2020 Q2 Form 10-Q Financial Statement

#000119312520139026 Filed on May 11, 2020

View on sec.gov

Income Statement

Concept 2020 Q2 2020 Q1 2019 Q4
Revenue $29.60M $29.14M $30.12M
YoY Change 2.64% 134.06% 5924.51%
Cost Of Revenue $4.140M $4.151M $4.400M
YoY Change -2.85% 142.49%
Gross Profit $25.46M $24.99M $25.72M
YoY Change 3.6% 132.71%
Gross Profit Margin 86.01% 85.75% 85.38%
Selling, General & Admin $10.83M $10.06M $11.41M
YoY Change 20.5% 19.56% 64.65%
% of Gross Profit 42.54% 40.28% 44.36%
Research & Development $4.350M $4.223M $6.310M
YoY Change -6.03% 27.66% -25.06%
% of Gross Profit 17.09% 16.9% 24.53%
Depreciation & Amortization $30.00K $13.54K $20.00K
YoY Change 200.0% -1.51% 100.0%
% of Gross Profit 0.12% 0.05% 0.08%
Operating Expenses $15.18M $14.29M $17.72M
YoY Change -15.09% 6.32% 15.51%
Operating Profit $10.28M $10.70M $8.007M
YoY Change -6.2% -1183.22% -153.94%
Interest Expense
YoY Change
% of Operating Profit
Other Income/Expense, Net $110.0K $336.2K $400.0K
YoY Change -75.58% -2.05% 17.65%
Pretax Income $10.39M $11.04M $8.410M
YoY Change -8.94% -1812.32% -158.0%
Income Tax $610.0K $610.0K $480.0K
% Of Pretax Income 5.87% 5.53% 5.71%
Net Earnings $9.780M $10.43M $7.930M
YoY Change -10.77% -1717.68% -154.69%
Net Earnings / Revenue 33.04% 35.78% 26.32%
Basic Earnings Per Share $0.10 $0.08
Diluted Earnings Per Share $91.63K $0.10 $0.07
COMMON SHARES
Basic Shares Outstanding 103.4M 103.4M 103.0M
Diluted Shares Outstanding 106.5M

Balance Sheet

Concept 2020 Q2 2020 Q1 2019 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $115.1M $101.8M $94.50M
YoY Change 92.15% 123.25% 76.64%
Cash & Equivalents $115.1M $101.8M $89.51M
Short-Term Investments $0.00 $0.00 $5.000M
Other Short-Term Assets $7.500M $6.000M $4.300M
YoY Change 400.0% 215.79% 152.94%
Inventory $1.800M $2.211M $1.957M
Prepaid Expenses
Receivables $6.800M $6.919M $10.54M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $131.2M $116.9M $111.4M
YoY Change 82.08% 113.16% 101.79%
LONG-TERM ASSETS
Property, Plant & Equipment $200.0K $196.9K $210.5K
YoY Change 35.48% 40.34% -14.24%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $0.00
YoY Change -100.0%
Other Assets $0.00 $0.00 $0.00
YoY Change
Total Long-Term Assets $200.0K $936.1K $1.013M
YoY Change -96.76% -84.94% -80.76%
TOTAL ASSETS
Total Short-Term Assets $131.2M $116.9M $111.4M
Total Long-Term Assets $200.0K $936.1K $1.013M
Total Assets $131.4M $117.9M $112.4M
YoY Change 67.96% 93.0% 85.9%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $5.800M $1.348M $4.117M
YoY Change 74.24% -54.17% 76.16%
Accrued Expenses $12.60M $16.29M $19.98M
YoY Change 16.42% 167.63% 178.52%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $20.20M $17.64M $24.10M
YoY Change 42.74% 95.38% 153.37%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $0.00 $600.0K $600.0K
YoY Change -100.0% -33.33% 200.0%
Total Long-Term Liabilities $0.00 $600.0K $600.0K
YoY Change -100.0% -33.33% 200.0%
TOTAL LIABILITIES
Total Short-Term Liabilities $20.20M $17.64M $24.10M
Total Long-Term Liabilities $0.00 $600.0K $600.0K
Total Liabilities $20.20M $18.20M $24.75M
YoY Change 35.09% 83.86% 156.01%
SHAREHOLDERS EQUITY
Retained Earnings -$118.3M -$128.7M
YoY Change -26.64% -19.85%
Common Stock $103.4K $103.4K
YoY Change 0.59% 0.64%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $111.2M $99.68M $87.63M
YoY Change
Total Liabilities & Shareholders Equity $131.4M $117.9M $112.4M
YoY Change 67.96% 93.0% 85.9%

Cashflow Statement

Concept 2020 Q2 2020 Q1 2019 Q4
OPERATING ACTIVITIES
Net Income $9.780M $10.43M $7.930M
YoY Change -10.77% -1717.68% -154.69%
Depreciation, Depletion And Amortization $30.00K $13.54K $20.00K
YoY Change 200.0% -1.51% 100.0%
Cash From Operating Activities $13.27M $7.213M $12.29M
YoY Change -5.35% -189.98% -255.57%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00 $0.00
YoY Change -100.0% -100.0% -100.0%
Acquisitions
YoY Change
Other Investing Activities $0.00 $5.000M $31.65M
YoY Change -100.0% -51.92% 130.01%
Cash From Investing Activities $0.00 $5.000M $31.65M
YoY Change -100.0% -52.15% 131.02%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 30.00K 26.15K 580.0K
YoY Change -84.21% -70.73% 286.67%
NET CHANGE
Cash From Operating Activities 13.27M 7.213M 12.29M
Cash From Investing Activities 0.000 5.000M 31.65M
Cash From Financing Activities 30.00K 26.15K 580.0K
Net Change In Cash 13.30M 12.24M 44.52M
YoY Change 207.16% 385.24% 648.24%
FREE CASH FLOW
Cash From Operating Activities $13.27M $7.213M $12.29M
Capital Expenditures $0.00 $0.00 $0.00
Free Cash Flow $13.27M $7.213M $12.29M
YoY Change -5.42% -189.92% -256.56%

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<div style="font-size: 6pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="font-size: 6pt; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-collapse: collapse; border-spacing: 0px; table-layout: fixed;;width:100%;"><tr style="page-break-inside: avoid;"><td style="width:4%;">&#160;</td><td style="text-align:left;;vertical-align:top;;width:5%;"><div style="font-weight:bold;display:inline;">o.</div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">CONCENTRATION OF RISK. </div>The financial instruments that potentially subject the Company to concentration of credit risk are cash equivalents (i.e., money market funds), investments and accounts receivable, net. The Company places its cash and cash equivalents with high-credit quality financial institutions. These amounts at times may exceed federally insured limits. The Company has not experienced any credit losses in these accounts. </div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px; background: none;"></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The Company sells its product in the United States through an exclusive distributor (its Customer) to specialty pharmacies. Therefore, its distributor and specialty pharmacies account for all of its trade receivables and net product revenues. The creditworthiness of its Customer is continuously monitored, and the Company has internal policies regarding customer credit limits. 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The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, Firdapse<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div>, and expects Firdapse<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div> to constitute virtually all of product revenue for the foreseeable future. The Company&#8217;s success depends on its ability to effectively commercialize Firdapse<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div>. </div></div><div style="font-size: 1px; margin-top: 6px; margin-bottom: 0px;"><div style="font-size: 1px; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; margin-left: 9%;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The Company relies exclusively on third parties to formulate and manufacture Firdapse<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div> and its drug candidates. 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If the Company is unable to continue its relationships with one or more of these third-party contractors, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers. The Company intends to rely on one or more third-party contractors to manufacture the commercial supply of its drugs. </div></div><table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table>
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<div style="font-size: 6pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="font-size: 6pt; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-collapse: collapse; border-spacing: 0px; table-layout: fixed;;width:100%;"><tr style="page-break-inside: avoid;"><td style="width:4%;">&#160;</td><td style="text-align:left;;vertical-align:top;;width:5%;"><div style="font-weight:bold;display:inline;">c.</div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">USE OF ESTIMATES. </div>The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. </div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div> <table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table>
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LesseeOperatingLeaseLiabilityPaymentsDueYearThree
329662
CY2020Q1 us-gaap Prior Period Reclassification Adjustment Description
PriorPeriodReclassificationAdjustmentDescription
<div style="font-size: 6pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="font-size: 6pt; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-collapse: collapse; border-spacing: 0px; table-layout: fixed;;width:100%;"><tr style="page-break-inside: avoid;"><td style="width:4%;">&#160;</td><td style="text-align:left;;vertical-align:top;;width:5%;"><div style="font-weight:bold;display:inline;">t.</div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">RECLASSIFICATIONS.</div> Certain prior year amounts in the consolidated financial statements have been reclassified to conform to the current year presentation. </div></div></td></tr></table><table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table>
CY2020Q1 cprx Maximum Maturity Period Of Cash And Cash Equivalent
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three months
CY2020Q1 us-gaap Lessee Operating Lease Liability Payments Due
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934994
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59896
CY2020Q1 cprx Lessee Operating Lease Liability Payments Total
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875098
CY2020Q1 cprx Accrued Non Clinical And Clinical Trial Expenses
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940963
CY2019Q4 cprx Accrued Non Clinical And Clinical Trial Expenses
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1183513
CY2020Q1 us-gaap Accrued Professional Fees Current
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3309351
CY2019Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
1241526
CY2020Q1 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
1814396
CY2019Q4 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
3064645
CY2020Q1 cprx Accrued License Fees Current
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3945991
CY2019Q4 cprx Accrued License Fees Current
AccruedLicenseFeesCurrent
8751991
CY2020Q1 cprx Accrued Variable Consideration
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1308344
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2143490
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139733
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172332
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16287936
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50783809
CY2019Q1 us-gaap Adjustments To Additional Paid In Capital Share Based Compensation Stock Options Requisite Service Period Recognition
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933411
CY2019Q1 us-gaap Stock Issued During Period Value Stock Options Exercised
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CY2019Q1 us-gaap Other Comprehensive Income Loss Net Of Tax
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CY2019Q1 us-gaap Stockholders Equity
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51175627
CY2019Q4 us-gaap Available For Sale Securities
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64939250
CY2019 us-gaap Available For Sale Securities Gross Unrealized Gains
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9505
CY2019 us-gaap Available For Sale Securities Gross Unrealized Loss
AvailableForSaleSecuritiesGrossUnrealizedLoss
0
CY2019Q4 us-gaap Available For Sale Securities Amortized Cost
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64929745
CY2020Q1 us-gaap Available For Sale Securities
AvailableForSaleSecurities
69997200
CY2020Q1 cprx Prepaid Manufacturing Expense
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3471078
CY2020Q1 us-gaap Prepaid Insurance
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995146
CY2019Q4 us-gaap Prepaid Insurance
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1263129
CY2020Q1 cprx Prepaid Subscription Fees
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492716
CY2019Q4 cprx Prepaid Subscription Fees
PrepaidSubscriptionFees
501251
CY2020Q1 cprx Prepaid Research Fee
PrepaidResearchFee
490102
CY2019Q4 cprx Prepaid Research Fee
PrepaidResearchFee
481057
CY2020Q1 cprx Prepaid Precommercial Expenses
PrepaidPrecommercialExpenses
287083
CY2019Q4 cprx Prepaid Precommercial Expenses
PrepaidPrecommercialExpenses
62959
CY2020Q1 us-gaap Other Prepaid Expense Current
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326590
CY2019Q4 us-gaap Other Prepaid Expense Current
OtherPrepaidExpenseCurrent
516665
CY2019Q4 cprx Prepaid Manufacturing Expense
PrepaidManufacturingExpense
1526013
CY2020Q1 us-gaap Operating Lease Cost
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74079
CY2020Q1 us-gaap Operating Lease Payments
OperatingLeasePayments
84061
CY2020Q1 us-gaap Right Of Use Asset Obtained In Exchange For Operating Lease Liability
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5305
CY2020Q1 us-gaap Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
730284
CY2020Q1 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
306677
CY2020Q1 us-gaap Operating Lease Liability Noncurrent
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568421
CY2020Q1 us-gaap Operating Lease Liability
OperatingLeaseLiability
875098
CY2019Q4 us-gaap Accrued Liabilities Current
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19981295
CY2020Q1 cprx Other Noncurrent Accrued Expenses And Other Liabilities
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568421
CY2019Q4 cprx Other Noncurrent Accrued Expenses And Other Liabilities
OtherNoncurrentAccruedExpensesAndOtherLiabilities
647532
CY2020Q1 us-gaap Accrued Liabilities Current And Noncurrent
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16856357
CY2019Q4 us-gaap Accrued Liabilities Current And Noncurrent
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20628827
CY2020Q1 cprx Accrued Purchases Current
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1243991
CY2020Q1 cprx Accrued Charitable Contributions
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1135000
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300518
CY2019Q4 cprx Accrued Variable Consideration
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884764
CY2019Q4 us-gaap Accrued Income Taxes Current
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1533696
CY2019Q4 us-gaap Operating Lease Liability Noncurrent
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647532
CY2019Q4 cprx Accrued Purchases Current
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1313310
CY2019Q4 cprx Accrued Charitable Contributions
AccruedCharitableContributions
1535000
CY2020Q1 us-gaap Preferred Stock Shares Outstanding
PreferredStockSharesOutstanding
0
CY2019Q1 us-gaap Trading Securities
TradingSecurities
0
CY2018Q4 us-gaap Trading Securities
TradingSecurities
0
CY2020Q1 cprx Trading Securities Sales
TradingSecuritiesSales
0
CY2020Q1 us-gaap Available For Sale Securities Gross Realized Gain Loss Net
AvailableForSaleSecuritiesGrossRealizedGainLossNet
0
CY2019 us-gaap Available For Sale Securities Gross Realized Gain Loss Net
AvailableForSaleSecuritiesGrossRealizedGainLossNet
0
CY2020Q1 us-gaap Lessor Operating Lease Option To Extend
LessorOperatingLeaseOptionToExtend
1 year
CY2020Q1 us-gaap Lessor Operating Lease Option To Terminate
LessorOperatingLeaseOptionToTerminate
1 year
CY2020Q1 us-gaap Finance Lease Liability
FinanceLeaseLiability
0
CY2020Q1 us-gaap Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
255544
CY2020Q1 cprx Period Of Collaboration Agreement
PeriodOfCollaborationAgreement
P10Y
CY2020Q1 cprx Number Of Votes Entitlement For Each Share Held By Common Stock Holders
NumberOfVotesEntitlementForEachShareHeldByCommonStockHolders
1
CY2020Q1 us-gaap Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range Number Of Exercisable Options
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12201668
CY2020Q1 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
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29136472
CY2019Q1 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
12448438
CY2019Q1 us-gaap Operating Lease Weighted Average Remaining Lease Term1
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P2Y8M12D
CY2020Q1 us-gaap Cash And Cash Equivalents At Carrying Value
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101750937
CY2020Q1 us-gaap Accounts Receivable Net Current
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6918563
CY2020Q1 us-gaap Inventory Net
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2211338
CY2020Q1 us-gaap Prepaid Expense And Other Assets Current
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6062715
CY2020Q1 us-gaap Assets Current
AssetsCurrent
116943553
CY2020Q1 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
196926
CY2020Q1 us-gaap Deposits Assets Noncurrent
DepositsAssetsNoncurrent
8888
CY2020Q1 us-gaap Assets
Assets
117879651
CY2020Q1 us-gaap Accounts Payable Current
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1347577
CY2020Q1 us-gaap Liabilities Current
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17635513
CY2020Q1 us-gaap Liabilities
Liabilities
18203934
CY2020Q1 us-gaap Common Stock Value
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103409
CY2020Q1 us-gaap Additional Paid In Capital
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217751166
CY2020Q1 us-gaap Accumulated Other Comprehensive Income Loss Net Of Tax
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83751
CY2020Q1 us-gaap Stockholders Equity
StockholdersEquity
99675717
CY2020Q1 us-gaap Liabilities And Stockholders Equity
LiabilitiesAndStockholdersEquity
117879651
CY2020Q1 us-gaap Cost Of Goods And Services Sold
CostOfGoodsAndServicesSold
4150866
CY2020Q1 us-gaap Research And Development Expense
ResearchAndDevelopmentExpense
4222811
CY2020Q1 us-gaap Selling General And Administrative Expense
SellingGeneralAndAdministrativeExpense
10063048
CY2020Q1 cprx Total Operating Expenses
TotalOperatingExpenses
18436725
CY2020Q1 us-gaap Operating Income Loss
OperatingIncomeLoss
10699747
CY2020Q1 us-gaap Other Nonoperating Income Expense
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336233
CY2020Q1 us-gaap Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest
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11035980
CY2020Q1 us-gaap Income Tax Expense Benefit
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609965
CY2020Q1 us-gaap Net Income Loss
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10426015
CY2020Q1 us-gaap Depreciation
Depreciation
13541
CY2020Q1 cprx Non Cash Change In Right Of Use Asset
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62968
CY2020Q1 us-gaap Share Based Compensation
ShareBasedCompensation
1519351
CY2020Q1 cprx Change In Accrued Interest And Accretion Of Discount On Investments
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-81296
CY2020Q1 us-gaap Increase Decrease In Prepaid Deferred Expense And Other Assets
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1711641
CY2020Q1 us-gaap Increase Decrease In Accounts Payable
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-2769870
CY2020Q1 us-gaap Increase Decrease In Accrued Liabilities And Other Operating Liabilities
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-3699518
CY2020Q1 cprx Increase Decrease In Operating Lease Liability
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72952
CY2020Q1 us-gaap Net Cash Provided By Used In Operating Activities
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7213078
CY2019Q1 us-gaap Payments To Acquire Property Plant And Equipment
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5633
CY2019Q1 us-gaap Payments To Acquire Investments
PaymentsToAcquireInvestments
9944974
CY2019Q1 us-gaap Proceeds From Maturities Prepayments And Calls Of Other Investments
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20400000
CY2020Q1 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Excluding Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseExcludingExchangeRateEffect
12239227
CY2019Q1 us-gaap Trading Securities Realized Gain Loss
TradingSecuritiesRealizedGainLoss
4980
CY2020Q1 us-gaap Preferred Stock Value
PreferredStockValue
0
CY2020Q1 us-gaap Incremental Common Shares Attributable To Share Based Payment Arrangements
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2774753
CY2020Q1 us-gaap Retained Earnings Accumulated Deficit
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CY2020Q1 us-gaap Nature Of Operations
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<table border="0" cellpadding="0" cellspacing="0" style="font-family: &quot;times new roman&quot;; font-size: 10pt; border-collapse: collapse; border-spacing: 0px;;width:100%;"><tr style="page-break-inside: avoid;"><td style="text-align:left;;vertical-align:top;;width:4%;"><div style="font-weight:bold;display:inline;">1.</div></td><td style="font-size: 10pt;;text-align:left;;vertical-align:top;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: normal;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Organization and Description of Business. </div></div></div></td></tr></table><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px;"></div><div style="clear: both; max-height: 0px; background: none;"></div><div style="text-indent: 4%; font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">Catalyst Pharmaceuticals, Inc. and subsidiary (collectively, the &#8220;Company&#8221;) is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton Myasthenic Syndrome (LEMS), Anti-MuSK antibody positive myasthenia gravis <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">(MuSK-MG),</div> and Spinal Muscular Atrophy (SMA) Type 3. </div></div><div style="text-indent: 4%; font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">On November&#160;28, 2018, the U.S. Food and Drug Administration, or FDA, granted approval of Firdapse<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div> for the treatment of adults with LEMS (ages 17 and above). On January&#160;15, 2019, the Company launched its first product, Firdapse<div style="font-size: 7.4pt; vertical-align: top; line-height: 5.476pt;;vertical-align: super;font-size: smaller;display:inline;">&#174;</div>, in the United States for the treatment of adults with LEMS. </div></div><div style="text-indent: 4%; font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">Since inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets, raising capital, and selling its product. The Company incurred operating losses in each period from inception, and started reporting operating income during the year ended December&#160;31, 2019. The Company has been able to fund its cash needs to date through several public and private offerings of its securities and from revenues from its product sales. See Note 11 (Stockholders&#8217; Equity). </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Capital Resources </div></div></div><div style="text-indent: 4%; font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;">While there can be no assurance, based on currently available information, the Company estimates that it currently has sufficient resources to support its operations for at least the next 12 months from the issuance date of this Form <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">10-Q.</div></div><div style="text-indent: 4%; font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;">The Company may raise required funds in the future through public or private equity offerings, debt financings, corporate collaborations, governmental research grants or other means. The Company may also seek to raise new capital to fund additional product development efforts, even if it has sufficient funds for its planned operations. Any sale by the Company of additional equity or convertible debt securities could result in dilution to the Company&#8217;s current stockholders. There can be no assurance that any required additional funding will be available to the Company at all or available on terms acceptable to the Company. Further, to the extent that the Company raises additional funds through collaborative arrangements, it may be necessary to relinquish some rights to the Company&#8217;s drug candidates or grant sublicenses on terms that are not favorable to the Company. If the Company is not able to secure additional funding when needed, the Company may have to delay, reduce the scope of, or eliminate one or more research and development programs, which could have an adverse effect on the Company&#8217;s business. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Risks and Uncertainties </div></div></div></div><div style="font-family: times new roman;font-size: 10pt;margin-top: 6pt;text-indent: 4%;margin-bottom: 0pt;"><div style="letter-spacing: 0px; top: 0px;;display:inline;">There are many uncertainties regarding the novel coronavirus <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">(COVID-19)</div> pandemic, and the Company is closely monitoring the impact of the pandemic on all aspects of its business, including how the pandemic is impacting its patients, employees, suppliers, vendors, business partners, clinical trials and distribution channels. The Company is unable to predict the impact that <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">COVID-19</div> will have on its financial position and operating results in future periods due to numerous uncertainties. The Company will continue to assess the evolving impact of the <div style="white-space: nowrap; letter-spacing: 0px; top: 0px;;display:inline;">COVID-19</div> pandemic and make adjustments to its operations as necessary. </div></div><table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table>

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