Last10K.com

Caredx, Inc. (CDNA) SEC Filing 8-K Material Event for the period ending Thursday, May 10, 2018

Caredx, Inc.

CIK: 1217234 Ticker: CDNA

Exhibit 99.1

 

LOGO

CareDx Reports First Quarter Results

AlloSure launch momentum drives 21% revenue growth

Further expands product offerings for transplant patients

BRISBANE, Calif., May 10, 2018 (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 financial results for the first quarter ended March 31, 2018.

Recent highlights:

 

    Accelerated AlloSure penetration in key kidney transplant centers

 

  - As of March 31, 2018, 52 U.S. transplant centers have provided AlloSure testing to patients

 

  - Continued progress in AlloSure Registry (K-OAR) enrollment, with 12 centers initiated as of March 31, 2018

 

    Achieved total revenue of $14.1 million for the first quarter of 2018, up 21% year-over-year

 

  - Testing revenue of $10.6 million, with 1,051 AlloSure and 3,847 AlloMap patient results provided

 

  - Product revenue of $3.3 million

 

    Broadened testing and product offerings

 

  - Entered into partnership with Illumina to develop and sell its Next Generation Sequencing transplant solutions

 

  - Launched HeartCare, a comprehensive solution for surveillance of heart transplant patients, combining AlloMap with AlloSure-Heart

 

  - Validated Olerup QTYPE on multiple platforms and received CE mark certification

 

    Completed balance sheet simplification by refinancing outstanding debt into a single $15 million term loan with Perceptive Advisors

“A number of our initiatives have delivered results in the first quarter. AlloSure has already made a big impact in many transplant centers and the community is embracing our approach to better surveillance. Our vision to be a leader in transplant care has been validated by becoming Illumina’s partner of choice for its Next Generation Sequencing transplant solutions.” said Peter Maag, CareDx President and Chief Executive Officer. “Our dedication to the field sets us apart and creates a platform for future innovations and partnerships in transplant patient care.”


First Quarter 2018 Financial Results

Revenue for the three months ended March 31, 2018 was $14.1 million, an increase of 21% compared with $11.6 million in the first quarter of 2017. Testing revenue for the quarter was $10.6 million compared with $7.9 million in the same period of 2017. Product revenue in the three months ended March 31, 2018 was $3.3 million, compared to $3.7 million in the same period of 2017.

For the first quarter of 2018, the net loss was $9.0 million compared to a net loss of $5.6 million in the same period of 2017. Basic and diluted net loss per share was $0.30 in the first quarter of 2018, compared to basic and diluted net loss per share of $0.26 in the first quarter of 2017.

Non-GAAP net loss was $4.0 million in the first quarter of 2017 compared to $6.7 million in the first quarter of 2017. Basic and diluted non-GAAP net loss per share was $0.14 in the first quarter of 2018, compared to $0.31 in the first quarter of 2017.

Cash and cash equivalents were $18.7 million as of March 31, 2018. Following the completion of our debt refinancing on April 17, 2018, the Company had approximately $22 million in cash and cash equivalents, and debt of $15 million.

For additional information regarding non-GAAP financial measures discussed herein, please see “Use of Non-GAAP financial Measures” and “Reconciliation of GAAP to Non-GAAP Financial Measures” below.

2018 Guidance

For the full year 2018, CareDx expects revenue to be in the range of $64 million to $66 million, with non-GAAP EBITDA profitability expected during the second half of the year. This guidance includes the anticipated contribution from the partnership agreement with Illumina to exclusively sell its Next Generation Sequencing transplantation products. Each of the components of CareDx’s guidance set forth above is an estimate only and actual performance could differ.

About CareDx

CareDx, Inc., headquartered in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant recipients. CareDx offers products across the transplant testing continuum, including AlloMap and AlloSure for post-transplant surveillance and Olerup SSP®, Olerup QTYPE®, and Olerup SBT™ for pre-transplant HLA testing.

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


Forward Looking Statements

This press release includes forward-looking statements, including expectations regarding the Company’s fiscal 2018 revenue, timing for profitability, achievement of our financial and operational goals and prospects. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including general economic and market factors, among others discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2017 filed by CareDx with the SEC on March 22, 2018 and the periodic reports that CareDx has subsequently filed with the SEC. Any of these may cause CareDx’s actual results, performance or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

Use of Non-GAAP Financial Measures

CareDx has presented certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis in this release, including non-GAAP net loss and non-GAAP basic and diluted net loss per share. We define non-GAAP net loss and per share results as the GAAP net loss and per share results excluding the impacts of stock-based compensation; changes in estimated fair value of warrants, derivative liabilities and contingent consideration; acquisition related impairment charges and amortization of intangible assets, purchase accounting adjustments and related tax effects, costs involved with completing an acquisition; amortization of debt discount; and certain other financing charges. We define non-GAAP EBITDA as net income before net interest expense, income tax expense, depreciation and amortization, impairment of goodwill, stock-based compensation expense, and restructuring, integration and other expenses. We are presenting these non-GAAP financial measures to assist investors in assessing our operating results through the eyes of management, and because we believe that these measures provide an additional tool for investors to use in comparing our core business operating results over multiple periods. Management believes this non-GAAP information is useful for investors, when considered in conjunction with CareDx’s GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of CareDx’s operating results as reported under GAAP. These non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. These non-GAAP financial measures are not necessarily comparable to similarly-titled measures presented by other companies. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables.

CONTACTS:

CareDx, Inc.

Sasha King

Chief Commercial Officer

415-287-2393

sking@caredx.com

Investor Relations

David Clair

Integrated Corporate Relations, Inc.

646-277-1266

david.clair@icrinc.com


CareDx, Inc.

Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share data)

 

     Three Months Ended March 31,  
     2018     2017  

Revenue:

    

Testing revenue

   $ 10,604     $ 7,902  

Product revenue

     3,307       3,667  

License and other revenue

     142       15  
  

 

 

   

 

 

 

Total revenue

     14,053       11,584  

Operating expenses:

    

Cost of testing

     4,112       3,057  

Cost of product

     2,272       2,327  

Research and development

     3,368       3,283  

Sales and marketing

     4,085       3,222  

General and administrative

     5,307       6,502  

Goodwill impairment

     —         1,958  

Change in estimated fair value of contingent consideration

     144       (221
  

 

 

   

 

 

 

Total operating expenses

     19,288       20,128  
  

 

 

   

 

 

 

Loss from operations

     (5,235     (8,544

Interest expense

     (2,695     (790

Other expense, net

     (2,809     (686

Change in estimated value of common stock warrant liability and derivative liability

     1,321       4,128  
  

 

 

   

 

 

 

Loss before income taxes

     (9,418     (5,892

Income tax benefit

     424       283  
  

 

 

   

 

 

 

Net loss

     (8,994     (5,609

Net loss attributable to noncontrolling interest

     (25     (47
  

 

 

   

 

 

 

Net loss attributable to CareDx, Inc.

   $ (8,969   $ (5,562
  

 

 

   

 

 

 

Net loss per share attributable to CareDx, Inc.:

    

Basic

   $ (0.30   $ (0.26
  

 

 

   

 

 

 

Diluted

   $ (0.30   $ (0.26
  

 

 

   

 

 

 

Weighted average shares used to compute net loss per share attributable to CareDx, Inc.:

    

Basic

     29,615,441       21,343,782  
  

 

 

   

 

 

 

Diluted

     29,615,441       21,343,782  
  

 

 

   

 

 

 


CareDx, Inc.

Condensed Consolidated Balance Sheets

(In thousands)

 

     March 31, 2018     December 31, 2017 (1)  
Assets             

Current assets:

    

Cash and cash equivalents

   $ 18,695     $ 16,895  

Accounts receivable

     6,536       2,991  

Inventory

     5,011       5,529  

Prepaid and other assets

     2,455       1,352  
  

 

 

   

 

 

 

Total current assets

     32,697       26,767  

Property and equipment, net

     2,055       2,075  

Intangible assets, net

     31,989       33,139  

Goodwill

     12,005       12,005  

Restricted cash

     206       9,579  
  

 

 

   

 

 

 

Total assets

   $ 78,952     $ 83,565  
  

 

 

   

 

 

 
Liabilities and stockholders’ (deficit) equity             

Current liabilities:

    

Accounts payable

   $ 4,269     $ 3,391  

Accrued payroll liabilities

     3,707       5,013  

Accrued and other liabilities

     4,392       3,735  

Deferred revenue

     39       39  

Deferred purchase consideration

     577       407  

Derivative liability

     —         14,600  

Current debt

     461       15,721  
  

 

 

   

 

 

 

Total current liabilities

     13,445       42,906  

Deferred rent, net of current portion

     802       913  

Deferred revenue, net of current portion

     721       730  

Deferred tax liability

     4,415       4,933  

Long-term debt, net of current portion

     9,729       18,338  

Contingent consideration

     1,816       1,672  

Common stock warrant liability

     13,247       18,712  

Other liabilities

     1,384       1,315  
  

 

 

   

 

 

 

Total liabilities

     45,559       89,519  

Stockholders’ equity:

    

Common stock

     35       29  

Additional paid-in capital

     309,898       264,204  

Accumulated other comprehensive loss

     (2,482     (2,345

Accumulated deficit

     (274,058     (268,022
  

 

 

   

 

 

 

Total CareDx, Inc. stockholders’ equity (deficit)

     33,393       (6,134

Noncontrolling interest

     —         180  
  

 

 

   

 

 

 

Total stockholders’ equity (deficit)

     33,393       (5,954
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 78,952     $ 83,565  
  

 

 

   

 

 

 

 

(1) The condensed balance sheets at December 31, 2017 have been derived from audited financial statements.

 


CareDx, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited)

(In thousands, except share and per share data)

 

 

     Three Months Ended March 31,  
     2018     2017  

Cost of testing reconciliation:

    

GAAP cost of testing

   $ 4,112     $ 3,057  

Acquisition related-amortization of purchased intangibles

     (127     —    

Stock-based compensation expense

     (61     (55
  

 

 

   

 

 

 

Non-GAAP cost of testing

   $ 3,924     $ 3,002  
  

 

 

   

 

 

 

Cost of product reconciliation:

    

GAAP cost of product

   $ 2,272     $ 2,327  

Acquisition related-amortization of purchased intangibles

     (383     (357

Acquisition related-amortization of inventory valuation adjustment

     (164     (32
  

 

 

   

 

 

 

Non-GAAP cost of product

   $ 1,725     $ 1,938  
  

 

 

   

 

 

 

Research and development expenses reconciliation:

    

GAAP research and development expenses

   $ 3,368     $ 3,283  

Stock-based compensation expense

     (213     (64
  

 

 

   

 

 

 

Non-GAAP research and development expenses

   $ 3,155     $ 3,219  
  

 

 

   

 

 

 

Sales and marketing expenses reconciliation:

    

GAAP sales and marketing expenses

   $ 4,085     $ 3,222  

Acquisition related-amortization of purchased intangibles

     (254     (231

Stock-based compensation expense

     (63     (38
  

 

 

   

 

 

 

Non-GAAP sales and marketing expenses

   $ 3,768     $ 2,953  
  

 

 

   

 

 

 

General and administrative expenses reconciliation:

    

GAAP general and administrative expenses

   $ 5,307     $ 6,502  

Stock-based compensation expense

     (368     (234
  

 

 

   

 

 

 

Non-GAAP general and administrative expenses

   $ 4,939     $ 6,268  
  

 

 

   

 

 

 

Goodwill impairment reconciliation:

    

GAAP goodwill impairment

   $ —       $ 1,958  

Goodwill impairment

     —         (1,958
  

 

 

   

 

 

 

Non-GAAP goodwill impairment

   $ —       $ —    
  

 

 

   

 

 

 

Change in estimated fair value of contingent consideration reconciliation:

    

GAAP change in estimated fair value of contingent consideration

   $ 144     $ (221

Change in estimated fair value of contingent consideration

     (144     221  
  

 

 

   

 

 

 

Non-GAAP change in estimated fair value of contingent consideration

   $ —       $ —    
  

 

 

   

 

 

 

Interest expense reconciliation:

    

GAAP interest expense

   $ (2,695   $ (790

Amortization of debt discount

     1,923       184  
  

 

 

   

 

 

 

Non-GAAP interest expense

   $ (772   $ (606
  

 

 

   

 

 

 

Other expense, net reconciliation:

    

GAAP other expense, net

   $ (2,809   $ (686

Debt financing related fees and expenses

     —         250  

Loss on conversion from debt to equity

     2,806       —    
  

 

 

   

 

 

 

Non-GAAP other expense, net

   $ (3   $ (436
  

 

 

   

 

 

 

Change in estimated fair value of common stock warrant and derivative liabilities reconciliation:

    

GAAP change in estimated fair value of common stock warrant and derivative liabilities

   $ 1,321     $ 4,128  

Change in estimated fair value of common stock warrant and derivative liabilities reconciliation:

     (1,321     (4,128
  

 

 

   

 

 

 

Non-GAAP change in estimated fair value of common stock warrant and derivative liabilities

   $ —       $ —    
  

 

 

   

 

 

 

Income tax benefit reconciliation:

    

GAAP income tax benefit

   $ 424     $ 283  

Tax effect related to amortization of purchased intangibles

     (232     (155
  

 

 

   

 

 

 

Non-GAAP income tax benefit

   $ 192     $ 128  
  

 

 

   

 

 

 

Net loss reconciliation:

    

GAAP net loss attributable to CareDx, Inc.

   $ (8,969   $ (5,562

Acquisition related-amortization of purchased intangibles

     764       588  

Acquisition related-amortization of inventory valuation adjustment

     164       32  

Tax effect related to amortization of purchased intangibles

     (232     (155

Debt financing related fees and expenses

     —         250  

Amortization of debt discount

     1,923       184  

Loss on conversion from debt to equity

     2,806       —    

Stock-based compensation expenses

     705       391  

Goodwill impairment

     —         1,958  

Change in estimated fair value of contingent consideration

     144       (221

Change in estimated fair value of common stock warrant liability and derivative liability

     (1,321     (4,128
  

 

 

   

 

 

 

Non-GAAP net loss

   $ (4,016   $ (6,663
  

 

 

   

 

 

 

Basic and diluted net loss per share reconciliation:

    

GAAP basic and diluted net loss per share attributable to CareDx

   $ (0.30   $ (0.26

Acquisition related-amortization of purchased intangibles

     0.03       0.03  

Acquisition related-amortization of inventory valuation adjustment

     0.01       0.00  

Tax effect related to amortization purchased intangibles

     (0.01     (0.01

Debt financing related fees and expenses

     —         0.01  

Amortization of debt discount

     0.06       0.01  

Loss on conversion from debt to equity

     0.09       —    

Stock-based compensation expenses

     0.02       0.02  

Goodwill impairment

     —         0.09  

Change in estimated fair value of contingent consideration

     0.00       (0.01

Change in estimated fair value of common stock warrant and derivative liabilities

     (0.04     (0.19
  

 

 

   

 

 

 

Non-GAAP basic net loss per share attributable to CareDx

   $ (0.14   $ (0.31
  

 

 

   

 

 

 

Non-GAAP diluted net loss per share attributable to CareDx

   $ (0.14   $ (0.31
  

 

 

   

 

 

 

Non-GAAP adjustment summary:

    

Cost of testing

   $ 188     $ 55  

Cost of product

     547       389  

Research and development

     213       64  

Sales and marketing

     317       269  

General and administrative

     368       234  

Goodwill impairment

     —         1,958  

Change in estimated fair value of contingent consideration

     144       (221

Interest expense, net

     1,923       184  

Other (expense) income, net

     2,806       250  

Change in estimated fair value of common stock warrant and derivative liabilities

     (1,321     (4,128

Tax effect related to amortization of purchased intangibles

     (232     (155
  

 

 

   

 

 

 

Total Non-GAAP adjustment summary:

   $ 4,953     $ (1,101
  

 

 

   

 

 

 

View differences made from one to another to evaluate Caredx, Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 8-K Corporate News to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Caredx, Inc..

Continue

Assess how Caredx, Inc.'s management team is paid from their Annual Proxy

Definitive Proxy Statement (Form DEF 14A)
Screenshot example of actual Proxy Statement

Caredx, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2018 10-K Annual Report includes:

  • Voting Procedures
  • Board Members
  • Executive Team
  • Salaries, Bonuses, Perks
  • Peers / Competitors

Continue

SEC Filing Tools

Material Contracts, Statements, Certifications & more

Caredx, Inc. provided additional information to their SEC Filing as exhibits

Ticker: CDNA
CIK: 1217234
Form Type: 8-K Corporate News
Accession Number: 0001193125-18-159198
Submitted to the SEC: Thu May 10 2018 4:05:56 PM EST
Accepted by the SEC: Thu May 10 2018
Period: Thursday, May 10, 2018
Industry: Medical Laboratories
Events:
  1. Earnings Release
  2. Financial Exhibit

External Resources:
Stock Quote
Social Media

Bookmark the Permalink:
https://last10k.com/sec-filings/cdna/0001193125-18-159198.htm