FolioObs › ARGENX SE (ARGX) › Earnings calls

ARGENX SE earnings calls

ARGX · every analyst question and management's answer

Jul 23, 2026 earnings call — VYVGART growth and upcoming readouts

Product net sales were $1.5 billion this quarter, driving strong growth and funding pipeline advances.

Revenue $2.8B (est $1.7B) · EPS $7.32 (est $6.27)

Key quotes

"VYVGART is now the first and only biologic approved across all serotypes of generalized MG, significantly expanding our addressable market in MG by 11,000 patients."

— Sandrine Piret-Gerard · VYVGART commercial expansion

"We saw a clear signal in both IMNM and DM in the Phase II, and we're on track for a readout this quarter."

— Karen Massey (CEO) · Myositis readout this quarter

"Empasiprubart remains on track to become our second pipeline of products with our first registrational readout in MMN expected later this year."

— Karen Massey (CEO) · Empasiprubart development

Analyst Q&A 22

commercial growth after seronegative launch

Q (Myles Minter · null): Analyst asked whether the future growth trend will change after launching for seronegative patients and whether broader payer moves (no serology tests) create tailwinds.

A: Management said they expect quarterly patterns to remain similar to prior years after Q1 seasonality, and they expect continued growth. They noted seronegative is off to a strong start but similar dynamics occurred with prior launches like the prefilled syringe.

"So I would expect to look -- continue to look to grow and to look similar to prior years." — Karen Massey (CEO)

ocular MG filing and impact

Q (Derek Archila · Wells Fargo): Analyst asked the status of the ocular myasthenia gravis filing and whether approval would materially change VYVGART's revenue.

A: Management said they are moving forward with urgency and will be first and only approved treatment if approved. They will update when they have a PDUFA date and see ocular approval as another launch to support growth since many patients are treated by neurologists already familiar with the drug.

"So we will be the first and only approved treatment in this population." — Karen Massey (CEO)

competition, efficacy and safety feedback

Q (Tazeen Ahmad · BofA): Analyst asked clinicians' satisfaction on efficacy and whether patients drop off therapy due to safety concerns versus new competitors' claims.

A: Management said Argenx has maintained market leadership and noted that 4 out of 5 physicians choose VYVGART before other biologics. They emphasized VYVGART's demonstrated MSE rate and safety over more than 25,000 patient years as reasons for early use and minimal impact on growth so far.

"We have 60% of patients that have reached minimal symptom expression." — Sandrine Piret-Gerard

myositis topline and filing path

Q (Alexander Thompson · Stifel): Analyst wanted expectations for Q3 myositis topline results, the primary endpoint, and potential path to filing particularly in dermatomyositis (DM).

A: Management said they expect a Q3 readout and will judge success as positive primary endpoint readout in one or more subsets. They view either indication as strategically important and noted a first-in-class FcRn approval in rheumatology would be important if they proceed with approval.

"What we see as success for myositis is positive readout on the primary endpoint in one or more subset, and that's the data that we'll share." — Karen Massey (CEO)

myositis statistical plan details

Q (Akash Tewari · Jefferies): Analyst asked whether DM and IMNM are analyzed independently without alpha split, and if Phase III would reach significance if Phase II effect size replicated.

A: Management confirmed subsets will be analyzed independently so each has its own chance to win, noting enrollment differences affect power. They said larger and longer Phase III could increase the chance for statistical difference but it is not guaranteed; they will plan forward regardless of statistical outcome.

"So the way we now approach the analysis of the Phase III is that we will independently analyze the subsets." — Luc Truyen

empasiprubart forward path after transplant study

Q (Rajan Sharma · Goldman Sachs): Analyst asked for more color on DGF update for empasiprubart, the forward path, what 52-week data showed, and read-through to MMN.

A: Management said the small Phase II was exploratory in transplant with DGF as a short-term target; 24-week data showed an intriguing signal leading to continuation to 52 weeks, which more or less confirmed effects on renal parameters but did not support DGF as an indication. They cautioned against direct MMN read-through except noting prior positive Phase II grip strength data for MMN.

"When we saw the data at 24 weeks, we found an intriguing signal which made us decide let's continue the exploration of the study up to 52 weeks." — Luc Truyen

ARGX-121 IgA reduction data

Q (Yatin Suneja · Guggenheim): Analyst asked what Phase I profile for ARGX-121 showed—level and duration of IgA reduction and implications for frequency and IgAN development.

A: Management said Phase I showed ARGX-121 reduces IgA by about 90% within days and that reduction is maintained out to day 28 after a single dose, which supports rapid movement into IgAN Phase II. They noted KOL enthusiasm and belief the drug's speed and depth set it apart in IgAN development.

"ARGX-121 reduces IgA by about 90% within a matter of days, and that reduction is maintained all the way out till day 28 with one single dose." — Karen Massey (CEO)

MMN Phase III design vs IVIg

Q (Yaron Werber · Cowen): Analyst asked about MMN trial design, powering, clinical meaningfulness of an 8-point GRI change, and expectations for baseline and outcomes.

A: Management described a head-to-head design versus IVIg after stabilization, with grip strength as the endpoint chosen with agency input and a defined non-inferiority margin plus opportunity for superiority. They referenced Phase II results showing large reduction in rescue IVIg and said noninferiority would be success with upside for superiority.

"We designed this trial where after stabilization on IVIg and optimizing that we initiate either a continuation of the IVIg regimen or switch to empasiprubart." — Luc Truyen

who enrolls in empa CIDP trials vs commercial VYVGART

Q (Alexander Nackenoff · Truist): Analyst asked which types of CIDP patients join empasiprubart trials instead of trying VYVGART in markets where VYVGART is available.

A: Management said CIDP is heterogeneous and some patients (~30% nonresponders) may have IgM-driven disease and are hypothesized to respond to empasiprubart; they are enrolling broader populations to learn and later compare to VYVGART data to guide commercial strategy.

"So our hypothesis is that there are some patients that we have a 70% response rate with VYVGART." — Karen Massey (CEO)

next-gen FcRn candidates and oral program

Q (Thomas Smith · Leerink Partners): Analyst asked how the company will advance ARGX-213 and ARGX-124, target profiles for 124, dosing/IgG lowering, and indication selection between life-cycle and expansion.

A: Management said 213 is Phase III ready with Q4 weekly dosing and 124 is in Phase I and may move to late-stage by year-end; they are assessing advantages of 124 over VYVGART and plan to lay out a portfolio strategy among VYVGART, 213, 124, plus an oral FcRn program advancing quickly.

"ARGX-213, we know has a Q4 weekly dosing schedule." — Karen Massey (CEO)

seronegative launch early trends and payer coverage

Q (Sean Laaman · Morgan Stanley): Analyst asked which early prescribing trends exceeded expectations and the revenue contribution prospects from seronegative patients over 12–24 months.

A: Management said seronegative launch feedback is overwhelmingly positive from patients and prescribers, noting a halo effect that simplifies decision-making and increases use beyond seronegative patients. They reported roughly 55% covered lives less than 3 months after launch with payers moving quickly and many removing testing requirements, expecting coverage to reach roughly 90% in 3–6 months.

"We have roughly 55% of the covered lives yet already, less than 3 months after launch." — Sandrine Piret-Gerard

CIDP treatment-naive adoption

Q (Samantha Semenkow · Citi): Analyst asked if treatment-naive CIDP patients are increasingly started on VYVGART and how the launch progression in that segment should be viewed.

A: Management said data show treatment-naive patients benefit—citing an AAN study where 87.5% of treatment-naive patients showed clinical response—and they are using data to encourage earlier use. They noted change is slow due to entrenched habits and payer IVIg-experience requirements, but traction in treatment-naive patients is growing.

"We presented a study at AAN where we showed that 87.5% of the patients that were treatment naive benefited from a clinical response." — Sandrine Piret-Gerard

CIDP plans after riliprubart result

Q (Gavin Clark-Gartner · Evercore): Analyst asked whether recent riliprubart data change CIDP plans for empasiprubart or the likelihood of superiority versus IVIg in CIDP or MMN.

A: Management said CIDP is heterogeneous and patient selection matters; they will look closely at data to see if study optimization is needed but will continue both their head-to-head IVIg and placebo-controlled CIDP studies. They noted it's hard to run CIDP trials and their VYVGART experience gives confidence moving forward.

"We will be looking more closely at the data and evaluate is there anything we need to do to optimize our studies, but we are continuing with our plans to continue both." — Luc Truyen

ASyS subset trial feasibility

Q (Sophia Graeff Buhl Nielsen · JPMorgan): Analyst asked if antisynthetase syndrome (ASyS) could be targeted with a dedicated trial despite polymyositis path forward being limited.

A: Management said enrollment numbers in the current trial prevent an ASyS-specific path now, but they will learn from the data and determine the plan forward since polymyositis is heterogeneous and subsets evolve as they learn more.

"We will definitely look at the data as they come and determine the plan forward for ASyS." — Luc Truyen

PFS patient mix and auto-injector timing

Q (Victor Floch · BNPP): Analyst asked whether rising share of new-to-VYVGART PFS patients increases confidence in auto-injector and asked milestone details and expected launch timing.

A: Management confirmed auto-injector remains on schedule for a 2027 launch. They explained the 80% PFS figure referred to the last quarter whereas launch-to-date comparable figure is about 70%, and the higher recent share shows more new patients start on PFS.

"Auto-injector is on target or on schedule for 2027 launch." — Karen Massey (CEO)

quarter impact from seronegative and ocular uptake

Q (Wolfe): Analyst asked how seronegative approval affected this quarter's earnings and whether seronegative and ocular launches might show similar uptake curves.

A: Management said PFS drove the quarter and seronegative also contributed, especially triple-negative patients and a halo effect on the broader market; they expect this to continue into Q3. For ocular, they reiterated the need for continued innovation and new launches to maintain growth and expressed excitement to continue delivering such launches.

"The quarter was driven by strong fundamentals and PFS was the key driver of growth." — Karl Gubitz (CFO)

myositis alpha split and filing strategy

Q (Luca Issi · RBC): Analyst asked whether FDA required alpha split between IMNM and DM given original all-comer trial and whether success needs p<0.05 or p<0.025.

A: Management declined to disclose specific alpha values, saying they won't comment on an actual alpha, but reiterated IMNM and DM have independent analysis plans. They noted IMNM has no approved treatments and breakthrough designation, and they will determine path forward after turning the data card in Q3.

"We're not going to comment on a specific alpha value because even in these rare diseases, even with alpha that are in between 0.05 and 0.1 even, you can have a conversation." — Luc Truyen

M&A and asset profile sought

Q (Sebastiaan van der Schoot · Kempen): Analyst asked about M&A ambitions for next 12–24 months and what profile of assets they'd seek.

A: Management said capital allocation focuses on fueling VYVGART growth and accelerating internal pipeline while optionally pursuing business development for novel biology in high unmet need areas. They said they will keep a high bar and will use the strong balance sheet to pursue opportunities that meet that bar.

"That bar is that it has to be novel biology, and it has to be in areas where there is significant unmet patient need." — Karen Massey (CEO)

untreated diagnosed CIDP patients reason

Q (Douglas Tsao · H.C. Wainwright): Analyst asked if diagnosed but untreated CIDP patients avoid treatment because of IVIg tolerability and whether VYVGART tolerability can bring them back to treatment.

A: Management said many diagnosed patients have adapted their lives and their unmet needs are underestimated; they are generating data and encouraging patient-provider discussions to show treatment can improve function and quality of life. They acknowledged this will take time, data, and patient engagement to change practice.

"What we are trying to do is generate data to show that you can get your life back if you really take that seriously." — Sandrine Piret-Gerard

BD focus: same or complementary areas

Q (Qize Ding · Redburn): Analyst asked if business development will target assets in same therapy areas or complementary ones to broaden the portfolio.

A: Management said they focus on immunology while diversifying beyond FcRn and look for novel biology they can de-risk clinically; internal and external assets must meet that high bar and address areas of high unmet need for first- or best-in-class potential.

"What we're looking for is novel biology, and we need to have clarity on how we can derisk that novel biology to move into patients." — Karen Massey (CEO)

DM subtypes and enrichment

Q (Xian Deng · UBS): Analyst asked whether DM has subtypes with better response and if the trial is enriched for those subtypes given interferon-driven aspects.

A: Management said both IMNM and DM have a biology rationale and multiple mechanisms can play roles; they referenced Phase II DM signal not explainable by interferon I and said addressing autoantibodies has a role, so multiple approaches may be needed. They will look at muscle involvement effects in Phase III readout.

"Our Phase II subset data demonstrate that there was a signal in DM, which could not be driven by interferon I." — Luc Truyen

pricing, gross-to-net and channel split

Q (Niall Alexander · Deutsche Bank): Analyst asked for realized list price per subcutaneous patient, gross-to-net and discount details, and channel split for VYVGART sales.

A: Management said U.S. list prices are public and net price per patient and gross-to-net remained stable in Q2 versus prior quarters. They noted slight quarter-over-quarter gross-to-net increase tied to higher PFS share which has higher gross-to-net but better adherence, and they said the business is good with nothing new to add.

"I think what is important is that the gross to net and the net price per patient continue to be stable." — Karl Gubitz (CFO)

AI-generated notes on the earnings call transcript. Quotes are taken from the transcript. This is not a FolioObs investment view.

ARGENX SE (ARGX) · Earnings calendar

Other earnings calls this week

  • GOOGL · ALPHABET INC — Gemini 4 models and Cloud TPU scaling
  • AMZN · AMAZON.COM INC — AWS AI growth and company results
  • MSFT · MICROSOFT CORP — Copilot expansion and AI-driven Azure growth
  • GOOG · ALPHABET INC-CL C — Gemini 4 launch and Cloud TPU scaling
  • V · VISA INC — Tokenization, VAS growth, and agentic commerce focus
  • MA · MASTERCARD INCORPORATED — Network expansion and agentic commerce push
  • SPGI · S&P GLOBAL INC — Strategic review of Capital IQ and data businesses
  • DASH · DOORDASH INC - A — Instacart deal and DashMart expansion

All of this week's earnings call summaries

FolioObs Features | 주요 기능

  • Dashboard — SEC 13F Portfolio Tracker, FolioObs 50 | 대시보드
  • AI Insights — Portfolio Analysis & Signals | AI 인사이트
  • Insider Trading — SEC Form 4 Tracker | 내부자 거래
  • Cathie Wood Today's Trades + AI Insights | 캐시 우드 오늘의 매매
  • ARK Invest Report — Daily Trades | ARK 리포트
  • Investment News — Data-Driven Updates | 뉴스
  • Weekly Report — Market Movers | 주간 리포트
  • How to Read a 13F — 5-Minute Guide | 13F 읽는 법
  • The FolioObs 50 — All Tracked Investors | FolioObs 50 전체 보기
  • Wall Street Consensus — Shared Holdings | 월가 컨센서스
  • US Politician Trades — STOCK Act | 정치인 매매 추적
  • Earnings Calendar | 실적 발표 캘린더
  • This Week's Earnings Call Summaries | 이번 주 어닝콜 한 줄 요약

FolioObs 50 | 추적 중인 월가 투자자 50인

  • Warren Buffett — Berkshire Hathaway | 워렌 버핏
  • Cathie Wood — ARK Invest | 캐시 우드
  • Stanley Druckenmiller — Duquesne Family Office | 스탠리 드러켄밀러
  • Ray Dalio — Bridgewater Associates | 레이 달리오
  • George Soros — Soros Fund Management | 조지 소로스
  • Bill Ackman — Pershing Square Capital | 빌 애크먼
  • David Tepper — Appaloosa Management | 데이비드 테퍼
  • Chase Coleman — Tiger Global Management | 체이스 콜먼
  • Dan Loeb — Third Point | 댄 로엡
  • Seth Klarman — Baupost Group | 세스 클라만
  • National Pension Service (NPS) — Korea National Pension Service | 국민연금
  • David Einhorn — Greenlight Capital | 데이비드 아인혼
  • John Paulson — Paulson & Co | 존 폴슨
  • Howard Marks — Oaktree Capital Management | 하워드 막스
  • Leon Cooperman — Omega Family Office | 레온 쿠퍼먼
  • Ken Griffin — Citadel | 켄 그리핀
  • Steve Cohen — Point72 Asset Management | 스티브 코헨
  • Li Lu — Himalaya Capital | 리 루
  • Mohnish Pabrai — Pabrai Investment Funds | 모니시 파브라이
  • Bruce Berkowitz — Fairholme Capital Management | 브루스 버코비츠
  • Nelson Peltz — Trian Fund Management | 넬슨 펠츠
  • Carl Icahn — Icahn Capital | 칼 아이칸
  • Paul Singer — Elliott Management | 폴 싱어
  • Philippe Laffont — Coatue Management | 필립 라퐁
  • Andreas Halvorsen — Viking Global | 안드레아스 할보르센
  • Daniel Sundheim — D1 Capital | 다니엘 선드하임
  • Masayoshi Son — SoftBank Group | 손정의
  • Terry Smith — Fundsmith | 테리 스미스
  • Joel Greenblatt — Gotham Asset Management | 조엘 그린블랫
  • Bill Miller — Miller Value Partners | 빌 밀러
  • Brad Gerstner — Altimeter Capital | 브래드 거스트너
  • Rajiv Jain — GQG Partners | 라지브 자인
  • Duan Yongping — H&H International | 돤융핑
  • Chris Hohn — TCI Fund Management | 크리스 혼
  • Stephen Mandel — Lone Pine Capital | 스티븐 만델
  • Prem Watsa — Fairfax Financial | 프렘 왓사
  • Sequoia Fund — Ruane Cunniff & Goldfarb | 세쿼이아 펀드
  • Guy Spier — Aquamarine Capital | 가이 스파이어
  • Lee Ainslie — Maverick Capital | 리 아인슬리
  • David Abrams — Abrams Capital | 데이비드 아브람스
  • Pat Dorsey — Dorsey Asset Management | 팻 도시
  • Dev Kantesaria — Valley Forge Capital | 데브 칸테사리아
  • Francois Rochon — Giverny Capital | 프랑수아 로숑
  • Thomas Russo — Gardner Russo & Quinn | 토마스 루소
  • Tweedy Browne — Tweedy Browne | 트위디 브라운
  • Temasek — Temasek Holdings | 테마섹
  • Saudi PIF — Public Investment Fund | 사우디 국부펀드
  • Baillie Gifford — Baillie Gifford | 베일리 기포드
  • Ron Baron — Baron Capital | 론 배런
  • Thomas Gayner — Markel Group | 토마스 게이너