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Earnings Call: H1 2021

Feb 18, 2021

Speaker 1

Ladies and gentlemen, good morning and welcome to CSL's Half Year Results Call for Fiscal 2021. It's Mark Dearing speaking and joining me online is Paul Perrault, CSL's Chief Executive Officer and John Levy, who is our Interim Chief Financial Officer. As with past practice, Paul will provide an overview of the results and operations and then John will provide some additional detail on the financials. We'll then move to Q and A. Look, with a view to giving everyone an opportunity to ask questions, could you please limit your questions to 2?

If you do have further questions, you are, of course, welcome to rejoin the queue. And please note, this briefing is being webcast. And lastly, Before we start, I draw your attention to the forward statement disclaimer contained in the slide deck. I'll now pass you over to CEO, Paul Perrault. Over to you, Paul.

Speaker 2

Thanks, Mark, and good morning and thank you for joining today's review of CSL's first half year results for 2021. As usual, I will provide, as Mark said, an overview of the results and the highlights and I'll hand over to John, our Interim Chief Financial Officer, who will provide more on the detailed financials and conclude with an update on our outlook. And as Mark mentioned, of course, always happy to take your questions. So With that, let's move on to the Slide 3, which is our first half twenty twenty one performance and I'm Very pleased to report that CSL delivered a very strong first half with revenue up 15% at constant currency and net profit after tax Up 44% at constant currency. This is an excellent performance, especially given the difficult and uncertain environment we've all faced with COVID-nineteen.

This result is not only a reflection of CSL's diversified and resilient business model, but mostly our dedicated employees who've remained focused on delivering on our promise to patients and to public health around the world. Some of the first half highlights are for CSL Behring, Earnings before tax and interest was up 24%. This was driven by strong performance of Hizentra, our market leading subcutaneous IG product, which was up 19%. Albumin sales grew 93% due to the successful transition to our own distribution model in China. Hey Garda continues to show solid growth and increased 16%.

CSL Behring has also been very busy manufacturing COVID-nineteen vaccine For the Australian government and our Broadmeadows facility, our influenza's vaccine business, Securus, delivered an exceptionally strong performance with its EBIT more than doubling to $693,000,000 Sales of seasonal influenza vaccines were exceptionally strong at 44%. And the business achieved a strong increase in its gross margin due to its high value and differentiated product portfolio. We also announced for Securus to construct a new world class biotech manufacturing facility in Melbourne, Australia. COVID-nineteen has certainly presented us and our industry with some challenges. However, we ensured our critical operations were well managed and maintained a real credit to our People that are right across the CSL group.

Later, I'll review details on how COVID-nineteen impacted our business, But at a high level, I would say the pandemic has tempered the performance of CSL bearing whilst boosting the performance of Securus. Plasma collections have continued to be challenging. However, we have actively put multiple initiatives in place and starting to see monthly improvements. Despite this challenging environment, CSL is well placed to emerge even stronger when the COVID-nineteen crisis recedes. Under the next slide where we have CSL bearing sales by therapeutic areas.

The portfolio recorded overall sales growth of 11% to constant currency. Immunoglobulins, our core franchise was up 7%. As I mentioned earlier, albumin was up 93%, Hemophilia was up 1% with specialty products up 3%. I'll go into more detail with each of these shortly. In terms of the geographic splits, you can see the broad reach of CSL bearing sales with our 2 key markets North America and Europe.

All regions recorded solid growth with Asia Pacific up 79% as a result of the strong growth in albumin in China. Immunoglobulins on Slide 5, demand for IG continues to be robust, driven by chronic indications, primary immune and secondary immune deficiencies as well as CIDP. And despite those challenges that I mentioned associated with COVID-nineteen, Our IT franchise still grew at 7%. This was led by strong growth in Hizentra, which I mentioned earlier was up 19%. In August last year, I said we were seeing early signs that COVID-nineteen was driving increased usages of Hizentra.

This has really come through strongly in the 6 months to December, given the preference for home treatment and the innovative nature of this product. Hizentra is an attractive option for patients. It gives them the convenience to self administer at home and with its other features such as flexible dosing and prefilled syringes. Hizentra assists patients to better control their disease state even more so than with the COVID-nineteen restrictions. Hizentra has also seen a continued uptake for the treatment of CIDP in the U.

S. Hizentra continues to build its leadership position. This relatively new orphan drug exclusivity for CIDP makes it the only subcu product with a CIDP label in the United States. More than 60% of our priority target physicians have now adopted Hizentra to treat CIDP patients. On the IVIG side, Pravagen grew modestly.

Disruptions and delays in infusion centers as a result of stay at home orders and Preference for home treatments such as Hizentra and the tightness of plasma supply have all tempered Pervogen's growth. As many of you know, IG supply was tight even before the pandemic. As global IG demand remains strong, this tightness of supply has intensified during COVID. Accordingly, we are closely managing our supply chain and have taken steps to avoid any significant supply disruptions. For example, we implemented a customer order fulfillment process to ensure fair and equitable supply to current customers.

Further, we are not opening many new accounts or taking new customers, but are focusing on supplying products to current customers. As I've always said Once we have patients on product, we want to continue to supply those patients. Turning now to albumin on Slide 6, where sales growth was up 90 3%. This reflects the successful transition to our own distribution model in China, where our Buman sales have now returned to a more normalized level after the one off impact we saw in the previous year. Having our own distribution model now in place will help improve our participation in the value chain and strengthen our sales and marketing efforts in China.

Excluding this change, our end market sales of albumin in China grew in the high single digits and we have maintained our market leadership. There has been some impact to hospital operations as a result of COVID-nineteen in China, But this has now returned to about 90% of normal. Whilst the competitive environment in China has increased, demand for albumin is still expected to be in the mid to high single digits. Outside of China, we have achieved strong growth in Europe and emerging markets, whereas in the mature U. S.

Market sales have been steady. Overall excluding the GSP impact in China sales of albumin were up modestly. Looking ahead, we expect an increase in albumin utilization and the treatment of liver cirrhosis and a preference for albumin over artificial colloids. On Slide 7 is hemophilia. Overall growth in the hemophilia portfolio was tempered by reduced doctor visits and patient consultations during COVID-nineteen, simply a function of lower societal movement.

However, against this challenging backdrop, Adelvion, our long acting Recombinant Factor IX product for hemophilia B recorded an impressive 6% growth. Its compelling clinical profile continues to drive patient demand with new patients and patients switching from other Factor IX products contributing to its growth. In a very competitive hemophilia A market, sales of our other recombinant coagulation product are still that were steady and the market competitiveness This also impacted our plasma derived hemophilia products. This was offset by some extent to a 6% increase in Humate, which is a leading product in the U. S.

For the treatment of Von Willebrand disease. On to Slide 8 in specialty products. Overall, specialty product sales grew 3%. The standout performer was Hey Garda, our transformational therapy for treating patients With HAE or hereditary angioedema, AGRTA grew strongly up 16% as new patients continue to take up the therapy. Also contributing were new launches in Europe and Australia, which exceeded our expectations.

Virenerd has steady It was steady as patients switched to more effective prophylactic products including Agarda. Despite this, Veronert continues to play an important role in the HAE market providing a safe and efficacious option for patients to treat acute attacks. The other main specialty product to record solid growth was Kcentra, which is up 6% and I think really impressive, but somewhat tempered by the current COVID environment. Generally speaking, the pandemic has caused a reduction in surgery and fewer incidents of trauma, both affecting the utilization of Kcentra. So in this COVID environment, the 6% was I think a really great result.

This dynamic has also impacted other hospital products. Sales of wound healing products We're down 26% and Re Establish flat. For Alpha-one and total Alpha-one sales were down 7%. Sales of Ximera were down in the U. S.

Following a supply interruption at Kankakee. The root cause of the issue has been identified and a plan is in It has been approved by the regulator to move ahead to resume supply. For RISPRISA, growth has been very strong following successful launches of the product and Europe. Turning now to plasma collections. As I mentioned earlier, COVID has presented us and continues to present us Many challenges including our ability to collect plasma.

All of our plasma collection centers have remained open and operational in the United States during the pandemic. However, the incidence from the spread of the virus in the U. S. Has led to measures such as social distancing, stay at home orders, restricted mobility of donors. Combined, these have had an adverse impact on our plasma collection volumes.

Additionally, the U. S. Government stimulus packages have also influenced plasma collection. As a result, Our collection volumes in December 2020 were around 80% of what we collected a year earlier in December 2019. Various COVID related hygiene measures also added pressure on the cost per liter of plasma collected.

To address the lower collection rates, we have implemented a number of initiatives to increase plasma collections. I'm pleased to say they have been Effective and month on month improvements are underway, which I'll show you on the next slide. First, I'd like to share some detail around that CSL Plasma has been undertaking to increase plasma collections. We've enhanced our marketing efforts and these include Increased plasma donation awareness and education to promote the importance of plasma donation, retention and reactivation campaigns for previous donors and referrals for family and friends. We've adopted new technologies such as a donor app, mobile phone video Consent and self administered health history questionnaire kiosks.

Usages of these technologies are growing and providing donors with a better user experience as they enter the centers. As the rollout of COVID-nineteen vaccines becomes more widespread, Mobility is expected to increase and lead to more foot traffic at our collection centers. CSL also led an industry initiative, which was It's been introduced and approved by the FDA. Now the whole period for plasma reduced by 15 days providing accelerated way to provide patients with the life saving medicines they need. We've been managing our supply chain very carefully and utilizing the available finished goods wherever possible.

We continue to lead the industry in new plasma collection centers. We opened 17 new centers in the first half and plan to open another 12 in the second half. We now have a network of over 280 centers globally and our centers are the largest and the most efficient in the industry. And finally, as our volumes recover, our cost per liter will reduce in line with the fixed cost distribution that we have across the business. So if I move to slide 10 in the plasma collections graph, you can see what's happened with the plasma collections and how our initiatives driving growth in donors.

On the graph, we have the number of donors that have come into our centers on a weekly basis. The black line is calendar 2019, the red line is 2020. As you can see, there is normally a seasonal dip In February March as tax refunds are distributed in the U. S. Then you can see where the pandemic hits and the lockdown begins in March April causing donor numbers From here, we see the numbers starting to stabilize.

In May and then in June, our initiatives are launched. We see an improving upward trend for the 6 months to December. There is a typical dip at the end of December, which is consistent with previous years and this is due to the holiday season. In summary, plasma collections have been challenging and will continue to be challenging. We have a range of initiatives in place to counter and we're focused on ensuring our plasma collections keep going in the right direction.

As you've heard me say before, collecting plasma is one of the hardest things we do at CSL. We're determined to get our plasma collection volumes back to where we want them to be. They're improving, but they're not there yet and we'll keep striving because our patients depend on us. Moving on to Slide 11 and our influenza vaccines business, Securus. Securus delivered an exceptionally strong performance.

For the first half, Sakerus reported revenue of over $1,400,000,000 a growth of 38%. This was driven by very strong sales and seasonal influenza vaccines of some 44%. Northern Hemisphere continues to be the dominant market for Securus with the U. S. And Europe accounting for over 90% of Securus sales and the period with both regions delivering strong growth.

Sales in Asia Pacific were down 9% or $8,000,000 due to lower in licensed vaccine sales as a result of COVID-nineteen. Garda sales declined since there was less international students in Australia And also the sales of travel vaccine, DUCRO, was impacted by the international travel bans. Continuing with Siqueuris on the next slide, the operating highlights included the significant growth in seasonal influenza vaccines, Seeing a record number of more than 100,000,000 doses sold in the Northern Hemisphere. COVID has been responsible for driving high demand for influenza vaccines as Governments around the world look to protect their populations from influenza so that the healthcare systems are not burdened or stretched further during the crisis. Securus has continued to benefit from the ongoing shift in the portfolio to our differentiated and high value influenza products Such as the cell based vaccine to Cellvax produced at Holly Springs and our adjuvanted vaccine for the elderly market flu ad.

Some other key milestones for Sakerus included the successful launch of Fluidad QIV in the U. S. And the re launch of business in Germany. To cope with the increased demand, all operations were maintained during the pandemic and capacity expansions at Holly Springs and Liverpool are well advanced. Finally, Securus has been instrumental in providing support for COVID-nineteen vaccine efforts and supplying our MF59 adjuvant to various vaccine candidates around the world.

Moving over to R and D on Slide 13. Now there's a lot On the slide, and it shows that we have a deep pipeline in R and D underpinning our company's future growth. In the interest of time, just a couple of highlights beginning with immunology. Provigen for this treatment of CIDP was launched in Japan. This is a great achievement in a tough market to get new indications.

In hematology, UniCure announced late breaking preliminary data from their pivotal Phase 3 trial of entronidaz. As you know, a product that we're in the process of acquiring. In cardiovascular and metabolic, the Phase 3 for CSL-one hundred and twelve continues Progress well, but now over 11,800 patients enrolled. In influenza vaccines, So it says 11,500, but I just gave you the most recent number. So just so there's no confusion.

In influenza vaccines, we have commenced the Phase 2 study for our adjuvanted QIV cell vaccine and we're undertaking preclinical assessment of mRNA Technology for Influenza. R and D COVID-nineteen response on Slide 14. Right from the beginning of the pandemic, we have really been focused at CSL on using our capabilities and expertise to respond to this COVID crisis. This has led us to reprioritizing our R and D projects Had some significant disruption to the company's normal activities. We've redeployed and recruited 400 personnel and we've pause clinical trials which are all now back up and running.

One of the major programs that we were working on was the development of a COVID-nineteen gene vaccine with the University of Queensland. This involves substantial activity across the company, including advanced preparation for the planned Phase 3 trial, Extensive retooling of our facilities scaling up and producing material to produce 11,000,000 doses to support the contract with the Australian government. Although the vaccine was progressing well due to testing issues, the program was ultimately halted and orders from the Australian government were canceled. In parallel to the UQ program, CSL entered into an agreement with the Australian government to manufacture 30,000,000 doses of the Oxford University AstraZeneca COVID-nineteen vaccine candidate. With the UQ candidate vaccine halted, CSL pivoted quickly And our attention was focused on accelerating the manufacture of the Oxford University AstraZeneca COVID vaccine candidate and supply an additional 20,000,000 doses ahead of the original schedule.

Manufacturing is well underway and the first doses are planned for release in late March, having just received TGA approval. In addition to our work on vaccines, we've also been working on COVID treatments. As a founder of the COVID-nineteen plasma alliance, CSL has made good progress with its partners on developing a plasma derived hyperimmune We're treating among the most severe complications resulting from COVID-nineteen. Phase 3 clinical trials are underway And CSL is producing trial lots at our Swiss facility. If successful, this will become one of the earliest treatment options for hospitalized COVID-nineteen patients.

I'm going to now hand over to John to go through some of the financials in more detail. John?

Speaker 3

Thank you, Paul. Good morning, everybody. It's a pleasure to be talking to you and reporting this really strong half year result. So turning to the financials. As we've reported, profit has increased both from $1,248,000,000 to 1 €810,000,000,000 an increase of 45%.

At constant currency, profit was €1,794,000,000 an increase of 44% after adjusting for an FX tailwind of $16,000,000 Included in the panel on the right are a number of Areas that Paul has already touched on, the transition is complete to our GSP, China business and sales of albumin have normalized. Securus had an unbelievably strong first half growth of differentiated products together with some manufacturing efficiencies. And we have responded to the COVID-nineteen pandemic in a number of ways and that's impacted on our financial statements through a number of different ways. We've had impact on R and D costs. We've incurred some costs on the reengineering of our facilities to be able to manufacture.

There have been some cost savings driven by just the changing environment in which we operate. And we obviously also have received some funding from government here in Australia in respect of the manufacturer of the COVID vaccines. In total, that represents a one off impact on net profit for the first half of around about US80 $1,000,000 Turning to more detail on the financials. Total revenue was up 15% on a constant currency basis to 5,653,000,000. Gross profit of €3,423,000,000 at constant currency was up 20%, reflecting a 270 basis point improvement in gross margin.

EBIT was up 42% on a constant currency basis with an associated EBIT margin expansion of 7.90 basis points improvement over the prior year. The margin expansion is largely a function of secure sales of new generation products. This flows down to net profit after tax and EPS, both up 44% at constant currency. Turning to cash flow. Cash flow from operations was €2,300,000,000 an 87% improvement on last year, Albeit positive in terms of percentage growth, this really is a reflection of the collections environment that Paul's just covered with a smaller pool of plasma donors resulting in lower cash payments for plasma, although these are at a higher unit cost in the short term.

We've also implemented ongoing cost control initiatives across the business and that has favorably impacted cash flow from operations for the period. Capital expenditure was down 13%. That's largely due to restrictions on-site access around the number of the major projects That we have across the globe driven by the COVID pandemic. The interim dividend is a US1.04 dollars per share, an increase of 9%. For Australian shareholders, this translates to a dividend of approximately AUD1.34 which is down 9% on the prior comparative period, driven by the strength of the Australian dollar over the past 12 months.

A little more detail on the segment results. Bearing revenue was up 9%, gross profit up 10% and EBIT up 24% all at constant currency. This reflects the demand that Paul has talked about for ongoing demand for our therapies, but also reflects the management of costs during the pandemic period. You'll notice a 54% reduction In other revenue, this is largely attributable to lower Gardasil royalties, driven by lower sales of Gardasil by Merck, largely in the United States and a one off favorable legal settlement that was reflected in the prior comparable period. For Securus, total revenue was up 38% and EBIT up 112%, reflecting the strong demand for products These drivers are also reflected in gross profit, which saw an increase of 64% of constant currency And an expansion of gross margin of over 1,000 basis points.

As was mentioned in August at the full year, the business, The Securus business has exceeded the long range financial targets when Securus was first formed 5 years ago. And I think everybody is now familiar with the seasonal nature of the business. The majority of sales are into the Northern Hemisphere and therefore reflected in the first half, Whereas a lot of the costs of the business are more evenly spread throughout the year, the upshot is that Securus, as it has in the past, will record a loss in the second So turning to expenses, walking through each of these items. R and D expense was down €24,000,000 or 5%. It's largely due to the impact of COVID On the R and D portfolio, as Paul highlighted, we had amended some of the projects, slowed them down, reprioritized in order to redirect to COVID vaccines.

However, with respect to the full year, we are still anticipating an R and D spend in the range previously guided of 10% to 11% of sales. Sales and marketing expenses are down 6%, Largely due to lower travel and marketing expenditure, again, due to the COVID outbreak. This is offset by an increase within Securus to support Current and future growth as well as entry to new market channels. In general and admin, down 18%, largely a function of initiatives to control expenditure that were put in place to in the environment of COVID uncertainty. The effective tax rate remains relatively steady at 20%, although for the full year, we do expect that to tick up to 22%.

As closing comment, while the group's expenses have been contained, as the global pandemic recedes, we would expect to see a lift in costs So societal mobility resumes and the business returns to some semblance of normal operations. With that, I'll hand back to Paul.

Speaker 2

Thanks, John. Returning now to Slide 20. I'll make a few comments on our outlook for 2021 and beyond before taking questions. The first point to note is that the full year result will be heavily Thank you to the first half. For the second half of twenty twenty one, the seasonality of the Securus business means that we'll make a loss, as John mentioned.

80% of our sales are made in the first half and the cost of goods as John mentioned are sold are relatively evenly spread throughout the duration of the year. Sales of albumin will continue to normalize following the transition to the new business model in China and the rate of growth in the second Half on the first half will not be as strong. Plasma products sold in the second half arise from plasma collected last year in a COVID environment. The higher cost of this plasma is expected to put some pressure on our margins. The additional work we've been doing on COVID-nineteen vaccines has resulted in the reprioritization of R and D projects and has resulted in the reprioritization of R and D projects and subsequently there'll be an increase in R and D spend in the second half as we restart the projects and build them back to scale.

For the full year, we do anticipate a return to our long term guidance of the 10% to 11% of revenue as John mentioned. Lastly, once COVID recedes and restrictions around social mobility are eased, we anticipate an increase in SG and A expenses. In terms of fiscal 2021 guidance, we affirm net profit after tax to be approximately $2,170,000,000 to $2,265,000,000 in constant currency. As per our usual practice, we'll be providing guidance for fiscal 2022 at our full year results announcements. So I'd like to finish up by making Some general comments about the longer term outlook for CSL.

We continue to believe the underlying demand for IG will remain strong. As with the second half of twenty twenty one, plasma collected today drive our 2022 sales for IG and albumin. We expect our collections to grow as the pandemic recedes and society returns to the more normal social mobility norms, Particularly noting the global community is on the cusp of a broad based COVID vaccine rollout. However, this takes time, Which means the impacts from COVID both positive and negative at a pretty heavy layer of complexity and uncertainty to our earnings profile until we get through this pandemic. COVID restrictions on social mobility Have also inhibited patients' ability to visit doctors, access emergency services.

And once these restrictions ease, we expect there will be an increase in product demand in general. And lastly, our multiple large late stage R and D programs underway provide potential new growth opportunities. I really do believe CSL is well positioned to emerge strongly when this pandemic recedes.

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