Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Jul. 26, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2023 | |
Entity File Number | 001-38223 | |
Entity Registrant Name | RHYTHM PHARMACEUTICALS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-2159271 | |
Entity Address, Address Line One | 222 Berkeley Street | |
Entity Address, Address Line Two | 12th Floor | |
Entity Address, City or Town | Boston | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02116 | |
City Area Code | 857 | |
Local Phone Number | 264-4280 | |
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Trading Symbol | RYTM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 56,901,530 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001649904 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 115,684 | $ 127,677 |
Short-term investments | 137,918 | 205,611 |
Accounts receivable, net | 13,831 | 6,224 |
Inventory | 6,178 | 2,917 |
Prepaid expenses and other current assets | 10,267 | 11,807 |
Total current assets | 283,878 | 354,236 |
Property and equipment, net | 1,773 | 2,197 |
Right-of-use asset | 990 | 1,182 |
Intangible assets, net | 7,456 | 7,883 |
Restricted cash | 328 | 328 |
Other long-term assets | 15,518 | 16,655 |
Total assets | 309,943 | 382,481 |
Current liabilities: | ||
Accounts payable | 8,383 | 4,797 |
Accrued expenses and other current liabilities | 35,708 | 32,894 |
Deferred revenue | 1,286 | 1,434 |
Lease liability | 726 | 684 |
Total current liabilities | 46,103 | 39,809 |
Long-term liabilities: | ||
Deferred royalty obligation | 79,347 | 75,810 |
Lease liability | 888 | 1,260 |
Derivative liability | 1,320 | 1,340 |
Total liabilities | 127,658 | 118,219 |
Stockholders' equity: | ||
Common stock, $0.001 par value: 120,000,000 shares authorized; 56,852,404 and 56,612,429 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 57 | 56 |
Additional paid-in capital | 991,182 | 974,356 |
Accumulated other comprehensive loss | (14) | (92) |
Accumulated deficit | (808,940) | (710,058) |
Total stockholders' equity | 182,285 | 264,262 |
Total liabilities and stockholders' equity | $ 309,943 | $ 382,481 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock par value per share | $ 0.001 | $ 0.001 |
Preferred stock, authorized | 10,000,000 | 10,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value per share | $ 0.001 | $ 0.001 |
Common stock, authorized | 120,000,000 | 120,000,000 |
Common stock, issued | 56,896,068 | 56,612,429 |
Common stock, outstanding | 56,896,068 | 56,612,429 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Product revenue, net | $ 19,221 | $ 9,066 | $ 30,691 | $ 10,564 |
Costs and expenses: | ||||
Cost of sales | 2,236 | 378 | 3,657 | 608 |
Research and development | 33,543 | 31,456 | 71,487 | 63,966 |
Selling, general, and administrative | 30,046 | 22,328 | 54,674 | 43,777 |
Total costs and expenses | 65,825 | 54,162 | 129,818 | 108,351 |
Loss from operations | (46,604) | (45,096) | (99,127) | (97,787) |
Other income: | ||||
Other expense, net | (17) | (133) | 34 | (366) |
Interest expense | (3,303) | (46) | (6,449) | (46) |
Interest income | 3,221 | 274 | 6,660 | 434 |
Total other income (expense), net | (99) | 95 | 245 | 22 |
Net loss | $ (46,703) | $ (45,001) | $ (98,882) | $ (97,765) |
Net loss per share, basic (in dollars per share) | $ (0.82) | $ (0.89) | $ (1.74) | $ (1.94) |
Net loss per share, diluted (in dollars per share) | $ (0.82) | $ (0.89) | $ (1.74) | $ (1.94) |
Weighted-average common shares outstanding, basic (in shares) | 56,867,662 | 50,398,003 | 56,788,757 | 50,362,512 |
Weighted-average common shares outstanding, diluted (in shares) | 56,867,662 | 50,398,003 | 56,788,757 | 50,362,512 |
Other comprehensive loss: | ||||
Net loss | $ (46,703) | $ (45,001) | $ (98,882) | $ (97,765) |
Foreign currency translation adjustment | (48) | (27) | ||
Unrealized gain (loss), net on marketable securities | 40 | (277) | 105 | (905) |
Comprehensive loss | (46,711) | (45,278) | (98,804) | (98,670) |
Product revenue | ||||
Product revenue, net | $ 19,221 | 2,312 | $ 30,691 | 3,810 |
License revenue | ||||
Product revenue, net | $ 6,754 | $ 6,754 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total |
Beginning balance at Dec. 31, 2021 | $ 50 | $ 813,041 | $ (1) | $ (528,939) | $ 284,151 |
Beginning balance (in shares) at Dec. 31, 2021 | 50,283,574 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 4,611 | 4,611 | |||
Issuance of common stock in connection with ESPP | 399 | 399 | |||
Issuance of common stock in connection with ESPP (in shares) | 61,518 | ||||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units (in shares) | 48,639 | ||||
Unrealized loss or gain on marketable securities | (628) | (628) | |||
Net loss | (52,764) | (52,764) | |||
Ending balance at Mar. 31, 2022 | $ 50 | 818,051 | (629) | (581,703) | 235,769 |
Ending balance (in shares) at Mar. 31, 2022 | 50,393,731 | ||||
Beginning balance at Dec. 31, 2021 | $ 50 | 813,041 | (1) | (528,939) | 284,151 |
Beginning balance (in shares) at Dec. 31, 2021 | 50,283,574 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (97,765) | ||||
Ending balance at Jun. 30, 2022 | $ 50 | 823,188 | (906) | (626,704) | 195,628 |
Ending balance (in shares) at Jun. 30, 2022 | 50,454,170 | ||||
Beginning balance at Mar. 31, 2022 | $ 50 | 818,051 | (629) | (581,703) | 235,769 |
Beginning balance (in shares) at Mar. 31, 2022 | 50,393,731 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 5,137 | 5,137 | |||
Issuance of common stock in connection with exercise of stock options (in shares) | 60,439 | ||||
Unrealized loss or gain on marketable securities | 23 | 23 | |||
Unrealized (loss) reversal on RareStone equity | (300) | (300) | |||
Net loss | (45,001) | (45,001) | |||
Ending balance at Jun. 30, 2022 | $ 50 | 823,188 | (906) | (626,704) | 195,628 |
Ending balance (in shares) at Jun. 30, 2022 | 50,454,170 | ||||
Beginning balance at Dec. 31, 2022 | $ 56 | 974,356 | (92) | (710,058) | 264,262 |
Beginning balance (in shares) at Dec. 31, 2022 | 56,612,429 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 6,376 | 6,376 | |||
Issuance of common stock in connection with ESPP | 665 | 665 | |||
Issuance of common stock in connection with ESPP (in shares) | 32,169 | ||||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units | 553 | 553 | |||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units (in shares) | 207,806 | ||||
Foreign currency translation adjustment | 21 | 21 | |||
Unrealized loss or gain on marketable securities | 65 | 65 | |||
Net loss | (52,179) | (52,179) | |||
Ending balance at Mar. 31, 2023 | $ 56 | 981,950 | (6) | (762,237) | 219,763 |
Ending balance (in shares) at Mar. 31, 2023 | 56,852,404 | ||||
Beginning balance at Dec. 31, 2022 | $ 56 | 974,356 | (92) | (710,058) | 264,262 |
Beginning balance (in shares) at Dec. 31, 2022 | 56,612,429 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Foreign currency translation adjustment | (27) | ||||
Net loss | (98,882) | ||||
Ending balance at Jun. 30, 2023 | $ 57 | 991,182 | (14) | (808,940) | 182,285 |
Ending balance (in shares) at Jun. 30, 2023 | 56,896,068 | ||||
Beginning balance at Mar. 31, 2023 | $ 56 | 981,950 | (6) | (762,237) | 219,763 |
Beginning balance (in shares) at Mar. 31, 2023 | 56,852,404 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Stock-based compensation expense | 8,891 | 8,891 | |||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units | $ 1 | 341 | 342 | ||
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units (in shares) | 43,664 | ||||
Foreign currency translation adjustment | (48) | (48) | |||
Unrealized loss or gain on marketable securities | 40 | 40 | |||
Net loss | (46,703) | (46,703) | |||
Ending balance at Jun. 30, 2023 | $ 57 | $ 991,182 | $ (14) | $ (808,940) | $ 182,285 |
Ending balance (in shares) at Jun. 30, 2023 | 56,896,068 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Operating activities | ||
Net loss | $ (98,882) | $ (97,765) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 15,267 | 9,748 |
Depreciation and amortization | 899 | 788 |
Non-cash interest expense and amortization of debt issuance costs | 6,194 | 46 |
Unrealized gain (loss) on short-term investments | 105 | |
Non-cash rent expense | 192 | (130) |
Change in fair value of embedded derivative liability | (20) | |
Acquired IPR&D assets classified as investing activities | 5,650 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (7,607) | (1,705) |
Inventory | (3,260) | (1,580) |
Prepaid expenses and other current assets | (2,864) | 2,705 |
Deferred revenue | (148) | 1,023 |
Other long-term assets | 1,123 | (3,971) |
Accounts payable, accrued expenses and other liabilities | 5,828 | (1,600) |
Net cash used in operating activities | (77,523) | (92,441) |
Investing activities | ||
Purchases of short-term investments | (145,078) | (50,440) |
Maturities of short-term investments | 217,175 | 163,128 |
Acquisition of IPR&D assets, including transaction costs | (5,395) | |
Payment of milestone obligation under license agreement | (4,000) | |
Purchases of property and equipment | (47) | (187) |
Net cash provided by investing activities | 66,655 | 108,501 |
Financing activities | ||
Proceeds from the exercise of stock options | 894 | |
Proceeds from issuance of common stock from ESPP | 665 | 399 |
Repayment of deferred royalty obligation | (2,657) | |
Proceeds from royalty financing agreement, net of issuance costs | 37,500 | |
Net cash (used in) provided by financing activities | (1,098) | 37,899 |
Effect of exchange rates on cash | (27) | |
Net (decrease) increase in cash, cash equivalents and restricted cash | (11,993) | 53,959 |
Cash, cash equivalents and restricted cash at beginning of period | 128,005 | 59,576 |
Cash, cash equivalents and restricted cash at end of period | 116,012 | 113,535 |
Supplemental disclosures: | ||
Deferred financing costs in accrued expenses | $ 1,311 | |
Supplemental disclosure of non-cash investing activities | ||
Holdback payable associated with the acquisition, in accrued expenses | 500 | |
Transaction costs associated with the acquisition, in accounts payable | $ 255 |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 30, 2023 | |
Nature of Business | |
Nature of Business | 1. Nature of Business Rhythm Pharmaceuticals, Inc. (the “Company” or “we”) is a global, commercial-stage biopharmaceutical company dedicated to transforming the lives of patients and their families living with rare diseases. We are focused on advancing our lead asset, IMCIVREE ® ® The Company is a Delaware corporation organized in February 2013 under the name Rhythm Metabolic, Inc., and as of October 2015, under the name Rhythm Pharmaceuticals, Inc. The Company has wholly-owned subsidiaries in the US, Ireland, the United Kingdom, the Netherlands, France, Germany, Italy, Spain and Canada. The Company is subject to risks and uncertainties common to commercial-stage companies in the biotechnology industry, including but not limited to, risks associated with the commercialization of approved products, completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Commercialization of approved products will require significant resources and in order to market IMCIVREE, the Company must continue to build its sales, marketing, managerial and other non-technical capabilities or make arrangements with third parties to perform these services. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. There are many uncertainties regarding the COVID-19 pandemic, and the Company is closely monitoring the impact of the pandemic on all aspects of its business, including how the pandemic may continue to impact its patients, employees, suppliers, vendors, business partners and distribution channels. While the pandemic did not materially affect the Company's financial results and business operations for the three and six months ended June 30, 2023, the Company is unable to predict the impact that COVID-19 will have on its financial position and operating results in future periods due to numerous uncertainties. The Company will continue to assess the evolving impact of the COVID-19 pandemic and will make adjustments to its operations as necessary. Liquidity The Company has incurred operating losses and negative cash flows from operations since inception. As of June 30, 2023, the Company had an accumulated deficit of $808,940. The Company has primarily funded these losses through the proceeds from the sales of common and preferred stock, asset sales, royalty financing, out-license arrangements, as well as capital contributions received from the former parent company, Rhythm Holdings LLC. To date, the Company has minimal product revenue and management expects operating losses to continue for the foreseeable future. The Company has devoted substantially all of its resources to its drug development efforts, comprising of research and development, the acquisition of in process research and development assets, manufacturing, conducting clinical trials for its product candidates, protecting its intellectual property, commercialization activities and general and administrative functions relating to these operations. The future success of the Company is dependent on its ability to develop its product candidates and ultimately upon its ability to attain profitable operations. At June 30, 2023, the Company had $253,602 of cash and cash equivalents and short-term investments on hand. In the future, the Company will be dependent on obtaining funding from third parties, such as proceeds from the issuance of debt, sale of equity, product sales and funded research and development programs to maintain the Company's operations and meet the Company's obligations. There is no guarantee that additional equity or other financings will be available to the Company on acceptable terms, or at all. If the Company fails to obtain additional funding when needed, the Company would be forced to scale back, terminate its operations or seek to merge with or be acquired by another company. Management believes that the Company's existing cash and cash equivalents and short-term investments will be sufficient to fund the Company’s operations through at least the next twelve months from the filing of this Quarterly Report on Form 10-Q with the SEC |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company's unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States, or GAAP, and the applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification, or ASC, and Accounting Standards Updates, or ASU, of the Financial Accounting Standards Board, or FASB. As permitted under these rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted. The accompanying condensed consolidated balance sheet as of June 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2023 and 2022, the condensed consolidated statements of stockholders’ equity for the three and six months ended June 30, 2023 and 2022 and the condensed consolidated statements of cash flows for the six months ended June 30, 2023 and 2022 and the related footnote disclosures are unaudited. In management's opinion, the unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2022 and include all adjustments, which are all normal recurring adjustments, necessary for the fair presentation of the interim financial statements. The results for the three and six months ended June 30, 2023 are not necessarily indicative of the results expected for the full fiscal year, any other interim periods, or any future year or period. The accompanying unaudited condensed consolidated financial statements reflect the application of certain significant accounting policies as described below and elsewhere in these notes to the unaudited condensed consolidated financial statements. As of June 30, 2023, there have been no material changes in the Company's significant accounting policies from those that were disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. Significant estimates relied upon in preparing these financial statements include estimates related to determining our net product revenue, license revenue, accruals related to research and development expenses, assumptions used to record stock-based compensation expense, interest expense on our deferred royalty obligation, assumptions used to value the embedded derivative in our deferred royalty obligation, assumptions used to value the common stock received from RareStone Group Ltd., or RareStone, and the valuation allowance on the Company's deferred tax assets. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ materially from those estimates. Principles of Consolidation The consolidated financial statements include the accounts of Rhythm Pharmaceuticals, Inc. and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. Reclassification of Prior Year Balances Certain prior year amounts have been reclassified to conform to the current period presentation. These reclassifications had no effect on the reported results of operations or cash flows. Specifically, in the condensed consolidated statement of operations and comprehensive loss, the Company reclassified from other (expense) income to interest income $274 and $434 for the three and six months ended June 30, 2022, respectively. The Company also reclassified from other (expense) income to interest expense $46 for each of the three and six months ended June 30, 2022. In the condensed consolidated statements of cash flows, the Company reclassified $1,705 to accounts receivable and $1,580 to inventory from prepaid expenses and other current assets for the six months ended June 30, 2022. The reason for the reclassifications was to conform with the current year’s presentation. Segment Information Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company currently operates in one business segment, which is the development and commercialization of therapies for patients with rare diseases. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business. The Company does not operate separate lines of business with respect to its product or product candidates. Accordingly, the Company has one reportable segment. Off-Balance Sheet Risk and Concentrations of Credit Risk Financial instruments, which potentially subject the Company to significant concentration of credit risk, consist primarily of cash and cash equivalents and short-term investments, which are maintained at two federally insured financial institutions. The deposits held at these two institutions are in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company has no off-balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. For the three months ended June 30, 2023 and 2022, approximately 84% and 86%, respectively, of all of the Company’s revenue was generated from a single customer in the United States. For the six months ended June 30, 2023 and 2022, approximately 83% and 90%, respectively, of all of the Company’s revenue was generated from a single customer in the United States. As of June 30, 2023 and December 31, 2022, approximately 80% and 78%, respectively, of the Company’s accounts receivable was outstanding from a single customer in the United States. The Company relies on third-party manufacturers and suppliers for the manufacture and supply of its product. The inability of the suppliers or manufacturers to fulfill supply requirements of the Company could materially impact future operating results. A change in the relationship with the suppliers or manufacturer, or an adverse change in their business, could materially impact future operating results. The Company relies on separate third parties to perform genetic testing in the United States and Europe, respectively. The inability of the vendor to fulfill testing services for the Company could materially impact future operating results and adversely impact our ability to further develop setmelanotide. A change in the relationship with the genetic testing service providers, or an adverse change in their business, could materially impact future operating results. Accounts Receivable, net Accounts receivable consists of amounts due from customers, net of customer allowances for cash discounts and any estimated expected credit losses. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. To date, the Company has not experienced any credit losses. The Company's contracts with its customers have customary payment terms that generally require payment within 90 days. The Company analyzes amounts that are past due for collectability, and periodically evaluates the creditworthiness of its customers. As of June 30, 2023 and December 31, 2022, the Company determined an allowance for doubtful accounts was not required based upon our review of contractual payments and our customers’ circumstances. Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers Product Revenue, net In the United States (the “U.S.”), which accounts for the largest portion of our total revenues, the Company sells its product to a limited number of specialty pharmacies. The product is distributed through third-party logistics, or 3PL, distribution agent that does not take title to the product. Once the product is delivered to the Company’s specialty pharmacy provider, our customer in the U.S., the customer (or “wholesaler”) takes title to the product. The wholesaler then distributes the product to patients. In our distribution agreement with the 3PL company, the Company acts as principal because we retain control of the product. Internationally, we make sales primarily to specialty distributors and retail pharmacy chains, as well as hospitals, many of which are government-owned or supported. The Company generally does not offer returns of product sold to the customer. Revenue from product sales is recognized when the customer obtains control of our product, which occurs at a point in time, upon transfer of title to the customer because at that point in time we have no ongoing obligations to the customer. There are no other performance obligations besides the sale of product. We classify payments to our customers or other parties in the distribution channel for services that are distinct and priced at fair value as selling, general and administrative expenses in our consolidated statements of operations and comprehensive (loss) income. Otherwise, payments to a customer or other parties in the distribution channel that do not meet those criteria are classified as a reduction of revenue, as discussed further below. Taxes collected from the customer relating to product sales and remitted to governmental authorities are excluded from revenue. Because our payment terms are generally ninety days or less, the Company concluded there is not a significant financing component because the period between the transfer of a promised good or service to the customer and when the customer pays for that good or service will be one year or less. The Company expenses incremental costs of obtaining a contract as and when incurred since the expected amortization period of the asset that we would have recognized is one year or less. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, or the transaction price, which includes estimates of variable consideration for which reserves are established and which result from discounts, returns, chargebacks, rebates, co-pay assistance and other allowances that are offered within contracts between us and our customers, health care providers and other indirect customers relating to the sale of IMCIVREE. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is considered probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The following are the components of variable consideration related to product revenue: Chargebacks: Government rebates: Trade discounts and allowances: Product returns: Other incentives: Provisions for cash discounts are recorded as reductions of accounts receivable, and fees, rebates, and other incentives are recorded as a component of accrued expenses. License Agreements We generate revenue from license or similar agreements with pharmaceutical companies for the development and commercialization of certain of our products and product candidates. Such agreements may include the transfer of intellectual property rights in the form of licenses, transfer of technological know-how, delivery of drug substances, research and development services, and participation on certain committees with the counterparty. Payments made by the customers may include non-refundable upfront fees, payments upon the exercise of customer options, payments based upon the achievement of defined milestones, and royalties on sales of products and product candidates if they are approved and commercialized. If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize the transaction price allocated to the license as revenue upon transfer of control of the license. We evaluate all other promised goods or services in the agreement to determine if they are distinct. If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct. Optional future services where any additional consideration paid to us reflects their standalone selling prices do not provide the customer with a material right and, therefore, are not considered performance obligations. If optional future services are priced in a manner which provides the customer with a significant or incremental discount, they are material rights, and are accounted for as separate performance obligations. We utilize judgment to determine the transaction price. In connection therewith, we evaluate contingent milestones at contract inception to estimate the amount which is not probable of a material reversal to include in the transaction price using the most likely amount method. Milestone payments that are not within our control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore the variable consideration is constrained. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each reporting period, we re-evaluate the probability of achieving development milestone payments that may not be subject to a material reversal and, if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and other revenue, as well as earnings, in the period of adjustment. We then determine whether the performance obligations or combined performance obligations are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. We evaluate the measure of progress, as applicable, for each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded within deferred revenue. Contract liabilities within deferred revenue are recognized as revenue after control of the goods or services is transferred to the customer and all revenue recognition criteria have been met. For arrangements that include sales-based royalties, including sales-based milestone payments, and a license of intellectual property that is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of when the related sales occur or when the performance obligation to which some or all of the royalties have been allocated has been satisfied (or partially satisfied). RareStone Group Ltd. In December 2021, the Company entered into an Exclusive License Agreement with RareStone Group Ltd., or the RareStone License. Pursuant to the RareStone License, we granted to RareStone an exclusive, sublicensable, royalty-bearing license under certain patent rights and know-how to develop, manufacture, commercialize and otherwise exploit any pharmaceutical product that contains setmelanotide in the diagnosis, treatment or prevention of conditions and diseases in humans in China, including mainland China, Hong Kong and Macao. RareStone has a right of first negotiation in the event that the Company chooses to grant a license to develop or commercialize the licensed product in Taiwan. The arrangement includes a license and an additional performance obligation to supply product upon the request of RareStone. According to the terms of the , RareStone has agreed to seek local approvals to commercialize IMCIVREE for the treatment of obesity and hyperphagia due to biallelic POMC, PCSK1 or LEPR deficiency, as well as Bardet-Biedl and Alström syndromes. Additionally, RareStone has agreed to fund efforts to identify and enroll patients from China in the Company’s global EMANATE trial, a Phase 3, randomized, double-blind, placebo-controlled trial to evaluate setmelanotide in four independent sub-studies in patients with obesity due to a heterozygous variant of POMC/PCSK1 or LEPR; certain variants of the SRCI gene, and certain variants of the SH2B1 gene. In accordance with the terms of the , RareStone made an upfront payment to Rhythm of $7,000 and issued Rhythm 1,077,586 ordinary shares. The Company is eligible to receive development and commercialization milestones of up to $62,500 , as well as tiered royalty payments on annual net sales of IMCIVREE. The Company initially estimated the fair value of the RareStone equity to be $2,440 based on a preliminary valuation during the first quarter of 2022. Upon completion of the valuation procedures during the second quarter of 2022, the Company concluded the initial fair value of the RareStone equity to be $1,040 . During the third quarter of 2022, the Company estimated the fair value of the RareStone equity to be de minimis based upon the results of an updated valuation and recorded an other-than-temporary impairment of $1,040 related to the decline in fair value as a component of other expense in our consolidated statements of operations and other comprehensive loss for the year ended December 31, 2022 . The other-than-temporary impairment of $1,040 included the reclassification of a $300 unrealized loss previously recorded as a component of accumulated other comprehensive income (loss) in our condensed consolidated statement of stockholders’ equity during the second quarter of 2022. The Company received total upfront consideration of $8,040 comprised of an upfront payment of $7,000 , and the estimated fair value of the RareStone equity of $1,040 . The Company determined that the RareStone License contains two performance obligations, the delivery of the license and the supply of clinical and commercial product. The Company further determined the supply of commercial product to RareStone contains a significant future discount and estimates the discount to be $1,286 , which is recorded as a component of deferred revenue on the condensed consolidated balance sheet at June 30, 2023 and December 31, 2022. Based on a relative fair-value allocation between the license and the manufacture of clinical and commercial product, the The discount related to commercial manufacturing supply will be deferred and recognized over the commercial supply period or upon termination of the agreement. No license revenue was recognized during the three and six month periods ended June 30, 2023, respectively. On October 28, 2022, we delivered written notice, or the October Notice, to RareStone that we have terminated the RareStone License for cause. In accordance with the Notice, we maintain that RareStone has materially breached its obligations under the RareStone License to fund, perform or seek certain key clinical studies and waivers, including with respect to our global EMANATE trial, among other obligations. On December 21, 2022, RareStone provided written notice to us that it objects to the claims in the Notice, including our termination of the RareStone License for cause. On March 16, 2023, we provided written notice, or the March Notice, to RareStone reaffirming our position that RareStone has materially breached its obligations under the RareStone License and that we have terminated the RareStone License for cause, and also requested documentation supporting RareStone’s purported dispute notice objecting to the claims in the Notice. On May 10, 2023, RareStone provided written notice to the Company reaffirming its objections to the claims in our October Notice and March Notice, including to the Company’s termination of the RareStone License for cause. Deferred Royalty Obligation The Company treats the debt obligation to HealthCare Royalty Management, LLC as discussed further in Note 12, “Long-Term Obligations”, as a deferred royalty obligation, amortized using the effective interest rate method over the estimated life of the revenue streams. The Company recognizes interest expense thereon using the effective rate, which is based on our current estimates of future revenues over the life of the arrangement. In connection therewith, the Company periodically assesses its expected revenues using internal projections, imputes interest on the carrying value of the deferred royalty obligation, and records interest expense using the imputed effective interest rate. To the extent the Company’s estimates of future revenues are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will account for any such changes by adjusting the effective interest rate on a prospective basis, with a corresponding impact to the reclassification of our deferred royalty obligation. The assumptions used in determining the expected repayment term of the deferred royalty obligation and amortization period of the issuance costs requires the Company to make estimates that could impact the classification of such costs, as well as the period over which such costs will be amortized. Inventory Prior to receiving approval from the FDA in November 2020 to sell IMCIVREE in the United States, the Company expensed all costs incurred related to the manufacture of IMCIVREE as research and development expense because of the inherent risks associated with the development of a drug candidate, the uncertainty about the regulatory approval process and the lack of history for the Company of regulatory approval of drug candidates. The Company values inventories at the lower of cost or estimated net realizable value. The Company determines the cost of inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis. Raw materials and work in process includes all inventory costs prior to packaging and labelling, including raw materials, active pharmaceutical ingredient, and drug product. Finished goods include packaged and labelled products. Raw materials and work in process that may be used for either research and development or commercial sale are classified as inventory until the material is consumed or otherwise allocated for research and development. If the material is intended to be used for research and development, it is expensed as research and development once that determination is made. Cost of Product Sales Cost of product sales consists of manufacturing costs, transportation and freight, amortization of capitalized intangibles, royalty payments and indirect overhead costs associated with the manufacturing and distribution of IMCIVREE. Cost of product sales may also include periodic costs related to certain manufacturing services and inventory adjustment charges. Finally, cost of sales may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. Intangible Assets, Net Definite-lived intangible assets related to capitalized milestones under license agreements are amortized on a straight-line basis over their remaining useful lives, which are estimated to be the remaining patent life. If our estimate of the product’s useful life is shorter than the remaining patent life, then a shorter period is used. Amortization expense is recorded as a component of cost of sales on the consolidated statements of operations and comprehensive loss. Impairment of Long-Lived Assets The Company evaluates its long-lived assets, which consist primarily of property and equipment and finite lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. The Company measures recoverability of assets to be held and used by comparing the carrying amount of an asset to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the Company measures the impairment to be recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset, less the cost to sell. No events or changes in circumstances existed to require an impairment assessment during the three and six months ended June 30, 2023 and 2022, respectively. Acquired IPR&D and Milestone Expense In an asset acquisition, payments incurred prior to regulatory approval to acquire rights to in-process research and development projects are expensed as acquired IPR&D and recorded as a component of research and development expense in the condensed consolidated statements of operations and comprehensive net loss unless the project has an alternative future use. These costs include upfront and development milestone payments related to licensing arrangements, or other asset acquisitions that provide rights to develop, manufacture and/or sell pharmaceutical products. Where contingent development milestone payments are due to third parties, prior to regulatory approval, the payment obligations are expensed when the milestone results are achieved. Regulatory and commercial milestone payments made to third parties subsequent to regulatory approval are capitalized as intangible assets and amortized to cost of products sold over the remaining useful life of the related product. Foreign Currency Translation The functional currencies of the Company’s foreign subsidiaries are Euros and British pound sterling. Foreign subsidiary earnings are translated into U.S. dollars using average exchange rates. The net assets of foreign subsidiaries are translated into U.S. dollars using period-end exchange rates. The U.S. dollar effects that arise from translating the net assets of these subsidiaries at changing rates are recognized in other comprehensive income (loss) in the condensed consolidated statements of operations and comprehensive loss. Fair Value Measurements Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Financial assets and liabilities carried at fair value are classified and disclosed in one of the following three categories: Level 1 — Quoted market prices in active markets for identical assets or liabilities. Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company’s cash equivalents and marketable securities, derivative liability and RareStone equity at June 30, 2023 and December 31, 2022 were carried at fair value, determined according to the fair value hierarchy. See Note 6 for further discussion. The carrying amounts reflected in the consolidated balance sheets for accounts payable and accrued expenses and other current liabilities approximate their fair values due to their short-term maturities at June 30, 2023 and December 31, 2022, respectively. Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period, without consideration of potential dilutive securities. Diluted net loss per common share is computed by adjusting the weighted average shares outstanding for the potential dilutive effects of common stock equivalents outstanding during the period calculated in accordance with the treasury stock method. For purposes of the diluted net loss per share calculation, stock options, performance stock units and restricted stock units are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share is the same for all periods presented. The following table includes the potential common shares that were excluded from the computation of diluted net loss per share as their effect would have been anti-dilutive for the periods indicated: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Stock options 6,992,200 7,176,554 6,992,200 7,176,554 Restricted stock units 1,131,632 718,107 1,131,632 718,107 Performance stock units 599,720 840,564 599,720 840,564 Potential common shares 8,723,552 8,735,225 8,723,552 8,735,225 Subsequent Events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence for certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated as required. Application of New or Revised Accounting Standards From time to time, new accounting pronouncements are issued by the FASB and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a materi |
Asset Acquisition
Asset Acquisition | 6 Months Ended |
Jun. 30, 2023 | |
Asset Acquisition | |
Asset Acquisition | 3. Asset Acquisition Xinvento B.V. On February 27, 2023, the Company, through its wholly-owned Dutch subsidiary, Rhythm Pharmaceuticals Netherlands B.V., a Dutch private limited liability company (“Rhythm BV”), entered into a Share Purchase Agreement (the “Purchase Agreement”) with Xinvento B.V., a Dutch private limited liability company based in the Netherlands (“Xinvento”), and the other parties named therein, pursuant to which, and concurrently with the execution thereof, Rhythm BV acquired all of the issued and outstanding shares of Xinvento. The aggregate consideration at closing was approximately $5,650, inclusive of transaction costs, as adjusted pursuant to the terms of the Purchase Agreement and subject to the distribution and payment terms set forth therein (the “Closing Purchase Price”). In addition to the Closing Purchase Price, the Purchase Agreement provides for the payment of additional contingent consideration totaling up to $206,000 upon achievement of certain development, regulatory and commercial milestones by Xinvento, as follows: (i) up to an aggregate of $6,000 in clinical development milestones; (ii) up to an aggregate of $125,000 in regulatory approval and commercial milestones; and (iii) up to an aggregate of $75,000 in sales milestones in the event a second molecule is selected, developed and approved. The total purchase consideration of $5,650 was composed of $4,520 of cash paid at closing, a $500 holdback, payable on the one-year anniversary of the acquisition, and $630 of acquisition-related costs. The Company determined that substantially all of the value as of acquisition date related to Xinvento’s In-Process Research and Development. As a result, the Company determined this transaction should be accounted for as an asset acquisition. The assets acquired were In-Process Research and Development (IPR&D) assets. However, since the IPR&D assets were determined to have no alternative future use, the Company recognized the $5,650 of purchase consideration as research and development expense in the six months ended June 30, 2023. The Company determined that the additional contingent consideration did not meet the definition of a derivative as of the acquisition date. Therefore, the Company did not record a contingent consideration liability on the acquisition date. The Company will recognize any future contingent consideration payments related to the Xinvento transaction in the period in which the achievement of the underlying milestones becomes probable. Xinvento's results of operations are included in the condensed consolidated financial statements from the date of acquisition. For the three and six months ended June 30, 2023, the net loss associated with the operations of Xinvento was de minimis in the Company’s condensed consolidated statements of operations. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2023 | |
Inventory | |
Inventory | 4. Inventory Inventory consists of the following: June 30, December 31, 2023 2022 Raw Materials $ 2,275 $ 2,722 WIP 2,946 — Finished Goods 957 195 Total Inventory $ 6,178 $ 2,917 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2023 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | 5. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: June 30, December 31, 2023 2022 Research and development costs $ 13,375 $ 11,379 Professional fees 3,252 4,502 Payroll related 9,366 11,444 Royalties 962 440 Sales Allowances 6,049 2,710 Other 2,704 2,419 Accrued expenses and other current liabilities $ 35,708 $ 32,894 |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value of Financial Assets and Liabilities | |
Fair Value of Financial Assets and Liabilities | 6. Fair Value of Financial Assets and Liabilities As of June 30, 2023 and December 31, 2022, the carrying amount of cash and cash equivalents and short-term investments was $253,602 and $333,288, respectively, which approximates fair value. Cash and cash equivalents and short-term investments includes investments in U.S. treasury securities and money market funds that invest in U.S. government securities that are valued using quoted market prices. Accordingly, money market funds and government funds are categorized as Level 1. The financial assets valued based on Level 2 inputs consist of corporate debt securities and commercial paper, which consist of investments in highly-rated investment-grade corporations. The following tables present information about the Company's financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values: Fair Value Measurements as of June 30, 2023 using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 93,855 $ — $ — $ 93,855 Marketable securities: Corporate debt securities and commercial paper — 137,918 — 137,918 Total $ 93,855 $ 137,918 $ — $ 231,773 Liabilities: Derivative liability $ — $ — $ 1,320 $ 1,320 Total $ — $ — $ 1,320 $ 1,320 Fair Value Measurements as of December 31, 2022 using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Commercial paper $ — $ 8,484 $ — $ 8,484 Money market funds 99,962 — — 99,962 Marketable securities: Corporate debt securities and commercial paper — 205,611 — 205,611 Total $ 99,962 $ 214,095 $ — $ 314,057 Liabilities: Derivative liability $ — $ — $ 1,340 $ 1,340 Total $ — $ — $ 1,340 $ 1,340 The estimated fair value of the derivative liability related to our Royalty Interest Financing Agreement (RIFA) with HealthCare Royalty Partners was determined using Level 3 inputs. The fair value measurement of the derivative liability is sensitive to changes in the unobservable inputs used to value the financial instrument. Changes in the inputs could result in changes to the fair value of each financial instrument. The embedded derivative liability associated with our deferred royalty obligation, as discussed further in Note 12, “Long-Term Obligations”, is measured at fair value using an option pricing Monte Carlo simulation model and is included as a component of the deferred royalty obligation. The embedded derivative liability is subject to remeasurement at the end of each reporting period, with changes in fair value recognized as a component of other (expense) income, net. The assumptions used in the option pricing Monte Carlo simulation model include: (1) our estimates of the probability and timing of related events; (2) the probability-weighted net sales of IMCIVREE, including worldwide net product sales, upfront payments, milestones and royalties; (3) our risk-adjusted discount rate that includes a company specific risk premium; (4) our cost of debt; (5) volatility; and (6) the probability of a change in control occurring during the term of the instrument. Six months ended June 30, 2023 2022 Beginning aggregate estimated fair value of Level 3 RareStone equity $ — $ — Initial recording of RareStone equity — 1,040 Change in fair value of embedded derivative — (300) Ending aggregate estimated fair value of Level 3 RareStone equity $ — $ 740 Six months ended June 30, 2023 2022 Beginning aggregate estimated fair value of Level 3 liabilities $ 1,340 $ — Change in fair value of embedded derivative (20) — Ending aggregate estimated fair value of Level 3 liabilities $ 1,320 $ — Marketable Securities The following tables summarize the Company's marketable securities: June 30, 2023 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Assets Corporate debt securities and commercial paper (due within 1 year) $ 137,905 $ 13 $ — $ 137,918 $ 137,905 $ 13 $ — $ 137,918 December 31, 2022 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Assets Corporate debt securities and commercial paper (due within 1 year) $ 205,702 $ — $ (91) $ 205,611 $ 205,702 $ — $ (91) $ 205,611 |
Right of Use Asset and Lease Li
Right of Use Asset and Lease Liability | 6 Months Ended |
Jun. 30, 2023 | |
Right of Use Asset and Lease Liability | |
Right of Use Asset and Lease Liability | 7. Right of Use Asset and Lease Liability The Company has a material operating lease for its head office facility and other immaterial operating leases for certain equipment. The Company’s office lease has a remaining lease term of 2 years. The Company measured the lease liability associated with the office lease using a discount rate of 10% at inception. The Company estimated the incremental borrowing rate for the leased asset based on a range of comparable interest rates the Company would incur to borrow an amount equal to the lease payments on a collateralized basis over a similar term in a similar economic environment. As of June 30, 2023, the Company has not entered into any lease arrangements classified as a finance lease. The Company’s corporate headquarters is located in Boston, Massachusetts. This facility houses the Company’s research, clinical, regulatory, commercial and administrative personnel. The Company’s lease agreement commenced May 2019 and has a term of six years with a five-year renewal option to extend the lease. The Company has not included the five-year renewal option to extend the lease in its measurement of the right-of-use asset or lease liability. The following table presents the maturities of the Company’s operating lease liability related to office space as of June 30, 2023, all of which is under a non-cancellable operating lease: Operating Lease 2023 $ 421 2024 851 2025 502 Thereafter — Total operating lease payments 1,774 Less: imputed interest (160) Total operating lease liability $ 1,614 |
Intangible Assets
Intangible Assets | 6 Months Ended |
Jun. 30, 2023 | |
Intangible Assets | |
Intangible Assets | 8. Intangible Assets As of June 30, 2023 As of December 31, 2022 Estimated life (years) Cost Accumulated Amortization Net Cost Accumulated Amortization Net Capitalized Milestones 11 $ 9,000 $ (1,544) $ 7,456 $ 9,000 $ (1,117) $ 7,883 As of June 30, 2023, the Company’s finite-lived net intangible assets, which totaled $7,456 resulted from the capitalization of certain milestone payments made to Ipsen Pharma, S.A.S., or Ipsen, in accordance with the terms of the Company’s license agreement with Ipsen, in As of June 30, 2023, amortization expense for the next five years and beyond is summarized as follows: 2023 $ 428 2024 855 2025 855 2026 855 2027 855 Thereafter 3,608 Total $ 7,456 Amortization expense totaled $214, $428, $114 and $216 for the three and six months ended June 30, 2023 and 2022, respectively. Amortization expense is included in cost of sales in the condensed consolidated statements of operations and comprehensive loss. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Taxes | |
Income Taxes | 9. Income Taxes The Company did not record an income tax provision for the three months ended June 30, 2023 and 2022, respectively, as the Company generated sufficient tax losses during the period. The Company expects to generate sufficient tax losses in the current year to offset income and thus no current year liability is expected. The Company expects to maintain a full valuation allowance against its net deferred tax assets for the year. |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2023 | |
Common Stock. | |
Common Stock | 10. Common Stock As of June 30, 2023, an aggregate of shares of common stock were reserved for future issuance under the Company’s stock plans, including outstanding stock options, restricted stock units, and performance stock units that have been issued totaling 8,723,552 and 1,340,676 shares are available for future grants under the Company’s 2017 Employee Stock Purchase Plan. On February 9, 2022, the Company’s board of directors adopted the Rhythm Pharmaceuticals, Inc. 2022 Employment Inducement Plan or the Inducement Plan, without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Stock Market LLC listing rules or Rule 5635(c)(4). In accordance with Rule 5635(c)(4), awards under the Inducement Plan may only be made to a newly hired employee who has not previously been a member of the Company’s board of directors, or an employee who is being rehired following a bona fide period of non-employment by the Company or a subsidiary, as a material inducement to the employee’s entering into employment with the Company or its subsidiary. An aggregate of 1,000,000 shares of the Company’s common stock have been reserved for issuance under the Inducement Plan. The Company will continue to grant awards under the 2017 Plan pursuant to the terms thereof. The exercise price of stock options granted under the Inducement Plan will not be less than the fair market value of a share of the Company’s common stock on the grant date. Other terms of awards, including vesting requirements, are determined by the Company’s board of directors and are subject to the provisions of the Inducement Plan. Stock options granted to employees generally vest over a four-year period but may be granted with different vesting terms. Certain options may provide for accelerated vesting in the event of a change in control. Stock options granted under the Inducement Plan expire no more than 10 years from the date of grant. As of June 30, 2023, 469,430 stock option awards have been issued under the Inducement Plan. As of June 30, 2023, 234,585 restricted stock unit awards have been granted under the Inducement Plan. As of June 30, 2023, 295,985 shares of common stock are available for future grant under the Inducement Plan. |
Related-Party Transactions
Related-Party Transactions | 6 Months Ended |
Jun. 30, 2023 | |
Related-Party Transactions | |
Related-Party Transactions | 11. Related-Party Transactions Expenses paid directly to consultants and vendors considered to be related parties amounted to $383, $705, $498 and $978 for the three and six months ended June 30, 2023 and 2022, respectively. Outstanding payments due to these related parties as of June 30, 2023 and December 31, 2022 were $6 and $13, respectively, and were included within accounts payable on the condensed consolidated balance sheet. |
Long-Term Obligations
Long-Term Obligations | 6 Months Ended |
Jun. 30, 2023 | |
Long-Term Obligations | |
Long-Term Obligations | 12. Long-Term Obligations On June 16, 2022, we entered into a RIFA with entities managed by HealthCare Royalty Management, LLC, collectively referred to as the Investors. Pursuant to the RIFA and subject to customary closing conditions, the Investors have agreed to pay the Company an aggregate investment amount of up to $100,000, or the Investment Amount. Under the terms of the RIFA, we received $37,500 on June 29, 2022 upon FDA approval of IMCIVREE in BBS, referred to as the Initial Investment Amount, and we received an additional $37,500 on September 29, 2022 of the Investment Amount upon EMA approval for BBS. We are entitled to receive the remaining $25,000 of the Investment Amount forty-five As consideration for the Investment Amount and pursuant to the RIFA, we agreed to pay the Investors a tiered royalty on our annual net revenues, or Revenue Interest, including worldwide net product sales and upfront payments and milestones. The applicable tiered percentage will initially be 11.5% on annual net revenues up to $125,000, 7.5% on annual net revenues of between $125,000 and $300,000 and 2.5% on annual net revenues exceeding $300,000. If the Investors have not received cumulative minimum payments equal to 60% of the amount funded by the Investors to date by March 31, 2027, or 120% of the amount funded by the Investors to date by March 31, 2029, we must make a cash payment immediately following each applicable date to the Investors sufficient to gross the Investors up to such minimum amounts after giving full consideration of the cumulative amounts paid by us to the Investors through each date, referred to as the Under Performance Payment. As the repayment of the funded amount is contingent upon worldwide net product sales and upfront payments, milestones, and royalties, the repayment term may be shortened or extended depending on actual worldwide net product sales and upfront payments, milestones, and royalties. The Investors’ rights to receive the Revenue Interests will terminate on the date on which the Investors have received payments equal to a certain percentage of the funded portion of the Investment Amount including the aggregate of all payments made to the Investors as of such date, each percentage tier referred to as the Hard Cap, unless the RIFA is earlier terminated. The total Revenue Interests payable by us to the Investors is capped between 185% and 250% of the Investment Amount paid, dependent on the aggregate royalty paid between 2028 and 2032. If a change of control of occurs, the Investors may accelerate payments due under the RIFA up to the Hard Cap plus any other obligations payable under the RIFA. The repayment period commenced on July 8, 2022 for the Initial Investment Amount, and expires on the earlier of (i) the date at which the Investors received cash payments totaling an aggregate of a Hard Cap ranging from 185% to 250% of the Initial Investment Amount or (ii) the legal maturity date of July 8, 2034. If the Investors have not received payments equal to 250% of the Investment Amount by the twelve-year anniversary of the initial closing date, we will be required to pay an amount equal to the Investment Amount plus a specific annual rate of return less payments previously received by Investors. In the event of a change of control, we are obligated to pay Investors an amount equal to the Hard Cap in effect at the time, ranging from 185% to 250% plus any Under Performance Payment of the Investment Amount less payments previously received by Investors. In addition, upon the occurrence of an event of default, including, among others, our failure to pay any amounts due to Investors under the deferred royalty obligation, insolvency, our failure to pay indebtedness when due, the revocation of regulatory approval of IMCIVREE in the U.S. or our breach of any covenant contained in the RIFA and our failure to cure the breach within the prescribed time frame, we are obligated to pay Investors an amount equal to the Hard Cap in effect at the time of default ranging from 185% to 250% plus any Under Performance Payment of the Investment Amount less payments previously received by Investors. In addition, upon an event of default, Investors may exercise all other rights and remedies available under the RIFA, including foreclosing on the collateral that was pledged to Investors, which consists of all of our present and future assets relating to IMCIVREE. We have evaluated the terms of the RIFA and concluded that the features are similar to those of a debt instrument. Accordingly, we have accounted for the transaction as long-term debt and presented it as a deferred royalty obligation on our condensed consolidated balance sheets. We have further evaluated the terms of the RIFA and determined that the repayment of the Hard Cap in effect at the time which ranges from 185% to 250% of the Investment Amount, less any payments made to date, upon a change of control is an embedded derivative that requires bifurcation from the debt instrument and fair value recognition. We determined the fair value of the derivative using an option pricing Monte Carlo simulation model taking into account the probability of change of control occurring and potential repayment amounts and timing of such payments that would result under various scenarios, as further described in Note 2, “Summary of Significant Accounting Policies” to our condensed consolidated financial statements. The aggregate fair value of the embedded derivative liability was $1,320 and $1,340 as of June 30, 2023 and December 31, 2022, respectively. We will remeasure the embedded derivative to fair value each reporting period until the time the features lapse and/or termination of the deferred royalty obligation. For the three and six month periods ended June 30, 2023 we recognized other expense (income) of $30 and ($20), due to the remeasurement of the embedded derivative liability, respectively. The carrying value of the deferred royalty obligation as of June 30, 2023 was $79,347 based on $75,000 of proceeds, net of the fair value of the bifurcated embedded derivative liability upon execution of the RIFA, and debt issuance costs incurred. The carrying value of the deferred royalty obligation approximated fair value as of June 30, 2023 and December 31, 2022. The effective interest rate as of June 30, 2023 was 16.18%. In connection with the deferred royalty obligation, we incurred debt issuance costs totaling $2,662. Debt issuance costs have been netted against the debt and are being amortized over the estimated term of the debt using the effective interest method, adjusted on a prospective basis for changes in the underlying assumptions and inputs. The assumptions used in determining the expected repayment term of the debt and amortization period of the issuance costs requires that we make estimates that could impact the short and long-term classification of these costs, as well as the period over which these costs will be amortized. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The Company's unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States, or GAAP, and the applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification, or ASC, and Accounting Standards Updates, or ASU, of the Financial Accounting Standards Board, or FASB. As permitted under these rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted. The accompanying condensed consolidated balance sheet as of June 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2023 and 2022, the condensed consolidated statements of stockholders’ equity for the three and six months ended June 30, 2023 and 2022 and the condensed consolidated statements of cash flows for the six months ended June 30, 2023 and 2022 and the related footnote disclosures are unaudited. In management's opinion, the unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2022 and include all adjustments, which are all normal recurring adjustments, necessary for the fair presentation of the interim financial statements. The results for the three and six months ended June 30, 2023 are not necessarily indicative of the results expected for the full fiscal year, any other interim periods, or any future year or period. The accompanying unaudited condensed consolidated financial statements reflect the application of certain significant accounting policies as described below and elsewhere in these notes to the unaudited condensed consolidated financial statements. As of June 30, 2023, there have been no material changes in the Company's significant accounting policies from those that were disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. Significant estimates relied upon in preparing these financial statements include estimates related to determining our net product revenue, license revenue, accruals related to research and development expenses, assumptions used to record stock-based compensation expense, interest expense on our deferred royalty obligation, assumptions used to value the embedded derivative in our deferred royalty obligation, assumptions used to value the common stock received from RareStone Group Ltd., or RareStone, and the valuation allowance on the Company's deferred tax assets. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ materially from those estimates. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of Rhythm Pharmaceuticals, Inc. and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. |
Reclassification of Prior Year Balances | Reclassification of Prior Year Balances Certain prior year amounts have been reclassified to conform to the current period presentation. These reclassifications had no effect on the reported results of operations or cash flows. Specifically, in the condensed consolidated statement of operations and comprehensive loss, the Company reclassified from other (expense) income to interest income $274 and $434 for the three and six months ended June 30, 2022, respectively. The Company also reclassified from other (expense) income to interest expense $46 for each of the three and six months ended June 30, 2022. In the condensed consolidated statements of cash flows, the Company reclassified $1,705 to accounts receivable and $1,580 to inventory from prepaid expenses and other current assets for the six months ended June 30, 2022. The reason for the reclassifications was to conform with the current year’s presentation. |
Segment Information | Segment Information Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company currently operates in one business segment, which is the development and commercialization of therapies for patients with rare diseases. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business. The Company does not operate separate lines of business with respect to its product or product candidates. Accordingly, the Company has one reportable segment. |
Off-Balance Sheet Risk and Concentrations of Credit Risk | Off-Balance Sheet Risk and Concentrations of Credit Risk Financial instruments, which potentially subject the Company to significant concentration of credit risk, consist primarily of cash and cash equivalents and short-term investments, which are maintained at two federally insured financial institutions. The deposits held at these two institutions are in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company has no off-balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. For the three months ended June 30, 2023 and 2022, approximately 84% and 86%, respectively, of all of the Company’s revenue was generated from a single customer in the United States. For the six months ended June 30, 2023 and 2022, approximately 83% and 90%, respectively, of all of the Company’s revenue was generated from a single customer in the United States. As of June 30, 2023 and December 31, 2022, approximately 80% and 78%, respectively, of the Company’s accounts receivable was outstanding from a single customer in the United States. The Company relies on third-party manufacturers and suppliers for the manufacture and supply of its product. The inability of the suppliers or manufacturers to fulfill supply requirements of the Company could materially impact future operating results. A change in the relationship with the suppliers or manufacturer, or an adverse change in their business, could materially impact future operating results. The Company relies on separate third parties to perform genetic testing in the United States and Europe, respectively. The inability of the vendor to fulfill testing services for the Company could materially impact future operating results and adversely impact our ability to further develop setmelanotide. A change in the relationship with the genetic testing service providers, or an adverse change in their business, could materially impact future operating results. |
Accounts Receivable, net | Accounts Receivable, net Accounts receivable consists of amounts due from customers, net of customer allowances for cash discounts and any estimated expected credit losses. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. To date, the Company has not experienced any credit losses. The Company's contracts with its customers have customary payment terms that generally require payment within 90 days. The Company analyzes amounts that are past due for collectability, and periodically evaluates the creditworthiness of its customers. As of June 30, 2023 and December 31, 2022, the Company determined an allowance for doubtful accounts was not required based upon our review of contractual payments and our customers’ circumstances. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers Product Revenue, net In the United States (the “U.S.”), which accounts for the largest portion of our total revenues, the Company sells its product to a limited number of specialty pharmacies. The product is distributed through third-party logistics, or 3PL, distribution agent that does not take title to the product. Once the product is delivered to the Company’s specialty pharmacy provider, our customer in the U.S., the customer (or “wholesaler”) takes title to the product. The wholesaler then distributes the product to patients. In our distribution agreement with the 3PL company, the Company acts as principal because we retain control of the product. Internationally, we make sales primarily to specialty distributors and retail pharmacy chains, as well as hospitals, many of which are government-owned or supported. The Company generally does not offer returns of product sold to the customer. Revenue from product sales is recognized when the customer obtains control of our product, which occurs at a point in time, upon transfer of title to the customer because at that point in time we have no ongoing obligations to the customer. There are no other performance obligations besides the sale of product. We classify payments to our customers or other parties in the distribution channel for services that are distinct and priced at fair value as selling, general and administrative expenses in our consolidated statements of operations and comprehensive (loss) income. Otherwise, payments to a customer or other parties in the distribution channel that do not meet those criteria are classified as a reduction of revenue, as discussed further below. Taxes collected from the customer relating to product sales and remitted to governmental authorities are excluded from revenue. Because our payment terms are generally ninety days or less, the Company concluded there is not a significant financing component because the period between the transfer of a promised good or service to the customer and when the customer pays for that good or service will be one year or less. The Company expenses incremental costs of obtaining a contract as and when incurred since the expected amortization period of the asset that we would have recognized is one year or less. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, or the transaction price, which includes estimates of variable consideration for which reserves are established and which result from discounts, returns, chargebacks, rebates, co-pay assistance and other allowances that are offered within contracts between us and our customers, health care providers and other indirect customers relating to the sale of IMCIVREE. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer). Where appropriate, these estimates take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is considered probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The following are the components of variable consideration related to product revenue: Chargebacks: Government rebates: Trade discounts and allowances: Product returns: Other incentives: Provisions for cash discounts are recorded as reductions of accounts receivable, and fees, rebates, and other incentives are recorded as a component of accrued expenses. |
License Agreements | License Agreements We generate revenue from license or similar agreements with pharmaceutical companies for the development and commercialization of certain of our products and product candidates. Such agreements may include the transfer of intellectual property rights in the form of licenses, transfer of technological know-how, delivery of drug substances, research and development services, and participation on certain committees with the counterparty. Payments made by the customers may include non-refundable upfront fees, payments upon the exercise of customer options, payments based upon the achievement of defined milestones, and royalties on sales of products and product candidates if they are approved and commercialized. If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize the transaction price allocated to the license as revenue upon transfer of control of the license. We evaluate all other promised goods or services in the agreement to determine if they are distinct. If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct. Optional future services where any additional consideration paid to us reflects their standalone selling prices do not provide the customer with a material right and, therefore, are not considered performance obligations. If optional future services are priced in a manner which provides the customer with a significant or incremental discount, they are material rights, and are accounted for as separate performance obligations. We utilize judgment to determine the transaction price. In connection therewith, we evaluate contingent milestones at contract inception to estimate the amount which is not probable of a material reversal to include in the transaction price using the most likely amount method. Milestone payments that are not within our control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received and therefore the variable consideration is constrained. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each reporting period, we re-evaluate the probability of achieving development milestone payments that may not be subject to a material reversal and, if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and other revenue, as well as earnings, in the period of adjustment. We then determine whether the performance obligations or combined performance obligations are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. We evaluate the measure of progress, as applicable, for each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded within deferred revenue. Contract liabilities within deferred revenue are recognized as revenue after control of the goods or services is transferred to the customer and all revenue recognition criteria have been met. For arrangements that include sales-based royalties, including sales-based milestone payments, and a license of intellectual property that is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of when the related sales occur or when the performance obligation to which some or all of the royalties have been allocated has been satisfied (or partially satisfied). RareStone Group Ltd. In December 2021, the Company entered into an Exclusive License Agreement with RareStone Group Ltd., or the RareStone License. Pursuant to the RareStone License, we granted to RareStone an exclusive, sublicensable, royalty-bearing license under certain patent rights and know-how to develop, manufacture, commercialize and otherwise exploit any pharmaceutical product that contains setmelanotide in the diagnosis, treatment or prevention of conditions and diseases in humans in China, including mainland China, Hong Kong and Macao. RareStone has a right of first negotiation in the event that the Company chooses to grant a license to develop or commercialize the licensed product in Taiwan. The arrangement includes a license and an additional performance obligation to supply product upon the request of RareStone. According to the terms of the , RareStone has agreed to seek local approvals to commercialize IMCIVREE for the treatment of obesity and hyperphagia due to biallelic POMC, PCSK1 or LEPR deficiency, as well as Bardet-Biedl and Alström syndromes. Additionally, RareStone has agreed to fund efforts to identify and enroll patients from China in the Company’s global EMANATE trial, a Phase 3, randomized, double-blind, placebo-controlled trial to evaluate setmelanotide in four independent sub-studies in patients with obesity due to a heterozygous variant of POMC/PCSK1 or LEPR; certain variants of the SRCI gene, and certain variants of the SH2B1 gene. In accordance with the terms of the , RareStone made an upfront payment to Rhythm of $7,000 and issued Rhythm 1,077,586 ordinary shares. The Company is eligible to receive development and commercialization milestones of up to $62,500 , as well as tiered royalty payments on annual net sales of IMCIVREE. The Company initially estimated the fair value of the RareStone equity to be $2,440 based on a preliminary valuation during the first quarter of 2022. Upon completion of the valuation procedures during the second quarter of 2022, the Company concluded the initial fair value of the RareStone equity to be $1,040 . During the third quarter of 2022, the Company estimated the fair value of the RareStone equity to be de minimis based upon the results of an updated valuation and recorded an other-than-temporary impairment of $1,040 related to the decline in fair value as a component of other expense in our consolidated statements of operations and other comprehensive loss for the year ended December 31, 2022 . The other-than-temporary impairment of $1,040 included the reclassification of a $300 unrealized loss previously recorded as a component of accumulated other comprehensive income (loss) in our condensed consolidated statement of stockholders’ equity during the second quarter of 2022. The Company received total upfront consideration of $8,040 comprised of an upfront payment of $7,000 , and the estimated fair value of the RareStone equity of $1,040 . The Company determined that the RareStone License contains two performance obligations, the delivery of the license and the supply of clinical and commercial product. The Company further determined the supply of commercial product to RareStone contains a significant future discount and estimates the discount to be $1,286 , which is recorded as a component of deferred revenue on the condensed consolidated balance sheet at June 30, 2023 and December 31, 2022. Based on a relative fair-value allocation between the license and the manufacture of clinical and commercial product, the The discount related to commercial manufacturing supply will be deferred and recognized over the commercial supply period or upon termination of the agreement. No license revenue was recognized during the three and six month periods ended June 30, 2023, respectively. On October 28, 2022, we delivered written notice, or the October Notice, to RareStone that we have terminated the RareStone License for cause. In accordance with the Notice, we maintain that RareStone has materially breached its obligations under the RareStone License to fund, perform or seek certain key clinical studies and waivers, including with respect to our global EMANATE trial, among other obligations. On December 21, 2022, RareStone provided written notice to us that it objects to the claims in the Notice, including our termination of the RareStone License for cause. On March 16, 2023, we provided written notice, or the March Notice, to RareStone reaffirming our position that RareStone has materially breached its obligations under the RareStone License and that we have terminated the RareStone License for cause, and also requested documentation supporting RareStone’s purported dispute notice objecting to the claims in the Notice. On May 10, 2023, RareStone provided written notice to the Company reaffirming its objections to the claims in our October Notice and March Notice, including to the Company’s termination of the RareStone License for cause. |
Deferred Royalty Obligation | Deferred Royalty Obligation The Company treats the debt obligation to HealthCare Royalty Management, LLC as discussed further in Note 12, “Long-Term Obligations”, as a deferred royalty obligation, amortized using the effective interest rate method over the estimated life of the revenue streams. The Company recognizes interest expense thereon using the effective rate, which is based on our current estimates of future revenues over the life of the arrangement. In connection therewith, the Company periodically assesses its expected revenues using internal projections, imputes interest on the carrying value of the deferred royalty obligation, and records interest expense using the imputed effective interest rate. To the extent the Company’s estimates of future revenues are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will account for any such changes by adjusting the effective interest rate on a prospective basis, with a corresponding impact to the reclassification of our deferred royalty obligation. The assumptions used in determining the expected repayment term of the deferred royalty obligation and amortization period of the issuance costs requires the Company to make estimates that could impact the classification of such costs, as well as the period over which such costs will be amortized. |
Inventory | Inventory Prior to receiving approval from the FDA in November 2020 to sell IMCIVREE in the United States, the Company expensed all costs incurred related to the manufacture of IMCIVREE as research and development expense because of the inherent risks associated with the development of a drug candidate, the uncertainty about the regulatory approval process and the lack of history for the Company of regulatory approval of drug candidates. The Company values inventories at the lower of cost or estimated net realizable value. The Company determines the cost of inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis. Raw materials and work in process includes all inventory costs prior to packaging and labelling, including raw materials, active pharmaceutical ingredient, and drug product. Finished goods include packaged and labelled products. Raw materials and work in process that may be used for either research and development or commercial sale are classified as inventory until the material is consumed or otherwise allocated for research and development. If the material is intended to be used for research and development, it is expensed as research and development once that determination is made. |
Cost of Product Sales | Cost of Product Sales Cost of product sales consists of manufacturing costs, transportation and freight, amortization of capitalized intangibles, royalty payments and indirect overhead costs associated with the manufacturing and distribution of IMCIVREE. Cost of product sales may also include periodic costs related to certain manufacturing services and inventory adjustment charges. Finally, cost of sales may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. |
Intangible Assets, net | Intangible Assets, Net Definite-lived intangible assets related to capitalized milestones under license agreements are amortized on a straight-line basis over their remaining useful lives, which are estimated to be the remaining patent life. If our estimate of the product’s useful life is shorter than the remaining patent life, then a shorter period is used. Amortization expense is recorded as a component of cost of sales on the consolidated statements of operations and comprehensive loss. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company evaluates its long-lived assets, which consist primarily of property and equipment and finite lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. The Company measures recoverability of assets to be held and used by comparing the carrying amount of an asset to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the Company measures the impairment to be recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset, less the cost to sell. No events or changes in circumstances existed to require an impairment assessment during the three and six months ended June 30, 2023 and 2022, respectively. |
Acquired IPR&D and Milestones Expenses | Acquired IPR&D and Milestone Expense In an asset acquisition, payments incurred prior to regulatory approval to acquire rights to in-process research and development projects are expensed as acquired IPR&D and recorded as a component of research and development expense in the condensed consolidated statements of operations and comprehensive net loss unless the project has an alternative future use. These costs include upfront and development milestone payments related to licensing arrangements, or other asset acquisitions that provide rights to develop, manufacture and/or sell pharmaceutical products. Where contingent development milestone payments are due to third parties, prior to regulatory approval, the payment obligations are expensed when the milestone results are achieved. Regulatory and commercial milestone payments made to third parties subsequent to regulatory approval are capitalized as intangible assets and amortized to cost of products sold over the remaining useful life of the related product. |
Foreign Currency Translation | Foreign Currency Translation The functional currencies of the Company’s foreign subsidiaries are Euros and British pound sterling. Foreign subsidiary earnings are translated into U.S. dollars using average exchange rates. The net assets of foreign subsidiaries are translated into U.S. dollars using period-end exchange rates. The U.S. dollar effects that arise from translating the net assets of these subsidiaries at changing rates are recognized in other comprehensive income (loss) in the condensed consolidated statements of operations and comprehensive loss. |
Fair Value Measurements | Fair Value Measurements Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Financial assets and liabilities carried at fair value are classified and disclosed in one of the following three categories: Level 1 — Quoted market prices in active markets for identical assets or liabilities. Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company’s cash equivalents and marketable securities, derivative liability and RareStone equity at June 30, 2023 and December 31, 2022 were carried at fair value, determined according to the fair value hierarchy. See Note 6 for further discussion. The carrying amounts reflected in the consolidated balance sheets for accounts payable and accrued expenses and other current liabilities approximate their fair values due to their short-term maturities at June 30, 2023 and December 31, 2022, respectively. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period, without consideration of potential dilutive securities. Diluted net loss per common share is computed by adjusting the weighted average shares outstanding for the potential dilutive effects of common stock equivalents outstanding during the period calculated in accordance with the treasury stock method. For purposes of the diluted net loss per share calculation, stock options, performance stock units and restricted stock units are considered to be common stock equivalents but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share is the same for all periods presented. The following table includes the potential common shares that were excluded from the computation of diluted net loss per share as their effect would have been anti-dilutive for the periods indicated: Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Stock options 6,992,200 7,176,554 6,992,200 7,176,554 Restricted stock units 1,131,632 718,107 1,131,632 718,107 Performance stock units 599,720 840,564 599,720 840,564 Potential common shares 8,723,552 8,735,225 8,723,552 8,735,225 |
Subsequent Events | Subsequent Events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence for certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated as required. |
Application of New or Revised Accounting Standards | Application of New or Revised Accounting Standards From time to time, new accounting pronouncements are issued by the FASB and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies | |
Schedule of potential common shares, presented based on amounts outstanding at each period end, excluded from computation of diluted net loss per share attributable to common stockholders | Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Stock options 6,992,200 7,176,554 6,992,200 7,176,554 Restricted stock units 1,131,632 718,107 1,131,632 718,107 Performance stock units 599,720 840,564 599,720 840,564 Potential common shares 8,723,552 8,735,225 8,723,552 8,735,225 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Inventory | |
Schedule of inventory | June 30, December 31, 2023 2022 Raw Materials $ 2,275 $ 2,722 WIP 2,946 — Finished Goods 957 195 Total Inventory $ 6,178 $ 2,917 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses | June 30, December 31, 2023 2022 Research and development costs $ 13,375 $ 11,379 Professional fees 3,252 4,502 Payroll related 9,366 11,444 Royalties 962 440 Sales Allowances 6,049 2,710 Other 2,704 2,419 Accrued expenses and other current liabilities $ 35,708 $ 32,894 |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value of Financial Assets and Liabilities | |
Schedule of financial assets and liabilities measured at fair value on a recurring basis | Fair Value Measurements as of June 30, 2023 using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 93,855 $ — $ — $ 93,855 Marketable securities: Corporate debt securities and commercial paper — 137,918 — 137,918 Total $ 93,855 $ 137,918 $ — $ 231,773 Liabilities: Derivative liability $ — $ — $ 1,320 $ 1,320 Total $ — $ — $ 1,320 $ 1,320 Fair Value Measurements as of December 31, 2022 using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Commercial paper $ — $ 8,484 $ — $ 8,484 Money market funds 99,962 — — 99,962 Marketable securities: Corporate debt securities and commercial paper — 205,611 — 205,611 Total $ 99,962 $ 214,095 $ — $ 314,057 Liabilities: Derivative liability $ — $ — $ 1,340 $ 1,340 Total $ — $ — $ 1,340 $ 1,340 |
Schedule of fair value net derivative asset liability measured on recurring Basis | Six months ended June 30, 2023 2022 Beginning aggregate estimated fair value of Level 3 RareStone equity $ — $ — Initial recording of RareStone equity — 1,040 Change in fair value of embedded derivative — (300) Ending aggregate estimated fair value of Level 3 RareStone equity $ — $ 740 Six months ended June 30, 2023 2022 Beginning aggregate estimated fair value of Level 3 liabilities $ 1,340 $ — Change in fair value of embedded derivative (20) — Ending aggregate estimated fair value of Level 3 liabilities $ 1,320 $ — |
Schedule of marketable securities | June 30, 2023 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Assets Corporate debt securities and commercial paper (due within 1 year) $ 137,905 $ 13 $ — $ 137,918 $ 137,905 $ 13 $ — $ 137,918 December 31, 2022 Gross Gross Amortized Unrealized Unrealized Fair Cost Gains Losses Value Assets Corporate debt securities and commercial paper (due within 1 year) $ 205,702 $ — $ (91) $ 205,611 $ 205,702 $ — $ (91) $ 205,611 |
Right of Use Asset and Lease _2
Right of Use Asset and Lease Liability (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Right of Use Asset and Lease Liability | |
Schedule of operating lease maturities | Operating Lease 2023 $ 421 2024 851 2025 502 Thereafter — Total operating lease payments 1,774 Less: imputed interest (160) Total operating lease liability $ 1,614 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Intangible Assets | |
Schedule of finite-lived intangible assets | As of June 30, 2023 As of December 31, 2022 Estimated life (years) Cost Accumulated Amortization Net Cost Accumulated Amortization Net Capitalized Milestones 11 $ 9,000 $ (1,544) $ 7,456 $ 9,000 $ (1,117) $ 7,883 |
Schedule of amortization expense | 2023 $ 428 2024 855 2025 855 2026 855 2027 855 Thereafter 3,608 Total $ 7,456 |
Nature of Business (Details)
Nature of Business (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Nature of Business | ||
Accumulated deficit | $ 808,940 | $ 710,058 |
Carrying amount of cash and cash equivalents and short term investments | $ 253,602 | $ 333,288 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) segment Institution | Jun. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Segment Information | |||||
Number of operating segments | segment | 1 | ||||
Number of reporting segments | segment | 1 | ||||
Off Balance Sheet Risk and Concentrations of Credit Risk | |||||
Number of federally insured financial institutions | Institution | 2 | ||||
Impairment of Long-Lived Assets | |||||
Tangible asset impairment charges | $ 0 | $ 0 | $ 0 | $ 0 | |
Accounts Receivable, net | |||||
Revenue | $ 19,221,000 | $ 9,066,000 | $ 30,691,000 | $ 10,564,000 | |
Customer concentration risk | Customer one | Revenue benchmark | |||||
Off Balance Sheet Risk and Concentrations of Credit Risk | |||||
Percentage of revenue generated from customer | 84% | 86% | 83% | 90% | |
Accounts Receivable, net | |||||
Accounts receivables | $ 80 | $ 80 | $ 78 | ||
Product revenue | |||||
Accounts Receivable, net | |||||
Revenue | $ 19,221,000 | $ 2,312,000 | $ 30,691,000 | $ 3,810,000 | |
Accounts receivable | |||||
Summary of Significant Accounting Policies | |||||
Reclassification of prior year balances | 1,705,000 | ||||
Inventory | |||||
Summary of Significant Accounting Policies | |||||
Reclassification of prior year balances | 1,580,000 | ||||
Interest income | |||||
Summary of Significant Accounting Policies | |||||
Reclassification of prior year balances | 274,000 | 434,000 | |||
Interest expense | |||||
Summary of Significant Accounting Policies | |||||
Reclassification of prior year balances | $ 46,000 | $ 46,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - License Agreements (Details) - Rare Stone Group Ltd. $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Dec. 31, 2021 USD ($) item shares | Jun. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2023 USD ($) project | Jun. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Mar. 31, 2022 USD ($) | |
Significant Agreements | ||||||||
Realized loss on RareStone equity | $ 1,040 | |||||||
Loss on RareStone equity investment | $ 300 | |||||||
Upfront consideration | $ 8,040 | |||||||
Contract with customer liability revenue recognized | $ 0 | $ 0 | ||||||
Number of independent sub studies in patients | project | 4 | |||||||
Upfront payment | 7,000 | |||||||
Equity recorded at fair value | 1,040 | $ 1,040 | $ 1,040 | $ 2,440 | ||||
Aggregate payment upon achievement of development and commercial milestones | $ 62,500 | |||||||
Shares issued for license agreement (in shares) | shares | 1,077,586 | |||||||
License agreement | ||||||||
Significant Agreements | ||||||||
Number of performance obligations | item | 2 | |||||||
License agreement commercial manufacturing supply discount | $ 1,286 | $ 1,286 | ||||||
Contract with customer liability revenue recognized | $ 6,754 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Net loss per share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Shares excluded from the computation of diluted net loss per share | ||||
Potential common shares | 8,723,552 | 8,735,225 | 8,723,552 | 8,735,225 |
Stock options | ||||
Shares excluded from the computation of diluted net loss per share | ||||
Potential common shares | 6,992,200 | 7,176,554 | 6,992,200 | 7,176,554 |
Restricted stock units | ||||
Shares excluded from the computation of diluted net loss per share | ||||
Potential common shares | 1,131,632 | 718,107 | 1,131,632 | 718,107 |
Performance stock units | ||||
Shares excluded from the computation of diluted net loss per share | ||||
Potential common shares | 599,720 | 840,564 | 599,720 | 840,564 |
Asset Acquisition (Details)
Asset Acquisition (Details) - Xinvento B.V. - USD ($) $ in Thousands | 6 Months Ended | |
Feb. 27, 2023 | Jun. 30, 2023 | |
Asset Acquisition [Line Items] | ||
Aggregate Payment Upon Achievement Of Development And Commercial Milestones | $ 206,000 | |
Clinical development milestone payments | 6,000 | |
Regulatory approval and commercial milestones milestone payments | 125,000 | |
Sales milestone payments | 75,000 | |
Purchase consideration | 5,650 | |
Cash consideration | 4,520 | |
Holdback, payable on the one-year anniversary of the acquisition | 500 | |
Acquisition related costs | $ 630 | |
Research and development | ||
Asset Acquisition [Line Items] | ||
Purchase consideration | $ 5,650 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Inventory | ||
Raw Materials | $ 2,275 | $ 2,722 |
WIP | 2,946 | |
Finished Goods | 957 | 195 |
Total Inventory | $ 6,178 | $ 2,917 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses and Other Current Liabilities | ||
Research and development costs | $ 13,375 | $ 11,379 |
Professional fees | 3,252 | 4,502 |
Payroll related | 9,366 | 11,444 |
Royalties | 962 | 440 |
Sales Allowances | 6,049 | 2,710 |
Other | 2,704 | 2,419 |
Accrued expenses and other current liabilities | $ 35,708 | $ 32,894 |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Fair Value of Financial Assets | ||
Carrying amount of cash and cash equivalents and short term investments | $ 253,602 | $ 333,288 |
Fair value of financial assets and liabilities | ||
Marketable Securities | 137,918 | 205,611 |
Derivative liability | 1,320 | 1,340 |
Corporate Debt Securities and Commercial Paper | ||
Fair value of financial assets and liabilities | ||
Marketable Securities | 137,918 | 205,611 |
Recurring | Estimated fair value | ||
Fair value of financial assets and liabilities | ||
Fair value of assets | 231,773 | 314,057 |
Derivative liability | 1,320 | 1,340 |
Recurring | Derivative on Royalty Financing | Estimated fair value | ||
Fair value of financial assets and liabilities | ||
Derivative liability | 1,320 | 1,340 |
Recurring | Commercial Paper | Estimated fair value | ||
Fair value of financial assets and liabilities | ||
Cash Equivalents | 8,484 | |
Recurring | Corporate Debt Securities and Commercial Paper | Estimated fair value | ||
Fair value of financial assets and liabilities | ||
Marketable Securities | 137,918 | 205,611 |
Recurring | Money Market Funds | Estimated fair value | ||
Fair value of financial assets and liabilities | ||
Cash Equivalents | 93,855 | 99,962 |
Recurring | Level 1 | Estimated fair value | ||
Fair value of financial assets and liabilities | ||
Fair value of assets | 93,855 | 99,962 |
Recurring | Level 1 | Money Market Funds | Estimated fair value | ||
Fair value of financial assets and liabilities | ||
Cash Equivalents | 93,855 | 99,962 |
Recurring | Level 2 | Estimated fair value | ||
Fair value of financial assets and liabilities | ||
Fair value of assets | 137,918 | 214,095 |
Recurring | Level 2 | Commercial Paper | Estimated fair value | ||
Fair value of financial assets and liabilities | ||
Cash Equivalents | 8,484 | |
Recurring | Level 2 | Corporate Debt Securities and Commercial Paper | Estimated fair value | ||
Fair value of financial assets and liabilities | ||
Marketable Securities | 137,918 | 205,611 |
Recurring | Level 3 | Estimated fair value | ||
Fair value of financial assets and liabilities | ||
Derivative liability | 1,320 | 1,340 |
Recurring | Level 3 | Derivative on Royalty Financing | Estimated fair value | ||
Fair value of financial assets and liabilities | ||
Derivative liability | $ 1,320 | $ 1,340 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities - Changes in Level 3 Securities (Details) - Level 3 $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Fair Value of Financial Assets | |
Initial recording of RareStone equity | $ 1,040 |
Change in fair value of embedded derivative | (300) |
Ending aggregate estimated fair value of Level 3 RareStone equity | $ 740 |
Fair Value of Financial Asset_5
Fair Value of Financial Assets and Liabilities - Changes in Embedded Derivative Liability (Details) - Revenue Interest Financing Agreement - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2023 | Jun. 30, 2023 | |
Fair value of embedded derivative liability | ||
Fair value of embedded derivative liability, beginning balance | $ 1,340 | |
Change in fair value of embedded derivative | $ 30 | (20) |
Fair value of embedded derivative liability, ending balance | $ 1,320 | $ 1,320 |
Fair Value of Financial Asset_6
Fair Value of Financial Assets and Liabilities - Marketable Securities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Fair Value of Financial Assets | ||
Amortized Cost | $ 137,905 | $ 205,702 |
Gross Unrealized Gains | 13 | |
Gross Unrealized Losses | (91) | |
Fair Value | 137,918 | 205,611 |
Corporate debt securities and commercial paper | ||
Fair Value of Financial Assets | ||
Amortized Cost | 137,905 | 205,702 |
Gross Unrealized Gains | 13 | |
Gross Unrealized Losses | (91) | |
Fair Value | $ 137,918 | $ 205,611 |
Right of Use Asset and Lease _3
Right of Use Asset and Lease Liability (Details) | 6 Months Ended |
Jun. 30, 2023 | |
Right of Use Asset and Lease Liability | |
Remaining term of operating lease (in years) | 2 years |
Operating lease discount rate | 10% |
Lease term (in years) | 6 years |
Lease renewal term (in years) | 5 years |
Option to extend | true |
Right of Use Asset and Lease _4
Right of Use Asset and Lease Liability - Operating Lease Maturities (Details) $ in Thousands | Jun. 30, 2023 USD ($) |
Right of Use Asset and Lease Liability | |
2023 | $ 421 |
2024 | 851 |
2025 | 502 |
Total operating lease payments | 1,774 |
Less: imputed interest | (160) |
Total operating lease liability | $ 1,614 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets | ||
Total | $ 7,456 | $ 7,883 |
Capitalized Milestones | ||
Finite-Lived Intangible Assets | ||
Estimated life (years) | 11 years | |
Cost | $ 9,000 | 9,000 |
Accumulated Amortization | (1,544) | (1,117) |
Total | $ 7,456 | $ 7,883 |
Intangible Assets - Amortizatio
Intangible Assets - Amortization expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Definite-lived intangible assets | |||||
2023 | $ 428 | $ 428 | |||
2024 | 855 | 855 | |||
2025 | 855 | 855 | |||
2026 | 855 | 855 | |||
2027 | 855 | 855 | |||
Thereafter | 3,608 | 3,608 | |||
Total | 7,456 | 7,456 | $ 7,883 | ||
Cost of sales | |||||
Definite-lived intangible assets | |||||
Amortization expense | $ 214 | $ 114 | $ 428 | $ 216 |
Income Taxes (Details)
Income Taxes (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Income Taxes | |
Income taxes | $ 0 |
Common Stock (Details)
Common Stock (Details) - shares | 6 Months Ended | |
Feb. 09, 2022 | Jun. 30, 2023 | |
2017 Employee Stock Purchase Plan | ||
Common Stock | ||
Common stock reserved for issuance | 14,503,475 | |
Shares available for future grant | 1,340,676 | |
2022 Employment Inducement Plan | ||
Common Stock | ||
Common stock reserved for issuance | 1,000,000 | |
Vesting period | 4 years | |
Expiration period | 10 years | |
Shares available for future grant | 295,985 | |
Equity Option | 2017 Employee Stock Purchase Plan | ||
Common Stock | ||
Common stock reserved for issuance | 8,723,552 | |
Stock options | 2022 Employment Inducement Plan | ||
Common Stock | ||
Issuance of stock (in shares) | 469,430 | |
Restricted stock units | 2022 Employment Inducement Plan | ||
Common Stock | ||
Issuance of stock (in shares) | 234,585 |
Related-Party Transactions (Det
Related-Party Transactions (Details) - Consultants and vendors - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Related-Party Transactions | |||||
Expenses paid to consultants | $ 383 | $ 498 | $ 705 | $ 978 | |
Accounts payable | |||||
Related-Party Transactions | |||||
Due to related party | $ 6 | $ 6 | $ 13 |
Long-Term Obligations (Details)
Long-Term Obligations (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 15 Months Ended | ||||
Jun. 16, 2022 | Jun. 30, 2023 | Jun. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 29, 2022 | Jun. 29, 2022 | |
Long-Term Obligations | |||||||
Debt repayment | $ 2,657 | ||||||
Deferred royalty obligation | $ 79,347 | 79,347 | $ 75,810 | ||||
Revenue Interest Financing Agreement | |||||||
Long-Term Obligations | |||||||
Initial investment amount received under Revenue Interest Financing Agreement ("RIFA") | $ 24,375 | $ 37,500 | $ 37,500 | ||||
Revenue interest payment period | 12 years | ||||||
Fair value of embedded derivative liability | 1,320 | 1,320 | $ 1,340 | ||||
Remeasurement of the embedded derivative liability | 30 | (20) | |||||
Deferred royalty obligation | $ 79,347 | 79,347 | |||||
Revenue Interest Financing Agreement ("RIFA") | $ 75,000 | ||||||
Effective interest rate | 16.18% | 16.18% | |||||
Debt issuance costs | $ 2,662 | $ 2,662 | |||||
Revenue Interest Financing Agreement | 45 business days after achievement | |||||||
Long-Term Obligations | |||||||
Initial investment amount received under Revenue Interest Financing Agreement ("RIFA") | $ 25,000 | ||||||
Business days | 45 days | ||||||
Revenue Interest Financing Agreement | Annual net revenues up to 125 million | |||||||
Long-Term Obligations | |||||||
Royalty interest (as a percent) | 11.50% | ||||||
Threshold annual net revenues | $ 125,000 | ||||||
Revenue Interest Financing Agreement | Annual net revenues between 125 million and 300 million | |||||||
Long-Term Obligations | |||||||
Royalty interest (as a percent) | 7.50% | ||||||
Revenue Interest Financing Agreement | Annual net revenues exceeding 300 million | |||||||
Long-Term Obligations | |||||||
Royalty interest (as a percent) | 2.50% | ||||||
Threshold annual net revenues | $ 300,000 | ||||||
Revenue Interest Financing Agreement | March 31, 2027 | |||||||
Long-Term Obligations | |||||||
Threshold cumulative minimum payments (as a percent) | 60% | ||||||
Revenue Interest Financing Agreement | March 31, 2029 | |||||||
Long-Term Obligations | |||||||
Threshold cumulative minimum payments (as a percent) | 120% | ||||||
Revenue Interest Financing Agreement | Minimum | |||||||
Long-Term Obligations | |||||||
Revenue interest cap (as a percent) | 185% | ||||||
Revenue Interest Financing Agreement | Minimum | Annual net revenues between 125 million and 300 million | |||||||
Long-Term Obligations | |||||||
Threshold annual net revenues | $ 125,000 | ||||||
Revenue Interest Financing Agreement | Maximum | |||||||
Long-Term Obligations | |||||||
Aggregate investment amount | $ 100,000 | ||||||
Revenue interest cap (as a percent) | 250% | ||||||
Revenue Interest Financing Agreement | Maximum | Annual net revenues between 125 million and 300 million | |||||||
Long-Term Obligations | |||||||
Threshold annual net revenues | $ 300,000 |