$EYPT
EyePoint Pharmaceuticals, Inc.

2013 Q2 Form 10-K Financial Statement

#000119312514338993 Filed on September 11, 2014

View on sec.gov

Income Statement

Concept 2013 Q2 2013 Q1 2012 Q4
Revenue $492.0K $513.0K $585.0K
YoY Change -29.61% -4.65% -7.14%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.150M $1.740M $1.660M
YoY Change 34.38% -1.14% 14.48%
% of Gross Profit
Research & Development $2.320M $1.587M $1.575M
YoY Change 64.54% 5.24% -20.93%
% of Gross Profit
Depreciation & Amortization $250.0K $250.0K $250.0K
YoY Change -10.71% 8.7% -71.26%
% of Gross Profit
Operating Expenses $4.470M $3.325M $3.233M
YoY Change 48.5% 1.84% -82.31%
Operating Profit -$3.981M -$2.812M -$2.648M
YoY Change 72.34% 3.12% -84.99%
Interest Expense $0.00 $0.00 $0.00
YoY Change -100.0% -100.0% -100.0%
% of Operating Profit
Other Income/Expense, Net $0.00 $3.000K $3.000K
YoY Change -72.73% -97.84%
Pretax Income -$3.980M -$2.809M -$2.645M
YoY Change 73.04% 3.42% -84.89%
Income Tax -$30.00K -$15.00K -$37.00K
% Of Pretax Income
Net Earnings -$3.947M -$2.794M -$2.608M
YoY Change 74.49% 4.02% -85.06%
Net Earnings / Revenue -802.24% -544.64% -445.81%
Basic Earnings Per Share
Diluted Earnings Per Share -$1.695M -$1.197M -$1.120M
COMMON SHARES
Basic Shares Outstanding 23.30M shares 23.30M shares 23.30M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2013 Q2 2013 Q1 2012 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $10.30M $13.70M $15.70M
YoY Change -29.45% -16.97% -16.04%
Cash & Equivalents $6.899M $7.998M $9.409M
Short-Term Investments $3.400M $5.700M $6.300M
Other Short-Term Assets $1.600M $500.0K $100.0K
YoY Change 300.0% 25.0% -50.0%
Inventory
Prepaid Expenses
Receivables $600.0K $1.000M $900.0K
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $12.46M $15.21M $16.81M
YoY Change -21.9% -15.06% -15.53%
LONG-TERM ASSETS
Property, Plant & Equipment $179.0K $223.0K $277.0K
YoY Change -46.57% -44.25% -30.75%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $200.0K $100.0K $100.0K
YoY Change 100.0% 0.0% 0.0%
Total Long-Term Assets $3.785M $3.915M $4.232M
YoY Change -18.39% -20.1% -15.36%
TOTAL ASSETS
Total Short-Term Assets $12.46M $15.21M $16.81M
Total Long-Term Assets $3.785M $3.915M $4.232M
Total Assets $16.25M $19.12M $21.04M
YoY Change -21.11% -16.14% -15.49%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $671.0K $355.0K $215.0K
YoY Change 70.3% 18.33% -28.33%
Accrued Expenses $1.894M $1.437M $1.084M
YoY Change 211.51% 79.63% 54.86%
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 $3.303M $2.685M $2.083M
YoY Change 3.93% 3.27% -19.88%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $5.200M $5.200M $5.100M
YoY Change 36.84% 10.64% 13.33%
Total Long-Term Liabilities $5.200M $5.200M $5.100M
YoY Change 36.84% 10.64% 13.33%
TOTAL LIABILITIES
Total Short-Term Liabilities $3.303M $2.685M $2.083M
Total Long-Term Liabilities $5.200M $5.200M $5.100M
Total Liabilities $8.549M $7.879M $7.232M
YoY Change 22.81% 7.93% 0.44%
SHAREHOLDERS EQUITY
Retained Earnings -$263.7M -$259.7M -$256.9M
YoY Change 4.73%
Common Stock $23.00K $23.00K $23.00K
YoY Change 9.52%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $7.700M $11.24M $13.81M
YoY Change
Total Liabilities & Shareholders Equity $16.25M $19.12M $21.04M
YoY Change -21.11% -16.14% -15.49%

Cashflow Statement

Concept 2013 Q2 2013 Q1 2012 Q4
OPERATING ACTIVITIES
Net Income -$3.947M -$2.794M -$2.608M
YoY Change 74.49% 4.02% -85.06%
Depreciation, Depletion And Amortization $250.0K $250.0K $250.0K
YoY Change -10.71% 8.7% -71.26%
Cash From Operating Activities -$3.380M -$1.970M -$1.780M
YoY Change 83.7% -7.94% -24.58%
INVESTING ACTIVITIES
Capital Expenditures -$20.00K -$10.00K -$40.00K
YoY Change 100.0% -50.0% -75.0%
Acquisitions
YoY Change
Other Investing Activities $2.300M $580.0K $2.900M
YoY Change 2200.0% 383.33% 158.93%
Cash From Investing Activities $2.280M $560.0K $2.870M
YoY Change 2433.33% 409.09% 198.96%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 0.000 0.000 -70.00K
YoY Change
NET CHANGE
Cash From Operating Activities -3.380M -1.970M -1.780M
Cash From Investing Activities 2.280M 560.0K 2.870M
Cash From Financing Activities 0.000 0.000 -70.00K
Net Change In Cash -1.100M -1.410M 1.020M
YoY Change -37.14% -30.54% -172.86%
FREE CASH FLOW
Cash From Operating Activities -$3.380M -$1.970M -$1.780M
Capital Expenditures -$20.00K -$10.00K -$40.00K
Free Cash Flow -$3.360M -$1.960M -$1.740M
YoY Change 83.61% -7.55% -20.91%

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<div> <table style="BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="100%" border="0"> <tr> <td valign="top" width="4%" align="left"><font style="FONT-FAMILY: Times New Roman" size="2"><b>1.</b></font></td> <td valign="top" align="left"><font style="FONT-FAMILY: Times New Roman" size="2"><b>Operations</b></font></td> </tr> </table> <!-- xbrl,body --> <p style="MARGIN-BOTTOM: 0px; PADDING-BOTTOM: 0px; MARGIN-TOP: 6px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2">pSivida Corp. (together with its subsidiaries, the &#x201C;Company&#x201D;), incorporated in Delaware, develops tiny, sustained-release products designed to deliver drugs and biologics at a controlled and steady rate for weeks, months or years. The Company&#x2019;s strategy is to use its Durasert&#x2122; and Tethadur&#x2122; drug delivery technologies to independently develop products that deliver proven drugs and biologics, while continuing to leverage these technologies through collaboration and license agreements. The Company is focused on treatment of chronic diseases of the back of the eye and is also exploring applications outside ophthalmology. The Company&#x2019;s lead product candidate Medidur&#x2122; is in a pivotal Phase III clinical trial, its lead licensed product ILUVIEN<font style="FONT-FAMILY: Times New Roman" size="1"><sup style="VERTICAL-ALIGN: baseline; POSITION: relative; BOTTOM: 0.8ex">&#xAE;</sup></font> has been approved in the European Union (&#x201C;EU&#x201D;) and is pending approval with the U.S. Food and Drug Administration (&#x201C;FDA&#x201D;), and the Company&#x2019;s pipeline includes potential product candidates at earlier stages of development. Using different generations of the Durasert technology, the Company developed three of the four sustained-release products for treatment of retinal diseases approved in the U.S. or EU.</font></p> <p style="MARGIN-BOTTOM: 0px; PADDING-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2"><i>Medidur</i>&#x2122; is an injectable, sustained-release micro-insert designed to treat chronic, non-infectious uveitis affecting the posterior of the eye (&#x201C;posterior uveitis&#x201D;) over a period of up to three years. Medidur uses the same Durasert micro-insert used in ILUVIEN and delivers a lower dose of the same drug as the Company&#x2019;s FDA-approved Retisert<font style="FONT-FAMILY: Times New Roman" size="1"><sup style="VERTICAL-ALIGN: baseline; POSITION: relative; BOTTOM: 0.8ex">&#xAE;</sup></font> for posterior uveitis, which is licensed to Bausch&#xA0;&amp; Lomb. Although the Company originally planned to seek FDA approval of Medidur based on two Phase III clinical trials, the Company now expects to seek approval based on safety and efficacy data from its single ongoing Phase III trial, with supplemental clinical data on the safety and usability of its proprietary inserter, if ILUVIEN is approved by the FDA later this year.&#xA0;The Company plans to have a confirmatory meeting with the FDA with respect to the Company&#x2019;s regulatory strategy. If the FDA does not approve the Company&#x2019;s regulatory strategy, the Company may be required to complete a second Phase III trial for Medidur in order to submit for FDA approval, which would increase the development time and cost of Medidur. The Company is developing Medidur independently.</font></p> <p style="MARGIN-BOTTOM: 0px; PADDING-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2"><i>ILUVIEN</i><font style="FONT-FAMILY: Times New Roman" size="1"><sup style="VERTICAL-ALIGN: baseline; POSITION: relative; BOTTOM: 0.8ex">&#xAE;</sup></font>, the Company&#x2019;s lead licensed product, is an injectable, sustained-release micro-insert that provides treatment over a period of up to three years of vision impairment associated with diabetic macular edema (&#x201C;DME&#x201D;). ILUVIEN is licensed to and sold by Alimera Sciences, Inc. (&#x201C;Alimera&#x201D;), and the Company is entitled to 20% of the net profits (as defined) from Alimera&#x2019;s sales of ILUVIEN on a country-by-country basis. The Company is also entitled to a one-time $25.0 million milestone payment from Alimera if ILUVIEN is approved by the FDA.</font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2">ILUVIEN is commercially available in the United Kingdom (&#x201C;U.K.&#x201D;) and Germany for the treatment of chronic DME considered insufficiently responsive to available therapies, and Alimera expects to launch in France and Portugal in late 2014. ILUVIEN has marketing authorization in six other EU countries and is pending authorization in seven more EU countries.</font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2">Alimera is also seeking marketing approval for ILUVIEN for DME in the U.S. Alimera entered into labeling discussions with the FDA in December 2013 and refiled its New Drug Application (&#x201C;NDA&#x201D;) with the FDA in March 2014. The FDA set a new Prescription Drug User Fee Act goal date of September&#xA0;26, 2014. The NDA resubmission responded to issues raised in the FDA&#x2019;s October 2013 Complete Response Letter (&#x201C;CRL&#x201D;).</font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2">The Company&#x2019;s pre-clinical research is primarily focused on its Tethadur and Durasert technology platforms. The Company is seeking to develop products using Tethadur, part of its BioSilicon&#x2122; technology, to provide sustained delivery of peptides, proteins, antibodies and other large biologic molecules. The Company is also researching the use of its Durasert technology, in some instances in combination with its BioSilicon technology, to provide sustained delivery of therapeutic agents to treat wet and dry age-related macular degeneration (&#x201C;AMD&#x201D;), osteoarthritis and glaucoma, as well as to provide systemic delivery of biologics.</font></p> <p style="MARGIN-BOTTOM: 0px; FONT-SIZE: 1px; MARGIN-TOP: 12px"> &#xA0;</p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2">The Company has a history of operating losses and has financed its operations primarily from the proceeds of sales of its equity securities and the receipt of license fees, research and development funding and royalty income from its collaboration partners. The Company believes that its cash, cash equivalents and marketable securities of $18.3 million at June&#xA0;30, 2014, together with expected cash inflows under existing collaboration agreements, will enable the Company to maintain its current and planned operations through the third quarter of calendar year 2015. This estimate includes expected costs of clinical development of Medidur, but excludes any potential milestone or net profits receipts under the Alimera collaboration agreement. The Company&#x2019;s ability to fund its planned operations beyond then, including completion of clinical development of Medidur, is expected to depend on the amount and timing of cash receipts under the Alimera collaboration agreement, as well as proceeds from any future collaboration or other agreements and/or financing transactions.</font></p> </div>
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<div> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 18px"><font style="FONT-FAMILY: Times New Roman" size="2"><b>Concentrations of Risk</b></font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 6px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2">Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and marketable securities. At June&#xA0;30, 2014, all of the Company&#x2019;s interest-bearing cash equivalent balances, aggregating $14.3 million, were concentrated in one institutional money market fund that has investments consisting primarily of certificates of deposit, commercial paper, time deposits and treasury repurchase agreements. Generally, these deposits may be redeemed upon demand and, therefore, the Company believes they bear minimal risk. Marketable securities at June&#xA0;30, 2014 and 2013 consist of investment-grade corporate bonds and commercial paper. The Company&#x2019;s investment policy, approved by the Board of Directors, includes guidelines relative to diversification and maturities designed to preserve principal and liquidity.</font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2">Pfizer revenues, which were inconsequential in fiscal 2014, accounted for $368,000, or 17%, of total revenues in fiscal 2013 and $754,000, or 21%, of total revenues in fiscal 2012. Bausch&#xA0;&amp; Lomb accounted for $1.3 million, or 38% of total revenues in fiscal 2014, $1.4 million, or 64%, of total revenues in fiscal 2013 and $1.4 million, or 41%, of total revenues in fiscal 2012. A completed feasibility study agreement accounted for $1.7 million, or 49%, of total revenues in fiscal 2014.</font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2">Bausch&#xA0;&amp; Lomb accounted for $302,000, or 58% of total accounts receivable at June&#xA0;30, 2014 and $316,000, or 53% of total accounts receivable at June&#xA0;30, 2013.</font></p> </div>
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