One positive note from that article was that the Comera exec admitted that the barriers to entry are high.

I could be wrong, but I think the author is off base regarding the comparison of enhanze and caffeine.
As I understand it, Enhanze is not used to "stabilize" the formulation but to dissolve the hyaluronan structures of the subcu region thereby making room for the injected material which then has access to the blood stream. This is always how it's been presented by HALO to the investing public, unless I've been missing something.

Thanks for the link. As I understand it, the primary source of medical hyaluronidase prior to rHUph20 was porcine. There are also ovine based products. I don't know about their tendency to invoke immunogenicity, but one could assume that they are both problematic and inferior to rHUph20.

Interestingly IMGN was trading at this price 23 years ago.

If anyone could just use plain old hyaluronidase in reformulating a drug to a subcu version, HALO wouldn't exist as a company. This leaves me wondering what exactly Merck has in their enzyme....

Thanks for sharing your thoughts about Musk; now I can put all of your opinions in a better context.

Thanks for the heads up. What were your key takeaways?

rare failure for ARGX sc efgartigimod

argenx Reports Topline Results from ADVANCE-SC Study of VYVGART Hytrulo in Primary Immune Thrombocytopenia



-????????????Study did not meet primary or secondary endpoints



-????????????Favorable safety and tolerability profile consistent with previous clinical trials



-????????????Conference call scheduled for today, November 28, 2023 at 8:30am ET (2:30pm CET)
--------------------------------------------------------------------------------------------------------------------------------------
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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 topline results from the ADVANCE-SC study evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with primary immune thrombocytopenia (ITP). The study did not meet the primary endpoint of a sustained platelet count response in chronic ITP patients.



Additional analyses of the dataset are ongoing and the full results will be presented at an upcoming medical meeting and in a peer-reviewed publication.

Mizuho cuts RVNC PT from $35 to $16.

ARGX Announces European Commission Approval of Subcu VYVGART® (efgartigimod alfa) for Generalized Myasthenia Gravis
Amsterdam, The Netherlands— November 16, 2023 —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 European Commission (EC) approved SC injectable VYVGART (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. The EC previously approved VYVGART IV in August 2022. Following this decision, VYVGART is now approved in Europe for both IV and self-administered SC use. The approval is applicable to all 27 European Union (EU) Member States plus Iceland, Norway and Liechtenstein. argenx will work with local health authorities to secure patient access for VYVGART SC in the region.

“Today’s approval reflects our commitment to providing a choice of effective, innovative therapies to people with autoimmune disease. We are proud to deliver this second formulation to the European gMG community, just 15 months after the initial approval of VYVGART IV,” said Anant Murthy, General Manager of argenx EMEA. “The availability of two formulations, including the possibility for patients to self-administer at home, allows people living with gMG to choose the treatment that best works for their lifestyle, further reinforcing the individualized treatment approach offered by VYVGART.”

The EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is based on positive results from the Phase 3 ADAPT-SC study. ADAPT-SC established the efficacy of VYVGART SC by demonstrating a reduction in anti-AChR antibody levels comparable to VYVGART IV in adult gMG patients. ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of VYVGART IV in Europe in August 2022.

About Phase 3 ADAPT-SC Trial

The Phase 3 ADAPT-SC trial was a multicenter, randomized, open-label, parallel-group study evaluating the noninferiority of the pharmacodynamic (PD) effect of VYVGART SC compared with VYVGART IV in adult patients with gMG. The pharmacodynamic effect was measured by percent change from baseline for both total IgG and AChR autoantibody levels at day 29. Safety, clinical efficacy, immunogenicity and pharmacokinetics (PK) were also assessed. A total of 110 adult patients with gMG in North America, Europe and Japan enrolled in the ADAPT-SC trial. Patients were randomized in a 1:1 ratio to receive VYVGART IV or SC for one treatment cycle consisting of four doses at once-weekly intervals. The total study duration was approximately 12 weeks, including seven weeks of follow-up after the treatment cycle. At the completion of ADAPT-SC, patients had the opportunity to roll-over to ADAPT-SC+, an open-label extension study.

About VYVGART® SC

VYVGART SC is a SC injectable formulation of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART. It is formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology, to facilitate SC injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART results in the reduction of circulating IgG autoantibodies. VYVGART SC was approved in the United States in June 2023 and is marketed as VYVGART® Hytrulo.

About Generalized Myasthenia Gravis

Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population.

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 further information, please contact:

Media:

Ben Petok
Bpetok@argenx.com

re Diagnostics: That's enlightening and surprising given the heft of the corporate lobby. One would think that this is an easily addressable issue.

Dew, wondering why is diagnostics such a tough space in which to make money?
Thanks,
-Fritz

Roche’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types

If approved, Tecentriq subcutaneous (SC) would be the first injectable PD-(L)1 cancer immunotherapy in the EU, cutting treatment time by approx. 80%1
The CHMP recommended Tecentriq SC for all indications of intravenous (IV) Tecentriq, including certain types of lung, liver, bladder and breast cancer2
A majority of healthcare professionals surveyed in the IMscin001 study found that the SC formulation is easy to administer and could save time compared with IV1

Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC, or under the skin) Tecentriq® (atezolizumab). Tecentriq SC can be injected in approximately seven minutes, with most injections taking between four and eight minutes compared with 30-60 minutes for intravenous (IV) infusion, which can free up time for patients, healthcare teams and caregivers.1 The CHMP recommended Tecentriq SC for all indications in which Tecentriq IV has been previously approved, including certain types of lung, liver, bladder and breast cancer.2 A final decision on its approval is expected from the European Commission in the near future.

“Tecentriq has helped to treat more than 430,000 people diagnosed with some of the most aggressive forms of cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Subcutaneous administration offers a faster and more convenient alternative to IV infusion. The CHMP’s recommendation brings us a step closer to offering the first subcutaneous PD-L1 cancer immunotherapy treatment to patients in the EU.”

The CHMP’s positive opinion is based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.3 Roche recently presented mature overall survival (OS) data with a median follow-up of 9.5 months at the European Society for Medical Oncology (ESMO) Congress 2023. The updated analysis confirmed the earlier results and showed that OS and other efficacy endpoints were consistent between the SC and IV treatment arms.1 A majority of healthcare professionals who were surveyed as part of the study agreed that the SC formulation is easy to administer (90%) and that it could save time for healthcare teams compared with the IV formulation (75%).1

Tecentriq SC, which recently received its first marketing authorisation in Great Britain, was developed to provide patients with an alternative to the IV administration of Tecentriq and the potential for treatment outside of the hospital setting. It is Roche’s fourth subcutaneous cancer therapy.4-6 Multiple oncology studies suggest that the majority of cancer patients generally prefer SC over IV administration due to reduced discomfort, ease of administration and shorter duration of treatment.7-11

About the IMscin001 study
IMscin001 is a Phase IB/III, global, multicentre, randomised study evaluating the pharmacokinetics, safety and efficacy of Tecentriq SC, compared with Tecentriq IV, in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The study enrolled 371 patients.

Part 2 of the study met its primary endpoints, demonstrating comparable levels of Tecentriq in the blood during a given dosing interval on the basis of established pharmacokinetic measurements; observed serum Ctrough and model-predicted area under the curve. Efficacy, as measured by progression-free survival (PFS), objective response rates (ORR) and OS, was similar between the SC and IV treatment arms and consistent with the known profile of Tecentriq IV. The safety profile of Tecentriq SC was also consistent with that of Tecentriq IV.



About Tecentriq SC (subcutaneous)

Tecentriq SC combines Tecentriq with Halozyme Therapeutics’ Enhanze® drug delivery technology.

Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

The Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for Tecentriq to enter, enabling it to be rapidly dispersed and absorbed into the bloodstream.

Tecentriq is approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS).

About Roche in cancer immunotherapy

To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.roche.com/solutions/focus-areas/oncology/cancer-immunotherapy

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Burotto M, Zvirbule Z, Alvarez R, et al. IMscin001 Part 2 updated results: Efficacy, safety, immunogenicity, healthcare provider perspectives and patient-reported outcomes from the randomised Phase III study of atezolizumab subcutaneous vs intravenous in patients with locally advanced or metastatic non-small cell lung cancer. Presented at ESMO; 23 October 2023. Poster #1447P.

[2] European Medicines Agency. Tecentriq, INN-atezolizumab. SmPC. [Internet; last updated 25 July 2023; cited October 2023] Available from: https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf.

[3] Burotto M, Zvirbule Z, Mochalova A, et al. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023;34(8):693-702.

[4] Phesgo, INN-pertuzumab/trastuzumab. SmPC. [Internet; last updated 02 March 2023; cited October 2023] Available from: https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf.

[5] European Medicines Agency. Herceptin, INN-trastuzumab. SmPC. [Internet; last updated 17 March 2023; cited October 2023] Available from: https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf.

[6] European Medicines Agency. MabThera, INN-rituximab. SmPC. [Internet; last updated 22 March 2023; cited October 2023] Available from:

https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf.

[7] Rummel M, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28(4):836-842.

[8] De Cock E, et al. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med. 2016;5(3):389-97.

[9] O’Shaugnessy, J. Patient (pt) preference for the pertuzumab-trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study. Presented at ESMO; 19-21 Sept 2020. Abstract #165MO.

[10] Pivot X, et al. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017;86:82-90.

[11] Denys H, et al. Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer. Breast Cancer Res Treat. 2020;181(1):97-105.





Roche Global Media Relations

Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Thanks for your input. Feel free to chime in any time. It's good to have differing opinions contending so that we all can be as clear as possible in making our decisions.
Good luck
-Fritz

Piper Sandler lowers PT from $44-$42, maintains OVERWEIGHT rating.

Needham adjusts PT from $35-$25, maintains BUY rating.

Herocar, What are your thoughts on all of the various schools of thought on the current situation?

Hero, no disrespect meant to be sent your way. My scorn is 100% directed at the HALO management who has frittered away about a billion dollars in cash buying back shares with no plan for the future, limping along in the status quo.
Buying shares and then selling them again to a financier at what will surely be a dilutive and more expensive proposition is what I fear will happen if Helen gets the buying itch again. Spinning wheels is not returning value to shareholders, IMHO.
Best wishes,
-Fritz

What, and unwind all of that enormous "value returned to shareholders"? LOL!

Cash flow is not money in the bank. In HALO's case the cash flow goes directly to service the debt and other operating expenses.

Funny how you spend so much time puzzling over my motives but little time wondering how Helen can run a business with no money in the bank.

Have a look at the chart. Then tell me it's over.

The share buyback program just continues to underscore the fact that Helen has no idea how to grow this company. Also, I'm not buying her lame excuses for why the three promised new deals are now pushed into next year or whenever. She's got no dry powder to make any future accretive transactions and can't even strike significant new deals in the core business of Enhanz.
This is the essence of what I learned in the call, despite her cheerleading demeanor.

Upon reflection, I think you guys are probably correct on the non-exclusivity part of the deal, and I'd agree that this leaves open the possibility of future deals in the indication. The lack of touting the upfront payments and the failure to include "mid-single digits" indicates that this is a very modest deal. I'm concerned that it shows enhanz's loss of position in the sub-cu formula marketplace.

It's legit.

The clear implication of this is that the single digit royalties are going to be "low single digits", i.e. 1-3%.
This is a very modest deal and very disappointing in all its aspects. Note the "non-exclusive" language in addition to the other issues.

Yes, I was referring to the small vol auto-injectors, which would be, it would seem, a differnet deal than just the Enhanz/Efgartigimod SC deal.
Helen had said the three deals would be comprised of a large vol AI deal, a small vol AI deal, and something else that was not described. At least that's how I remember her comments FWIW.

Do you think this is the "small vol" deal that Helen has mentioned as one of three pending deals? Maybe the announcement was hinging upon the trial outcome?

ARGX Reports

argenx Reports Third Quarter 2023 Financial Results and Provides Business Update
October 31 2023 - 02:00AM
GlobeNewswire Inc.
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$329 million in third quarter global net product sales

On track to submit VYVGART® Hytrulo sBLA for CIDP by year-end 2023

Results from the ADVANCE-IV study published in The Lancet

Management to host conference call today at 1:30 pm CET (8:30 am ET)

October 31, 2023

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 its third quarter 2023 financial results and provided a business update and outlook for the remainder of the year.

“We continue to prioritize patient impact with VYVGART and VYVGART Hytrulo, broadening our two gMG products into earlier treatment lines and new geographies. VYVGART has now been used in thousands of patients over multiple treatment years, and its unique clinical profile has built patient trust and physician confidence in the brand,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “There is a significant opportunity before us to transform autoimmunity across multiple indications with VYVGART. Based on the successful ADHERE trial, we are ready to file the sBLA by the end of 2023 to bring our first-in-class FcRn blocker to CIDP patients as quickly as possible. We are also on track with two near-term pivotal readouts and an ambitious plan forward over the coming years as we continue to execute and drive innovation within our FcRn portfolio and across immunology more broadly.”

THIRD QUARTER 2023 AND RECENT BUSINESS UPDATE

VYVGART Expansion

VYVGART® is a first-in-class antibody fragment targeting the neonatal Fc receptor (FcRn) and is now approved globally in seven countries or regions (U.S., Japan, EU, UK, Israel, China, Canada) for generalized myasthenia gravis (gMG). VYVGART Hytrulo (subcutaneous (SC) injection) was approved in the U.S. in June 2023. argenx is planning for multi-dimensional expansion to reach more patients with gMG and other severe autoimmune diseases through additional global regulatory approvals.

Generated global net product revenues (inclusive of both VYVGART and VYVGART Hytrulo) of $329 million in the third quarter of 2023
Health Canada approved VYVGART on September 21, 2023, marking the seventh global approval for gMG
European Commission (EC) approval of SC efgartigimod for gMG expected in fourth quarter of 2023 following positive recommendation from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
Japan approval decision regarding SC efgartigimod for gMG expected by first quarter of 2024
Japan marketing authorization application (MAA) filed for VYVGART for primary immune thrombocytopenia (ITP); approval decision expected in first quarter of 2024
U.S. supplemental Biologics License Application (sBLA) for VYVGART Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) on track to be filed by end of 2023
China approval decision regarding SC efgartigimod for gMG expected by end of 2024 through partnership with Zai Lab

Efgartigimod Research and Development

argenx is solidifying its leadership in FcRn blockade and demonstrating the broad potential of efgartigimod by advancing its clinical development programs of IgG-mediated autoimmune diseases. By 2025, efgartigimod is expected to be approved, in regulatory review or in development in 15 severe autoimmune diseases

Topline data from ADVANCE-SC (ITP) expected in fourth quarter of 2023; results from ADVANCE-IV study were published in The Lancet in September 2023
Topline data from ADDRESS (pemphigus) and GO/NO GO decision from BALLAD (bullous pemphigoid) both expected around year-end 2023
GO/NO GO decision expected from ALKIVIA (myositis) in second half of 2024
Topline data from ALPHA (post-COVID postural orthostatic tachycardia syndrome (PC-POTS)) expected in first quarter of 2024 and RHO (Sjogren’s syndrome) in first half of 2024
Pipeline Progress

argenx is advancing a robust portfolio of innovative clinical programs, including empasiprubart (C2 inhibitor) and ARGX-119 (muscle-specific kinase (MuSK) agonist). Both programs have the potential to be first-in-class opportunities for multiple severe indications.

Topline data from Phase 2 ARDA study of empasiprubart (ARGX-117) in multifocal motor neuropathy (MMN) expected in 2024
Phase 1 study of ARGX-119 ongoing in healthy volunteers; subsequent Phase 1b trial planned to assess early signal detection in patients with congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS)
Immunology Innovation Program

argenx continues to invest in its discovery engine, the Immunology Innovation Program, to foster a robust innovation ecosystem and drive early-stage pipeline growth. argenx expects to nominate one new pipeline candidate in 2023.

THIRD QUARTER 2023 FINANCIAL RESULTS

argenx SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

Three Months Ended
September 30, Nine Months Ended
September 30,
(in thousands of $ except for shares and EPS) 2023 2022 2023 2022
Product net sales $ 329,097 $ 131,329 $ 816,432 $ 227,325
Collaboration revenue 692 6,652 3,047 9,262
Other operating income 10,050 8,508 31,275 26,565
Total operating income $ 339,839 $ 146,489 $ 850,754 $ 263,152

Cost of sales $ (35,999) $ (10,264) $ (78,358) $ (16,646)
Research and development expenses (191,755) (236,681) (553,119) (515,568)
Selling, general and administrative expenses (191,930) (108,181) (503,079) (336,845)
Loss from investment in joint venture (743) - (2,623) -
Total operating expenses (420,427) (355,126) (1,137,179) (869,059)

Operating loss $ (80,588) $ (208,637) $ (286,425) $ (605,907)

Financial income $ 30,049 $ 8,007 $ 67,078 $ 13,740
Financial expense (231) (785) (626) (2,916)
Exchange gains/(losses) (32,509) (39,609) (23,345) (92,991)

Loss for the period before taxes $ (83,279) $ (241,024) $ (243,318) $ (688,074)
Income tax (expense)/benefit $ 10,637 $ 5,982 $ 47,437 $ 17,096
Loss for the period $ (72,642) $ (235,042) $ (195,881) $ (670,978)
Loss for the year attributable to: -
Owners of the parent $ (72,642) $ (235,042) $ (195,881) $ (670,978)
Weighted average number of shares outstanding 58,128,233 55,203,655 56,512,254 54,049,119
Basis and diluted loss per share (in $) (1.25) (4.26) (3.47) (12.41)
Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2022 and 2021 $ 993,035 $ 48,813
Cash and cash equivalents and current financial assets at the end of the period $ 3,185,583 $ 2,385,541
DETAILS OF THE FINANCIAL RESULTS

Total operating income for the third quarter and year-to-date in 2023 was $339.8 million and $850.8 million, respectively, compared to $146.5 million and $263.2 million for the same periods in 2022, and mainly consists of:

Product net sales of VYVGART for the three months ended and nine months ended September 30, 2023, were $329.1 million and $816.4 million, compared to $131.3 million and $227.3 million for the same periods in 2022.
Other operating income for the third quarter and year-to-date in 2023 was $10.1 million and $31.3 million, respectively, compared to $8.5 million, and $26.6 million for the same periods in 2022. The other operating income for the three and nine months ended September 30, 2023, primarily relates to research and development tax incentives and payroll tax rebates. Other income also includes $0.7 million in royalty revenue from VYVGART sales in China.
Total operating expenses for the third quarter and year-to-date in 2023 were $420.4 million and $1,137.2 million, respectively, compared to $335.1 million and $869.1 million for the same periods in 2022, and mainly consists of:

Cost of sales for the third quarter and year-to-date in 2023 was $36.0 million and $78.4 million, respectively, compared to $10.3 million and $16.6 million for the same periods in 2022. 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 2023 were $191.8 million and $553.1 million, respectively, compared to $236.7 million and $515.6 million for the same periods in 2022. 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 2023 were $191.9 million and $503.1 million, respectively, compared to $108.2 million and $336.8 million for the same periods in 2022. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the commercialization of VYVGART and VYVGART Hytrulo in the U.S., EU and Japan, and personnel expenses.

Financial income for the third quarter and year-to-date in 2023 was $30.0 million and $67.1 million, respectively, compared to $8.0 million and $13.7 million for the same periods in 2022. The increase in financial income is mainly due to an increase in interest income on current financial assets and cash and cash equivalents attributable to higher interest rates.

Exchange losses for the third quarter and year-to-date in 2023 were $32.5 million and $23.3 million respectively, compared to $39.6 million and $93.0 million of exchange losses for the same periods in 2022. 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 2023 was $10.6 million and $47.4 million of tax benefit, respectively, compared to $6.0 million and $17.1 million of tax benefit for the same periods in 2022. Tax benefit for the nine months ended September 30, 2023, consists of $23.8 million of income tax expense and $71.3 million of deferred tax income, compared to $15.0 million of income tax expense and $32.1 million of deferred tax income for the comparable prior period.

Net loss for the three and nine-month periods ended September 30, 2023, was $72.6 million and $195.9 million, respectively, compared to $235.0 million and $671.0 million over the prior year periods. On a per weighted average share basis, the net loss was $3.47 and $12.41 for the nine months ended September 30, 2023 and 2022, respectively.

Cash, cash equivalents and current financial assets totalled $3.2 billion as of September 30, 2023, compared to $2.2 billion as of December 31, 2022. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering of shares, including a U.S. offering, which resulted in the receipt of $1.2 billion in net proceeds in July 2023, partially offset by net cash flows used in operating activities.

EXPECTED 2024 FINANCIAL CALENDAR

February 29, 2024: FY 2023 financial results and business update
May 9, 2024: Q1 2024 financial results and business update
July 25, 2024: Q2 2024 financial results and business update
October 24, 2024: Q3 2024 financial results and business update
CONFERENCE CALL DETAILS
The third quarter 2023 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 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.

Dial-in numbers:
Please dial in 15 minutes prior to the live call.

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

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, China and Canada. 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.

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It is an issue but the patent expiry is less immediately concerning than the current prospect of other competing technologies.

9 months ago, JPM had a PT of $51 on HALO, so this is a significant downgrade in the PT.

You have a good point and based on that it would seem that HALO, a one trick pony, is on very thin ice.

Maybe. Helen has always said that competitors will have a long hard slog to approval, while new Enhanz
formulations will be given a more friendly treatment by the FDA in light of its large data set in regards to safety.
Apropos of that, I note that the Subcu Injected version of Eisai/Biogen's Leqembi shows a spike in AE's compared to the infusion version.
This might cause them problems.

Argenx (ARGX),HALO's most important partner, reports10/31.
Probably worth a listen.
Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Tuesday, October 31, 2023 at 1:30 pm CET (8:30 am ET) to discuss its third quarter 2023 financial results and provide a business update.

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 for approximately one year following the presentation.

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Belgium 32 800 50 201
France 33 800 943355
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United Kingdom 44 800 358 0970
United States 1 888 415 4250
Japan 81 3 4578 9081
Switzerland 41 43 210 11 32

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, China and Canada. 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 https://www.argenx.com and follow us on LinkedIn, Twitter, and Instagram.

Howee clearly you are right about the greater market forces, and the news has been positive. The lack of announcements is a negative,though, given the many months that have passed since Helen made her comments about three new deals. To what do you attribute the holdup?

Benchmark reiterates BUY on HALO and affirms $50 PT

Thanks for posting that. Query: If there are three possible methods of delivery mentioned in the patent filings, can anybody articulate what makes the HiVol AI stand out from the three?