2024 Q2 Form 10-Q Financial Statement

#000155837024007964 Filed on May 13, 2024

View on sec.gov

Income Statement

Concept 2024 Q2 2024 Q1
Revenue $991.0K $2.135M
YoY Change -85.71% -65.37%
Cost Of Revenue $0.00 $620.0K
YoY Change -100.0% -76.06%
Gross Profit $991.0K $1.515M
YoY Change -82.03% -57.62%
Gross Profit Margin 100.0% 70.96%
Selling, General & Admin $6.369M $6.786M
YoY Change -15.24% -1.11%
% of Gross Profit 642.68% 447.92%
Research & Development $9.308M $21.96M
YoY Change -69.29% -9.74%
% of Gross Profit 939.25% 1449.77%
Depreciation & Amortization $77.00K $42.00K
YoY Change 28.33% -27.59%
% of Gross Profit 7.77% 2.77%
Operating Expenses $18.30M $31.80M
YoY Change -53.41% -5.96%
Operating Profit -$17.31M -$29.67M
YoY Change -46.49% 7.29%
Interest Expense $689.0K $952.0K
YoY Change -19.98% -3.35%
% of Operating Profit
Other Income/Expense, Net $689.0K $952.0K
YoY Change -19.98% -3.35%
Pretax Income -$20.02M -$30.70M
YoY Change -36.41% 15.12%
Income Tax $0.00 $0.00
% Of Pretax Income
Net Earnings -$20.02M -$30.70M
YoY Change -36.41% 15.12%
Net Earnings / Revenue -2019.78% -1437.75%
Basic Earnings Per Share -$0.37 -$0.56
Diluted Earnings Per Share -$0.37 -$0.56
COMMON SHARES
Basic Shares Outstanding 54.68M 54.66M
Diluted Shares Outstanding 54.72M 54.59M

Balance Sheet

Concept 2024 Q2 2024 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $56.62M $69.77M
YoY Change -40.21% -38.95%
Cash & Equivalents $49.24M $47.00M
Short-Term Investments $7.379M $22.78M
Other Short-Term Assets $3.777M $5.790M
YoY Change -75.45% -67.11%
Inventory $1.644M $2.741M
Prepaid Expenses $3.777M $5.790M
Receivables $359.0K $1.718M
Other Receivables $764.0K $506.0K
Total Short-Term Assets $63.86M $81.23M
YoY Change -48.8% -43.06%
LONG-TERM ASSETS
Property, Plant & Equipment $3.490M $3.548M
YoY Change 1033.12% 864.13%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $1.500M $1.500M
YoY Change 0.0%
Total Long-Term Assets $8.636M $8.874M
YoY Change -10.54% -16.42%
TOTAL ASSETS
Total Short-Term Assets $63.86M $81.23M
Total Long-Term Assets $8.636M $8.874M
Total Assets $72.50M $90.10M
YoY Change -46.06% -41.22%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $6.755M $4.978M
YoY Change -44.27% 12.52%
Accrued Expenses $7.146M $10.12M
YoY Change -46.41% -17.44%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $13.90M $15.10M
YoY Change -45.39% -9.49%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $47.00M $45.20M
YoY Change
Total Long-Term Liabilities $47.00M $45.20M
YoY Change
TOTAL LIABILITIES
Total Short-Term Liabilities $13.90M $15.10M
Total Long-Term Liabilities $47.00M $45.20M
Total Liabilities $60.90M $60.30M
YoY Change 139.22% 261.53%
SHAREHOLDERS EQUITY
Retained Earnings -$735.5M -$715.4M
YoY Change 17.79% 20.67%
Common Stock $747.2M $745.4M
YoY Change 1.79% 2.03%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $11.60M $29.80M
YoY Change
Total Liabilities & Shareholders Equity $72.50M $90.10M
YoY Change -46.06% -41.22%

Cashflow Statement

Concept 2024 Q2 2024 Q1
OPERATING ACTIVITIES
Net Income -$20.02M -$30.70M
YoY Change -36.41% 15.12%
Depreciation, Depletion And Amortization $77.00K $42.00K
YoY Change 28.33% -27.59%
Cash From Operating Activities -$12.44M -$30.45M
YoY Change -39.17% -12.03%
INVESTING ACTIVITIES
Capital Expenditures $210.0K $836.0K
YoY Change
Acquisitions
YoY Change
Other Investing Activities $15.50M $26.79M
YoY Change -52.75% 51.27%
Cash From Investing Activities $15.29M $25.95M
YoY Change -53.39% 46.55%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -610.0K -685.0K
YoY Change -222.32%
NET CHANGE
Cash From Operating Activities -12.44M -30.45M
Cash From Investing Activities 15.29M 25.95M
Cash From Financing Activities -610.0K -685.0K
Net Change In Cash 2.243M -5.187M
YoY Change -81.85% -68.28%
FREE CASH FLOW
Cash From Operating Activities -$12.44M -$30.45M
Capital Expenditures $210.0K $836.0K
Free Cash Flow -$12.65M -$31.29M
YoY Change -38.14% -9.62%

Facts In Submission

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CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
47799000
CY2024Q1 us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
211000
CY2024Q1 us-gaap Nature Of Operations
NatureOfOperations
<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 development-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 studies 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;">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. Commercial launch of KORSUVA injection began in the United States in April 2022 and the Company began recording the associated profit-sharing 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;">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 approved 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 United Kingdom in April 2022. Commercial launches in Austria, Germany, Sweden, France, the Netherlands, Finland, and Norway have commenced. In August 2022, as part of the Access Consortium, difelikefalin injection was approved in Switzerland under the brand name Kapruvia, as well as Singapore and Canada under the brand name KORSUVA. Commercial launch in Switzerland has also commenced. In November 2022, difelikefalin injection was approved in the last Access Consortium country, Australia, under the brand name KORSUVA. Difelikefalin injection was also approved in the United Arab Emirates, Kuwait, Israel, Japan, and Saudi Arabia under the brand name KORSUVA in January 2023, May 2023, June 2023, September 2023, and January 2024, respectively. The Company expects additional approvals and commercial launches over the next <span style="-sec-ix-hidden:Hidden_AXsHQmz9Q0C_YjRFs_dgGw;"><span style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:normal;">12</span></span>-18 months. On November 1, 2023, the Company entered into a Purchase and Sale Agreement, or the HCR Agreement, with HCRX Investments Holdco, L.P. and Healthcare Royalty Partners IV, L.P., or collectively HCR, pursuant to which HCR will receive current and future royalty and milestone payments for Kapruvia and KORSUVA (ex U.S. only) up to certain capped amounts in exchange for certain payments made to the Company (see Note 10, <i style="font-style:italic;">Royalty Purchase and Sale Agreement)</i>.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">In 2018, the Company entered into a license and collaboration agreement with a joint venture between Vifor Pharma Group and Fresenius Medical Care Renal Pharmaceutical Ltd., or Vifor Fresenius Medical Care Renal Pharma Ltd., that provides full commercialization rights of Kapruvia, and where applicable KORSUVA, to Vifor Fresenius Medical Care Renal Pharma Ltd. worldwide (excluding the United States, Japan and South Korea). In 2020, the Company entered into a second licensing and collaboration agreement, along with stock purchase agreements, with Vifor (International) Ltd., or Vifor International, that provides full commercialization rights of KORSUVA injection to Vifor International in dialysis clinics in the United States under a profit-sharing arrangement (see Note 12, <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;">In May 2022, Vifor International assigned its rights and obligations under the license agreement and a supply agreement, as permitted under the agreements, to Vifor Fresenius Medical Care Renal Pharma Ltd. The Company’s rights and obligations under these agreements were unaffected by this assignment and the assignment did not affect the Company’s economic rights under the agreements with Vifor International. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">In August 2022, Vifor Pharma Group (which includes Vifor International) was acquired by CSL Limited and subsequently renamed CSL Vifor as part of the acquisition. The acquisition of Vifor Pharma Group did not affect any of the Company’s rights and obligations pursuant to these agreements.</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 2023, Maruishi received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA IV Injection Syringe for the treatment of pruritus in hemodialysis patients (see Note 12, <i style="font-style:italic;">Collaboration and Licensing Agreements)</i>. In the fourth quarter of 2023, the Company entered into the HCR Agreement pursuant to which HCR will receive current and future royalty and milestone payments for KORSUVA (Japan) up to certain capped amounts in exchange for certain payments to the Company (see Note 10, <i style="font-style:italic;">Royalty Purchase and Sale Agreement)</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, 2024, the Company has raised aggregate net proceeds of approximately $520,700 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, the issuance of common stock pursuant to its open market sales agreement with Jefferies LLC as sales agent, or the Sales Agreement, in 2023, and the issuance of convertible preferred stock and debt prior to the IPO. The Company has also earned approximately $288,600 under its license and supply agreements for difelikefalin, primarily with CSL Vifor, Maruishi, and Chong Kun Dang Pharmaceutical Corp., or CKDP, and an earlier product candidate for which development efforts ceased in 2007. Under the terms of the HCR Agreement, the Company received net proceeds of $36,474 for the sale of future ex-U.S. royalties and milestones under Vifor Agreement No. 2 and the Maruishi Agreement in November and December 2023. The Company has also received aggregate net proceeds of approximately $98,000 from the issuance and sale of the Company’s common stock to Vifor International in connection with the Company’s license agreement with CSL Vifor (see Note 12, <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, 2024, the Company had unrestricted cash and cash equivalents and marketable securities of $69,773 and an accumulated deficit of $715,441. 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 $30,696 and $26,665 for the three months ended March 31, 2024 and 2023, respectively, and had net cash used in operating activities of $30,453 and $34,618 for the three months ended March 31, 2024 and 2023, 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 develop and commercialize its other product candidate, it will be unable to generate additional recurring product revenue or achieve profitability.</p>
CY2024Q1 dei Entity Incorporation Date Of Incorporation
EntityIncorporationDateOfIncorporation
2004-07-02
CY2024Q1 cara Aggregate Net Proceeds From Equity Financing And Issuance Of Debt
AggregateNetProceedsFromEquityFinancingAndIssuanceOfDebt
520700000
CY2024Q1 cara Number Of Followon Public Offerings
NumberOfFollowonPublicOfferings
4
CY2024Q1 us-gaap Cash Cash Equivalents And Short Term Investments
CashCashEquivalentsAndShortTermInvestments
69773000
CY2024Q1 us-gaap Retained Earnings Accumulated Deficit
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-715441000
CY2024Q1 us-gaap Net Income Loss
NetIncomeLoss
-30696000
CY2023Q1 us-gaap Net Income Loss
NetIncomeLoss
-26665000
CY2024Q1 us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-30453000
CY2023Q1 us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-34618000
CY2024Q1 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 0pt 12pt 0pt;">The Company’s condensed consolidated financial statements include the results of the financial operations of Cara Therapeutics, Inc. and its wholly-owned subsidiary, Cara Royalty Sub, LLC, or Cara Royalty Sub, a Delaware limited liability company which was formed in November 2023 for the purpose of the transactions contemplated by the HCR Agreement described in Note 10, <i style="font-style:italic;">Royalty Purchase and Sale Agreement</i>. All intercompany balances and transactions have been eliminated.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;">The unaudited interim condensed consolidated 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 </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">the opinion of management, these unaudited interim condensed consolidated 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 consolidated balance sheet data as of December 31, 2023 were derived from audited financial statements, but do not include all disclosures required by GAAP. These unaudited interim condensed consolidated 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, 2023.</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 condensed consolidated 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 condensed consolidated 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 and future ex-U.S. royalties and milestones projected in relation to the HCR Agreement, related party accounts receivable reserve, as applicable, inventory valuation and related reserves, research and development, or R&amp;D, clinical costs and accrued research projects included in prepaid expenses and accounts payable and accrued expenses, the amount of non-cash compensation costs related to share-based payments to employees and non-employees, restructuring costs, the amount of lease incentives, as applicable, and 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 impact from global economic conditions and potential and continuing disruptions to and volatility in the credit and equity markets in the United States and worldwide are highly uncertain and cannot be predicted, including impacts from global health crises, geopolitical tensions, such as the ongoing conflicts between Russia and Ukraine, conflict in the Middle East, and increasing tensions between China and Taiwan, and government actions implemented as a result of the foregoing, fluctuations in inflation, rising interest rates, uncertainty and liquidity concerns in the broader financial services industry, and a potential recession in the United States. 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 consolidated 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 consolidated 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;">There have been no material changes to the significant accounting policies previously disclosed in Note 2 to the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;"><span style="margin-bottom:12pt;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;"><span style="margin-bottom:12pt;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;"><i style="font-style:italic;">Accounting Pronouncements Recently Adopted </i></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;"><span style="font-style:italic;margin-bottom:12pt;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">In November 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2023-07, <i style="font-style:italic;">Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures</i>, or ASU 2023-07, which expanded the disclosures for reportable segments made by public entities. These amendments within ASU 2023-07 retained the existing disclosure requirements in ASC 280 and expanded upon them to require public entities to disclose significant expenses for reportable segments in both interim and annual reporting periods, as well as items that were previously disclosed only annually on an interim basis, including disclosures related to a reportable segment’s profit or loss and assets. In addition, entities with a single reportable segment must provide all segment disclosures required in ASC 280, including the new disclosures for reportable segments under the amendments in ASU 2023-07. The amendments did not change the existing guidance on how a public entity identified and determined its reportable segments. A public entity should apply the amendments in ASU 2023-07 retrospectively to all prior periods presented in the financial statements. Upon transition, the segment expense categories and amounts disclosed in the prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. The amendments in ASU 2023-07 are effective for annual periods for all public entities in fiscal years beginning after December 15, 2023, and in interim periods within fiscal years beginning after December 15, 2024. The Company adopted ASU 2023-07 on January 1, 2024, and will comply with any new applicable disclosures in its Annual Report on Form 10-K for the year ended December 31, 2024. The Company does not expect the adoption to have a material effect on its results of operations, financial position, and cash flows.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;"><i style="font-style:italic;">Accounting Pronouncements Not Yet Adopted</i></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;"><span style="font-style:italic;margin-bottom:12pt;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;">In December 2023, the FASB issued ASU 2023-09, <i style="font-style:italic;">Income Taxes (Topic 740): Improvements to Income Tax Disclosures</i>, or ASU 2023-09, which applies to all entities subject to income taxes. ASU 2023-09 requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is intended to provide more detailed income tax disclosures. For public business entities (PBEs), the new requirements will be effective for annual periods beginning after December 15, 2024. ASU 2023-09 will be applied on a prospective basis with the option to apply the standard retrospectively. The Company expects to adopt ASU 2023-09 on January 1, 2025, and it does not expect the adoption to have a material effect on its results of operations, financial position, and cash flows.</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>
CY2024Q1 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 condensed consolidated 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 condensed consolidated 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 and future ex-U.S. royalties and milestones projected in relation to the HCR Agreement, related party accounts receivable reserve, as applicable, inventory valuation and related reserves, research and development, or R&amp;D, clinical costs and accrued research projects included in prepaid expenses and accounts payable and accrued expenses, the amount of non-cash compensation costs related to share-based payments to employees and non-employees, restructuring costs, the amount of lease incentives, as applicable, and 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 impact from global economic conditions and potential and continuing disruptions to and volatility in the credit and equity markets in the United States and worldwide are highly uncertain and cannot be predicted, including impacts from global health crises, geopolitical tensions, such as the ongoing conflicts between Russia and Ukraine, conflict in the Middle East, and increasing tensions between China and Taiwan, and government actions implemented as a result of the foregoing, fluctuations in inflation, rising interest rates, uncertainty and liquidity concerns in the broader financial services industry, and a potential recession in the United States. 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 consolidated 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 consolidated 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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3000
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263000
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4
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9
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22968000
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48983000
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48496000
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53683000
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CY2024Q1 us-gaap Inventory Work In Process
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CY2023Q4 us-gaap Inventory Gross
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CY2024Q1 us-gaap Inventory Valuation Reserves
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CY2023Q4 us-gaap Inventory Valuation Reserves
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CY2024Q1 us-gaap Inventory Net
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CY2023Q4 us-gaap Inventory Net
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0
CY2024Q1 us-gaap Inventory Write Down
InventoryWriteDown
0
CY2024Q1 us-gaap Prepaid Expense Current
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CY2024Q1 cara Prepaid Research And Development Expenses
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CY2024Q1 us-gaap Prepaid Insurance
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CY2023Q4 cara Prepaid Research And Development Expenses
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CY2023Q4 us-gaap Other Prepaid Expense Current
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CY2024Q1 us-gaap Accounts Payable Current
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CY2023Q4 us-gaap Accounts Payable Current
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11583000
CY2024Q1 cara Accrued Research Projects
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5895000
CY2023Q4 cara Accrued Research Projects
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CY2024Q1 us-gaap Accrued Employee Benefits Current
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2064000
CY2023Q4 us-gaap Accrued Employee Benefits Current
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6519000
CY2024Q1 us-gaap Accrued Professional Fees Current
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CY2023Q4 us-gaap Accrued Professional Fees Current
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3147000
CY2024Q1 us-gaap Accounts Payable And Accrued Liabilities Current
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14875000
CY2023Q4 us-gaap Accounts Payable And Accrued Liabilities Current
AccountsPayableAndAccruedLiabilitiesCurrent
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CY2024Q1 us-gaap Weighted Average Number Of Shares Outstanding Basic
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54588090
CY2023Q1 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
53872038
CY2024Q1 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
54588090
CY2023Q1 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
53872038
CY2024Q1 us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
54588090
CY2023Q1 us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
53872038
CY2023Q1 us-gaap Incremental Common Shares Attributable To Share Based Payment Arrangements
IncrementalCommonSharesAttributableToShareBasedPaymentArrangements
0
CY2024Q1 us-gaap Incremental Common Shares Attributable To Share Based Payment Arrangements
IncrementalCommonSharesAttributableToShareBasedPaymentArrangements
0
CY2024Q1 us-gaap Net Income Loss
NetIncomeLoss
-30696000
CY2023Q1 us-gaap Net Income Loss
NetIncomeLoss
-26665000
CY2024Q1 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
54588090
CY2023Q1 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
53872038
CY2024Q1 us-gaap Earnings Per Share Basic
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CY2024Q1 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-0.56
CY2023Q1 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-0.49
CY2023Q1 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-0.49
CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
8816532
CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Nonvested Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsNonvestedNumber
250267
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
8992759
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Nonvested Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsNonvestedNumber
695720
CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate
0.0412
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMinimum
0.0362
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMaximum
0.0422
CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate
0.896
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Minimum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMinimum
0.763
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate Maximum
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMaximum
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CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0
CY2023Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
7897647
CY2023Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
12.99
CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Gross
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross
1875125
CY2024Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Grants In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice
0.99
CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod
679165
CY2024Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Forfeitures In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice
10.87
CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Expirations In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExpirationsInPeriod
277075
CY2024Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Expirations In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExpirationsInPeriodWeightedAverageExercisePrice
13.36
CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
8816532
CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
10.59
CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber
4827562
CY2023Q1 cara Excess Tax Benefits From Stock Option Activity Or Stock Based Compensation Expense Recognized In Cash Flows From Operations
ExcessTaxBenefitsFromStockOptionActivityOrStockBasedCompensationExpenseRecognizedInCashFlowsFromOperations
0
CY2024Q1 cara Excess Tax Benefits From Stock Option Activity Or Stock Based Compensation Expense Recognized In Cash Flows From Operations
ExcessTaxBenefitsFromStockOptionActivityOrStockBasedCompensationExpenseRecognizedInCashFlowsFromOperations
0
CY2023Q1 us-gaap Effective Income Tax Rate Continuing Operations
EffectiveIncomeTaxRateContinuingOperations
0
CY2024Q1 us-gaap Effective Income Tax Rate Continuing Operations
EffectiveIncomeTaxRateContinuingOperations
0
CY2023Q1 cara Percentage Of Research And Development Tax Credits Exchanged For Cash
PercentageOfResearchAndDevelopmentTaxCreditsExchangedForCash
0.65
CY2024Q1 cara Percentage Of Research And Development Tax Credits Exchanged For Cash
PercentageOfResearchAndDevelopmentTaxCreditsExchangedForCash
0.65
CY2023Q1 us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
0
CY2024Q1 us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
0
CY2024Q1 cara Income Tax Receivable Related To Research And Development Credit
IncomeTaxReceivableRelatedToResearchAndDevelopmentCredit
697000
CY2024Q1 cara Restructuring And Related Cost Maximum Percentage Of Planned Workforce Reduction
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0.50
CY2024Q1 us-gaap Severance Costs1
SeveranceCosts1
2401000
CY2024Q1 us-gaap Severance Costs1
SeveranceCosts1
2401000
CY2024Q1 us-gaap Payments For Restructuring
PaymentsForRestructuring
1702000
CY2024Q1 us-gaap Restructuring Reserve Noncurrent
RestructuringReserveNoncurrent
699000
CY2023Q1 us-gaap Operating Lease Payments
OperatingLeasePayments
494000
CY2024Q1 us-gaap Lessee Operating Lease Term Of Contract
LesseeOperatingLeaseTermOfContract
P10Y7M6D
CY2023Q1 us-gaap Lessee Operating Lease Term Of Contract
LesseeOperatingLeaseTermOfContract
P0Y9M18D
CY2024Q1 us-gaap Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
0.128
CY2023Q1 us-gaap Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
0.070
CY2024Q1 us-gaap Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
108000
CY2024Q1 us-gaap Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
1298000
CY2024Q1 us-gaap Lessee Operating Lease Liability Payments Due Year Two
LesseeOperatingLeaseLiabilityPaymentsDueYearTwo
1330000
CY2024Q1 us-gaap Lessee Operating Lease Liability Payments Due Year Three
LesseeOperatingLeaseLiabilityPaymentsDueYearThree
1363000
CY2024Q1 us-gaap Lessee Operating Lease Liability Payments Due Year Four
LesseeOperatingLeaseLiabilityPaymentsDueYearFour
1398000
CY2024Q1 us-gaap Lessee Operating Lease Liability Payments Due After Year Five
LesseeOperatingLeaseLiabilityPaymentsDueAfterYearFive
8874000
CY2024Q1 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
14371000
CY2024Q1 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
7115000
CY2024Q1 cara Lease Incentive To Be Reimbursed
LeaseIncentiveToBeReimbursed
211000
CY2024Q1 us-gaap Operating Lease Liability
OperatingLeaseLiability
7045000
CY2024Q1 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
220000
CY2024Q1 us-gaap Operating Lease Liability Noncurrent
OperatingLeaseLiabilityNoncurrent
6825000
CY2024Q1 us-gaap Operating Lease Liability
OperatingLeaseLiability
7045000
CY2024Q1 ecd Rule10b51 Arr Adopted Flag
Rule10b51ArrAdoptedFlag
false
CY2024Q1 ecd Non Rule10b51 Arr Adopted Flag
NonRule10b51ArrAdoptedFlag
false
CY2024Q1 ecd Rule10b51 Arr Trmntd Flag
Rule10b51ArrTrmntdFlag
false
CY2024Q1 ecd Non Rule10b51 Arr Trmntd Flag
NonRule10b51ArrTrmntdFlag
false

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