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EyePoint Pharmaceuticals(EYPT) - 2022 Q3 - Quarterly Report
2022-11-03 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 EYPT The Nasdaq Stock Market LLC FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ CO ...
Eyepoint Pharmaceuticals (EYPT) Investor Presentation - Slideshow
2022-10-01 20:59
EYP-1901 Pipeline Program - EYP-1901 is a key pipeline program utilizing Durasert drug delivery technology[4] - Phase 2 "DAVIO 2" clinical trial in wet AMD is underway, and the NPDR "PAVIA" trial is expected to begin in September 2022[4] - Phase 1 "DAVIO" clinical trial demonstrated positive safety and efficacy data for EYP-1901[4] - EYP-1901 utilizes a bioerodible formulation of Durasert for sustained, zero-order kinetics drug release over 6-9 months[8] - In the DAVIO Phase 1 clinical trial, 53% of patients did not require supplemental anti-VEGF treatment at 6 months[18, 20] - The DAVIO Phase 1 clinical trial demonstrated a clinically significant reduction in treatment burden of 73% at 12 months[17] Financial Position - The company had $171 million in cash and investments as of June 30, 2022, providing a cash runway into the second half of 2024[5, 42] - Net product revenues in Q2 2022 were $11.3 million, a 30% increase over Q2 2021[42] - The commercial franchise is projected to break even in 2022[5, 42] YUTIQ Product - YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg is approved for the treatment of posterior segment uveitis[36] - Customer demand for YUTIQ increased by 43% in Q2 2022 compared to Q1 2022[41]
EyePoint Pharmaceuticals(EYPT) - 2022 Q2 - Quarterly Report
2022-08-04 16:00
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 June 30, 2022 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 jurisdi ...
EyePoint Pharmaceuticals(EYPT) - 2022 Q2 - Earnings Call Transcript
2022-08-03 19:05
Financial Data and Key Metrics Changes - Total net revenue for Q2 2022 was $11.6 million, an increase from $9 million in Q2 2021, representing a 30% growth [38] - Net product revenue for Q2 2022 was $11.3 million compared to $8.7 million in the prior year period [38] - Net loss for Q2 2022 was $19.4 million or $0.52 per share, compared to a net loss of $10 million or $0.35 per share in the prior year [40] Business Line Data and Key Metrics Changes - YUTIQ generated $7.4 million in revenue for Q2 2022, while DEXYCU contributed $3.9 million [32] - Customer demand for YUTIQ increased by approximately 40% from Q1 2022, with 900 units sold [32] - Customer demand for DEXYCU remained consistent with Q1 2022, with 14,700 units sold [32] Market Data and Key Metrics Changes - YUTIQ received approval for commercial use in China, marking a significant milestone for the company in expanding its global reach [14] - The company anticipates continued growth in customer demand for YUTIQ, particularly among retina specialists [33] Company Strategy and Development Direction - The company aims to become a leader in sustained ocular delivery, focusing on improving retinal treatment and bringing therapies to patients globally [17] - EYP-1901 is positioned as a maintenance therapy for wet AMD, with the goal of extending treatment intervals to up to six months [21] - The company is exploring additional indications for EYP-1901, including non-proliferative diabetic retinopathy (NPDR) [27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical trials and the potential of EYP-1901 to address significant unmet needs in ocular therapies [18][31] - The company is well-capitalized to fund operations into the second half of 2024, supporting ongoing clinical and commercial initiatives [40] Other Important Information - The company hosted its first Investor Day, showcasing its Durasert drug delivery platform and clinical results [13] - Two new Board appointments were made to strengthen the leadership team, including experts in ophthalmology and biopharmaceuticals [15][16] Q&A Session Summary Question: Will the company provide quarterly enrollment updates for the Phase 2 DAVIO 2 trial? - Management stated that they do not plan to provide such updates, as clinical trial enrollments can fluctuate significantly [44] Question: What are the powering assumptions for the DAVIO 2 trial? - Management indicated that specific statistics around DAVIO 2 have not been publicly announced yet, as the study is not powered to a high enough level for confidence [46] Question: What testing work led to the choice of 2 and 3 milligram doses for the diabetic retinopathy study? - The decision was based on the highest doses used in the DAVIO trial, as the maximally tolerated dose has not been established [52] Question: When will the company know about the CMS pass-through decision for DEXYCU? - The final rules are expected to be released in November, which will clarify the pass-through status [55] Question: Are there other molecules being explored for potential partnerships? - The company is looking at various molecules, including complement inhibitors, and is interested in partnering with companies that have proven mechanisms of action [67][70]
Eyepoint Pharmaceuticals (EYPT) Investor Presentation - Slideshow
2022-05-07 14:07
1 | EYEPOINT PHARMACEUTICALS Delivering Innovation to the Eye Investor Presentation March 2022 Forward Looking Statements Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, including but not limite ...
EyePoint Pharmaceuticals(EYPT) - 2022 Q1 - Quarterly Report
2022-05-05 16:00
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, 2022 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 jurisdiction of incorp ...
EyePoint Pharmaceuticals(EYPT) - 2021 Q4 - Annual Report
2022-03-13 16:00
Part I [Business](index=7&type=section&id=ITEM%201.%20BUSINESS) EyePoint Pharmaceuticals develops and commercializes eye disorder therapeutics using Durasert® technology, with lead candidate EYP-1901 and commercial products YUTIQ® and DEXYCU®, though COVID-19 has impacted revenues [Overview and Strategy](index=7&type=section&id=Overview%20and%20Strategy) The company's strategy focuses on advancing pipeline candidates EYP-1901 and YUTIQ 50, growing commercial product revenues, and leveraging its Durasert and Verisome technologies - Key strategic elements include: - Advancing EYP-1901 through clinical development for wet AMD, DR, and RVO - Advancing YUTIQ 50 for chronic non-infectious uveitis - Growing commercial revenues for YUTIQ and DEXYCU in the U.S - Leveraging Durasert and Verisome technologies through collaborations and out-licenses[34](index=34&type=chunk) [Our Pipeline and Commercial Products](index=8&type=section&id=Our%20Pipeline%20and%20Commercial%20Products) The company's portfolio features lead candidate EYP-1901 in Phase 1/2, commercial products YUTIQ and DEXYCU, and YUTIQ 50 in Phase 3, all leveraging Durasert technology Product and Pipeline Status | Program | Indication | Stage | | :--- | :--- | :--- | | **Pipeline** | | | | EYP-1901 | Wet AMD | Phase 1/2 | | EYP-1901 | Diabetic Retinopathy (DR) | Preclinical | | EYP-1901 | Retinal Vein Occlusion (RVO) | Preclinical | | YUTIQ 50 | Posterior Segment Uveitis | Phase 3 | | **Commercial** | | | | YUTIQ® | Posterior Segment Uveitis | Approved | | DEXYCU® | Post-Operative Inflammation | Approved | - EYP-1901, the lead product candidate, combines the bioerodible Durasert technology with vorolanib, a TKI, for a potential **six-month** sustained delivery treatment for wet AMD. Positive interim **six-month** data from the Phase 1 DAVIO trial was reported in November 2021, with a Phase 2 trial anticipated to start in Q3 2022[26](index=26&type=chunk)[43](index=43&type=chunk)[59](index=59&type=chunk) - YUTIQ is a **three-year** implant for chronic non-infectious uveitis, while DEXYCU is a single-dose treatment for post-operative inflammation. Effective January 1, 2022, commercial partner ImprimisRx assumed all sales and marketing for DEXYCU[27](index=27&type=chunk)[28](index=28&type=chunk)[81](index=81&type=chunk) [Manufacturing, Sales, and Distribution](index=14&type=section&id=Manufacturing%2C%20Sales%2C%20and%20Distribution) The company manufactures YUTIQ in-house and outsources DEXYCU production, utilizing Key Account Managers for YUTIQ and a partnership with ImprimisRx for DEXYCU sales and distribution - YUTIQ is manufactured in-house at the company's Watertown, MA facility, while DEXYCU manufacturing is outsourced to a contract manufacturing organization (CMO)[88](index=88&type=chunk)[89](index=89&type=chunk) - As of February 28, 2022, **19** Key Account Managers sell YUTIQ. Effective January 1, 2022, ImprimisRx assumed all sales and marketing responsibilities for DEXYCU in the U.S[91](index=91&type=chunk) - Both YUTIQ and DEXYCU have been granted permanent J-codes by CMS for reimbursement. DEXYCU's pass-through status, which provides for separate reimbursement, was extended through **December 31, 2022**[82](index=82&type=chunk)[95](index=95&type=chunk) [Intellectual Property and Competition](index=16&type=section&id=Intellectual%20Property%20and%20Competition) The company protects its technology with patents for YUTIQ (2027), DEXYCU (2034), and EYP-1901 (2037-2041), operating in a highly competitive eye disease treatment market Key Product Patent Expirations | Product/Candidate | U.S. Patent Expiration | | :--- | :--- | | YUTIQ® | At least August 2027 | | DEXYCU® | At least 2034 | | EYP-1901 (vorolanib compound) | September 2037 | | EYP-1901 (product) | Potentially until 2041 (if application issues) | - Competition in the wet AMD space includes established anti-VEGF biologics like EYLEA and LUCENTIS, as well as newer long-acting treatments and delivery systems from companies like Kodiak Sciences, Graybug Vision, and REGENXBIO[116](index=116&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk) - Competitors for YUTIQ in posterior segment uveitis include Allergan's OZURDEX® and AbbVie's HUMIRA®. DEXYCU competes with topical treatments like Kala Pharmaceuticals' INVELTYS™ and Ocular Therapeutix's DEXTENZA®[123](index=123&type=chunk)[124](index=124&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) [Government Regulation](index=19&type=section&id=Government%20Regulation) The company faces extensive FDA regulation across product development and post-market activities, alongside complex healthcare laws, pricing programs, fraud and abuse statutes, and data privacy regulations - The FDA drug approval process requires extensive pre-clinical and clinical trials (Phase 1, 2, and 3) to demonstrate safety and efficacy before an NDA can be submitted and approved[134](index=134&type=chunk)[136](index=136&type=chunk)[139](index=139&type=chunk) - Post-approval, the company must adhere to cGMP for manufacturing, QSR for drug-device combination products, and strict regulations on advertising and promotion[153](index=153&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk) - Sales and reimbursement are significantly impacted by U.S. healthcare reform (ACA) and government pricing programs, including the Medicaid Drug Rebate Program and the 340B drug pricing program, which require substantial discounts and rebates[184](index=184&type=chunk)[194](index=194&type=chunk)[195](index=195&type=chunk) - The company's relationships with healthcare providers and payors are governed by federal and state anti-kickback, fraud, and abuse laws, as well as data privacy laws like HIPAA in the U.S. and GDPR in the EU[219](index=219&type=chunk)[222](index=222&type=chunk)[231](index=231&type=chunk) - The company's core business revolves around its proprietary Durasert® technology for sustained intraocular drug delivery, with two commercial products (YUTIQ®, DEXYCU®) and a lead pipeline candidate (EYP-1901)[23](index=23&type=chunk)[24](index=24&type=chunk) - The COVID-19 pandemic has had a material adverse impact on the business, significantly affecting cash flows from revenues due to the reduction in physician office visits for YUTIQ and the closure of ambulatory surgery centers for DEXYCU[31](index=31&type=chunk)[33](index=33&type=chunk) [Risk Factors](index=33&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces significant risks including financial losses, capital needs, clinical trial uncertainties for EYP-1901, commercialization challenges for YUTIQ and DEXYCU, intellectual property protection, and reliance on third-party partners [Risks Related To Our Financial Position and our Capital Resources](index=33&type=section&id=Risks%20Related%20To%20Our%20Financial%20Position%20and%20our%20Capital%20Resources) The company faces ongoing losses, requires additional capital, is impacted by COVID-19, and must comply with credit facility covenants and manage DEXYCU acquisition payment obligations - The company has a history of significant losses, with a net loss of **$58.4 million** in 2021 and an accumulated deficit of **$569.1 million** as of December 31, 2021[240](index=240&type=chunk) - Cash, cash equivalents, and investments of **$211.6 million** at year-end 2021, along with product sales, are expected to fund operations into the **second half of 2024**. However, the company will likely need to raise additional capital[237](index=237&type=chunk) - The company entered into a new loan agreement with Silicon Valley Bank in March 2022 which contains financial covenants, including minimum product revenue levels for YUTIQ and DEXYCU or a minimum cash balance[253](index=253&type=chunk)[256](index=256&type=chunk) [Risks Related To The Regulatory Approval And Clinical Development Of Our Product Candidates](index=39&type=section&id=Risks%20Related%20To%20The%20Regulatory%20Approval%20And%20Clinical%20Development%20Of%20Our%20Product%20Candidates) The company's success hinges on early-stage EYP-1901 development, facing inherent clinical trial uncertainties, potential delays, and risks of failing to demonstrate safety and efficacy - The company's success is highly dependent on its lead product candidate, EYP-1901, which is still in the early stages of development and faces the significant risks and uncertainties of clinical trials[275](index=275&type=chunk)[296](index=296&type=chunk) - Clinical trials are subject to numerous risks that can cause delays or failure, including difficulty enrolling patients, adverse side effects, and failure to demonstrate safety and efficacy[277](index=277&type=chunk)[291](index=291&type=chunk) - Success in early-stage clinical trials does not ensure success in later-stage trials, and data is subject to varying interpretations by regulatory authorities like the FDA[285](index=285&type=chunk)[288](index=288&type=chunk) [Risks Related To The Commercialization Of Our Products And Product Candidates](index=42&type=section&id=Risks%20Related%20To%20The%20Commercialization%20Of%20Our%20Products%20And%20Product%20Candidates) Commercial success for YUTIQ and DEXYCU is uncertain due to market acceptance, reimbursement challenges (especially DEXYCU's pass-through status), intense competition, and regulatory risks - A critical risk for DEXYCU is the potential loss of its Medicare Part B pass-through status after **December 31, 2022**. If payment for DEXYCU becomes bundled with the cataract procedure, it would materially decrease revenues[305](index=305&type=chunk)[316](index=316&type=chunk) - The company must comply with complex government pricing programs (Medicaid, 340B). Failure to comply with reporting and payment obligations could lead to significant penalties, sanctions, and fines[317](index=317&type=chunk)[321](index=321&type=chunk) - The company faces extensive ongoing FDA regulatory requirements for its approved products, including post-approval studies for DEXYCU under the Pediatric Research Equity Act (PREA)[323](index=323&type=chunk)[324](index=324&type=chunk) [Risks Related To Our Intellectual Property](index=52&type=section&id=Risks%20Related%20To%20Our%20Intellectual%20Property) Commercial success relies on robust intellectual property protection, but the patent process is uncertain, vulnerable to challenges, and may lead to costly infringement litigation - The company's ability to protect its products from competition is highly dependent on obtaining and maintaining patent protection, which is an uncertain, complex, and expensive process[368](index=368&type=chunk)[371](index=371&type=chunk) - The company may face lawsuits from third parties alleging patent infringement, which could be costly and force the company to cease commercialization or obtain licenses on unfavorable terms[387](index=387&type=chunk)[390](index=390&type=chunk) - Changes in U.S. or foreign patent law, such as the America Invents Act (AIA), could weaken the company's ability to enforce its patents[395](index=395&type=chunk)[396](index=396&type=chunk) [Risks Related To Our Reliance On Third Parties](index=57&type=section&id=Risks%20Related%20To%20Our%20Reliance%20On%20Third%20Parties) The company heavily relies on third parties for EYP-1901 development (Equinox), DEXYCU commercialization (ImprimisRx), and manufacturing/clinical trials, posing significant operational risks - The development and commercialization of EYP-1901 depend on a license and API supply agreement with Equinox Science. Termination of this agreement would materially harm the business[412](index=412&type=chunk)[414](index=414&type=chunk) - The company relies on its commercial alliance partner, ImprimisRx, for all sales and marketing of DEXYCU. Any failure in this partnership could materially reduce DEXYCU sales[415](index=415&type=chunk)[418](index=418&type=chunk) - The company depends on contract manufacturing organizations (CMOs) for DEXYCU supply and contract research organizations (CROs) for clinical trials. Issues with these third parties could impair supply and delay development[419](index=419&type=chunk)[434](index=434&type=chunk) [Properties](index=66&type=section&id=ITEM%202.%20PROPERTIES) The company leases its primary 21,649 sq ft Watertown, MA facility for office, lab, and manufacturing, with an extended lease to 2028 and planned expansion - The company's principal facility is leased space in Watertown, MA, which includes office, lab, and manufacturing operations. The lease was recently amended to extend the term to 2028 and expand the office space[474](index=474&type=chunk) [Legal Proceedings](index=66&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The SEC concluded its investigation into the company on May 4, 2021, and does not intend to recommend an enforcement action - On May 4, 2021, the SEC Division of Enforcement concluded its investigation and does not intend to recommend an enforcement action against the company[478](index=478&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=67&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT%27S%20COMMON%20EQUITY%2C%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's common stock trades on the Nasdaq Global Market under "EYPT", with approximately 76 holders of record as of March 4, 2022 - The company's common stock trades on the Nasdaq Global Market under the symbol "EYPT"[482](index=482&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=68&type=section&id=ITEM%207.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) In 2021, net product sales grew **70%** to **$35.3 million**, but total revenues increased only **7%** to **$36.9 million** due to lower collaboration revenue, resulting in a **$58.4 million** net loss Results of Operations (2021 vs. 2020) | Metric | 2021 (in thousands) | 2020 (in thousands) | Change (%) | | :--- | :--- | :--- | :--- | | **Product sales, net** | $35,312 | $20,831 | 70% | | **Total revenues** | $36,939 | $34,437 | 7% | | Research and development | $28,500 | $17,424 | 64% | | Total operating expenses | $92,215 | $71,727 | 29% | | **Loss from operations** | ($55,276) | ($37,290) | 48% | | **Net loss** | ($58,417) | ($45,394) | (29)% | - Net product sales increased by **$14.5 million (70%)** in 2021, driven by a return of customer demand for YUTIQ and DEXYCU as pandemic-related restrictions eased[523](index=523&type=chunk) - Research and development expenses increased by **$11.1 million (64%)** in 2021, primarily due to clinical costs for the EYP-1901 Phase 1 trial and the YUTIQ 50 Phase 3 trial, as well as increased personnel expenses[528](index=528&type=chunk) - The company ended 2021 with **$211.6 million** in cash, cash equivalents, and marketable securities, which is expected to fund operations into the **second half of 2024**[543](index=543&type=chunk) [Controls and Procedures](index=78&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls and procedures, along with internal control over financial reporting, were effective at a reasonable assurance level as of December 31, 2021 - Management concluded that as of December 31, 2021, the company's disclosure controls and procedures were effective at the reasonable assurance level[559](index=559&type=chunk) - Based on an assessment using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2021[562](index=562&type=chunk) [Other Information](index=78&type=section&id=ITEM%209B.%20OTHER%20INFORMATION) On March 9, 2022, the company refinanced its debt with a new **$45 million** credit facility from Silicon Valley Bank and amended its Watertown, MA lease to extend the term and expand space - On March 9, 2022, the company refinanced its debt by entering into a new **$45 million** credit facility with Silicon Valley Bank and terminating its previous agreement with CRG Servicing LLC[564](index=564&type=chunk)[577](index=577&type=chunk) - On March 8, 2022, the company amended its Watertown, MA lease to extend the term to **May 31, 2028** for its lab/manufacturing space and to rent an additional **11,999 square feet** of office space[579](index=579&type=chunk) Part III [Directors, Executive Officers, and Corporate Governance](index=81&type=section&id=ITEM%2010.%20DIRECTORS%2C%20EXECUTIVE%20OFFICERS%2C%20AND%20CORPORATE%20GOVERNANCE) Information on directors, executive officers, and corporate governance is incorporated by reference from the company's 2022 annual meeting proxy statement [Executive Compensation](index=81&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) Executive compensation information is incorporated by reference from the company's 2022 Proxy Statement [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=81&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) Security ownership and related stockholder matters information is incorporated by reference from the company's 2022 Proxy Statement [Certain Relationships and Related Transactions, and Director Independence](index=81&type=section&id=ITEM%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS%2C%20AND%20DIRECTOR%20INDEPENDENCE) Information on certain relationships, related transactions, and director independence is incorporated by reference from the company's 2022 Proxy Statement [Principal Accounting Fees and Services](index=81&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTING%20FEES%20AND%20SERVICES) Principal accounting fees and services information is incorporated by reference from the company's 2022 Proxy Statement Part IV [Exhibits and Financial Statement Schedules](index=82&type=section&id=ITEM%2015.%20EXHIBITS%20AND%20FINANCIAL%20STATEMENT%20SCHEDULES) This section presents the audited consolidated financial statements for 2021 and 2020, with Deloitte & Touche LLP identifying estimation of clinical trial expenses as a critical audit matter Consolidated Balance Sheet Highlights (as of Dec 31, 2021) | Account | Amount (in thousands) | | :--- | :--- | | Cash, cash equivalents, and marketable securities | $211,558 | | Total Assets | $263,372 | | Long-term debt | $36,562 | | Total Liabilities | $78,992 | | Total Stockholders' Equity | $184,380 | Consolidated Statement of Cash Flows Highlights (Year ended Dec 31, 2021) | Cash Flow Activity | Amount (in thousands) | | :--- | :--- | | Net cash used in operating activities | ($50,097) | | Net cash used in investing activities | ($33,121) | | Net cash provided by financing activities | $216,902 | - The independent auditor, Deloitte & Touche LLP, identified prepaid and accrued clinical trial expenses as a critical audit matter due to the significant management judgment required to estimate the stage of completion and costs incurred for research activities[621](index=621&type=chunk)[622](index=622&type=chunk)
EyePoint Pharmaceuticals(EYPT) - 2021 Q3 - Earnings Call Transcript
2021-11-03 16:27
EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT) Q3 2021 Earnings Conference Call November 3, 2021 8:30 AM ET Company Participants George O. Elston - CFO & Head, Corporate Development Nancy Lurker - President & CEO Jay Duker - COO Scott Jones - Chief Commercial Officer Conference Call Participants Unidentified Analyst - Cowen and Company Jennifer Kim - Cantor Fitzgerald Yatin Suneja - Guggenheim Partners Yale Jen - Laidlaw & Company Yi Chen - H.C. Wainwright Operator Good day and thank you for standing by. Welc ...
EyePoint Pharmaceuticals(EYPT) - 2021 Q2 - Quarterly Report
2021-08-05 16:00
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 June 30, 2021 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 jurisdiction of incorpo ...
EyePoint Pharmaceuticals(EYPT) - 2021 Q1 - Earnings Call Transcript
2021-05-05 17:33
Financial Data and Key Metrics Changes - For Q1 2021, total net revenue was $7.3 million, a decrease from $7.5 million in Q1 2020. Net product revenue was $6.8 million, up 45% from $4.7 million in Q1 2020 [20][21] - The net loss for Q1 2021 was $12.3 million, or $0.50 per share, compared to a net loss of $13.2 million, or $1.14 per share, in the prior year [21] - Cash and cash equivalents at March 31, 2021, totaled $138.6 million, significantly up from $44.9 million at December 31, 2020 [21] Business Line Data and Key Metrics Changes - Net product revenue for YUTIQ was $3.8 million and for DEXYCU was $3 million in Q1 2021, with customer demand for DEXYCU at approximately 7,000 units and for YUTIQ at 400 units [16] - The introduction of a new siliconized needle for YUTIQ is expected to enhance patient and physician experience [8][17] Market Data and Key Metrics Changes - The company reported a strong first quarter despite the ongoing challenges of the COVID-19 pandemic, with a 45% increase in net product revenues compared to the previous year [8][15] - The Asia partner, Ocumension Therapeutics, received approval for review of a new drug application for YUTIQ in China, indicating potential for future revenue streams [9] Company Strategy and Development Direction - The company aims to expand its product pipeline and drive growth for its commercial products, targeting profitability for DEXYCU and YUTIQ by year-end [9][18] - Plans to initiate studies for EYP-1901 in diabetic retinopathy and retinal vein occlusion are underway, with hopes to start these studies in late 2021 or early 2022 [7][14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth of the Wet AMD market due to the aging population and the need for innovative treatment options [24] - The company remains focused on maintaining a strong balance sheet and disciplined spending to support its growth initiatives [9][21] Other Important Information - The company successfully completed a $115.1 million follow-on offering to strengthen its balance sheet [7] - The revenue covenant with CRG was reduced to $25 million at no cost, reflecting improved financial conditions [8][20] Q&A Session Summary Question: How will the Wet AMD space evolve over the next 5 to 10 years? - Management believes the demand will continue to grow due to the aging population and the prevalence of the disease, with a place for innovative drugs like EYP-1901 [24][25] Question: What are the opportunities in other retinal indications? - The company is evaluating studies in diabetic retinopathy and retinal vein occlusion, which are large patient populations [28] Question: Can you provide spending guidance for the year? - Q1 spending is a good run rate, with expectations for continued investment in clinical trials [30][31] Question: What is the status of the SEC investigation? - The SEC concluded its investigation with no intent to recommend enforcement action, which the company views positively [36][37] Question: What trends are seen in retinal specialists and ASCs? - Most cataract surgery centers are returning to normal, though some academic centers still face restrictions [38] Question: What is the expected efficacy of EYP-1901 compared to existing treatments? - Management believes that extended delivery could lead to better patient outcomes, although long-term studies are needed to confirm this [56]