Core Insights - Harrow has launched a new Direct-to-Prescriber (DTP) cash-pay offering called PharmaPack, aimed at providing affordable FDA-approved ophthalmic products as alternatives to off-label compounded formulations [1][2]. Product Offering - PharmaPack kits are designed to enhance access to FDA-approved ophthalmic products for millions of Americans needing infection control and treatment of pain and inflammation related to cataract surgery [2]. - The kits simplify the prescribing process by eliminating insurance-related administrative complexities and reducing regulatory and medical-legal risks associated with off-label compounded products [2]. Market Demand - The PharmaPack program addresses a significant challenge in ophthalmology by providing reliable and affordable FDA-approved therapies, which has been a request from optometrists [4]. - The offering is expected to foster greater confidence among prescribers when considering FDA-approved branded alternatives to compounded products [4]. Availability and Expansion - Initially, PharmaPack kits will be available in California, Mississippi, Arkansas, Connecticut, and Alabama, with plans for nationwide expansion in the coming weeks [6].

Core Insights - Harrow reaffirms its full-year 2025 revenue guidance of $270-280 million, highlighting strong execution across commercial and development programs [1] - The company is on track to double its VEVYE sales force, expand IHEEZO into office-based settings, and double the TRIESENCE sales force in surgical settings [1][2] - Harrow's ImprimisRx has settled regulatory matters with the California Board of Pharmacy and will exit the California market while focusing on other states [1][10] VEVYE Sales Force Expansion - Harrow plans to double the VEVYE sales force from approximately 50 to 100 territories by Memorial Day 2026, driven by recent coverage wins and expected stabilization of net pricing [3] IHEEZO Commercial Expansion - The company is expanding IHEEZO's focus to the office-based setting, targeting over 2.5 million annual procedures, which is expected to accelerate demand and adoption [4] TRIESENCE Sales Force Expansion - Harrow intends to double the surgical sales force for TRIESENCE, responding to positive clinical feedback and increasing demand metrics for the product [6] OneHarrow Initiative - The OneHarrow initiative aims to unify branding and operations under a single organization to enhance patient access, affordability, and clinical outcomes [7] Leadership Changes - Patrick W. Sullivan has been promoted to Chief Commercial Officer, focusing on strengthening Harrow's commercial foundation and aligning with the company's revenue goals [8] MELT-300 and MELT-210 Programs - Harrow is on track to submit New Drug Applications for MELT-300 and MELT-210, with all necessary studies initiated [1][9] ImprimisRx Regulatory Settlement - ImprimisRx has settled with the California Board of Pharmacy, agreeing to a fine of approximately $157,000, and will exit the California market effective February 1, 2026 [10]

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.

Financial Data and Key Metrics Changes - Total revenue for the second quarter was $63.7 million, a 30% increase year-over-year and a sequential increase of 33% from the previous quarter [13][14] - Adjusted EBITDA for the second quarter was $17 million, with net income of $5 million, highlighting the operating leverage built into the business [15][16] - The company aims for more than $280 million in revenue for 2025, needing approximately $169 million in the second half to meet this guidance [13][14] Business Line Data and Key Metrics Changes - VeeVai generated $18.6 million in revenue, a 13% decrease from the previous year, attributed to a normalization in average selling price (ASP) [16][17] - iHizo generated $18.3 million in revenue, a 251% increase from the previous year, driven by momentum from the retina pivot and expanded distribution [19][20] - Triassence achieved $5.2 million in revenue, a 447% increase from the previous year, with volumes accelerating and market share expanding [20][21] - ImprimisRx generated $21.5 million in revenue, a 7% increase from the previous year, performing as expected and on track to reach $80 million for the year [21] Market Data and Key Metrics Changes - VeeVai captured a 7.8% share of the national dry eye disease market, a 2.6% increase quarter-over-quarter [26] - iHizo's volume grew 33% quarter-over-quarter within the largest retina GPO, representing approximately 70% of the retina market [34] - Triassence achieved 84% coverage with only 8% of claims requiring prior authorization, indicating strong market penetration [36] Company Strategy and Development Direction - The company aims to deliver a quarterly revenue of $250 million by 2027, supported by a sophisticated infrastructure and a diverse portfolio of over 59 prescription products [8][9] - Recent strategic alliances, such as with Apollo Care, are expected to enhance distribution networks and improve ASP for VeeVai [18][19] - The company is preparing to launch Biclovy, a new FDA-approved steroid, in 2026, which is expected to capture significant market opportunities [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting revenue guidance for 2025, citing strong momentum in key growth drivers and a stable cost basis [15][16] - The company anticipates meaningful revenue growth as early as the third quarter, driven by increased prescription volumes and a more stable ASP [24][25] - Management highlighted the importance of maintaining a strong supply chain and safety stock to support future growth [59][60] Other Important Information - The company has secured additional manufacturing capacity for 2025 to meet growing demand for VeeVai and other products [25] - The recent acquisition of Samsung's ophthalmic biosimilars portfolio is expected to enhance the company's competitive position in the market [38] Q&A Session Summary Question: Can you help us with any kind of business rule changes within VeeVai as you onboard Apollo Care? - Management indicated that minor tweaks to the algorithm are ongoing, and the ASP is expected to stabilize and potentially improve by the end of the year due to expanded network coverage [44][45][47] Question: Any thoughts on the contribution of the biosimilars to the model in 2026 and 2027? - Management expressed excitement about the Samsung portfolio and anticipates launching BioViz in 2026, expecting immediate demand due to the existing market [49][50][51] Question: How much of the growth in new prescriptions for VeeVai was driven by Clarity C switchers? - Approximately 7,000 units came from Clarity C during the period, and management is confident in the loyalty of these patients for refills [55][56] Question: What are the expectations for the Specialty Branded and Triassence segment? - Management expects to double revenue levels for ex-Tri Essence products by the end of the year and sees strong growth potential for Triassence in the ocular inflammation market [60][62] Question: How does ApolloCare differ from PHIL in terms of integration with existing plans? - ApolloCare offers extensive contracted plans, which helps capture more commercial covered prescriptions, enhancing ASP stability [78][80]