argenx SE Q2 FY2026 earnings call

• Core Commercial Performance

  • Delivered 18th consecutive quarter of growth, marking one of the company's strongest quarters to date.
  • The pre-filled syringe (PFS) presentation continues to drive adoption: ~80% of US PFS patients in Q2 2026 were new to VivGuard, expanding the prescriber base and enabling earlier patient access to treatment.
  • Received approval for VivGuard in seronegative generalized MG (GMG), making it the first and only approved treatment across all GMG serotypes, expanding the US addressable market by 11,000 patients, with 55% of US commercial covered lives already accessing coverage within 10 weeks of approval.
  • In CIDP: Phase 4 data confirmed 87% of patients successfully transitioned from IVIG to VivGuard, with ongoing efforts to drive adoption in treatment-naive and under-treated patient populations, who have substantial unmet need for improved functional outcomes.

• Pipeline Progress

  • Two registrational top-line readouts are expected before the end of 2026: phase 3 myositis (IMNM and DM subsets) in Q3 2026, and phase 3 multifocal motor neuropathy (MMN) for efgartigimod alfa (Impulse Approval) in Q4 2026.
  • Myositis (autoimmune, including IMNM and DM) has no approved treatments, and the program is on track for Q3 2026 readout, with subsets analyzed independently to support potential separate approval paths.
  • ARGX-121 (IgA sweeper) demonstrated 90% IgA reduction within days that is maintained for 28 days after a single dose in Phase 1, supporting rapid advancement into Phase 2 development.
  • Next-gen FCRN candidates: ARGX-213 is Phase 3-ready, ARGX-124 is in Phase 1 and expected to enter late-stage development by the end of 2026, with an oral FCRN program also progressing quickly.

• Strategic Priorities

  • Long-term strategy (Vision 2030) targets 10 labeled indications for VivGuard and 5 late-stage pipeline molecules by 2030, built on disciplined capital allocation focused on durable long-term growth. The company will leverage its strong balance sheet to pursue business development opportunities for novel immunology assets with high unmet need, prioritizing first-in-class/best-in-class opportunities beyond the core FCRN platform.

ArgenX's only commercial product is VivGuard, which generated total product net sales of $1.5 billion in Q2 2026, representing 60% year-over-year growth and 17% quarter-over-quarter growth. By region: US net sales were $1.3 billion (86.7% of total product revenue), with 15% quarter-over-quarter growth; Japan net sales were $102 million (6.8% of total), with 55% quarter-over-quarter growth including a one-time $25 million benefit from a distribution model change; Rest of World net sales were $136 million (9.1% of total); $5 million in revenue came from product supply to Xilab in China (0.3% of total). By indication: VivGuard is approved for myasthenia gravis (MG, including newly approved seronegative generalized MG) and chronic inflammatory demyelinating polyneuropathy (CIDP), with growth driven by both indications across all regions. No revenue contribution breakdown by indication was provided.

• Management maintained the expected consistent quarterly growth trajectory for the remainder of 2026, consistent with prior years, following strong Q2 2026 growth after typical Q1 seasonality.
• Ocular MG regulatory filing is on track, with a PDUFA date to be shared once confirmed; management expects potential Ocular MG approval to add a new leg of long-term growth, leveraging existing relationships with treating neurologists.
• Autoinjector presentation of VivGuard remains on schedule for a 2027 launch.
• Phase 3 assentation data for myositis (for broader rheumatology expansion) is expected in the second half of 2027.
• Net pricing per patient for VivGuard is expected to remain stable, consistent with prior quarters, with only a slight gradual increase in gross-to-net due to the higher share of PFS sales, offset by higher treatment adherence.

• Clinical trial outcomes are uncertain: even if Phase 3 myositis matches the effect size observed in Phase 2, statistical significance is not guaranteed, and regulatory approval paths depend on final data results.
• The DGF (delayed graft function) indication for Impulse Approval did not support continued development, though a positive signal in renal parameters supports further exploration of transplant indications more broadly.
• Clinical trials in heterogeneous diseases like CIDP are inherently challenging, and it is unclear if changes to trial design may be needed to optimize outcomes for Impulse Approval in CIDP.
• Competitor new launches in MG could potentially impact market share, though management has not observed meaningful impact to date.
• Changing entrenched physician prescribing habits for first-line CIDP treatment (which currently favors IVIG) and securing payer coverage for earlier use of VivGuard in treatment-naive patients is a gradual process that may slow adoption growth.

Q: Miles Minter asked if the consistent mid-teens quarterly growth trajectory will change following the seronegative GMG approval, and what tailwinds exist from the removal of serology testing requirements by most payers. / A: Management stated that after typical Q1 seasonality, Q2's rebound aligns with historical patterns. They expect the growth trajectory for the remainder of 2026 to remain consistent with prior years, even with the tailwind from the new seronegative approval. The approval has already delivered a positive halo effect on all GMG prescriptions, driving increased uptake even in seropositive populations.

Q: Tazine Ahmad asked how management responds to competitor claims about VivGuard's limited efficacy and safety-related patient dropouts, and what field feedback shows on physician and patient satisfaction. / A: Management noted that ArgenX established the MG biologic market and has maintained market leadership despite entry of multiple competitors, with 4 out of 5 physicians ranking VivGuard as their first-choice biologic. Management highlighted that 60% of VivGuard patients achieve sustained minimal symptom expression (a key efficacy endpoint) which no competitor has demonstrated to date, and VivGuard has a well-established safety profile across more than 25,000 patient years, supporting its position as a preferred first-line therapy with no meaningful impact on growth to date.

Q: Akash Tiwari asked if the myositis Phase 3 program now analyzes DM and IMNM subsets as independent trials, and if the Phase 2 DM effect size replicates in Phase 3, will the trial hit statistical significance. / A: The CMO confirmed that subsets are now analyzed independently, each with a separate chance to meet trial endpoints. Enrollment differs between subsets, which impacts statistical power, but analysis plans are fully parallel. If the Phase 2 effect size is replicated in the larger, longer Phase 3 trial, this increases the chance of statistical significance, but a positive outcome is not guaranteed, and management will finalize the path forward after reviewing the topline data regardless of the outcome.

Q: Sean Lauman asked what early prescribing trends from the seronegative GMG launch exceeded expectations, and what revenue contribution to expect over the next 1-2 years. / A: Management reported that early feedback exceeded expectations, with particularly strong enthusiasm from both patients and providers. The biggest unexpected positive was the large halo effect: providers now see VivGuard as the go-to option for all GMG patients, driving increased uptake even in the existing seropositive population beyond just the new seronegative patient segment. Payer coverage reached 55% of commercial lives in under 10 weeks, and is on track to hit 90% coverage within 3-6 months as planned, with most payers removing serology testing requirements to streamline prescribing.