On May 3, 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 first quarter 2022 financial results and provided a corporate update (Press release, Kiniksa Pharmaceuticals, MAY 3, 2022, View Source [SID1234613397]).
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"With the one-year anniversary of our commercial launch of ARCALYST for recurrent pericarditis, we remain committed to supporting the continued growth in prescriber adoption, patient adherence, and payer coverage," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "Looking to the rest of the year, we anticipate continued efficient commercial execution and key progress of our clinical-stage pipeline."
Corporate Update:
In February, Kiniksa and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (Huadong Medicine) announced a strategic collaboration to develop and commercialize ARCALYST and mavrilimumab in the Asia Pacific Region, excluding Japan.
Kiniksa received a total upfront payment of $22.0 million, consisting of $12.0 million and $10.0 million for the rights to ARCALYST and mavrilimumab, respectively, in the Asia Pacific Region.
Kiniksa is eligible to receive up to approximately $640.0 million in specified development, regulatory, and sales-based milestones as well as tiered 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 $22.2 million for the first quarter of 2022.
More than 400 prescribers have written ARCALYST prescriptions for recurrent pericarditis since launch, with a growing number of repeat prescribers.
Approximately 95% of completed patient enrollment cases for recurrent pericarditis were approved for coverage in the first quarter of 2022.
Approximately 60% of recurrent pericarditis patients who started ARCALYST in the second quarter of 2021 remained on continuous therapy through the end of the first quarter of 2022.
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.
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.
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)
Kiniksa is evaluating the development of mavrilimumab in rare 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.
Financial Results
Total revenue for the first quarter of 2022 was $32.2 million, consisting of $22.2 million in ARCALYST net product revenue and $10.0 million in collaboration revenue, representing the upfront payment from Huadong Medicine for the rights to mavrilimumab in the Asia Pacific Region. Kiniksa did not generate revenue in the first quarter of 2021.
The upfront payment of $12.0 million from Huadong Medicine for the rights to ARCALYST in the Asia Pacific Region was deferred and will be recognized over the life of the agreement.
Total operating expenses for the first quarter of 2022 were $55.5 million, compared to $49.3 million for the first quarter of 2021.
Collaboration expenses in the first quarter of 2022 were $8.3 million reflecting two obligations payable to Regeneron Pharmaceuticals, Inc. (Regeneron): a $2.3 million ARCALYST profit-split expense and a $6.0 million expense, representing 50% of the upfront payment from Huadong Medicine for the rights to ARCALYST in the Asia Pacific Region. Kiniksa did not report collaboration expenses in the first quarter of 2021.
Non-cash, share-based compensation expense for the first quarter of 2022 was $6.0 million, compared to $7.1 million for the first quarter of 2021.
Net loss for the first quarter of 2022 was $25.2 million, compared to a net loss of $49.5 million for the first quarter of 2021.
As of March 31, 2022, the company had $145.6 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 expects that its cash and cash equivalents will fund its current operating plan into at least 2024.
Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, May 3, 2022, to discuss first quarter 2022 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 7787467. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.