Agreements with Royalty Pharma | Note 6 — Agreements with Royalty Pharma On January 7, 2022, we announced that we had entered into the 2022 RPI Transactions with affiliates of Royalty Pharma International plc. Pursuant to the 2022 RPI Transactions, the RP Multi Tranche Loan Agreement and the RP Aficamten RPA described below, are determined to be debt instruments subsequently measured at amortized cost and were entered into with parties that were at the time of our entry into the 2022 RPI Transactions affiliated and in contemplation of one another. We used the relative fair value method and made separate estimates of the fair value of each freestanding financial instrument and then allocated the proceeds in proportion to those fair value amounts. Arrangement consideration for the RP Multi Tranche Loan Agreement and the RP Aficamten RPA totaled $ 150 million, consisting of the two $ 50 million up front payments for the signing of the RP Multi Tranche Loan Agreement and the RP Aficamten RPA and milestone of $ 50 million for initiation of the first pivotal trial in oHCM for aficamten that was deemed probable at the signing of the agreements. On May 22, 2024, we announced that we had entered into the 2024 RPI Transactions as an amendment to the 2022 RPI Transactions with affiliates of Royalty Pharma International plc. The 2024 RPI Transactions include the 2024 RP OM Loan Agreement, the RP CK-586 RPA, the RP Stock Purchase Agreement, the RP Multi Tranche Loan Agreement Amendment and the RP Aficamten RPA Amendment, as described below, are accounted for as a debt modification of the 2022 RPI Transactions. The 2024 RPI Transactions consideration of $ 200.0 million was allocated as follows (in thousands): Allocation Units of Accounting: RP Aficamten RPA $ 33,300 Tranche 6 of RP Multi Tranche Loan Agreement 41,200 Tranche 6 of RP Multi Tranche Loan Agreement - Embedded Derivatives 4,400 Tranche 4 of RP Multi Tranche Loan Agreement - Embedded Derivatives 3,700 RP CK-568 RPA 12,700 RP OM Loan Agreement 104,700 Total consideration $ 200,000 Liabilities Related to RPI Transactions Measured at Fair Value As permitted under Accounting Standards Codification 825, Financial Instruments, or ASC 825, we elected the fair value option for recognizing the liabilities related to the 2024 RP OM Loan Agreement and the RP CK-586 RPA. The fair value option was elected because these liabilities included embedded derivatives which would have otherwise required separate recognition and measurement. The Company elected the fair value option as it is believed to more practical for each liability as a single unit of account at fair value. Under the fair value option, debt issuance costs are expensed as incurred and the Company is required to record the fair value option elected arrangements at their fair value on the date of issuance and at each balance sheet thereafter. Changes in the estimated fair value of the arrangements are recognized as non-cash gains or losses in the statements of operations and comprehensive loss. RP OM Loan The RP OM Loan Agreement provides for a loan in a principal amount of $ 100.0 million that was drawn at the closing. The loan under the RP OM Loan Agreement matures on the 10 year anniversary of the funding date and is repayable in quarterly installments as follows: • Scenario 1: If the Phase 3 clinical trial of Cytokinetics’ proprietary small molecule cardiac myosin activator known as omecamtiv mecarbil is successful (defined as meeting the composite primary endpoint of the first event, whichever occurs first, comprising of cardiovascular death, heart failure event, LVAD implementation/cardiac transplantation, or stroke, with a hazard ratio (HR) of less than 0.85 and cardiovascular death endpoint HR of less than 1.0) by June 30, 2028 and we receive the marketing approval from the FDA for omecamtiv mecarbil on or prior to December 31, 2029 (“OM Approval Date”), commencing on the calendar quarter during which the FDA approval is obtained, we are required to pay RPDF (x) (i) $ 75.0 million ten business days after the OM Approval Date and (ii) $ 25.0 million on the first anniversary of the OM Approval Date and (y) on a quarterly basis an amount equal to 2.0 % of the annual worldwide net sales of omecamtiv mecarbil, subject to a minimum floor amount ranging from $ 5.0 million to $ 8.0 million during the first 18 calendar quarters (the payment of the 2.0 % of the annual worldwide net sales starting from the 19th calendar quarter shall be referred to as the “Royalty Payment”). Our obligation to pay the Royalty Payment will continue after maturity of the Loan; • Scenario 2: If the Phase 3 clinical trial of omecamtiv mecarbil is successful by June 30, 2028 but we have not received the marketing approval from the FDA for omecamtiv mecarbil on or prior to December 31, 2029, we are required to pay RPDF 18 equal quarterly cash payments totaling 237.5 % of the principal amount of the loan commencing on March 31, 2030 ; • Scenario 3: If the Phase 3 clinical trial of omecamtiv mecarbil is not successful by June 30, 2028, we are required to pay RPDF 22 equal quarterly cash payments totaling 227.5 % of the principal amount of the loan commencing on September 30, 2028 ; and • Scenario 4: If the Phase 3 clinical trial of omecamtiv mecarbil has not been initiated by June 30, 2026, we are required to pay RPDF 22 equal quarterly cash payments totaling 227.5 % of the principal amount of the loan commencing on September 30, 2026 ; (the aggregate amount to be paid by us with respect to each scenario is referred to as the “Scheduled Payment Amount”). The interest of the loan is included in the Scheduled Payment Amount for each scenario. In each scenario, we may prepay the loan in full (but not in part) at any time at its option by paying an amount equal to the unpaid portion of Scheduled Payment Amount for the outstanding loan; provided that, in scenario 1, we would be required to continue to pay the Royalty Payment after such prepayment. In addition, upon the occurrence of a change of control of the Company, the loan is repayable in full at the option of either the Company or the lender in an amount equal to (x) depending on when such change of control occurs, 150.0 % to 237.5 % of the principal amount of the loan minus (y) the then paid Scheduled Payment Amount. The RP OM Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants applicable to the Company and its subsidiaries, including, among other things, restrictions on dispositions, mergers, indebtedness, encumbrances, distributions, stock repurchases, investments and transactions with affiliates. The RP OM Loan Agreement also includes customary events of default, including but not limited to the nonpayment of principal or interest, violations of covenants, material adverse changes, attachment, levy, restraint on business, cross-defaults on material indebtedness, bankruptcy, delisting, material judgments, misrepresentations, governmental approvals, payment defaults under other royalty purchase agreements and development funding agreements with RPDF or RPI ICAV. Upon an event of default or simultaneously with payment in full of the term loans in the RP OM Loan Agreement, the lenders may, among other things, accelerate the loan (with the amount payable between 227.5 % and 237.5 % of the principal amount (less amounts previously paid) in the case of other events of default). Upon execution of the RP OM Loan Agreement in the second quarter of 2024, we recorded liabilities of $ 104.7 million using the probability-weighted expected return method and the fair value inputs are classified as Level 3 in the fair value hierarchy. The following table demonstrates the future minimum payments for our RP OM Loan under Scenario 3, based on 227.5 % of the principal amount with repayment expected to start in 2028 as defined above, as of June 30, 2024 (in thousands): Years ending December 31: 2024 remainder $ — 2025 — 2026 — 2027 — 2028 20,682 Thereafter 206,818 Future minimum payments 227,500 As defined above, the minimum repayment schedule under Scenario 1 would be a total of 124.0 % of the principal amount and the royalty payment with quarterly payments starting in 2028. In addition, under Scenario 1 we would be obligated to make the royalty payment each quarter, and such amounts are not determinable at this time. The repayment schedule under Scenario 2 would be 237.5 % of the principal amount with quarterly payments starting in 2030, and Scenario 4 would be 227.5 % of the principal amount with quarterly payments starting in 2026. CK-586 RPA Pursuant to the RP CK-586 RPA, RPI ICAV purchased rights to certain revenue streams from worldwide net sales of CK-586 by us, our affiliates or licensees, in exchange for up to $ 200 million in consideration, $ 50 million of which was paid upfront and, following the initiation of the first Phase 3 clinical trial (or the Phase 3 portion of the first Phase 2b/3 clinical trial) in heart failure with preserved ejection fraction in humans for CK-586, at RPI ICAV’s sole discretion, up to in aggregate $ 150 million in quarterly payments to fund 50.0 % of the research and development cost of CK-586. Pursuant to the RP CK-586 RPA, RPI ICAV purchased the right to receive a percentage of net sales ranging from 1.0 % to up to 4.5 % for annual worldwide net sales of CK-586 (depending on the aggregate amounts funded by RPI ICAV), subject to reduction in certain circumstances, and will receive a 0.75x milestone payment upon market approval of CK-586 by the FDA, or if market approval of CK-586 by the European Medicines Agency is obtained prior to market approval by the FDA, 0.375x milestone payment for such obtained approval and 0.375x milestone payment upon subsequent market approval by the FDA. The RP CK-586 RPA contains customary representations, warranties and indemnities of the Company and RPI ICAV and customary covenants relating to the royalty payments. As the RP CK-586 RPA includes embedded derivative features that would require bifurcation, it meets the definition of a hybrid instrument. Upon execution of the RP CK-586 RPA in the second quarter of 2024, we recorded a liability of $ 12.7 million using a combination of the discounted cash flow method and the probability-weighted expected return method. The fair value inputs are classified as Level 3 in the fair value hierarchy. We account for the RP CK-586 RPA as a liability because, among other reasons, we have significant continuing involvement in generating the related revenue stream from which the liability will be repaid. Accounting for RPI Transactions Measured at Fair Value The fair values of the liabilities for the RP OM Loan Agreement and CK-586 RPA are based on significant unobservable inputs, including the probability of clinical success and regulatory approval based on historical industry success rates for product development specific to cardiovascular products, the estimated date of a product launch, estimates of pricing, sales ramp, variables for the timing of the related events, probability of change of control, and discount rates (which range from 13 % to 18 %), which are deemed to be Level 3 inputs in the fair value hierarchy. As products containing omecamtiv mecarbil and CK-586 have not yet been commercialized, the estimates are highly subjective. For example, assumed increases in the probability of the clinical success for the omecamtiv mecarbil or CK-586 programs could increase the value of the liabilities. For the three months ended June 30, 2024 , the Company recorded a gain of $ 0.2 million associated with the change in fair value of the liabilities related to 2024 RP OM Loan Agreement and the CK-586 RPA. The change in the fair value has been recognized in the statement of operations and comprehensive loss. The following table summarizes the changes of the fair value of the CK-586 RPA and RP OM Loan for the three months ended June 30, 2024 (in thousands): 2024 CK-586 RPA RP OM Loan Beginning balance, May 22 $ 12,700 $ 104,700 Change in fair value — ( 200 ) Ending balance, June 30 $ 12,700 $ 104,500 Liabilities Related to Revenue Participation Right Purchase Agreements RP Aficamten Royalty Purchase Agreement On January 7, 2022, we entered into the RP Aficamten RPA with RPI ICAV, pursuant to which RPI ICAV purchased rights to certain revenue streams from net sales of pharmaceutical products containing aficamten by us, our affiliates and our licensees in exchange for up to $ 150.0 million in consideration, $ 50.0 million of which was paid on the closing date, $ 50.0 million of which was paid to us in March 2022 following the initiation of the first pivotal trial in oHCM for aficamten, and $ 50.0 million of which was paid to us in September 2023 following the initiation of the first pivotal clinical trial in nHCM for aficamten. Th e RP Aficamten RPA also provides that the parties will negotiate terms for additional funding if we achieve proof of concept results in certain other indications for aficamten, with a reduction in the applicable royalty if we and RPI ICAV fail to agree on such terms in certain circumstances. Pursuant to the RP Aficamten RPA, RPI ICAV purchased the right to receive a percentage of net sales equal to 4.5 % for annual worldwide net sales of pharmaceutical products containing aficamten up to $ 1 billion and 3.5 % for annual worldwide net sales of pharmaceutical products containing aficamten in excess of $ 1 billion, subject to reduction in certain circumstances. On May 22, 2024, we entered into the RP Aficamten RPA Amendment to restructure the royalty so that RPI will now receive 4.5 % up to $ 5.0 billion of worldwide annual net sales of aficamten and 1 % above $ 5.0 billion of worldwide annual net sales. Our liability to RPI ICAV is referred to as the “RP Aficamten Liability”. We account for the RP Aficamten Liability as a liability primarily because we have significant continuing involvement in generating the related revenue stream from which the liability will be repaid. If and when aficamten is commercialized and royalties become due, we will recognize the portion of royalties paid to RPI ICAV as a decrease to the RP Aficamten Liability and a corresponding reduction in cash. The carrying amount of the RP Aficamten Liability is based on our estimate of the future royalties to be paid to RPI ICAV over the life of the arrangement as discounted using an imputed rate of interest. In the second quarter of 2024, w e recorded an additional $ 33.3 million to the carrying value related to the 2024 RPI Transactions entered into May 22, 2024. The imputed rate of interest on the carrying value of the RP Aficamten Liability was approximately 24.3 % as of June 30, 2024 and 19.0 % as of June 30, 2023. 2017 RP Omecamtiv Mecarbil Royalty Purchase Agreement In February 2017, we entered into the RP OM RPA pursuant to which we sold a portion of our right to receive royalties from Amgen on future net sales of omecamtiv mecarbil to RPFT for a one-time payment of $ 90 million, which is non-refundable even if omecamtiv mecarbil is never commercialized. Concurrently, we entered into a common stock purchase agreement with RPFT through which RPFT purchased 875,656 shares of the Company’s common stock for $ 10.0 million. We allocated the consideration and issuance costs on a relative fair value basis to our liability to RPFT related to sale of future royalties under the RP OM RPA (the “RP OM Liability”) and the common stock sold to RPFT, which resulted in the RP OM Liability being initially recognized at $ 92.3 million. The RP OM RPA provides for the sale of a royalty to RPFT of 4.5 % on worldwide net sales of omecamtiv mecarbil, subject to a potential increase of up to an additional 1 % under certain circumstances. As a result of our receipt of a CRL on February 28, 2023 in connection to our NDA for omecamtiv mecarbil, pursuant to the terms of the RP OM RPA, the applicable royalty rate will increase to a maximum of 5.5 % if omecamtiv mecarbil obtains FDA approval at any time after June 30, 2023. As a result of the termination of the Amgen Agreement and pursuant to our obligations under the RP OM RPA, we and RPFT amended the RP OM RPA on January 7, 2022 to preserve RPFT’s rights under the RP OM RPA by providing for direct payments by us to RPFT of up to 5.5 % of our and our affiliates and licensees worldwide net sales of omecamtiv mecarbil. The RP OM RPA, as amended, had no impact on the original accounting for the $ 92.3 million associated with the RP OM Liability established in February 2017. We account for the RP OM Liability as a liability primarily because we have significant continuing involvement in generating the related revenue stream from which the liability will be repaid. If and when omecamtiv mecarbil is commercialized and royalties become due, we will recognize the portion of royalties paid to RPFT as a decrease to the RP OM Liability and a corresponding reduction in cash. The carrying amount of the RP OM Liability is based on our estimate of the future royalties to be paid to RPFT over the life of the arrangement as discounted using an imputed rate of interest. The excess of future estimated royalty payments over the $ 92.3 million of allocated proceeds, less issuance costs, is recognized as non-cash interest expense using the effective interest method. The imputed rate of interest on the carrying value of the RP OM Liability was approximately 0.1 % as of June 30, 2024 and 2.9 % as of June 30, 2023. Accounting for Revenue Participation Right Purchase Agreements We periodically assess the amount and timing of expected royalty payments using a combination of internal projections and forecasts from external sources. To the extent such payments are greater or less than our initial estimates or the timing of such payments is materially different than its original estimates, we will prospectively adjust the amortization of the RP OM Liability and the RP Aficamten Liability and the effective interest rate. There are a number of factors that could materially affect the amount and timing of royalty payments, a number of which are not within our control. The RP OM Liability and the RP Aficamten Liability are recognized using significant unobservable inputs. The estimates of future royalties requires the use of several assumptions such as: the probability of clinical success, the probability of regulatory approval, the estimated date of a product launch, estimates of eligible patient populations, estimates of prescribing behavior and patient compliance behavior, estimates of pricing, payor reimbursement and coverage, and sales ramp. A significant change in unobservable inputs could result in a material increase or decrease to the effective interest rate of the RP OM Liability and the RP Aficamten Liability. We recorded $ 50.0 million of additional consideration associated with the 2022 RP Aficamten Royalty Purchase Agreement upon receipt of the cash in the third quarter of 2023. In the second quarter of 2024, w e recorded an additional $ 33.3 million to the carrying value related to the 2024 RPI Transactions entered in May 22, 2024. We review our assumptions on a regular basis and our estimates may change in the future as we refine and reassess our assumptions. Changes to the RP Aficamten Liability and the RP OM Liability are as follows (in thousands): RP Aficamten Liability RP OM Liability 2024 2023 2024 2023 Beginning balance, January 1 $ 180,591 $ 105,117 $ 199,384 $ 195,384 Interest accretion 10,239 5,363 ( 21 ) 917 Amortization of issuance costs — — 26 33 Ending balance, March 31 $ 190,830 $ 110,480 $ 199,389 $ 196,334 Modification in the 2024 RPI Transactions 33,300 — — — Interest accretion 11,525 4,903 42 1,419 Amortization of issuance costs — — 26 27 Ending balance, June 30 $ 235,655 $ 115,383 $ 199,457 $ 197,780 RP Multi Tranche Term Loan Under the 2022 RP Loan Agreement, we were initially entitled to receive up to $ 300.0 million in term loans, $ 50.0 million of which was disbursed to us on closing and the remaining $ 250.0 million scheduled to have been available to us upon our satisfaction of customary disbursement conditions and certain development conditions by specific deadlines, as follows: • $ 50.0 million of tranche 2 term loans during the one year period following the receipt on or prior to March 31, 2023 of marketing approval from FDA of omecamtiv mecarbil; • $ 25.0 million of tranche 3 term loans during the one year period following the commercial availability of a diagnostic test measuring levels of omecamtiv mecarbil to support the final FDA label language applicable to such drug, subject to such commercial availability and the conditions to the tranche 2 term loans having occurred on or prior to March 31, 2023; • $ 75.0 million of tranche 4 term loans during the one year period following the receipt on or prior to September 30, 2024 of positive results from SEQUOIA-HCM, the Phase 3 trial for aficamten; and • $ 100.0 million of tranche 5 term loans during the one year period following the acceptance by the FDA on or prior to March 31, 2025 of an NDA for aficamten, subject to the conditions to the tranche 4 term loans having occurred on or prior to September 30, 2024. As a result of our receipt of a CRL on February 28, 2023, in connection to our NDA for omecamtiv mecarbil, we have not satisfied the conditions to the availability of the tranche 2 and tranche 3 loans under the RP Multi Tranche Loan Agreement. In December 2023, we announced positive topline results from SEQUOIA-HCM, the Phase 3 trial for aficamten. This entitled us to draw $ 75.0 million under tranche 4 during the period April 4, 2024 through April 3, 2025, and requires us to complete a minimum mandatory draw of at least $ 50.0 million of the $ 75.0 million available during the same period. The remaining $ 100.0 million under tranche 5 remains available for disbursement to us, subject to satisfaction of the conditions described above. On May 22, 2024, we entered into the RP Multi Tranche Loan Agreement Amendment to provide for two tranches of additional term loans in an aggregate principal amount up to $ 225.0 million, consisting of a $ 50.0 million tranche 6 term loan drawn immediately and a $ 175.0 million tranche 7 term loan drawable at Cytokinetics’ discretion within one year of a future U.S. Food and Drug Administration (“FDA”) approval of aficamten in obstructive hypertrophic cardiomyopathy if such approval is obtained on or prior to December 31, 2025. Each term loan under the RP Multi Tranche Loan Agreement matures on the 10 year anniversary of the funding date for such term loan and is repayable in quarterly installments of principal, interest and fees commencing on the last business day of the seventh full calendar quarter following the calendar quarter of the applicable funding date for such term loan, with the aggregate amount payable in respect of each term loan (including interest and other applicable fees) equal to 190 % of the principal amount of the term loan for the tranche 1, tranche 4, tranche 5, tranche 6, and tranche 7 term loans (such amount with respect to each term loan, “Final Payment Amount”). We account for amounts drawn under the RP Multi Tranche Loan Agreement using the effective interest method. The RP Multi Tranche Loan Agreement and amendment contains embedded derivative features. The fair values of the embedded derivatives are based on significant unobservable inputs, including the probability of change of control, the probability of default, discount rates and other factors. We have bifurcated and recognized the embedded derivatives as Derivative Liabilities Measured at Fair Value as discussed below. We may prepay the term loans in full (but not in part) at any time at our option by paying an amount equal to the unpaid portion of Final Payment Amount for the outstanding term loans under the RP Multi Tranche Loan Agreement. We must borrow at least $ 50 million principal amount of the tranche 4 within the applicable draw period. In addition, the term loans under the RP Multi Tranche Loan Agreement are repayable in full at the option of either us or the lender in an amount equal to the unpaid portion of Final Payment Amount for the outstanding term loans upon a change of control of Cytokinetics. Future minimum payments under the existing borrowing under Tranche 1 and Tranche 6 of RP Multi Tranche Loan are (in thousands): Years ending December 31: Tranche 1 Term Loan Tranche 6 Term Loan 2024 remainder $ 5,760 $ — 2025 11,520 — 2026 11,520 8,640 2027 11,520 11,520 2028 11,520 11,520 Thereafter 37,440 63,320 Future minimum payments 89,280 95,000 Less: Unamortized interest and loan costs ( 26,786 ) ( 53,143 ) Term Loan, net $ 62,494 $ 41,857 The weighted-average effective rate of interest on the Tranche 1 and Tranche 6 term loans was approximately 11.6 % as of June 30, 2024. As of June 30, 2024, the estimated fair value of the Tranche 1 and Tranche 6 term loans was $ 51.2 million and $ 40.2 million , respectively. The fair value was estimated based on Level 3 inputs. Derivative Liabilities Measured at Fair Value We have bifurcated and recognized the embedded derivatives in the RP Multi Tranche Loan Agreement. These embedded derivatives include repayment features based upon a change in control and default. We recognize the derivative liabilities at fair value in the consolidated balance sheets. Each period, the fair value of the derivative liabilities will be recalculated and resulting gains and losses from the changes in fair value of the derivatives with non-credit components are recognized in income, while the change in fair value associated with credit components is recognized in accumulated other comprehensive loss. Estimating fair values of derivative instruments requires the development of significant and subjective estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. The fair values of the derivative liabilities is determined using the probability-weighted expected return method and the “with and without” method. The fair values are based on significant unobservable inputs, including the probability of change of control, the probability of default (less than 10 %), discount rates (ranging between 14 % to 16 %) and other factors. For the three months ended June 30, 2024 , the Company recorded a loss of $ 0.6 million associated with the change in fair value of the derivative liabilities. The amounts have been recorded as other expense in the condensed consolidated statement of operations and comprehensive loss. The following table summarizes the changes of the fair value of the derivative liabilities for the RP Multi Tranche Loan Agreement for three months ended June 30, 2024 (in thousands): RP Multi Tranche Loan Agreement Derivatives 2024 Beginning balance, May 22 $ 12,600 Change in fair value 600 Ending balance, June 30 $ 13,200 RP Stock Purchase Agreement Pursuant to the RP Stock Purchase Agreement, we, at our option, could require RPI ICAV to purchase shares of Common Stock for an aggregate purchase price of $ 50 million in our next equity financing on or before August 20, 2024, with minimum gross proceeds to us of $ 250 million. The Stock Purchase Agreement also includes lockup provisions. Concurrently with the closing of our underwritten public offering on May 28, 2024, RPI ICAV purchased 980,392 shares of Common Stock pursuant to the RP Stock Purchase Agreement at a price of $ 51.00 per share. The proceeds from the concurrent private placement were $ 50 million . |