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Belite Bio, Inc. ADR (BLTE)
NASDAQ:BLTE
Earnings Data
Report Date
May 19, 2026Before Open (Confirmed)
Period Ending
2026 (Q1)Consensus EPS Forecast
-0.64Last Year’s EPS
-0.45Same Quarter Last Year
Strong Buy
Based on 7 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
Overall the call was positive: the company reported a major clinical milestone (DRAGON Phase III success with 36% lesion-growth reduction), completed strong fundraising and set a clear regulatory and commercial timeline (rolling NDA in Q2 2026; target launch Q1 2027). The company is investing heavily in commercialization and R&D (reflected in sharply higher R&D and SG&A and wider net losses), and there are execution and timing risks around patient identification, pricing, ex-US filings and deprioritized programs. On balance the clinical success and cash runway materially de-risk the near-term path to approval and launch, outweighing the financial burn and execution risks described.Company Guidance
Phase III DRAGON Pivotal Success
DRAGON met its primary efficacy endpoint: a statistically significant and clinically meaningful 36% reduction in growth rate of upper lesion (definitely decreased autofluorescence) versus placebo.
Robust Clinical Enrollment Progress
DRAGON II reached target enrollment and had 72 subjects enrolled as of Feb 27 (final expected 72–75); Phase III PHOENIX (GA) completed enrollment with 530 subjects.
NDA Timing and Regulatory Path
Company plans a rolling NDA submission to FDA in Q2 2026 with CSR finalization expected immediately prior; US regulatory pathway prioritized with ex-US submissions to follow.
Commercial Launch Preparation and Timeline
Commercial build underway with key leadership hires and plans for ~25–30 field reps; target commercial launch by Q1 2027 (subject to approval).
Strong Balance Sheet and Fundraising
Completed a $402M public offering (overallotment exercised) and closed FY2025 with $772.6M in cash, equivalents and treasuries vs $145.2M at end-2024 — ~+432% year-over-year cash increase.
Forward Financial Planning
Three-year resource plan detailed: estimated R&D-related spend of ~$150M and commercialization spend of ~$200–250M to support NDA, launch and pipeline development.
Oral Therapy Differentiation and GA Opportunity
Management highlighted potential for oral Tinlarebant to be standard of care in GA if it reaches similar lesion-growth inhibition as injectables (injectable comparators showed ~13%–21% benefit); company believes 15%–20% could be clinically meaningful for GA given oral dosing advantage.
Pediatric Expansion Plans
EMA pediatric investigational plan approved; a 2-year pediatric study in ages 3–11 planned to start in April to evaluate safety/efficacy in younger patients.
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 |
|---|---|---|---|
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% |
May 14, 2025 | $60.89 | $61.60 | +1.17% |
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 May 19, 2026, Before Open (Confirmed).
What is Belite Bio, Inc. ADR (BLTE) earnings time?
Belite Bio, Inc. ADR (BLTE) earnings time is at May 19, 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 (Q1) is -0.64.