maumar
21 hours ago
Some of the positive comments, especially about Ocrevus ('We expect that Ocrevus subcut represents an incremental CHF2 billion in sales opportunity and we expect this to be increasingly visible in the coming quarters as we are already starting to see some strong pickup in our very early launch countries in the EU.'), may be behind the strong price action lately. From the Roche earnings call:
"Our key brands Vabysmo, Phesgo, Ocrevus, Polivy, Evrysdi, Hemlibra, they delivered an additional almost CHF2 billion in the first half of the year.
....
Phesgo continues to grow very impressively....I want to touch quickly on Tecentriq here, if you sort of scoot down to the bottom part of the chart. So you can see here that the decline in Tecentriq is actually being more than made up for by the growth in international and in Europe. Going forward, we expect Tecentriq to grow in a low-single digit range as we see sort of more increased competition as we begin to reach peak in some of our key indications like HCC and small cell. While we're on the topic of Tecentriq, I'll also mention our subcu formulation, we are seeing good uptake following the EU approval, especially in the UK, where the conversion rate has already reached 32% and we are expecting EU approval -- I'm sorry U.S. approval later this year.
...and Phesgo growing year-to-date by 60%, that strong growth momentum for Phesgo just continues. The global conversion rate currently stands at 41%. You may be looking at that and saying well that looks the same as we saw in Q1 and that is correct. In Q2, we added another five launch countries to the calculation of the global conversion rate, so that's why the rate remains stable. However, if you actually look at the rates in earlier launch countries, we do continue to see that conversion increase. A great example is the U.S., where we are up from 24% percent in Q1 to 26% in Q2. We also continue to see an overall further penetration in HER2 positive breast cancer in general. So if you take Phesgo and Perjeta together, and this bodes well for a scenario in which you see more than 50% of Perjeta sales being converted to Phesgo by 2026.
....
I will just quickly touch here on Lunsumio and the fact that we are excited about the positive phase, the positive data for subcutaneous formulation and third-line follicular lymphoma. The subcu formulation has all the benefits of the already available IV formulation, including no need for hospitalization, fixed treatment duration, but on top of the convenience of administration, it also seems to require less steroid use.
We plan to file Lunsumio subcut in the second half of 2024 with global regulators. (I haven't really looked into this but I am assuming Halo is not involved and I wonder if any other company is.)
Moving on to neurology. Our neurology franchise achieved CHF4.6 billion in sales for the first half, representing an impressive 13% growth. Ocrevus' strong growth momentum continues at 8%, driven by all regions. Not only is Ocrevus the market leader in the U.S. and the EU, but it has also reached a milestone of 1 million patient years of cumulative exposure. Furthermore, our six-month subcutaneous formulation has received EU approval and U.S.
PDUFA is set for the 12th of September. Again, this is 2 times per year, 10 minutes to treat your MS. We expect that Ocrevus subcut represents an incremental CHF2 billion in sales opportunity and we expect this to be increasingly visible in the coming quarters as we are already starting to see some strong pickup in our very early launch countries in the EU.
.....
And again, we are very much focused on the conversion into Phesgo, which provides a lot of stickiness and that we would fully expect Phesgo conversion to be above 50% in many markets.
Bruno Eschli
Okay. Then we move on. The next one would be Simon Baker of Redburn. Simon?
Simon Baker
Thanks very much, Bruno, for taking my questions. Two if I may please. Firstly, Teresa, you mentioned on Tecentriq subcutaneous, the strong reception that's received in the UK. The other strongly received subcutaneous formulation in the UK recently has been Ocrevus, according to the media, there have been suggestions that there is very considerable demand for Ocrevus subcut. So I was just wondering if you could give us an idea of how generalizable that UK experience is? I know the UK has a particular passion for subcut formulations. And what does this mean for Ocrevus subcutaneous beyond the UK, across the world? And do you see maybe the US, ex-US sales split, balancing up between now that we get to a subcut formulation?...
Teresa Graham
Absolutely. And when we look -- so it's a great question on Tecentriq subcut. So I think that in terms of the UK experience, we saw great uptake with Phesgo. We've seen strong uptake with Tecentriq subcut. I think that is quite generalizable for the UK market. I think anything that removes patients from having to go into the system and allows them to go home or to get a faster infusion or a faster injection, that actually frees up chair time and frees up office time, those are going to be very attractive to the UK system, and frankly, attractive to any system that's under financial pressure, which is most global healthcare systems around the world. So I think this is why we are again, really doubling down on devices going forward.
In terms of the Ocrevus subcut, I do believe that bringing the subcut formulation to Europe and to the rest of the world will provide additional opportunities for Ocrevus to reach patients. The initial out-of-the-gate orders for Ocrevus in those countries that have the ability to move quite quickly after approval are already quite strong. Again, you'll start to see the sales for Ocrevus play out of in the coming quarters. But I think this could be something that does equalize that US, EU, rest of world balance as we start getting reimbursement for Ocrevus subcut around the world.
Again, we think that in and of itself, it's a USD2 billion opportunity. And so that's USD2 billion on top of what we've already gotten from the IV space. So this isn't just going to be about cannibalizing our IV business. This is going to be about both in the US and outside the US, expanding to new patient pools. It's very attractive on the Ocrevus side. Just to control expectations a little bit, on the Tecentriq side, I know I mentioned it in my presentation, but we think with Tecentriq, it's largely going to be a conversion strategy. And so that's probably about an incremental USD200 million upside for Tecentriq, while the opportunity for Ocrevus, we believe, is much, much larger.
Simon Baker
Yeah. That was really, really helpful. Just one very quick follow-on going back to Ocrevus subcutaneous. And if you just remind us what the IP situation is? It looks like it's patent-protected to September 2030, but any additional comment on that would be really helpful?
Teresa Graham
Yeah. So I think clearly Ocrevus is sort of end of the decade, but we shouldn't make any broad, sweeping statements about where we think that might go with new formulations and new doses."
Fred Kadiddlehopper
4 days ago
ARGX reports
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https://ih.advfn.com/stock-market/NASDAQ/argenx-ARGX/stock-news/94250967/form-6-k-report-of-foreign-issuer-rules-13a-16
argenx Reports Half Year 2024 Financial Results and Provides Second Quarter Business Update
$478 million in second quarter global net product sales
First CIDP patients treated with VYVGART® Hytrulo following June 21st FDA approval
On track to begin four additional registrational studies across efgartigimod and empasiprubart by end of 2024
Management to host conference call today at 2:30 PM CET (8:30 AM ET)
July 25, 7:00 AM CET
Amsterdam, the Netherlands โ argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its half year 2024 results and provided a second quarter business update.
โWe were excited to unveil our ambition for the future of argenx โ Vision 2030 โ last week, outlining our plan to develop and deliver continued and sustainable innovation for patients,โ said Tim Van Hauwermeiren, Chief Executive Officer, argenx. โWe are already delivering on this promise with impressive commercial execution throughout the first half of the year, expanding our patient reach in MG, and launching in CIDP with our broad FDA label. Our development pipeline is stronger than ever, driven by our unique innovation engine. And we are well-positioned to capture the sizeable growth opportunity before us as we seek to reach earlier-line MG patients over the next 12-18 months with potential label expansions and a pre-filled syringe.โ
Vision 2030
During its R&D Day on July 16, 2024, argenx unveiled its โVision 2030โ as part of its long-term commitment to transform the treatment of autoimmune diseases by strengthening its leadership in neonatal Fc receptor (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. โVision 2030โ includes the following goals:
? 50,000 patients globally on treatment with an argenx medicine
? 10 labeled indications across all approved assets, including VYVGART franchise and potentially empasiprubart and ARGX-119
? Five new molecules in Phase 3 development indicating ongoing investment in internal discovery engine, the Immunology Innovation Program
Reaching 50,000 Patients Globally
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, and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S.
? Generated global net product sales (inclusive of both VYVGART and VYVGART SC) of $478 million in second quarter of 2024
? National Medical Products Administration (NMPA) approved VYVGART SC for treatment of gMG in China through Zai Lab on July 16, 2024
? Additional VYVGART regulatory decisions on approval expected for gMG in 2024, including in Switzerland, Australia, and Saudi Arabia
? Launched VYVGART Hytrulo in CIDP in U.S. with first patients injected in July
? Multiple VYVGART SC regulatory submissions under review or planned for CIDP, including:
o Regulatory submissions completed in China, Japan, and Europe with decisions on approval expected in 2025
o Regulatory submission filing in Canada by end of 2024
? Announced plan to evaluate VYVGART in ocular MG with registrational study (ADAPT OCULUS) to start by end of year; OCULUS to support label-expansion strategy into broader MG populations along with ongoing ADAPT SERON study in seronegative MG
? Regulatory submission filed and under regulatory review for VYVGART SC pre-filled syringe (PFS) for gMG and and CIDP
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)
? Advancing development of efgartigimod in primary Sjogrenโs disease (SjD) with Phase 3 study to begin by end of 2024
? Following alignment meeting with FDA, confirmatory study of VYVGART (IV) 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 in fourth quarter of 2024
? Update on BALLAD study development plan evaluating efgartigimod in bullous pemphigoid (BP) expected by end of 2024
? Proof-of-concept studies ongoing with efgartigimod in membranous nephropathy (MN) and lupus nephritis (LN) with studies expected to initiate this year in antibody mediated rejection (AMR) and systemic sclerosis (SSc)
? Phase 3 study of empasiprubart for MMN to initiate in fourth quarter of 2024
? CIDP nominated as fourth empasiprubart indication, recognizing opportunity to bring multiple innovative treatments to patients
? Phase 1b/2a studies of ARGX-119 to assess early signal detection in patients with CMS and ALS to start by end of 2024
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 argenxโs 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
SECOND QUARTER 2024 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS
Three Months Ended
Six Months Ended
June 30,
June 30,
(in thousands of $ except for shares and EPS)
2024
2023
2024
2023
Product net sales
$
477,635
$
269,313
$
875,918
$
487,335
Collaboration revenue
-
1,237
2,718
2,355
Other operating income
11,793
10,485
23,305
21,225
Total operating income
$
489,428
$
281,035
$
901,941
$
510,915
Cost of sales
$
(52,383)
$
(24,024)
$
(95,561)
$
(42,359)
Research and development expenses
(225,286)
(195,509)
(450,255)
(361,364)
Selling, general and administrative expenses
(255,699)
(161,977)
(491,694)
(311,149)
Loss from investment in joint venture
(1,521)
(1,619)
(3,313)
(1,880)
Total operating expenses
$
(534,889)
$
(383,129)
$
(1,040,823)
(716,752)
Operating loss
$
(45,461)
$
(102,094)
$
(138,882)
$
(205,837)
Financial income
$
38,933
$
20,441
$
77,828
$
37,029
Financial expense
(572)
(207)
(1,084)
(395)
Exchange gains/(losses)
(7,903)
(2,001)
(27,215)
9,164
Loss for the period before taxes
$
(15,003)
$
(83,861)
$
(89,353)
$
(160,039)
Income tax benefit/(expense)
$
44,069
$
(10,507)
$
56,822
$
36,800
Profit/(loss) for the period
$
29,066
$
(94,368)
$
(32,531)
$
(123,239)
Profit/(loss) for the period attributable to:
Owners of the parent
$
29,066
$
(94,368)
$
(32,531)
$
(123,239)
Weighted average number of shares outstanding
59,490,437
55,828,239
59,400,217
55,690,873
Basic profit/(loss) per share (in $)
0.49
(1.69)
(0.55)
(2.21)
Diluted profit/(loss) per share (in $)
0.45
(1.69)
(0.55)
(2.21)
Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2022 and 2023
(77,497)
$
(195,580)
Cash and cash equivalents and current financial assets at the end of the period
3,102,347
$
1,996,968
DETAILS OF THE FINANCIAL RESULTS
Total operating income for the three and six months ended June 30, 2024 was $489 million and $902 million compared to $281 million and $511 million for the same periods in 2023, and mainly consists of:
?Product net sales of VYVGART and VYVGART SC for the three and six months ended June 30, 2024, were $478 million and $876 million compared to $269 million and $487 million for the same periods in 2023.
?Other operating income for the three and six months ended June 30, 2024 was $12 million and $23 million compared to $10 million and $21 million for the same periods in 2023. The other operating income for the three and six months ended June 30, 2024 and 2023, primarily relates to research and development tax incentives.
Total operating expenses for the three and six months ended June 30, 2024 were $535 million and $1,041 million compared to $383 million and $717 million for the same periods in 2023, and mainly consists of:
? Cost of sales for the three and six months ended June 30, 2024 was $52 million and $96 million compared to $24 million and $42 million for the same periods in 2023. The cost of sales was recognized with respect to the sale of VYVGART and VYVGART SC.
? Research and development expenses for the three and six months ended June 30, 2024 were $225 million and $450 million compared to $196 million and $361 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 three and six months ended June 30, 2024 were $256 million and $492 million compared to $162 million and $311 million for the same periods in 2023. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the commercialization of VYVGART and VYVGART SC, and personnel expenses.
Financial income for the three and six months ended June 30, 2024, was $39 million and $78 million compared to $20 million and $37 million for the same periods in 2023. The increase in financial income is mainly due to an increase in interest income coming from an increase of cash, cash equivalents and current financial assets as a result of the July 2023 financing round.
Exchange losses for the three and six months ended June 30, 2024, were $8 million and $27 million compared to $2 million exchange losses and $9 million of exchange gains 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 denominated in Euro.
Income tax for the three and six months ended June 30, 2024, was $44 million and $57 million of income tax benefit, respectively, compared to $11 million of income tax expense and $37 million of income tax benefit for the same periods in 2023.
Net Result for the three and six months ended June 30, 2024, was $29 million profit and $33 million loss compared to $94 million and $123 million loss for the same periods in 2023. On a per weighted average share basis, the basic profit was $0.49 and diluted profit was $0.45 for the three months ended June 30, 2024, compared to a basic and diluted loss of $1.69 for the same period in 2023. On a per weighted average share basis, the basic and diluted loss was $0.55 for the six months ended June 30, 2024, compared to a basic and diluted loss of $2.21 for the same period in 2023.
Cash, cash equivalents and current financial assets totalled $3.1 billion as of June 30, 2024, compared to $3.2 billion as of December 31, 2023. The decrease in cash and cash equivalents and current financial assets result from a net cash flows used in operating activities.
FINANCIAL GUIDANCE
Based on its current operating plans, argenx expects its combined research and development and selling, general and administrative expenses in 2024 to be less than $2 billion. argenx updated its cash burn guidance and now expects to utilize less than $500 million of net cash* iin 2024 on anticipated operating expenses as well as working capital and capital expenditures.
EXPECTED 2024 FINANCIAL CALENDAR
? October 31, 2024: 3Q 2024 financial results and business update
? February 27, 2025: Full-year 2024 financial results and 4Q 2024 business update
CONFERENCE CALL DETAILS
The half-year 2024 financial results and second 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 and replay may be accessed on the Investors section of the argenx website at argenx.com/investors.
Dial-in numbers:
Please dial in 15 minutes prior to the live call.
Belgium32 800 50 201
France33 800 943355
Netherlands31 20 795 1090
United Kingdom44 800 358 0970
United States1 800 715 9871
Japan81 3 4578 9081
Switzerland41 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, globally 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, X/Twitter, Instagram, Facebook, and YouTube.
For further information, please contact: