OPKO Health Reports Fourth Quarter 2024 Business Highlights and Financial Results
February 27 2025 - 3:10PM
OPKO Health, Inc. (NASDAQ: OPK) reports business
highlights and financial results for the three and 12 months ended
December 31, 2024.
Highlights from the fourth quarter of 2024 and
recent weeks include the following:
- Enrollment and dosing
underway by Merck in the Phase 1 Epstein-Barr virus (EBV) vaccine
trial. Dosing of patients has commenced for the Phase I
study (NCT06655324) of an EBV vaccine candidate being developed in
collaboration with Merck. The investigational vaccine, based on
ModeX’s ferritin nanoparticle vaccine platform, is being evaluated
for safety and tolerability in up to 200 healthy adults.
Commencement of this study triggered a milestone payment to
ModeX.
- Awarded $51 million of
additional funding under an existing BARDA contract to develop
COVID multispecific antibodies and to initiate an influenza
program. ModeX Therapeutics was awarded $26.9 million of
new funding under an existing contract with the Biomedical Advanced
Research and Development Authority (BARDA). This funding supports
the development of a second novel multispecific antibody to
SARS-CoV-2 from preclinical through Phase 1 trials, as well as
preclinical work on gene-based expression of multispecific
antibodies to SARS-CoV-2 including mRNA and DNA vectors. In
addition, BARDA activated an option for the second phase of funding
totaling $24.1 million for ModeX to begin development of influenza
multispecifics with gene and protein delivery modalities. Together,
these funds bring the total awarded to ModeX to $110 million (and
ModeX could receive up to $205 million if all options are
executed).
- Enrollment underway in the
MDX2001 Phase 1 trial for the treatment of solid tumor
cancers. MDX2001, a tetraspecific antibody, is
designed to optimize T-cell function while preventing tumor antigen
escape. This Phase 1 open-label trial is expected to enroll up to
45 patients at four clinical sites. The Phase 1a portion is
primarily designed to evaluate the safety and immunogenicity of
ascending doses of MDX2001 in patients with various solid
tumors.
- Pfizer’s global
commercialization of NGENLA® continues; available
in all major markets. OPKO is entitled to a share of gross
profits based on sales of both NGENLA and Pfizer’s daily growth
hormone product, Genotropin®.
- BioReference Health made
significant strides toward near-term profitability. With
the goal of achieving profitability for 2025, BioReference
continued to reduce costs and improve productivity by enhancing
innovation of its higher-value specialty testing segments. In
September 2024 OPKO sold a portion of BioReference Health’s
laboratory testing businesses focused on clinical diagnostics and
women’s health, excluding operations in New York and New Jersey,
for $237.5 million. This transaction accelerated the path to
sustained growth and profitability while retaining core laboratory
services operations.
- Capital structure
realignment through a series of transactions providing the Company
with the liquidity and flexibility to execute its long-term
plans. During the fourth quarter of 2024 the Company
repurchased $17.0 million of principal convertible notes for $25.0
million and repurchased an additional 10.9 million common shares
for $16.5 million. Under its previously announced stock
repurchase program, OPKO has repurchased 25.8 million shares for
$40.2 million with $59.8 million remaining under the program.
During 2024, the Company reduced its common share count by 81.0
million shares, or 10% of shares outstanding. In addition,
the Company received $166.6 million of proceeds from the sale of
GeneDx Holdings Corp. (“GeneDx”) shares as well as $51.7 million
after December 31, 2024.
Fourth Quarter Financial
Results
- Consolidated:
Consolidated total revenues for the fourth quarter of 2024 were
$183.6 million compared with $181.9 million for the comparable
period of 2023. Net income for the fourth quarter of 2024 was $14.0
million, or $0.01 per diluted share, compared with net loss of
$66.5 million, or $0.09 per share, for the 2023 quarter. Operating
loss for the fourth quarter of 2024 was $33.1 million compared with
operating loss of $69.1 million for the 2023 quarter. The fourth
quarter of 2024 included a realized gain of $54.1 million from the
sale of shares of GeneDx, as well as non-cash other income of $21.4
million compared with non-cash other expense of $3.2 million in the
comparable quarter related to the change in the fair value of the
GeneDx shares.
- Pharmaceuticals:
Revenue from products in the fourth quarter of 2024 was $37.4
million compared with $43.0 million in the fourth quarter of 2023,
primarily reflecting unfavorable foreign currency exchange
fluctuations. Revenue from sales of Rayaldee was $9.1 million
compared with $9.3 million in the same period in 2023. Revenue from
the transfer of intellectual property and other was $43.1 million
in the fourth quarter of 2024 compared with $14.7 million in the
2023 period. This increase was driven by revenue from the BARDA
contract of $23.8 million in 2024 compared with $1.2 million in
2023, as well as $9.8 million from contract manufacturers'
commercial milestones, compared with $0.4 million in 2023, and a
$12.5 million milestone from Merck. This increase was partially
offset by a decrease in gross profit share payments for NGENLA,
which totaled $9.6 million in the 2024 period compared with $12.2
million in the 2023 period. Total costs and expenses increased to
$82.6 million in the fourth quarter of 2024 from $73.8 million in
the prior-year period, primarily due to higher research and
development expenses related primarily to increased activity within
the ModeX development programs. Operating loss was $2.1 million in
the fourth quarter of 2024, which included $18.1 million of
depreciation and amortization expense, compared with $16.0 million
in the fourth quarter of 2023, which included $17.9 million of
depreciation and amortization expense.
- Diagnostics:
Revenue from services in the fourth quarter of 2024 was $103.1
million compared with $124.2 million in the prior-year period, with
the decrease primarily due to lower clinical test volume
principally as a result of the sale of certain BioReference assets.
Total costs and expenses were $124.8 million in the fourth quarter
of 2024 compared with $166.4 million in the fourth quarter of 2023.
The decrease was primarily attributable to the aforementioned asset
sales and continued cost-reduction initiatives at BioReference,
which included a reduction in employee headcount and the
streamlining of certain smaller operations, resulting in operating
efficiencies. Operating loss was $21.7 million in the fourth
quarter of 2024, which included $7.4 million in adjustments to the
life of certain leases and the associated expense, compared with a
loss of $42.3 million in the 2023 period, which included $4.7
million of non-recurring expenses and $5.4 million of revenue
adjustments.
- Cash, cash equivalents,
marketable securities and restricted cash: Cash, cash
equivalents, and current restricted cash were $431.9 million,
marketable securities, principally shares of GeneDx, were $54.6
million and long term restricted cash and escrow was $37.2 million
as of December 31, 2024.
Conference Call and Webcast
Information
OPKO’s senior management will provide a business
update, discuss fourth quarter financial results, provide financial
guidance and answer questions during a conference call and live
audio webcast today beginning at 4:30 p.m. Eastern time.
Participants are encouraged to pre-register for the conference call
here. Callers who pre-register will receive a unique PIN to gain
immediate access to the call and bypass the live operator.
Participants may register at any time, including up to and after
the call start time. Those unable to pre-register may participate
by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A
webcast of the call can also be accessed at OPKO’s Investor
Relations page and here.
A telephone replay will be available until March
6, 2025, by dialing 877-344-7529 (U.S.) or 412-317-0088
(International) and providing the passcode 8087517. A webcast
replay will be available beginning approximately one hour after the
completion of the live conference call here.
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, whether our product
development efforts will be successful and whether the expected
benefits of our products will be realized, including whether
enrollment in a clinical trials for MDX2001 and MDX 2201 will be
successful and whether the data will be positive, whether we will
receive additional funding from BARDA, whether the relationship
with our commercial and strategic partners will be successful,
whether our commercial and strategic partners will be able to
commercialize our products and successfully utilize our
technologies, whether our partner will be able to continue to
successfully commercialize NGENLA and the NGENLA profits will
provide adequate upside, whether we will continue to repurchase
shares under a buyback program, our ability to market and sell any
of our products in development, whether we will continue to
successfully advance products in our pipeline and whether they can
be commercialized, whether BioReference will be able to streamline
its laboratory services business and better position the division
for sustained growth and profitability, whether BioReference’s
attempts at returning its core business to profitability will be
successful, 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 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:Alliance
Advisors IRYvonne Briggs,
310-691-7100ybriggs@allianceadvisors.com orBruce Voss, 310-691-7100
bvoss@allianceadvisors.com
—Tables to Follow—
OPKO Health, Inc. and SubsidiariesCondensed
Consolidated Balance Sheets(in millions)Unaudited
| |
As of |
| |
December 31, 2024 |
|
December 31, 2023 |
|
Assets: |
|
|
|
|
|
|
|
|
Cash, cash equivalents, and current restricted cash |
$ |
431.9 |
|
|
$ |
95.9 |
|
|
Other current assets |
|
230.2 |
|
|
|
213.6 |
|
| Total current assets |
|
662.1 |
|
|
|
309.5 |
|
| In-process research and
development and goodwill |
|
724.3 |
|
|
|
793.3 |
|
| Other assets |
|
813.8 |
|
|
|
908.9 |
|
|
Total Assets |
$ |
2,200.2 |
|
|
$ |
2,011.7 |
|
| |
|
|
|
|
|
|
|
| Liabilities and Equity: |
|
|
|
|
|
|
|
|
Accounts payable |
$ |
47.1 |
|
|
$ |
69.7 |
|
|
Accrued expenses |
|
118.4 |
|
|
|
90.1 |
|
|
Current portion of convertible notes |
|
0.2 |
|
|
|
0.0 |
|
|
Other current liabilities |
|
27.4 |
|
|
|
40.3 |
|
| Total current liabilities |
|
193.1 |
|
|
|
200.1 |
|
|
Long-term portion of convertible notes |
|
173.6 |
|
|
|
214.3 |
|
|
Senior secured notes |
|
245.6 |
|
|
|
0.0 |
|
|
Deferred tax liabilities, net |
|
140.8 |
|
|
|
126.8 |
|
|
Other long-term liabilities, principally leases, and lines of
credit |
|
81.7 |
|
|
|
81.3 |
|
|
Total Liabilities |
|
834.8 |
|
|
|
622.5 |
|
|
Equity |
|
1,365.4 |
|
|
|
1,389.2 |
|
|
Total Liabilities and Equity |
$ |
2,200.2 |
|
|
$ |
2,011.7 |
|
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 twelve months endedDecember 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
| Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from services |
$ |
103.1 |
|
|
$ |
124.2 |
|
|
$ |
480.7 |
|
|
$ |
515.3 |
|
|
Revenue from products |
|
37.4 |
|
|
|
43.0 |
|
|
|
155.1 |
|
|
|
167.5 |
|
|
Revenue from transfer of intellectual property and other |
|
43.1 |
|
|
|
14.7 |
|
|
|
77.3 |
|
|
|
180.7 |
|
|
Total revenues |
|
183.6 |
|
|
|
181.9 |
|
|
|
713.1 |
|
|
|
863.5 |
|
| Costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service revenues |
|
76.3 |
|
|
|
112.4 |
|
|
|
402.1 |
|
|
|
445.8 |
|
|
Cost of product revenues |
|
22.7 |
|
|
|
24.8 |
|
|
|
92.5 |
|
|
|
99.5 |
|
|
Selling, general, and administrative |
|
67.0 |
|
|
|
72.9 |
|
|
|
304.2 |
|
|
|
300.6 |
|
|
Research and development |
|
30.4 |
|
|
|
19.4 |
|
|
|
105.2 |
|
|
|
89.6 |
|
|
Contingent consideration |
|
0.0 |
|
|
|
(0.0 |
) |
|
|
0.0 |
|
|
|
(1.0 |
) |
|
Amortization of intangible assets |
|
20.3 |
|
|
|
21.5 |
|
|
|
82.7 |
|
|
|
86.0 |
|
|
Gain on sale of assets |
|
0.0 |
|
|
|
0.0 |
|
|
|
(121.5 |
) |
|
|
0.0 |
|
|
Total costs and expenses |
|
216.7 |
|
|
|
251.0 |
|
|
|
865.2 |
|
|
|
1,020.5 |
|
|
Operating loss |
|
(33.1 |
) |
|
|
(69.1 |
) |
|
|
(152.1 |
) |
|
|
(157.0 |
) |
| Other income (expense),
net |
|
68.0 |
|
|
|
(3.4 |
) |
|
|
141.7 |
|
|
|
(27.4 |
) |
| Income (loss) before income
taxes and investment losses |
|
34.9 |
|
|
|
(72.5 |
) |
|
|
(10.4 |
) |
|
|
(184.4 |
) |
| Income tax (provision)
benefit |
|
(20.9 |
) |
|
|
6.0 |
|
|
|
(42.8 |
) |
|
|
(4.4 |
) |
| Income (loss) before
investment losses |
|
14.0 |
|
|
|
(66.5 |
) |
|
|
(53.2 |
) |
|
|
(188.8 |
) |
| Loss from investments in
investees |
|
(0.0 |
) |
|
|
(0.0 |
) |
|
|
(0.0 |
) |
|
|
(0.1 |
) |
| Net income (loss) |
$ |
14.0 |
|
|
$ |
(66.5 |
) |
|
$ |
(53.2 |
) |
|
$ |
(188.9 |
) |
| Income (loss) per
share, basic |
$ |
0.02 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.25 |
) |
| Income (loss) per
share, diluted |
$ |
0.01 |
|
|
$ |
(0.09 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.25 |
) |
| Weighted average common shares
outstanding, basic |
|
676,788,895 |
|
|
|
751,506,257 |
|
|
|
694,019,535 |
|
|
|
751,765,915 |
|
| Weighted average common shares
outstanding, diluted |
|
951,837,287 |
|
|
|
751,506,257 |
|
|
|
694,019,535 |
|
|
|
751,765,915 |
|
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