2015 Q1 Form 10-Q Financial Statement

#000119312515179302 Filed on May 08, 2015

View on sec.gov

Income Statement

Concept 2015 Q1 2014 Q1
Revenue $328.0K $1.992M
YoY Change -83.53% 288.3%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.040M $1.950M
YoY Change 4.62% 12.07%
% of Gross Profit
Research & Development $3.339M $2.269M
YoY Change 47.16% 42.97%
% of Gross Profit
Depreciation & Amortization $210.0K $220.0K
YoY Change -4.55% -12.0%
% of Gross Profit
Operating Expenses $5.380M $4.211M
YoY Change 27.76% 26.65%
Operating Profit -$5.052M -$2.219M
YoY Change 127.67% -21.09%
Interest Expense $10.00K $0.00
YoY Change
% of Operating Profit
Other Income/Expense, Net $10.00K $1.000K
YoY Change 900.0% -66.67%
Pretax Income -$5.042M -$2.218M
YoY Change 127.32% -21.04%
Income Tax -$44.00K -$31.00K
% Of Pretax Income
Net Earnings -$4.998M -$2.187M
YoY Change 128.53% -21.73%
Net Earnings / Revenue -1523.78% -109.79%
Basic Earnings Per Share -$0.17 -$0.08
Diluted Earnings Per Share -$0.17 -$0.08
COMMON SHARES
Basic Shares Outstanding 29.41M shares 27.67M shares
Diluted Shares Outstanding 29.41M shares 27.67M shares

Balance Sheet

Concept 2015 Q1 2014 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $31.70M $21.30M
YoY Change 48.83% 55.47%
Cash & Equivalents $23.01M $18.56M
Short-Term Investments $8.700M $2.700M
Other Short-Term Assets $1.000M $600.0K
YoY Change 66.67% 20.0%
Inventory
Prepaid Expenses
Receivables $400.0K $600.0K
Other Receivables $0.00 $0.00
Total Short-Term Assets $33.08M $22.46M
YoY Change 47.26% 47.73%
LONG-TERM ASSETS
Property, Plant & Equipment $280.0K $292.0K
YoY Change -4.11% 30.94%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $300.0K $300.0K
YoY Change 0.0% 200.0%
Total Long-Term Assets $2.625M $3.559M
YoY Change -26.24% -9.09%
TOTAL ASSETS
Total Short-Term Assets $33.08M $22.46M
Total Long-Term Assets $2.625M $3.559M
Total Assets $35.70M $26.02M
YoY Change 37.2% 36.09%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $812.0K $761.0K
YoY Change 6.7% 114.37%
Accrued Expenses $1.371M $1.203M
YoY Change 13.97% -16.28%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $2.218M $2.276M
YoY Change -2.55% -15.23%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $5.600M $5.400M
YoY Change 3.7% 3.85%
Total Long-Term Liabilities $5.600M $5.400M
YoY Change 3.7% 3.85%
TOTAL LIABILITIES
Total Short-Term Liabilities $2.218M $2.276M
Total Long-Term Liabilities $5.600M $5.400M
Total Liabilities $7.855M $7.675M
YoY Change 2.35% -2.59%
SHAREHOLDERS EQUITY
Retained Earnings -$265.5M -$273.0M
YoY Change -2.76% 5.13%
Common Stock $29.00K $29.00K
YoY Change 0.0% 26.09%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $27.85M $18.35M
YoY Change
Total Liabilities & Shareholders Equity $35.70M $26.02M
YoY Change 37.2% 36.09%

Cashflow Statement

Concept 2015 Q1 2014 Q1
OPERATING ACTIVITIES
Net Income -$4.998M -$2.187M
YoY Change 128.53% -21.73%
Depreciation, Depletion And Amortization $210.0K $220.0K
YoY Change -4.55% -12.0%
Cash From Operating Activities -$3.960M -$1.860M
YoY Change 112.9% -5.58%
INVESTING ACTIVITIES
Capital Expenditures -$40.00K -$60.00K
YoY Change -33.33% 500.0%
Acquisitions
YoY Change
Other Investing Activities -$2.740M -$2.210M
YoY Change 23.98% -481.03%
Cash From Investing Activities -$2.780M -$2.260M
YoY Change 23.01% -503.57%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $7.000M
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 0.000 7.460M
YoY Change -100.0%
NET CHANGE
Cash From Operating Activities -3.960M -1.860M
Cash From Investing Activities -2.780M -2.260M
Cash From Financing Activities 0.000 7.460M
Net Change In Cash -6.740M 3.340M
YoY Change -301.8% -336.88%
FREE CASH FLOW
Cash From Operating Activities -$3.960M -$1.860M
Capital Expenditures -$40.00K -$60.00K
Free Cash Flow -$3.920M -$1.800M
YoY Change 117.78% -8.16%

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<div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 12pt; MARGIN-TOP: 0pt"> &#xA0;</p> <table style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="100%" border="0"> <tr> <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> <!-- 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 March&#xA0;31, 2015 and for the three and nine months ended March&#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, 2014. 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, 2014, 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 nine months ended March&#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 is a leader in the development of sustained-release pharmaceutical products for treating eye diseases. Its approved products deliver drugs at a controlled and steady rate for months or years. The Company has developed three of the four approved sustained-release products for treating retinal diseases. The Company&#x2019;s lead product candidate Medidur&#x2122; for posterior uveitis is in pivotal clinical trials. Marketing of its lead licensed product ILUVIEN&#xAE; for diabetic macular edema (&#x201C;DME&#x201D;) commenced in the U.S. in the fiscal 2015 third quarter. The Company&#x2019;s pre-clinical development program is focused on developing products for chronic retinal diseases utilizing our core technology platforms. The Company&#x2019;s strategy includes developing products independently while continuing to leverage our 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%"> Medidur, the Company&#x2019;s lead development product, is an injectable, micro-insert designed to treat posterior uveitis, a blinding eye disease, on a sustained basis for 36 months. Medidur uses the same micro-insert used in ILUVIEN for DME (same design, same drug, same polymers, same release rate) and delivers a lower dose of the same drug as Retisert<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup>, the Company&#x2019;s approved implant for posterior uveitis. 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%"> In recent meetings, the Company reached agreement with the U.S. Food and Drug Administration (&#x201C;FDA&#x201D;) on a regulatory path for Medidur that should allow a new drug application (&#x201C;NDA&#x201D;) to be filed in the first half of 2017. The FDA indicated that, pending clinical trial results, it would accept an NDA based on data from the ongoing Medidur Phase III trial (which has a 12-month primary endpoint), data from a second Phase III trial with a shorter six-month primary endpoint and data referenced from the already completed Phase III ILUVIEN trials. The ongoing Phase III trial for Medidur completed enrollment with 129 patients in the fiscal 2015 third quarter. The last 12-month follow-up visit is scheduled in March 2016, and the Company expects top-line data in the second calendar quarter of 2016. The Company has already initiated a second Phase III Medidur trial, which will recruit up to 150 patients in India. Both trials will follow participants for three years.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> The Company had previously planned to file an NDA with data from only the first Phase III trial and data referenced from the ILUVIEN studies, subject to FDA confirmation. Because of the shorter six-month primary endpoint permitted for the second trial, the Company expects that the new regulatory path will allow it to file the Medidur NDA with only a several month delay from the time frame anticipated with one Phase III trial. The Company had budgeted for a second Phase III trial, pending FDA guidance, so the second trial does not affect the Company&#x2019;s liquidity projections.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> The Company plans to commercialize Medidur with a newly designed, proprietary inserter that uses a standard 27 gauge needle routinely used in intraocular injections. As a result of the new design, the Company will conduct a utilization study on the new inserter, with data to be submitted as part of the Medidur NDA. Data from this study is expected to be available before data from the other trials and should not delay the NDA submission.</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%"> ILUVIEN, the Company&#x2019;s most recently approved product, is an injectable, sustained-release micro-insert that provides treatment of DME for three years from a single administration. 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 country-by-country basis. ILUVIEN was launched in the U.S. in late February 2015 and is now widely available to physicians in the U.S. 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.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> ILUVIEN was also launched in Portugal in January 2015, and has been commercially available in the United Kingdom and Germany since June 2013. 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%"> Distribution, regulatory and reimbursement matters for ILUVIEN for DME in Australia and New Zealand have been sublicensed. The Company is entitled to 20% of any royalties and 33% of all other payments received by our licensee, including any milestone payments.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> The Company&#x2019;s pre-clinical research is primarily focused on developing pharmaceutical products to provide targeted and systemic sustained delivery of drugs and large biologic molecules for treatment of various conditions, and to provide sustained delivery of therapeutic agents to treat wet and dry age-related macular degeneration, glaucoma and osteoarthritis.</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 $31.7 million at March&#xA0;31, 2015 will enable the Company to maintain its current and planned operations (including its two Medidur trials) into calendar year 2017. This estimate excludes any potential net profits receipts from sales of ILUVIEN.</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 April 2015, the FASB tentatively deferred the effective date of ASU 2014-09, while also tentatively permitting early adoption. If such deferral is ratified, ASU 2014-09 will become effective on July&#xA0;1, 2018. 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> </div>
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