EyePoint Pharmaceuticals(EYPT)
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EyePoint Pharmaceuticals(EYPT) - 2023 Q2 - Quarterly Report
2023-08-03 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, 2023 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) - 2023 Q1 - Quarterly Report
2023-05-03 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, 2023 OR (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 480 Pleasant Street Watertown, MA (Address of principal executive offices) 26-2774444 (I.R.S. Employer Identification No.) 02472 (Zip Code) ☐ TRANSITION REPORT PURS ...
EyePoint Pharmaceuticals(EYPT) - 2022 Q4 - Annual Report
2023-03-09 16:00
Financial Performance - Product sales increased by $4.6 million, or 13%, to $39.9 million in 2022 compared to $35.3 million in 2021, driven by a return of customer demand as procedures resumed [457]. - License and collaboration agreement revenues decreased by $394,000, or 52%, to $362,000 in 2022, primarily due to reduced revenue from Ocumension for technical assistance [460]. - Royalty income increased by $266,000, or 31%, to $1.1 million in 2022, attributed to Ocumension royalties of $269,000 [461]. - The company recorded a total revenue of $41.4 million in 2022, an increase of $4.5 million, or 12%, from $36.9 million in 2021 [457]. - The net loss for 2022 was $102.3 million, compared to a net loss of $58.4 million in 2021, representing an increase of $43.8 million, or 75% [457]. - Total operating expenses increased by $48.8 million, or 53%, to $141.0 million in 2022, with significant contributions from impairment of acquired intangible assets [457]. - General and administrative expenses increased by $9.2 million, or 36%, to $34.8 million for 2022 from $25.6 million for the prior year [465]. - Research and development expenses rose by $21.1 million, or 74%, to $49.6 million in 2022, mainly due to personnel costs and increased clinical trial expenses [463]. Regulatory and Clinical Developments - The FDA has updated regulatory requirements for combination drug/device products, necessitating additional clinical trials for YUTIQ 50, leading to increased program costs and a pause in enrollment for the clinical trial [428]. - EYP-1901 is currently in Phase 2 clinical trials for wet AMD, with initial top-line data expected in the second half of 2023 [428]. - The twelve-month DAVIO Phase 1 clinical trial data for EYP-1901 showed a treatment burden reduction of 75% at six months and 73% at twelve months [428]. - YUTIQ 0.18mg was approved by China's CDE for the treatment of posterior segment uveitis in June 2022 [426]. Cash Flow and Financing - Cash, cash equivalents, and investments in marketable securities totaled $144.6 million as of December 31, 2022, expected to fund operations into the second half of 2024 [478]. - Operating cash outflows for the year ended December 31, 2022 totaled $65.0 million, primarily due to a net loss of $102.3 million [482]. - Net cash used in investing activities for 2022 was $17.3 million, compared to $33.1 million in 2021 [484]. - The company entered into a loan agreement with Silicon Valley Bank providing for a senior secured term loan facility of $30.0 million and a revolving credit facility of up to $15.0 million [472]. - The repayment of loans under the Credit Facilities is due on January 1, 2027, with interest rates based on the Wall Street Journal prime rate plus a margin [473]. - Net cash used in financing activities for fiscal 2022 totaled $690,000 [485]. - $38.2 million was used to pay off the CRG loan in fiscal 2022 [485]. Market and Operational Impact - The fiscal year ended December 31, 2022, was impacted by a reduction in physician office visits due to the ongoing pandemic, adversely affecting YUTIQ sales, particularly in early 2022 [426]. - Customer demand for YUTIQ in Q4 2022 increased by 11% compared to Q3 2022, while demand for DEXYCU decreased by 70% due to the loss of pass-through coverage by CMS [433]. - The company received a subpoena from the U.S. Attorney's Office regarding sales and marketing practices, which may have a material adverse effect on its business [428]. - Sales and marketing expenses decreased by $2.0 million, or 7%, to $25.5 million in 2022, mainly due to lower promotional activities for DEXYCU [464]. - Impairment of acquired intangible assets amounted to $20.7 million in Q4 2022, related to the DEXYCU technology [456]. Debt and Interest - Interest expense totaled $3.2 million for 2022, down from $5.5 million in 2021 due to a lower interest rate on the SVB Loan [467]. - Interest income from investments in marketable securities increased to $2.1 million for fiscal 2022 compared to $292,000 in the prior year [468]. - The total accumulated deficit reached $671.3 million as of December 31, 2022, with operations financed primarily through equity sales and debt issuance [470]. Company Structure and Reporting - The company does not have any off-balance sheet arrangements that would materially affect financial conditions [486]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [487].
Eyepoint Pharmaceuticals (EYPT) Investor Presentation - Slideshow
2022-12-12 14:17
EYEPOINT® PHARMACEUTICALS Investor Presentation November 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 limited to statements about our expecta ...
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
[Report Information](index=1&type=section&id=Report%20Information) - This is a Quarterly Report on Form 10-Q for the period ended June 30, 2022, filed by EyePoint Pharmaceuticals, Inc. (Trading Symbol: EYPT) with Commission File Number 000-51122[1](index=1&type=chunk)[2](index=2&type=chunk)[3](index=3&type=chunk) - The registrant is classified as a **Non-accelerated filer** and a **Smaller reporting company**[4](index=4&type=chunk)[5](index=5&type=chunk) - As of August 1, 2022, **34,071,899 shares** of common stock were outstanding[5](index=5&type=chunk) [PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Unaudited Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for periods ended June 30, 2022, and December 31, 2021, prepared in accordance with GAAP [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Metric | June 30, 2022 (in thousands of USD) | December 31, 2021 (in thousands of USD) | Change (in thousands of USD) | | :------------------------------------ | :----------------------------- | :------------------------------- | :-------------------- | | **Assets** | | | | | Cash and cash equivalents | $82,134 | $178,593 | $(96,459) | | Marketable securities | $89,033 | $32,965 | $56,068 | | Total current assets | $205,866 | $237,745 | $(31,879) | | Total assets | $233,433 | $263,372 | $(29,939) | | **Liabilities** | | | | | Total current liabilities | $33,390 | $23,658 | $9,732 | | Total liabilities | $82,067 | $78,992 | $3,075 | | **Stockholders' Equity** | | | | | Total stockholders' equity | $151,366 | $184,380 | $(33,014) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric | Three Months Ended June 30, 2022 (in thousands of USD) | Three Months Ended June 30, 2021 (in thousands of USD) | Six Months Ended June 30, 2022 (in thousands of USD) | Six Months Ended June 30, 2021 (in thousands of USD) | | :---------------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :------------------------------------------ | :------------------------------------------ | | Product sales, net | $11,318 | $8,738 | $20,328 | $15,540 | | Total revenues | $11,565 | $9,013 | $20,859 | $16,336 | | Total operating expenses | $30,781 | $19,992 | $58,360 | $38,250 | | Loss from operations | $(19,216) | $(10,979) | $(37,501) | $(21,914) | | Net loss | $(19,406) | $(10,010) | $(40,382) | $(22,290) | | Net loss per share - basic and diluted | $(0.52) | $(0.35) | $(1.08) | $(0.83) | | Comprehensive loss | $(19,592) | $(10,010) | $(40,621) | $(22,290) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) | Metric | Balance at April 1, 2022 (in thousands of USD) | Balance at June 30, 2022 (in thousands of USD) | Balance at January 1, 2022 (in thousands of USD) | Balance at June 30, 2022 (in thousands of USD) | | :------------------------------------ | :------------------------------------ | :------------------------------------ | :------------------------------------ | :------------------------------------ | | Common Stock Par Value Amount | $34 | $34 | $34 | $34 | | Additional Paid-In Capital | $756,070 | $760,209 | $752,602 | $760,209 | | Accumulated Deficit | $(590,073) | $(609,479) | $(569,097) | $(609,479) | | Total Stockholders' Equity | $166,819 | $151,366 | $184,380 | $151,366 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Metric | Six Months Ended June 30, 2022 (in thousands of USD) | Six Months Ended June 30, 2021 (in thousands of USD) | | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Net cash used in operating activities | $(39,281) | $(25,642) | | Net cash used in investing activities | $(56,454) | $(25) | | Net cash (used in) provided by financing activities | $(724) | $108,388 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $(96,459) | $82,721 | | Cash, cash equivalents and restricted cash at end of period | $82,284 | $127,780 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [Note 1. Operations](index=7&type=section&id=Note%201.%20Operations) - EyePoint Pharmaceuticals develops and commercializes innovative therapeutics for serious eye disorders using its proprietary Durasert® technology[23](index=23&type=chunk) - Commercial products include **YUTIQ®** for chronic non-infectious uveitis and **DEXYCU®** for postoperative inflammation, both sold in the U.S.[23](index=23&type=chunk) - As of June 30, 2022, the company held **$171.2 million** in cash, cash equivalents, and marketable securities, expected to fund operations for at least the next twelve months[26](index=26&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=8&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) - Revenue is recognized when customers obtain control of promised goods or services, reflecting expected consideration, following the five-step model under ASC 606[30](index=30&type=chunk) - Product sales (YUTIQ and DEXYCU) are recorded at wholesale acquisition costs, net of reserves for variable consideration including discounts, chargebacks, rebates, and returns[31](index=31&type=chunk)[32](index=32&type=chunk) - License and collaboration revenue is recognized based on agreement terms, with upfront payments upon IP delivery and sales-based milestones upon cumulative sales achievement[39](index=39&type=chunk)[41](index=41&type=chunk) [Note 3. Revenue](index=10&type=section&id=Note%203.%20Revenue) | Product | Three Months Ended June 30, 2022 (in thousands of USD) | Three Months Ended June 30, 2021 (in thousands of USD) | Six Months Ended June 30, 2022 (in thousands of USD) | Six Months Ended June 30, 2021 (in thousands of USD) | | :------ | :-------------------------------------------- | :-------------------------------------------- | :------------------------------------------ | :------------------------------------------ | | YUTIQ | $7,421 | $4,166 | $12,032 | $7,196 | | DEXYCU | $3,897 | $4,572 | $8,296 | $8,344 | | **Total Product Sales, net** | **$11,318** | **$8,738** | **$20,328** | **$15,540** | | Category | Beginning Balance Jan 1, 2022 (in thousands of USD) | Provision Current Year Sales (in thousands of USD) | Deductions/Payments Made (in thousands of USD) | Ending Balance June 30, 2022 (in thousands of USD) | | :------------------------------------ | :----------------------------------------- | :---------------------------------------- | :-------------------------------------- | :---------------------------------------- | | Chargebacks, Discounts and Fees | $1,153 | $6,580 | $(5,698) | $2,035 | | Government and Other Rebates | $1,821 | $3,554 | $(3,490) | $1,885 | | Returns | $379 | $329 | $(198) | $510 | | **Total** | **$3,353** | **$10,463** | **$(9,386)** | **$4,430** | - An Exclusive License Agreement with Betta Pharmaceuticals in May 2022 granted an exclusive, royalty-bearing license for **EYP-1901** in Greater China for tiered mid-to-high single-digit royalties on net sales[72](index=72&type=chunk)[73](index=73&type=chunk) [Note 4. Inventory](index=14&type=section&id=Note%204.%20Inventory) | Category | June 30, 2022 (in thousands of USD) | December 31, 2021 (in thousands of USD) | | :------------- | :--------------------------- | :------------------------------- | | Raw materials | $1,946 | $2,727 | | Work in process | $595 | $405 | | Finished goods | $713 | $484 | | **Total inventory** | **$3,254** | **$3,616** | [Note 5. Intangible Assets](index=14&type=section&id=Note%205.%20Intangible%20Assets) | Metric | June 30, 2022 (in thousands of USD) | June 30, 2021 (in thousands of USD) | | :------------------------------------ | :--------------------------- | :--------------------------- | | Patented technologies (Gross carrying amount) | $68,322 | $68,322 | | Accumulated amortization | $(46,803) | $(44,343) | | **Net book value** | **$21,519** | **$23,979** | - Amortization expense for intangible assets was **$615 thousand** for both three-month periods and **$1.2 million** for both six-month periods ended June 30, 2022 and 2021[78](index=78&type=chunk) [Note 6. Accrued Expenses](index=14&type=section&id=Note%206.%20Accrued%20Expenses) | Category | June 30, 2022 (in thousands of USD) | December 31, 2021 (in thousands of USD) | | :------------------------------------ | :--------------------------- | :------------------------------- | | Personnel costs | $4,881 | $7,321 | | Clinical trial costs | $2,243 | $753 | | Sales chargebacks, rebates and other revenue reserves | $3,920 | $2,974 | | Commissions due to DEXYCU commercial partner | $1,837 | $1,518 | | **Total accrued expenses** | **$14,312** | **$14,422** | [Note 7. Leases](index=15&type=section&id=Note%207.%20Leases) - The company amended its headquarters lease in March 2022, extending 13,650 square feet of lab/manufacturing space to May 2028 and adding 11,999 square feet of office space[83](index=83&type=chunk) - An out-of-period adjustment of **$2.9 million** increased lease liabilities and ROU assets due to the lease amendment, with no impact on operations or cash flows[84](index=84&type=chunk) | Category | June 30, 2022 (in thousands of USD) | December 31, 2021 (in thousands of USD) | | :---------------------------------------- | :--------------------------- | :------------------------------- | | Operating lease current portion | $301 | $645 | | Operating lease noncurrent portion | $4,826 | $1,860 | | **Total operating lease liabilities** | **$5,127** | **$2,505** | [Note 8. Loan Agreements](index=17&type=section&id=Note%208.%20Loan%20Agreements) - The company repaid the remaining **$41.4 million** CRG Loan balance on March 9, 2022, resulting in a **$1.6 million** loss on extinguishment of debt[98](index=98&type=chunk) - On March 9, 2022, a new SVB Loan Agreement was executed for a **$30.0 million** Term Facility and a **$15.0 million** Revolving Credit Facility, due January 1, 2027[99](index=99&type=chunk)[101](index=101&type=chunk) | Year | Amount (in thousands of USD) | | :--- | :-------------------- | | 2024 | $9,167 | | 2025 | $10,000 | | 2026 | $10,000 | | Thereafter | $833 | | **Total** | **$30,000** | [Note 9. Stockholders' Equity](index=19&type=section&id=Note%209.%20Stockholders'%20Equity) - In February 2021, the company sold **10,465,000 shares** of common stock in a public offering, generating approximately **$115.1 million** in gross proceeds[108](index=108&type=chunk) - No shares of common stock were sold under the ATM Facility during the three and six months ended June 30, 2022[110](index=110&type=chunk) | Metric | Number of Warrants | Weighted Average Exercise Price (USD) | | :------------------------------------ | :----------------- | :------------------------------ | | Balance and exercisable at June 30, 2022 | 48,683 | $12.33 | [Note 10. Share-Based Payment Awards](index=20&type=section&id=Note%2010.%20Share-Based%20Payment%20Awards) - As of June 30, 2022, approximately **82,000 shares** were available for new awards under the 2016 Long-Term Incentive Plan[114](index=114&type=chunk) | Metric | Number of Options | Weighted Average Exercise Price (USD) | | :------------------------------------ | :---------------- | :------------------------------ | | Outstanding at January 1, 2022 | 2,517,680 | $16.49 | | Granted | 1,643,300 | $10.43 | | Exercised | (4,223) | $9.44 | | Forfeited | (98,470) | $11.98 | | Expired | (6,000) | $21.00 | | **Outstanding at June 30, 2022** | **4,052,287** | **$14.14** | | Exercisable at June 30, 2022 | 1,306,830 | $19.82 | - Total stock-based compensation expense was **$4.14 million** for the three months and **$7.62 million** for the six months ended June 30, 2022, reflecting increased investment in new employees and organizational expansion[125](index=125&type=chunk)[166](index=166&type=chunk)[168](index=168&type=chunk)[179](index=179&type=chunk)[181](index=181&type=chunk) [Note 11. License and Asset Purchase Agreements](index=22&type=section&id=Note%2011.%20License%20and%20Asset%20Purchase%20Agreements) - The company holds an exclusive license with Equinox Sciences, LLC for vorolanib for local eye delivery, with potential milestone payments up to **$50 million** and tiered royalties[126](index=126&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk) - A May 2022 amendment expanded the license field to cover all ophthalmology indications using the company's proprietary localized delivery technologies[129](index=129&type=chunk) [Note 12. Fair Value Measurements](index=23&type=section&id=Note%2012.%20Fair%20Value%20Measurements) | Category | Carrying Value (in thousands of USD) | Fair Value (in thousands of USD) | Cash Equivalents (in thousands of USD) | Marketable Securities (in thousands of USD) | | :----------------------- | :---------------------------- | :------------------------ | :------------------------------ | :----------------------------------- | | **Level 1:** | | | | | | Money market funds | $62,178 | $62,178 | $62,178 | — | | **Level 2:** | | | | | | Commercial paper | $30,926 | $30,926 | $4,999 | $25,927 | | U.S. treasury securities | $63,345 | $63,106 | — | $63,106 | | **Total** | **$156,449** | **$156,210** | **$67,177** | **$89,033** | - As of June 30, 2022, most interest-bearing cash equivalent balances were concentrated in one U.S. Government institutional money market fund[134](index=134&type=chunk) [Note 13. Contingencies](index=24&type=section&id=Note%2013.%20Contingencies) - The company is subject to routine legal proceedings and claims, which management believes will not materially affect its financial position, results of operations, or cash flows[139](index=139&type=chunk) [Note 14. Net Loss per Share](index=24&type=section&id=Note%2014.%20Net%20Loss%20per%20Share) - Basic net loss per share is calculated by dividing net loss by weighted average common shares outstanding; potentially dilutive shares were excluded as anti-dilutive[140](index=140&type=chunk) | Category | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :------------------- | :----------------------------- | :----------------------------- | | Stock options | 4,052,287 | 2,099,810 | | ESPP | 18,394 | 10,793 | | Warrants | 48,683 | 48,683 | | Restricted stock units | 541,880 | 290,917 | | **Total** | **4,661,244** | **2,450,203** | [Note 15. Subsequent Events](index=24&type=section&id=Note%2015.%20Subsequent%20Events) - CMS published a Proposed Rule in July 2022, which, if finalized, would result in **DEXYCU** losing pass-through separate payment status on December 31, 2022, and being bundled into the general cataract procedure reimbursement code[142](index=142&type=chunk) - The anticipated loss of **DEXYCU's** pass-through status is expected to significantly reduce product revenues and result in a material impairment of the related **$21.5 million** intangible asset[142](index=142&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition and operations, including forward-looking statements, R&D, accounting policies, performance, and liquidity [Note Regarding Forward-Looking Statements](index=25&type=section&id=Note%20Regarding%20Forward-Looking%20Statements) - The report contains forward-looking statements regarding future activities, including **EYP-1901** expectations, clinical trial timing, COVID-19 impact, cash flow, manufacturing, IP, and future expenses[145](index=145&type=chunk) - Actual results may differ materially due to factors like Pandemic impact, clinical trial effectiveness, capital access, operating fluctuations, manufacturing success, commercial infrastructure, side effects, collaborations, competition, market acceptance, and IP protection[147](index=147&type=chunk)[149](index=149&type=chunk) [Our Business](index=26&type=section&id=Our%20Business) - EyePoint Pharmaceuticals develops and commercializes innovative therapeutics for serious eye disorders using its **Durasert®** technology for sustained intraocular drug delivery[152](index=152&type=chunk) - Key products include **EYP-1901** (investigational anti-VEGF for wet AMD), **YUTIQ®** (chronic non-infectious uveitis), and **DEXYCU®** (postoperative inflammation)[152](index=152&type=chunk) - Recent developments include CMS's intention to remove **DEXYCU's** pass-through reimbursement status, new board appointments, China's **YUTIQ** approval, and an exclusive license agreement with Betta Pharmaceuticals for **EYP-1901** in Greater China[153](index=153&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk) - R&D highlights include dosing the first patient in the Phase 2 **DAVIO2** clinical trial for **EYP-1901** (wet AMD), positive 12-month safety/efficacy data from Phase 1 **DAVIO** trial for **EYP-1901**, and pausing **YUTIQ 50** enrollment due to updated FDA requirements[156](index=156&type=chunk) [Critical Accounting Policies and Estimates](index=27&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - Financial statement preparation requires management estimates, judgments, and assumptions affecting reported amounts, particularly for revenue recognition, variable consideration reserves, and outsourced clinical trial agreements[157](index=157&type=chunk)[159](index=159&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) [Three Months Ended June 30, 2022 Compared to Three Months Ended June 30, 2021](index=28&type=section&id=Three%20Months%20Ended%20June%2030,%202022%20Compared%20to%20Three%20Months%20Ended%20June%2030,%202021) | Metric | 2022 (in thousands of USD) | 2021 (in thousands of USD) | Change (in thousands of USD) | % Change | | :---------------------------------------------------- | :------------------ | :------------------ | :-------------------- | :--------- | | Product sales, net | $11,318 | $8,738 | $2,580 | 30% | | License and collaboration agreements | $49 | $94 | $(45) | -48% | | Royalty income | $198 | $181 | $17 | 9% | | **Total revenues** | **$11,565** | **$9,013** | **$2,552** | **28%** | | Cost of sales, excluding amortization of acquired intangible assets | $1,734 | $1,929 | $(195) | -10% | | Research and development | $12,992 | $5,605 | $7,387 | 132% | | Sales and marketing | $6,883 | $6,659 | $224 | 3% | | General and administrative | $8,557 | $5,184 | $3,373 | 65% | | **Total operating expenses** | **$30,781** | **$19,992** | **$10,789** | **54%** | | **Loss from operations** | **$(19,216)** | **$(10,979)** | **$(8,237)** | **75%** | | Interest expense | $(552) | $(1,376) | $824 | -60% | | Gain (loss) on extinguishment of debt | — | $2,065 | $(2,065) | -100% | | **Net loss** | **$(19,406)** | **$(10,010)** | **$(9,396)** | **94%** | - Net product sales increased by **$2.6 million (30%)** to **$11.3 million** due to higher customer demand, while license and collaboration revenue decreased by **48%**[161](index=161&type=chunk)[162](index=162&type=chunk) - Research and development expenses surged by **$7.4 million (132%)** to **$13.0 million**, primarily due to increased personnel costs (**$3.6 million**, including **$1.7 million** stock-based compensation) and **EYP-1901** clinical costs[166](index=166&type=chunk) - General and administrative expenses increased by **$3.4 million (65%)** to **$8.6 million**, mainly due to personnel expense (**$2.3 million**, including **$1.0 million** stock-based compensation) for organizational expansion and higher consulting fees[168](index=168&type=chunk) [Six Months Ended June 30, 2022 Compared to Six Months Ended June 30, 2021](index=30&type=section&id=Six%20Months%20Ended%20June%2030,%202022%20Compared%20to%20Six%20Months%20Ended%20June%2030,%202021) | Metric | 2022 (in thousands of USD) | 2021 (in thousands of USD) | Change (in thousands of USD) | % Change | | :---------------------------------------------------- | :------------------ | :------------------ | :-------------------- | :--------- | | Product sales, net | $20,328 | $15,540 | $4,788 | 31% | | License and collaboration agreements | $108 | $435 | $(327) | -75% | | Royalty income | $423 | $361 | $62 | 17% | | **Total revenues** | **$20,859** | **$16,336** | **$4,523** | **28%** | | Cost of sales, excluding amortization of acquired intangible assets | $3,511 | $3,319 | $192 | 6% | | Research and development | $22,937 | $11,084 | $11,853 | 107% | | Sales and marketing | $13,576 | $12,318 | $1,258 | 10% | | General and administrative | $17,106 | $10,299 | $6,807 | 66% | | **Total operating expenses** | **$58,360** | **$38,250** | **$20,110** | **53%** | | **Loss from operations** | **$(37,501)** | **$(21,914)** | **$(15,587)** | **71%** | | Interest expense | $(1,745) | $(2,722) | $977 | -36% | | Gain (loss) on extinguishment of debt | $(1,559) | $2,065 | $(3,624) | -175% | | **Net loss** | **$(40,382)** | **$(22,290)** | **$(18,092)** | **81%** | - Net product sales increased by **$4.8 million (31%)** to **$20.3 million**, driven by increased cataract surgeries, ASC re-openings, and ongoing sales efforts[174](index=174&type=chunk) - Research and development expenses increased by **$11.9 million (107%)** to **$22.9 million**, primarily due to personnel costs (**$6.9 million**, including **$2.9 million** stock-based compensation) and increased **EYP-1901** clinical costs[179](index=179&type=chunk) - General and administrative expenses increased by **$6.8 million (66%)** to **$17.1 million**, mainly due to personnel expense (**$4.8 million**, including **$2.1 million** stock-based compensation) for organizational expansion, and higher consulting, legal, and facilities costs[181](index=181&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) - The company continues to experience operating losses, relying on equity sales and debt for financing, with an accumulated deficit of **$609.5 million** at June 30, 2022[185](index=185&type=chunk) - As of June 30, 2022, the company held **$171.2 million** in cash, cash equivalents, and marketable securities, projected to fund operations into the second half of 2024[193](index=193&type=chunk) - Future capital requirements are influenced by **EYP-1901** development, **YUTIQ** and **DEXYCU** commercialization costs, potential loss of **DEXYCU's** pass-through coverage, and the ongoing Pandemic impact[194](index=194&type=chunk)[197](index=197&type=chunk) | Metric | 2022 (in thousands of USD) | 2021 (in thousands of USD) | Change (in thousands of USD) | | :---------------------------------------------------- | :------------------ | :------------------ | :-------------------- | | Net cash used in operating activities | $(39,281) | $(25,642) | $(13,639) | | Net cash used in investing activities | $(56,454) | $(25) | $(56,429) | | Net cash (used in) provided by financing activities | $(724) | $108,388 | $(109,112) | [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, EyePoint Pharmaceuticals is not required to provide detailed market risk disclosures - The company is a **smaller reporting company** and is not required to provide quantitative and qualitative disclosures about market risk[205](index=205&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2022, with no material changes in internal control [Evaluation of Disclosure Controls and Procedures](index=34&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management concluded the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2022[206](index=206&type=chunk) [Changes in Internal Control over Financial Reporting](index=34&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - No material changes in internal control over financial reporting occurred or are reasonably likely to occur during the quarter ended June 30, 2022[207](index=207&type=chunk) [PART II: OTHER INFORMATION](index=35&type=section&id=PART%20II%3A%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in routine legal proceedings not expected to materially affect its financial position, results, or cash flows - The company is subject to routine legal proceedings and claims, which management believes will not materially affect its financial position, results of operations, or cash flows[210](index=210&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) Updates risk factors, highlighting adverse impacts from pricing, reimbursement, healthcare reform, and DEXYCU's pass-through status loss - The company's products may face unfavorable pricing regulations, third-party reimbursement practices, or healthcare reform, including the potential loss of **DEXYCU's** pass-through status, which could harm the business[212](index=212&type=chunk)[214](index=214&type=chunk) - If the CMS Proposed Rule is finalized, **DEXYCU** will lose pass-through separate payment status on December 31, 2022, leading to bundled payment rates, significantly reduced revenues, and a material adverse effect on financial condition[214](index=214&type=chunk) - Delays in obtaining coverage and profitable reimbursement for new drugs, along with mandatory discounts or rebates from government programs (Medicaid, Medicare Part B, 340B, VA FSS), could adversely affect operating results and capital raising[215](index=215&type=chunk)[216](index=216&type=chunk)[217](index=217&type=chunk)[218](index=218&type=chunk)[220](index=220&type=chunk)[224](index=224&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales or use of proceeds occurred during the reporting period - No unregistered sales of equity securities or use of proceeds to report[227](index=227&type=chunk) [Item 3. Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the reporting period - No defaults upon senior securities to report[228](index=228&type=chunk) [Item 4. Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) No mine safety disclosures are applicable or required for the company - No mine safety disclosures to report[229](index=229&type=chunk) [Item 5. Other Information](index=38&type=section&id=Item%205.%20Other%20Information) No other information is required to be disclosed under this item - No other information to report[231](index=231&type=chunk) [Item 6. Exhibits](index=39&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed with the Form 10-Q, including corporate governance, stock, license, and loan agreements - Exhibits include corporate governance documents (Certificate of Incorporation, By-Laws), stock-related documents (Specimen Stock Certificate, Warrants, Registration Rights Agreements), and key commercial agreements (Amendment 1 to Exclusive License Agreement with Equinox, Exclusive License Agreement with Betta Pharmaceuticals, First Amendment to Loan and Security Agreement with Silicon Valley Bank)[234](index=234&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk) [Signatures](index=41&type=section&id=Signatures) - The report was signed on August 5, 2022, by Nancy Lurker, President and CEO, and George O. Elston, CFO[242](index=242&type=chunk)
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 ...