2021 Q3 Form 10-Q Financial Statement

#000156459021054795 Filed on November 05, 2021

View on sec.gov

Income Statement

Concept 2021 Q3 2020 Q3 2020 Q2
Revenue $9.059M $15.70M $4.122M
YoY Change -42.3% 525.75% -42.83%
Cost Of Revenue $1.825M $1.880M $500.0K
YoY Change -2.93% 469.7% -29.18%
Gross Profit $7.234M $13.81M $3.620M
YoY Change -47.62% 533.49% -44.34%
Gross Profit Margin 79.85% 87.96% 87.82%
Selling, General & Admin $13.43M $11.07M $10.88M
YoY Change 21.36% -8.84% -10.07%
% of Gross Profit 185.71% 80.16% 300.58%
Research & Development $8.498M $4.090M $3.276M
YoY Change 107.78% 17.39% -17.17%
% of Gross Profit 117.47% 29.62% 90.5%
Depreciation & Amortization $701.0K $670.0K $670.0K
YoY Change 4.63% 3.08% 3.08%
% of Gross Profit 9.69% 4.85% 18.51%
Operating Expenses $22.55M $15.77M $15.27M
YoY Change 42.97% -4.82% -12.09%
Operating Profit -$15.31M -$1.960M -$11.15M
YoY Change 681.28% -86.06% 9.71%
Interest Expense -$1.382M -$1.840M $1.806M
YoY Change -24.89% -203.95% 12.95%
% of Operating Profit
Other Income/Expense, Net -$1.382M -$1.798M
YoY Change 34.88%
Pretax Income -$16.70M -$3.800M -$12.95M
YoY Change 339.34% -75.72% 12.61%
Income Tax
% Of Pretax Income
Net Earnings -$16.70M -$3.801M -$12.95M
YoY Change 339.23% -75.71% 12.63%
Net Earnings / Revenue -184.29% -24.21% -314.17%
Basic Earnings Per Share -$0.58
Diluted Earnings Per Share -$580.4K -$297.1K -$1.038M
COMMON SHARES
Basic Shares Outstanding 28.77M
Diluted Shares Outstanding 28.77M

Balance Sheet

Concept 2021 Q3 2020 Q3 2020 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $119.7M $28.70M $22.80M
YoY Change 317.11% -9.75% -48.42%
Cash & Equivalents $119.7M $28.70M $22.80M
Short-Term Investments
Other Short-Term Assets $3.892M $5.800M $5.900M
YoY Change -32.9% 48.72% 90.32%
Inventory $4.571M $3.642M $3.773M
Prepaid Expenses
Receivables $13.60M $9.400M $7.400M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $141.8M $47.60M $39.80M
YoY Change 197.85% 1.15% -32.05%
LONG-TERM ASSETS
Property, Plant & Equipment $2.962M $3.200M $3.300M
YoY Change -7.44% 729.02% 691.37%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $150.0K $200.0K $200.0K
YoY Change -25.0% 0.0% 0.0%
Total Long-Term Assets $26.48M $29.20M $29.90M
YoY Change -9.33% -8.77% -8.72%
TOTAL ASSETS
Total Short-Term Assets $141.8M $47.60M $39.80M
Total Long-Term Assets $26.48M $29.20M $29.90M
Total Assets $168.3M $76.80M $69.70M
YoY Change 119.08% -2.87% -23.68%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $6.639M $5.200M $3.900M
YoY Change 27.67% -4.78% -35.71%
Accrued Expenses $11.46M $6.845M $5.131M
YoY Change 67.47% 53.96% 21.76%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $147.0K $100.0K $100.0K
YoY Change 47.0%
Total Short-Term Liabilities $19.93M $12.90M $9.586M
YoY Change 54.52% 24.42% -10.59%
LONG-TERM LIABILITIES
Long-Term Debt $36.47M $50.80M $50.26M
YoY Change -28.22% 8.7% 8.67%
Other Long-Term Liabilities $19.10M $5.500M $3.026M
YoY Change 247.35% 83.33% 0.87%
Total Long-Term Liabilities $55.57M $56.30M $53.29M
YoY Change -1.3% 13.2% 8.19%
TOTAL LIABILITIES
Total Short-Term Liabilities $19.93M $12.90M $9.586M
Total Long-Term Liabilities $55.57M $56.30M $53.29M
Total Liabilities $75.50M $69.20M $65.50M
YoY Change 9.11% 9.62% 3.77%
SHAREHOLDERS EQUITY
Retained Earnings -$491.4M
YoY Change 11.88%
Common Stock $494.8M
YoY Change 6.03%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $92.75M $7.594M $4.194M
YoY Change
Total Liabilities & Shareholders Equity $168.3M $76.80M $69.69M
YoY Change 119.08% -2.87% -23.7%

Cashflow Statement

Concept 2021 Q3 2020 Q3 2020 Q2
OPERATING ACTIVITIES
Net Income -$16.70M -$3.801M -$12.95M
YoY Change 339.23% -75.71% 12.63%
Depreciation, Depletion And Amortization $701.0K $670.0K $670.0K
YoY Change 4.63% 3.08% 3.08%
Cash From Operating Activities -$7.787M $1.140M -$5.120M
YoY Change -783.07% -107.72% -70.08%
INVESTING ACTIVITIES
Capital Expenditures -$131.0K -$130.0K -$20.00K
YoY Change 0.77% -33.33%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities -$131.0K -$130.0K -$20.00K
YoY Change 0.77% -33.33%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -2.000K 4.900M 1.660M
YoY Change -100.04% 106.75% -90.74%
NET CHANGE
Cash From Operating Activities -7.787M 1.140M -5.120M
Cash From Investing Activities -131.0K -130.0K -20.00K
Cash From Financing Activities -2.000K 4.900M 1.660M
Net Change In Cash -7.920M 5.910M -3.480M
YoY Change -234.01% -147.66% -546.15%
FREE CASH FLOW
Cash From Operating Activities -$7.787M $1.140M -$5.120M
Capital Expenditures -$131.0K -$130.0K -$20.00K
Free Cash Flow -$7.656M $1.270M -$5.100M
YoY Change -702.83% -108.6% -70.14%

Facts In Submission

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<p style="margin-bottom:0pt;margin-top:10pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">1.<span style="font-weight:normal;margin-left:36pt;"/>Operations</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;"><span style="Background-color:#FFFFFF;">The accompanying condensed consolidated financial statements of EyePoint Pharmaceuticals, Inc., a Delaware corporation </span><span style="color:#000000;">(together with its subsidiaries, the “Company”), </span><span style="Background-color:#FFFFFF;">as of September 30, 2021 and for the three and nine months ended September 30, 2021 and 2020 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, 2020. 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, 2020, 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, 2021 are not necessarily indicative of the results that may be expected for the entire fiscal year or any future period.</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;">The Company is a pharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious eye disorders. The Company’s pipeline leverages its proprietary Durasert<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> technology for extended intraocular drug delivery including EYP-1901, a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration (“wet AMD”), the leading cause of vision loss among people 50 years of age and older in the United States. The Company’s product candidate pipeline also includes YUTIQ<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> 50, a potential six-month treatment for non-infectious uveitis affecting the posterior segment of the eye, one of the leading causes of blindness. The Company also has two commercial products: YUTIQ<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup>, a once every three-year treatment for chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup>, a single dose treatment for postoperative inflammation following ocular surgery<span style="Background-color:#FFFFFF;">.</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;">Local drug delivery for treating ocular diseases is a significant challenge due to the effectiveness of the blood-eye barrier. This barrier makes it difficult for systemically-administered drugs to reach the eye in sufficient quantities to have a beneficial effect without causing unacceptable adverse side effects to other organs. The Company’s validated Durasert technology, which has already been included in four products approved for marketing by the U.S. Food and Drug Administration (“FDA”), is designed to provide consistent, sustained delivery of small molecule drugs over a period of months to years through a single intravitreal injection.</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;">The<span style="Background-color:#FFFFFF;"> Company’s lead product candidate, EYP-1901, combines a bioerodible formulation of its proprietary Durasert sustained-release technology with vorolanib, a tyrosine kinase inhibitor (“TKI”). Current approved treatments for wet AMD require monthly or bi-monthly eye injections in a physician’s office, which can cause inconvenience and discomfort and often lead to reduced compliance and poor outcomes. The Company is currently evaluating EYP-1901 in a Phase 1 clinical trial (“DAVIO”) as a potential twice-yearly sustained delivery intravitreal treatment for wet AMD. On September 17, 2021, the Company announced that a late-breaking abstract highlighting topline data for the DAVIO trial was selected for presentation at the American Academy of Ophthalmology (“AAO”) 2021 Annual Meeting scheduled on November 13, 2021. On October 12, 2021, the Company reported positive 3-month safety data results for all dose levels from the ongoing DAVIO trial of EYP-1901 for wet AMD at the American Society of Retina Specialists (“ASRS”) Annual Meeting.</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;"><span style="Background-color:#FFFFFF;">The Company is also developing YUTIQ 50 as a potential six-month intravitreal treatment for non-infectious uveitis affecting the posterior segment of the eye. The Company anticipates the initiation of a Phase 3 clinical trial for YUTIQ 50 in the fourth quarter of 2021 and expects to file for a supplemental new drug application (“sNDA”) approval with the FDA upon successful completion of the trial.</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;"><span style="Background-color:#FFFFFF;">The Company also has two commercial products, YUTIQ<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> and DEXYCU<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup>, that are being sold directly in the U.S.</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;"><span style="Background-color:#FFFFFF;">YUTIQ<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> (fluocinolone acetonide intravitreal implant) 0.18 mg for intravitreal injection, is a non-erodible intravitreal implant containing fluocinolone acetonide (“FA”) lasting for up to 36 months and is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. This disease affects between 60,000 to 100,000 people each year in the U.S. causes approximately 30,000 new cases of blindness every year and is the third leading cause of blindness. YUTIQ utilizes the Company’s proprietary Durasert<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> sustained-release drug delivery technology platform.</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;"><span style="Background-color:#FFFFFF;">DEXYCU<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> (dexamethasone intraocular suspension) 9%, for intraocular administration, is indicated for the treatment of post-operative ocular inflammation, with the Company’s primary focus on its use immediately following cataract surgery as a single dose treatment. DEXYCU utilizes the Company’s proprietary Verisome<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> drug-delivery technology.</span></p> <p style="Background-color:#FFFFFF;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;">The Company is also seeking to enhance its long-term growth potential by expanding EYP-1901 beyond wet AMD into diabetic retinopathy (“DR”) and retinal vein occlusion (“RVO”), both large and growing ocular disease areas. The Company also expects to potentially identify and advance additional product pipeline candidates through clinical and regulatory development. This may be accomplished through internal discovery efforts, potential research collaborations and/or in-licensing arrangements with partner molecules and potential acquisitions of additional ophthalmic products, product candidates or technologies that complement the Company’s current product portfolio.</p> <p style="Background-color:#FFFFFF;margin-bottom:0pt;margin-top:10pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;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-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;">The ongoing COVID-19 coronavirus pandemic<span style="Background-color:#FFFFFF;"> (the “Pandemic”)</span> has had a material and adverse impact on the Company’s business, including as a result of measures that the Company, other businesses, and governments have taken and will possibly 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 in 2020. The ongoing Pandemic continued to have an adverse impact on the Company’s revenues, financial condition and cash flows through the third quarter of 2021. Additionally, the emergence of new variants of the coronavirus has caused and may continue to cause intermittent or prolonged periods of reduced patient services at the Company’s customers’ facilities, which may negatively affect customer demand. The progression of the Pandemic and its effects on the Company’s business and operations are uncertain at this time. Depending on the future developments that are uncertain and difficult to predict, including new information that may emerge concerning the Pandemic, the Company’s revenues, financial condition and cash flows may be adversely affected in the future as well. The Company is continuously 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 periodic financial results, including reserves for variable consideration related to product sales, realizability of certain receivables, assessment for excess or obsolete inventory, and impairment of long-lived assets. <span style="Background-color:#FFFFFF;">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-bottom:0pt;margin-top:10pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Liquidity</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;">The Company had cash and cash equivalents of $119.7<span style="font-size:12pt;color:#000000;"> </span>million at September 30, 2021.<span style="Background-color:#FFFFFF;"> T</span>he Company has a history of operating losses and has not had significant recurring cash inflows from revenue. 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 style="Background-color:#FFFFFF;">.</span> 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. The Company expects to continue fulfilling its funding needs through cash inflows from revenue of YUTIQ and DEXYCU product sales, licensing and research collaboration transactions, additional equity capital raises and other arrangements. The Company believes that its cash and cash equivalents of $<span style="color:#000000;">119.7 </span> million at September 30, 2021, coupled with expected cash inflows from its product sales will enable the Company to fund its current and planned operations for <span style="Background-color:#FFFFFF;">at least the next twelve months from the date these consolidated financial statements were issued. A</span>ctual cash requirements could differ from management’s projections due to many factors, including the continued effect of the Pandemic on the Company’s business and the medical community, <span style="Background-color:#FFFFFF;">the timing and results of the Company’s clinical trials for EYP-1901 and YUTIQ 50, </span>additional <span style="Background-color:#FFFFFF;">investments</span> in research and development programs, the success of ongoing <span style="Background-color:#FFFFFF;">commercialization</span> efforts for YUTIQ and DEXYCU, the actual costs of these ongoing commercialization efforts, competing technological and market developments and the costs of any strategic acquisitions and/or development of complementary business opportunities.</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;">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 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-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;">In May 2021, the FASB issued ASU No. 2021-04, <span style="font-style:italic;color:#000000;">Earnings Per Share (Topic 260), Debt— Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40)</span> (“ASU 2021-04”)<span style="font-style:italic;">: </span><span style="font-style:italic;color:#000000;">Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options</span><span style="font-style:italic;">. </span>The amendments are designed to clarify an issuer’s accounting for certain modifications or exchanges of freestanding equity-classified written call options that remain equity-classified after modification or exchange. The ASU provides guidance on how an issuer would measure and recognize the effects of these transactions. The standard provides a principles-based framework to determine whether an issuer should recognize the modification or exchange as an adjustment to equity or an expense. ASU 2021-04 is effective for fiscal years beginning after December 15, 2021, 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. ASU 2021-04 will be effective for the Company in the first quarter of its fiscal year ending December 31, 2022. The Company is currently evaluating the impact the adoption of this update will have on its consolidated financial statements.</p>
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