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

Date of Report (Date of earliest event Reported): February 15, 2018  

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

Delaware000-5063394-3291317
(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 15, 2018, Cytokinetics, Incorporated issued a press release announcing its results for the fourth quarter ended December 31, 2017. 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.

(d) Exhibits.


Exhibit 99.1. Press release dated February 15, 2018


SIGNATURE

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 15, 2018By: /s/ Peter S. Roddy        
  Peter S. Roddy
  Senior Vice President, Chief Accounting Officer
  

EdgarFiling

EXHIBIT 99.1

Cytokinetics, Inc. Reports Fourth Quarter 2017 Financial Results

 Company Provides 2018 Financial Guidance and Expected Milestones; 
Reduced Operating Expenses vs. 2017; Over Two Years of Cash Based on Current Burn Rate

CK-2127107 Advancing in Four Clinical Trials Under Collaboration with Astellas;
Results Expected in 2018 with Data from Phase 2 Clinical Trial in Patients with SMA Anticipated in Q2

Enrollment in GALACTIC-HF on Track Under Collaboration with Amgen;
Finalizing Plans for Second Phase 3 Clinical Trial in 2018

SOUTH SAN FRANCISCO, Calif., Feb. 15, 2018 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the fourth quarter of 2017. Net loss for the fourth quarter was $40.5 million, or $0.75 per basic share and diluted share, respectively, compared to net income for the same period in 2016 of $7.2 million, or $0.18 and $0.16 per basic and diluted share, respectively. Cash, cash equivalents and investments totaled $285.4 million at December 31, 2017.   

“We had a productive fourth quarter and begin the year with optimism for our growing pipeline of muscle biology directed drug candidates,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “In 2018, we are looking forward to results from four mid-stage clinical trials of CK-2127107 in our skeletal muscle activator program which may inform plans to advance to a Phase 3 clinical program under our collaboration with Astellas. Additionally, enrollment in GALACTIC-HF remains on track with planning under our collaboration with Amgen. Our research continues to power innovation with two potential drug candidates expected to move through IND-enabling studies and into Phase 1 trials in 2018.”

Recent Highlights and Upcoming Milestones

Cardiac Muscle Program

omecamtiv mecarbil (cardiac myosin activator)

Skeletal Muscle Program

tirasemtiv (fast skeletal muscle troponin activator (FSTA))

CK-2127107, reldesemtiv (next-generation fast skeletal muscle troponin activator)

Pre-Clinical Research and Development

Financials

Revenues for the year ended December 31, 2017 included $11.0 million in milestone revenues from Amgen as well as $1.3 million of research and development revenues from our collaboration with Amgen, and $11.9 million of research and development revenues plus $8.8 million of license revenues from our collaboration with Astellas. Revenues for the year ended December 31, 2017 were offset by $20.0 million (out of the total of $40 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. Revenues in 2016 were primarily due to license revenue from the September 2016 expansion of our collaboration with Astellas and a $26.7 million milestone payment from Amgen.

Research and development expenses for the three months and year ended December 31, 2017 increased to $26.3 million and $90.3 million, respectively, from $18.8 million and $59.9 million for the same periods in 2016, primarily due to increased clinical activity, including activity for VITALITY-ALS, increased clinical trials activity for reldesemtiv, as well as increased personnel.

General and administrative expenses for the three months and year ended December 31, 2017 increased to $10.3 million and $36.5 million, respectively, from $6.7 million and $27.8 million for the same periods in 2016, primarily due to increased personnel, non-cash stock compensation expense and commercial readiness activities.

2018 Financial Guidance

The Company also announced financial guidance for 2018. The company anticipates cash revenue will be in the range of $17 to $23 million, operating expenses will be in the range of $105 to $115 million, and net cash utilization will be approximately $100 million.

2018 Corporate Milestones

Cardiac Muscle Program

omecamtiv mecarbil (cardiac myosin activator)

Skeletal Muscle Program

CK-2127107 (reldesemtiv), (next-generation fast skeletal muscle troponin activator (FSTA))

Pre-Clinical Research

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s fourth quarter 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 3665278.

An archived replay of the webcast will be available via Cytokinetics’ website until February 22, 2018. 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 3665278 from February 15, 2018 at 7:30 PM Eastern Time until February 22, 2018.

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators 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 increase 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 GALACTIC-HF, an international Phase 3 clinical trial in patients with heart failure. 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 collaborating with Astellas Pharma Inc. (“Astellas”) to develop reldesemtiv (CK-2127107), a next-generation FSTA. Reldesemtiv has been granted orphan drug designation by the FDA for the potential treatment of SMA. Reldesemtiv is the subject of three ongoing Phase 2 clinical trials enrolling patients with spinal muscular atrophy, chronic obstructive pulmonary disease and ALS. Astellas is also conducting a Phase 1b clinical trial of reldesemtiv in elderly adults with limited mobility. Astellas holds an exclusive worldwide license to develop and commercialize reldesemtiv. Licenses held by Amgen and Astellas are subject to Cytokinetics' specified co-development and co-commercialization rights. Cytokinetics continues its 20-year history of innovation with three new muscle biology directed compounds advancing from research to development in 2018.  For additional information about Cytokinetics, visit www.cytokinetics.com.

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.

Contact:
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(650) 624-3000


Cytokinetics, Incorporated
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
          
  Three Months Ended Year Ended 
 December 31, December 31,
 December 31, December 31, 
 2017 2016
 2017 2016
             
Revenues:            
             
License and research and development revenues from Astellas$5,216 $6,792 $20,733 $77,281 
Milestone revenues from Amgen 1,000  26,667  11,000  26,667 
Research and development revenues from Amgen   -  616  1,279  2,466 
Co-investment payments to Amgen (6,250) (1,250) (20,000) (1,250)
Grant and other revenues 16  313  356  1,243 
             
Total revenues, net (18) 33,138  13,368  106,407 
             
Operating Expenses:            
Research and development 26,250  18,775  90,296  59,897 
General and administrative 10,259  6,675  36,468  27,823 
             
Total operating expenses 36,509  25,450  126,764  87,720 
             
Operating (loss) income (36,527) 7,688  (113,396) 18,687 
             
Interest expense   (670)   (714)   (3,016)   (2,698)
Non-cash interest expense on liability related to sale of royalties   (4,061)   -    (13,980)   - 
Interest and other income (expense), net 774  183  2,602  464 
             
Net (loss) income$(40,484)$7,157 $(127,790)$16,453 
             
             
Net (loss) income per share – basic $(0.75)$0.18 $(2.59)$0.41 
Net (loss) income per share – diluted$(0.75)$0.16 $(2.59)$0.39 
             
Weighted average shares used in computing net (loss) income per share – basic  53,929  40,581  49,404  39,943 
Weighted average shares used in computing net (loss) income per share – diluted 53,929  43,696  49,404  42,561 



Cytokinetics, Incorporated
Condensed Consolidated Balance Sheets
(in thousands)
       
  December 31,  December 31, 
  2017  2016(1) 
  (unaudited)    
Assets      
       
Cash and cash equivalents$125,206 $66,874 
       
Short term investments 143,685  89,375 
       
Accounts receivable 1,112  24 
       
Other current assets 4,292  2,360 
       
Total current assets 274,295  158,633 
       
Long-term investments 16,518  7,672 
       
Property and equipment, net   3,568    3,637 
       
Other assets 429  200 
       
Total assets$294,810 $170,142 
       
Liabilities and stockholders' equity       
       
Deferred revenue, current$9,572 $8,060 
       
Other current liabilities 22,872  25,198 
       
Total current liabilities 32,444  33,258 
       
Long-term debt 31,777  27,381 
       
Deferred revenue, non-current 15,000  15,000 
       
Liability related to sale of future royalties 104,650  - 
       
Other non-current liabilities   1,097  142 
       
Stockholders’ equity  109,842  94,361 
       
Total liabilities and stockholders' equity $294,810 $170,142 

(1) Derived from the audited financial statements, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016.