Arrowhead Pharmaceuticals Reports Fiscal 2024 Second Quarter Results
Arrowhead Pharmaceuticals, Inc. reported its fiscal 2024 second quarter results, showcasing progress in its RNAi-based medicines. The company received a $50 million milestone payment, presented positive data from its plozasiran study, and initiated an Expanded Access Program. Additionally, Arrowhead strengthened its balance sheet through a stock offering. Financially, the company reported a net loss and increased cash reserves.
Received a $50 million milestone payment from Royalty Pharma plc for completing enrollment in the Phase 3 OCEAN Outcomes Trial of olpasiran.
Presented positive data from the Phase 2 SHASTA-2 study of plozasiran, showing significant reductions in triglycerides and APOC3 levels.
Initiated an Expanded Access Program (EAP) for investigational plozasiran to aid patients with familial chylomicronemia syndrome.
Launched the 2024 Summer Series of R&D webinars to highlight therapeutic areas in Arrowhead's pipeline.
Dosed the first subjects in Phase 1/2a clinical trials of ARO-CFB and ARO-DM1, aimed at treating diseases associated with complement pathway activation and type 1 myotonic dystrophy.
Strengthened the balance sheet with a $450 million stock offering, increasing cash reserves.
Reported a net loss in the fiscal 2024 second quarter, indicating financial challenges.
Insights
The latest financial release from Arrowhead Pharmaceuticals indicates a substantial operating loss of
Arrowhead’s update highlights the progress in their RNAi-based therapeutic programs, such as nearing completion of the PALISADE Phase 3 study for plozasiran, a notable milestone which, if successful, could lead to a new treatment option for hypertriglyceridemia. The reported
Arrowhead's financial results also underscore the critical phase of their R&D journey with several Phase 3 trials underway and the initiation of new Phase 1/2a trials. The success of these trials, particularly for their lead candidates like plozasiran and zodasiran, will be pivotal in determining the company's future. The balance between investment in these trials and the need for financial sustainability is evident in their increased R&D expenditure. It's worth noting the company’s strategy to begin the regulatory submission process, which suggests confidence in their trial outcomes. However, as with all clinical trials, there remains significant risk until regulatory approval is secured and commercial viability is proven.
- Conference Call and Webcast Today, May 9, 2024, at 4:30 p.m. ET
Christopher Anzalone, Ph.D., President and CEO at Arrowhead, said: “Arrowhead has achieved significant progress across our broad pipeline of investigational RNAi-based medicines that leverage the proprietary TRiMTM platform and we continued to strengthen our focus on and investment in our late-stage cardiometabolic programs. As we approach completion of the PALISADE Phase 3 study of plozasiran and initiate additional Phase 3 trials of both plozasiran and zodasiran, we will continue to efficiently execute our clinical studies. Simultaneously, we plan to begin the regulatory submission process, refine our commercial strategy, and build the commercial infrastructure to support it.”
Webcast and Conference Call and Details
Investors may access a live audio webcast on the Company's website at https://ir.arrowheadpharma.com/events-and-presentations. 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/BIf9305354ec6b44e3b3e946792a393a5e. 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
-
Received a
$50 million -
Presented final data from the Phase 2 SHASTA-2 study of investigational plozasiran in patients with severe hypertriglyceridemia in a late-breaking oral presentation at the American College of Cardiology 73rd Annual Scientific Session & Expo and simultaneously published in the journal JAMA Cardiology. Key results included the following:
-
Treatment with plozasiran led to dose-dependent placebo-adjusted reductions in triglycerides (primary endpoint) of -
49% (P < 0.001), -53% (P < 0.001), and -57% (P < 0.001), driven by placebo-adjusted reductions in APOC3 of -68% (P < 0.001), -72% (P < 0.001), and -77% (P < 0.001) at week 24, after receiving two doses of 10 mg, 25 mg, and 50 mg plozasiran, respectively. Mean maximum, non-placebo adjusted reductions from baseline in triglycerides and APOC3 were up to86% and90% and typically occurred around week 16 or week 20. -
Among patients treated with plozasiran,
90.6% achieved a triglyceride level less than 500 mg/dL, the level associated with increased risk of acute pancreatitis, at week 24. In addition,48.4% of patients achieved normal triglyceride levels of less than 150 mg/dL at week 24. - Subjects treated with plozasiran also showed improvements in multiple atherogenic lipid and lipoprotein levels, including remnant cholesterol, HDL-cholesterol, and non-HDL cholesterol.
- Plozasiran demonstrated a favorable safety profile in the SHASTA-2 study. The adverse event and serious adverse event profile were similar across treatment groups. Observed adverse events generally reflected the comorbidities and underlying conditions of the study population.
-
Treatment with plozasiran led to dose-dependent placebo-adjusted reductions in triglycerides (primary endpoint) of -
-
Initiated an Expanded Access Program (EAP) to make investigational plozasiran available outside of a clinical trial for patients with familial chylomicronemia syndrome (FCS) who meet certain program eligibility criteria.
- The plozasiran EAP is for individuals living with FCS. As with any investigational medicine that has not been approved by regulatory authorities, investigational plozasiran may or may not be effective in treating your diagnosis or condition, and there may be risks associated with its use. If you are a patient or caregiver wishing to know more about this plozasiran EAP for FCS, please discuss this EAP and all treatment options with your treating physician. If you are a treating physician and are seeking information about the plozasiran EAP or would like to request access for a patient, please contact EAP@arrowheadpharma.com.
-
Launched the 2024 Summer Series of R&D webinars to highlight specific therapeutic areas in Arrowhead’s pipeline. Each event will feature presentations by Arrowhead team members and external key opinion leaders, who will discuss the respective disease areas and treatment landscapes. 2024 Summer Series Schedule:
- May 23, 2024 – Muscular
- June 25, 2024 – Cardiometabolic
- July 16, 2024 – Pulmonary
- August 15, 2024 – Obesity/Metabolic
- September 25, 2024 – Central Nervous System
- Dosed the first subjects in a Phase 1/2a clinical trial (NCT06209177) of ARO-CFB, designed to reduce hepatic expression of complement factor B, and is being developed as a potential treatment for diseases associated with activation of the complement pathway.
- Dosed the first subjects in a Phase 1/2a clinical trial (NCT06138743) of ARO-DM1, designed to reduce expression of the dystrophia myotonica protein kinase gene in the muscle, and is being developed as a potential treatment for type 1 myotonic dystrophy, the most common adult-onset muscular dystrophy.
-
Strengthened the balance sheet through an underwritten registered offering of common stock for gross proceeds of approximately
$450 million
Selected Fiscal 2024 Second Quarter Financial Results
ARROWHEAD PHARMACEUTICALS, INC.
|
|||||||
OPERATING SUMMARY |
Three Months Ended March 31, |
||||||
|
2024 |
|
|
2023 |
|
||
|
(unaudited) |
||||||
Revenue |
$ |
- |
|
$ |
146,267 |
|
|
Operating Expenses: |
|
|
|
||||
Research and development |
|
101,122 |
|
|
74,881 |
|
|
General and administrative expenses |
|
25,069 |
|
|
|
23,221 |
|
Total operating expenses |
|
126,191 |
|
|
98,102 |
|
|
Operating (loss) income |
|
(126,191 |
) |
|
|
48,165 |
|
Total other expense |
|
(805 |
) |
|
(489 |
) |
|
(Loss) income before income tax expense and noncontrolling interest |
|
(126,996 |
) |
|
|
47,676 |
|
Income tax expense |
|
- |
|
|
|
- |
|
Net (loss) income including noncontrolling interest |
|
(126,996 |
) |
|
|
47,676 |
|
Net (loss) income attributable to noncontrolling interest, net of tax |
|
(1,696 |
) |
|
(999 |
) |
|
Net (loss) income attributable to Arrowhead Pharmaceuticals, Inc. |
$ |
(125,300 |
) |
|
$ |
48,675 |
|
Net (loss) income per share attributable to Arrowhead Pharmaceuticals, Inc. - Diluted |
$ |
(1.02 |
) |
|
$ |
0.45 |
|
Weighted-average shares used in calculating - Diluted |
|
123,285 |
|
|
108,143 |
|
|
FINANCIAL POSITION SUMMARY |
|
||||||
March 31, 2024 |
|
September 30, 2023 |
|||||
|
(unaudited) |
|
|
||||
Cash, cash equivalents and restricted cash |
$ |
127,704 |
|
$ |
110,891 |
|
|
Investments |
|
395,410 |
|
|
292,735 |
|
|
Total cash resources (cash and investments) |
|
523,114 |
|
|
|
403,626 |
|
Other assets |
|
432,036 |
|
|
361,926 |
|
|
Total Assets |
$ |
955,150 |
|
|
$ |
765,552 |
|
Current deferred revenue |
$ |
- |
|
|
$ |
866 |
|
Other liabilities |
|
459,745 |
|
|
|
477,524 |
|
Total Liabilities |
$ |
459,745 |
|
$ |
478,390 |
|
|
Total Arrowhead Pharmaceuticals, Inc. Stockholders' Equity |
$ |
483,794 |
|
$ |
271,343 |
|
|
Noncontrolling Interest |
|
11,611 |
|
|
|
15,819 |
|
Total Noncontrolling Interest and Stockholders' Equity |
$ |
495,405 |
|
$ |
287,162 |
|
|
Total Liabilities, Noncontrolling Interest and Stockholders' Equity |
$ |
955,150 |
|
|
$ |
765,552 |
|
Shares Outstanding |
|
124,133 |
|
|
|
107,312 |
|
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 or on LinkedIn. 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/20240509969239/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 financial results did Arrowhead Pharmaceuticals report for the fiscal 2024 second quarter?
What milestone payment did Arrowhead receive in the third quarter of fiscal 2024?
What study did Arrowhead present final data from at the American College of Cardiology 73rd Annual Scientific Session & Expo?
What program did Arrowhead initiate to make investigational plozasiran available outside of a clinical trial?
What initiative did Arrowhead launch to highlight therapeutic areas in its pipeline?
