0001193125-13-223103.txt : 20130516 0001193125-13-223103.hdr.sgml : 20130516 20130515214810 ACCESSION NUMBER: 0001193125-13-223103 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20130515 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20130516 DATE AS OF CHANGE: 20130515 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CANCER GENETICS, INC CENTRAL INDEX KEY: 0001349929 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071] IRS NUMBER: 043462475 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35817 FILM NUMBER: 13849355 BUSINESS ADDRESS: STREET 1: 201 ROUTE 17 NORTH STREET 2: 2ND FLOOR CITY: RUTHERFORD STATE: NJ ZIP: 07070 BUSINESS PHONE: 201.528.9200 MAIL ADDRESS: STREET 1: 201 ROUTE 17 NORTH STREET 2: 2ND FLOOR CITY: RUTHERFORD STATE: NJ ZIP: 07070 FORMER COMPANY: FORMER CONFORMED NAME: CANCER GENETICS INC DATE OF NAME CHANGE: 20060117 8-K 1 d540155d8k.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 15, 2013

 

 

CANCER GENETICS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   001-35817   04-3462475

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

201 Route 17 North 2nd Floor, Rutherford, New Jersey   07070
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code (201) 528-9200

(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 (see General Instruction A.2. below):

 

¨ 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))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On May 15, 2013, Cancer Genetics, Inc. (the “Registrant”) issued a press release regarding financial results for the fiscal quarter ended March 31, 2013. A copy of the press release is being furnished as Exhibit 99.1 to this report.

The information in this report is being furnished pursuant to Item 2.02 of Form 8-K. In accordance with General Instruction B.2 of Form 8-K, the information in this report, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as may be expressly set forth by specific reference in such a filing.

Forward-Looking Statements

This report, including Exhibit 99.1 furnished herewith, contains forward-looking statements within the meaning of the federal securities laws. Forward-looking statements typically are identified by use of terms such as “may,” “will,” “should,” “plan,” “expect,” “anticipate,” “estimate” and similar words, and the opposites of such words, although some forward-looking statements are expressed differently. Forward-looking statements involve known and unknown risks and uncertainties that exist in the Registrant’s operations and business environment, which may be beyond the Registrant’s control, and which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. For example, forward-looking statements include, without limitation: statements regarding prospects for additional customers; market forecasts; projections of earnings, revenues, synergies, accretion or other financial information; and plans, strategies and objectives of management for future operations. The risks and uncertainties referred to above include, but are not limited to, risks detailed from time to time in the Registrant’s filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2013. These risks could cause actual results to differ materially from those expressed in any forward-looking statements made by, or on behalf of, the Registrant. Forward-looking statements represent the judgment of management of the Registrant regarding future events. Although the Registrant believes that the expectations reflected in such forward-looking statements are reasonable at the time that they are made, the Registrant can give no assurance that such expectations will prove to be correct. Unless otherwise required by applicable law, the Registrant assumes no obligation to update any forward-looking statements, and expressly disclaims any obligation to do so, whether as a result of new information, future events or otherwise.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

As described above, the following exhibit is furnished as part of this report:

Exhibit 99.1 – Press release, dated May 15, 2013.

 

-2-


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.

 

CANCER GENETICS, INC.
By:  

/s/ Elizabeth A. Czerepak

  Name: Elizabeth A. Czerepak
  Title:   Chief Financial Officer

Date: May 15, 2013

 

-3-


EXHIBIT INDEX

 

Exhibit Number    Description
99.1    Press release, dated May 15, 2013.
EX-99.1 2 d540155dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

Cancer Genetics Announces First Quarter 2013 Financial Results

and Significant Business and Portfolio Progress

First quarter revenue increased 46% YoY

Clinical test volume increased 19% YoY

Institutional client base grows to 42% of revenues

DNA-Probe product manufacturing moved to India, reducing cost of goods

RUTHERFORD, NJ, May 15, 2013 /Business Wire/ — Cancer Genetics, Inc. (OTCQB: CGIX) (“CGI” or the “Company”) is an emerging leader in the diagnosis and disease management for the most complex and difficult-to-treat cancers, including hematologic, urogenital, and gynecological malignancies. CGI’s focused portfolio of IP-protected and clinically validated genomic tests, CAP- and CLIA-certified reference laboratory, and suite of unique service offerings are ideally positioned to serve the needs of clinicians, pathologists and laboratories across the entire ecosystem of cancer diagnosis and treatment. CGI today reported financial results for the quarter ended March 31, 2013.

Revenue for the first quarter of 2013 increased 46% to $1.2 million, compared with $835,000 in the first quarter of 2012.

Clinical test volume increased 19% to 1,911 tests in the first quarter, compared with 1,610 tests in the first quarter of 2012.

Average revenue per test increased 23% to $615, from $502 in the first quarter of 2012, driven by an increase in direct bill revenue.

DNA-probe sales by the Company’s wholly-owned subsidiary, CGI Italia, increased 193% to $44,000 for the first quarter of 2013, from $15,000 for the same period of 2012.

Gross profit increased to $149,000 in the first quarter, from $12,000 for the same period of 2012, while gross margin improved to 12% compared to 1% in the first quarter of 2012 and 9% for the full year 2012.

Adjusted for a one-time write off of $618,000 in IPO-related costs, operating expenses were unchanged at $1.8 million in the first quarter, compared to the same period of 2012. R&D expense remained relatively flat at $491,000, compared to $524,000 in the first quarter of 2012. Sales and marketing expense increased 16% to $396,000 in the first quarter, from $340,000 in the year-ago period.

Adjusted for the one-time write off in IPO-related costs, loss from operations in the first quarter was $1.7 million, compared to $1.8 million in the same period of 2012.

Net income for the first quarter was $2.4 million, or $1.75 per share, compared to a net loss of $1.1 million, or ($0.81) per share, in the first quarter of 2012. This increase in income was primarily the result of income related to a $5.3 million decrease in the fair value of derivative


warrant liability, plus an income tax benefit of $664,000 from the sale of certain net operating losses (“NOLs”) in the state of New Jersey. These gains were partially offset by the increase in operating loss and an increase in interest expense. Interest expense increased from $865,000 in the first quarter of 2012 to $1.3 million in the first quarter of 2013. As of the Company’s initial public offering in April, $9.6 million of debt was converted to equity, which is expected to significantly decrease interest expense going forward.

In April, CGI completed a 690,000 share equity offering, including the 90,000 share overallotment option, for which the Company received gross proceeds of $6.9 million. After deducting transaction fees and offering-related expenses not previously paid, CGI netted approximately $5.0 million. Prior to the offering, as of March 31, cash-on-hand was $217,000, compared to $820,000 at December 31, 2012. Cash used in operations in the first quarter was $560,000, compared to $3.2 million cash used in the first quarter of 2012. The reduction in cash usage was the result of $664,000 received in the first quarter of 2013 from the sale of certain state tax NOLs, plus the non-recurrence of $2.1 million in one-time payments that were made in the first quarter of 2012.

Panna Sharma, President and CEO of CGI, commented, “We made significant progress during this past quarter, and it places us in a great position for 2013. The growth in clinical volumes has been due to both new relationships with community hospitals and biotechnology companies using our proprietary programs and from existing customers expanding the range of oncology-focused biomarker testing CGI is providing them. We see this past quarter, which was completed prior to our IPO, as a good foundation for further growth in 2013 as we continue our investment in sales professionals, marketing and brand awareness.”

Mr. Sharma continued, “The recent launches of our microarrays in our hematological and urogenital franchises, namely our DLBCL and kidney cancer tests, clearly demonstrate our ability to effectively innovate and develop the genomic products that will help drive improved diagnosis, deeper insights about outcome, and better therapeutic decision making. Our relationship with Gilead, which was announced in March, clearly highlights the value and future growth that our proprietary products can generate for our company. We expect further launches in 2013 that will increase our portfolio of commercially available genomic tests and drive additional value for community hospitals, biopharma companies and patients.”

“We have a deep knowledge base in these underserved cancers; this, coupled with our approach to commercialization, will be a cornerstone for our joint venture with Mayo Clinic in next-generation sequencing. We believe our investors will be able to participate in both a high-growth genomics company serving the market today, and participate in the long-term upside of proprietary programs that are positioned to change the nature of oncology diagnosis and management in the future.”

Recent Business Highlights:

 

   

Selected by Gilead Sciences to provide molecular profiling and clinical trial testing for all national and international trials for chronic lymphocytic leukemia (CLL), which will include the proprietary MatBA-CLL array.


   

Successfully completed migration of DNA-Probe manufacturing to India in order to reduce cost, increase capacity and improve operational flexibility.

 

   

Launched unique genomic microarrays for lymphoma (MatBA®-DLBCL) in February 2013 and kidney cancer (UroGenRA™-Renal) in April 2013 that have been approved by both CLIA and New York State.

 

   

Expanded clinical sales force into Midwestern United States and Texas.

 

   

Established distribution partnership with Nikon Instruments for sale of CGI’s DNA-Probe portfolio into Italy and Europe as a key component of their cytogenetic fluorescent microscope equipment offering.

Meetings & Presentations

 

   

Presenting at UBS Global Healthcare Conference on May 22 at 12:30 p.m. ET

 

   

Presenting at Marcum MicroCap Conference on May 30

 

   

Attending the ASCO Annual Meeting from May 31-June 4

 

   

Moderating the BioNJ Diagnostics & Personalized Medicine Panel on June 6 at the Annual BioNJ Personalized Medicine Innovation Summit

Conference Call Details:

CGI will hold a conference call on Thursday, May 16, 2013, at 9:00 a.m. Eastern time to discuss its results for the first quarter ended March 31, 2013. To participate in the call, please dial (877) 941-1428, or (480) 629-9665 for international calls, approximately 10 minutes prior to the scheduled start time. Interested parties can also listen via a live Internet webcast, which can be found via the Company’s website at http://ir.stockpr.com/cancergenetics/events, or alternately at http://ViaVid.net.

A replay of the call will be available for two weeks from 5:00 p.m. ET on May 16, 2013, until 11:59 p.m. ET on May 30, 2013. The number for the replay is (877) 870-5176, or (858) 384-5517 for international calls; the passcode for the replay is 4619856. In addition, a recording of the call will be available via the Company’s website at http://www.cancergenetics.com.

About Cancer Genetics

Cancer Genetics, Inc. (CGI) is an emerging leader in DNA-based cancer diagnostics and services some of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict treatment outcomes. These cancers include hematological, urogenital and HPV-associated cancers. We also provide a comprehensive range of non-proprietary oncology-focused tests and laboratory services.

CGI’s cutting-edge proprietary tests and state-of-the-art reference laboratory provide critical genomic information to healthcare professionals as well as biopharma and biotech. Our state-of-the-art reference lab is focused entirely on maintaining clinical excellence and is both CLIA certified and CAP accredited and has licensure from several states including New York State.


Founded in 1999 by world-renowned cytogeneticist Dr. R.S.K. Chaganti, the Company has been built on a foundation of world-class scientific knowledge and IP in solid and blood-borne cancers, and has established strong research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic and the National Cancer Institute. For further information, please see www.cancergenetics.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development and potential opportunities for Cancer Genetics, Inc. products and services, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights and other risks discussed in the Company’s Form 10-Q for the quarter ended March 31, 2013 and other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics disclaims any obligation to update these forward-looking statements.

Contact:

Investor Relations

RedChip Companies, Inc.

Jon Cunningham, 800-733-2447, ext. 107

jon@redchip.com


Consolidated Balance Sheets

(Unaudited)

 

     March  31,
2013
(Unaudited)
    December 31,
2012
 

ASSETS

    

CURRENT ASSETS

    

Cash and cash equivalents

   $ 216,872      $ 819,906   

Accounts receivable, net of allowance for doubtful accounts of $36,000

     1,124,893        850,545   

Other current assets

     598,631        489,278   
  

 

 

   

 

 

 

Total current assets

     1,940,396        2,159,729   
  

 

 

   

 

 

 

FIXED ASSETS, net of accumulated depreciation

     899,049        964,923   
  

 

 

   

 

 

 

OTHER ASSETS

    

Security deposits

     1,564        1,564   

Restricted cash

     250,000        250,000   

Loan guarantee and financing fees, net of accumulated amortization of 2013 $1,334,610; 2012 $929,498

     1,516,631        1,907,502   

Patents

     329,309        324,764   

Deferred initial public offering costs

     2,473,763        3,343,289   
  

 

 

   

 

 

 
     4,571,267        5,827,119   
  

 

 

   

 

 

 

Total Assets

   $ 7,410,712      $ 8,951,771   
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

    

CURRENT LIABILITIES

    

Accounts payable and accrued expenses

   $ 4,885,145      $ 4,578,761   

Obligations under capital leases, current portion

     20,464        17,158   

Deferred revenue

     676,327        468,010   

Notes payable, current portion

     4,530,640        3,836,567   

Line of credit

     2,989,577        2,871,200   
  

 

 

   

 

 

 

Total current liabilities

     13,102,153        11,771,696   

Obligations under capital leases

     —         7,490   

Deferred rent payable

     165,920        164,298   

Notes payable, long-term

     2,148,494        2,440,683   

Line of credit

     6,000,000        6,000,000   

Warrant liability

     7,518,000        12,549,000   
  

 

 

   

 

 

 

Total liabilities

     28,934,567        32,933,167   

STOCKHOLDERS’ DEFICIT

    

Series A Preferred Stock, authorized 588,000 shares $0.0001 par value (converted to common stock on April 10, 2013), 587,691 shares issued and outstanding

     59        59   

Series B Preferred Stock, authorized 2,000,000 shares $0.0001 par value (converted to common stock on April 10, 2013), 1,821,600 shares issued and outstanding

     182        182   

Common stock, authorized 100,000,000 and 24,000,000 shares, respectively, $0.0001 par value, 1,349,936 shares issued and outstanding

     135        135   

Additional paid-in capital

     25,067,388        24,970,255   

Treasury stock

     —          (17,442

Accumulated deficit

     (46,591,619     (48,934,585
  

 

 

   

 

 

 

Total Stockholders’ Deficit

     (21,523,855     (23,981,396
  

 

 

   

 

 

 

Total Liabilities and Stockholders’ Deficit

   $ 7,410,712      $ 8,951,771   
  

 

 

   

 

 

 


Consolidated Statements of Operations

(Unaudited)

 

     Three Months Ended March 31,  
     2013     2012  

Revenue

   $ 1,218,667      $ 834,752   

Cost of revenues

     1,070,020        823,052   
  

 

 

   

 

 

 

Gross profit

     148,647        11,700   
  

 

 

   

 

 

 

Operating expenses:

    

Research and development

     490,577        523,511   

General and administrative

     1,570,629        936,157   

Sales and marketing

     396,554        339,568   
  

 

 

   

 

 

 

Total operating expenses

     2,457,760        1,799,236   
  

 

 

   

 

 

 

Loss from operations

     (2,309,113     (1,787,536

Other income (expense):

    

Interest expense

     (1,293,985     (864,981

Interest income

     606        —     

Change in fair value of warrant liability

     5,299,000        1,580,000   
  

 

 

   

 

 

 

Total other income (expense)

     4,005,621        715,019   
  

 

 

   

 

 

 

Income (loss) before income taxes

     1,696,508        (1,072,517

Income tax provision (benefit)

     (663,900     —      
  

 

 

   

 

 

 

Net income (loss)

   $ 2,360,408      $ (1,072,517
  

 

 

   

 

 

 

Basic net income (loss) per share

   $ 1.75      $ (0.81
  

 

 

   

 

 

 

Diluted net loss per share

   $ (2.18   $ (1.85
  

 

 

   

 

 

 

Basic Weighted Average Shares Outstanding

     1,349,936        1,329,279   
  

 

 

   

 

 

 

Diluted Weighted Average Shares Outstanding

     1,349,936        1,433,182   
  

 

 

   

 

 

 


Consolidated Statements of Cash Flows

(Unaudited)

 

     Three Months Ended March 31,  
     2013     2012  

CASH FLOWS FROM OPERATING ACTIVITIES

    

Net income (loss)

   $ 2,360,408      $ (1,072,517

Adjustments to reconcile net income (loss) to net cash used in operating activities:

    

Depreciation

     77,783        82,963   

Amortization

     3,807        3,807   

Provision for bad debts

     —         48,931   

Equity-based consulting and compensation expenses

     97,133        276,867   

Change in fair value of warrant liability

     (5,299,000     (1,580,000

Amortization of loan guarantee and financing fees

     407,871        244,336   

Accretion of discount on debt

     538,911        404,150   

Deferred rent

     1,622        1,997   

Deferred initial public offering costs expensed

     617,706        —     

Change in working capital components:

    

Accounts receivable

     (274,348     (110,000

Other current assets

     10,647        (152,969

Accounts payable, accrued expenses and deferred revenue

     897,521        (1,350,859
  

 

 

   

 

 

 

Net cash (used in) operating activities

     (559,939     (3,203,294
  

 

 

   

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

    

Purchase of fixed assets

     (11,909     (7,677

Patent costs

     (8,352     (43,201

Increase in restricted cash

     —         (50,000
  

 

 

   

 

 

 

Net cash (used in) investing activities

     (20,261     (100,878
  

 

 

   

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

    

Principal payments on capital lease obligations

     (4,184     (10,569

Payment of equity issuance costs

     —         (688,969

Proceeds from warrant exercises

     —         619,980   

Proceeds from borrowings on notes payable

     —         3,000,000   

Principal payments on notes payable

     (18,650     —     
  

 

 

   

 

 

 

Net cash provided by (used in) financing activities

     (22,834     2,920,442   
  

 

 

   

 

 

 

Net (decrease) in cash and cash equivalents

     (603,034     (383,730

CASH AND CASH EQUIVALENTS

    

Beginning

     819,906        2,417,256   
  

 

 

   

 

 

 

Ending

   $ 216,872      $ 2,033,526   
  

 

 

   

 

 

 

SUPPLEMENTAL CASH FLOW DISCLOSURE

    

Cash paid for interest

   $ 128,215      $ 241,987   

SUPPLEMENTAL DISCLOSURE OF NONCASH

    

INVESTING AND FINANCING ACTIVITIES

    

Warrants issued for financing fees

   $ 47,000      $ —     

Warrants issued with debt

     —         940,000   

Warrants issued for debt guarantee fee

     —         1,061,000   

Accrued IPO costs

     601,430        —     

Payment of accrued IPO costs

     —         162,878   

IPO costs discounted

     733,250     

IPO costs reclassified to accounts receivable

     120,000     

Accrued expenses reclassified as derivative warrant liability

     221,000        —     

Accrued expenses recorded as financing fees

     —         147,000   

Retirement of treasury stock

     17,442        —     


RECONCILIATION OF GAAP OPERATING EXPENSES TO NON-GAAP

ADJUSTED OPERATING EXPENSES

 

     For the Three Months Ended
March 31,
 
     2013      2012  

Operating Expenses

     2,458         1,799   

Adjustments to Operating Expense

     

One-Time Write Off of IPO Costs

     618         —     
  

 

 

    

 

 

 

Adjusted Operating Expenses

     1,840         1,799   

The non-GAAP metric above is not a substitute for GAAP but is viewed as useful by management this quarter because of its recent IPO.

RECONCILIATION OF GAAP LOSS FROM OPERATIONS TO NON-GAAP

ADJUSTED LOSS FROM OPERATIONS

 

     For the Three Months Ended
March 31,
 
     2013     2012  

Loss from Operations

     (2,309     (1,788

Adjustments to Loss from Operations

    

One-Time Write Off of IPO Costs

     618        —     
  

 

 

   

 

 

 

Adjusted Loss from Operations

     (1,691     (1,788

The non-GAAP metric above is not a substitute for GAAP but is viewed as useful by management this quarter because of its recent IPO.

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