5/9/2023

speaker
Nuria Pascual
Investor Relations and Sustainability Officer

Hello, everyone, and welcome to the Grifols First Quarter 2023 conference call. Thank you very much for taking the time to join us today. This is Nuria Pascual, Investor Relations and Sustainability Officer, and I'm joined by Thomas Glassman, our Executive Chairman and CEO, Victor Grifols-Deu, our Chief Operating Officer, and Alfredo Arroyo, Chief Financial Officer. This call will last for about 60 minutes. There will be a presentation of approximately 30 minutes, followed by a Q&A session. If you want to raise a question, press star followed by five when the Q&A session begins. We will kindly ask you to limit your questions to a maximum of two, please. As a reminder, this call is being recorded. The materials for the call are on the investor relations sections at griffols.com. And the transcript and webcast replay of the call will also be available on the investor relations website within 24 hours after the end of the live conference call. Let me turn now to the legal disclaimer on slide two. And before we start, I draw your attention to the forward-looking statements, disclaimer on this slide, of the release. And forward-looking statements on the call are subject to substantial risk and uncertainties, speak only as of the call's original date, and we undertake no obligation to update or revise any of these statements. Now, I would like to turn the call over to Thomas Glassman.

speaker
Thomas Glassman
Executive Chairman and CEO

Thank you, Nuria, and thank you, everyone, for joining the call today. Before we turn to the specifics of our business performance, financials, and full year 23 guidance, I would like to make some introductory comments. Over the past few months, we had the opportunity, after many years, to meet in person with more than 80 investors and 60 investment houses in London and New York, addressing questions and concerns about performance, depth, governance, and whether any fundamental changes will be made directionally at the company of the plans that had been laid out. For me and the management team, these meetings were of great value and I would like to take this opportunity to thank all participants for their honest and often very direct feedback, which was much appreciated. We have indeed taken note of what we heard and were told. In light of that, I would also like to take this opportunity to reiterate my key messages from these meetings. First, and very importantly, Grifols is committed to creating value for all our shareholders and in restoring our credibility and trust of the financial community. As I noted in our meetings, we understand that to do so, we will need to consider to deliver on our commitments, which we are already doing and will continue to do. The priorities set with our board remain the same. We will improve our financial profile, reduce debt, execute and deliver our operating improvement plan, capture commercial opportunities, and unlock biotest substantial value. Today's Q1 results should give you confidence that we are very focused on doing just that. Third, we outlined that we would clarify governance, streamline the organization, and implement a performance culture that is aligned with our shareholders. In fact, over the last year, the senior leadership team has already made significant strides to reinforce our operational excellence, of which the most important first step was establishing a new organizational model. This involved the creation of four strategic business units and the appointment of new management under whom we have refocused our strategic efforts to accelerate growth. Upon my appointment as Executive Chairman in February this year, I quickly thought to streamline GRIFL's leadership structure, establishing a core senior leadership team with clear responsibility. And now, as yesterday was announced, my appointment to CEO further clarifies our decision-making process to accelerate GRIFL's growth and strategic progress. Victor has been appointed as the Chief Operating Officer, and Raymond Griffels has been appointed as the Chief Corporate Officer. We have now clearly defined the responsibilities of our senior executive leadership team, enabling us to continue to deliver on our successful transformation with the greatest accuracy and speed. I will return to this key topic in more detail later in the presentation. And returning to our commitments, our fourth commitment was to improve our communication with stakeholders, and we are and will certainly do so. We have our quarterly calls, and we will follow up on a regular communication with our global investor base. With the input from some of our investors, we have also decided to expand our IR footprint into the United States to better serve investors in North America. Going forward, we are also determined to expand our reach and continue to engage with equity and fixed income market participants. I hope and trust that you will walk away from this presentation with a sense that Griffles is stepping up and aggressively aligning all the needed pieces to position the company for a successful future. With that, let me turn to slide four to kick off our presentation. In 22, we set clear priorities to reposition the company and made a number of key commitments in our February 23 call. I am pleased to report that in the first quarter of 23, we are effectively meeting and exceeding our commitments while we continue to execute on key priorities. Griffles is on the rebound, and our operational delivery in this first quarter reflects this. while it also demonstrates the company's strong fundamentals in a growing market. So let me review a few highlights of the first quarter. As I mentioned earlier, we implemented significant changes to our executive governance, clarifying the leadership structure. In Q1, we also strengthened our performance culture by rolling out new short- and long-term incentive plans aligned with shareholders' interests. The new plans award participants for overachievement and for Griffill's share price appreciation in the long term. Now, turning to the numbers, we delivered a solid start to the year, meeting and exceeding on our commitments in some key metrics. Revenues grew by 23% and by 14% on a like-for-like basis, excluding biotests, driven by a strong performance of biopharma, which delivered an increase of 26% and by 15% like-for-like. Excluding biotest, adjusted EBTA margin for Q1 was 21%, exceeding the 19 to 20 guidance set for the first half of 23. Consequently, we are raising our guidance to above 21% for the first half and for the whole year to 22 to 24%. Therefore, we now expect to exceed the €1.4 billion EBTA guidance for 2023. The execution of our operational improvement plan is also exceeding our expectations, with more than 80% of the €400 million already deployed as of today. We have identified additional savings and are raising also here our target to more than €450 million. This achievement has not been easy and I would like to take this opportunity to express my gratitude to all those working tirelessly on the front lines to make this happen. The plan, as it stands today, has resulted in a reduction of our cost per liter of more than 15 percent, driven primarily by a 25 percent decline in donor compensation. Both figures compared to the peak in July of 22. We are laser-focused on further reducing cost per liter, and we expect this to contribute to EBITDA expansion in the range of 200 to 400 BIPs starting in the second half of 2023. Additionally, we continue to make good progress on several work streams to meet our debt reduction commitment in order to get to a leverage ratio of four times by 2024. Returning to our commercial and innovation priorities, we continue to see significant opportunities for our high-margin Alpha-1 Prolastin and our subcontainers IG product, Sembify. Additionally, we are making significant efforts to accelerate the approval and successful launch of the new biotest proteins. Once launched, these proteins are expected to have a substantial positive impact on GRIFL's financial performance And bringing them to market quickly is a critical aspect of our current integration with BioTest. Turning now to slide five. Over the past years, Griffles has made significant strides to reinforce its board of directors with diverse competencies, backgrounds, and experiences. The board now consists of 11 members, six independents that are led by a lead independent director. The board operates today very well and decisions are made by consensus with effective checks and balances while promoting great transparency and accountability. To further enhance its governance, Griffles is currently in the process of hiring a 12th board member who will be independent and possess strong credentials. In addition, with the latest appointments, all committees of the board are now led by independent board members. As I mentioned before, the co-CEO office has transitioned to the senior leadership executive team, which I'm honored to chair. We have now defined the responsibility of this committee. Victor, as chief operating officer, is responsible for the day-to-day operations and has all the operating units reporting to him. He will also continue to serve on the Board of Directors. Raymond, current Vice Chairman of Griffles, in addition to his board duties, assumes the role of Chief Corporate Officer, focused on optimizing the value of our corporate alliances and partnerships, as well as leading other key ad hoc initiatives. The Senior Executive Leadership Team has a hands-on operating approach and meets weekly to ensure that we deliver. Its responsibilities include capital allocation, the strategy, communication, human resources policies, overall business performance, and very importantly, oversight of critical projects and priorities. A key priority right now is obviously our operational improvement plan and delivering on our commitment to further improve our operating performance and, very importantly, reduce our debt level. Now turning to slide six. It is important to note that we have also made changes across the organization beyond the senior executive team. In 2022, a new organizational model was established to increase focus and build a performance culture that is more efficient, effective, agile, decisive, and accountable. These changes included the appointments of new management to lead the biopharma and plasma procurement business units and a new president for diagnostic. These new leaders have extensive experience in diverse industries, including healthcare, particularly biopharmaceuticals, as well as retail distribution channels. Their knowledge will be key to ensure effective product launches, especially considering the key biotest proteins, while creating the most efficient, advanced, and very importantly, donor-friendly global plasma network. Finally, as I mentioned before, we have reinforced our performance culture by rolling out short and long-term incentive plans. The new short-term variable remuneration is an important step forward as it further aligns with our current key priorities. The equity-based long-term incentive plan aims to support and accelerate the achievement of the company's long-term strategy while increasing alignment with shareholders as the stock price is a key metric. As you can see, much is happening at Griffles to reposition us across the board for the future. Let us now turn to Victor and then Alfredo, and then I will be back for the final remarks, and then we will be happy to take your questions.

speaker
Victor Grifols-Deu
Chief Operating Officer

Thank you, Thomas. Good morning or good afternoon to everyone. And thank you for joining us today. Let's turn now to slide dates for business performance comments. In Q1 23, Griffith's total revenue grew by 18% at constant currency. and 23% on a reported basis, reaching a record level of 1,561 million euros. If we exclude biotests, total revenue reached 1,444 million euros, an increase of 9% at constant currency and 14% on a reported basis. This growth was mainly driven by the performance of our biopharma business unit. which grew by 21% at constant currency and 10% at constant currency like for like, excluding biotest. Back by robust underlying demand, favorable pricing, and product mix. Now turning to slide number nine. We delivered a robust first quarter driven by the strong performance of our flagship product IG in both the US and international markets. It experienced a significant 14.5% growth in Q1 at constant currency. We expect this, our momentum to persist backed by robust underlying demand. Our efforts to grow The market share and revenue of our subcutaneous immunoglobulin ShenB5 are yielding positive results, with an increase of 34% in Q1 2023. Albumin growth was supported by higher demand and price increases in China, offsetting current market dynamics in the US. Looking ahead, we expect volume demand to rebound to high single-digit growth, mainly driven by China. Also, improved product mix was supported by the albumin in box container. Finally, Alpha-1 and specialty proteins delivered amid single-digit growth, thanks to the higher demand of Alpha-1 and strong demand of favorable customer mix in our Hypers portfolio. Now turning to slide 10, we continue to maintain a strong position in the IG market with a diversified product portfolio that includes Grifols and biotest intravenous immunoglobulins, our subcutaneous immunoglobulin commercialized in the US, and having received approval in several European countries and Australia for PID and secondary immune deficiency in 2022, as well as our hyperimmunes. The global IG market is valued at more than 40 billion euros and is expected to grow by high single digits in the upcoming years, mainly driven by primary and secondary immune deficiencies, which represent approximately 40 to 55% of the total IG market. Secondary immune deficiencies have notably increased due to an ageing population and the use of immunosuppressive therapies such as immuno-oncology treatments, for which IgG is often the preferred and only option. Additionally, the increasing awareness around the benefits of IgG therapy and improved diagnosis of primary immune deficiency have led to more patients receiving treatment with IgG therapies. With a broader and top market that is increasing at a pace above the rest of the IG usages, we believe this represents a substantial growth opportunity for our franchises. Grifols Immune Global Strategy is based on key three pillars. We are focused on growth in the U.S. and on prioritizing selected countries in line with our aim to leverage our geomix. We are focused on the immune deficiency market, with PID and secondary immune deficiency growing ahead of the rest of the users, while continuing to accelerate our subcutaneous GMP5 adoption, building upon the important traction gained over the last quarters. To leverage on this expected growth, among others, we are dedicating efforts to life cycle management, which includes seeking new indications. One of these lines, we are pursuing the approval of Shembify to treat patients with CLL, which is the fastest growing indication within the secondary immune deficiencies. CLL is expected to grow 9.5% from the period 2018 to 2025, with a market potential of over US$1 billion. We also aim to maintain leadership in neurology and acute care within autoimmune diseases, where IVIG remains the standard of care. Our flagship Gammon XC remains the most prescribed IVIG for CIDP as of today. We plan to build on this track record for further strengthening our leadership, especially through continued uptake of our subcutaneous GMB5, which offer an improved patient experience and a vast commercial opportunity for us. Having said all this, we are well positioned to capitalize on this IG market growth, which is expected to outpace any potential impact from new technologies within the CIDP space. On top of this, the company has a robust pipeline of 5G products in different phases of development, with several key milestones anticipated for 2023. Now turning to slide 11. As Thomas has already commented, the cost per liter trend is encouraging and reflects the significant progress we are making in the execution of our operational improvement plan. Taking the figures we reported in fiscal year 2022 results, cost per liter and donor compensation declines have notably expanded from 10 and 20% to more than 15 and 25% respectively. This positive trend will be reflected at a larger extent in our P&L starting in second half of 2023 due to the inventory accounting practices of the plasma industry. which entail a nine-month period lag. Initiatives triggering this positive cost-per-liter trend are donor compensation reduction, optimization and reduction of staffing and overheads, and the rationalization of our plasma center network. In the first three months of 2023, seven underperforming plasma centers were consolidated. As of today, adding up to 18 centers shut down in Q4 2022, we have consolidated more than 75 of the total 25 centers to minimize the impact on plasma collection volumes. Going forward, we expect this cost per liter to drop to amplify following current in development and under evaluation savings initiatives focused on implementing lean processes and digitalization. Now turning to slide 12, we continue to advance on our innovation pipeline as we are delivering on our commitments on this first quarter. Our subcutaneous alpha 1, 15%, phase 1, phase 2 study advanced from single dose to repeat dose phase. And in terms of life cycle management, we provided final results of the Chembify biweekly dosing study. and is being prepared the complete clinical study report, as well as for the IVIGPEG study, which has also been concluded, and at the same time, we are finalizing our CSR data. Additionally, we expect this patient to be enrolled and treated in the ChemB5 CLL study very shortly. In Q2 2023, we also expect to finalize the enrollment of the PRECIOSA trial, while the enrollment of the SPARTA trial will be completed during the second half of this year. BioTest milestones for its novel proteins trials in 2023 continue on track. For trimodeling, we expect study initiation in the first half and 5-binogen trial to be completed, as well as top-line study results in the second half of this year, 2023. The developments expected for 23 are very solid, are a very solid combination of life cycle management and new proteins, such as trimodulin, fibrinogen, AT3, and sepsis, which we expect to continue significantly to the company plasma economics in the midterm. Now turning to slide 13 for diagnostic and biosupplies performance. Plot typing solutions were the main driver of the diagnostic business unit, with a robust high single digit growth rate recorded in key geographies such as the US and China. Performance of the NIT technology has been impacted by the pricing concessions in exchange for extending a large contract with a key customer for 15 years. Recombinant proteins increased by 28%, including a diagnostic company commercial true-up of 19 million, which was partially offset by lower joint business profits. Excluding this true-up, revenues decreased by 32%. Biosupplies increased by 70% at constant currency and by 78% on a reported basis, following the acquisition of the remaining 51% capital of Access Biologicals in 2022. This acquisition of Access Biological was driven by the goal of achieving higher margins through vertical integration and gaining commercial footprint to expand in the cell culture market, as well as in vitro diagnostics and diagnostic R&D solutions. It also strengthened the company's offering of biological products. And now, turning to Alfredo.

Disclaimer

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