2015 Q4 Form 10-Q Financial Statement

#000119312516455089 Filed on February 09, 2016

View on sec.gov

Income Statement

Concept 2015 Q4 2014 Q4
Revenue $526.0K $521.0K
YoY Change 0.96% -11.99%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.040M $1.870M
YoY Change 9.09% 9.36%
% of Gross Profit
Research & Development $3.721M $2.767M
YoY Change 34.48% 10.95%
% of Gross Profit
Depreciation & Amortization $220.0K $210.0K
YoY Change 4.76% -8.7%
% of Gross Profit
Operating Expenses $5.764M $4.637M
YoY Change 24.3% 12.19%
Operating Profit -$5.238M -$4.116M
YoY Change 27.26% 16.24%
Interest Expense $10.00K $0.00
YoY Change
% of Operating Profit
Other Income/Expense, Net $10.00K $3.000K
YoY Change 233.33% 200.0%
Pretax Income -$5.228M -$4.113M
YoY Change 27.11% 16.19%
Income Tax -$42.00K -$38.00K
% Of Pretax Income
Net Earnings -$5.186M -$4.075M
YoY Change 27.26% 15.96%
Net Earnings / Revenue -985.93% -782.15%
Basic Earnings Per Share -$0.18 -$0.14
Diluted Earnings Per Share -$0.18 -$0.14
COMMON SHARES
Basic Shares Outstanding 29.44M shares 29.37M shares
Diluted Shares Outstanding 29.44M shares 29.37M shares

Balance Sheet

Concept 2015 Q4 2014 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $21.10M $35.70M
YoY Change -40.9% 127.39%
Cash & Equivalents $11.21M $29.75M
Short-Term Investments $9.900M $5.900M
Other Short-Term Assets $200.0K $900.0K
YoY Change -77.78% 0.0%
Inventory
Prepaid Expenses
Receivables $600.0K $700.0K
Other Receivables $0.00 $0.00
Total Short-Term Assets $21.86M $37.35M
YoY Change -41.46% 116.74%
LONG-TERM ASSETS
Property, Plant & Equipment $311.0K $265.0K
YoY Change 17.36% 99.25%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $300.0K $300.0K
YoY Change 0.0% 0.0%
Total Long-Term Assets $2.088M $2.832M
YoY Change -26.27% -21.05%
TOTAL ASSETS
Total Short-Term Assets $21.86M $37.35M
Total Long-Term Assets $2.088M $2.832M
Total Assets $23.95M $40.18M
YoY Change -40.39% 93.0%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $303.0K $384.0K
YoY Change -21.09% 118.18%
Accrued Expenses $3.552M $1.820M
YoY Change 95.16% 51.16%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $3.883M $2.273M
YoY Change 70.83% 5.67%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $5.600M $5.600M
YoY Change 0.0% -8.2%
Total Long-Term Liabilities $5.600M $5.600M
YoY Change 0.0% -8.2%
TOTAL LIABILITIES
Total Short-Term Liabilities $3.883M $2.273M
Total Long-Term Liabilities $5.600M $5.600M
Total Liabilities $9.526M $7.905M
YoY Change 20.51% -3.83%
SHAREHOLDERS EQUITY
Retained Earnings -$280.8M -$260.5M
YoY Change 7.78% -3.82%
Common Stock $294.3M $29.00K
YoY Change 1014779.31% 7.41%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $14.42M $32.28M
YoY Change
Total Liabilities & Shareholders Equity $23.95M $40.18M
YoY Change -40.39% 93.0%

Cashflow Statement

Concept 2015 Q4 2014 Q4
OPERATING ACTIVITIES
Net Income -$5.186M -$4.075M
YoY Change 27.26% 15.96%
Depreciation, Depletion And Amortization $220.0K $210.0K
YoY Change 4.76% -8.7%
Cash From Operating Activities -$3.180M $21.25M
YoY Change -114.96% -1044.44%
INVESTING ACTIVITIES
Capital Expenditures -$30.00K -$20.00K
YoY Change 50.0% 100.0%
Acquisitions
YoY Change
Other Investing Activities $0.00 -$3.040M
YoY Change -100.0% -330.3%
Cash From Investing Activities -$20.00K -$3.060M
YoY Change -99.35% -333.59%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 330.0K 180.0K
YoY Change 83.33% -88.89%
NET CHANGE
Cash From Operating Activities -3.180M 21.25M
Cash From Investing Activities -20.00K -3.060M
Cash From Financing Activities 330.0K 180.0K
Net Change In Cash -2.870M 18.37M
YoY Change -115.62% 2601.47%
FREE CASH FLOW
Cash From Operating Activities -$3.180M $21.25M
Capital Expenditures -$30.00K -$20.00K
Free Cash Flow -$3.150M $21.27M
YoY Change -114.81% -1049.55%

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<div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt"> <b>1. Operations and Basis of Presentation</b></p> <!-- xbrl,body --> <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 December&#xA0;31, 2015 and for the three and six months ended December&#xA0;31, 2015 and 2014 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 10-K for the fiscal year ended June&#xA0;30, 2015. 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, 2015, 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) income 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 and six months ended December&#xA0;31, 2015 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. Its products 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 back-of-the-eye diseases. Medidur&#x2122; for posterior uveitis, the Company&#x2019;s lead product candidate, is in pivotal Phase III clinical trials, and ILUVIEN<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> for diabetic macular edema (&#x201C;DME&#x201D;), its lead licensed product, is sold in the U.S. and three European Union (&#x201C;EU&#x201D;) countries. The Company&#x2019;s pre-clinical development program is focused primarily on developing products utilizing the Company&#x2019;s two core technology platforms, Durasert&#x2122; and Tethadur&#x2122;. The Company&#x2019;s strategy includes developing products independently while continuing to leverage its technology platforms through collaborations and license agreements as appropriate.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> Medidur, the Company&#x2019;s most advanced development product, is a sustained-release micro-insert designed to treat chronic non-infectious uveitis affecting the posterior segment of the eye (&#x201C;posterior uveitis&#x201D;). Medidur, which is designed to provide sustained treatment for three years from a single injection, is in two Phase III trials. In December 2015, the Company announced positive top-line results from the first Phase III trial, which met its primary efficacy endpoint with high statistical significance and achieved positive safety results. The second Phase III trial is ongoing. Assuming favorable results from the second trial, the Company plans to file a new drug application (&#x201C;NDA&#x201D;) with the FDA in the first half of 2017 based on the results from both trials, data from a short-duration utilization study of its redesigned proprietary inserter and data referenced from the Phase III trials of ILUVIEN. Due to the high level of statistical significance achieved in the first trial, the Company plans to file for EU marketing approval based on the results of that single Phase III trial rather than both trials. The Company is developing Medidur independently.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> ILUVIEN, the Company&#x2019;s most recently approved product, is a sustained-release micro-insert that provides treatment of DME. Like Medidur, it is injected into the eye in an office visit and provides three years of treatment from a single injection. ILUVIEN is licensed to and sold by Alimera Sciences, Inc. (&#x201C;Alimera&#x201D;), and the Company is entitled to a share of the net profits (as defined) from Alimera&#x2019;s sales of ILUVIEN on a quarter-by-quarter, country-by-country basis. ILUVIEN was launched in the U.S. in late February 2015, where it is indicated for the treatment of DME in patients previously treated with a course of corticosteroids without a clinically significant rise in intraocular pressure. ILUVIEN has been commercially available in the United Kingdom and Germany since June 2013 and in Portugal since January 2015. ILUVIEN has marketing approvals in 17 EU countries for the treatment of chronic DME considered insufficiently responsive to available therapies.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> The Company&#x2019;s FDA-approved Retisert<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> is an implant that provides sustained release treatment of posterior uveitis for approximately two and a half years. It is licensed to Bausch&#xA0;&amp; Lomb, and the Company receives royalties from its sales.</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 pre-clinical development program is focused on developing products using its Durasert&#x2122; and Tethadur&#x2122; technology platforms to deliver drugs and biologics to treat wet and dry age-related macular degeneration (&#x201C;AMD&#x201D;), glaucoma, osteoarthritis and other diseases.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> The Company has a history of operating losses and has financed its operations primarily from the receipt of license fees, milestone payments, research and development funding and royalty income from its collaboration partners and from proceeds of sales of its equity securities. The Company believes that its cash, cash equivalents and marketable securities of $21.1 million at December&#xA0;31, 2015, together with the estimated net proceeds of approximately $16.4 million from an underwritten public offering of common shares in January 2016, as well as expected cash inflows under existing collaboration agreements, will enable the Company to maintain its current and planned operations (including its two Medidur Phase III clinical trials) into the fourth quarter of calendar year 2017. This estimate excludes any potential future receipts from the commercialization of ILUVIEN. 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 ILUVIEN collaboration agreement, as well as proceeds from any future collaboration or other agreements and/or financing transactions.</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 No.&#xA0;2014-09, <i>Revenue from Contracts with Customers</i> (Topic 606) (&#x201C;ASU 2014-09&#x201D;), 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 2015-14, which officially deferred the effective date of ASU 2014-09 by one year, while also permitting early adoption. As a result, ASU 2014-09 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 this standard will have on its financial statements.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> In August 2014, the FASB issued ASU 2014-15, <i>Presentation of Financial Statements &#x2013; Going Concern</i>. ASU 2014-15 provides guidance around management&#x2019;s responsibility to evaluate whether there is substantial doubt about an entity&#x2019;s ability to continue as a going concern and to provide related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company&#x2019;s ability to continue as a going concern within one year from the date the financial statements are issued. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December&#xA0;15, 2016. Early adoption is permitted. The Company is evaluating the potential impact of adopting this standard on its financial statements.</p> </div>
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