2013 Q4 Form 10-Q Financial Statement

#000119312514047202 Filed on February 12, 2014

View on sec.gov

Income Statement

Concept 2013 Q4 2012 Q4
Revenue $592.0K $585.0K
YoY Change 1.2% -7.14%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $1.710M $1.660M
YoY Change 3.01% 14.48%
% of Gross Profit
Research & Development $2.494M $1.575M
YoY Change 58.35% -20.93%
% of Gross Profit
Depreciation & Amortization $230.0K $250.0K
YoY Change -8.0% -71.26%
% of Gross Profit
Operating Expenses $4.133M $3.233M
YoY Change 27.84% -82.31%
Operating Profit -$3.541M -$2.648M
YoY Change 33.72% -84.99%
Interest Expense $0.00 $0.00
YoY Change -100.0%
% of Operating Profit
Other Income/Expense, Net $1.000K $3.000K
YoY Change -66.67% -97.84%
Pretax Income -$3.540M -$2.645M
YoY Change 33.84% -84.89%
Income Tax -$26.00K -$37.00K
% Of Pretax Income
Net Earnings -$3.514M -$2.608M
YoY Change 34.74% -85.06%
Net Earnings / Revenue -593.58% -445.81%
Basic Earnings Per Share -$0.13
Diluted Earnings Per Share -$0.13 -$1.120M
COMMON SHARES
Basic Shares Outstanding 26.95M shares 23.30M shares
Diluted Shares Outstanding 26.95M shares

Balance Sheet

Concept 2013 Q4 2012 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $15.70M $15.70M
YoY Change 0.0% -16.04%
Cash & Equivalents $15.22M $9.409M
Short-Term Investments $500.0K $6.300M
Other Short-Term Assets $900.0K $100.0K
YoY Change 800.0% -50.0%
Inventory
Prepaid Expenses
Receivables $600.0K $900.0K
Other Receivables $0.00 $0.00
Total Short-Term Assets $17.23M $16.81M
YoY Change 2.51% -15.53%
LONG-TERM ASSETS
Property, Plant & Equipment $133.0K $277.0K
YoY Change -51.99% -30.75%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $300.0K $100.0K
YoY Change 200.0% 0.0%
Total Long-Term Assets $3.587M $4.232M
YoY Change -15.24% -15.36%
TOTAL ASSETS
Total Short-Term Assets $17.23M $16.81M
Total Long-Term Assets $3.587M $4.232M
Total Assets $20.82M $21.04M
YoY Change -1.06% -15.49%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $176.0K $215.0K
YoY Change -18.14% -28.33%
Accrued Expenses $1.204M $1.084M
YoY Change 11.07% 54.86%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $2.151M $2.083M
YoY Change 3.26% -19.88%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $6.100M $5.100M
YoY Change 19.61% 13.33%
Total Long-Term Liabilities $6.100M $5.100M
YoY Change 19.61% 13.33%
TOTAL LIABILITIES
Total Short-Term Liabilities $2.151M $2.083M
Total Long-Term Liabilities $6.100M $5.100M
Total Liabilities $8.220M $7.232M
YoY Change 13.66% 0.44%
SHAREHOLDERS EQUITY
Retained Earnings -$270.9M -$256.9M
YoY Change 5.43%
Common Stock $27.00K $23.00K
YoY Change 17.39%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $12.60M $13.81M
YoY Change
Total Liabilities & Shareholders Equity $20.82M $21.04M
YoY Change -1.06% -15.49%

Cashflow Statement

Concept 2013 Q4 2012 Q4
OPERATING ACTIVITIES
Net Income -$3.514M -$2.608M
YoY Change 34.74% -85.06%
Depreciation, Depletion And Amortization $230.0K $250.0K
YoY Change -8.0% -71.26%
Cash From Operating Activities -$2.250M -$1.780M
YoY Change 26.4% -24.58%
INVESTING ACTIVITIES
Capital Expenditures -$10.00K -$40.00K
YoY Change -75.0% -75.0%
Acquisitions
YoY Change
Other Investing Activities $1.320M $2.900M
YoY Change -54.48% 158.93%
Cash From Investing Activities $1.310M $2.870M
YoY Change -54.36% 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 1.620M -70.00K
YoY Change -2414.29%
NET CHANGE
Cash From Operating Activities -2.250M -1.780M
Cash From Investing Activities 1.310M 2.870M
Cash From Financing Activities 1.620M -70.00K
Net Change In Cash 680.0K 1.020M
YoY Change -33.33% -172.86%
FREE CASH FLOW
Cash From Operating Activities -$2.250M -$1.780M
Capital Expenditures -$10.00K -$40.00K
Free Cash Flow -$2.240M -$1.740M
YoY Change 28.74% -20.91%

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<div> <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 December&#xA0;31, 2013 and for the three and six months ended December&#xA0;31, 2013 and 2012 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, 2013. 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, 2013, 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 and six months ended December&#xA0;31, 2013 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 tiny, sustained-release products designed to deliver drugs and biologics at a controlled and steady rate for weeks, months or years. Using its core technology platforms, Durasert&#x2122; and BioSilicon&#x2122;, the Company is focused on treatment of chronic diseases of the back of the eye and is also exploring applications outside ophthalmology. The Company has developed three of the four sustained-release products for treatment of retinal diseases that have been approved in the U.S. or European Union (&#x201C;EU&#x201D;), and its lead development product began a Phase III clinical trial in the quarter ended June 2013. 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%"> ILUVIEN&#xAE;, the Company&#x2019;s most recently approved product, is an injectable, sustained-release micro-insert that provides treatment over a period of up to three years of vision impairment associated with chronic diabetic macular edema (&#x201C;DME&#x201D;) considered insufficiently responsive to available therapies. ILUVIEN is licensed to 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 for DME. Alimera commenced the commercial launch of ILUVIEN for DME in the U.K. and Germany in 2013 and expects to launch in France in 2014. In November 2013, the U.K.&#x2019;s National Institute for Health and Care Excellence (&#x201C;NICE&#x201D;) recommended ILUVIEN as a treatment option for pseudophakic patients (those who have had cataract surgery), subject to a patient access scheme, and in January 2014 Alimera commenced shipments of initial orders for ILUVIEN to U.K. National Health Service (&#x201C;NHS&#x201D;) facilities. ILUVIEN has also received marketing authorization in Austria, Portugal and Spain and has been recommended for authorization in Italy. In addition, Alimera has filed for ten additional EU country approvals.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> In an October 2013 third Complete Response Letter (&#x201C;CRL&#x201D;), the U.S. Food and Drug Administration (&#x201C;FDA&#x201D;) identified concerns regarding the benefit to risk and safety profiles of ILUVIEN for DME and stated that the New Drug Application (&#x201C;NDA&#x201D;) could not be approved in its present form. In December 2013, Alimera announced that it had entered into labeling discussions with the FDA. Alimera plans to respond to the CRL in the first quarter of 2014 and provide a safety update on ILUVIEN, including data from ILUVIEN patients and from physician experience with the applicator in the U.K. and Germany. The FDA has indicated that new clinical trials will not be required in connection with the FDA&#x2019;s review of ILUVIEN for DME prior to any approval. Alimera also intends to address concerns the FDA raised in the CRL regarding the facility at which ILUVIEN is manufactured. FDA approval of ILUVIEN for DME would entitle the Company to a $25.0 million milestone payment.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> Medidur&#x2122;, the Company&#x2019;s lead development product, commenced the first of two planned pivotal Phase III clinical trials for the treatment of chronic non-infectious uveitis affecting the posterior of the eye (&#x201C;posterior uveitis&#x201D;) in the quarter ended June 2013. 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&#xAE; for posterior uveitis. The Company is developing Medidur independently.</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%"> Retisert, which provides sustained release treatment of posterior uveitis for approximately two and a half years, is licensed to and sold by Bausch&#xA0;&amp; Lomb.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> The Company is engaged in pre-clinical research with respect to its BioSilicon and Durasert technology platforms. The primary focus of the BioSilicon technology research is the use of Tethadur&#x2122; for the sustained delivery of peptides, proteins, antibodies and other large biologic molecules in both ophthalmic and non-ophthalmic applications. The Company&#x2019;s research program also includes the use of Durasert technology in orthopedic applications and for systemic delivery of therapeutic agents.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> The Company is also developing a bioerodible, injectable micro-insert delivering latanoprost (the &#x201C;Latanoprost Product&#x201D;) to treat glaucoma and ocular hypertension. Under an amended collaboration agreement, Pfizer Inc. (&#x201C;Pfizer&#x201D;) has an option, under certain circumstances, to license the development and commercialization of the Latanoprost Product worldwide.</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 proceeds of sales of its equity securities and the receipt of license fees, research and development funding, royalties and contingent cash payments from its collaboration partners. The Company believes that its cash, cash equivalents and marketable securities of $15.7 million at December&#xA0;31, 2013, together with expected Retisert royalty income and other expected cash inflows under existing collaboration and technology evaluation agreements, will enable the Company to maintain its current and planned operations through the first quarter of calendar year 2015. This includes expected costs through that date of Phase III clinical trials of Medidur, but excludes any potential milestone or net profits receipts under the Alimera collaboration agreement. The Company&#x2019;s ability to fund its planned operations beyond then, including completion of Phase III trials of Medidur, is expected to depend on the amount and timing of cash receipts under existing collaboration agreements, as well as any future collaboration or other agreements and/or financing transactions.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> References to &#x201C;$&#x201D; are to U.S. dollars and references to &#x201C;A$&#x201D; are to Australian dollars.</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 the impact of recently issued 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> </div>
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