How much of the gMG patient add growth is due to PFS unlocking new patients, and what is the confidence/rationale for the seronegative trial's primary endpoint change?

PFS is expanding the market, fueling strong MG growth by increasing the prescriber base (15% new prescribers). IV business also continues to grow due to patient/prescriber preference. For the seronegative trial, the primary endpoint was changed to absolute MG-ADL drop to retain more information and increase power, with a p-value of 0.1 negotiated with the agency. Confidence is high, but clinical trials carry intrinsic risks. “We changed to a change from baseline in MG-ADL because compared to a responder kind of definition and therefore, dichotomy, you retain more information and therefore, intrinsically, it would increase the power.”

Are you seeing use in Ig-naive CIDP patients, and what is the gross margin outlook given IRA discounts and reduced production costs?

One year into the CIDP launch, 85-90% of patients are still coming from IVIg switches, aligning with expectations for uncontrolled patients. While the label allows for earlier use, payer access and HCP/patient experience are key for broader expansion. The year-to-date gross margin is 11% and is expected to remain around 11% going forward, as decreasing standard cost of sales (due to larger CDMO sites and higher yields) offsets increasing royalties to Halozyme (due to higher Hytrulo share). “The gross margin on a year-to-date basis is currently at around 11%. Going forward, we expect that number to remain around 11%.”

How do you see the business evolving with new profitability, cash flow, and upcoming clinical trials? What is the balance sheet strategy?

The company is not focused on specific margin ratios but on capital allocation. Priorities are: 1) delivering on VYVGART's promise across indications, 2) advancing empasiprubart and the rest of the pipeline, 3) investing in global supply chain expansion, and 4) exploring business development (M&A/licensing) using the strong balance sheet. Returning cash to shareholders is a future consideration. “Our capital allocation priorities has always been clear. Priority #1 is to deliver on the promise of VYVGART. There's still a lot of work to do, many indications and studies. Following that is empa and the rest of the pipeline.”

ARGX

argenx SE (ARGX) Q2 FY25 earnings call: guidance and Q&A

Earnings call· Jun 2025 (Q2 FY25)· Health Care· Jul 31, 2025

Source: earnings call transcript

Executive summary

argenx SE Q2 FY25 — Strong VYVGART Growth and Pipeline Advancement

argenx delivered a strong second quarter, driven by exceptional growth in VYVGART sales and patient adoption across all indications and formulations, particularly with the successful introduction of the prefilled syringe. The company continues to advance a robust pipeline with multiple assets in late-stage development, reinforcing its long-term growth strategy. While navigating anticipated gross-to-net increases and monitoring a potential safety signal for CIDP, management remains focused on market expansion and innovation.

Highlights

VYVGART achieved exceptional year-over-year growth of 97% across all approved indications, reaching $949 million in product net sales.
Global VYVGART patient count reached 15,000, including 2,500 CIDP patients just one year into launch.
The prefilled syringe (PFS) drove new patient starts, with 50% of PFS patients being new to VYVGART and over 1,000 physicians writing a PFS prescription (15% first-time prescribers).
The company ended the quarter with a strong cash balance of $3.9 billion, up from $3.4 billion at the beginning of the year.
Advanced 4 new molecules into Phase I studies and expects data from 6 Phase III and 6 Phase II trials over the next 18 months.

Concerns

Gross-to-net adjustments increased from 12% at the end of 2024 to approximately 20% at the end of Q2 2025, primarily due to PFS introduction and Medicare Part D redesign.
A potential safety signal for CIDP worsening was issued by the FDA (FAERS update), requiring monitoring, though the company maintains the benefit-risk ratio.

Guidance & targets

Category	Target	Timeline	Confidence
VYVGART patient reach	50,000 patients high materiality	FY2030 · FY30	High
Labeled indications and late-stage pipeline	10 labeled indications and a robust late-stage pipeline high materiality	FY2030 · FY30	High
Clinical trial data readouts	Data from 6 Phase III and 6 Phase II trials high materiality	Next 18 months	High
Year-to-date gross margin	around 11% medium materiality	Going forward	High
Gross to net adjustments	smaller increases medium materiality	Going forward	Medium
Net revenue per patient	consistent high materiality	Foreseeable future	High
CIDP growth rate	growth will continue through the end of the year medium materiality	H2 FY25	High
MG patients on self-administered therapies	40% medium materiality	FY2030 · FY30	Medium

Segment performance

Segment	Revenue	YoY	QoQ	Margin
Total Company Total product net sales for the second quarter 2025, reflecting significant year-over-year and quarter-over-quarter growth.	$949M	97%	19%	—
United States Product net sales in the U.S. showing strong quarter-over-quarter growth across all three VYVGART presentations (IV, subcu vial, PFS).	$802M	—	18%	—
Japan Product net sales in Japan, contributing to global growth.	$52M	—	—	—
Rest of World (Europe, Canada, Partner Markets) Product net sales across Europe, Canada, and other partner markets, representing more than 15% of global product net sales.	$83M	—	—	—
China (Zai Lab Supply) Product supply to Zai Lab in China; growth is not reflective of demand and depends on shipping schedule.	$12M	—	—	—

Deals & partnerships

Unnatural Products Collaboration to gain access to AI-driven microcycle discovery platform

This collaboration expands capabilities beyond antibodies and reinforces commitment to innovate on the patient experience by enabling development of potent, selective, and orally available peptides.

Risks & headwinds

Increased gross-to-net adjustments Q2 2025 onwards

From 12% (end of 2024) to approximately 20% (end of Q2 2025)

Mitigation:Anticipated and managed; net revenue per patient remains consistent; growth driven by patient reach; future increases expected to be smaller and driven by product mix.

Potential safety signal for CIDP worsening (FAERS update) Ongoing monitoring (typical 12-month evaluation period for 'potential' signals)

NIS issued as a potential safety signal; company's observed rate of severe CIDP worsening is <2% among >2,500 exposed patients.

Mitigation:Monitoring internally and in conversations with the FDA; maintaining that the current benefit-risk ratio is preserved; noting that any therapeutic switch carries risk of CIDP worsening.

Competitive environment in MG Ongoing

Competition is heating up, with UPLIZNA mentioned.

Mitigation:Continuing to raise the bar on patient/prescriber expectations with high MSE rates, rapid/sustained efficacy, 10,000+ patient years of safety, and multiple product presentations; positioned to lead and be the fastest-growing biologic.

Intrinsic risks of clinical trials Until trial readout

Seronegative trial has intrinsic risks despite high confidence.

Mitigation:Designed with increased power (MG-ADL endpoint, p-value 0.1) and better diagnostic accuracy ascertainment.

What to watch in Q3 FY25

Gross-to-net adjustments

Next quarter

Current 20%

Target Smaller increases

Why it matters

To confirm that the bulk of the gross-to-net increase is indeed behind the company and that future increases are minimal, impacting net revenue.

Going forward, we will see increases in gross to net, but it will be smaller increases driven by the product mix, i.e., if PFS becomes a bigger share of a business, which it will, you're going to see gross to net creeping up.

Find out whether ARGX delivers this. Inve re-checks your case every morning.

Q&A highlights

How have MG cycles per year evolved with chronic dosing data, and is higher gross-to-net driven by higher gross price per patient followed by greater discounting?

The net revenue per patient for MG and CIDP remains consistent despite higher gross-to-net, as various factors (product mix, list price, utilization, adherence) offset the impact. No price increases were taken in 2025. MG patients average 5 cycles per year, but PFS convenience and patient desire to maintain minimum symptom expression (MSE) could lead to higher utilization and adherence.

“The net revenue per patient for MG and CIDP remains consistent even with a higher gross to net. There are many variables that go into the net revenue per patient. It includes product mix, list price, gross to net utilization and adherence.”

asked by Alex Thompson · answered by Karl Gubitz

3 min read 6 chapters

Detailed narrative

VYVGART Commercial Momentum and Market Expansion

VYVGART demonstrated exceptional commercial performance, achieving 97% year-over-year growth and 19% quarter-over-quarter growth in product net sales. The global patient count reached 15,000, with 2,500 CIDP patients treated within a year of launch. The company is focused on shifting the treatment paradigm in MG, aiming for symptom-free outcomes, and expanding the branded biologics market share beyond the current 10%.

In CIDP, strong growth is observed across all markets, driven by unmet need and the clear value proposition of VYVGART Hytrulo.

Impact of Prefilled Syringe (PFS) and Gross-to-Net Dynamics

The introduction of the prefilled syringe (PFS) for VYVGART has been a significant growth enabler, leading to increased patient demand and expansion of the prescriber base. 50% of PFS patients were new to VYVGART, and over 1,000 physicians have written a PFS prescription, with 15% being first-time prescribers.

While the PFS is expanding the market, it contributed to an increase in gross-to-net adjustments from 12% at the end of 2024 to 20% by Q2 2025, primarily due to Medicare Part D redesign. However, the net revenue contribution per patient remains consistent.

Pipeline Advancement and Innovation Platform

argenx is building momentum with its Phase III pipeline assets, including efgartigimod in myositis and Sjögren's, and empasiprubart in MMN and CIDP. ARGX-119, an agonistic antibody, has entered a registrational study in CMS following positive proof-of-biology data, with potential applications in ALS and SMA.

The immunology innovation platform continues to advance, with 4 new molecules (IL-6 inhibitor, second FcRn blocker, IgA targeting antibody) entering Phase I studies. A collaboration with Unnatural Products aims to leverage AI-driven microcycle discovery for new therapeutic modalities.

Financial Strength and Capital Allocation Strategy

The company reported a strong financial position with $3.9 billion in cash, cash equivalents, and current financial assets, driven by $0.4 billion in net cash flow from operating activities in the first half of the year. Total operating income was $967 million, with an operating profit of $201 million for the quarter.

Capital allocation priorities focus on maximizing VYVGART's potential, advancing the broader pipeline, investing in global supply chain expansion, and exploring business development opportunities, with shareholder returns as a future consideration.

CIDP Market Dynamics and Regulatory Monitoring

The CIDP launch is progressing well, with over 2,500 patients treated globally. The majority (85-90%) of patients are switches from IVIg, aligning with the initial target population of 12,000 uncontrolled patients. The FDA's FAERS system issued a potential safety signal for CIDP worsening, which the company is monitoring.

Management notes that any therapeutic switch carries a risk of worsening in CIDP, but their internal data shows the rate of severe worsening is stable or decreasing, remaining below 2% of exposed patients, maintaining the current benefit-risk profile.

ITP Launch in Japan

The launch of VYVGART for ITP in Japan is proceeding as planned, with clinical data mirroring real-world outcomes. The drug is primarily used as a fourth-line treatment for refractory ITP patients who have failed steroids, IVIg, and TPOs, demonstrating a 50% response rate. Physicians appreciate the fast-acting and safe profile of the product, indicating a gradual move up the treatment paradigm in the Japanese market.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.