Q2 2026 Basilea Pharmaceutica AG Earnings Call

August 18, 2026

Operator: Ladies and gentlemen, welcome to the Basilea Pharmaceutica Half Year Results 2026 conference call and live webcast. I'm Matilde, the conference call operator. I would like to remind you that all participants will be in listen-only mode, and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and 1 on your telephone. For operator assistance, please press star and 0. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to David Veitch, Chief Executive Officer. Please go ahead.

Speaker #1: I'm Matilde, the Chorus Call operator. I would like to remind you that all participants will be in listen-only mode and that the conference is being recorded.

Speaker #1: The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and 1 on your telephone.

Speaker #1: For operator assistance, please press star and 0. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to David Veach, Chief Executive Officer.

Speaker #1: Please go ahead.

Speaker #2: Thank you. Hello, I'm David Veach, CEO of Basilea. Thank you for joining us today on our conference call and webcast. We'll be reviewing our financial results and key achievements for the first half year 2026, as well as highlighting our priorities going forward.

David Veitch: Thank you. Hello, I'm David Veitch, CEO of Basilea. Thank you for joining us today on our conference call and webcast. We will be reviewing our financial results and key achievements for the H1 2026, as well as highlighting our priorities going forwards. For further detailed information, please see the ad hoc announcement issued this morning and our half year report. These documents, together with the webcast presentation, are all available on our website at basilea.com. I would like to mention that this call contains forward-looking statements. Joining me on our call today are Adesh Kaul, our Chief Financial Officer, and Dr. Marc Engelhardt, our Chief Medical Officer. We have had a great start to the year, delivering strong financial results and continued execution across the business. Let me briefly summarize some of the key highlights from the H1 2026. Starting with our strong financial performance.

Speaker #2: For further detailed information, please see the ad hoc announcement issued this morning and our half-year report. These documents, together with the webcast presentation, are all available on our website at basilea.com.

Speaker #2: I would like to mention that this call contains forward-looking statements. Joining me on our call today are Odesh Kaul, our Chief Financial Officer, and Dr. Mark Engelhart, our Chief Medical Officer.

Speaker #2: We have had a great start to the year, delivering strong financial results and continued execution across the business. Let me briefly summarize some of the key highlights from the first half of 2026.

Speaker #2: Starting with our strong financial performance, Basilea's total revenue grew 14% year-on-year to CHF 119 million, resulting in an operating profit of CHF 32 million, an increase of 32% year-on-year.

David Veitch: Basilea's total revenue grew 14% year-on-year to CHF 119 million, resulting in an operating profit of CHF 32 million, an increase of 32% year-on-year. Our net cash position doubled to CHF 105 million. During the first 6 months of 2026, we were awarded $61 million of non-dilutive funding, which offsets a significant proportion of our R&D costs. Portfolio highlights include continued strong in-market sales of our lead commercial product, Cresemba, which are now close to $800 million and growing almost 30% year-on-year. The phase III program of fosmanogepix, our lead antifungal in development, is progressing as planned, evidenced by the recent BARDA funding award for achievement of a particular enrollment milestone. Also, our novel antibiotic, BAL2420, has started its first-in-human phase I study. We also continue to invest in our earlier pipeline.

Speaker #2: Our net cash position doubled to CHF 105 million. During the first six months of 2026, we were awarded $61 million of non-dilutive funding, which offsets a significant proportion of our R&D costs.

Speaker #2: Portfolio highlights include continued strong in-market sales of our lead commercial product, QuSemba, which are now close to $800 million and growing almost 30% year-on-year.

Speaker #2: The Phase 3 program of Fastmanager Epix, our lead antifungal in development, is progressing as planned, as evidenced by the recent BARDA funding award for the achievement of a particular enrollment milestone.

David Veitch: The phase III program of fosmanogepix, our lead antifungal in development, is progressing as planned, evidenced by the recent BARDA funding award for achievement of a particular enrollment milestone. Also, our novel antibiotic, BAL2420, has started its first-in-human phase I study. We also continue to invest in our earlier pipeline.

Speaker #2: Also, our novel antibiotic BAO2420 has started its first in-human Phase 1 study. We also continue to invest in our earlier pipeline. In this context, we signed a collaboration agreement with Prokaryotics for the preclinical development of a novel broad-spectrum antifungal candidate.

David Veitch: In this context, we signed a collaboration agreement with Prokaryotics Inc. for the preclinical development of a novel broad-spectrum antifungal candidate. Basilea's pipeline today combines two commercial products, Cresemba and Zevtera, with a diversified portfolio of development stage anti-infective assets, all added over the last 3 years. We have now two phase III assets, fosmanogepix and ceftibuten-ledaborbactam, which together have the potential to generate peak sales of approximately $1.5 billion, roughly doubling our current in-market sales level. Our earlier stage programs, BAL2062 and BAL2420, continue to advance towards their next decision points, adding further depth to the pipeline. Overall, we have built a balanced anti-infective portfolio, combining commercial growth drivers, late-stage value creation opportunities, and early-stage innovation. Behind these assets, we also have preclinical research programs developed both internally and from external collaborations.

Speaker #2: Basilea's pipeline today combines two commercial products, QuSemba and Zeptera, with a diversified portfolio of development-stage anti-infective assets, all added over the last three years.

Speaker #2: We now have two Phase 3 assets: Fastmanager Epix and Ceftibutin Leaderboard Bactam, which together have the potential to generate peak sales of approximately $1.5 billion—roughly doubling our current in-market sales level.

Speaker #2: Our earlier-stage programs, BAO2062 and BAO2420, continue to advance towards their next decision points, adding further depth to the pipeline. Overall, we have built a balanced anti-infective portfolio, combining commercial growth drivers, late-stage value creation opportunities, and early-stage innovation.

David Veitch: Our earlier stage programs, BAL2062 and BAL2420, continue to advance towards their next decision points, adding further depth to the pipeline. Overall, we have built a balanced anti-infective portfolio, combining commercial growth drivers, late-stage value creation opportunities, and early-stage innovation. Behind these assets, we also have preclinical research programs developed both internally and from external collaborations.

Speaker #2: Behind these assets, we also have preclinical research programs, developed both internally and through external collaborations. We announced two early-stage collaborations in the last eight months that further expand our innovative research pipeline.

David Veitch: We announced two early-stage collaborations in the last 8 months that further expand our innovative research pipeline. The first is a partnership with Phare Bio, which applies generative artificial intelligence to the discovery of novel antibiotics, aiming to improve the efficiency of identifying and developing a new antibiotic candidate. Then we entered the collaboration with Prokaryotics Inc. to develop a first-in-class broad-spectrum antifungal candidate. The program aims to deliver an effective, safe, and easy-to-administer treatment for severe invasive fungal infections. Together, these partnerships expand our access to innovative technologies and new approaches with limited upfront investment from Basilea. I will now hand over to Adesh for the commercial and financial update.

David Veitch: We announced two early-stage collaborations in the last 8 months that further expand our innovative research pipeline. The first is a partnership with Phare Bio, which applies generative artificial intelligence to the discovery of novel antibiotics, aiming to improve the efficiency of identifying and developing a new antibiotic candidate. Then we entered the collaboration with Prokaryotics to develop a first-in-class broad-spectrum antifungal candidate. The program aims to deliver an effective, safe, and easy-to-administer treatment for severe invasive fungal infections. Together, these partnerships expand our access to innovative technologies and new approaches with limited upfront investment from Basilea. I will now hand over to Adesh for the commercial and financial update.

Speaker #2: The first is a partnership with Fair Bio, which applies generative artificial intelligence to the discovery of novel antibiotics, aiming to improve the efficiency of identifying and developing a new antibiotic candidate.

Speaker #2: Then we entered into the collaboration with Prokaryotics to develop a first-in-class, broad-spectrum antifungal candidate. The program aims to deliver an effective, safe, and easy-to-administer treatment for severe invasive fungal infections.

Speaker #2: Together, these partnerships expand our access to innovative technologies and new approaches, with limited upfront investment from Basilea. I'll now hand over to Odesh for the commercial and financial update.

Speaker #3: Thank you, David. Starting with QuSemba, which remains the cornerstone of our current commercial business. Global in-market sales in the 12-month period to the end of March 2026 amounted to $782 million. This 27% increase year-on-year underscores the continued strong demand across all key markets and is driven by continued gains in market share, even in markets where QuSemba is already the market leader.

Adesh Kaul: Thank you, David. Starting with Cresemba, which remains the cornerstone of our current commercial business. Global in-market sales in the 12-month period to the end of March 2026 amounted to $782 million. This 27% increase year-on-year underscores the continued strong demand across all key markets and is driven by continued gain in market share, even in markets where Cresemba is already market leader. Let me turn to Zevtera, which was commercially launched in the US about a year ago by our partner, Innoviva Specialty Therapeutics. For novel hospital antibiotics, the key focus in the initial 12-month period of the launch phase is on establishing broad market access and on supporting positive clinical experience. The KPIs we track in this early phase reflect these focus areas.

Speaker #3: Let me turn to Zeptera, which was commercially launched in the U.S. about a year ago by our partner Innoviva Specialty Therapeutics. For novel hospital antibiotics, the key focus in the initial 12-month period of the launch phase is on establishing broad market access and on supporting positive clinical experience.

Speaker #3: The KPIs we track in this early phase reflect these focus areas. Zeptera continues to make good progress in securing access across the healthcare system, with important wins in group purchasing organizations, formularies, and reimbursement programs, helping to support future uptake.

Adesh Kaul: Zevtera continues to make good progress in securing access across the healthcare system, with important wins in group purchasing organizations, formularies, and reimbursement programs, helping to support future uptake. At the same time, increasing account numbers and repeat ordering trends, combined with encouraging medical community feedback, provide early evidence of positive clinical experience and acceptance. Innoviva Specialty Therapeutics has also further expanded its field force to increase hospital coverage, from which Zevtera is expected to benefit. We are therefore pleased with the progress in this launch phase and are looking forward to seeing these encouraging key lead indicators translate into increasing adoption and sales in the quarters and years to come, especially as Zevtera has market exclusivity in the US until April 2034. All of our clinical programs continue to be supported through BARDA and CARB-X agreements, which provide non-dilutive funding for our R&D portfolio.

Speaker #3: At the same time, increasing account numbers and repeat ordering trends, combined with encouraging feedback from the medical community, provide early evidence of positive clinical experience and acceptance.

Speaker #3: Innoviva has also further expanded its field force to increase hospital coverage, from which Zeptera is expected to benefit. We are therefore pleased with the progress in this launch phase and are looking forward to seeing these encouraging key lead indicators translate into increased adoption and sales in the quarters and years to come.

Adesh Kaul: Innoviva Specialty Therapeutics has also further expanded its field force to increase hospital coverage, from which Zevtera is expected to benefit. We are therefore pleased with the progress in this launch phase and are looking forward to seeing these encouraging key lead indicators translate into increasing adoption and sales in the quarters and years to come, especially as Zevtera has market exclusivity in the US until April 2034. All of our clinical programs continue to be supported through BARDA and CARB-X agreements, which provide non-dilutive funding for our R&D portfolio.

Speaker #3: Especially as Zevtera has market accessibility in the U.S. until April 2034. All of our clinical programs continue to be supported through BARDA and CARB-X agreements, which provide non-dilutive funding for our R&D portfolio.

Speaker #3: Across these contracts, more than $440 million has been committed to Basilea. Approximately $165 million has been awarded to date, out of which $61 million was awarded in the first half of 2026.

Adesh Kaul: Across these contracts, more than $440 million has been committed to Basilea. Approximately $165 million has been awarded to date, out of which $61 million was awarded in the H1 2026. This non-dilutive funding enables us to advance our clinical programs in a capital-efficient manner. Moving now to the financial results for the first six months of 2026. Unless otherwise stated, all numbers are in CHF. Cresemba and Zevtera-related revenue totaled CHF 92.3 million. This included royalty income of CHF 57.8 million, which grew by about 11% year on year. Milestone and upfront payments were CHF 4.7 million. Other revenue, which include mainly reimbursements from BARDA and CARB-X, rose to CHF 26.7 million. This brings total revenue to CHF 119 million, an increase of 14% compared to the H1 2025.

Speaker #3: This non-dilutive funding enables us to advance our clinical programs in a capital-efficient manner. Moving now to the financial results for the first six months of 2026.

Speaker #3: Unless otherwise stated, all numbers are in Swiss francs. QuSemba- and Zeptera-related revenue totaled CHF 92.3 million. This included royalty income of CHF 57.8 million, which grew by about 11% year-on-year.

Speaker #3: Milestone and upfront payments were $4.7 million. Other revenue, which includes mainly reimbursements from BARDA and CARB-X, rose to $26.7 million. This brings total revenue to $119 million, an increase of 14% compared to the first half of 2025.

Speaker #3: Cost of products sold decreased to $15.4 million in the first half of 2026, positively impacted by the customer and product mix. Operating expenses amounted to $72.0 million, increasing mainly due to costs associated with the progress of the Fastmanager Epix Phase 3 program, preparations for the Ceftibutin Leaderboard Bactam Phase 3 program, as well as the Phase 1 study for BAL2420.

Adesh Kaul: Cost of products sold decreased to CHF 15.4 million in the H1 2026, positively impacted by the customer and product mix. Operating expenses amounted to CHF 72 million, increasing mainly due to costs associated with the progress of the fosmanogepix phase III program, preparations for the ceftibuten-ledaborbactam phase III program, as well as the phase I study for BAL2420. As a result, we achieved an operating profit of CHF 31.6 million and a net profit of CHF 27.9 million, both significantly increasing year on year. Finally, cash and cash equivalents and restricted cash rose to CHF 176 million. The cash flow from operating activities amounted to CHF 19 million, including the impact from a temporary increase in receivables and inventory, reflecting the continued growth of our commercial business and strong operational execution in the first half of the year.

Speaker #3: As a result, we achieved an operating profit of $31.6 million and a net profit of $27.9 million, both significantly increasing year-on-year. Finally, cash and cash equivalents, as well as restricted cash, rose to $176 million.

Speaker #3: The cash flow from operating activities amounted to $19 million, including the impact from a temporary increase in receivables and inventory, reflecting the continued growth of our commercial business and strong operational execution in the first half of the year.

Speaker #3: The receivables are expected to be collected within their respective due dates in Q3 2026, and the inventories will allow us to address the increased product demand in the second half of 2026.

Adesh Kaul: The receivables are expected to be collected within their respective due dates in Q3 2026, and the inventories will allow us to address the increased product demand in the H2 2026. We also continued to strengthen our balance sheet through debt reduction. During the reporting period, we repurchased CHF 5 million in nominal value of our convertible bonds, reducing the outstanding nominal balance to CHF 71 million. The convertible bond is due to mature in July 2027. Let me now turn to our updated full-year guidance. Based on the strong performance in the first half of this year and the continued positive outlook, we now expect total revenue for full year 2026 to grow by approximately 15%. Within this, Cresemba and Zevtera-related revenue is expected to reach around CHF 210 million, compared to our previous guidance of around CHF 200 million.

Speaker #3: We also continued to strengthen our balance sheet through debt reduction. During the reporting period, we repurchased $5 million in nominal value of our convertible bonds, reducing the outstanding nominal balance to $71 million.

Speaker #3: The convertible bond is due to mature in July 2027. Let me now turn to our updated folio guidance. Based on the strong performance in the first half of this year, and the continued positive outlook, we now expect total revenue for FY2026 to grow by approximately 15%.

Speaker #3: Within this, QuSemba- and Zeptera-related revenue is expected to reach around $210 million, compared to our previous guidance of around $200 million. This is expected to translate into a cash contribution of approximately $180 million from our commercial business.

Adesh Kaul: Within this, Cresemba and Zevtera-related revenue is expected to reach around CHF 210 million, compared to our previous guidance of around CHF 200 million. This is expected to translate into a cash contribution of approximately CHF 180 million from our commercial business. We continue to expect an increase of 20% year-on-year of our investments into R&D. Driven by the higher expected revenue, we are raising our operating profit guidance and now expect an increase by approximately 40% year-on-year, compared with our previous expectation of around 20% increase.

Adesh Kaul: This is expected to translate into a cash contribution of approximately CHF 180 million from our commercial business. We continue to expect an increase of 20% year-on-year of our investments into R&D. Driven by the higher expected revenue, we are raising our operating profit guidance and now expect an increase by approximately 40% year-on-year, compared with our previous expectation of around 20% increase.

Speaker #3: We continue to expect a 20% year-on-year increase in our investments into R&D. Driven by the higher expected revenue, we are raising our operating profit guidance and now expect an increase of approximately 40% year-on-year, compared with our previous expectation of around a 20% increase.

Speaker #3: This demonstrates the strength of our business model and our ability to maintain solid profitability while increasing investments in our growth. At the components of our full-year guidance on QuSemba and Zeptera-related revenues, we expect approximately $125 million from royalties, $35 million from milestone payments, and $50 million from product revenue.

Adesh Kaul: This demonstrates the strength of our business model and our ability to maintain solid profitability while increasing investments in our growth pipeline. Looking at the components of our full year guidance on Cresemba, Zevtera-related revenues, we expect approximately CHF 125 million from royalties, CHF 35 million from milestone payments, and CHF 50 million from product revenue. We expect the revenue mix to keep on shifting towards higher margin royalties and milestones, resulting in a significantly higher cash flow contribution from our commercial business in the H2 of the year. I will now hand over to Marc for the portfolio update.

Speaker #3: We expect the revenue mix to continue shifting towards higher-margin royalties and milestones, resulting in a significantly higher cash flow contribution from our commercial business in the second half of the year.

Speaker #3: I will now hand over to Mark for the portfolio update.

Speaker #2: Thank you, Adesh. As David mentioned earlier, we currently have two Phase 3 programs: Fasimiba, Epix, and Ceftibuten-leaderboard Bactam. Advancing these programs efficiently and successfully through development remains a key priority for Basilea.

Marc Engelhardt: Thank you, Adesh. As David mentioned earlier, we currently have two phase III programs, fosmanogepix and ceftibuten-ledaborbactam. Advancing these programs efficiently and successfully through development remains a key priority for Basilea. Ceftibuten-ledaborbactam, which we in-licensed in August 2025, is now in preparations for a global phase III program with study initiation expected in mid-2027. This program benefits from a well-established study design aligned with published FDA guidance for complicated urinary tract infections. Fosmanogepix is currently being evaluated in two global phase III studies, FAST-IC in invasive candidiasis and candidemia, and FORWARD-IM in invasive mold infections. We expect both studies to read out in 2028. Importantly, the fosmanogepix phase III program is supported by a growing body of real-world experience, which I will discuss in more detail shortly. Fosmanogepix has a truly differentiated profile, combining a first-in-class mechanism of action with broad-spectrum activity against both molds and yeasts.

Speaker #2: Ceftibutin, Leaderboard Bactam, which we in-licensed in August 2025, is now in preparations for a global Phase 3 program, with study initiation expected in mid-2027.

Speaker #2: This program benefits from a well-established study design aligned with published FDA guidance for complicated urinary tract infections. Fasigyn epix is currently being evaluated in two global Phase 3 studies: FASGICASE in invasive candidiasis and candidemia, and FORWARD in IM infections.

Marc Engelhardt: Fosmanogepix is currently being evaluated in two global phase III studies, FAST-IC in invasive candidiasis and candidemia, and FORWARD-IM in invasive mold infections. We expect both studies to read out in 2028. Importantly, the fosmanogepix phase III program is supported by a growing body of real-world experience, which I will discuss in more detail shortly. Fosmanogepix has a truly differentiated profile, combining a first-in-class mechanism of action with broad-spectrum activity against both molds and yeasts.

Speaker #2: We expect both studies to read out in 2028. Importantly, the Fastmanager Epix Phase 3 program is supported by a growing body of real-world experience, which I will discuss in more detail shortly.

Speaker #2: Fosmanogepix has a truly differentiated profile, combining a first-in-class mechanism of action with broad-spectrum activity against both molds and yeasts. In addition, it has demonstrated excellent tissue penetration and offers both intravenous and oral formulations, providing important flexibility for patient management.

Marc Engelhardt: In addition, it has demonstrated excellent tissue penetration and offers both intravenous and oral formulations, providing important flexibility for patient management. We continue to make good progress with the phase III development program that I mentioned earlier, which remains on track. At the same time, we continue to gain valuable real-world experience with fosmanogepix through a global expanded access program. This program provides access to fosmanogepix for patients with serious or life-threatening invasive fungal infections who have limited or no alternative treatment options. To date, nearly 600 patients have been treated across 22 countries, and the continuous increase in patient numbers and the geographic reach reflect the significant global medical need addressed by fosmanogepix. Additionally, this growing body of real-world experience may complement the clinical data package and support future market access following regulatory approval. BAL2420 is our first-in-class antibiotic targeting highly resistant invasive pathogens.

Speaker #2: We continue to make good progress with the Phase 3 development program that I mentioned earlier, which remains on track. At the same time, we continue to gain valuable real-world experience with Fastmanager Epix through a globally expanded access program.

Speaker #2: This program provides access to Fastmanager Epix for patients with serious or life-threatening invasive fungal infections who have limited or no alternative treatment options. To date, nearly 600 patients have been treated across 22 countries, and the continuous increase in patient numbers and geographic reach reflect the significant global medical need addressed by Fastmanager Epix.

Marc Engelhardt: To date, nearly 600 patients have been treated across 22 countries, and the continuous increase in patient numbers and the geographic reach reflect the significant global medical need addressed by fosmanogepix. Additionally, this growing body of real-world experience may complement the clinical data package and support future market access following regulatory approval. BAL2420 is our first-in-class antibiotic targeting highly resistant invasive pathogens.

Speaker #2: Additionally, this growing body of real-world experience may complement the clinical data package and support future market access following regulatory approval. BAL2420 is our first-in-class antibiotic targeting highly resistant Gram-negative pathogens.

Speaker #2: These infections remain a major global health challenge, including those caused by carbapenem-resistant Enterobacteriaceae, where treatment options are often limited and patient outcomes can be poor.

Marc Engelhardt: These infections remain a major global health challenge, including those caused by carbapenem-resistant Enterobacterales, where treatment options are often limited, and patient outcomes can be poor. BAL2420 offers a novel mechanism of action based on inhibition of LptA, which then leads to rapid bacterial cell death. Importantly, this mechanism is distinct from existing antibiotic classes, creating the potential to overcome resistance. We have initiated the first human phase I dose-escalation study in Q1 2026, and I am pleased to report that the study is progressing as planned. In addition to fosmanogepix and BAL2420, we are also progressing our other clinical-stage antibacterial and antifungal programs towards their next milestones. The antibiotic ceftibuten-ledaborbactam is being developed as a potential first oral beta-lactam/beta-lactamase inhibitor combination for complicated urinary tract infections caused by Enterobacterales.

Speaker #2: BAL2420 offers a novel mechanism of action based on inhibition of LPTA, which then leads to rapid bacterial cell death. Importantly, this mechanism is distinct from existing antibiotic classes, creating the potential to overcome resistance.

Speaker #2: We've initiated the first immune Phase 1 dose escalation study in the first quarter of 2026, and I'm pleased to report that the study is progressing as planned.

Speaker #2: In addition to fasiglifam, Epix, and BAL2420, we are also progressing our other clinical-stage antibacterial and antifungal programs towards the next milestones. The antibiotic ceftibuten-leadboard bactam is being developed as a potential first oral beta-lactam/beta-lactamase inhibitor combination for complicated urinary tract infections caused by Enterobacterales.

Marc Engelhardt: In addition to fosmanogepix and BAL2420, we are also progressing our other clinical-stage antibacterial and antifungal programs towards their next milestones. The antibiotic ceftibuten-ledaborbactam is being developed as a potential first oral beta-lactam/beta-lactamase inhibitor combination for complicated urinary tract infections caused by Enterobacterales.

Speaker #2: The program addresses a significant need for new treatment options for multi-drug-resistant or negative infections, and benefits from both Fast Track and QIDP designations from the FDA.

Marc Engelhardt: The program addresses a significant need for new treatment options for multi-drug resistant or negative infections, and benefits from both Fast Track and QIDP designations from the FDA. BAL2062 is a novel antifungal candidate for the treatment of invasive aspergillosis, including resistant strains. Following encouraging phase I safety and tolerability data, discussions with regulatory authorities regarding the optimal phase II and phase III development pathway are ongoing. With this, I will hand back to David.

Speaker #2: BAL2062 is a novel antifungal candidate for the treatment of invasive aspergillosis, including resistant strains. Following encouraging Phase 1 safety and tolerability data, discussions with regulatory authorities regarding the optimal Phase 2 and Phase 3 development pathway are ongoing.

Speaker #2: With this, I'll hand back to David.

Speaker #1: Thank you, Mark. Building on what Mark showed you, we expect our commercial portfolio to expand over time. QuSemba will continue to generate substantial revenues, while with the US launch of Zeptera, we expect increasingly meaningful revenues over the coming years.

David Veitch: Thank you, Marc. Building on what Marc showed you, we expect our commercial portfolio to expand over time. Cresemba will continue to generate substantial revenues, while with the US launch of Zevtera, we expect increasingly meaningful revenues over the coming years. Assuming successful clinical and regulatory outcomes, fosmanogepix could become our third commercial product in 2029, followed by ceftibuten-ledaborbactam as our fourth commercial product approximately a year later. Together, these two assets are expected to become important future growth drivers for Basilea and diversify our revenue streams. At peak, they could generate combined in-market sales equivalent to approximately twice the level of today's sales, illustrating the significant value creation opportunity in our late-stage pipeline. Earlier this year, we announced our Agenda 2030, our roadmap for Basilea's next phase of development.

Speaker #1: Assuming successful clinical and regulatory outcomes, Fastmanager Epix could become our third commercial product in 2029, followed by Ceftibutin/Leaderboard Bactam as our fourth commercial product approximately a year later.

Speaker #1: Together, these two assets are expected to become important future growth drivers for Basilea and diversify our revenue streams. At peak, they could generate combined in-market sales equivalent to approximately twice the level of today's sales.

David Veitch: Together, these two assets are expected to become important future growth drivers for Basilea and diversify our revenue streams. At peak, they could generate combined in-market sales equivalent to approximately twice the level of today's sales, illustrating the significant value creation opportunity in our late-stage pipeline. Earlier this year, we announced our Agenda 2030, our roadmap for Basilea's next phase of development. We communicated that at the end of 2025, we had CHF 162 million in cash, and we expect approximately CHF 600 million in cumulative cash flow from Cresemba and Zevtera alone between 2026 and 2030. In addition, more than $350 million of potential non-dilutive R&D funding remained available under existing agreements.

Speaker #1: Illustrating the significant value creation opportunity in our late-stage pipeline. Earlier this year, we announced our Agenda 2030, our roadmap for Basilea's next phase of development.

Speaker #1: We communicated that at the end of 2025, we had CHF 162 million in cash, and we expect approximately CHF 600 million in cumulative cash flow from QuSemba and Zeptera alone between 2026 and 2030.

Adesh Kaul: We communicated that at the end of 2025, we had CHF 162 million in cash, and we expect approximately CHF 600 million in cumulative cash flow from Cresemba and Zevtera alone between 2026 and 2030. In addition, more than $350 million of potential non-dilutive R&D funding remained available under existing agreements.

Speaker #1: In addition, more than $350 million of potential non-dilutive R&D funding remained available under existing agreements. These resources provide the foundation for the next phase of growth for Basilea.

David Veitch: These resources provide the foundation for the next phase of growth of Basilea. They allow us to advance fosmanogepix and ceftibuten-ledaborbactam towards commercialization, continue investing in our earlier-stage pipeline, and further strengthen our portfolio through targeted business development opportunities. Currently, we are fully on track to deliver on these targets set out in our Agenda 2030. This is evidenced by our progress in the H1 2026. We delivered another strong operational and financial performance, with double-digit growth in Cresemba revenue, leading to an increase in our full-year operating profit guidance. Across the pipeline, both fosmanogepix phase III studies continue to advance as planned. Also, preparations for the ceftibuten-ledaborbactam phase III program continue, and we initiated the first in-human study of BAL2420. We entered into a new preclinical collaboration and secured $61 million in non-dilutive funding for our clinical programs.

Speaker #1: They allow us to advance Fastmanager, EPI-X, and Ceftibuten/Leaderboard Bactam towards commercialization, continue investing in our earlier-stage pipeline, and further strengthen our portfolio through targeted business development opportunities.

Speaker #1: Currently, we are fully on track to deliver on these targets set out in our Agenda 2030. This is evidenced by our progress in the first half of 2026.

Speaker #1: We delivered another strong operational and financial performance, with double-digit growth in QuSemba revenue leading to an increase in our full-year operating profit guidance. Across the pipeline, both Fastmanager Epix Phase 3 studies continue to advance as planned. Preparations for the Ceftibutin leaderboard Bactam Phase 3 program also continue, and we initiated the first-in-human study of BAL2420.

David Veitch: Across the pipeline, both fosmanogepix phase III studies continue to advance as planned. Also, preparations for the ceftibuten-ledaborbactam phase III program continue, and we initiated the first in-human study of BAL2420. We entered into a new preclinical collaboration and secured $61 million in non-dilutive funding for our clinical programs. With a strong H1 2026, we look forward to continuing building on this momentum for the remainder of the year. Thank you for your attention, and we will now open the line for your questions.

Speaker #1: We entered into a new preclinical collaboration and secured $61 million in non-dilutive funding for our clinical programs. With a strong first half of 2026, we look forward to continuing to build on this momentum for the remainder of the year.

David Veitch: With a strong H1 2026, we look forward to continuing building on this momentum for the remainder of the year. Thank you for your attention, and we will now open the line for your questions.

Speaker #1: Thank you for your attention. We will now open the line for your questions.

Speaker #3: We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their telephone. You will hear a tone to confirm that you have entered the queue.

Operator: We will now begin the question and answer session. Anyone who wishes to ask a question may press star and 1 on their telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Questioners on the phone are requested to disable the loudspeaker mode and eventually turn off the volume from the webcast while asking a question. In the interest of time, please limit yourself to 2 questions. Anyone who has a question may press star and 1 at this time. The first question comes from the line of Brian White from Calvine Partners. Please go ahead.

Speaker #3: If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode and eventually turn off the volume from the webcast while asking a question.

Speaker #3: In the interest of time, please limit yourself to two questions. Anyone who has a question may press 'Start' and one at this time. The first question comes from the line of Brian White from Calvin Partners.

Speaker #3: Please go ahead.

Speaker #4: Yes, hello, and thanks for taking my question. The first one is on Fastmanager Epix, and I'm just thinking about the commentary on enrollment. We are still seeing quite an explosion of resistant candidate errors in the U.S.

Brian White: Yes. Hello, and thanks for taking my question. The first one is on fosmanogepix, and just thinking about the commentary on enrollment. We still are seeing quite an explosion of resistant Candida auris in the US. I just wondered if that, if you are seeing a positive impact on enrollment there. Also, if you could remind us if you need both studies to read out for filing and approval, or if one was faster than the other, could you go ahead with one ahead of the second? Then also on the ceftibuten-ledaborbactam program. I know you are obviously looking forward to the initiation of phase III next year. It is early days since the approval of Tedzse in the US, and I wondered, have you seen anything from the label or the approval that has given you some insight into the positioning of ceftibuten-ledaborbactam in cUTI?

Speaker #4: And I just wondered if that—if you're seeing a positive impact on enrollment there. And just also, if you could remind us: do you need both studies to read out for filing and approval, or if one was faster than the other, could you go ahead with one ahead of the second?

Speaker #4: And then also, on the ceftibuten-leaderboard bactam program, now obviously looking forward to the initiation of Phase 3 next year. It's early days since the approval of UTEBSI in the US, and I wondered if you've seen anything from the label or the approval that has given you some insight into the positioning of ceftibuten-leaderboard bactam in cUTI.

Brian White: Then also on the ceftibuten-ledaborbactam program. I know you are obviously looking forward to the initiation of phase III next year. It is early days since the approval of Tedzse in the US, and I wondered, have you seen anything from the label or the approval that has given you some insight into the positioning of ceftibuten-ledaborbactam in cUTI? Thank you.

Speaker #4: Thank you.

Brian White: Thank you.

Speaker #1: Okay, thank you, Brian. Actually, Mark, why don't you take the one about candidate oris and the potential impact on our study, and also whether both studies are needed?

David Veitch: Okay. Thank you, Brian. Mark, why don't you take the one about Candida auris and the impact potentially on our study and also are both studies needed? You take that question first.

David Veitch: Okay. Thank you, Brian. Marc, why don't you take the one about Candida auris and the impact potentially on our study and also are both studies needed? You take that question first.

Speaker #1: You take that question first.

Speaker #2: Yeah, Brian, thank you very much for the question. So, usually, outbreaks do not have such a great impact on clinical trial enrollment; they are often localized.

Marc Engelhardt: Yeah, Brian, thank you very much for the question. Usually outbreaks do not have such a great impact on clinical trial enrollment. They are often localized. For primary therapy of Candida infection, which is the study, it is restricted to no more than 48 hours of prior antifungal treatments. Otherwise, patients cannot be enrolled. That is often auris outbreaks, they have already started for a couple of days of treatment. In principle, it could support enrollment. In practice, the number of outbreaks is relatively small compared to the overall prevalence of Candida infections. The second question was about the two phase III studies. We could file them separately, but we will need the candidemia study completed, because of the required safety database for the NDA. There are several options.

Speaker #2: And then for primary therapy of candidemia infection, which is the study, it's restricted to no more than 48 hours of prior antifungal treatments. Otherwise, patients cannot be enrolled, and that's often an area of outbrakes.

Speaker #2: They have already started for a couple of days of treatment. So, in principle, it could support enrollment, but in practice, the number of outbreaks is relatively small compared to the overall prevalence of candidate infections.

Speaker #2: The second question was about the two Phase 3 studies. So we could file them separately, but we will need the candidemia study completed because of the required safety database for the NDA.

Marc Engelhardt: The second question was about the two phase III studies. We could file them separately, but we will need the candidemia study completed, because of the required safety database for the NDA. There are several options. We file candidemia and mold together, or we file candidemia first and then mold and mold infections, depending on completion dates.

Speaker #2: So, there are several options: we file candidemia and mold together, or we file candidemia first and then mold infections, depending on completion dates.

Marc Engelhardt: We file candidemia and mold together, or we file candidemia first and then mold and mold infections, depending on completion dates.

Speaker #1: Thanks, Mark.

Brian White: Thanks, Mark.

Brian White: Thanks, Marc.

Speaker #5: And then, on your Tebipenem question—actually, it's interesting. I mean, obviously, all we've read is what's public, but it looks like GSK and Spero are positioning Tebipenem as an oral carbapenem, which, obviously, wouldn't directly overlap with Ceftibuten–lidobactam, as that's an oral beta-lactam/beta-lactamase inhibitor.

David Veitch: On your tebipenem question, actually, it is interesting. Obviously, all we have read is what is public, but it looks like GSK's Spero are positioning tebipenem as an oral carbapenem, which obviously would not directly overlap with ceftibuten-ledaborbactam as that is an oral beta-lactam/beta-lactamase inhibitor. But obviously in terms of the concept, the value proposition of an oral step-down or alternative to IV carbapenems, it will be similar. So actually from that point of view, it would actually, I think, be quite helpful for us in terms of GSK's Spero doing a lot of the groundwork in terms of educating the market in terms of the oral complicated UTI concept, which I think we would benefit from, if and when we come to market with ceftibuten-ledaborbactam. So, that is how we are sort of initially thinking about it.

Speaker #5: But obviously, in terms of the concept, the value proposition of an oral step-down or alternative to IV carbapenems, it will be similar. So actually, from that point of view, it would actually I think be quite helpful for us in terms of GSK, Sphero, doing a lot of the groundwork in terms of educating the market in terms of the oral complicated UTI concept, which I think we would benefit from if and when we come to market with Ceftibutin leaderboard Bactam.

David Veitch: Actually from that point of view, it would actually, I think, be quite helpful for us in terms of GSK's Spero doing a lot of the groundwork in terms of educating the market in terms of the oral complicated UTI concept, which I think we would benefit from, if and when we come to market with ceftibuten-ledaborbactam. So, that is how we are sort of initially thinking about it. Obviously, we will see what happens when they launch and the positioning going forward and the response to that.

Speaker #5: So that's how we're sort of initially thinking about it. But obviously, we'll see what happens when they launch, and the positioning going forward, and the response to that.

David Veitch: But obviously, we will see what happens when they launch and the positioning going forward and the response to that.

Speaker #4: Okay, that's great. Thanks, David.

Brian White: Okay. That is great. Thanks, David.

Speaker #3: The next question comes from the line of UOT Prakash from Edison Group. Please go ahead.

Operator: The next question comes from the line of Jyoti Prakash from Edison Group. Please go ahead.

Speaker #6: Hi, thank you for taking my questions, and congratulations on the strong first half. My first question is related to the guidance, and I'm just trying to reconcile the numbers here.

Jyoti Prakash: Hi. Thank you for taking my questions and congratulations on the strong H1. My first question is related to the guidance, and I am just trying to reconcile the numbers here. The operating profit is now expected to grow by 40% versus 20% previously, which is, if I do the math, around CHF 10 million increase. CHF 5 million of that would obviously come from the increase in royalties. Just trying to understand where the other growth is going to come from, given that the milestone payments are not expected to change from last guidance. That is the first question. The second question is again on royalties. If you just look at the breakup of royalties in the H1, the growth looks to be primarily driven by Astellas. How do we think about this for the H2 of the year?

Speaker #6: So, the operating profit is now expected to go up by 40% versus 20% previously. Which is, if I do the math, around a 10 million Swiss franc increase, and 5 million of that would obviously come from the increase in royalties.

Speaker #6: So, just trying to understand where the other growth is going to come from, given that the milestone payments are not expected to change from last guidance.

Speaker #6: That's the first question. And the second question is, again, on royalties. If you just look at the breakup of royalties in the first half, the growth looks to be primarily driven by Estellas.

Speaker #6: How should we think about this for the second half of the year?

Speaker #1: Yeah, thanks, UOT, for those questions. Adesh, do you want to take those?

David Veitch: Yeah. Thanks, Jyoti, for those questions. Adesh, do you want to take those?

Speaker #5: Yep, thank you, UOT. So maybe initially on your first question on how the guidance works— we are, in essence, guiding for an increase of $12 million in revenues.

Adesh Kaul: Yep. Thank you, Jyoti. So maybe initially on your first question on how the guidance works, we are in essence guiding for an increase in CHF 12 million in revenues, you could say. As you correctly pointed out, CHF 5 million is the increase in royalties that we expect, CHF 5 million in product revenues. So Cresemba and Zevtera-related revenues are expected to increase from CHF 200 million previously guided to CHF 210 million in the new guidance. Then there is the residual value of CHF 2 million that is coming from other revenues, in essence. Out of those CHF 12 million, basically CHF 10 million flow all the way down to the operating profit. As you correctly pointed out, our operating profit guidance increases from CHF 62 million to CHF 72 million.

Speaker #5: You could say. And as you correctly pointed out, 5 million is the increase in royalties that we expect—5 million in product revenues. So Cresemba and Ceftera-related revenues are expected to increase from 200 million previously guided to 210 million in the new guidance.

Speaker #5: And then there is sort of the residual value of $2 million that is coming from other revenues, in essence. And out of those $12 million, basically $10 million flow all the way down to the operating profits.

Speaker #5: So, as you correctly pointed out, our operating profit guidance increases from 62 million to 72 million, and I think the structure, basically, how this works, reflects also how our business model works—that we have actually quite high translation of revenue growth into profit.

Adesh Kaul: I think the structure basically how this works reflects also how our business model works, that we have actually quite high translation of revenue growth into profit. With regard to your second question on the royalty breakdown, I would point you simply first of all, to the full year guidance. In essence, we are guiding for CHF 125 million in royalties for the full year, and hence, yes, there will be quite a lot of, I would say, positive dynamic in the H2 of the year, driven by the underlying growth of Cresemba that we are seeing in the market.

Speaker #5: And then, with regard to your second question on the royalty breakdown, I would point you, first of all, to the full-year guidance.

Speaker #5: So, in essence, we are guiding for $125 million in royalties for the full year, and hence, yes, there will be quite a lot of, I would say, positive dynamic in the second half of the year, driven by the underlying growth of Cresemba that we're seeing in the market.

Speaker #5: One point to bear in mind when you're just looking at the year-on-year comparison in the first half is that the first half of last year was, to some degree, positively impacted by some, I would say, mitigation measures that some of our partners took with regard to the tariffs and tax situation that was announced in April 2025.

Adesh Kaul: One point to bear in mind when you are just looking at the year-on-year comparison in the H1 is that the H1 of last year was, to some degree, positively impacted by some, I would say, mitigation measures that some of our partners took with regard to the tariffs and tax situation that was announced in April 2025. So the H1 of the year saw some mitigation measures, therefore, the royalties in the H1 of 2025 as a baseline were probably a little bit higher than they would have been on a run rate that normalized in the H2. Now if you are comparing the full year 2025 to the full year 2026, you are seeing the healthy double-digit growth in royalties that reflects on the in-market performance that we also see with Cresemba.

Speaker #5: So, the first half of the year saw some mitigation measures. Therefore, the royalties in the first half of 2025, as a baseline, were probably a little bit higher than they would have been on a run rate.

Speaker #5: That normalized in the second half, and now, if you're comparing the full year 2025 to the full year 2026, you're seeing the healthy double-digit growth in royalties that reflects the in-market performance that we also see with Cresemba.

Speaker #1: Yeah, so to build on that—so therefore, when you ask the question, would the second half of the year, the royalty rate growth, come from Astellas, which you observed in the first half of the year—I think the point is, it will come from more than just Astellas.

David Veitch: Yeah. To build on that, therefore, when you ask the question, would the H2 of the year the royalty rate growth come from Astellas, which you observed in the H1 of the year, I think the point is it will come from more than just Astellas. It will come from both Pfizer and Astellas.

Speaker #1: It will come from both Pfizer and Astellas.

Speaker #6: Great. I think that's very helpful, so I'll get back in the queue. Thank you so much.

Jyoti Prakash: Great. I think that is very helpful. I will get back in the queue. Thank you so much.

Speaker #1: Thank you.

David Veitch: Thank you.

Speaker #3: We now have a question from the line of Joris Timmerman from Octavian. Please go ahead.

Operator: We now have a question from the line of Joris Zimmerman from Octavian. Please go ahead.

Speaker #4: Yeah, hello. Thank you for taking the questions. Congratulations on this strong set of results in H1. Two questions, if I may. One is also related to revenues.

Joris Zimmerman: Yeah. Hello. Thank you for taking the questions, and congratulations on this strong set of results in H1. Two questions, if I may. One is also related to revenues, specifically to product sales. With almost CHF 30 million, those have been significant despite some of your partners actually shifting to in-house production. I think also for the full year guidance now you expect a slight increase. Could you maybe talk a little bit to the drivers behind that? Then on ceftibuten-ledaborbactam and the phase III initiation, which you confirmed for mid-2027, I was wondering where you stand in terms of the meetings with the regulators, FDA, EMA, and then if you already have more clarity, if indeed it will be one study or it might still be multiple studies. Thank you so much.

Speaker #4: Specifically regarding product sales, with almost 30 million, those have been significant—despite some of your partners actually shifting to in-house production. And I think also, for the full-year guidance now, you expect a slight increase.

Speaker #4: Could you maybe talk a little bit about the drivers behind that? And then, on safety booting, Lila Boerbakdam and the phase three initiation, which you confirmed for mid-2027, I was wondering where you stand in terms of the meetings with the regulators—FDA, EMA—and if you already have more clarity on whether it will indeed be one study, or if it might still be multiple studies.

Speaker #4: Thank you so much.

Speaker #1: Yeah, thanks. Joris, for those questions—do you want to take on the product sales and why we have the levels we have in Q1?

David Veitch: Yeah. Thanks, Joris, for those questions. Do you want to take on the product sales and why we have the levels we have in Q1? Sorry, H1 versus full year.

Speaker #1: Sorry, half of the year versus full year.

Speaker #5: Yeah, also on the full year. So thank you, Joris, for your question. So maybe just giving a little bit of background initially. Indeed, Pfizer and GoZoon, as two big partners, have moved to largely supplying themselves, as was always planned.

Adesh Kaul: Yeah. Also on the full year. Thank you, Joris, for your question. Maybe just giving a little bit of background initially. Indeed, Pfizer and Fosun as two big partners have moved largely to supplying themselves as it was always planned, and that was also reflected in our initial guidance for 2026. We had guided for product sales of CHF 45 million for the full year, versus about CHF 50 million that we had in 2025. Now we increased our guidance to basically CHF 50 million. So in essence, flat product sales, compensating fully for the product sales that we are no longer doing to Pfizer and Fosun. That is really driven by the underlying demand that our distribution partners and other partners that we are supplying have primarily for Cresemba. So on the one hand, you are seeing the positive dynamic in the increase in royalties.

Speaker #5: And that was also reflected in our initial guidance for 2026. We had guided for product sales of CHF 45 million for the full year, versus about CHF 50 million that we had in 2025.

Speaker #5: Now, we increased our guidance to basically $50 million, so in essence, flat product sales, compensating fully for the product sales that we are no longer doing to Pfizer and GoZoon.

Adesh Kaul: In essence, flat product sales, compensating fully for the product sales that we are no longer doing to Pfizer and Fosun. That is really driven by the underlying demand that our distribution partners and other partners that we are supplying have primarily for Cresemba. So on the one hand, you are seeing the positive dynamic in the increase in royalties. That is why the royalty guidance has gone up, and correspondingly, our partners are also ordering basically more, and that is then reflected in the product sales guidance.

Speaker #5: And that is really driven by the underlying demand that our distribution partners and other partners that we are supplying have, primarily for Cresemba. So, on the one hand, you're seeing the positive dynamic in the increase in royalties.

Speaker #5: So that's why the royalty guidance has gone up. And correspondingly, our partners are also ordering more, and that is then reflected in the product sales guidance.

Adesh Kaul: That is why the royalty guidance has gone up, and correspondingly, our partners are also ordering basically more, and that is then reflected in the product sales guidance.

Speaker #5: Product sales, just as a reminder, do not perfectly correlate with the in-market sales because we recognize product sales whenever we do the delivery. So they are more distinct whenever we do a delivery; basically, we recognize the full amount, and that's why it's not a clear linear growth rate.

Adesh Kaul: Product sales, just as a reminder, do not perfectly correlate with the in-market sales because we recognize product sales whenever we do the delivery. So they are sort of more distinct. Whenever we do a delivery, then basically we recognize the full amount, and that is why it is not a clear linear growth rate. But I think the dynamic is clear. Underlying demand is increasing, and that is why our product sales across the partners that we are supplying is increasing as well. Maybe as the last remark I would like to make, which you did not ask, but I am volunteering the answer, is basically that our product mix or our revenue mix on product sales is improving as well because we are selling more to partners where we have a higher margin, in essence, and that is also being reflected in our overall guidance.

Speaker #5: But I think the dynamic is clear. Underlying demand is increasing, and that's why our product sales across the partners that we are supplying are increasing as well.

Speaker #5: Maybe as a last remark, I would like to make—which you didn't ask, but I'm volunteering the answer—is basically that our product mix, or our revenue mix on product sales, is improving as well because we are selling more to partners where we have a higher margin, in essence, and that's also being reflected in our overall guidance.

Speaker #1: Yeah. Thank you, Adesh. Hopefully that answers your question there. And then, on the safety booting, Lila Boerbakdam, one, and Mark, maybe you're best placed to comment on discussions with FDA or EMA and how many studies are required, et cetera.

David Veitch: Yeah. Thank you, Adesh. Hope that answers your question there. Then the Cefditobutin injectable BCTM1 and Marc, maybe you are best placed to comment on discussions with FDA or EMA and how many studies are required, et cetera. Can you just comment on that?

Speaker #1: Can you just comment on that?

Speaker #4: Yeah, so we've entered into an active discussion and a formal process with the FDA and EMA. For the program, the discussions include the overall scope of the program, critical design elements, regimen selection, comparative endpoints, and our objective is to agree on a Phase 3 program that provides a clear and efficient path forward to registration and also to have the data to optimize the commercial positioning.

Marc Engelhardt: Yeah. So we have entered into an active discussion and a formal process with FDA and EMA for the program. The discussions include the overall scope of the program, critical design elements, regimen selection, comparator, and endpoints. Our objective is to agree on a phase III program that provides a clear and efficient path forward to registration, and also to have the data to optimize the commercial positioning. That is a process in progress, so we have not yet come to a conclusion on, for example, the number of required studies, but we will communicate once we have come to a conclusion.

Speaker #4: That is a process and program. So, we have not yet come to a conclusion on, for example, the number of required studies, but we'll communicate once we have come to a conclusion.

Speaker #1: But the idea is that this process goes in parallel with our other preparation activities, so that we can start the study in mid-2026.

David Veitch: But the idea is that this process goes in parallel with our other preparation activities so that we can start the study mid-2026.

David Veitch: The idea is that this process goes in parallel with our other preparation activities so that we can start the study mid-2026.

Marc Engelhardt: Exactly. So that is an ongoing process that runs in parallel with the operational preparations.

Marc Engelhardt: Exactly. That is an ongoing process that runs in parallel with the operational preparations.

Speaker #4: Exactly. So that's an ongoing process that runs in parallel with the operational preparation of the study.

Speaker #1: Hopefully that answers.

David Veitch: Hope that answers.

Joris Zimmerman: Perfect. Thank you.

Speaker #4: Thank you.

Speaker #1: Thanks.

Joris Zimmerman: Thanks very much.

Joris Zimmerman: Yeah. Perfect.

Speaker #4: Perfect.

Speaker #3: The next question comes from the line of Tian Sun Li from Pareto Securities. Please go ahead.

Operator: The next question comes from the line of Chen Soon Lee from Pareto Securities. Please go ahead.

Operator: The next question comes from the line of Chien-Hsun Lee from Pareto Securities. Please go ahead.

Chen Soon Lee: Hi. Congrats on the strong result. Just two questions from me. One is a follow-up question on fosmanogepix enrollment. Earlier this year in your business update, you announced that you are activating 21 new centers in China. Do you see any trends in these Chinese sites, and do you see any impact on the overall timeline? The second question is about the cash position. With its continued improving, how are you thinking about the allocation between bond buybacks, funding the clinical development, and any additional BD activity? Thank you.

Chien-Hsun Lee: Hi. Congrats on the strong result. Just two questions from me. One is a follow-up question on fosmanogepix enrollment. Earlier this year in your business update, you announced that you are activating 21 new centers in China. Do you see any trends in these Chinese sites, and do you see any impact on the overall timeline? The second question is about the cash position. With its continued improving, how are you thinking about the allocation between bond buybacks, funding the clinical development, and any additional BD activity? Thank you.

Speaker #2: Hi, congrats on the strong result. Just two questions from me. The first is a follow-up on first manager tips enrollment. Earlier this year, in your business update, you announced that you are activating 21 new centers in China.

Speaker #2: For Fast IC, do you see any trends in these Chinese sites? And do you see any impact on the overall timeline? And the second question is about the cash position.

Speaker #2: So, with its continued improvement, how are you thinking about the allocation between bond buybacks, funding the clinical development, and any additional BD activities? Thank you.

Speaker #1: Yeah, so maybe Mark, you could comment on: has the inclusion of China in the invasive candidiasis phospholipid study changed the trend in any way?

David Veitch: Yeah. Maybe, Marc, you could comment on has the inclusion of China in the invasive candidiasis fosmanogepix study changed the trend in any way? I think that was Chen's first question.

Speaker #1: I think that was Chen's first question.

Speaker #4: Yeah, so yeah, thanks for the question. I think we are on track with the program. There's no change, really, in the timelines, and as expected, opening China contributes to the enrollment of the study.

Marc Engelhardt: Yeah. So yeah, thanks for the question. I think we are on track with the program. There's no change really in the timelines. And as expected, opening China contributes to the enrollment of the study. So I think there's nothing really unexpected from that end.

Speaker #4: So I think there's nothing really unexpected from that end.

Speaker #1: Yeah. I think, on your cash position question and basically the use of capital, as we've said, at the moment for 2026 and 2027, it's clear that our focus, as we laid out in Agenda 2030, is investing in our R&D, so that's both the late-stage programs and the earlier-stage programs.

David Veitch: Yeah. I think on your cash position question and basically the use of capital, I think as we've said at the moment for 2026, 2027, it is clear that our focus as we laid out in Agenda 2030 is basically investing in our R&D. So both the late-stage programs and the earlier-stage programs. In addition to selectively in-licensing, acquiring assets like we have done for the last three years, assets that are both innovative but have what we believe is commercial potential. That is the focus of our capital allocation now.

Speaker #1: And in addition to selectively in-licensing and acquiring assets, like we've done for the last three years—assets that are both innovative and have, what we believe is, commercial potential.

Speaker #1: And that's the focus of our capital allocation now. And then what we've always what we've said publicly up until now, and it's still the current thinking, is that when we get more visibility following the maturity of the convertible bond mid-2027, and we get visibility on the results, the initial results from phospholipids at the beginning of 2028 of the phase three studies, then we'll be in a position to assess capital distribution in terms of whether it be buybacks or dividends, in addition to the other uses of capital that I've just mentioned.

David Veitch: And then what we have said publicly up until now, and it is still the current thinking, is that when we get more visibility following the maturity of the convertible bond mid 2027, and we get visibility on the initial results from fosmanogepix at the beginning of 2028 of the phase III studies, then we will be in a position to assess capital distribution in terms of whether it be buybacks or dividends, in addition to the other uses of capital that I have just mentioned. That is the way we are thinking of it, Chen, at this moment.

Speaker #1: That's the way we're thinking of it, Chen, at this moment.

Speaker #3: As a reminder, if you wish to register for a question, please press star one on your telephone. We now have a question from the line of Yasmin Shberi from Zurich Kantonal Bank.

Operator: As a reminder, if you wish to register for a question, please press star and one on your telephone. We now have a question from the line of Jasmin Spoerri from Zürcher Kantonalbank. Please go ahead.

Operator: As a reminder, if you wish to register for a question, please press star and one on your telephone. We now have a question from the line of Jasmin Spörri

Speaker #3: Please go ahead.

Speaker #5: Thank you for taking my questions, and also congratulations from my side. I have two questions. One is related to Cefiderocol, and the other one to your phase one asset, BAL-2420.

Jasmin Spoerri: Thank you for taking my questions, and also congratulations from my side. I have two questions. One is related to Zevtera and the other one to your phase I asset BAL2420. The first one about Zevtera is mainly that the US launch of Zevtera appears to be progressing. Could you provide more details on maybe hospital adaptation and how you see this translating into revenue growth over the next 12 until 18 months? Second, BAL2420 has entered phase I trials. Could you share any early insights or timelines for when we might expect initial data read-outs? Or how do you see this asset fitting into your broader portfolio strategy time-wise? Thank you.

Jasmin Spörri: Thank you for taking my questions, and also congratulations from my side. I have two questions. One is related to Zevtera and the other one to your phase I asset BAL2420. The first one about Zevtera is mainly that the US launch of Zevtera appears to be progressing. Could you provide more details on maybe hospital adaptation and how you see this translating into revenue growth over the next 12 until 18 months? Second, BAL2420 has entered phase I trials. Could you share any early insights or timelines for when we might expect initial data read-outs? Or how do you see this asset fitting into your broader portfolio strategy time-wise? Thank you.

Speaker #5: The first question about Cefdera is mainly that the US launch of Cefdera appears to be progressing. Could you provide more details on maybe hospital adoption and how you see this translating into revenue growth over the next 12 to 18 months?

Speaker #5: And second, Bubble 2420 has entered phase one trials. Could you share any early insights or timelines for when we might expect initial data readouts?

Speaker #5: Or, how do you see this asset fitting into your broader portfolio strategy, time-wise? Thank you.

Speaker #1: Yeah, thanks, Yasmin, for the questions. I mean, maybe Adesh, you can comment on the Cefiderocol sort of 12- to 18-month vision.

David Veitch: Yeah. Thanks, Jasmin, for the questions. Maybe Adesh, you comment on the Zevtera sort of 12 to 18 months sort of vision.

Speaker #4: Yeah. So and.

Adesh Kaul: Yeah. I will even go beyond that. Just as a reminder, Zevtera has exclusivity in the US until April 2034. The way that we have structured the transaction and also the way that we philosophically think about our assets is, that we look at optimizing the value over the entire product life cycle. Hence, for us to focus when we are looking at the key performance indicators that we are tracking at this point in time is, are we, together with our partner, of course, Innoviva Specialty Therapeutics, setting the ground for long-lasting success, basically. In this respect, we have done indeed, as you indicated, we have seen good progress. We believe that market access has been established very well.

Speaker #6: I'll even go beyond that. So, just as a reminder, Cefdera has exclusivity in the US until April 2034. The way that we have structured the transaction, and also the way that we philosophically think about our assets, is that we look at optimizing the value over the entire product lifecycle.

Speaker #6: And hence, for us, the focus when we're looking at the key performance indicators that we are tracking at this point in time is, are we, together with our partner—of course, in Aviva Specialty Therapeutics—setting the ground for long-lasting success, basically.

Speaker #6: And in this respect, we've done, indeed, as you indicated. We've seen good progress and we believe that market access has been established very well.

Speaker #6: We believe that the hurdles have been overcome that may have been there, or barriers with regard to affordability, broad adoption, positive initial clinical experience, and so on.

Adesh Kaul: We believe that the hurdles have been overcome that may have been there or barriers with regard to affordability, broad adoption, positive initial clinical experience, and so on. The expansion of the field force by Innoviva Specialty Therapeutics also plays into the expectation that we will see an increasing dynamic now going forward. However, to manage expectations, for us, again, more material impact or more material visibility on revenues from Zevtera are probably going to come in the 2028, 2029 timeframe. That is when we start to really look at, do these early indicators translate into tangible revenues that we are seeing? Are we on a good trajectory to achieving our goal of maximizing the value?

Speaker #6: And the expansion of the field force by Innoviva Specialty Therapeutics also plays into the expectation that we will see an increasing dynamic now, going forward.

Speaker #6: However, to manage expectations, for us, again, more material impact or more material visibility on revenues from Cefdera are probably going to come in the '28–'29 timeframe.

Speaker #6: That's when we start to really look at: do these early indicators translate into tangible revenues that we're seeing, and are we on a good trajectory to achieving our goal of maximizing the value.

Speaker #1: And just the 2420 question, Mark, about where we are with data readout timelines and thinking about next steps, could you comment on that?

David Veitch: Just the BAL2420 question mark about, where are we data readout timelines and thinking about next steps. Could you comment on that?

Speaker #4: Yeah, I think first-in-human study timelines are always not exactly predictable because we don't know how many dose levels we will have to dose until getting to an effective and safe dose.

Marc Engelhardt: Yeah. I think, first-in-human study timelines are always not exactly to be predicted because we do not know how many dose levels we will have to go with until getting to an effective and safe dose. Our current expectation is that this study could be completed in around mid-2027. But as I said, it depends on the number of dose levels and dose cohorts. This is single dose and multiple doses, and they go on in parallel with the multiple doses starting sometime after the single doses have been qualified. From a portfolio perspective, it is a completely novel mechanism of action overcoming resistance. One of the indications we are currently thinking about for this compound is gram-negative bacterial infections, which are frequent with a high unmet medical need. I think that kind of describes the portfolio. That would be our development direction.

Speaker #4: But our current expectation is that this study could be completed around mid-2027. But as said, it depends on the number of dose levels and those calls.

Speaker #4: So, this is single dose and multiple doses, and they go on in parallel, with the multiple doses starting sometime after the single doses have been qualified.

Marc Engelhardt: This is single dose and multiple doses, and they go on in parallel with the multiple doses starting sometime after the single doses have been qualified. From a portfolio perspective, it is a completely novel mechanism of action overcoming resistance. One of the indications we are currently thinking about for this compound is gram-negative bacterial infections, which are frequent with a high unmet medical need. I think that kind of describes the portfolio. That would be our development direction.

Speaker #4: From a portfolio perspective, it's a completely novel mechanism of action, overcoming resistance. One of the indications we are currently thinking about for this compound is gram-negative bloodstream infections, which are frequent, with a high unmet medical need.

Speaker #4: And I think that kind of describes the portfolio that would be our development direction.

Speaker #1: Hopefully that answers your question.

David Veitch: Hopefully that answers your question.

Speaker #5: Yes, thank you very much.

Jasmin Spoerri: Yes. Thank you very much.

Jasmin Spörri: Yes. Thank you very much.

Speaker #3: Once again, to ask a question, please press star one on your telephone. Ladies and gentlemen, there are no more questions at this time.

Operator: Once again, to ask a question, please press star and one on your telephone. Ladies and gentlemen, there are no more questions at this time. I would now like to turn the conference back over to David Veitch for any closing remarks.

Speaker #3: I would now like to turn the conference back over to David Veach for any closing remarks.

Speaker #1: Yeah, thank you. Thanks for your questions. Before we close, I'd just like to remind you of our Capital Markets Day, which will take place on October 28 in Zurich.

David Veitch: Yeah. Thank you. Thanks for your questions. Before we close, I would just like to remind you of our Capital Markets Day, which will take place on 28 October in Zurich. During the event, we provide a more comprehensive update on our strategy, our development portfolio, and future value creation opportunities. In addition, we will have two globally renowned infectious disease physicians who will share their insights on the medical need in serious fungal and bacterial diseases, which underpins our portfolio's development programs. Hopefully you can join us at that meeting. But thank you very much for your time today.

Speaker #1: During the event, we provide a more comprehensive update on our strategy, our development portfolio, and future value creation opportunities. In addition, we will have two globally renowned infectious disease physicians who will share their insights on the medical need in serious fungal and bacterial diseases, which underpins our portfolio's development programs.

Speaker #1: So, hopefully you can join us at that meeting. But thank you very much for your time today.

Speaker #3: Ladies and gentlemen, the conference is now over. Thank you for choosing Carscall, and thank you for participating in the Basilea Pharmaceutica Healthy Results 2026 conference call.

Operator: Ladies and gentlemen, the conference is now over. Thank you for attending the conference call, and thank you for participating in the Basilea Pharmaceutica H1 2026 conference call. You may now disconnect your lines. Goodbye.

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Q2 2026 Basilea Pharmaceutica AG Earnings Call

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