Risks and Fair Value | 9. Risks and Fair Value Concentration of Credit Risk and of Significant Suppliers and Customers Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company has its cash and cash equivalents balances at two accredited financial institutions, in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company is dependent on a small number of third-party manufacturers to supply products for research and development activities in its preclinical and clinical programs and for sales of its products. The Company’s development programs as well as revenue from future product sales could be adversely affected by a significant interruption in the supply of any of the components of these products. For the three and nine months ended September 30, 2023, three specialty distributor customers accounted for 47%, 24% and 12%, and 51%, 23%, and 11%, respectively, of the Company’s gross product revenue, and at September 30, 2023, three specialty distributor customers accounted for 51%, 26%, and 11% of the Company’s total accounts receivable. No other customer accounted for more than 10% of total revenue for the three and nine months ended September 30, 2023, or accounts receivable at September 30, 2023. For the three and nine months ended September 30, 2022, three specialty distributor customers accounted for 42%, 30%, and 14%, and 41%, 27% and 18%, respectively, of the Company’s gross product revenue. At December 31, 2022, three specialty distributor customers accounted for 52%, 24%, and 15% of the Company’s total accounts receivable. No other customer accounted for more than 10% of total revenue for the three and nine months ended September 30, 2022, or accounts receivable at December 31, 2022. Change in Fair Value of Derivative Liabilities Other income (expenses) from the change in the fair values of derivative liabilities as presented on the Company’s consolidated statements of operations and comprehensive loss includes the following: Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Change in the fair value of the Conversion Option Derivative Liability $ 7,144 $ (1,133) $ 1,712 $ 8,598 Change in the fair value of Royalty Fee Derivative Liability (34) — (34) — Barings Royalty Fees (Note 7) (388) — (388) — $ 6,722 $ (1,133) $ 1,290 $ 8,598 Fair Value of Financial Assets and Liabilities The following tables present information about the Company’s financial assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022 and indicate the level of the fair value hierarchy utilized to determine such fair value: Fair Value Measurements as of September 30, 2023 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 101,480 $ — $ — $ 101,480 Liability: Derivative liabilities $ — $ — $ 24,022 $ 24,022 Fair Value Measurements as of December 31, 2022 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 30,188 $ — $ — $ 30,188 Liability: Derivative liabilities $ — $ — $ 6,351 $ 6,351 At September 30, 2023, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $65,982 comprised of the $65,124 non-current liability (Note 7) and $858 accrued interest (Note 6). The estimated fair value of the Barings Credit Facility, without the Royalty Fee Derivative Liability, was $69,159 at September 30, 2023. The fair value of the Royalty Fee Derivative Liability is estimated using a Monte Carlo simulation. The use of this approach requires the use of Level 3 unobservable inputs. The main inputs when determining the fair value of the Royalty Fee Derivative Liability are the amount and timing of the expected future revenue of the Company, the estimated volatility of these revenues, and the discount rate corresponding to the risk of revenue. The estimated fair value presented is not necessarily indicative of an amount that could be realized in a current market exchange. The use of alternative inputs and estimation methodologies could have a material effect on these estimates of fair value. The main inputs to valuing the Royalty Fee Derivative Liability are as follows: As of September 30, 2023 Revenue volatility 60.0 % Revenue discount rate 16.4 % The main inputs to valuing the Royalty Fee Derivative Liability as of the Closing Date were revenue volatility of 61.0% and a revenue discount rate of 15.8%. A roll-forward of the Royalty Fee Derivative Liability is as follows: As of Balance at August 2, 2023 $ 12,604 Change in fair value 34 Balance at September 30, 2023 $ 12,638 At September 30, 2023, the Convertible Notes, net of the Conversion Option Derivative Liability, were carried at amortized cost totaling $19,084, comprised of the $8,765 non-current liability (Note 7) and $10,319 accrued interest (Note 6). At December 31, 2022, the Convertible Notes, net of the Conversion Option Derivative Liability, were carried at amortized cost totaling $37,505, comprised of the $28,749 non-current liability (Note 7) and $8,756 accrued interest (Note 6). The estimated fair value of the Convertible Notes, without the Conversion Option Derivative Liability, was $19,357 and $33,177 at September 30, 2023 and December 31, 2022, respectively. The fair value of the Convertible Notes with and without the conversion option is estimated using a binomial lattice approach. The use of this approach requires the use of Level 3 unobservable inputs. The main input when determining the fair value of the Convertible Notes is the bond yield that pertains to the host instrument without the conversion option. The significant assumption used in determining the bond yield is the market yield movements of a comparable instrument issued as of the valuation date, which is assessed and updated each period. The main input when determining the fair value for disclosure purposes is the bond yield which is updated each period to reflect the yield of a comparable instrument issued as of the valuation date. To determine the gain on extinguishment related to the Amendment of the Convertible Notes as of August 2, 2023 (Note 7), the Company has determined the fair value of the Convertible Notes with and without the conversion option immediately before and immediately after the Amendment based on the same approach. The estimated fair value presented is not necessarily indicative of an amount that could be realized in a current market exchange. The use of alternative inputs and estimation methodologies could have a material effect on these estimates of fair value. The main inputs to valuing the Convertible Notes with the conversion option on a recurring basis are as follows: As of September 30, December 31, 2023 2022 Company's stock price $ 3.14 $ 2.81 Volatility 76.3 % 93.8 % Bond yield 22.7 % 16.2 % The main inputs to valuing the Convertible Notes with the conversion option immediately before the Amendment on August 2, 2023 were the Company’s stock price of $4.30, volatility of 78.5%, and a bond yield of 22.6%. The main inputs to valuing the Convertible Notes with the conversion option immediately after the Amendment on August 2, 2023 were the Company’s stock price of $4.30, volatility of 77.8%, and a bond yield of 22.9%. A roll-forward of the Conversion Option Derivative Liability, including the impact from accounting for the Convertible Notes Amendment, is as follows: As of Balance at December 31, 2022 $ 6,351 Change in fair value 5,432 Balance at June 30, 2023 11,783 Change in fair value (827) Balance at August 2, 2023 before the Convertible Notes Amendment 10,956 Change in fair value from Convertible Notes Amendment 6,745 Balance at August 2, 2023 after the Convertible Notes Amendment 17,701 Change in fair value (6,317) Balance at September 30, 2023 $ 11,384 |