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Keytruda (pembrolizumab) · individualised mRNA neoantigen therapy + anti-PD-1 (investigational) · Merck & Co.
This page covers the adjuvant high-risk resected melanoma indication only (the INTerpath-001 regimen). It is a PRE-APPROVAL scenario: revenue is contingent on a positive Phase 3 RFS readout and regulatory approval, neither of which has occurred. See all Keytruda indications →
Pivotal Ph3 with Moderna mRNA neoantigen vaccine; builds on Ph2b KEYNOTE-942 (recurrence reduction ~49%). Verified 2026-08-16, no change. NCT05933577 is ACTIVE_NOT_RECRUITING with estimated primary completion 2029-10-26 and no results posted; Merck's 2026-01-20 release confirms only that the trial is fully enrolled. Analyst caution: the '~49% recurrence reduction' belongs to the Phase 2b KEYNOTE-942 5-year RFS analysis in resected stage III/IV melanoma (HR 0.510, 95% CI 0.294-0.887, one-sided NOMINAL p=0.0075), not to this Phase 3 and not to a stage IIB-IV population. Keytruda's melanoma label is unchanged and makes no mention of intismeran autogene. VERIFIED 2026-08-16. NCT05933577 (V940-001), Ph3, n=1089, ACTIVE_NOT_RECRUITING (fully enrolled, not recruiting), RFS primary, PCD 2029-10-26; eligibility is resected Stage IIB/IIC, III or IV cutaneous melanoma. FIGURE CORRECTION: the '~49%' is the 3-year KEYNOTE-942 follow-up (Merck/Moderna 3 Jun 2024: HR 0.510, 95% CI 0.288-0.906, two-sided nominal p=0.019), sustained at 5 years (20 Jan 2026). The Lancet 2024 primary analysis reported HR 0.561 (95% CI 0.309-1.017), p=0.053 - a 44% reduction that did NOT reach significance. KEYNOTE-942 also enrolled stage IIIB-IV only, narrower than the Ph3.
Shared model · 2 pages
Est. peak net revenue · modelled scenario, ~2033
$1.08B
CONCLUDED · 2033 modelled net revenue - indication slice, all markets; Merck & Co. reports no indication revenue. Whole modelled scope (Adjuvant high-risk resected melanoma (Stage IIB-IV)), not this setting alone
No model change since the 20 Sep 2026 snapshot.
The 15-second read
This is the highest-profile binary in oncology rendered as a revenue curve: a $1.08B peak in 2033 that is worth exactly zero until INTerpath-001 (NCT05933577) reports its Phase 3 recurrence-free-survival result, which it has not. The whole scenario rests on a Phase 2b precedent, KEYNOTE-942 gave RFS HR 0.561 with 18-month RFS of 79% versus 62% and durable multi-year separation, but that trial narrowly missed a significance threshold at p=0.053, and a 44% risk reduction in a randomised Phase 2b is not the same thing as a replicated Phase 3. If it does replicate, intismeran autogene plus pembrolizumab would be the first individualised cancer vaccine in a large adjuvant solid tumour, and because Merck partners both agents it can monetise the entire ~1-year combination course. The commercial mechanic is conversion, not creation: the combination takes patients who are already on adjuvant pembrolizumab, so this is Merck upgrading its own installed base, usefully, right as Keytruda approaches its ~2028 loss of exclusivity. The honest read: an enormous option with a single, undated, unhedged dependency.
Threats land:The Phase 3 RFS readout fails to replicate the KEYNOTE-942 signal, entirely plausible given that the precedent's confidence interval crossed 1.0 (95% CI 0.309-1.017, p=0.053), and there is no approval, no launch, and no revenue at all rather than a smaller number.
Modelled path:Phase 3 RFS is positive, first US approval lands ~2029, and the combination converts a portion of the adjuvant anti-PD-1-treated Stage IIB-IV pool from pembrolizumab monotherapy, ramping from $254M in 2029 through $825M in 2031 to a $1.08B peak in 2033.
Levers land:A clean RFS result with distant-metastasis-free-survival support drives rapid conversion of the pembrolizumab-monotherapy share and pulls nivolumab-treated patients across too, while bespoke manufacturing scales fast enough to serve a US/Western-weighted pool without the throughput constraint capping uptake.
The ~25% of invasive melanoma incidence modelled as high-risk resectable Stage IIB-IV, the model's own stated softest input, AJCC/SEER-derived rather than counted, and set higher (~40%) in Japan and China on thicker acral-lentiginous presentation. Everything above it in the funnel is a scoping estimate too, but this is the multiplier that sizes the addressable pool before any share assumption is applied.
At a glance
Mechanism individualised mRNA neoantigen therapy + anti-PD-1 (investigational)
Clinical
Commercial
Development to approval
This indication is not yet approved: the phases show development stage and regulatory approval is expected, not granted (Est. first approval ~2029 (US, contingent on positive Phase 3 RFS)). Per-market timing is modelled from the Phase 3 readout plus standard regulatory lags (US/EU ~1 yr; Japan/China ~2 yr), an estimate, not company guidance. Status cross-checked against Merck & Co. disclosures and trial registries.
V940 is one of the highest-profile assets in oncology, the lead individualised (patient-specific) mRNA neoantigen therapy, co-developed by Merck and Moderna, and melanoma (INTerpath-001) is its lead registrational setting. A positive Phase 3 RFS readout would be a first-in-class validation of individualised cancer vaccines and a franchise-extending pillar for Keytruda as it approaches its own loss of exclusivity (~2028). Because both agents are Merck-partnered, Merck can monetise the full combination course. The forecast is gated entirely on the pivotal readout: this is a pre-approval, binary scenario, not a launched product.
After complete resection, high-risk (Stage IIB-IV) melanoma still recurs in a large share of patients despite adjuvant anti-PD-1. INTerpath-001 adds an individualised mRNA neoantigen therapy (V940) to pembrolizumab to attack each tumour's private mutations. The Phase 2b precedent (KEYNOTE-942) showed RFS HR 0.561 (~44% risk reduction) and durable multi-year separation, but the Phase 3 RFS readout is still pending, so the forecast is an explicitly conditional pre-approval scenario. If positive, this is the first individualised cancer vaccine in a large adjuvant solid-tumour setting.
Cutaneous melanoma is common in fair-skinned Western populations and rare in East Asia. Most cases present as thin, low-risk Stage I/IIA disease cured by surgery alone. The adjuvant-therapy pool is the minority who are resected but high-risk, AJCC Stage IIB, IIC, III or resected IV, where relapse risk exceeds ~40%. Pembrolizumab (KEYNOTE-716 for IIB/IIC, KEYNOTE-054 for III) and nivolumab (CheckMate 238) already define adjuvant anti-PD-1 as standard of care for this pool. INTerpath-001 targets exactly these patients, layering an individualised neoantigen therapy on top of the pembrolizumab backbone. Across the modelled markets roughly 33,000 patients/year are resected high-risk melanoma eligible for adjuvant anti-PD-1; the East-Asian pool (Japan, China) is far smaller because melanoma incidence is an order of magnitude lower there.
INTerpath-001 (V940-001, NCT05933577) is the Phase 3 test of whether adding a patient-individualised mRNA neoantigen therapy (V940 / mRNA-4157, co-developed by Merck and Moderna) to adjuvant pembrolizumab further lowers recurrence in resected high-risk melanoma. It follows the randomised Phase 2b KEYNOTE-942, where the combination cut the risk of recurrence or death by ~44% versus pembrolizumab alone (RFS HR 0.561). The pivotal Phase 3 recurrence-free-survival result is NOT yet public, so no INTerpath-001 efficacy figure is asserted here; the KEYNOTE-942 hazard ratio is cited only as the labelled precedent that motivated the trial.
This is a pre-approval investigational regimen. Guideline bodies today recommend adjuvant anti-PD-1 monotherapy (pembrolizumab KEYNOTE-716/054, nivolumab CheckMate 238) as standard. V940 + pembrolizumab would need a positive Phase 3 RFS readout and approval before any guideline inclusion.
Randomised, double-blind, placebo- and active-comparator-controlled Phase 3; ~1,089 patients at 165+ sites in 25+ countries; completely resected high-risk (Stage IIB-IV) cutaneous melanoma, no prior systemic therapy, enrolled within 13 weeks of final resection. Randomised 2:1 to intismeran autogene (V940 / mRNA-4157) + pembrolizumab vs placebo + pembrolizumab. Fully enrolled; primary RFS readout NOT yet public (hasResults = false).
Pre-approval · Phase III · conditional scenario
This indication is not approved. The revenue below is a modelled scenario that assumes approval and launch around 2029, every input (epidemiology, trial, pricing) is cited, but the approval itself is uncertain. It is an estimate, not guidance and not a reported figure. Read the pivotal-trial and development-timeline sections below for the regulatory basis.
Load-bearing 0/1 sourced. ASSUMED uptake is yours to change.
PRE-APPROVAL SCENARIO. INTerpath-001 (V940 / mRNA-4157 + pembrolizumab) has NOT reported its Phase 3 recurrence-free-survival result and is not approved. Revenue below is a conditional forward scenario contingent on a positive readout and regulatory approval. The only efficacy figure shown (KEYNOTE-942 RFS HR 0.561) is the Phase 2b PRECEDENT, not an INTerpath-001 result.
This indication only, not Keytruda + V940's total revenue
Adjuvant individualised neoantigen therapy: intismeran autogene (V940 / mRNA-4157, up to 9 IM doses) plus pembrolizumab (200 mg IV q3w, ~1 year), after complete resection of high-risk (Stage IIB-IV) cutaneous melanoma. Pembrolizumab-eligible, no prior systemic therapy beyond surgery. The INTerpath-001 (V940-001) Phase 3 regimen. PRE-APPROVAL, pivotal RFS readout not yet public.
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.
$0
8 modelled markets (US, EU5, JP, CN) · modelled net revenue · 2026 (forecast)
Peak $1.08B · launch 2029 → 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-APPROVAL SCENARIO. There is NO reported revenue for this indication, V940 is unapproved and INTerpath-001 has not read out. Every figure below is a conditional forward scenario contingent on a positive Phase 3 RFS readout and regulatory approval; the 'today' marker sits before any launch.
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 three modelled inputs and no observed ones: the ~25% high-risk-resectable share of melanoma incidence, the mature branded share the combination converts out of adjuvant anti-PD-1 monotherapy, and a combination net price that does not exist, constructed as the pembrolizumab backbone plus a modelled individualised-therapy increment of roughly 40-60% (US ~$200k, EU ~$88-115k, Japan ~$95k).
What would change our mind
The base case is wrong the moment INTerpath-001 reports a negative or non-significant RFS primary, this is a single-point binary, and the outcome is zero revenue, not reduced revenue. Two conditions falsify it short of that: if the Phase 3 hazard ratio lands materially weaker than the KEYNOTE-942 precedent of 0.561, payers and clinicians will not fund a bespoke manufactured therapy at a ~40-60% premium over a pembrolizumab backbone that patients already receive, and the modelled conversion share is too high; and if BioNTech's autogene cevumeran reaches an adjuvant approval first, the first-in-class individualised-vaccine premium underpinning the price increment is gone before launch.
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Melanoma incidence | 101k | 16k | 22k | 14k | 8.0k | 20k | 2.5k | 8.8k | 192k | GLOBOCAN 2022 |
New invasive cutaneous melanoma cases per year; ~+1.5%/yr (rising Western incidence). New invasive melanoma-of-skin cases (GLOBOCAN 2022 / WCRF): US 101.4k, DE 22.0k, UK 19.7k, FR 15.7k, IT 13.8k, CN 8.8k; Spain ~8.0k (RNMC/REDECAN 2024) and Japan ~2.5k (National Cancer Registry, very low Asian incidence) added from national sources. +1.5%/yr rising-incidence trend in the West. | ||||||||||
| x High-risk resectable (Stage IIB-IV)est | 25% | 25% | 25% | 25% | 24% | 25% | 40% | 42% | share, not summed | modelled (AJCC/SEER) |
AJCC Stage IIB, IIC, III or resected IV - the >40%-relapse-risk adjuvant band. The INTerpath-001 population is completely resected high-risk melanoma, AJCC Stage IIB, IIC, III or resected IV, where relapse risk exceeds ~40%. Most melanoma is thin, low-risk Stage I/IIA cured by excision alone; the high-risk adjuvant band is ~20-28% of invasive cases. Modelled at ~25%, the softest funnel input. | ||||||||||
| x Resected + adjuvant-treatedest | 70% | 70% | 70% | 68% | 68% | 70% | 65% | 55% | share, not summed | modelled estimate |
Completely resected, fit for and electing adjuvant anti-PD-1 therapy. Of high-risk resected patients, most but not all proceed to adjuvant anti-PD-1 (some decline, some unfit, some Stage IIB/IIC opt for surveillance). Modelled at ~70% reaching the adjuvant-IO pool INTerpath-001 addresses. | ||||||||||
| = Addressable adjuvant pool | 18k | 2.8k | 3.8k | 2.3k | 1.3k | 3.4k | 650 | 2.0k | 34k | computed |
Incidence x the rates above: completely resected high-risk (Stage IIB-IV) melanoma patients fit for and electing adjuvant anti-PD-1 therapy this year (all-comers by PD-L1). The adjuvant high-risk melanoma pool drifts modestly UPWARD with rising Western melanoma incidence and expanding adjuvant treatment of earlier (Stage IIB/IIC) disease, partially offset by earlier detection shifting some cases to low-risk stages. | ||||||||||
| × Keytruda + V940 uptake (branded) | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 0% | 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 + V940 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | computed · assumed input |
Addressable pool × branded uptake. | ||||||||||
| × Net price / patient | $200K | $105K | $115K | $100K | $88K | $100K | $95K | $55K | per patient, not summed | modelled (analogue) |
PRE-APPROVAL, no V940 price exists. Pembrolizumab adjuvant is ~$150k/yr US list (Merck), ~$110-130k net. V940 is an individualised (bespoke-manufactured) therapy; the incremental net is MODELLED (personalised-therapy analogue) at roughly +40-60% over the backbone. Combination net modelled at ~$200k US, scaled to each market's IO price level. All figures modelled; flag as analogue pricing. | ||||||||||
| = Net revenue / yrOutput | $0 | $0 | $0 | $0 | $0 | $0 | $0 | $0 | $0 | 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, adjuvant therapy in resected high-risk melanoma: 8 modelled markets (US, EU5, JP, CN)
Each agent's share of the addressable adjuvant pool (resected high-risk Stage IIB-IV, fit for anti-PD-1). V940 + pembrolizumab is PRE-APPROVAL: its share line is a conditional scenario that starts only at estimated launch (~2029) and ramps as the combination converts a portion of the pembrolizumab-monotherapy share. Pembrolizumab and nivolumab monotherapy hold the pool today.
Share of the 34k-patient addressable adjuvant pool this regimen is modelled to treat, by year
Keytruda + V940 is modelled at 0% of this pool in 2026, peaking at 23% in 2034; 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
Pembrolizumab monotherapy (adjuvant) holds the largest rival share in 2026, 21% of the pool; that is the share Keytruda + V940 has to take or hold.
Rivals, rescaled - note the axis maximum (30%), 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.
Shares are stated pre-approval ASSUMPTIONS, not reported figures. Category timing: nivolumab adjuvant 2017 (CheckMate 238), pembrolizumab adjuvant Stage III 2019 (KEYNOTE-054) and Stage IIB/IIC 2021 (KEYNOTE-716); V940 + pembrolizumab estimated ~2029 CONTINGENT on a positive Phase 3 RFS readout. The combination converts a portion of the pembrolizumab-treated pool rather than creating new demand.
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.
Estimated first regulatory approval (US), contingent on a positive Phase 3 RFS readout. Pre-approval, not confirmed.
PIVOTAL binary catalyst: the Phase 3 recurrence-free-survival readout. Positive = first-in-class individualised cancer vaccine; the entire scenario hinges on this.
✓ = 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
Even on adjuvant anti-PD-1, a substantial share of resected high-risk melanoma still recurs, the unmet need INTerpath-001 addresses. Open questions that cap the near-term scenario: whether the Phase 2b RFS signal (HR 0.561, which narrowly missed one significance threshold at p=0.053) replicates in a larger Phase 3; the operational complexity and cost of manufacturing a bespoke therapy per patient; and how the benefit distributes across the wide Stage IIB-IV band. Until the Phase 3 RFS result is public, efficacy in this exact population is unproven.
The synthesis for this indication, grounded in the cited trial, guideline and access facts above.
Rivals in this setting (Adjuvant high-risk resected melanoma (Stage IIB-IV))
Swipe to explore →
| Rival / regimen | Developer | Position in this setting | Approved (date, trial, n) | Head start vs this regimen (months) | Source |
|---|---|---|---|---|---|
| Pembrolizumab monotherapy (adjuvant) (Merck & Co. pipeline) | Merck | Merck & Co. pipelinewhyThe entrenched adjuvant standard: Stage IIB/IIC (KEYNOTE-716) and Stage III (KEYNOTE-054). The share V940 + pembrolizumab would convert (same backbone, same company). | not in the record | not in the record | INTerpath-001 (V940-001), Phase 3 adjuvant melanoma (NCT05933577, CT.gov) |
| Nivolumab monotherapy (adjuvant) (Live threat) | BMS | Live threatwhyAdjuvant anti-PD-1 standard since 2017; holds a large share of the resected high-risk pool. | not in the record | not in the record | INTerpath-001 (V940-001), Phase 3 adjuvant melanoma (NCT05933577, CT.gov) |
| BNT122 (autogene cevumeran) (Watch) | BioNTech / Genentech | WatchwhyThe principal personalised-cancer-vaccine class rival; investigational in adjuvant solid tumours. | not in the record | not in the record | INTerpath-001 (V940-001), Phase 3 adjuvant melanoma (NCT05933577, CT.gov) |
| Adjuvant BRAF/MEK (dabrafenib + trametinib) (Pool erosion) | Novartis | Pool erosionwhyAdjuvant option for BRAF-mutant Stage III melanoma (~40-50% of cases); a targeted-therapy alternative to anti-PD-1 in that subset. | not in the record | not in the record | KEYNOTE-716 / KEYNOTE-054 |
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
PRE-APPROVAL: no V940 price is published. The combination is modelled as a ~1-year adjuvant course, pembrolizumab (200 mg q3w) plus up to 9 doses of the individualised V940 therapy. Per-patient net revenue is a MODELLED analogue: the pembrolizumab backbone net plus a modelled individualised-therapy increment.
Figures below are 2026 net prices, the basis the model is anchored on. The funnel applies -4%/yr from 2026, 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.
INTerpath-001 is a ~1-year adjuvant course: pembrolizumab 200 mg IV q3w plus up to 9 intramuscular doses of intismeran autogene (V940). Because V940 is unapproved, no price exists; the combination net is MODELLED as the pembrolizumab backbone (~$150k/yr US list, ~$120k net) plus a modelled individualised-therapy increment of roughly +40-60% (personalised-cell/vaccine-therapy analogue): US ~$200k, France ~$105k, Germany ~$115k (AMNOG), Italy ~$100k, Spain ~$88k, UK ~$100k (PAS), Japan ~$95k, China ~$55k. All figures are modelled analogues, not disclosed prices; -4%/yr forward.
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 | Est. ~2029 | reference | None (all-comers) | Pembrolizumab + placebo | PRE-APPROVAL. Estimated launch contingent on a positive Phase 3 RFS readout; Breakthrough Therapy designation held. No approval yet. |
| EU | EMA / EC | Est. ~2030 | ~1 yr | None | Pembrolizumab + placebo | PRE-APPROVAL. PRIME designation; estimated EC approval ~1 year after FDA if Phase 3 positive. |
| UK | NICE | Est. ~2030 | ~1 yr | None | Pembrolizumab + placebo | PRE-APPROVAL. UK is an INTerpath-001 trial country; NICE appraisal would follow EC approval. |
| Japan | PMDA / NHI | Est. ~2031 | ~2 yr | None | Pembrolizumab + placebo | PRE-APPROVAL. Very small melanoma pool (low Japanese incidence); later access. |
| China | NMPA | Est. ~2031 | ~2 yr | None | Pembrolizumab + placebo | PRE-APPROVAL. Small pool; individualised-manufacturing logistics and pricing uncertain. |
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.