2015 Q4 Form 10-Q Financial Statement
#000119312516455089 Filed on February 09, 2016
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% |
Facts In Submission
Frame | Concept Type | Concept / XBRL Key | Value | Unit |
---|---|---|---|---|
CY2016Q1 | dei |
Entity Common Stock Shares Outstanding
EntityCommonStockSharesOutstanding
|
34072919 | shares |
CY2014Q1 | us-gaap |
Security Deposit
SecurityDeposit
|
150000 | |
CY2014Q4 | us-gaap |
Stockholders Equity
StockholdersEquity
|
32275000 | |
CY2014Q4 | us-gaap |
Unrecognized Tax Benefits
UnrecognizedTaxBenefits
|
0 | |
CY2014Q4 | us-gaap |
Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
|
29751000 | |
CY2014Q4 | psdv |
Milestone Payment Received Upon Fda Approval
MilestonePaymentReceivedUponFdaApproval
|
25000000 | |
CY2014Q4 | psdv |
Warrants Weighted Average Exercise Price
WarrantsWeightedAverageExercisePrice
|
3.67 | |
CY2015Q4 | us-gaap |
Common Stock Shares Authorized
CommonStockSharesAuthorized
|
60000000 | shares |
CY2015Q4 | us-gaap |
Preferred Stock Shares Outstanding
PreferredStockSharesOutstanding
|
0 | shares |
CY2015Q4 | us-gaap |
Common Stock Shares Outstanding
CommonStockSharesOutstanding
|
29627919 | shares |
CY2015Q4 | us-gaap |
Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
|
0.001 | |
CY2015Q4 | us-gaap |
Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
|
5000000 | shares |
CY2015Q4 | us-gaap |
Preferred Stock Shares Issued
PreferredStockSharesIssued
|
0 | shares |
CY2015Q4 | us-gaap |
Common Stock Shares Issued
CommonStockSharesIssued
|
29627919 | shares |
CY2015Q4 | us-gaap |
Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
|
0.001 | |
CY2015Q4 | us-gaap |
Additional Paid In Capital Common Stock
AdditionalPaidInCapitalCommonStock
|
294286000 | |
CY2015Q4 | us-gaap |
Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
|
14000 | |
CY2015Q4 | us-gaap |
Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
|
617000 | |
CY2015Q4 | us-gaap |
Stockholders Equity
StockholdersEquity
|
14424000 | |
CY2015Q4 | us-gaap |
Unrecognized Tax Benefits Income Tax Penalties And Interest Accrued
UnrecognizedTaxBenefitsIncomeTaxPenaltiesAndInterestAccrued
|
0 | |
CY2015Q4 | us-gaap |
Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
|
342000 | |
CY2015Q4 | us-gaap |
Unrecognized Tax Benefits
UnrecognizedTaxBenefits
|
0 | |
CY2015Q4 | us-gaap |
Deferred Rent Credit Noncurrent
DeferredRentCreditNoncurrent
|
59000 | |
CY2015Q4 | us-gaap |
Deferred Revenue Current
DeferredRevenueCurrent
|
28000 | |
CY2015Q4 | us-gaap |
Accounts Payable Current
AccountsPayableCurrent
|
303000 | |
CY2015Q4 | us-gaap |
Accrued Liabilities Current
AccruedLiabilitiesCurrent
|
3552000 | |
CY2015Q4 | us-gaap |
Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
|
-280785000 | |
CY2015Q4 | us-gaap |
Liabilities
Liabilities
|
9526000 | |
CY2015Q4 | us-gaap |
Liabilities And Stockholders Equity
LiabilitiesAndStockholdersEquity
|
23950000 | |
CY2015Q4 | us-gaap |
Deferred Revenue Noncurrent
DeferredRevenueNoncurrent
|
5584000 | |
CY2015Q4 | us-gaap |
Common Stock Value
CommonStockValue
|
29000 | |
CY2015Q4 | us-gaap |
Commitments And Contingencies
CommitmentsAndContingencies
|
||
CY2015Q4 | us-gaap |
Liabilities Current
LiabilitiesCurrent
|
3883000 | |
CY2015Q4 | us-gaap |
Preferred Stock Value
PreferredStockValue
|
||
CY2015Q4 | us-gaap |
Accumulated Other Comprehensive Income Loss Net Of Tax
AccumulatedOtherComprehensiveIncomeLossNetOfTax
|
894000 | |
CY2015Q4 | us-gaap |
Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized
EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognized
|
3000000 | |
CY2015Q4 | us-gaap |
Assets
Assets
|
23950000 | |
CY2015Q4 | us-gaap |
Available For Sale Securities Accumulated Gross Unrealized Loss Before Tax
AvailableForSaleSecuritiesAccumulatedGrossUnrealizedLossBeforeTax
|
9000 | |
CY2015Q4 | us-gaap |
Assets Fair Value Disclosure Recurring
AssetsFairValueDisclosureRecurring
|
17952000 | |
CY2015Q4 | us-gaap |
Accounts And Other Receivables Net Current
AccountsAndOtherReceivablesNetCurrent
|
573000 | |
CY2015Q4 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
311000 | |
CY2015Q4 | us-gaap |
Restricted Cash And Cash Equivalents Noncurrent
RestrictedCashAndCashEquivalentsNoncurrent
|
150000 | |
CY2015Q4 | us-gaap |
Available For Sale Securities Current
AvailableForSaleSecuritiesCurrent
|
9881000 | |
CY2015Q4 | us-gaap |
Assets Current
AssetsCurrent
|
21862000 | |
CY2015Q4 | us-gaap |
Cash Equivalents At Carrying Value
CashEquivalentsAtCarryingValue
|
8071000 | |
CY2015Q4 | us-gaap |
Marketable Securities Current
MarketableSecuritiesCurrent
|
9881000 | |
CY2015Q4 | us-gaap |
Other Assets
OtherAssets
|
115000 | |
CY2015Q4 | us-gaap |
Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
|
1512000 | |
CY2015Q4 | us-gaap |
Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
|
198000 | |
CY2015Q4 | us-gaap |
Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
|
11210000 | |
CY2015Q4 | us-gaap |
Available For Sale Securities Amortized Cost
AvailableForSaleSecuritiesAmortizedCost
|
9890000 | |
CY2015Q4 | psdv |
Collaboration Agreement Ownership Percentage In Company
CollaborationAgreementOwnershipPercentageInCompany
|
0.063 | pure |
CY2015Q4 | psdv |
Estimated Annual Amortization Of Intangible Assets
EstimatedAnnualAmortizationOfIntangibleAssets
|
756000 | |
CY2015Q4 | psdv |
Cash And Cash Equivalents And Marketable Securities Fair Value
CashAndCashEquivalentsAndMarketableSecuritiesFairValue
|
21100000 | |
CY2015Q4 | psdv |
Accrued Clinical Expense Current
AccruedClinicalExpenseCurrent
|
2579000 | |
CY2015Q4 | psdv |
Warrants Weighted Average Exercise Price
WarrantsWeightedAverageExercisePrice
|
3.67 | |
CY2014Q2 | us-gaap |
Stockholders Equity
StockholdersEquity
|
14924000 | |
CY2014Q2 | us-gaap |
Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
|
15334000 | |
CY2015Q2 | us-gaap |
Common Stock Shares Authorized
CommonStockSharesAuthorized
|
60000000 | shares |
CY2015Q2 | us-gaap |
Preferred Stock Shares Outstanding
PreferredStockSharesOutstanding
|
0 | shares |
CY2015Q2 | us-gaap |
Common Stock Shares Outstanding
CommonStockSharesOutstanding
|
29412365 | shares |
CY2015Q2 | us-gaap |
Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
|
0.001 | |
CY2015Q2 | us-gaap |
Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
|
5000000 | shares |
CY2015Q2 | us-gaap |
Preferred Stock Shares Issued
PreferredStockSharesIssued
|
0 | shares |
CY2015Q2 | us-gaap |
Common Stock Shares Issued
CommonStockSharesIssued
|
29412365 | shares |
CY2015Q2 | us-gaap |
Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
|
0.001 | |
CY2015Q2 | us-gaap |
Additional Paid In Capital Common Stock
AdditionalPaidInCapitalCommonStock
|
293060000 | |
CY2015Q2 | us-gaap |
Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
|
28000 | |
CY2015Q2 | us-gaap |
Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
|
735000 | |
CY2015Q2 | us-gaap |
Stockholders Equity
StockholdersEquity
|
23368000 | |
CY2015Q2 | us-gaap |
Unrecognized Tax Benefits Income Tax Penalties And Interest Accrued
UnrecognizedTaxBenefitsIncomeTaxPenaltiesAndInterestAccrued
|
0 | |
CY2015Q2 | us-gaap |
Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
|
384000 | |
CY2015Q2 | us-gaap |
Deferred Rent Credit Noncurrent
DeferredRentCreditNoncurrent
|
55000 | |
CY2015Q2 | us-gaap |
Deferred Revenue Current
DeferredRevenueCurrent
|
33000 | |
CY2015Q2 | us-gaap |
Cash Equivalents At Carrying Value
CashEquivalentsAtCarryingValue
|
15835000 | |
CY2015Q2 | us-gaap |
Marketable Securities Current
MarketableSecuritiesCurrent
|
9414000 | |
CY2015Q2 | us-gaap |
Other Assets
OtherAssets
|
116000 | |
CY2015Q2 | us-gaap |
Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
|
1925000 | |
CY2015Q2 | us-gaap |
Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
|
681000 | |
CY2015Q2 | us-gaap |
Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
|
19121000 | |
CY2015Q2 | psdv |
Accrued Clinical Expense Current
AccruedClinicalExpenseCurrent
|
1424000 | |
CY2015Q2 | us-gaap |
Accounts Payable Current
AccountsPayableCurrent
|
744000 | |
CY2015Q2 | us-gaap |
Accrued Liabilities Current
AccruedLiabilitiesCurrent
|
2571000 | |
CY2015Q2 | us-gaap |
Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
|
-270666000 | |
CY2015Q2 | us-gaap |
Liabilities
Liabilities
|
8999000 | |
CY2015Q2 | us-gaap |
Liabilities And Stockholders Equity
LiabilitiesAndStockholdersEquity
|
32367000 | |
CY2015Q2 | us-gaap |
Deferred Revenue Noncurrent
DeferredRevenueNoncurrent
|
5596000 | |
CY2015Q2 | us-gaap |
Common Stock Value
CommonStockValue
|
29000 | |
CY2015Q2 | us-gaap |
Commitments And Contingencies
CommitmentsAndContingencies
|
||
CY2015Q2 | us-gaap |
Liabilities Current
LiabilitiesCurrent
|
3348000 | |
CY2015Q2 | us-gaap |
Preferred Stock Value
PreferredStockValue
|
||
CY2015Q2 | us-gaap |
Accumulated Other Comprehensive Income Loss Net Of Tax
AccumulatedOtherComprehensiveIncomeLossNetOfTax
|
945000 | |
CY2015Q2 | us-gaap |
Assets
Assets
|
32367000 | |
CY2015Q2 | us-gaap |
Assets Fair Value Disclosure Recurring
AssetsFairValueDisclosureRecurring
|
25249000 | |
CY2015Q2 | us-gaap |
Accounts And Other Receivables Net Current
AccountsAndOtherReceivablesNetCurrent
|
622000 | |
CY2015Q2 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
338000 | |
CY2015Q2 | us-gaap |
Restricted Cash And Cash Equivalents Noncurrent
RestrictedCashAndCashEquivalentsNoncurrent
|
150000 | |
CY2015Q2 | us-gaap |
Assets Current
AssetsCurrent
|
29838000 | |
us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
0.54 | ||
us-gaap |
Net Cash Provided By Used In Operating Activities Continuing Operations
NetCashProvidedByUsedInOperatingActivitiesContinuingOperations
|
17257000 | ||
us-gaap |
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
|
2376324 | shares | |
us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
30618144 | shares | |
us-gaap |
Incremental Common Shares Attributable To Share Based Payment Arrangements
IncrementalCommonSharesAttributableToShareBasedPaymentArrangements
|
1016710 | shares | |
us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
29344689 | shares | |
us-gaap |
Earnings Per Share Basic
EarningsPerShareBasic
|
0.56 | ||
us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
28000 | ||
us-gaap |
Payments To Acquire Marketable Securities
PaymentsToAcquireMarketableSecurities
|
3287000 | ||
us-gaap |
Net Income Loss
NetIncomeLoss
|
16491000 | ||
us-gaap |
Marketable Securities Unrealized Gain Loss
MarketableSecuritiesUnrealizedGainLoss
|
-5000 | ||
us-gaap |
Other Comprehensive Income Loss Net Of Tax
OtherComprehensiveIncomeLossNetOfTax
|
-101000 | ||
us-gaap |
Revenues
Revenues
|
25828000 | ||
us-gaap |
Adjustments To Additional Paid In Capital Sharebased Compensation Requisite Service Period Recognition Value
AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationRequisiteServicePeriodRecognitionValue
|
726000 | ||
us-gaap |
Increase Decrease In Accounts Receivable And Other Operating Assets
IncreaseDecreaseInAccountsReceivableAndOtherOperatingAssets
|
618000 | ||
us-gaap |
License And Services Revenue
LicenseAndServicesRevenue
|
25245000 | ||
us-gaap |
Operating Income Loss
OperatingIncomeLoss
|
16673000 | ||
us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
6000 | ||
us-gaap |
Royalty Revenue
RoyaltyRevenue
|
583000 | ||
us-gaap |
Comprehensive Income Net Of Tax
ComprehensiveIncomeNetOfTax
|
16390000 | ||
us-gaap |
Other Comprehensive Income Loss Foreign Currency Transaction And Translation Adjustment Net Of Tax
OtherComprehensiveIncomeLossForeignCurrencyTransactionAndTranslationAdjustmentNetOfTax
|
-96000 | ||
us-gaap |
Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest
IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest
|
16679000 | ||
us-gaap |
Income Tax Expense Benefit
IncomeTaxExpenseBenefit
|
188000 | ||
us-gaap |
Share Based Compensation
ShareBasedCompensation
|
726000 | ||
us-gaap |
Increase Decrease In Deferred Revenue
IncreaseDecreaseInDeferredRevenue
|
-69000 | ||
us-gaap |
Cash And Cash Equivalents Period Increase Decrease
CashAndCashEquivalentsPeriodIncreaseDecrease
|
14417000 | ||
us-gaap |
Operating Expenses
OperatingExpenses
|
9155000 | ||
us-gaap |
Net Cash Provided By Used In Investing Activities Continuing Operations
NetCashProvidedByUsedInInvestingActivitiesContinuingOperations
|
-3065000 | ||
us-gaap |
Net Cash Provided By Used In Financing Activities Continuing Operations
NetCashProvidedByUsedInFinancingActivitiesContinuingOperations
|
235000 | ||
us-gaap |
Research And Development Expense
ResearchAndDevelopmentExpense
|
5551000 | ||
us-gaap |
Employee Service Share Based Compensation Cash Received From Exercise Of Stock Options
EmployeeServiceShareBasedCompensationCashReceivedFromExerciseOfStockOptions
|
235000 | ||
us-gaap |
Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
|
235000 | ||
us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
726000 | ||
us-gaap |
General And Administrative Expense
GeneralAndAdministrativeExpense
|
3604000 | ||
us-gaap |
Effect Of Exchange Rate On Cash And Cash Equivalents
EffectOfExchangeRateOnCashAndCashEquivalents
|
-10000 | ||
us-gaap |
Amortization Of Debt Discount Premium
AmortizationOfDebtDiscountPremium
|
41000 | ||
us-gaap |
Current Federal Tax Expense Benefit
CurrentFederalTaxExpenseBenefit
|
260000 | ||
us-gaap |
Amortization Of Intangible Assets
AmortizationOfIntangibleAssets
|
389000 | ||
us-gaap |
Increase Decrease In Accounts Payable And Other Operating Liabilities
IncreaseDecreaseInAccountsPayableAndOtherOperatingLiabilities
|
230000 | ||
us-gaap |
Depreciation
Depreciation
|
57000 | ||
psdv |
Incremental Common Shares Attributable To Warrants
IncrementalCommonSharesAttributableToWarrants
|
256745 | shares | |
psdv |
Increase Decrease In Deferred Rent
IncreaseDecreaseInDeferredRent
|
10000 | ||
psdv |
Proceeds From Maturity Of Marketable Securities
ProceedsFromMaturityOfMarketableSecurities
|
250000 | ||
psdv |
Warrants To Purchase Common Shares Outstanding And Exercisable
WarrantsToPurchaseCommonSharesOutstandingAndExercisable
|
1176105 | shares | |
dei |
Document Fiscal Period Focus
DocumentFiscalPeriodFocus
|
Q2 | ||
us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-0.34 | ||
us-gaap |
Nature Of Operations
NatureOfOperations
|
<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 “Company”) as of December 31, 2015 and for the three and six months ended December 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 “SEC”). These financial statements should be read in conjunction with the Company’s audited consolidated financial statements and footnotes included in its Annual Report on Form 10-K for the fiscal year ended June 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 30, 2015, and include all adjustments, consisting only of normal recurring adjustments, that are necessary for the fair presentation of the Company’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 (“GAAP”) requires management to make assumptions and estimates that affect, among other things, (i) reported amounts of assets and liabilities; (ii) disclosure of contingent assets and liabilities at the date of the consolidated financial statements; and (iii) reported amounts of revenues and expenses during the reporting period. The results of operations for the three and six months ended December 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 (“FDA”) for treatment of back-of-the-eye diseases. Medidur™ for posterior uveitis, the Company’s lead product candidate, is in pivotal Phase III clinical trials, and ILUVIEN<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">®</sup> for diabetic macular edema (“DME”), its lead licensed product, is sold in the U.S. and three European Union (“EU”) countries. The Company’s pre-clinical development program is focused primarily on developing products utilizing the Company’s two core technology platforms, Durasert™ and Tethadur™. The Company’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’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 (“posterior uveitis”). 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 (“NDA”) 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’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. (“Alimera”), and the Company is entitled to a share of the net profits (as defined) from Alimera’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’s FDA-approved Retisert<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">®</sup> is an implant that provides sustained release treatment of posterior uveitis for approximately two and a half years. It is licensed to Bausch & Lomb, and the Company receives royalties from its sales.</p> <p style="MARGIN-BOTTOM: 0px; FONT-SIZE: 1px; MARGIN-TOP: 12px">  </p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 0pt; TEXT-INDENT: 4%"> The Company’s pre-clinical development program is focused on developing products using its Durasert™ and Tethadur™ technology platforms to deliver drugs and biologics to treat wet and dry age-related macular degeneration (“AMD”), 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 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’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 (“FASB”) 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’s financial position, results of operations and cash flows or do not apply to the Company’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. 2014-09, <i>Revenue from Contracts with Customers</i> (Topic 606) (“ASU 2014-09”), 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 1, 2018, with early adoption permitted on July 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 – Going Concern</i>. ASU 2014-15 provides guidance around management’s responsibility to evaluate whether there is substantial doubt about an entity’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’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 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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