On March 3, 2022 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported financial results for the full year 2021 and provided a fourth quarter business update (Press release, argenx, MAR 3, 2022, View Source [SID1234609465]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"2021 was a transformational year for argenx, culminating with the FDA approval of VYVGART, our first-in-class FcRn blocker, in December. We carried this momentum into 2022 with the official U.S. launch of VYVGART and the Japan approval. We were well-prepared to launch VYVGART at the time of approval and are encouraged by the early response of the medical community, the engagement from patients, and the coverage decisions that have been made by payers. We continue to expect steady launch progress in 2022 as we aim to deliver this new therapy to patients living with generalized myasthenia gravis," said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
"In addition to executing the global commercial launch of VYVGART, we are primed to deliver several upcoming catalysts through our development pipeline in high-value autoimmune indications. We expect multiple registrational trial readouts for efgartigimod in the next four quarters, the first of which is the SC bridging study in gMG this month. We are expanding the scope of development for efgartigimod to 10 indications and ARGX-117 to two indications by the end of this year, and will also advance ARGX-119 into first-in-human studies. We remain focused on all components of our integrated business so that we can continue to redefine immunology on behalf of patients and deliver shareholder value," continued Mr. Van Hauwermeiren.
FOURTH QUARTER 2021 AND RECENT BUSINESS UPDATE
U.S. commercial launch ongoing for VYVGART, the first FDA-approved FcRn blocker for adult gMG patients who are anti-acetylcholine receptor (AChR) antibody positive
VYVGART U.S. salesforce launched in early January; team interacted with over 60% of the 1,000 top priority neurologist targets as of end of February
VYVGART-specific payer policies have been published in plans covering approximately 25% of U.S. commercial lives; expected to have broad coverage in place by end of second quarter 2022
Commercial launch preparedness enabled immediate activation of key launch activities
My VYVGART Path, a personalized patient support system, was active at time of approval; approximately 90% of enrollment forms have come in through this program
Distribution channels stocked within one week following FDA approval
On track with global launch strategy to make VYVGART available in Japan, Europe, China and Canada, as well as additional regions through license and distribution agreements
VYVGART approved for adult patients with gMG on January 20, 2022 by Japan’s Ministry of Health, Labour and Welfare with expected launch to occur in second quarter 2022
Decision from European Medicines Agency on Marketing Authorization Application expected in second half of 2022
argenx Canada established in preparation for potential Health Canada approval and commercial launch
Medison to file for approval in Israel in second quarter of 2022
Zai Lab to file for approval in China in mid-2022
Entered into commercial and distribution agreement with GenPharm for VYVGART commercialization in the Middle East
Additional license and distribution agreements expected in 2022 to expand global patient reach
Topline data expected from five ongoing efgartigimod registrational trials by end of first quarter of 2023
Neuromuscular franchise
ADAPT-SC: Topline data from bridging study of SC efgartigimod for gMG expected in first quarter of 2022
ADHERE: Topline data of SC efgartigimod for chronic inflammatory demyelinating
polyneuropathy expected in first quarter of 2023
Hematology franchise
ADVANCE: Topline data of intravenous efgartigimod for primary immune thrombocytopenia (ITP) expected in second quarter of 2022
ADVANCE-SC: Topline data of SC efgartigimod for primary ITP expected in first quarter of 2023
Dermatology franchise
ADDRESS: Timing of topline data of SC efgartigimod for pemphigus foliaceous and vulgaris is currently under review given geopolitical events in Ukraine
argenx’s leadership position in FcRn blockade to be solidified through expansion of efgartigimod development portfolio into ten total autoimmune conditions by end of 2022
BALLAD: Registrational trial ongoing of SC efgartigimod for bullous pemphigoid with interim analysis planned of first 40 patients
ALKIVIA: Registrational trial on track to start in first quarter of 2022 for idiopathic inflammatory myopathy (myositis); interim analysis planned of first 30 patients of each subtype (immune-mediated necrotizing myopathy, anti-synthetase syndrome and dermatomyositis)
Zai Lab to launch proof-of-concept trials in lupus nephritis and membranous nephropathy in 2022 with argenx to lead global registrational programs for each potential indication
Entered strategic collaboration with IQVIA to leverage its global clinical development capabilities and accelerate expansion of efgartigimod into additional potential indications
Proof-of-concept trials in primary Sjogren’s syndrome expected to initiate in second half of 2022 and COVID-19-mediated postural orthostatic tachycardia syndrome (POTS) in mid-2022
ARGX-117, a novel C2 inhibitor, has potential to be second pipeline-in-a-product for multiple autoimmune indications
Ongoing proof-of-concept trial to evaluate safety, tolerability, and potential dosing regimen in multifocal motor neuropathy (MMN)
Phase 2 proof-of-concept trial expected to start in 2022 for prevention of delayed graft function and/or allograft failure after kidney transplantation
Continued investment in Immunology Innovation Program (IIP) to broaden autoimmune pipeline for sustained value creation opportunities
Phase 1 dose-escalation trial of ARGX-119, an agonist SIMPLE Antibody to muscle-specific kinase (MuSK), expected to start after Clinical Trial Application filing in fourth quarter of 2022
Trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers, and also early signal detection in patients
Strengthened leadership team with appointment of Malini Moorthy as General Counsel
Ms. Moorthy brings to argenx over 20 years of global legal and compliance experience in the pharmaceutical and medical device industries
DETAILS OF THE FINANCIAL RESULTS
Cash, cash equivalents and current financial assets totaled $2,336.7 million as of December 31, 2021, compared to $1,996.5 million on December 31, 2020. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering of shares, which resulted in the receipt of $1,092.1 million in net proceeds in February 2021 and the net receipt of a $73.1 million non-creditable, non-refundable development cost-sharing payment from Zai Lab as part of the strategic collaboration for efgartigimod in Greater China in part offset by the payment of $98.0 million related to the purchase of the priority review voucher from Bayer HealthCare Pharmaceuticals, and other net cash flows used in operating activities.
Revenue increased by $456.0 million for the twelve months ended December 31, 2021 to $497.3 million, compared to $41.2 million for the twelve months ended December 31, 2020. The increase was primarily due to the recognition of the transaction price as a consequence of the termination of the collaboration agreement with Janssen resulting in the one-time recognition of $315.1 million, and the recognition of $177.5 million in collaboration revenue related to the strategic collaboration with Zai Lab, including the cost-sharing payment and the development milestone, triggered by the FDA approval of VYVGART.
Other operating income increased by $18.5 million to $42.1 million for the year ended December 31, 2021, compared to $23.7 million for the year ended December 31, 2020. The increase was primarily driven by (i) the increase in research and development incentives, as a result of the increased research and development costs incurred, (ii) the increase in payroll tax rebates, as a direct result of the increase in the employment of highly qualified research and development personnel eligible for specific payroll tax rebates, and (iii) the increase in fair value of argenx’s profit share in AgomAb Therapeutics NV.
Research and development expenses increased by $209.6 million for the twelve months ended December 31, 2021 to $580.5 million, compared to $370.9 million for the twelve months ended December 31, 2020. The increase resulted primarily from higher external research and development expenses, mainly related to the efgartigimod program in various indications and other clinical and preclinical programs. Furthermore, the research and development personnel expenses increased due to a planned increase in headcount and the increased costs of the share-based payment compensation plans related to the grant of stock options.
Selling, general and administrative expenses totaled $307.6 million for the twelve months ended December 31, 2021, compared to $171.6 million for the twelve months ended December 31, 2020. The increase resulted primarily from higher personnel expenses, including the costs of the share-based payment compensation plans related to the grant of stock options, and consulting fees linked to the preparation for a commercialization of VYVGART.
Exchange losses totaled $50.1 million for the twelve months ended December 31, 2021, compared to $126.2 million for the twelve months ended December 31, 2020 and are mainly attributable to unrealized exchange rate losses on the cash, cash equivalents and current financial assets position in Euro.
FINANCIAL GUIDANCE
Based on current plans to fund anticipated operating expenses and capital expenditures, argenx expects to utilize up to half of its available cash, cash equivalents and current financial assets in 2022. The increased spend will support the global VYVGART launches, clinical development of efgartigimod in 10 indications and ARGX-117 in two indications, investment in the global supply chain, and continued focus on pipeline expansion through the Immunology Innovation Program.
US SEC AND STATUTORY FINANCIAL REPORTING
argenx’s primary accounting standard for quarterly earnings releases and annual reports is International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). Quarterly summarized statements of profit or loss based on IFRS as issued by the IASB are available on www.argenx.com.
In addition to reporting financial figures in accordance with IFRS as issued by the IASB, argenx also reports financial figures in accordance with IFRS as adopted by the EU for statutory purposes. The consolidated statements of financial position, the consolidated statements of profit or loss, the consolidated statements of comprehensive income / loss, the consolidated statements of cash flows, and the consolidated statements of changes in equity are not affected by any differences between IFRS as issued by the IASB and IFRS as adopted by the EU.
The consolidated statements of profit or loss of argenx SE for the year ended December 31, 2021, as presented in this press release are unaudited.
EXPECTED 2022 FINANCIAL CALENDAR:
May 5, 2022: Q1 2022 financial results and business update
July 28, 2022: HY 2022 financial results and business update
October 27, 2022: Q3 2022 financial results and business update
CONFERENCE CALL DETAILS
The full year 2021 results and fourth quarter business update will be discussed during a conference call and webcast presentation today at 2:30 pm CET/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website.