UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of June 2024
Commission File Number: 001-38097
ARGENX SE
(Translation of registrant’s name into English)
Laarderhoogtweg 25
1101 EB Amsterdam, the Netherlands
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
EXPLANATORY NOTE
On June 21, 2024, argenx SE (the “Company”) issued a press release and an investor presentation, copies of which are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated by reference herein.
The information contained in this Current Report on Form 6-K, including Exhibits 99.1 and 99.2, shall be deemed to be incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-258251) and S-8 (File Nos. 333-225375, 333-258253, and 333-274721), and to be part thereof from the date on which this Current Report on Form 6-K is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit | Description | |
99.1 | Press Release June 21, 2024 | |
99.2 | Investor Presentation |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ARGENX SE | ||
Date: June 24, 2024 | By: | /s/ Hemamalini (Malini) Moorthy |
Name: Hemamalini (Malini) Moorthy | ||
Title: General Counsel |
Exhibit 99.1
argenx Announces FDA Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy
VYVGART®
Hytrulo is first and only neonatal Fc receptor (FcRn) blocker approved to treat chronic
inflammatory demyelinating polyneuropathy (CIDP)
First novel, precision mechanism of action in more than 30 years for patients with CIDP
Third approved indication for VYVGART® and VYVGART Hytrulo franchise
Management to host conference call on June 21, 2024 at 11:00pm CET (5:00pm ET)
June 21, 2024, 4:40pm ET
Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker approved for the treatment of CIDP.
“argenx continues to pursue our ambition to turn science into solutions for patients with severe autoimmunity,” said Luc Truyen M.D., Ph.D., Chief Medical Officer, argenx. “Patients have been waiting, and today argenx is delivering the first innovative treatment for CIDP in more than 30 years. VYVGART Hytrulo is a precision tool that has been shown to drive meaningful benefits for patients. Today’s FDA approval means that CIDP patients have a transformational new treatment option and further affirms the therapeutic profile of VYVGART Hytrulo and the potential of FcRn blockade in IgG-mediated autoimmune diseases.”
CIDP is a rare, debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system. Patients experience a range of disabling mobility and sensory issues, including trouble standing from a seated position, pain and fatigue, and frequent tripping or falling. Many patients become wheelchair bound and are unable to work as the disease progresses. Currently, 85% of patients require ongoing treatment and nearly 88% of treated patients experience residual impairment and disability.
“While CIDP patients face many daily concerns and challenges, fear of disease progression should not be one of them. CIDP can be debilitating and have significant impact on quality of life and many patients with CIDP require treatments that may be burdensome. The approval of this promising new treatment option for CIDP may provide hope to patients that they can treat their disease beyond just managing symptoms. CIDP patients deserve treatment options and we look forward to a future of choices for optimal and individualized care,” said Lisa Butler, Executive Director, GBS|CIDP Foundation.
“Today marks a groundbreaking day for the treatment of CIDP. Existing treatments have been limited to corticosteroids and plasma-derived therapies. These treatments, while effective for many patients, can be challenging for some patients to receive,” said Jeffrey Allen, M.D., Professor, Department of Neurology,
University of Minnesota and Principal Investigator in the ADHERE trial. “Today’s approval of VYVGART Hytrulo gives doctors and patients a new, safe and effective treatment option that may lessen the burden of treatment that some patients experience.”
The FDA approval is based on the ADHERE Study, the largest clinical trial to date studying CIDP. In the ADHERE study, 69% (221/322) of patients treated with VYVGART Hytrulo, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength. ADHERE met its primary endpoint (p<0.0001) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. Ninety-nine percent of trial participants elected to participate in the ADHERE open-label extension. The safety results were generally consistent with the known safety profile of VYVGART in previous clinical studies and real-world use.
VYVGART Hytrulo is also approved in the U.S. for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
Access to VYVGART Hytrulo
argenx is committed to supporting access for patients to its medicines and VYVGART Hytrulo is expected to be available for patients in the U.S. immediately. The typical patient will have an annual out-of-pocket cost similar to that of a VYVGART or VYVGART Hytrulo patient with gMG, or an IVIg patient with CIDP.
argenx has established a patient support program, My VYVGART Path, which can help patients and HCPs navigate access. My VYVGART Path program resources include disease and product education, access support and benefits verification, and financial assistance programs for eligible patients. More information is available at VYVGART.com.
Conference Call Details
argenx will host a conference call Friday, June 21, 2024, at 11:00 pm CET (5:00pm ET) to discuss the approval. A webcast of the live call and replay may be accessed on the Investors section of the argenx website.
Dial-in numbers:
Belgium | 32 800 50 201 |
France | 33 800 943355 |
Netherlands | 31 20 795 1090 |
United Kingdom | 44 800 358 0970 |
United States | 1 888 415 4250 |
Japan | 81 3 4578 9081 |
Switzerland | 41 43 210 11 32 |
See FDA-approved Important Safety Information below and full Prescribing Information for VYVGART Hytrulo for additional information.
What is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)?
VYVGART HYTRULO is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
IMPORTANT SAFETY INFORMATION
Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
VYVGART HYTRULO may cause serious side effects, including:
· | Infection. VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain. |
· | Allergic Reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab. |
· | Infusion-Related Reactions. VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain. |
Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.
Before taking VYVGART HYTRULO, tell your doctor if you:
· | take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, |
· | have received or are scheduled to receive a vaccine (immunization), or |
· | have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding. |
What are the common side effects of VYVGART HYTRULO?
The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.
These are not all the possible side effects of VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
Please see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor.
About ADHERE Trial Design
The ADHERE trial was a multicenter, randomized, double-blind, placebo-controlled trial evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). ADHERE enrolled 322 adult patients with CIDP who were treatment naïve (not on active treatment within the past six months or newly diagnosed) or being treated with immunoglobulin therapy or corticosteroids. The trial consisted of an open-label Stage A followed by a randomized, placebo-controlled Stage B. In order to be eligible for the trial, the diagnosis of CIDP was confirmed by an independent panel of experts. Patients entered a run-in stage, where any ongoing CIDP treatment was stopped and in order to be eligible for Stage A had to demonstrate active disease, with clinically meaningful worsening on at least one CIDP clinical assessment tool, including INCAT, I -RODS, or mean grip strength. Treatment naïve patients were able to skip the run-in period with proof of recent worsening. To advance to Stage B, patients needed to demonstrate evidence of clinical improvement (ECI) with VYVGART Hytrulo. ECI was achieved through improvement of the INCAT score, or improvement on I-RODS or mean grip strength if those scales had demonstrated worsening during the run-in period. In Stage B, patients were randomized to either VYVGART Hytrulo or placebo for up to 48 weeks. The primary endpoint was measured once 88 total relapses or events were achieved in Stage B and was based on the hazard ratio for the time to first adjusted INCAT deterioration (i.e. relapse). After Stage B, all patients had the option to roll-over to an open-label extension study to receive VYVGART Hytrulo.
About VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating IgG. It is the first-and-only approved FcRn blocker administered by subcutaneous injection.
VYVGART Hytrulo is the proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It may be marketed under different proprietary names following approval in other regions.
About Chronic Inflammatory Demyelinating Polyneuropathy
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person’s ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair. There are approximately 24,000 patients in the U.S. currently receiving treatment for CIDP.
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody -based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Twitter, and Instagram.
Contacts
Media:
Ben Petok
bpetok@argenx.com
Investors:
Alexandra Roy (US)
aroy@argenx.com
Lynn Elton (EU)
lelton@argenx.com
VYVGART® HYTRULO NOW INDICATED FOR CIDP FDA APPROVAL CALL | JUNE 21, 2024 |
Forward Looking Statements This presentation has been prepared by argenx se (“argenx” or the “company”) for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company or any director, employee, agent, or adviser of the company. This presentation does not purport to be all-inclusive or to contain all ofthe information you may desire. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the company’s own internal estimates and research. While argenx believes these third-party studies, publications, surveys and other data to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of argenx’sinternal estimates or research, and no reliance should be made on any information or statements made in this presentation relating to or based on such internal estimates and research. Certain statements contained in this presentation, other than present and historical facts and conditions independently verifiable at the date hereof, may constitute forward-looking statements. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “expected,” and include statements argenx makes regarding its expected net revenue per patient and annual net revenues stemming from the FDA approval of VYVGART Hytrulo for CIDP; the average annual out-of-pocket cost to patients; its expansion efforts, through geographic expansion and into new autoimmune indications; and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements in products and product candidates; the acceptance of argenx's products and product candidates by patients as safe, effective and cost-effective; the impact of governmental laws and regulations on our business; disruptions caused on our reliance of third parties suppliers, service provides and manufacturing; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’sU.S. Securities and Exchange Commission (the “SEC”) filings and reports, including in argenx’smost recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this presentation, including any forward-looking statements, except as may be required by law. This presentation contains trademarks, trade names and service marks of other companies, which are the property of their respective owners. 2 |
Approval Overview T I M VAN H AU WE R ME I R E N |
1958* 1979* 1985* Corticosteroids PLEX IG 2024 • Non-plasma derived biologic therapy for CIDP • Targets FcRn, reducing IgG antibodies, including pathogenic autoantibodies First and only targeted IgG Fc-antibody fragment† VYVGART Hytrulo is a coformulation of efgartigimod alfa and hyaluronidase. By depolymerizing hvaluronan, hyaluronidase increases permeability of the subcutaneous tissue. *Indicates the date of the f irst published description of positiv e clinical ef f icacy in CIDP. †Human IgG-deriv ed. VYVGART Hytrulo Now FDA-Approved for CIDP 4 |
Highlights of U.S. Prescribing Information INDICATION STATEMENT VYVGART Hytrulo is a neonatal Fc receptor blocker indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) DOSING AND ADMINISTRATION • Evaluate need to administer age -appropriate vaccines according to immunization guidelines before initiation of new treatment cycle • Recommended dosage is 1,008 mg / 11,200 units (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase) administered subcutaneously over approximately 30 to 90 seconds as once weekly injections WARNINGS AND PRECAUTIONS • Delay administration to patients with active infection. Monitor for signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART Hytrulo until infection has resolved • Angiodema, dyspnea, urticaria, and rash have occurred. If a hypersensitivity reaction occurs, discontinue the infusion and institute appropriate therapy 5 |
≤20% achieve remission on current SOC 3 CIDP Patients Need New Options Significant pain, numbness in hands and feet Feelings of isolation and depression report difficulty standing 1 dissatisfied with symptom burden 2 have residual neurological symptoms 4 >50% 80% 88% 6 J A M I L A H 1. Wonink HA et al. 2023 2. Mendoza M, et al. 2023 3. Gorson KC, et al. 2010 4. Bunschoten C et al. 2019 |
Clinical Data Review L U C T R U YE N |
Innovative ADHERE Study Design 8 Patients need to demonstrate disease worsening off-treatment based on INCAT, I-RODS, grip strength Clinical Confirmation Committee Confirm IgG involvement Assess efficacy & safety Run-in period Screening ≤12 WEEKS ≤4 WEEKS VYVGART HYTRULO WEEKLY VYVGART HYTRULO OR PLACEBO WEEKLY Primary analysis: % documented improvement in functional ability and/or strength Primary endpoint: relative risk of relapse based on time to first INCAT deterioration Open-label Randomized, placebo-controlled Identify patients with active CIDP RESPONDERS ONLY ADVANCE TO STAGE B ≤12 WEEKS ≤48 WEEKS Treatment Period Stage A (N=322) Stage B (N=221) 99% eligible patients rolled over to Open Label Extension study |
Key Data from ADHERE Trial 9 2/3 Improved / progressed to Stage B HR: 0.39 P = < 0.0001 61% reduced risk of relapse 9 Consistent response across subgroups STAGE A STAGE B 40% Demonstrated improvement by Week 4 Probability(%) of No Clinical Worsening Time to Improvement |
Patients Experienced Deep and Clinically Meaningful Improvements in Functional Ability *The INCAT disability score1 is a 10-point scale that assesses activ ity limitations of arms and legs; both are scored separately f rom 0–5, with 0 representing no f unctional impairment and 5 representing inability to make any purposef ul mov ement. **ADHERE clinical trial data 0 10 20 30 40 50 60 70 80 90 100 ≥1 ≥2 ≥3 ≥4 Functional Ability (aINCAT) Cumulativ e Frequency of Stage B Best Improv ement f rom Stage A Baseline (n=110) 80.9% 42.7% 28.2% 11.8% Ef gartigimod PH20 SC Percent of Participants Change in aINCAT Score INCAT Disability Scale: Arm Disability* Best score Worst score 0 1 2 3 4 5 0= No upper limb problems; 1= Symptoms in one/both arms without impacting the ability to perform certain functions 2= Symptoms in one/both arms affecting but not preventing the ability to perform functions; 3= Symptoms in one/both arms preventing the performance of 1-2 functions; 4= Symptoms in one/both arms preventing the performance of ≥3 functions; 5= Inability to use either arm for any purposeful movement Best score Worst score 0 1 2 3 4 5 0= Walking not affected; 1= Walking affected, but walks independently outdoors; 2= Usually uses unilateral support to walk outdoors; 3= Usually uses bilateral support to walk outdoors; 4= Usually uses wheelchair to travel outdoors, but able to stand and walk a few steps with help; 5 = Restricted to wheelchair, unable to stand and walk a few steps with help ~30% patients able to improve 3-4 points on INCAT** INCAT Disability Scale: Leg Disability* 10 |
ADHERE Trial Safety: Summary of Adverse Events 11 AE, adverse event; CIDP, chronic inflammatory demyelinating polyneuropathy; COVID-19, coronavirus disease 2019; PH20, recombinant human hyaluronidase PH20; PYFU, participants years of follow-up; SAE, serious adverse event; SC, subcutaneous; TEAE, treatment-emergent adverse event. aTEAEs grouped under Preferred Terms leading to efgartigimod PH20 SC discontinuation were Cardiac arrest (n=1), Injection site rash (n=1), COVID-19 (n=1), COVID-19 pneumonia (n=1), Muscular weakness (n=1), CIDP (n=15), Quadriparesis (n=1), and Pruritus (n=1) in stage A; COVID-19 pneumonia (n=1), Prostate cancer (n=1), and Transitional cell carcinoma (n=1) in stage B efgartigimod PH20 SC; and Pneumonia (n=1) in stage B placebo SC. bTwo deaths (cardiac arrest and deterioration of CIDP) in stage A were considered not related to efgartigimod PH20 SC by the investigator; one death (pneumonia) in the placebo arm of stage B was considered treatment related by the investigator. Open-Label Stage A Double-Blinded Stage B n (%) Efgartigimod PH20 SC (N=322; PYFU=46.9) Efgartigimod PH20 SC (N=111; PYFU=56.7) Placebo (N=110; PYFU=42.1) PARTICIPANT WITH EVENT Any TEAE 204 (63.4) 71 (64.0) 62 (56.4) Any SAE 21 (6.5) 6 (5.4) 6 (5.5) Injection site reactions 62 (19.3) 16 (14.4) 7 (6.4) Discontinued due to AEsa 22 (6.8) 3 (2.7) 1 (0.9) Deathsb 2 (0.6) 0 (0) 1 (0.9) MOST COMMON TEAES (≥5% OF PARTICIPANTS IN ANY GROUP) Injection site erythema 33 (10.2) 6 (5.4) 0 (0) CIDP 17 (5.3) 1 (0.9) 1 (0.9) Headache 16 (5.0) 4 (3.6) 2 (1.8) Upper respiratory tract infection 11 (3.4) 2 (1.8) 11 (10.0) COVID-19 6 (1.9) 19 (17.1) 14 (12.7) Injection site bruising 4 (1.2) 6 (5.4) 1 (0.9) |
Commercial Strategy K AR E N MAS S E Y |
Raising Expectations for CIDP Patients “Every day is your new normal. I had to learn how to continue life - every single day - even though things are going to be different for me.” “ SCOTT- CIDP PATIENT “ 13 |
Empower Patients to Demand more from their Treatment Provide Best in Class Patient Support Deliver Broad Access Drive Rapid Healthcare Provider Adoption Maximizing Impact of VYVGART Hytrulo 14 |
12,000 Adult CIDP Patients in U.S. Not Well-Managed with Current Treatment Options Diagnosed CIDP Patients Treated CIDP Patients Includes all patients treated on IVIG/SCIG, PLEX, steroids, biologics, other Patients Not Well-Managed on Current Therapy* ~12K ~24K ~41K *This is defined as patients w ho either are not responding w ell to current treatment or experiencing negative side effects Source: argenx market research, IQVIA LAAD data 15 |
Activating an Empowered Patient Community 16 |
Driving Rapid Adoption with Neurologists Neurology Landscape Reaching the Right Physicians Leveraging the Strength of ADHERE data Providing Reimbursement Support • Expansion of deeply experienced sales force • Strong relationships with existing VYVGART prescribers • First innovation in 30 years • Compelling combined safety, efficacy, convenience • Support navigating the reimbursement process 10K Target Neurologists 72% CIDP/MG Prescriber Overlap Source: Komodo claims data; argenx market research 17 |
Securing Broad Access 18 Established price per vial Real World Utilization Data based on ADHERE+ Payor Mix - % of patients covered by VBA Expected annual net revenue per patient of ~$450,000* Average annual out-of-pocket cost to the patient similar to MG Ability to leverage existing established relationships with payors CIDP VBA designed to cap the exposure of payors based on number of vials per year Designed to enable access for eligible patients and provide predictability to payors Establishing Value Based Agreements Net Revenue Per Patient *Revenue per patient to vary based on individualized dosing and specific insurance coverage, and mandatory government discounts and rebates |
Filing submitted (VYVDURA) April 2024 Multidimensional Expansion in CIDP Zai Lab announced acceptance of sBLA in China May 2024 Submission filed with EMA June 2024 VYVGART® Hytrulo Approved June 21, 2024 Pre-filled syringe (PFS) filed June 2024 Expected Decisions on Approval 2025 19 |
Looking Ahead T I M VAN H AU WE R ME I R E N |
Where Innovation Meets Critical Unmet Need Patient Science 21 |