H1 surpassed expectations, Bimzelx’s US approval much-awaited in Q3

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 expect

Hardman & Co Monthly: April 2023

Feature article: 2022 Pharma Statistics - 8.7% growth – but worrying signs An efficient reporting system has seen all the listed multinational pharmaceutical companies announcing results for 2022, which has given us the opportunity to update our industry statistics and drug database. This report provides the first snapshot of the global and US rankings of the top 20 drug companies for 2022. 2022 was characterised by 8.7% underlying growth, offset by a large forex impact (-12%), due to USD stren

Exceeded 2022 expectations; promising prospects, despite muted 2023 guidance

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 dr

Decent H1 overshadowed by future uncertainties

UCB reported a decent set of H1 results, with sales and profitability beating expectations. While the Neurology portfolio posted a mixed showing due to patent expiry for Vimpat, it was offset by the recovering Cimzia-driven Immunology. However, given the significant future uncertainties, pressure on profitability, timing of Bimzelx’s US launch and pipeline execution, the markets remain jittery. Nevertheless, given UCB’s dominant position in its target markets and Bimzelx’s industry-leading effic

2021 results: a major confidence reinforcing event

UCB ended 2021 on a strong note, largely driven by promising growth in the Neurology portfolio. While the top line is expected to witness some moderation as the firm enters a critical transition period, UCB seems well-prepared with Bimzelx’s US launch, expected in mid-2022, and Zogenix’s acquisition. Re-affirmation of the mid-term targets was all the more comforting. Our positive stock recommendation is reiterated.

Pricing & pandemic concerns impede upward revision to full-year outlook, despite strong H1

UCB reported strong H1 results with the core drug portfolio leading the pack. While momentum in the core portfolio should sustain and the upcoming launch of Bimekizumab provide an additional push, management refrained from upgrading the full-year outlook. In our view, increasing pricing pressure on Cimzia and resurfacing COVID-19 concerns held them back. Despite these near-term uncertainties and the upcoming patent expiry of key drugs, we remain confident of the group’s medium-to-long fortunes a

Encouraging long-term outlook

Despite the COVID-19-related disruptions, UCB’s core portfolio showcased resilience and the launch of new drugs further bolstered growth. However, higher marketing spend on new launches and higher R&D investments on the five late-stage drugs suppressed profitability. In our view, the upcoming approval of Bimekizumab should boost investors’ confidence. Furthermore, the healthy FY25 outlook, at a time when key drugs are set to lose exclusivity, is also encouraging.

Strong H1 20; Bimekizumab set to become new core-driver

UCB reported robust top-line growth led by a strong show in the core portfolio (except for Neupro). However, the EBITDA margin softened due to higher marketing spend on drug launches. RA Pharma and Engage Therapeutics have been fully integrated and their mid-to-late stage pipeline could keep R&D expenses on the high side, thereby pressuring the margin in H2. However, the upcoming launch of high-margin drug, Bimekizumab, should ensure that the mid-term profitability targets are met.

UCB’s psoriasis candidate is racing ahead of its rivals

UCB’s psoriasis candidate, Bimekizumab has shown promising clinical data vs. J&J’s Stelara. While this increases the probability that the drug could hit the market in Q1 21, its real competition in the overly-crowded space would come from Novartis’s Cosentyx. Bimekizumab should report head-to-head data with Cosentyx in the next few weeks and, if it is found to be superior, we will increase our peak sales potential for Bimekizumab by €500m to €2bn.

Strong performance in H2 19; peak sales guidance of key drugs upgraded

H2 19 sales and profitability beat was driven by the robust show of Cimzia and Vimpat. Given that the strong momentum is likely to continue and could be bolstered further with the geographic/label expansion, management has upgraded the peak sales potential of these drugs for the second time. Though the near-term margin could come under pressure, due to the integration of RA pharmaceuticals and increased investments into R&D, Bimekizumab (approval likely in 2020) should ensure that the mid-term p

RA’s acquisition expands UCB’s neuromuscular portfolio

UCB has broadened its neuromuscular portfolio with the €2.2bn acquisition of RA pharmaceuticals – blockbuster potential drug, Zilucoplan (expected launch in 2023), is RA’s key drug which complements UCB’s rozanolixizumab. As UCB will invest in R&D and marketing of the drug, the deal would be margin-dilutive until 2023. Nonetheless, we foresee EPS accretion thereafter as sales momentum picks up. The deal is all the more important at a time when UCB’s CVN drugs are about to hit the patent cliff.

CFO exit weighs on the performance in H1 19

UCB reported strong top-line growth, driven by the CVN portfolio and Briviact, partially offset by the off-patent Keppra. The EBITDA margin remained subdued due to higher R&D expenses, while the net results were further impacted by a higher tax rate. Evenity was approved in the US, Canada, South Korea, and Australia but rejected in Europe. Management maintained its FY 19 outlook, implying a weak H2 19 (sequentially). The CFO exit came as a big surprise, overshadowing the results.

Weak performance in Q4 and mixed guidance for 2019

UCB reported a weak quarter with a decline in top-line and margin, revenue getting impacted by a decline in Cimzia’s US sales and profitability further pulled down by high R&D expenses on the next wave of molecules. Evenity approval in US and Europe would be the next big trigger for the share price. Management upgraded Cimzia and Vimpat sales estimates but downgraded Neupro sales and short-term EBITDA margins.

Steady quarter but no assurance from the labs

UCB’s 9M 18 (trading update) performance came in line with our as well as consensus estimates, although variations were seen at the drug level. Revenue grew by 6% ytd at CER to €3.4bn, on the back of the continued strength in the core portfolio (+12% at CER) — Cimzia (+9%), Vimpat (+19%), Keppra (+5%), Briviact (+81%) and Neupro (+2%). FX had a negative impact of 3% on the group sales. NB all sales numbers are at calculated CER unless specified otherwise (the company does not report quarterly CE

Strong momentum in Q2

UCB reported strong quarter after a weak start in Q1 18. Cimzia, Vimpat and Briviact clocked strong performances, but Neupro continued to languish. Cost control and a significant decline in the effective tax rate boosted net profit by 33%. Evenity’s approval and biosimilar impact on Cimzia are likely to be the triggers in the upcoming quarters, however, given the lack of convincing drivers, including in the pipeline, makes us believe that the recent run-up is unlikely to continue.

Mixed interims; placing forecasts Under Review

ReNeuron Group - H124 results reaffirm focus on CustomEX

ReNeuron has announced its H124 results (to end-September 2023), reaffirming its commitment to advance CustomEX(TM), its proprietary stem cell-derived exosome delivery platform. The key operational update from the period included in vivo data, marking a crucial step towards validating CustomEX(TM) and distinguishing it from peers in the exosome delivery space due to its cellular and tissue-targeting capabilities. As of 30 September 2023, ReNeuron had a cash balance of £5.1m, which we estimate sh

Wynnstay Group+ (WYN, House Stock, 430p) - Tough H2 –FY23F downgrades - FY24F recovery

Cambridge Nutritional Sciences - H1 2024 interims: Executing a newly focussed st

Cambridge Nutritional Sciences (CNS) has published its H1 2024 results to end September 2023. Group revenues grew 44% to £4.9m and gross profits increased by 63% to £3.1m, with the company benefitting from newfound operational efficiencies. With its now streamlined strategy focussing on the core Health & Nutrition business and the initial signs of an encouraging uptick in sales momentum, we believe the company is well positioned for growth that will help create future value for shareholders. We

Hardman & Co Research: Tissue Regenix (TRX) - Continuing postive momentum 1H'23

TRX is focused on the development and commercialisation of two proprietary processing technologies for the repair of soft tissue (dCELL®) and bone (BioRinse®). It has a broad portfolio of regenerative medicine products for the biosurgery, orthopaedics and dental markets. 1H’23 results highlighted the benefits and efficiencies being derived from investment and reorganisation in manufacturing capacity, with the first underlying EBITDA-positive reporting period. With further strong growth forecast

Trading Update

RUA have released a trading update ahead of its December interim results announcement. In contrast to the previous year, revenues have been weighted to the second half and while this has suppressed first half revenue growth, October’s and November’s revenues have largely caught up to align with management’s budget expectations. RUA’s recent strategy update and its trading update have several common themes. The reliance on partnerships to fund the development of RUA’s products in RUA Structural

Creo Medical - Potential UltraSlim upside with swift EU pathway

Creo Medical has announced that its EU notified body has guided for an accelerated clinical pathway for its Speedboat UltraSlim device, the slimmest Speedboat Inject version that is compatible with most endoscopes. The reduced regulatory path will enable the company to launch the versatile product in Europe in early 2024, roughly 18 months earlier than planned. As the FDA application was submitted for this device in February 2023 (management expects clearance in Q423), UltraSlim is now projected

Morning Note – 13 September 2023

Creo Medical - Entering phase of accelerating growth inflection

FY22 was a key inflection period for Creo with significant traction in the adoption of Speedboat Inject (its flagship electrosurgical device) and its proprietary CROMA technology platform, reflected in major robotic deals with Intuitive Surgical and CMR Surgical. Total revenue growth (8% y-o-y to £27.2m) was in line with consensus (£27m) and was primarily driven by Creo’s core technology business. Operating losses rose to £30.8m, affected by increased personnel and R&D expenses, although managem

Expert view on Creo's tech

In a well-attended Capital Markets Day on Nov 7, Creo made no new announcements but showed qualitatively how the next few years are likely to evolve with insights from three enthusiastic medical users. We took on board three important qualitative observations from the event.Firstly, the importance

The Hardman & Co Monthly: September 2022

Feature article: Macro issues dominate investor sentiment - Some basics for investors The big topics in the investment world at the moment seem to be macroeconomic. With that in mind, we thought it would be useful to revisit some of the basics of the terms being used in the current environment, and to remind investors of the things to look out for (indeed, many younger investors may not have come across some of these influences in their investing lifetime): • Recession does not affect

LIBERUM: Futura Medical: The Futura's coming

Morning Note – 27 November 2023

The Hardman & Co Monthly: September 2023

Feature article: Equity Income – UK or Global? Should investors widen their horizons? Introduction: ► The UK Equity Income sector (UKEI) is the fourth-largest investment company (IC) sector in the Association of Investment Companies’ (AIC) universe, with £12.5bn of assets (as at August 2023), and is the traditional home for investors looking for income in the equity market. ► The UKEI not only provides investors with a better dividend yield than the ge

Hybridan Small Cap Feast - 29/11/2023

29th November 2023 @HybridanLLP Status of this Note and Disclaimer This document has been issued to you by Hybridan LLP for information purposes only and should not be construed in any circumstances as an offer to sell or solicitation of any offer to buy any security or other financial instrument, nor shall it, or the fact of its distribution, form the basis of, or be relied upon in connection with, any contract relating to such action. This document has no regard for the specific investment obj