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What happened? Bimzelx trends remain robust (HS 20% of Rx with the value of a HS almost double that of a psoriasis patient), and point to EUR2bn sales in FY25, versus consensus EUR1.8bn, with risks to the upside in our view. Bimzelx 2036e peak sales EUR7bn versus consensus at EUR8bn (BBG Cons 2035e). We believe reference pricing pressure from Cosentyx biosimilars from 2029 needs to be considered, as well as the opportunity from further label expansion (e.g. paediatric indications and palmoplantar pustulosis, which itself represents a potentially addressable population 500k). We also flag encouraging EU IQVIA data, and continue to highlight the potential of galvokimig, based on recent feedback. See Thesis galvo-nised, KOL galvo call, and postcard from EADV. Consensus peak just EUR0.3bn; we are at EUR5bn risk adjusted. BNPP Exane View: Our PT is EUR235 with a bull-bear valuation range of EUR373-130. Our base case assumes revenues growth from EUR7bn in 2025e to EUR17bn in 2036e before returning to EUR11bn in 2040e. We assume cumulative RandD/capex through 2040 of EUR36/9bn. We also assume UCB goes net cash in the next 12-18 months and that the growing cash pile earns a meagre rate of return of just 2%. Accordingly, we argue out base case valuation is built on conservative assumptions, and we would urge investors to consider our bull case valuation of EUR373 to better asses the risk-reward at current levels. Bimzelx''s stellar upward trajectory continues with weekly TRX 6k and YoY TRx/NRx growth of 355/294% respectively. Bimzelx holds an 8/9% TRx/NRx market share in psoriasis. We forecast peak Bimzelx sales of EUR7bn with psoriasis/HS making up 35/43%. IQVIA data summarised below. Separately we note Evenity dynamics worth flagging given the drug contributes 30% to UCB group profits, is growing 30%, but where consensus seems to ignore the growing EBITDA contribution. Bimzelx Dynamics to consider . Although NVS''s Cosentyx and ABBV''s Humira already have approval for HS, the...
UCB UCB S.A.
What happened? UCB remains one of our Top Picks. We recently provided a detailed update (see Thesis galvo-nised; bull-bear EUR373-130), arguing the threat from Moonlake was overplayed and the potential of ''pipeline-in-an-asset'' galvokimig in atopic dermatitis underappreciated (risk-adjusted peak sales $5bn versus consensus $0.5bn). We note incoming from long-only investors has materially increased. UCB offers significant growth and margin expansion potential, a strong innovation story, financial strength (net cash 2026/27e), and an undemanding valuation in our view. We provide feedback below from a KOL call UCB hosted following presentation of Ph IIa galvokimig data at EADV. For other recent feedback see Galvokimig EADV nuggets and Get ready to go galactic on galvo. BNPP Exane View: As a quick reminder, Ph IIa galvokimig data was presented at EADV (slides available upon request). Galvo is a bispecific antibody targeting IL-17xIL-13 bispecific. Combinatorial biologics are likely the way to raising the future efficacy bar in autoimmune diseases, with galvo essentially combining the target action of Dupixent (anti-IL13/4) and Bimzelx (anti-IL17 A/F). Despite taking the last slot on a Friday evening, the EADV room was nearly full. Incremental data on itch and the safety profile were presented on top of the previously shared 65% EASI75 response (53% PBO-adjusted) and 47% EASI90 response (43% PBO-adjusted). There was an audible response to the disclosure that 73% patients achieved NRS itch score reduction ≥4 at Week 12, versus 27% for placebo, indicating galvokimig not only has potential for best-in-class skin clearance but also on itch reduction, which is cited consistently as the key unmet need in AD. UCB hosted Professor Silverberg from Washington to discuss the galvo data, and the competitive landscape in atopic dermatitis. He described the data as ''impressive and provocative'', demonstrating ''premier efficacy'' with a ''clean'' side effect profile....
Last night, Moonlake Tx reported the week 16 results, most notably HiSC75, from its VELA Ph3 study with sonelokimab for hidradenitis suppurativa (HS, Bimzelx 2nd largest indication).VELA-1/2 combined placebo-corrected HiSCR75 amounted to 13.8% thereby being clearly inferior to Bimzelx (17.5%, BE HEARD I/II). Moonlake previously stated ≥20% was necessary to be considered the gold standard with 18.5% "a meaningful improvement over other options”.We already took an above CSS bullish stance on the commercial opportunity of Bimzelx for HS with peak sales amounting to EUR 3bn at peak assuming a competitive/comparable efficacy profile of sonelokimab. However, given this underwhelming result, we
What happened? The much-awaited Moonlake Ph III 16-week data for sonelokimab in HS (IL17A/F nanobody; hidradenitis suppurativa) has materially underwhelmed, consistent with our expectations (see Thesis galvo-nised; bull-bear EUR373-130). Moonlake was perceived by some to be a significant threat to UCB''s key growth driver Bimzelx (see IQVIA data in US/EU worth flagging). We anticipate a wave of investors to step into the stock, based on incoming over the past few weeks, and in light of the $10bn peak sales potential for galvokimig. Both UCB and Moonlake are holding analyst calls today to discuss Ph II galvokimig and Ph III sonelokimab data. Finally, we note Merck KGaA has a 4% equity stake in Moonlake but has passed on the potential 10-15% royalty stream, which is now set to be materially delayed, and de minimis in our view. BNPP Exane View: . Why did we think Moonlake data was a red herring? - We have consistently argued the perceived competitive threat from Moonlake''s solenokimab to Bimzelx as overdone, arguing there was little biologic rationale that a nanobody construct targeting IL-17 A/F would result in materially higher efficacy than Bimzelx, a bispecific antibody targeting IL-17 A/F. Furthermore, Bimzelx has just posted highly encouraging 3-year data in HS, is approved across five indications (Ps/HS/PsA/AS/nr-axSpA) and across every major region (US/EU/Japan/China). Lastly biologic penetration in HS remains modest with recent data suggesting the prevalence could be as high as 1% of the population. . HS market sizing likely to increase - UCB recently estimated peak biologics penetration at least 50% by the end of the decade (equating to 200k patients in the US, EU5 and JP alone) as well as highlighting efforts to improve time to diagnosis which stands 7 years in the Europe and the US. There are an estimated 80k HS patients currently treated with Bimzelx with US dynamic patient share in April 2025 reaching 26% and Rx trends showing no signs...
What happened? Bimzelx trends remain robust (HS 20% of Rx with the value of a HS almost double that of a psoriasis patient), and point to EUR2bn sales in FY25, versus consensus EUR1.8bn, with risks to the upside in our view. Bimzelx 2036e peak sales EUR7bn versus consensus at EUR8bn (BBG Cons 2034e). We believe reference pricing pressure from Cosentyx biosimilars from 2029 needs to be considered, as well as the opportunity from further label expansion (e.g. paediatric indications and palmoplantar pustulosis, which itself represents a potentially addressable population 500k). We also flag encouraging EU IQVIA data, and continue to highlight the potential of galvokimig, based on recent KOL and EADV feedback. Thoughts on Moonlake ''risks'' and tariffs can be found here; Thesis galvo-nised.and Trump Tweets again. BNPP Exane View: Bimzelx''s stellar upward trajectory continues with weekly TRX 6k and YoY TRx/NRx growth of 327/331% respectively. Bimzelx holds an 8%/9% TRx/NRx market share in psoriasis. We forecast peak Bimzelx sales of EUR7bn with psoriasis/HS making up 35/43%. IQVIA data summarised below. Separately we note Evenity dynamics worth flagging given the drug contributes 30% to UCB group profits, is growing 30%, but where consensus seems to ignore the growing EBITDA contribution. Bimzelx Dynamics to consider . Although NVS''s Cosentyx and ABBV''s Humira already have approval for HS, the patient population remains underdiagnosed leaving plenty of room for the market to expand and accommodate multiple sponsors. We estimate a ~$10bn total HS market opportunity. . We do not see recent Incyte/Sanofi data and expected Moonlake data in Sep/Oct being able to surpass Bimzelx, which itself recently presented stellar 3-year data at EADV. KOL feedback points to solonekimab needing to demonstrate a 30%+ placebo adjusted benefit on the primary endpoint to be considered potentially differentiated. . Given the Q2W dosing recommended in HS (vs Q4W in PsO/PsA/axSpA/AS),...
A detailed update of our model supports a revised EUR235 PT and attractive EUR373-130 bull-bear valuation range (WACC 8.5%, g=2%). While UCB has become more consensual we continue to have points of differentiation. We anticipate material patent term extensions to be granted for key growth drivers, continue to argue Evenity and royalty contributions are significantly underappreciated, and carry materially higher pipeline forecasts. Galvokimig has the potential to be a $10bn mega-blockbuster based on efficacy/safety data seen to date and KOL/EADV feedback. EPS upgrades up to 50%; BNPP Exane EPS up to 54% ahead of consensus We now model a faster ramp, higher peak, and extended patent protection for Bimzelx until 2037. We continue to argue Evenity is materially underappreciated (EUR0.6-1.2bn annual profit share up to 60% ahead of consensus) and carry EUR4.5/1.5bn risk-adjusted peak sales forecasts for galvokimig/donzakimig in atopic dermatitis. Galvokimig essentially a ''pipeline in an asset'' and will likely be explored beyond AD. Our forecasts reflect EUR100m+ of tariff costs from 2027 and cumulative RandD/capex spend of EUR36/9bn through 2040. We forecast net cash from 2026; FCF yield 3-17%. Bimzelx momentum strong; we remain sanguine ahead of Moonlake data We publish highly encouraging EU/US IQVIA Rx trends. As expected, recent Ph II competitor datasets from Incyte/Sanofi in HS failed to match Bimzelx, which itself recently posted stellar 3YR data. We expect Moonlake Ph III 16-week data imminently; KOL feedback suggests a HiSCR75 placebo adjusted response rate 30% needed to be considered potentially differentiated. Regardless, low biologic penetration and label breadth leave us comfortable with Bimzelx''s position. 2026/27 PE 25/17x for a 2025-30e revenue/EPS CAGR of 12/27% UCB''s valuation and growth stacks up well versus EU Pharma on 13x offering a 2025-30e revenue/EPS CAGR of just 6/9%. Our PT implies a deserved 91% 2026e PE premium.
What happened? UCB unveiled additional Ph II data from its IL17A/F x IL13 bispecific galvokimig at EADV on Friday. Despite taking the last slot on Friday evening, the room was nearly full in anticipation of the data. While no new information was disclosed around dosing (UCB reportedly in the process of securing a patent), incremental data on itch and the safety profile were presented on top of the previously shared 65% EASI75 response (53% PBO-adjusted) and 47% EASI90 response (43% PBO-adjusted). There was an audible response to the disclosure that 73% patients achieved NRS itch score reduction ≥4 at Week 12 indicating galvokimig not only has potential for best-in-class skin clearance but also strong effect on itch, cited consistently as the number one unmet need in the AD space. For more feedback on our takeaways from EADV see EADV + Sanofi CSO roundtable feedback. BNPP Exane View: Galvokimig Phase 2 data positions it as potential best-in-class treatment in AD with oral JAK-like efficacy (Figure 1 and Figure 2) and impressive response on itch with 73% patients achieving NRS itch score reduction ≥4 at Week 12. For context, 33/36% patients treated with Nemluvio in the Ph3 ARCADIA trials achieved ≥4 reduction in PP-NRS at Week 16, which is currently considered best-in-class for itch. We also flag data shared at 12 weeks vs the typical 16 weeks for other AD assets indicating a faster onset of action versus market incumbents. There were 2 discontinuations in the galvokimig treated patients, one due to haemorrhagic diarrhoea and the other due to moderate pyrexia. Diarrhoea was reported in two other galvokimig-treated patients which were short-lived. Speaker keen to highlight that there was some prior biologic use amongst the galvo-treated patients and that overall the placebo arm patients had more severe disease highlighting the strength of the data from the active arm. Across sessions that we attended at EADV, there was compelling evidence for the...
Placebo-corrected EASI75 (primary endpoint) of 52.6%, vs. 50% for leading atopic dermatitis (AD) biologic dupilumab (NCT01548404), hence convincing and warranting further development in our view.Ph2b start, as previously announced, still expected by end of the year.TP and Buy rating reiterated. Ph2a data of donzakimig, UCB's other AD biologic in development, still expected by YE.
What happened? We hosted Dr Charles Gropper, Chief of Dermatology at St Barnabas Hospital and Clinical Associate Professor of Dermatology at Icahn School of Medicine, Mount Sinai. Topics discussed included the current unmet need in atopic dermatitis (AD) and drivers for increased biologics penetration. Notable feedback on UCB''s galvokimig/donzakimig as well as upcoming Moonlake data in HS, Sanofi''s amlitelimab, and Galderma''s Nemluvio. Key takeaways summarised below, our detailed notes are available upon request. BNPP Exane View: Current treatment paradigm - Dr. Gropper argues all patients with moderate to severe AD should be treated with one of the three approved biologics (Dupixent, Nemluvio, or Ebglyss) as 1L treatment, versus estimated treatment rates of 15-20% across the community. This discrepancy highlights a substantial opportunity for biologics penetration to increase meaningfully, and the space for more entrants to help grow the market. The most common barriers to broader biologic use remain commercial coverage and access, resistance to adopting innovative medicines, and some patient hesitancy around injections. Key unmet need in mod-to-severe AD - Dr Gropper described ''the holy grail'' for a next generation therapy being ''oral JAKi like'' efficacy (EASI75 in 60-70% range) with a ''Dupixent-like'' side effect profile, fast onset of action, and preferably longer dosing intervals. UCB''s galvokimig/donzakimig turning heads - We note particularly bullish commentary on galvokimig in AD with Dr Gropper viewing the IL17/IL13 bispecific approach as ''very promising'' with potential to move towards, if not meet, ''the holy grail'' with its promise of faster onset of action, safety profile and efficacy approaching oral JAKi range. We note comments that evolving studies of disease pathophysiology indicates a high overlap between Psoriasis and AD diagnosed patients indicating the potential utility for an IL-17 mediated approach. We keenly await further...
UCB UCB SAN SAN GALD
We have updated several of our model inputs following the company's latest earnings and updated guidance. Most notably, we revised estimates for Bimzelx, including commercial ramp-up & peak penetration, and net pricing based on expected evolution of gross-to-net and pay-to-bridge ratio. As a result thereof, our Bimzelx sales revenue estimate now amounts to EUR 7.3bn by 2030 (+15% vs. VA CSS), excluding contributions from potential follow-on indications. We are especially bullish on hidradenitis suppurativa (EUR 3bn at peak) and consider this opportunity to be underappreciated by the market. With sonelokimab's Ph3 ‘VELA' readout expected in Sept, competition within the anti-IL17
This morning, UCB provided its H1 update, most notably announcing EUR 3.5bn in revenue (vs. EUR 3.22bn VA CSS), EUR 1.03bn in adj. EBITDA (vs. EUR 957m VA CSS), and EUR 3.53 in Core EPS (vs. EUR 3.51 VA CSS). Financial guidance for 2025 updated: revenue expected to grow to at least EUR 7bn, adj. EBITDA to reach at least 30% of revenue, Core EPS of at least EUR 7.25/share.Solid set of result taking into account the almost 10% beat on VA CSS revenue driven by strong performance of UCB's growth drivers (with most notably Bimzelx beating VA CSS estimate
What happened? H1 9% ahead on revenues/adjusted EBITDA with core EPS slight ahead of consensus. Bimzelx EUR0.8bn (30% ahead of consensus with HS 20% of sales and psoriasis 60%) with notable beats from Cimzia and Zilbrysq. FY25 guidance revisions imply 4-5% consensus upgrades and we anticipate Bimzelx expectations to near EUR2bn, once increased HS rebating impacts in H2 taken into account. Peak sales guidance for Bimzelx (currently EUR4bn versus BNPP/cons EUR7/6bn) will only be updated once sales exceed EUR4bn (possibly as early as 2026/7; we note consensus expectations for 2027 just EUR3bn). Positive KOL feedback below on Ph IIa galvokimig atopic dermatitis data (details here) worth flagging. We continue to be sanguine ahead of 16-week Ph III sonelokimab HS data, supported by KOL feedback BNPP Exane View: UCB has a long-standing track record of providing guidance for the year and ending up at the top of the range, and in many cases ahead. 2025 continues the theme. Bimzelx EUR799m (100% CER growth) with US sales of EUR545m implying price of EUR5.5k/Rx, a net increase in price per Rx vs last quarter. The company expects more rebating in the second half as HS access expands but taking this price decline into consideration in 2H and extrapolating current script trends we see EUR2.0bn for FY25 achievable Key financials . 1H revenues (26% CER), Adjusted EBITDA (61% CER) and Core EPS (+73% CER) were +9/9/1% versus consensus respectively. . Bimzelx 30% ahead of consensus posting EUR545m in the US and EUR254m ROW. US sales imply price of EUR5.5k/Rx implying net increase in price per Rx vs last quarter. The company expects more rebating in the second half as HS access expands but taking this price decline into consideration in 2H and extrapolating current script trends we see EUR2.0bn for FY25 achievable. . Rystiggo/Zilbrysq grew 90/100% at CER respectively with Rystiggo in-line and Zilbrysq beating cons by 23%. . On the PandL, greater than expected OpEx offset by higher...
What happened? EU clinical trials register has posted impressive atopic dermatitis efficacy data for key Ph II pipeline asset galvokimig (IL17xIL13 bispecific), which will likely be presented at EADV on Friday Sep 19th. Ph IIa data in 57 moderate-severe atopic dermatitis patients (randomised 2:1 drug:placebo) demonstrated EASI50/75/90 efficacy data at Week 12 of 80/65/47%, versus 14/12/4% for placebo. Cross trial comparisons to Ph II data sets from marketed atopic dermatitis products highly encouraging (e.g. Dupixent, Ebglyss, Nemluvio) BNPP Exane View: Versus currently available AD therapies Dupixent (SASY) and Nemluvio (GALD) the 53% / 66% placebo-adjusted response on EASI-75/-50 looks competitive and supportive for galvokimig being able to raise the efficacy bar versus market incumbents (see Figure 1 below). We do note that the data available is from one Dose arm of the galvokimig trial (n=33 vs the total n=107 enrolled). We will see full data presentation at EADV in September. We see galvokimig (IL13 x IL17 bispecific) as having broad utility beyond AD yet only carry EUR1.9bn risk-adjusted pipeline forecasts (non risk-adjusted forecasts of EUR6bn). Our pipeline forecasts for UCB''s immunology pipeline (galvokimig, donzakimig (IL13 x IL22) and dapirolizumab pegol (anti-CD40L antibody in lupus) remain conservative with risk-adjusted 2035/40e sales of EUR2/4bn versus a potential EUR10bn opportunity. Investment thesis: We argue our base case forecasts leave risks to the upside, as evidenced by 2040e revenues returning to EUR7bn, despite forecast cumulative RandD spend of EUR30bn. While Bimzelx is well appreciated by the market, we anticipate excitement around dapirolizumab, galvokimig and donzakimig increasing over the coming months. We carry combined 2035/40 peak sales of EUR2/4bn though note multi-billion-dollar potential for each. We remain sanguine in light of competitor HS (hidradenitis suppurativa) datasets as we anticipate no asset will be able to surpass...
What happened? Strengthening Bimzelx trends (HS 20% of Rx with the value of a HS almost double that of a psoriasis patient) point to EUR1.7bn sales in FY25, versus consensus EUR1.4bn, with rising risks to the upside. We expect group revenue guidance to be raised at H1, though note cost phasing needs to be better modelled; H1 margin likely lower than H2 with FY25 EBITDA margin guidance 30% set to be reiterated. Bimzelx 2036e peak sales EUR7bn versus cons. at EUR6bn. Food for thought; after nearly 90 weeks, Bimzelx is strongly outpacing the launch ramp of Skyrizi, which itself delivered EUR4.5bn in global sales 4 years after launch. Bimzelx consensus for Year 4 (2027) sales currently just EUR3bn. BNPP Exane View: Bimzelx TRx reached all-time highs this week at 5,780 TRx with YoY TRx/NRx growth of 274/257% respectively. We are hosting Novartis management in London today, who conceded the impact from Bimzelx on Cosentyx is being felt, particularly in HS. Bimzelx holds a 7%/8% TRx/NRx market share in psoriasis. We forecast peak Bimzelx sales of EUR7bn with psoriasis/HS making up 35/50%. We forecast up to 9% Bimzelx penetration of the treated mod-to-severe psoriasis market and up to 40% of the treated mod-to-severe HS market. IQVIA data summarised below. Separately we note Evenity dynamics worth flagging given the drug contributes 30% to UCB group profits, is growing 30%, but where consensus seems to ignore the growing EBITDA contribution. Bimzelx Dynamics to consider . Although NVS''s Cosentyx and ABBV''s Humira already have approval for HS, the patient population remains underdiagnosed leaving plenty of room for the market to expand and accommodate multiple sponsors. We estimate a ~$10bn total HS market opportunity. . We do not see recent Incyte/Sanofi data and expected Moonlake data in September being able to surpass Bimzelx, which itself recently presented stellar 2-year data. . Given the Q2W dosing recommended in HS (vs Q4W in PsO/PsA/axSpA/AS), HS is set to...
What happened? Strengthening Bimzelx trends (HS 20% of Rx with the value of a HS almost double that of a psoriasis patient) point to EUR1.7bn sales in FY25, versus consensus EUR1.4bn, with rising risks to the upside. We expect group revenue guidance to be raised at H1, though note cost phasing needs to be better modelled; H1 margin likely lower than H2 with FY25 EBITDA margin guidance 30% set to be reiterated. Bimzelx 2036e peak sales EUR7bn versus cons at EUR6bn. Food for thought; after 80 weeks Bimzelx is strongly outpacing the launch ramp of Skyrizi, which itself delivered EUR4.5bn in global sales 4 years after launch. Bimzelx consensus for Year 4 (2027) sales currently just EUR3bn. BNPP Exane View: Bimzelx TRx reached all-time highs this week at 5,333 TRx with YoY TRx/NRx growth of 307/305% respectively. Bimzelx holds a 7%/8% TRx/NRx market share in psoriasis. We forecast peak Bimzelx sales of EUR7bn with psoriasis/HS making up 35/50%. We forecast up to 9% Bimzelx penetration of the treated mod-to-severe psoriasis market and up to 40% of the treated mod-to-severe HS market. IQVIA data summarised below. Separately we note Evenity dynamics worth flagging given the drug contributes 30% to UCB group profits, is growing 30%, but where consensus seems to ignore the growing EBITDA contribution. Bimzelx Dynamics to consider . Although NVS''s Cosentyx and ABBV''s Humira already have approval for HS, the patient population remains underdiagnosed leaving plenty of room for the market to expand and accommodate multiple sponsors. We estimate a ~$10bn total HS market opportunity. . We do not see recent Incyte/Sanofi data and expected Moonlake data in September being able to surpass Bimzelx, which itself recently presented stellar 2-year data. . Given the Q2W dosing recommended in HS (vs. Q4W in PsO/PsA/axSpA/AS), HS is set to be the most profitable indication. While dosing implies a doubled treatment cost for a HS versus psoriasis patient, we conservatively assume an...
What happened? Strengthening Bimzelx trends (HS 20% of Rx with the value of a HS almost double that of a psoriasis patient) point to EUR1.6bn sales in FY25, versus consensus EUR1.4bn. Consequently, we expect group guidance to be raised at H1, though note cost phasing needs to be better modelled; H1 margin likely lower than H2 with FY25 EBITDA margin at least 30%. Bimzelx 2036e peak sales EUR7bn versus cons. at EUR6bn. Food for thought; after 80 weeks Bimzelx is strongly outpacing the launch ramp of Skyrizi, which itself delivered EUR4.5bn in global sales 4 years after launch. Bimzelx consensus for Year 4 sales post launch currently at just EUR3bn. Positive Fintepla label expansion data in CDD (ultra rare disease) is an added tonic; BNPP peak sales EUR1bn versus consensus EUR0.9bn and guidance EUR0.8bn. BNPP Exane View: Bimzelx TRx reached 4,956 TRx with YoY TRx/NRx growth of 322/297% respectively. Bimzelx holds a 7%/8% TRx/NRx market share in psoriasis. We forecast peak Bimzelx sales of EUR7bn with psoriasis/HS making up 35/50%. We forecast up to 9% Bimzelx penetration of the treated mod-to-severe psoriasis market and up to 40% of the treated mod-to-severe HS market. IQVIA data summarised below. Separately we note Evenity dynamics worth flagging given the drug contributes 30% to UCB group profits, is growing 30%, but consensus seems to ignore the growing EBITDA contribution. Bimzelx Dynamics to consider . Although NVS''s Cosentyx and ABBV''s Humira already have approval for HS, the patient population remains underdiagnosed leaving plenty of room for the market to expand and accommodate multiple sponsors. We estimate a ~$10bn total HS market opportunity. . We do not see recent Incyte/Sanofi data and expected Moonlake data in September being able to surpass Bimzelx, which itself recently presented stellar 2-year data. . Given the Q2W dosing recommended in HS (vs. Q4W in PsO/PsA/axSpA/AS), HS is set to be the most profitable indication. While dosing implies a doubled...
This morning, UCB reported positive Ph3 results for fenfluramine in CDKL5 deficiency disorder (CDD), an ultra-rare childhood-onset epilepsy form. Remember that fenfluramine is already marketed as ‘Fintepla' for two other indications being Dravet and Lennox-Gastaut syndrome.Full dataset of the GEMZ Ph3 to be disclosed at an upcoming conference.The CDKL5 deficiency disorder program contributed <5% to our valuation with current peak sales estimate relatively modest vs. other growth drivers (e.g. Bimzelx). We bump our TP to EUR 196 (vs. EUR 195 before) as a result of increasing our Ph3 success rate to 100%.
What happened? We caught up with the company ahead of H1 earnings (Jul-31). No changes in guidance were given and this report should be read as our interpretation of the discussion, Rx and FX trends rather than specific company commentary. BNPP Exane View: UCB has a long-standing track record of providing guidance for the year and ending up at the top of the range, and in many cases ahead. We see 2025 being no different on the back of stellar Rx data for Bimzelx (driven by HS that we estimate already represents 20% of weekly Rx), robust Evenity dynamics, and solid launch trends for Rystiggo/Zilbrysq. We expect UCB to provide an update on payer access for Bimzelx in HS at H1. Separately, we note UCB''s manufacturing footprint is 35/65 split between owned and CMOs, with engagement with 18 CMOs in the US expected to have an impact on US-sourced manufacturing from 2027. Consensus beatable Consensus 1H Bimzelx sales, group revenues, adjusted EBITDA and core EPS currently sit at EUR0.5/3.2/12bn and EUR3.51 respectively. We believe UCB on track to exceed H1 consensus. For FY25, consensus Bimzelx sales, group revenues, adjusted EBITDA and core EPS currently sit at EUR1.4/6.9/2.0bn and EUR7.28. Based on our analysis Bimzelx trending toward EUR1.6bn for the year. Pipeline update We expect a qualitative update at H1 on Ph III Fintepla data in CDKL5 deficiency, and Ph II glovadalen data in Parkinson''s. Galvokimig (IL-17/IL-13) Ph II AD data to be presented at EADV in September; we expect consensus forecasts to materially increase thereafter (BNPP Exane peak 2040e risk adjusted sales EUR1.9bn). Donzakimig Ph II AD data to be released with FY25 results. Points of differentiation For more details on our thesis see UCB: High conviction in turbulent time. Our NPV price target of EUR182 is based on a conservative WACC of 9.3%, with a highly positively skewed EUR282-123 bull-bear range. While UCB has become more consensual we continue to have points of differentiation. We...
What happened? We have been extensively marketing since our sector launch in April (see Pharma Drama). Investor appetite to engage with Pharma is limited, with Novo Nordisk, UCB and Galderma key exceptions. Strengthening Bimzelx trends (HS 20% of Rx with the value of a HS almost double that of a psoriasis patient) point to EUR1.7bn sales in FY25, versus consensus EUR1.4bn. Consequently, we expect group guidance to be raised at H1. Bimzelx 2036e peak sales EUR7bn versus cons at EUR6bn. Food for thought; after 80 weeks Bimzelx is strongly outpacing the launch ramp of Skyrizi, which itself delivered EUR4.5bn in global sales 4 years after launch. Bimzelx consensus for Year 4 sales post launch currently just EUR3bn. Separately, we note UCB has committed $2bn in incremental US capex over the next 7 years to build a new plant to support Bimzelx/Rystiggo/Zilbrysq and has increased its number of contracted US CMOs 50% to 18. BNPP Exane View: Bimzelx TRx reached all time high this week at 5,167 TRx with YoY TRx/NRx growth of 291/294% respectively. Bimzelx holds a 7%/8% TRx/NRx market share in psoriasis. We forecast peak Bimzelx sales of EUR7bn with psoriasis/HS making up 35/50%. We forecast up to 9% Bimzelx penetration of the treated mod-to-severe psoriasis market and up to 40% of the treated mod-to-severe HS market. IQVIA data summarised below. Separately we note Evenity dynamics worth flagging given the drug contributes 30% to UCB group profits, is growing 30%, but where consensus seems to ignore the growing EBITDA contribution. Bimzelx Dynamics to consider . Although NVS''s Cosentyx and ABBV''s Humira already have approval for HS, the patient population remains underdiagnosed leaving plenty of room for the market to expand and accommodate multiple sponsors. We estimate a ~$10bn total HS market opportunity. . We do not see recent Incyte/Sanofi data and expected Moonlake data in September being able to surpass Bimzelx, which itself recently presented stellar 2-year...
Last night, UCB announced that they'll invest in a US manufacturing plant for biologics and expand their CMO network.Following in the slipstream of other pharma names incl Roche, Novartis, Eli Lilly, & J&J, UCB expands its US production capabilities to have a stronger local manufacturing presence (remember that some US drugs are supplied through ex-US CMOs) which we view as a strategic move in light of recent tariff threats made by the US administration.We'll gather more feedback on these plans next week during our pre-closing call to be able to more accurately assess valuation impact.
This morning, UCB released additional Ph3 PHOENYCS GO data of dapirolizumab pegol (DZP) + standard of care (SoC) from the EULAR conference. Remember that 1/ primary endpoint detail was already shared in '24 (BICLA delta vs. SoC of 15%, in line with AZ's approved Saphnelo), and 2/ a confirmatory Ph3 PHOENYCS FLY is currently ongoing with readout expected late '27 (we model a '29 launch for now).In short, DZP showed statistically significant improvements across a series of fatigue and disease activity-related secondary measures, thereby further strengthening its competitive profile for this hard-to-beat indication. Discontinuations due to TEAEs in line with
What happened? We have been in the US this week marketing our sector launch (Pharma Drama: where do we have conviction?). Investor appetite to engage with the sector is limited with UCB an exception. Investor interest, especially from LOs is rising. Given strengthening Rx trends, and with HS now representing 20% of Rx (value of HS almost double that of a psoriasis patient), we see growing upside earnings risk: extrapolating trends imply 2025e Bimzelx sales EUR1.6bn without considering the value uplift from a rising share of HS prescriptions (BNPP and consensus EUR1.3-1.4bn). We forecast peak Bimzelx 2036e sales EUR7bn versus cons at EUR6bn. BNPP Exane View: Bimzelx TRx reached all time high this week at 4,733 TRx with YoY TRx/NRx growth of 358/323% respectively. Bimzelx holds a 6% market share in psoriasis. We forecast peak Bimzelx sales of EUR7bn with psoriasis/HS making up 35/50%. We forecast up to 9% Bimzelx penetration of the treated mod-to-severe psoriasis market and up to 40% of the treated mod-to-severe HS market. IQVIA data summarised below. Separately we note Evenity dynamics worth flagging given the drug contributes 30% to UCB group profits, is growing 30%, but where consensus seems to ignore the growing EBITDA contribution. Bimzelx Dynamics to consider . Although NVS''s Cosentyx and ABBV''s Humira already have approval for HS, the patient population remains underdiagnosed leaving plenty of room for the market to expand and accommodate multiple sponsors. We estimate a ~$10bn total HS market opportunity. . We do not see recent Incyte/Sanofi data and expect Moonlake data in September being able to surpass Bimzelx, which itself recently presented stellar 2-year data. . Given the Q2W dosing recommended in HS (vs Q4W in PsO/PsA/axSpA/AS), HS is set to be the most profitable indication. While dosing implies a doubled treatment cost for a HS versus psoriasis patient, we conservatively assume an 85% value uplift in our model. . Our analysis suggests HS...
What happened? We have been extensively marketing since our sector launch in April (see Pharma Drama: where do we have conviction?). Investor appetite to engage with the sector is limited, with Novo Nordisk and UCB the two key exceptions. Given strengthening Rx trends, and with HS now representing 20% of Rx (value of HS almost double that of a psoriasis patient), we see growing upside earnings risk: extrapolating trends imply 2025e Bimzelx sales EUR1.6bn without considering the value uplift from a rising share of HS prescriptions (BNPP and consensus EUR1.3-1.4bn). We forecast peak Bimzelx 2036e sales EUR7bn versus cons at EUR6bn. BNPP Exane View: Bimzelx TRx reached all time high this week at 4,710 TRx with YoY TRx/NRx growth of 351/293% respectively. Bimzelx holds a 7% market share in psoriasis. We forecast peak Bimzelx sales of EUR7bn with psoriasis/HS making up 35/50%. We forecast up to 9% Bimzelx penetration of the treated mod-to-severe psoriasis market and up to 40% of the treated mod-to-severe HS market. IQVIA data summarised below. Separately we note Evenity dynamics worth flagging given the drug contributes 30% to UCB group profits, is growing 30%, but where consensus seems to ignore the growing EBITDA contribution. Bimzelx Dynamics to consider . Although NVS''s Cosentyx and ABBV''s Humira already have approval for HS, the patient population remains underdiagnosed leaving plenty of room for the market to expand and accommodate multiple sponsors. We estimate a ~$10bn total HS market opportunity. . We do not see recent Incyte/Sanofi data and expected Moonlake data in September being able to surpass Bimzelx, which itself recently presented stellar 2-year data. . Given the Q2W dosing recommended in HS (vs Q4W in PsO/PsA/axSpA/AS), HS is set to be the most profitable indication. While dosing implies a doubled treatment cost for a HS versus psoriasis patient, we conservatively assume an 85% value uplift in our model. . Our analysis suggests HS already...
What happened? UCB''s messaging on Bimzelx YTD has been to make it clear that rebating has stepped up considerably in order to gain improved access in psoriasis, though they are comfortable with 2025 consensus expectations of EUR1.4bn. Given strengthening Rx trends, and with HS now representing 20% of Rx (value of HS almost double that of a psoriasis patient), we see growing upside risks: extrapolating trends imply 2025e Bimzelx sales EUR1.5bn without considering the value uplift from a rising share of HS prescriptions. We forecast peak Bimzelx 2036e sales EUR7bn versus cons at EUR6bn. BNPP Exane View: Bimzelx TRx reached all time high this week at 4,637 TRx with YoY TRx/NRx growth of 337/287% respectively. Bimzelx holds 6%/7% TRx/NRx market share in psoriasis. BNPP Exane forecast peak Bimzelx sales of EUR7bn of which 35% in Psoriasis and 50% in HS. We forecast up to 9% Bimzelx penetration of the treated mod-to-severe psoriasis market and up to 40% of the treated mod-to-severe HS market. IQVIA data summarised in figures below. Separately we note Evenity dynamics worth flagging given the drug contributes 30% to UCB group profits, is growing 30%, but where consensus seems to ignore the growing EBITDA contribution. Bimzelx Dynamics to consider . Although NVS''s Cosentyx and ABBV''s Humira already have approval for HS, the patient population remains underdiagnosed leaving plenty of room for the market to expand and accommodate multiple sponsors. We estimate a ~$10bn total HS market opportunity. . We do not see recent Incyte/Sanofi data and expected Moonlake data in September being able to surpass Bimzelx, which itself recently presented stellar 2-year data. . Given the Q2W dosing recommended in HS (vs Q4W in PsO/PsA/axSpA/AS), HS is set to be the most profitable indication. While dosing implies a doubled treatment cost for a HS versus psoriasis patient, we conservatively assume an 85% value uplift in our model. . Our analysis suggests HS already represents 20%...
What happened? To date, the messaging on Bimzelx from the company has been to make it clear that rebating has stepped up considerably in order to gain improved access in psoriasis, though they were comfortable with 2025 consensus expectations of EUR1.4bn. Given strengthening Rx trends, and with HS now representing 20% of Rx (value of HS almost double that of a psoriasis patient), we see growing upside risks. BNP Paribas Exane peak sales EUR7bn vs cons at EUR6bn. BNPP Exane View: Bimzelx TRx reach all time high this week at 4,447 TRx and YoY TRx/NRx growth of 405/317% respectively. Bimzelx holds 6%/7% TRx/NRx market share in psoriasis. BNPP Exane forecast peak Bimzelx sales of EUR7bn of which 35% in Psoriasis and 50% in HS. We forecast up to 9% Bimzelx penetration of the treated mod-to-severe psoriasis market and up to 40% of the treated mod-to-severe HS market. IQVIA data summarised in figures below. Evenity dynamics worth flagging with AMGN reporting overnight Q1 Evenity sales of $442m beating consensus by 2%. Evenity is growing 29% and annualising at $1.8bn. UCB book 50% of Evenity profits through other operating income (EUR0.6bn in 2024 or 38% of group EBITDA). We see OOI rising to EUR1.2bn in 2029 versus consensus at just EUR800m. Bimzelx Dynamics to consider . Although NVS''s Cosentyx and ABBV''s Humira already have approval for HS, the patient population remains underdiagnosed leaving plenty of room for the market to expand and accommodate multiple sponsors. We estimate a ~$10bn total HS market opportunity. . We do not see recent Incyte/Sanofi data, and expected Moonlake data in September being able to surpass Bimzelx, which itself recently presented stellar 2-year data. . Given the Q2W dosing recommended in HS (vs Q4W in PsO/PsA/axSpA/AS), HS is set to be the most profitable indication for UCB. While dosing implies a doubled treatment cost for a HS versus psoriasis patient, we conservatively assume an 85% value uplift in our model. . Our analysis suggests...
What happened? AMGN reported overnight with Q1 Evenity sales of $442m beating consensus by 2%. Evenity is growing 29% and annualising at $1.8bn (BNPP Exane forecast 2033e peak global sales of $3.3bn; consensus $3.1bn). UCB book 50% of Evenity profits through other operating income (EUR0.6bn in 2024 or 38% of group EBITDA). We see OOI rising to EUR1.2bn in 2029 versus consensus at just EUR800m. BNPP Exane View With tariff/drug pricing concerns around UCB abating (Bimzelx being shipped in high volume to US ahead of tariffs and CMO network being activated that will see more US sourcing of product from 2027), we argue investors can return to what we consider to be an unbelievably strong investment case. Key points include: . Double-digit revenue growth on offer over the next decade from 5 products that are already approved globally with label expansion completed. . We anticipate UCB will shortly announce a 5-year patent term extension for Bimzelx to 2037, and potentially 2-3 years for Rystiggo/Zilbrysq. . We remain sanguine ahead of Moonlake Ph III VELA 16-week data for sonelokimab in HS (now expected September), arguing the market can sustain multiple players given current biologics penetration is low, and the strength of the 2-year data recently presented for UCB. . We see pipeline expectations rising materially post-galvokimig (IL13 x IL17 bispecific) Ph II atopic dermatitis data presentation at EADV (Sep 17-20th), with optionality for donzakimig (IL13 x IL22 - Ph IIa data 2H25). Based on our recent conversations with management galvokimig has the potential to go beyond AD and become a ''pipeline in a product''. . Our Bimzelx Rx Tracker highlights the strong momentum in US prescriptions as well as European IQVIA sales data. Our analysis suggests HS already represents 20% of Rx. The value of an HS patient is almost double that of a psoriasis patient, reflecting dosing differences. Bimzelx Rx trends are such that we now see UCB raising their expectations...
What happened? Bimzelx continues to launch favourably in comparison to comparators with increased momentum following HS indication expansion in Nov-2024. We publish our weekly tracker summarising key Rx/sales trends. BNP Paribas Exane peak sales EUR7bn versus consensus at EUR6bn. Gross to net adjustments have gone up significantly as UCB secures improved access. Management comfortable with consensus at EUR1.4bn, we are at EUR1.3 bn. BNPP Exane View: Bimzelx TRx reach all time high this week at 4,257 TRx and YoY TRx/NRx growth of 374/285% respectively. Bimzelx now holds 6%/7% TRx/NRx market share within the Psoriasis class. BNPP Exane forecast peak Bimzelx sales of EUR7bn of which 35% in Psoriasis and 50% in HS. We forecast up to 9% Bimzelx penetration of the treated mod-to-severe Psoriasis market and up to 40% of the treated mod-to-severe HS market. IQVIA data summarised in figures below. Bimzelx Dynamics to consider . Although NVS''s Cosentyx and ABBV''s Humira already have approval for HS, the patient population remains underdiagnosed leaving plenty of room for the market to expand and accommodate multiple sponsors. We estimate a ~$10bn total HS market opportunity. . We do not see recent Incyte/Sanofi, and expected Moonlake HS datasets being able to surpass Bimzelx, which itself recently presented stellar 2-year data. . Given the Q2W dosing recommended in HS (vs Q4W in PsO/PsA/axSpA/AS), HS is set to be the most profitable indication for UCB. While dosing implies a doubled treatment cost for a HS versus psoriasis patient, we conservatively assume an 85% value uplift in our model. . We note that as of Jan-25 Bimzelx has improving commercial coverage across the top 3 US healthcare plans in existing indications. We would expect HS coverage to be similar to that in Psoriasis given limited approved products . BNP Paribas Exane peak sales for Bimzelx EUR7bn versus consensus at EUR6bn. Specifically, we forecast peak HS sales of EUR3.4bn. For reference Novartis reported...
We initiate at Outperform with a EUR182 PT and highly positively skewed EUR282-123 bull-bear range (WACC 9.3%, g=2%). While UCB has become more consensual we continue to have points of differentiation. We anticipate material patent term extensions to be granted for key growth drivers, continue to argue Evenity and royalty contributions are significantly underappreciated, and see three pipeline assets emerging each with multi-billion-dollar peak sales potential. Points of differentiation versus consensus We anticipate a 5YR patent term extension for Bimzelx to shortly be granted and accord a 50% probability for similar PTE efforts with Rystiggo/Zilbrysq. We continue to argue Evenity is materially underappreciated (EUR0.6-1.3bn annual profit share up to 60% ahead of consensus) and flag royalty exposure to Merck''s oral PCSK9 and Sanofi''s oral TNF (NPV EUR4/share). With respect to the pipeline we note positive KOL feedback on dapirolizumab in lupus, see galvokimig (IL13xIL17 bispecific) having broad utility beyond AD (Ph II data at EADV in September) and donzakimig (IL13xIL22 bispecific) potentially being a ''super-Dupixent'' (Ph II AD data H2). We forecast combined risk adjusted 2035/40e sales of EUR2/4bn versus a potential EUR10bn revenue opportunity. Bimzelx momentum strong; we are sanguine into competitor datasets We publish highly encouraging US and EU IQVIA Rx trends, as well as key excerpts from recent physician survey work. BNP Paribas Exane peak EUR7bn versus consensus at EUR6bn. We do not see recent Incyte, and expected Moonlake/Sanofi, HiS datasets being able to surpass Bimzelx, which itself recently presented stellar 2-year data. Despite higher gross-to-nets to reflect expanded access, UCB is comfortably on track to meet/exceed 2025e Bimzelx consensus expectations of EUR1.4bn. 2026 PE 16x for a 2025-30e revenue/EPS CAGR of 10/27% UCB''s valuation and growth stacks up well versus EU Pharma on 12x offering a 2025-30e revenue/EPS CAGR of just 6/9%. Our PT implies...
What happened? In this report we provide feedback on several pharma companies attending day two of our annual BNPP Exane Healthcare Conference including Galderma (+), Novartis (=), Rovi (+) and UCB (+). BNPP Exane View: Galderma (Outperform, CHF106) Speaker(s): Thomas Dittrich, Chief Financial Officer Feedback: Galderma continues to be confident that a continuation of recent strong international region growth (~60% of Group) in countries where its penetration rates remain low (China, India etc) will allow it to deliver continued robust growth despite risk of continued softness in the US consumer. Notably, Galderma points to 2025 as representing a strong year for new international launches (including Sculptra in China) and the company expects a further four new product launches in the US in 2026 which should help it to sustain that strong momentum. The company notes positive anecdotal feedback on the rapid speed-of-onset with Relfydess versus current neuromodulators following recent initial launches and seems confident remaining questions from the FDA can be addressed, with a US launch possible in 2026. The company also continues to report positive feedback from the Nemluvio launch, noting good insurance access that has not been a barrier to patient uptake and anecdotal reports of use in biologic naive patients in the AD setting which has been a positive surprise to expectations. Importantly, currently known tariff headwinds (Cetaphil/Canada) are reflected in guidance and management sees additional tariff risk as manageable as there is a level playing field in the neuromodulator space (both Dysport and Botox are manufactured outside the US) and the economic value of Nemluvio imported into the US is low. Although the Nemluvio launch will restrain margins in 2025, the company sees potential for significant margin accretion beyond its current mid-term targets if Nemluvio achieves its $2bn sales target. Novartis (Neutral, CHF106) Speaker(s): Harry...
UCB UCB NOVN ROVI ROVI GALD
What happened? UCB last night hosted an informal meet management dinner with equity analysts in London. BNPP Exane View: Our quick takeaways are as follows: (1) The below consensus revenue guide reflects expected pressure on Cimzia but management is comfortable with consensus forecasts for all the key driving new launch products; (2) UCB feels it has set a realistic rather than conservative target for Bimzelx within this given the need to rebate to get a seat at the table in competitive access negotiations; (3) Messaging was bullish on the new IL-13/IL-17AF bispecific antibody (UCB9741/galvokimig) with a high bar having been set (and met) in the proof-of-concept trial. UCB believes it can go broad and beyond atopic dermatitis with galvokimig and hopes its IL17/IL-22 bispecific (UCB1381/donzakimig) can be a ''Super Dupixent''; (4) It is too early to assess possible impact of tariffs but UCB seems optimistic it has the supply chain flexibility and other avenues to potentially to mitigate this impact; and (5) UCB seems increasingly confident that Bimzelx will receive a 5-year patent term extension taking protection to 2037.
Although UCB''s 2025 guidance ranges may have slightly disappointed some investors, its new launches are exceeding expectations with this expected to drive a 600bp margin expansion and ~50% EPS growth this year and its pipeline continues to deliver. Our revised forecasts are ahead of guidance, which we expect to ultimately be exceeded. We continue to believe UCB offers unique exposure to innovation-driven growth in EU mid cap Biopharma. Outperform reiterated. Guidance likely to prove conservative; 24-28E sales/Core EPS CAGR = 11%/29% We believe 2025E Bimzelx consensus forecasts are achievable based on the current prescription trajectory even with very conservative pricing/rebate assumptions, leaving significant room for upside. Our forecasts are modestly ahead of UCB''s guidance ranges. Longer term, we assume a 24-28E sales/Core EPS CAGR = 11%/29% with EBITDA margins likely to reach the high 30s by the end of the decade. Takeaways from FY24 results call (1) UCB is comfortable with consensus forecasts for all the key drivers. Guidance reflects divestments and expected Cimzia price pressure; (2) Bimzelx paid drug now at 50% of scrips. Increased rebates to enable unencumbered patient access will impact going forward partly offset by expected higher revenue per patient in HS; (3) UCB is confident Bimzelx sets a very high bar to other possible new entrants in the HS market, which it expects to grow by 3 fold over 10 yrs; (4) UCB is assessing next steps for AD drug bepranemab and remains optimistic despite return of rights from Roche; (5) UCB is analysing data to identify a patient population that benefits most from IL-13/17AF bispecific for future development following positive POC data. Reiterate Outperform with EUR215 price target Our TP of EUR215 implies 23x 2026E Core PE in return for a 2024-28E Core EPS CAGR of 29%. We expect ongoing launch execution to continue to drive the shares, with further upside if the new pipeline continues to deliver.
This morning, UCB released its FY24 results, most notably announcing beats on revenue, net sales (incl. bimzelx), and core EPS. Adj. EBITDA margin in line with guidance and CSS but below DPe. Overall solid results.Conservative 2025 guidance: revenue guidance below our estimate and VA CSS, Adj EBITDA in line, and core EPS below our estimate but above CSS.We will revise our model based on update guidance and pipeline updates. Hold reiterated as we believe the commercial potential of UCB's most relevant assets is factored in.
What happened? UCB has reported 2H24/FY24 financial results. BNPP Exane View: UCB has reported a very strong end to 2024 with most of its new drug launches significantly exceeding expectations driven by very strong sales of Bimzelx, Rystiggo and Zilbrysq. As expected, guidance implies a dramatic 600bp EBITDA margin improvement in 2025 and close to 50% Core EPS growth. Although the mid-point of guidance ranges implies 3% downside risk to consensus, we note UCB has a track record of beating expectations and we believe guidance for 2025 sets a bar that is likely to be beaten given current strength of its new drug portfolio. Importantly, UCB has reported that initial results of Phase 2a trial of UCB9741/galvokimig (IL-13/IL-17AF bispecific) has shown ''positive and convincing proof-of-concept data'' suggesting potential for a further leg to UCB''s long-term growth story. With its clutch of five new launches exceeding expectations and a strong pipeline behind them, we believe UCB offers unique exposure to innovation-driven growth in EU mid cap Biopharma. Key financials . FY revenues (+19% CER), adjusted EBITDA (+18% CER) and Core EPS (+32% CER) were 5%, 5% and 17% ahead of consensus and were above management guidance. . Within this, new drugs Bimzelx, Rystiggo and Zilbrysq all exceeded expectations in 2H24 by 12%, 24% and 8%. Offsetting this, Evenity sales in UCB regions were weaker but we flag that US/Japan sales reported by Amgen have continued to exceed expectations. Fintepla sales were broadly in-line with expectations. . 2H EBITDA margins improved by 390bps yoy and were in-line with consensus, while EPS benefited from a lower FY tax rate than expected (8% vs BNPPE 17%). Guidance . FY25 guidance looks for revenue of EUR 6.5 - 6.7 bn (VA cons = EUR6.8bn), adjusted EBITDA margin reaching 30.0% (VA cons = 30.0%), Core EPS in the range of EUR 6.80-7.40 (VA cons = EUR7.31). . Importantly, this guidance implies a dramatic 600bp EBITDA margin improvement in...
Last Friday, UCB announced that the CHMP has issued a positive opinion for the self-admin option of Rystiggo via infusion (syringe pump) or a new manual push syringe method. These new admin strategies provide patient optionality and add additional administration convenience which we expect the younger gMG patient population to benefit from especially. As a result thereof, we revised our sales estimates upwards with our 2030 sales now amounting to close to EUR 850m (+17% vs. VA CSS). While the JPN dossier is in review, IR indicated that a U.S. approval is “not for the near term”.Remember that ARGX's Hytrulo
Very strong EPS growth in 2025 to drive shares; significant hidden pipeline value remaining With its clutch of five new launches exceeding expectations and a strong pipeline behind them, we believe UCB offers unique exposure to innovation-driven growth in EU mid cap Biopharma. We expect momentum behind the new launches to be sustained or accelerate in 2025 and see potential for the pipeline to surprise positively. Despite more than doubling this year, we view the shares'' 26x ''25E PE as still undervaluing UCB''s strong growth (''24-28 EPS CAGR of 30%). US physician survey supports bullish view on continued Bimzelx growth and HS uptake We recently surveyed 35 US dermatologists who reported very positive experiences with Bimzelx in psoriasis, plans to increase prescribing through switches and enthusiasm for 1L prescribing. Most importantly, physicians perceive Bimzelx as superior to Cosentyx in its new indication of hidradenitis suppurativa (HS) and predict Bimzelx to rapidly emerge as the leading biologic in this key less competitive indication suggesting upside potential to our EUR4.2bn peak sales forecast. Further leg to upturn in innovation represents additional upside Recent impressive Phase 3 data for dapirolizumab in lupus underlines that UCB is experiencing a renaissance of innovation. We see potential for this to be sustained into 2025, with expected P2 data for Rystiggo in new indications (FMS) and on multiple innovative new drugs in Parkinson''s (α-syn-misfolding inhibitor with Novartis and internal D1 modulator) and atopic dermatitis (UCB9741/1381) due in 2H24/1H25. We are most enthusiastic on UCB''s IL-13/IL17AF bispecific given UCB''s past track record on delivering drugs with improved profiles based on existing targets. Reiterate Outperform with EUR215 price target Our TP of EUR215 implies 22x 2026E Core PE in return for a 2024-28E Core EPS CAGR of 32%. We expect ongoing launch execution to continue to drive the shares, with further upside if...
What happened? UCB and partner Biogen will today present detailed positive results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate for moderate-to-severe systemic lupus erythematosus (SLE) at the American College of Rheumatology''s annual meeting, in Washington, DC. UCB and Biogen will initiate a second Phase 3 trial called PHOENYCS FLY (NCT06617325) before the end of 2024. BNPP Exane View: We believe the data looks highly competitive with other novel innovative treatments for SLE that have launched in recent years that are on track to deliver $1-2bn in peak sales. Although UCB and Biogen will need to conduct a further study prior to approval - suggesting a launch in late 2028 or 2029 - we view the opportunity as largely de-risked based on the strength of presented data. Importantly, the opportunity mostly represents upside to consensus expectations (2029E VA consensus = EUR129m; 1% of Group) and could help sustain UCB''s strong growth into the next decade. In addition, the data further increases our optimism that the recent upturn in innovation at UCB can be sustained with its upcoming mid stage pipeline readouts representing further optionality to the upside. We are most enthusiastic on UCB''s IL-13/IL17AF bispecific (P2 data due shortly) given UCB''s past track record on delivering drugs with improved profiles based on existing targets. UCB is our top mid cap biopharma pick for 2024. Key points: . Key efficacy measures look highly competitive with other innovative new drugs for SLE. As outlined in the figure below, we see dapirolizumab''s activity at 48 weeks on key measures of disease activity including BICLA, SRI-4 and BILAG flares as comparable or better than currently approved drugs for the treatment of SLE. . Statistical miss on 24-week BICLA response not likely to be a drawback. On the first secondary endpoint of BICLA response at Week 24 the benefit of dapirolizumab did...
What happened? UCB has announced completion of the sale of rights to two established brands, Atarax and Nootropil for Europe and selected other countries with income to be booked as other revenue . Given this transaction, along with strong performance of the key growth drivers Bimzelx and Rystiggo, UCB is updating its 2024 financial guidance, with revenue expected to reach close to EUR6 billion, up from the prior guidance of the ''upper end of the range of EUR5.5 - 5.7 billion''. EBITDA margin is expected to reach the upper part of the confirmed range of 23.0-24.5%, with Core EPS now projected between EUR4.25-4.65 (vs EUR3.70-4.40). BNPP Exane View: UCB''s upgraded guidance implies 4%, 7% and 9% upside to current consensus forecasts. Although the contribution to this from the completed divestment is not disclosed, we believe this likely accounts for around 70% of the upside to revenues (assuming a payment of 2.2x sales for Atarax/Nootropil which had sales of EUR64m), with the remainder reflecting strong performance of Bimzelx and Rystiggo. The one time payment arguably underpins most of the implied upside to earnings. However, we believe UCB will have utilised opportunity for reinvestment behind the launches within this. UCB continues to a top mid cap pick and we optimistic that the company can continue to generate value for shareholders through commercial excellence and delivery on its pipeline despite recent very strong share price performance.
What happened? UCB hosted a call to discuss two-year data for Bimzelx in hidradenitis suppurativa (HS), recently reported at the European Academy of Dermatology and Venereology (EADV) Congress. Key opinion leaders, including Dr. Amit Garg from the Zucker School of Medicine and Dr. Falk Bechara from the Ruhr-University Bochum shared their feedback. BNPP Exane View: UCB outlined recently presented data supporting Bimzelx''s leading depth of response in one of the most debilitating and difficult to treat diseases in dermatology, hidradenitis suppurativa (HS). Both KOLs notably praised Bimzelx''s unprecedented effect on draining tunnels, the most burdensome HS lesion according to patients. This is believed to support a transformative improvement of quality of life as a third of patients treated reported minimal or no effect impact of the disease after 2 years. We believe Bimzelx''s perceived superior profile could drive adoption considering the disease''s progressive and destructive nature advocates for the use of the most effective treatments upfront. While we stand by our c.$1bn peak sales for HS, we see several tailwinds to our assumptions (i.e., higher proportion of moderate to severe patients, higher dosing regimen and more rapid biologic adoption) that could make these overly conservative. With HS market estimates ranging from $4bn to $10bn at peak as new treatments become available, the opportunity represents one that could continue to drive upside to Bimzelx''s forecasts. We continue to expect an FDA decision on Bimzelx''s HS filing by the end of the year. . Two-year data support our bullish view on Bimzelx in HS. Overall, all clinical response endpoints from the BE HEARD I and II studies have been sustained for at least 2 years of treatment with most patients continuing to improve, suggesting that benefits have yet to plateau and implying possible further improvements with longer follow-up. KOL''s pointed out the ''remarkable'' depth of response with...
PHOENYCS GO, a Ph3 study for systemic lupus erythematosus (SLE) met its primary endpoint. Data detail to be shared at upcoming conference.Positive news for UCB which we expect to be applauded by the markets as SLE is a tough indication to beat with, so far, few effective therapeutic options available. We look forward to the full dataset to gain more insights on the competitive positioning of the asset.We have adjusted our clinical development timeline and now expect a launch closer to 2030 following a 3y-long confirmatory study (Ph3 success rate 75%, overall LoA 68% vs. 25% before). Net result of
This morning, UCB announced FDA approval of Bimzelx for indications psoriatic arthritis (PsA) and (non-)radiographic axial spondyloarthritis (axSpA). Positive news (decision outcome was expected in H2 2024) but likely no surprise (incl. the suicidal ideation and liver biochemical abnormalities warning) for the market given the previous approval for plaque psoriasis and solid Ph3 datasets for PsA & AxSpA.We already accounted for these approvals in our model by allocating a 100% LoA, hence no impact on estimates and valuation. We model c. EUR 6bn peak sales for Bimzelx (54% of our enterprise value/share) with 30% of sales revenue stemming from PsA
*UCB has been the top performer of the BEL 20 index YTD (+95%), fuelled primarily by Bimzelx's performance in the US boosting investor confidence in the asset's overall commercial potential.*Following the H1 update from last week, we have adjusted our TP to EUR 160 (+21%) mainly as a result of upwards-revised Bimzelx peak sales (+c. EUR 2bn to EUR 6bn, +18% vs. VA CSS).*Given the limited upside of our new TP to yesterday's closing price (+3.4%), we now consider the potential of UCB's growth drivers and most advanced pipeline to be more accurately reflected in its share price. Hence, we
Raising EPS and TP on strong 1H24; further upside still from pipeline execution We are raising our forecasts and target price on strong Bimzelx and Rystiggo launch momentum and improved confidence in the margin outlook. Despite recent share price performance, we continue to see the shares valuation as undemanding given the very strong growth on offer and see significant potential for upside on remaining pipeline readouts. We believe UCB offers unique exposure to innovation-driven growth in EU mid cap Biopharma. Raising forecasts on strong execution; 24-28E sales/Core EPS CAGR = 11%/31% We have raised our 2024-28E sales and Core EPS forecasts by 2-5% and 3-9% respectively given strong new launch performance in 1H24 and improved confidence in the trajectory of expected margin improvements. Our forecasts assume UCB delivers a 24-28E sales/Core EPS CAGR = 11%/31% with 1,000bp margin expansion driven by top line leverage, gross margin improvements and a growing contribution from Evenity. Continued launch execution and pipeline progress to support the shares Although pipeline updates in 1H were mixed (Rystiggo MOG-AD delay and AIE failure), we are still optimistic near-term pipeline readouts could lead to further upgrades to expectations including: (1) P2 data for Rystiggo (FMS); (2) P2/3 data on higher risk/reward largely unmodelled partnered pipeline assets (AD, PD, SLE); and most importantly, (3) P2 data on two internal atopic dermatitis antibodies (one an IL-13/IL17A/F bispecific) which could emerge as a key future growth pillar. Increasing TP to EUR180 (from EUR160) on raised forecasts; maintaining Outperform Our raised TP of EUR180 (from EUR160) reflects increases to our Bimzelx and Rystiggo forecasts and raised margin assumptions. This implies 24.5x 2025E Core PE in return for a 2024-28E Core EPS CAGR of 31%. We expect ongoing launch execution to continue to drive the shares, with further upside if the new pipeline delivers.
This morning, UBC provided an H1 update announcing a strong set of results largely beating CSS expectations (excl. Zilbrysq). FY24 (with revenue now top of the range) + FY25 guidance reiterated.On a slightly negative note, some of the pipeline programs were either dropped or delayed but this should not put too much of a burden on investor sentiment this morning as the key revenue drivers for UCB (especially Bimzelx) performed strongly.We will adjust our estimates following this release and come back shortly. Stock should react positively to this news.
Remaining constructive: valuation still undemanding and pipeline still overlooked We are raising our forecasts and target price on strong launch momentum, delayed Cimzia biosimilars and raised margin expectations. Although UCB''s strong growth outlook is better reflected by recent strong performance, the shares'' valuation on 2025E PE remains undemanding and we see significant potential for upside on remaining pipeline readouts and launch momentum. We believe UCB offers unique exposure to innovation-driven growth in EU mid cap Biopharma. Raising forecasts on strong launches; 24-28E sales/Core EPS CAGR = 11%/30% We have raised our Bimzelx (peak now EUR4.0bn), Rystiggo (peak now EUR800m) and Cimzia sales forecasts given continued strong US launches and delayed biosimilar entry. Our discussions with UCB suggest it is committed to its 2025 margin targets (implying a 550bp improvement) and we expect continued improvements thereafter (op. leverage; Bimzelx manuf. changes), leading to 4-15% increases to our EPS forecasts (24-28E sales/Core EPS CAGR = 11%/30%). Strong launches better understood but upside from pipeline delivery remains Despite the strong share performance, we continue to see upside given still conservative new launch assumptions and from potential of near-term pipeline readouts including: (1) P2/pivotal data for Rystiggo (MOG, AIE, FMS); (2) P2/3 data on higher risk/reward largely unmodelled pipeline (AD, PD, SLE); (3) P2 data on internal programmes, including two atopic dermatitis antibodies (one an IL-13/IL17AF bispecific). Positive data could lead to further upgrades to UCB''s growth outlook. Increasing PT to EUR160 on raised forecasts; maintaining Outperform Our raised PT of EUR160 (from EUR125) reflects increases to our Bimzelx, Rystiggo and Cimzia forecasts, raised margin assumptions and improved confidence in long-term growth. This implies 22.5x 2025E Core PE in return for a 2024-28E Core EPS CAGR of 30%. We expect ongoing launch...
BIMZELX® has been granted marketing authorization in EU for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults. This approval follows positive CHMP opinion issued in March 2024.We model HS as the 2nd biggest indication for BIMZELX®, with close to EUR1bn in peak sales, after plaque psoriasis, with the EU making up about 25% of peak sales.We have a combined 85% LoA for the USA, EU, & JPN in our model and upon approval in all said geographies our TP moves up EUR 1.8 only so little impact on valuation. Buy reiterated as we consider the portfolio
*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
*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...
