2022 Q4 Form 10-Q Financial Statement

#000155837022016625 Filed on November 07, 2022

View on sec.gov

Income Statement

Concept 2022 Q4 2022 Q3 2021 Q3
Revenue $3.261M $10.81M $20.27M
YoY Change 297.2% -46.66% 118.78%
Cost Of Revenue $2.130M $3.055M
YoY Change
Gross Profit $1.131M $7.758M
YoY Change
Gross Profit Margin 34.68% 71.75%
Selling, General & Admin $6.396M $6.912M $5.851M
YoY Change -44.29% 18.13% 12.52%
% of Gross Profit 565.52% 89.1%
Research & Development $25.98M $24.69M $15.51M
YoY Change 13.95% 59.15% -26.36%
% of Gross Profit 2297.17% 318.27%
Depreciation & Amortization $61.00K $61.00K $62.00K
YoY Change -1.61% -1.61% 24.0%
% of Gross Profit 5.39% 0.79%
Operating Expenses $32.44M $34.66M $21.40M
YoY Change -5.55% 61.98% -18.6%
Operating Profit -$31.31M -$23.85M -$1.124M
YoY Change 2021.44% -93.4%
Interest Expense $968.0K $665.0K $111.0K
YoY Change 591.43% 499.1% -72.25%
% of Operating Profit
Other Income/Expense, Net $665.0K $111.0K
YoY Change 499.1% -70.71%
Pretax Income -$30.34M -$23.18M -$1.013M
YoY Change -9.12% 2188.25% -93.91%
Income Tax $0.00 $0.00
% Of Pretax Income
Net Earnings -$30.34M -$23.18M -$1.013M
YoY Change -9.12% 2188.25% -93.86%
Net Earnings / Revenue -930.36% -214.37% -5.0%
Basic Earnings Per Share -$0.43 -$0.02
Diluted Earnings Per Share -$0.56 -$0.43 -$20.21K
COMMON SHARES
Basic Shares Outstanding 53.73M 53.73M 50.11M
Diluted Shares Outstanding 53.73M 50.11M

Balance Sheet

Concept 2022 Q4 2022 Q3 2021 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $145.4M $155.6M $144.2M
YoY Change -12.95% 7.92% 19.3%
Cash & Equivalents $63.74M $42.81M $22.99M
Short-Term Investments $81.66M $112.8M $121.2M
Other Short-Term Assets $16.68M $18.56M $6.258M
YoY Change 561.97% 196.61% -39.24%
Inventory $2.383M $1.835M
Prepaid Expenses $16.27M $18.56M $6.258M
Receivables $3.260M $9.623M
Other Receivables $496.0K $451.0K $20.35M
Total Short-Term Assets $168.9M $186.8M $171.5M
YoY Change -2.53% 8.91% 29.1%
LONG-TERM ASSETS
Property, Plant & Equipment $426.0K $487.0K $654.0K
YoY Change -32.49% -25.54% -10.53%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $11.35M $23.92M $49.22M
YoY Change -83.73% -51.41% 368.77%
Other Assets $0.00 $408.0K $408.0K
YoY Change -100.0% 0.0% 2.0%
Total Long-Term Assets $13.33M $26.73M $53.59M
YoY Change -81.93% -50.13% 274.8%
TOTAL ASSETS
Total Short-Term Assets $168.9M $186.8M $171.5M
Total Long-Term Assets $13.33M $26.73M $53.59M
Total Assets $182.2M $213.5M $225.1M
YoY Change -26.24% -5.15% 52.98%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $9.604M $15.22M $5.369M
YoY Change 70.74% 183.44% -17.18%
Accrued Expenses $13.85M $1.876M $10.16M
YoY Change 15.54% -81.53% 5.82%
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 $23.46M $28.19M $15.53M
YoY Change 33.16% 81.56% -6.45%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $0.00 $497.0K $2.373M
YoY Change -100.0% -79.06% -12.11%
Total Long-Term Liabilities $0.00 $497.0K $2.373M
YoY Change -100.0% -79.06% -12.11%
TOTAL LIABILITIES
Total Short-Term Liabilities $23.46M $28.19M $15.53M
Total Long-Term Liabilities $0.00 $497.0K $2.373M
Total Liabilities $23.46M $28.69M $17.90M
YoY Change 20.09% 60.26% -7.25%
SHAREHOLDERS EQUITY
Retained Earnings -$566.2M -$535.9M -$447.4M
YoY Change 17.78% 19.79% -5.06%
Common Stock $726.7M $722.9M $699.5M
YoY Change 2.55% 3.33% 16.84%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $158.8M $184.8M $207.2M
YoY Change
Total Liabilities & Shareholders Equity $182.2M $213.5M $225.1M
YoY Change -26.24% -5.15% 52.98%

Cashflow Statement

Concept 2022 Q4 2022 Q3 2021 Q3
OPERATING ACTIVITIES
Net Income -$30.34M -$23.18M -$1.013M
YoY Change -9.12% 2188.25% -93.86%
Depreciation, Depletion And Amortization $61.00K $61.00K $62.00K
YoY Change -1.61% -1.61% 24.0%
Cash From Operating Activities -$23.51M -$25.19M -$14.12M
YoY Change 1788.35% 78.46% -34.71%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00
YoY Change -100.0%
Acquisitions
YoY Change
Other Investing Activities $44.42M $21.18M $14.43M
YoY Change -182.97% 46.72% -63.66%
Cash From Investing Activities $44.42M $21.18M $14.43M
YoY Change -182.91% 46.72% -63.5%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 22.00K 104.0K 339.0K
YoY Change -99.95% -69.32% -13.08%
NET CHANGE
Cash From Operating Activities -23.51M -25.19M -14.12M
Cash From Investing Activities 44.42M 21.18M 14.43M
Cash From Financing Activities 22.00K 104.0K 339.0K
Net Change In Cash 20.93M -3.912M 656.0K
YoY Change -319.49% -696.34% -96.42%
FREE CASH FLOW
Cash From Operating Activities -$23.51M -$25.19M -$14.12M
Capital Expenditures $0.00 $0.00
Free Cash Flow -$23.51M -$25.19M
YoY Change 1849.42%

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CY2021Q3 us-gaap Stockholders Equity
StockholdersEquity
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ShareBasedCompensation
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us-gaap Depreciation Depletion And Amortization
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us-gaap Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
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cara Amortization Expense Component Of Lease Expense
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cara Amortization Expense Component Of Lease Expense
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us-gaap Gain Loss On Sale Of Property Plant Equipment
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us-gaap Increase Decrease In Other Receivables
IncreaseDecreaseInOtherReceivables
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us-gaap Net Cash Provided By Used In Operating Activities
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us-gaap Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
48830000
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us-gaap Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
1320000
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289000
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
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29353000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Excluding Exchange Rate Effect
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CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
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CY2022Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
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CY2021Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
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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 a 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;">In August 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;"> </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 International, that provides full commercialization rights of KORSUVA injection to Vifor in dialysis clinics in the U.S. under a profit-sharing arrangement, whereby total net sales of KORSUVA injection in the U.S., as recorded by Vifor International, are reduced by Vifor International’s cost of goods sold, or COGS, as well as 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 International) profit split (excluding sales to Fresenius Medical Center dialysis clinics, compensation for which is governed by the agreement with Vifor Fresenius Medical Care Renal Pharma Ltd., or Vifor), subject to potential temporary adjustment in future years based on certain conditions (see Note 11, <i style="font-style:italic;">Collaboration and Licensing Agreements)</i>. Commercial launch of KORSUVA injection began in the U.S. in April 2022 and the Company began recording the associated profit-sharing revenues in the second quarter of 2022. In May 2022, as permitted by the agreements with Vifor International, Vifor International assigned its rights and obligations under the license agreement and a related supply agreement to Vifor. The Company’s rights and obligations under these agreements were unaffected by this assignment and the assignment does not affect the Company’s economic rights under the agreements. Throughout the Notes to Condensed Financial Statements, unless the context requires otherwise, references to Vifor’s commercialization of KORSUVA injection pursuant to this license agreement, and the Company’s provision of KORSUVA injection under this supply agreement, should be understood to refer to Vifor International prior to the assignment and to Vifor following the assignment, as applicable. Vifor International was acquired by CSL Limited in August 2022. The acquisition of Vifor International by CSL did not affect any of the Company’s rights or obligations pursuant to its agreements with Vifor.</p><p style="font-family:'Times New Roman','Times','serif';font-size:12pt;text-indent:18pt;margin:0pt;"><span style="font-size:10pt;text-decoration-color:#000000;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;">In April 2022, the European Commission granted marketing authorization to difelikefalin injection under the brand name Kapruvia® (difelikefalin), or Kapruvia, for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients. The marketing authorization approves Kapruvia for use in all member states of the European Union, or EU, as well as Iceland, Liechtenstein, and Norway. Kapruvia was also approved in the UK in April 2022. In addition, as part of the Access Consortium, the product was approved in August 2022 in Switzerland as Kapruvia, as well as Singapore and Canada as KORSUVA. In 2018, the Company entered into a license agreement with Vifor that provides full commercialization rights of Kapruvia, and where applicable KORSUVA, to Vifor worldwide (excluding the U.S., Japan and South Korea). In markets outside of the U.S., the Company is eligible to receive tiered double-digit royalty payments based on annual net sales, as defined in the agreement with Vifor, of difelikefalin injection in the licensed territories. In the U.S. market, the agreement with Vifor provides that Vifor will promote difelikefalin injection in the dialysis clinics of Fresenius Medical Care North America, or FMCNA, under a profit-sharing arrangement, whereby the Company is generally entitled to 50% of the annual net profits (as defined in the agreement with Vifor) based on net FMCNA clinic sales (as defined in the agreement with Vifor) and Vifor is entitled to 50% of such net profits, subject to potential adjustments in a calendar year based on certain conditions (see Note 11,<i style="font-style:italic;"> </i></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;"><i style="font-style:italic;">Collaboration and Licensing Agreements</i>). Commercial launch of Kapruvia in the EU commenced in September 2022 in Austria and shortly thereafter in Germany. Launches in additional EU countries are planned in the coming months.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company also has a license agreement with Maruishi Pharmaceutical Co. Ltd., or Maruishi, under which the Company granted Maruishi an exclusive license to develop, manufacture, and commercialize drug products containing difelikefalin for acute pain and/or uremic pruritus in Japan. In September 2022, Maruishi submitted a New Drug Application in Japan for approval of difelikefalin injection for the treatment of pruritus in hemodialysis patients (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 September 30, 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. Including profit share revenue, the Company had also earned approximately $263,500 under its license and supply agreements for difelikefalin, primarily with Vifor International, Vifor, 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 International 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 International in connection with the Company’s license agreement with Vifor International. 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 International in connection with the Company’s license agreement with Vifor (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 September 30, 2022, the Company had unrestricted cash and cash equivalents and marketable securities of $179,528 and an accumulated deficit of $535,893. 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 $23,180 and $1,013 for the three months ended September 30, 2022 and 2021, respectively, and $55,135 and $55,059 for the nine months ended September 30, 2022 and 2021, respectively, and had net cash used in operating activities of $55,220 and $58,842 for the nine months ended September 30, 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, Kapruvia or any of its other product candidates, it will be unable to generate additional recurring product revenue or achieve profitability.</p>
dei Entity Incorporation Date Of Incorporation
EntityIncorporationDateOfIncorporation
2004-07-02
CY2022Q3 cara Aggregate Net Proceeds From Equity Financing And Issuance Of Debt
AggregateNetProceedsFromEquityFinancingAndIssuanceOfDebt
519600000
cara Number Of Followon Public Offerings
NumberOfFollowonPublicOfferings
4
CY2022Q3 cara Upfront And Milestone Payments Earned In Connection With License Agreements
UpfrontAndMilestonePaymentsEarnedInConnectionWithLicenseAgreements
263500000
CY2022Q3 us-gaap Cash Cash Equivalents And Short Term Investments
CashCashEquivalentsAndShortTermInvestments
179528000
CY2022Q3 us-gaap Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
-535893000
CY2022Q3 us-gaap Net Income Loss
NetIncomeLoss
-23180000
CY2021Q4 us-gaap Available For Sale Debt Securities Accumulated Gross Unrealized Loss Before Tax
AvailableForSaleDebtSecuritiesAccumulatedGrossUnrealizedLossBeforeTax
363000
CY2021Q3 us-gaap Net Income Loss
NetIncomeLoss
-1013000
us-gaap Net Income Loss
NetIncomeLoss
-55135000
us-gaap Net Income Loss
NetIncomeLoss
-55059000
us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-55220000
us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-58842000
us-gaap Basis Of Accounting
BasisOfAccounting
<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;">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 </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">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, revenue recognition associated with profit-sharing arrangements, 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, net – related party, 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 COVID-19 pandemic and geopolitical tensions, such as Russia’s incursion into Ukraine, resulted in a global slowdown of economic activity, decades-high inflation, rising interest rates, and a potential recession in the U.S. 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;"><i style="font-style:italic;">Accounts Receivable, Net – 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, net – related party consists of amounts due from sales of KORSUVA injection under the Company’s supply agreements with Vifor, as well as revenues earned from its profit-sharing agreement from sales of KORSUVA injection in the U.S. under the licensing agreements 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;">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 </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">allowance for credit losses for any receivable based on various factors including payment history and historical bad debt experience. The Company had an insignificant allowance for credit losses as of September 30, 2022. </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;">Revenue Recognition – Profit-Sharing Arrangement</i></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company receives its share of the net profits from Vifor’s sale of KORSUVA injection to third parties in the U.S. under its existing license agreements. The Company has adopted a policy to recognize revenue net of tax withholdings, as applicable. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company determined that Vifor is a customer under Accounting Standards Update, or ASU, 2014-09, <i style="font-style:italic;">Revenue from Contracts with Customers (Topic 606)</i>, as amended by ASU 2016-08, 2016-10, 2016-12 and 2016-20, or ASC 606, in relation to its profit share arrangement with Vifor. The Company sells commercial product to Vifor, who ultimately sells the commercial product to third parties. The Company’s profit share arrangement revenues generated from sales of KORSUVA injection in the U.S. are considered akin to sales-based royalties. In accordance with the sales-based royalty exception, the Company recognizes its share of the pre-tax commercial net profit generated from the sales of KORSUVA injection in the U.S. in the period the product sales are earned, as reported by Vifor. The related COGS for Vifor associated with the net profit share arrangement as well as the marketing and distribution fee for the applicable period reduces the Company’s profit share revenue for the period. The net sales amounts are determined based on amounts provided by Vifor and involve the use of estimates and judgments, such as product sales allowances and accruals related to prompt payment discounts, chargebacks, governmental and contractual rebates, wholesaler fees, product returns, and co-payment assistance costs, which could be adjusted based on actual results in the future. The Company is dependent on Vifor for timely and accurate information regarding the net revenues from sales of KORSUVA injection in the U.S. in accordance with ASC 606 to accurately report its results of operations. If the Company does not receive timely and accurate information or incorrectly estimates activity levels associated with the profit share arrangement at a given point in time, the Company could be required to record adjustments in future periods.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">In accordance with ASC 606-10-55, <i style="font-style:italic;">Principal Agent Considerations</i>, the Company records revenue transactions as net product revenue if it is deemed the principal in the transaction, which includes being the primary obligor, retaining inventory risk, and control over pricing. Given that the Company is not the primary obligor and does not have the inventory risks in the license agreement with Vifor, it records its share of the net profits from the sales of KORSUVA injection in the U.S. on a net basis and presents the settlement payments from Vifor as Collaborative revenue. The Company and Vifor settle the profit sharing quarterly (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;"><span style="font-size:1pt;margin-bottom:12pt;visibility:hidden;">​</span></p>
us-gaap Use Of Estimates
UseOfEstimates
<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, revenue recognition associated with profit-sharing arrangements, 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, net – related party, 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 COVID-19 pandemic and geopolitical tensions, such as Russia’s incursion into Ukraine, resulted in a global slowdown of economic activity, decades-high inflation, rising interest rates, and a potential recession in the U.S. 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>
CY2022Q3 us-gaap Debt Securities Available For Sale Amortized Cost Excluding Accrued Interest Before Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAmortizedCostExcludingAccruedInterestBeforeAllowanceForCreditLoss
138870000
CY2022Q3 us-gaap Available For Sale Debt Securities Accumulated Gross Unrealized Loss Before Tax
AvailableForSaleDebtSecuritiesAccumulatedGrossUnrealizedLossBeforeTax
2148000
CY2022Q3 us-gaap Debt Securities Available For Sale Excluding Accrued Interest
DebtSecuritiesAvailableForSaleExcludingAccruedInterest
136722000
CY2021Q4 us-gaap Debt Securities Available For Sale Amortized Cost Excluding Accrued Interest Before Allowance For Credit Loss
DebtSecuritiesAvailableForSaleAmortizedCostExcludingAccruedInterestBeforeAllowanceForCreditLoss
223694000
CY2021Q4 us-gaap Available For Sale Debt Securities Accumulated Gross Unrealized Gain Before Tax
AvailableForSaleDebtSecuritiesAccumulatedGrossUnrealizedGainBeforeTax
5000
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CY2021Q3 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
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us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
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us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
50031615
CY2022Q3 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
53726123
CY2021Q3 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
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us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
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us-gaap Weighted Average Number Of Shares Outstanding Basic
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CY2022Q3 us-gaap Weighted Average Number Of Diluted Shares Outstanding
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us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
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us-gaap Incremental Common Shares Attributable To Share Based Payment Arrangements
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CY2021Q3 us-gaap Incremental Common Shares Attributable To Share Based Payment Arrangements
IncrementalCommonSharesAttributableToShareBasedPaymentArrangements
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us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMaximum
0.819
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMinimum
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CY2022Q3 us-gaap Incremental Common Shares Attributable To Share Based Payment Arrangements
IncrementalCommonSharesAttributableToShareBasedPaymentArrangements
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CY2022Q3 us-gaap Net Income Loss
NetIncomeLoss
-23180000
CY2021Q3 us-gaap Net Income Loss
NetIncomeLoss
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us-gaap Net Income Loss
NetIncomeLoss
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NetIncomeLoss
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CY2022Q3 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
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CY2021Q3 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
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us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
53616753
us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
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EarningsPerShareBasic
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EarningsPerShareBasic
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EarningsPerShareBasic
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CY2022Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
7654523
CY2022Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Nonvested Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsNonvestedNumber
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CY2021Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
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CY2021Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Nonvested Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsNonvestedNumber
365029
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0.0265
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ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMaximum
0.0409
CY2021Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMinimum
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us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate Minimum
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us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMaximum
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us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMinimum
0.0066
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMaximum
0.0123
CY2022Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMinimum
0.777
CY2022Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMaximum
0.782
CY2021Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMinimum
0.830
CY2021Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMaximum
0.834
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMinimum
0.777
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMaximum
0.835
CY2022Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0
CY2021Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0
cara Excess Tax Benefits From Stock Option Activity Or Stock Based Compensation Expense Recognized In Cash Flows From Operations
ExcessTaxBenefitsFromStockOptionActivityOrStockBasedCompensationExpenseRecognizedInCashFlowsFromOperations
0
cara Excess Tax Benefits From Stock Option Activity Or Stock Based Compensation Expense Recognized In Cash Flows From Operations
ExcessTaxBenefitsFromStockOptionActivityOrStockBasedCompensationExpenseRecognizedInCashFlowsFromOperations
0
CY2022Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Plan Modification Incremental Compensation Cost
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0
us-gaap Effective Income Tax Rate Continuing Operations
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0
CY2021Q3 us-gaap Effective Income Tax Rate Continuing Operations
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us-gaap Effective Income Tax Rate Continuing Operations
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CY2022Q3 us-gaap Effective Income Tax Rate Continuing Operations
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0
cara Percentage Of Research And Development Tax Credits Exchanged For Cash
PercentageOfResearchAndDevelopmentTaxCreditsExchangedForCash
0.65
CY2021Q3 cara Percentage Of Research And Development Tax Credits Exchanged For Cash
PercentageOfResearchAndDevelopmentTaxCreditsExchangedForCash
0.65
cara Percentage Of Research And Development Tax Credits Exchanged For Cash
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CY2022Q3 cara Percentage Of Research And Development Tax Credits Exchanged For Cash
PercentageOfResearchAndDevelopmentTaxCreditsExchangedForCash
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us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
0
CY2021Q3 us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
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us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
0
CY2022Q3 us-gaap Income Tax Expense Benefit
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0
CY2021Q3 us-gaap Lessee Operating Lease Discount Rate
LesseeOperatingLeaseDiscountRate
0.070
CY2022Q3 us-gaap Lessee Operating Lease Discount Rate
LesseeOperatingLeaseDiscountRate
0.070
CY2021Q3 us-gaap Lessee Operating Lease Discount Rate
LesseeOperatingLeaseDiscountRate
0.070
CY2022Q3 us-gaap Operating Lease Payments
OperatingLeasePayments
491000
CY2021Q3 us-gaap Operating Lease Payments
OperatingLeasePayments
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us-gaap Operating Lease Payments
OperatingLeasePayments
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us-gaap Operating Lease Payments
OperatingLeasePayments
1436000
CY2022Q3 us-gaap Lessee Operating Lease Term Of Contract
LesseeOperatingLeaseTermOfContract
P1Y3M18D
CY2021Q3 us-gaap Lessee Operating Lease Term Of Contract
LesseeOperatingLeaseTermOfContract
P2Y3M18D
CY2022Q3 us-gaap Lessee Operating Lease Term Of Contract
LesseeOperatingLeaseTermOfContract
P1Y3M18D
CY2021Q3 us-gaap Lessee Operating Lease Term Of Contract
LesseeOperatingLeaseTermOfContract
P2Y3M18D
CY2022Q3 us-gaap Lessee Operating Lease Discount Rate
LesseeOperatingLeaseDiscountRate
0.070
CY2022Q3 us-gaap Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
494000
CY2022Q3 us-gaap Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
1992000
CY2022Q3 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
2486000
CY2022Q3 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
113000
CY2022Q3 us-gaap Operating Lease Liability
OperatingLeaseLiability
2373000
CY2022Q3 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
1876000
CY2022Q3 us-gaap Operating Lease Liability Noncurrent
OperatingLeaseLiabilityNoncurrent
497000
CY2022Q3 us-gaap Operating Lease Liability
OperatingLeaseLiability
2373000

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