$EYPT
EyePoint Pharmaceuticals, Inc.

2020 Q3 Form 10-Q Financial Statement

#000156459020051654 Filed on November 06, 2020

View on sec.gov

Income Statement

Concept 2020 Q3 2019 Q3 2019 Q2
Revenue $15.70M $2.509M $7.210M
YoY Change 525.75% 416.26% 908.39%
Cost Of Revenue $1.880M $330.0K $706.0K
YoY Change 469.7%
Gross Profit $13.81M $2.180M $6.504M
YoY Change 533.49% 809.65%
Gross Profit Margin 87.96% 86.89% 90.21%
Selling, General & Admin $11.07M $12.14M $12.10M
YoY Change -8.84% 55.54% 111.08%
% of Gross Profit 80.16% 557.02% 186.02%
Research & Development $4.090M $3.484M $3.955M
YoY Change 17.39% -44.1% -17.0%
% of Gross Profit 29.62% 159.82% 60.81%
Depreciation & Amortization $670.0K $650.0K $650.0K
YoY Change 3.08% 1411.63% 0.0%
% of Gross Profit 4.85% 29.82% 9.99%
Operating Expenses $15.77M $16.57M $17.38M
YoY Change -4.82% 18.01% 65.52%
Operating Profit -$1.960M -$14.06M -$10.17M
YoY Change -86.06% 3.73% 3.92%
Interest Expense -$1.840M $1.770M $1.599M
YoY Change -203.95% 117.18% 122.08%
% of Operating Profit
Other Income/Expense, Net -$1.587M -$1.333M
YoY Change -91.89% -94.59%
Pretax Income -$3.800M -$15.65M -$11.50M
YoY Change -75.72% -52.76% -66.6%
Income Tax
% Of Pretax Income
Net Earnings -$3.801M -$15.65M -$11.50M
YoY Change -75.71% -52.77% -66.6%
Net Earnings / Revenue -24.21% -623.63% -159.47%
Basic Earnings Per Share
Diluted Earnings Per Share -$297.1K -$1.464M -$1.083M
COMMON SHARES
Basic Shares Outstanding 106.3M 106.1M
Diluted Shares Outstanding

Balance Sheet

Concept 2020 Q3 2019 Q3 2019 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $28.70M $31.80M $44.20M
YoY Change -9.75% -43.01% 13.92%
Cash & Equivalents $28.70M $31.76M $44.16M
Short-Term Investments
Other Short-Term Assets $5.800M $3.900M $3.100M
YoY Change 48.72% 178.57% 287.5%
Inventory $3.642M $2.559M $1.670M
Prepaid Expenses
Receivables $9.400M $8.900M $9.600M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $47.60M $47.06M $58.57M
YoY Change 1.15% -18.36% 46.77%
LONG-TERM ASSETS
Property, Plant & Equipment $3.200M $386.0K $417.0K
YoY Change 729.02% 20.63% 64.82%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $200.0K $200.0K $200.0K
YoY Change 0.0% 0.0% 0.0%
Total Long-Term Assets $29.20M $32.01M $32.76M
YoY Change -8.77% 2.54% 3.14%
TOTAL ASSETS
Total Short-Term Assets $47.60M $47.06M $58.57M
Total Long-Term Assets $29.20M $32.01M $32.76M
Total Assets $76.80M $79.07M $91.33M
YoY Change -2.87% -11.02% 27.43%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $5.200M $5.461M $6.066M
YoY Change -4.78% 34.01% 106.33%
Accrued Expenses $6.845M $4.446M $4.214M
YoY Change 53.96% 32.99% 13.19%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $100.0K
YoY Change
Total Short-Term Liabilities $12.90M $10.37M $10.72M
YoY Change 24.42% -53.75% -50.51%
LONG-TERM LIABILITIES
Long-Term Debt $50.80M $46.73M $46.25M
YoY Change 8.7% 167.61% 167.2%
Other Long-Term Liabilities $5.500M $3.000M $3.000M
YoY Change 83.33% 136.41% 143.7%
Total Long-Term Liabilities $56.30M $49.73M $49.25M
YoY Change 13.2% 165.5% 165.64%
TOTAL LIABILITIES
Total Short-Term Liabilities $12.90M $10.37M $10.72M
Total Long-Term Liabilities $56.30M $49.73M $49.25M
Total Liabilities $69.20M $63.13M $63.12M
YoY Change 9.62% 53.41% 5.23%
SHAREHOLDERS EQUITY
Retained Earnings -$454.9M -$439.2M
YoY Change 14.61% 20.67%
Common Stock $470.0M $466.6M
YoY Change 5.91% 24.48%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $7.594M $15.94M $28.21M
YoY Change
Total Liabilities & Shareholders Equity $76.80M $79.07M $91.33M
YoY Change -2.87% -11.02% 27.43%

Cashflow Statement

Concept 2020 Q3 2019 Q3 2019 Q2
OPERATING ACTIVITIES
Net Income -$3.801M -$15.65M -$11.50M
YoY Change -75.71% -52.77% -66.6%
Depreciation, Depletion And Amortization $670.0K $650.0K $650.0K
YoY Change 3.08% 1411.63% 0.0%
Cash From Operating Activities $1.140M -$14.77M -$17.11M
YoY Change -107.72% 25.53% 181.41%
INVESTING ACTIVITIES
Capital Expenditures -$130.0K $0.00 -$30.00K
YoY Change -100.0% -40.0%
Acquisitions
YoY Change
Other Investing Activities $0.00 $0.00
YoY Change -100.0%
Cash From Investing Activities -$130.0K $0.00 -$30.00K
YoY Change -100.0% -98.29%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 4.900M 2.370M 17.92M
YoY Change 106.75% -91.79% -40.78%
NET CHANGE
Cash From Operating Activities 1.140M -14.77M -17.11M
Cash From Investing Activities -130.0K 0.000 -30.00K
Cash From Financing Activities 4.900M 2.370M 17.92M
Net Change In Cash 5.910M -12.40M 780.0K
YoY Change -147.66% -172.99% -96.52%
FREE CASH FLOW
Cash From Operating Activities $1.140M -$14.77M -$17.11M
Capital Expenditures -$130.0K $0.00 -$30.00K
Free Cash Flow $1.270M -$14.77M -$17.08M
YoY Change -108.6% 24.38% 183.25%

Facts In Submission

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<div style="align:left;"> <table border="0" cellpadding="0" cellspacing="0" style="border-collapse:collapse; width:100%;"> <tr> <td style="width:5.24%;white-space:nowrap" valign="top"> <p style="margin-top:10pt;margin-bottom:0pt;font-weight:bold;color:#000000;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;"><span style="font-weight:bold;color:#000000;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">1.</span></p></td> <td valign="top"> <p style="margin-top:10pt;margin-bottom:0pt;font-weight:bold;color:#000000;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">Operations and Basis of Presentation  </p></td></tr></table></div> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Overview</p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:5.24%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The accompanying condensed consolidated financial statements of EyePoint Pharmaceuticals, Inc. and subsidiaries (collectively, the “Company”) as of September 30, 2020 and for the three and nine months ended September 30, 2020 and 2019 are unaudited. Certain information in the footnote disclosures of these financial statements has been condensed or omitted in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”). These financial statements should be read in conjunction with the Company’s audited consolidated financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019. In the opinion of management, these statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2019, and include all adjustments, consisting only of normal recurring adjustments, that are necessary for the fair presentation of the Company’s financial position, results of operations, comprehensive loss and cash flows for the periods indicated. The preparation of financial statements in accordance with United States (“U.S.”) generally accepted accounting principles (“GAAP”) requires management to make assumptions and estimates that affect, among other things, (i) reported amounts of assets and liabilities; (ii) disclosure of contingent assets and liabilities at the date of the consolidated financial statements; and (iii) reported amounts of revenues and expenses during the reporting period. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the entire fiscal year or any future period. </p> <p style="Background-color:#FFFFFF;margin-top:10pt;margin-bottom:0pt;text-indent:5.24%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company is a pharmaceutical company committed to developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders. <span style="Background-color:#FFFFFF;color:#000000;">The Company has two products, YUTIQ</span><span style="color:#000000;"><sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup></span><span style="Background-color:#FFFFFF;color:#000000;"> and DEXYCU</span><span style="color:#000000;"><sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup></span><span style="Background-color:#FFFFFF;color:#000000;">, which were approved by the U.S. Food and Drug Administration (“FDA”) in 2018.</span></p> <p style="Background-color:#FFFFFF;margin-top:10pt;margin-bottom:0pt;text-indent:5.24%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for intravitreal injection, was launched directly in the U.S. in February 2019. YUTIQ is indicated for the treatment of chronic </span>non-infectious<span style="Background-color:#FFFFFF;"> uveitis affecting the posterior segment of the eye, which affects between 60,000 to 100,000 people in the U.S. each year and causes approximately 30,000 new cases of blindness annually, making it the third leading cause of blindness. Injected into the vitreous humor during a physician office visit, YUTIQ delivers a micro-dose of a corticosteroid on a sustained constant (zero order release) basis for up to 36 months. YUTIQ is based on the Company’s proprietary Durasert</span><span style="color:#000000;"><sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup></span><span style="Background-color:#FFFFFF;"> sustained-release drug delivery technology that can deliver drug for predetermined periods of time ranging from months to years.</span></p> <p style="margin-bottom:0pt;margin-top:10pt;text-indent:5.24%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">DEXYCU (dexamethasone intraocular suspension) 9%, </span>for intraocular administration, was launched directly in the U.S. in March 2019.  Indicated for the treatment of post-operative ocular inflammation, DEXYCU <span style="Background-color:#FFFFFF;">is administered locally as a single dose at the conclusion of ocular surgery and is the first long-acting intraocular product approved by the FDA for this indication. DEXYCU utilizes the Company’s proprietary Verisome</span><sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup><span style="Background-color:#FFFFFF;"> drug-delivery technology that allows for a single intraocular injection that releases dexamethasone, a corticosteroid, over time. There were approximately 3.8 million cataract surgeries performed during 2018 in the U.S.</span><span style="font-size:12pt;color:#000000;"> </span><span style="Background-color:#FFFFFF;">and the Company launched DEXYCU with a primary focus on its use following cataract surgery. The Company acquired DEXYCU in connection with its acquisition of Icon Bioscience, Inc. (“Icon”) in March 2018 (the “Icon Acquisition”). </span></p> <p style="Background-color:#FFFFFF;margin-top:10pt;margin-bottom:0pt;text-indent:5.24%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">ILUVIEN<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> for diabetic macular edema (“DME”), the Company’s licensed product, is sold directly in the U.S. and several European Union (“EU”) countries by Alimera Sciences, Inc. (“Alimera”) under a license agreement with the Company. In July 2017, the Company expanded the Alimera license agreement to include the uveitis indication for Europe, the Middle East and Africa (“EMEA”). European regulatory approval of ILUVIEN for the uveitis indication was granted in March 2019, subject to obtaining pricing and reimbursement in each applicable country. The Company receives royalty payments from Alimera for its sales of ILUVIEN.</p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:5.24%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">EYP-1901 is being developed by the Company as a potential 6-month intravitreal treatment for wet age-related macular degeneration (“wAMD”).  EYP-1901 utilizes the Company’s bioerodible Durasert technology combined with vorolanib, an anti-VEGF tyrosine kinase inhibitor (“TKI”).  Vorolanib has previously been studied in human clinical trials as an orally delivered therapy. The Company completed initial animal pharmacokinetic and toxicology studies and initiated a GLP toxicology study in March 2020 to support the anticipated filing of an Investigational New Drug (“IND”) application with the FDA by the end of 2020. A</span> Phase 1 clinical trial is expected to follow upon acceptance of the IND <span style="Background-color:#FFFFFF;">by the FDA.</span> The Company believes EYP-1901 has potential<span style="Background-color:#FFFFFF;color:#000000;"> for additional</span><span style="Background-color:#FFFFFF;"> </span></p> <p style="margin-top:10pt;margin-bottom:0pt;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">indications in diabetic retinopathy (“DR”) and retinal vein occlusion (“RVO”).</span></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:5.24%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">YUTIQ50 is being developed by the Company as a potential 6-month intravitreal treatment for chronic non-infectious uveitis affecting the posterior segment of the eye. The Company has consulted with the FDA and identified a clinical pathway for a supplemental new drug application (“sNDA”) filing that involves a clinical trial of a small study, randomized 2:1. The Company is currently evaluating the timeline and investment requirements for the initiation of this trial.</p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Effects of the COVID-19 Coronavirus Pandemic<span style="Background-color:#FFFFFF;"> </span></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:5.07%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The outbreak of the <span style="color:#000000;">COVID-19 Coronavirus Pandemic</span><span style="Background-color:#FFFFFF;color:#000000;"> (the “Pandemic”)</span> in March 2020 has had and will likely continue to have, a material and adverse impact on the Company’s business, including as a result of measures that the Company, other businesses, and government have and will likely continue to take. This includes a significant impact on cash flows from expected revenues due to the closure of ambulatory surgery centers for DEXYCU and a significant reduction in physician office visits impacting YUTIQ. These closures precipitated the restructuring of the Company’s commercial organization that was announced on April 1, 2020 along with a reduction in planned spending for the calendar year. Due to the continued Pandemic, these factors continued to have an adverse impact on the Company’s revenues, financial condition and cash flows in the third quarter of 2020. Although customer demand for the Company’s products resumed by the third quarter, the extent and duration of the impact on the Company’s business is uncertain at this time. The Company is monitoring the Pandemic and its potential effect on the Company’s financial position, results of operations and cash flows. This uncertainty could have an impact in future periods on certain estimates used in the preparation of the Company’s quarterly financial results, including reserves for variable consideration related to product sales, realizability of certain receivables, assessment for<span style="color:#000000;"> excess or obsolete inventory, and impairment of long-lived assets</span>. <span style="Background-color:#FFFFFF;color:#000000;">Uncertainty around the extent and duration of the Pandemic, and any future related financial impact cannot be reasonably estimated at this time.</span></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Liquidity</p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:5.77%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">The Company has a history of operating losses and has not had significant recurring cash inflows from revenue.</span><span style="color:#000000;"> The Company’s operations have been financed primarily from sales of its equity securities, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from its collaboration partners</span><span style="Background-color:#FFFFFF;">.</span><span style="color:#000000;"> In the first quarter of 2019, the Company commenced the U.S. launch of its first two commercial products, YUTIQ and DEXYCU. However, the Company has not received sufficient revenues from its product sales to fund operations and the Company does not expect revenues from its product sales to generate sufficient funding to sustain its operations in the near-term. As of September 30, 2020, the Company has had recurring operating losses since its inception and has an accumulated deficit of approximately $495.2 million and working capital of $34.7 million. The Company had cash and cash equivalents of $28.7 million at September 30, 2020.  </span></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:5.77%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Accordingly, the foregoing conditions, taken together, continue to raise substantial doubt about the Company’s ability to continue as a going concern for one year from the issuance of these financial statements. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.</p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:5.77%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company’s plans that are intended to mitigate those conditions include continuing to fulfill its funding needs through cash inflows from revenue of YUTIQ and DEXYCU product sales, licensing and research collaboration transactions, <span style="Background-color:#FFFFFF;">at-the-market facility (the “ATM Facility”) </span> financing, additional capital raises and other arrangements. <span style="Background-color:#FFFFFF;color:#000000;">The Company’s plans also include the continuation of expense reductions to conserve cash in response to a continued adverse impact on the Company’s </span>revenue of YUTIQ and DEXYCU product sales due to the continued Pandemic, slower recovery in product demand associated with phased reopening of customer facilities, <span style="Background-color:#FFFFFF;color:#000000;">elective surgical procedures and physician office visits in response to the Pandemic. </span><span style="Background-color:#FFFFFF;">During October 2020, the Company received net proceeds of $5.7 million through its </span>ATM Facility <span style="Background-color:#FFFFFF;">financing. At October 31, 2020, the Company had cash and cash equivalents of $30.5 million. </span>The Company believes that its cash and cash equivalents of $30.5 million at October 31, 2020 and expected cash inflows from its product sales, royalty agreements, and ATM Facility financing, coupled with cash conservation activities will enable the Company to fund its current and planned operations into 2021. <span style="Background-color:#FFFFFF;color:#000000;">There can be no assurance that the Company will receive the additional funding from any of these potential resources and, even if such cash proceeds are received, that such proceeds would be sufficient to support the Company’s current operating plan for the next twelve months from the date of issuance of these financial statements. A</span>ctual cash requirements could differ from management’s projections due to many factors, including the success of <span style="Background-color:#FFFFFF;color:#000000;">commercialization</span> for YUTIQ and DEXYCU, the actual costs of these commercialization efforts, the continued effect of the Pandemic on our business and the medical community, additional <span style="Background-color:#FFFFFF;color:#000000;">investments</span> in </p> <p style="margin-bottom:0pt;margin-top:12pt;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">research and development programs, competing technological and market developments and the costs of any strategic acquisitions and/or development of complementary business opportunities.</span></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">Recently Adopted and Recently Issued Accounting Pronouncements</p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:5.24%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">New accounting pronouncements are issued periodically by the Financial Accounting Standards Board (“FASB”) and are adopted by the Company as of the specified effective dates. Unless otherwise disclosed below, the Company believes that recently issued and adopted accounting pronouncements will not have a material impact on the Company’s financial position, results of operations and cash flows or do not apply to the Company’s operations.</p> <p style="margin-bottom:0pt;margin-top:10pt;text-indent:5.24%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In December 2019, the FASB issued ASU No. 2019-12, <span style="font-style:italic;">Income Taxes (Topic 740)</span><span style="color:#000000;"> (“ASU 2019-12”)</span><span style="font-style:italic;">: Simplifying the Accounting for Income Taxes.</span> The amendments simplify the accounting for income taxes by removing certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. Early adoption is permitted, including adoption in interim or annual periods for which financial statements have not yet been issued. This standard will be effective for the Company in the first quarter of its fiscal year ending December 31, 2021. The Company is<span style="color:#000000;"> currently evaluating the impact the adoption of this update will have on its consolidated financial statements.</span></p>
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