OPKO Health Reports 2021 First Quarter Business Highlights and Financial Results
April 28 2021 - 4:05PM
OPKO Health, Inc. (NASDAQ: OPK) reports business
highlights and financial results for the three months ended March
31, 2021.
Business Highlights
- BioReference Laboratories
test volume increased 158% compared with the first quarter of
2020. During the first quarter of 2021, BioReference
Laboratories (BRL) processed approximately 4.3 million COVID-19 PCR
tests and has current capacity to process more than 100,000 PCR
tests per day. In addition, during the quarter, BRL performed
approximately 200,000 COVID-19 serology tests to measure SARS-CoV-2
antibody levels and currently has significant additional
capacity.BRL continues to provide COVID-19 solutions to meet the
testing needs of physicians, health systems, long-term care
facilities, governments, schools, employers, professional sports
leagues and entertainment venues, as well as the general public
through relationships with retail pharmacy chains including
Rite-Aid and CVS. In April 2021, BRL announced a COVID-19 testing
agreement for players and staff, stadium employees and league staff
for the 2021 Major League Baseball season and the renewal of a
similar agreement for the 2021 Major League Soccer season.In March
2021, BRL announced expansion of its COVID-19 school testing
program to support return to in-person classroom instruction across
the country. For two of the nation’s largest school systems, BRL
provides testing services to nearly 200 schools every day and has
tested nearly 500,000 public school students, teachers and
principals.
- Topline results reported
from first cohort of Phase 2 trial with Rayaldee in patients with
stage 5 chronic kidney disease (CKD) on dialysis. Cohort 1
of the Phase 2 clinical trial explored the safety and efficacy of a
high-strength formulation of Rayaldee (calcifediol) as a new
treatment for secondary hyperparathyroidism (SHPT) in adults with
vitamin D insufficiency and stage 5 CKD who require hemodialysis.
Topline results from 44 subjects (33 Rayaldee; 11 placebo)
demonstrated that the prohormone Rayaldee was well tolerated at a
dose of 900 mcg/week, decreased intact parathyroid hormone (iPTH)
versus placebo, and was activated to calcitriol (the active
hormone) despite the lack of functional kidneys. A full analysis of
the data is underway and will be reviewed with both FDA and OPKO’s
development partners.
- Regulatory submission for
somatrogon by Pfizer, OPKO’s commercial partner, accepted by the
European Medicines Agency (EMA). In February 2021, the EMA
validated for review the Marketing Authorization Application (MAA)
for somatrogon, a long-acting recombinant human growth hormone
intended to be administered once-weekly to treat pediatric patients
with growth hormone deficiency (GHD). Pfizer expects a decision
from the European Commission in 2022. In January 2021, the FDA
accepted for filing the initial Biologics License Application for
somatrogon with a target Prescription Drug User Fee Act action date
in October 2021. Pfizer also submitted a New Drug Application for
somatrogon to the Pharmaceuticals and Medical Devices Agency in
Japan.
- Multiple presentations
highlighting somatrogon clinical data were presented at two
endocrinology conferences. Data from OPKO’s somatrogon
clinical studies were presented virtually at ENDO 2021, the
Endocrine Society's 2021 Annual Meeting held March 20-23, 2021, and
at ICE 2021, the 19th International Congress of Endocrinology
Annual Meeting held February 24-28, 2021. Utilizing OPKO’s
proprietary long-acting technology, somatrogon represents a
significant advancement to increase patient adherence and improve
quality of life compared with daily injections. Posters and
abstracts from the endocrinology conferences can be viewed on the
Company’s website in the Investors section. In addition, OPKO
will be participating in the 2021 Pediatric Endocrine Society
Virtual Annual Meeting to be held today through May 3, 2021.
- Phase 2 trial with RAYALDEE
in COVID-19 outpatients is 71% enrolled and ongoing at 10 U.S.
sites. The trial is a randomized, double-blind,
placebo-controlled study and is expected to enroll approximately
160 outpatients, including some with stage 3 or 4 CKD who are at
higher risk for developing more severe illness. The qualified
outpatients are being randomized one-to-one to four weeks of daily
treatment with either RAYALDEE or placebo, and then monitored for
another two weeks. Topline data from this trial are expected in the
third quarter and, if sufficiently positive, will form the basis
for an immediate request to FDA for an Emergency Use
Authorization.
First Quarter Financial
Results
- Consolidated revenues for the first
quarter of 2021 were $545.2 million compared with $211.5 million
for the comparable period of 2020. Net income for the first quarter
of 2021 was $31.1 million, or $0.05 per diluted share, compared
with a net loss of $59.1 million, or $0.09 per share, for the
comparable period of 2020.
- Diagnostics:
Revenue from services in the first quarter of 2021 increased to
$507.0 million from $170.8 million in the prior-year period,
primarily due to COVID-19 testing, partially offset by lower
revenue in our base testing business reflecting the negative impact
of the COVID-19 pandemic. Total costs and expenses were $439.9
million in the first quarter of 2021 compared with $189.0 million
in the first quarter of 2020, resulting in operating income of
$67.0 million compared with an operating loss of $18.1 million in
the 2020 period. The increase in operating income of $85.1 million
reflects the increased demand for COVID-19 PCR testing.
- Pharmaceuticals:
Revenue from products in the first quarter of 2021 was $33.9
million compared with $31.1 million in the first quarter of 2020,
primarily attributable to an increase in sales at OPKO Chile and
FineTech, partially offset by a decline in sales of RAYALDEE, which
were negatively impacted by the COVID-19 pandemic. Total
prescriptions of RAYALDEE for the first quarter of 2021 decreased
to approximately 12,300 from approximately 18,300 for the first
quarter of 2020. Revenue from the transfer of intellectual property
was $4.3 million in the first quarter of 2021 compared with $9.6
million in the first quarter of 2020, reflecting a decrease in the
amortization of payments received from Pfizer with respect to
somatrogon. Total costs and expenses were $57.4 million in the
first quarter of 2021 compared with $54.8 million in the prior-year
period, primarily due to increased sales and an inventory reserve
for RAYALDEE. The operating loss was $19.2 million in the first
quarter of 2021 compared with $14.1 million in the first quarter of
2020.
- Cash and
equivalents: Cash, cash equivalents and marketable
securities were $89.5 million as of March 31, 2021. In addition,
the Company has availability under its present line of credit with
JP Morgan of $64.7 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 first quarter financial results and answer
questions during a conference call and live audio webcast beginning
at 4:30 p.m. Eastern time today, April 28, 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 9993698. 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 1Q21 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 1Q21 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
9993698.
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, 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 enrollment for our Phase 2 trial with
RAYALDEE in COVID-19 may not complete and topline data may not be
available when anticipated and may not, in any event, be positive
such that an Emergency Use Authorization could be sought, that
regulatory approvals for our products, particularly somatrogon, may
not be received when anticipated or at all, 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
—Tables to Follow—
OPKO Health, Inc. and SubsidiariesCondensed
Consolidated Balance Sheets(in millions)Unaudited
|
As of |
|
March 31, 2021 |
|
December 31, 2020 |
Assets: |
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
89.5 |
|
|
$ |
72.2 |
|
Other current assets |
|
509.5 |
|
|
|
451.0 |
|
Total Current Assets |
|
599.0 |
|
|
|
523.2 |
|
In-process Research and
Development and Goodwill |
|
1,266.4 |
|
|
|
1,270.8 |
|
Other assets |
|
654.2 |
|
|
|
679.1 |
|
Total Assets |
$ |
2,519.6 |
|
|
$ |
2,473.1 |
|
|
|
|
|
|
|
|
|
Liabilities and Equity: |
|
|
|
|
|
|
|
Current liabilities |
$ |
403.9 |
|
|
$ |
375.5 |
|
Convertible Notes |
|
224.8 |
|
|
|
222.0 |
|
Deferred tax liabilities, net |
|
135.2 |
|
|
|
137.2 |
|
Other long-term liabilities, principally contract
liabilities, leases, contingent consideration and lines of
credit |
|
59.2 |
|
|
|
66.8 |
|
Total Liabilities |
|
823.1 |
|
|
|
801.5 |
|
Equity |
|
1,696.5 |
|
|
|
1,671.6 |
|
Total Liabilities and Equity |
$ |
2,519.6 |
|
|
$ |
2,473.1 |
|
|
|
|
|
|
|
|
|
OPKO Health, Inc. and SubsidiariesCondensed
Consolidated Statements of Operations(in millions, except share and
per share data)Unaudited
|
For the three months ended March 31, |
|
|
|
2021 |
|
|
|
2020 |
|
Revenues |
|
|
|
|
|
|
Revenue from services |
|
$ |
507.0 |
|
|
$ |
170.8 |
|
Revenue from products |
|
|
33.9 |
|
|
|
31.1 |
|
Revenue from transfer of intellectual property |
|
|
4.3 |
|
|
|
9.6 |
|
Total revenues |
|
|
545.2 |
|
|
|
211.5 |
|
Costs and expenses |
|
|
|
|
|
|
Cost of revenues |
|
|
363.5 |
|
|
|
140.3 |
|
Selling, general and administrative |
|
|
112.3 |
|
|
|
76.1 |
|
Research and development |
|
|
19.3 |
|
|
|
21.8 |
|
Contingent consideration |
|
|
(1.0 |
) |
|
|
(0.9 |
) |
Amortization of intangible assets |
|
|
12.6 |
|
|
|
14.9 |
|
Total Costs and expenses |
|
|
506.7 |
|
|
|
252.2 |
|
Operating income (loss) |
|
|
38.5 |
|
|
|
(40.7 |
) |
Other income and (expense),
net |
|
|
(6.8 |
) |
|
|
(17.1 |
) |
Income (loss) before income
taxes and investment losses |
|
|
31.7 |
|
|
|
(57.8 |
) |
Income tax provision |
|
|
(0.6 |
) |
|
|
(1.2 |
) |
Net income (loss) before
investment losses |
|
|
31.1 |
|
|
|
(59.0 |
) |
Loss from investments in
investees |
|
|
0.0 |
|
|
|
(0.1 |
) |
Net income (loss) |
|
$ |
31.1 |
|
|
$ |
(59.1 |
) |
Income (loss) per share, basic and diluted |
|
$ |
0.05 |
|
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
|
640,853,200 |
|
|
|
640,578,794 |
|
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