---
endpoint: analytics
pattern: Healthcare
status: done
latency_ms: 234745
conversation_id: 948d83f5-3d69-456d-9278-a3d38d04df89
citations: 0
created: 2026-05-31 20:20:03Z
---

# What catalysts could drive upside/downside for CSL in the next 12–18 months?

# CSL Limited (CSL AU) — Catalysts for the Next 12–18 Months

CSL's catalyst path is anchored by **Behring gross-margin recovery** (the dominant FY26/FY27 driver) layered with **a thin but rising portfolio of new-product launches**, set against **regulatory uncertainty in the US, a structurally weaker Seqirus franchise, and FX volatility**. The CLSA desk rates the stock O-PF with a 12-month price target of **A$330** vs. spot **A$239.10** at the time of its 17-Jun-2025 ANDEMBRY update (~+38% potential return; the stock was -17.3% over the prior 12M, -25.3% vs ASX200) [14]. Forecast trajectory at CLSA: revenue **US$15.76bn → US$16.70bn → US$17.70bn** across FY25CL/FY26CL/FY27CL with NPATA growing **+8.9% → +12.4% → +12.1% YoY** [14].

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## 1. UPSIDE CATALYSTS

### 1A. Behring gross-margin recovery — the central, highest-conviction lever
This is the single most important earnings driver into FY26/FY27 and is named explicitly as the catalyst in both the Feb-2025 1H result note and the May-2025 update [2][3].

- **Sequence of GM expansion**: CLSA models FY25 Behring GM at **50.8%**, stepping up **+150bps to 52.3% in FY26** and **+190bps to 54.2% in FY27** — the FY27 step is the bulk of the benefit [4]. 1HFY25 already delivered **51.1%** GM (+118bps YoY, +21bps vs cons), validating the trajectory [4].
- **Yield-gain mechanics**: ~220 of c.350 plasma centres are running **Rika + iNomo** as of 1HFY25, delivering the targeted **~10% yield uplift**; full rollout completes by end-FY25. CLSA estimates the 10% yield benefit alone adds **~110bps of GM expansion**, with further upside from cost-per-litre (CPL) reduction, labour-model optimisation and dynamic pricing [4].
- **Margin-recovery drivers** are multi-pronged: CPL reduction (donor fees, Rika, centre efficiencies), **new products** (Hemgenix, Hizentra PFS, Garadacimab/ANDEMBRY), **ASP mix shift** (Hizentra vs Privigen, geographic mix), **Ig yield improvements** (Horizon 1), and **scale & manufacturing efficiencies** [17].
- **Timing risk now flagged**: management confirmed the **57% Behring GM target now lands FY27/FY28**, not FY26, on FX delays — CLSA views this as already in consensus and notes "the clock starts ticking on the potential acceleration of Behring's GM" with **positive share-price momentum expected over the next 12 months** as clarity emerges [3].

### 1B. ANDEMBRY (Garadacimab) US launch — incremental HAE franchise
- **FDA approved June 2025** with **immediate US launch** and third-party pharmacy network access by end-Jun-25 [1].
- CLSA models **+10.2% 5-yr CAGR** for the combined ANDEMBRY + Haegarda HAE prophylaxis portfolio to FY29CL, with **+38bps Behring GM contribution by FY29CL** [1].
- Modelled revenue ramp: Garadacimab US$10m (FY25CL) → US$74m → US$171m → US$246m → **US$341m by FY29CL**; combined HAE portfolio GM rises from 60.0% (FY24A) to **66.4% by FY29CL** [10].
- Share-gain mechanism is **new-patient growth** rather than direct displacement of Takhzyro near-term, with possible cannibalisation from Haegarda switchers [1].

### 1C. Hemgenix (haemophilia B gene therapy) — defensive ramp
- 1HFY25 commentary "incrementally more positive" across US and EU; CLSA views the next 12 months as **key for realisation of uptake**, framing Hemgenix as a defensive switching play vs Idelvion [12].
- **FDA regulatory risk now seen as limited**: under new CBER director Vinay Prasad, gene-therapy criticism has focused on Sarepta/Elevidys rather than Hemgenix (whose approval did not require FDA-director override) [8].

### 1D. mRNA disadvantage for competitors → relative tailwind for Seqirus
- Heightened FDA stringency under Prasad may **delay or block upcoming Covid-mRNA approvals**, including combo Covid+flu mRNA products from Moderna and others, which CLSA had flagged as the principal medium-term threat to Seqirus' protein-based flu franchise — therefore now a **net positive** for CSL [18].

### 1E. Bird-flu / pandemic-preparedness optionality
- Already a 1HFY25 tailwind (pandemic preparedness revenue **+126% YoY to US$143m**, most of it recognised in 2H25) [15].
- CLSA's framework sizes the potential opportunity at up to **US$280m** of US/EU5/developed-market vaccine revenue if procurement covers ~0.7% of population at ~US$30/dose; significantly larger if antigen-only HHS-style contracts scale to ~6% of population coverage [15].

### 1F. Vifor — modest upside if IV iron stabilises
- 1HFY25 was **+7% revenue growth, beat consensus by 7%**; IV iron stabilised with European volumes +6% YoY despite generics, and US Injectafer +3% post step-edit rebasing [13].
- CSL guides Vifor to **low-single-digit growth in FY25** (vs initial flat outlook) — incrementally positive [13].

### 1G. PE re-rating optionality
- CSL trades **>1 std dev below** its 10-year trailing 1- and 2-yr forward PE Rel — once earnings-acceleration evidence emerges, CLSA argues this warrants a **PE re-rating** [4].

---

## 2. DOWNSIDE CATALYSTS / RISKS

### 2A. FDA regulatory regime under Vinay Prasad — the biggest top-down overhang
- New CBER director takes a **"brash"** stance on the "broken" US healthcare system; CLSA expects **more rigorous trial requirements** and a **less predictable approvals environment** [5][19].
- **Direct exposure points for CSL**: heightened focus on "waste and unnecessary treatment" creates downside risk to **CIDP Ig utilisation** (where some patients may be over-diagnosed) — though rare diseases are seen as a "lower-risk target" given Prasad's focus on end-of-life care [19].
- This was the proximate trigger for CLSA's **HC O-PF → O-PF rating downgrade** in May 2025 [5].

### 2B. Seqirus — structural vaccine fatigue + competitive pressure
- 1HFY25 Seqirus sales **-8% vs pcp**, flu **-15% YoY**, missed consensus by **-10%**; CSL appears to have lost share vs Sanofi [6].
- Reduced US Government awareness campaigns under Prasad's "hands off" stance pose **further uptake risk to flu vaccines** during ongoing vaccine fatigue [6].
- CLSA cut FY26CL+ Seqirus revenues **-6%** as a rebasing event [6].

### 2C. US tariff / trade-policy risk
- CLSA called out **US tariff risk on the horizon** as a near-term overhang explicitly contributing to the May-2025 rating downgrade [5].

### 2D. R&D pipeline setbacks
- Oct-2024 R&D Day delivered **three late-stage trial failures** simultaneously (Hizentra DM Ph 3, Kcentra trauma Ph 3, clazakizumab Ph 3 futility), plus the original **Garadacimab US approval delay** — illustrating the recurring Phase-3 disappointment risk inherent in the portfolio [11]. The remaining late-stage catalysts to watch over the next 12–18 months include Hizentra POTS Ph 3, HEMGENIX Japan Ph 3, KOSTAIVE sa-mRNA EU approval, CSL403 (aTIVc), and the clazakizumab MACE-in-ESKD readouts [9].

### 2E. Kcentra contract loss / specialty erosion
- Kcentra **-20% YoY in 1HFY25** on Octapharma's Balfaxxar pricing competition; recovery awaits indication-expansion study readouts. Haegarda growth moderated to **+1% YoY** [12].

### 2F. China albumin / rational-utilisation policy
- CSL has so far avoided the impact that hit Takeda from China's rational-utilisation controls, but CLSA flags **medium-term policy risk** and **potential recombinant-albumin substitution** as ongoing concerns [12].

### 2G. Vifor IV iron — third generic entrant in Europe
- A third generic manufacturer (Viatris) was flagged to enter Europe IV iron, layering on existing pricing pressure [13].

### 2H. FX
- FY25 NPATA FX headwind was **lifted from US$50m to US$90m**, contributing directly to the PT cut from A$337 → A$330. Persistent FX volatility remains a near-term sentiment driver [3].

### 2I. Structural / operational risks listed by CLSA
1. R&D commercialisation risk (unfruitful candidates); 2) patient safety / product quality (biologics); 3) **manufacturing operations across multiple geographies** (natural disasters, outages); 4) **plasma supply** (donor availability is the critical input); 5) cybersecurity / data protection [7].

---

## 3. SUMMARY CATALYST TABLE (12–18 MONTH HORIZON)

| Catalyst | Direction | Magnitude | Timing | Conviction |
|---|---|---|---|---|
| Behring GM stepping +150bps in FY26 / +190bps in FY27 [4] | Upside | High (anchors EPS CAGR) | 2HFY26 onwards | High [16] |
| Rika + iNomo full rollout, ~10% yield uplift [4] | Upside | ~110bps GM alone | End-FY25 completion | High |
| ANDEMBRY US launch + HAE portfolio +10.2% CAGR [1] | Upside | +38bps Behring GM by FY29CL | Live (Jun-2025) | High |
| Hemgenix gene-therapy ramp [12] | Upside | Medium (defensive vs Idelvion) | Next 12 months | Medium |
| Pandemic-preparedness / bird-flu revenue [15] | Upside | Up to US$280m TAM US/EU5 | 2H25 + optionality | Medium |
| Covid-mRNA combo approvals delayed by FDA [18] | Upside (relative) | Removes Seqirus risk | Through 2026 | Medium |
| FDA stringency under Prasad (CIDP, R&D) [19] | Downside | Medium | Continuous | Medium |
| Seqirus flu fatigue + Sanofi share loss [6] | Downside | -6% FY26CL+ revenue cut booked | FY26 flu seasons | High |
| US tariff risk [5] | Downside | Undefined | 2025–2026 | Medium |
| Pipeline Ph 3 failure recurrence [11] | Downside | Variable | Continuous | Medium |
| Kcentra / specialties erosion [12] | Downside | Low–medium | Through FY26 | Medium |
| China albumin policy / recombinant substitution [12] | Downside | Medium-term | 12–24 months+ | Low–medium |
| FX volatility (US$90m FY25 headwind) [3] | Downside | Recurring | Continuous | High |

---

## 4. BOTTOM LINE

The 12–18-month CSL setup is a **"GM recovery deferred but intact"** story. Upside is dominated by the FY26-into-FY27 **Behring margin acceleration**, validated already by the 1HFY25 +118bps print [4][17], reinforced by the **ANDEMBRY launch** kicking off a +10.2% HAE-portfolio CAGR with +38bps Behring GM by FY29CL [1][10]. The principal **downside vectors** are structurally weaker Seqirus, the unpredictable Prasad-era FDA, and FX [5][6][18]. CLSA's O-PF rating with **A$330 PT (+38% to spot of A$239)** reflects the view that recent share-price weakness is "overdone" and a "buying opportunity," contingent on consensus FY26 numbers being de-risked and yield-gain evidence emerging in 2HFY26 [4]. The current PE Rel (>1 std dev below 10-yr trailing average) is the **release valve**: positive evidence on Rika yields, Garadacimab uptake, or Hemgenix ramp would likely trigger a re-rating [4].

---
**Sources**
[1] CSL — O-PF (ANDEMBRY approval) — CLSA (17 Jun 2025) — 607962154LinqAlpha.PDF
[2][5][8][18] CSL — O-PF (Thunderstruck) — CLSA (7 May 2025) — 607958392LinqAlpha.PDF
[3][4][6][12][13][15][19][20] CSL — O-PF (Shot through the heart) — CLSA (11 Feb 2025) — 607950323LinqAlpha.PDF
[9][11][16] CSL — O-PF (CSL R&D Day 2024) — CLSA (22 Oct 2024) — 607941692LinqAlpha.PDF
[10] CSL — O-PF (Swelling the portfolio) — CLSA (11 Oct 2024) — 607941034LinqAlpha.PDF
[7][14] CSL — O-PF (ANDEMBRY approval) cover page — CLSA (17 Jun 2025) — 607962154LinqAlpha.PDF
[17] CSL — O-PF (Horizon in sight) — CLSA (13 Aug 2024) — 607936197LinqAlpha.PDF

