An overview of the science behind DURAVYU™ (vorolanib intravitreal insert), formerly known as EYP1901, an investigational sustained-release therapy with the potential to alter the treatment paradigm for patients suffering from VEGF-mediated retinal diseases A review of the positive Phase 2 DAVIO 2 trial results in wet AMD, including 12-month topline data An update on the pivotal non-inferiority Phase 3 trial plans for DURAVYU™ in wet AMD A KOL roundtable discussion with Drs. Regillo and Modi moderated by Ey ...

Core Points - EyePoint Pharmaceuticals, Inc. announced the granting of non-statutory stock options to new employees as inducement awards outside the Company's 2023 Long-Term Incentive Plan [1] - A total of 44,200 stock options were granted to four new employees, with an exercise price of $12.94 per share, the closing price on May 15, 2024 [2] - The options have a ten-year term and vest over four years, with 25% vesting on the first anniversary and the remainder vesting in equal monthly installments [2] Company Overview - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for serious retinal diseases [3] - The Company utilizes its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery [3] - The lead product candidate, DURAVYU (EYP-1901), is an investigational treatment for VEGF-mediated retinal diseases [3][4] - Vorolanib, a selective tyrosine kinase inhibitor, is licensed exclusively to EyePoint for ophthalmic diseases outside of certain Asian regions [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ COMMISSION FILE NUMBER 000-51122 EyePoint Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisd ...

– DURAVYU demonstrates stable or improved disease severity with reduced rates of NPDR progression at nine months – – DURAVYU continues to demonstrate favorable safety and tolerability profile with no drug-related serious adverse events – – Conference call to discuss the results to be held at 8:00 a.m. ET – WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with se ...

Preliminary Note Regarding Forward-Looking Statements [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section clarifies that various statements are forward-looking, involving risks and uncertainties, and the company does not commit to public updates - Forward-looking statements address future activities, events, or developments, including expectations of **revenues**, **expenses**, **cash flows**, **earnings**, and plans for product research, development, and commercialization, as well as **regulatory approvals**[11](index=11&type=chunk)[12](index=12&type=chunk) - Factors that could cause actual results to differ materially include the potential of **EYP-1901**, timing and outcome of **clinical trials**, strategic alliances, ability to obtain **additional capital**, future expenses, **DOJ subpoena** outcome, manufacturing capabilities, **intellectual property** protection, global economic conditions, and legal/regulatory developments[13](index=13&type=chunk) - The company does **not undertake any obligation to publicly update or revise** its forward-looking statements, even if future changes indicate that projected results will not be realized[16](index=16&type=chunk) Risk Factor Summary [Risks Related To Our Financial Position And Our Capital Resources](index=6&type=section&id=Risks%20Related%20To%20Our%20Financial%20Position%20And%20Our%20Capital%20Resources) This section summarizes risks related to financial stability, including capital needs, significant losses, and potential adverse effects from a DOJ subpoena - The company will likely need **additional capital** to fund operations, and failure to obtain it could lead to curtailment of activities and modification of business strategy[21](index=21&type=chunk) - The company has incurred **significant losses** since inception and anticipates **continued losses**, with **no guarantee of future profitability**[21](index=21&type=chunk) - A **subpoena** from the U.S. Attorney's Office regarding sales and marketing practices, particularly for DEXYCU®, could have a **material adverse effect** on the business and financial condition[21](index=21&type=chunk) [Risks Related To The Regulatory Approval And Clinical Development Of Our Product Candidates](index=6&type=section&id=Risks%20Related%20To%20The%20Regulatory%20Approval%20And%20Clinical%20Development%20Of%20Our%20Product%20Candidates) This section highlights uncertainties and potential delays in clinical trials for product candidates, emphasizing unpredictable outcomes and no guarantee of later-stage approval - **Clinical trial outcomes are uncertain**, and delays or termination of trials for EYP-1901 or other product candidates could harm the business[20](index=20&type=chunk) - Clinical trial results may fail to support continued investigations or **regulatory approval**[24](index=24&type=chunk) - Success in early-stage clinical trials does not ensure success in later-stage trials[24](index=24&type=chunk) [Risks Related To The Commercialization Of Our Products And Product Candidates](index=8&type=section&id=Risks%20Related%20To%20The%20Commercialization%20Of%20Our%20Products%20And%20Product%20Candidates) This section outlines risks associated with commercializing products, including challenges in market acceptance, unfavorable pricing, and healthcare law compliance - The business strategy relies on successful commercialization, but products may not achieve **market acceptance** or commercial success[24](index=24&type=chunk) - Product candidates, if approved, may be impacted by **unfavorable pricing regulations**, third-party reimbursement practices, or healthcare reform initiatives[24](index=24&type=chunk) - Failure to comply with Medicaid Drug Rebate program or other governmental pricing programs could lead to **penalties and sanctions**[24](index=24&type=chunk) [Risks Related To Our Intellectual Property](index=8&type=section&id=Risks%20Related%20To%20Our%20Intellectual%20Property) This section details risks concerning the company's intellectual property, such as inability to protect rights, potential infringement claims, and impact of changes in patent law - Inability to protect **intellectual property rights** or inadequate protection could allow competitors to commercialize similar technologies, harming the company's competitive position[24](index=24&type=chunk) - The company may become involved in expensive, time-consuming, and potentially unsuccessful lawsuits to protect or enforce its patents[24](index=24&type=chunk) - Changes in U.S. or foreign patent law or their interpretation could diminish the value of patents, impairing the ability to protect products[24](index=24&type=chunk) [Risks Related To Our Reliance On Third Parties](index=10&type=section&id=Risks%20Related%20To%20Our%20Reliance%20On%20Third%20Parties) This section addresses risks from the company's dependence on third parties for intellectual property, API supply, and clinical trial execution, highlighting potential adverse impacts - Development and commercialization of EYP-1901 depend on intellectual property licensed from Equinox Science and API supply of vorolanib from third parties; **breach or termination of agreements** could lead to loss of rights or supply[26](index=26&type=chunk) - Reliance on CROs, vendors, and investigators for development efforts means their failure to carry out responsibilities could cause **delays**[26](index=26&type=chunk) - Disruptions to manufacturing operations or third-party suppliers could adversely affect commercial viability of products like YUTIQ® and DEXYCU®[26](index=26&type=chunk) [Risks Related To Ownership Of Our Common Stock](index=10&type=section&id=Risks%20Related%20To%20Ownership%20Of%20Our%20Common%20Stock) This section covers risks related to the company's common stock, including high price volatility, significant control by a small group of stockholders, and potential dilution - The trading price of the common stock has been **highly volatile**, potentially leading to substantial losses for purchasers[26](index=26&type=chunk) - A small concentration of approximately **ten stockholders beneficially own 65%** of total outstanding common stock, giving them significant control over matters subject to stockholder approval[26](index=26&type=chunk) PART I [BUSINESS](index=11&type=section&id=ITEM%201.%20BUSINESS) EyePoint Pharmaceuticals develops sustained delivery therapeutics for serious retinal diseases, with EYP-1901 as its lead Phase 2 candidate - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics for serious retinal diseases, utilizing its **Durasert E™ technology** for sustained intraocular drug delivery[28](index=28&type=chunk) - The lead product candidate, **EYP-1901**, is an investigational sustained delivery treatment for anti-VEGF-mediated retinal diseases, combining vorolanib with Durasert E™, currently in Phase 2 clinical trials for wet AMD, NPDR, and DME[28](index=28&type=chunk)[31](index=31&type=chunk)[33](index=33&type=chunk) - In May 2023, the company transitioned to a clinical-stage focus by licensing its commercial product, **YUTIQ®**, to Alimera Sciences Inc. for **$82.5 million** plus potential royalties[34](index=34&type=chunk) [Overview](index=11&type=section&id=Overview) EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company developing sustained intraocular drug delivery therapeutics for serious retinal diseases using Durasert E™ technology - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing therapeutics for serious retinal diseases, leveraging its proprietary **bioerodible Durasert E™ technology** for sustained intraocular drug delivery[28](index=28&type=chunk) - **EYP-1901**, combining vorolanib with Durasert E™, is in Phase 2 clinical trials for wet AMD, NPDR, and DME, with pivotal Phase 3 trials in wet AMD expected to initiate in the **second half of 2024**[28](index=28&type=chunk)[31](index=31&type=chunk) - **Positive topline six-month safety and efficacy data** from the Phase 2 DAVIO 2 clinical trial for wet AMD were reported in **December 2023**, demonstrating non-inferiority in visual acuity and significant reduction in treatment burden[32](index=32&type=chunk)[34](index=34&type=chunk) [Pipeline](index=12&type=section&id=Pipeline) The company's pipeline includes EYP-1901 in Phase 2 trials for wet AMD, NPDR, and DME, and EYP-2301 in preclinical development Development Pipeline | DEVELOPMENT PROGRAM | STATUS | PARTNER | | :------------------ | :----- | :------ | | EYP-1901 – vorolanib in Durasert E™ | Phase 2 clinical trials underway in wet AMD, NPDR and DME | Partnered with Betta in China, Hong Kong, Taiwan and Macau | | EYP-2301 – razuprotafib in Durasert E™ | Preclinical development | Unpartnered | [Strategy](index=12&type=section&id=Strategy) EyePoint's strategy is to become a leader in sustained delivery therapeutics for serious eye disorders, advancing EYP-1901 and EYP-2301, and expanding its pipeline - The company's goal is to become a leader in developing and commercializing innovative **sustained delivery therapeutics** for serious eye disorders, focusing on retinal diseases[37](index=37&type=chunk) - Key strategic elements include advancing **EYP-1901 through Phase 3** clinical development for wet AMD, NPDR, and DME, and into clinical trials for additional indications like myopic choroidal neovascularization (CNV) and retinal vein occlusion (RVO)[41](index=41&type=chunk) - The strategy also involves advancing **EYP-2301 into clinical development** for serious retinal diseases and expanding the product pipeline through in-license, partnership, or acquisition, with an initial focus on Durasert®-compatible molecules[41](index=41&type=chunk) [Durasert Technology](index=14&type=section&id=Durasert%20Technology) Durasert® technology enables sustained drug release in the eye for months to years via a single intravitreal injection, with EYP-1901 utilizing the bioerodible Durasert E™ formulation - Durasert® technology provides **sustained, consistent (zero-order kinetics) release** of drugs in the eye for months to years through a single intravitreal injection, tailored for each drug and disease[29](index=29&type=chunk)[43](index=43&type=chunk)[46](index=46&type=chunk) - **Four FDA-approved products** (YUTIQ®, ILUVIEN, Retisert®, Vitrasert®) utilize Durasert® technology, with ILUVIEN and YUTIQ® designed for intravitreal delivery in a physician's office[43](index=43&type=chunk) - **EYP-1901 deploys Durasert E™**, a bioerodible formulation that allows for potentially higher drug doses and complete bioerosion of the insert after drug release[45](index=45&type=chunk) [Our Product Candidates](index=14&type=section&id=Our%20Product%20Candidates) EyePoint's lead product candidate, EYP-1901, is an investigational sustained delivery treatment for anti-VEGF-mediated retinal diseases, currently in Phase 2 trials for wet AMD, NPDR, and DME - EYP-1901 is an investigational product combining **vorolanib**, a selective and patent-protected tyrosine kinase inhibitor (TKI), with bioerodible Durasert E™ technology, targeting anti-VEGF-mediated retinal diseases[46](index=46&type=chunk) - Vorolanib blocks all VEGF isoforms and has shown encouraging **neuroprotection data** in preclinical studies, potentially offering an additional treatment benefit beyond existing anti-VEGF therapies[47](index=47&type=chunk) - Wet AMD, NPDR, and DME represent significant market opportunities due to increasing prevalence (**wet AMD expected to more than double by 2050**) and the unmet need for sustained delivery to improve outcomes over frequent intravitreal injections[49](index=49&type=chunk)[50](index=50&type=chunk)[54](index=54&type=chunk)[59](index=59&type=chunk) [EYP-1901 for wet AMD, NPDR and DME](index=14&type=section&id=EYP-1901%20for%20wet%20AMD,%20NPDR%20and%20DME) EYP-1901 is in Phase 2 clinical trials for wet AMD, NPDR, and DME, addressing significant market opportunities due to increasing prevalence and the need for sustained delivery [Market Opportunity in wet AMD](index=14&type=section&id=Market%20Opportunity%20in%20wet%20AMD) Wet AMD is a major cause of vision loss, with prevalence projected to more than double by 2050, creating an unmet need for sustained delivery maintenance therapy like EYP-1901 - Wet AMD is a leading cause of vision loss, with the number of affected individuals in the U.S. projected to **more than double from 2.07 million in 2010 to 5.44 million by 2050**[48](index=48&type=chunk)[50](index=50&type=chunk) - Current effective treatments (Lucentis, Eylea, Vabysmo, Beovu, Avastin) require **frequent intravitreal injections**, leading to inconvenience, discomfort, reduced compliance, and vision loss over time[52](index=52&type=chunk)[53](index=53&type=chunk) - EYP-1901, if approved as a **six-month sustained delivery maintenance therapy**, has the potential to offer a safe and effective treatment option with a unique mechanism of action, addressing the unmet need for longer duration of action[53](index=53&type=chunk) [Market Opportunity in Non-Proliferative Diabetic Retinopathy](index=16&type=section&id=Market%20Opportunity%20in%20Non-Proliferative%20Diabetic%20Retinopathy) NPDR is a growing complication of diabetes, with no typical treatment at early stages, highlighting an unmet need for sustainable dosing to prevent progression - Diabetic retinopathy (DR) is a frequent complication of diabetes, progressing from NPDR to PDR and/or DME, which can lead to severe visual loss and is the **leading cause of new cases of blindness in adults**[54](index=54&type=chunk)[56](index=56&type=chunk) - Currently, **no treatment is typically administered at the NPDR stages**, indicating a significant unmet medical need for a sustainable dosing regimen to slow or prevent progression to vision-threatening complications[56](index=56&type=chunk) [Market Opportunity in Diabetic Macular Edema](index=16&type=section&id=Market%20Opportunity%20in%20Diabetic%20Macular%20Edema) DME, a complication of diabetic retinopathy, causes macular swelling and blurred vision, affecting a significant portion of diabetics, highlighting the need for improved, sustained delivery options - Diabetic Macular Edema (DME) is a complication of diabetic retinopathy, caused by fluid leakage into the macula, leading to blurred vision and is a **leading cause of incident blindness in U.S. adults aged 20-74**[57](index=57&type=chunk)[59](index=59&type=chunk) - DME affects **3.8% of U.S. adults 40 years and older with diabetes**, with nearly 80% of Type 1 and 50% of Type 2 diabetics developing DR after 15-20 years[58](index=58&type=chunk)[59](index=59&type=chunk) - Intravitreal anti-VEGF agents are the preferred first-line treatment for DME, but the need for frequent injections highlights the demand for **sustained delivery options**[60](index=60&type=chunk) [Clinical Development](index=17&type=section&id=Clinical%20Development) EYP-1901 has shown positive safety and efficacy in Phase 1 and 2 trials for wet AMD, demonstrating non-inferiority in visual acuity and significant reduction in treatment burden - Phase 1 DAVIO trial (wet AMD) showed positive interim six-month safety and efficacy, with **no ocular SAEs**, **75% reduction in treatment burden**, and **53% of patients supplement-free** up to six months; 12-month data confirmed continued positive safety and efficacy with **73% reduction in treatment burden** and **35% supplement-free**[62](index=62&type=chunk)[63](index=63&type=chunk) - Phase 2 DAVIO 2 trial (wet AMD) reported positive topline data at week 32 (December 2023): both EYP-1901 doses (2mg and 3mg) achieved all primary and secondary endpoints, demonstrating **statistical non-inferiority in BCVA vs. aflibercept control** (numerical difference of -0.3 and -0.4 letters, respectively)[65](index=65&type=chunk) - DAVIO 2 also showed a **positive safety profile** (no EYP-1901-related ocular or systemic SAEs), **89% (2mg) and 85% (3mg) reduction in treatment burden**, **65% (2mg) and 64% (3mg) of eyes supplement-free** up to six months, and strong anatomical control[65](index=65&type=chunk) [Intellectual Property (EYP-1901)](index=19&type=section&id=Intellectual%20Property%20(EYP-1901)) EyePoint Pharmaceuticals holds an exclusive license from Equinox Science for vorolanib, the active compound in EYP-1901, covering ophthalmology indications globally (excluding Greater China) - EyePoint has an **exclusive, sublicensable license from Equinox Science for vorolanib** (EYP-1901's compound) for ophthalmology indications globally, excluding Greater China, including milestone payments up to **$50 million** and tiered royalties (high-single to low-double digits) on annual net sales[69](index=69&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk) - The company granted Betta Pharmaceuticals (an Equinox affiliate) an **exclusive, sublicensable license for EYP-1901 in Greater China**, with tiered mid-to-high single-digit royalties on annual net sales in that territory[72](index=72&type=chunk)[73](index=73&type=chunk) [EYP-2301](index=21&type=section&id=EYP-2301) EYP-2301, delivering razuprotafib (a TIE-2 agonist) in Durasert E™, is in preclinical development for serious retinal diseases, with related patents acquired from Aerpio Pharmaceuticals - **EYP-2301**, which delivers razuprotafib (a TIE-2 agonist) formulated in Durasert E™, is currently in **preclinical development** to potentially improve outcomes in serious retinal diseases[74](index=74&type=chunk) - In August 2021, EyePoint acquired all rights to certain U.S. and ex-U.S. patents and applications relating to Tie-2 activating molecules, including razuprotafib, from Aerpio Pharmaceuticals Inc. for **$450,000**[75](index=75&type=chunk) [Our Previously Commercialized Products](index=21&type=section&id=Our%20Previously%20Commercialized%20Products) EyePoint Pharmaceuticals has transitioned from commercializing YUTIQ® and DEXYCU®, licensing YUTIQ® to Alimera Sciences and terminating DEXYCU® promotion due to reimbursement changes - **YUTIQ®** (fluocinolone acetonide intravitreal implant), a once every three-year treatment for chronic non-infectious uveitis, was licensed for U.S. rights to Alimera Sciences in May 2023 for **$82.5 million cash** plus potential royalties[76](index=76&type=chunk) - YUTIQ®'s clinical development, regulatory, reimbursement, and distribution rights for Mainland China, Hong Kong, Macau, Taiwan, South Korea, and other Southeast Asian jurisdictions were licensed to Ocumension Therapeutics, with sales commencing in China in 2022 and royalties due to EyePoint[76](index=76&type=chunk) - **DEXYCU®** (dexamethasone intraocular suspension), approved for post-operative ocular inflammation, had its U.S. promotion terminated in 2023 due to the **elimination of separate pass-through reimbursement by CMS**, significantly impacting its market opportunity[77](index=77&type=chunk)[78](index=78&type=chunk) [Manufacturing](index=21&type=section&id=Manufacturing) The company's manufacturing operations are subject to cGMP regulations, with EYP-1901 materials produced at Watertown, MA, and a new Northbridge, MA facility expected in H2 2024 - Production, assembly, and packaging of EYP-1901 clinical trial materials are conducted in Class 10,000 clean rooms at the Watertown, MA facility, with vorolanib API sourced from Betta and a U.S.-based contract manufacturing supplier being established[81](index=81&type=chunk) - A new **40,000-square-foot GMP-compliant manufacturing facility** in Northbridge, MA, is under design and construction, expected to be operational in the **second half of 2024**, to support global manufacturing of programs including EYP-1901[81](index=81&type=chunk) - YUTIQ® is manufactured at the Watertown, MA facility, while DEXYCU® relies on contract manufacturers for commercial supply, kitting, packaging, sterilization, testing, and storage services[82](index=82&type=chunk)[83](index=83&type=chunk) [U.S. Sales and Marketing](index=23&type=section&id=U.S.%20Sales%20and%20Marketing) As of May 2023, the company ceased internal sales and marketing for YUTIQ® due to its out-licensing, and terminated DEXYCU® promotion following reimbursement changes - Commercial support for YUTIQ® was **terminated in May 2023** due to its out-license to Alimera, with no internal employees currently supporting sales and marketing[84](index=84&type=chunk) - Promotion of DEXYCU® was **terminated in 2023** following the elimination of separate pass-through reimbursement by CMS, though it remains available through specialty distributors[84](index=84&type=chunk) [U.S. Market Access and Payer Reimbursement](index=23&type=section&id=U.S.%20Market%20Access%20and%20Payer%20Reimbursement) YUTIQ®'s reimbursement responsibilities were transferred to Alimera in May 2023, while DEXYCU® lost its Medicare pass-through status, leading to terminated commercial support - YUTIQ®'s reimbursement responsibilities, including its permanent J code for Medicare and commercial payers, were **transferred to Alimera in May 2023**[85](index=85&type=chunk) - DEXYCU® **lost its three-year Medicare pass-through status** effective January 1, 2023, leading to the termination of commercial support, sales and marketing, and all patient assistance programs[85](index=85&type=chunk) [U.S. Product Distribution Channel](index=23&type=section&id=U.S.%20Product%20Distribution%20Channel) The company previously established a U.S. distribution channel for YUTIQ® and DEXYCU®; YUTIQ® responsibilities were transferred to Alimera, while DEXYCU® remains available without commercial support - The company previously established a U.S. distribution channel for YUTIQ® and DEXYCU® through a third-party logistics provider (3PL), distributors, and specialty pharmacy providers[86](index=86&type=chunk) - All YUTIQ® product responsibilities, including distribution, were **transferred to Alimera effective May 2023**[86](index=86&type=chunk) - DEXYCU® is still available through this distribution network, but it is **no longer commercially supported** by the company[86](index=86&type=chunk) [Research Agreements](index=25&type=section&id=Research%20Agreements) EyePoint Pharmaceuticals periodically enters into research agreements with third parties to evaluate its technology platforms for ophthalmic and other diseases, aiming for future milestones and royalties - The company enters into research agreements with third parties to evaluate its Durasert and Verisome technology platforms for ophthalmic and other diseases, with the potential for future clinical and commercial milestones and royalties[87](index=87&type=chunk) [FDA Approved Products Licensed to Other Entities](index=25&type=section&id=FDA%20Approved%20Products%20Licensed%20to%20Other%20Entities) EyePoint Pharmaceuticals has licensed its FDA-approved products YUTIQ® and ILUVIEN® to other entities, securing cash and royalties from these agreements - YUTIQ® U.S. rights were licensed to Alimera in May 2023 for **$82.5 million** ($75 million upfront, $7.5 million in 2024 installments) plus low-to-mid double-digit royalties on U.S. net sales above defined thresholds for 2025-2028[88](index=88&type=chunk) - YUTIQ®'s clinical development, regulatory, reimbursement, and distribution rights for Mainland China, Hong Kong, Macau, Taiwan, South Korea, and other Southeast Asian jurisdictions were licensed to Ocumension, with royalties on product sales[89](index=89&type=chunk) - ILUVIEN®, an injectable, sustained-release micro-insert based on Durasert® technology for DME, is licensed to Alimera Sciences; EyePoint sold its interest in royalties from ILUVIEN® sales to SWK Funding, LLC for a one-time **$16.5 million payment** in December 2020[90](index=90&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk) [Intellectual Property](index=25&type=section&id=Intellectual%20Property) EyePoint Pharmaceuticals owns or licenses patents covering its sustained-release therapeutics, with key patents for EYP-1901 extending to 2037 and additional applications potentially to 2043 - The last expiring patent covering the vorolanib compound in EYP-1901 expires in **September 2037**, with additional patent applications filed that, if issued, could extend coverage to at least **2041 or 2043**[95](index=95&type=chunk) - The acquired Aerpio patent portfolio for Tie-2 activating molecules (including razuprotafib for EYP-2301) includes approximately **150 U.S. or ex-U.S. patents and applications**, with potential expiration dates ranging from **2027 to 2041**[96](index=96&type=chunk) - The latest expiring U.S. patent for ILUVIEN® and YUTIQ® expires in **August 2027**, with the YUTIQ® injector patent expiring in **January 2028**; issued patents for DEXYCU® cover until at least **May 2034**, and injection dosing guides until **June 2039**[97](index=97&type=chunk)[98](index=98&type=chunk) [Human Capital Resources](index=27&type=section&id=Human%20Capital%20Resources) EyePoint Pharmaceuticals focuses on attracting and retaining top talent through a safe, rewarding, and inclusive workplace, offering competitive compensation and professional development opportunities - The company prioritizes attracting and retaining top talent by ensuring a safe and rewarding workplace, offering opportunities for career growth, and fostering a collaborative, inclusive, and productive environment[99](index=99&type=chunk)[101](index=101&type=chunk)[104](index=104&type=chunk) Human Capital Metrics (as of Feb 29, 2024) | Metric | Value | | :----- | :---- | | Full-time employees (U.S.) | 121 | | Voluntary turnover rate (FY2023) | 7.6% | - Compensation and incentives include market-competitive pay, equity grants, performance bonuses, healthcare benefits, retirement plans (401(k) with employer match), employee stock purchase program, and flexible work schedules[99](index=99&type=chunk)[102](index=102&type=chunk) [Competition](index=29&type=section&id=Competition) The market for eye disease treatments is highly competitive, with many larger, better-resourced companies developing drugs and delivery methods, based on efficacy, side effects, and reimbursement - The market for eye disease treatments is **highly competitive**, characterized by extensive research and rapid technological progress, with many competitors having substantially more resources[105](index=105&type=chunk)[106](index=106&type=chunk) - Leading FDA-approved treatments for wet AMD, DR, and DME include **LUCENTIS®** (ranibizumab), **EYLEA®** (aflibercept 2mg), **EYLEA® HD** (aflibercept 8mg), **VABYSMO®** (faricimab), and off-label **AVASTIN®** (bevacizumab), along with biosimilars[106](index=106&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk) - Investigational treatments in development include gene therapies (REGENXBIO, Adverum, 4DMT), other TKIs (AXPAXLI/OTX-TKI by Ocular Therapeutix, CLS-AX by Clearside Biomedical), and novel therapies (Tarcocimab Tedromer by Kodiak, OPT-302 by Opthea, THR-149 by Oxurion, OCS-01 by Oculis, UBX1325 by Unity Biotechnology)[109](index=109&type=chunk)[110](index=110&type=chunk)[112](index=112&type=chunk)[113](index=113&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) [Government Regulation](index=31&type=section&id=Government%20Regulation) EyePoint Pharmaceuticals is subject to extensive regulation by the FDA and other global agencies, covering drug development, approval, manufacturing, and post-market surveillance - The company is subject to **extensive regulation by the FDA** and other federal, state, local, and foreign regulatory agencies, covering all aspects of drug development, approval, manufacturing, and commercialization[121](index=121&type=chunk)[122](index=122&type=chunk) - The process of obtaining regulatory marketing approvals and ensuring subsequent compliance requires **substantial time and financial resources** and may not be successful[122](index=122&type=chunk) - Failure to comply with applicable regulatory requirements during any phase of development or post-market can result in administrative or judicial sanctions, including clinical holds, refusal of approvals, product recalls, fines, and criminal prosecution[167](index=167&type=chunk) [Development and Approval](index=33&type=section&id=Development%20and%20Approval) Drug development and approval in the U.S. require extensive preclinical data, an IND application, and multi-phase clinical trials, followed by NDA submission and rigorous FDA review - FDA approval of a New Drug Application (NDA) is required for marketing new drugs in the U.S., necessitating extensive studies and data submission[123](index=123&type=chunk) - The development process includes preclinical testing (GLP-compliant animal studies), submission of an Investigational New Drug (IND) application, and multi-phase human clinical trials (Phase 1, 2, 3) conducted under Good Clinical Practice (GCP) and IRB oversight[124](index=124&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk) - NDA review involves FDA assessment of safety, effectiveness, manufacturing controls (cGMP), and labeling, potentially requiring a Risk Evaluation and Mitigation Strategy (REMS) or pediatric studies (PREA); the process is lengthy and may result in delays or denial of approval[131](index=131&type=chunk)[133](index=133&type=chunk)[134](index=134&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) [Post-Approval Regulation](index=37&type=section&id=Post-Approval%20Regulation) After FDA approval, drug products are subject to continuous regulation, including cGMP compliance, safety reporting, and restrictions on advertising, with new legislation potentially expanding FDA authority - Approved drug products are subject to continuing FDA regulation, including monitoring and reporting adverse events, submitting new/supplemental applications for changes, and complying with cGMP requirements for manufacturing facilities[140](index=140&type=chunk)[141](index=141&type=chunk) - Advertising and promotion must comply with FDA regulations, and manufacturers are restricted from promoting off-label uses; non-compliance can lead to adverse publicity and enforcement actions[143](index=143&type=chunk) - New legislation, such as the Food and Drug Omnibus Reform Act of 2022, can significantly change statutory provisions, expanding FDA authority in areas like R&D alternatives, pre-approval inspections, accelerated approvals, and clinical trial diversity[144](index=144&type=chunk)[145](index=145&type=chunk) [Hatch-Waxman Act](index=39&type=section&id=Hatch-Waxman%20Act) The Hatch-Waxman Act provides abbreviated approval pathways for generic drugs and 505(b)(2) NDAs, establishing regulatory exclusivities and patent term restoration - The Hatch-Waxman Act establishes abbreviated approval pathways for generic drugs (ANDA) and 505(b)(2) NDAs, allowing applicants to rely on the FDA's previous findings of safety and effectiveness for an approved reference drug[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) - Sponsors of ANDAs or 505(b)(2) applications must make certifications regarding listed patents, potentially leading to **30-month stays on approval** if patent infringement suits are filed[150](index=150&type=chunk)[154](index=154&type=chunk) - The Act provides regulatory exclusivities (e.g., **5 years for New Chemical Entities**, **3 years for new clinical data**) and patent term restoration (up to **5 years**) to compensate for development and FDA review periods[151](index=151&type=chunk)[152](index=152&type=chunk)[155](index=155&type=chunk) [European and Other International Government Regulation](index=41&type=section&id=European%20and%20Other%20International%20Government%20Regulation) Outside the U.S., drug development and commercialization are subject to similar regulations, including CTAs and MAAs, with the EU streamlining trial approvals via CTIS - Outside the U.S., clinical trials require approvals from regulatory authorities, often involving Clinical Trial Applications (CTAs) similar to INDs; the EU's Clinical Trials Regulation (effective Jan 31, 2022) streamlines this process via the Clinical Trials Information System (CTIS)[156](index=156&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk) - To commercialize in the EU, a Marketing Authorization Application (MAA) is required, which can be obtained through centralized (EU-wide), mutual recognition, decentralized, or national procedures, with the EMA's CHMP responsible for assessment[159](index=159&type=chunk)[160](index=160&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) - Marketing authorization holders are subject to comprehensive regulatory oversight, including compliance with EU cGMP rules and other national requirements, with failure to comply potentially leading to administrative or judicial sanctions[165](index=165&type=chunk)[167](index=167&type=chunk) [Other Exclusivities](index=43&type=section&id=Other%20Exclusivities) Additional exclusivities include Pediatric Exclusivity (6 months extension) and Orphan Drug Exclusivity (7 years in U.S., 10 years in EU), providing market protection with specific criteria - Pediatric Exclusivity (Section 505A of FD&C Act) grants **six months of additional exclusivity** or patent protection for submitting pediatric data that responds to an FDA Written Request[168](index=168&type=chunk) - Orphan Drug Exclusivity provides incentives for developing drugs for rare diseases (affecting <200,000 in U.S. or economically unviable otherwise), granting **7 years of market exclusivity in the U.S.** and **10 years in the EU**, with specific conditions and exceptions[170](index=170&type=chunk)[171](index=171&type=chunk) - In the EU, Data Exclusivity grants **8 years of data protection** and **10 years of market exclusivity** for medicinal products containing a new active substance, extendable to 11 years under certain conditions[172](index=172&type=chunk) [U.S. Healthcare Reform](index=47&type=section&id=U.S.%20Healthcare%20Reform) The ACA and IRA have significantly impacted U.S. healthcare, affecting drug pricing, reimbursement, and manufacturer obligations, potentially reducing revenues and increasing liabilities - The Affordable Care Act (ACA) and subsequent legislation have substantially changed healthcare financing, impacting federal healthcare programs, reimbursement, Medicaid Drug Rebate program, and imposing fees on pharmaceutical manufacturers[173](index=173&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk) - The Inflation Reduction Act of 2022 (IRA) introduces significant drug pricing policies, including requiring the Secretary of Health and Human Services to **negotiate prices for high Medicare spend drugs** starting in 2026[178](index=178&type=chunk) - The IRA also penalizes manufacturers for price increases above inflation for certain Medicare Part B and D drugs and makes changes to the Medicare Part D benefit, including a limit on annual out-of-pocket costs and altered manufacturer liability[178](index=178&type=chunk) [Coverage and Reimbursement](index=49&type=section&id=Coverage%20and%20Reimbursement) Commercial success depends on coverage and reimbursement from Medicare, Medicaid, and private payors, which are subject to cost-containment efforts and complex pricing regulations - Sales of approved product candidates depend on coverage and reimbursement from Medicare, Medicaid, and private payors, which vary and are subject to cost-containment efforts, potentially limiting market acceptance or pricing[179](index=179&type=chunk)[180](index=180&type=chunk)[181](index=181&type=chunk) - Manufacturers must participate in programs like the Medicaid Drug Rebate Program, 340B drug pricing program, and VA Federal Supply Schedule (FSS), involving complex pricing and rebate calculations that can lead to significant liabilities if not complied with[182](index=182&type=chunk)[183](index=183&type=chunk)[186](index=186&type=chunk)[191](index=191&type=chunk)[192](index=192&type=chunk) - The Inflation Reduction Act (IRA) introduces Medicare drug price negotiation, Part B and D inflation rebates, and changes to the Part D benefit, which could significantly impact product pricing, revenue, and manufacturer liabilities[187](index=187&type=chunk)[190](index=190&type=chunk) [Healthcare Fraud and Abuse Laws](index=54&type=section&id=Healthcare%20Fraud%20and%20Abuse%20Laws) The company's commercial operations are subject to U.S. federal and state anti-kickback, fraud and abuse, and patient privacy laws, with non-compliance leading to significant sanctions - Commercial operations are subject to U.S. federal and state healthcare laws, including the Anti-Kickback Statute, False Claims Act, and HIPAA, which prohibit fraudulent activities and improper remuneration[202](index=202&type=chunk)[203](index=203&type=chunk)[205](index=205&type=chunk) - State laws often mirror federal regulations, with some requiring reporting of marketing expenses and gifts to healthcare professionals, or imposing limits on co-pay assistance[206](index=206&type=chunk) - Non-compliance can result in significant civil, criminal, and administrative penalties, including fines, imprisonment, exclusion from government healthcare programs, and reputational harm[208](index=208&type=chunk) [Healthcare Privacy Laws](index=56&type=section&id=Healthcare%20Privacy%20Laws) The company is subject to evolving federal, state, and foreign data privacy and security laws, with complex compliance requirements and potential for significant penalties for non-compliance - The company is subject to federal, state (e.g., CCPA, CPRA), and foreign (e.g., GDPR) laws and regulations governing data privacy and security of health and personal information, which are constantly evolving and complex to comply with[209](index=209&type=chunk)[210](index=210&type=chunk)[212](index=212&type=chunk)[213](index=213&type=chunk) - Failure to comply with these laws can result in significant government enforcement actions, civil/criminal penalties, private litigation, adverse publicity, and increased compliance costs[212](index=212&type=chunk)[213](index=213&type=chunk) - European/UK data protection laws (GDPR) restrict cross-border data transfers, requiring specific safeguards; a lack of valid transfer mechanisms could increase exposure to enforcement actions and commercial costs[213](index=213&type=chunk)[214](index=214&type=chunk)[215](index=215&type=chunk)[216](index=216&type=chunk) [Foreign Corrupt Practices Act](index=60&type=section&id=Foreign%20Corrupt%20Practices%20Act) The U.S. Foreign Corrupt Practices Act (FCPA) prohibits corporations and individuals from offering or paying anything of value to foreign officials to obtain or retain business - The U.S. Foreign Corrupt Practices Act (FCPA) prohibits corporations and individuals from engaging in activities to obtain or retain business or influence officials by paying, offering, or authorizing payments of anything of value to foreign officials, government staff, political parties, or candidates[217](index=217&type=chunk) [Corporate Information](index=60&type=section&id=Corporate%20Information) EyePoint Pharmaceuticals, Inc. was incorporated in Delaware in 2008 and is headquartered in Watertown, Massachusetts - EyePoint Pharmaceuticals, Inc. was incorporated in Delaware on March 19, 2008, and is headquartered in Watertown, Massachusetts[218](index=218&type=chunk) [Additional Information](index=60&type=section&id=Additional%20Information) The company's website provides investor information, including SEC filings, which are also available on www.sec.gov - Additional information, including Annual Reports on Form 10-K, proxy statements, quarterly reports on Form 10-Q, and current reports on Form 8-K, is available free of charge on the company's website (www.eyepointpharma.com) and the SEC's website (www.sec.gov)[219](index=219&type=chunk) [RISK FACTORS](index=60&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section details significant risks that could materially harm EyePoint Pharmaceuticals' business, operating results, and financial condition - The company's business, operating results, and financial condition could be **materially harmed** by various risks, including those related to financial position, regulatory approval, commercialization, intellectual property, reliance on third parties, and common stock ownership[220](index=220&type=chunk) [RISKS RELATED TO OUR FINANCIAL POSITION AND OUR CAPITAL RESOURCES](index=60&type=section&id=RISKS%20RELATED%20TO%20OUR%20FINANCIAL%20POSITION%20AND%20OUR%20CAPITAL%20RESOURCES) The company has a history of significant operating losses and will likely require additional capital, with potential limitations on net operating loss carryforwards - The company has incurred **significant losses since inception**, with an accumulated deficit of **$742.1 million** at December 31, 2023, and anticipates continued losses for the foreseeable future[222](index=222&type=chunk) - **Additional capital will likely be needed** to fund operations, especially for clinical development of EYP-1901 and EYP-2301; failure to obtain sufficient capital on favorable terms could force the company to delay or discontinue programs, seek unfavorable partnerships, or curtail operations[220](index=220&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk)[227](index=227&type=chunk)[229](index=229&type=chunk) - The company's ability to use its U.S. net operating loss (NOL) carryforwards (**$296.5 million federal, $254.7 million state** as of Dec 31, 2023) and tax credits may be limited by Section 382 ownership changes, potentially increasing future tax liabilities[231](index=231&type=chunk)[232](index=232&type=chunk)[233](index=233&type=chunk) [RISKS RELATED TO THE REGULATORY APPROVAL AND CLINICAL DEVELOPMENT OF OUR PRODUCT CANDIDATES](index=67&type=section&id=RISKS%20RELATED%20TO%20THE%20REGULATORY%20APPROVAL%20AND%20CLINICAL%20DEVELOPMENT%20OF%20OUR%20PRODUCT%20CANDIDATES) Clinical trials for product candidates are uncertain, expensive, and time-consuming, with potential for delays, termination, or failure to demonstrate safety and efficacy, impacting business success - Clinical trials are expensive, time-consuming, and uncertain, with potential for delays or termination due to factors like insufficient funding, regulatory disagreements, patient enrollment difficulties, adverse side effects, or manufacturing issues[234](index=234&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk)[237](index=237&type=chunk) - Clinical trial results may fail to support regulatory approval, and success in early-stage trials (Phase 1 or 2) does not guarantee success in later-stage pivotal trials; interim or preliminary data are subject to change and audit[238](index=238&type=chunk)[241](index=241&type=chunk)[244](index=244&type=chunk)[245](index=245&type=chunk) - The company is largely dependent on the clinical and future commercial success of its lead product candidate, EYP-1901, and adverse developments could have a significant impact[239](index=239&type=chunk)[251](index=251&type=chunk) [RISKS RELATED TO THE COMMERCIALIZATION OF OUR PRODUCTS AND PRODUCT CANDIDATES](index=74&type=section&id=RISKS%20RELATED%20TO%20THE%20COMMERCIALIZATION%20OF%20OUR%20PRODUCTS%20AND%20PRODUCT%20CANDIDATES) Commercial success depends on market acceptance, favorable pricing, and adequate reimbursement, with risks from unfavorable regulations, healthcare reform, competition, and non-compliance - Commercial success depends on **market acceptance** by physicians, patients, and third-party payors, which is influenced by efficacy, safety, convenience, cost, and reimbursement levels[251](index=251&type=chunk)[256](index=256&type=chunk)[257](index=257&type=chunk)[258](index=258&type=chunk) - Products may become subject to **unfavorable pricing regulations**, third-party reimbursement practices, or healthcare reform initiatives (e.g., ACA, IRA), which could limit sales, reduce revenue, and increase liabilities (e.g., Medicare drug price negotiation, inflation rebates, Part D changes)[260](index=260&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk)[263](index=263&type=chunk)[268](index=268&type=chunk)[274](index=274&type=chunk)[275](index=275&type=chunk)[296](index=296&type=chunk)[298](index=298&type=chunk)[300](index=300&type=chunk)[301](index=301&type=chunk)[302](index=302&type=chunk) - Failure to comply with reporting and payment obligations under government pricing programs (Medicaid Drug Rebate, 340B, VA/FSS) could result in **significant penalties, sanctions, and fines**; newly discovered safety problems with any product could seriously harm the business[271](index=271&type=chunk)[272](index=272&type=chunk)[273](index=273&type=chunk)[289](index=289&type=chunk) [RISKS RELATED TO OUR INTELLECTUAL PROPERTY](index=94&type=section&id=RISKS%20RELATED%20TO%20OUR%20INTELLECTUAL%20PROPERTY) The company's commercial success relies on protecting intellectual property, facing risks of patent invalidation, unenforceability, infringement, and changes in patent law - Commercial success depends on obtaining and maintaining patent and other **intellectual property protection** (trade secrets, trademarks) in the U.S. and other countries[315](index=315&type=chunk) - Patent prosecution is expensive, time-consuming, and uncertain; patents may not adequately protect technology, may be challenged (e.g., under AIA procedures like post-grant review or inter partes review), or may be found invalid, unenforceable, or not infringed[316](index=316&type=chunk)[317](index=317&type=chunk)[320](index=320&type=chunk)[322](index=322&type=chunk)[323](index=323&type=chunk)[337](index=337&type=chunk) - The company may become involved in expensive and time-consuming lawsuits to protect or enforce patents, or defend against infringement claims by third parties, which could result in substantial liabilities, loss of rights, or diversion of resources[324](index=324&type=chunk)[325](index=325&type=chunk)[331](index=331&type=chunk)[333](index=333&type=chunk)[334](index=334&type=chunk) [RISKS RELATED TO OUR RELIANCE ON THIRD PARTIES](index=103&type=section&id=RISKS%20RELATED%20TO%20OUR%20RELIANCE%20ON%20THIRD%20PARTIES) The company is highly dependent on third parties for intellectual property, API supply, clinical trial execution, and manufacturing, with potential for significant delays and costs from failures - The development and commercialization of EYP-1901 are dependent on intellectual property licensed from Equinox Science and API supply of vorolanib from third parties (Betta); **breach or termination of these agreements** could materially harm the business[346](index=346&type=chunk)[347](index=347&type=chunk) - Reliance on Contract Research Organizations (CROs), vendors, and investigators for preclinical testing and clinical trials means their failure to fulfill responsibilities or inadequate performance could **delay development efforts**[348](index=348&type=chunk)[349](index=349&type=chunk)[350](index=350&type=chunk) - Disruptions to manufacturing operations at the Watertown facility, delays in developing the Northbridge facility, or issues with Contract Manufacturing Organizations (CMOs) and suppliers for DEXYCU® could impair the ability to manufacture and supply products[351](index=351&type=chunk)[354](index=354&type=chunk)[355](index=355&type=chunk)[356](index=356&type=chunk) [RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK](index=109&type=section&id=RISKS%20RELATED%20TO%20OWNERSHIP%20OF%20OUR%20COMMON%20STOCK) The company's common stock price is highly volatile, influenced by clinical trial results and financial performance, with significant control by a small group of stockholders and potential future dilution - The trading price of the company's common stock has been **highly volatile**, influenced by clinical trial results, regulatory actions, competitive factors, financial results, and market conditions, potentially leading to substantial losses for investors[360](index=360&type=chunk)[361](index=361&type=chunk) - Approximately **ten stockholders beneficially own 65%** of the total outstanding common stock, giving them significant control over matters subject to stockholder approval, which could delay or prevent changes in control or influence corporate decisions[362](index=362&type=chunk) - Substantial future sales or other issuances of common stock, including through equity offerings or employee trading plans, could depress the market price and result in **significant dilution for existing stockholders**[363](index=363&type=chunk)[364](index=364&type=chunk)[365](index=365&type=chunk) [GENERAL RISK FACTORS](index=112&type=section&id=GENERAL%20RISK%20FACTORS) General risks include challenges in managing organizational growth, potential computer system failures, cyberattacks, and non-compliance with evolving data protection and privacy laws - The company will need to grow its organization, which may lead to difficulties in managing expansion, potentially resulting in weaknesses in infrastructure, operational mistakes, and diversion of financial resources[369](index=369&type=chunk) - Computer system failures, cyberattacks, or cybersecurity deficiencies could interrupt operations, lead to loss or misuse of confidential information, and result in regulatory actions, litigation, or reputational damage[370](index=370&type=chunk) - Failure to comply with evolving data protection laws and regulations (federal, state, and foreign like GDPR, CCPA) could lead to government enforcement actions, civil/criminal penalties, private litigation, adverse publicity, and increased compliance costs, particularly concerning cross-border data transfers[371](index=371&type=chunk)[374](index=374&type=chunk)[375](index=375&type=chunk)[376](index=376&type=chunk)[377](index=377&type=chunk)[378](index=378&type=chunk) [UNRESOLVED STAFF COMMENTS](index=116&type=section&id=ITEM%201B.%20UNRESOLVED%20STAFF%20COMMENTS) The company has no unresolved staff comments - There are no unresolved staff comments[381](index=381&type=chunk) [CYBERSECURITY](index=116&type=section&id=ITEM%201C.%20CYBERSECURITY) EyePoint Pharmaceuticals maintains a robust cybersecurity program, leveraging industry frameworks, with regular evaluations, audits, and employee training, overseen by the Audit Committee - The company maintains a robust cybersecurity program, leveraging industry frameworks like the NIST Cybersecurity Framework (CSF), with regular evaluations, internal/external audits, penetration tests, and incident response simulations[383](index=383&type=chunk) - A risk-based approach is used for third-party service providers, including vendor questionnaires and due diligence; cybersecurity training is required for all employees and contractors[384](index=384&type=chunk) - The Audit Committee oversees cybersecurity risk, receiving quarterly briefings from the SVP of IT on prevention, detection, mitigation, and remediation of threats; to date, no material cybersecurity incidents or threats have been experienced[388](index=388&type=chunk)[389](index=389&type=chunk) [PROPERTIES](index=118&type=section&id=ITEM%202.%20PROPERTIES) EyePoint Pharmaceuticals leases its headquarters in Watertown, MA, and is developing a new 40,000 sq ft GMP-compliant manufacturing facility in Northbridge, MA, expected to be operational in H2 2024 - The company's headquarters in Watertown, MA, includes leased office, laboratory, and manufacturing operations space, with the lease extended to **May 31, 2028**[390](index=390&type=chunk)[391](index=391&type=chunk) - A new **40,000-square-foot standalone manufacturing facility**, including office and lab space, is under lease agreement in Northbridge, MA, with a term of fifteen years and four months, expected to be operational in the **second half of 2024**[392](index=392&type=chunk) [LEGAL PROCEEDINGS](index=120&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The company is involved in routine legal proceedings and is cooperating with a U.S. Department of Justice subpoena regarding DEXYCU® sales and marketing practices - The company is subject to various routine legal proceedings and claims incidental to its business, which management believes will not have a material effect on its financial position, results of operations, or cash flows[394](index=394&type=chunk) - In August 2022, the company received a **subpoena from the U.S. Attorney's Office** for the District of Massachusetts (DOJ) seeking documents related to sales, marketing, and promotional practices, including for DEXYCU®[395](index=395&type=chunk) - The company is cooperating fully with the DOJ subpoena but is unable to predict its duration, scope, or outcome, or whether it could have a material impact on financial condition, results of operation, or cash flow[395](index=395&type=chunk) [MINE SAFETY DISCLOSURES](index=120&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the company - This item is not applicable[396](index=396&type=chunk) PART II [MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES](index=121&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT%27S%20COMMON%20EQUITY%2C%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) EyePoint Pharmaceuticals' common stock trades on the Nasdaq Global Market under "EYPT," with approximately 38 record holders as of February 29, 2024 - The company's common stock is traded on the Nasdaq Global Market under the symbol "**EYPT**"[399](index=399&type=chunk) - As of March 1, 2024, there were **49,830,792 shares of common stock outstanding**[7](index=7&type=chunk) - As of February 29, 2024, there were approximately **38 holders of record** of the company's common stock[399](index=399&type=chunk) [RESERVED]](index=121&type=section&id=ITEM%206.%20%5BRESERVED%5D) This item is reserved and contains no information - This item is reserved and contains no information[403](index=403&type=chunk) [MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=122&type=section&id=ITEM%207.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section discusses EyePoint Pharmaceuticals' financial condition and results for 2023 and 2022, covering revenue, expenses, net loss, and liquidity, reflecting its clinical-stage transition - The company is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapeutics for serious retinal diseases, leveraging its Durasert E™ technology[406](index=406&type=chunk) - The lead product candidate, EYP-1901, is in Phase 2 clinical trials for wet AMD, NPDR, and DME, with pivotal Phase 3 trials in wet AMD expected to initiate in the second half of 2024[406](index=406&type=chunk) - Fiscal year 2023 highlights include executive promotions, plans for a new manufacturing facility, out-licensing of YUTIQ® to Alimera for **$82.5 million** plus royalties, positive FDA inspection classification, and a public offering raising **$230.0 million**[407](index=407&type=chunk)[408](index=408&type=chunk) [Overview](index=122&type=section&id=Overview) EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapeutics for serious retinal diseases, leveraging its Durasert E™ technology - EyePoint Pharmaceuticals is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics for serious retinal diseases, leveraging its proprietary Durasert E™ technology[406](index=406&type=chunk) - The company's lead product candidate, EYP-1901, is an investigational sustained delivery treatment for anti-VEGF-mediated retinal diseases, combining vorolanib with Durasert E™, currently in Phase 2 clinical trials for wet AMD, NPDR, and DME[406](index=406&type=chunk) - Pivotal Phase 3 clinical trials in wet AMD are expected to initiate in the **second half of 2024**[406](index=406&type=chunk) [Fiscal 2023 Overview](index=122&type=section&id=Fiscal%202023%20Overview) Fiscal year 2023 was marked by strategic shifts and financial activities, including executive promotions, plans for a new manufacturing facility, the out-licensing of YUTIQ®, and a public offering - Jay S. Duker, M.D. was promoted to President and Chief Executive Officer in July 2023, and Nancy S. Lurker transitioned to Executive Vice Chair[407](index=407&type=chunk) - The company entered into a lease agreement to design and construct a **40,000-square-foot manufacturing facility** in Northbridge, Massachusetts[407](index=407&type=chunk) - YUTIQ® was exclusively licensed to Alimera Sciences, Inc. for **$75 million upfront cash payment**, **$7.5 million in 2024 quarterly installments**, and low-to-mid double-digit royalties on U.S. net sales from 2025-2028[407](index=407&type=chunk) [R&D Highlights](index=123&type=section&id=R%26D%20Highlights) Key R&D highlights for 2023 include completion of enrollment for Phase 2 DAVIO 2 and PAVIA trials, positive DAVIO 2 topline data, and advancement of EYP-2301 - Completed enrollment in Phase 2 DAVIO 2 (wet AMD) and PAVIA (NPDR) clinical trials for EYP-1901[409](index=409&type=chunk) - Announced **positive topline data for EYP-1901** from the Phase 2 DAVIO 2 clinical trial in wet AMD in December 2023[409](index=409&type=chunk) - Advanced pipeline program EYP-2301 into preclinical development and announced the first patient dosing in the Phase 2 VERONA clinical trial of EYP-1901 in DME in January 2024[409](index=409&type=chunk) [Recent Developments](index=123&type=section&id=Recent%20Developments) In early 2024, EyePoint Pharmaceuticals announced additional subgroup analyses from the Phase 2 DAVIO 2 clinical trial for wet AMD and appointed a new Chief Medical Officer - In February 2024, the company announced two presentations of topline data with additional subgroup analyses from the Phase 2 DAVIO 2 clinical trial of EYP-1901 for wet AMD[410](index=410&type=chunk) - In March 2024, Ramiro Ribeiro, M.D., Ph.D. was appointed as Chief Medical Officer[410](index=410&type=chunk) [Summary of Critical Accounting Policies and Estimates](index=123&type=section&id=Summary%20of%20Critical%20Accounting%20Policies%20and%20Estimates) The company's financial statements are prepared under U.S. GAAP, requiring significant estimates and judgments for revenue recognition, variable consideration reserves, and outsourced clinical trial expenses - The preparation of financial statements requires significant estimates, judgments, and assumptions, particularly for revenue recognition, variable consideration reserves, and expense recognition in outsourced clinical trial agreements[411](index=411&type=chunk)[412](index=412&type=chunk)[413](index=413&type=chunk) [Revenue Recognition](index=125&type=section&id=Revenue%20Recognition) Revenue is recognized following a five-step model under ASC 606, based on customer control of goods/services and expected consideration, including product sales, license/collaboration agreements, and royalties - Revenue is recognized when a customer obtains control of promised goods or services, in an amount reflecting the consideration expected, following the five-step model of ASC 606[414](index=414&type=chunk) - Product sales are recorded at wholesale acquisition costs, net of reserves for variable consideration (trade discounts, chargebacks, rebates, returns), which are based on best estimates and adjusted for variances[415](index=415&type=chunk)[416](index=416&type=chunk) - License and collaboration agreement revenue includes non-refundable upfront fees (recognized upon intellectual property delivery), milestone payments (recognized upon achievement of specified objectives), and royalties on product sales (recognized when sales occur)[417](index=417&type=chunk)[419](index=419&type=chunk)[423](index=423&type=chunk) [Deferred Revenue](index=127&type=section&id=Deferred%20Revenue) Amounts received before revenue recognition criteria are met are recorded as deferred revenue, classified as current or non-current based on expected recognition timing - Amounts received prior to satisfying revenue recognition criteria are recorded as deferred revenue on the consolidated balance sheets, classified as non-current if not expected to be recognized within one year[425](index=425&type=chunk) [Recognition of Expense in Outsourced Clinical Trial Agreements](index=127&type=section&id=Recognition%20of%20Expense%20in%20Outsourced%20Clinical%20Trial%20Agreements) Research and development expenses for outsourced clinical trials are recognized as services are provided, based on progress assessments, invoices, and internal tracking, with flexible financial obligations - Research and development expenses for outsourced clinical trials with CROs are recognized as services are provided, based on assessments of study progress, invoices, and internal tracking[427](index=427&type=chunk) - Financial obligations under these agreements are determined by requested services and depend on factors like patient enrollment, milestone achievement, and protocol changes; agreements can be terminated without penalty, with liability limited to services through the termination date[427](index=427&type=chunk) [Results of Operations](index=128&type=section&id=Results%20of%20Operations) For 2023, total revenues increased by 11% to $46.0 million, driven by license and collaboration revenue, while operating expenses decreased by 14%, leading to a reduced net loss of $70.8 million Consolidated Statements of Comprehensive Loss (Years Ended December 31, 2023 and 2022) | Metric (in thousands) | 2023 | 2022 | Change (Amount) | Change (%) | | :-------------------- | :--- | :--- | :-------------- | :--------- | | **Revenues:** | | | | | | Product sales, net | $14,232 | $39,905 | $(25,673) | -64% | | License and collaboration agreements | $30,797 | $362 | $30,435 | 8407% | | Royalty income | $989 | $1,137 | $(148) | -13% | | **Total revenues** | **$46,018** | **$41,404** | **$4,614** | **11%** | | **Operating expenses:** | | | | | | Cost of sales | $4,632 | $8,326 | $(3,694) | -44% | | Research and development | $64,662 | $49,642 | $15,020 | 30% | | Sales and marketing | $11,689 | $25,507 | $(13,818) | -54% | | General and administrative | $40,102 | $34,817 | $5,285 | 15% | | Amortization of acquired intangible assets | $0 | $2,050 | $(2,050) | -100% | | Impairment of acquired intangible assets | $0 | $20,699 | $(20,699) | -100% | | **Total operating expenses** | **$121,085** | **$141,041** | **$(19,956)** | **-14%** | | **Loss from operations** | **$(75,067)** | **$(99,637)** | **$24,570** | **-25%** | | **Net loss** | **$(70,795)** | **$(102,254)** | **$31,459** | **-31%** | | **Net loss per share (basic and diluted)** | **$(1.82)** | **$(2.74)** | **$0.92** | **-34%** | [Product Sales, net](index=128&type=section&id=Product%20Sales%2C%20net) Net product sales decreased by $25.7 million (64%) to $14.2 million in 2023, primarily due to the out-licensing of YUTIQ® and de minimis DEXYCU® sales - Net product sales decreased by **$25.7 million, or 64%**, to **$14.2 million** for 2023 compared to $39.9 million for the prior year[430](index=430&type=chunk) - The decrease was driven by the license and rights for YUTIQ® to Alimera in May 2023 and de minimis DEXYCU® sales in 2023 due to the loss of pass-through reimbursement as of January 1, 2023[430](index=430&type=chunk) [License and collaboration agreement](index=128&type=section&id=License%20and%20collaboration%20agreement) License and collaboration agreement revenues significantly increased by $30.4 million (8407%) to $30.8 million in 2023, primarily due to the Alimera license and supply agreement - License and collaboration agreement revenues increased by **$30.4 million, or 8407%**, to **$30.8 million** in 2023 compared to $0.4 million in 2022[432](index=432&type=chunk) - This increase was driven by revenue recognized as the combined performance obligations under the Alimera license and supply ag

EyePoint Pharmaceuticals (EYPT) reported $14.03 million in revenue for the quarter ended December 2023, representing a year-over-year increase of 33.2%. EPS of -$0.33 for the same period compares to -$0.61 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $8.71 million, representing a surprise of +61.00%. The company delivered an EPS surprise of +45.00%, with the consensus EPS estimate being -$0.60.While investors scrutinize revenue and earnings changes year-over-year and how they ...

– Announced positive topline efficacy and safety data from the Phase 2 DAVIO 2 trial of EYP-1901 in wet AMD achieving all primary and secondary endpoints; initiation of the first Phase 3 clinical trial expected in 2H 2024 – – Dosed first patient in Phase 2 VERONA clinical trial of EYP-1901 in DME; topline data expected in 1Q 2025 – – Phase 2 PAVIA clinical trial topline data of EYP-1901 in moderately severe-to-severe NPDR anticipated in 2Q 2024 – – Announced appointment of Ramiro Ribeiro, M.D., Ph.D. as Chi ...

The market expects EyePoint Pharmaceuticals (EYPT) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended December 2023. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report might help the stock move higher if these key numbers are better than expectations. On the other ...

Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it.The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the stock alive.Our " ...

WATERTOWN, Mass., Feb. 29, 2024 (GLOBE NEWSWIRE) --  EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, March 7, 2024 to report its fourth quarter and full-year 2023 financial results and highlight recent corporate developments. To access the live conference call, please register using the au ...