OPKO Health Reports 2020 Fourth Quarter Business Highlights and Financial Results
February 18 2021 - 4:05PM
OPKO Health, Inc. (NASDAQ: OPK) reports business
highlights and financial results for the three months ended
December 31, 2020.
Business Highlights
- BioReference Laboratories’
volume in the fourth quarter of 2020 increased 170% compared to
2019. COVID-19 PCR testing volume increased 24% over the third
quarter of 2020. During the fourth quarter of 2020,
BioReference Laboratories (BRL) processed approximately 4.3 million
COVID-19 PCR tests and currently has the capacity to process more
than 100,000 PCR tests per day. In addition, BRL performed
approximately 220,000 COVID-19 serology tests to measure SARS-CoV-2
antibody levels and currently has significant additional
capacity.BRL continues to provide innovative solutions to the
COVID-19 testing needs of physicians, health systems, long-term
care facilities, governments, schools, employers, professional
sports teams, entertainment venues, and the general public through
relationships with Rite-Aid and CVS. In January 2021, BRL announced
COVID-19 testing agreements for players and officials, as well as
team and league staff for the 2020-2021 seasons for the National
Basketball Association (NBA) and National Hockey League. BRL is
also supporting the COVID-19 testing needs of the Winter X Games in
Aspen, U.S. Soccer's Women's and Men's National Teams and the NBA G
League in Orlando.
- BRL introduced Scarlet
Health™ to expand digital health access. In January 2021,
BRL launched Scarlet Health, an in-home, fully integrated digital
platform providing access to on-demand diagnostic services. Backed
by BRL’s national presence and infrastructure, with laboratory
facilities and professionals across the
country, Scarlet Health delivers an innovative,
flexible, mobile alternative to traditional patient service centers
or other draw locations when phlebotomy and other specimen
collection services are needed.
- GeneDx added repeat
expansion analysis genetic tests. GeneDx launched several
new genetic tests, including repeat expansion analysis for
spinocerebellar ataxia, Friedreich ataxia and other forms of
hereditary ataxias. With these additions, GeneDx has created a
comprehensive and affordable offering that covers the vast majority
of genes involved with pediatric-onset and adult-onset
ataxias.
- Regulatory submission from
OPKO’s commercial partner, Pfizer, accepted in the U.S. and filed
in Japan for somatrogon to treat pediatric patients with growth
hormone deficiency. The U.S. Food and Drug Administration
(FDA) accepted for filing the initial Biologics License Application
for somatrogon, a long-acting human growth hormone intended to be
administered once-weekly for the treatment of pediatric patients
with growth hormone deficiency. The target Prescription Drug User
Fee Act action date for decision by the FDA is October 2021. In
addition, a New Drug Application was submitted to the Ministry of
Health, Labour, and Welfare in Japan for somatrogon. Pfizer remains
on schedule with respect to its regulatory submission for marketing
approval of somatrogon in Europe in the first quarter of this
year.
- RAYALDEE has received
marketing authorizations in 11 European countries. Vifor
Fresenius Medical Care Renal Pharma, OPKO’s commercial partner for
RAYALDEE in Europe, has received marketing authorizations for
RAYALDEE for the treatment of secondary hyperparathyroidism in
adults with stage 3 or 4 chronic kidney disease and vitamin D
insufficiency in 11 European countries, adding Spain, Portugal,
Italy and Switzerland to previously announced approvals in the
United Kingdom, Germany, Sweden, Norway, Ireland, Denmark and the
Netherlands. Market launch of RAYALDEE in authorized countries is
expected later this year.
Fourth Quarter Financial
Results
- Net income for the fourth quarter
of 2020 was $32.3 million, or $0.05 per diluted share, compared
with a net loss of $112.4 million, or $0.18 per share, for the
comparable period of 2019. Consolidated revenues for the fourth
quarter of 2020 were $494.6 million compared with $224.3 million
for the comparable period of 2019.
- Diagnostics:
Revenue from services in the fourth quarter of 2020 increased to
$457.9 million from $177.9 million in the prior-year period, due to
COVID-19 testing volume, partially offset by lower clinical test
volume reflecting the negative impact of the pandemic and by
reduced clinical and genomic test reimbursement. Total costs and
expenses were $388.0 million in the fourth quarter of 2020 compared
with $223.4 million in the fourth quarter of 2019, resulting in
operating income of $69.9 million compared with an operating loss
of $45.4 million in the 2019 period. The increase in operating
income of $115.3 million reflects increased volumes as a result of
COVID-19 testing and a non-cash impairment charge of $38.7 included
in the 2019 period for goodwill and intangible assets related to
the acquisition of Claros.
- Pharmaceuticals:
Revenue from products in the fourth quarter of 2020 was $30.8
million compared with $32.0 million in the fourth quarter of 2019,
primarily attributable to a decline in sales of Rayaldee, which
were negatively impacted by challenges in onboarding new patients
due to the intensified COVID-19 pandemic, offset by an increase in
sales from OPKO Chile. Total prescriptions of Rayaldee for the
fourth quarter of 2020 decreased to approximately 15,000, compared
with approximately 17,900 for the fourth quarter of 2019. Revenue
from the transfer of intellectual property was $5.9 million in the
fourth quarter of 2020 compared with $14.4 million in the fourth
quarter of 2019, reflecting a decrease in the amortization of
payments received from Pfizer with respect to somatrogon. Total
costs and expenses were $45.7 million in the fourth quarter of 2020
compared with $103.2 million in the prior-year period, which
included a non-cash impairment charge of $53.1 million for goodwill
and intangible assets related to the acquisitions of CURNA and
Transition Therapeutics. The operating loss was $9.0 million in the
fourth quarter of 2020 compared with $56.8 million in the fourth
quarter of 2019.
- Cash and
equivalents: Cash, cash equivalents and marketable
securities were $72.2 million as of December 31, 2020. In addition,
the Company has availability under its present line of credit with
JP Morgan of $57.6 million and an unutilized $100 million credit
facility that provides access to incremental capital on a
non-dilutive basis.
CONFERENCE CALL & WEBCAST
INFORMATION
OPKO’s senior management will provide a business
update, discuss fourth quarter financial results and answer
questions during a conference call and live audio webcast at 4:30
p.m. Eastern time today, February 18, 2021. Participants are
requested to pre-register for the conference call using the link
here, or dialing (888) 869-1189 or (706) 643-5902 and using
conference ID 8597848. Upon registering, participants will receive
dial-in numbers, an event passcode and a unique registrant ID to
gain immediate access to the call and bypass the live operator.
Participants may pre-register at any time, including up to and
after the start of the call.
To access the live call via webcast, please
click on the link OPKO 4Q20 Results Conference Call. Individual
investors and investment community professionals who do not plan to
ask a question during the call’s Q&A session are encouraged to
listen to the call via the webcast.
For those unable to listen to the live
conference call, a replay can be accessed for a period of time on
OPKO’s website at OPKO 4Q20 Results Conference Call. A telephone
replay will be available beginning approximately two hours after
the completion of the conference call. To access the replay, please
dial (855) 859-2056 or (404) 537-3406, and use conference ID
8597848.
About OPKO Health
OPKO is a multinational biopharmaceutical and
diagnostics company that seeks to establish industry-leading
positions in large, rapidly growing markets by leveraging its
discovery, development, and commercialization expertise and novel
and proprietary technologies. For more information, visit
www.opko.com.
Cautionary Statement Regarding Forward
Looking Statements
This press release contains "forward-looking
statements," as that term is defined under the Private Securities
Litigation Reform Act of 1995 (PSLRA), which statements may be
identified by words such as "expects," "plans," "projects," "will,"
"may," "anticipates," "believes," "should," "intends," "estimates,"
and other words of similar meaning, including statements regarding
expected financial performance and expectations regarding the
market for and sales of our products, expectations about COVID-19
testing, the demand for testing, our capacity for testing, the
impact of COVID-19 on all of our businesses, positively and
negatively, our ability to expand our capacity should there be
additional demand, the availability of resources, including labor,
equipment and supplies, to meet demand for testing and the
potential impact on us should these resources be constrained, our
product development efforts and the expected benefits of our
products, whether our products in development will be
commercialized, the possibility of further analyses of existing
clinical data, the risk that clinical trial data are subject to
differing interpretations and assessments by regulatory
authorities, whether regulatory authorities will be satisfied with
the design of and results from our clinical studies, whether
RAYALDEE prescriptions will increase, our ability to market and
sell any of our products in development, GeneDx’s test offerings
and the effectiveness and utility of its ataxias
tests, BioReference's Scarlet Health mobile service, the
availability of and demand for the service, whether the
service and the integrated platform will function or perform as
designed, the role and value of the service to patients
and healthcare providers and whether the demand for at home
health care will continue or increase as anticipated, as well
as other non-historical statements about our expectations, beliefs
or intentions regarding our business, technologies and products,
financial condition, strategies or prospects. Many factors could
cause our actual activities or results to differ materially from
the activities and results anticipated in forward-looking
statements. These factors include those described in our Annual
Reports on Form 10-K filed and to be filed with the Securities and
Exchange Commission and under the heading “Risk Factors” in our
other filings with the Securities and Exchange Commission, as well
as the ongoing effects of the COVID-19 pandemic, the continuation
and success of our relationship with Pfizer, Vifor and our other
partners, liquidity issues and the risks inherent in funding,
developing and obtaining regulatory approvals of new,
commercially-viable and competitive products and treatments, that
earlier clinical results of effectiveness and safety may not be
reproducible or indicative of future results, that somatrogon,
RAYALDEE, and/or any of our compounds or diagnostic products under
development may fail, may not achieve the expected results or
effectiveness and may not generate data that would support the
approval or marketing of products for the indications proposed or
for other indications, that currently available over-the-counter
and prescription products, as well as products under development by
others, may prove to be as or more effective than our products for
the indications being studied. In addition, forward-looking
statements may also be adversely affected by general market
factors, competitive product development, product availability,
federal and state regulations and legislation, the regulatory
process for new products and indications, manufacturing issues that
may arise, patent positions and litigation, among other factors.
The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not
undertake any obligation to update forward-looking statements. We
intend that all forward-looking statements be subject to the
safe-harbor provisions of the PSLRA.
Contacts:
LHA Investor RelationsYvonne
Briggs, 310-691-7100ybriggs@lhai.comorBruce Voss, 310-691-7100
bvoss@lhai.com
OPKO Health, Inc. and SubsidiariesCondensed
Consolidated Balance Sheets(in millions)Unaudited
|
As of |
|
December 31, 2020 |
|
December 31, 2019 |
Assets: |
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
72.2 |
|
|
$ |
85.5 |
|
Other current assets |
|
451.0 |
|
|
|
238.5 |
|
Total Current Assets |
|
523.2 |
|
|
|
324.0 |
|
In-process Research and
Development and Goodwill |
|
1,270.8 |
|
|
|
1,262.1 |
|
Other assets |
|
679.1 |
|
|
|
723.2 |
|
Total Assets |
$ |
2,473.1 |
|
|
$ |
2,309.3 |
|
|
|
|
|
|
|
|
|
Liabilities and Equity: |
|
|
|
|
|
|
|
Current liabilities |
$ |
375.5 |
|
|
$ |
249.1 |
|
Convertible Notes |
|
222.0 |
|
|
|
211.2 |
|
Deferred tax liabilities, net |
|
137.2 |
|
|
|
118.7 |
|
Other long-term liabilities, principally contract liabilities,
leases, contingent consideration and lines of credit |
|
66.8 |
|
|
|
115.5 |
|
Total Liabilities |
|
801.5 |
|
|
|
694.5 |
|
Equity |
|
1,671.6 |
|
|
|
1,614.8 |
|
Total Liabilities and Equity |
$ |
2,473.1 |
|
|
$ |
2,309.3 |
|
OPKO Health, Inc. and SubsidiariesCondensed
Consolidated Statements of Operations(in millions, except share and
per share data)Unaudited
|
For the three months endedDecember 31, |
|
For the year endedDecember 31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
Revenue from services |
$ |
457.9 |
|
|
$ |
177.9 |
|
|
$ |
1,262.2 |
|
|
$ |
716.4 |
|
Revenue from products |
|
30.8 |
|
|
|
32.0 |
|
|
|
120.0 |
|
|
|
112.2 |
|
Revenue from transfer of intellectual property |
|
5.9 |
|
|
|
14.4 |
|
|
|
53.2 |
|
|
|
73.3 |
|
Total revenues |
|
494.6 |
|
|
|
224.3 |
|
|
|
1,435.4 |
|
|
|
901.9 |
|
Costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
318.7 |
|
|
|
142.3 |
|
|
|
894.4 |
|
|
|
572.5 |
|
Selling, general and administrative |
|
101.8 |
|
|
|
79.1 |
|
|
|
355.6 |
|
|
|
343.3 |
|
Research and development |
|
17.5 |
|
|
|
23.0 |
|
|
|
75.3 |
|
|
|
117.9 |
|
Contingent consideration |
|
(5.3 |
) |
|
|
(14.8 |
) |
|
|
(4.0 |
) |
|
|
(14.9 |
) |
Amortization of intangible assets |
|
12.6 |
|
|
|
15.4 |
|
|
|
56.4 |
|
|
|
64.8 |
|
Asset impairment charges |
|
0.0 |
|
|
|
91.8 |
|
|
|
0.0 |
|
|
|
92.4 |
|
Total Costs and expenses |
|
445.3 |
|
|
|
336.8 |
|
|
|
1,377.7 |
|
|
|
1,176.0 |
|
Operating Income (loss) |
|
49.3 |
|
|
|
(112.5 |
) |
|
|
57.7 |
|
|
|
(274.1 |
) |
Other income and (expense),
net |
|
(3.4 |
) |
|
|
4.0 |
|
|
|
(9.0 |
) |
|
|
(30.8 |
) |
Income loss before income taxes
and investment losses |
|
45.9 |
|
|
|
(108.5 |
) |
|
|
48.7 |
|
|
|
(304.9 |
) |
Income tax provision |
|
(13.6 |
) |
|
|
(3.4 |
) |
|
|
(17.6 |
) |
|
|
(7.1 |
) |
Income (loss) before investment
losses |
|
32.3 |
|
|
|
(111.9 |
) |
|
|
31.1 |
|
|
|
(312.0 |
) |
Loss from investments in
investees |
|
(0.0 |
) |
|
|
(0.5 |
) |
|
|
(0.5 |
) |
|
|
(2.9 |
) |
Net Income (loss) |
$ |
32.3 |
|
|
$ |
(112.4 |
) |
|
$ |
30.6 |
|
|
$ |
(314.9 |
) |
Loss per share, basic and diluted |
$ |
0.05 |
|
|
$ |
(0.18 |
) |
|
$ |
0.05 |
|
|
$ |
(0.53 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
640,590,427 |
|
|
|
622,474,281 |
|
|
|
640,655,290 |
|
|
|
595,454,394 |
|
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