The earnings call presented a positive outlook with several major achievements in product sales, FDA approvals, and financial performance, despite some challenges related to product labeling and regulatory hurdles.

Company Guidance

During the Eton Pharmaceuticals Q2 2025 earnings call, CEO Sean Brynjelsen highlighted several key achievements and future prospects. The company reported a record revenue of $18.9 million for the quarter, marking a 108% increase year-over-year, driven by product sales, particularly of Alkindi Sprinkle, Increlex, and Galzin. Eton anticipates reaching an $80 million annual revenue run rate by Q3 2025, three months ahead of schedule. The relaunches of Increlex and Galzin have significantly contributed to this growth, with Increlex patient numbers surpassing expectations. The FDA's approval of Khindivi, with a subsequent launch, and the NDA submission for ET-600, with a February 2026 PDUFA date, were also major milestones. Financially, the company generated $8 million in operating cash flow and $3.1 million in adjusted EBITDA, maintaining a strong cash position of over $30 million post-Q2. Looking ahead, Eton plans to expand its product portfolio, with ongoing efforts to address the unmet needs in pediatric endocrinology and ultra-rare diseases.

Record Product Sales and Revenue Growth

The company achieved record product sales with more than 100% revenue growth year-over-year, and revenue for Q2 2025 was $18.9 million, a 108% increase over the prior year period.

Strong Performance of Increlex

The relaunch of Increlex exceeded expectations, reaching 100 active patients months ahead of schedule, with a goal now set to reach 110 patients by the end of the year.

FDA Approval of Khindivi

Khindivi received FDA approval and was launched within days, addressing a critical unmet need in pediatric endocrinology.

ET-600 NDA Submission

The NDA for ET-600 was submitted and accepted for review, with a PDUFA date set for February 2026.

Financial Performance and Cash Flow

The company generated $8 million of cash flow from operations and achieved $3.1 million of adjusted EBITDA, demonstrating strong financial performance and profitability.

Eton Pharmaceuticals (ETON) Earnings, Revenues Date & History

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ETON Earnings History

Report Date	Fiscal Quarter	Forecast / EPS	Last Year's EPS	EPS YoY Change	Slides	Play Transcript
Nov 12, 2025	2025 (Q3)	0.09 / -	0.02	―	―	―
Aug 07, 2025	2025 (Q2)	-0.04 / -0.10	-0.12	16.67% (+0.02)	―
May 13, 2025	2025 (Q1)	0.05 / -0.06	-0.03	-100.00% (-0.03)	―
Mar 18, 2025	2024 (Q4)	>-0.01 / -0.02	-0.09	77.78% (+0.07)	―	―
Nov 12, 2024	2024 (Q3)	-0.01 / 0.02	-0.02	200.00% (+0.04)	―
Aug 08, 2024	2024 (Q2)	-0.07 / -0.12	0.18	-166.67% (-0.30)	―
May 09, 2024	2024 (Q1)	-0.07 / -0.03	-0.1	70.00% (+0.07)	―
Mar 14, 2024	2023 (Q4)	-0.04 / -0.09	0.04	-325.00% (-0.13)	―
Nov 09, 2023	2023 (Q3)	-0.10 / -0.02	-0.12	83.33% (+0.10)	―
Aug 10, 2023	2023 (Q2)	-0.09 / 0.18	-0.06	400.00% (+0.24)	―

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

ETON Earnings-Related Price Changes

Report Date	Price 1 Day Before	Price 1 Day After	Percentage Change
Aug 07, 2025	$15.26	$17.14	+12.32%
May 13, 2025	$17.07	$17.12	+0.29%
Mar 18, 2025	$15.29	$14.68	-3.99%
Nov 12, 2024	$9.17	$10.60	+15.59%

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.