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V our traditional seaweed salad seasoned with sesame oil and vinegar dressing. Topped with sesame seeds and a carrot garnish. GF V freshly cut cucumber seasoned with our house-made togarashi vinaigrette made with sushi vinegar, sesame seed, and sesame chili flake. GF V romaine lettuce, carrot and a house-made carrot-ginger dressing. Nutrition Info. I will highlight some of the key financial figures that were published in today's press release and in more detail in the half year report.

I would like to mention that all the figures I will refer to are in swiss francs. The financials for the first half year are characterized by a significant increase of the revenue contributions from Cresemba and Zevtera. Deferred revenue from Cresemba and Zevtera increased The increase in revenue from Cresemba and Zevtera more than offset the already anticipated decrease in other revenue components, which is mainly driven by lower order reimbursements due to lower costs incurred related to the completed ceftobiprole skin infection study and the impact of the slight delay in recruitment in the blood stream infection study due to COVID Total revenue increased by 9.

Cost of products sold increased by We reported an operating profit of CHF Even without the CHF15 million one-time positive impact from the sale of our headquarters property, we have seen a very strong underlying operational performance in the first half of Net cash used for operating activities was reduced significantly by As of June 30,Basilea's combined cash and short-term and long-term investments amounted to CHF The reported cash position does not include the net proceeds from the convertible bond transactions, which we completed in July.

Turning now to points that may be relevant for the second half of and beyond. We had previously indicated that Pfizer would aim to assume full responsibility for its own supply of Cresemba in the course of The plan has changed, and Basilea will likely now continue to supply Pfizer with API and bulk vials through and into An extension of the supply period would have several consequences for us.

Our product sales in Swiss francs would be higher, especially in Correspondingly, we would anticipate an increase in cost of products sold in Swiss francs. The reported gross margin in percentage of product sales would decrease inwhich, however, would be partially offset by economies of scale for product supply to distribution partners.

We would expect a temporary increase in working capital, which would be expected to be reversed as we deliver products to Pfizer. In summary, an extension of the Pfizer supply period would result in an increase in net cash flow, Fusin (Short Mix), especially in Now turning the discussion to gross margins.

Let me start with an overview of the distributor structure. Distributors purchase product from Basilea at a transfer price, which for the lay of books as product revenue. Basilea bears the manufacturing costs or COGS. The gross margin in percentage for Basilea is, therefore, COGS divided by the transfer price, not the net selling price. Let us now look at our licensing structure, where Basilea supplies its licensed partner with products, such as currently in the case of Pfizer.

Basilea books separately product revenue on deliveries to its license partner, which in essence, are COGS plus a small markup. The gross margin in percentage for Basilea based on COGS divided by product revenue is therefore significantly smaller as compared to the distribution setup. As a consequence, the gross margin in percentage largely depends on the partner mix. Importantly, in any event, there is a positive cash flow in absolute terms for Basilea in both settings.

Moving on to our convertible bond transactions, which were completed in July. To this end, we conducted 2 transactions. The first transaction concerns the issuance of a new convertible bond with maturity The provisional allocation was very successful reflected by the fact that we were able to allocate the maximum targeted amount of CHF million.

Because many bondholders held on to their bonds rather than taking the opportunity to sell them at a cash premium, we reduced the size of the convertible bond as we had no intention of significantly increasing our debt level through the transactions. Hence we remain confident that we will meet our initial goal of reducing the convertible bond exposure significantly, but over time rather than in a single step.

The updated guidance for full year is based on 2 important assumptions for the second half year. On these assumptions, we confirm our previous guidance for the revenue contributions of Cresemba and Zevtera, reflecting the continued significant growth of the in-market sales by our partners. We assume a lower operating loss based on a onetime positive impact from the sale of our headquarters property. The underlying operating loss remains in line with our original guidance. Finally, we assume a strong cash position of around CHF million at year-end.

The positive cash flow impact from our convertible bond transactions in July is expected to be partially offset by a temporary increase in working capital at year-end. The working capital impact is expected to be reversed in early Thank you, Adesh. Let me start with our antibiotic ceftobiprole.

In Europe and several markets outside of Europe, ceftobiprole is approved for the treatment of community and hospital-acquired pneumonia. One of our key priorities for ceftobiprole is to gain access to the U. Based on special protocol assessment agreements with the U. Our Phase III program includes one study in acute bacterial skin and construction infections and one study in Staphylococcus aureus bacteremia or bloodstream infections. Department of Health and Human Services.

This allows us to advance the development of ceftobiprole for the U. Inwe reported positive top line results from the first of these studies, the so-called TARGET study, a Phase III study in patients with acute bacterial skin and construction infections. It is on track to report top line results in the first quarter of If the bacteremia study is also positive, Basilea plans to submit a new drug application to the U. As ceftobiprole is designated a qualified infectious disease product by the FDA for these indications, if approved, it will be eligible to receive 10 years of market exclusivity in the U.

Ceftobiprole provides a number Fusin (Short Mix) key attributes supporting its use in SAB. The beta-lactam antibiotic with rapid bactericidal activity.

Against MSSA and MRSA has shown a superior activity profile in preclinical models of endocarditis or heart valve infections compared to vancomycin and daptomycin and has a low propensity for resistance development.

It also provides gram-negative coverage in cases with polymicrobial infections. Efficacy has been demonstrated in Phase III clinical trials in pneumonia with optimized if not effective and in complicated skin and soft tissue infections and ceftobiprole has an established safety profile, which is consistent with the cephalosporin class. Now moving on to oncology. Our lead oncology drug candidate is derazantinib. Derazantinib is a targeted orally available small molecule inhibitor of the fibroblast growth factor receptor or FGFR family of kinases.

FGFR genetic operations, for example, gene fusions, mutations or amplifications has been identified as potentially important therapeutic targets for various cancers, including intrahepatic cholangiocarcinoma or iCCA, urothelial, gastric, breast and lung cancer.

Our development strategy focuses on achieving differentiation over other FGFR kinase inhibitors by leveraging the unique properties of derazantinib. Key differentiation factors include its unique kinase inhibition profile and its clinical safety profile. Besides FGFR, derazantinib also inhibits the Colony-stimulating Factor 1 Receptor or CSF1R kinase, which has been reported to play a role in immune response to tumors and the vascular endothelial growth factor 2 or VEGFR2 kinase, which is known as a therapeutic target in the anti-androgenic treatment in multiple cancers, including gastric cancer.

Fusin (Short Mix) clinical development program currently comprises 3 studies. And we are planning to start the third study FIDES in gastric cancer in the third quarter of Enrollment into this cohort has been completed in Julyand top line results for this cohort are expected in the second half of Through this additional cohort, we intend to further define the full therapeutic potential of derazantinib in patients with iCCA as other FGFR kinase inhibitor in advanced clinical development have so far only reported very limited clinical activity in this patient population.

Interim data from the second cohort will be presented in the second half of This is a biomarker-driven multi-core clinical study in patients with advanced urothelial cancer expressing FGFR genetic aberrations and first interim results are anticipated for Fusin (Short Mix) second half of This study will explore derazantinib in patients with advanced gastric cancer and FGFR genetic operations and will also include a cohort in which derazantinib is combined with atezolizumab.

We've decided to investigate derazantinib in gastric cancer based on its unique kinase inhibition profile, convincing preclinical in-vivo data and the high medical need in this indication. Clinical supply agreements are in place with Roche, who provides atezolizumab for both the urothelial and the gastric cancer studies.

Moving to our tumor checkpoint controller lisavanbulin formerly known as BAL We are focusing our clinical development activities with lisavanbulin on glioblastoma, the most common and aggressive form of primary malignant brain tumors and an area of high unmet medical need with very few treatment options available.

Lisavanbulin is a novel microtubule targeting small molecule, which induces tumor cell death through spindle assembly checkpoint activation, which impacts tumor cell division.

It can be administered oral and IV, crosses the blood-brain barrier and has shown potent activity in brain tumor models in monotherapy and in combination therapy.

In line with our approach to involve biomarkers early in clinical development, we have been evaluating a panel of biomarkers. One of those is end binding protein 1 or EB1, which was previously identified in preclinical models as a potentially response-predictive biomarker for glioblastoma. Based on our clinical and presented data with EB1, we will start a biomarker-driven clinical Phase II study in glioblastoma in the next few months, using EB1 positivity as a patient selection criteria.

In our completed Phase I glioblastoma clinical study with daily oral dosing, we have observed a profound and exceptional objective response in the glioblastoma patients whose tumor tissue was EB1 positive.

Thank you, Marc. To summarize, we are on track with the execution of our strategy. We are significantly growing our cash relevant revenues from our marketed brands, Cresemba and Zevtera. The remainder of the year holds a number of important milestones, especially related to our oncology programs. And the interim results from the second cohort with iCCA patients with other FGFR2 genetic aberrations, these are also expected in the second half of this year.

In addition, we're looking forward to the safety data and the recommended Phase II dose for the combination of derazantinib and Tecentriq in the FIDES urothelial cancer study. We believe that derazantinib could enhance the response to such immunooncology drugs and are going to further explore this too in the FIDES study in gastric cancer patients planning to start in Q3 this year. For lisavanbulin, we're currently preparing the start of the biomarker-driven study in patients with glioblastoma in the next few months, with interim results then expected in the first half of I would like to thank you for your attention, and we'll now open the line for your questions.

Congratulations on the quarter. So my first question is, what are your capital allocation priorities as you build upon this cash balance that you have? Secondly, can you give more color on how the expansion of Zevtera for bacteremia from 4 to 6 weeks really enhances your competitive advantage in the market?

And the last question I have for you is, what do you expect to see from the lisavanbulin biomarker study with patients in GBM? Louise, and thank you for your questions. Actually, in terms of where we allocate our capital, maybe I'll hand that over to Adesh and then the comment on the 4 to 6 weeks of ceftobiprole, Marc can answer that question.

And in terms of -- yes. So why don't you start, Adesh? Louise, from -- I think if you think about where we invest our resources at the moment.

So the key is the derazantinib program and almost at an equal level we are with the ceftobiprole Phase III program on a gross level, pre-order reimbursement. I think purely from, let's say, allocation of costs in FTA and FTE, so internal and external costs, these are the biggest investments that we're making. Otherwise, we are -- the next level is then the pediatric programs for ceftobiprole and for isavuconazole, especially for isavuconazole, that would also result in a potential extension of exclusivity in Europe, especially by 2 years and by 6 months in the U.

So that's another important element. And the last bit is that we keep on investing into the optimization of the supply chain. I think broadly speaking, these are sort of the priorities that we currently have. To the second question about the expansion from 4 to 6 weeks, this had several unofficial components. First of all, there are a number of infections, which the guideline require treatment that is longer than 4 weeks in Staphylococcus aureus bacteremia.

These include, for example, osteomyelitis or vertebral bone infections or central nervous system infections, but also for other infections that usually can be treated with 4 weeks of treatment. The flexibility to be able to expand to 6 weeks, I think, is quite beneficial.

So just increase the versatility of the compound in treating more indications and just have the flexibility to increase the treatment duration, if needed. And then your third question on the biomarker study in terms of what are we looking for in the GBM biomarker study, Marc, maybe you want to comment on that. And we believe that the biomarker-driven approach will potentially enrich for patients that are more prone to respond to lisavanbulin.

So it's an enrichment by selection biomarker EB1. And we hope that we will, therefore, increase the number of responses and being able to predict which patients are more likely to respond to lisavanbulin.

It can feel like a lost opportunity, because the wonderful thing about poodle-type coat is how many options it gives you for turning up the wow factor. The recent Asian fusion grooming trend is a wonderful way to capitalize on the versatility of a poodle-type coat without making the dog "look like a poodle" while still sending clients home with a reasonably low-maintenance look.

There's a lot about settling on a style for a dog that's really about problem-solving than aesthetics. This dog likes to chew her ears, so we decided to take them short. Her owner is good at keeping her combed out in between appointments, so we can leave her legs fairly long, but they also have an active and busy lifestyle, so we want to make sure they don't get too long. Sometimes that means trying things and then asking Fusin (Short Mix) client for feedback, as well as taking note of the condition of the coat when the dog comes in for their next appointment.


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