Before U.S. markets opened for trading yesterday, biopharmaceutical company Kiniksa Pharmaceuticals Ltd. (KNSA:NASDAQ), which is working to develop and commercialize its portfolio of therapeutics engineered to modulate immunological pathways across a wide range of diseases, announced operating and financial results for the third quarter of 2022 ended September 2022.
The company's Chairman and CEO, Sanj K. Patel, led the report by stating, "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."
The firm reported that the net sales of ARCALYST® (rilonacept) (IL-1α and IL-1β cytokine trap) rose by 176% year-over-year to US$33.4 million in Q3/22 and noted that since its commercial launch, more than 650 prescribers have written prescriptions for the medication.
"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," Patel added.
The company mentioned that in September 2022, it closed on a global license and collaboration agreement with Roche and Genentech to develop and commercialize vixarelimab. The agreement provides for upfront and near-term payments of US$100 million and up to an additional US$600 million if certain clinical, regulatory, and sales-based milestones and other upstream obligations are achieved, along with future annual net sales royalties.
The firm reported that the net sales of ARCALYST® (rilonacept) (IL-1α and IL-1β cytokine trap) rose by 176% year-over-year to US$33.4 million in Q3/22 and noted that since its commercial launch, more than 650 prescribers have written prescriptions for the medication for use in the treatment of recurrent pericarditis.
The company advised that, on average, patients were prescribed ARCALYST for a period of 12 months and listed that it registered a payer approval rate of over 90% for recurrent pericarditis patients.
The company explained that "ARCALYST is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling."
The company indicated that it will be presenting long-term extension (LTE) data from its Phase 3 RHAPSODY clinical trial at the American Heart Association (AHA) Scientific conference. The RHAPSODY study is designed to evaluate the effectiveness of rilonacept in treating recurrent pericarditis. The firm stated that the LTE data show that treatment with rilonacept beyond 18 months produces continued positive treatment responses.
Kiniksa Pharmaceuticals added that it is now enrolling the second and final cohort in its Phase 2 KPL-404 rheumatoid arthritis clinical trial. The company stated that first, it will conduct a multiple ascending dose study which will be followed by the proof-of-concept portion of the trial. The company indicated that it anticipates that it will receive the first readout data from the study in H1/24.
The company added that it is also pursuing collaborative opportunities for mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα) to address treatments for rare cardiovascular diseases.
The company reported that for Q3/22, it posted total revenue of US$99.1 million, compared to US$12.1 million in Q3/21. The firm noted that the amount included US$33.4 million from ARCALYST net product revenue and US$65.7 million from vixarelimab global license and collaboration revenue earned under its agreement with Genentech.
The firm stated that it had total operating expenses of US$52.7 million in Q3/22 versus US$42.8 million in Q3/21.
Kiniksa Pharmaceuticals advised that for Q3/22, it recorded a net income of US$224.1 million, or US$3.18 per diluted share, compared to a net loss of US$30.5 million, or US$0.44 per diluted share in Q3/21.
The firm pointed out that the net income total reported during Q3/22 included a US$177.4 million tax benefit which it advised was attributed mostly to "the release of a valuation allowance on non-cash deferred tax assets." Excluding this adjustment for taxes, the firm posted pretax income of US$46.7 million in Q3/22, compared to a pretax loss of US$30.7 million in Q3/21.
The company stated that at the end of Q3/22, it had US$200.7 million in cash and other highly liquid assets on its balance sheet and did not have any outstanding debt.
The company offered some forward-looking guidance and advised that for FY/22, it expects to generate net revenue from ARCALYST of US$115-130 million. The firm added that it estimates that it will be able to fully fund its operations into 2025 with the cash and cash equivalents that it currently holds on its balance sheet.
Kiniksa is a global biopharmaceutical firm company based in Hamilton, Bermuda, that concentrates its efforts on discovering, creating, and commercializing novel medicines for patients suffering from debilitating diseases.
The company's leading assets include ARCALYST (for recurrent pericarditis, cryopyrin-associated periodic syndromes, and deficiency of the interleukin-1 receptor antagonist), KPL-404 (for rheumatoid arthritis), and mavrilimumab (for rare cardiovascular diseases), which are being developed for use in underserved conditions and work by modulating immunological pathways over a wide range of indications.
Kiniksa Pharmaceuticals began yesterday with a market cap of around US$793.36 million with approximately 69.47 million shares outstanding. KNSA shares opened nearly 12% higher yesterday at US$12.77 (+US$1.35, +11.82%) over the previous day's US$11.42 closing price. The stock traded yesterday between US$12.00 and US$13.37 per share and closed for trading at US$12.80 (+US$1.38, +12.08%).
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