0001144204-14-004844.txt : 20140130 0001144204-14-004844.hdr.sgml : 20140130 20140130110455 ACCESSION NUMBER: 0001144204-14-004844 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20140127 ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140130 DATE AS OF CHANGE: 20140130 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Chelsea Therapeutics International, Ltd. CENTRAL INDEX KEY: 0001333763 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 203174202 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51462 FILM NUMBER: 14559295 BUSINESS ADDRESS: STREET 1: 3530 TORINGDON WAY STREET 2: SUITE 200 CITY: CHARLOTTE STATE: NC ZIP: 28277 BUSINESS PHONE: 704-341-1516 MAIL ADDRESS: STREET 1: 3530 TORINGDON WAY STREET 2: SUITE 200 CITY: CHARLOTTE STATE: NC ZIP: 28277 8-K 1 v366708_8k.htm FORM 8-K

 

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): January 27, 2014

 

Chelsea TherapEUtics International, Ltd.
(Exact name of registrant as specified in its charter)

  

Delaware 000-51462 20-3174202

(State or other jurisdiction of

incorporation)

(Commission File Number) (IRS Employer ID Number)

  

3530 Toringdon Way, Suite 200, Charlotte, North Carolina 28277
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (704) 341-1516

 

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 (see General Instruction A.2. below):

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 
 

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Appointment of Chief Commercial Officer

 

On January 27, 2014, Chelsea Therapeutics International, Ltd. (the “Company”), appointed Keith W. Schmidt to be the Company’s Chief Commercial Officer, effective January 28, 2014.

 

From July 2006 to July 2012, Mr. Schmidt served as the Company’s Vice President, Marketing and Sales. Since July 2012, Mr. Schmidt had served as a consultant to the Company. Mr. Schmidt has over 30 years of experience in domestic and international pharmaceutical sales and strategic marketing, including the launch of many industry leading drugs.

 

Mr. Schmidt, age 63, has no familial relationships with any executive officer or director of the Company. Other than his consulting arrangement with us, pursuant to which we have paid Mr. Schmidt an aggregate of approximately $125,000, there have been no transactions in which we have participated and in which Mr. Schmidt had a direct or indirect material interest involving in excess of $120,000 since January 1, 2013, the beginning of our last completed fiscal year.

 

In connection with his hiring, Mr. Schmidt entered into an offer letter with the Company dated January 27, 2014. Pursuant to the terms of the offer letter, Mr. Schmidt will receive an annual base salary of $275,000 and will be eligible for an annual discretionary performance-based bonus with a target award of 20% of his base salary. Mr. Schmidt also received an initial stock option grant of 100,000 shares of the Company’s common stock at an exercise price of $4.50 per share, which was the closing price of the Company’s common stock on the Nasdaq Capital Market on the date of the grant. The options will vest in equal annual installments over four years, beginning January 28, 2015.

 

Mr. Schmidt will also be added as an “Eligible Executive” under the Company’s Executive Retention Bonus Plan (the “Retention Plan”) and its Executive Severance Plan (the “Severance Plan”). Under the Retention Plan, Mr. Schmidt will be eligible to receive a cash bonus equal to 50% of his annual base salary upon the occurrence of a “Sale Event” (as defined in the Retention Plan). However, Mr. Schmidt will not be eligible to receive any “NDA Approval Bonus” (as defined in the Retention Plan) that may become payable under the Retention Plan. Any bonus payable to Mr. Schmidt pursuant to the Retention Plan will supplant any annual performance-based bonus for which Mr. Schmidt might otherwise be eligible. Under the Severance Plan, Mr. Schmidt will be entitled to a separation bonus equal to one month of base salary for every full month of employment with the Company, up to a maximum of 11 months’ severance pay, in the event that Mr. Schmidt’s employment is terminated by the Company without “cause” (as defined in the Severance Plan) or by Mr. Schmidt for “good reason” (as defined in the Severance Plan).

 

On January 30, 2014, the Company issued a press release regarding Mr. Schmidt’s appointment. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

Amendment to CEO Target Bonus Award

 

On January 27, 2014, the Company’s Board of Directors approved an increased 45% annual target bonus to the $350,000 annual base salary of Joseph G. Oliveto, the Company’s President and Chief Executive Officer, provided Mr. Oliveto does not receive any 2014 bonus payment under the Executive Retention Bonus Plan.

 

 
 

 

Item 9.01 Financial Statements and Exhibits.

 

(d)Exhibits.

 

99.1Press release dated January 30, 2014.

 
 

 

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.

 

 

  CHELSEA THERAPEUTICS INTERNATIONAL, LTD.
     
     
  By:   /s/ J. Nick Riehle
    J. Nick Riehle
    Chief Financial Officer

 

Dated: January 30, 2014

 

 
 

 

Exhibit Index

 

Exhibit No.   Description
99.1   Press release dated January 30, 2014.

 

 

EX-99.1 2 v366708_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

Description: image

 

Chelsea Therapeutics Names Keith W. Schmidt Chief Commercial Officer

 

CHARLOTTE, N.C., January 30, 2014 -- Chelsea Therapeutics International, Ltd. (Nasdaq: CHTP) today announced that Keith W. Schmidt has been named Chief Commercial Officer, effective January 28, 2014. Mr. Schmidt has served as a consultant to the Company since 2012. Prior to this role, he was Vice President, Marketing and Sales, of the Company, a role he held since joining Chelsea in 2006. Mr. Schmidt brings more than 30 years of experience in domestic and international pharmaceutical sales and strategic marketing, including the launch of many industry leading drugs.

 

“While we work toward the PDUFA action date for our Northera new drug application, the Company will continue to pursue a dual path of preparing for the potential commercial launch of Northera and actively assessing our strategic alternatives,” said Joseph G. Oliveto, President and Chief Executive Officer of Chelsea Therapeutics. “Keith has a strong understanding of the neurogenic orthostatic hypotension orphan market, having led the team which designed our initial commercial strategies and having more recently consulted for the Company. He is ideally positioned to help execute a launch plan for Northera, as well as to support our review of strategic alternatives.”

 

“I am thrilled to rejoin the Chelsea team during this important time for the Company,” said Mr. Schmidt. “NOH remains an underserved orphan indication with significant commercial potential, one that may be effectively served by a highly targeted commercial effort.”

 

About Symptomatic nOH

 

It is estimated that nearly 300,000 patients suffer from chronic symptomatic nOH in the U.S. and EU combined. Symptomatic nOH is a chronic disorder that is caused by an underlying neurogenic disorder, such as Parkinson's disease, multiple system atrophy or pure autonomic failure. Symptoms of nOH include dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and fainting episodes when a person assumes a standing position. These symptoms often severely limit a person's ability to perform routine daily activities that require standing or walking for both short or long periods of time.

 

About Northera

 

NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, is currently under FDA review for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure — an indication that includes a significant number of patients with Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally.

 

Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd. (DSP), initially received Japanese approval in 1989 for the treatment of frozen gait and dizziness on standing associated with Parkinson's Disease and for the treatment of orthostatic hypotension, syncope or dizziness on standing associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy. In 2000, Droxidopa received expanded marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.

 

 
 

 

About Chelsea Therapeutics

 

Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system disorders. Chelsea acquired global development and commercialization rights to droxidopa (L-DOPS), or NORTHERA, from Dainippon Sumitomo Pharma Co., Ltd. in 2006, excluding Japan, Korea, China and Taiwan. For more information about the Company, visit www.chelseatherapeutics.com.

 

This press release contains forward-looking statements regarding future events including our intention to pursue the development of NORTHERA. These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include reliance on key personnel and our ability to attract and/or retain key personnel; the risk that FDA will not agree that our clinical trial results demonstrate the safety and effectiveness of droxidopa; the risk that the FDA will not accept our proposal regarding any trial or other data to support a new drug application; the risk that the FDA will not approve the resubmitted NDA; the risk that our resources will not be sufficient to conduct any study of Northera that will be acceptable to the FDA; the risk that we cannot complete Study 401 or any other additional study for Northera without the need for additional capital; the risks and costs of drug development and that such development may take longer or be more expensive than anticipated; our need to raise additional operating capital in the future; our reliance on our lead drug candidate droxidopa; the risk that we will not be able to obtain regulatory approvals of droxidopa or our other drug candidates for additional indications; the risk of volatility in our stock price, related litigation, and analyst coverage of our stock; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; market acceptance for our products if any are approved for marketing.

 

###

 

CONTACT:

 

Media:

David Connolly

LaVoie Group

617-374-8800, Ext. 104

dconnolly@lavoiegroup.com 

Investors:

Susan Kim

Argot Partners

212-600-1902

susan@argotpartners.com 

 

 

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