OPK Opko Health Inc

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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.

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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).

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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.

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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®.

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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.

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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.

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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.

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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.

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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.

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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. 

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

For the three months ended

December 31,

For the twelve months ended

December 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