Genomic Health Announces Record Revenue and Profit in Third Quarter 2018 Financial Results; Raises Full Year Guidance
REDWOOD CITY, Calif., Nov. 6, 2018 /PRNewswire/ -- 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(TM)) 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(TM) 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(TM) 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(TM) 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(TM) 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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