis, which led to a meaningful increase in patients on therapy. As a result, we have raised our 2026 ARCALYST net sales guidance to between $980 and $995 million,” said Sanj K. Patel, Chairman & Chief Executive Officer of Kiniksa. “In our clinical portfolio, KPL-387 Phase 2 data supported initiation of the pivotal Phase 3 trial, PASTORALE, which is now enrolling and dosing patients. We are excited to advance KPL-387 with its target product profile of once-monthly subcutaneous dosing in a liquid formulation. We expect to bring this potential additional treatment option to patients in the 2028/2029 timeframe. Additionally, we continue to develop KPL-1161 with a target profile of once-quarterly dosing and are on track to initiate a Phase 1 trial by the end of this year.” Portfolio ExecutionARCALYST (IL-1α and IL-1β cytokine trap) ARCALYST net product revenue was $243.6 million for the second quarter of 2026. As of the end of the second quarter of 2026, approximately 21% of the 14,000 multiple-recurrence patients were actively on ARCALYST treatment. Since launch, more than 5,000 prescribers have written ARCALYST prescriptions for recurrent pericarditis. As of the end of the second quarter of 2026, average total duration of ARCALYST therapy in recurrent pericarditis was approximately 3 years, in line with the median duration of disease. KPL-387 (monoclonal antibody IL-1 receptor antagonist) Kiniksa today announced data from an interval analysis of the ongoing KPL-387 Phase 2/3 trial in recurrent pericarditis. The Phase 2 dose-focusing portion of the trial is designed to evaluate the dose response and safety of different subcutaneously (SC) administered KPL-387 dose regimens and to support dose selection for the pivotal Phase 3 portion of the trial. Kiniksa is enrolling and dosing patients in PASTORALE, the pivotal Phase 3 portion of the Phase 2/3 clinical trial. Kiniksa is also conducting a supplemental Phase 2 Transition to KPL-387 Monotherapy Dosing & Administration Study evaluating the efficacy and safety of dosing regimens used to transition patients from standard therapies to KPL-387 monotherapy. ________________* Reported as median (95% confidence interval).1 Treatment Response is defined as Pain Response (NRS score ≤ 2 on the 11-point daily pericarditis pain NRS pain scale) and at least one CRP level ≤ 0.5 mg/dL within 7 days before or after the Pain Response.2 CRP Normalization is defined as CRP ≤ 0.5 mg/dL. KPL-1161 (Fc-modified monoclonal antibody IL-1 receptor antagonist) Kiniksa is conducting preclinical development activities with KPL-1161 with a target profile of quarterly SC dosing. The company expects to initiate a Phase 1 first-in-human clinical trial by the end of 2026. Financial Results Total revenue for the second quarter of 2026 was $243.6 million, compared to $156.8 million for the second quarter of 2025. Total operating expenses for the second quarter of 2026 were $216.4 million, compared to $136.6 million for the second quarter of 2025, and comprised the following: Net income for the second quarter of 2026 was $25.4 million, compared to $17.8 million for the second quarter of 2025. As of June 30, 2026, Kiniksa had $525.9 million of cash, cash equivalents, and short-term investments and no debt. Financial Guidance Kiniksa expects 2026 ARCALYST net product revenue of between $980 million and $995 million, compared to prior guidance of between $930 million and $945 million. Kiniksa expects its current operating plan to remain cash flow positive on an annual basis. Conference Call Information Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, July 28, 2026, to discuss second quarter 2026 financial results and recent portfolio execution. Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event. About KiniksaKiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa’s portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit www.kiniksa.com. About ARCALYSTARCALYST is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. ARCALYST was discovered by Regeneron Pharmaceuticals, Inc. (Regeneron) and is approved by the U.S. Food and Drug Administration (FDA) for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and deficiency of IL-1 receptor antagonist (DIRA). The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug exclusivity to ARCALYST in 2021 for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and pediatric patients 12 years and older. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2021. IMPORTANT SAFETY INFORMATION ABOUT ARCALYST ARCALYST may affect your immune system and can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death, have happened in patients taking ARCALYST. If you have any signs of an infection, call your doctor right away. Treatment with ARCALYST should be stopped if you get a serious infection. You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection). While taking ARCALYST, do not take other medicines that block interleukin-1, such as Kineret® (anakinra), or medicines that block tumor necrosis factor, such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab), as this may increase your risk of getting a serious infection. Talk with your doctor about your vaccine history. Ask your doctor whether you should receive any vaccines before you begin treatment with ARCALYST. Medicines that affect the immune system may increase the risk of getting cancer. Stop taking ARCALYST and call your doctor or get emergency care right away if you have any symptoms of an allergic reaction. Your doctor will do blood tests to check for changes in your blood cholesterol and triglycerides. Common side effects include injection-site reactions (which may include pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site), upper respiratory tract infections, joint and muscle aches, rash, ear infection, sore throat, and runny nose. For more information about ARCALYST, talk to your doctor and see the Product Information. About KPL-387KPL-387 is an independently developed, investigational, fully human immunoglobulin G2 (IgG2) monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling of the cytokines IL-1α and IL-1β. Kiniksa believes KPL-387 could expand the treatment options for recurrent pericarditis patients by potentially enabling dosing with a single monthly SC self-injection in a liquid formulation. In October 2025, the FDA granted Orphan Drug Designation to KPL-387 for the treatment of pericarditis. About PASTORALEPASTORALE is a double-blind, placebo controlled, randomized withdrawal (RW) study enrolling up to approximately 85 patients with recurrent pericarditis. In the first period, a single-blind run-in (RI), all participants will receive KPL-387 while conventional oral pericarditis medications are weaned and discontinued. Participants achieving Clinical Response in the RI period will then be randomized in a 1:1 ratio to receive either KPL-387 300 mg SC once-monthly or placebo in an event-driven, double-blind, RW period. The primary efficacy endpoint is time to first-adjudicated pericarditis recurrence during the RW period. Participants in the RW period may be eligible to enter a long-term extension. About KPL-1161KPL-1161 is an independently developed, investigational, Fc-modified IgG2 monoclonal antibody that binds IL-1R1, inhibiting the signaling of the cytokines IL-1α and IL-1β, with a target profile of quarterly SC dosing. Kiniksa is currently engaging in preclinical development activities for KPL-1161. Forward-Looking StatementsThis press release contains forward-looking statements. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our expectation that ARCALYST 2026 net product revenue will be between $980 million and $995 million; our expectation to begin commercialization of KPL-387 in 2028 or 2029; our belief that we are on track to initiate a Phase 1 first-in-human clinical trial of KPL-1161 by the end of 2026; our expectation that our current operating plan will remain cash flow positive on an annual basis; our target profile of quarterly subcutaneous dosing for KPL-1161; our beliefs about the mechanisms of our assets and potential impact of their approach; statements regarding our belief about the future of our commercial opportunities; and our belief that our portfolio of assets offers the potential for differentiation. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials, including the data from the interval analysis of our Phase 2 clinical trial of KPL-387 in recurrent pericarditis; our inability to replicate results from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; potential undesirable side effects caused by our products and product candidates; our inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities to not accept our filings, delay or deny approval of any of our product candidates or require additional data or trials to support approval; our reliance on third parties as the sole source of supply of the drug substance and drug product used in our products and product candidates; raw material, important ancillary product and drug substance and/or drug product shortages; business development activities and their impact on our financial performance and strategy; changes in our operating plan, business development strategy or funding requirements; existing or new competition; current and future healthcare reforms, including those affecting the delivery of or payment for healthcare products and services; and the impact of global economic policy, including any uncertainty in national and international markets. These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. ARCALYST® is a registered trademark of Regeneron Pharmaceuticals, Inc. Every Second Counts! ® Kiniksa Investor & Media ContactJonathan Kirshenbaum(781) [email protected]
TranscriptFY2026 Q22026-07-28FY2026 Q2 earnings call transcript
Earnings source - 61 paragraphs
FY2026 Q2 earnings call transcript
Thank you for standing by, and welcome to the Kiniksa Pharmaceuticals Q2 2026 earnings conference call. At this time, all participants are in listen only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. If your question has been answered and you would like to remove yourself from the queue, simply press star one one again. As a reminder, today's program is being recorded. Now I would like to introduce your host for today's program, Jonathan Kirshenbaum, Senior Manager of Investor Relations. Please go ahead, sir.
Thank you, operator. Good morning, everyone, and welcome to the Kiniksa Pharmaceuticals Q2 2026 earnings call. A press release highlighting our financial results and recent portfolio execution can be found on our website under the investors section. As for the agenda, our Chief Executive Officer, Sanj K. Patel, will start with an introduction that will be followed by Ross Moat, our Chief Operating Officer, who will provide an update on ARCALYST commercial execution. From there, Kiniksa's Chief Medical Officer, Dr. John Paolini, will review our KPL-387 development program and the ongoing phase II/III clinical trial in recurrent pericarditis. After that, Mark Ragosa, our Chief Financial Officer, will review our Q2 2026 financial results. Finally, Sanj will share closing remarks and kick off the Q&A session.
Before getting started, please note that we will be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from such statements. A review of these statements and risk factors can be found on this slide, as well as under the caption Risk Factors contained in our SEC filings. These statements speak only as of the date of this presentation and we undertake no obligation to update such statements except as required by law. With that, I will turn it over to Sanj.
Thanks, Jonathan. Good morning or good afternoon, everyone. Kiniksa is in a strong position more than halfway through 2026 as we continue to execute across our portfolio. We continue to make excellent progress with ARCALYST and have advanced the KPL-387 program into the pivotal stage with the initiation of the phase III trial, which we have named PASTEURAL. Additionally, KPL-1161, which is our Fc-modified IL-1 alpha and beta inhibitor with a target profile of quarterly dosing, is progressing well, and the program remains on track to initiate a phase I study by the end of this year. Importantly, we have continued to maintain a robust financial position, which together with strong commercial momentum and key advancements in our development pipeline, positions the company with multiple value-creating drivers in both the near and long term.
Our ongoing execution of the ARCALYST commercial strategy resulted in a meaningful increase in the number of patients on therapy. Robust revenue growth of more than $29 million over the previous quarter drove sales of $243.6 million in the Q2. We continue to build on our strong commercial momentum, and we've raised our full year 2026 revenue guidance from $930 million-$945 million to between $980 million and $995 million. On the clinical side, just this morning, we announced data from the dose focusing portion of the KPL-387 phase II/phase III study in recurrent pericarditis. On the basis of the phase II data, I'm happy to report that we are moving forward with the target profile of a monthly dose into the pivotal phase III portion of the trial.
Today, we also announced that this phase III study has already started and is now enrolling and dosing patients. The ongoing phase III study, PASTEURAL, marks a key milestone in bringing additional treatment options to patients suffering from recurrent pericarditis. This trial follows RHAPSODY, the successful phase III program with ARCALYST, with both trials having the same registrational endpoint of reduction in the risk of pericarditis recurrence. John will share additional details about the phase II data in a moment, as well as provide an overview of the design of this phase III study. We anticipate a potential commercial launch of KPL-387 in the 2028 and 2029 timeframe, extending our leadership in the recurrent pericarditis market so we can help many more patients. With that, I'll turn it over to Ross to review our commercial execution. Ross?
Thank you, Sanj. In Q2, the Kiniksa commercial team continued to drive strong growth with ARCALYST. Our net revenue was $243.6 million, which is more than $85 million growth versus Q2 of 2025, and more than $29 million growth compared to Q1 2026.
This represents the largest quarterly net revenue increase since our launch more than five years ago, and is a direct result of the execution of the strategy that we laid out at the beginning of this year. Our commercial approach has helped to change the treatment paradigm for recurrent pericarditis, and we are focused on continuing to unlock future growth for ARCALYST. Over time, we have made disciplined, value-driven investments across our sales infrastructure, as well as innovative strategies that have enabled us to reach more patients. Firstly, we've been diligently ensuring that prescribers have a positive prescribing experience, which encourages deeper prescribing as well as peer-to-peer education to other healthcare professionals. Additionally, we've been invested in machine learning and the use of AI to provide our sales team with insights on not just who to target, but importantly, when to visit and what messages should be delivered.
Secondly, in April of this year, we launched our targeted DTC campaign called Heart's Home. This campaign is aimed at educating and empowering patients who are suffering from recurrent pericarditis to visit their healthcare professional and ask for ARCALYST. So far, the campaign has reached thousands of patients who are suffering from recurrent pericarditis. While it's still in the early stages, we are starting to see encouraging signs of engagement with our campaign and patients visiting their healthcare professional to discuss ARCALYST. Thirdly, our teams have been highly focused on disseminating the 2025 ACC Concise Clinical Guidance for Recurrent Pericarditis. The understanding of this guidance and the recommendation of moving ARCALYST earlier in line after NSAIDs and colchicine and ahead of corticosteroids, has helped to expand the utilization of ARCALYST.
Since our focus on disseminating this publication, we've seen an increase in doctors who have changed their treatment approach and are now using ARCALYST earlier in the disease course. Finally, the commercialization is underpinned by ARCALYST's highly efficacious and well-tolerated profile, along with robust compliance, growing persistence, and an excellent payer approval rate. As of the end of Q2, our penetration into the multiple recurrence population had grown to approximately 21%, compared to around 18% at the end of 2025. This demonstrates both strong growth as well as the substantial opportunity ahead. As mentioned on the last slide, we're seeing continued momentum in the breadth and depth of ARCALYST prescribing, which in Q2 led to significantly higher number of new patient enrollments compared to any quarter since our launch.
Approximately 450 additional healthcare professionals wrote their first ARCALYST prescription in the Q2, bringing the total prescriber base to more than 5,000 launch to date. As a reminder, there are more than 25,000 healthcare professionals across the country who manage recurrent pericarditis patients. Therefore, the opportunity for continued growth is evident. Additionally, the number of healthcare professionals who have written multiple prescriptions increased by approximately 150 compared to Q1 of 2026, meaning that around 29% of the prescriber base have written ARCALYST for two or more patients. The dual acceleration in both new and repeat prescribing led to an increase in patient enrollments, which resulted in a substantial increase to the number of patients on therapy, and illustrates the demand for a highly efficacious treatment that protects patients from suffering unnecessary additional flares.
As you can hear, we're pleased with the Q2 performance, but we continue to be even more excited by the opportunity that's ahead. With that, I'll turn the call over to Dr. John Paolini to share more information on our KPL-387 program in recurrent pericarditis. John.
Thank you, Ross. As Sanj mentioned, the pivotal phase III trial of KPL-387 in recurrent pericarditis has now been initiated and is already enrolling and dosing patients. Before that, I'll provide a brief overview of the phase II dose-focusing portion of the trial, data from which affirmed the dose level for phase III. As a reminder, for the phase II/III study, we have combined both portions into a single integrated protocol in order to maximize operational efficiency, thus allowing the phase III portion to begin even while the phase II trial is still ongoing. Phase II is designed to define the PK/PD relationship and provide information on the cadence and magnitude of initial response as well as the durability of effect of defined subcutaneously administered KPL-387 dose levels.
Up to approximately 80 participants presenting at screening with a pericarditis recurrence despite treatment with NSAIDs and colchicine are randomized equally into four arms to receive subcutaneously administered KPL-387 at 100 milligrams or 300 milligrams dosed biweekly or once monthly. Concomitant treatment with conventional oral therapies is weaned and discontinued within two weeks to attain KPL-387 monotherapy. The primary endpoint of the phase II dose-focusing study is time to treatment response through 24 weeks, defined as an NRS score of less than or equal to two on the 11-point daily pericarditis NRS pain scale and normalization of C-reactive protein, a marker of pericardial inflammation. The data we announced today show that the KPL-387 300-mg monthly dose level demonstrated rapid and sustained onset of action with durable efficacy throughout the monthly dosing interval, affirming the 300-mg monthly dose being evaluated in the phase III study, PASTEURAL.
Specifically, in this analysis, median time to treatment response was four days with a 95% confidence interval of three - six days. Median time to pain response was four days with a confidence interval of three - six days, and median time to CRP normalization was eight days with a confidence interval of seven - nine days. The cadence and magnitude of these reductions in pain and inflammation are consistent with prior studies which supported ARCALYST approval in recurrent pericarditis. KPL-387 was generally well-tolerated, consistent with the well-known safety profile of IL-1 pathway inhibition. Regarding the other dose levels in the study not selected for phase III, the 100-mg subcutaneous biweekly and monthly dose levels showed some effect, but not at the level to support further study. The KPL-387 300-mg biweekly dose level was efficacious without incremental benefit above the monthly dose level.
The totality of data available supported the initiation of PASTEURAL with the 300-mg subcutaneous monthly dose level. The PASTEURAL design should look familiar based upon our prior work in RHAPSODY. This pivotal phase III trial is a placebo-controlled, event-driven, randomized withdrawal study designed to measure the reduction in risk of pericarditis recurrence as the primary demonstration of KPL-387 efficacy for the label. The primary efficacy endpoint is time to first adjudicated pericarditis recurrence during the randomized withdrawal period. The trial will enroll up to approximately 85 participants experiencing a pericarditis recurrence despite conventional oral therapies into a single blind run-in period, during which KPL-387 is initiated, and oral therapies are weaned and discontinued. Participants are blinded to the duration of the run-in period.
Subsequently, participants who respond to KPL-387 in the run-in period then enter the randomized withdrawal period in which they either continue receiving KPL-387 300 milligrams once monthly or switch to placebo. Upon closure of the randomized withdrawal period, participants may be eligible to continue into a long-term extension. As we have mentioned, our goal is to bring this potential new additional treatment option to patients in the 2028 - 2029 timeframe. I will now turn the call over to Mark to cover our Q2 financials. Mark?
Thanks, John. This morning, I'll walk us through our Q2 2026 financial performance and highlight the key drivers behind the results. As always, detailed financial information is available in today's press release. The quarter reflected strong execution with continued momentum across our commercial business, advancement of our development pipeline, and further strengthening of our financial position. Starting on the left-hand side of this slide with the income statement, ARCALYST revenue grew 55% year-over-year to $243.6 million in the Q2. As you heard from Ross, this growth was driven by continued expansion in new and repeat prescribers as well as patient enrollments. Operating expense growth year-over-year was driven by several factors.
Higher cost of goods sold due to ARCALYST revenue growth, increased collaboration expenses aligned with higher ARCALYST revenue and collaboration profit, higher R&D, primarily due to the increased KPL-387 clinical trial costs as well as manufacturing costs, also increased preclinical development investment. Lastly, additional SG&A, primarily driven by investment associated with the commercialization of ARCALYST. Together, these factors contributed to year-over-year increases in operating income and net income, which were $27.2 million and $25.4 million, respectively. The calculation for ARCALYST collaboration profit drives total collaboration expenses is on the right-hand side of the slide. Here, we continue to leverage disciplined commercial investment as ARCALYST collaboration profit grew faster than sales on a year-over-year basis, increasing 68% to $176.1 million.
Turning next to cash, at the bottom of the slide, we ended the Q2 with a $525.9 million cash balance, representing approximately $58 million of net cash generation for the period. Looking ahead, we believe our operating plan enables us to continue helping patients while creating additional value over both the near and longer term. With that, I'll turn the call back to Sanj for closing remarks.
Thanks, Mark. As you've heard, Kiniksa is well-positioned to build significant future value as we grow our IL-1 alpha and beta inhibition franchise. We are dedicated to helping as many patients as possible with ARCALYST and to advancing the development of our clinical portfolio in order to bring additional therapies to patients. With that, I'll now turn the call back to the operator for questions.
Certainly. Once again, if you have a question at this time, please press star one one on your telephone. Our first question comes from the line of Nicholas Lorusso from TD Cowen. Your question please.
Thanks very much for taking our question, congrats on the very strong quarter, guys. As you guys mentioned, this was the strongest quarter of ARCALYST absolute sales growth since launch. Just wanted to dive into what drove this growth specifically in Q2, could this level of growth continue throughout the rest of the year and into next year? Thanks.
Thanks, Nick. I'll say a few comments, I'm sure I'll leave it to Ross to dive into some detail. Look, as always, it's continuing to execute across the entire commercial strategy and overall growing the adoption of IL-1 pathway inhibition as the preferred treatment for recurrent pericarditis. That continues to happen every quarter. Certainly, this quarter, Ross will dive into the number of new unique prescribers we've had this quarter, as well as the number of new repeat prescribers and the new enrollments. Ultimately, it's a matter of just continuing to penetrate into the total population, which we're doing. Obviously, the total duration of therapy is very important. That's about in line really with the median duration of the disease, about three years. Ultimately penetrating into that. As we just reported, we're now around 21% penetrated into the multiple recurrence population.
That to me represents a meaningful opportunity ahead, that's what we're focused on. Very excited about it. Ross, why don't you dive into some of the drivers and the actual numbers across those metrics, the special sauce is just continuing to execute.
Thanks, Sanj, thanks for the question, Nick. I think that's absolutely right. This is a culmination of a lot of work across all our commercial and cross-functional teams at this point, and where we've got to really understanding the recurrent pericarditis market and really just generally executing flawlessly across the board. Really kudos to all of the team that have been able to help so many patients throughout Q2. Ultimately, we've seen a substantial uplift in the number of both new prescribers and new repeat prescribers. As Sanj said, we have more than 450 new prescribers come into the total prescribing base in Q2, more than 150 new repeat prescribers, meaning they've prescribed for two or more patients in the quarter.
Ultimately, that's grown the number of patients that are on therapy, which led to both the results in Q2 being the highest number of nice new revenue, incremental revenue that we've had in any quarter since launch, as well as the highest number of new prescribers. Ultimately, some of the driving factors underneath that, as well as some of the actions that we've put into place around investing in AI and machine learning, trying to make our field team even more effective than they historically have been. Knowing just not only who to call upon in a very traditional targeting approach, but more importantly now seeing when to call upon doctors and some of that is through claims analysis alerts, but importantly predictive alerts as well of when patients may be coming into flare and visiting particular healthcare professionals.
As you know, we've also invested in the DTC campaign, that's starting to show some early signs of success, driving patients into the clinic to ask specifically for ARCALYST. I think the third point that's worth mentioning is around the dissemination of the ACC Concise Clinical Guidance, which actually was published in August of last year. Generally speaking, because these recurrent pericarditis patients are very widely dispersed around the country, many of the general cardiologists are not familiar with the ACC Concise Clinical Guidance for recurrent Pericarditis. Our dissemination efforts in really explaining what that guidance document means, and how IL-1 inhibition is now placed after NSAIDs and colchicine use and prior to corticosteroids, has been a key part in the transformation of really changing the treatment paradigm and being able to help many more patients.
I think all said, it's really rolled up to just ongoing solid execution across the team and acknowledging that even now, five years plus into the launch, there remains very significant opportunity for ARCALYST moving forward.
Thank you very much. It's all very helpful.
Thank you. Our next question comes from the line of Eva Fortea from Wells Fargo. Your question, please.
Hey, good morning. Thanks for taking our question and congrats on the quarter. Two quick ones from us. On your prepared remarks, you mentioned a higher number of new patient enrollment for ARCALYST this quarter. Is there a specific patient profile that you're seeing coming at this stage of the launch? The follow-up was, can you comment on the gross to net for the quarter? Thanks.
Ross, why don't you start with the beginning part on Mark, if you can comment on the Go-To-Market?
Yeah, absolutely. Let's do that. Thank you, Eva, for the question. We haven't really seen any changes in the actual patient profiles as such, whether that's through kind of demographics of the patients to what level we know about that or the type of institutions or healthcare professionals that are prescribing. It's still really across the board, kind of academic centers, more rural centers. The opportunity, I think, is still very broad across the country. We haven't really seen a change in patient profile or phenotype to what we've seen. I think this is really more through just a greater understanding of recurrent pericarditis, greater efforts from the cardiology community to really differentiate between the first index pericarditis episode and actually when this becomes recurrent pericarditis.
You know, historically, the misdiagnosis and underdiagnosis rate is pretty substantial, and patients go through seeing many healthcare professionals before getting the recurrent pericarditis diagnosis. We've seen that, I think, improve over time. I think that's really everything. That there's no major changes and just happy to see more patients getting the help that they really need and deserve.
I guess, David, your second question regarding gross to net in the quarter. Historically, gross to net does move lower sequentially in the Q2. That was the case again this year. Year to date, gross to net is 7.2%, down from 8.6% in the Q1, with the main driver being lower co-pay due to the changes that we made to our support program at the beginning of the year. I think as you look throughout the rest of the year here, we don't provide specific gross to net guidance, but we do anticipate co-pay support to continue to be favorable to gross to net on an annual basis, with the majority of the impact having taken place in the Q1. Additionally, we do expect sort of the normal pattern to hold here.
Absent any prior period reserve adjustments, our gross to net historically has been highest in the Q1, lower in Q2 and Q3, then works a little bit higher in the Q4 as industry dynamics begin to play a factor. I'll leave it there.
Very helpful. Thanks.
Thank you. Our next question comes from the line of Geoff Meacham from Citi. Your question, please.
Great. Hey, guys. Thanks for the question. Congrats on the data and the quarter. Just have a couple. The first on 387, now that you have the phase II data in hand and with commercial knowledge of the market, is there anything you guys have embedded in the phase III, perhaps to further differentiate the profile of 387? Then second question I know I usually ask, but wanted to check on demand trends from the first recurrence population for ARCALYST. Is there maybe some element of that driving this quarter? Thank you.
John Paolini, I'm not sure if you want to comment on the phase III study. Essentially, obviously, we're pretty excited about the phase II results we've seen. We're obviously now moving into phase III. As we've said, we're excited about the target profile of KPL-387, potential for monthly dosing, liquid formulation. That in and of itself, I think is very exciting. Obviously, the data will be the data from the phase III. We're just focusing on really getting through the rest of the enrollment on the phase III study and hopefully seeing the results and being on the market in the 2028, 2029 time frame. John Paolini, any comments from the phase III study?
No. I would say that the profile, as Andrew mentioned, of KPL-387 that we're taking into the phase III study is one that we're very excited about. Rapid onset of action, durable efficacy throughout the monthly dosing interval that's being studied in phase III in PASTEURAL. That sets us up in an excellent position for the pivotal phase III trial. The design of the phase III trial is one that we understand well and that is well understood in the scientific community as a randomized withdrawal study design. We are prepared to execute on that and to bring the trial forward.
Thanks, Geoff. Appreciate your question. If I just answer your question on ARCALYST, thinking about the demand in the first recurrence population, we've seen that physicians are continuing to utilize ARCALYST broadly across the very broad label that we have. Which is, as you know, is agnostic to the number of recurrences that a patient has suffered from. There's around 40,000 patients in any given year that fit within the recurrent pericarditis label. When you break that down, we have about 80% of all new patient prescribing happening in the two plus recurrence. That's about 80% of new prescriptions that are coming in in a quarter are for patients that are on their second or more recurrence. That's a 14,000 patient population. Based upon that population, that's where we mentioned that we're now penetrated around 21% into that opportunity.
That's not accounting for the patients to your question directly, that are on their first recurrence. Again, fitting within the label, that's a larger patient group. It's around 26,000 of the 40,000 patients. We see about 20% of the ARCALYST prescriptions in Q2 that are within that patient group. That's been growing over time, and I think some of that reflects the acknowledgement of the broad label, the increasing confidence of using ARCALYST, and ultimately the ongoing opportunity that there is ahead. Thank you. Thank you.
Thank you. Our next question comes from the line of Anupam Sharma from JPMorgan. Your question please.
Hey, guys. Thanks so much for taking the question, and congrats on all the progress. Just wanted to follow up on Geoff Meacham's question here. On KPL-387 300 mg dose, when I look at time to response, pain, CRP, I compare it to the RHAPSODY New England Journal of Medicine paper, the run-in period for ARCALYST, it looks very in line-ish, ± a day or so. Is that a fair assessment? Can you remind us what your market research suggests a monthly regimen could mean commercially? Thanks so much. John, why don't you start, Ross, you can jump in.
Sounds great. Thank you, Anupam, for the question. Yes, we would concur that the data that we have shown from the phase II trial in terms of time to treatment response, time to pain response, and time to CRP normalization are very robust and are consistent with what has been seen previously in trials that supported rilonacept approval in recurrent pericarditis, especially when one takes a confidence interval approach to looking at the numbers with your point estimates.Ross?
Yeah. Thank you, Anupam. Yes, we did previously share some market research around thoughts from both patients and healthcare professionals on the target product profile of KPL-387 versus current commercial and other investigational therapies. Really that showed that both to a high degree for both the patients and the healthcare professionals, they were pretty excited about the KPL-387 target product profile, with around 75% of patients saying that they would prefer the KPL-387 target product profile over current commercial or available or investigational therapies. Additionally, around 92% of healthcare professionals indicated a high likelihood to prescribe for new patients in the context of the target product profile. Additionally, the potential availability of another IL-1 therapy could also expand the pool of patients for IL-1 inhibition overall with the monthly target product profile.
Thank you. Our next question comes from the line of Paul Choi from Goldman Sachs. Your question please.
Hi. Thank you. Good morning, thanks for taking our questions, and congrats on the quarter and progress. My first question is on the commercial side, I was just curious if you're thinking about adding incremental headcount to your sales force at this point, just given the commercial momentum, or is the plan to continue to leverage AI and the advancement of the ACC clinical guidelines? My second question is on KPL-387, specifically the transition study for patients who are stable. Can you maybe highlight what you're trying to show there and what data are needed to support a potential switch strategy from ARCALYST down the road? Thank you.
Maybe I'll start, John, if you can take the rest. Thanks, Paul. Look, we're always looking at our sales force analytics and working out the best way to reach these physicians and healthcare professionals.
That's an ongoing basis for us. I don't think there's anything to report really on that side. As Ross mentioned, we continue to leverage the AI and machine learning and digital marketing, which has been really helpful. Again, it's just really one part. There are a multitude of ways that we've got to continue to keep working to continue to penetrate into the total population, which we're doing. It's really a matter of no one size fits all. You've got to continue to execute across all those functions. We'll continue to crack on. Clearly, the 21% penetration so far tells you there's an awful lot more work to do, and that's what we're geared up to do. We'll do it with the best way we can across all those different areas and hopefully continue to report information to you going forward.
Thank you, Paul, for your question. Yes, the KPL-387 transition to monotherapy dosing and administration study. It was a phase II study designed to provide supplemental information for the label and to provide basically the information to assist clinicians as they move across different therapies, if you will, for recurrent pericarditis. That trial is designed to, with different dosing regimens, to test that efficacy and safety as patients move from regimens of NSAIDs and colchicine or corticosteroids or IL-1 pathway inhibitors, including anakinra and rilonacept. At the end of that study, with these different dosing paradigms having been tested, that enables the writing, if you will, of the dosing and administration section of the label in order to allow patients to move smoothly across therapeutic lines.
Okay, great. Thank you.
Thank you. Our next question comes from the line of David Nierengarten from Wedbush. Your question please.
Hey, thanks for taking the question. I have one on 387. I have maybe two. First, just what was the kind of median follow-up? Was it the full six months for these patients or something else? If you saw any recurrences in the population in the study in the 300 milligram arms or any of the other ones actually. Thanks.
Yeah. No, thank you, David, for the question. The data that were obtained for this analysis, it was an interval analysis of the ongoing study, and as such, the disclosure is limited. What we can say is that we have harvested this information to affirm the 300 mg monthly dose, certainly beyond the monthly dosing interval, right, in order to show that at the trough, if you will, of the monthly dosing interval, the treatment effect is robust. Other than that is the limit of what we have said. What we have also said, though, is that the 300 mg biweekly dose level, which of course delivers more drug, did not provide incremental benefit above the 300 mg monthly dose.
Okay. Thanks.
Thank you. This does conclude the question and answer session of today's program. I'd like to hand the program back to Sanj for any further remarks.
Thank you, operator. Well, we better crack on. Thank you for all the questions today, joining the call. We look forward to the remainder of the year and to providing additional updates in the future. Thank you.
Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day
Investor releaseQuarter not tagged2026-07-23Kiniksa Pharmaceuticals to Report Second Quarter 2026 Financial Results on July 28, 2026
GlobeNewswire
Kiniksa Pharmaceuticals to Report Second Quarter 2026 Financial Results on July 28, 2026
LONDON, July 23, 2026 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) announced today that it will host a conference call and live webcast on Tuesday, July 28, 2026 at 8:30 a.m. Eastern Time to report its second quarter 2026 financial results and recent portfolio execution. A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event. About KiniksaKiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa’s portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit www.kiniksa.com. Every Second Counts!® Kiniksa Investor & Media ContactJonathan Kirshenbaum(781) [email protected]
Investor releaseQuarter not tagged2026-05-01Kiniksa Pharmaceuticals International (KNSA) Announces Q1 2026 Financial Results
Insider Monkey
Kiniksa Pharmaceuticals International (KNSA) Announces Q1 2026 Financial Results
Kiniksa Pharmaceuticals International, plc (NASDAQ:KNSA) is one of the best drug stocks to buy according to analysts. Kiniksa Pharmaceuticals International, plc (NASDAQ:KNSA) announced its fiscal Q1 2026 financial results on April 28 and also provided updates regarding its recent portfolio execution. The company reported that net product revenue for ARCALYSTᆴ in fiscal Q1 2026 reached $214.3 million, representing 56% year-over-year growth. The company experienced growth in both new and repeat prescribers as fiscal Q1 progressed, which offered momentum for its ARCALYST franchise for the rest of the year. Kiniksa Pharmaceuticals International, plc (NASDAQ:KNSA) thus raised its 2026 ARCALYST net sales guidance to between $930 and $945 million from between $900 and $920 million. Total revenue for fiscal Q1 rose to $214.3 million, compared to $137.8 million for the first quarter of 2025. The company further reported that the KPL-387 Phase 2 recurrent pericarditis data is expected in the second half of 2026, with the Phase 3 pivotal trial expected to initiate by the end of the year. In addition, management stated that the fiscal Q1 2026 cash balance grew to $468.1 million. Kiniksa Pharmaceuticals International, plc (NASDAQ:KNSA) is a commercial-stage biopharmaceutical company that discovers, acquires, develops, and commercializes therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical needs. While we acknowledge the potential of KNSA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 15 Stocks That Will Make You Rich in 10 Years AND 12 Best Stocks That Will Always Grow. Disclosure: None. Follow Insider Monkey on Google News.
Investor releaseQuarter not tagged2026-04-29Kiniksa Pharmaceuticals International PLC (KNSA) Q1 2026 Earnings Call Highlights: Robust ...
GuruFocus.com
Kiniksa Pharmaceuticals International PLC (KNSA) Q1 2026 Earnings Call Highlights: Robust ...
This article first appeared on GuruFocus. ARCALYST Revenue: $214.3 million in Q1 2026, a 56% year-over-year increase. Full-Year Revenue Guidance: Raised to $930 million to $945 million from previous $900 million to $920 million. Net Income: Increased to $22.6 million in Q1 2026 from $8.5 million in Q1 2025. ARCALYST Collaboration Profit: Grew 73% year-over-year to $151.2 million. Cash Balance: Ended Q1 2026 with $468.1 million, representing $54 million of net cash generation. New Prescribers: Approximately 400 new prescribers in Q1 2026, bringing the total to over 4,550. Repeat Prescribers: Approximately 1,320 prescribers have prescribed ARCALYST multiple times. Warning! GuruFocus has detected 9 Warning Sign with SEI. Is KNSA fairly valued? Test your thesis with our free DCF calculator. Release Date: April 28, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Kiniksa Pharmaceuticals International PLC (NASDAQ:KNSA) reported strong revenue growth for ARCALYST, with sales reaching $214.3 million in the first quarter of 2026, a 56% increase year-over-year. The company raised its full-year 2026 revenue guidance to $930 million to $945 million, up from the previous guidance of $900 million to $920 million. Kiniksa's financial position remains robust, with a cash balance of $468.1 million and positive cash flow, enabling continued investment in growth opportunities. The company is advancing its clinical pipeline, with the KPL-387 Phase 2, Phase 3 study in recurrent pericarditis on track, and plans to start a Phase 1 study for KPL-1161 by the end of the year. Kiniksa has launched a targeted direct-to-consumer campaign, 'Hearts Home,' to increase awareness and adoption of ARCALYST among recurrent pericarditis patients, leveraging digital innovation and AI for cost-effective outreach. Despite the strong performance, Kiniksa faces industry-wide headwinds related to co-pay resets and changes in insurance plans, which could impact future revenue growth. The company's gross to net increased in Q1 compared to the prior quarter, although it was lower than Q1 of 2025, indicating potential fluctuations in financial metrics. There is a significant awareness gap, with only 14% of recurrent pericarditis patients being unaided aware of ARCALYST, which could limit market penetration. The transition to KPL-387 monotherapy invo…Read full documentShow less
This article first appeared on GuruFocus. ARCALYST Revenue: $214.3 million in Q1 2026, a 56% year-over-year increase. Full-Year Revenue Guidance: Raised to $930 million to $945 million from previous $900 million to $920 million. Net Income: Increased to $22.6 million in Q1 2026 from $8.5 million in Q1 2025. ARCALYST Collaboration Profit: Grew 73% year-over-year to $151.2 million. Cash Balance: Ended Q1 2026 with $468.1 million, representing $54 million of net cash generation. New Prescribers: Approximately 400 new prescribers in Q1 2026, bringing the total to over 4,550. Repeat Prescribers: Approximately 1,320 prescribers have prescribed ARCALYST multiple times. Warning! GuruFocus has detected 9 Warning Sign with SEI. Is KNSA fairly valued? Test your thesis with our free DCF calculator. Release Date: April 28, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Kiniksa Pharmaceuticals International PLC (NASDAQ:KNSA) reported strong revenue growth for ARCALYST, with sales reaching $214.3 million in the first quarter of 2026, a 56% increase year-over-year. The company raised its full-year 2026 revenue guidance to $930 million to $945 million, up from the previous guidance of $900 million to $920 million. Kiniksa's financial position remains robust, with a cash balance of $468.1 million and positive cash flow, enabling continued investment in growth opportunities. The company is advancing its clinical pipeline, with the KPL-387 Phase 2, Phase 3 study in recurrent pericarditis on track, and plans to start a Phase 1 study for KPL-1161 by the end of the year. Kiniksa has launched a targeted direct-to-consumer campaign, 'Hearts Home,' to increase awareness and adoption of ARCALYST among recurrent pericarditis patients, leveraging digital innovation and AI for cost-effective outreach. Despite the strong performance, Kiniksa faces industry-wide headwinds related to co-pay resets and changes in insurance plans, which could impact future revenue growth. The company's gross to net increased in Q1 compared to the prior quarter, although it was lower than Q1 of 2025, indicating potential fluctuations in financial metrics. There is a significant awareness gap, with only 14% of recurrent pericarditis patients being unaided aware of ARCALYST, which could limit market penetration. The transition to KPL-387 monotherapy involves complex clinical trials and regulatory processes, which could pose challenges in terms of time and resource allocation. Kiniksa's growth strategy relies heavily on the success of its clinical trials and commercialization efforts, which are subject to regulatory approvals and market dynamics. Q: Can you discuss the early impact of the direct-to-consumer (DTC) campaign and future plans to accelerate demand? A: Ross Moat, Chief Operating Officer, explained that the DTC campaign is in its early stages and aims to educate recurrent pericarditis patients about ARCALYST. The campaign targets patients to encourage discussions with healthcare providers, as ARCALYST is prescribed in about 80% of cases when patients inquire. The company is also focusing on digital marketing and peer-to-peer education to increase awareness and adoption. Q: For KPL-387, what endpoints are most important for dose selection moving to Phase 3? A: John Paolini, Chief Medical Officer, highlighted that the Phase 2 trial will focus on the time of onset, magnitude of suppression of pain and inflammation, and durability of response. These elements will help define the PK/PD relationship and affirm the therapeutic concentration and dose level for Phase 3. Q: Is the increased marketing spend primarily due to the DTC campaign, or are there other factors? A: Mark Ragosa, Chief Financial Officer, noted that SG&A expenses increased due to personnel-related costs and sales and marketing initiatives. The DTC campaign is part of a broader digital marketing strategy, and while specific guidance on spending wasn't provided, SG&A has remained consistent as a percentage of sales. Q: How does the transition study for KPL-387 differ in treatment duration, and why was 16 weeks chosen? A: John Paolini explained that the 16-week duration is designed to transition patients from other therapies to KPL-387, achieving monotherapy within this period. The study allows for a long-term extension of up to two years, providing a comprehensive view of the transition process. Q: What impact have reimbursement and referral patterns had on new patient starts for ARCALYST? A: Ross Moat stated that reimbursement remains strong across payer mixes, and referral patterns are supported by centers of excellence and initiatives like the AHA's addressing recurrent pericarditis. The company focuses on educating physicians and patients to increase awareness and adoption. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

