Arrowhead Pharmaceuticals Reports Fiscal 2025 First Quarter Results
Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported its fiscal 2025 first quarter results, highlighting significant developments. The company secured a major licensing agreement with Sarepta Therapeutics, receiving $825 million upfront ($500M cash, $325M equity investment) plus $250 million over five years, with potential additional payments of $300 million and approximately $10 billion in milestones.
The FDA accepted Arrowhead's NDA for plozasiran for familial chylomicronemia syndrome treatment, with a PDUFA date of November 18, 2025. Phase 3 PALISADE study showed positive results with significant reductions in triglycerides.
Financial results showed revenue of $2.5 million, down from $3.55 million year-over-year. Net loss widened to $173.1 million ($1.39 per share) compared to $132.9 million ($1.24 per share) in the previous year. Total cash resources stood at $552.9 million as of December 31, 2024.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) ha riportato i risultati del primo trimestre fiscale 2025, evidenziando sviluppi significativi. L'azienda ha ottenuto un importante accordo di licenza con Sarepta Therapeutics, ricevendo 825 milioni di dollari in anticipo (500 milioni in contante, 325 milioni in investimento azionario), più 250 milioni in cinque anni, con potenziali pagamenti aggiuntivi di 300 milioni e circa 10 miliardi in traguardi.
La FDA ha accettato la NDA di Arrowhead per plozasiran per il trattamento della sindrome da chilomicronemia familiare, con una data PDUFA fissata per il 18 novembre 2025. Lo studio di fase 3 PALISADE ha mostrato risultati positivi con significative riduzioni nei trigliceridi.
I risultati finanziari hanno mostrato un fatturato di 2,5 milioni di dollari, in calo rispetto ai 3,55 milioni dell'anno precedente. La perdita netta è aumentata a 173,1 milioni di dollari (1,39 dollari per azione) rispetto ai 132,9 milioni di dollari (1,24 dollari per azione) dell'anno precedente. Le risorse totali in contante ammontavano a 552,9 milioni di dollari al 31 dicembre 2024.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) informó sus resultados del primer trimestre fiscal 2025, destacando desarrollos significativos. La compañía aseguró un importante acuerdo de licencia con Sarepta Therapeutics, recibiendo 825 millones de dólares por adelantado (500 millones en efectivo, 325 millones en inversión de capital), más 250 millones durante cinco años, con posibles pagos adicionales de 300 millones y aproximadamente 10 mil millones en hitos.
La FDA aceptó la NDA de Arrowhead para plozasiran para el tratamiento del síndrome de quilomicronemia familiar, con una fecha PDUFA del 18 de noviembre de 2025. El estudio de fase 3 PALISADE mostró resultados positivos con reducciones significativas en los triglicéridos.
Los resultados financieros mostraron ingresos de 2,5 millones de dólares, por debajo de los 3,55 millones del año anterior. La pérdida neta se amplió a 173,1 millones de dólares (1,39 dólares por acción) en comparación con 132,9 millones de dólares (1,24 dólares por acción) del año anterior. Los recursos totales en efectivo se situaron en 552,9 millones de dólares hasta el 31 de diciembre de 2024.
Arrowhead Pharmaceuticals (NASDAQ: ARWR)는 2025 회계연도 1분기 결과를 발표하며 중요한 발전 사항을 강조했습니다. 이 회사는 Sarepta Therapeutics와 큰 라이센스 계약을 체결하며 8억 2500만 달러를 선지급받았고(5억 달러 현금, 3억 2500만 달러 주식 투자), 5년 동안 2억 5000만 달러를 추가로 받게 됩니다. 또한 3억 달러의 추가 지급 및 약 100억 달러의 이정표 지급 가능성이 있습니다.
FDA는 가족성 초미세 염증증 치료를 위한 Arrowhead의 plozasiran에 대한 NDA를 수리하였으며, PDUFA 날짜는 2025년 11월 18일로 설정되었습니다. 3상 PALISADE 연구는 중성지방의 유의미한 감소와 함께 긍정적인 결과를 보였습니다.
재무 결과는 수익이 250만 달러로, 전년 동기 대비 355만 달러에서 감소했음을 나타냈습니다. 순손실은 1주당 1.39달러인 1억 7310만 달러로 확대되었으며, 이는 전년 동기 1주당 1.24달러인 1억 3290만 달러와 비교됩니다. 2024년 12월 31일 기준 총 현금 자원은 5억 5290만 달러입니다.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) a annoncé ses résultats pour le premier trimestre de l'exercice 2025, mettant en évidence des développements significatifs. La société a conclu un important accord de licence avec Sarepta Therapeutics, recevant 825 millions de dollars à l'avance (500 millions en espèces, 325 millions en investissement en actions), ainsi que 250 millions sur cinq ans, avec des paiements supplémentaires potentiels de 300 millions de dollars et environ 10 milliards de dollars en jalons.
La FDA a accepté la NDA d'Arrowhead pour le plozasiran pour le traitement du syndrome de chylomicronémie familiale, avec une date PDUFA fixée au 18 novembre 2025. L'étude PALISADE de phase 3 a montré des résultats positifs avec des réductions significatives des triglycérides.
Les résultats financiers ont montré des revenus de 2,5 millions de dollars, en baisse par rapport à 3,55 millions de dollars l'année précédente. La perte nette s'est creusée à 173,1 millions de dollars (1,39 dollar par action) par rapport à 132,9 millions de dollars (1,24 dollar par action) l'année précédente. Les ressources liquides totales s'élevaient à 552,9 millions de dollars au 31 décembre 2024.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) hat die Ergebnisse des ersten Quartals des Geschäftsjahres 2025 veröffentlicht und bedeutende Entwicklungen hervorgehoben. Das Unternehmen sicherte sich eine bedeutende Lizenzvereinbarung mit Sarepta Therapeutics und erhielt 825 Millionen Dollar im Voraus (500 Millionen in bar, 325 Millionen in Eigenkapitalinvestition), plus 250 Millionen über fünf Jahre, mit potenziellen zusätzlichen Zahlungen von 300 Millionen und etwa 10 Milliarden an Meilensteinen.
Die FDA hat die NDA von Arrowhead für plozasiran zur Behandlung des familiären Chylomikronämie-Syndroms angenommen, das PDUFA-Datum ist für den 18. November 2025 angesetzt. Die Phase-3-Studie PALISADE zeigte positive Ergebnisse mit signifikanten Reduzierungen der Triglyceride.
Die finanziellen Ergebnisse zeigten einen Umsatz von 2,5 Millionen Dollar, im Vergleich zu 3,55 Millionen Dollar im Vorjahr. Der Nettoverlust weitete sich auf 173,1 Millionen Dollar (1,39 Dollar pro Aktie) im Vergleich zu 132,9 Millionen Dollar (1,24 Dollar pro Aktie) im Vorjahr aus. Die gesamten liquiden Mittel beliefen sich zum 31. Dezember 2024 auf 552,9 Millionen Dollar.
- Secured $825M upfront payment from Sarepta Therapeutics deal
- FDA acceptance of plozasiran NDA with PDUFA date set
- Positive Phase 3 PALISADE study results
- Funded operations into 2028
- Additional $250M payments scheduled over five years
- Potential for $10B in milestone payments
- Revenue decreased 29.6% YoY to $2.5M
- Net loss increased to $173.1M from $132.9M YoY
- Operating expenses increased 17% to $163.9M
- Cash resources declined to $552.9M from $681M in September 2024
Insights
Arrowhead's Q1 FY2025 results reveal a strategic transformation phase marked by three critical developments. First, the landmark Sarepta deal brings immediate strength to the balance sheet with
Second, the FDA's acceptance of plozasiran's NDA represents a important milestone toward becoming a commercial-stage company. With strong Phase 3 PALISADE results showing up to
Third, the increased R&D investment (up
- Conference Call and Webcast Today, February 10, 2025, at 4:30 p.m. ET
“During the recent period, Arrowhead signed and closed a potentially transformational licensing and collaboration agreement with Sarepta Therapeutics and submitted our first NDA for investigational plozasiran, which was subsequently accepted for filing by the
Selected Recent Events
-
Announced that the
U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational plozasiran for the treatment of familial chylomicronemia syndrome, a severe and rare genetic disease.- The clinical basis of the NDA submission is comprised of the positive findings from the Phase 3 PALISADE study with supportive confirmatory evidence from the Phase 2 clinical studies of the SUMMIT program.
- PALISADE successfully met its primary endpoint and all multiplicity-controlled key secondary endpoints, including statistically significant reductions in triglycerides, apolipoprotein C-III, and the incidence of acute pancreatitis.
- The FDA provided a Prescription Drug User Fee Act (PDUFA) action date of November 18, 2025, and indicated it is not currently planning to hold an advisory committee meeting.
-
Signed and closed a licensing and collaboration agreement with Sarepta Therapeutics. Upon closing, Arrowhead receives
$825 million $500 million $325 million $27.25 0735% premium to the 30-day volume weighted average price. Arrowhead will also receive$250 million $300 million $10 billion -
Announced new results from the Phase 3 PALISADE study and the open-label extension from the Phase 2 MUIR and SHASTA-2 studies of investigational plozasiran. These data were presented in two oral presentations at the American Heart Association Scientific Sessions 2024 (AHA24) and PALISADE data was simultaneously published in the AHA journal, Circulation. Key results include the following:
- Plozasiran induced deep and sustained reductions in triglycerides and impacted a wide spectrum of lipoproteins that may be involved with atherosclerotic cardiovascular disease.
- Similar responses were observed in patients with genetically confirmed and clinically diagnosed familial chylomicronemia syndrome.
-
Mean reductions from baseline in triglycerides of up to -
73% in patients from MUIR and -86% in patients from SHASTA-2 with favorable reductions in remnant cholesterol and non-HDL-cholesterol were observed through 15 months follow up in the open-label extension. - Overall, plozasiran has been generally well-tolerated to date. In the PALISADE study, the most frequently reported treatment emergent adverse events for the 25 mg dose were abdominal pain, COVID-19, nasopharyngitis, and nausea. Across clinical studies and study populations, the most frequently reported treatment emergent adverse events for the 25 mg dose were COVID-19, upper respiratory tract infection, headache, Type 2 diabetes mellitus, and abdominal pain.
-
Initiated a Phase 1/2a clinical trial of ARO-INHBE, the company’s investigational RNAi therapeutic being developed as a potential treatment for obesity.
- ARO-INHBE targets a known pathway that signals the body to store fat in adipose tissue.
- In preclinical studies, ARO-INHBE reduced body weight and fat mass with a novel mechanism of action that may better preserve lean muscle mass compared to currently approved obesity therapies.
-
Filed for and recently received regulatory clearance in
New Zealand to initiate a Phase 1/2a clinical trial of ARO-ALK7, the company’s investigational RNAi therapeutic being developed as a potential treatment for obesity. -
Presented interim results from a Phase 1/2a clinical study of ARO-CFB, the company’s investigational RNAi therapeutic targeting complement factor B being developed as a potential treatment for complement mediated diseases.
- Demonstrated near complete inhibition in hemolytic activity and functional activity of the alternative complement pathway.
Selected Fiscal 2025 First Quarter Financial Results
ARROWHEAD PHARMACEUTICALS, INC.
|
|||||||
OPERATING SUMMARY |
Three Months December 31, |
||||||
|
2024 |
|
|
|
2023 |
|
|
(unaudited) |
|||||||
Revenue |
$ |
2,500 |
|
$ |
3,551 |
|
|
Operating Expenses: |
|
||||||
Research and development |
|
137,002 |
|
|
116,491 |
|
|
General and administrative expenses |
|
26,910 |
|
|
|
23,605 |
|
Total operating expenses |
|
163,912 |
|
|
140,096 |
|
|
Operating loss |
|
(161,412 |
) |
|
|
(136,545 |
) |
Total other expense |
|
(13,703 |
) |
|
|
(2,144 |
) |
Loss before income tax expense and noncontrolling interest |
|
(175,115 |
) |
|
|
(138,689 |
) |
Income tax expense (benefit) |
|
103 |
|
|
|
(3,313 |
) |
Net loss including noncontrolling interest |
|
(175,218 |
) |
|
|
(135,376 |
) |
Net loss attributable to noncontrolling interest, net of tax |
|
(2,133 |
) |
|
(2,512 |
) |
|
Net loss attributable to Arrowhead Pharmaceuticals, Inc. |
$ |
(173,085 |
) |
|
$ |
(132,864 |
) |
Net loss per share attributable to Arrowhead Pharmaceuticals, Inc. - Diluted |
$ |
(1.39 |
) |
|
$ |
(1.24 |
) |
Weighted-average shares used in calculating - Diluted |
|
124,848 |
|
|
107,415 |
|
|
FINANCIAL POSITION SUMMARY |
|||||||
December 31, 2024 |
September 30, 2024 |
||||||
(unaudited) |
|||||||
Cash, cash equivalents and restricted cash |
$ |
53,889 |
|
|
$ |
102,685 |
|
Investments |
|
499,046 |
|
|
578,276 |
|
|
Total cash resources (cash and investments) |
|
552,935 |
|
|
|
680,961 |
|
Other assets |
|
460,759 |
|
|
458,841 |
|
|
Total Assets |
$ |
1,013,694 |
|
|
$ |
1,139,802 |
|
Liability related to the sale of future royalties |
$ |
346,776 |
|
|
$ |
341,361 |
|
Credit Facility |
|
409,414 |
|
|
393,183 |
|
|
Other liabilities |
|
201,429 |
|
|
|
214,195 |
|
Total Liabilities |
$ |
957,619 |
|
$ |
948,739 |
|
|
Total Arrowhead Pharmaceuticals, Inc. Stockholders' Equity |
|
52,589 |
|
|
|
185,444 |
|
Noncontrolling Interest |
|
3,486 |
|
|
5,619 |
|
|
Total Noncontrolling Interest and Stockholders' Equity |
$ |
56,075 |
|
|
$ |
191,063 |
|
Total Liabilities, Noncontrolling Interest and Stockholders' Equity |
$ |
1,013,694 |
|
$ |
1,139,802 |
|
|
Shares Outstanding |
|
125,572 |
|
|
124,376 |
|
|
Webcast and Conference Call and Details
Investors may access a live audio webcast on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two hours after the conclusion of the call.
For analysts that wish to participate in the conference call, please register at https://register.vevent.com/register/BI10095fd77113444788810d4774d5fae3. Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call.
About Plozasiran
Plozasiran, previously called ARO-APOC3, is a first-in-class investigational RNA interference (RNAi) therapeutic designed to reduce production of apolipoprotein C-III (APOC3) which is a component of triglyceride rich lipoproteins (TRLs) and a key regulator of triglyceride metabolism. APOC3 increases triglyceride levels in the blood by inhibiting breakdown of TRLs by lipoprotein lipase and uptake of TRL remnants by hepatic receptors in the liver. The goal of treatment with plozasiran is to reduce the level of APOC3, thereby reducing triglycerides and restoring lipids to more normal levels.
In multiple clinical studies, investigational plozasiran has demonstrated reductions in triglycerides and multiple atherogenic lipoproteins in patients with familial chylomicronemia syndrome (FCS), severe hypertriglyceridemia (SHTG), and mixed hyperlipidemia. Plozasiran has been generally well tolerated to date with treatment emergent adverse events reported that generally reflect the comorbidities and underlying conditions of the study populations. Across clinical studies and study populations, the most frequently reported treatment emergent adverse events for the 25 mg dose were COVID-19, upper respiratory tract infection, headache, Type 2 diabetes mellitus, and abdominal pain.
Plozasiran is being investigated in the SUMMIT program of clinical studies, including the PALISADE Phase 3 study in patients with FCS, the SHASTA studies in patients with SHTG, and the MUIR and CAPITAN studies in patients with mixed hyperlipidemia.
Plozasiran in the treatment of patients with FCS has been granted Breakthrough Therapy Designation, Orphan Drug Designation, and Fast Track Designation by the
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
For more information, please visit www.arrowheadpharma.com, or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.
Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” “continue,” “target,” “forecast” or “continue” or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.
Source: Arrowhead Pharmaceuticals, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250210172575/en/
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400
ir@arrowheadpharma.com
Investors:
LifeSci Advisors, LLC
Brian Ritchie
212-915-2578
britchie@lifesciadvisors.com
Media:
LifeSci Communications, LLC
Kendy Guarinoni, Ph.D.
724-910-9389
kguarinoni@lifescicomms.com
Source: Arrowhead Pharmaceuticals, Inc.
FAQ
What are the key terms of ARWR's licensing deal with Sarepta Therapeutics?
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What were ARWR's Q1 2025 financial results?
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