Want to see BLTE full AI Analyst Report?
Earnings Data
Report Date
Aug 12, 2026Before Open (Confirmed)
Period Ending
2026 (Q2)Consensus EPS Forecast
-0.77Last Year’s EPS
-0.5Same Quarter Last Year
Strong Buy
Based on 5 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call conveyed strong program and commercial progress—Phase 3 report received, NDA rolling submission underway, Dragon 2 enrollment completed, substantial commercial hires, and a robust cash position (~$799M). However, the company is incurring sharply higher R&D and SG&A expenses, net losses widened materially, and several clinical and regulatory uncertainties remain (GA interim unknown; FDA guidance requires completion of Dragon 1 at 2 years). On balance the positive development and financial runway outweigh the near‑term expense and uncertainty headwinds.Company Guidance
Phase 3 Milestone and NDA Rolling Submission
Received the Phase 3 clinical study report in Q1 2026 without delay and initiated an NDA rolling submission to the FDA in April; company is on track to complete the submission by Q2 2026.
Enrollment Completion for Japan Registration Study (Dragon 2)
Completed enrollment in the Phase 2/3 Dragon 2 trial (73 adolescents and adults aged 12–20 across Japan, U.S., and U.K.), a registration-enabling study for Japan.
Regulatory Dialogue and Potential Single-Study Path
FDA meetings indicated a recommendation to complete Dragon 1 at 2 years with a possible path to single-study approval based on data robustness; Dragon 2 is positioned mainly to satisfy Japan regulatory requirements and could serve as confirmatory evidence if needed.
Strong Balance Sheet
Ended Q1 2026 with $799 million in cash equivalents and U.S. Treasury bills—position described as ample capital to finalize the NDA, prepare for commercialization in Stargardt disease, and complete ongoing trials; management estimates launch-related needs of roughly $300M and total near-term pipeline spend of about $150M (total ~$450M), well below current cash.
Commercial Buildout and Manufacturing Readiness
Hired all commercial leadership roles and is building sales, market access, and medical affairs teams (planning ~30–40 commercial team members); headcount expanded from ~30 to ~90 employees. Manufacturing is a small-molecule program and described as straightforward, with supply chain preparations underway to enable a rapid launch upon approval.
Payer Engagement and Pricing Reference Range
Payer research undertaken; payers reportedly supportive of the company’s pricing range concept. Management referenced a benchmark average orphan drug price around $350,000 and indicated a conceivable range up to ~$500,000 as an early reference point (price not finalized).
BLTE Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
BLTE Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
May 20, 2026 | $139.70 | $143.36 | +2.62% |
Mar 02, 2026 | $190.30 | $177.58 | -6.68% |
Nov 10, 2025 | $113.19 | $117.34 | +3.67% |
Aug 11, 2025 | $69.88 | $69.50 | -0.54% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Belite Bio, Inc. ADR (BLTE) report earnings?
Belite Bio, Inc. ADR (BLTE) is schdueled to report earning on Aug 12, 2026, Before Open (Confirmed).
What is Belite Bio, Inc. ADR (BLTE) earnings time?
Belite Bio, Inc. ADR (BLTE) earnings time is at Aug 12, 2026, Before Open (Confirmed).
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.
What companies are reporting earnings today?
You can see a list of the companies which are reporting today on TipRanks earnings calendar.
What is BLTE EPS forecast?
BLTE EPS forecast for the fiscal quarter 2026 (Q2) is -0.77.