$CARA
Cara Therapeutics, Inc.

2022 Q1 Form 10-Q Financial Statement

#000155837022007824 Filed on May 09, 2022

View on sec.gov

Income Statement

Concept 2022 Q1 2021 Q1
Revenue $4.790M $1.935M
YoY Change 147.55% -76.09%
Cost Of Revenue $2.081M
YoY Change
Gross Profit $2.709M
YoY Change
Gross Profit Margin 56.56%
Selling, General & Admin $9.315M $6.300M
YoY Change 47.86% 40.0%
% of Gross Profit 343.85%
Research & Development $21.27M $19.13M
YoY Change 11.2% -42.95%
% of Gross Profit 785.27%
Depreciation & Amortization $63.00K $63.00K
YoY Change 0.0% 31.25%
% of Gross Profit 2.33%
Operating Expenses $32.70M $25.50M
YoY Change 28.26% -33.07%
Operating Profit -$27.91M -$23.56M
YoY Change 18.46% -21.47%
Interest Expense $162.0K $300.0K
YoY Change -46.0% -70.0%
% of Operating Profit
Other Income/Expense, Net $162.0K $260.0K
YoY Change -37.69% -72.83%
Pretax Income -$27.75M -$23.30M
YoY Change 19.09% -19.77%
Income Tax $0.00 $0.00
% Of Pretax Income
Net Earnings -$27.75M -$23.30M
YoY Change 19.09% -19.44%
Net Earnings / Revenue -579.31% -1204.19%
Basic Earnings Per Share -$0.52 -$0.47
Diluted Earnings Per Share -$0.52 -$0.47
COMMON SHARES
Basic Shares Outstanding 53.51M 49.92M
Diluted Shares Outstanding 53.51M 49.92M

Balance Sheet

Concept 2022 Q1 2021 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $141.1M $171.6M
YoY Change -17.76% 42.75%
Cash & Equivalents $21.36M $22.52M
Short-Term Investments $119.7M $149.1M
Other Short-Term Assets $5.113M $13.00M
YoY Change -60.67% 21.5%
Inventory $1.907M
Prepaid Expenses $5.113M $13.02M
Receivables $2.496M
Other Receivables $438.0K $2.244M
Total Short-Term Assets $151.8M $188.4M
YoY Change -19.43% 41.97%
LONG-TERM ASSETS
Property, Plant & Equipment $611.0K $778.0K
YoY Change -21.47% 19.33%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $68.46M $56.70M
YoY Change 20.73% -4.87%
Other Assets $408.0K $400.0K
YoY Change 2.0% 0.0%
Total Long-Term Assets $72.10M $61.88M
YoY Change 16.53% -2.56%
TOTAL ASSETS
Total Short-Term Assets $151.8M $188.4M
Total Long-Term Assets $72.10M $61.88M
Total Assets $223.9M $250.2M
YoY Change -10.54% 27.55%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $5.594M $4.765M
YoY Change 17.4% -48.81%
Accrued Expenses $12.70M $11.80M
YoY Change 7.64% 29.67%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $18.30M $16.52M
YoY Change 10.76% -49.33%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $1.455M $3.300M
YoY Change -55.91% 6.45%
Total Long-Term Liabilities $1.455M $3.300M
YoY Change -55.91% 6.45%
TOTAL LIABILITIES
Total Short-Term Liabilities $18.30M $16.52M
Total Long-Term Liabilities $1.455M $3.300M
Total Liabilities $19.75M $19.80M
YoY Change -0.25% -44.54%
SHAREHOLDERS EQUITY
Retained Earnings -$508.5M -$415.6M
YoY Change 22.35% -3.27%
Common Stock $714.3M $646.1M
YoY Change 10.57% 9.47%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $204.1M $230.5M
YoY Change
Total Liabilities & Shareholders Equity $223.9M $250.2M
YoY Change -10.54% 27.55%

Cashflow Statement

Concept 2022 Q1 2021 Q1
OPERATING ACTIVITIES
Net Income -$27.75M -$23.30M
YoY Change 19.09% -19.44%
Depreciation, Depletion And Amortization $63.00K $63.00K
YoY Change 0.0% 31.25%
Cash From Operating Activities -$25.53M -$23.72M
YoY Change 7.61% -38.07%
INVESTING ACTIVITIES
Capital Expenditures $43.00K
YoY Change
Acquisitions
YoY Change
Other Investing Activities $33.47M $13.87M
YoY Change 141.34% -62.47%
Cash From Investing Activities $33.43M $13.87M
YoY Change 141.05% -62.47%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 3.000K 688.0K
YoY Change -99.56% 817.33%
NET CHANGE
Cash From Operating Activities -25.53M -23.72M
Cash From Investing Activities 33.43M 13.87M
Cash From Financing Activities 3.000K 688.0K
Net Change In Cash 7.909M -9.164M
YoY Change -186.31% 622.14%
FREE CASH FLOW
Cash From Operating Activities -$25.53M -$23.72M
Capital Expenditures $43.00K
Free Cash Flow -$25.57M
YoY Change

Facts In Submission

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CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
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CY2021Q1 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
22927000
CY2022Q1 us-gaap Nature Of Operations
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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">1. Business</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">Cara Therapeutics, Inc., or the Company, is an early commercial-stage biopharmaceutical corporation formed on July 2, 2004. The Company is leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company’s primary activities to date have been organizing and staffing the Company, developing its lead product and product candidates, including conducting preclinical and clinical trials of difelikefalin-based product candidates, and raising capital.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">On August 23, 2021, the Company received U.S. Food and Drug Administration, or FDA, approval for KORSUVA<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">TM </sup>(difelikefalin) injection, or KORSUVA injection, for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The Company has a license agreement with Vifor (International) Ltd., or Vifor, that provides full commercialization rights of KORSUVA injection to Vifor in dialysis clinics in the United States under a profit-sharing arrangement, whereby total net sales of KORSUVA injection in the U.S., as recorded by Vifor, are reduced by a marketing and distribution fee owed by the Company based on the level of annual net sales, and the resulting amount is shared according to a 60% (Company)/40% (Vifor) profit split (see Note 11, <i style="font-style:italic;">Collaboration and Licensing Agreements)</i>. The Company expects commercial launch of KORSUVA injection in the U.S. in April 2022 and associated revenues in the second quarter of 2022.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">As of March 31, 2022, the Company had raised aggregate net proceeds of approximately $519,600 from several rounds of equity financing, including its initial public offering, or IPO, which closed in February 2014 and four follow-on public offerings of common stock, which closed in July 2019, July 2018, April 2017 and August 2015, respectively, and the issuance of convertible preferred stock and debt prior to the IPO. The Company had also earned approximately $229,710 under its license and supply agreements for difelikefalin, primarily with Vifor, Vifor Fresenius Medical Care Renal Pharma Ltd., or VFMCRP, Maruishi Pharmaceutical Co. Ltd., or Maruishi, and Chong Kun Dang Pharmaceutical Corp., or CKDP, and an earlier product candidate for which development efforts ceased in 2007. In October 2021, the Company received net proceeds of $44,969 from the issuance and sale of 3,282,391 shares of the Company’s common stock to Vifor in connection with U.S. regulatory approval for KORSUVA injection in August 2021. Additionally, in October 2020, the Company received net proceeds of $38,449 from the issuance and sale of 2,939,552 shares of the Company’s common stock to Vifor in connection with the Company’s license agreement with Vifor. Furthermore, in May 2018, the Company received net proceeds of $14,556 from the issuance and sale of 1,174,827 shares of the Company’s common stock to Vifor in connection with the Company’s license agreement with VFMCRP (see Note 11, <i style="font-style:italic;">Collaboration and Licensing Agreements</i>).</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">As of March 31, 2022, the Company had unrestricted cash and cash equivalents and marketable securities of $209,567 and an accumulated deficit of $508,507. The Company has incurred substantial net losses and negative cash flows from operating activities in nearly every fiscal period since inception and expects this trend to continue for the foreseeable future. The Company recognized net losses of $27,749 and $23,301 for the three months ended March 31, 2022 and 2021, respectively, and had net cash used in operating activities of $25,525 and $23,721 for the three months ended March 31, 2022 and 2021, respectively.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;">The Company is subject to risks common to other life science companies including, but not limited to, uncertainty of product development and commercialization, lack of marketing and sales history, development by its competitors of new technological innovations, dependence on key personnel, market acceptance of products, product liability, protection of proprietary technology, ability to raise additional financing, and compliance with FDA and other government regulations. If the Company does not successfully commercialize KORSUVA injection or any of its other product candidates, it will be unable to generate additional recurring product revenue or achieve profitability.</p>
CY2022Q1 dei Entity Incorporation Date Of Incorporation
EntityIncorporationDateOfIncorporation
2004-07-02
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519600000
CY2022Q1 cara Number Of Followon Public Offerings
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4
CY2022Q1 cara Upfront And Milestone Payments Earned In Connection With License Agreements
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CY2022Q1 us-gaap Basis Of Accounting
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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">2. Basis of Presentation</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The unaudited interim condensed financial statements included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission, or SEC. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company’s financial position, results of operations and cash flows in conformity with generally accepted accounting principles in the United States of America, or GAAP. In the opinion of management, these unaudited interim financial statements reflect all adjustments, consisting primarily of normal recurring accruals, necessary for a fair presentation of results for the periods presented. The results of operations for interim periods are not necessarily indicative of the results for the full year. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by SEC rules and regulations; however, the Company believes that the disclosures are adequate to make the information presented not misleading. The condensed balance sheet data as of December 31, 2021 were derived from audited financial statements, but do not include all disclosures required by GAAP. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;margin:0pt 0pt 12pt 18pt;">Use of Estimates</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The preparation of financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, as of the date of the financial statements as well as the reported amounts of revenues and expenses during the reporting period. The more significant estimates include the fair value of marketable securities that are classified as level 2 of the fair value hierarchy, the amount and periods over which certain revenues will be recognized, including licensing and collaborative revenue recognized from non-refundable up-front and milestone payments, accounts receivable, inventory valuation and related reserves, the determination of prepaid research and development, or R&amp;D, clinical costs and accrued research projects, the amount of non-cash compensation costs related to share-based payments to employees and non-employees, the incremental borrowing rate used in lease calculations and the likelihood of realization of deferred tax assets.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The ongoing COVID-19 pandemic and geopolitical tensions, such as Russia’s recent incursion into Ukraine, have interrupted business operations across the globe. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these condensed financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the reported amounts of assets and liabilities or the disclosure of contingent assets and liabilities. These estimates, however, may change as new events occur and additional information is obtained, and are recognized in the condensed financial statements as soon as they become known.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">Actual results could differ materially from the Company’s estimates and assumptions. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;margin:0pt 0pt 12pt 18pt;">Significant Accounting Policies</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">There have been no material changes to the significant accounting policies previously disclosed in Note 2 to the Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, except as disclosed below.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;"><i style="font-style:italic;">Accounts Receivable – Related Party</i></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">Accounts receivable – related party consists of amounts due from sales of KORSUVA injection under the Company’s licensing agreement with Vifor. The Company does not obtain collateral for its accounts receivable. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company makes judgments as to its ability to collect outstanding receivables and provides an allowance for credit losses when collection becomes doubtful. Provisions are made based upon a specific review of all significant outstanding invoices and the overall quality and age of those invoices not specifically reviewed. The Company believes that credit risk associated with its licensing partner Vifor is not significant. The Company reviews the need for an allowance for credit losses for any receivable based on various factors including payment history and historical bad debt experience. The Company had no allowance for credit losses as of March 31, 2022. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;"><span style="font-size:1pt;margin-bottom:12pt;visibility:hidden;">​</span></p>
CY2022Q1 us-gaap Use Of Estimates
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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;margin:0pt 0pt 12pt 18pt;">Use of Estimates</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The preparation of financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, as of the date of the financial statements as well as the reported amounts of revenues and expenses during the reporting period. The more significant estimates include the fair value of marketable securities that are classified as level 2 of the fair value hierarchy, the amount and periods over which certain revenues will be recognized, including licensing and collaborative revenue recognized from non-refundable up-front and milestone payments, accounts receivable, inventory valuation and related reserves, the determination of prepaid research and development, or R&amp;D, clinical costs and accrued research projects, the amount of non-cash compensation costs related to share-based payments to employees and non-employees, the incremental borrowing rate used in lease calculations and the likelihood of realization of deferred tax assets.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The ongoing COVID-19 pandemic and geopolitical tensions, such as Russia’s recent incursion into Ukraine, have interrupted business operations across the globe. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these condensed financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the reported amounts of assets and liabilities or the disclosure of contingent assets and liabilities. These estimates, however, may change as new events occur and additional information is obtained, and are recognized in the condensed financial statements as soon as they become known.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">Actual results could differ materially from the Company’s estimates and assumptions. </p>
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ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMaximum
0.0235
CY2021Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMinimum
0.0066
CY2021Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMaximum
0.0121
CY2022Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMinimum
0.814
CY2022Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMaximum
0.819
CY2021Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMinimum
0.716
CY2021Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMaximum
0.718
CY2022Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0
CY2021Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0
CY2021Q1 us-gaap Excess Tax Benefit From Share Based Compensation Operating Activities
ExcessTaxBenefitFromShareBasedCompensationOperatingActivities
0
CY2022Q1 us-gaap Excess Tax Benefit From Share Based Compensation Operating Activities
ExcessTaxBenefitFromShareBasedCompensationOperatingActivities
0
CY2021Q1 us-gaap Effective Income Tax Rate Continuing Operations
EffectiveIncomeTaxRateContinuingOperations
0
CY2022Q1 us-gaap Effective Income Tax Rate Continuing Operations
EffectiveIncomeTaxRateContinuingOperations
0
CY2021Q1 cara Percentage Of Research And Development Tax Credits Exchanged For Cash
PercentageOfResearchAndDevelopmentTaxCreditsExchangedForCash
0.65
CY2022Q1 cara Percentage Of Research And Development Tax Credits Exchanged For Cash
PercentageOfResearchAndDevelopmentTaxCreditsExchangedForCash
0.65
CY2021Q1 us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
0
CY2022Q1 us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
0
CY2022Q1 us-gaap Operating Lease Payments
OperatingLeasePayments
485000
CY2021Q1 us-gaap Operating Lease Payments
OperatingLeasePayments
476000
CY2022Q1 us-gaap Lessee Operating Lease Term Of Contract
LesseeOperatingLeaseTermOfContract
P1Y9M18D
CY2021Q1 us-gaap Lessee Operating Lease Term Of Contract
LesseeOperatingLeaseTermOfContract
P2Y9M18D
CY2022Q1 us-gaap Lessee Operating Lease Discount Rate
LesseeOperatingLeaseDiscountRate
0.070
CY2021Q1 us-gaap Lessee Operating Lease Discount Rate
LesseeOperatingLeaseDiscountRate
0.070
CY2022Q1 us-gaap Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
1473000
CY2022Q1 us-gaap Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
1991000
CY2022Q1 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
3464000
CY2022Q1 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
214000
CY2022Q1 us-gaap Operating Lease Liability
OperatingLeaseLiability
3250000
CY2022Q1 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
1795000
CY2022Q1 us-gaap Operating Lease Liability Noncurrent
OperatingLeaseLiabilityNoncurrent
1455000
CY2022Q1 us-gaap Operating Lease Liability
OperatingLeaseLiability
3250000

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