0001193125-17-178145.txt : 20170522 0001193125-17-178145.hdr.sgml : 20170522 20170522164733 ACCESSION NUMBER: 0001193125-17-178145 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20170519 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170522 DATE AS OF CHANGE: 20170522 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CareDx, Inc. CENTRAL INDEX KEY: 0001217234 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071] IRS NUMBER: 943316839 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36536 FILM NUMBER: 17861498 BUSINESS ADDRESS: STREET 1: 3260 BAYSHORE BOULEVARD CITY: BRISBANE STATE: CA ZIP: 94005 BUSINESS PHONE: 415-287-2300 MAIL ADDRESS: STREET 1: 3260 BAYSHORE BOULEVARD CITY: BRISBANE STATE: CA ZIP: 94005 FORMER COMPANY: FORMER CONFORMED NAME: XDx, Inc. DATE OF NAME CHANGE: 20071010 FORMER COMPANY: FORMER CONFORMED NAME: EXPRESSION DIAGNOSTICS INC DATE OF NAME CHANGE: 20030203 8-K 1 d351708d8k.htm FORM 8-K 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): May 19, 2017

 

 

CAREDX, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   001-36536   94-3316839

(State or Other Jurisdiction

of Incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

3260 Bayshore Boulevard

Brisbane, California 94005

(Address of Principal Executive Offices) (Zip Code)

(415) 287-2300

Registrant’s telephone number, including area code

N/A

(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 (§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 May 22, 2017, CareDx, Inc. (the “Company”) issued a press release announcing certain preliminary financial results for the quarter ended March 31, 2017. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The preliminary financial information presented in this press release is based on the Company’s current expectations and may be adjusted as a result of, among other things, completion of customary quarterly review procedures.

The information in this Item 2.02, including the press release attached hereto as Exhibit 99.1, is intended to be furnished under Item 2.02 and Item 9.01 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

On May 22, 2017, the Company received a written notice (the “Notice”) from the Listing Qualifications Department of The NASDAQ Stock Market LLC (“Nasdaq”) stating that the Company is not in compliance with Nasdaq Listing Rule 5250(c)(1) for continued listing because the Company did not timely file with the U.S. Securities and Exchange Commission (the “SEC”) its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2017 (the “Form 10-Q”). The Notice was issued in accordance with standard Nasdaq procedures and has no immediate effect on the continued listing of the Company’s common stock on the Nasdaq Global Market.

The Notice indicates that the Company has until July 21, 2017 to submit a plan to regain compliance with the Nasdaq continued listing standards. As previously disclosed in the Company’s Notification of Late Filing on Form 12b-25 filed with the SEC on May 15, 2017, the Company requires additional time to complete the disclosures in the Form 10-Q. The Company intends to file the Form 10-Q as promptly as possible, and intends to do so prior to July 21, 2017. However, if the Company is still unable to file the Form 10-Q by July 21, 2017, then the Company intends to submit a compliance plan on or prior to that date. If submission of a compliance plan is necessary and Nasdaq accepts the Company’s compliance plan, Nasdaq can grant an exception of up to 180 calendar days from the Form 10-Q’s filing due date, or until November 13, 2017, to regain compliance.

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

On May 19, 2017, Douglas Miller resigned as a member of the Board of Directors of the Company, effective immediately. Mr. Miller’s departure was not as a result of any disagreement with the Company or any matters relating to the Company’s operations, policies or practices.

 

Item 7.01. Regulation FD Disclosure.

On May 22, 2017, the Company issued a press release disclosing the Company’s receipt of the Notice. A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.

The information contained in this Item 7.01, including Exhibit 99.2 hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference to such filing.

Cautionary Note Regarding Forward-Looking Statements. This Current Report on Form 8-K and the press releases furnished as Exhibits 99.1 and 99.2 hereto contain forward-looking statements which involve certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these statements. Please refer to the note in the press releases under the heading “Forward-Looking Statements” regarding these forward-looking statements.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

The following exhibits are being furnished herewith:

 

Number

   

Description

99.1    Press Release, dated May 22, 2017 regarding preliminary financial results of CareDx, Inc.
99.2    Press Release, dated May 22, 2017 regarding receipt of notice from Listing Qualifications Department of The NASDAQ Stock Market LLC.

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.

 

Date: May 22, 2017     CAREDX, INC.
    By:  

/s/ Peter Maag, Ph.D.

      Peter Maag, Ph.D.
      President and Chief Executive Officer
 EX-99.1 2 d351708dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

CareDx Reports Preliminary First Quarter 2017 Financial Results

BRISBANE, Calif., May 22, 2017 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, today reported preliminary financial results for the first quarter ended March 31, 2017.

Recent highlights:

 

  •   Achieved total preliminary revenues for the first quarter of 2017 of $11.4M to $11.6M

 

  ○    AlloMap® preliminary revenues were $7.7M to $7.9M in the quarter, with quarterly US tests volume up by 12% year-over-year

 

  ○    Olerup® preliminary revenues contributed $3.7M in the first quarter

 

  •   Attained AlloSure draft local coverage determination (LCD) by Palmetto GBA. AlloSure is the first and only non-invasive test that uses donor derived cell free DNA to measure allograft injury and identify the probability of active rejection

 

  •   Advanced launch readiness at the 2017 American Transplantation Congress

 

  ○    Presented data showing high correlation with active kidney transplant rejection in a large prospective multi-center study

 

  ○    Demonstrated AlloSure’s use in monitoring immunosuppressive treatment for patient recovery from active rejection

 

  ○    Highlighted intended use in clinical setting with numerous patient case studies

 

  •   Appointed Michael Bell as Chief Financial Officer effective April 21, 2017 and retained top-tier accounting firm to support financial reporting team

“Our strong AlloMap volume and revenue growth in the quarter underscores the build out in our core business. In addition, we are thrilled to receive a draft LCD for AlloSure and we continue to anticipate CMS coverage this year, and with this milestone achieved, we are well on track to make AlloSure available to kidney transplant patients later in 2017,” said Peter Maag, CareDx President and Chief Executive Officer. “With our new CFO, Michael Bell, on board, we are making significant improvements within our finance organization.”

Preliminary First Quarter 2017 Financial Results

These financial results for the three months ended March 31, 2017 are preliminary and will be updated with the filing of the upcoming Quarterly Report on Form 10-Q for the quarter ended March 31, 2017.

Preliminary revenues for the three months ended March 31, 2017 were $11.4 million to $11.6 million compared with $6.6 million in the first quarter of 2016. Preliminary revenues from AlloMap tests for the three months ended March 31, 2017, were $7.7 million to $7.9 million compared with $6.5 million in the first quarter of 2016. Preliminary Olerup revenues in the three months ended March 31, 2017, were $3.7 million.

For the first quarter of 2017, preliminary net loss was in the range of $6.8 million to $5.8 million, compared to net loss of $9.8 million in the first quarter of 2016. Preliminary basic and diluted net loss per share were in the range $0.32 to $0.27 in the first quarter of 2017, compared to basic and diluted net loss per share of $0.81 in the first quarter of 2016.

Preliminary cash and cash equivalents was $12.2 million as of March 31, 2017, compared with $17.3 million as of December 31, 2016.

2017 Guidance

For the full year 2017, the Company continues to expect revenue to be in the range of $45 million to $50 million, excluding any potential AlloSure revenue.

About CareDx

CareDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value, non-invasive diagnostic surveillance solutions for transplant recipients. The Company has commercialized AlloMap®, a gene expression test that aids clinicians in identifying heart transplant recipients. CareDx is also pursuing the development of additional products for post-transplant monitoring of other solid organs that use a variety of technologies, including next-generation sequencing, to detect donor-derived cell-free DNA to monitor the health of organs after transplantation.

CareDx, with its presence through Olerup, also develops, manufactures, markets and sells high quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs.

For more information, please visit: www.CareDx.com.

Forward Looking Statements

This press release contains forward-looking statements about our business, research, development and commercialization efforts including, but not limited to our anticipated future financial results, including our guidance for full fiscal 2017 revenue and preliminary financial results for the three months ended March 31, 2017, which final results could change materially, and the development, commercialization, utility, performance and adoption of AlloSure. These forward-looking statements are based upon information that is currently available to us and our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including risk associated with successful research, development and planned commercialization of our technologies. These factors, together with those that are described in our filings with the Securities and Exchange Commission (SEC), including the Annual Report on Form 10-K for the fiscal year ended December 31, 2016 filed by us with the SEC on April 21, 2017. Any of these may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

Investor Contact

Caroline Corner, Managing Director

Westwicke Partners, LLC

T: +1 415-314-1725

E: caroline.corner@westwicke.com

EX-99.2 3 d351708dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

LOGO

CareDx Announces Receipt of Expected Letter from Nasdaq

BRISBANE, CA, May 22, 2017: CareDx, Inc. (Nasdaq: CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, today announced that, as expected, on May 22, 2017 it received a standard notification letter from The Nasdaq Stock Market LLC (“Nasdaq”) stating that because the Company did not timely file its Form 10-Q for the quarter ended March 31, 2017 (the “Form 10-Q”), the Company is not in compliance with Nasdaq Listing Rule 5250(c)(1), which requires timely filing of periodic reports with the Securities and Exchange Commission (the “SEC”).

Nasdaq provided the Company until July 21, 2017 to submit a plan to regain compliance. The Company intends to file the Form 10-Q with the SEC as promptly as possible, and intends to do so prior to July 21, 2017. However, if the Company is still unable to file the Form 10-Q by July 21, 2017, then the Company intends to submit a compliance plan on or prior to that date. If submission of a compliance plan is necessary and Nasdaq accepts the Company’s compliance plan, Nasdaq can grant an exception of up to 180 calendar days from the Form 10-Q’s filing due date, or until November 13, 2017, to regain compliance.

The notice from Nasdaq has no immediate effect on the listing of the Company’s common stock on the Nasdaq Global Market.

About CareDx

CareDx, Inc., headquartered in Brisbane, California, is a global molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients. CareDx offers AlloMap®, a gene expression test that aids clinicians in identifying heart transplant patients with stable graft function who have a low probability of moderate to severe acute cellular rejection (ACR). CareDx is developing additional products for transplant monitoring using a variety of technologies, including AlloSure®, a proprietary next-generation sequencing–based test to detect donor-derived cell-free DNA (dd-cfDNA) after transplantation.

CareDx, with its presence through Olerup, also develops, manufactures, markets and sells high quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. Olerup SSP® is a set of HLA typing products used prior to hematopoietic stem cell/bone marrow transplantation and organ transplantation. XM-ONE® is the first standardized test that quickly identifies a patient’s antigens against HLA Class I, Class II or antibodies against a donor’s endothelium. For more information, please visit: www.CareDx.com.

Forward Looking Statements

In addition to historical information, this press release contains forward-looking statements with respect to the expected timing for the filing of the Form 10-Q and our ability to regain compliance with the Nasdaq continued listing standards. These forward-looking statements are based upon information that is currently available to us and our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including those related to our ability to file the Form 10-Q before July 21, 2017 and our ability to regain compliance with the Nasdaq continued listing standards. These factors, together with those that are described in our filings with the SEC, including the Annual Report on Form 10-K for the year ended December 31, 2016 as filed by us with the SEC, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

Investor Contact

Caroline Corner, Managing Director

Westwicke Partners, LLC

T: +1 415-314-1725

E: caroline.corner@westwicke.com

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