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): November 4, 2014

 


 

CombiMatrix Corporation

(Exact name of registrant as specified in its charter)

 


 

Delaware

 

001-33523

 

47-0899439

(State or other jurisdiction of incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification Number)

 

310 Goddard, Suite 150
Irvine, CA 92618

(Address of principal executive offices, including zip code)

 

(949) 753-0624

(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 (see General Instruction A.2 below):

 

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

 

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

 

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.24d-2(b))

 

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.23e-4(c))

 

 

 



 

Item 2.02.   Results of Operations and Financial Condition.

 

On November 4, 2014, CombiMatrix Corporation (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 2014.  A copy of that release is furnished as Exhibit 99.1 to this report.

 

Item 9.01.    Financial Statements and Exhibits.

 

(d)         Exhibits.

 

99.1 Press Release dated November 4, 2014 of the Registrant (furnished herewith but not filed pursuant to Item 2.02).

 

The information in Item 2.02 of this Current Report on Form 8-K and in Exhibit 99.1 is being furnished and shall not be deemed “filed” for the 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.  Such information shall not be incorporated by reference into any registration statement or other document or filing pursuant to the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

2



 

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.

 

 

 

COMBIMATRIX CORPORATION

 

 

 

Dated: November 4, 2014

By:

/s/ SCOTT R. BURELL

 

 

Scott R. Burell, Chief Financial Officer

 

3



 

Exhibit Index

 

Exhibit Number

 

Description

 

 

 

99.1

 

Press Release dated November 4, 2014 of the Registrant (furnished herewith but not filed pursuant to Item 2.02).

 

4




Exhibit 99.1

 

 

CombiMatrix Reports Third Quarter

2014 Financial and Operating Results

 

— Reports Record Revenue, Cash Reimbursement and Test Volumes —

 

Company to Host Conference Call and Webcast Today at 1:30 p.m. PST —

 

IRVINE, Calif. — November 4, 2014 — CombiMatrix Corporation (Nasdaq: CBMX), a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today reported financial results for the third quarter and nine months ended September 30, 2014. The Company will host a conference call and webcast at 1:30 p.m. PST, today.

 

“We continued to execute on our three-point plan during the third quarter of 2014,” said Mark McDonough, President and Chief Executive Officer of CombiMatrix. “Once again, our team’s focus resulted in record microarray testing volumes and revenues in our core service offerings. During the quarter, we secured two customer contracts and obtained conditional approval for both miscarriage and pediatric development disorder microarray-based tests in New York State. Investment will continue in these areas and in our partnerships as we continue focus on increasing volumes from existing customers as well as adding new customers in key geographic markets.”

 

Operational Highlights

 

·                  Record prenatal microarray volume of 925 tests in the third quarter of 2014, a 71 percent increase compared to the third quarter of 2013 (see table below). For the nine months ended September 30, 2014, core prenatal microarray test volume grew 64 percent compared to the same period in 2013.

 

·                  The Company’s customer base continued to grow, reaching 175 customers sending tests during the third quarter of 2014, a new record for CombiMatrix, compared to 136 customers sending tests during the third quarter of 2013.

 

·                  Record cash collections of $2.0 million and $5.4 million for the three and nine months ended September 30, 2014, respectively.

 

1



 

Additional test volume and revenue data are as follows:

 

 

 

Volumes

 

Revenues (in 000’s)

 

 

 

Q3 ’14

 

Q3 ’13

 

% Δ

 

Q3 ’14

 

Q3 ’13

 

% Δ

 

Prenatal

 

265

 

178

 

48.9%

 

$

369

 

$

242

 

52.5%

 

Miscarriage analysis

 

660

 

363

 

81.8%

 

944

 

606

 

55.8%

 

Subtotal - prenatal arrays

 

925

 

541

 

71.0%

 

1,313

 

848

 

54.8%

 

Pediatric

 

478

 

495

 

-3.4%

 

501

 

458

 

9.4%

 

Oncology

 

17

 

109

 

-84.4%

 

23

 

75

 

-69.3%

 

Subtotal - all arrays

 

1,420

 

1,145

 

24.0%

 

1,837

 

1,381

 

33.0%

 

Non-array tests

 

539

 

293

 

84.0%

 

174

 

87

 

100.0%

 

Total - all tests

 

1,959

 

1,438

 

36.2%

 

2,011

 

1,468

 

37.0%

 

Royalties

 

 

 

 

 

 

 

51

 

35

 

45.7%

 

Total revenues

 

 

 

 

 

 

 

$

2,062

 

$

1,503

 

37.2%

 

 

 

 

Volumes

 

Revenues (in 000’s)

 

 

 

YTD ’14

 

YTD ’13

 

% Δ

 

YTD ’14

 

YTD ’13

 

% Δ

 

Prenatal

 

718

 

535

 

34.2%

 

$

979

 

$

767

 

27.6%

 

Miscarriage analysis

 

1,816

 

1,013

 

79.3%

 

2,676

 

1,752

 

52.7%

 

Subtotal - prenatal arrays

 

2,534

 

1,548

 

63.7%

 

3,655

 

2,519

 

45.1%

 

Pediatric

 

1,488

 

1,485

 

0.2%

 

1,505

 

1,506

 

-0.1%

 

Oncology

 

198

 

249

 

-20.5%

 

180

 

134

 

34.3%

 

Subtotal - all arrays

 

4,220

 

3,282

 

28.6%

 

5,340

 

4,159

 

28.4%

 

Non-array tests

 

1,252

 

1,359

 

-7.9%

 

367

 

340

 

7.9%

 

Total - all tests

 

5,472

 

4,641

 

17.9%

 

5,707

 

4,499

 

26.9%

 

Royalties

 

 

 

 

 

 

 

118

 

115

 

2.6%

 

Total revenues

 

 

 

 

 

 

 

$

5,825

 

$

4,614

 

26.2%

 

 

Financial Results

 

Quarter ended September 30, 2014 compared to quarter ended September 30, 2013

 

For the quarter ended September 30, 2014, CombiMatrix reported total revenues of $2.1 million, a 37 percent increase over total revenues of $1.5 million for the third quarter of 2013.  The increase in revenues was driven primarily by increased volumes of both microarray and non-microarray diagnostic tests performed as highlighted in the table above.

 

Total operating expenses were $4.6 million for the third quarter of 2014 compared to $3.0 million in the comparable quarter of 2013. The increase was driven primarily by continued investment in revenue generating departments such as sales, marketing, billing and genetic counseling, as well as higher legal defense costs from ongoing litigation, which alone accounted for $696,000 of the increase in general and administrative expenses over the third quarter of 2013. Excluding litigation costs, general and administrative expense growth was slower than revenue growth.  Total operating expenses also reflect increased cost of services due to higher diagnostic test volumes.  Due to improved lab efficiencies, the Company realized a 142 basis point improvement in gross margins during the third quarter ended September 30, 2014 vs. the comparable 2013 period.

 

2



 

Net loss was $2.5 million for the third quarter of 2014 compared to a net loss of $1.4 million in the comparable quarter of 2013. The net loss in the third quarter of 2014 was negatively impacted primarily by increased sales and marketing costs and litigation costs discussed above, partially offset by increased diagnostic revenues and gross margin gains previously discussed.  The 2013 third quarter net loss was also benefited by $119,000 of non-cash warrant derivative gains, which did not repeat during the third quarter of 2014. As a result of certain warrant contract modifications that occurred in the second quarter of 2014, the Company no longer classifies certain warrant securities as derivative liabilities.

 

The Company reported a net loss attributable to common stockholders of $2.5 million, or $0.23 per basic and diluted shares outstanding in the third quarter of 2014, compared to a net loss attributable to common stockholders of $1.4 million, or $0.30 per basic and diluted shares outstanding, for the same period in 2013.

 

Nine months ended September 30, 2014 compared to nine months ended September 30, 2013

 

For the nine months ended September 30, 2014, CombiMatrix reported total revenues of $5.8 million, a 26 percent increase over total revenues of $4.6 million for the same period in 2013.  The increase in revenues was driven primarily by increased volumes of microarray diagnostic tests performed as reflected in the table above.

 

Total operating expenses were $13.0 million for the nine months ended September 30, 2014, compared to $9.2 million in the comparable period in 2013. The increase was driven primarily by continued investment in sales and marketing as well as higher legal defense costs from ongoing litigation, which alone accounted for $1.9 million of the increase in general and administrative expenses over the comparable period in 2013.  Excluding litigation costs, general and administrative expense growth was slower than revenue growth.  Total operating expenses also reflect increased cost of services due to higher diagnostic test volumes.  Due to improved lab efficiencies, the Company realized a 280 basis point improvement in gross margins during the nine months ended September 30, 2014 vs. the comparable 2013 period.

 

3



 

Net loss was $7.1 million for the nine months ended September 30, 2014, compared to $2.6 million in the comparable period in 2013. A significant component of the increase period-over-period was due to a $2.4 million non-cash warrant derivative gain recognized in the first nine months of 2013 compared to only $152,000 of non-cash warrant derivative gain recognized in the first nine months of 2014.  A reduction in the number of derivative warrants outstanding due to warrant exercises in early 2014 as well as the warrant contract modifications that occurred in the second quarter of 2014 were the primary reasons for the decrease in the gain period-over-period.  Increases in sales and marketing and general and administrative expenses also contributed to the overall increase in net loss period-over-period.

 

Net loss attributable to common stockholders was $7.1 million, or $0.64 per basic and diluted shares outstanding for the nine months ended September 30, 2014, compared to $4.5 million, or $1.29 per basic and diluted shares outstanding in the prior year period.

 

Cash, cash equivalents and short-term investments totaled $7.4 million as of September 30, 2014, compared to $14.0 million as of December 31, 2013.  For the three and nine months ended September 30, 2014, net cash used in operating activities was $2.6 million and $6.6 million, respectively, compared to $1.2 million and $4.1 million in the comparable 2013 periods, respectively.  The increase in net cash used in operating activities for all periods presented was due primarily to increased cash spent on ongoing litigation, which totaled $1.0 million and $1.9 million for the three and nine months ended September 30, 2014, respectively, compared to only $84,000 and $146,000 for the comparable 2013 periods, respectively.  The increase in cash used in operating activities was partially mitigated by record cash reimbursement on diagnostic services billed, which were $2.0 million and $5.4 million for the three and nine months ended September 30, 2014, respectively, compared to $1.5 million and $4.4 million for the comparable 2013 periods, respectively.

 

4



 

Recent Business Highlights

 

·                  CombiMatrix’s chromosomal microarray analysis (CMA) test to identify development disorders in pediatric patients, the CombiSNP™ Array for Pediatric Analysis, and its fresh tissue or paraffin-embedded tissue sample miscarriage analysis test, the CombiSNP™ Array for Pregnancy Loss, have received conditional approval from the New York Department of Health for testing on patient samples.

 

·                  CombiMatrix signed a contract with Stratose Networks Division, one of the largest directly-managed PPO networks in the U.S., to provide coverage of CombiMatrix’s diagnostic laboratory services.

 

·                  CombiMatrix signed a contract with Blue Cross Blue Shield of Illinois for coverage of the Company’s diagnostic services.

 

·                  Data was presented by Dr. Sahoo, Director of Cytogenetics for CombiMatrix, at the American Society of Human Genetics (ASHG) showing that chromosomal microarray analysis yields a successful result in more than 85 percent of cases.(1)

 

·                  The evidence portion of the previously reported lawsuit concluded on August 22, 2014.  The summation briefs have been filed and responses to the briefs have been submitted to the Superior Court of Orange County, California. The case is now under judicial review. By statute, the Superior Court has 90 days from the date that final briefs have been filed to issue its decision, and another 60 days to consider arguments from the parties in the case before its final findings of fact and conclusions of law are issued. It is also possible that such findings and conclusions could be issued sooner.

 

Conference Call and Webcast

 

CombiMatrix will host a conference call at 1:30 p.m. PST (4:30 p.m. EST) today to discuss the third quarter and year-to-date 2014 financial and operating results. To access the presentation by phone, dial 1-877-407-0784 for domestic callers and 1-201-689-8560 for direct dial or international callers. Please ask for the “CombiMatrix Corporation 2014 Third Quarter Financial Results Conference Call.” The conference call will be webcast live under the investor relations section of CombiMatrix’s website at www.combimatrix.com. A replay of the presentation will be available following the presentation for 30 days, either via the CombiMatrix website Investor/Events section or by dialing 1-877-870-5176 for domestic callers or 1-858-384-5517 for direct-dial international callers. When prompted, enter playback pin number 13592247.

 


(1)  T. Sahoo, M. Strecker, A. Mehta, N. Dzidic, R. W. Tyson, K. Hovanes., Comprehensive genetic analysis of pregnancy loss by chromosomal microarrays: outcomes, benefits and challenges. (Platform presentation; Abstract #227/Program #44 Prenatal, Perinatal, and Reproductive Genetics). Presented at the 64th Annual Meeting of The American Society of Human Genetics, October 20, 2014 in San Diego, California.

 

5



 

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

 

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations, speak only as of the date hereof and are subject to change. All statements, other than statements of historical fact included in this press release, are forward-looking statements. Forward-looking statements can often be identified by words such as “anticipates,” “expects,” “intends,” “plans,” “goal,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “could,” “potential,” “continue,” “ongoing,” similar expressions, and variations or negatives of these words and include, but are not limited to, statements regarding projected results of operations and management’s future business, operational and strategic plans, recruiting efforts and test menu expansion. These forward-looking statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause our actual results to differ materially and adversely from those expressed in any forward-looking statement. The risks and uncertainties referred to above include, but are not limited to: our ability to successfully expand the base of our customers and strategic partners, add to the menu of our diagnostic tests, develop and introduce new tests and related reports, expand and improve our current suite of services, optimize the reimbursements received for our microarray testing services, and increase operating margins by improving overall productivity and expanding sales volumes; our ability to successfully accelerate sales, steadily increase the size of our customer rosters in both prenatal and developmental genetic testing markets; our ability to attract and retain a qualified sales force in wider geographies; our ability to ramp production from our sales force and our strategic partners; rapid technological change in our markets; changes in demand for our future services; legislative, regulatory and competitive developments; litigation; general economic conditions; and various other factors. Further information on potential factors that could affect our financial results is included in our Annual Report on Form 10-K, Quarterly Reports of Form 10-Q, and in other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.

 

Company Contact:

 

Media Contact:

Mark McDonough

 

David Schull or Lena Evans

President & CEO, CombiMatrix Corporation

 

Russo Partners LLC

(949) 753-0624

 

(212) 845-4271

 

 

david.schull@russopartnersllc.com

Investor Contact:

 

lena.evans@russopartnersllc.com

Robert Flamm, Ph.D.

 

 

Russo Partners, LLC

 

 

(212) 845-4226

 

 

robert.flamm@russopartnersllc.com

 

 

 

TABLES FOLLOW

 

6



 

COMBIMATRIX CORPORATION

CONSOLIDATED SUMMARY FINANCIAL INFORMATION

(In thousands, unaudited)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2014

 

2013

 

2014

 

2013

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

Diagnostic services

 

$

2,011

 

$

1,468

 

$

5,707

 

$

4,499

 

Royalties

 

51

 

35

 

118

 

115

 

Total revenues

 

2,062

 

1,503

 

5,825

 

4,614

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Cost of services

 

1,129

 

845

 

3,180

 

2,633

 

Research and development

 

228

 

247

 

586

 

607

 

Sales and marketing

 

1,191

 

657

 

3,186

 

1,993

 

General and administrative

 

1,983

 

1,149

 

5,956

 

3,773

 

Patent amortization and royalties

 

28

 

64

 

88

 

190

 

Total operating expenses

 

4,559

 

2,962

 

12,996

 

9,196

 

Operating loss

 

(2,497

)

(1,459

)

(7,171

)

(4,582

)

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest income

 

7

 

3

 

36

 

4

 

Interest expense

 

(25

)

(18

)

(63

)

(339

)

Warrant derivative gains

 

 

119

 

152

 

2,363

 

Warrant modification charge

 

 

 

(44

)

 

Total other income (expense)

 

(18

)

104

 

81

 

2,028

 

Net loss

 

$

(2,515

)

$

(1,355

)

$

(7,090

)

$

(2,554

)

 

 

 

 

 

 

 

 

 

 

Series A convertible preferred stock dividends

 

$

 

$

 

$

 

$

(246

)

Series C convertible preferred stock dividends

 

 

(14

)

 

(25

)

Deemed dividends from issuing Series B convertible preferred stock

 

 

 

 

(417

)

Deemed dividends from issuing Series C convertible preferred stock

 

 

 

 

(1,213

)

Net loss attributable to common stockholders

 

$

(2,515

)

$

(1,369

)

$

(7,090

)

$

(4,455

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.23

)

$

(0.30

)

$

(0.64

)

$

(0.74

)

Series A convertible preferred stock dividends

 

 

 

 

(0.07

)

Series C convertible preferred stock dividends

 

 

 

 

(0.01

)

Deemed dividends from issuing Series B convertible preferred stock

 

 

 

 

(0.12

)

Deemed dividends from issuing Series C convertible preferred stock

 

 

 

 

(0.35

)

Basic and diluted net loss per share attributable to common stockholders

 

$

(0.23

)

$

(0.30

)

$

(0.64

)

$

(1.29

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted weighted average common shares outstanding

 

11,063,246

 

4,464,380

 

11,018,231

 

3,450,166

 

 

CONSOLIDATED BALANCE SHEET INFORMATION:

 

 

 

September 30,

 

December 31,

 

 

 

2014

 

2013

 

Total cash, cash equivalents and short-term investments

 

$

7,380

 

$

14,036

 

Total assets

 

$

10,663

 

$

16,832

 

Total liabilities

 

$

2,021

 

$

2,168

 

Total stockholders’ equity

 

$

8,642

 

$

14,664

 

#  #  #

 

7


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