On October 31, 2024 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported its third quarter 2024 financial results and provided a business update (Press release, argenx, OCT 31, 2024, View Source [SID1234647581]).

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"We delivered significant patient impact with VYVGART over the quarter, expanding our gMG footprint and delivering innovation to CIDP patients three months into launch," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "We continued to advance our goal of reaching more gMG patients earlier in their treatment journey, supported by VYVGART’s strong safety and efficacy profile, and real world data showing the ability to meaningfully reduce steroid use. Expanding upon our leadership in gMG, we are now paving the future in CIDP. The strength of our data, combined with execution across the team to reach key stakeholders, contributed to the initial success of our CIDP launch, with more than 300 patients on therapy at the end of the third quarter. There remains significant opportunity ahead as we work towards achieving our Vision 2030, with innovation implemented across our pipeline to deliver transformative outcomes to more patients."

Advancing ‘Vision 2030’ in Third Quarter 2024

Vision 2030 is the next phase in argenx’s long-term commitment to transform the treatment of autoimmune diseases by strengthening its leadership in FcRn biology, investing in its continuous pipeline of differentiated antibody candidates, and scaling in a disciplined way to ensure innovation remains core to the argenx mission. As a part of this vision, argenx plans to reach at least 50,000 patients globally, advance the pipeline to achieve 10 labeled indications, and bring five new molecules into Phase 3 by 2030.

Reaching 50,000 Patients Globally by 2030

VYVGART (efgartigimod alfa-fcab) is a first-in-class antibody fragment targeting FcRn and is now approved for both intravenous use and subcutaneous injection (SC) (efgartigimod alfa and hyaluronidase-qvfc) in three indications, including generalized myasthenia gravis (gMG) globally, primary immune thrombocytopenia (ITP) in Japan (IV-only), and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S. (SC-only).
•Generated global net product revenues (inclusive of both VYVGART and VYVGART SC) of $573 million in the third quarter of 2024
•Multiple VYVGART regulatory submissions completed or underway for gMG, including:
◦Swissmedic approved VYVGART for the treatment of gMG in Switzerland
◦Regulatory decisions on approval expected in Australia and Saudi Arabia in 2024, and South Korea in 2025
•Multiple VYVGART SC regulatory submissions under review or planned for CIDP, including:
◦Regulatory submissions completed in Japan, Europe, and China with decisions on approval expected in 2025
◦Regulatory submission to be completed in Canada by end of 2024
•VYVGART now reimbursed in 11 countries in Europe, with new agreements in place in France Luxembourg, and Belgium

•FDA review of VYVGART SC pre-filled syringe (PFS) for gMG and CIDP ongoing with Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2025

Advancing Pipeline to Achieve 10 Labeled Indications by 2030

argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple pipeline-in-a-product candidates. argenx is solidifying its leadership in FcRn biology, with efgartigimod currently in development in 15 indications. argenx is also advancing its first-in-class C2 inhibitor, empasiprubart, which is being evaluated in multifocal motor neuropathy (MMN), delayed graft function (DGF), dermatomyositis (DM), and CIDP. In addition, argenx is evaluating ARGX-119, a muscle-specific kinase (MuSK) agonist in both congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS).
•Registrational studies ongoing of efgartigimod in thyroid eye disease (TED)
•Registrational studies ongoing to support label-expansion into broader MG, including ADAPT SERON in seronegative gMG and ADAPT OCULUS in ocular MG
•Registrational study in primary Sjögren’s disease (SjD) on track to start by end of 2024
•Confirmatory study of efgartigimod in primary ITP to start by end of 2024 to enable registration in U.S.
•Topline data from seamless Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and DM) expected by end of 2024
•Update on BALLAD study development plan evaluating efgartigimod in bullous pemphigoid (BP) expected by end of 2024
•Decision made to discontinue development of efgartigimod in membranous nephropathy (MN); proof-of concept study ongoing with efgartigimod in lupus nephritis (LN)
•Proof-of-concept study ongoing with efgartigimod in antibody mediated rejection (AMR), with systemic sclerosis (SSc) to start by end of 2024
•Registrational study of empasiprubart in MMN to start by end of 2024
•Additional proof-of-concept studies of empasiprubart ongoing, including VARVARA study in DGF and EMPACIFIC study in DM
•Registrational study of empasiprubart in CIDP to start in 2025
•Ongoing Phase 1b/2a studies of ARGX-119 to assess early signal in patients with CMS and ALS

Investing in Immunology Innovation Program to Support Five New Molecules in Phase 3 by 2030

argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx’s leadership in this new class of medicine; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and ARGX-220, a first-in-class sweeping antibody for which the target has not yet been disclosed.
•Phase 1 studies of ARGX-213 and ARGX-121 expected to start in second half of 2025
•Investigational new drug (IND) applications for ARGX-220 and ARGX-109 on track to be filed by end of 2025

THIRD QUARTER 2024 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS
Three Months Ended Nine Months Ended
September 30 September 30
(in thousands of $ except for shares and EPS) 2024 2023 2024 2023
Product net sales $ 572,997 $ 329,097 $ 1,448,915 $ 816,432
Collaboration revenue 239 692 2,905 3,047
Other operating income 15,642 10,050 38,999 31,275
Total operating income $ 588,878 $ 339,839 $ 1,490,819 $ 850,754
Cost of sales $ (59,072) $ (35,999) $ (154,633) $ (78,358)
Research and development expenses (235,940) (191,755) (686,195) (553,119)
Selling, general and administrative expenses (277,698) (191,930) (769,392) (503,079)
Loss from investment in a joint venture (1,981) (743) (5,294) (2,623)
Total operating expenses $ (574,691) $ (420,427) $ (1,615,514) $ (1,137,179)
Operating profit/(loss) $ 14,187 $ (80,588) $ (124,695) $ (286,425)
Financial income $ 40,586 $ 30,049 $ 118,414 $ 67,078
Financial expense (676) (231) (1,760) (626)
Exchange gains/(losses) 33,927 (32,509) 6,712 (23,345)
Profit/(loss) for the period before taxes $ 88,024 $ (83,279) $ (1,329) $ (243,318)
Income tax (expense)/benefit $ 3,386 $ 10,637 $ 60,208 $ 47,437
Profit/(loss) for the period $ 91,410 $ (72,642) $ 58,879 $ (195,881)
Profit/(loss) for the period attributable to:
Owners of the parent $ 91,410 $ (72,642) $ 58,879 $ (195,881)
Weighted average number of shares outstanding 60,087,498 58,128,233 59,633,179 56,512,254
Basic profit/(loss) per share (in $) 1.52 (1.25) 0.99 (3.47)
Diluted profit/(loss) per share (in $) 1.39 (1.25) 0.91 (3.47)
Net increase in cash, cash equivalents and current financial assets compared to year-end 2023 and 2022 $ 194,523 $ 993,035
Cash and cash equivalents and current financial assets at the end of the period $ 3,374,367 $ 3,185,583

DETAILS OF THE FINANCIAL RESULTS
Total operating income for the third quarter and year-to-date in 2024 was $589 million and $1,491 million, respectively, compared to $340 million and $851 million for the same periods in 2023, and mainly consists of:
•Product net sales of VYVGART for the three months ended and nine months ended September 30, 2024, were $573 million and $1,449 million, compared to $329 million and $816 million for the same periods in 2023.

•Other operating income for the third quarter and year-to-date in 2024 was $16 million and $39 million, respectively, compared to $10 million, and $31 million for the same periods in 2023. The other operating income for the three and nine months ended September 30, 2024 primarily relates to research and development tax incentives and payroll tax rebates.
Total operating expenses for the third quarter and year-to-date in 2024 were $575 million and $1,616 million, respectively, compared to $420 million and $1,137 million for the same periods in 2023, and mainly consists of:
•Cost of sales for the third quarter and year-to-date in 2024 was $59 million and $155 million, respectively, compared to $36 million and $78 million for the same periods in 2023. The cost of sales was recognized with respect to the sale of VYVGART and VYVGART Hytrulo.

•Research and development expenses for the third quarter and year-to-date in 2024 were $236 million and $686 million, respectively, compared to $192 million and $553 million for the same periods in 2023. The research and development expenses mainly relate to external research and development expenses and personnel expenses incurred in the clinical development of efgartigimod in various indications and the expansion of other clinical and preclinical pipeline candidates.

•Selling, general and administrative expenses for the third quarter and year-to-date in 2024 were $278 million and $769 million, respectively, compared to $192 million and $503 million for the same periods in 2023. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to global commercialization of VYVGART and VYVGART Hytrulo, and personnel expenses.
Financial income for the third quarter and year-to-date in 2024 was $41 million and $118 million, respectively, compared to $30 million and $67 million for the same periods in 2023. The increase in financial income is mainly due to an increase in interest income on current financial assets and cash and cash equivalents.
Exchange gains for the third quarter and year-to-date in 2024 were $34 million and $7 million respectively, respectively, compared to $(33) million and $(23) million of exchange losses for the same periods in 2023. Exchange gains/losses are mainly attributable to unrealized exchange rate gains or losses on the cash, cash equivalents and current financial assets position in Euro.
Income tax for the third quarter and year-to-date in 2024 was $3 million and $60 million of tax benefit, respectively, compared to $11 million and $47 million of tax benefit for the same periods in 2023. Tax benefit for the nine months ended September 30, 2024 consists of $29 million of income tax expense and $89 million of deferred tax income, compared to $24 million of income tax expense and $71 million of deferred tax income for the comparable prior period.
Net income for the three and nine month periods ended September 30, 2024, was $91 million and $59 million, respectively, compared to a net loss of $(73) million and $(196) million over the prior year periods. On a per weighted average share basis, the earnings per share was $0.99 for the nine months ended September 30, 2024 and a net loss per share of $(3.47) for the nine months ended September 30, 2023.

Cash, cash equivalents and current financial assets totaled $3.4 billion as of September 30, 2024, compared to $3.2 billion as of December 31, 2023. The increases in cash and cash equivalents and current financial assets over the period was from financing activities due to the exercise of stock options which is offset by net cash flows used in operating and investing activities.

FINANCIAL GUIDANCE

With the increase in cash, cash equivalents and current financial assets in the quarter and year-to-date, the previously issued cash guidance no longer applies. The financial guidance on the combined selling, general and administrative expenses and research and development expenses remains unchanged at approximately $2 billion.

EXPECTED 2024 FINANCIAL CALENDAR

•February 27, 2025: Full-year 2024 financial results and 4Q 2024 business update

CONFERENCE CALL DETAILS

The third quarter 2024 financial results and business update will be discussed during a conference call and webcast presentation today at 1:30 pm CET/8:30 am ET. A webcast of the live call and replay may be accessed on the Investors section of the argenx website at argenx.com/investors.

On October 30, 2024 Aileron Therapeutics, Inc. ("Aileron") (NASDAQ: ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, and Advancium Health Network ("Advancium"), a public charity founded by Deerfield Management and the Deerfield Foundation to meet the needs of underserved patient populations, reported entry into an exclusive option agreement for the acquisition of ALRN-6924, a clinical-stage oncology agent developed by Aileron prior to its 2023 merger with Lung Therapeutics, Inc (Press release, Aileron Therapeutics, OCT 31, 2024, View Source [SID1234647580]).

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During the option period, Advancium intends to evaluate ALRN-6924 as a potential therapy for retinoblastoma (RB), a rare but devastating cancer of the eye, with around 300 cases diagnosed in the United States and 9,000 cases worldwide each year, nearly all in children [1]. With early intervention the disease is rarely fatal; however, non-selective chemotherapy with its attendant side effects remains the usual treatment strategy, and removal of the affected eye(s) is a frequent outcome. In contrast to chemotherapy, ALRN-6924 selectively targets MDM2 and MDMX, the endogenous inhibitors of the regulatory protein p53, to activate p53-mediated tumor suppression in cancer cells [2]. Previous studies have implicated the MDMX protein as a key driver of RB tumorigenesis [3], and ALRN-6924 is the first and only clinical-stage drug that acts on MDMX. ALRN-6924 has previously been studied in preclinical models of RB, where it showed potent, on-mechanism anti-proliferative activity in RB cell lines and was found to be highly soluble and compatible with intraocular injection [4].

Under the terms of the option agreement, Advancium paid Aileron a non-refundable fee for the exclusive option to acquire ALRN-6924 and related assets. If Advancium exercises its option, Aileron will receive an exercise payment with potential for additional development, regulatory and commercial milestone payments and sales royalties.

"This agreement is a significant landmark for our work at Advancium, as it is the first drug opportunity we are pursuing in our mission as a public charity to develop much-needed therapies for children with cancer," said Mark Veich, Chief Executive Officer of Advancium and Vice President of Philanthropy and Executive Director of the Deerfield Foundation. "We look forward to evaluating ALRN-6924 as a potential treatment for children with retinoblastoma who currently have limited care options."

"Aileron is a strong supporter of Advancium’s cause," said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. "Although we remain focused on developing novel therapies for the treatment of orphan pulmonary and fibrosis indications, we are honored that they have chosen to partner with us in this important step towards their goal of delivering therapies to pediatric patients with high unmet need."

On October 31, 2024 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, reported business highlights and financial results for the third quarter ended September 30, 2024 (Press release, Agios Pharmaceuticals, OCT 31, 2024, View Source [SID1234647579]).

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"We had a strong quarter, marked by several important advancements across our pipeline. We completed enrollment of our Phase 3 RISE UP study of mitapivat in sickle cell disease, on our way to sharing topline results in late 2025. Our Phase 2b study of tebapivat in lower-risk MDS was initiated, and we received orphan drug designation from the FDA to support the development of tebapivat in this indication," said Brian Goff, chief executive officer of Agios. "Our cash position was further strengthened by the receipt of $1.1 billion in payments. This will allow us to maintain this great momentum and fuel our next phase of growth, building towards a franchise with multi-billion-dollar potential. We remain focused on progressing our promising clinical programs to address the critical needs of rare disease patients and look forward to sharing our progress in the coming months."

Third Quarter 2024 and Recent Highlights

PYRUKYND Revenues: Generated $9.0 million in net revenue for the third quarter of 2024, a 4 percent increase from the second quarter of 2024, primarily driven by increased patient demand. A total of 211 unique patients have completed prescription enrollment forms, representing an increase of 5 percent over the second quarter of 2024. A total of 127 patients are on PYRUKYND therapy, inclusive of new prescriptions and continued therapy.
Sickle Cell Disease: Completed enrollment of the 52-week Phase 3 RISE UP study of mitapivat in sickle cell disease, with more than 200 patients enrolled worldwide, and topline data expected in late 2025.
Lower-risk Myelodysplastic Syndromes:
Initiated patient enrollment in the Phase 2b study of tebapivat (AG-946).
Granted Orphan Drug Designation from the FDA to tebapivat for the treatment of myelodysplastic syndromes (MDS).
Presented topline data from Agios’ Phase 3 ACTIVATE-KidsT trial of mitapivat in pediatric patients with PKD.
Observed transfusion reduction response rates were higher in the mitapivat arm compared to placebo and were clinically meaningful despite not meeting prespecified statistical criterion for the primary endpoint; secondary endpoints of transfusion-free response and normal hemoglobin response were observed only in the mitapivat arm.
Safety was consistent with the profile observed in adults with PK deficiency who are regularly transfused.
Presented data from the Phase 3 ENERGIZE trial as an encore session at the 19th Annual Academy for Sickle Cell and Thalassemia (ASCAT) Conference.
Corporate Development:
The FDA approved Servier’s vorasidenib for the treatment of IDH-mutant diffuse glioma. As a result, Agios received a $200 million milestone payment from Servier and a $905 million payment from Royalty Pharma in connection with the purchase agreement announced in May 2024.
Entered into a distribution agreement with NewBridge Pharmaceuticals to advance commercialization of PYRUKYND in the Gulf Cooperation Council (GCC) region. NewBridge, a leading specialty company headquartered in Dubai, will commercialize PYRUKYND in Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates.
Key Upcoming Milestones & Priorities

Agios expects to achieve the following key milestones by the end of 2024:

Thalassemia: File sNDA for mitapivat in thalassemia based on the positive results from the Phase 3 ENERGIZE and ENERGIZE-T clinical trials.
Present additional clinical data at the 66th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Congress, taking place December 7-10, 2024, in San Diego.
Third Quarter 2024 Financial Results

Revenue: Net product revenue from sales of PYRUKYND for the third quarter of 2024 was $9.0 million, compared to $7.4 million for the third quarter of 2023.

Cost of Sales: Cost of sales for the third quarter of 2024 was $0.8 million.

Research and Development (R&D) Expenses: R&D expenses were $72.5 million for the third quarter of 2024, compared to $81.8 million for the third quarter of 2023. The year-over-year decrease was primarily driven by the $17.5 million upfront payment associated with the license agreement with Alnylam, which was recorded in the prior year.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $38.5 million for the third quarter of 2024 compared to $25.8 million for the third quarter of 2023. The year-over-year increase was primarily attributable to an increase in commercial-related activities as the company prepares for the potential approval of PYRUKYND in thalassemia.

Net Income (Loss): Net income was $947.9 million for the third quarter of 2024 compared to a net loss of $91.3 million for the third quarter of 2023, reflecting the milestone and royalty agreement income recorded in the third quarter of 2024.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of September 30, 2024, were $1.7 billion compared to $806.4 million as of December 31, 2023. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to prepare for potential PYRUKYND launches in thalassemia and sickle cell disease, advance existing programs, and to opportunistically expand its pipeline through both internally and externally discovered assets.

Conference Call Information

Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss third quarter 2024 financial results and recent business highlights. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

On October 31, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion [generic name: atezolizumab (genetical recombination)] for an additional indication of relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (R/R ENKL) (Press release, Chugai, OCT 31, 2024, View Source [SID1234647537]).

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"ENKL is a rare type of malignant lymphoma that primarily develops in the nose. It is known to have a poor prognosis, with about 60% of patients in advanced stages relapsing after initial treatment, and there is no standard therapy for relapsed cases. We are working to obtain approval so that Tecentriq, a cancer immunotherapy that demonstrated favorable efficacy, can be delivered to patients as soon as possible as a new therapeutic option for ENKL," said Chugai’s President and CEO, Dr. Osamu Okuda.

This filing is based on the results from a phase II ATTACK study initiated by investigators in Japan including National Cancer Center Hospital, which evaluated the efficacy and safety of Tecentriq in patients with R/R ENKL. Response was shown in 7 out of 13 cases and the study met its primary endpoint with an overall response rate of 53.8% (95% CI: 25.1-80.8%). The safety profile was consistent with that in other tumors.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical need in cancer treatment with innovative medicines for patients and healthcare professionals.

About ATTACK study1
ATTACK study (NCCH1903, jRCT2031190177) is a Japanese Phase II, multicenter, open-label, single-arm study led by physicians including National Cancer Center Hospital to evaluate the efficacy and safety of Tecentriq in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type. The study enrolled 14 patients to investigate safety and efficacy. The primary endpoint is independent review committee (IRC)-assessed overall response rate. Key secondary endpoints include progression-free survival, overall survival, and safety.
ATTACK study is being conducted as a substudy of the MASTER KEY project, which promotes the development of treatments for rare cancers through industry-academia collaboration with the National Cancer Center Hospital.

About extranodal natural killer/T-cell lymphoma, nasal type (ENKL)
ENKL is a form of malignant lymphoma that primarily affects the nasal cavity. It can occur in individuals of all ages, from children to adults.2,3,4 ENKL is rare, accounting for approximately 0.68% of all malignant lymphoma cases (annual incidence: about 36,000 cases) in Japan.5 For patients with advanced ENKL, about 60% experience relapse following initial treatment.6,7 Relapsed or refractory ENKL has a poor prognosis, and there is currently no established standard treatment.

About Tecentriq8
Tecentriq is a cancer immune checkpoint inhibitor targeting PD-L1, which is a protein expressed on tumor and tumor-infiltrating immune cells. PD-L1 blocks T cell activity by binding with PD-1 and B7.1 receptors on T cell surface. By inhibiting PD-L1, Tecentriq may enable the activation of T cells and boost immune response against cancer cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 4 indications (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, and hepatocellular carcinoma). Tecentriq was filed for additional indication of alveolar soft part sarcoma in March 2024.

Trademarks used or mentioned in this release are protected by law.

On October 30, 2024 GlaxoSmithKline reported its Third quarter 2024 financial results (Press release, GlaxoSmithKline, OCT 30, 2024, View Source [SID1234648916]).

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