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Keytruda (pembrolizumab) · anti-PD-1 · Merck & Co.
This page covers the advanced (LA or R/M) cSCC indication only (KEYNOTE-629, monotherapy), not the NSCLC, melanoma, head-and-neck, or other Keytruda settings, and not the adjuvant/curative-surgery cSCC population. See all Keytruda indications →
On label; year correct, date added. Label 1.19: 'for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.' The row's 'Recurrent / metastatic cutaneous SCC' captures the first half; the label was subsequently broadened in July 2021 to add locally advanced disease not curable by surgery or radiation, so the current indication is wider than the row states. Approved 2020-06-24 on KEYNOTE-629 as a traditional approval from the outset - it appears in none of the three FDA accelerated-approval registries, so it was never an accelerated approval. No EU extension of indication on the EPAR as of 2026-09-16.
All markets
2026 net revenue · modelled cSCC slice, 8-geo
$558M
CONCLUDED · 2026 modelled net revenue - indication slice, all markets; Merck & Co. reports no indication revenue. Modelled net revenue · sourced funnel
No model change since the 20 Sep 2026 snapshot.
The 15-second read
Advanced cSCC is one of the few settings where Keytruda is the second mover rather than the category creator, cemiplimab got there two years earlier and holds the leading in-class position, and the model sizes this accordingly: a modest slice cresting at ~$566M in 2027, well under 2% of a ~$31.7B franchise, then falling to a ~$270-280M floor from 2030 onward. The value here is breadth, not scale. KEYNOTE-629 showed real activity (ORR 35.2% in recurrent/metastatic, 50.0% in locally advanced), but it is single-arm Phase 2 evidence, which makes for a weaker HTA dossier in Europe, and the pool is intrinsically small: only about 4% of a very common skin cancer becomes advanced and needs systemic anti-PD-1, and cSCC incidence is far lower in Japan and China. US biologic LOE around 2028 then removes most of what is left.
Threats land:Pembrolizumab biosimilars arrive promptly after the ~2028 US expiry while cemiplimab extends its lead on the back of its 2025 adjuvant approval, pushing Keytruda's in-class minority share down at the same time price collapses.
Modelled path:The slice plateaus through 2027, biosimilar erosion from ~2028 in the US and ~2029 in the EU is gradual rather than a cliff, and a residual branded line settles near $270M from 2030 to 2034 on slowly rising Western cSCC incidence.
Levers land:Neoadjuvant and perioperative anti-PD-1 in resectable high-risk cSCC expands the treated population earlier in the disease course, growing the addressable pool faster than biosimilars erode the branded share of it.
The advanced fraction of cSCC, an Ormeval scoping estimate of roughly 4% (a 2-5% range) of a very large keratinocyte-cancer incidence base, which is the single cut that turns hundreds of thousands of cases into a small systemic-therapy pool and is never reported anywhere.
At a glance
Mechanism anti-PD-1
Clinical
Commercial
Development to approval
These are regulatory approval dates (FDA/EMA/NMPA/PMDA), not commercial launch; launch follows after pricing & reimbursement (see the access-lag column in the HTA table). All four regulators have approved this indication. Cross-checked against Merck & Co. disclosures and regulator databases.
Advanced cSCC is a modest Keytruda indication by revenue (~$0.3-0.7bn/yr global at maturity, a low-single-digit % of the franchise), but strategically it (1) extended pembrolizumab into a dermatologic-oncology setting where chemotherapy and EGFR-directed therapy had been the unsatisfactory standard, and (2) is a head-to-head proof point against cemiplimab, the rare indication where Keytruda is the second mover rather than the category creator. It is not a franchise pillar; its value is breadth and label-expansion optionality rather than scale, and it carries the same ~2028 US biologic-LOE exposure as the rest of Keytruda.
Advanced cSCC, the locally-advanced (not curable by surgery/RT) or recurrent/metastatic fraction (~2-5%) of a very common skin cancer, is a modest but genuine immuno-oncology setting. Pembrolizumab monotherapy (KEYNOTE-629; R/M ORR 35.2%, LA ORR 50.0%) is an approved anti-PD-1 option, but cemiplimab (Libtayo, FDA Sep 2018) is the first-in-class leader and dominates the setting, so Keytruda holds a minority in-class share. A small slice of the Keytruda franchise (~$0.3-0.7bn/yr global at maturity), ramping from the 2020 launch, exposed to the ~2028 US biologic LOE.
Cutaneous squamous cell carcinoma is the second-most-common skin cancer (after basal cell carcinoma) and one of the most common malignancies overall, US incidence is very high (~700,000-1,000,000+ cases/yr) and rising with ageing and cumulative UV exposure. The overwhelming majority are cured by simple excision or radiation and never need systemic therapy. Only a SMALL fraction, ~2-5%, those with deeply invasive/unresectable locally-advanced disease or regional/distant metastasis, become candidates for systemic anti-PD-1 therapy. This advanced pool is the setting this model sizes. Incidence is markedly lower in pigmented/Asian populations (China age-standardised cSCC incidence ~2/100k vs Western 20-150/100k), so the US and other high-UV-exposure, fair-skinned Western markets dominate the addressable base; Japan and China contribute far less per capita.
KEYNOTE-629 established pembrolizumab as an anti-PD-1 option for advanced cutaneous squamous cell carcinoma, the second-most-common skin cancer, but only a small advanced/unresectable fraction needs systemic therapy. The single-arm Phase 2 trial showed durable responses in both the recurrent/metastatic cohort (ORR 35.2%) and the locally-advanced cohort (ORR 50.0%), supporting FDA approval (R/M Jun 2020; LA Jul 2021). It is a modest, real but second-mover Keytruda indication: cemiplimab (Libtayo) entered the same setting ~2 years earlier (FDA Sep 2018) and remains the cSCC market leader, so Keytruda takes a MINORITY in-class share.
Eligibility hinges on a multidisciplinary judgement that the tumour is unresectable / not curable by surgery or radiation (locally-advanced) or has recurred/metastasized. Immunosuppressed patients (notably solid-organ-transplant recipients, a meaningful cSCC subgroup) are largely excluded from checkpoint blockade and are the main pre-treatment funnel leak alongside the small advanced fraction itself.
KEYNOTE-629 (NCT03284424): global, open-label, non-randomized, multicenter single-arm Phase 2 trial in locally-advanced (LA, not curable by surgery/RT) or recurrent/metastatic (R/M) cutaneous squamous cell carcinoma. Patients received pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles (~2 years). Primary endpoint ORR by independent central review (RECIST v1.1). Immunosuppressed patients (e.g. solid-organ-transplant recipients) excluded.
Load-bearing 4/5 sourced. ASSUMED uptake is yours to change.
This indication only, not Keytruda's total revenue
Locally-advanced (not curable by surgery or radiation) or recurrent/metastatic cutaneous squamous cell carcinoma, pembrolizumab 200 mg q3w monotherapy (KEYNOTE-629, single-arm Phase 2). A second-line-of-class anti-PD-1 entrant behind cemiplimab (Libtayo), the first-in-class cSCC leader.
Reported actuals are always drawn and need no chip: a cited reported figure is a fact, not a claim. Everything forward of them is one of the 4 kinds above.
$558M
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $566M · launch 2020 → 2034
modeled history (left of today)·click any year to decompose its funnel below.
Measured band: none - no measured band: n<8
Bull / bear elsewhere in the product are a sensitivity (fixed multipliers), not this band.
Pre-2026 figures are MODELLED (no indication × country actuals are reported) and calibrated so the advanced-cSCC slice is a MODEST minority of the Keytruda franchise: the slice ramps from the 2020 R/M launch (small), through the 2021 LA expansion, to a ~$0.3-0.7bn/yr global (8-geo) plateau across the mid-2020s, well under ~2% of the ~$31.7B FY2025 Keytruda franchise, reflecting (1) the small advanced-cSCC pool (~2-5% of a common-but-mostly-curable cancer), and (2) Keytruda's MINORITY in-class share behind cemiplimab (Libtayo), the first-in-class cSCC leader. The slice rises every year from 2020 rather than peaking mid-decade, then erodes from ~2028 as the US composition-of-matter patent expires and pembrolizumab biosimilars enter (EU ~2029). The 'today' marker splits modelled history from forecast.
No reported anchor exists at this grain: companies publish this asset as one product line and never split it by indication × country, so every year above is modelled, including the years already past. The claims below are scored against reported actuals wherever a program has them.
A forecast year closes when an actual is reported for it. A miss is the distance from that actual, signed as the claim fell: under it, or over it.
| Claim | Closed years | Worst miss | Worst miss % |
|---|---|---|---|
| Ormeval modelMODELLED · Ormeval · live | - | no closed year yet | - |
A superseded team version keeps its own row: what it was off by is still a fact about that version. A row with no closed year is not a good score.
What it shows. A modelled base-case net-revenue curve for this indication, year by year, split at 'today' into modelled history and forecast, with the branded curve shown against its in-class rivals.
What to look for. The peak year and how steep the decline is after loss of exclusivity, and where a rival's curve crosses yours, that crossing is the share the model has you losing.
Common misread. Reading the pre-'today' portion as reported actuals (it's modelled), or treating the base case as a company target. It is one deterministic Ormeval-modelled scenario anchored to cited actuals, not guidance and not analyst consensus.
Key model assumptions · The headline rests on that advanced fraction, on an anti-PD-1-eligible-and-treated reach gate running from about 0.40 in China to 0.70 in the US, and on Keytruda holding a minority in-class share against cemiplimab's roughly half of the pool, all estimates layered on brand-wide Keytruda pricing rather than any cSCC-specific price.
The decline is defended, not certain
The 2028-2030 decline is anchored to a dated and franchise-wide event, US pembrolizumab composition-of-matter expiry around 2028 with the EU following in 2029, and it is modelled as gradual biologic share loss rather than an overnight cliff, but the depth of the residual floor is uncertain, since checkpoint-inhibitor biosimilar uptake in a small dermatologic-oncology setting has no precedent to calibrate against.
What would change our mind
If no pembrolizumab biosimilar has launched in the US by end-2029, the modelled 2028-2030 fall is premature and the plateau should extend; conversely, if cemiplimab's adjuvant approval pulls high-risk cSCC patients into earlier treatment and locks the anti-PD-1 relationship before advanced disease, Keytruda's minority in-class share erodes for competitive reasons well before the patent date.
A scenario is your own assumptions layered on Ormeval’s cited baseline. We never change the baseline; save as many named scenarios as you like and click one to load it back later.
| Driver · 2026 | US | FR | DE | IT | ES | UK | JP | CN | Total | Source |
|---|---|---|---|---|---|---|---|---|---|---|
| cSCC incidence (2026) | 849k | 58k | 106k | 48k | 42k | 53k | 27k | 64k | 1.25M | AAD · Stang 2019 · GBD |
New cutaneous squamous-cell carcinoma cases per year; rising ~2-4%/yr (ageing + cumulative UV). Shown for 2026: 2024 basis +3%/yr → ×1.061. cSCC is the second-most-common skin cancer and one of the most common malignancies overall, but registry capture is poor (keratinocyte cancers are under-reported). US incidence is very high (~700,000-1,000,000+ cases/yr, fair-skinned + high UV). Western Europe is high but lower than the US. Japan and especially China have FAR lower incidence (pigmented skin; China age-standardised incidence ~2/100k), so the Asian addressable base is small. Country values are order-of-magnitude estimates of annual cSCC cases, all FLAGGED. | ||||||||||
| × Advanced (LA unresectable or R/M)est | 4% | 4% | 4% | 4% | 4% | 4% | 4% | 4% | share, not summed | Caudill 2023 · JCAD |
The locally-advanced-not-curable-by-surgery/RT or recurrent/metastatic fraction, the only cSCC needing systemic therapy. The dominant funnel gate. The overwhelming majority of cSCC is cured by simple excision or radiation. Only ~2-5% become advanced, deeply invasive/unresectable locally-advanced disease or regional/distant metastasis, and are candidates for systemic anti-PD-1. Modelled at ~0.04 (4%) of incident cSCC across Western markets, slightly lower in Asia. THE biggest funnel cut in this model, a small advanced pool off a huge incidence base. | ||||||||||
| × Anti-PD-1-eligible & systemic-treatedest | 70% | 68% | 68% | 65% | 65% | 66% | 65% | 40% | share, not summed | checkpoint-eligibility lit. |
Fit for and receiving anti-PD-1 systemic therapy, excludes immunosuppressed (transplant) patients, the very frail, and those kept on chemo/EGFR or best supportive care. Branded pembrolizumab UPTAKE is the share row below (excluded here). Of advanced-cSCC patients, a share are unfit for or excluded from checkpoint blockade, solid-organ-transplant recipients (a meaningful cSCC subgroup, risk of graft rejection + poor response), the very frail/elderly, and those who remain on chemo/EGFR or best supportive care. Western markets ~0.65-0.70 anti-PD-1-treated of the advanced pool; lower in China (~0.40, access). Excludes pembrolizumab UPTAKE, which is the competitive share layer below. | ||||||||||
| = Addressable advanced-cSCC IO pool | 28k | 1.9k | 3.4k | 1.5k | 1.3k | 1.7k | 772 | 1.1k | 40k | computed |
Incidence × the rates above, advanced (LA unresectable or R/M) cSCC patients fit for and receiving anti-PD-1 systemic therapy this year. The advanced-cSCC pool grows slowly, rising keratinocyte-cancer incidence (+2-4%/yr, ageing + cumulative UV) lifts the Western advanced pool a low single-digit %/yr; East Asia (much lower cSCC incidence) flatter. No major stage-shift or screening headwind applies (unlike NSCLC). The pool is small in absolute terms and capped by the ~2-5% advanced fraction. | ||||||||||
| × Keytruda uptake (branded) | 10% | 9% | 9% | 8% | 8% | 8% | 9% | 6% | share, not summed | ASSUMED |
Per-market branded uptake of the addressable pool this year (launch ramp net of competitors & biosimilars). See the competitive curve below; pick a market for its access basis. | ||||||||||
| = Treated with Keytruda | 2.8k | 163 | 297 | 117 | 104 | 139 | 71 | 67 | 3.7k | computed · assumed input |
Addressable pool × branded uptake. | ||||||||||
| × Net price / patient (2026) | $173K | $86K | $91K | $82K | $77K | $85K | $72K | $29K | per patient, not summed | ASP · HTA · NHI |
Pembrolizumab pricing is brand-wide (same 200 mg q3w / 400 mg q6w dosing, up to 35 cycles), so per-patient net revenue mirrors the Keytruda 1L-NSCLC model: US ~$180k/yr net (ASP ~$11.8k/200mg net of ~10-15% GTN), EU ~$80-95k, Japan ~$75k (biennial NHI cuts), China ~$30k. A prevalent patient generates ~a year of revenue per forecast year (incident-pool × annual-net structure). −2%/yr forward erosion; held flat before 2024. ALL net prices are ESTIMATES. SHOWN FOR 2026: the per-market figures in "Net pricing: assumptions & basis" below are the 2024 basis; this row applies -2%/yr from 2024 (×0.9604), so it is the same source value at a later date, not a second price. | ||||||||||
| = Net revenue / yrOutput | $481M | $14.1M | $27.1M | $9.6M | $8.0M | $11.7M | $5.1M | $1.9M | $558M | computed · assumed input |
Treated patients × realized net price. | ||||||||||
Regional revenue mix · 2026 modelled
Model estimate, sourced from the funnel table above
No reported competitor-share series exists for this setting, so every trajectory below is modelled from approval timing, label breadth and the funnel, not reported data.
In-class share, advanced cSCC immunotherapy: 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the addressable advanced-cSCC IO pool (LA unresectable or R/M cSCC fit for anti-PD-1). The branded-pembrolizumab line shows the launch ramp from 2020 to a MINORITY plateau behind cemiplimab, then ~2028 LOE biosimilar erosion; the gap below the top line is patients on cemiplimab, residual chemo/EGFR, or untreated. The branded pembrolizumab line is the only line this model monetizes.
Share of the 40k-patient addressable advanced-cSCC IO pool this regimen is modelled to treat, by year
Keytruda is modelled at 9% of this pool in 2026, peaking at 9% in 2025; each point of share is revenue on the chart above.
Scope: 8 modelled markets (US, EU5, JP, CN) · follows the market selector above
Rivals' share, same pool
Cemiplimab (Libtayo) holds the largest rival share in 2026, 15% of the pool; that is the share Keytruda has to take or hold.
Rivals, rescaled - note the axis maximum (20%), which is smaller than the plot above. Same data, a linear axis of its own, so a low-share entrant is readable rather than a hairline on the baseline.
Launch ramp = market-by-market approval + reimbursement timing (US R/M Jun 2020, LA Jul 2021; EU 2021-22; Japan 2022-23). Cemiplimab (Libtayo, FDA Sep 2018) is the first-mover leader and takes the majority in-class share; residual chemo/EGFR (cetuximab) holds a shrinking tail; pembrolizumab biosimilars timed to the ~2028 US / ~2029 EU LOE. Competitor trajectories are stated assumptions, not reported shares.
Readouts, approvals and LOE events for pembrolizumab and its rivals in this setting. Estimated timing is flagged; confirmed dates cited from Merck & Co. disclosures and regulator databases.
Pembrolizumab composition-of-matter expiry (~2028); biosimilars erode this slice with the rest of Keytruda
EU biosimilar entry erodes the branded cSCC slice
Neoadjuvant anti-PD-1 and IO-combination readouts could expand the treated cSCC population and reshuffle in-class share
✓ = reported public fact, cited. Upcoming timing is estimated from company guidance and trial registries, a projection, not a commitment. Approvals = US (FDA) · EU (EMA) · Japan (PMDA) · China (NMPA). ● = pembrolizumab, competitor tag = a same-setting rival.
Residual unmet need: why the field stays alive
Most advanced-cSCC patients still do not respond to anti-PD-1 monotherapy, R/M ORR is ~35% (KEYNOTE-629), so roughly two-thirds progress, and immunosuppressed patients (solid-organ-transplant recipients, a meaningful cSCC subgroup) are largely excluded from or respond poorly to checkpoint blockade and risk graft rejection. There is no established post-PD-1 standard, and the locally-advanced/borderline-resectable boundary is judgement-dependent. That residual need sustains development of neoadjuvant IO, IO combinations, and transplant-safe approaches despite the entrenched cemiplimab/pembrolizumab options.
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (Advanced cutaneous squamous cell carcinoma (cSCC))
Swipe to explore →
| Rival / regimen | Developer | Position in this setting | Approved (date, trial, n) | Head start vs this regimen (months) | Source |
|---|---|---|---|---|---|
| Cemiplimab (Libtayo) (Live threat) | Regeneron / Sanofi | Live threatwhyFirst and only FDA-approved therapy for advanced cSCC at launch (Sep 2018), the first-in-class and in-class share LEADER; 2025 adjuvant high-risk cSCC approval extends the franchise | Sep 2018, EMPOWER-CSKIN / advanced cSCC registration program | 21 | Cemiplimab (Libtayo), first FDA approval for advanced cSCC (Regeneron, Sep 2018) |
| Chemo / EGFR (cetuximab, platinum/5-FU) (Watch) | Generic / Merck KGaA (Erbitux) | WatchwhyHistorical pre-IO standard for advanced cSCC; a shrinking tail still used in IO-ineligible (e.g. transplant) patients | not in the record | not in the record | pre-IO standard of care |
| Pembrolizumab biosimilars (Watch) | Generic (post-LOE) | WatchwhyUS composition-of-matter LOE ~2028; EU ~2029, erodes the branded cSCC slice with the rest of Keytruda | not in the record | not in the record | pembrolizumab LOE ~2028 (US) |
Not every rival is approved in every region, so a share here is the modelled position in the markets where it competes, not a global one.
Net pricing: assumptions & basis
Pembrolizumab is dosed 200 mg q3w (or 400 mg q6w) IV, continued up to 35 cycles (~2-year cap), so per-patient revenue is the annual net cost while on-drug, not a fixed course. Pricing is brand-wide and identical to the Keytruda 1L-NSCLC model: US ASP ~$11.8k per 200 mg dose (~$205k/yr list); net prices below are per-market, net of country discounts.
Figures below are 2024 net prices, the basis the model is anchored on. The funnel applies -2%/yr from 2024, so the price it consumes for a later year is lower than the figure quoted here. Both come from this one value; the funnel row states the year it is showing.
Pembrolizumab dosing and pricing are brand-wide, so advanced cSCC uses the same per-patient net prices as the Keytruda 1L-NSCLC model: US ASP ≈ $11,795/200 mg q3w (~$205k/yr list) ⇒ ~$180k/yr net after ~10-15% physician-administered-biologic gross-to-net; Germany AMNOG ~$95k, France ~$90k, UK NICE PAS ~$88k, Italy AIFA ~$85k, Spain ~$80k (lowest Western); Japan NHI ~$75k (biennial cuts); China ~$30k. Per-patient revenue is modelled as the annual net cost while on treatment (incident-pool × annual-net, capturing ~one patient-year per forecast year). −2%/yr forward net erosion reflects ongoing HTA/NHI pressure into LOE; held flat before 2024. ALL net prices are ESTIMATES.
What it shows. The approval-to-reimbursement journey by market: when each payer granted access, on what terms (PD-L1 or comparator restrictions), and the lag between regulatory approval and reimbursed revenue.
What to look for. The access-lag column, approval is not revenue and some markets take a year or more. And the restrictions that narrow the eligible population below the full label.
Common misread. Assuming a US price or approval transfers to other markets. Ex-US payers benchmark against comparators and reference prices, so the net price and the covered population are usually smaller.
Rows ordered by access speed. The approval→reimbursement lag is commercially load-bearing, and it is not one number per drug: a monotherapy indication and a later combination extension file separately with a payer and can reach routine commissioning years apart, even within the same asset’s first-line setting.
| Market | HTA body | Decision | Access lag | PD-L1 | Comparator | Key outcome / MEA note |
|---|---|---|---|---|---|---|
| US | FDA | Jun 2020 (R/M); Jul 2021 (LA) | reference | biomarker-agnostic | Chemo / EGFR therapy | Medicare Part B (J9271); broad commercial. Second to Libtayo (Sep 2018) but on Keytruda's established access rails. List ~$200k/yr; ~10-15% GTN → ~$180k/yr net |
| Germany | G-BA / IQWiG | 2021-2022 | ~0.5 yr | biomarker-agnostic | Chemo / EGFR / cemiplimab | Reimbursed; AMNOG net below list; single-arm dossier limits added-benefit rating. ~$95k/yr net |
| France | HAS | 2021-2022 | ~0.7 yr | biomarker-agnostic | Chemo / cemiplimab | Reimbursed for advanced cSCC; SMR/ASMR modest given single-arm data. ~$90k/yr net |
| UK | NICE | 2021-2023 | ~1.5 yr | biomarker-agnostic | Chemo / cemiplimab | Appraised for advanced cSCC; confidential PAS; cemiplimab appraised in parallel. ~$88k/yr net |
| Italy | AIFA | 2022-2023 | ~1.5 yr | biomarker-agnostic | Chemo / cemiplimab | Class H; managed entry + regional formulary lag. ~$85k/yr net |
| Spain | SEFH / MoH | 2022-2023 | ~2 yr | biomarker-agnostic | Chemo / cemiplimab | Financed for advanced cSCC; +17-region formulary lag. ~$80k/yr net |
| Japan | PMDA / NHI | 2022-2023 | ~1 yr | biomarker-agnostic | Chemo / cemiplimab | NHI-listed; very small cSCC pool (low incidence in pigmented skin); biennial NHI price cuts. ~$75k/yr net |
| China | NMPA | post-2022 (limited) | ~2 yr | biomarker-agnostic | Chemo | Very low cSCC incidence; limited NMPA cSCC-specific positioning; not NRDL-prioritised for this niche. ~$30k/yr net |
How much each assumption could move the forecast, one at a time, over the same cited baseline.
This is a sensitivity illustration, not a probability: it shows how far each assumption could move the forecast, never how likely it is.
Set a target and solve for one lever, what it would have to reach, benchmarked against real comparable launches.
One lever at a time: the other assumptions stay at baseline, so the trade-off stays visible.
A model that shows where its own risk is, not a number to trust. Never investment advice.
Cite this forecast as recorded on Q2 2026 → A permanent record of these figures that does not change when the model does.
Every reported figure here traces to a public source below; the model's own assumptions are labelled where they appear.
Reported figures are public facts from company filings; the forward peak is Ormeval's own modelled estimate, not company guidance and not analyst consensus. Approval and readout dates are cross-checked against public regulator and company disclosures. Not investment advice.