2019 Q4 Form 10-K Financial Statement

#000156459020010956 Filed on March 16, 2020

View on sec.gov

Income Statement

Concept 2019 Q4 2019 Q3 2019 Q2
Revenue $8.634M $2.509M $7.210M
YoY Change 253.56% 416.26% 908.39%
Cost Of Revenue $1.320M $330.0K $706.0K
YoY Change
Gross Profit $7.310M $2.180M $6.504M
YoY Change 809.65%
Gross Profit Margin 84.67% 86.89% 90.21%
Selling, General & Admin $11.55M $12.14M $12.10M
YoY Change 24.6% 55.54% 111.08%
% of Gross Profit 158.0% 557.02% 186.02%
Research & Development $4.130M $3.484M $3.955M
YoY Change -1.2% -44.1% -17.0%
% of Gross Profit 56.5% 159.82% 60.81%
Depreciation & Amortization $640.0K $650.0K $650.0K
YoY Change -4.48% 1411.63% 0.0%
% of Gross Profit 8.76% 29.82% 9.99%
Operating Expenses $16.30M $16.57M $17.38M
YoY Change 21.19% 18.01% 65.52%
Operating Profit -$8.985M -$14.06M -$10.17M
YoY Change -18.36% 3.73% 3.92%
Interest Expense -$1.430M $1.770M $1.599M
YoY Change 142.37% 117.18% 122.08%
% of Operating Profit
Other Income/Expense, Net -$1.587M -$1.333M
YoY Change -91.89% -94.59%
Pretax Income -$10.41M -$15.65M -$11.50M
YoY Change -10.18% -52.76% -66.6%
Income Tax
% Of Pretax Income
Net Earnings -$10.41M -$15.65M -$11.50M
YoY Change -10.21% -52.77% -66.6%
Net Earnings / Revenue -120.57% -623.63% -159.47%
Basic Earnings Per Share
Diluted Earnings Per Share -$959.4K -$1.464M -$1.083M
COMMON SHARES
Basic Shares Outstanding 108.1M 106.3M 106.1M
Diluted Shares Outstanding

Balance Sheet

Concept 2019 Q4 2019 Q3 2019 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $22.20M $31.80M $44.20M
YoY Change -50.99% -43.01% 13.92%
Cash & Equivalents $22.21M $31.76M $44.16M
Short-Term Investments
Other Short-Term Assets $6.000M $3.900M $3.100M
YoY Change 328.57% 178.57% 287.5%
Inventory $2.138M $2.559M $1.670M
Prepaid Expenses
Receivables $11.40M $8.900M $9.600M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $41.72M $47.06M $58.57M
YoY Change -12.36% -18.36% 46.77%
LONG-TERM ASSETS
Property, Plant & Equipment $357.0K $386.0K $417.0K
YoY Change 23.96% 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 $31.25M $32.01M $32.76M
YoY Change 2.25% 2.54% 3.14%
TOTAL ASSETS
Total Short-Term Assets $41.72M $47.06M $58.57M
Total Long-Term Assets $31.25M $32.01M $32.76M
Total Assets $72.97M $79.07M $91.33M
YoY Change -6.65% -11.02% 27.43%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $4.192M $5.461M $6.066M
YoY Change 58.79% 34.01% 106.33%
Accrued Expenses $6.832M $4.446M $4.214M
YoY Change 80.31% 32.99% 13.19%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $11.52M $10.37M $10.72M
YoY Change -46.32% -53.75% -50.51%
LONG-TERM LIABILITIES
Long-Term Debt $47.22M $46.73M $46.25M
YoY Change 167.99% 167.61% 167.2%
Other Long-Term Liabilities $3.000M $3.000M $3.000M
YoY Change 106.19% 136.41% 143.7%
Total Long-Term Liabilities $50.22M $49.73M $49.25M
YoY Change 163.28% 165.5% 165.64%
TOTAL LIABILITIES
Total Short-Term Liabilities $11.52M $10.37M $10.72M
Total Long-Term Liabilities $50.22M $49.73M $49.25M
Total Liabilities $64.64M $63.13M $63.12M
YoY Change 59.47% 53.41% 5.23%
SHAREHOLDERS EQUITY
Retained Earnings -$465.3M -$454.9M -$439.2M
YoY Change 13.9% 14.61% 20.67%
Common Stock $472.8M $470.0M $466.6M
YoY Change 6.17% 5.91% 24.48%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $8.330M $15.94M $28.21M
YoY Change
Total Liabilities & Shareholders Equity $72.97M $79.07M $91.33M
YoY Change -6.65% -11.02% 27.43%

Cashflow Statement

Concept 2019 Q4 2019 Q3 2019 Q2
OPERATING ACTIVITIES
Net Income -$10.41M -$15.65M -$11.50M
YoY Change -10.21% -52.77% -66.6%
Depreciation, Depletion And Amortization $640.0K $650.0K $650.0K
YoY Change -4.48% 1411.63% 0.0%
Cash From Operating Activities -$11.49M -$14.77M -$17.11M
YoY Change 6.19% 25.53% 181.41%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00 -$30.00K
YoY Change -100.0% -100.0% -40.0%
Acquisitions
YoY Change
Other Investing Activities $0.00 $0.00 $0.00
YoY Change -100.0%
Cash From Investing Activities $0.00 $0.00 -$30.00K
YoY Change -100.0% -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 1.940M 2.370M 17.92M
YoY Change 470.59% -91.79% -40.78%
NET CHANGE
Cash From Operating Activities -11.49M -14.77M -17.11M
Cash From Investing Activities 0.000 0.000 -30.00K
Cash From Financing Activities 1.940M 2.370M 17.92M
Net Change In Cash -9.550M -12.40M 780.0K
YoY Change -9.05% -172.99% -96.52%
FREE CASH FLOW
Cash From Operating Activities -$11.49M -$14.77M -$17.11M
Capital Expenditures $0.00 $0.00 -$30.00K
Free Cash Flow -$11.49M -$14.77M -$17.08M
YoY Change 6.39% 24.38% 183.25%

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us-gaap Net Cash Provided By Used In Financing Activities
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CY2018 us-gaap Net Cash Provided By Used In Financing Activities
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CY2019 us-gaap Nature Of Operations
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<div align="left"> <table border="0" cellspacing="0" cellpadding="0" style="border-collapse:collapse; width:100%;"> <tr> <td valign="top" style="width:4.54%;white-space:nowrap"> <p style="margin-bottom:0pt;margin-top:10pt;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">1.</font></p></td> <td valign="top"> <p style="margin-bottom:0pt;margin-top:10pt;font-weight:bold;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;"><font style="font-weight:normal;"></font>Operations</p></td></tr></table></div> <p style="margin-bottom:0pt;margin-top:10pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">EyePoint Pharmaceuticals, Inc. (together with its subsidiaries, the &#8220;Company&#8221;), incorporated in Delaware, is a pharmaceutical company committed to developing and commercializing innovative ophthalmic products for the treatment of eye diseases. The Company has two products, YUTIQ<sup style="font-size:85%;line-height:120%;vertical-align:top">&#174;</sup> and DEXYCU<sup style="font-size:85%;line-height:120%;vertical-align:top">&#174;</sup>, which were approved by the United States (&#8220;U.S.&#8221;) Food and Drug Administration (&#8220;FDA&#8221;) in 2018. </p> <p style="Background-color:#FFFFFF;margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font 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 </font>non-infectious<font 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 every year, making it the third leading cause of blindness. Injected into the eye in an office visit, YUTIQ is a micro-insert that delivers a micro-dose of a corticosteroid to the back of the eye on a sustained constant (zero order release) basis for up to 36 months. YUTIQ is based on the Company&#8217;s proprietary Durasert</font><font style="color:#000000;"><sup style="font-size:85%;line-height:120%;vertical-align:top">&#174;</sup></font><font style="Background-color:#FFFFFF;"> sustained-release drug delivery technology platform, which can deliver drugs for predetermined periods of time ranging from months to years.</font></p> <p style="margin-bottom:0pt;margin-top:10pt;text-indent:4.54%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">DEXYCU (dexamethasone intraocular suspension) 9%, </font>for intraocular administration, was launched directly in the U.S. in March 2019.&nbsp;&nbsp;Indicated for the treatment of post-operative ocular inflammation, DEXYCU <font style="Background-color:#FFFFFF;">is administered as a single dose at the end of ocular surgery and is the first long-acting intraocular product approved by the FDA for this indication. DEXYCU utilizes the Company&#8217;s proprietary Verisome</font><sup style="font-size:85%;line-height:120%;vertical-align:top">&#174;</sup><font style="Background-color:#FFFFFF;"> drug-delivery platform, which allows for a single intraocular injection that releases dexamethasone, a corticosteroid, over time. There were approximately 3.8&#160;million cataract surgeries performed during 2018 in the U.S.</font><font style="font-size:12pt;color:#000000;">&#160;</font><font 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. (&#8220;Icon&#8221;) in March 2018. </font></p> <p style="Background-color:#FFFFFF;margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">ILUVIEN<sup style="font-size:85%;line-height:120%;vertical-align:top">&#174;</sup>&#160;for diabetic macular edema (&#8220;DME&#8221;), the Company&#8217;s lead licensed product, is sold directly in the U.S. and several European Union (&#8220;EU&#8221;) countries by Alimera Sciences, Inc. (&#8220;Alimera&#8221;). In July 2017, the Company expanded its license agreement with Alimera to include the uveitis indication utilizing the Durasert technology in Europe, the Middle East and Africa (&#8220;EMEA&#8221;), which received European regulatory approval in March 2019 and, subject to obtaining pricing and reimbursement in each applicable country, will be marketed as ILUVIEN. Retisert<sup style="font-size:85%;line-height:120%;vertical-align:top">&#174;</sup>, one of the Company&#8217;s earlier generation products, was approved in 2005 by the FDA for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye and is sold in the U.S. by Bausch &amp; Lomb Inc. (&#8220;Bausch &amp; Lomb&#8221;). <font style="color:#000000;">The patent with which Retisert is marked expired in March 2019. As such, Bausch &amp; Lomb discontinued paying royalties after March 2019. </font></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">EYP-1901, 6-Month bioerodible Durasert Vorolanib &#8211; Tyrosine Kinase Inhibitor (&#8220;TKI&#8221;) is being advanced as a potential treatment for wet age-related macular degeneration (&#8220;wAMD&#8221;), diabetic retinopathy (&#8220;DR&#8221;) and retinal vein occlusion (&#8220;RVO&#8221;). The Company has completed initial animal pharmacokinetic and toxicology studies and expect to initiate GLP toxicology studies in the first quarter of 2020 to support the filing of an Investigational New Drug application with the FDA.</font></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">YUTIQ50 is being developed as a 6-month dosing option for treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The Company has consulted with the FDA and identified a clinical pathway for an sNDA filing that involves a clinical trial of approximately 60 patients, randomized 2:1. The Company is currently evaluating the timeline and investment requirements for the initiation of this study.</font></p> <p style="Background-color:#FFFFFF;margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company&#8217;s development programs are focused primarily on developing sustained release products that utilize its Durasert technology platform to deliver drugs to treat chronic diseases. The Company&#8217;s strategy includes developing products independently while continuing to leverage its technology platforms, including Verisome, through collaborations and license agreements.</p> <p style="margin-top:10pt;margin-bottom:0pt;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-top:10pt;margin-bottom:0pt;text-indent:4.54%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company has a history of operating losses and has not had significant recurring cash inflows from revenue. The Company&#8217;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. 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 no history of direct commercialization of its products and management does not yet have sufficient historical evidence to assert that it is probable that the Company will receive sufficient revenues from its product sales to fund operations. As of December 31, 2019, the Company has had recurring operating losses since its inception and has an accumulated deficit of approximately $465.3 million and working capital of $30.2 million. In addition to total cash and cash equivalents of $22.2 million at December 31, 2019, the Company received net proceeds of $20.3 million on February 25, 2020 from the issuance of common stock (&#8220;Common Stock&#8221;), excluding approximately $300,000 of additional unpaid share issue costs (see Note 18). </p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.03%;color:#000000;font-size:10pt;font-family:Times New Roman;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&#8217;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.<font style="font-size:12pt;color:#000000;">&#160;</font></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.03%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company&#8217;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 arrangements, additional capital raise or other arrangement. The Company believes its plans in place will be sufficient to fund the Company&#8217;s operating plan for the next 12 months. Although the Company believes such plans, if executed, should provide the Company sufficient financing to meet its needs, there is no assurance that additional funding will be achieved and that the Company will succeed in its future operations. Actual cash requirements could differ from management&#8217;s projections due to many factors, including the success of commercialization for YUTIQ and DEXYCU, the actual costs of these commercialization efforts, additional investments in research and development programs, competing technological and market developments and the costs of any strategic acquisitions and/or development of complementary business opportunities. <font style="font-size:12pt;color:#000000;">&#160;&#160;</font></p>
CY2019 us-gaap Fiscal Period
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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;">Change in Fiscal Year</p> <p style="margin-bottom:0pt;margin-top:10pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">As previously reported, the Company changed its fiscal year end to December&#160;31 from June&#160;30 effective January 1, 2019. This Annual report on Form 10-K is for the twelve months ended December 31, 2019, which may be referred to in this report as fiscal 2019. The Company previously filed a Transition Report for the six-month transitional financial statements as of and for the period ended December&#160;31, 2018, which was referred to as the transition period. The years ended June&#160;30, 2018 and 2017 may be referred to herein as fiscal 2018 and fiscal 2017, respectively. </p>
CY2019 us-gaap Use Of Estimates
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CY2019 us-gaap Concentration Risk Credit Risk
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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;">Concentrations of Credit Risk </p> <p style="margin-bottom:0pt;margin-top:10pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and marketable securities. At December&#160;31, 2019, a total of $20.0&#160;million, representing all of the Company&#8217;s interest-bearing cash equivalent balances, were concentrated in one U.S. Government institutional money market fund that had investments consisting primarily of U.S. Government Agency debt, U.S. Treasury debt, U.S. Treasury Repurchase Agreements and U.S. Government Agency Repurchase Agreements. Generally, these deposits may be redeemed upon demand and, therefore, the Company believes they have minimal risk. The Company had no investments in marketable securities at December&#160;31, 2019 and 2018, respectively. The Company&#8217;s investment policy, approved by the Company&#8217;s Board of Directors, includes guidelines relative to diversification and maturities designed to preserve principal and liquidity. </p> <p style="margin-bottom:0pt;margin-top:10pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">As of December 31, 2019, accounts receivable from the Third-party Logistics Provider (the &#8220;3PL&#8221;), ASD Specialty Healthcare LLC, FFF Enterprises, Inc., and McKesson Specialty Care Distribution LLC accounted for 37.0%, 34.0%, 15%, and 12.0% of total accounts receivable, respectively. For the year ended December 31, 2019, revenues from the 3PL, ASD Specialty Healthcare LLC, and Alimera Sciences accounted for 56.0%, 15.0%, and 10.0% of total revenues, respectively.</p>
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us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
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10121820
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30321078
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CY2018Q4 eypt Accrued Sales Chargebacks Rebates And Other Revenue Reserves
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345000
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