On August 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 second quarter 2022 financial results and provided a corporate update (Press release, Kiniksa Pharmaceuticals, AUG 3, 2022, View Source [SID1234617378]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The continued momentum of ARCALYST in recurrent pericarditis in the second quarter of 2022 provides conviction in our full-year expectation for net revenue of between $115 to 130 million. Additionally, we believe the strong performance of ARCALYST since launch supports incremental investment to broaden our reach and help even more patients suffering from recurrent pericarditis," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "We are also focused on expanding our portfolio by leveraging our cross-functional cardiovascular expertise. These efforts will be enabled in part by the non-dilutive proceeds from our global license agreement with Genentech."

Corporate Update:

Today, Kiniksa announced a global license agreement with Roche and Genentech, a member of the Roche Group (Genentech), for the rights to develop and commercialize vixarelimab.
Kiniksa will receive upfront and near-term proceeds of $100 million. In addition, the company is eligible to receive up to approximately $600 million in certain development, regulatory, and sales-based milestones, before fulfilling upstream financial obligations, as well as royalties on annual net sales.
Kiniksa completed screening patients for the Phase 2b clinical trial of vixarelimab in prurigo nodularis and plans to complete the trial. The company will not disclose data in the second half of 2022.
Kiniksa plans to use the non-dilutive proceeds received from the transaction to advance synergistic cardiovascular opportunities.
Portfolio Execution
ARCALYST (IL-1α and IL-1β cytokine trap)

ARCALYST net revenue was $27.0 million for the second quarter of 2022.
More than 550 prescribers have written ARCALYST prescriptions for recurrent pericarditis since launch, with a growing number of repeat prescribers.
More than 90% payer approval rate of completed patient cases for recurrent pericarditis in the second quarter of 2022.
ARCALYST use in recurrent pericarditis to date indicates continuous treatment durations of approximately 12 months.
Kiniksa plans to evolve its sales operation with approximately 20 additional field sales representatives in the fourth quarter of 2022.
KPL-404 (monoclonal antibody inhibitor of CD40-CD154 interaction)

Kiniksa is conducting a Phase 2 clinical trial of KPL-404 in rheumatoid arthritis which is designed to evaluate the efficacy, dose response, pharmacokinetics, and safety of chronic subcutaneous dosing over 12 weeks.
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 net revenue for ARCALYST product sales in the second quarter of 2022 was $27.0 million, compared to $7.7 million for the second quarter of 2021.
Total operating expenses for the second quarter of 2022 were $46.3 million, compared to $48.3 million for the second quarter of 2021.
Collaboration expense in the second quarter of 2022 was $3.7 million. Kiniksa did not report a collaboration expense in the second quarter of 2021.
Non-cash, share-based compensation expense for the second quarter of 2022 was $6.7 million, compared to $5.7 million for the second quarter of 2021.
Net loss for the second quarter of 2022 was $20.0 million, compared to a net loss of $41.6 million for the second quarter of 2021.
As of June 30, 2022, the company had $138.2 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 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 2025 following the close of the vixarelimab global license agreement with Genentech.
Conference Call Information

Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Wednesday, August 3, 2022, to discuss second quarter 2022 financial results and to provide a corporate update.
Individuals interested in participating in the call should dial (800) 715-9871 (U.S. and Canada) or (646) 307-1963 (international) using conference ID number 1606846. 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.