Kiniksa Pharmaceuticals International (KNSA) FY Conference June 10, 2025 08:00 AM ET Speaker0 Thank you. Good morning, everyone. I'm Paul Choi. I'm a biotech analyst here at Goldman Sachs. It's my pleasure to welcome Conixa for our session this morning on the day of the conference. I'm required to read off certain disclosures, which primarily relate to investment banking relationships that Goldman Sachs may have with firm, companies presenting here at the conference. These relationships include, investment ...

Jefferies Global Healthcare Conference JUNE 5, 2025 Forward Looking Statements This presentation (together with any other statements or information that we may make in connection herewith) contains forward-looking statements with respect to Kiniksa Pharmaceuticals International, plc (and its consolidated subsidiaries, collectively, unless context otherwise requires, "Kiniksa," "we," "us" or "our"). In some cases, you can identify forward looking statements by terms such as "may," "will," "should," "expect," ...

Kiniksa Pharmaceuticals International (KNSA) 2025 Conference June 05, 2025 12:50 PM ET Speaker0 Alright. Okay. Good afternoon. Welcome to twenty twenty five Jefferies Global Healthcare Conference. My name is Roger Sung, one of the seniors cover SimiCA Biotech in The US. It is my pleasure to introduce our next printing company, Connexa, and then we have the chief commercial chief commercial officer Ross and then chief medical officer John. So, they will do a normal corporate presentation and then we'll save ...

– KPL-387 Phase 2/3 trial on track to initiate in mid-2025; Phase 2 data expected in 2H 2026 – – KPL-387 Phase 1 single ascending dose data support profile for monthly dosing – – Presentation and webcast at Jefferies 2025 Global Healthcare Conference scheduled for 12:50 pm ET today– LONDON, June 05, 2025 (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 ...

Company Overview - Kiniksa Pharmaceuticals International, plc is a biopharmaceutical company focused on improving the lives of patients with debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet needs, particularly in cardiovascular indications [2] Upcoming Events - Kiniksa will present at the Jefferies 2025 Global Healthcare Conference on June 5 at 12:50 p.m. Eastern Time [3] - The company will also participate in the Goldman Sachs 46th Annual Global Healthcare Conference on June 10 at 8:00 a.m. Eastern Time, featuring a fireside chat [3] - Live webcasts of Kiniksa's presentations will be available on the company's website, with replays accessible approximately 48 hours after the events [1]

Group 1 - The biotech forum has seen significant discussions around covered call opportunities in recent quarters, indicating a focus on options trading strategies within the sector [1] - Kiniksa Pharmaceuticals (NASDAQ: KNSA) has experienced a notable increase in share price over the past week, suggesting positive market sentiment and potential trading opportunities for investors [2] - The Biotech Forum offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat discussions and weekly market commentary, which may attract investors looking for insights and trading ideas [2]

Financial Performance - Total revenue for Q1 2025 was $137.785 million, a 72.5% increase from $79.858 million in Q1 2024[23] - Product revenue for Q1 2025 reached $137.785 million, compared to $78.885 million in Q1 2024, indicating strong growth in product sales[23] - Net income for Q1 2025 was $8.539 million, a significant improvement from a net loss of $17.704 million in Q1 2024[23] - For the three months ended March 31, 2025, the company reported net product revenue of $137,785, a 74.5% increase from $78,885 in the same period of 2024[45] - The net income for the three months ended March 31, 2025, was $8.5 million, a turnaround from a net loss of $17.7 million in the prior year[130] - The basic net income per share for the three months ended March 31, 2025, was $0.12, while the diluted net income per share was $0.11, compared to a basic and diluted loss per share of $(0.25) in 2024[102] Assets and Liabilities - Total current assets increased to $355.907 million as of March 31, 2025, up from $331.799 million at the end of 2024[21] - Total assets rose to $599.326 million as of March 31, 2025, compared to $580.553 million at the end of 2024[21] - Total liabilities decreased slightly to $141.837 million as of March 31, 2025, from $142.117 million at the end of 2024[21] - Shareholders' equity increased to $457.489 million as of March 31, 2025, up from $438.436 million at the end of 2024[21] - Cash and cash equivalents at the end of Q1 2025 were $157.132 million, down from $183.581 million at the end of 2024[27] - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments totaling $268,340, indicating a strong liquidity position[36] Operating Expenses - Operating expenses totaled $124.5 million, up from $96.4 million in 2024, primarily driven by increased collaboration expenses and selling, general, and administrative costs[130] - Research and development expenses for Q1 2025 were $19.325 million, a decrease from $26.334 million in Q1 2024[23] - Selling, general and administrative expenses rose to $43.5 million in Q1 2025, compared to $38.7 million in Q1 2024, an increase of $4.8 million[181] - Collaboration expenses increased to $43.8 million in Q1 2025 from $20.8 million in Q1 2024, a rise of $23.0 million[174] Cash Flow - Net cash provided by operating activities for Q1 2025 was $22.324 million, compared to $3.987 million in Q1 2024[27] - The company incurred net cash used in investing activities of $51.5 million in Q1 2025, a significant change from net cash provided of $25.5 million in Q1 2024, attributed to cash and short-term investment portfolio management[189] Revenue Recognition and Agreements - Under the Genentech License Agreement, the company received an upfront payment of $80,000 and is eligible for approximately $600,000 in contingent payments, with $570,000 remaining as of March 31, 2025[64] - The company received a total upfront cash payment of $22,000 under the Huadong Collaboration Agreements, with an additional $20,000 received in the first quarter of 2025 following a regulatory milestone[72] - The company has recognized $0.2 million of revenue from the $32.0 million transaction price under the ARCALYST license agreement as of March 31, 2025[148] - The Company recognized $10,000 of collaboration revenue during the year ended December 31, 2022, under the mavrilimumab Huadong Collaboration Agreement[78] Future Plans and Expectations - The company plans to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025, with data expected in the second half of 2026[135] - The company expects substantial research and development expenses in the coming years due to ongoing and planned clinical trials[160] - The company anticipates requiring additional capital for collaboration, licensing, or strategic transactions, as well as for product development and manufacturing if regulatory approvals are obtained[193] Regulatory and Market Challenges - The successful commercialization of ARCALYST and future products depends on favorable coverage and reimbursement from third-party payors, including governmental authorities and private health insurers[215] - Coverage and reimbursement barriers may significantly impact the demand and pricing of ARCALYST and any future product candidates[217] - The EU Regulation on Health Technology Assessment will apply from January 12, 2025, affecting the pricing and reimbursement process for new medicines and medical devices[218] - There is a risk that patients may discontinue ARCALYST treatment during transitions between specialty pharmacies, impacting business and financial results[214] Shareholder and Equity Information - Total unrecognized compensation expense related to outstanding unvested share option awards was $32,988, expected to be recognized over a weighted average remaining period of 2.31 years[57] - The 2018 Plan has 8,261,134 shares available for future grant as of March 31, 2025, following an increase of 2,900,642 shares on January 1, 2025[54] - The company has 10,992,948 share options outstanding as of March 31, 2025, with an average exercise price of $15.27[56]

Financial Data and Key Metrics Changes - Kynixa Pharmaceuticals reported net product revenue of $137.8 million in Q1 2025, representing a 75% year-over-year increase compared to Q1 2024 [6][10] - Operating expenses grew by 29% year-over-year, driven by costs associated with the growth of Arclis revenue and commercialization efforts [16] - The company achieved a net income of $8.5 million in Q1 2025, a significant improvement from a net loss of $17.7 million in the same quarter last year [17] Business Line Data and Key Metrics Changes - Arclis revenue increased by 75% year-over-year, driven by a substantial rise in active commercial patients [10][16] - The average duration of therapy for patients increased from approximately 27 months to 30 months, indicating a growing acceptance of the treatment among healthcare professionals [11][14] - The number of unique prescribers for Arclis grew to over 3,150, an increase of more than 1,150 from the same period in 2024 [12][14] Market Data and Key Metrics Changes - Approximately 70% of Arclis's payer mix is commercial, with recent changes to the Medicare Part D program improving patient affordability and contributing to a one-time increase in patients transitioning to paid therapy [11][12] - The gross-to-net ratio for Q1 2025 was 10.7%, down from 13.5% in Q1 2024, attributed to a shift in patient mix due to Medicare changes [42][44] Company Strategy and Development Direction - Kynixa is focused on expanding its commercial franchise with Arclis and advancing the KPL-387 program in recurrent pericarditis, with plans to initiate a Phase 2/3 clinical trial in mid-2025 [7][20] - The company aims to provide additional treatment options for patients with unmet needs, emphasizing the importance of long-term therapy for recurrent pericarditis [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong performance and ability to build on momentum throughout 2025, highlighting the effectiveness of their commercial strategies [6][20] - The management acknowledged the challenges posed by specialty drug headwinds but noted that these were outweighed by strong growth in prescribers and patient adherence [10][11] Other Important Information - Kynixa ended Q1 2025 with a cash balance of $268.3 million, indicating a positive cash flow for the period [18] - The company is in the process of transferring Arclis manufacturing to Samsung Biologics in South Korea, which is expected to have an immaterial impact on costs [19] Q&A Session Summary Question: What is driving the increased duration of therapy? - Management noted that the increase is due to healthcare professionals' growing understanding of recurrent pericarditis as a multi-year disease and positive patient experiences with the therapy [23][25] Question: How many prescriptions are from first recurrence? - Approximately 15% of patients on Arclis are on their first recurrence, with 85% on two or more recurrences, indicating a broad utilization of the treatment [31][32] Question: What initiatives are being taken to increase the prescriber base? - The company is focused on targeted execution in the field, digital marketing initiatives, and educating physicians about the disease and treatment options [38][40] Question: What is the outlook for Medicare Part D patients? - The majority of Medicare Part D patients transitioning to commercial therapy were previously on the patient assistance program, and this shift is seen as a one-time event [58][60]

Core Viewpoint - Kiniksa Pharmaceuticals reported a quarterly earnings of $0.11 per share, significantly exceeding the Zacks Consensus Estimate of $0.02 per share, and showing a substantial improvement from a loss of $0.25 per share a year ago, indicating a strong earnings surprise of 450% [1] Financial Performance - The company achieved revenues of $137.79 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 7.35%, and reflecting a year-over-year increase from $79.86 million [2] - Over the last four quarters, Kiniksa Pharmaceuticals has exceeded consensus EPS estimates two times and topped consensus revenue estimates four times [2] Stock Performance - Kiniksa Pharmaceuticals shares have increased approximately 8.5% since the beginning of the year, contrasting with a decline of -6% in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is $0.08 on revenues of $138.46 million, and for the current fiscal year, it is $0.59 on revenues of $571.35 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Kiniksa Pharmaceuticals belongs, is currently ranked in the top 31% of over 250 Zacks industries, suggesting a favorable outlook as the top 50% of Zacks-ranked industries tend to outperform the bottom 50% by more than 2 to 1 [8]

Financial Data and Key Metrics Changes - Kynixa Pharmaceuticals reported a net product revenue of $137.8 million in Q1 2025, representing a 75% year-over-year increase compared to Q1 2024 [7][11] - Operating expenses grew by 29% year-over-year, driven by cost of goods sold and SG&A expenses related to Arclis commercialization [17] - The company achieved a net income of $8.5 million in Q1 2025, a significant improvement from a net loss of $17.7 million in the same quarter last year [17] Business Line Data and Key Metrics Changes - Arclis revenue grew 75% year-over-year to $137.8 million, driven by an increase in active commercial patients [11][17] - The number of unique prescribers for Arclis increased to over 3,150, with a growth of more than 1,150 from the same period in 2024 [13][14] - The average duration of therapy for patients increased from approximately 27 months to 30 months, indicating a growing appreciation for the treatment's long-term benefits [12][15] Market Data and Key Metrics Changes - The company noted a one-time increase in patients due to federal changes in the Medicare Part D program, which improved patient affordability [12][13] - Approximately 70% of Arclis's payer mix is commercial, with the Medicare program changes leading to a bolus of patients converting to paid therapy [12][13] Company Strategy and Development Direction - Kynixa is focused on expanding its commercial franchise with Arclis and advancing the KPL-387 program in recurrent pericarditis, with plans to initiate a Phase 2/3 clinical trial in mid-2025 [9][20] - The company is dedicated to helping as many patients as possible with Arclis and aims to bring additional treatment options to patients with unmet needs [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong performance and ability to build on momentum throughout 2025 [7][20] - The management highlighted the importance of understanding recurrent pericarditis as a multi-year disease, which has influenced prescribing practices [12][27] Other Important Information - Kynixa ended Q1 2025 with a cash balance of $268.3 million, indicating a net cash flow of approximately $25 million for the period [18] - The company is in the process of transferring Arclis manufacturing to Samsung Biologics in South Korea, which is expected to have an immaterial impact on cost of goods sold [19] Q&A Session Summary Question: What is driving the increased usage and patient experience feedback? - Management noted that the increase in duration is driven by healthcare professionals' understanding of the chronic nature of the disease and positive patient experiences with therapy [23][25][27] Question: How many prescriptions are from first recurrence and R&D cost trends? - Approximately 15% of patients on Arclis are on their first recurrence, with the majority on two or more recurrences. R&D costs have declined but are expected to remain stable moving forward [31][32][34] Question: What initiatives are being taken to increase the prescriber base? - The company is focused on targeted execution in the field and digital marketing initiatives to educate physicians about Arclis and its benefits [38][40][41] Question: How many new physicians were driven by Medicare Part D? - The majority of Medicare Part D patients were historic patients transitioning from free goods to commercial therapy, not new prescribers [60][62] Question: Will the trial for KPL-387 resemble Arclis's pivotal study? - The company is not sharing specific details about the KPL-387 trial design at this time but is moving forward with regulatory interactions [55][56]