Arrowhead Pharmaceuticals Reports 2024 Fiscal Year-End Results
Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported its fiscal year 2024 results, highlighting significant financial and R&D developments. The company secured major financing through a $825 million licensing agreement with Sarepta Therapeutics and a $500 million credit facility with Sixth Street, extending cash runway into 2028. Key achievements include submitting their first NDA for plozasiran and receiving Breakthrough Therapy designation from FDA. However, financial results showed a significant increase in net loss to $599.5 million compared to $205.3 million in 2023, with revenue declining to $3.6 million from $240.7 million previous year.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) ha pubblicato i risultati per l'anno fiscale 2024, evidenziando sviluppi finanziari e di ricerca e sviluppo significativi. L'azienda ha ottenuto un finanziamento importante attraverso un accordo di licenza da 825 milioni di dollari con Sarepta Therapeutics e una linea di credito da 500 milioni di dollari con Sixth Street, estendendo così la disponibilità di liquidità fino al 2028. Tra i risultati chiave si segnala la presentazione della loro prima NDA per plozasiran e l'ottenimento della designazione di Terapia Innovativa da parte della FDA. Tuttavia, i risultati finanziari hanno mostrato un significativo incremento delle perdite nette, arrivando a 599,5 milioni di dollari rispetto ai 205,3 milioni del 2023, con un calo dei ricavi a 3,6 milioni di dollari rispetto ai 240,7 milioni dell'anno precedente.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) informó sobre sus resultados del año fiscal 2024, destacando desarrollos financieros y de I+D significativos. La compañía aseguró una importante financiación a través de un acuerdo de licencia por 825 millones de dólares con Sarepta Therapeutics y una línea de crédito por 500 millones de dólares con Sixth Street, extendiendo así su liquidez hasta 2028. Los logros clave incluyen la presentación de su primera NDA para plozasiran y la recepción de la designación de Terapia Innovadora por parte de la FDA. Sin embargo, los resultados financieros mostraron un aumento significativo en la pérdida neta, alcanzando 599,5 millones de dólares en comparación con los 205,3 millones de 2023, con ingresos que cayeron a 3,6 millones de dólares desde los 240,7 millones del año anterior.
Arrowhead Pharmaceuticals (NASDAQ: ARWR)는 2024 회계 연도 결과를 발표하며 유의미한 재무 및 연구 개발의 발전을 강조했습니다. 이 회사는 Sarepta Therapeutics와의 8억 2500만 달러 규모 라이센스 계약과 Sixth Street와의 5억 달러 신용 시설을 통해 주요 자금을 확보해 2028년까지 현금 소진 기간을 연장했습니다. 주요 성과로는 plozasiran에 대한 첫 NDA 제출과 FDA로부터 혁신 치료제 지정을 받은 것이 있습니다. 그러나 재무 결과는 2023년 2억 5300만 달러에서 5억 9950만 달러로 순손실이 상당히 증가한 것으로 나타났고, 수익은 지난해 2억 4070만 달러에서 360만 달러로 감소했습니다.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) a publié ses résultats pour l'exercice fiscal 2024, soulignant des développements financiers et R&D significatifs. La société a obtenu un financement majeur grâce à un contrat de licence de 825 millions de dollars avec Sarepta Therapeutics et une ligne de crédit de 500 millions de dollars avec Sixth Street, prolongeant ainsi sa trésorerie jusqu'en 2028. Parmi les réalisations clés, on note la soumission de leur première NDA pour plozasiran et l'obtention de la désignation de Thérapie Innovante par la FDA. Cependant, les résultats financiers ont montré une augmentation significative de la perte nette à 599,5 millions de dollars contre 205,3 millions en 2023, les revenus ayant chuté à 3,6 millions de dollars contre 240,7 millions de dollars l'année précédente.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) hat über die Ergebnisse des Geschäftsjahres 2024 berichtet und dabei wichtige finanzielle sowie F&E-Entwicklungen hervorgehoben. Das Unternehmen sicherte sich eine bedeutende Finanzierung durch einen Lizenzvertrag über 825 Millionen USD mit Sarepta Therapeutics und eine Kreditfazilität über 500 Millionen USD mit Sixth Street, wodurch die Liquidität bis 2028 verlängert wurde. Zu den wichtigsten Erfolgen gehört die Einreichung ihrer ersten NDA für plozasiran sowie die Erlangung der Breakthrough-Therapie-Bezeichnung von der FDA. Allerdings zeigten die finanziellen Ergebnisse einen signifikanten Anstieg des Nettodverlusts auf 599,5 Millionen USD im Vergleich zu 205,3 Millionen im Jahr 2023, wobei die Einnahmen auf 3,6 Millionen USD von 240,7 Millionen USD im Vorjahr zurückgingen.
- Secured $825 million licensing deal with Sarepta Therapeutics ($500M cash + $325M equity investment)
- Obtained $500 million credit facility from Sixth Street
- Extended cash runway into 2028
- Submitted first NDA for plozasiran
- Received FDA Breakthrough Therapy designation for plozasiran
- Net loss increased to $599.5 million from $205.3 million YoY
- Revenue declined to $3.6 million from $240.7 million YoY
- Operating expenses increased to $604.6 million from $445.7 million YoY
Insights
This earnings report reveals significant financial developments for Arrowhead Pharmaceuticals. The company reported a substantial revenue decline to
Key Financial Highlights:
- Secured
$825M from Sarepta deal ($500M cash +$325M equity investment) - Additional
$500M credit facility from Sixth Street - Extended cash runway into 2028
- Total cash resources of
$681M
The Sarepta collaboration, potential milestone payments of
The pipeline progress shows promising developments, particularly with plozasiran. Key clinical achievements include:
- NDA submission for plozasiran in familial chylomicronemia syndrome
- Breakthrough Therapy designation from FDA
- Impressive Phase 3 PALISADE results showing
73-86% triglyceride reductions - Initiation of Phase 3 SHASTA-3 and SHASTA-4 studies
The expansion into obesity treatment with ARO-INHBE and the establishment of GMP manufacturing capabilities demonstrate strong R&D execution. The positive safety profile and efficacy data from multiple trials suggest a high probability of regulatory success.
- Conference Call and Webcast Today, November 26, 2024, at 4:30 p.m. ET
“Arrowhead is well positioned, both individually and with partners, to advance and ultimately commercialize important new medicines using our proprietary TRiM™ technology. We have the potential to impact the lives of millions of patients in need. We believe we now have all the necessary pieces in place to drive significant value for shareholders in the short-term, mid-term, and, more importantly, over the long-term as we seek to build a sustainable, financially sound business,” said Christopher Anzalone, Ph.D., President and CEO at Arrowhead. “Key events have occurred during the recent period that we see as potentially transformational for Arrowhead. Earlier this month, we submitted our first NDA to the
Selected Recent Financial Events
-
Strengthened the balance sheet through a strategic financing agreement and licensing and collaboration agreement. We estimate that together, these transactions extend Arrowhead’s cash runway into 2028 and potentially through multiple new drug launches, including wholly owned and partnered programs. These two events were:
-
Signed a licensing and collaboration agreement with Sarepta Therapeutics. Upon closing, Arrowhead will receive
$825 million $500 million $325 million $27.25 0735% premium to the 30-day volume weighted average price. Arrowhead also receives$250 million $300 million $10 billion -
Closed a strategic financing agreement with Sixth Street for significant, long-term, non-dilutive capital. The
$500 million $400 million $100 million
-
Signed a licensing and collaboration agreement with Sarepta Therapeutics. Upon closing, Arrowhead will receive
Selected Recent R&D Events
-
Submitted a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for investigational plozasiran for the treatment of familial chylomicronemia syndrome, a severe and rare genetic disease which currently has no FDA approved treatments. - Received Breakthrough Therapy designation from the FDA for investigational plozasiran as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome.
-
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 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 pivotal Phase 3 SHASTA-3 and SHASTA-4 studies of plozasiran in patients with severe hypertriglyceridemia.
- Launched a new disease awareness campaign, ‘We’ll Get There Soon,’ to inspire hope for the rare disease community affected by familial chylomicronemia syndrome.
- Presented data from the Phase 3 PALISADE study of plozasiran in a late-breaking oral presentation at the European Society of Cardiology (ESC) Congress 2024 and simultaneously published in The New England Journal of Medicine.
-
Arrowhead’s
Verona, WI manufacturing and testing facility successfully completed requirements to manufacture GMP drug substance to support clinical trials conducted inthe United States and many other countries abroad, and recently successfully completed a Qualified Person (QP) audit, which allows for internally produced drug substance to be used in support of clinical programs in EU countries and theUnited Kingdom . -
Filed for regulatory clearance in
New Zealand to initiate a Phase 1/2a clinical trial of ARO-INHBE, the company’s investigational RNAi therapeutic being developed as a potential treatment for obesity.- In preclinical studies ARO-INHBE reduced body weight and fat mass with a novel mechanism of action that may preserve lean muscle mass compared to currently approved obesity therapies.
-
Completed the 2024 Summer Series of R&D webinars, each highlighting a specific therapeutic area in Arrowhead’s pipeline, including the following events:
- May 23, 2024 – Muscular
- June 25, 2024 – Cardiometabolic
- July 16, 2024 – Pulmonary
- August 14, 2024 – Obesity/Metabolic
- September 25, 2024 – Central Nervous System
Selected Fiscal 2024 Year End Financial Results
ARROWHEAD PHARMACEUTICALS, INC.
|
|||||||
OPERATING SUMMARY |
Year Ended September 30, |
||||||
|
2024 |
|
|
2023 |
|
||
Revenue |
$ |
3,551 |
|
$ |
240,735 |
|
|
Operating Expenses: |
|
|
|
||||
Research and development |
|
505,870 |
|
|
353,188 |
|
|
General and administrative expenses |
|
98,761 |
|
|
|
92,549 |
|
Total Operating Expenses |
|
604,631 |
|
|
445,737 |
|
|
Operating loss |
|
(601,080 |
) |
|
|
(205,002 |
) |
Total other expense |
|
(11,380 |
) |
|
|
(1,489 |
) |
Loss before income tax expense and noncontrolling interest |
|
(612,460 |
) |
|
|
(206,491 |
) |
Income tax (benefit) expense |
|
(2,767 |
) |
|
|
2,784 |
|
Net loss including noncontrolling interest |
|
(609,693 |
) |
|
|
(209,275 |
) |
Net loss attributable to noncontrolling interest, net of tax |
|
(10,200 |
) |
|
(4,000 |
) |
|
Net loss attributable to Arrowhead Pharmaceuticals, Inc. |
$ |
(599,493 |
) |
|
$ |
(205,275 |
) |
Net loss per share attributable to Arrowhead Pharmaceuticals, Inc. - Diluted |
$ |
(5.00 |
) |
|
$ |
(1.92 |
) |
Weighted-average shares used in calculating - Diluted |
|
119,784 |
|
|
106,750 |
|
|
FINANCIAL POSITION SUMMARY |
September 30, |
||||||
|
2024 |
|
|
2023 |
|
||
Cash, cash equivalents and restricted cash |
$ |
102,685 |
|
$ |
110,891 |
|
|
Investments |
|
578,276 |
|
|
292,735 |
|
|
Total cash resources (cash and investments) |
|
680,961 |
|
|
|
403,626 |
|
Other assets |
|
458,841 |
|
|
361,926 |
|
|
Total Assets |
$ |
1,139,802 |
|
|
$ |
765,552 |
|
Current deferred revenue |
$ |
- |
|
|
$ |
866 |
|
Credit Facility |
|
393,183 |
|
|
- |
|
|
Other liabilities |
|
555,556 |
|
|
|
477,524 |
|
Total Liabilities |
$ |
948,739 |
|
$ |
478,390 |
|
|
|
|
|
|
||||
Total Arrowhead Pharmaceuticals, Inc. Stockholders' Equity |
$ |
185,444 |
|
$ |
271,343 |
|
|
Noncontrolling Interest |
|
5,619 |
|
|
|
15,819 |
|
Total Noncontrolling Interest and Stockholders' Equity |
$ |
191,063 |
|
$ |
287,162 |
|
|
Total Liabilities, Noncontrolling Interest and Stockholders' Equity |
$ |
1,139,802 |
|
|
$ |
765,552 |
|
Shares Outstanding |
|
124,376 |
|
|
|
107,312 |
|
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/BIc060a13ae8224934aac09d48abe7b2f6. 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/20241126683832/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 was Arrowhead Pharmaceuticals (ARWR) revenue in fiscal year 2024?
How much was the Sarepta Therapeutics deal worth to ARWR?
What was ARWR's net loss in fiscal year 2024?
When did ARWR submit its NDA for plozasiran?
