$EYPT
EyePoint Pharmaceuticals, Inc.

2017 Q4 Form 10-Q Financial Statement

#000119312517337396 Filed on November 08, 2017

View on sec.gov

Income Statement

Concept 2017 Q4 2017 Q3 2016 Q3
Revenue $933.0K $385.0K $277.0K
YoY Change -84.37% 38.99% -40.56%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.470M $2.572M $3.290M
YoY Change -14.83% -21.82% 67.01%
% of Gross Profit
Research & Development $4.269M $3.819M $4.178M
YoY Change 34.88% -8.59% 19.99%
% of Gross Profit
Depreciation & Amortization $230.0K $39.00K $6.000K
YoY Change 15.0% 550.0% -79.31%
% of Gross Profit
Operating Expenses $6.741M $6.391M $7.463M
YoY Change 11.15% -14.36% 36.94%
Operating Profit -$5.808M -$6.006M -$7.186M
YoY Change 6078.72% -16.42% 44.18%
Interest Expense $30.00K $0.00 $20.00K
YoY Change 0.0% -100.0% 100.0%
% of Operating Profit
Other Income/Expense, Net $26.00K $23.00K $24.00K
YoY Change -3.7% -4.17% 140.0%
Pretax Income -$5.780M -$5.980M -$7.162M
YoY Change 8526.87% -16.5% 43.99%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income
Net Earnings -$5.782M -$5.983M -$7.162M
YoY Change 8529.85% -16.46% 45.19%
Net Earnings / Revenue -619.72% -1554.03% -2585.56%
Basic Earnings Per Share
Diluted Earnings Per Share -$1.299M -$1.518M -$2.094M
COMMON SHARES
Basic Shares Outstanding 45.26M shares 39.37M shares 34.18M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2017 Q4 2017 Q3 2016 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $12.90M $11.80M $22.50M
YoY Change -26.29% -47.56% -6.25%
Cash & Equivalents $12.88M $11.83M $14.31M
Short-Term Investments $8.200M
Other Short-Term Assets $500.0K $400.0K $500.0K
YoY Change 0.0% -20.0% -16.67%
Inventory
Prepaid Expenses
Receivables $300.0K $300.0K $500.0K
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $13.65M $12.55M $23.50M
YoY Change -26.38% -46.62% -6.6%
LONG-TERM ASSETS
Property, Plant & Equipment $293.0K $337.0K $257.0K
YoY Change 26.84% 31.13% -19.18%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $300.0K $300.0K $300.0K
YoY Change 0.0% 0.0% 0.0%
Total Long-Term Assets $552.0K $780.0K $1.430M
YoY Change -54.42% -45.45% -37.74%
TOTAL ASSETS
Total Short-Term Assets $13.65M $12.55M $23.50M
Total Long-Term Assets $552.0K $780.0K $1.430M
Total Assets $14.20M $13.33M $24.93M
YoY Change -28.1% -46.55% -9.2%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.483M $1.756M $1.015M
YoY Change 33.6% 73.0% 13.66%
Accrued Expenses $2.262M $2.513M $3.688M
YoY Change -38.55% -31.86% 78.42%
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 $4.250M $4.279M $4.842M
YoY Change -13.74% -11.63% 61.78%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $0.00 $0.00 $5.600M
YoY Change -100.0% -100.0% 0.0%
Total Long-Term Liabilities $0.00 $0.00 $5.600M
YoY Change -100.0% -100.0% 0.0%
TOTAL LIABILITIES
Total Short-Term Liabilities $4.250M $4.279M $4.842M
Total Long-Term Liabilities $0.00 $0.00 $5.600M
Total Liabilities $4.292M $4.326M $10.49M
YoY Change -13.88% -58.74% 21.4%
SHAREHOLDERS EQUITY
Retained Earnings -$322.6M -$316.8M -$299.4M
YoY Change 7.73% 5.82% 8.63%
Common Stock $331.7M $325.0M $313.0M
YoY Change 5.83% 3.83% 6.64%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $9.905M $9.001M $14.33M
YoY Change
Total Liabilities & Shareholders Equity $14.20M $13.33M $24.93M
YoY Change -28.1% -46.55% -9.2%

Cashflow Statement

Concept 2017 Q4 2017 Q3 2016 Q3
OPERATING ACTIVITIES
Net Income -$5.782M -$5.983M -$7.162M
YoY Change 8529.85% -16.46% 45.19%
Depreciation, Depletion And Amortization $230.0K $39.00K $6.000K
YoY Change 15.0% 550.0% -79.31%
Cash From Operating Activities -$5.040M -$5.968M -$6.490M
YoY Change 0.6% -8.04% 44.54%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $64.00K $0.00
YoY Change -100.0% -100.0%
Acquisitions
YoY Change
Other Investing Activities $0.00 $0.00 $5.480M
YoY Change -100.0% -100.0% -1114.81%
Cash From Investing Activities $0.00 -$64.00K $5.480M
YoY Change -100.0% -101.17% -1096.36%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $963.0K $0.00
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 6.080M 963.0K 10.00K
YoY Change 9530.0% 0.0%
NET CHANGE
Cash From Operating Activities -5.040M -5.968M -6.490M
Cash From Investing Activities 0.000 -64.00K 5.480M
Cash From Financing Activities 6.080M 963.0K 10.00K
Net Change In Cash 1.040M -5.065M -1.000M
YoY Change -139.69% 406.5% -80.12%
FREE CASH FLOW
Cash From Operating Activities -$5.040M -$5.968M -$6.490M
Capital Expenditures $0.00 $64.00K $0.00
Free Cash Flow -$5.040M -$6.032M -$6.490M
YoY Change 0.8% -7.06% 44.19%

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CY2017Q3 us-gaap Payments To Acquire Available For Sale Securities
PaymentsToAcquireAvailableForSaleSecurities
0
CY2017Q3 us-gaap License And Services Revenue
LicenseAndServicesRevenue
140000
CY2017Q3 us-gaap Nature Of Operations
NatureOfOperations
<div> <table style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="100%" border="0"> <tr style="PAGE-BREAK-INSIDE: avoid"> <td valign="top" width="4%" align="left"><b>1.</b></td> <td valign="top" align="left"><b>Operations and Basis of Presentation</b></td> </tr> </table> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 6pt; TEXT-INDENT: 4%"> The accompanying condensed consolidated financial statements of pSivida Corp. and subsidiaries (the &#x201C;Company&#x201D;) as of September&#xA0;30, 2017 and for the three months ended September&#xA0;30, 2017 and 2016 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 &#x201C;SEC&#x201D;). These financial statements should be read in conjunction with the Company&#x2019;s audited consolidated financial statements and footnotes included in its Annual Report on Form <font style="WHITE-SPACE: nowrap">10-K</font> for the fiscal year ended June&#xA0;30, 2017 (&#x201C;fiscal 2017&#x201D;). 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 June&#xA0;30, 2017, and include all adjustments, consisting only of normal recurring adjustments, that are necessary for the fair presentation of the Company&#x2019;s financial position, results of operations, comprehensive loss and cash flows for the periods indicated. The preparation of financial statements in accordance with U.S. generally accepted accounting principles (&#x201C;GAAP&#x201D;) requires management to make assumptions and estimates that affect, among other things, (i)&#xA0;reported amounts of assets and liabilities; (ii)&#xA0;disclosure of contingent assets and liabilities at the date of the consolidated financial statements; and (iii)&#xA0;reported amounts of revenues and expenses during the reporting period. The results of operations for the three months ended September&#xA0;30, 2017 are not necessarily indicative of the results that may be expected for the entire fiscal year or any future period.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> The Company develops sustained-release drug delivery products primarily for the treatment of chronic eye diseases. The Company&#x2019;s approved products and product candidates deliver drugs at a controlled and steady rate for months or years. The Company has developed three of only four sustained-release products approved by the U.S. Food and Drug Administration (&#x201C;FDA&#x201D;) for treatment of <font style="WHITE-SPACE: nowrap"><font style="WHITE-SPACE: nowrap"><font style="WHITE-SPACE: nowrap">back-of-the-eye</font></font></font> diseases. Durasert&#x2122; three-year <font style="WHITE-SPACE: nowrap">non-erodible</font> fluocinolone acetonide (&#x201C;FA&#x201D;) insert for posterior segment uveitis (&#x201C;Durasert three-year uveitis&#x201D;), the Company&#x2019;s lead product candidate, has an expected new drug application (&#x201C;NDA&#x201D;) filing date in late December 2017 or early January 2018, and ILUVIEN<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup>&#xA0;for diabetic macular edema (&#x201C;DME&#x201D;), the Company&#x2019;s lead licensed product, is sold by Alimera Sciences, Inc. (&#x201C;Alimera&#x201D;) directly in the U.S. and three European Union (&#x201C;EU&#x201D;) countries. Retisert<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup>, an earlier generation product approved in 2005 by the FDA for the treatment of posterior segment uveitis, is sold in the U.S. by Bausch&#xA0;&amp; Lomb Incorporated (&#x201C;Bausch&#xA0;&amp; Lomb&#x201D;). The Company&#x2019;s development programs are focused primarily on developing sustained release products that utilize its Durasert technology platform to deliver approved drugs to treat chronic diseases. The Company&#x2019;s strategy includes developing products independently while continuing to leverage its technology platforms through collaborations and license agreements.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> Durasert three-year uveitis, the Company&#x2019;s most advanced development product candidate, is designed to treat chronic <font style="WHITE-SPACE: nowrap">non-infectious</font> uveitis affecting the posterior segment of the eye (&#x201C;posterior segment uveitis&#x201D;) for three years from a single administration. Injected into the eye in an office visit, this product candidate is a tiny micro-insert that delivers a micro-dose of a corticosteroid to the back of the eye on a sustained constant (zero order release) basis. The Company is developing Durasert three-year uveitis independently.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> Both Phase 3 clinical trials investigating Durasert three-year uveitis met their primary efficacy endpoint of prevention of recurrence of disease through six months with statistical significance (p &lt; 0.001, intent to treat analysis) and with safety data consistent with the known effects of ocular corticosteroid use. The same statistical significance for efficacy and encouraging safety results was maintained through 12 months of <font style="WHITE-SPACE: nowrap">follow-up</font> for the first Phase 3 clinical trial, and <font style="WHITE-SPACE: nowrap">read-out</font> at 12 months of <font style="WHITE-SPACE: nowrap">follow-up</font> for the second Phase 3 trial is expected in the first half of calendar 2018. The Company plans to file an NDA with the FDA in late December 2017 or early January 2018. In Europe, the Company filed a marketing authorization application (&#x201C;MAA&#x201D;) in June 2017 and subsequently withdrew the application after <font style="WHITE-SPACE: nowrap">out-licensing</font> the European rights for Durasert three-year uveitis to Alimera. Alimera plans to submit the Durasert three-year uveitis data under its existing ILUVIEN MAA and, if approved, to commercialize the uveitis indication under the ILUVIEN trademark.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> ILUVIEN is an injectable, sustained-release micro-insert that provides three years of treatment of DME from a single injection. ILUVIEN is based on the same technology as the Durasert three-year uveitis insert and delivers the same corticosteroid, FA. ILUVIEN was developed in collaboration with, and is licensed to and sold by Alimera. ILUVIEN has been sold directly in the United Kingdom (&#x201C;U.K.&#x201D;) and Germany since 2013 and in the U.S. and Portugal since 2015, and also has marketing approvals in 14 other European countries. Alimera has sublicensed distribution, regulatory and reimbursement matters for ILUVIEN in Australia and New Zealand, Canada, Italy, Spain, France and numerous countries in the Middle East.</p> <p style="MARGIN-BOTTOM: 0px; FONT-SIZE: 1px; MARGIN-TOP: 12px"> &#xA0;</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 0pt; TEXT-INDENT: 4%"> The Company&#x2019;s development programs are focused primarily on developing sustained release drug products using its proven Durasert technology platform to deliver small molecule drugs to treat uveitis, wet <font style="WHITE-SPACE: nowrap">age-related</font> macular degeneration, glaucoma, osteoarthritis and other diseases. A sustained release implant, surgically administered in an outpatient procedure, delivering a corticosteroid to treat pain associated with severe knee osteoarthritis, was jointly developed by the Company and Hospital for Special Surgery and is currently being evaluated in an investigator-sponsored safety and tolerability study.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> The Company has financed its operations primarily from sales of equity securities and the receipt of license fees, milestone payments, research and development funding and royalty income from its collaboration partners. The Company has a history of operating losses and, to date, has not had significant recurring cash inflows from revenue. The Company&#x2019;s anticipated recurring use of cash to fund operations in combination with no probable source of additional capital raises substantial doubt about its ability to continue as a going concern for one year from the issuance of its financial statements. The Company believes that its cash and cash equivalents of $11.8&#xA0;million at September&#xA0;30, 2017, together with subsequent gross cash proceeds of approximately $6.2&#xA0;million received from additional utilization of its <font style="WHITE-SPACE: nowrap"><font style="WHITE-SPACE: nowrap">at-the-market</font></font> (&#x201C;ATM&#x201D;) equity program (refer to Note 7) and expected proceeds from existing collaboration agreements, will enable the Company to maintain its current and planned operations (including its two Durasert three-year uveitis Phase 3 clinical trials) through approximately the second quarter of calendar year 2018. In order to extend the Company&#x2019;s ability to fund its operations beyond then, including its planned commercial launch of Durasert three-year uveitis in the U.S. if approved by the FDA, management&#x2019;s plans include accessing additional equity financing from the sale of its common stock through an underwritten public offering, its ATM program or other financing transactions and/or, as applicable, reducing or deferring operating expenses. On November&#xA0;3, 2017, the Company filed a preliminary proxy statement with the SEC in connection with its annual meeting of stockholders to be held on December&#xA0;15, 2017, which includes proposals to (i)&#xA0;ratify the ATM sales pursuant to Australian Securities Exchange (&#x201C;ASX&#x201D;) Listing Rule 7.4 in order to refresh the Company&#x2019;s capacity to issue shares of common stock up to 15% of the Company&#x2019;s issued capital without prior stockholder approval pursuant to ASX Listing Rule 7.1 and (ii)&#xA0;approve the issuance of equity securities up to an additional 10% of the Company&#x2019;s issued capital which, if approved, would permit the Company to issue up to 25% of its issued and outstanding capital without any further stockholder approval in the next 12 months, unless such stockholder approval is required by applicable law, the rules of the ASX or the rules of another stock exchange on which the Company&#x2019;s securities may be listed at the time. The timing and extent of the Company&#x2019;s implementation of these plans is expected to depend on the amount and timing of cash receipts from existing or any future collaboration or other agreements and/or proceeds from any financing transactions. There is no assurance that the Company will receive significant revenues from the commercialization of ILUVIEN or financing from any other sources.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> New accounting pronouncements are issued periodically by the Financial Accounting Standards Board (&#x201C;FASB&#x201D;) 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&#x2019;s financial position, results of operations and cash flows or do not apply to the Company&#x2019;s operations.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> In May 2014, the FASB issued Accounting Standards Update <font style="WHITE-SPACE: nowrap">No.&#xA0;2014-09,</font> <i>Revenue from Contracts with Customers</i> (Topic 606) (&#x201C;ASU <font style="WHITE-SPACE: nowrap">2014-09&#x201D;),</font> which requires an entity to recognize revenue in an amount that reflects the consideration to which the entity expects to be entitled in exchange for the transfer of promised goods or services to customers. The standard will replace most existing revenue recognition guidance in U.S. GAAP. In August 2015, the FASB issued ASU <font style="WHITE-SPACE: nowrap">2015-14,</font> which officially deferred the effective date of ASU <font style="WHITE-SPACE: nowrap">2014-09</font> by one year, while also permitting early adoption. As a result, ASU <font style="WHITE-SPACE: nowrap">2014-09</font> will become effective on July&#xA0;1, 2018, with early adoption permitted on July&#xA0;1, 2017. The standard permits the use of either the retrospective or cumulative effect transition method. The Company is evaluating the impact the adoption of this standard will have on its consolidated financial statements.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> In February 2016, the FASB issued ASU <font style="WHITE-SPACE: nowrap">No.&#xA0;2016-02,</font> <i>Leases</i>. The new standard establishes a <font style="WHITE-SPACE: nowrap"><font style="WHITE-SPACE: nowrap">right-of-use</font></font> (&#x201C;ROU&#x201D;) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December&#xA0;15, 2018, including interim periods within those fiscal years. As a result, ASU <font style="WHITE-SPACE: nowrap">2016-02</font> will become effective on July&#xA0;1, 2019. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is evaluating the impact the adoption of this standard will have on its consolidated financial statements.</p> </div>
CY2017Q3 us-gaap Net Cash Provided By Used In Investing Activities Continuing Operations
NetCashProvidedByUsedInInvestingActivitiesContinuingOperations
-64000
CY2017Q3 us-gaap Net Cash Provided By Used In Operating Activities Continuing Operations
NetCashProvidedByUsedInOperatingActivitiesContinuingOperations
-5968000
CY2017Q3 us-gaap Operating Expenses
OperatingExpenses
6391000
CY2017Q3 us-gaap Net Cash Provided By Used In Financing Activities Continuing Operations
NetCashProvidedByUsedInFinancingActivitiesContinuingOperations
963000
CY2017Q3 us-gaap Net Income Loss
NetIncomeLoss
-5983000
CY2017Q3 us-gaap Operating Income Loss
OperatingIncomeLoss
-6006000
CY2017Q3 us-gaap Other Comprehensive Income Loss Net Of Tax
OtherComprehensiveIncomeLossNetOfTax
4000
CY2017Q3 us-gaap Proceeds From Issuance Of Common Stock
ProceedsFromIssuanceOfCommonStock
963000
CY2017Q3 us-gaap Proceeds From Sale Of Property Plant And Equipment
ProceedsFromSaleOfPropertyPlantAndEquipment
0
CY2017Q3 us-gaap Proceeds From Sale And Maturity Of Marketable Securities
ProceedsFromSaleAndMaturityOfMarketableSecurities
0
CY2017Q3 us-gaap Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
0
CY2017Q3 us-gaap Research And Development Expense
ResearchAndDevelopmentExpense
3819000
CY2017Q3 us-gaap Royalty Revenue
RoyaltyRevenue
245000
CY2017Q3 us-gaap Revenues
Revenues
385000
CY2017Q3 us-gaap Share Based Compensation
ShareBasedCompensation
681000
CY2017Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod
1155530 shares
CY2017Q3 us-gaap Stock Issued During Period Value New Issues
StockIssuedDuringPeriodValueNewIssues
963000
CY2017Q3 dei Trading Symbol
TradingSymbol
PSDV
CY2017Q3 us-gaap Weighted Average Number Of Share Outstanding Basic And Diluted
WeightedAverageNumberOfShareOutstandingBasicAndDiluted
39430000 shares
CY2017Q3 psdv Finite Lived Intangible Assets Foreign Currency Translation Of Accumulated Amortization
FiniteLivedIntangibleAssetsForeignCurrencyTranslationOfAccumulatedAmortization
587000
CY2017Q3 psdv Increase Decrease In Deferred Rent
IncreaseDecreaseInDeferredRent
-4000
CY2017Q3 psdv Warrants To Purchase Common Shares Expired
WarrantsToPurchaseCommonSharesExpired
623605 shares
CY2017Q3 psdv Exercise Price Of Expired Warrants
ExercisePriceOfExpiredWarrants
2.50

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