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// LIFE SCIENCES

STAGE 07 · MARKET ACCESS · COMMERCIAL

ATLAS recommends walking from Korea. Sarah's call.

⬢ ATLAS·market access & payer negotiation·HK live · SG live · AU launching 28 May

!

WALK PROPOSAL · CRO SIGN-OFF · STRATEGIC EXIT

ATLAS recommends Medtronic does not launch LINQ-NEXT in Korea.

ACC-WALK-KR-2026-001 · escalated 17 May 11:42 SGT · response sought within 5 business days

KFDA HTA Committee returned a payer-acceptable price point of $8,400 / unit (vs Medtronic asking price $12,800). ATLAS modeled 6 negotiation scenarios. Every scenario that closes the gap triggers reference-price ripple to PMDA, HSA, TFDA, and HK, costing more in cross-market price erosion ($28M / 3 yr) than the Korean revenue gained ($14M / 3 yr). The math says walk. The KFDA file remains live; we can return in 18 months with a new HTA dossier without prejudice.

SCENARIO A · ACCEPT PRICE

$8,400/unit list, no MEA

KR 3yr revenue$14.2M

KR 3yr gross margin$3.8M

Ripple cost (4 markets)−$28.4M

Net NPV−$24.6M

Triggers IRP: JP (loss $14.2M), SG ($6.1M), TW ($4.8M), HK ($3.3M). Korean list is referenced by 4 of 6 other APAC markets.

SCENARIO B · CONFIDENTIAL MEA

$11,200 list · $2,800 rebate

KR 3yr revenue$18.6M

KR 3yr gross margin$5.4M

Ripple cost (rebate leaks)−$8.2M

Net NPV−$2.8M

Confidentiality leakage historical risk ~40% per OECD 2024 MEA review. JP and SG payers actively monitor Korean rebate disclosure court cases.

SCENARIO C · WALK · ATLAS RECOMMENDS

No launch · re-file in 18mo

KR 3yr revenue$0

Foregone margin−$3.8M to −$5.4M

Ripple cost$0

Net NPV+$22.8M vs Scn A

Preserves $12,800 reference floor across 6 markets. New 5-yr LINQ-NEXT outcomes data due Q4 2027 — strengthens HTA dossier for KR re-file at higher CET threshold.

Reference-price ripple analysis · current Medtronic asking $12,800 / unit

KR · KFDA

$8,400 ↓

→

JP −$14.2MSG −$6.1MTW −$4.8MHK −$3.3MAU not refCN independent

SG · HSA

$12,800 ✓

→

HK alignedMY alignedTH aligned

JP · PMDA C2

$13,400 ✓

→

EU IRP basket trackedUS blue-book tracked

POL-WALK-DECISION-V1 · policy://aegis.medtronic/access/walk/v1
"Market-walk recommendations are non-delegable to agent. ATLAS may model the recommendation but the decision to forego market entry requires CRO sign-off with VP Finance acknowledgment of cross-market NPV impact. Walk decisions older than 24 months auto-trigger re-evaluation."

Sarah Chen (CRO) sign-off · VP Finance acknowledgment required · 24-month auto-revisit

Per-market access state · 7 APAC markets

2 live · 1 launching · 2 negotiating · 1 walk · 1 pre-CT

HKHong Kong

LIVE

List price

HK$ 99,840

≈ US$ 12,800

Units · MTD

14

since 12 May

Funded by

HA + private

Reimbursement

SUBSCRIBED

2 hospitals placing orders (HKU-QMH · PYNEH)

Private pay Bupa, AXA reimbursing

2nd-wave hospitals 4 in onboarding pipeline

SGSingapore

LIVE

List price

S$ 17,408

≈ US$ 12,800

Units · MTD

5

since 16 May

Funded by

MOH + private

MediShield Life

LISTED

SGH, NUH, Mt Elizabeth all placing orders

MediShield Life subsidy confirmed S$ 4,200/unit

HSA reliance approval cited PMDA pending

AUAustralia

LAUNCHING 28 MAY

List price

A$ 19,200

≈ US$ 12,800

MSAC decision

POSITIVE

22 May meeting

PBS listing

PENDING

CET A$ 28k/QALY

Pre-launch units

23

channel-loaded

MSAC positive ICER $19,400 vs $28k threshold

PBS schedule 28 May effective date

Private channel Medibank, Bupa onboarding

KRKorea

WALK PROPOSED

HTA price

₩ 11.3M

≈ US$ 8,400

Asking

US$ 12,800

−34% gap

Ripple risk

$28.4M

cross-mkt loss

Net NPV

−$24.6M

if accept

HTA delta $4,400/unit below floor

IRP-referenced by JP · SG · TW · HK

Re-file window 18 months · 5-yr data due Q4 2027

JPJapan

NEGOTIATING

C2 ask

¥ 1.99M

≈ US$ 13,400

Chuikyo schedule

Q3 2026

26-27 Aug

Predicate gap

+18%

vs Reveal LINQ

PMDA review

DAY 47/120

PMDA RFI #14 label-narrowing in Stage 05 affects positioning

Predicate precedent Reveal LINQ C2 at ¥ 1.69M

Anchor effect JP price sets SG, HK, TW references

TWTaiwan

GATED · POST PMDA

NHI target

NT$ 384K

≈ US$ 12,800

TFDA review

DAY 28/72

NHI schedule

Q4 2026

Reference to

JP, SG

Awaiting TFDA approval (Stage 05)

NHI pre-meeting scheduled 14 Jul

CNChina

GATED · LOCAL CT M4/18

Provincial CET

¥ 140K

≈ US$ 19,400

VBP risk

HIGH

2027 tender

CT progress

m4 / 18

Filing ETA

Q4 2026

Local trial month 4 of 18 (NMPA req)

VBP wave 4 ICM category included Q1 2027

Provincial heterogeneity high · 31 provincial schedules

Active hospital tenders & payer contracts

8 in pipeline · $4.2M committed

TND-HK-001

Hospital Authority HK · ICM unified procurement Q2 2026

21 public hospitals · 18-month contract · CER + IFU verified

HK$ 14.0M

est 180 units

AWARDED

TND-SG-001

MOH Singapore · National device procurement framework

SGH, NUH, KKH, CGH, NTFGH · 24-month · MediShield linked

S$ 3.5M

est 200 units

AWARDED

TND-AU-001

PBS · National PBS listing Schedule 3

All eligible public + private · MSAC positive 12 May

A$ 8.6M

est Y1 forecast

LISTING 28 MAY

TND-AU-002

Royal Melbourne & Royal Prince Alfred · joint procurement

Bid submitted 14 May · award decision 03 Jun

A$ 1.2M

est 60 units

BID OPEN

TND-JP-001

JCHO group hospitals · pre-listing rate negotiation

57 hospitals · awaits PMDA approval + Chuikyo C2 listing

¥ 1.8B

est Y1

PRE-LIST

TND-HK-002

Bupa Hong Kong · Tier 1 reimbursement listing

Private payer formulary · 36-month exclusive

HK$ 6.8M

est 87 units

AWARDED

TND-KR-001

Samsung Medical Center · Seoul Asan · Severance · early access

Withdrawn pending walk decision (ACC-WALK-KR-2026-001)

₩ 0

withdrawn

WITHDRAWN

TND-TW-001

NTU Hospital + Veterans General Taipei · joint formulary

Pre-application · awaits TFDA approval

NT$ 19.2M

est 50 units

PRE-APP

WORKFLOWATLAS's substages · per-marketaccess secured for HK + SG · AU in 11d · JP/TW pending · KR walk decision · CN pending CT

▶

ATLAS runs an independent access workflow per market. Each market progresses through 5 stages: HTA dossier prep → payer modeling → negotiation → contract execution → first sale. First-sale events automatically trigger ORACLE (Stage 08) for that market.

HTA prep
Payer model
Negotiation
Contract
First sale

Hong Kong

✓

▲ LIVE

Singapore

✓

▲ LIVE

Australia

✓

LIVE

28 May

queued

Korea

✓

WALK?

PAUSED

—

Japan

✓

CHUIKYO Q3

Q3

Q4

Taiwan

DRAFTING

—

China

CT m4/18

—

Stage ThreadATLAS · WALK

07 ACCS · 312 events · CRO sign-off pending on KR walk

ATLAS → WALK17 May · 11:42

Surfacing walk recommendation for Korea. KFDA HTA Committee returned $8,400/unit floor against our $12,800 ask — a $4,400/unit gap. 6 MEA scenarios modeled. Best confidential rebate scenario leaves $2.8M net NPV negative (40% leakage risk to Japanese and Singapore payers, who are actively monitoring Korean rebate disclosures). Walk preserves the $12,800 reference floor across the 6 markets that reference Korean list pricing. NPV difference: walk +$22.8M vs Scenario A accept. Re-file viable in 18 months with stronger 5-year outcomes data. Sarah, this is your call per POL-WALK-DECISION-V1.

d219...7e91 · CRO ESCALATE

ATLAS17 May · 09:18

Completed MEA model sweep for Korea. 6 scenarios: outright accept (A), confidential rebate (B), outcomes-based pay-per-detection (C), volume-tiered (D), risk-share with KFDA (E), walk (F). Ran each through reference-price ripple analysis across all 6 APAC markets that reference KR. Posted full numbers to MEA Models surface.

ATLAS16 May · 14:20

First sale event recorded · SG · 5 units to Singapore General Hospital. Channel-loaded units at NUH and Mt Elizabeth not yet sold. Stage 08 (ORACLE) handoff triggered for SG. PMCF cohort enrollment begins on first 30 SG units per locked PMCF v3 protocol.

ATLAS15 May · 16:05

KFDA HTA Committee meeting concluded. Verdict received: ₩ 11.3M (~ $8,400) acceptable price. Below our floor by 34%. Committee chair Dr. J. Park cited the 2024 MFDS HTA reform threshold of $30k/QALY and noted that LINQ-NEXT ICER of $24,800 (Option B Lifetime comparator from Stage 03) gives them room to negotiate harder. They want stroke prevention outcomes data to support higher pricing.