Arrowhead Pharmaceuticals Reports Fiscal 2022 Second Quarter Results

Rhea-AI Summary

Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported strong financial results for Q2 FY2022, demonstrating a revenue increase to $151.8 million, up from $32.8 million in Q2 FY2021. The company achieved a net income of $44.4 million, or $0.41 per diluted share, compared to a loss of $26.8 million in the previous year. Key developments include the initiation of several clinical studies for its investigational RNA interference therapeutics, which target various conditions, alongside the formation of a joint venture in Greater China and the groundbreaking of a new manufacturing facility.

Positive

• Q2 2022 revenue increased to $151.8 million from $32.8 million in Q2 2021.
• Net income reached $44.4 million, compared to a net loss of $26.8 million in Q2 2021.
• Initiated PALISADE Phase 3 study for ARO-APOC3 therapeutic.
• Completed enrollment of 204 patients in the Phase 2b ARCHES-2 clinical study.
• Formed a joint venture, Visirna Therapeutics, to enhance market reach in Greater China.
• Started construction of a new drug manufacturing facility.

Negative

• Total cash resources decreased to $603.5 million from $613.4 million.
• Operating expenses increased significantly, totaling $110.3 million in Q2 2022 vs. $61.0 million in Q2 2021.

- Conference Call and Webcast Today, May 10, 2022 at 4:30 p.m. ET

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal second quarter ended March 31, 2022. The company is hosting a conference call today, May 10, 2022, at 4:30 p.m. ET to discuss the results.

Conference Call and Webcast Details

Investors may access a live audio webcast on the Company's website at http://ir.arrowheadpharma.com/events.cfm. For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 3791265.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 3791265.

Selected Recent Events

• Initiated the PALISADE Phase 3 clinical study to evaluate the efficacy and safety of ARO-APOC3, Arrowhead’s investigational RNA interference (RNAi) therapeutic designed to inhibit the production of apolipoprotein C-III (APOC3), a key regulator of triglyceride metabolism, in adults with familial chylomicronemia syndrome
• Completed enrollment of 204 patients in the Phase 2b ARCHES-2 clinical study of ARO-ANG3, our investigational medicine designed to reduce production of angiopoietin-like protein 3 ANGPTL3 as a potential treatment for patients with mixed dyslipidemia
  • ARCHES-2 is expected to be complete around the end of 2022 and topline data are anticipated to be available in the first half of 2023
• Initiated the Phase 2 GATEWAY clinical study of ARO-ANG3, Arrowhead’s investigational medicine designed to silence the hepatic expression of angiopoietin-like protein 3 (ANGPTL3), in patients with homozygous familial hypercholesterolemia (HoFH)
• Initiated a Phase 1/2 study of ARO-C3, Arrowhead’s investigational medicine designed to reduce production of complement component 3 (C3) as a potential therapy for various complement mediated diseases, in up to 24 adult healthy volunteers, up to 24 adult patients with paroxysmal nocturnal hemoglobinuria (PNH), and up to 14 adult patients with complement-mediated renal disease
• Filed Clinical Trial Applications (CTA) requesting regulatory clearance to begin clinical studies for two new investigational medicines designed to treat various muco-obstructive and inflammatory pulmonary conditions
  • ARO-MUC5AC, an investigational RNAi therapeutic designed to inhibit the production of mucin 5AC (MUC5AC)
  • ARO-RAGE, an investigational RNAi therapeutic designed to inhibit the production of Receptor for Advanced Glycation End products (RAGE)
• Formed a joint venture, Visirna Therapeutics, with Vivo Capital to expand the reach of innovative medicines in Greater China
• Broke ground on construction of a new drug manufacturing facility and announced awards of up to $18.5 million in tax incentives from the city of Verona and the Wisconsin Economic Development Corporation

Selected Fiscal 2022 Second Quarter Financial Results

ARROWHEAD PHARMACEUTICALS, INC.
CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited)
(in thousands, except per share amounts)
		Three months ended March 31,								Six months ended March 31,
OPERATING SUMMARY		2022				2021				2022				2021
REVENUE		$	151,805			$	32,811			$	179,244			$	54,113
OPERATING EXPENSES
Research and development			75,985				44,697				141,750				81,251
General and administrative expenses			34,267				16,346				59,262				25,147
TOTAL OPERATING EXPENSES			110,252				61,043				201,012				106,398
OPERATING INCOME (LOSS)			41,553				(28,232	)			(21,768	)			(52,285	)
OTHER INCOME/(EXPENSE)			2,813				1,414				3,262				4,735
NET INCOME (LOSS)		$	44,366			$	(26,818	)		$	(18,506	)		$	(47,550	)
NET INCOME (LOSS) PER SHARE (DILUTED)		$	0.41			$	(0.26	)		$	(0.18	)		$	(0.46	)
WEIGHTED AVERAGE SHARES OUTSTANDING (DILUTED)			107,929				103,867				105,034				103,303
FINANCIAL POSITION SUMMARY		March 31,				September 30,
		2022				2021
CASH AND CASH EQUIVALENTS		$	86,408			$	184,434
SHORT-TERM INVESTMENTS AND MARKETABLE SECURITIES			315,487				183,355
LONG-TERM INVESTMENTS			201,590				245,595
TOTAL CASH RESOURCES (CASH AND INVESTMENTS)			603,485				613,384
OTHER ASSETS			100,090				96,764
TOTAL ASSETS			703,575				710,148
TOTAL CURRENT DEFERRED REVENUE			97,869				111,055
TOTAL LONG-TERM DEFERRED REVENUE			89,754				131,495
OTHER LIABILITIES			63,686				58,776
TOTAL LIABILITIES			251,309				301,326
TOTAL STOCKHOLDERS' EQUITY			452,266				408,822
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY		$	703,575			$	710,148
SHARES OUTSTANDING			105,702				104,327

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 Twitter @ArrowheadPharma. 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,” or “continue” 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 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/20220510006259/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

www.lifesciadvisors.com

Media:

LifeSci Communications, LLC

Josephine Belluardo, Ph.D.

646-751-4361

jo@lifescicomms.com

www.lifescicommunications.com

Source: Arrowhead Pharmaceuticals, Inc.

FAQ

What were Arrowhead Pharmaceuticals' Q2 2022 revenue results?

Arrowhead Pharmaceuticals reported Q2 2022 revenue of $151.8 million, a significant increase from $32.8 million in Q2 2021.

What was Arrowhead Pharmaceuticals' net income in Q2 2022?

The net income for Arrowhead Pharmaceuticals in Q2 2022 was $44.4 million, or $0.41 per diluted share.

What clinical studies did Arrowhead Pharmaceuticals initiate recently?

Arrowhead initiated the PALISADE Phase 3 study for ARO-APOC3 and completed enrollment for the Phase 2b ARCHES-2 study.

How did Arrowhead Pharmaceuticals' operating expenses change in Q2 2022?

Operating expenses increased to $110.3 million in Q2 2022, up significantly from $61.0 million in Q2 2021.

What significant financial developments occurred for Arrowhead Pharmaceuticals?

Arrowhead reported an increase in revenue and net income while also announcing the formation of a joint venture in Greater China.