Harrow — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue reached $99.3 million, representing a 41% sequential increase and a 39% year-over-year increase compared to $71.6 million in Q3 2025.
• Branded revenue was $83.5 million, up 62% year-over-year, accounting for approximately 84% of total revenue.
• GAAP net income was $9.8 million, including a $5.0 million litigation settlement gain, compared to a net loss of $17.3 million in Q2 2026 and net income of $1.0 million in Q3 2025.
• Adjusted EBITDA was $21.2 million, compared to a loss of $1.2 million in Q2 2026 and $22.8 million in Q3 2025.
• Gross margin was 75% for the quarter, compared to 75% in Q3 2025 and 71% for the nine months ended September 30, 2026.
• Cash and cash equivalents totaled $75.3 million as of September 30, 2026.
• Notes payable, net increased to $292.7 million as of September 30, 2026, from $243.2 million as of December 31, 2025.
• Net cash used in operating activities was $27.4 million for the nine months ended September 30, 2026, compared to $35.5 million provided in the same period in 2025.

Guidance and Future Outlook:

• Reaffirmed full-year 2026 revenue guidance of $350 million to $365 million.
• Updated full-year 2026 Adjusted EBITDA guidance to more than $40 million, down from the prior range of $80 million to $100 million.
• Updated fourth quarter 2026 Adjusted EBITDA guidance to more than $33 million.
• Management expects the fourth quarter to be the strongest on record, with second-half revenue expected to exceed the high end of the March outlook.
• Full-year revenue guidance achievement is described as achievable with strong execution.
• The updated EBITDA outlook reflects a first-half operating shortfall and additional spending to accelerate G-MELT NDA submission, advance development programs, and integrate TYRVAYA.

Business Segments and Product Lines:

• VEVYE generated record revenue of $39.7 million, up 35% sequentially and 75% year-over-year; total prescriptions increased approximately 17% sequentially and 83% year-over-year.
• IHEEZO revenue was $25.3 million, up 62% sequentially and 15% year-over-year; unit demand was 62,210, up 21% year-over-year.
• TRIESENCE achieved record revenue of $10.7 million, the highest quarterly revenue under Harrow ownership; unit demand was 20,022, up 37% sequentially and 110% year-over-year.
• BYOOVIZ reported its first full quarter of commercialization with increasing ordering accounts and strengthening demand through September.
• TYRVAYA acquisition completed on October 1, 2026, adding a complementary dry eye treatment; approximately 40 commercial personnel joined the team, with first revenue expected in Q4 2026.
• HarrowRx launched on November 1, 2026, as a single destination for prescribing Harrow products integrated into electronic medical record workflows.
• Commercial organization restructured into four focused teams: Ocular Surface Disease, Retina, Surgical, and Access+.

Market and Competitive Landscape:

• Harrow expanded coverage for VEVYE with a major national plan representing over 10 million commercial lives, effective January 2027.
• The company expects to launch at least one new product annually through the end of the decade, beginning with the anticipated 2027 U.S. launch of OPUVIZ.
• Management anticipates IHEEZO unit demand will grow in the fourth quarter, historically its strongest period.

Risks and Challenges:

• The IHEEZO QUELL study did not meet its prespecified primary endpoint of non-inferiority, though secondary findings showed lower cumulative pain and fewer adverse events for IHEEZO.
• Successful anesthesia rates were lower than anticipated in both treatment groups in the QUELL study.
• Risks include the ability to achieve revenue and Adjusted EBITDA guidance, successfully integrate TYRVAYA, and manage pharmacy operations.
• Regulatory risks include ongoing communications with the FDA regarding compliance and quality plans at the New Jersey outsourcing facility.
• Potential risks involve competition from pharmaceutical companies, outsourcing facilities, and pharmacies, as well as general economic conditions and supply chain challenges.

Management Commentary and Tone:

• CEO Mark L. Baum stated the third quarter delivered the anticipated second-half acceleration, driven by record branded revenue growth.
• Management expressed confidence that the amended Adjusted EBITDA outlook is a floor with opportunity to exceed it.
• Baum noted that while achieving full-year revenue guidance requires strong execution, the company continues to believe it is achievable.
• Management highlighted continued prescription growth, improving economics, and increasing productivity from the expanded sales force for VEVYE.

Other Key Points:

• Completed the acquisition of TYRVAYA (varenicline solution) nasal spray on October 1, 2026.
• Submitted a pre-NDA meeting with the FDA for G-MELT, with an NDA submission expected before the end of 2026.
• Phase 3 study for TRIESENCE evaluating treatment of ocular inflammation and pain following cataract surgery is enrolling, with initial data expected in early 2027.
• Phase 4 QUELL study results for IHEEZO will be presented at the Hawaiian Eye & Retina Conference in January 2027.
• An investigator-initiated study for NATACYN regarding fungal involvement in blepharitis is ongoing, with initial data expected in Q4 2026.
• Ex-U.S. proof-of-concept study for CR-01 has enrolled first patients, with initial clinical data expected in Q4 2026.