2014 Q2 Form 10-Q Financial Statement
#000119312514194946 Filed on May 12, 2014
Income Statement
Concept | 2014 Q2 | 2014 Q1 | 2013 Q1 |
---|---|---|---|
Revenue | $5.851M | $4.405M | $1.717M |
YoY Change | 209.41% | 156.55% | |
Cost Of Revenue | $215.0K | $174.0K | $20.00K |
YoY Change | 834.78% | 770.0% | |
Gross Profit | $5.636M | $4.231M | $1.697M |
YoY Change | 201.71% | 149.32% | |
Gross Profit Margin | 96.33% | 96.05% | 98.84% |
Selling, General & Admin | $7.965M | $9.805M | $8.383M |
YoY Change | -2.39% | 16.96% | 11.97% |
% of Gross Profit | 141.32% | 231.74% | 493.99% |
Research & Development | $4.252M | $7.285M | $4.257M |
YoY Change | -5.32% | 71.13% | 20.19% |
% of Gross Profit | 75.44% | 172.18% | 250.85% |
Depreciation & Amortization | $100.0K | $28.00K | $14.00K |
YoY Change | 100.0% | 366.67% | |
% of Gross Profit | 1.77% | 0.66% | 0.82% |
Operating Expenses | $12.43M | $17.26M | $12.66M |
YoY Change | -1.91% | 36.37% | 14.79% |
Operating Profit | -$6.581M | -$12.86M | -$10.94M |
YoY Change | -38.97% | 17.51% | -0.78% |
Interest Expense | -$970.0K | -$1.070M | -$1.140M |
YoY Change | -12.61% | -6.14% | 11300.0% |
% of Operating Profit | |||
Other Income/Expense, Net | |||
YoY Change | |||
Pretax Income | -$7.550M | -$13.93M | -$12.08M |
YoY Change | -36.55% | 15.31% | 9.52% |
Income Tax | $0.00 | $0.00 | $0.00 |
% Of Pretax Income | |||
Net Earnings | -$7.552M | -$13.93M | -$12.08M |
YoY Change | -36.52% | 15.28% | 9.52% |
Net Earnings / Revenue | -129.07% | -316.23% | -703.79% |
Basic Earnings Per Share | |||
Diluted Earnings Per Share | -$73.83K | -$138.1K | -$121.0K |
COMMON SHARES | |||
Basic Shares Outstanding | 100.9M shares | 100.6M shares | 99.81M shares |
Diluted Shares Outstanding |
Balance Sheet
Concept | 2014 Q2 | 2014 Q1 | 2013 Q1 |
---|---|---|---|
SHORT-TERM ASSETS | |||
Cash & Short-Term Investments | $34.00M | $43.60M | $81.50M |
YoY Change | -52.91% | -46.5% | 91.31% |
Cash & Equivalents | $33.97M | $43.62M | $81.46M |
Short-Term Investments | |||
Other Short-Term Assets | $2.200M | $1.500M | $600.0K |
YoY Change | 175.0% | 150.0% | 500.0% |
Inventory | $1.072M | $1.127M | $1.026M |
Prepaid Expenses | |||
Receivables | $2.225M | $1.922M | $1.143M |
Other Receivables | $0.00 | $0.00 | $0.00 |
Total Short-Term Assets | $39.44M | $48.12M | $84.20M |
YoY Change | -47.11% | -42.85% | 96.73% |
LONG-TERM ASSETS | |||
Property, Plant & Equipment | $296.0K | $285.0K | $154.0K |
YoY Change | 112.95% | 85.06% | |
Goodwill | |||
YoY Change | |||
Intangibles | |||
YoY Change | |||
Long-Term Investments | |||
YoY Change | |||
Other Assets | $87.00K | $96.00K | $136.0K |
YoY Change | -32.03% | -29.41% | 36.0% |
Total Long-Term Assets | $4.953M | $4.711M | $3.940M |
YoY Change | -3.21% | 19.57% | 3840.0% |
TOTAL ASSETS | |||
Total Short-Term Assets | $39.44M | $48.12M | $84.20M |
Total Long-Term Assets | $4.953M | $4.711M | $3.940M |
Total Assets | $44.39M | $52.83M | $88.14M |
YoY Change | -44.29% | -40.06% | 105.46% |
SHORT-TERM LIABILITIES | |||
YoY Change | |||
Accounts Payable | $2.595M | $3.666M | $2.263M |
YoY Change | -14.44% | 62.0% | 7.76% |
Accrued Expenses | $1.624M | $1.271M | $958.0K |
YoY Change | 100.0% | 32.67% | -36.13% |
Deferred Revenue | |||
YoY Change | |||
Short-Term Debt | $0.00 | $0.00 | $0.00 |
YoY Change | |||
Long-Term Debt Due | $7.396M | $6.896M | $3.900M |
YoY Change | 102.63% | 76.82% | |
Total Short-Term Liabilities | $13.30M | $15.24M | $8.243M |
YoY Change | 46.51% | 84.91% | 128.97% |
LONG-TERM LIABILITIES | |||
Long-Term Debt | $27.64M | $28.22M | $28.90M |
YoY Change | -8.6% | -2.34% | |
Other Long-Term Liabilities | |||
YoY Change | |||
Total Long-Term Liabilities | $27.64M | $28.22M | $28.90M |
YoY Change | -8.6% | -2.34% | |
TOTAL LIABILITIES | |||
Total Short-Term Liabilities | $13.30M | $15.24M | $8.243M |
Total Long-Term Liabilities | $27.64M | $28.22M | $28.90M |
Total Liabilities | $40.94M | $43.46M | $37.14M |
YoY Change | 4.13% | 17.02% | 931.61% |
SHAREHOLDERS EQUITY | |||
Retained Earnings | -$314.1M | -$306.5M | -$258.7M |
YoY Change | 16.08% | 18.5% | |
Common Stock | $101.0K | $101.0K | $100.0K |
YoY Change | 1.0% | 1.0% | |
Preferred Stock | |||
YoY Change | |||
Treasury Stock (at cost) | |||
YoY Change | |||
Treasury Stock Shares | |||
Shareholders Equity | $3.452M | $9.371M | $51.00M |
YoY Change | |||
Total Liabilities & Shareholders Equity | $44.39M | $52.83M | $88.14M |
YoY Change | -44.29% | -40.06% | 105.46% |
Cashflow Statement
Concept | 2014 Q2 | 2014 Q1 | 2013 Q1 |
---|---|---|---|
OPERATING ACTIVITIES | |||
Net Income | -$7.552M | -$13.93M | -$12.08M |
YoY Change | -36.52% | 15.28% | 9.52% |
Depreciation, Depletion And Amortization | $100.0K | $28.00K | $14.00K |
YoY Change | 100.0% | 366.67% | |
Cash From Operating Activities | -$8.900M | -$11.10M | -$11.55M |
YoY Change | -3.26% | -3.93% | 13.75% |
INVESTING ACTIVITIES | |||
Capital Expenditures | -$100.0K | $110.0K | $18.00K |
YoY Change | 511.11% | 157.14% | |
Acquisitions | |||
YoY Change | |||
Other Investing Activities | |||
YoY Change | |||
Cash From Investing Activities | -$100.0K | -$100.0K | -$18.00K |
YoY Change | 455.56% | 157.14% | |
FINANCING ACTIVITIES | |||
Cash Dividend Paid | |||
YoY Change | |||
Common Stock Issuance & Retirement, Net | |||
YoY Change | |||
Debt Paid & Issued, Net | $995.0K | ||
YoY Change | |||
Cash From Financing Activities | -600.0K | -100.0K | 0.000 |
YoY Change | -100.0% | ||
NET CHANGE | |||
Cash From Operating Activities | -8.900M | -11.10M | -11.55M |
Cash From Investing Activities | -100.0K | -100.0K | -18.00K |
Cash From Financing Activities | -600.0K | -100.0K | 0.000 |
Net Change In Cash | -9.600M | -11.30M | -11.57M |
YoY Change | 4.35% | -2.35% | -486.76% |
FREE CASH FLOW | |||
Cash From Operating Activities | -$8.900M | -$11.10M | -$11.55M |
Capital Expenditures | -$100.0K | $110.0K | $18.00K |
Free Cash Flow | -$8.800M | -$11.21M | -$11.57M |
YoY Change | -4.35% | -3.13% | 13.85% |
Facts In Submission
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---|---|---|---|---|
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Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
|
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Common Stock Shares Outstanding
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CY2014Q1 | us-gaap |
Liabilities Current
LiabilitiesCurrent
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15242000 | |
CY2014Q1 | us-gaap |
Long Term Debt Noncurrent
LongTermDebtNoncurrent
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Common Stock Shares Authorized
CommonStockSharesAuthorized
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Common Stock Par Or Stated Value Per Share
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Cash And Cash Equivalents At Carrying Value
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Common Stock Shares Issued
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Preferred Stock Shares Outstanding
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Retained Earnings Accumulated Deficit
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2014 | |
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10-Q | |
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2014-03-31 | |
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|
<div> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 18px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2"><b>Net Product Sales</b></font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 6px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2">From our initial launch in April 2012 through June 30, 2013, we sold Korlym primarily to a specialty pharmacy and a specialty distributor, which subsequently resold Korlym to patients and healthcare providers. Korlym is not available in retail pharmacies. As of July 1, 2013, we began using Dohmen Life Science Services. (Dohmen), formerly known as Centric Health Resources, Inc., as our specialty pharmacy. Dohmen operates on a consignment basis, without carrying any Korlym inventory. Accordingly, all of our sales through Dohmen are made directly to patients.</font></p> <p style="MARGIN-BOTTOM: 0px; FONT-SIZE: 1px; MARGIN-TOP: 12px">  </p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2">We recognize product revenues from sales of Korlym upon delivery to patients as long as (i) there is persuasive evidence that an arrangement exists between ourselves and the customer, (ii) collectability is reasonably assured and (iii) the price is fixed or determinable. Prior authorization or confirmation of coverage level by the patient’s private insurance plan or government payor is a prerequisite to the shipment of product to a patient. In order to conclude that the price is fixed or determinable, we must be able to (i) calculate gross product revenues from the sales to our customers and (ii) reasonably estimate net product revenues.</font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2">We provide cash donations to a non-profit third party organization that supports patients who meet certain eligibility requirements with financial assistance for the treatment of Cushing’s syndrome, which treatment may include Korlym. We do not include as net product revenues sales of Korlym tablets funded through this source.</font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2">We calculate gross product revenues based on the price that we charge our customers. We estimate our net product revenues by deducting from our gross product revenues (a) trade allowances, such as discounts for prompt payment and distributor fees, (b) estimated government rebates and chargebacks, (c) reserves for expected product returns and (d) estimated costs of our patient co-pay assistance program. We initially record estimates for these deductions at the time we recognize the gross revenue. We update our estimates on a recurring basis as new information becomes available.</font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2"><i>Trade Allowances:</i> Through June 30, 2013, we offered our specialty pharmacy and specialty distributor customers a discount on Korlym sales for payment within 30 days. We also offered them a small discount for providing data services. We expected these customers to earn these discounts and, accordingly, deducted them in full from gross product revenues and trade receivables at the time we recognized such revenues. Beginning in the third quarter of 2013, we ceased incurring a prompt-payment discount to our specialty pharmacy.</font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2"><i>Rebates and Chargebacks:</i> We contract with Medicaid and other government programs so that Korlym will be eligible for purchase by, or qualify for partial or full reimbursement from, such government programs. We estimate the rebates and chargebacks that we are obligated to provide to government programs and deduct these estimated amounts from our gross product sales at the time the revenues are recognized. We base our estimates of these rebates and chargebacks upon (i) the discount amounts applicable to government-funded programs and (ii) information obtained from our vendors regarding the percentage of sales by our customers to patients who are covered by entities or programs that are eligible for such rebates and chargebacks.</font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2"><i>Allowances for Patient Assistance Program:</i> We provide financial assistance to eligible patients whose insurance policies require them to pay high deductibles and co-pays. We estimate the cost of assistance to be provided under this program by applying our actual experience regarding such assistance to our estimate of the percentage of our sales in the period that will be provided to patients covered by the program.</font></p> <p style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 12px; TEXT-INDENT: 4%"> <font style="FONT-FAMILY: Times New Roman" size="2"><i>Sales Returns:</i> Because sales through Dohmen, our specialty pharmacy, are made to individual patients who do not have the right to return the product, our exposure to product returns is now limited to the specialty distributor channel and is not expected to be material.</font></p> </div> | |
CY2014Q1 | us-gaap |
Net Cash Provided By Used In Operating Activities Continuing Operations
NetCashProvidedByUsedInOperatingActivitiesContinuingOperations
|
-11060000 | |
CY2014Q1 | us-gaap |
Additional Cash And Cash Equivalent Related Text
AdditionalCashAndCashEquivalentRelatedText
|
We consider all highly liquid investments purchased with maturities of three months or less from the date of purchase to be cash equivalents. | |
CY2014Q1 | us-gaap |
Weighted Average Number Of Share Outstanding Basic And Diluted
WeightedAverageNumberOfShareOutstandingBasicAndDiluted
|
100521000 | shares |
CY2014Q1 | us-gaap |
Increase Decrease In Other Current Liabilities
IncreaseDecreaseInOtherCurrentLiabilities
|
92000 | |
CY2014Q1 | us-gaap |
Accretion Expense
AccretionExpense
|
1044000 | |
CY2014Q1 | us-gaap |
Research And Development Expense
ResearchAndDevelopmentExpense
|
7285000 | |
CY2014Q1 | us-gaap |
Proceeds From Issuance Or Sale Of Equity
ProceedsFromIssuanceOrSaleOfEquity
|
906000 | |
CY2014Q1 | us-gaap |
Net Cash Provided By Used In Financing Activities Continuing Operations
NetCashProvidedByUsedInFinancingActivitiesContinuingOperations
|
-89000 | |
CY2014Q1 | us-gaap |
Amortization Of Financing Costs
AmortizationOfFinancingCosts
|
8000 | |
CY2014Q1 | us-gaap |
Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
|
1378000 | |
CY2014Q1 | us-gaap |
Stock Issued During Period Shares Stock Options Exercised
StockIssuedDuringPeriodSharesStockOptionsExercised
|
840000 | shares |
CY2014Q1 | us-gaap |
Concentration Risk Credit Risk
ConcentrationRiskCreditRisk
|
<div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 0pt"> <b>Credit Risks and Concentrations</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 6pt; TEXT-INDENT: 4%"> We have a concentration of credit risk related to our cash and cash equivalents. We are exposed to credit risk in the event of default by the financial institutions holding these funds or by the entity or entities that issued the securities held by the fund to the extent of the amount recorded on our balance sheet. We mitigate this risk by investing in a money market fund that invests primarily in short-term U.S. Treasury notes and bills. We experienced no loss or lack of access to cash and cash equivalents in our operating or investment accounts during the three-month periods ended March 31, 2014 and 2013.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> We are exposed to credit risk in regard to our trade receivables with this risk being spread among various third-party payors – pharmacy benefit managers, insurance companies, private charities, government programs – and individual patients. We extend credit to third-party payors based on their creditworthiness. We monitor our exposure and will record a reserve against uncollectible trade receivables as necessary. To date, we have not incurred any credit losses.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> We have a concentration of risk in regard to the manufacture of our product. As of March 31, 2014, we had one tablet manufacturer for Korlym with an operational facility – AAI Pharma Services Corp. (AAI). AAI was approved by the FDA in November 2012 for the manufacture of our commercial tablets, subject to the successful manufacture of validation batches. The manufacture of these batches began in April 2014. In addition, we have a single-source manufacturer of mifepristone, the active pharmaceutical ingredient (API), in Korlym - Produits Chimiques Auxiliaires et de Synthèse SA (PCAS). If either of these manufacturers is unable to manufacture API or Korlym tablets in the quantities and time frame required, we may not be able to manufacture our product in a timely manner. In order to mitigate these risks related to the manufacture of our product, we placed orders for additional quantities of mifepristone API and Korlym tablets, which are now in inventory.</p> </div> | |
CY2014Q1 | us-gaap |
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
|
23249000 | shares |
CY2014Q1 | us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
110000 | |
CY2014Q1 | us-gaap |
Increase Decrease In Other Operating Assets
IncreaseDecreaseInOtherOperatingAssets
|
-9000 | |
CY2014Q1 | us-gaap |
Use Of Estimates
UseOfEstimates
|
<div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 18pt"> <b>Use of Estimates</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 6pt; TEXT-INDENT: 4%"> The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> We evaluate our estimates and assumptions on an ongoing basis, including those related to our reserves for chargebacks and rebates, patient assistance, potential product returns and excess/obsolete inventories, allowances for doubtful accounts, accruals of clinical and preclinical expenses, contingent liabilities, and the timing of payments with respect to our long-term capped royalty obligation, which determine its effective interest rate. We base our estimates on relevant experience and on other specific assumptions that we believe are reasonable.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> We update our assumptions and estimates on a recurring basis as new information becomes available. Any changes in estimates are recorded in the period of the change.</p> </div> | |
CY2014Q1 | us-gaap |
Earnings Per Share Basic And Diluted
EarningsPerShareBasicAndDiluted
|
-0.14 | |
CY2014Q1 | us-gaap |
Sales Revenue Goods Net
SalesRevenueGoodsNet
|
4405000 | |
CY2014Q1 | us-gaap |
Repayments Of Long Term Debt
RepaymentsOfLongTermDebt
|
995000 | |
CY2014Q1 | us-gaap |
Increase Decrease In Accounts Receivable
IncreaseDecreaseInAccountsReceivable
|
494000 | |
CY2014Q1 | us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
543000 | |
CY2014Q1 | us-gaap |
Operating Income Loss
OperatingIncomeLoss
|
-12859000 | |
CY2014Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-13930000 | |
CY2014Q1 | us-gaap |
Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
-89000 | |
CY2014Q1 | us-gaap |
Number Of Operating Segments
NumberOfOperatingSegments
|
1 | Segment |
CY2014Q1 | us-gaap |
Share Based Compensation
ShareBasedCompensation
|
1378000 | |
CY2014Q1 | us-gaap |
Cash And Cash Equivalents Period Increase Decrease
CashAndCashEquivalentsPeriodIncreaseDecrease
|
-11259000 | |
CY2014Q1 | us-gaap |
Net Cash Provided By Used In Investing Activities Continuing Operations
NetCashProvidedByUsedInInvestingActivitiesContinuingOperations
|
-110000 | |
CY2014Q1 | us-gaap |
Operating Expenses
OperatingExpenses
|
17264000 | |
CY2014Q1 | us-gaap |
Selling General And Administrative Expense
SellingGeneralAndAdministrativeExpense
|
9805000 | |
CY2014Q1 | us-gaap |
Increase Decrease In Deferred Revenue
IncreaseDecreaseInDeferredRevenue
|
4000 | |
CY2014Q1 | us-gaap |
Interest And Debt Expense
InterestAndDebtExpense
|
1071000 | |
CY2014Q1 | us-gaap |
Increase Decrease In Other Accounts Payable And Accrued Liabilities
IncreaseDecreaseInOtherAccountsPayableAndAccruedLiabilities
|
-30000 | |
CY2014Q1 | us-gaap |
Increase Decrease In Accounts Payable
IncreaseDecreaseInAccountsPayable
|
1285000 | |
CY2014Q1 | us-gaap |
Financing Receivable Allowance For Credit Losses Write Offs
FinancingReceivableAllowanceForCreditLossesWriteOffs
|
0 | |
CY2014Q1 | us-gaap |
Cost Of Revenue
CostOfRevenue
|
174000 | |
CY2014Q1 | us-gaap |
Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
|
28000 |