Kiniksa Pharmaceuticals Reports Second Quarter 2024 Financial Results and Recent Portfolio Execution
Kiniksa Pharmaceuticals reported strong Q2 2024 financial results, with ARCALYST net product revenue of $103.4 million, representing 90% year-over-year growth. The company increased its 2024 ARCALYST revenue guidance to $405-$415 million. Key highlights include:
1. Approximately 11% of the 14,000 multiple-recurrence target population actively on ARCALYST treatment.
2. Average total duration of ARCALYST therapy increased to ~26 months.
3. Enrollment began in the abiprubart Phase 2b trial for Sjögren's Disease.
4. Total revenue for Q2 2024 was $108.6 million.
5. Net loss for Q2 2024 was $3.9 million.
6. Cash position of $218.8 million with no debt as of June 30, 2024.
Kiniksa expects to remain cash flow positive on an annual basis, with abiprubart's clinical development fully funded in the current operating plan.
Kiniksa Pharmaceuticals ha riportato risultati finanziari solidi per il secondo trimestre del 2024, con un fatturato netto del prodotto ARCALYST di 103,4 milioni di dollari, che rappresenta una crescita del 90% rispetto all'anno precedente. L'azienda ha aumentato le previsioni di fatturato per ARCALYST nel 2024 a 405-415 milioni di dollari. I punti salienti includono:
1. Circa l'11% della popolazione target di 14.000 pazienti con recidive multiple è attualmente in trattamento con ARCALYST.
2. La durata totale media della terapia con ARCALYST è aumentata a ~26 mesi.
3. È iniziato il reclutamento per la fase 2b dello studio abiprubart per la malattia di Sjögren.
4. Il fatturato totale per il secondo trimestre del 2024 è stato di 108,6 milioni di dollari.
5. La perdita netta per il secondo trimestre del 2024 è stata di 3,9 milioni di dollari.
6. Posizione di cassa di 218,8 milioni di dollari senza debiti al 30 giugno 2024.
Kiniksa prevede di rimanere positiva in termini di flusso di cassa su base annuale, con lo sviluppo clinico di abiprubart completamente finanziato nel piano operativo attuale.
Kiniksa Pharmaceuticals informó resultados financieros sólidos para el segundo trimestre de 2024, con un ingreso neto por producto ARCALYST de 103,4 millones de dólares, lo que representa un crecimiento del 90% en comparación con el año anterior. La compañía aumentó su guía de ingresos para ARCALYST en 2024 a 405-415 millones de dólares. Los aspectos destacados incluyen:
1. Aproximadamente el 11% de la población objetivo de 14.000 pacientes con recurrencias múltiples está actualmente en tratamiento con ARCALYST.
2. La duración total promedio de la terapia con ARCALYST aumentó a ~26 meses.
3. Se inició la inscripción en el ensayo de fase 2b de abiprubart para la enfermedad de Sjögren.
4. El ingreso total para el segundo trimestre de 2024 fue de 108,6 millones de dólares.
5. La pérdida neta para el segundo trimestre de 2024 fue de 3,9 millones de dólares.
6. La posición de efectivo fue de 218,8 millones de dólares sin deudas al 30 de junio de 2024.
Kiniksa espera mantenerse positiva en flujo de caja a nivel anual, con el desarrollo clínico de abiprubart completamente financiado en el plan operativo actual.
Kiniksa Pharmaceuticals는 2024년 2분기 강력한 재무 결과를 보고했으며, ARCALYST 순제품 매출이 1억 340만 달러로 연간 90% 성장했습니다. 회사는 2024년 ARCALYST 매출 전망을 4억 500만 달러에서 4억 1500만 달러로 상향 조정했습니다. 주요 내용은 다음과 같습니다:
1. 14,000명의 다발성 재발 목표 인구 중 약 11%가 ARCALYST 치료를 받고 있습니다.
2. ARCALYST 요법의 평균 총 기간이 약 26개월로 증가했습니다.
3. 쇼그렌 증후군에 대한 abiprubart의 2b 단계 시험에 참여가 시작되었습니다.
4. 2024년 2분기 총 수익은 1억 860만 달러입니다.
5. 2024년 2분기 순손실은 390만 달러입니다.
6. 2024년 6월 30일 기준으로 부채 없이 2억 1880만 달러의 현금 잔액을 보유하고 있습니다.
Kiniksa는 연간 현금 흐름이 긍정적으로 유지될 것으로 예상하며, abiprubart의 임상 개발은 현재 운영 계획에 의해 전액 자금 지원됩니다.
Kiniksa Pharmaceuticals a rapporté des résultats financiers solides pour le deuxième trimestre 2024, avec un chiffre d'affaires net du produit ARCALYST de 103,4 millions de dollars, représentant une croissance de 90% par rapport à l'année précédente. L'entreprise a relevé son objectif de chiffre d'affaires ARCALYST pour 2024 à 405-415 millions de dollars. Les points saillants comprennent :
1. Environ 11% de la population cible de 14 000 patients ayant des récidives multiples sont actuellement sous traitement par ARCALYST.
2. La durée totale moyenne de la thérapie ARCALYST est augmentée à environ 26 mois.
3. L'inscription a commencé dans l'essai de phase 2b d'abiprubart pour la maladie de Sjögren.
4. Le chiffre d'affaires total pour le deuxième trimestre 2024 était de 108,6 millions de dollars.
5. La perte nette pour le deuxième trimestre 2024 était de 3,9 millions de dollars.
6. La position de trésorerie était de 218,8 millions de dollars sans dettes au 30 juin 2024.
Kiniksa prévoit de rester positive en termes de flux de trésorerie sur une base annuelle, le développement clinique d'abiprubart étant entièrement financé dans le plan opérationnel actuel.
Kiniksa Pharmaceuticals meldete starke finanzielle Ergebnisse für das zweite Quartal 2024, mit einem Nettoumsatz von ARCALYST in Höhe von 103,4 Millionen Dollar, was einem Wachstum von 90% im Vergleich zum Vorjahr entspricht. Das Unternehmen hat seine Umsatzprognose für ARCALYST im Jahr 2024 auf 405-415 Millionen Dollar angehoben. Die wichtigsten Highlights sind:
1. Ungefähr 11% der 14.000 Patienten der Zielpopulation mit wiederholten Erkrankungen erhalten derzeit eine Behandlung mit ARCALYST.
2. Die durchschnittliche Gesamtdauer der ARCALYST-Therapie erhöhte sich auf etwa 26 Monate.
3. Die Rekrutierung für die Phase-2b-Studie von Abiprubart zur Sjögren-Krankheit begann.
4. Der Gesamtumsatz für das zweite Quartal 2024 betrug 108,6 Millionen Dollar.
5. Der Nettoverlust für das zweite Quartal 2024 betrug 3,9 Millionen Dollar.
6. Die Liquiditätsposition betrug zum 30. Juni 2024 218,8 Millionen Dollar ohne Verbindlichkeiten.
Kiniksa erwartet, dass der jährliche Cashflow positiv bleibt, wobei die klinische Entwicklung von Abiprubart vollständig im aktuellen Betriebsplan finanziert ist.
- ARCALYST Q2 2024 net product revenue grew 90% year-over-year to $103.4 million
- Increased 2024 ARCALYST net product revenue guidance to $405-$415 million
- 11% of the 14,000 multiple-recurrence target population actively on ARCALYST treatment
- Average total duration of ARCALYST therapy increased to 26 months
- Total revenue for Q2 2024 was $108.6 million, up from $71.5 million in Q2 2023
- Strong cash position of $218.8 million with no debt as of June 30, 2024
- Company expects to remain cash flow positive on an annual basis
- Net loss of $3.9 million in Q2 2024, compared to net income of $15.0 million in Q2 2023
- Total operating expenses increased to $108.7 million in Q2 2024 from $74.6 million in Q2 2023
- Collaboration expenses increased to $30.0 million in Q2 2024 from $14.0 million in Q2 2023
Insights
Kiniksa Pharmaceuticals' second-quarter results for 2024 present a notable performance surge, driven primarily by the strong market adoption of ARCALYST. With a hefty
The company's commitment to remaining cash flow positive on an annual basis further underscores its robust financial health. Kiniksa's ample liquidity, highlighted by
However, a slight dip to a net loss of
The market potential for ARCALYST is becoming increasingly evident, with an 11% penetration in the target population of 14,000 multiple-recurrence pericarditis patients. This growth in market share, alongside the increase in average therapy duration to 26 months, signals strong patient retention and satisfaction.
Strategic partnerships and awareness campaigns, such as those with the American Heart Association and NHL Hall-of-Famer Henrik Lundqvist, are likely to further enhance ARCALYST's market presence. These initiatives can improve patient outcomes and drive higher adoption rates, which is promising for long-term revenue stability.
Additionally, the growth prospects from abiprubart's clinical development for Sjögren’s Disease represent a potential new revenue stream. The ongoing phase 2b trials and full funding for this development indicate strategic foresight in addressing unmet medical needs, which could yield substantial future returns for investors as the market for autoimmune therapies expands.
The clinical progress of Kiniksa's portfolio, particularly with abiprubart, showcases the company's commitment to innovation in autoimmune disease treatment. Sjögren’s Disease, a chronic condition with no FDA-approved therapies, represents a significant unmet need. The enrollment in Phase 2b trials for abiprubart is a critical milestone. If successful, this could pave the way for a novel therapeutic option and open new revenue avenues.
Moreover, ARCALYST's efficacy in recurrent pericarditis, as evidenced by the growing number of prescribers and longer therapy durations, indicates the drug's effectiveness and acceptance. This real-world data supports ARCALYST's positioning as a standard care option, which could solidify its market stronghold and drive sustained revenue growth.
Looking forward, the clinical milestones achieved by Kiniksa are likely to enhance its reputation and credibility in the biopharmaceutical sector. For retail investors, the clinical progress provides a important insight into the potential long-term value and growth opportunities within Kiniksa's pipeline.
– ARCALYST® (rilonacept) Q2 2024 net product revenue of
– ARCALYST 2024 expected net product revenue increased to
– Abiprubart clinical development fully funded; Phase 2b clinical trial in Sjögren’s Disease enrolling patients –
– Kiniksa expects to remain cash flow positive on an annual basis –
– Conference call and webcast scheduled for 8:30 am ET today –
LONDON, July 23, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today reported second quarter 2024 financial results and recent portfolio execution.
“Kiniksa’s work to establish ARCALYST as the standard of care in recurrent pericarditis continues to drive the company’s commercial performance. As of the end of the second quarter, ~
Portfolio Execution
ARCALYST (IL-1α and IL-1β cytokine trap)
- ARCALYST net product revenue was
$103.4 million for the second quarter of 2024. - Since launch in April 2021, more than 2,300 prescribers have written ARCALYST prescriptions for recurrent pericarditis.
- As of the end of the second quarter of 2024, the average total duration of ARCALYST therapy in recurrent pericarditis increased to approximately 26 months, compared to ~23 months as of the end of the first quarter of 2024.
- As of the end of the second quarter of 2024, approximately
11% of the target 14,000 multiple-recurrence patients were actively on ARCALYST treatment, compared to ~9% as of the end of 2023. - In June 2024, Kiniksa announced its sponsorship of the American Heart Association’s Addressing Recurrent Pericarditis initiative, a multi-faceted effort aimed at improving access to expert care and quality of care for patients with recurrent pericarditis.
- In June 2024, Kiniksa announced a partnership with National Hockey League Hall-of-Famer, Henrik Lundqvist, to raise awareness in support of patients suffering from recurrent pericarditis.
Abiprubart (anti-CD40 monoclonal antibody inhibitor of CD40-CD154 interaction)
- Kiniksa is enrolling patients in a Phase 2b clinical trial designed to evaluate the efficacy and safety of biweekly and monthly abiprubart administered subcutaneously in patients with Sjögren’s Disease.
Financial Results
- Total revenue for the second quarter of 2024 was
$108.6 million , compared to$71.5 million for the second quarter of 2023.- Total revenue for the second quarter of 2024 included
$5.2 million in license and collaboration revenue, compared to$17.0 million for the second quarter of 2023.
- Total revenue for the second quarter of 2024 included
- Total operating expenses for the second quarter of 2024 were
$108.7 million , compared to$74.6 million for the second quarter of 2023.- Total operating expenses for the second quarter of 2024 included
$30.0 million in collaboration expenses, which are driven by ARCALYST collaboration profitability, compared to$14.0 million for the second quarter of 2023. - Total operating expenses for the second quarter of 2024 included
$7.4 million in non-cash, share-based compensation expense, compared to$6.5 million for the second quarter of 2023.
- Total operating expenses for the second quarter of 2024 included
- Net loss for the second quarter of 2024 was
$3.9 million , compared to a net income of$15.0 million for the second quarter of 2023. - As of June 30, 2024, Kiniksa had
$218.8 million of cash, cash equivalents, and short-term investments and no debt.
Financial Guidance
- Kiniksa expects 2024 ARCALYST net product revenue of between
$405 million and$415 million , compared to prior guidance of between$370 million and$390 million . - Kiniksa expects to remain cash flow positive on an annual basis.
Conference Call Information
- Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, July 23, 2024, to discuss second quarter 2024 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
Kiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s immune-modulating assets, ARCALYST, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation. For more information, please visit www.kiniksa.com.
About ARCALYST
ARCALYST is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. ARCALYST was discovered by Regeneron Pharmaceuticals, Inc. (Regeneron) and is approved by the U.S. Food and Drug Administration (FDA) for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and deficiency of IL-1 receptor antagonist (DIRA). The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug exclusivity to ARCALYST in 2021 for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and pediatric patients 12 years and older. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2021.
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 Abiprubart
Abiprubart is an investigational humanized monoclonal antibody that binds to CD40 and is designed to inhibit the CD40-CD154 (CD40 ligand) interaction, a key T-cell co-stimulatory signal critical for B-cell maturation and immunoglobulin class switching and Type 1 immune responses. Kiniksa believes disrupting the CD40-CD154 co-stimulatory interaction is an attractive approach to addressing multiple autoimmune disease pathologies.
Forward-Looking Statements
This press release contains forward-looking statements. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our expectation that ARCALYST 2024 net product revenue will be between
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; 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; 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.
Every Second Counts! ®
Kiniksa Investor and Media Contact
Rachel Frank
(339) 970-9437
rfrank@kiniksa.com
| KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC | ||||||||||||||||
| (FORMERLY KNOWN AS 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, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue, net | $ | 103,394 | $ | 54,495 | $ | 182,279 | $ | 97,154 | ||||||||
| License and collaboration revenue | 5,237 | 16,978 | 6,210 | 22,664 | ||||||||||||
| Total revenue | 108,631 | 71,473 | 188,489 | 119,818 | ||||||||||||
| Costs and operating expenses: | ||||||||||||||||
| Cost of goods sold | 12,322 | 7,699 | 22,905 | 14,735 | ||||||||||||
| Collaboration expenses | 30,014 | 13,986 | 50,815 | 22,274 | ||||||||||||
| Research and development | 24,017 | 23,767 | 50,351 | 38,939 | ||||||||||||
| Selling, general and administrative | 42,395 | 29,175 | 81,077 | 58,220 | ||||||||||||
| Total operating expenses | 108,748 | 74,627 | 205,148 | 134,168 | ||||||||||||
| Loss from operations | (117 | ) | (3,154 | ) | (16,659 | ) | (14,350 | ) | ||||||||
| Other income | 2,421 | 1,915 | 4,687 | 3,747 | ||||||||||||
| Income (loss) before income taxes | 2,304 | (1,239 | ) | (11,972 | ) | (10,603 | ) | |||||||||
| Benefit (provision) for income taxes | (6,212 | ) | 16,211 | (9,640 | ) | 13,305 | ||||||||||
| Net income (loss) | $ | (3,908 | ) | $ | 14,972 | $ | (21,612 | ) | $ | 2,702 | ||||||
| Net income (loss) per share attributable to ordinary shareholders—basic | $ | (0.06 | ) | $ | 0.21 | $ | (0.31 | ) | $ | 0.04 | ||||||
| Net income (loss) per share attributable to ordinary shareholders—diluted | $ | (0.06 | ) | $ | 0.21 | $ | (0.31 | ) | $ | 0.04 | ||||||
| Weighted average ordinary shares outstanding—basic | 71,004,640 | 69,918,287 | 70,818,831 | 69,835,452 | ||||||||||||
| Weighted average ordinary shares outstanding—diluted | 71,004,640 | 71,634,729 | 70,818,831 | 71,420,026 | ||||||||||||
| KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC | ||||||||
| (FORMERLY KNOWN AS KINIKSA PHARMACEUTICALS, LTD.) | ||||||||
| SELECTED CONSOLIDATED BALANCE SHEET DATA | ||||||||
| (In thousands) | ||||||||
| (Unaudited) | ||||||||
| As of | ||||||||
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash, cash equivalents, and short-term investments | $ | 218,758 | $ | 206,371 | ||||
| Working capital | 216,730 | 212,631 | ||||||
| Total assets | 542,428 | 526,322 | ||||||
| Accumulated deficit | (499,562 | ) | (477,950 | ) | ||||
| Total shareholders' equity | 435,095 | 438,839 | ||||||
FAQ
What was Kiniksa Pharmaceuticals' (KNSA) ARCALYST revenue in Q2 2024?
Has Kiniksa (KNSA) updated its 2024 revenue guidance for ARCALYST?
What is the status of Kiniksa's (KNSA) abiprubart clinical trial for Sjögren's Disease?
What was Kiniksa Pharmaceuticals' (KNSA) financial position as of June 30, 2024?
Did Kiniksa Pharmaceuticals (KNSA) report a profit or loss for Q2 2024?
