OPKO Health Reports 2021 Second Quarter Business Highlights and Financial Results
30 July 2021 - 6:05AM
OPKO Health, Inc. (NASDAQ: OPK) reports business
highlights and financial results for the three months ended June
30, 2021.
Business Highlights
- BioReference Laboratories
(BRL) test volume increased 32% compared with the second quarter of
2020. During the second quarter of 2021, BRL processed
approximately 2.8 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 132,000
COVID-19 serology tests to measure SARS-CoV-2 antibody levels and
currently has significant additional capacity.In June 2021, BRL
announced a COVID-19 custom testing program for U.S.-based
crew and guests who cruise with Royal Caribbean Group, helping
provide a safe environment for travelers and crew members. 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 and 2021-2022 National Football League
season.Also, BRL announced the appointment of Katherine Stueland as
President and Chief Executive Officer of GeneDx, Inc., its global
genomics subsidiary. Ms. Stueland joined GeneDx from Invitae
Corporation, where she served most recently as Chief Commercial
Officer.
- Executed agreement with
Nicoya Therapeutics for the development and commercialization of
RAYALDEE® in Greater
China. OPKO entered into an agreement with Nicoya Macau
Limited, an affiliate of Nicoya Therapeutics (Nicoya), for the
development and commercialization in Greater China including
mainland China, Hong Kong, Macau and Taiwan of RAYALDEE for
the treatment of secondary hyperparathyroidism (SHPT) in patients
with stage 3 or 4 chronic kidney disease (CKD). OPKO received an
upfront payment of $5 million and is entitled to receive an
additional $5 million payment upon the earlier of the 12-month
anniversary of the agreement or Nicoya achieving a certain
predetermined development milestone. In addition, OPKO will be
eligible to receive up to $115 million upon the achievement of
certain development, regulatory and sales-based milestones. Nicoya
will pay OPKO tiered, double-digit royalties on product sales and
will be responsible for regulatory approvals and commercial
activities pertaining to RAYALDEE in their territory.
- Executed exclusive
worldwide agreement with CAMP4 Therapeutics Corporation (CAMP4) for
the development, manufacture and commercialization of therapeutics
utilizing the AntagoNAT technology. The AntagoNAT
technology is an oligonucleotide platform developed under OPKO
CURNA. CAMP4 has prioritized OPKO’s lead AntagoNAT compound to
progress into clinical trials for the treatment of Dravet syndrome.
Under the terms of the agreement, OPKO received an upfront cash
payment and shares of privately held CAMP4. In addition, OPKO will
be eligible to receive up to $93.5 million and additional shares
upon the achievement of certain development and sales milestones
for products developed from this technology and associated
intellectual property. CAMP4 will also pay OPKO double-digit
royalties on product sales.
- Sale of sterile
fill-and-finish manufacturing facility in Ireland. OPKO
sold one of its facilities in Waterford, Ireland to Horizon
Therapeutics plc for $65 million less certain assumed and accrued
liabilities relating to transferred employees. The facility
previously housed EirGen’s sterile fill-and-finish business.
Second Quarter Financial
Results
- Diagnostics:
Revenue from services in the second quarter of 2021 increased to
$397.2 million from $251.0 million in the prior-year period,
primarily due to an increase in volume of COVID-19, clinical and
genomic testing. Total costs and expenses were $367.2 million in
the second quarter of 2021 compared with $216.2 million in the
second quarter of 2020, resulting in operating income of $30.0
million compared with $40.9 million in the 2020 period. The
decrease in operating income is primarily due to non-recurring
benefits in the second quarter of 2020 including $10.9 million of
revenue from the successful 4Kscore Medicare appeal and a $6.2
million grant received under the CARES Act.
- Pharmaceuticals:
Revenue from products in the second quarter of 2021 was $35.7
million compared with $29.3 million in the second quarter of 2020,
primarily attributable to accelerating growth within OPKO’s
international pharmaceutical businesses partially offset by a
decline in sales of RAYALDEE. Total prescriptions for RAYALDEE in
the second quarter of 2021 decreased to approximately 11,700 from
approximately 18,400 in the second quarter of 2020. Revenue from
sales of RAYALDEE in the second quarter of 2021 and 2020 was $5.0
million and $8.6 million, respectively. Revenue from the
transfer of intellectual property was $9.5 million in the second
quarter of 2021 compared with $14.7 million in the 2020 period,
reflecting a decrease in the amortization of payments received from
Pfizer with respect to somatrogon. The second quarter of 2021
included a $5.0 million upfront payment under the license
agreement with Nicoya. Total costs and expenses were $58.9 million
in the second quarter of 2021 compared with $50.0 million in the
prior year period, primarily due to the growth of OPKO’s
international pharmaceutical operations. Operating loss was $13.7
million in the second quarter of 2021 compared with an operating
loss of $6.0 million in the second quarter of 2020.
- Consolidated:
Consolidated total revenues for the second quarter of 2021 were
$442.4 million compared with $301.2 million for the comparable
period of 2020. Operating income for the second quarter of 2021 was
$5.6 million compared with operating income of $27.2 million for
the comparable period of 2020. Net loss for the second quarter of
2021, which included an $11.1 million non-cash, non-recurring loss
as a result of the issuance of shares in connection with the $55.4
million convertible notes exchange, was $16.2 million, or $0.03 per
share, compared with net income of $33.7 million, or $0.05 per
diluted share, for the comparable period of 2020.
- Cash and
equivalents: Cash, cash equivalents and marketable
securities were $65.8 million as of June 30, 2021. The Company has
availability under its present line of credit with JP Morgan of
$64.3 million. Also, in July 2021 OPKO received gross proceeds of
$65.0 million from the sale of its fill-and-finish manufacturing
facility in Ireland.
- Convertible notes:
In May 2021, certain noteholders of the Company’s 4.50% Convertible
Senior Notes due 2025 agreed to exchange $55.4 million of the
outstanding notes for shares of the Company’s common stock, plus a
cash payment equal to the accrued and unpaid interest on the
exchanged notes.
CONFERENCE CALL & WEBCAST
INFORMATION
OPKO’s senior management will provide a business
update, discuss second quarter financial results and answer
questions during a conference call and live audio webcast beginning
at 4:30 p.m. Eastern time today, July 29, 2021. Participants are
requested to pre-register for the conference call using the link
here. Upon pre-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. Alternatively, please dial (888)
869-1189 or (706) 643-5902 and use conference ID 7028169
To access the live call via webcast, please
click on the link OPKO 2Q21 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 2Q21 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
7028169.
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, our product development efforts and the expected
benefits of our products, whether our products in development will
be commercialized, whether the relationship with our business
partners will be successful, 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 our commercial partners, liquidity issues and the
risks inherent in funding, developing and obtaining regulatory
approvals of new, commercially-viable and competitive products and
treatments. 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.com orBruce Voss, 310-691-7100
bvoss@lhai.com
—Tables to Follow—
OPKO Health, Inc. and SubsidiariesCondensed
Consolidated Balance Sheets(in millions)Unaudited
|
As of |
|
June 30, 2021 |
|
December 31, 2020 |
Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
65.8 |
|
|
$ |
72.2 |
|
Other current assets |
|
481.2 |
|
|
|
451.0 |
|
Total current assets |
|
547.0 |
|
|
|
523.2 |
|
In-process research and
development and goodwill |
|
1,267.6 |
|
|
|
1,270.8 |
|
Other assets |
|
607.1 |
|
|
|
679.1 |
|
Total Assets |
$ |
2,421.7 |
|
|
$ |
2,473.1 |
|
|
|
|
|
|
|
|
|
Liabilities and Equity: |
|
|
|
|
|
|
|
Current liabilities |
$ |
304.0 |
|
|
$ |
375.5 |
|
Convertible notes |
|
183.2 |
|
|
|
222.0 |
|
Deferred tax liabilities, net |
|
136.4 |
|
|
|
137.2 |
|
Other long-term liabilities, principally contract liabilities, |
|
|
|
|
|
|
|
leases, contingent consideration and lines of credit |
|
55.5 |
|
|
|
66.8 |
|
Total Liabilities |
|
679.1 |
|
|
|
801.5 |
|
Equity |
|
1,742.6 |
|
|
|
1,671.6 |
|
Total Liabilities and Equity |
$ |
2,421.7 |
|
|
$ |
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 endedJune 30, |
|
For the six months endedJune 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from services |
$ |
397.2 |
|
|
$ |
251.0 |
|
|
$ |
904.2 |
|
|
$ |
421.8 |
|
Revenue from products |
|
35.7 |
|
|
|
29.3 |
|
|
|
69.6 |
|
|
|
60.4 |
|
Revenue from transfer of intellectual |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
property and other |
|
9.5 |
|
|
|
20.9 |
|
|
|
13.8 |
|
|
|
30.5 |
|
Total revenues |
|
442.4 |
|
|
|
301.2 |
|
|
|
987.6 |
|
|
|
512.7 |
|
Costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
292.9 |
|
|
|
162.7 |
|
|
|
656.5 |
|
|
|
302.9 |
|
Selling, general and administrative |
|
113.2 |
|
|
|
77.7 |
|
|
|
225.5 |
|
|
|
153.8 |
|
Research and development |
|
18.2 |
|
|
|
17.6 |
|
|
|
37.5 |
|
|
|
39.4 |
|
Contingent consideration |
|
(0.1 |
) |
|
|
1.1 |
|
|
|
(1.1 |
) |
|
|
0.3 |
|
Amortization of intangible assets |
|
12.6 |
|
|
|
14.9 |
|
|
|
25.2 |
|
|
|
29.9 |
|
Total costs and expenses |
|
436.8 |
|
|
|
274.0 |
|
|
|
943.6 |
|
|
|
526.3 |
|
Operating income (loss) |
|
5.6 |
|
|
|
27.2 |
|
|
|
44.0 |
|
|
|
(13.6 |
) |
Other income and (expense),
net |
|
(16.9 |
) |
|
|
12.7 |
|
|
|
(23.7 |
) |
|
|
(4.3 |
) |
Income (loss) before income taxes
and |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
investment losses |
|
(11.3 |
) |
|
|
39.9 |
|
|
|
20.3 |
|
|
|
(17.9 |
) |
Income tax provision |
|
(4.8 |
) |
|
|
(6.0 |
) |
|
|
(5.3 |
) |
|
|
(7.2 |
) |
Income (loss) before investment
losses |
|
(16.1 |
) |
|
|
33.9 |
|
|
|
15.0 |
|
|
|
(25.1 |
) |
Loss from investments in
investees |
|
(0.1 |
) |
|
|
(0.2 |
) |
|
|
(0.1 |
) |
|
|
(0.3 |
) |
Net income (loss) |
$ |
(16.2 |
) |
|
$ |
33.7 |
|
|
$ |
14.9 |
|
|
$ |
(25.4 |
) |
Income (loss) per share, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
basic and diluted |
$ |
(0.03 |
) |
|
$ |
0.05 |
|
|
$ |
0.02 |
|
|
$ |
(0.04 |
) |
Weighted average common
shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
outstanding, basic and diluted |
|
646,996,891 |
|
|
|
640,578,794 |
|
|
|
644,001,280 |
|
|
|
640,578,794 |
|
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