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Harrow (NasdaqGM:HROW) FY Conference Transcript
2025-12-02 21:02
Summary of Harrow (NasdaqGM:HROW) FY Conference Call - December 02, 2025 Company Overview - **Company**: Harrow Health, Inc. - **Industry**: Biopharmaceuticals, specifically focusing on ophthalmology and anesthesiology Key Points MELT Acquisition and Technology - The MELT acquisition, closed in mid-November, is seen as a strategic fit to expand into procedural sedation beyond ophthalmology, targeting markets like dental and plastic surgery [5][6][7] - The MELT-300 product aims to reduce opioid exposure in cataract surgeries, with over 90% of patients currently receiving IV fentanyl [6] - The company has a patent portfolio that supports both domestic and international markets [7] - A special protocol agreement (SPA) with the FDA is in place, with efficacy studies completed showing MELT-300's superiority over individual components [8] Commercialization Strategy - Harrow plans to leverage its established infrastructure in ophthalmology while seeking partnerships in non-ophthalmology markets [10][11] - The company has hired Frank Mullery, a former Mylan executive, to enhance its access to the hospital market [10] Product Pipeline - **MELT-210**: Positioned as an oral dissolving tablet for sedation, targeting a wide range of procedures and potentially tens of millions of use cases [12][14][15] - **Vevye**: A product for dry eye disease that has nearly doubled its market share in recent quarters due to a significant coverage win, allowing for easier patient access [16][18][20] - **IHEEZO**: A topical anesthetic for intravitreal injections, expected to generate around $50 million in revenue for the year, with a goal of capturing 10% market share by 2027 [27][28][29] - **TRIESENCE**: After a disappointing start, the product is showing signs of recovery with new commercial leadership and a focus on full-label promotion [30][31][32] Biosimilars Strategy - Harrow plans to enter the biosimilar market with ranibizumab and aflibercept, aiming to create a comprehensive solution for retinal practices [34][36] - The company expects to capture a modest market share, focusing on quality and service rather than competing aggressively with existing products [39][40] Access Programs - The Harrow Access for All program aims to ensure that patients have access to medications with minimal out-of-pocket costs, achieving over 90% coverage for key products [42][44] Business Development and M&A - The company is open to further business development and M&A opportunities, particularly if they can acquire valuable assets at favorable prices [45] Additional Insights - The company emphasizes a patient-centric approach in its product development and marketing strategies, aiming to improve patient experiences across its offerings [6][16][27] - Harrow's focus on building a comprehensive suite of products for surgical and retinal markets positions it well for future growth [35][36] This summary encapsulates the key insights from the conference call, highlighting Harrow's strategic initiatives, product developments, and market positioning within the biopharmaceutical industry.
Harrow Health(HROW) - 2025 Q3 - Earnings Call Transcript
2025-11-11 14:00
Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $71.6 million, a 45% increase year-over-year and a 12% sequential increase from Q2 2025 [12][13] - Adjusted EBITDA for Q3 was $22.7 million, with GAAP-based net income of $1 million [14] - For the first nine months of 2025, total revenue reached $183.2 million, with an updated full-year revenue outlook of $270-$280 million [13][17] Business Line Data and Key Metrics Changes - VEVYE generated approximately $22.6 million in revenue during Q3, a 22% increase from Q2 2025, and is expected to finish the year strong [14][15] - IHEEZO revenue for Q3 was $21.9 million, up 20% from Q2, with strong demand expected to continue into Q4 [15][16] - TRIESENCE and the specialty portfolio generated $6.9 million in revenue, showing a 33% sequential increase, with new strategies in place to reignite growth [16][30] Market Data and Key Metrics Changes - VEVYE captured 10.5% of the total dry eye market by the end of Q3, up 2.7 share points from the prior quarter [22] - IHEEZO's unit demand was up 47% year-over-year, indicating strong market resonance [25] - TRIESENCE is gaining traction in the retina market, with a 67% sequential increase in unit demand [28] Company Strategy and Development Direction - The company aims to become a leading U.S. ophthalmic company, with plans for four new product launches over the next two years [6][11] - A focus on building a scalable commercial infrastructure to support multiple product launches without heavy additional investment [6][11] - The acquisition of Melt Pharmaceuticals and the expansion of the Access for All program are key strategic moves to enhance growth [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the overall trajectory of the business, despite some areas underperforming due to seasonal factors [7] - The company anticipates a strong finish to 2025, with expectations for continued growth in 2026 driven by improved coverage and commercial investments [18][24] - Management is actively working to resolve licensing disputes in California, which could impact future revenue [11] Other Important Information - The company is preparing for the launch of new products, including BioViz, OpioViz, Biclovi, and Melt 300, which are expected to drive future growth [11][30] - The ImprimisRx business remains stable, generating approximately $20.1 million in revenue, but may face challenges due to ongoing regulatory disputes [17] Q&A Session Summary Question: Why was VEVYE prescription data not available this quarter? - Management decided to withdraw from certain reporting services to ensure accuracy and maintain competitive positioning [34][35] Question: Can you discuss the operating leverage achieved? - The company is seeing operating leverage from new revenue growth, with expectations for moderate increases in operating expenses as investments are made in commercial infrastructure [36][37] Question: What is the expected impact of VEVYE's coverage win on ASP? - Management anticipates that improved coverage will lead to a stabilization and potential increase in ASP, particularly as the ratio of covered prescriptions increases [39][40] Question: What proportion of cash-pay patients is expected to transition to insurance coverage? - While precise figures are not available, management believes that many cash-pay patients will transition to covered prescriptions due to favorable coverage wins [46][47] Question: What are the dynamics expected between Q3 and Q4 revenue? - Management expects Q4 to be strong, driven by volume growth across the portfolio, particularly from VEVYE and TRIESENCE [55][58]
Harrow Health(HROW) - 2025 Q3 - Earnings Call Presentation
2025-11-11 13:00
Corporate Presentation November 2025 Safe Harbor This presentation contains "forward-looking statements" as defined in the U.S. Private Securities Litigation Reform Act of 1995. You are cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Harrow, Inc. (the "Co ...
Harrow, Inc. (HROW): A Bull Case Theory
Yahoo Finance· 2025-10-08 15:23
Core Thesis - Harrow, Inc. (HROW) presents a bullish investment opportunity due to its diverse portfolio, strong revenue growth, and strategic positioning in the ophthalmic market [1][6][7] Company Overview - Harrow Pharmaceuticals is a U.S.-based company focused on ophthalmology, operating in three main areas: FDA-approved drugs, compounded formulations, and equity stakes in emerging innovators [2] - The company's portfolio includes treatments for dry eye disease, glaucoma, ocular inflammation, post-surgical recovery, and retina therapies, making it a "full-spectrum" player in the U.S. ophthalmic market [2] Product Highlights - Key products include VEVYE for dry eye, projected to generate over $100 million in FY25, IHEEZO, the first new branded ocular anesthetic in 14 years, expected to reach over $50 million in FY25, and TRIESENCE, a corticosteroid with patent protection until 2029 [3] - HROW is expanding into the retina category with products like BYOOVIZ and OPUVIZ, while its ImprimisRx compounding division provides stable cash flow and enhances operational efficiency [3] Financial Performance - HROW reported $116.6 million in revenue for the first half of FY25 and anticipates $280 million for the full fiscal year, with gross margins improving from 68% to 74% [4] - EBITDA is expected to grow from approximately 26% in FY25 to 38% in FY27, supported by debt refinancing and $250 million in senior notes [4] Valuation and Growth Potential - Analysts project HROW's revenue to reach $529 million by 2027, with management targeting $1 billion, indicating a potential upside of 3x to 5x over three years [5] - The combination of high-growth branded products, stable cash-generating operations, and strategic equity stakes presents a unique investment opportunity ahead of the upcoming Investor Day [5]
Harrow (NasdaqGM:HROW) 2025 Investor Day Transcript
2025-09-26 16:32
Summary of Harrow's 2025 Investor Day Company Overview - **Company**: Harrow (NasdaqGM:HROW) - **Industry**: Ophthalmic pharmaceuticals - **Event**: Inaugural Investor and Analyst Day held on September 26, 2025 Key Points and Arguments Vision and Market Position - Harrow aims to become the next great U.S. ophthalmic company, following the legacy of Alcon and Allergan, which were founded over 77 years ago [6][16] - The company has built the largest and most diversified portfolio of prescription ophthalmic products in North America with only $1 million of initial capital [7] Business Strategy - Harrow's growth strategy is based on four pillars: founder-led management, a profitable base business, a strong team, and a bright future with multiple product launches [9][10] - The company has been active in ophthalmic M&A, acquiring approximately 17 branded products over the last five years [7] Product Pipeline and Future Launches - Upcoming product launches include TRIESENCE in Q4 2025, BICLOVI and BioViz in 2026, and Opuviz and Melt 300 in 2027 [9][10] - Melt 300 is expected to generate over $100 million in annual revenue post-FDA approval, with a clear path to market due to existing commercial relationships [12][13] Financial Performance and Projections - Harrow anticipates over $280 million in revenue for 2025, with a medium-term goal of $250 million in quarterly revenue by Q4 2027 [22][25] - The company expects gross margins in the low to mid-80s and operating margins in the 30 to 40% range at projected revenue levels [26] Recent Debt Financing - Harrow successfully refinanced $250 million in unsecured notes, lowering its cost of capital and extending its debt maturity profile [19][20] - The refinancing is expected to reduce cash-based interest expenses by approximately $3 million annually [21] Product Development Philosophy - Harrow employs a disciplined approach to product development, focusing on de-risked assets with high probabilities of success [27][28] - The company has three key pipeline products: Melt 300, a prefilled syringe of TRIESENCE, and CR01, a conjunctival delivery device for ocular cancer [29][30] Melt 300 Overview - Melt 300 is a sublingual tablet designed for procedural sedation, targeting a market with over 100 million potential procedures [35][37] - The product aims to eliminate the need for IV sedation and opioids, addressing significant patient and procedural needs [41][42] Dry Eye Market Opportunity - The dry eye market presents a significant opportunity, with 16 million patients in the U.S. and only 8% optimally controlled [56] - Harrow's VEVYE is positioned as the leading therapy in this space, with a unique delivery mechanism that enhances efficacy [62][63] Additional Important Content - Harrow emphasizes its commitment to corporate citizenship, having supported approximately 17,000 patients in 38 countries in 2024 [14] - The company acknowledges the potential for failure but remains focused on long-term growth and learning from mistakes [14][16] - Harrow's leadership team includes experienced professionals from various sectors, enhancing its operational capabilities [3][4][53] This summary encapsulates the critical insights and strategic directions discussed during Harrow's 2025 Investor Day, highlighting the company's commitment to growth, innovation, and market leadership in the ophthalmic sector.
Harrow (NasdaqGM:HROW) 2025 Earnings Call Presentation
2025-09-26 15:30
Financial Performance and Goals - Harrow's consolidated revenues have grown significantly, from $48.871 million in 2020 to $199.614 million in 2024, with a projected $280 million in 2025[38] - The company aims for $250 million+ in quarterly revenue by Q4 2027, driven by Surgical + Rare & Specialty Products ($75M), Retina Portfolio ($140M), ImprimisRx ($15M+), and Dry Eye Disease ($20M)[40] - ImprimisRx's revenue for compounded products reached $41.519 million in H1 2025[351] Product Pipeline and Acquisitions - Harrow acquired BYQLOVI for $0.5 million + Royalty[16] - Harrow is planning to file an NDA for MELT-300 in H1 2027, with a potential launch in H2 2028[50] - Harrow is developing a next-generation TRIESENCE with a goal to file an NDA by the end of 2027[53] Market and Commercial Strategy - VEVYE has captured 7.8% of the total Dry Eye Disease (DED) market as of Q2 2025, an increase of 2.6% from Q1 2025[120] - Over 7 million ocular surgeries are performed annually in the US, representing a significant market for Harrow's surgical portfolio[192] - Harrow expects to launch BYOOVIZ in mid-2026 and OPUVIZ in the second half of 2027[233, 234] Debt Refinancing - Harrow refinanced $240 million of unsecured notes with a coupon of 8.625%, resulting in $10 million of new cash to the balance sheet and $40 million undrawn revolver[33]
Harrow (NasdaqGM:HROW) Earnings Call Presentation
2025-09-26 13:43
Financial Performance and Growth - Harrow expects 2025 revenue to be more than $280 million[8] - Adjusted EBITDA in Q2 2025 was $17006 thousand[15] - Harrow had $52963 thousand in cash and cash equivalents as of June 30, 2025[16] Product Portfolio and Market Position - VEVYE experienced 66% Q/o/Q Rx volume growth[9, 33] - VEVYE has captured 78% of the total DED market as of Q2 2025, an increase of 26% from Q1 2025[38] - IHEEZO saw a 25% growth in unit demand in Q2 2025 vs Q1 2025[9] - TRIESENCE experienced 32% growth in Q2 2025 vs Q1 2025[9] Strategic Initiatives and Acquisitions - Harrow acquired the exclusive U S commercial rights for BYQLOVI in June 2025[8] - Harrow acquired the exclusive U S rights to Samsung Boepis ophthalmology biosimilars pipeline, including BYOOVIZ and OPUVIZ in July 2025[8] - In August 2025, Harrow expands VAFA program capacity with a strategic alliance with Apollo Care[8]
Harrow Announces Agenda and Speakers for Investor & Analyst Day
Globenewswire· 2025-09-15 11:00
Core Insights - Harrow, a leading provider of ophthalmic disease management solutions in North America, is set to hold its Investor & Analyst Day on September 26, 2025, in New York, which will also be available via live webcast [1][2] Company Overview - Harrow offers a comprehensive portfolio of products addressing various ocular conditions, including dry eye disease, age-related macular degeneration, cataracts, glaucoma, and other retinal diseases [7] Event Details - The Investor & Analyst Day will feature presentations from Harrow's leadership team, covering the company's commercial portfolio, pipeline, and long-term vision, along with insights from key opinion leaders in the field [2][5] - The preliminary agenda includes topics such as Harrow's financial update, pipeline products, and expert perspectives on procedural sedation and specific ophthalmic conditions [5] Featured Speakers - Notable physician speakers include Dr. Paul Karpecki, Dr. Raj Patel, Dr. Seenu Hariprasad, and Dr. Maggie Jeffries, each bringing extensive experience in various areas of ophthalmology [3][4] Webcast Information - A live webcast of the event will be available, along with a replay and presentation materials posted on Harrow's investor relations page [6]
Harrow Health(HROW) - 2025 Q2 - Earnings Call Presentation
2025-08-12 12:00
Financial Performance & Growth - Harrow expects 2025 revenue to be more than $280 million[9] - In Q2 2025, Adjusted EBITDA was $17006 thousand[16] - Harrow had $52963 thousand in cash and cash equivalents as of June 30, 2025[17] Product Portfolio & Market Position - VEVYE showed 66% Q/o/Q Rx volume growth[10, 34] - VEVYE captured 78% of the total DED market in Q2 2025, an increase of 26% from Q1 2025[39] - IHEEZO experienced 25% growth in unit demand in Q2 2025 vs Q1 2025[10] - TRIESENCE showed 32% growth in Q2 2025 vs Q1 2025, with Q4 2025 expansion to a new market[10] Strategic Initiatives & Acquisitions - Harrow expanded the VAFA program capacity with a strategic alliance with Apollo Care in August 2025[9] - Harrow acquired the exclusive U S rights to Samsung Bioepis ophthalmology biosimilars pipeline, including BYOOVIZ (Lucentis) & OPUVIZ (Eylea) in July 2025[9] - Harrow acquired the exclusive U S commercial rights for BYQLOVI in June 2025, planning a launch in Q1 2026[9, 46]
Harrow Health(HROW) - 2025 Q1 - Earnings Call Presentation
2025-05-08 21:40
Financial Performance and Projections - 2025 revenue is expected to be more than $280 million[7] - Adjusted EBITDA for 2024 was $40327 thousand[10] - Consolidated revenues for 2024 were $199614 thousand[10] - ImprimisRx generated $83499 thousand in revenues in 2024[26] Product Launches and Performance - VEVYE Access for All launched in mid-March 2025, leading to a fourfold increase in weekly new prescriptions and prescribers in the first seven weeks[8] - IHEEZO customer unit demand in Q1 2025 reached 38940[14] - VEVYE quarterly prescriptions in Q1 2025 were 72017[17] Strategic Investments and Developments - Harrow holds a 46% ownership in Melt Pharmaceuticals[8] - Melt Pharmaceuticals' MELT-300 showed positive Phase 3 efficacy results, with potential FDA approval and launch in Q1 2027[8] - TRIESENCE has pass-through status granted by CMS effective April 1, 2025[23]