On November 1, 2022 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, reported third quarter 2022 financial results and provided a corporate update (Press release, Kiniksa Pharmaceuticals, NOV 1, 2022, View Source [SID1234622757]).
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"Physician adoption, patient satisfaction, and payer access drove continued strong ARCALYST performance in the third quarter. We remain focused on positioning ARCALYST as the standard of care for recurrent pericarditis, with the goal of broadening our reach and helping even more patients," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "Additionally, with the profitable ARCALYST collaboration and initial proceeds from the global license agreement with Genentech for the rights to develop and commercialize vixarelimab, we are well-positioned to execute on synergistic growth opportunities across our portfolio, including the expansion of our ARCALYST cardiovascular franchise."
Corporate Update
·In September 2022, Kiniksa announced the closing of its global license agreement with Roche and Genentech, a member of the Roche Group (Genentech), for the rights to develop and commercialize vixarelimab in exchange for $100 million in upfront and near-term payments, approximately $600 million in clinical, regulatory, and sales-based milestones before fulfilling upstream obligations, and royalties on annual net sales.
Portfolio Execution
ARCALYST (IL-1α and IL-1β cytokine trap)
·ARCALYST net revenue was $33.4 million for the third quarter of 2022.
-Greater than 650 prescribers have written ARCALYST prescriptions for recurrent pericarditis since launch.Greater than 90% payer approval rate of completed patient cases for recurrent pericarditis in the third quarter of 2022.
·As of the end of the third quarter of 2022, the average duration of initial therapy in the commercial setting was approximately 12 months, and approximately 35% of recurrent pericarditis patients who had discontinued ARCALYST therapy restarted treatment.
KPL-404 (monoclonal antibody inhibitor of CD40-CD154 interaction)
·Kiniksa is enrolling the second and final cohort of the multiple ascending dose portion of the Phase 2 clinical trial of KPL-404 in rheumatoid arthritis. Following completion of this portion of the trial, the proof-of-concept portion will begin. The company expects data from the trial in the first half of 2024.
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)
·Kiniksa is pursuing collaborative study agreements to evaluate the potential of mavrilimumab in rare cardiovascular diseases where the granulocyte macrophage colony stimulating factor (GM-CSF) mechanism has been implicated.
Upcoming Scientific Conference Presentation
·Kiniksa reported that an abstract highlighting long-term extension (LTE) data from RHAPSODY, the pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis, has been accepted for presentation at the American Heart Association (AHA) Scientific Sessions 2022.1,2
·LTE data included in the abstract demonstrated rilonacept treatment beyond 18 months resulted in continued treatment response.
-The median [maximum at end of LTE] duration of continuous rilonacept therapy for all patients in RHAPSODY was 18 [27] months for US patients (n=45) and 27 [33] months for non-US patients (n=29).3
-The annualized incidence of pericarditis recurrences while on therapy for all patients (n=74) during the first 18 months of the LTE portion of the trial was 0.04 events per patient-year.
-Patients were given the option at 18 months from their most recent pericarditis recurrence to continue or suspend rilonacept treatment for observation.
1 Dr. Massimo Imazio of University Hospital Santa Maria della Misericordia, Udine, will present a poster presentation entitled Prolonged Rilonacept Treatment in RHAPSODY Long-Term Extension Provided Persistent Reduction of Pericarditis Recurrence Risk on Sunday, November 6, 2022, from 3:45 to 4:45 p.m. Central Time (4:45 – 5:45 p.m. Eastern Time).
2 Data in the abstract are as of the abstract cutoff date; final data are under embargo until the poster presentation.
3 Upon commercial availability of ARCALYST for recurrent pericarditis in April 2021, the LTE portion in the US ended, and patients continuing therapy transitioned to commercial ARCALYST. Non-US patients remained in the LTE without interruption until the LTE closed in June 2022.
§75% of patients who suspended treatment (n=8) experienced pericarditis recurrence (n=6). The median [interquartile range (IQR)] time-to-event was 11.8 [3.7, Not-Estimable (NE)] weeks.
§There was a 98.2% reduction in risk of recurrent pericarditis events in patients who continued rilonacept treatment beyond 18 months (Hazard Ratio = 0.018, p<0.0001).
Financial Results
·Total revenue for the third quarter of 2022 was $99.1 million, compared to $12.1 million for the third quarter of 2021.
-Total revenue for the third quarter of 2022 included $33.4 million in ARCALYST net product revenue and $65.7 million in license and collaboration revenue from the vixarelimab global license agreement with Genentech. Kiniksa did not report license and collaboration revenue in the third quarter of 2021.
·Total operating expenses for the third quarter of 2022 were $52.7 million, compared to $42.8 million for the third quarter of 2021.
-Total operating expenses for the third quarter of 2022 included $4.6 million in collaboration expense. Kiniksa did not report collaboration expense in the third quarter of 2021.
-Total operating expenses for the third quarter of 2022 included $6.0 million of non-cash, share-based compensation expense, compared to $6.2 million for third quarter of 2021.
·Net income for the third quarter of 2022 was $224.1 million, compared to a net loss of $30.5 million for the third quarter of 2021.
-Net income for the third quarter of 2022 included a $177.4 million tax benefit primarily due to the release of a valuation allowance on non-cash deferred tax assets.
·As of September 30, 2022, the company had $200.7 million of cash, cash equivalents, and short-term investments and no debt.
Financial Guidance
·Kiniksa continues to expect ARCALYST net revenue for the full-year 2022 of between $115 million and $130 million.
·Kiniksa expects that its cash and cash equivalents will fund its current operating plan into at least 2025.
Conference Call Information
·Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, November 1, 2022, to discuss third quarter 2022 financial results and to provide a corporate update.
·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.