On February 22, 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 fourth quarter and full-year 2021 financial results and provided a corporate update (Press release, Kiniksa Pharmaceuticals, FEB 22, 2022, View Source [SID1234608803]).
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"The successful launch of ARCALYST in recurrent pericarditis has been marked by continuous growth in prescriber adoption, expansion in payer coverage, and strong patient adherence," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "In 2022, we anticipate continued robust commercial execution and the further advancement of our clinical-stage pipeline. We expect data from the Phase 2b study of vixarelimab in prurigo nodularis in the second half of this year and will continue to enroll the Phase 2 trial of KPL-404 in rheumatoid arthritis. Our collaboration with Huadong Medicine provides non-dilutive capital and the opportunity to accelerate the development of ARCALYST and mavrilimumab in areas complementary to our existing autoinflammatory cardiovascular business."
Corporate Update
·Kiniksa and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (Huadong Medicine) reported a strategic collaboration to develop and commercialize ARCALYST and mavrilimumab in the Asia Pacific Region, excluding Japan.
-Kiniksa will receive $22 million upfront and is eligible to receive up to approximately $640 million in specified development, regulatory and sales-based milestones. Kiniksa is also eligible to receive tiered percentage royalties ranging from the low-teens to the low-twenties on annual net sales.
Portfolio Execution
ARCALYST (IL-1α and IL-1β cytokine trap)
·ARCALYST net revenue was $18.7 million for the fourth quarter of 2021 and $38.5 million since launch on April 1, 2021.
·Kiniksa’s ARCALYST collaboration achieved profitability in the fourth quarter of 2021, following three quarters of commercial availability for recurrent pericarditis.
·More than 300 prescribers have written for ARCALYST for recurrent pericarditis since launch, with more than 50 repeat prescribers.
·Approximately 95% of completed patient enrollment cases for recurrent pericarditis were approved for coverage in the fourth quarter of 2021.
·Approximately 70% of recurrent pericarditis patients who started ARCALYST in the second quarter of 2021 were still on therapy at the end of 2021.
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)
·Kiniksa is evaluating the development of mavrilimumab in cardiovascular diseases where the granulocyte macrophage colony stimulating factor (GM-CSF) mechanism has been implicated and that have synergies with the company’s existing commercial infrastructure.
·Kiniksa does not plan to initiate a Phase 3 trial for mavrilimumab in giant cell arteritis (GCA).
Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ)
·Kiniksa expects data from the Phase 2b dose-ranging clinical trial of once-monthly subcutaneous vixarelimab in prurigo nodularis in the second half of 2022.
-Kiniksa previously reported that the Phase 2a clinical trial of vixarelimab in prurigo nodularis had achieved its primary and secondary efficacy endpoints.
KPL-404 (monoclonal antibody inhibitor of CD40-CD154 signaling)
·Kiniksa is conducting a Phase 2 clinical trial of KPL-404 in rheumatoid arthritis which is designed to enable potential development in a spectrum of autoimmune diseases believed to be mediated by the CD40-CD154 pathway.
·In January 2022, Kiniksa provided KPL-404 to the University of Maryland School of Medicine to be used experimentally as part of an immunosuppressive regimen administered in connection with a transplant of a genetically-modified pig heart into an adult human with end-stage heart disease who was not eligible for a standard allogeneic heart transplant.
Financial Results
·Net revenue from ARCALYST product sales in the fourth quarter and full-year 2021 was $18.7 million and $38.5 million, respectively.
-ARCALYST became commercially available through Kiniksa on April 1, 2021.
·Net loss for the fourth quarter of 2021 was $36.3 million, compared to a net loss of $53.7 million for the fourth quarter of 2020. Net loss for the full-year 2021 was $157.9 million, compared to a net loss of $161.4 million for the full-year 2020.
·Total operating expenses for the fourth quarter of 2021 were $54.9 million, compared to $52.9 million for the fourth quarter of 2020. Total operating expenses for the full-year 2021 were $195.2 million, compared to $157.4 million for the full-year 2020.
–Collaboration expense in the fourth quarter and full-year 2021 was $0.84 million. Kiniksa did not report a collaboration expense in 2020.
–Non-cash, share-based compensation expense for the fourth quarter of 2021 was $6.1 million, compared to $6.3 million for the fourth quarter of 2020. Non-cash, share-based compensation expense for the full-year 2021 was $25.2 million, compared to $20.9 million for the full-year 2020.
·Kiniksa ended 2021 with $182.2 million of cash, cash equivalents and short-term investments and no debt.
Financial Guidance
·Kiniksa expects ARCALYST net revenue for the full-year 2022 to be between $115 million and $130 million.
·Kiniksa continues to expect that its cash and cash equivalents will fund its current operating plan into 2024.
Upcoming Scientific Conference Presentations
·Presentations of new rilonacept and recurrent pericarditis data are planned at the upcoming American College of Cardiology (ACC) 71st Annual Scientific Session & Expo, being held in Washington DC and virtually from April 2, 2022 to April 4, 2022. Details of the presentations are as follows:
–Paul Cremer, MD, Cleveland Clinic, will present a poster entitled, Neutrophil to Lymphocyte Ratio for Tracking Inflammation and Recurrence in Patients with Recurrent Pericarditis: Post Hoc Assessment of a Phase 3 Trial, RHAPSODY.
–Ajit Raisinghani, MD, University of California San Diego, will present a poster entitled, Real-World Experience and Unmet Needs in the Current Management of Recurrent Pericarditis: A Physician Survey and Medical Chart Review.
Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 am ET on Tuesday, February 22, 2022, to discuss fourth quarter and full-year 2021 financial results and to provide a corporate update.
Individuals interested in participating in the call should dial (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 8145539. To access the webcast, please visit the Investors and Media section of Kiniksa’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.