2014 Q3 Form 10-Q Financial Statement

#000119312514303137 Filed on August 08, 2014

View on sec.gov

Income Statement

Concept 2014 Q3 2014 Q2 2013 Q2
Revenue $7.282M $5.851M $1.891M
YoY Change 176.46% 209.41% 116.11%
Cost Of Revenue $235.0K $215.0K $23.00K
YoY Change 487.5% 834.78% -52.08%
Gross Profit $7.047M $5.636M $1.868M
YoY Change 171.67% 201.71% 125.88%
Gross Profit Margin 96.77% 96.33% 98.78%
Selling, General & Admin $9.103M $7.965M $8.160M
YoY Change 26.8% -2.39% 41.89%
% of Gross Profit 129.18% 141.32% 436.83%
Research & Development $3.047M $4.252M $4.491M
YoY Change -40.89% -5.32% 68.33%
% of Gross Profit 43.24% 75.44% 240.42%
Depreciation & Amortization $0.00 $100.0K $0.00
YoY Change -100.0%
% of Gross Profit 0.0% 1.77% 0.0%
Operating Expenses $12.39M $12.43M $12.67M
YoY Change 0.09% -1.91% 49.69%
Operating Profit -$5.103M -$6.581M -$10.78M
YoY Change -47.61% -38.97% 42.03%
Interest Expense -$900.0K -$970.0K -$1.110M
YoY Change -23.08% -12.61% 11000.0%
% of Operating Profit
Other Income/Expense, Net
YoY Change
Pretax Income -$6.010M -$7.550M -$11.90M
YoY Change -44.91% -36.55% 56.58%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income
Net Earnings -$6.006M -$7.552M -$11.90M
YoY Change -44.93% -36.52% 56.6%
Net Earnings / Revenue -82.48% -129.07% -629.14%
Basic Earnings Per Share
Diluted Earnings Per Share -$59.43K -$73.83K -$119.2K
COMMON SHARES
Basic Shares Outstanding 101.1M shares 100.9M shares 99.81M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2014 Q3 2014 Q2 2013 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $26.80M $34.00M $72.20M
YoY Change -57.59% -52.91% 106.88%
Cash & Equivalents $26.78M $33.97M $72.22M
Short-Term Investments
Other Short-Term Assets $1.800M $2.200M $800.0K
YoY Change 80.0% 175.0% 33.33%
Inventory $1.080M $1.072M $694.0K
Prepaid Expenses
Receivables $2.746M $2.225M $855.0K
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $32.38M $39.44M $74.57M
YoY Change -51.11% -47.11% 94.7%
LONG-TERM ASSETS
Property, Plant & Equipment $273.0K $296.0K $139.0K
YoY Change 48.37% 112.95% 135.59%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $81.00K $87.00K $128.0K
YoY Change -32.5% -32.03% -50.77%
Total Long-Term Assets $4.784M $4.953M $5.117M
YoY Change -1.03% -3.21% 1504.08%
TOTAL ASSETS
Total Short-Term Assets $32.38M $39.44M $74.57M
Total Long-Term Assets $4.784M $4.953M $5.117M
Total Assets $37.16M $44.39M $79.69M
YoY Change -47.71% -44.29% 106.35%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.960M $2.595M $3.033M
YoY Change -16.13% -14.44% -28.38%
Accrued Expenses $1.539M $1.624M $812.0K
YoY Change 98.07% 100.0% 26.88%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $8.661M $7.396M $3.650M
YoY Change 92.47% 102.63%
Total Short-Term Liabilities $12.49M $13.30M $9.079M
YoY Change 23.11% 46.51% 56.1%
LONG-TERM LIABILITIES
Long-Term Debt $25.99M $27.64M $30.24M
YoY Change -13.77% -8.6%
Other Long-Term Liabilities
YoY Change
Total Long-Term Liabilities $25.99M $27.64M $30.24M
YoY Change -13.77% -8.6%
TOTAL LIABILITIES
Total Short-Term Liabilities $12.49M $13.30M $9.079M
Total Long-Term Liabilities $25.99M $27.64M $30.24M
Total Liabilities $38.48M $40.94M $39.32M
YoY Change -4.49% 4.13% 577.86%
SHAREHOLDERS EQUITY
Retained Earnings -$320.1M -$314.1M -$270.6M
YoY Change 13.72% 16.08%
Common Stock $101.0K $101.0K $100.0K
YoY Change 1.0% 1.0% 12.36%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$1.317M $3.452M $40.37M
YoY Change
Total Liabilities & Shareholders Equity $37.16M $44.39M $79.69M
YoY Change -47.71% -44.29% 106.35%

Cashflow Statement

Concept 2014 Q3 2014 Q2 2013 Q2
OPERATING ACTIVITIES
Net Income -$6.006M -$7.552M -$11.90M
YoY Change -44.93% -36.52% 56.6%
Depreciation, Depletion And Amortization $0.00 $100.0K $0.00
YoY Change -100.0%
Cash From Operating Activities -$6.000M -$8.900M -$9.200M
YoY Change -30.23% -3.26% 17.95%
INVESTING ACTIVITIES
Capital Expenditures $0.00 -$100.0K $0.00
YoY Change -100.0%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities $0.00 -$100.0K $0.00
YoY Change -100.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -1.300M -600.0K 0.000
YoY Change 225.0% -100.0%
NET CHANGE
Cash From Operating Activities -6.000M -8.900M -9.200M
Cash From Investing Activities 0.000 -100.0K 0.000
Cash From Financing Activities -1.300M -600.0K 0.000
Net Change In Cash -7.300M -9.600M -9.200M
YoY Change -19.78% 4.35% 21.05%
FREE CASH FLOW
Cash From Operating Activities -$6.000M -$8.900M -$9.200M
Capital Expenditures $0.00 -$100.0K $0.00
Free Cash Flow -$6.000M -$8.800M -$9.200M
YoY Change -29.41% -4.35% 17.95%

Facts In Submission

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<div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 18pt; TEXT-INDENT: 4%"> <b>Net Product Sales</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 6pt; TEXT-INDENT: 4%"> From our initial launch in April 2012 through June&#xA0;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&#xA0;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.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 0pt; TEXT-INDENT: 4%"> We recognize product revenues from sales of Korlym upon delivery to patients as long as (i)&#xA0;there is persuasive evidence that an arrangement exists between ourselves and the customer, (ii)&#xA0;collectability is reasonably assured and (iii)&#xA0;the price is fixed or determinable. Prior authorization or confirmation of coverage level by the patient&#x2019;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)&#xA0;calculate gross product revenues from the sales to our customers and (ii)&#xA0;reasonably estimate net product revenues.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> We make cash donations to a non-profit third party organization that provides patients who meet certain eligibility requirements with financial assistance for the treatment of Cushing&#x2019;s syndrome, which treatment may include Korlym. We do not include in net product revenues sales of Korlym tablets to such patients funded through this source.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> 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)&#xA0;trade allowances, such as discounts for prompt payment and distributor fees, (b)&#xA0;estimated government rebates and chargebacks, (c)&#xA0;reserves for expected product returns and (d)&#xA0;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.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> <i>Trade Allowances:&#xA0;</i>Through June&#xA0;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.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> <i>Rebates and Chargebacks:&#xA0;</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)&#xA0;the discount amounts applicable to government-funded programs and (ii)&#xA0;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.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> <i>Allowances for Patient Assistance Program:&#xA0;</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.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> <i>Sales Returns:&#xA0;</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.</p> </div>
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We consider all highly liquid investments purchased with maturities of three months or less from the date of purchase to be cash equivalents.
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<div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 0pt; TEXT-INDENT: 4%"> <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- and six-month periods ended June&#xA0;30, 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 &#x2013; pharmacy benefit managers, insurance companies, private charities and government programs &#x2013; 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 June&#xA0;30, 2014, we had one tablet manufacturer for Korlym with an operational facility &#x2013; AAI Pharma Services Corp. (AAI). In addition, we have a single-source manufacturer of mifepristone, the active pharmaceutical ingredient (API), in Korlym - Produits Chimiques Auxiliaires et de Synth&#xE8;se SA (PCAS). If either of these companies 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>
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us-gaap Use Of Estimates
UseOfEstimates
<div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 18pt; TEXT-INDENT: 4%"> <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>
us-gaap Number Of Operating Segments
NumberOfOperatingSegments
1 Segment
us-gaap Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
158000
us-gaap Increase Decrease In Other Operating Assets
IncreaseDecreaseInOtherOperatingAssets
-12000
us-gaap Sales Revenue Goods Net
SalesRevenueGoodsNet
10255000
us-gaap Repayments Of Long Term Debt
RepaymentsOfLongTermDebt
2012000
us-gaap Increase Decrease In Accounts Receivable
IncreaseDecreaseInAccountsReceivable
797000
us-gaap Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
1256000
us-gaap Operating Income Loss
OperatingIncomeLoss
-19440000
us-gaap Increase Decrease In Deferred Revenue
IncreaseDecreaseInDeferredRevenue
19000
us-gaap Interest And Debt Expense
InterestAndDebtExpense
2041000
us-gaap Selling General And Administrative Expense
SellingGeneralAndAdministrativeExpense
17769000
us-gaap Net Income Loss
NetIncomeLoss
-21481000
us-gaap Increase Decrease In Inventories
IncreaseDecreaseInInventories
94000
us-gaap Net Cash Provided By Used In Financing Activities Continuing Operations
NetCashProvidedByUsedInFinancingActivitiesContinuingOperations
-701000
us-gaap Share Based Compensation
ShareBasedCompensation
2603000
us-gaap Cash And Cash Equivalents Period Increase Decrease
CashAndCashEquivalentsPeriodIncreaseDecrease
-20903000
us-gaap Net Cash Provided By Used In Investing Activities Continuing Operations
NetCashProvidedByUsedInInvestingActivitiesContinuingOperations
-158000
us-gaap Operating Expenses
OperatingExpenses
29695000
us-gaap Increase Decrease In Other Accounts Payable And Accrued Liabilities
IncreaseDecreaseInOtherAccountsPayableAndAccruedLiabilities
323000
us-gaap Increase Decrease In Accounts Payable
IncreaseDecreaseInAccountsPayable
214000
us-gaap Financing Receivable Allowance For Credit Losses Write Offs
FinancingReceivableAllowanceForCreditLossesWriteOffs
0
us-gaap Cost Of Revenue
CostOfRevenue
389000
us-gaap Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
65000
us-gaap Amortization Of Financing Costs
AmortizationOfFinancingCosts
14000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
2603000
us-gaap Increase Decrease In Other Current Liabilities
IncreaseDecreaseInOtherCurrentLiabilities
-1645000
us-gaap Accretion Expense
AccretionExpense
1979000
us-gaap Research And Development Expense
ResearchAndDevelopmentExpense
11537000
us-gaap Proceeds From Issuance Or Sale Of Equity
ProceedsFromIssuanceOrSaleOfEquity
1311000
CY2013Q2 us-gaap Weighted Average Number Of Share Outstanding Basic And Diluted
WeightedAverageNumberOfShareOutstandingBasicAndDiluted
99814000 shares
CY2013Q2 us-gaap Earnings Per Share Basic And Diluted
EarningsPerShareBasicAndDiluted
-0.12
CY2013Q2 us-gaap Sales Revenue Goods Net
SalesRevenueGoodsNet
1891000
CY2013Q2 us-gaap Operating Income Loss
OperatingIncomeLoss
-10783000
CY2013Q2 us-gaap Net Income Loss
NetIncomeLoss
-11897000
CY2013Q2 us-gaap Operating Expenses
OperatingExpenses
12674000
CY2013Q2 us-gaap Selling General And Administrative Expense
SellingGeneralAndAdministrativeExpense
8160000
CY2013Q2 us-gaap Interest And Debt Expense
InterestAndDebtExpense
1114000
CY2013Q2 us-gaap Cost Of Revenue
CostOfRevenue
23000
CY2013Q2 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1265000
CY2013Q2 us-gaap Accretion Expense
AccretionExpense
1100000
CY2013Q2 us-gaap Research And Development Expense
ResearchAndDevelopmentExpense
4491000
CY2014Q2 us-gaap Weighted Average Number Of Share Outstanding Basic And Diluted
WeightedAverageNumberOfShareOutstandingBasicAndDiluted
100980000 shares
CY2014Q2 us-gaap Earnings Per Share Basic And Diluted
EarningsPerShareBasicAndDiluted
-0.07
CY2014Q2 us-gaap Sales Revenue Goods Net
SalesRevenueGoodsNet
5851000
CY2014Q2 us-gaap Operating Income Loss
OperatingIncomeLoss
-6581000
CY2014Q2 us-gaap Net Income Loss
NetIncomeLoss
-7552000
CY2014Q2 us-gaap Operating Expenses
OperatingExpenses
12432000
CY2014Q2 us-gaap Selling General And Administrative Expense
SellingGeneralAndAdministrativeExpense
7965000
CY2014Q2 us-gaap Interest And Debt Expense
InterestAndDebtExpense
971000
CY2014Q2 us-gaap Cost Of Revenue
CostOfRevenue
215000
CY2014Q2 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1226000
CY2014Q2 us-gaap Accretion Expense
AccretionExpense
935000
CY2014Q2 us-gaap Research And Development Expense
ResearchAndDevelopmentExpense
4252000

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