Arrowhead Pharmaceuticals, INC. 10-K Filing

Ticker: ARWR · Form: 10-K · Filed: Nov 26, 2024 · CIK: 879407

Sentiment: neutral

Filing Stats: 4,346 words · 17 min read · ~14 pages · Grade level 16.5 · Accepted 2024-11-26 16:18:02

Key Financial Figures

Filing Documents

C YBERSECURITY

ITEM 1C. C YBERSECURITY 58 I TEM 2. P ROPERTIES 59 I TEM 3. L EGAL P ROCEEDINGS 60 I TEM 4. M INE S AFETY D ISCLOSURES 60 PART II I TEM 5. M ARKET FOR THE R EGISTRANT'S C OMMON E QUITY, R ELATED S TOCKHOLDER M ATTERS AND I SSUER P URCHASES OF E QUITY S ECURITIES 61 I TEM 6. R ESERVED 62 I TEM 7. M ANAGEMENT'S D ISCUSSION AND A NALYSIS OF F INANCIAL C ONDITION AND R ESULTS OF O PERATIONS 62 I TEM 7A. Q UANTITATIVE AND Q UALITATIVE D ISCLOSURES A BOUT M ARKET R ISK 71 I TEM 8. F INANCIAL S TATEMENTS AND S UPPLEMENTARY D ATA 72 I TEM 9. C HANGES IN AND D ISAGREEMENTS WITH A CCOUNTANTS ON A CCOUNTING AND F INANCIAL D ISCLOSURE 72 I TEM 9A. C ONTROLS AND P ROCEDURES 72 I TEM 9B. O THER I NFORMATION 73 I TEM 9C. D ISCLOSURE R EGARDING F OREIGN J URISDICTIONS T HAT P REVENT I NSPECTIONS 75 PART III I TEM 10. D IRECTORS, E XECUTIVE O FFICERS, AND C ORPORATE G OVERNANCE 75 I TEM 11. E XECUTIVE C OMPENSATION 75 I TEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 75 I TEM 13. C ERTAIN R ELATIONSHIPS, R ELATED T RANSACTIONS AND D IRECTORS I NDEPENDENCE 75 I TEM 14. P RINCIPAL A CCOUNTANT F EES AND S ERVICES 75 PART IV I TEM 15. E XHIBITS AND F INANCIAL S TATEMENT S CHEDULES 76 I TEM 16. F ORM 10-K S UMMARY 80 SIGNATURE INDEX TO FINANCIAL STATEMENTS AND SCHEDULES F- 1

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and we intend that such forward-looking statements be subject to the safe harbors created thereby. For this purpose, any statements contained in this Annual Report on Form 10-K except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "might," "will," "expect," "believe," "anticipate," "goal," "endeavor," "strive," "intend," "plan," "project," "could," "estimate," "target," "might," "forecast," or "continue" or the negative of these words or other variations thereof or comparable terminology are intended to identify forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, 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 regulatory approval for and commercial launch of plozasiran 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 the amount and timing of future 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. The forward-looking statements included herein are based on cur

BUSINESS

ITEM 1. BUSINESS A. Overview The Company 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, the Company's therapies trigger the RNA interference mechanism to induce rapid, deep and durable knockdown of target genes. The Company's most advanced candidate, plozasiran, has completed a Phase 3 study in patients with familial chylomicronemia syndrome (FCS) and expects to have its first commercial launch in 2025, provided the United States Food and Drug Administration (the "FDA") accepts the New Drug Application ("NDA") for filing and after a successful review and subsequent approval. The Company's pipeline of 16 clinical stage investigational medicines range in development stage from Phase 1 to Phase 3. In addition, the Company has a robust discovery stage pipeline which is capable of generating multiple new clinical candidates each year. The Company endeavors to serve unmet medical needs and change lives leveraging the versatility of its proprietary RNAi-based technology. The Company is acutely aware of the urgent need to develop solutions for the many diseases that have genetic targets that are otherwise undruggable by small molecules or biologics. To that end, the Company embraced its bold goal and strives to have 20 individual drugs, either partnered or wholly owned, in clinical trials or on the market in 2025. RNA Interference and the Benefits of RNAi Therapeutics RNA interference ("RNAi") is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. RNAi-based therapeutics may leverage this natural pathway of gene silencing to target and shut down specific disease-causing genes. Small molecule and antibody drugs have proven effective at inhibiting certain cell surface, intracellular, and extracellular targets. However, other drug targets have proven difficult to

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