Washington, D.C. 20549

Form 8-K


Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): February 21, 2019  

Cytokinetics, Incorporated
(Exact Name of Registrant as Specified in Charter)

Delaware 000-50633 94-3291317
(State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification Number)


280 East Grand Avenue, South San Francisco, California 94080
(Address of Principal Executive Offices) (Zip Code)

(650) 624-3000
(Registrant's telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last report)

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:

  [ ]   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
  [ ]   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
  [ ]   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
  [ ]   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 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 February 21, 2019, Cytokinetics, Incorporated issued a press release announcing its results for the fourth quarter ended December 31, 2018. A copy of the press release is being filed as Exhibit 99.1 to this Current Report and is hereby incorporated by reference into this item 2.02.

Item 9.01. Financial Statements and Exhibits.

Exhibit 99.1. Press release dated February 21, 2019


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.

  Cytokinetics, Incorporated
Date: February 21, 2019 By:  /s/ Peter S. Roddy        
    Peter S. Roddy
    Senior Vice President, Chief Accounting Officer


Cytokinetics Reports Fourth Quarter 2018 Financial Results

Company Provides 2019 Financial Guidance and Expected Milestones

Reduced Operating Expenses vs. 2018; Over Two Years of Cash Based on Current Burn Rate

Interim Analysis for GALACTIC-HF on Track for 1H 2019

Results from FORTITUDE-ALS Expected in Q2 2019

SOUTH SAN FRANCISCO, Calif., Feb. 21, 2019 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for 2018. Net loss for 2018 was $106 million, or $1.95 per share, compared to net loss for 2017 of $128 million, or $2.59 per share. Cash, cash equivalents and investments totaled $199 million at December 31, 2018.

“We had a productive fourth quarter 2018 highlighted by the expansion of our clinical pipeline of muscle-directed investigational medicines and the advancement of our wholly-owned cardiac myosin inhibitor which we are developing for the potential treatment of patients with hypertrophic cardiomyopathies,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Our progress is continuing with the achievement of key milestones under our partnered programs. Under our collaboration with Amgen, we recently opened METEORIC-HF to enrollment and expect GALACTIC-HF to complete enrollment in the next few months. In that same timeframe, we are also looking forward to results from FORTITUDE-ALS under our collaboration with Astellas. We believe that our pioneering leadership in muscle biology, alongside our partnerships and current financials, position us well for upcoming company milestones.”

Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

AMG 594 (cardiac troponin activator)

CK-3773274 (CK-274, cardiac myosin inhibitor)

Skeletal Muscle Program

reldesemtiv (next-generation fast skeletal muscle troponin activator (FSTA))

Pre-Clinical Development and Ongoing Research



Revenues for 2018 included $29.4 million in revenue from our collaboration with Astellas and $1.9 million from our collaboration with Amgen. Revenues from Astellas in 2018 included $22.3 million for reimbursement of research and development expenses, $5.1 million in license revenue and $2.0 million in a milestone payment. Revenues from Amgen in 2018 include $1.9 million for reimbursement of research and development expenses. Revenues for 2017 were offset by $20.0 million for payments to Amgen related to our option to co-fund the Phase 3 development program of omecamtiv mecarbil in exchange for an increased royalty upon potential commercialization.

Research and development expenses decreased to $89.1 million in 2018 from $90.3 million in 2017, primarily due to the suspension of development of tirasemtiv in late 2017, offset in part by increased development activities for reldesemtiv and CK-274.

General and administrative expenses decreased to $31.3 million in 2018 from $36.5 million in 2017, primarily due to decreased commercial readiness activities.

2019 Financial Guidance

The company also announced financial guidance for 2019. The company anticipates cash revenue will be in the range of $28 to $32 million, operating expenses will be in the range of $110 to $115 million, and net cash utilization will be approximately $85 to $90 million.

2019 Corporate Milestones

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

AMG 594 (cardiac troponin activator)

CK-3773274 (CK-274, cardiac myosin inhibitor)

Skeletal Muscle Program

reldesemtiv (next-generation FSTA)

Pre-Clinical Research

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s fourth quarter 2018 results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 9798766.

An archived replay of the webcast will be available via Cytokinetics’ website until February 28, 2019. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 9798766 from February 21, 2019 at 7:30 PM Eastern Time until February 28, 2019.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and best-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop  omecamtiv mecarbil , a novel cardiac muscle activator.  Omecamtiv mecarbil  is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF and METEORIC-HF. Amgen holds an exclusive worldwide license to develop and commercialize  omecamtiv mecarbil  with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is also collaborating with Amgen to develop AMG 594, a first-in-class cardiac troponin activator, discovered under the companies’ joint research program. Further development of AMG 594 is subject to the collaboration agreement between Amgen and Cytokinetics. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to develop  reldesemtiv , a fast skeletal muscle troponin activator (FSTA).  Reldesemtiv  has been granted orphan drug designation by the FDA for the potential treatment of spinal muscular atrophy.  Reldesemtiv  was the subject of a positive Phase 2 clinical study in patients with spinal muscular atrophy which showed increases in measures of endurance and stamina consistent with the mechanism of action.  Reldesemtiv  is currently the subject of FORTITUDE-ALS, a Phase 2 clinical trial in patients with amyotrophic lateral sclerosis.  Cytokinetics is also advancing CK-601, a next-generation FSTA, under the collaboration with Astellas. Astellas holds an exclusive worldwide license to develop and commercialize  reldesemtiv . Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.

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. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of clinical trials; the significance and utility of pre-clinical study and clinical trial results; planned interactions with regulatory authorities and the outcomes of such interactions; the expected timing of events and milestones, including the receipt of milestone payments; and the properties and potential benefits of Cytokinetics’ drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Cytokinetics need for additional funding and such additional funding may not be available on acceptable terms, if at all; 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; Amgen’s and Astellas’ decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil and reldesemtiv , respectively; Cytokinetics may incur unanticipated research and development and other costs; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission. 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. 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.

Diane Weiser
Vice President, Corporate Communications, Investor Relations
(415) 290-7757

Cytokinetics, Incorporated
Condensed Consolidated Statements of Operations
(in thousands, except per share data)


  Three Months Ended December 31,     Years Ended December 31,  
  2018     2017     2018     2017  
Research and development, milestone, grant and other revenues, net $ 9,377     $ (5,234 )   $ 26,368     $ 4,569  
License revenues         5,216       5,133       8,799  
Total revenues   9,377       (18 )     31,501       13,368  
Operating expenses:                              
Research and development   23,278       26,250       89,135       90,296  
General and administrative   7,558       10,259       31,282       36,468  
Total operating expenses   30,836       36,509       120,417       126,764  
Operating loss   (21,459 )     (36,527 )     (88,916 )     (113,396 )
Interest expense   (1,170 )     (670 )     (3,797 )     (3,016 )
Non-cash interest expense on liability related to sale of future royalties   (4,740 )     (4,061 )     (17,767 )     (13,980 )
Interest and other income, net   900       774       4,191       2,602  
Net loss $ (26,469 )   $ (40,484 )   $ (106,289 )   $ (127,790 )
Net loss per share $ (0.48 )   $ (0.75 )   $ (1.95 )   $ (2.59 )
Weighted-average shares in net loss per share   54,689       53,929       54,420       49,404  

Cytokinetics, Incorporated
Condensed Consolidated Balance Sheets
(in thousands)

    December 31, 2018     December 31, 2017 (1)  
Current assets:                
Cash and short term investments   $ 198,731     $ 268,891  
Other current assets     8,943       5,404  
Total current assets     207,674       274,295  
Long-term investments           16,518  
Property and equipment, net     3,204       3,568  
Other assets     300       429  
Total assets   $ 211,178     $ 294,810  
Current liabilities:                
Accounts payable and accrued liabilities   $ 19,521     $ 22,645  
Deferred revenue, current           9,572  
Current portion of long-term debt     2,607        
Other current liabilities     66       227  
Total current liabilities     22,194       32,444  
Long-term debt, net     39,806       31,777  
Liability related to the sale of future royalties, net     122,473       104,650  
Deferred revenue, non-current           15,000  
Other long-term liabilities     771       1,097  
Total liabilities     185,244       184,968  
Stockholders’ equity:                
Common stock and additional paid-in capital     768,758       755,580  
Accumulated other comprehensive income     500       343  
Accumulated deficit     (743,324 )     (646,081 )
Total stockholders’ equity     25,934       109,842  
Total liabilities and stockholders’ equity   $ 211,178     $ 294,810  

(1) Derived from the audited financial statements, included in the company’s Annual Report on Form 10-K for the year ended December 31, 2017.