Arrowhead Pharmaceuticals (ARWR) Q3 2024 earnings summary

Executive summary

• Advanced plozasiran as the lead candidate, with positive phase III PALISADE results in FCS, meeting all primary and key secondary endpoints, and targeting commercial launch in 2025 pending regulatory approval.

• Strengthened balance sheet with a $500 million senior secured credit facility, $400 million funded upfront, and a $50 million milestone payment from Royalty Pharma for olpasiran phase III enrollment.

• Raised $429.3 million net from a January 2024 equity offering, supporting innovation and bridging to commercial revenue.

• Expanded commercial infrastructure and patient support programs in preparation for plozasiran launch.

• Reported strong clinical progress across a diverse RNAi pipeline, including later-stage studies and new data presentations.

Financial highlights

• Q3 2024 net loss was $170.8 million ($1.38 per share), compared to $102.9 million ($0.96 per share) in Q3 2023.

• Q3 2024 revenue was $15.8 million, down from $152.4 million in Q3 2023, primarily due to timing of milestone payments.

• Operating expenses rose to $176.1 million from $118.5 million year-over-year, driven by increased R&D as pipeline candidates advanced.

• Cash, cash equivalents, and investments totaled $436.7 million at June 30, 2024, up from $403.6 million at September 30, 2023.

• Pro forma cash balance post-financing is approximately $840 million.

Outlook and guidance

• Targeting regulatory filings for plozasiran in FCS by year-end 2024, with commercial launch expected in 2025, pending approval.

• Plans to expand plozasiran indications to SHTG (targeting 2027) and mixed hyperlipidemia after completion of CVOT.

• Ongoing and planned phase III studies (SHASTA-3, SHASTA-4, SHASTA-5, CAPITAN) to support broader label and market expansion.

• Continued investment in early-stage cardiometabolic, obesity, pulmonary, muscle, and CNS programs, with new clinical trial applications expected by year-end.

• Management expects R&D and G&A expenses to continue increasing as the pipeline advances and inflationary pressures persist.