Executive Summary

Q4 2024 revenue was $183.6M (+0.9% y/y) and diluted EPS was $0.01, aided by a $54.1M realized gain on GeneDx share sales and $21.4M non-cash other income; operating loss narrowed materially versus last year .
Segment results were mixed: Diagnostics services revenue fell to $103.1M on asset sales, while Pharmaceuticals “transfer of IP and other” surged to $43.1M on BARDA ($23.8M), Merck EBV milestone ($12.5M) and contract manufacturing milestones ($9.8M) .
Versus prior guidance, Q4 totals were a significant beat on total revenue and “other” revenue, a beat on services, but a miss on product revenue and costs/expenses; FY 2025 guidance introduced: revenue $675–$700M, costs/expenses $825–$875M with BARDA offset for R&D and Diagnostics GM threshold ≥27% .
BioReference restructuring progressed (operating loss cut ~50% y/y), with management targeting Q1 2025 breakeven then profitability and an additional $20M of annualized cost savings; continued buybacks and note repurchases support capital structure realignment .
Wall Street consensus (S&P Global) EPS/revenue estimates for Q4 2024 were unavailable due to data access limits; comparisons to consensus cannot be provided (see Estimates Context) [GetEstimates error].

What Went Well and What Went Wrong

What Went Well

ModeX pipeline advanced: Merck commenced Phase 1 EBV vaccine trial, triggering a $12.5M milestone; MDX2001 solid tumor tetraspecific antibody continues dose escalation with safety/tolerability readouts expected later in 2025 .
Strong “other” revenue drivers: BARDA contributed $23.8M in Q4 (cumulative BARDA awards now $110M committed, potential up to $205M), plus contract manufacturing milestones; “transfer of IP and other” revenue rose to $43.1M from $14.7M y/y .
Diagnostics operating efficiency improved: costs/expenses declined to $124.8M from $166.4M y/y; operating loss narrowed to $21.7M (vs $42.3M y/y), supporting a path to breakeven/profitability in 2025 .

Management quotes:

“2024 was a transformative year for OPKO…we are adequately funded to advance our pharmaceutical pipeline and to return capital to our shareholders” .
“We have established gross margin threshold targets…above 27% and expect positive cash flow for the full year 2025” .

What Went Wrong

Product revenue softness: Pharmaceuticals product revenue fell to $37.4M (from $43.0M y/y), primarily due to unfavorable FX and stable Rayaldee sales ($9.1M vs $9.3M y/y) .
NGENLA gross profit share declined: $9.6M in Q4 (vs $12.2M y/y), with management citing prior-period catch-ups in Q3’23 and inventory pull-through timing; CFO referenced $9.5M in prepared remarks (minor discrepancy vs press) .
Total costs/expenses of $216.7M were above prior Q4 guidance ($200–$210M), reflecting higher R&D into ModeX and restructuring/lease adjustments in Diagnostics .

Financial Results

Metric	Q4 2023	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD Millions)	181.9	182.2	173.6	183.6
Operating Income (Loss) ($USD Millions)	(69.1)	(61.7)	14.2	(33.1)
Net Income (Loss) ($USD Millions)	(66.5)	(10.3)	24.9	14.0
Diluted EPS ($USD)	(0.09)	(0.01)	0.03	0.01

Segment breakdown and key drivers:

Metric	Q4 2023	Q4 2024
Diagnostics: Revenue from services ($USD Millions)	124.2	103.1
Pharmaceuticals: Revenue from products ($USD Millions)	43.0	37.4
Transfer of IP and Other ($USD Millions)	14.7	43.1
NGENLA Gross Profit Share ($USD Millions)	12.2	9.6
Pharmaceuticals total revenue ($USD Millions)	57.7	80.5
Diagnostics costs/expenses ($USD Millions)	166.4	124.8
Diagnostics operating loss ($USD Millions)	(42.3)	(21.7)

Note: CFO referenced $9.5M NGENLA gross profit share in Q4 vs 12.2M in Q4’23; press table shows $9.6M .

KPIs

KPI	Q3 2024	Q4 2024
Pfizer gross profit share ($USD Millions)	7.4	9.5 (CFO)
BARDA revenue recognized ($USD Millions)	5.5	11.0 (within “other”)
Oncology net revenue growth YoY (%)	5% (Q4 commentary compares to Q4’23)	5%
4Kscore test volume/revenue growth YoY (%)	16% (FY 2024 vs 2023)	16%
Cash, cash equivalents & current restricted cash ($USD Millions)	400.1 (as of 9/30/24)	431.9 (as of 12/31/24)
Marketable securities ($USD Millions)	92.2 (as of 9/30/24)	54.6 (as of 12/31/24)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenues ($M)	FY 2025	N/A	675–700	New
Revenue from Services ($M)	FY 2025	N/A	405–425	New
Revenue from Products ($M)	FY 2025	N/A	165–175	New
Other Revenue ($M)	FY 2025	N/A	80–95 (incl. Pfizer GPS $35–45; BARDA $40–48)	New
Costs & Expenses ($M)	FY 2025	N/A	825–875 (excl. non-recurring)	New
R&D Expense ($M)	FY 2025	N/A	120–140 (offset $40–48 BARDA)	New
Depreciation & Amortization ($M)	FY 2025	N/A	~90	New
Diagnostics GM Threshold (%)	FY 2025	≥27%	≥27%	Maintained

Q4 2024 guidance vs actuals:

Metric	Period	Previous Guidance	Actual	Change
Total Revenues ($M)	Q4 2024	155–160	183.6	Beat
Revenue from Services ($M)	Q4 2024	95–98	103.1	Beat
Revenue from Products ($M)	Q4 2024	41–44	37.4	Miss
Other Revenue ($M)	Q4 2024	13–18	43.1	Beat
Costs & Expenses ($M)	Q4 2024	200–210 (excl. non-recurring)	216.7	Miss

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 & Q3)	Current Period (Q4 2024)	Trend
ModeX EBV vaccine with Merck	EBV nearing clinic; $50M upfront; milestones up to ~$860M	Phase 1 dosing commenced; $12.5M milestone earned	Accelerating
MDX2001 solid tumor antibody	IND cleared; first patients enrolling	Dose escalation ongoing; safety/tolerability readouts late 2025	Progressing
BARDA funding (COVID/flu multispecifics)	$59M prior, additional awards to reach $110M committed; potential up to $205M	Additional $51M awarded; FY25 BARDA revenue $40–48M guided	Expanding
BioReference restructuring/profitability	Post-Labcorp sale; breakeven run-rate by YE’24; GM ≥27% target	Q4 OpLoss cut; Q1’25 breakeven then profitability; +$20M savings in 2025	Improving
NGENLA commercialization/profit share	Global launch; H2’24 GPS $15–20M guided	Q4 GPS ~$9.5–9.6M; FY25 GPS $35–45M guided	Steady growth
GLP-1/glucagon OPK-88006	Oral and SC forms advancing; animal PK promising	Expect both forms IND-ready by year-end	Advancing
Rayaldee	CKD outcomes evidence; stable sales	Q4 sales $9.1M; China launch phased by Nicoya	Stable with catalysts
Macro/regulatory (vaccines)	N/A	No current indications of funding pullback; maintain close BARDA contact	Neutral

Management Commentary

Phillip Frost: “With the infusion of cash from various transactions, we are adequately funded to advance our pharmaceutical pipeline and to return capital to our shareholders…” .
Elias Zerhouni: “Merck will assume all development activities of the EBV vaccine candidate through commercialization…we achieved one of our milestone payments” .
Adam Logal: “We have established gross margin threshold targets…above 27% and expect positive cash flow for the full year 2025…Total revenues between $675M and $700M” .
Elias Zerhouni: “On a comparable basis…overall testing volume grew by 1% in Q4 2024 as compared to Q4 2023…Oncology net revenues +5% y/y” .
Gary Nabel: “Second-generation HIV multispecific antibody…about ten-fold more potent…about to declare a lead candidate” .

Q&A Highlights

BioReference profitability timeline: Management targets breakeven in Q1’25 and profitability thereafter, with remaining restructuring charges in Q1 and cost programs to drive efficiencies .
EBV milestones/timing: Phase 1 data could enable a Phase 2 decision around Q3’25; specific milestone amounts undisclosed until earned .
Dual agonist (GLP-1/glucagon): Pursuing weekly injectable and daily oral; focus populations include obesity and fatty liver disease (NASH/MASH) .
Rayaldee China launch: Nicoya expected to start small-scale selling in early territories, broadening post-NDA approval; milestone/royalty-driven economics .
BARDA program runway: Committed $110M supports development through Phase 1 and into early Phase 2; FY25 expected BARDA revenue $40–48M .
MDX2001 biomarker approach: c-MET/TROP2 expression widely distributed; trials likely “all comers,” with post hoc threshold assessment (e.g., debated 45% cutoff) .

Estimates Context

S&P Global (Capital IQ) consensus estimates for Q4 2024 EPS and revenue were unavailable due to API daily request limit; comparison to Wall Street consensus cannot be provided at this time [GetEstimates error].
Given the strong “other” revenue drivers (BARDA, Merck milestone), sell-side models may need to adjust “transfer of IP and other” line items upward, offset by lower product revenue due to FX and Diagnostics asset sale impacts .

Key Takeaways for Investors

Significant top-line beat versus prior Q4 guidance driven by BARDA and Merck milestone; watch for continued non-dilutive funding flow-through in FY25 (“other” guided $80–95M) .
Diagnostics margin and cost trajectory improving post-asset sale; breakeven targeted in Q1’25 with incremental $20M annualized savings—monitor Q1 restructuring charges and GM ≥27% threshold .
ModeX clinical catalysts: EBV Phase 1 underway (Merck-led) and MDX2001 dose escalation advancing; initial safety/tolerability readouts for MDX2001 later in 2025 could be a pipeline validation event .
NGENLA profit share stable with FY25 GPS guided at $35–45M; conversion from daily Genotropin supporting long-term stream—watch adult/pediatric indication milestones .
GLP-1/glucagon dual agonist advancing toward IND readiness (injectable and oral); differentiation potential in NASH/MASH suggests optionality for partnering .
Capital allocation supportive: ~$495M total liquidity at year-end across cash, investments, and restricted cash; buybacks ($40.2M) and note repurchases reflect commitment to shareholder value .
Near-term trading implications: Positive reaction likely to guidance beat and funding milestones, tempered by product revenue miss and elevated R&D; medium-term thesis hinges on Diagnostics profitability execution and ModeX clinical progress .

Citations:
Press release and 8-K Q4 financials and highlights .
Q4 2024 earnings call transcripts and guidance .
Q3 2024 8-K/press and call .
Q2 2024 8-K/press and call .

OPKO HEALTH, INC. (OPK)·Q4 2024 Earnings Summary