Analyst Conference Summary

biotechnology

conference date: May 7, 2024 @ 8:30 AM Pacific Time
for quarter ending: March 31, 2024 (Q1, first quarter 2024)

Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $ million, up % sequentially from $325 million, and up % from $ million year-earlier.

Net income was negative $ million, up sequentially from negative $6 million, and up from negative $ million year-earlier.

EPS (diluted) was negative $, up sequentially from negative $0.06, and up from negative $ year-earlier.

Guidance:

Conference Highlights:

CEO Brett Monia said ""

The Wainua launch is off to a good start. Preparing for possible independent launch of Olezarsen later this year.

In Q4 2023 the FDA approved Wainua (eplontersen) on December 21. In Q2 2023 had presented additional positive data from the Phase 3 NEURO-TTRansform study of eplontersen in patients with polyneuropathy caused by hereditary TTR amyloidosis; on track to file a with partner Astra-Zeneca outside the US. ATTR Cardiomyopathy trial continues, with enrollment completed in Q3 2023, but data not expected until 1H 2025. In Q4 2023 eplontersen was granted Fast Track status by the FDA for ATTR-CM.

In Q3 2023 reported positive data Olezarsen for familial chylomicronemia syndrome from the Phase 3 trial. This included remarkable reductions in pancreatitis attacks. Would be the first Ionis independent commercial drug launch. Preparing to submit NDA to FDA; if it received priority review, could become commercial in late 2024. In SHTG the Phase 3 data should be available in 2024. In Q1 2024 received Breakthrough Therapy and orphan drug status from the FDA

Donidalorsen for hereditary angioedema was granted orphan drug status in Q3 2023. Phase 3 data positive top line data read out in Q1 2024. Sees potential peak sales at $500 million per year. EU rights were licensed to Otsuka.

In Q4 2023 Biogen sales of Spinraza were $341 million, down 23% from $443 million year-earlier. Biogen continues to work to expand sales.

Non-GAAP numbers: net income $ million, sequentially up from $20 million, and up from negative $ million year-earlier. No non-GAAP EPS given.

Cash ended at $ billion, up sequentially from $2.3 billion. Debt was $ billion in convertible senior notes. Plans to pay off 2024 convertible notes.

Ionis continues to develop technologies that allow RNA therapies to almost any part of the body, including inhaled agents.

Ionis has a pipeline of about 45 potential drugs, with 12 in clinical development. A growing number are wholly-owned.

GAAP Operating expense was $ million, consisting of $ million for cost of goods sold; $ million for R&D and $ million for selling, general and administrative. Operating income was negative $ million. Other income was $ million. Income tax $ million.

Q&A selective summary:

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