Kiniksa Pharmaceuticals Reports Second Quarter 2023 Financial Results and Recent Portfolio Execution
Kiniksa Pharmaceuticals reports Q2 2023 net product revenue of $54.5 million, increases 2023 net product revenue guidance to $220-$230 million, expects Phase 2 rheumatoid arthritis data in 1H 2024, and extends cash reserves to at least 2027.
Positive
ARCALYST net product revenue for Q2 2023 was $54.5 million.
2023 net product revenue guidance for ARCALYST increased to $220-$230 million, representing ~84% YoY growth at the midpoint.
KPL-404 Phase 2 rheumatoid arthritis data expected in 1H 2024.
Cash reserves now expected to fund operations into at least 2027.
07/25/2023 - 07:30 AM
– ARCALYST ® (rilonacept) Q2 2023 net product revenue of $54.5 million – – ARCALYST 2023 net product revenue guidance increased to $220 - $230 million , representing ~84% year-over-year growth at the midpoint – – KPL-404 Phase 2 rheumatoid arthritis data expected in 1H 2024 – – Cash reserves now expected to fund operations into at least 2027 – – Conference call and webcast scheduled for 8:30 am ET today –
HAMILTON, Bermuda, July 25, 2023 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today reported second quarter 2023 financial results and recent portfolio execution.
“Kiniksa continues to make significant progress in bringing ARCALYST, the first and only FDA-approved therapy for recurrent pericarditis, to patients in need. As a result of increased call frequency and expanded reach with target prescribers, we are seeing increased prescriber adoption and patient enrollments. We are still in the early stages of building the recurrent pericarditis market and remain encouraged by the high level of patient satisfaction, payer approval rates, and duration of therapy. These key metrics provide conviction in raising our 2023 ARCALYST sales guidance to between $220 million and $230 million ,” said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. “Within our pipeline, we continue to enroll patients in the KPL-404 Phase 2 trial in rheumatoid arthritis and expect data in the first half of 2024. Additionally, we have a strong financial position and our cash reserves, combined with our continued ARCALYST commercial execution and financial discipline, now provide cash runway into at least 2027.”
Portfolio and Collaboration Execution ARCALYST (IL-1α and IL-1β cytokine trap)
ARCALYST net product revenue was $54.5 million for the second quarter of 2023. Since launch, more than 1,250 prescribers have written ARCALYST prescriptions for recurrent pericarditis. As of the end of the second quarter of 2023, average total duration of ARCALYST therapy in recurrent pericarditis was approximately 20 months. Average total duration of therapy includes the approximately 45% of patients who restarted ARCALYST, within an average of 8 weeks, after having discontinued therapy. KPL-404 (monoclonal antibody inhibitor of CD40-CD154 interaction)
Kiniksa is enrolling patients in the Phase 2 clinical trial of KPL-404 in rheumatoid arthritis. 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. Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ)
In the second quarter of 2023, Kiniksa recognized a $15.0 million development milestone related to a new indication under its global license agreement with Genentech, a member of the Roche Group (Genentech). Financial Results
Total revenue for the second quarter of 2023 was $71.5 million , compared to $27.0 million for the second quarter of 2022. Total revenue for the second quarter of 2023 included $54.5 million in ARCALYST net product revenue and $17.0 million in license and collaboration revenue, compared to $27.0 million in ARCALYST net product revenue and $0.0 million in license and collaboration revenue for the second quarter of 2022. Total operating expenses for the second quarter of 2023 were $74.6 million , compared to $46.3 million for the second quarter of 2022. Total operating expenses for the second quarter of 2023 included $6.5 million in non-cash, share-based compensation expense, compared to $6.7 million for the second quarter of 2022. Net income for the second quarter of 2023 was $15.0 million , compared to a net loss of $20.0 million for the second quarter of 2022. Net income for the second quarter of 2023 included a $16.2 million tax benefit primarily due to the release of a valuation allowance on non-cash deferred tax assets. As of June 30, 2023, Kiniksa had $185.0 million of cash, cash equivalents, and short-term investments and no debt. Financial Guidance
Kiniksa now expects 2023 ARCALYST net product revenue of between $220 million and $230 million compared to prior guidance of between $200 million and $215 million . Kiniksa now expects that its cash and cash equivalents will fund its current operating plan into at least 2027. Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, July 25, 2023, to discuss second quarter 2023 financial results and recent portfolio execution. 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. About Kiniksa www.kiniksa.com .
About ARCALYST
IMPORTANT SAFETY INFORMATION ABOUT ARCALYST
ARCALYST may affect your immune system and can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death, have happened in patients taking ARCALYST. If you have any signs of an infection, call your doctor right away. Treatment with ARCALYST should be stopped if you get a serious infection. You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection). While taking ARCALYST, do not take other medicines that block interleukin-1, such as Kineret® (anakinra), or medicines that block tumor necrosis factor, such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab), as this may increase your risk of getting a serious infection. Talk with your doctor about your vaccine history. Ask your doctor whether you should receive any vaccines before you begin treatment with ARCALYST. Medicines that affect the immune system may increase the risk of getting cancer. Stop taking ARCALYST and call your doctor or get emergency care right away if you have any symptoms of an allergic reaction. Your doctor will do blood tests to check for changes in your blood cholesterol and triglycerides. Common side effects include injection-site reactions (which may include pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site), upper respiratory tract infections, joint and muscle aches, rash, ear infection, sore throat, and runny nose. For more information about ARCALYST, talk to your doctor and see the Product Information .
About KPL-404
About Mavrilimumab
Forward-Looking Statements $220 million and $230 million ; our expectation that we will report data from our Phase 2 clinical trial of KPL-404 in rheumatoid arthritis in the first half of 2024; our expectation about our cash reserves funding our current operating plan into at least 2027; our beliefs about the mechanisms of action of our product candidates and potential impact of their approach, including that using KPL-404 to disrupt the CD40-CD154 interaction is an attractive approach to address multiple autoimmune disease pathologies; and our belief that all of our product candidates offer the potential for differentiation.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials; our inability to replicate results from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; potential undesirable side effects caused by our products and product candidates; our inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities to not accept our filings, delay or deny approval of any of our product candidates or require additional data or trials to support approval; inability to successfully execute on our commercial strategy for ARCALYST; our reliance on third parties as the sole source of supply of the drug substance and drug product used in our products and product candidates; our reliance on Regeneron as the current sole manufacturer of ARCALYST; risks arising from our ongoing technology transfer of ARCALYST drug substance manufacturing; raw material, important ancillary product and drug substance and/or drug product shortages; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; changes in our operating plan, business development strategy or funding requirements; and existing or new competition.
These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
ARCALYST® is a registered trademark of Regeneron. All other trademarks are the property of their respective owners.
Every Second Counts! ®
Kiniksa Investor and Media Contact rfrank@kiniksa.com
KINIKSA PHARMACEUTICALS, LTD. SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (In thousands) (Unaudited) Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Revenue: Product revenue, net $ 54,495 $ 26,972 $ 97,154 $ 49,161 License and collaboration revenue 16,978 — 22,664 10,000 Total revenue 71,473 26,972 119,818 59,161 Costs and operating expenses: Cost of goods sold 7,699 5,029 14,735 9,248 Collaboration expenses 13,986 3,672 22,274 11,926 Research and development 23,767 13,798 38,939 34,615 Selling, general and administrative 29,175 23,841 58,220 46,059 Total operating expenses 74,627 46,340 134,168 101,848 Loss from operations (3,154 ) (19,368 ) (14,350 ) (42,687 ) Other income 1,915 103 3,747 137 Loss before income taxes (1,239 ) (19,265 ) (10,603 ) (42,550 ) Benefit (provision) for income taxes 16,211 (716 ) 13,305 (2,641 ) Net income (loss) $ 14,972 $ (19,981 ) $ 2,702 $ (45,191 ) Net income (loss) per share attributable to common shareholders—basic $ 0.21 $ (0.29 ) $ 0.04 $ (0.65 ) Net income (loss) per share attributable to common shareholders—diluted $ 0.21 $ (0.29 ) $ 0.04 $ (0.65 ) Weighted average common shares outstanding—basic 69,918,287 69,289,972 69,835,452 69,213,860 Weighted average common shares outstanding—diluted 71,634,729 69,289,972 71,420,026 69,213,860
KINIKSA PHARMACEUTICALS, LTD. SELECTED CONSOLIDATED BALANCE SHEET DATA (In thousands) (Unaudited) As of June 30, December 31, 2023 2022 Cash, cash equivalents, and short-term investments $ 184,992 $ 190,608 Working capital 198,568 195,994 Total assets 484,332 459,672 Accumulated deficit (489,332 ) (492,034 ) Total shareholders' equity 411,656 396,149
What was Kiniksa Pharmaceuticals' Q2 2023 net product revenue?
Kiniksa Pharmaceuticals reported net product revenue of $54.5 million for Q2 2023.
What is the updated net product revenue guidance for ARCALYST in 2023?
The updated net product revenue guidance for ARCALYST in 2023 is $220-$230 million.
When is the expected release of Phase 2 rheumatoid arthritis data for KPL-404?
The data from the Phase 2 trial of KPL-404 in rheumatoid arthritis is expected in the first half of 2024.
How long are the cash reserves expected to fund operations?
The cash reserves are now expected to fund operations into at least 2027.
