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Harrow, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 9 November 2026: press release, letter to shareholders. Guidance figures: 1 lowered, 2 new, 1 kept. The quarter’s numbers.

Key takeaways

  • Revenue rose 41% sequentially: Total revenue was $99.3 million, up 41% sequentially from $70.7 million and 39% year over year from $71.6 million. Source
  • Adjusted EBITDA turned positive again: Adjusted EBITDA was $21.2 million, against $(1.2) million in the second quarter and $22.8 million a year earlier; the nine-month total was $7.3 million. Source
  • VEVYE revenue and prescriptions grew: VEVYE revenue reached $39.7 million, up 35% sequentially and 75% year over year; total prescriptions rose about 17% sequentially and 83% year over year. Source
  • Adjusted EBITDA reset reflects margins and spending: Management attributes the Adjusted EBITDA change to lower-than-anticipated gross margins, the third-quarter profitability shortfall, and added fourth-quarter initiatives. Source
  • Revenue range reaffirmed, needs sharp Q4 rise: The $350 - 365 million revenue range is reaffirmed; management said finishing modestly below the low end is a reasonable scenario, mostly on order timing and year-end purchasing. Source
  • QUELL did not meet primary endpoint: Successful anesthesia was 55.2% (63 of 115) with IHEEZO against 59.7% (68 of 113) with proparacaine drops plus subconjunctival lidocaine; secondary measures favored IHEEZO. Source
  • G-MELT pre-NDA meeting completed: The pre-NDA meeting with the FDA for G-MELT is complete, and the company plans to submit the NDA this year. Source

“The third quarter delivered the second-half acceleration we anticipated”

Mark L. Baum, Chairman and Chief Executive Officer

Guidance

AreaPeriodFigureAgainst last quarter
Revenue Sourcefull year 2026$350 million to $365 millionKept
Adjusted EBITDA Sourcefull year 2026more than $40 millionLowered from $80 million to $100 million
Adjusted EBITDA Sourcefourth quarter 2026more than $33 millionNew
Revenue Sourcefourth quarter 2026about $136 - 151 millionNew
Adjusted EBITDA (original low end) Sourcefourth quarter 2026close to $73 million

What changed from last quarter

  • Guidance kept: Full-year 2026 revenue guidance was reaffirmed at $350 - 365 million. Source
  • New guidance: A fourth-quarter 2026 Adjusted EBITDA figure of more than $33 million was given for the first time. Source
  • New: TYRVAYA acquisition was completed on October 1, 2026, adding a dry eye nasal spray to the portfolio. Source
  • New: Commercial organization was reorganized into four focused teams after the TYRVAYA closing. Source
  • New: HarrowRx, a single prescribing and fulfillment platform, launched on November 1, 2026. Source
  • New: QUELL Phase 4 topline results were reported; the primary endpoint was not met. Source
  • New: A VEVYE coverage win with a major national plan was announced, effective January 2027. Source
  • New: First patients were enrolled in the CR-01 ex-U.S. proof-of-concept study. Source
  • New: Management intends to return to annual revenue guidance for 2027, with quarterly progress reports. Source

Results and growth drivers

  • Revenue rose 41% sequentially: Total revenue was $99.3 million, up 41% sequentially from $70.7 million and 39% year over year from $71.6 million. Source
  • Net income included a litigation gain: GAAP net income was $9.8 million, including a $5.0 million litigation settlement gain, against a net loss of $17.3 million in the second quarter. Source
  • Adjusted EBITDA turned positive again: Adjusted EBITDA was $21.2 million, against $(1.2) million in the second quarter and $22.8 million a year earlier; the nine-month total was $7.3 million. Source
  • First-half revenue below plan: Management said first-half revenue of $114.9 million was about $28 million below the first-half midpoint of its guidance range. Source

Products and customers

  • VEVYE revenue and prescriptions grew: VEVYE revenue reached $39.7 million, up 35% sequentially and 75% year over year; total prescriptions rose about 17% sequentially and 83% year over year. Source
  • IHEEZO units fell sequentially: IHEEZO revenue was $25.3 million; unit demand of 62,210 was down about 5% sequentially, reflecting seasonality and elevated second-quarter purchasing of the discontinued single-unit presentation. Source
  • TRIESENCE passed $10 million quarterly: TRIESENCE revenue was $10.7 million, the highest quarterly revenue under Harrow ownership, with unit demand of 20,022, up about 37% sequentially and 110% year over year. Source
  • BYOOVIZ launch reached more accounts: BYOOVIZ revenue was below management's launch expectations, while more accounts tried the product than modeled; September had the highest demand of the quarter. Source
  • Compounding revenue declined year over year: Compounding revenue was $15.8 million against $20.1 million a year earlier; management expects the fourth quarter to be the highest period for compounded products. Source

“We expect the fourth quarter to be Harrow’s strongest on record and that second-half revenue will exceed the high end of what we contemplated in March.”

Mark L. Baum, Chairman and Chief Executive Officer

Margins, costs and VEVYE pricing

  • Gross margin held at 75%: GAAP gross margin was 75% in both the third quarter of 2026 and the third quarter of 2025; the nine-month gross margin was 71% against 73%. Source
  • SG&A rose on commercial headcount: SG&A was $53.1 million against $35.9 million, mainly from commercial headcount and related expenses plus other commercial activity. Source
  • R&D spend rose on G-MELT and trials: R&D was $10.3 million against $3.3 million, driven by G-MELT NDA-enabling trials and formulation work and by IHEEZO and TRIESENCE clinical development. Source
  • Gross-to-net gap hit VEVYE revenue: Management said VEVYE assumptions on gross-to-net were too optimistic, and the gap between projected and actual gross-to-net was the main driver of the first-half shortfall. Source
  • Covered VEVYE mix reversing from cash pay: Management said the ratio of covered to cash-pay VEVYE prescriptions is reversing, with improved VEVYE economics in the third quarter continuing into October. Source
  • Royalties step up in fourth quarter: Certain product royalties are expected to step up in the fourth quarter as annual revenue passes thresholds, moving to a slightly higher royalty tier. Source

Revised guidance and fourth-quarter drivers

  • Adjusted EBITDA reset reflects margins and spending: Management attributes the Adjusted EBITDA change to lower-than-anticipated gross margins, the third-quarter profitability shortfall, and added fourth-quarter initiatives. Source
  • Revenue range reaffirmed, needs sharp Q4 rise: The $350 - 365 million revenue range is reaffirmed; management said finishing modestly below the low end is a reasonable scenario, mostly on order timing and year-end purchasing. Source
  • Fourth-quarter spending items named: Q4 profitability is affected by G-MELT submission costs including the FDA application fee, R&D expense, TYRVAYA onboarding and acquired inventory accounting, and royalty step-ups. Source
  • Floor set to limit Q4 dependence: Management said the Adjusted EBITDA floor was set so that results do not rely on an unusually favorable fourth-quarter revenue mix to cover added costs. Source

“Today, like Bezos in 2000, I see a disconnect between our stock's performance and the operational progress we have made.”

Mark L. Baum, Founder, Chairman of the Board, and Chief Executive Officer

Capital, cash and balance sheet

  • Cash ended the quarter at $75.3 million: Cash and equivalents were $75.3 million at September 30, 2026, against $83.9 million at June 30 and $72.9 million at December 31, 2025. Source
  • Nine-month operating cash flow negative: Nine-month operating activities used $27.4 million, against $35.5 million provided a year earlier; financing activities provided $48.9 million. Source
  • Receivables at $155.3 million: Accounts receivable stood at $155.3 million at September 30, 2026, alongside cash of $75.3 million. Source
  • Stockholders' equity fell from year-end: Total stockholders' equity was $28.8 million at September 30, 2026, against $52.1 million at December 31, 2025; notes payable, net were $292.7 million. Source

Commercial teams, TYRVAYA and HarrowRx

  • TYRVAYA team joined in October: About 40 experienced commercial personnel joined the Ocular Surface Disease team, and first TYRVAYA revenue is expected in the fourth quarter of 2026. Source
  • Four teams with shared customers: Ocular Surface Disease is now the largest team after the Viatris additions; Retina, Surgical and Access+ complete the structure around shared prescribers and purchasing dynamics. Source
  • HarrowRx routes all Harrow prescriptions: Prescribers can send any Harrow prescription to one destination; HarrowRx sends pharmacy-benefit products to partner pharmacies and buy-and-bill orders to a distributor. Source
  • TYRVAYA transition about six weeks in: Management said the company is about six weeks into the Viatris transition, with dozens of new key account managers in the field and key commercial and supply activities transferred. Source
  • Specialty and dry eye teams merged: Specialty Products and Dry Eye Disease teams merged into Ocular Surface Disease, which now promotes VEVYE, VERKAZIA and NATACYN alongside TYRVAYA. Source

Pipeline and regulatory

  • QUELL did not meet primary endpoint: Successful anesthesia was 55.2% (63 of 115) with IHEEZO against 59.7% (68 of 113) with proparacaine drops plus subconjunctival lidocaine; secondary measures favored IHEEZO. Source
  • IHEEZO secondary measures on pain and staining: Cumulative pain through 24 hours was 2.9 with IHEEZO against 3.7; ocular surface staining rose 1.7 against 3.2; adverse events were 27% against 47%. Source
  • G-MELT pre-NDA meeting completed: The pre-NDA meeting with the FDA for G-MELT is complete, and the company plans to submit the NDA this year. Source
  • TRIESENCE Phase 3 still enrolling: The Phase 3 study of TRIESENCE for inflammation and pain after cataract surgery continues to enroll. Source
  • CR-01 first patients enrolled: CR-01, a sustained-release conjunctival drug-delivery device for ocular cancer, is in an ex-U.S. proof-of-concept study with first patients receiving treatment. Source
  • NATACYN fungal study ongoing: An investigator-initiated study of fungal involvement in blepharitis and the potential benefits of NATACYN is ongoing. Source

Leadership and people

  • Chief Scientific Officer leads NDA work: Management credited Amir Shojaei, Chief Scientific Officer, and his team with preparing the G-MELT NDA submission. Source
  • VEVYE field force more than doubled: The field organization supporting VEVYE was more than doubled this year, and management said it is now seeing a return on that investment. Source
  • Execution set as the priority: Management said the company's responsibility is to turn built capabilities into consistent operating and financial performance. Source

Coming up, as management said on 9 November 2026

  • QUELL full results in January: Full QUELL results are to be presented at the Hawaiian Eye & Retina Conference in January 2027. Source
  • VEVYE coverage starts January 2027: The coverage win with a major national plan for more than 10 million commercial lives is expected to take effect in January 2027. Source
  • OPUVIZ launch follows BYOOVIZ learnings: Management said lessons from the BYOOVIZ launch will inform the anticipated 2027 launch of OPUVIZ. Source
  • TRIESENCE Phase 3 data early 2027: Initial data from the TRIESENCE Phase 3 study are expected in early 2027. Source
  • NATACYN initial data in Q4 2026: Initial data from the investigator-initiated NATACYN study are expected in the fourth quarter of 2026. Source
  • CR-01 data in Q4, Investor Day in March: Initial CR-01 clinical data are expected in the fourth quarter of 2026, with a fuller interim read at the Investor Day in New York in March 2027. Source

Figures management reported

FigureReported
VEVYE product revenue, Q3 2026 Source$39.7 million
IHEEZO product revenue, Q3 2026 Source$25.3 million
TRIESENCE product revenue, Q3 2026 Source$10.7 million
Other branded products revenue, Q3 2026 Source$7.6 million
Compounding revenue, Q3 2026 Source$15.8 million
R&D expense, Q3 2026 Source$10.3 million
QUELL trial readout, IHEEZO arm Source55.2% (63 of 115); primary endpoint not met
G-MELT NDA submission timing Sourcebefore the end of 2026

Risks management discussed

  • Operational: Onboarding and transition from Viatris are affecting fourth-quarter profitability, including purchase accounting on acquired inventory. Source
  • Demand: Management said quarterly results are uneven across the product portfolio, which makes 90-day predictions difficult. Source
  • Financial: Cash-pay fills historically weighed on VEVYE net product pricing, which management is working to change through covered fills. Source
  • External: IHEEZO lost pass-through status, and the units lost from that change are being offset by new accounts and deeper penetration. Source
  • Regulatory: The G-MELT benefit described by management depends on the product being approved for marketing. Source
  • Demand: Successful anesthesia rates in QUELL were lower than anticipated in both groups, which may affect how retina practices view IHEEZO. Source

Earlier plans management reported on

  • Ahead: Management said the NDA submission moved ahead of the first-half 2027 timeline it discussed in August. Source
  • Delayed: Management said VEVYE revenue remains behind the level initially hoped for, though it is gaining ground as gross-to-net improves. Source
  • Not stated: Management expects the third and fourth quarters together to bring BYOOVIZ into range of its internal full-year model. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.