Cytokinetics Inc 8-K, filed Nov 4, 2026
Cytokinetics Inc (CYTK)
About this 8-K
Cytokinetics Inc filed this 8-K on November 4, 2026.
Cytokinetics reported third-quarter 2026 revenue of $47.6 million, including $44.5 million in MYQORZO net product revenue, and expects to submit a Supplemental New Drug Application for aficamten in non-obstructive HCM in Q4 2026. AI summary
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 4, 2026, Cytokinetics, Incorporated announced its financial results for the third quarter ended September 30, 2026. The full text of the press release issued in connection with this announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information furnished under this Item 2.02 and under Exhibit 99.1 shall not be considered “filed” under the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any future filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, unless the Registrant expressly sets forth in such future filing that such information is to be considered “filed” or incorporated by reference therein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 Press Release dated November 4, 2026
104 The cover page of this report has been formatted in Inline XBRL
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CYTOKINETICS, INCORPORATED |
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Date: |
November 4, 2026 |
By: |
/s/ John O. Faurescu |
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John O. Faurescu, Esq. |
Exhibit 99.1
Cytokinetics Reports Third Quarter 2026 Financial Results and Provides Business Update
MYQORZO® (aficamten) Net Product Revenue of $44.5 Million
Expect to Submit Supplemental NDA for Aficamten in Non-Obstructive HCM in Q4 2026 and Type II Variation in the European Union in Early 2027
~$1.6 Billion in Cash, Cash Equivalents and Investments as of September 30, 2026
SOUTH SAN FRANCISCO, Calif., Nov. 4, 2026 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the third quarter of 2026.
“Our third quarter results demonstrate continued strong execution as Cytokinetics enters its next phase of growth as a global specialty cardiology biopharmaceutical company,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “In the U.S., the launch of MYQORZO continued to build solid momentum and increased velocity with growing adoption across a broadening base of prescribers. Internationally, we continued to expand access to MYQORZO to bring this important medicine to more patients around the world. Now, with our having presented and published the primary results from ACACIA-HCM, the first positive Phase 3 clinical trial in nHCM, we believe aficamten has the potential to become the first and only cardiac myosin inhibitor approved across the full spectrum of HCM. Building on these key results, we are moving swiftly to seek regulatory approvals in both the U.S. and Europe, important next steps toward achieving our Vision 2030.”
Q3 and Recent Highlights
Cardiac Muscle Programs
MYQORZO® (aficamten) (cardiac myosin inhibitor)
omecamtiv mecarbil (cardiac myosin activator)
ulacamten (cardiac myosin inhibitor)
CK-4015089 (CK-089, fast skeletal muscle troponin activator)
Pre-Clinical Development and Ongoing Research
Q3 2026 Financial Results
Cash, Cash Equivalents and Investments
Revenues
Research and Development (R&D) Expenses
Selling, General and Administrative (SG&A) Expenses
Cost of Goods Sold
Collaboration Cost of Revenues
Net Income (Loss)
2026 Financial Guidance
The company is reaffirming its full year 2026 financial guidance:
GAAP combined R&D and SG&A Expense |
$860 million to $890 million |
Non-cash stock-based compensation expense included in GAAP combined R&D and SG&A Expense |
$140 million to $130 million |
The financial guidance does not include the effect of GAAP adjustments as may be caused by events that occur subsequent to publication of this guidance including, but not limited to, Business Development activities.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s third quarter 2026 results on a conference call today at 4:30 PM Eastern Time. The conference call will be simultaneously webcast and can be accessed from the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com or directly at the following link: Cytokinetics Q3 2026 Earnings Conference Call. An archived replay of the webcast will be available via Cytokinetics’ website for six months.
About Cytokinetics
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union, United Kingdom and Canada for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.
For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.
Disclaimer
Omecamtiv mecarbil, ulacamten and CK-089 are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. All statements in this press release other than statements of historical fact are forward-looking statements. Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “potential,” “seek,” “should,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such statements include, but are not limited to, statements, express or implied, relating to our plans to submit a Supplemental NDA for aficamten in non-obstructive HCM in the fourth quarter of 2026 and a Type II Variation in the European Union in early 2027, and the timing and outcome of any related regulatory review; our belief that aficamten has the potential to become the first and only cardiac myosin inhibitor approved across the full spectrum of HCM; the continued commercial launch of MYQORZO in the U.S., including launch momentum, prescriber adoption, patient uptake, market acceptance and net product revenue; our plans to launch MYQORZO in additional markets outside the U.S., including our expectation to launch in the United Kingdom in the fourth quarter of 2026 and in additional countries in 2027, and the timing and outcome of pending regulatory, pricing and reimbursement reviews in Switzerland, Hong Kong, Taiwan and other jurisdictions; our or our partners’ research and development and commercial readiness activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of any of our clinical trials, including ACACIA-HCM (including its Japan cohort), CAMELLIA-HCM, ASPEN-HCM, COMET-HF, AMBER-HFpEF and CEDAR-HCM and our clinical study of CK-089; our expectations to present topline data from the adolescent cohort of CEDAR-HCM in early 2027, to complete patient enrollment in Cohort 1 of AMBER-HFpEF in the fourth quarter of 2026 and to complete patient enrollment in COMET-HF in 2027; the clinical meaningfulness, persuasiveness, or interpretation of the results of MAPLE-HCM, SEQUOIA-HCM, ACACIA-HCM or any of our other clinical trials, including for purposes of regulatory approval, labeling, or market acceptance, the results of long-term, secondary or exploratory analyses, our ability to announce the results of any of our clinical trials by any particular date, the timing of interactions with FDA or any other regulatory authorities in connection with any of our drug candidates and the outcomes of such interactions; statements related to our receipt of regulatory approvals for aficamten in any ex-US jurisdiction, including Japan, for any indication and by any particular date, statements relating to the potential patient population who could benefit from aficamten, omecamtiv mecarbil, ulacamten, CK-089 or any of our other drug candidates; statements related to the potential approval and launch of MYQORZO in non-obstructive HCM; our research collaboration with Accutar Biotech and our other pre-clinical research activities, including any future milestone payments under such collaboration; our strategic goals, including our Vision 2030; our full year 2026 financial guidance, including our combined GAAP research and development and selling, general and administrative expense guidance and related non-cash stock-based compensation expense estimates, and the assumptions underlying such guidance; statements relating to our ability to receive additional capital or other funding, including, but not limited to, our ability to meet any of the conditions relating to or to otherwise secure additional loan disbursements under any of our agreements with entities affiliated with Royalty Pharma or additional milestone payments from Sanofi
or Bayer in connection with our collaborations for aficamten in China or Japan respectively; statements relating to our operating expenses or cash utilization for the remainder of 2026 or any other period, and statements relating to our cash balance at any particular date or the amount of cash runway such cash balances represent at any particular time. Such statements are based on management's current expectations and assumptions, but actual results may differ materially due to various risks and uncertainties, including, but not limited to: risks related to the commercialization of MYQORZO, including the degree of market acceptance among physicians, patients and payors, the availability of adequate coverage, pricing and reimbursement in the U.S. and other markets, our ability to maintain and expand our commercial capabilities and those of our partners, and fluctuations in net product revenue from period to period; competition from other cardiac myosin inhibitors and other existing or future therapies; the FDA or foreign regulatory agencies may not accept for review, or may delay, limit or deny approval of, our Supplemental NDA, Type II Variation or other marketing applications, or may require additional clinical trials or impose restrictive labeling or post-marketing requirements; the identification of new safety signals or adverse events relating to MYQORZO or our drug candidates as they are used more broadly; our dependence on third-party manufacturers and suppliers and on our collaboration and commercial partners, including Bayer and Sanofi, to perform their obligations; Cytokinetics’ need for additional funding and such additional funding may not be available on acceptable terms, if at all; our outstanding indebtedness and payment obligations, including under our agreements with entities affiliated with Royalty Pharma; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may incur unanticipated research and development, commercial and other costs; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target; our ability to obtain, maintain and enforce intellectual property protection; and changes in laws, regulations or government policies affecting drug pricing, reimbursement, tariffs or trade, as well as general economic, market and geopolitical conditions. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Annual Report on Form 10-K for the year ended December 31, 2025 and its subsequent Quarterly Reports on Form 10-Q, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2026. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Except as required by law, Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.
MYQORZO® is a registered trademark of Cytokinetics in the U.S., European Union, United Kingdom and Canada.
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Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757
Cytokinetics, Incorporated |
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Condensed Consolidated Balance Sheets |
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(in thousands) |
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September 30, 2026 |
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December 31, 2025 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and short term investments |
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$ 1,130,021 |
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$ 882,221 |
Other current assets |
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57,130 |
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34,754 |
Total current assets |
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1,187,151 |
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916,975 |
Long-term investments |
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453,631 |
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335,048 |
Property and equipment, net |
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76,124 |
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79,194 |
Operating lease right-of-use assets |
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71,563 |
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75,979 |
Inventories, long-term |
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16,128 |
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— |
Other assets |
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20,183 |
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17,341 |
Total assets |
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$ 1,824,780 |
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$ 1,424,537 |
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ 116,835 |
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$ 105,615 |
Short-term operating lease liabilities |
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21,391 |
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19,111 |
Current portion of convertible and long-term debt |
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174,399 |
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41,181 |
Derivative liabilities measured at fair value |
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31,300 |
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31,100 |
Deferred revenue |
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1,653 |
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1,612 |
Other current liabilities |
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7,841 |
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3,833 |
Total current liabilities |
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353,419 |
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202,452 |
Term loan, net |
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244,332 |
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246,384 |
Convertible notes, net |
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732,771 |
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869,597 |
Liabilities related to revenue participation right purchase agreements, net |
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579,564 |
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520,559 |
Long-term operating lease liabilities |
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99,665 |
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107,970 |
Liabilities related to RPI Transactions measured at fair value |
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136,200 |
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137,200 |
Total liabilities |
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2,145,951 |
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2,084,162 |
Commitments and contingencies |
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Stockholders' deficit |
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Common stock |
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139 |
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123 |
Additional paid-in capital |
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3,768,661 |
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2,826,341 |
Accumulated other comprehensive (loss) income |
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(8,390) |
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630 |
Accumulated deficit |
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(4,081,581) |
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(3,486,719) |
Total stockholders' deficit |
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(321,171) |
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(659,625) |
Total liabilities and stockholders' deficit |
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$ 1,824,780 |
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$ 1,424,537 |
Cytokinetics, Incorporated |
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Condensed Consolidated Statements of Operations |
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(in thousands except per share data) |
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(unaudited) |
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Three Months Ended |
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Nine Months Ended |
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September 30, 2026 |
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September 30, 2025 |
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September 30, 2026 |
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September 30, 2025 |
Revenues: |
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Net product revenue |
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$ 44,507 |
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$ — |
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$ 74,630 |
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$ — |
Collaboration revenues |
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3,050 |
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1,936 |
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8,977 |
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5,931 |
License and milestone revenues |
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- |
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— |
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11,929 |
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64,353 |
Total revenues |
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47,557 |
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1,936 |
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95,536 |
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70,284 |
Operating expenses: |
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Research and development |
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99,285 |
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97,297 |
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292,617 |
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305,697 |
Selling, general and administrative |
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113,144 |
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69,458 |
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322,437 |
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192,548 |
Cost of goods sold |
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(454) |
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— |
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2,437 |
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— |
Collaboration cost of revenues |
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2,670 |
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1,936 |
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7,923 |
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5,931 |
Total operating expenses |
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214,645 |
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168,691 |
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625,414 |
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504,176 |
Operating loss |
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(167,088) |
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(166,755) |
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(529,878) |
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(433,892) |
Interest and other expense, net |
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(14,842) |
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(11,353) |
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(44,015) |
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(31,305) |
Non-cash interest expense on liabilities related to revenue participation right purchase agreements |
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(23,642) |
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(14,969) |
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(62,635) |
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(42,228) |
Interest and other income, net |
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15,903 |
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10,248 |
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40,866 |
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36,950 |
Change in fair value of derivative liabilities |
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(600) |
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700 |
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(200) |
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3,300 |
Change in fair value of liabilities related to RPI Transactions |
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200 |
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(2,800) |
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1,000 |
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(13,500) |
Debt conversion expense |
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— |
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(121,249) |
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— |
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(121,249) |
Net loss |
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$ (190,069) |
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$ (306,178) |
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$ (594,862) |
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$ (601,924) |
Net loss per share — basic and diluted |
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$ (1.37) |
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$ (2.55) |
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$ (4.52) |
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$ (5.04) |
Weighted-average number of shares used in computing net loss per share — basic and diluted |
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139,045 |
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119,982 |
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131,526 |
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119,317 |