Arrowhead Pharmaceuticals, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 25 November 2025: press release. The quarter’s numbers.

Key takeaways

Revenue rose to $829,448 thousand: Revenue was $829,448 thousand for fiscal 2025, compared with $3,551 thousand for fiscal 2024. Source
Operating income against prior loss: Operating income was $98,346 thousand, against an operating loss of $(601,080) thousand in fiscal 2024. Source
Net loss attributable to Arrowhead: The company reported a net loss attributable to Arrowhead of $(1,631) thousand, or $(0.01) diluted EPS, against $(599,493) thousand, or $(5.00), a year earlier. Source
FDA approved REDEMPLO for FCS: The company describes REDEMPLO as its first FDA-approved medicine and the first and only FDA-approved siRNA medicine for people living with FCS. Source
Sarepta milestones reached $300 million: The company earned $300 million in milestone payments from Sarepta Therapeutics, including $100 million on the first enrollment target and $200 million on the second. Source
R&D spend rose to $607,159 thousand: Research and development expense was $607,159 thousand, up $101,289 thousand from $505,870 thousand in fiscal 2024. Source
Total cash resources rose to $919,366 thousand: Total cash resources were $919,366 thousand at September 30, 2025, against $680,961 thousand a year earlier, including $226,548 thousand of cash, cash equivalents and restricted cash. Source

“The recent FDA approval of REDEMPLO, indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), is a transformational milestone for Arrowhead.”
Christopher Anzalone, Ph.D., President and CEO at Arrowhead

What changed from last quarter

New: FDA approval of REDEMPLO (plozasiran) is reported. The prior release listed the plozasiran NDA as under FDA review, with a PDUFA date of November 18, 2025. Source
New: One-REDEMPLO pricing model announced, setting one consistent price across current and potential future indications. Source
New: Rely On REDEMPLO patient support program launched, with financial assistance options for eligible patients. Source
New: Global licensing and collaboration agreement with Novartis for ARO-SNCA, a preclinical siRNA therapy against alpha-synuclein, plus other targets using the TRiM platform. Source
New: Regulatory clearance requested to start a Phase 1/2a trial of ARO-DIMER-PA for atherosclerotic cardiovascular disease with mixed hyperlipidemia. Source
New: Regulatory clearance requested to start a Phase 1/2a trial of ARO-MAPT for tauopathies, including Alzheimer’s disease. Source
New: The company elected to receive about $50 million in Arrowhead common stock and about $50 million in cash from Sarepta for the first $100 million milestone, at $18.79 per share. The shares were placed into treasury. Source

Full-year results and profitability

Revenue rose to $829,448 thousand: Revenue was $829,448 thousand for fiscal 2025, compared with $3,551 thousand for fiscal 2024. Source
Operating income against prior loss: Operating income was $98,346 thousand, against an operating loss of $(601,080) thousand in fiscal 2024. Source
Net loss attributable to Arrowhead: The company reported a net loss attributable to Arrowhead of $(1,631) thousand, or $(0.01) diluted EPS, against $(599,493) thousand, or $(5.00), a year earlier. Source
Income tax and noncontrolling interest: Income tax expense was $21,419 thousand, against a $(2,767) thousand benefit in fiscal 2024. Net income attributable to noncontrolling interest was $31,745 thousand. Source

REDEMPLO approval and label

FDA approved REDEMPLO for FCS: The company describes REDEMPLO as its first FDA-approved medicine and the first and only FDA-approved siRNA medicine for people living with FCS. Source
Pivotal PALISADE results cited: The approval is based on the Phase 3 PALISADE study, where REDEMPLO reduced triglycerides 80% from baseline and lowered the numerical incidence of acute pancreatitis compared to placebo. Source
Home dosing once every three months: REDEMPLO can be self-administered at home by simple subcutaneous injection, once every three months. Source
Common adverse reactions listed: The label lists hyperglycemia, headache, nausea and injection site reaction as the most common adverse reactions in REDEMPLO-treated patients. Source

“Arrowhead is truly just getting started and we are well positioned to execute on our aggressive goals in discovery, clinical development, business development, and commercial”
Christopher Anzalone, Ph.D., President and CEO at Arrowhead

Partner payments and milestones

Sarepta milestones reached $300 million: The company earned $300 million in milestone payments from Sarepta Therapeutics, including $100 million on the first enrollment target and $200 million on the second. Source
Sanofi upfront for Greater China rights: Visirna Therapeutics, a majority-owned Arrowhead subsidiary, will receive a $130 million upfront payment from Sanofi for four cardiometabolic candidates in Greater China. Source
Novartis upfront payment received: Arrowhead received a $200 million upfront payment from Novartis for the ARO-SNCA license, a preclinical siRNA therapy against alpha-synuclein for synucleinopathies such as Parkinson’s Disease. Source

Pipeline and clinical programs

Zodasiran enters YOSEMITE Phase 3: The first subject was dosed in the YOSEMITE Phase 3 study of zodasiran for homozygous familial hypercholesterolemia. The company calls zodasiran its fourth candidate to reach late-stage pivotal studies. Source
ARO-DIMER-PA targets two genes: ARO-DIMER-PA is designed to silence PCSK9 and APOC3 in one molecule, described as the first clinical candidate to target two genes simultaneously in one molecule. Source
ARO-MAPT uses new delivery system: In preclinical studies, the new delivery system for ARO-MAPT achieved blood-brain-barrier penetration and deep knockdown across the central nervous system after subcutaneous injection. Source

Operating expenses and research spend

R&D spend rose to $607,159 thousand: Research and development expense was $607,159 thousand, up $101,289 thousand from $505,870 thousand in fiscal 2024. Source
G&A expense increased: General and administrative expenses were $123,943 thousand, up $25,182 thousand from $98,761 thousand in fiscal 2024. Source
Total operating expenses rose about 21%: Total operating expenses were $731,102 thousand, up about 21% from $604,631 thousand, with research and development the largest line. Source

Cash, debt and royalty liability

Total cash resources rose to $919,366 thousand: Total cash resources were $919,366 thousand at September 30, 2025, against $680,961 thousand a year earlier, including $226,548 thousand of cash, cash equivalents and restricted cash. Source
Credit facility balance declined: The credit facility balance was $254,883 thousand, down from $393,183 thousand a year earlier. Source
Royalty sale liability increased: The liability related to the sale of future royalties was $367,397 thousand, up from $341,361 thousand a year earlier. Source

Equity, shares and diluted count

Equity attributable to Arrowhead rose: Stockholders' equity attributable to Arrowhead was $466,052 thousand, against $185,444 thousand. Noncontrolling interest was $37,364 thousand, up from $5,619 thousand. Source
Shares outstanding rose: Shares outstanding were 135,702 thousand at September 30, 2025, against 124,376 thousand a year earlier. Source
Diluted weighted-average shares rose: Weighted-average diluted shares used in the EPS calculation were 133,758 thousand, against 119,784 thousand in fiscal 2024. Source

Coming up, as management said on 25 November 2025

Sanofi milestones tied to China approval: Visirna may receive up to $265 million in further milestone payments upon approval of plozasiran across various indications in mainland China. Source
Novartis milestones and royalties eligible: Arrowhead is eligible for up to $2 billion in development, regulatory and sales milestones from Novartis, plus tiered royalties on commercial sales up to the low double digits. Source

Figures management reported

Figure	Reported
R&D expense, fiscal 2025 Source	$607,159 thousand
FDA approvals Source	REDEMPLO (plozasiran), FCS
Phase 3 triglyceride reduction (PALISADE) Source	-80% from baseline
Clearance requests filed Source	2 (ARO-DIMER-PA, ARO-MAPT)
Partner milestone payments (Sarepta) Source	$300 million

Earlier plans management reported on

Not stated: The prior release said the commercial build-out was designed for launch readiness on day one. The current release reports approval but does not state the approval date against the November 18, 2025 PDUFA date.
Met: The prior release expected the second enrollment target by the end of 2025, which would trigger a $200 million milestone. The current release reports that milestone earned on achieving that target.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

Arrowhead Pharmaceuticals Reports 2025 Fiscal Year-End Results

Conference Call and Webcast Today, November 25, 2025 at 4:30 p.m. ET

PASADENA, Calif., November 25, 2025 - Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its 2025 fiscal year ended September 30, 2025. The Company is hosting a conference call today, November 25, 2025, at 4:30 p.m. ET to discuss the results.

“The recent FDA approval of REDEMPLO, indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), is a transformational milestone for Arrowhead. REDEMPLO is the first and only FDA-approved siRNA medicine for people living with FCS and represents the first FDA-approval for a medicine leveraging Arrowhead’s proprietary and differentiated Targeted RNAi Molecule (TRiMTM) platform,” said Christopher Anzalone, Ph.D., President and CEO at Arrowhead. “However, Arrowhead is truly just getting started and we are well positioned to execute on our aggressive goals in discovery, clinical development, business development, and commercial to enable multiple potential new launches, both independently and with partners, over the coming years”

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 who wish to participate in the conference call, please register at https://register-conf.media-server.com/register/BI2700430252ab408a89dff83808477869. Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call.

Selected Recent Events

Announced that the U.S. Food and Drug Administration (FDA) has approved REDEMPLO (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
FCS is a severe, rare disease, with an estimated 6,500 people in the U.S. living with genetic or clinical FCS, characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis.
This is Arrowhead’s first FDA-approved medicine, marking a major milestone for the company as it transitions into commercial-stage.
REDEMPLO is the first and only FDA-approved siRNA medicine for people living with FCS and can be self-administered at home with a simple subcutaneous injection once every three months.
REDEMPLO is the first and only FDA-approved medicine to be studied in patients with genetically confirmed and clinically diagnosed FCS.
The FDA approval is based on positive results from the Phase 3 PALISADE study where REDEMPLO significantly reduced triglycerides -80% from baseline and lowered the numerical incidence of acute pancreatitis compared to placebo.
Announced the One-REDEMPLO pricing model that creates one consistent price across current and potential future indications.
Launched Rely On REDEMPLO, a patient support program providing support services and resources for patients at each stage of the treatment journey with REDEMPLO, including financial assistance options for eligible patients.
Announced a global licensing and collaboration agreement with Novartis for ARO-SNCA, Arrowhead’s preclinical stage siRNA therapy against alpha-synuclein for the treatment of synucleinopathies, such as Parkinson’s Disease, and for other additional collaboration targets that will utilize Arrowhead’s proprietary Targeted RNAi Molecule (TRiM™) platform. Financial terms of the agreement include:
Arrowhead received a $200 million upfront payment from Novartis. Arrowhead is also eligible to receive development, regulatory, and sales milestone payments of up to $2 billion. Arrowhead is further eligible to receive tiered royalties on commercial sales up to the low double digits.
Filed a request for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-DIMER-PA, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for atherosclerotic cardiovascular disease (ASCVD) due to mixed hyperlipidemia.
ARO-DIMER-PA is a dual functional RNAi therapeutic designed to silence expression of the proprotein convertase subtilisin kexin 9 (PCSK9) and apolipoprotein C3 (APOC3) genes. This represents an important step forward for the RNAi field as it is the first clinical candidate to target two genes simultaneously in one molecule.
Filed a request for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-MAPT, the company’s investigational RNAi therapeutic being developed as a potential treatment for tauopathies including Alzheimer’s disease, a progressive neurodegenerative disease characterized by cognitive and functional decline.
ARO-MAPT is Arrowhead’s first investigational RNAi-based therapy to utilize a new proprietary delivery system which, in preclinical studies, has achieved blood-brain-barrier penetration and deep knockdown of target genes across the central nervous system (CNS), including deep brain regions, after subcutaneous injections.
Earned $300 million in milestone payments from Sarepta Therapeutics.
$100 million milestone earned when Arrowhead reached the first of two pre-specified enrollment targets and subsequent authorization to dose escalate in a Phase 1/2 clinical study of ARO-DM1, an investigational RNA interference (RNAi) therapeutic for the treatment of type 1 myotonic dystrophy (DM1), the most common adult-onset muscular dystrophy.
$200 million milestone earned following a drug safety committee review and subsequent authorization to dose escalate, and achievement of the second pre-specified patient enrollment target.
Elected to receive approximately $50 million worth of Arrowhead common stock and approximately $50 million in cash from Sarepta Therapeutics to satisfy the payment of the first $100 million milestone owed to Arrowhead. The company believed this direct stock buyback of Arrowhead shares from Sarepta at $18.79 per share was an attractive option, given Arrowhead’s significant growth potential, both near- and longer-term. These shares were subsequently placed into treasury to reduce the number of Arrowhead shares outstanding.
Dosed the first subject in the YOSEMITE Phase 3 clinical trial of zodasiran, the company’s investigational RNAi therapeutic being developed as a potential treatment for homozygous familial hypercholesterolemia (HoFH), a rare genetic condition that leads to severely elevated LDL-cholesterol and early onset cardiovascular disease. Zodasiran is the fourth investigational RNAi-based candidate developed by Arrowhead to reach late-stage pivotal studies, after investigational drugs plozasiran, fazirsiran (licensed to Takeda) and olpasiran (licensed to Amgen).
Announced the signing of an asset purchase agreement between Sanofi and Visirna Therapeutics, a majority-owned subsidiary of Arrowhead created to develop and commercialize four of Arrowhead’s investigational cardiometabolic candidates in Greater China. Summary terms of the agreement include:
Visirna will receive an upfront payment of $130 million from Sanofi. In addition, Visirna will be eligible to receive further milestone payments of up to $265 million upon approval of plozasiran across various indications in mainland China.
Sanofi will receive an exclusive license to develop and commercialize investigational plozasiran in Greater China from Visirna Therapeutics, offering potential treatment to people living with elevated triglycerides.

Selected Fiscal 2025 Year-End Financial Results

ARROWHEAD PHARMACEUTICALS, INC.

CONSOLIDATED CONDENSED FINANCIAL INFORMATION

(in thousands, except per share amounts)

	Year Ended September 30,
OPERATING SUMMARY		2025		2024
Revenue	$829,448		$3,551
Operating Expenses:
Research and development	607,159		505,870
General and administrative expenses	123,943		98,761
Total operating expenses	731,102		604,631
Operating income (loss)	98,346		(601,080)
Total other expense	(46,813)		(11,380)
Income (loss) before income tax expense and noncontrolling interest	51,533		(612,460)
Income tax (benefit) expense	21,419		(2,767)
Net income (loss) including noncontrolling interest	30,114		(609,693)
Net income (loss) attributable to noncontrolling interest, net of tax	31,745		(10,200)
Net income (loss) attributable to Arrowhead Pharmaceuticals, Inc.	$(1,631)		$(599,493)
Net income (loss) per share attributable to Arrowhead Pharmaceuticals, Inc. - Diluted	$(0.01)		$(5.00)
Weighted-average shares used in calculating - Diluted	133,758		119,784

	September 30,
FINANCIAL POSITION SUMMARY		2025		2024
Cash, cash equivalents and restricted cash	$226,548		$102,685
Available-for-sale securities, at fair value	692,818		578,276
Total cash resources (Cash, cash equivalents and restricted cash and Available-for-sale securities, at fair value)	919,366		680,961
Other current and long-term assets	465,929		458,841
Total Assets	$1,385,295		$1,139,802
Liability related to the sale of future royalties	$367,397		$341,361
Credit Facility	254,883		393,183
Deferred revenue	2,399		-
Other liabilities	257,200		214,195
Total Liabilities	$881,879		$948,739
Total Arrowhead Pharmaceuticals, Inc. Stockholders' Equity	466,052		185,444
Noncontrolling Interest		37,364		5,619
Total Noncontrolling Interest and Stockholders' Equity	$503,416		$191,063
Total Liabilities, Noncontrolling Interest and Stockholders' Equity	$1,385,295		$1,139,802
Shares Outstanding	135,702		124,376

About REDEMPLO® (plozasiran)

REDEMPLO (plozasiran) is approved by the U.S. Food and Drug Administration as an adjunct to diet to reduce triglycerides in adults with Familial Chylomicronemia Syndrome (FCS). REDEMPLO is an siRNA therapeutic designed to suppress the production of apoC-III, a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting apoC-III with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is the first and only siRNA FDA-approved treatment studied in both genetically confirmed and clinically diagnosed patients living with FCS.

For more information about REDEMPLO, visit Our Medicines.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

None.

ADVERSE REACTIONS

Most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and >5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction.

Please see full Prescribing Information for REDEMPLO®.

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:

Forward-looking statements notice

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, products or product candidate or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about our beliefs and expectations regarding the long-term impacts of REDEMPLO (plozasiran) on patient health and the health care system; our beliefs and expectations regarding the pricing, value, or expected timing for availability of our drugs and drug candidates; and our believes and expectations around the potential uses and value of the TRiM™ platform. These statements are based upon our current expectations and speak only as of the date hereof. Actual results or outcomes may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties the safety and efficacy of our products and product candidates, pricing and reimbursement decisions related to our products, demand for our products, 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, 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.

Contacts
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400 ir@arrowheadpharma.com
LifeSci Advisors, LLC
Brian Ritchie
212-915-2578 britchie@lifesciadvisors.com
LifeSci Communications, LLC
Kendy Guarinoni, Ph.D.
724-910-9389 kguarinoni@lifescicomms.com
Source: Arrowhead Pharmaceuticals, Inc.