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*This morning, UCB announced that the CHMP issued a positive opinion for Bimzelx for the treatment of hidradenitis suppurativa (HS). The European Commission (EC) will decide on approval within 60 days.*We model HS as the 2nd biggest indication for Bimzelx, with close to EUR 1bn in peak sales, after plaque psoriasis, with the EU making up about 25% of peak sales. We consider Bimzelx well positioned for the HS market due to its superiority vs. Novartis' Cosentyx based on Ph3 datasets. Moonlake's sonelokimab, on the other hand, is only in Ph2 allowing Bimzelx to grab significant market share before Sone
UCB UCB S.A.
*In light of the FY23 result, most notably revealing strong Bimzelx and Evenity contributions, we have updated several of our model inputs. In line with guidance, we now expect EUR 5.6bn (in line with BB CSS) and EUR 6.2bn (-2.5% vs. BB CSS) in revenue for '24 and '25, respectively. On top, we included estimates related to 1/ hidradenitis suppurativa (HS) indication for Bimzelx (1st approvals expected this year) resulting in Bimzelx peak sales > EUR 4bn and 2/ most advanced (P3) pipeline programs with '24 readouts.*As a result, we see room to bump our TP to EUR 132.4 (+30%,
Strong end to the year and bullish messaging; raising PT to EUR125 We expect UCB''s confident messaging over Bimzelx uptake and achievement of near-term consensus forecasts to drive growing investor confidence as the company enters what we expect to be a sustained period of strong growth. We continue to believe UCB offers unique exposure to innovation driven growth in EU mid cap Biopharma and expect execution on new launches and a strong flow of pipeline catalysts through 2024 to continue to drive the shares through the year. On track for return-to-strong growth; 23-27E sales/Core EPS CAGR = 9%/22% We have raised our peak Bimzelx sales (EUR3.0bn vs EUR2.4bn) given solid uptake post the US launch, confident management messaging and expected impact of expanded approvals later this year. Although we trim our near-term margin forecasts given investment behind new launches, we are consistent with mid-term targets which imply a marked acceleration in EBITDA growth in ''25 (BNPPE 40% yoy) and expect sustained strong dd earnings growth (23-27 EPS CAGR 22%). Key catalysts; launch momentum and pipeline delivery Key catalysts in 2024: (1) Rx data for new launches (Bimzelx/Rystiggo); (2) Bimzelx expanded approvals and likely acceleration in sales; (3) P2/pivotal data for Rystiggo in new indications (MOG, AIE, FMS); (4) P2/3 data on higher risk but largely unmodelled pipeline drugs (AD, PD, SLE); (5) P2 data on pipeline drugs including two AD antibodies (one an IL-13/IL17AF bispecific). Increasing PT on raised Bimzelx and LT growth assumptions Our raised PT of EUR125 (from EUR100) reflects raised Bimzelx forecasts and increased confidence in long-term growth given patent settlements on Fintepla that will secure exclusivity until late 2033. We expect execution on UCB''s five ongoing launches to drive the shares; with 25% upside based on an assumed c.18x 2025 core PE we reiterate our Outperform rating.
*UCB reported FY23 results this morning: revenue in line with guidance, beat vs. DPe and BB CSS. Adj EBITDA margin higher than guidance and beat vs. DPe and BB CSS. Bimzelx® net sales revenues beat DPe and BB CSS. Cimzia® stable.*2024 guidance implies revenue growth but lower EBITDA margin vs. 2023 mostly due to direct-to-consumer (DTC) marketing campaign in the US for BIMZELX®. 2025 guidance reiterated.*Based on these results and reiterated guidance, we will revise our estimates upwards. Buy rating reiterated. We consider UCB to be well positioned for a period of growth in the years to come.
We believe UCB''s shares have written off a US Bimzelx launch We believe UCB''s shares are reflecting a very bearish scenario for the US launch with our NPV underpinning the shares at ~EUR83 excluding Bimzelx and the remaining pipeline. Even with modest assumptions (i.e. EUR500m in US sales), we see a compelling growth potential with a mid-to-high single digit revenue and strong teens EPS growth given currently depressed margins. We view the shares on 18x 2024E PE as undervaluing this return to strong growth with 30% upside likely if our less bearish scenario materialises (''23-27 EPS CAGR of 25%). UCB likely to prioritise launch investments in 2024 but still on track for 2025 targets We expect UCB to return to growth in 2024 driven by easing drags from Vimpat generics and growth of its five new launches, combined with easing pipeline investment pressures. However, we expect UCB to prioritise investments behind new launches, including an expected Bimzelx DTC campaign that will likely restrain margin expansion. We reduce our 2024 EPS forecasts which are now 10% below consensus but expect UCB to reiterate its 2025 targets implying a dramatic acceleration in growth underpinning significant share price upside (''23-27 EPS CAGR of 25%). We see a large opportunity for Bimzelx even using conservative assumptions Unexpected label disadvantages for Bimzelx (suicidal ideation; liver monitoring) will provide armour for counter detailing and require careful education to overcome. However, we believe this is unlikely to materially damage near-term use of the drug which is likely to come from the large pool of patients that have failed or lost response to other therapies in growing markets worth $35bn. Even in bearish scenarios, we believe UCB can garner a 3-5% market share based on this potential, underpinning global sales of $1.5-2.0bn by 2030 based on market growth expectations. Shares implying very bearish assumptions for the Bimzelx launch Our NPV...
*The CHMP has issued a positive opinion for rozanolixizumab. If approved in Q1 2024, the drug will be the first anti-FcRn approved in Europe for both anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive gMG, the two most common subtypes of gMG.*In addition, UCB released the results from a post-hoc analysis indication meaningful efficacy of CIMZIA® in rheumatoid arthritis (RA) patients with high rheumatoid factor (RF) levels.*No impact on estimates and investment case. Buy rating reiterating considering the upside to Friday's closing price (>50%). We consider the market reaction to BIMZELX® 's approval overdone: ramp-up will take time as
*Following previous approvals in the EU and Japan, the FDA finally gave BIMZELX® green light for the treatment of moderate-severe plaque psoriasis in the US. The drug will be available from next month onwards.*UCB guides for BIMZELX® global peak sales of EUR 4bn while we currently project BIMZELX® peak sales of close to EUR 3bn with 50% stemming from psoriasis (of which 60% US sales), while still excluding hidradenitis suppurativa. Hence our estimate might still be somewhat conservative. We consider BIMZELX® as a best-in-class anti-IL17 efficacy-wise but highlight the suicidal ideation among other factors in the drug label which could
*Last night, UCB announced approval of zilucoplan (ZILBRYSQ®) for the treatment of generalysed myasthenia gravis (gMG) in the US. ZILBRYSQ ® is the 1st approved self-administered innovative gMG solution in the US, allowing for administration at home thereby offering additional patient comfort and differentiating it from the competition, including ARGX's VYVGART® (Hytrulo).*Approval of zilucoplan adds a 2nd option to UCB's gMG treatment arsenal in the US, following the June US approval of rozanolixizumab. We foresee these drugs to coexist (rather than cannabilize) since ZILBRYSQ® is intended to be used as a long-term maintenance treatment while RYSTIGGO® is positioned as an
Last night, UCB announced approval of both RYSTIGGO® and zilucoplan ‘ZILBRYSQ®' for the treatment of generalysed myasthenia gravis (gMG) in Japan. ZILBRYSQ® is the 1st approved self-administered innovative gMG solution, allowing for administration at home thereby offering additional patient comfort and differentiating it from the competition, including ARGX's VYVGART® (Hytrulo).This 1st approval for zilucoplan adds a 2nd option to UCB's gMG treatment arsenal, following the June US approval of rozanolixizumab. We foresee these drugs to coexist (rather than cannabilize) since ZILBRYSQ® is intended to be used as a long-term maintenance treatment while RYSTIGGO® is positioned as an add-on treatment during
Last night, UCB provided a regulatory update on bimekizumab's BLA, most notably announcing they do not longer anticipate FDA action in Q3. No new guidance provided.Although unfortunate, not entirely unexpected considering that the FDA never confirmed this timing. On a positive note, the manufacturing facility inspection has been successfully finished, indicating that the main reason for 2022's CRL has been solved now.We do maintain our believe in ultimate approval of bime in the US but remain in the dark about precise timing thereof. We stick to our Buy rating on the name but expect a negative market reaction today. Next
With LOE pressures in the rear view UCB is one step away from a return to strong growth We remain confident that an FDA approval of Bimzelx in the coming weeks will act as a significant driver for the shares. Notably, UCB confirmed on its call that it has yet to receive any FDA action, suggesting FDA capacity constraints are the most likely explanation for the missed PDUFA date. We expect this approval to drive confidence in the company''s return to very strong growth as it delivers on its 2025 targets. Updating model for 1H; return to sales growth expected in 2H23 We update our model for 1H results, with aggressive erosion of Vimpat offset by solid performance of the new launches and continued delivery on Cimzia growth despite overall TNF market pressures. Going forward, we now expect LOE pressures to stabilise, with a return to sales growth expected from 2H23. Although we modestly decrease our 2024 margin assumptions to reflect commentary on margin phasing, our 2025 sales/EBITDA margins are little changed and imply a 2023-25 sales/EBITDA CAGR of 11%/30%. Bimzelx ex US sales and metrics reassure; FDA approval due in 3Q23 Disclosed uptake metrics for Bimzelx in ex US markets ( 35% dynamic share of IL-17 class) continue to reassure over the drug''s commercial potential and we note that Evenity continues to perform well globally with slowly improving momentum in European markets. Importantly, Rystiggo''s recent approval with a differentiated label further increases our confidence in UCB''s ability to grow its FcRN franchise by generating clinical data in niche differentiated patient populations, leveraging its global footprint and providing differentiated patient support. Reiterate Outperform with EUR105 price target; Bimzelx approval key driver Our price target implies that UCB should trade at ~21x 2024 Core PE given our expectations for extremely strong near-term EPS growth (34% 2023-26E EPS CAGR vs 9% for peers) with upside to ~EUR120 and 15%...
The H1 23 results were much better than the street’s expectations, as the strong performance from the key drugs managed to partly offset the sales erosion for some of the older drugs. The management nonetheless maintained the 2023 outlook. While the firm is undergoing a transition period amid patent expiries, our positive stance on UCB is supported by the promising growth prospects for newer on-market as well as upcoming drugs. All eyes will henceforth be on Bimzelx’s US approval which is expected in Q3 23.
The delay in the FDA's decision on Bime's approval could revive investor concerns and mitigate the very good news of Roza's approval.We remain positive on bime's approval prospects, but this new delay has an impact on our revenue scenarios for the product in the short to medium term. Adjusted TP at EUR 93.1 and Buy maintained.
UCB receives European marketing approval for Bimzelx in the treatment of PsA and axSpA. This is good news, extending the product's market potential while awaiting potential approval in the USA by the end of Q2'23. Buy recommendation reiterated, TP at EUR 94.0.
The CHMP issued a positive opinion recommending the approval of bimekizumab for the treatment of PsA and axSpA in EU. Marketing approvals expected within 2 months.TP and Buy rating maintained, while waiting for the FDA's decision regarding the marketing approval applications for bimekizumab in psoriasis and Roza in gMG in the US, in the coming week.
Three major new drug approvals in 2023 will position UCB for a period of strong growth We expect 2023 guidance to represent a clearing event as it sets a defined base to UCB''s return to strong revenue growth and rapidly improving margins driven by its clutch of recently launched and soon-to-be approved drugs. We view the shares'' 22x trough PE as undervaluing this growth (''23-26 EPS CAGR of 34%) and see 50% upside to the shares in Bull cases. On the verge of a return to strong growth; 2023-26E revenue/EPS CAGR 8%/34% We have updated our forecasts post UCB''s FY22 results, with moderate reductions to our near-term Core EPS forecasts given higher expected tax rate and financing costs. However, these effects wash out longer term. More importantly, reiterated 2025 targets imply a minimum 7%/22% revenue/EBITDA CAGR over 2023-25E. Combined with financial de-leveraging, we forecast a 2022-26 revenue/Core EPS CAGR of 8%/34%. Bimzelx and FcRN approvals should build confidence in 2Q23 We expect disclosed uptake metrics for Bimzelx in ex US markets and UCB''s willingness to give its blessing to 2023E Bimzelx consensus sales of ~EUR200m to help reassure investors. In addition, we believe UCB''s ability to grow its FcRN franchise by generating clinical data in niche differentiated patient populations, leveraging its global footprint and providing differentiated patient support is underappreciated. Approval with a unique MUSK+ gMG label in 2Q23 would help address this. Shares undervaluing return to strong growth We believe UCB''s sustainable post 2022 growth prospects are not reflected in the shares'' ~22x trough PE. We expect our price target of EUR105 to be achieved as Bimzelx, rozanolixizumab and zilucoplan approvals are achieved, bullish peak sales expectations for its new portfolio are provided and clinical data for Bimzelx is HS presented (AAD March 17-21). We see upside to EUR125 based on a more rapid launch of Bimzelx launch and better sales of the...
Despite facing patent expiries for key drugs, UCB’s full-year results exceeded expectations, including its own guidance, driven by patent-protected key immunology and neurology drugs. However, the 2023 guidance was muted, in terms of sales and profitability, as sales erosion due to generic competition is likely to continue. Nevertheless, we remain positive on UCB, supported by the healthy growth prospects of its current and upcoming drugs, with the potential US approval of Bimzelx and two gMG drug candidates being key catalysts for 2023.
FY 2022 figures are better than expected, showing a strong business resilience facing generic competition.Many product launches expected in 2023 should mark the end of the portfolio transition period and fuel the stock's momentum.Profitability in 2023 should still be impacted by multiple factors (inflation, tax rate, pre-launch expenses...), but we see a very positive outlook beyond.We will adjust our model following this publication and after the analyst conference this afternoon.
We expect improving confidence in UCB''s return to strong growth to drive the shares UCB is on the verge of a sustained period of strong revenue growth and margin expansion as it emerges from its trough driven by its clutch of recently launched and soon-to-be approved drugs. Although investor fears over 2023 guidance have dominated recent commentary, we expect confidence to be rebuilt as Bimzelx is approved in the US and its 2025 targets are reiterated. We view the shares on 19x trough PE as undervaluing this return to strong growth (''22-26 EPS CAGR of 22%) and see 20% upside to consensus 2026 EPS in Bull cases. 2023 another year of investment but reiterated 2025 targets expected We have rebased our margin assumptions (now broadly stable in 2023) to reflect inflationary pressures on Belgian wages and UCB''s desire to invest aggressively behind its new launches and pipeline. Despite this, we expect 2025 targets to be reiterated with these implying a minimum 4% revenue/16% EBITDA CAGR over 2022-25E. In addition, we expect UCB to give bullish guidance on Fintepla in early 2023 and for Bimzelx in late 2023 or early 2024, with company commentary suggesting it continues to believe consensus for Bimzelx can be exceeded (~EUR3bn). We are optimistic on a rapid Bimzelx approval and upside to expectations Based on expert consultation over 483 observations we are optimistic that Bimzelx can be reviewed by the FDA more rapidly than expected leading to an earlier than expected launch. In addition, strong performance of ex US launches and likely positive upcoming Phase 3 data in hidradenitis suppurativa should help increase confidence in both the Bimzelx launch trajectory and peak sales potential. Shares undervaluing return to strong growth We believe UCB''s sustainable post 2022 growth prospects are not reflected in the shares'' ~19x trough PE. We expect our price target of EUR110 to be achieved as reiterated 2025 targets reassure on its growth path, Bimzelx...
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