Cytokinetics(CYTK)
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Cytokinetics(CYTK) - 2023 Q1 - Quarterly Report
2023-05-04 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-50633 CYTOKINETICS, INCORPORATED (Exact name of registrant as specified in its charter) | Title of each class ...
Cytokinetics (CYTK) Investor Presentation - Slideshow
2023-03-17 18:55
empowering muscle empowering lives ©2023 CYTOKINETICS, All Rights Reserved. CYTOKINETICS® and the C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Actual pa Chuck, diagnosed with ALS Forward-Looking Statements 2 Not for Promotional Use, For Investors Only O V E R V I E W C A R D I A C M U S C L E S K E L E T A L M U S C L E C O R P O R A T E P R O F I L E Our Mission 3 Build commercial capabilities to market and sell our medicines reflective of their innovatio ...
Cytokinetics(CYTK) - 2022 Q4 - Earnings Call Transcript
2023-03-02 00:05
Cytokinetics, Incorporated (NASDAQ:CYTK) Q4 2022 Earnings Conference Call March 1, 2023 4:30 PM ET Company Participants Diane Weiser - Senior Vice President, Corporate Communications & Investor Relations Robert Blum - President & Chief Executive Officer Fady Malik - Executive Vice President, Research & Development Andrew Callos - Executive Vice President and Chief Commercial Officer Stuart Kupfer - Senior Vice President & Chief Medical Officer Robert Wong - Vice President & Chief Accounting Officer Ching Ja ...
Cytokinetics(CYTK) - 2022 Q4 - Annual Report
2023-02-28 16:00
Part I [Business](index=12&type=section&id=Item%201.%20Business) Cytokinetics is a late-stage biopharmaceutical company specializing in muscle biology, developing treatments for diseases with compromised muscle performance, with a strategic focus on regulatory approvals, commercial capabilities, and pipeline expansion - The company is a late-stage biopharmaceutical firm focused on discovering and developing first-in-class muscle activators and next-in-class muscle inhibitors for diseases involving compromised muscle function[33](index=33&type=chunk) - The company's "Vision 2025" strategic plan aims to achieve regulatory approvals for at least two drugs, build commercial capabilities, generate sustainable revenue, double the development pipeline to ten programs, and expand its discovery platform[36](index=36&type=chunk)[37](index=37&type=chunk)[39](index=39&type=chunk) - Cytokinetics has no manufacturing capabilities and is entirely dependent on third-party contract manufacturing organizations (CMOs) for the supply of raw materials, active pharmaceutical ingredients, and finished drug products for both clinical trials and potential commercial supply[107](index=107&type=chunk) [Research and Development Programs](index=14&type=section&id=Research%20and%20Development%20Programs) The company's R&D programs are segmented into cardiac and skeletal muscle contractility, featuring lead candidates like *omecamtiv mecarbil*, *aficamten*, and *reldesemtiv*, with R&D expenses significantly increasing to $240.8 million in 2022 Research and Development Expenses (2020-2022) | Year | R&D Expenses (in millions) | | :--- | :--- | | 2022 | $240.8 | | 2021 | $159.9 | | 2020 | $97.0 | - The cardiac muscle program focuses on modulating the cardiac sarcomere with activators like *omecamtiv mecarbil* for heart failure and inhibitors like *aficamten* for hypertrophic cardiomyopathy (HCM)[44](index=44&type=chunk)[45](index=45&type=chunk) - The skeletal muscle program leverages expertise from the cardiac program to develop activators for the skeletal sarcomere, targeting conditions like ALS and SMA associated with muscle weakness and fatigue[88](index=88&type=chunk)[89](index=89&type=chunk) [Competition](index=24&type=section&id=Competition) Cytokinetics faces substantial competition from major pharmaceutical and biotechnology companies across its therapeutic areas, including established and emerging treatments for HFrEF, HCM, and ALS - If approved, *omecamtiv mecarbil* will compete with a crowded HFrEF market including generics (milrinone, digoxin), branded drugs (Entresto®, Verquvo®), and SGLT2 inhibitors (Forxiga®, Jardiance®)[113](index=113&type=chunk) - *Aficamten*'s main competitor for HCM is Camzyos™ (mavacamten) from Bristol Myers Squibb, with other companies like Novartis, Eli Lilly, and Gilead also active in this space[114](index=114&type=chunk) - In the ALS market, *reldesemtiv* would compete with approved drugs Radicava™ (edaravone) and Relyvrio™ (AMX0035), as well as other therapies in development by companies like Biogen and Ionis[118](index=118&type=chunk) [Intellectual Property Resources](index=26&type=section&id=Intellectual%20Property%20Resources) The company's intellectual property strategy is built on patents, trade secrets, and technical know-how, with a portfolio including 73 U.S. and over 650 foreign patents, and key U.S. composition of matter patents expiring between 2027 and 2039 - As of year-end 2022, the company's portfolio included **73 issued U.S. patents**, over **650 issued foreign patents**, and over **430 pending applications worldwide**[119](index=119&type=chunk) Key U.S. Patent Expiration Dates | Drug Candidate | U.S. Patent Expiration Year | | :--- | :--- | | Omecamtiv mecarbil | 2027 | | Reldesemtiv | 2031 | | Aficamten | 2039 | [Human Capital](index=32&type=section&id=Human%20Capital) As of December 31, 2022, Cytokinetics had 409 employees and 167 consultants, maintaining a 9% turnover rate and demonstrating leadership diversity with significant representation from ethnic or racial minorities and women - The company employed **409 people** and **167 consultants** as of December 31, 2022, with an employee turnover rate of **9%** for the year[146](index=146&type=chunk) - Leadership diversity is a focus, with employees identifying as ethnic or racial minorities holding **43% of director-level and above roles**, and women holding **44% of such positions**[150](index=150&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks in its R&D and commercial operations, including the FDA's Complete Response Letter for *omecamtiv mecarbil*, potential clinical trial failures, reliance on third parties, intense competition, and the ongoing need for significant capital due to historical losses - The FDA issued a Complete Response Letter (CRL) for the *omecamtiv mecarbil* New Drug Application (NDA), stating that an additional clinical trial is required to establish substantial evidence of effectiveness, and the company has no plans to conduct another trial[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk) - Clinical trials for key drug candidates *aficamten* and *reldesemtiv* may fail to demonstrate the required safety and efficacy, which could prevent or significantly delay their development and regulatory approval[162](index=162&type=chunk) - The company has a history of significant financial losses and will require substantial additional capital to fund its operations, with no guarantee of achieving or sustaining profitability[253](index=253&type=chunk)[254](index=254&type=chunk) - Cytokinetics is entirely dependent on contract research organizations (CROs) to conduct clinical trials and contract manufacturing organizations (CMOs) for product supply, creating risks related to performance, quality, and timelines[194](index=194&type=chunk)[221](index=221&type=chunk) [Properties](index=63&type=section&id=Item%202.%20Properties) The company's primary facilities comprise 234,892 square feet of leased office and laboratory space in South San Francisco, California, with the lease expiring in 2033, deemed adequate for current operations - The company's material facilities are comprised of **234,892 square feet** of leased office and laboratory space in South San Francisco, California, with the lease expiring in **2033**[321](index=321&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=64&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Cytokinetics' common stock trades on the Nasdaq Global Select Market under "CYTK," with the company having never paid cash dividends and intending to retain future earnings for business operations - The company's common stock is listed on the Nasdaq Global Select Market under the trading symbol "**CYTK**"[327](index=327&type=chunk) - Cytokinetics has never declared or paid cash dividends and does not plan to in the foreseeable future, retaining earnings for business growth[332](index=332&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=66&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In 2022, Cytokinetics reported increased revenues of $94.6 million, driven by a one-time royalty sale, but incurred a net loss of $389.0 million due to rising R&D and G&A expenses, ending the year with $829.3 million in cash and investments Key Financial Results (in millions) | Metric | 2022 | 2021 | 2020 | | :--- | :--- | :--- | :--- | | Total Revenues | $94.6 | $70.5 | $55.8 | | R&D Expenses | $240.8 | $159.9 | $97.0 | | G&A Expenses | $178.0 | $96.8 | $52.8 | | Net Loss | $(389.0) | $(215.3) | $(127.3) | - The increase in 2022 revenue was primarily driven by the recognition of **$87.0 million** related to the full extinguishment of the Mavacamten Royalty obligation following a tripartite agreement with RTW ICAV and MyoKardia, Inc[357](index=357&type=chunk) - The company's cash, cash equivalents, and investments increased to **$829.3 million** at the end of 2022 from **$623.8 million** at the end of 2021, mainly due to net cash of **$516.2 million** provided by financing activities[380](index=380&type=chunk)[384](index=384&type=chunk) - Due to the FDA's CRL for *omecamtiv mecarbil*, the company does not expect to satisfy the conditions for the disbursement of **$75 million** in term loans (tranche 2 and 3) under its RP Loan Agreement[387](index=387&type=chunk)[532](index=532&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=75&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate exposure on its $829.3 million investment portfolio and fixed-rate convertible notes, while foreign currency risk is considered immaterial due to U.S. dollar-denominated transactions - The company is exposed to interest rate risk on its **$829.3 million** portfolio of cash and investments, where a 10% change in interest rates is not expected to have a material effect on financial results[404](index=404&type=chunk) - The company's outstanding convertible notes (**$21.1 million** due 2026 and **$540.0 million** due 2027) have fixed interest rates, exposing them to fair value risk from market changes but not cash flow risk from interest rate fluctuations[405](index=405&type=chunk) - Foreign currency exchange risk is minimal as the majority of the company's transactions are conducted in U.S. dollars[406](index=406&type=chunk) [Financial Statements and Supplementary Data](index=77&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The consolidated financial statements for 2022 show total assets of $1.01 billion, liabilities of $1.12 billion, a stockholders' deficit of $107.9 million, and a net loss of $389.0 million, with a critical audit matter identified regarding revenue participation right estimates Consolidated Balance Sheet Summary (as of Dec 31, 2022, in millions) | Account | Amount | | :--- | :--- | | Total Assets | $1,014.8 | | Total Liabilities | $1,122.7 | | Total Stockholders' (Deficit) Equity | $(107.9) | Consolidated Statement of Operations Summary (for year ended Dec 31, 2022, in millions) | Account | Amount | | :--- | :--- | | Total Revenues | $94.6 | | Total Operating Expenses | $418.8 | | Net Loss | $(389.0) | - The independent auditor, Ernst & Young LLP, identified 'Estimates Related to Revenue Participation Right Purchase Agreements' as a critical audit matter due to the significant and subjective judgments required by management in forecasting future royalty payments[416](index=416&type=chunk)[417](index=417&type=chunk) - A significant subsequent event noted was the receipt of a Complete Response Letter (CRL) from the FDA on February 28, 2023, regarding the NDA for *omecamtiv mecarbil*, stating an additional clinical trial is required[624](index=624&type=chunk) [Controls and Procedures](index=116&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2022, a conclusion affirmed by an unqualified opinion from Ernst & Young LLP - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[633](index=633&type=chunk) - Based on an evaluation using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2022[634](index=634&type=chunk) - The independent registered public accounting firm, Ernst & Young LLP, provided an unqualified opinion on the effectiveness of the company's internal control over financial reporting[635](index=635&type=chunk)[639](index=639&type=chunk) Part III [Directors, Executive Compensation, and Corporate Governance](index=119&type=section&id=Item%2010,%2011,%2012,%2013,%2014) Information on directors, executive compensation, and corporate governance is incorporated by reference from the 2023 Proxy Statement, with the company maintaining a Code of Ethics applicable to all personnel - Detailed information for Items 10 through 14 is incorporated by reference from the company's 2023 Annual Meeting of Stockholders Proxy Statement[654](index=654&type=chunk)[655](index=655&type=chunk)[656](index=656&type=chunk) - The company has a Code of Ethics that applies to all directors, officers, and employees, and is available on its website[654](index=654&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=120&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section provides an index of all financial statements and exhibits filed with the Form 10-K, including consolidated financials, omitted schedules, and detailed agreements - This section contains the index of all financial statements and exhibits filed with the Form 10-K[659](index=659&type=chunk)
Cytokinetics (CYTK) Investor Presentation - Slideshow
2022-11-10 04:28
Sarcomere Directed Therapies | --- | --- | --- | --- | --- | --- | |-------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | EMPOWERING | | | | | | | | | | | | | | MUSCLE EMPOWERING | | | | | | | LIVES | | | | | | Nefertari, diagnosed with heart failure Jillian, diagnosed with HCM Chuck, diagnosed with ALS Actual patients who consented to use of their name, image, and condition. CYTOKINETICS® and the C-shaped logo are registered trademarks of Cytokinetics in the U.S. and ce ...
Cytokinetics(CYTK) - 2022 Q3 - Earnings Call Transcript
2022-11-06 11:55
Cytokinetics, Incorporated (NASDAQ:CYTK) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Diane Weiser - Senior Vice President, Corporate Communications & Investor Relations Robert Blum - President & Chief Executive Officer Fady Malik - Executive Vice President, Research & Development Andrew Callos - Executive Vice President & Chief Commercial Officer Stuart Kupfer - Senior Vice President & Chief Medical Officer Robert Wong - Vice President & Chief Accounting Officer Ching J ...
Cytokinetics(CYTK) - 2022 Q3 - Quarterly Report
2022-11-03 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-50633 CYTOKINETICS, INCORPORATED (Exact name of registrant as specified in its charter) Delaware 94-32913 ...
Cytokinetics (CYTK) Investor Presentation - Slideshow
2022-09-15 17:26
Sarcomere Directed Therapies | --- | --- | --- | --- | |-------------------|-------|-------|-------| | | | | | | EMPOWERING | | | | | MUSCLE EMPOWERING | | | | | LIVES | | | | Nefertari, diagnosed with heart failure Jillian, diagnosed with HCM Chuck, diagnosed with ALS Actual patients who consented to use of their name, image, and condition. CYTOKINETICS® and the C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries Copyright©2022 CYTOKINETICS, All Rights Reserved F ...
Cytokinetics(CYTK) - 2022 Q2 - Earnings Call Transcript
2022-08-07 15:19
Financial Data and Key Metrics Changes - The company ended Q2 2022 with approximately $597 million in cash and investments, and revenue primarily came from deferred revenue for royalties on mavacamten [38][40] - R&D expenses increased to $57.1 million from $36.4 million in Q2 2021, with over 50% attributed to the cardiovascular program [38][39] - G&A expenses rose to $42.7 million from $21.2 million in Q2 2021, driven by higher commercial readiness spending and personnel-related costs [39] Business Line Data and Key Metrics Changes - Significant progress was made in the development of omecamtiv mecarbil, with an Advisory Committee Meeting scheduled for December 13, 2022, and a PDUFA date extended to February 28, 2023 [8][10] - Aficamten's development program advanced with ongoing trials, including SEQUOIA-HCM, and a second Phase 3 trial expected to start in Q4 2022 [11][24] - Reldesemtiv continued patient enrollment in COURAGE-ALS, with an open-label extension study recently started [13][35] Market Data and Key Metrics Changes - The company is actively engaging with key payers to share clinical and economic data related to omecamtiv mecarbil [30] - The market for HCM treatments is evolving, with enthusiasm for new mechanisms of action, particularly for aficamten [32][78] Company Strategy and Development Direction - The company aims to expand its clinical development program for aficamten and enhance commercial capabilities for potential launches of omecamtiv mecarbil and aficamten [41][42] - The strategy includes advancing earlier-stage drug candidates and expanding muscle biology-focused research activities [42][45] - The company is also pursuing partnerships in Asia and Europe to bolster its pipeline and financial position [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong financial footing and the progress of multiple programs across the pipeline [45] - The company anticipates a significant opportunity to demonstrate the efficacy of aficamten as a next-in-class therapy [72] - Management acknowledged the evolving regulatory landscape and its potential impact on drug pricing and market access [62] Other Important Information - The company raised approximately $523 million in net proceeds from the offering of convertible senior notes, which will support various development and operational activities [40][42] - The company plans to open a new office on the East Coast to enhance its operational capabilities [47] Q&A Session Summary Question: Connection between IND-enabling studies and HFpEF - Management confirmed that HFpEF is a key interest, and further details on compounds targeting this indication are still to be determined [51][52] Question: Impact of beta blockers on mavacamten's efficacy - It was noted that while benefits from mavacamten may be limited in patients on beta blockers, improvements can still be observed [56][59] Question: Spending reductions in 2022 - Spending reductions are primarily due to the delay in hiring the sales force and marketing activities, which have been pushed to 2023 [65][66] Question: Expected outcomes from the Advisory Committee meeting - Management indicated that discussions regarding potential labeling and indications will depend on FDA feedback post-AdCom [68][69] Question: Aficamten's competitive positioning against first-line therapies - Management expressed confidence in aficamten's potential to demonstrate superior efficacy compared to current therapies, with ongoing preparations for the second Phase 3 trial [72][73]
Cytokinetics(CYTK) - 2022 Q2 - Quarterly Report
2022-08-04 16:00
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining the company's accounting policies, R&D arrangements, fair value measurements, balance sheet components, debt, equity, and commitments [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | ASSETS | June 30, 2022 (in thousands) | December 31, 2021 (in thousands) | | :---------------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $93,631 | $112,666 | | Short-term investments | $492,395 | $358,972 | | Accounts receivable | $1,973 | $51,819 | | Total current assets | $602,250 | $535,672 | | Total assets | $771,717 | $841,319 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $66,843 | $71,860 | | Term loan, net | $62,344 | $47,367 | | Convertible notes, net | $134,674 | $95,471 | | Liabilities related to revenue participation right purchase agreements, net | $282,266 | $179,072 | | Total liabilities | $660,303 | $597,456 | | Total stockholders' equity | $111,414 | $243,863 | - Total assets decreased from **$841.3 million** at December 31, 2021, to **$771.7 million** at June 30, 2022. Total liabilities increased from **$597.5 million** to **$660.3 million**, while total stockholders' equity decreased from **$243.9 million** to **$111.4 million**[11](index=11&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric (in thousands) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :------------------------------------------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development revenues | $968 | $2,843 | $2,116 | $9,391 | | Milestone revenues | $1,000 | — | $1,000 | — | | Realization of revenue participation right purchase agreement | $87,000 | — | $87,000 | — | | Total revenues | $88,968 | $2,843 | $90,116 | $9,391 | | Research and development expenses | $57,126 | $36,443 | $103,061 | $68,004 | | General and administrative expenses | $42,716 | $21,197 | $75,786 | $36,795 | | Total operating expenses | $99,842 | $57,640 | $178,847 | $104,799 | | Operating loss | $(10,874) | $(54,797) | $(88,731) | $(95,408) | | Net loss | $(19,820) | $(61,554) | $(109,265) | $(108,658) | | Net loss per share — basic and diluted | $(0.23) | $(0.86) | $(1.28) | $(1.52) | | Weighted-average number of shares used in computing net loss per share — basic and diluted | 85,731 | 71,754 | 85,366 | 71,476 | - Total revenues significantly increased to **$88.968 million** for the three months ended June 30, 2022, from **$2.843 million** in the prior year, primarily due to the realization of a revenue participation right purchase agreement. Net loss decreased to **$(19.820) million** from **$(61.554) million** in the same period[13](index=13&type=chunk) - For the six months ended June 30, 2022, total revenues were **$90.116 million**, up from **$9.391 million** in the prior year. Net loss remained relatively stable at **$(109.265) million** compared to **$(108.658) million**[13](index=13&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) | Stockholders' Equity Component (in thousands) | Balance, December 31, 2021 | Balance, June 30, 2022 | | :-------------------------------------------- | :------------------------- | :--------------------- | | Common Stock | $84 | $85 | | Additional Paid-In Capital | $1,452,268 | $1,422,127 | | Accumulated Other Comprehensive Loss | $(869) | $(4,494) | | Accumulated Deficit | $(1,207,620) | $(1,306,304) | | Total Stockholders' Equity | $243,863 | $111,414 | - Total stockholders' equity decreased from **$243.863 million** at December 31, 2021, to **$111.414 million** at June 30, 2022, primarily due to a net loss of **$(109.265) million** and a decrease in additional paid-in capital[15](index=15&type=chunk)[13](index=13&type=chunk) - The adoption of ASU 2020-06 on January 1, 2022, resulted in a decrease of **$49.476 million** in additional paid-in capital and an increase of **$10.581 million** in accumulated deficit[27](index=27&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(117,286) | $(59,015) | | Net cash provided by investing activities | $989 | $13,605 | | Net cash provided by (used in) financing activities | $97,262 | $(421) | | Net decrease in cash and cash equivalents | $(19,035) | $(45,831) | | Cash and cash equivalents, end of period | $93,631 | $37,154 | - Net cash used in operating activities increased to **$(117.286) million** for the six months ended June 30, 2022, from **$(59.015) million** in the prior year, primarily due to ongoing R&D and G&A expenses[17](index=17&type=chunk)[300](index=300&type=chunk) - Net cash provided by financing activities significantly increased to **$97.262 million**, driven by **$149.6 million** from the RP Aficamten RPA and RP Loan Agreement, partially offset by term loan repayments[17](index=17&type=chunk)[302](index=302&type=chunk) [Note 1 — Organization and Significant Accounting Policies](index=7&type=section&id=Note%201%20%E2%80%94%20Organization%20and%20Significant%20Accounting%20Policies) - The Company is a late-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics that modulate muscle function for serious diseases[19](index=19&type=chunk) - The Company has incurred an accumulated deficit of **$1,306.3 million** since inception and anticipates future operating losses and net cash outflows[20](index=20&type=chunk)[319](index=319&type=chunk) Impact of ASU 2020-06 Adoption (as of January 1, 2022, in thousands): | Balance Sheet Account Description | Ending Balance of December 31, 2021 | ASU 2020-06 Adjustments | Beginning Balance of January 1, 2022 | | :-------------------------------- | :---------------------------------- | :---------------------- | :----------------------------------- | | Convertible notes, net | $95,471 | $38,895 | $134,366 | | Additional paid-in capital | $1,452,268 | $(49,476) | $1,402,792 | | Accumulated deficit | $(1,207,620) | $10,581 | $(1,197,039) | [Note 2 — Net Loss Per Share](index=8&type=section&id=Note%202%20%E2%80%94%20Net%20Loss%20Per%20Share) | Instrument (in thousands) | June 30, 2022 | June 30, 2021 | | :------------------------ | :------------ | :------------ | | Options to purchase common stock | 11,057 | 9,463 | | Warrants to purchase common stock | 31 | 48 | | Restricted stock and performance units | 1,280 | 1,562 | | Shares issuable related to the ESPP | 11 | 10 | | Shares issuable upon conversion of convertible notes | 16,675 | 16,675 | | Total shares | 29,054 | 27,758 | - A total of **29.054 million** and **27.758 million** shares were excluded from diluted net loss per share computation for the six months ended June 30, 2022 and 2021, respectively, as their effect would have been antidilutive[29](index=29&type=chunk) [Note 3 — Research and Development Arrangements](index=9&type=section&id=Note%203%20%E2%80%94%20Research%20and%20Development%20Arrangements) - The Ji Xing OM License Agreement, part of the 2021 RTW Transactions, granted Ji Xing exclusive rights to develop and commercialize omecamtiv mecarbil in China and Taiwan, with a **$50.0 million** upfront payment received in January 2022 and potential milestones up to **$330.0 million**[32](index=32&type=chunk)[34](index=34&type=chunk) - The Ji Xing Aficamten License Agreement, part of the 2020 RTW Transactions, provided a **$25.0 million** upfront payment and potential milestones up to **$200.0 million** for aficamten development and commercialization in China and Taiwan[41](index=41&type=chunk)[45](index=45&type=chunk) - The Mavacamten Royalty Purchase Agreement resulted in **$87.0 million** revenue recognition in Q2 2022 due to the full extinguishment of the Mavacamten Royalty[50](index=50&type=chunk)[277](index=277&type=chunk) | Revenue Source (in thousands) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :---------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Astellas R&D revenue | $1,000 | $300 | $2,100 | $2,000 | | Amgen R&D revenue | — | $2,500 | — | $7,400 | [Note 4 — Fair Value Measurements](index=13&type=section&id=Note%204%20%E2%80%94%20Fair%20Value%20Measurements) Fair Value of Financial Assets (June 30, 2022, in thousands): | Asset Type | Fair Value Hierarchy Level | Amortized Cost | Unrealized Gains | Unrealized Losses | Fair Value | | :------------------------------ | :------------------------- | :------------- | :--------------- | :---------------- | :--------- | | Money market funds | Level 1 | $69,939 | — | — | $69,939 | | U.S. Treasury securities | Level 1 | $223,239 | $9 | $(1,830) | $221,418 | | U.S. and non-U.S. government agency bonds | Level 2 | $27,751 | — | $(209) | $27,542 | | Commercial paper | Level 2 | $130,739 | $19 | $(420) | $130,338 | | U.S. and non-U.S. corporate obligations | Level 2 | $148,212 | — | $(2,062) | $146,150 | | Total | | $599,880 | $28 | $(4,521) | $595,387 | Available-for-Sale Securities (in thousands): | Category | June 30, 2022 | December 31, 2021 | | :----------------- | :------------ | :---------------- | | Cash equivalents | $92,324 | $115,937 | | Short-term investments | $492,395 | $358,972 | | Long-term investments | $10,668 | $152,050 | | Total | $595,387 | $626,959 | - Interest and other income, net, increased to **$0.9 million** for the three months ended June 30, 2022, from **$0.2 million** in the prior year, and to **$1.3 million** for the six months ended June 30, 2022, from **$0.5 million** in the prior year[71](index=71&type=chunk) [Note 5 — Balance Sheet Components](index=14&type=section&id=Note%205%20%E2%80%94%20Balance%20Sheet%20Components) Accrued Liabilities (in thousands): | Category | June 30, 2022 | December 31, 2021 | | :------------------------- | :------------ | :---------------- | | Clinical and preclinical costs | $16,488 | $13,872 | | Compensation related | $12,522 | $14,930 | | Other accrued expenses | $7,692 | $5,568 | | Total accrued liabilities | $36,702 | $34,370 | - Total accrued liabilities increased to **$36.702 million** at June 30, 2022, from **$34.370 million** at December 31, 2021, primarily driven by an increase in clinical and preclinical costs[75](index=75&type=chunk) [Note 6 — Agreements with Royalty Pharma](index=14&type=section&id=Note%206%20%E2%80%94%20Agreements%20with%20Royalty%20Pharma) - The 2022 RPI Transactions include a Development Funding Loan Agreement (RP Loan Agreement) for up to **$300.0 million** in term loans, with **$50.0 million** disbursed at closing and the remaining **$250.0 million** contingent on development milestones[82](index=82&type=chunk)[306](index=306&type=chunk) - The RP Loan Agreement has an effective interest rate of **7.65%** over a ten-year term, with aggregate repayment equal to **190%** of the principal amount[83](index=83&type=chunk) - The Revenue Participation Right Purchase Agreement (RP Aficamten RPA) provides up to **$150.0 million** in consideration for rights to aficamten net sales, with **$100.0 million** received to date and **$50.0 million** contingent on nHCM trial initiation[88](index=88&type=chunk)[311](index=311&type=chunk) - The RP Aficamten RPA involves a royalty of **4.5%** on annual worldwide net sales up to **$1 billion** and **3.5%** above **$1 billion**, with an imputed interest rate of approximately **11.7%** as of June 30, 2022[89](index=89&type=chunk)[91](index=91&type=chunk) Non-cash Interest Expense on Revenue Participation Right Purchase Agreements (in thousands): | Agreement | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :----------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | RP OM Liability | $4,429 | $2,871 | $8,707 | $5,666 | | RP Aficamten Liability | $2,574 | — | $4,860 | — | | Total | $7,003 | $2,871 | $13,567 | $5,666 | [Note 7 — Debt](index=18&type=section&id=Note%207%20%E2%80%94%20Debt) - The Term Loan Agreement with Silicon Valley Bank and Oxford Finance LLC was terminated in January 2022, resulting in a **$2.7 million** loss on debt extinguishment for the six months ended June 30, 2022[108](index=108&type=chunk)[288](index=288&type=chunk) - The 2026 Convertible Senior Notes have an aggregate principal amount of **$138.0 million**, bear **4.0%** annual interest, and mature on November 15, 2026. The effective interest rate was **4.6%** for the three and six months ended June 30, 2022[111](index=111&type=chunk)[119](index=119&type=chunk) Interest Expense for 2026 Notes (in thousands): | Type of Interest Cost | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Contractual interest expense | $1,380 | $1,380 | $2,760 | $2,760 | | Amortization of debt discount | — | $1,445 | — | $2,816 | | Amortization of debt issuance costs | $164 | $14 | $309 | $28 | | Total interest expense recognized | $1,544 | $2,839 | $3,069 | $5,604 | - The fair value of the convertible notes was estimated at **$655.8 million** as of June 30, 2022, significantly exceeding its principal amount[120](index=120&type=chunk) [Note 8 — Stockholders' Equity](index=20&type=section&id=Note%208%20%E2%80%94%20Stockholders'%20Equity) - The 2004 Equity Incentive Plan was amended in May 2022, increasing authorized shares by **6.0 million** for general issuance and **1.6 million** for inducement grants, totaling **10.3 million** shares available for grant as of June 30, 2022[123](index=123&type=chunk) - The first tranche of Performance Stock Units (PSUs) met its performance target during the six months ended June 30, 2022, resulting in **$0.4 million** expense. The second tranche is unlikely to vest due to the FDA's extended PDUFA date for omecamtiv mecarbil[126](index=126&type=chunk) - Silicon Valley Bank exercised **16,901** warrants in May 2022, resulting in the issuance of **14,136** common shares via cashless settlement. As of June 30, 2022, **30,821** warrants remained outstanding[127](index=127&type=chunk) [Note 9 — Commitments and Contingencies](index=21&type=section&id=Note%209%20%E2%80%94%20Commitments%20and%20Contingencies) - The Oyster Point Lease for office and laboratory space has a remaining term of **11.3 years** as of June 30, 2022, with total undiscounted future lease payments of **$224.5 million**[133](index=133&type=chunk) - A new Radnor Lease for office space commenced in Q3 2022, with total undiscounted lease payments of **$2.9 million**, but no right-of-use asset or lease liability was recognized as of June 30, 2022[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) - Finance leases for laboratory equipment, classified as such due to a bargain purchase option, have a weighted average remaining term of **4.5 years** and total undiscounted future lease payments of **$2.7 million**[138](index=138&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk)[142](index=142&type=chunk) Rent Expense (in thousands): | Lease Type | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Operating and Finance Leases | $5,500 | $5,300 | $11,100 | $6,700 | [Note 10 — Subsequent Events](index=23&type=section&id=Note%2010%20%E2%80%94%20Subsequent%20Events) - On July 6, 2022, the Company issued **$540.0 million** aggregate principal amount of **3.50%** Convertible Senior Notes due 2027 (2027 Notes), with net proceeds of approximately **$523.3 million**[143](index=143&type=chunk)[145](index=145&type=chunk)[147](index=147&type=chunk) - The 2027 Notes have an initial conversion rate of **19.5783 shares** per **$1,000** principal amount, equating to an initial conversion price of approximately **$51.08** per share[146](index=146&type=chunk) - Concurrently with the 2027 Notes offering, the Company repurchased approximately **$116.9 million** aggregate principal amount of its 2026 Notes using **$140.3 million** in cash and issuing approximately **8.0 million** common shares[147](index=147&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, including a discussion of forward-looking statements, business overview, research and development programs, critical accounting policies, detailed financial results, liquidity, and capital resources [Forward-Looking Statements](index=24&type=section&id=Forward-Looking%20Statements) - The report contains forward-looking statements regarding future performance, capital requirements, clinical trial progress, regulatory approvals, and commercialization plans, which involve inherent risks and uncertainties[150](index=150&type=chunk)[155](index=155&type=chunk) - Key risks include regulatory decisions (e.g., FDA approval for omecamtiv mecarbil), ability to meet funding conditions under Royalty Pharma agreements, patient enrollment, and the impact of the COVID-19 pandemic[155](index=155&type=chunk) [Business](index=26&type=section&id=Business) - Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors[158](index=158&type=chunk) - The company's clinical-stage drug candidates include omecamtiv mecarbil (cardiac myosin activator for heart failure), CK-136 (cardiac troponin activator), reldesemtiv (fast skeletal muscle troponin activator for ALS), aficamten (cardiac myosin inhibitor for HCM), and CK-271 (second cardiac myosin inhibitor)[159](index=159&type=chunk) - The FDA accepted the NDA for omecamtiv mecarbil for HFrEF, and aficamten is in Phase 3 for symptomatic oHCM[160](index=160&type=chunk)[163](index=163&type=chunk) [Research and Development Programs](index=27&type=section&id=Research%20and%20Development%20Programs) - Research and development expenses increased by **$20.7 million** (YoY Q2) and **$35.1 million** (YoY H1) primarily due to increased clinical development activities for COURAGE-ALS, cardiac muscle inhibitor programs, and early research[27](index=27&type=chunk)[171](index=171&type=chunk)[279](index=279&type=chunk) Research and Development Expenses by Program (in thousands): | Program | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :---------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Cardiac muscle contractility | $27,664 | $26,175 | $53,151 | $42,412 | | Skeletal muscle contractility | $14,841 | $3,094 | $26,300 | $11,450 | | All other research programs | $14,621 | $7,174 | $23,610 | $14,142 | | Total | $57,126 | $36,443 | $103,061 | $68,004 | [Cardiac Muscle Program](index=27&type=section&id=Cardiac%20Muscle%20Program) - Omecamtiv mecarbil's NDA for HFrEF was accepted by the FDA, but the PDUFA target action date was extended to February 28, 2023, due to additional pharmacokinetic analyses[202](index=202&type=chunk) - GALACTIC-HF showed a statistically significant reduction in the primary composite endpoint (CV death or heart failure events) for omecamtiv mecarbil, with a potentially greater effect in patients with lower LVEF[184](index=184&type=chunk)[187](index=187&type=chunk)[190](index=190&type=chunk) - METEORIC-HF, a Phase 3 trial for omecamtiv mecarbil, did not meet its primary endpoint of improving exercise capacity (peak oxygen uptake)[201](index=201&type=chunk) - Aficamten received Breakthrough Therapy Designation for oHCM and showed positive topline results in REDWOOD-HCM Cohorts 1, 2, and 3, demonstrating significant reductions in LVOT-G and improvements in NYHA class[215](index=215&type=chunk)[217](index=217&type=chunk)[220](index=220&type=chunk)[223](index=223&type=chunk)[224](index=224&type=chunk) - SEQUOIA-HCM, a Phase 3 trial for aficamten in symptomatic oHCM, is open for enrollment, aiming for **270** patients[218](index=218&type=chunk)[219](index=219&type=chunk) [Skeletal Muscle Contractility Program](index=36&type=section&id=Skeletal%20Muscle%20Contractility%20Program) - Reldesemtiv has Orphan Drug Designation for SMA and ALS in the U.S. and E.U[244](index=244&type=chunk) - COURAGE-ALS, a Phase 3 clinical trial of reldesemtiv in ALS patients, is open for enrollment, building on insights from FORTITUDE-ALS[257](index=257&type=chunk)[258](index=258&type=chunk) - FORTITUDE-ALS did not achieve statistical significance for its primary endpoint but showed numerical effects favoring reldesemtiv, particularly in faster-progressing ALS patients[250](index=250&type=chunk)[252](index=252&type=chunk)[256](index=256&type=chunk) - The Astellas OSSA Agreement, focused on other skeletal sarcomere activators, was terminated effective November 1, 2021, with all licenses reverting to Cytokinetics[240](index=240&type=chunk)[242](index=242&type=chunk) [Beyond Muscle Contractility](index=40&type=section&id=Beyond%20Muscle%20Contractility) - The Company is leveraging its expertise in muscle biology to investigate new ways of modulating muscle function beyond contractility for other potential therapeutic applications[262](index=262&type=chunk) [COVID-19 Business Update](index=40&type=section&id=COVID-19%20Business%20Update) - The Company transitioned to a hybrid work model in March 2022 and continues to monitor and comply with guidance to protect employee and patient safety[264](index=264&type=chunk)[265](index=265&type=chunk) - The COVID-19 pandemic continues to pose risks of significant and prolonged disruption to global financial markets, potentially affecting liquidity and business operations, including clinical trials[266](index=266&type=chunk)[267](index=267&type=chunk) [Critical Accounting Policies and Significant Estimates](index=41&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Estimates) - The Company's financial statements are prepared in accordance with GAAP, requiring estimates and assumptions that affect reported amounts, which are evaluated on an ongoing basis[270](index=270&type=chunk) - Refer to Note 1 for a discussion of recently adopted and not yet adopted accounting pronouncements[271](index=271&type=chunk) [Results of Operations](index=41&type=section&id=Results%20of%20Operations) Revenues (in thousands): | Revenue Type | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :---------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development revenues | $968 | $2,843 | $2,116 | $9,391 | | Milestone revenues | $1,000 | — | $1,000 | — | | Realization of revenue participation right purchase agreement | $87,000 | — | $87,000 | — | | Total revenues | $88,968 | $2,843 | $90,116 | $9,391 | - Total revenues for the three and six months ended June 30, 2022, increased significantly by **$86.1 million** and **$80.7 million**, respectively, primarily due to the **$87.0 million** revenue recognition from the extinguishment of the Mavacamten Royalty[275](index=275&type=chunk)[277](index=277&type=chunk) Operating Expenses (in thousands): | Expense Type | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :---------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $57,126 | $36,443 | $103,061 | $68,004 | | General and administrative | $42,716 | $21,197 | $75,786 | $36,795 | | Total operating expenses | $99,842 | $57,640 | $178,847 | $104,799 | - General and administrative expenses increased by **$21.5 million** (YoY Q2) and **$39.0 million** (YoY H1) due to higher outside service spend for commercial launch preparation of omecamtiv mecarbil, increased personnel costs, and facilities expense[285](index=285&type=chunk) - Interest expense decreased by **$1.266 million** (YoY Q2) and **$2.508 million** (YoY H1) due to the termination of the Term Loan Agreement, partially offset by interest from the RP Loan Agreement and 2026 Notes[287](index=287&type=chunk) - Non-cash interest expense on liabilities related to revenue participation right purchase agreements increased by **$4.132 million** (YoY Q2) and **$7.901 million** (YoY H1), primarily due to the RP Aficamten RPA[296](index=296&type=chunk) [Liquidity and Capital Resources](index=44&type=section&id=Liquidity%20and%20Capital%20Resources) Financial Position (in thousands): | Category | June 30, 2022 | December 31, 2021 | | :---------------------------------------- | :------------ | :---------------- | | Total cash, cash equivalents and marketable securities | $596,694 | $623,688 | | Total borrowings | $197,018 | $142,838 | | Working capital | $535,407 | $463,812 | Cash Flow Summary (in thousands): | Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :---------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(117,286) | $(59,015) | | Net cash provided by investing activities | $989 | $13,605 | | Net cash provided by (used in) financing activities | $97,262 | $(421) | - Net cash provided by financing activities was **$97.3 million**, primarily from **$149.6 million** net proceeds from the RP Aficamten RPA and RP Loan Agreement, offset by term loan repayments[302](index=302&type=chunk) - The Company believes existing cash, cash equivalents, and investments will fund operations for at least the next **12 months**, but significant additional funding will be required for future R&D and commercialization[22](index=22&type=chunk)[320](index=320&type=chunk) [Off-Balance Sheet Arrangements](index=47&type=section&id=Off-Balance%20Sheet%20Arrangements) - The Company is not party to any off-balance sheet arrangements that have, or are reasonably likely to have, a material current or future effect on its financial condition, revenues, or expenses[321](index=321&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=48&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that the company's exposure to market risk has not materially changed since the disclosures in its Annual Report on Form 10-K for the year ended December 31, 2021 - The Company's exposure to market risk has not materially changed since its Annual Report on Form 10-K for December 31, 2021[323](index=323&type=chunk) [Item 4. Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of disclosure controls and procedures, confirming their effectiveness at a reasonable assurance level as of June 30, 2022, and states there were no material changes in internal control over financial reporting during the quarter - The Chief Executive Officer and Chief Financial Officer concluded that disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2022[324](index=324&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2022, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[325](index=325&type=chunk) [PART II. OTHER INFORMATION](index=48&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) This section states that there are no legal proceedings - The Company is not involved in any legal proceedings[327](index=327&type=chunk) [Item 1A. Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) This section outlines various risks that could materially and adversely affect the company's business, results of operations, financial condition, or investment in its securities. These risks span business operations, industry-specific challenges, and general financial and legal considerations - The Company has a history of significant losses and requires substantial additional capital to fund operations, with no guarantee of future profitability or financing availability on favorable terms[329](index=329&type=chunk)[331](index=331&type=chunk)[332](index=332&type=chunk) - The ability to obtain additional loan disbursements under the RP Loan Agreement and RP Aficamten RPA is subject to specific conditions and deadlines, which may not be met, especially given the extended PDUFA date for omecamtiv mecarbil[333](index=333&type=chunk)[334](index=334&type=chunk) - Clinical trials are expensive, time-consuming, and prone to failure, with no guarantee that drug candidates like omecamtiv mecarbil, aficamten, or reldesemtiv will demonstrate the desired safety and efficacy for regulatory approval[360](index=360&type=chunk)[361](index=361&type=chunk)[382](index=382&type=chunk) - The Company relies heavily on CROs and CMOs for clinical trials and manufacturing, and any failure in their performance or inability to secure alternative partners could lead to significant delays and increased costs[405](index=405&type=chunk)[407](index=407&type=chunk)[411](index=411&type=chunk) - Intellectual property protection is crucial, but obtaining and enforcing patents is costly and uncertain, and the Company faces risks of infringement claims, challenges to ownership, and the potential for competitors to develop similar drugs[419](index=419&type=chunk)[436](index=436&type=chunk)[440](index=440&type=chunk) - The commercial success of approved products depends on market acceptance, third-party payor coverage, and favorable reimbursement, which are subject to significant uncertainty and potential cost-containment measures[490](index=490&type=chunk)[493](index=493&type=chunk)[495](index=495&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=86&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities or use of proceeds to report - No unregistered sales of equity securities or use of proceeds to report[554](index=554&type=chunk) [Item 3. Defaults Upon Senior Securities](index=86&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities - No defaults upon senior securities to report[555](index=555&type=chunk) [Item 4. Mine Safety Disclosures](index=86&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that there are no mine safety disclosures - No mine safety disclosures to report[556](index=556&type=chunk) [Item 5. Other Information](index=86&type=section&id=Item%205.%20Other%20Information) This section states that there is no other information to report - No other information to report[557](index=557&type=chunk) [Item 6. Exhibits](index=87&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certifications and XBRL documents - Exhibits include certifications from principal executive, financial, and accounting officers, as well as Inline XBRL documents[560](index=560&type=chunk)[561](index=561&type=chunk)[562](index=562&type=chunk)[563](index=563&type=chunk)[565](index=565&type=chunk)[566](index=566&type=chunk) [SIGNATURES](index=88&type=section&id=SIGNATURES) - The report is signed by Robert I. Blum (President and Chief Executive Officer), Ching W. Jaw (Senior Vice President, Chief Financial Officer), and Robert C. Wong (Vice President, Chief Accounting Officer)[572](index=572&type=chunk)