2014 Q2 Form 10-Q Financial Statement

#000119312514194946 Filed on May 12, 2014

View on sec.gov

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%

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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&#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.</font></p> <p style="MARGIN-BOTTOM: 0px; FONT-SIZE: 1px; MARGIN-TOP: 12px"> &#xA0;</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)&#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.</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&#x2019;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)&#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.</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&#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.</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)&#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.</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>
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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&#xA0;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 &#x2013; pharmacy benefit managers, insurance companies, private charities, 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 March&#xA0;31, 2014, we had one tablet manufacturer for Korlym with an operational facility &#x2013; 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 Synth&#xE8;se 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

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