Genomic Health, Inc.
GENOMIC HEALTH INC (Form: 8-K, Received: 11/06/2018 16:50:46)

 

 

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 6, 2018

 

GENOMIC HEALTH, INC.

(Exact name of registrant as specified in its charter)

 

 

 

 

Delaware

000-51541

77-0552594

(State or other jurisdiction

(Commission

(IRS Employer

of incorporation)

File Number)

Identification No.)

 

 

 

 

301 Penobscot Drive, Redwood City, California

94063

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code:  (650) 556-9300

 

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 Regulation S-K of the Securities Act (17 CFR 230.405) or Rule 12b-2 of the Exchange Act (17 CFR 240.12b-2):

 

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 November 6, 2018, Genomic Health, Inc. issued a press release announcing financial results for its third fiscal quarter ended September 30, 2018.  The full text of the press release is furnished as Exhibit 99.1.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

99.1 Press release issued by Genomic Health, Inc. dated November 6, 2018.

 


 

GENOMIC HEALTH, INC.

EXHIBIT INDEX

 

 

 

 

Exhibit
Number

 

Description

99.1

 

Press release issued by Genomic Health, Inc. dated November 6, 201 8

 


 

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.

 

 

Dated:  November 6, 2018

 

 

 

 

 

GENOMIC HEALTH, INC.

 

 

 

 

 

 

 

By

/s/ G. Bradley Cole

 

Name:

G. Bradley Cole

 

Title:

Chief Financial Officer

 

 


Exhibit 99.1

 

PICTURE 1

Contacts :

 

Investors:

Emily Faucette

Genomic Health

650-569-2824

investors@genomichealth.com

 

Media:

Victoria Steiner

Genomic Health

415-370-5804

media@genomichealth.com

 

Genomic Health Announces Record Revenue and Profit in Third Quarter 2018 Financial Results; Raises Full Year Guidance

 

Reported $101M in Revenue and Delivered 23 Percent Growth on a Pre-606 Adjusted Revenue Basis

Delivered $12M Profit on a GAAP Basis; $13M Profit on a Non-GAAP Basis

Achieved 13 th Consecutive Quarter of Improved Non-GAAP Profitability

Raises Full Year 2018 Revenue and Net Income Guidance

REDWOOD CITY, Calif., November 6, 2018 -- Genomic Health, Inc. (NASDAQ: GHDX)   today reported financial results and business progress for the quarter ended September 30, 2018.

“We continue to deliver record results in 2018, including 23 percent revenue growth and $12 million in profit for the third quarter. Our strong performance this year reflects increasing global demand and revenue for the Oncotype DX Breast Recurrence Score test, continued demand and growing reimbursement for the Genomic Prostate Score test and success in driving operational efficiencies across the business,” said  Kim Popovits , chairman of the board, chief executive officer and president of  Genomic Health . “With three quarters of record performance this year, we are raising our full year 2018 guidance and expect to deliver more than 17 percent revenue growth for the year.”

Third Quarter and Nine Months Ended September 30, 2018, Financial Results

Total revenue was $101.3 million in the third quarter of 2018, compared with pre-606 adjusted revenue* of $82.2 million for the third quarter of 2017, an increase of 23 percent. Reported revenue was $83.8 million in the third quarter of 2017. 

U.S. product revenue was $85.8 million in the third quarter of 2018, compared with pre-606 adjusted revenue of $69.5 million for the third quarter of 2017, an increase of 23 percent. U.S. product reported revenue was $70.9


 

 

million in the third quarter of 2017. U.S. invasive breast revenue from Oncotype DX Breast Recurrence Score ® tests was $76.7 million in the third quarter of 2018, compared with U.S. invasive breast pre-606 adjusted revenue of $61.6 million for the third quarter of 2017, an increase of 24 percent. U.S. invasive breast reported revenue was $63.1 million in the third quarter of 2017. U.S. prostate test revenue from Oncotype DX ® Genomic Prostate Score ®   (GPS™) tests was $6.9 million in the third quarter of 2018, compared with $5.4 million in the third quarter of 2017, an increase of 28 percent.

International product revenue was $15.5 million in the third quarter of 2018, compared with pre-606 adjusted revenue of $12.7 million for the third quarter of 2017, an increase of 22 percent, and a 20 percent increase on a non-GAAP constant currency basis. International product reported revenue was $12.9 million in the third quarter of 2017.

Net income was $12.2 million, or $0.34 and $0.32 per share on a basic and diluted basis, respectively, in the third quarter of 2018 , an improvement of $14.4 million, compared with a net loss of $2.2 million, or $0.06 per share on a basic and diluted basis, in the third quarter of 2017. Operating income was $11.8 million in the third quarter of 2018, an improvement of $14.4 million, compared with an operating loss of $2.6 million in the third quarter of 2017.

On a non-GAAP basis, net income was $13.3 million in the third quarter of 2018, compared with a non-GAAP net income of $1.1 million in the third quarter of 2017. Non-GAAP operating income was $12.9 million in the third quarter of 2018, compared with a non-GAAP operating income of $0.6 million in the third quarter of 2017.

More than 34,810 Oncotype™ test results were delivered in the third quarter of 2018, an increase of 10 percent, compared with more than 31,580 test results delivered in the same period in 2017. Oncotype DX Breast Recurrence Score tests delivered in the U.S. grew 12 percent in the third quarter of 2018, compared with the same period in 2017. Oncotype DX GPS tests delivered in the U.S. grew 15 percent in the third quarter of 2018, compared with the same period in 2017. The number of international tests delivered grew 6 percent in the third quarter of 2018, compared with the same period in 2017 and represented approximately 25 percent of total test volume in the quarter.

Total revenue for the nine months ended September 30, 2018, was $289.5 million, compared with pre-606 adjusted revenue of $248.2 million for the same period in 2017, an increase of 17 percent, and an increase of 16 percent on a non-GAAP constant currency basis. Reported revenue was $253.3 million for the nine months ended September 30, 2017.

International product revenue was $43.4 million for the nine months ended September 30, 2018, compared with pre-606 adjusted revenue of $38.6 million for the nine months ended September 30, 2017, an increase of 12 percent, and a 9 percent increase on a non-GAAP constant currency basis. International product reported revenue was $39.4 million for the nine months ended September 30, 2017.

GAAP net income was $16.8 million for the nine months ended September 30, 2018, an improvement of $22.5 million, compared with a net loss of $5.7 million for the nine months ended September 30, 2017. Operating income increased to $14.5 million for the nine months ended September 30, 2018, an improvement of $23.1 million, compared with an operating loss of $8.6 million for the nine months ended September 30, 2017.

Non-GAAP net income was $27.3 million for the nine months ended September 30, 2018, compared with a $4.5 million non-GAAP net loss for the nine months ended September 30, 2017. Non-GAAP operating income was $26.5 million for the nine months ended September 30, 2018, compared with a non-GAAP operating loss of $5.4 million for the same period in 2017.


 

 

Cash and cash equivalents and short-term marketable securities at September 30, 2018 were $183.3 million, which included the fair value of the company’s investment in marketable securities of $3.8 million, compared with $129.6 million at December 31, 2017, which included the fair value of the company’s investment in marketable securities of $3.5 million.

2018 Financial Outlook

“We are on track to deliver revenue growth of 17 percent in 2018, surpassing both the top-end of our original revenue guidance for the full year and our annual revenue growth goal of 15 percent,” said Brad Cole, chief financial officer of Genomic Health. “We are raising our revenue and net income guidance for the full year ending December 31, 2018, which assumes 17 to 19 percent year-over-year revenue growth in the fourth quarter and our 14 th consecutive quarter of improved non-GAAP profitability.”

Below is a table summarizing the 2018 full-year guidance revisions:

 

 

Updated Guidance

Former Guidance

 

 

Low

 

High

Low

High

Revenue (1)

 

$      389

 

$     391

$     366

$     382

Revenue Growth (2)

 

17%

 

17%
10%
15%

 

 

 

 

 

 

 

Net Income (GAAP) (1)

 

$        26

 

$       28

   $        0

  $        5

GAAP Basic EPS (3)

 

$     0.72

 

$    0.78

$    0.00

$    0.14

 

 

 

 

 

 

 

Net Income (Non-GAAP) (1) (4)

 

$        37

 

$       39

$       14

$       20

Non-GAAP Basic EPS (3)

 

$     1.03

 

$    1.08

$    0.39

$    0.56

 

 

 

 

 

 

 

(1)

In millions.

(2)

The outlook for revenue growth in 2018 represents management's estimates for 2018 versus 2017 reported revenues adjusted to reflect the impact of ASC 606 revenue recognition rules, which were effective January 1, 2018. Under the new rules, the company will report most uncollectible balances as a reduction in net revenues; historically, certain uncollectible amounts were classified as bad debt expense and were approximately 2.5% of revenue and classified within selling, general and administrative expenses. The company does not expect ASC 606 to impact net income or EPS.

(3)

Based on 36 million estimated shares outstanding.

(4)

Non-GAAP net income exclusions, see “Non-GAAP Disclosure” paragraph in press release below.

 

 

 

Recent Business Highlights

·

The National Comprehensive Cancer Network (NCCN) elevated the Oncotype DX Breast Recurrence Score to its “preferred” category as the only multi-gene test to predict chemotherapy treatment benefit for patients with node-negative early-stage breast cancer in its 2018 breast cancer guidelines.

·

The German Institute for Quality and Efficiency in Health Care ( IQWiG ) concluded that “only the Oncotype DX Breast Recurrence Score test has sufficient evidence to guide breast cancer adjuvant chemotherapy decisions based on TAILORx study results” in its updated assessment of breast cancer gene expression profiling tests.

·

Nature Partner Journals Breast Cancer   published a systematic review of seven studies including more than 8,000 patients with node-positive breast cancer, confirming that the Oncotype DX test accurately predicts clinical outcomes in node-positive breast cancer.


 

 

·

Palmetto GBA, a Medicare Administrative Contractor that assesses molecular diagnostic technologies, issued a positive final local coverage determination (LCD) for the Oncotype DX ® AR-V7 Nucleus Detect™ test for qualified Medicare patients throughout the U.S., effective in December 2018.

·

Established new reimbursement for the Oncotype DX Genomic Prostate Score test with Blue Shield California, bringing the total number of U.S. covered lives to more than 100 million, including Medicare.

·

Reviews in Urology   published real-world clinical evidence demonstrating that Oncotype DX Genomic Prostate Score testing resulted in significantly higher use of active surveillance compared to no testing.

·

An independent study published by University of California, San Francisco (UCSF) researchers in the Journal of Urology demonstrated that the Oncotype DX GPS test was predictive of an increased risk of biopsy upgrade in men with clinically low-risk prostate cancer managed by active surveillance.  

·

Presented results from five studies at the ESMO 2018 Congress reinforcing the utility of Oncotype   DX   tests in optimizing treatment for patients with various stages of breast and prostate cancer. 

·

Received acceptance to present two studies at the 2018 San Antonio Breast Cancer Symposium (SABCS) in December.

 

*Pre-606 Adjusted Product Revenue

Effective January 1, 2018, the company adopted the new ASC 606 accounting standard for revenue, using the modified retrospective method, which applies the new standard prospectively and does not impact prior years’ financial statements. Since the as-reported 2017 quarterly and annual financial statements will not be restated to reflect the new accounting standard, the company has provided a supplemental financial schedule in the non-GAAP tables at the end of this press release, reflecting an estimate of revenue as if the new standard had been applied to the historical 2017 product revenue portion of revenue as of January 1, 2017, referred to herein as “pre-606 adjusted revenue.” 

 

Non-GAAP Disclosure

The company makes reference in this press release to "non-GAAP operating income (loss)," which excludes 2018 expenses resulting from the restructuring charges for the cessation of the Oncotype SEQ ® Liquid Select™ test product development and commercialization activities in the first quarter of 2018, the cessation of its collaboration with Cleveland Diagnostics in the second quarter of 2018, and the expenses for milestone payments to Biocartis N.V., in the second and third quarters of 2018. Additionally, the company references “non-GAAP net income (loss),” which also excludes fair value adjustments related to its collaborations with Biocartis and Epic Sciences, and the gain on sale of marketable securities in the first quarter of 2017. The company believes that excluding these items and their related tax effects from its financial results reflects operating results that are more indicative of the company's ongoing operating performance while improving comparability to prior periods, and, as such, may provide investors with an enhanced understanding of the company's past financial performance and prospects for the future. The company also considers the impact of foreign currency exchange rates on its global business as described in the constant currency table accompanying this press release. The company's management uses such non-GAAP measures internally to evaluate and assess its core operations and to make ongoing operating decisions. This information is not intended to be considered in isolation or as a substitute for income (loss) from operations or net income (loss) information prepared in accordance with GAAP. An explanation and reconciliation of the non-GAAP financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this press release.

Conference Call Details  
To access the live conference call today, November 6, at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada, or +1 (224) 357-2389 internationally. The conference call ID is 9448559. Please dial in approximately ten minutes prior to the start of the call. To access the live and subsequently archived webcast of the conference call, go to the
Investor Relations section of the company’s website at http://investor.genomichealth.com . Please connect to the website at least 15 minutes prior to the presentation to allow for any software download that may be necessary.


 

 

About Genomic Health 
Genomic Health , Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that help optimize cancer care, including addressing the overtreatment of the disease, one of the greatest issues in healthcare today. With its Oncotype IQ ®  Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX ® gene expression tests that have been used to guide treatment decisions for more than 950,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype DX ®  AR-V7 Nucleus Detect™ test. The company is based in  Redwood City , California, with international headquarters in Geneva, Switzerland. For more information, please visit  www.GenomicHealth.com  and follow the company on Twitter:  @GenomicHealth Facebook YouTube  and  LinkedIn .

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's beliefs regarding its future performance, including updated 2018 guidance, the company’s beliefs regarding its revenue growth for the remainder of 2018 and the drivers of growth; the commercial performance of its tests; the favorable impact of TAILORx results on revenue in 2018; the attributes and focus of the company's product pipeline; the ability of any potential tests the company may develop to optimize cancer treatment; the ability of the company to develop and commercialize and collaborate with third parties to commercialize additional tests in the future; expectations regarding additional public and private reimbursement coverage for   our tests worldwide and the ability of additional coverage to result in additional revenue; and the company’s methodology for calculating financial performance under the new ASC 606 accounting standard as compared against prior periods under the previously applicable ASC 605 accounting standard. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the risk that the company may not achieve expected revenue growth for the remainder of 2018; the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies and their impact on reimbursement and adoption; the applicability of clinical study results to actual outcomes; the company's ability to develop and commercialize new tests and expand into new markets domestically and internationally; the commercial success of any collaborations entered into by the company; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; the company's ability to obtain capital when needed and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2018. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

 

NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Breast Recurrence Score, DCIS Score, Oncotype SEQ, Liquid Select, Genomic Prostate Score, GPS, Oncotype DX AR-V7 Nucleus Detect, and Oncotype IQ are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

 

 


 

 

GENOMIC HEALTH, INC.

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

September 30,

 

September 30,

 

 

2018

 

2017

 

2018

 

2017

REVENUES:

    

 

 

 

 

 

 

 

 

 

 

 

Product revenues - United States

 

$

85,747

 

$

70,881

 

 

246,054

 

$

213,878

Product revenues - Outside of the United States

 

 

15,511

 

 

12,940

 

 

43,448

 

 

39,409

Total revenues

 

 

101,258

 

 

83,821

 

 

289,502

 

 

253,287

 

 

 

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES (1)(2):

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenues

 

 

15,518

 

 

13,433

 

 

48,635

 

 

40,904

Research and development

 

 

15,433

 

 

17,212

 

 

47,552

 

 

47,868

Selling and marketing

 

 

40,051

 

 

38,303

 

 

122,143

 

 

120,464

General and administrative

 

 

18,498

 

 

17,505

 

 

56,702

 

 

52,651

Total operating expenses

 

 

89,500

 

 

86,453

 

 

275,032

 

 

261,887

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

 

11,758

 

 

(2,632)

 

 

14,470

 

 

(8,600)

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

676

 

 

263

 

 

1,492

 

 

627

Unrealized gain on investments, net

 

 

127

 

 

 —

 

 

1,538

 

 

 —

Gain on sales of marketable securities

 

 

 —

 

 

 —

 

 

 —

 

 

2,807

Other income (expense), net

 

 

39

 

 

340

 

 

101

 

 

792

Income (loss) before income taxes

 

 

12,600

 

 

(2,029)

 

 

17,601

 

 

(4,374)

Income tax expense

 

 

375

 

 

162

 

 

834

 

 

1,362

Net income (loss)

 

$

12,225

 

$

(2,191)

 

$

16,767

 

$

(5,736)

Basic net income (loss) per share

 

$

0.34

 

$

(0.06)

 

$

0.47

 

$

(0.17)

Diluted net income (loss) per share

 

$

0.32

 

$

(0.06)

 

$

0.45

 

$

(0.17)

Shares used in computing basic net income (loss) per share

 

 

35,925

 

 

34,675

 

 

35,558

 

 

34,373

Shares used in computing diluted net income (loss) per share.

 

 

38,026

 

 

34,675

 

 

37,044

 

 

34,373


 

(1)

Included in operating expenses for the three months ended September 30,  2018 were non-cash charges of $8.5 million, including $5.4 million of stock-based compensation expense and $3.1 million of depreciation and amortization expenses, compared with non-cash charges for the same period in 2017 of $8.1 million, including $5.0 million of stock-based compensation expense and $3.1 million of depreciation and amortization expenses.

 

(2)

Included in operating expenses for the nine months ended September 30, 2018 were non-cash charges of $25.1 million, including $15.7 million of stock-based compensation expense and $9.4 million of depreciation and amortization expenses, compared with non-cash charges for the same period in 2017 of $23.8 million, including $15.2 million of stock-based compensation expense and $8.6 million of depreciation and amortization expenses.

 

 


 

 

GENOMIC HEALTH, INC.

Condensed Consolidated Balance Sheets

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

As of

 

As of

 

 

 

September 30,

 

December 31,

 

 

 

2018

 

2017

 

 

 

(Unaudited)

 

(1)

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

69,242

 

$

45,518

 

Short-term marketable securities (2)

 

 

114,021

 

 

84,057

 

Accounts receivable, net

 

 

51,553

 

 

31,161

 

Prepaid expenses and other current assets

 

 

11,886

 

 

13,524

 

Total current assets

 

 

246,702

 

 

174,260

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

39,804

 

 

46,440

 

Other assets

 

 

13,860

 

 

10,917

 

Total assets

 

$

300,366

 

$

231,617

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

6,545

 

$

156

 

Accrued expenses and other current liabilities

 

 

43,860

 

 

39,360

 

Other liabilities

 

 

3,944

 

 

3,810

 

Stockholders’ equity

 

 

246,017

 

 

188,291

 

Total liabilities and stockholders’ equity

 

$

300,366

 

$

231,617

 


(1)

The condensed consolidated balance sheet at December 31, 2017, has been derived from the audited consolidated financial statements at that date included in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017.

 

(2)

Included in short-term marketable securities as of September 30, 2018 and December 31, 2017 is $3.8 million and $3.5 million, respectively, of corporate equity securities, representing the company’s investment in Biocartis N.V.

 


 

 

GENOMIC HEALTH, INC.

GAAP to Non-GAAP Reconciliations

(In thousands)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2018

 

2017

 

2018

 

2017

 

Income (loss) from operations reconciliation:

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP income (loss) from operations

 

$

11,758

 

$

(2,632)

 

$

14,470

 

$

(8,600)

 

Cost of product revenues – cessation of Oncotype SEQ

 

 

 —

 

 

 —

 

 

3,519

 

 

 —

 

Research and development – cessation of Oncotype SEQ

 

 

 —

 

 

 —

 

 

3,039

 

 

 —

 

Selling and marketing – cessation of Oncotype SEQ

 

 

 —

 

 

 —

 

 

1,064

 

 

 —

 

General and administrative – cessation of Oncotype SEQ

 

 

 —

 

 

 —

 

 

909

 

 

 —

 

Research and development – Biocartis license and option fee

 

 

1,169

 

 

3,249

 

 

1,169

 

 

3,249

 

Research and development – milestone payment Biocartis

 

 

 —

 

 

 —

 

 

990

 

 

 —

 

Research and development – Cleveland Diagnostics cancellation of collaboration agreement

 

 

 —

 

 

 —

 

 

1,329

 

 

 —

 

Non-GAAP income (loss) from operations

 

$

12,927

 

$

617

 

$

26,489

 

$

(5,351)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) reconciliation:

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP net income (loss)

 

$

12,225

 

$

(2,191)

 

$

16,767

 

$

(5,736)

 

Cost of product revenues – cessation of Oncotype SEQ

 

 

 —

 

 

 —

 

 

3,519

 

 

 —

 

Research and development – cessation of Oncotype SEQ

 

 

 —

 

 

 —

 

 

3,039

 

 

 —

 

Selling and marketing – cessation of Oncotype SEQ

 

 

 —

 

 

 —

 

 

1,064

 

 

 —

 

General and administrative – cessation of Oncotype SEQ

 

 

 —

 

 

 —

 

 

909

 

 

 —

 

Research and development – Biocartis license and option fee

 

 

1,169

 

 

3,249

 

 

1,169

 

 

3,249

 

Research and development – milestone payment Biocartis

 

 

 —

 

 

 —

 

 

990

 

 

 —

 

Research and development – Cleveland Diagnostics cancellation of collaboration agreement

 

 

 —

 

 

 —

 

 

1,329

 

 

 —

 

Other income – Biocartis - change in fair value

 

 

(56)

 

 

 —

 

 

(295)

 

 

 —

 

Other income – Epic Sciences - revaluation of investment

 

 

 —

 

 

 —

 

 

(1,171)

 

 

 

 

Non-recurring gain on sale of marketable securities

 

 

 —

 

 

 —

 

 

 —

 

 

(2,807)

 

Reduced income tax expense from the sale of marketable securities

 

 

 —

 

 

 —

 

 

 —

 

 

821

 

Non-GAAP net income (loss)

 

$

13,338

 

$

1,058

 

$

27,320

 

$

(4,473)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

GENOMIC HEALTH, INC.

Non-GAAP Constant Currency Reconciliations 

(In thousands)  

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

September 30,

 

September 30,

 

 

2018

 

2017

 

2018

 

2017

Constant currency reconciliations:

 

 

 

 

 

 

 

 

 

 

 

 

International Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

International revenue (1)

 

$

15,511

 

$

12,682

 

$

43,448

 

$

38,621

  Currency exchange adjustments (2)

 

 

(305)

 

 

 —

 

 

(1,393)

 

 

 —

Non-GAAP International revenue

 

$

15,206

 

$

12,682

 

$

42,055

 

$

38,621

  Period over period constant currency increase

 

 

2,524

 

 

 

 

 

3,434

 

 

 

  Period over period constant currency increase percentage

 

 

20%

 

 

 

 

 

9%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Total revenue (1)

 

$

101,258

 

$

82,150

 

$

289,502

 

$

248,237

  Currency exchange adjustments (2)

 

 

(305)

 

 

 —

 

 

(1,393)

 

 

 —

Non-GAAP total revenue

 

$

100,953

 

$

82,150

 

$

288,109

 

$

248,237

  Period over period constant currency increase

 

 

18,803

 

 

 

 

 

39,872

 

 

 

  Period over period constant currency increase percentage

 

 

23%

 

 

 

 

 

16%

 

 

 

_________________

(1)

For the three and nine months ended September 30, 2018, International revenue and total revenue is based on GAAP under ASC 606 and for the three and nine months ended September 30, 2017, International revenue and total revenue is based on the Pre-606 Adjusted revenue on the following table.

 

(2)

Constant currency is a non-GAAP measure that is calculated by comparing the company’s quarterly average foreign exchange rates for the three and nine months ended September 30, 2018 and 2017. The constant currency disclosures take current local currency revenue and translate it into U.S. dollars based upon the foreign currency exchange rates used to translate the local currency revenue for the applicable comparable period in the prior year, rather than the actual exchange rates in effect during the current period. It does not include any other effect of changes in foreign currency rates on the company’s results or business. 

 


 

 

 

GENOMIC HEALTH, INC.

Non-GAAP Supplemental Financial Information (1)

(In thousands)

(Unaudited)

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

September 30,

 

September 30,

 

 

2017

 

2017

U.S. Product revenue, under ASC 605:

 

 

 

 

 

 

Invasive breast test revenue

 

$

63,050

 

$

193,516

Prostate test revenue

 

 

5,501

 

 

12,940

All other test revenue

 

 

2,330

 

 

7,422

Total U.S. product revenue

 

 

70,881

 

 

213,878

Adjustment related to new ASC 606 accounting standard:

 

 

 

 

 

 

Invasive breast test revenue

 

 

1,413

 

 

4,251

Prostate test revenue

 

 

 —

 

 

 —

All other test revenue

 

 

 —

 

 

 —

Total ASC 606 adjustment to U.S. product revenue

 

 

1,413

 

 

4,251

Pre-606 Adjusted U.S. Product revenue, net of adjustments:

 

 

 

 

 

 

Invasive breast test revenue

 

 

61,637

 

 

189,266

Prostate test revenue

 

 

5,501

 

 

12,940

All other test revenue

 

 

2,330

 

 

7,421

Total Pre-606 Adjusted U.S. product revenue

 

$

69,468

 

$

209,627

 

 

 

 

 

 

 

International product revenue, under ASC 605:

 

 

 

 

 

 

Invasive breast test revenue

 

$

12,811

 

$

38,919

Prostate test revenue

 

 

41

 

 

106

All other test revenue

 

 

88

 

 

384

Total International product revenue

 

 

12,940

 

 

39,409

Adjustment related to new ASC 606 accounting standard:

 

 

 

 

 

 

Invasive breast test revenue

 

 

258

 

 

799

Prostate test revenue

 

 

 —

 

 

 —

All other test revenue

 

 

 —

 

 

 —

Total ASC 606 adjustment to International product revenue

 

 

258

 

 

799

Pre-606 Adjusted International product revenue, net of adjustments:

 

 

 

 

 

 

Invasive breast test revenue

 

 

12,553

 

 

38,120

Prostate test revenue

 

 

41

 

 

106

All other test revenue

 

 

88

 

 

384

Total Pre-606 Adjusted International product revenue

 

$

12,682

 

$

38,610

 

 

 

 

 

 

 

Total Product Revenue, under ASC 605:

 

 

 

 

 

 

Invasive breast test revenue

 

$

75,861

 

$

232,435

Prostate test revenue

 

 

5,542

 

 

13,046

All other test revenue

 

 

2,418

 

 

7,806

Total product revenue

 

 

83,821

 

 

253,287

Adjustment related to new ASC 606 accounting standard:

 

 

 

 

 

 

Invasive breast test revenue

 

 

1,671

 

 

5,050

Prostate test revenue

 

 

 —

 

 

 —

All other test revenue

 

 

 —

 

 

 —

Total ASC 606 adjustment to total product revenue

 

 

1,671

 

 

5,050

Pre-606 Adjusted Total product revenue, net of adjustments:

 

 

 

 

 

 

Invasive breast test revenue

 

 

74,190

 

 

227,386

Prostate test revenue

 

 

5,542

 

 

13,046

All other test revenue

 

 

2,418

 

 

7,806

Total Pre-606 Adjusted total product revenue

 

$

82,150

 

$

248,237

 


 

 

GENOMIC HEALTH, INC.

Non-GAAP Supplemental Financial Information (1)

(In thousands)  

(Unaudited)

 

(1)

Effective January 1, 2018, the company adopted new accounting guidance ASC Topic 606 (“ASC 606”), related to revenue from contracts with customers, using a modified retrospective method. Since the 2017 annual and quarterly financial statements will not be restated to reflect ASC 606, the company is providing this supplemental schedule to present 2017 revenue reflecting an estimate as if ASC 606 had been applied effective January 1, 2017. This Pre-606 adjusted revenue information is intended to provide investors with a basis for considering the potential directional impact the adoption of ASC 606 might have on the company’s financial information that will be reported in 2018. The Pre-606 adjusted revenue information is provided only for illustrative purposes and does not constitute a restatement of the company’s historical financial statements previously filed with the SEC, which should be considered by investors in their entirety as filed. 

 

 

GHDX-F

 

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