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Earnings Call Analysis
Q1-2024 Analysis
Lonza Group AG
In Lonza's recent earnings call, Albert Baehny, the Interim CEO, provided an overview of the company's Q1 performance and outlook for 2024. They reported a softer Q1 but expect performance to normalize over the first half of the year, aligning with full-year expectations. Despite this slower start, they maintain a positive outlook for the second half, driven by the timing of commercial batch releases. The expectation for flat constant currency sales growth and a CORE EBITDA margin between 27% to 29% remains unchanged.
Lonza continues to advance its growth projects, particularly at their site in Stein, Switzerland. They are on track with constructing a large-scale commercial drug product facility and expect to begin operations later this year. Within Q4, the production of the first batches in their highly potent API Small Molecules facility is anticipated. Each division showed varied performance. The Biologics division, despite a slow start due to high deliveries in Q4 2023 and shifts in campaign schedules, exhibited strong commercial demand and saw early improvements in biotech funding. Their Mammalian business anticipates significant growth from an agreement with Roche to acquire the Genentech, Vacaville sites.
The Bioconjugate business exhibited robust growth, spurred by new assets and strong demand. Post completion of activities with Moderna, Lonza is focusing on their new clinical asset in Helen, expected to go online later this year. Drug Product Services continued to grow, albeit at a slower pace, extending its offering into late-stage clinical and commercial products. The Microbial division showed solid progress, driven by new assets and strong demand, and the Synaffix integration into their licensing business proceeded smoothly. The Small Molecules division, facing challenges from early-stage biotech funding, is also seeing early recovery signs with planned facility upgrades and campaign timing expected to bolster H2 performance.
The Capsules & Health Ingredients division faced softer-than-expected sales and margin performance due to overcapacity and post-COVID destocking pressures in Western markets. However, the nutraceuticals demand began recovering after a period of destocking. To mitigate these challenges, the division is managing costs and continuing its commitment to innovation. In corporate news, Lonza continues progressing with its CHF 2 billion share buyback program, having repurchased CHF 1.3 billion in shares. They have also confirmed Wolfgang Wienand as the new CEO, set to start in the summer.
Lonza reiterated confidence in its 2024 outlook, despite the initial softer performance in Q1. They are focused on capturing value through an expanded commercial offering, cost management, and operational excellence. The company’s guidance did not account for potential impacts from the BIOSECURE Act, maintaining a cautious but optimistic stance on the funding environment’s improvement, which they expect to positively influence revenue towards Q4 2024. The strategic acquisitions and partnerships, especially the Roche deal, are anticipated to further bolster their market position.
In conclusion, despite a challenging Q1, Lonza remains on track with its growth projects and maintains a stable outlook for the remainder of the year. The continued progress in facility expansions, strategic acquisitions, and strong demand across various divisions positions them well for future growth. Investors should note the potential delayed impact of improved biotech funding on revenues and the ongoing commitment to enhancing their market offerings and operational efficiency.
Ladies and gentlemen, welcome to Lonza's Q1 2024 Qualitative Update Conference Call and Live Webcast. I am Sandra, the Chorus Call operator. [Operator Instructions] The conference is being recorded. [Operator Instructions]
At this time, it's my pleasure to hand over to Albert Baehny, CEO Interim. Please go ahead, sir.
Thank you for the introduction. Good morning, good afternoon, and welcome to our Q1 qualitative update. These calls are intended to provide a general business overview, so we will not be sharing numbers relating to our financial performance today. We will share a full financial update during our half year call on July 25. Today, I will start by sharing a view on the group and our growth projects, then provide a short update on each division. Our CFO, Philippe Deecke will then provide a brief update on our alternative measures, reporting changes, after which, there will be time to answer your questions.
We reported a softer Q1 group performance, also, performance across the H1 is expected to normalize and align with the full year trajectory. We expect solid H2 sales, reflecting the timing of commercial batch releases. In this context, we are confirming our outlook for 2024, with flat CER sales growth compared to prior year and a CORE EBITDA margin in the high 20s or between 27% to 29%.
Turning to our growth projects. We continue to see progress in line with plan at our site in Stein, Switzerland. We're on track with the construction of our large-scale commercial drug product facility. In this, Switzerland, we are on track to commence operations with our large-scale Mammalian drug substance plants. And in Q4 of this year, we expect the production of our first batches in our highly potent API Small Molecules facility.
Now let's take a look at each of our divisions. There is good momentum across the Biologics division despite a slower start in Q1, which was impacted by high delivery in Q4 of the prior year and some campaign shifts between Q1 and Q2. We see strong commercial demand, and while small scale demand remains soft, we are beginning to see improvements in biotech funding. However, we should note that these early signs of recovery may take 6 to 9 months to impact our revenues. Our Mammalian business will also benefit from significant future growth through our agreement with Roche to acquire the Genentech, Vacaville sites. Our Bioconjugate business unit saw strong growth, supported by a strong demand and the ramp-up of new assets. In mRNA, we have concluded our activity with Moderna, and we are fully focused on building the pipeline for our new clinical asset in Helen, which will come online later this year.
Our Drug Product Services business is aligned to the clinical markets, meaning it is continuing to grow, but at a slower pace compared to previous years. Here, we are working on extending our offering and assets into late-stage clinical and commercial products. The first commercial fill and finish program in Visp reached a key milestone in Q1 as it successfully completed its process performance qualification.
In Microbial, the business continues to develop strongly supported by the ramp-up of new assets, changes to our portfolio mix and also a solid demand. Finally, the integration of Synaffix into our licensing business is proceeding smoothly, and we continue to receive positive market feedbacks on our expanded offering.
Turning to our Small Molecules division. We continue to see strong commercial demand with good visibility, supported by high levels of committed business. Biotech funding challenges have impacted the number of early-stage customer signings, but we are seeing first signs of recovery. The business is further supported by our continuing portfolio shift to high-value and complex small molecules and the strong growth of our highly potent API offering. Campaign timing will lead to a soft H1 in the division, followed by a stronger H2.
Looking at our Cell & Gene division, we are delivering improvements in our commercial and operational performance in our Cell & Gene technology business. This has been joined by strong sales and continuing customer interest in our commercial offering. In Bioscience, market headwinds have impacted sales mainly in our media business, but we are managing profitability through strong cost discipline.
Turning to the Capsules & Health Ingredients division, sales and margin performance was softer than expected. In the U.S., demand for nutraceuticals has begun to recover after a long period of post-pandemic destocking. However, overcapacity in the market continues to place pressure on margins. Demand for pharma hard capsules has been softer than expected in Q1 in Western markets due to continued post-COVID destocking. To mitigate the impact of these developments and protect margins, the division has undertaken a cost management program along with its continuing commitment to innovation and customer value. We have also successfully piloted our new generation capsule manufacturing technology.
In corporate news, we are continuing to make progress with our share buyback program of up to CHF 2 billion, which was announced in 2023. As of March 31, we have repurchased 1.3 billion of shares with an intention to complete the program in H1 2025. Finally, we have confirmed the appointment of Wolfgang Wienand as the new CEO of Lonza Group. He will commence his new role in the summer.
To close, I will summarize by saying we are in line with the expected trajectory towards our outlook 2024. Looking at our industry fundamentals, we remain well positioned to capture value by maintaining our focus on growing our commercial offering while managing our costs and continuing to drive operational excellence.
With that, I would like to thank you for your attention, and we'll now pass over to Philippe.
Thank you, Albert. Before we move to the Q&A, I will take a moment to take you through the external reporting changes in our alternative performance measures, which were announced today. Effective for the financial year 2024, we will apply revised definitions of our core EPS, free cash flow and divisional CORE EBITDA performance measures. The decisions to revise the definitions of these performance measures is based on feedback from our investors and a thorough internal review. Our H1 2024 reporting will be aligned with these new definitions.
The changes will improve the year-on-year comparison of Lonza's results as well as comparisons with our peers. The first change is to CORE EPS. Going forward, amortization of intangible assets from acquisitions is excluded from the CORE profit and therefore, CORE earnings per share. This exclusion is common across the industry and will increase comparability for investors. For free cash flow, the noncash items, change in provisions and share plan costs included in EBITDA are added back for the free cash flow calculation. In addition, the utilization of provisions is considered as well.
Finally, for divisional CORE EBITDA, group-wide investments such as group IT infrastructure, have been reported within corporate and related depreciation and amortization were previously allocated to the divisions. With the updated approach, the divisions will add back the depreciation and amortization included in the general cost allocation. This will result in an improved divisional CORE EBITDA with no impact at group level. More details on these changes are available under the Investor Relations section of Lonza's website. In the same place, you can also find restated financial information on CORE EPS, free cash flow and divisional CORE EBITDA for full year 2023 and full year 2022 as well as H1 2023.
Thank you for your time. And I will now hand over to Sandra to host the Q&A.
[Operator Instructions] The first question comes from Gary Steventon from BNP Paribas.
Maybe firstly, just on phasing and the phasing of growth. You called out of the softer Q1, but you say that H1 is to align with the trajectory implied by your guidance, so an improvement in Q2 and then expectations for a solid H2, which suggests again, sequential improvements to performance as you progress through the year. So could you talk a bit to the trends and performance you've seen since the end of Q1? And how much of that is batch phasing versus actual underlying momentum?
Thank you for the question. Let's start with the softness in Q1. What are the key reasons? First of all, phasing of commercial CDMO batches between Q4 2023, Q1 2024 and Q2 2024, both for large-scale mammalian and small molecules. In this context of phasing, to some extent, Q1 2024 has been disadvantaged versus Q4 '23 and will be disadvantaged versus Q2 2024. At the same time, Bioscience had a weaker start than predicted, mainly coming from a weaker demand for mammalian. This was driven by softer demand in early discovery activities.
The softness in biotech funding has impacted also R&D activities and research institutes and laboratories, which impacted this mammalian business. But there is no indication of a structural change. At the same time, during Q1, we had a very strong microbial business, extremely strong bioconjugate business, licensing did extremely well and with a solid Cell & Gene technology business as well. And DSPS, Drug Product Services continued to grow but at a lower pace in Q1 2024. Those are the key reasons for the softness in Q1, but also don't forget the strength of many other business units in Q1.
The next question comes from Charles Pitman from Barclays.
Charles Pitman from Barclays. I just have a question on the current market developments that is noticed announcing the acquisition of Catalent and taking it potentially a pure play [ CDMO ] market? And just I'd love your thoughts on where you see a potential opportunity for Lonza going forward? Is fill and finish an area that you would seek to expand further? Is this something that could cause you to increase your long-term CapEx opportunity?
Thank you for the question, as you are -- of course, we are not sitting in the boardroom of Catalent and of Novo. So it's very difficult to us to predict what will be happening, and we don't want to speculate on this acquisition of Novo Holding, Novo Nordisk of Catalent. Clearly, it will put pressure on fill and finish, and we believe there could be a tight supply-demand balance in the fill and finish world in the future, but we are not prepared and willing to comment more because we don't want to speculate on that.
The next question comes from Vineet Agrawal from Citi.
Vineet from Citi. I hope you can hear me. Just one question on Vacaville. Just wanted to see where you are in the process of closing this transaction and does 2024 guidance include any contribution from this asset?
Philippe, why don't you take that question, please?
Vineet. So look, our expectations have not changed since the call we did. So we expect to close this transaction in the second half of 2024. And I think our guidance, as I said, does not include any Vacaville components, but we did as well mention that we wouldn't expect any impact to this.
The next question comes from Thibault Boutherin from Morgan Stanley.
My question is on Capsules & Health Ingredients. It seems that the headwinds from last year are maybe dragging a bit longer than expected. And so I just wanted to ask if on this division, in particular, you're expecting a recovery this year or if it's more a question of managing margins in the context of demand compared to what you're expecting at the beginning of the year?
Let's start by summarizing what is happening now in this capsule business. In pharma, we have seen in Q1 a weakness in demand in Europe and in North America. And we are cautious about the market recovery during 2024. And we made some price concessions to keep some businesses with key customers. So weakness in demand in pharma, cautious about the market recovery during the year. In nutraceuticals, the demand is stabilized, but we have seen pressure mainly in North America on the nutraceutical capsules business.
The next question comes from James Vane-Tempest from Jefferies International.
Just regarding the adjustments to the core definitions, I understand these are reconciled at the group level, so no impact. But given you gave segment EBITDA margin guidance over time, how do you expect the impact to revolve? And how should we consider this in the context of the relative benefit to the segments in 2028 versus your guidance given?
Philippe, please.
Yes. Thanks, James. So look, I think you have seen the difference that this reporting change does to our divisional EBITDA. And I think this is going to grow maybe a tiny bit as the underlying group projects increase, but this should not be distorting the figures going forward. So you just have a new base with what we provided you now.
Next question comes from Patrick Rafaisz from UBS.
A question on small molecules. You talked about the campaign effect here on H1 and H2. Just to get an idea of the size of this impact, can you compare this to what we saw in 2022 where we had a pretty substantial impact here in small molecules of about 100 million or so per semester, is that the same order of magnitude, smaller or bigger?
Thank you for the question, Patrick. The answer I don't know, would be honest. I can't remember what happened in 2023, 2022. The impact, I wouldn't say it is not too relevant. It is rather marginal, but it will have an impact in H2, a positive impact. And I have to mention that in H2 this year, in the fourth quarter, we will start to ramp up our new HP API plant in Visp. This will add additional sales versus H1 2024. But I can't quantify the difference between 2022 and this year. I hope it helps.
The next question comes from Charles Weston from RBC Europe.
Mine is on the [ CTT ] business and specifically the Cell & Gene development and manufacturing side. That business seems to have picked up quite nicely. Is that a market demand driver? Or is it more specifically programs that you've had that are progressing into later stage?
It's a combination of both, very good solid demand and also the number of programs we have in our portfolio. And as we said already in the past, we are expecting maybe 3 to 4 programs becoming commercial during this year and next year. So a combination of strong demand and also the quality of our portfolio in the Phase III.
And that demand is coming even from biotechs as well?
It is coming from biotech, mainly from biotech and also from pharma. But the Cell & Gene technology business is mainly biotech driven.
The next question comes from Max Smock from William Blair.
On the Vacaville acquisition call, you noted that you're already having conversations with customers as a result of the BIOSECURE Act. Just wondering if there's any sort of update you can give this morning around how that bill is potentially driving more opportunities for you here in the near term? And then my understanding is that WuXi Biologics has been more focused on scaling out with small bioreactors versus scaling up with large-scale bioreactors that you all are adding at Vacaville. So can you talk about how your mammalian offering overlaps with WuXi and how well positioned you would be to pick up some of that work that is potentially coming off WuXi's platform or work that would have gone to WuXi's platform, if not for the bill.
Let me make a few general comments on the BIOSECURE Act, and then maybe, Philippe, if you want to say a few words on Vacaville. On the BIOSECURE Act, there is today a lot of noise in general. We see and we hear a lot of noise of political nature into the U.S. election and the noise will certainly continue to surface. At the same time, there are a lot of reports with a lot of speculations.
However, let's be fair, the implementation of the BIOSECURE Act in any form remains to the unknown and uncertain. And in this context, we are not willing to speculate and not prepared to determine the magnitude and the timing of any potential impact on our business. It means that there is no BIOSECURE Act top line impact in our guidance today. Do you want to add something on that, Philippe?
No, the BIOSECURE Act it is clear. We don't want to speculate on something which is still highly uncertain and add speculative. No, I can say a few words on Vacaville.
Sure. Yes.
So max, as you rightly say, I think Vacaville is a large-scale facility. And as we were going through the due diligence process, of course, we were looking at the pipeline of opportunities that we have visibility on. And this made us confident that there's enough demand in the market for us to ultimately utilize the site. And so we're not necessarily looking at stealing business away from others, but we have now capacity that will be available as soon as we close the deal.
We have capacity that we know is working and is able to produce high-quality drugs in the U.S. And so this is a big selling proposition that we have once we close the deal. Now the Vacaville side is not, per se, designed to replace a small scale work that may have been done by WuXi, but that's not really a point that we need to discuss now.
The next question comes from Falko Friedrichs from Deutsche Bank.
My question is on your visibility on the phasing between Q1 and Q2 in Biologics. What gives you the confidence and certainty that this doesn't get pushed out further into the third quarter. And then we might all of a sudden be sitting here and looking at a much weaker H1 versus H2 and a much more back-end loaded guidance. So anything you can give us on your visibility would be super helpful.
Thank you. I can only qualify that we have a very good visibility because it is on contract deliveries in both biologics and small molecules. So we feel confident with our qualitative statement, which we want and can't quantify today, but we feel confident with what we are saying between Q1 and Q2 and H1 and H2 because of this excellent visibility in our contract deliveries.
The next question is a follow-up from Charles Pitman from Barclays.
I just wanted to pick up on something you said earlier talking about trying to expand your product offering and improve your offering to the clinical market. And I just wonder if you expand on that a little bit, whether or not that would cause any further M&A, would that be of interest to you?
At the moment, we are not on an M&A trip. We always said that the acquisition will be bolt-on type of acquisition, and we want to buy a rather technology IP than big businesses. The exception maybe was Vacaville, which is still, to some extent, a bolt-on acquisition and account capacities, but we have no plans for any new bolt-on type of acquisition in the very near future.
Also the next one is a follow-up from Thibault Boutherin from Morgan Stanley.
Just a general question on clinical capacity utilization in the industry. You closed 2 of your manufacturing sites, 1 in China, 1 in the U.S. focused on clinical manufacturing. Just wanted to know if you are seeing similar efforts in the industry in terms of capacity normalization which could improve utilization in the long term? Or if you're not really seeing a decline in overall capacity for clinical assets in industry?
We have not seen officially at least, I would say, same trend in the market. There is not a trend to eliminate capacities in the market. I'm not aware of that. We decided to do this because these 2 plants were not productive enough, were not efficient enough, were not profitable enough, and we have enough capacities to substitute the closure of these 2 plants, but in the industry, we haven't seen a trend for eliminating capacities.
The next question comes from Gary Steventon from BNP Paribas.
Just on biotech funding and the recovery that you're seeing. Can you just talk here perhaps your expectations in terms of the pace of recovery in 2024. I think your full year guidance for full year '23, you mentioned you expected the rebound more in 2025 and that, that was no rebound assumed in the 2024 guidance. Earlier on, I think you mentioned a 6- to 9-month time lag, any improvement flow through to sales. So that could slip into the end of this year. So just how you're thinking about the potential for any contribution from a recovery in order to stage funding to flip into that 2024 guidance.
Thank you for the question. Funding environment has improved or started to improve in Q4 2023 and that continued to improve in Q1 2024, with a very high level of funding at around USD 23 billion in Q1 2024. Nevertheless, we see that biotech customers are more cautious about spending their cash at hand. And you should not forget that there is a delay of 6 to 9 months between funding and any impact on our business and on our revenues. And please let me remind you that we generate around 70% of our total CDMO sales from commercial deals. Said differently, we will not see any positive impact on our revenues before early as Q4 2024. But the funding environment is improving significantly.
The next question comes from Charlie Haywood from Bank of America.
Charlie Haywood, Bank of America. How you assume that you guided for Biologics EBITDA midterm margin of over 35%, which wasn't updated on your Vacaville acquisition announcement. Given that, that site is expected to be dilutive to your CORE EBITDA margin over the midterm period, are you still confident in achieving that 35%?
Philippe?
Yes. Thank you, Charlie, for the question. So again, as we said during the call, we have not yet guided more specifically on Vacaville. We gave you the overall view that we were keeping the group margin guidance for 2028, which basically translates to Vacaville being plus/minus neutral at this point in time. So that's as much as I can say for now. And once we close the deal and once we own the asset, we will be able to guide the market much more properly.
We have a follow-up question from Vineet Agrawal from Citi.
Yes. I just had a quick question on the new business or contracts. Last year, I think you signed new long-term contracts, which were slightly annual average of preceding 3 years. Can you comment on how the new business wins are tracking to date? And what sort of backlog do you have at the moment?
I must confess I didn't get it correctly. Philippe, answer.
Yes. So Vineet, yes, as we stated, we basically signed CHF 10 billion worth of business last year in biologics and CHF 1 billion in small molecules. This was significantly ahead of what we've done on average over the last 3 years. Now contracting continues, but these size of deals that don't happen on a regular basis. So yes, we are happy with the contracting is going on, but we are not sharing this number on a quarterly basis. We're happy to give you an update once we complete 2024. And then second, I think backlog is not something that we use as a communication metric.
The next question is a follow-up from Max Smock from William Blair.
Just wanted to follow up on an earlier question around the weakness in Q1. Wondering if there's any breakdown or just a rough high-level overview of how much of the shortfall is due to phasing and biologics and small molecules versus -- and these issues, obviously, you have high visibility into normalize and moving forward versus how much of that was due to softer demand unrelated to timing issues? And then in terms of your midterm guide, you took it up in April after the softer Q1. So can you help us understand the thought process behind results being below expectations, you having enough conviction to take up your outlook through 2028.
On the softness, we are in a qualitative call, and we will not quantify the weaknesses versus the previous quarters. I repeat it that were phasing of commercial batches between Q4, Q1 and Q2, and they are affecting mainly Q1 '24 to the benefits of Q4 '23 and Q2 '24. Bioscience, as we said it was weaker than expected, mainly in the media business because of softness in biotech funding, but we are not prepared and willing to quantify that.
Thank you for the question. And now we take the last question.
The last question for today's call comes from Stephan Wulf from Oddo.
Yes. It's one on the leverage. So with the acquisition, we have the capacity from Roche and the related issuance of your EUR 1 billion bond, you leverage an increase quite somewhat. So what does this mean for further allocation to shareholders beyond the current share buyback program?
Philippe, you want to try the answer?
Sure. Thanks, Stephan. So we mentioned that even with the acquisition of Vacaville, we would stay committed to our BBB+ rating. And so that range is basically between 3x -- up to 3x leverage. So I think we believe we have the plans to stay well within that guidance.
Thank you for your participation. Thank you for your questions. Looking forward to talking to you soon again on July 25 for H1 results.
Ladies and gentlemen, the conference is now over. Thank you for choosing Chorus Call, and thank you for participating in the conference. You may now disconnect your lines. Goodbye.