Denali Therapeutics Inc. (DNLI) Earnings Call Transcripts
Denali Therapeutics Inc.'s Latest Earnings Call - June 9, 2026
In the second quarter of fiscal year 2026, Denali Therapeutics Inc. (DNLI:US) reported a modest revenue outlook as it launched its first commercial product, AVLAYAH, for Hunter syndrome. The company emphasized that 2026 is a 'setup year' for revenue, with expectations for significant growth in 2027 as payer dynamics stabilize. Management highlighted early enthusiasm for AVLAYAH, with initial patient dosing exceeding expectations, although revenue is expected to lag behind prescription activity in the early stages of the launch.
Reported metrics
| Metric | Value |
|---|---|
| Revenue Guidance | $X million (negative) |
| Patient Dosing Timeline | 3.5 weeks (positive) |
| Market Opportunity | $1 billion+ (positive) |
| Payer Mix | 50-50 (neutral) |
| FDA Filing Timeline for DNL126 | 2027 (positive) |
| Initial Patient Conversion Rate | Exceeds expectations (positive) |
Guidance from management
Denali maintains its revenue guidance for 2026 as a setup year, with expectations for significant growth in 2027 as payer dynamics stabilize and patient adoption increases.
What management said
Yes. I'll take that one. So the pricing does reflect the clinical profile. So what we've shown in the clinical studies is that we are able to normalize the key biomarkers, heparan sulfate and also neurofilament. And it is the one, the first and the only drug that treats the whole body, including the brain, and that is appreciated by payers. So we have not encountered pushback on the price by payers. It has not been a...
Yes, I'll take that one. So Takeda made a strategic portfolio prioritization decision in the broader context of their restructuring of the rare disease and neurology portfolio. Takeda has been a great partner for 9 years since we started the partnership, but now we take the program forward ourselves. It's very strong biology. It's a very direct mechanism substituting progranulin, which is missing or lacking in these ...
What analysts pressed on
Analysts expressed concerns regarding the modest revenue expectations for 2026, questioning the pace of payer engagement and the potential impact on the company's financial performance. There is also apprehension about the competitive landscape as more companies enter the blood-brain barrier space.
Main topics on the call
- Launch of AVLAYAH — Denali successfully launched AVLAYAH for Hunter syndrome, marking its first commercial product. CEO Ryan Watts noted, "we were able to do that within 2 weeks" of approval, indicating strong early adoption. The company is...
- Revenue Guidance — Management indicated that 2026 is a 'setup year' for revenue, with modest expectations due to the nature of rare disease launches. CFO Alex Schuth stated, "prescription activity will outpace revenues in the early stages ...
- FDA Engagement for DNL126 — Denali's engagement with the FDA regarding DNL126 for Sanfilippo syndrome remains consistent, with management expressing confidence in the use of heparan sulfate as a surrogate endpoint. CEO Watts mentioned, "our engagem...
- Future Pipeline Developments — Denali is advancing multiple programs, including therapies for Sanfilippo and Pompe diseases. Management highlighted that the combination of AVLAYAH and DNL126 represents a potential "$1 billion-plus opportunity worldwid...
Read the full Denali Therapeutics Inc. transcript (June 9, 2026) → Summary generated from the call transcript; every figure above is stated by management on the record.
About Denali Therapeutics Inc.
Denali Therapeutics Inc. (DNLI) is a publicly listed company in the Biotechnology industry, within the Health Care sector. It trades on NasdaqGS and is based in US. EarningsCalls.dev maintains a free, full-text archive of its earnings call transcripts — 45 calls on record spanning January 14, 2020 to August 6, 2026. Every transcript is split into speaker-by-speaker segments with headline metrics, free to read or available through our REST API.
Earnings Call History
EarningsCalls.dev has 45 Denali Therapeutics Inc. earnings call transcripts on record, spanning January 14, 2020 to August 6, 2026. Based on this history, Denali Therapeutics Inc. reports quarterly. The most recent call on file is dated August 6, 2026. The full list is below — each row opens the complete, free-to-read transcript.
- Ticker
- DNLI
- Exchange
- NasdaqGS
- Country
- US
- Sector
- Health Care
- Industry
- Biotechnology
- Calls on record
- 45
- First call
- January 14, 2020
- Most recent
- August 6, 2026
- Reporting cadence
- quarterly