Hello, this is David Veitch, CEO of Basilea. I would like to welcome you to our Conference Call and Webcast, reviewing our financial results and key achievements for the full year 2020, discussing our upcoming milestones and financial guidance for 2021. I would also 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. This morning we issued a press release and our financial report on our results for the full year 2020. These documents are available on our website at basilea.com. I would first like to provide a brief summary of our key achievements for 2020 and year to date 2021. As already outlined at the half year, we have remained fully operational despite COVID-19. We achieved significant clinical milestones. We started two new clinical studies for derazantinib and lisavanbulin, our other clinical studies are progressing well. Our two marketed drugs, Cresemba and Zevtera, continued to show a strong commercial performance in 2020, leading to CHF 78 million of non-deferred revenue contributions, a more than 13% increase versus prior year. In the 12 months to September 2020, in-market sales of Cresemba grew by almost 30% year-on-year. We have executed two strategic transactions. We successfully issued a new convertible bond due 2027, extended the maturity of a substantial part of our debt from 2022 to 2027 by repurchasing a proportion of our 2022 convertible bond. We have also taken the first step to move from two different locations in Basel into a new headquarters in mid-2022 by a sale and leaseback agreement for our current headquarters property. These transactions resulted in a positive one-off effect of about CHF 15 million on our P&L and generated a cash inflow of approximately CHF 59 million. As of December 31st, 2020, Basilea's combined cash and investments amounted to approximately CHF 167 million. We also announced just yesterday the divestment of our Chinese R&D facility. This transaction provides us with both increased sourcing flexibility going forwards and reduced operational costs in the midterm. Adesh will now give you an update on our commercial progress and present more detailed financial highlights for the full year 2020, as well as provide our financial guidance for 2021. Marc will provide you with detailed information on the progress of our clinical programs. I'll now hand over to Adesh. Thank you, David. In 2020, together with our partners, we continued to make significant progress in the commercialization of Cresemba and Zevtera. The most current public in-market sales numbers available for Cresemba show that in the 12-month period ending September 30th, 2020, the global sales of Cresemba grew by more than 28% year-on-year to $244 million. Partnerships continue to play an important role in the execution of our global commercialization strategy of our brands and provide a strong basis for the future revenue growth. In 2020, Cresemba was launched in key countries in Asia-Pacific and gained regulatory approval in Russia. Zevtera was approved in China for the treatment of lung infections. These achievements triggered milestone payments of around CHF 9 million for both brands combined. In January 2021, Pfizer crossed the Cresemba sales threshold that triggered a $10 million milestone payment to us. This is an impressive sign of the continued strong sales performance of Cresemba and the high medical need it serves. In total, Basilea has received to date more than $260 million in upfront and milestone payments from its Cresemba and Zevtera partnerships. There are potential milestones remaining of more than $1 billion in total. Marketing application processes have been initiated in a number of additional countries, including for Cresemba in China, where the marketing authorization applications were accepted for regulatory review last year. Moving on to financials. I will highlight some of the key financial figures that were published in today's press release, and in more detail in the full-year report. I would like to mention that all figures I will refer to are in Swiss francs. The financials for the full year 2020 are characterized by a significant change in revenue mix and the positive impact from our headquarters property sale. As already anticipated at the beginning of 2020, deferred revenue contributions from Cresemba and Zevtera, which relates to upfront development and regulatory milestone payments received in prior years, decreased 25.9% to CHF 33.8 million. Most importantly, non-deferred revenue contributions, which most closely correlate with the actual in-market performance of our brands, increased 13.8% to CHF 78.2 million. Other revenue components decreased by 22% to CHF 15.6 million, mainly driven by lower partner reimbursements due to lower costs incurred related to the completed cefepime for skin infection study and the impact of the slight delay in recruitment in the bloodstream infection study due to COVID-19. Considering all these factors, total revenue decreased by 5.1% to CHF 127.6 million. Cost of products sold increased by 27.6% to CHF 24.1 million, mainly due to the increase in product deliveries to partners. R&D and SG&A expenses decreased 4.4% to CHF 126.8 million, reflecting our continued focus on cost management. We reported an operating loss of CHF 8.2 million, which is an improvement of 52.3% compared to 2019, and a net loss of CHF 14.7 million, which is an improvement of 34.4% year-on-year. Net cash used for operating activities was reduced significantly by 15.2% to CHF 54.1 million. This does not even consider the proceeds from the headquarters property sale and our convertible bonds transactions. As of December 31st, 2020, Basilea's combined cash and investments amounted to CHF 167.3 million. Moving on to our convertible bond transactions, which were completed in July. The main purpose of the transactions was to improve the debt maturity profile. To this end, we conducted two transactions. The first transaction concerned the issuance of a new bond with maturity 2027. The provisional allocation was very successful, reflected by the fact that we were able to allocate the maximum targeted amount of CHF 125 million. The second transaction concerns using the proceeds from the new bond to repurchase approximately 50% of the 2022 bond. Because many bond holders held onto their bonds rather than taking the opportunity to sell them at a cash premium, we reduced the size of the 2027 bond as we had no intention of significantly increasing our debt level through this transaction. We were therefore able to reduce the 2022 bond by around 25% in a first step. We've earmarked the majority of the cash from the issuance of the 2027 bond not already used to repurchase the 2022 bond to further reduce the 2022 bond by another 25%. By year end 2020, we have reduced the outstanding nominal amount of the 2022 bond by more than CHF 50 million. Hence, we remain confident that we will meet our initial goal of reducing the 2022 bond exposure significantly, but over time rather than in a single step. Yesterday, we announced that we have entered into an agreement with a custom manufacturing organization, PHT International, to divest our Chinese R&D subsidiary. The total purchase price will be $6.3 million, of which $2.5 million are due upon closing, and the remaining $3.8 million over the course of next three years. All 72 employees and the facilities will be transferred to PHT, which ensures continuity for our ongoing R&D projects and also provides sufficient time to optimize our external sourcing of R&D services. We expect closing of the transaction in the second quarter 2021. With regard to the expected financial impact, the annual operating expenses related to our Chinese subsidiary are in the mid-single digit million range. The transaction will have immediately a small positive P&L impact upon closing in 2021. Due to the transition period and the continued support being provided by PHT to ensure continuity in our R&D activities, the positive impact on our operating expenses will be limited in the initial 12 months after closing. We expect to see increasing levels of cost savings thereafter as we can start leveraging the increased flexibility in sourcing external R&D services. I'm turning now to our financial guidance for 2021. We expect a continued improvement of our revenue mix reflected by an anticipated 38%-51% increase to CHF 108 million-CHF 118 million in non-deferred revenue contributions from Cresemba and Zevtera. As in the past, the range reflects several potential milestone events for 2021. This should be the last financial year that we separately discuss deferred revenue contributions from Cresemba and Zevtera, as they are expected to decline by around 90% to CHF 2.5 million now that we have fully recognized the past upfront and milestone payments from our partners, Pfizer, Astellas and Gosun. Overall, we expect an increase in total revenue to CHF 128 million-CHF 138 million. Once again, we expect total R&D and SG&A expenses to remain approximately stable. Cost of products sold is expected to increase based on higher product deliveries to partners. Based on this, the anticipated operating loss amounts to CHF 13 million-CHF 23 million, which is below the operating loss reported for 2020, excluding the one-off positive impact from the sale of the headquarters property. We assume a strong cash position of around CHF 110 million-CHF 120 million at year-end, excluding any potential impact from a reduction of the outstanding convertible bonds. Our year-end cash and investment guidance considers that certain milestone payments and product deliveries may actually occur towards the end of the year, which would result in us reporting the P&L impact in 2021, but the corresponding cash inflow only happening in 2022. Our guidance takes into consideration that part of the purchase price for our Chinese subsidiary is only going to be paid after 2021. This should bridge the cash guidance to the operating loss guidance. I will now hand over to Marc for the clinical development update. Thank you, Adesh. Let me start with our antibiotic, Zevtera. In Europe and several markets outside of Europe, Zevtera is approved for the treatment of community and hospital-acquired pneumonia. One of our key priorities for Zevtera is to gain access to the U.S. market, which is by far the most important country for the commercialization of branded hospital antibiotics. Based on special protocol assessment agreements with the U.S. FDA, two successful, cross-support phase III studies are necessary for registration in the U.S. Our phase III program includes one study called TARGET in acute bacterial skin and structure infections and one study called ERADICATE in Staphylococcus aureus bacteremia or bloodstream infections. The program is funded up to approximately 70% by the Biomedical Advanced Research and Development Authority or BARDA, which is part of the U.S. Department of Health and Human Services. This allows it to advance the development of Ceftobiprole for the U.S. market in a cost-effective way. In 2019, we reported positive top-line results from the TARGET study. For the ERADICATE study, we expect that patient enrollment will be completed by year-end 2021, leading to the reporting of top-line results in the first half of 2022. If the bacteremia study is also positive, Basilea plans to submit a new drug application to the U.S. FDA. 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.S. from the date of approval. Nearly 120,000 Staphylococcus aureus bacteremia or SAB infections have been reported in the U.S. in 2017. The ERADICATE study targets complicated SAB, which are characterized by concomitant or metastatic infections such as bone, joint, or heart valve infections, persistent bacteremia, or bacteremia in patients on dialysis. There are limited antibiotic treatment options with only two approved treatments in the U.S., which are vancomycin and daptomycin, that cover both methicillin-susceptible and methicillin-resistant Staphylococcus aureus or MSSA and MRSA. In 2020, the FDA approved a protocol amendment extending the maximum treatment duration from four to now up to six weeks in the ERADICATE study. This is important because it allows for the inclusion of patients with more difficult to treat infections, including those with complications such as osteomyelitis and epidural or cerebral abscess. Now moving on to oncology. Our lead oncology drug candidate is derazantinib, which we in-licensed in 2018 from the U.S. company ArQule, which is now a wholly-owned subsidiary of Merck. Derazantinib is a targeted, orally available, small molecule inhibitor of the fibroblast growth factor receptor by FGFR family of kinases. FGFR genetic aberrations, for example, gene fusions, mutations, or amplifications, have been identified as potentially important therapeutic targets for various cancers, including intrahepatic cholangiocarcinoma or iCCA, urothelial, gastric, breast, and lung cancers. Due to this broad potential, we refer to derazantinib as a pipeline-in-a-product. Our development strategy focuses on achieving differentiation over other FGFR kinase inhibitors by leveraging the unique properties of derazantinib. Key differentiating factors include its unique kinase inhibition profile and its clinical safety profile. Besides FGFR, derazantinib also inhibits the colony-stimulating factor one receptor or CSF1R kinase, which has been reported to play a role in immune response tumors. Derazantinib also inhibits the vascular endothelial growth factor two or VEGFR-2 kinase, which is known as a therapeutic target in the anti-angiogenic treatment in multiple cancers, including gastric cancer. Basilea's clinical development program currently comprises three ongoing studies: FIDES-01 in intrahepatic cholangiocarcinoma or iCCA, which is a type of bile duct cancer, FIDES-02 in urothelial cancer, and FIDES-03, which was started in 2020 in gastric cancer. In February 2021, we reported positive top-line results from the first cohort of the FIDES-01 study, which provides the clinical proof of concept for derazantinib as monotherapy in its first indication. This first cohort includes 103 patients with FGFR2 gene fusion-positive advanced iCCA in a second-line and post-second-line treatment setting. FGFR2 fusions occur in about 16% of patients with iCCA. The objective response rate in these patients was 20.4% with a median progression-free survival of 6.6 months. These results are consistent with an earlier phase I/II study conducted by ArQule, they also confirm the interim results from the FIDES-01 study that we reported in 2019. The efficacy results shown with derazantinib are consistent with the efficacy seen with FGFR inhibitors as a class in FGFR2 fusion-positive iCCA patients, the safety and tolerability data support derazantinib's potential differentiation versus other FGFR inhibitors. It should be noted that the data from FIDES-01 are not fully mature yet, a number of patients are still continuing their treatment. We have expanded the FIDES-01 study with an additional cohort of iCCA patients with FGFR2 gene mutations and amplifications in their tumors. In October 2020, we present pooled efficacy data, including patients from the second cohort, the ARQ phase I study, our expanded access program. This pooled analysis demonstrated that derazantinib also has anti-tumor activity in this patient population. These are encouraging results as other FGFR inhibitors in advanced clinical development have so far only reported very limited benefit activity in this patient population. We are therefore looking forward to interim results from the second quarter of FIDES-01, which are expected in the first half of 2021. FIDES-02 is a phase I/II study with derazantinib as monotherapy and in combination with Roche's PD-L1 checkpoint inhibitor, atezolizumab. This is a biomarker-driven multi-cohort clinical study in patients with advanced urothelial cancer expressing FGFR genetic aberrations, and interim results from derazantinib monotherapy are expected to become available in the first half of 2021. We recently reported the recommended phase II dose for the derazantinib- atezolizumab combination in patients with advanced solid tumors in this study. Interim efficacy results for the derazantinib- atezolizumab combination in patients with urothelial cancer are expected to become available in the second half of 2021. We also plan to amend the FIDES-02 protocol to explore higher dose of derazantinib in two cohorts of this study. This dose increase is supported by the observed safety and tolerability profile of derazantinib at the current dose of 300 mg a day. This may provide additional benefits in monotherapy and combination to patients with FGFR-positive urothelial cancer, and also considered the evolving highly competitive treatment landscape in urothelial cancer in patients both with and without FGFR genetic aberrations. FIDES-03 was started in 2020. This study explores derazantinib as monotherapy and in combination with atezolizumab and with Lilly's anti-angiogenic drug, ramucirumab, in patients with advanced gastric cancer and FGFR genetic aberrations. Interim results for derazantinib monotherapy and the definition of the recommended phase II dose for the combination of derazantinib with ramucirumab, plus another anticancer drug, patritumab, are anticipated for the second half of 2021. We have decided to investigate durvalumab in gastric cancer based on its unique kinase inhibition profile from this preclinical in vivo data and a high medical need in this indication. Supply agreements are in place with Roche and Lilly, who provide atezolizumab and ramucirumab. Our tumor checkpoint controller, lisavanbulin, formerly known as BAL101553. We are focusing our clinical development activities with lisavanbulin on glioblastoma, the most common and aggressive form of primary malignant brain tumors in an area of high unmet medical need with poor survival, high morbidity, and very few treatment options available. Lisavanbulin is a novel microtubule-targeting small molecule which induces tumor cell death through spindle assembly checkpoint activation. It can be administered oral and IV, crossing the blood-brain barrier, and has shown potency 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 EB1, which was previously identified in preclinical models as a potentially responsive biomarker for glioblastoma. In our completed phase I glioblastoma clinical study with daily oral dosing, we have observed a profound and exceptional objective response in a glioblastoma patient whose tumor tissue was EB1 positive. This patient continues on treatment for more than two years now. Based on our encouraging clinical and preclinical data with EB1, we have started a biomarker-driven clinical phase II study in glioblastoma in 2020 using EB1 positivity as a patient selection criterion. Interim results from this study are expected in the second half of 2021. I will now turn over to David. Thank you, Marc. In summary, we are on track with the execution of our strategy with our two business pillars of oncology and infectious diseases. We are significantly growing our cash-relevant revenues from our marketed brands, Cresemba and Zevtera. We are also on track to have Cresemba launched in 60 countries by the end of 2021. We are also continuing to advance our clinical programs towards the next milestones through 2021 and 2022. 2021 holds a number of important milestones, especially related to our clinical programs. We anticipate the top-line results from the isavuconazole phase III study conducted in Japan by our partner Asahi Kasei Pharma. We also expect completion of patient enrollment into the Ceftobiprole phase III ERADICATE-SAB study. For derazantinib, we have already reported top-line results for the FIDES-01 FGFR2 gene fusion cohort in iCCA. In the first half of the year, we are also expecting interim results from the second cohort with other FGFR2 genetic aberrations. In addition, we are looking forward to interim results for derazantinib as monotherapy and in combination in urothelial cancer. We also expect the first data in gastric cancer in monotherapy and combination therapy for derazantinib. for lisavanbulin, we are expecting interim results from the EB1 biomarker-driven phase II study in recurrent glioblastoma. Finally, as we've just recently announced, we have passed an important preclinical milestone for a compound that we hope can be in the clinic early in 2022, hopefully adding to our already exciting pipeline. Thank you for your attention, and we'll now open the line up for your questions. The first question comes from Louise Chen from Cantor. Please go ahead. Hi. Congratulations on all the progress this year, and thanks for taking my questions. My first question for you is, how do you plan to show the competitive advantages of derazantinib through your clinical trial programs? You have several readouts coming up still through the end of the year. Then second question is, can you elucidate more the market opportunity for lisavanbulin, the competitive advantages of that product, and where it would fit into the treatment paradigm if it were approved? The last question is, can you provide any more color on your potential first-in-class, small-molecule kinase inhibitor that you had disclosed recently? Thank you. Okay. Thank you, Louise, for those questions. Actually, why don't we begin, Marc, with you in terms of how do we hope to show sort of advantages or differentiation for derazantinib, and then also maybe you could also address, Marc, the lisavanbulin and its sort of positioning in the glioblastoma market. Why don't we start with you, Marc? Certainly, David. Thank you very much for the question. As mentioned before, we are building on the intrinsic features of derazantinib, the kinase inhibition profile, and the safety profile to show differentiation. I think one of the key studies that we're conducting are the combination with atezolizumab and also the combination with ramucirumab and paclitaxel, because it's the standard treatment second-line gastric cancer. These readouts that we're going to see during the year or towards the end of the year will certainly provide us with a direction of how to pursue the development further. I think the FGFR inhibition together with the CSF1R inhibition rationalizes this combination. Considering that the CSF1R inhibition of derazantinib is unique amongst FGFR inhibitors, we think that this really could provide the differentiation in addition to the clinical safety profile. To the second question, the market opportunity of lisavanbulin. Here GBM is clearly a proof of concept indication. We have seen effective signals in the phase I study that we could link to EB1 positivity. We have now relatively robust prevalence estimates for EB1 positivity in GBM, which is in a range of 5%. This will not be a huge market segment, but if we are successful in GBM in a refractory setting, we would certainly be able, in this indication, to move directly in a first-line, newly diagnosed setting. I just wanted to mention that we have a study with the Adult Brain Tumor Consortium in the U.S. ongoing to assess the recommended phase II dose and the maximum tolerated dose in a radiotherapy combination. That would support a study in a first-line setting. In addition, we are conducting, and we will be presenting later this year, prevalence assessments in non-GBM tumor types, and this would provide the basis for a market size estimate beyond GBM. I think that's in short the answer to these two questions. I'm not sure, Adesh, did you want to add anything to that? No. I think the only thing I would add is that the GBM, of course, is a high unmet medical need area. At the end of the day, the market opportunity will also be driven by the extent of the clinical benefits that can be provided to this patient population. Maybe on the earlier compound that you asked, I think at this point in time, we have provided the level of specificity that we can give. Just as a reminder, this is an externally sourced compound as an example for a partnership that we have done on the preclinical side in 2018 and taken it now to this milestone. It's a small molecule, so our area of focus, a kinase with a unique kinase inhibition profile, which we believe would provide the opportunity for a targeted development on one hand, and also for a potentially first-to-market opportunity with this specific mode of action. It is probably a little bit too early to disclose more about the compound. We will certainly provide more information when we enter the clinic, which is planned for the early part of 2022. Thank you. Thank you. The next question comes from Arsène Guekam from Kepler Cheuvreux. Please go ahead. Hello, gentlemen. Thank you for taking my question. First of all, a follow-up question on derazantinib. What is your strategy with this drug? Let's assume that the next results will be positive. What will be your strategy? Are you seeking for a partner? If you could elaborate a little bit, it would be great. Two quick questions. Could you remind me the patent expiration in Europe and in the U.S. for Cresemba and Zevtera? On the last one for Adesh, I'm not sure to well understand. Could you give us more color on your guidance on mainly in the discrepancy between EBIT forecast and the cash expectation at the end of 2021? Thanks a lot. Okay. I'll take the middle one of those questions in terms of the Cresemba. It's not always patent, actually, but the exclusivity, the effect of exclusivity in the U.S. is 2027. It's the end of Q1 2027 without the pediatric program approved. With the pediatric program, which is ongoing, it extends into the end of Q3 2027. Then in Europe it's 2025. With the pediatric program, which is ongoing, as I say, if that's approved, that takes you to 2027 in Europe as well. In terms of Europe and the U.S., we talk about the effect of exclusivity as long as we complete the pediatric program, which is well on track, to 2027 in those two areas, geographies. In terms of the strategy and the partnering strategy for derazantinib, I think the important point is that we've got a history, obviously, as a company of partnering at the end of phase II. We aim to try and participate in the phase III to enable us more participation sort of down the line. We've participated with pharma or in the case of Ceftobiprole, obviously, with the U.S. government. That doesn't mean that forevermore we will always go down that model. We have a view at the moment, that for derazantinib to maximize this pipeline in a product, that we would probably seek the partnering approach for the phase III. As I said, that's not sort of a rule cast in stone. That's just like our history and looking at the potential to maximize this pipeline in a product. It probably makes most sense. Having said that, for lisavanbulin, it might be a very different situation. For lisavanbulin in a smaller targeted niche area, if it was initially, for example, in GBM, we could even consider commercializing ourself in selected markets. Not everywhere, but in selected markets. It depends a little bit on a number of factors, the strength of the data, the speed, the size of the market opportunity, et cetera. There are a few factors that come into play, obviously, clearly also the interest from potential partners. That's what I'd say a little bit about the strategy. Adesh, do you want to come back on the financial question? Sure. Thanks for the question, Arsène. I suppose the biggest gap between the P&L guidance, which is the operating loss guidance of CHF 13 million-CHF 23 million that we have guided for, and the cash position at the end of the year, is probably the timing when certain milestones would happen and when product deliveries happen. Because how this usually happens is, we hit a milestone, we get a notification, at some point, we issue an invoice, and if such a milestone, for instance, is hit in November or December, we would of course record the milestone in accordance with US GAAP in our profit and loss statements. The cash would only be coming in after December 31st. Because it's sort of really binary, either the invoice has been paid on the 31st of December or not. We sort of have to assume the full, let's say, invoicing or the due date of invoices. That's the whole secret behind it. In essence, you could almost say there is a buildup or an expected buildup of working capital towards the end of the year. The working capital does not relate to any product in the sense of inventory. It relates to receivables. Okay. Very clear. Thanks a lot. The next question comes from Ram Selvaraju from H.C. Wainwright. Please go ahead. Hi, guys. This is Robert Burns online for Ram. Thank you for taking my question. It's just two, if I may. The first one, could you discuss how you're thinking about the revenue opportunity for derazantinib in the FGFR2 mutated biliary tract cancer space, given the relatively comparable median PFS to that of pemigatinib and also taking into account pemigatinib's lead time in that area. My second question is, how are you thinking about the kind of landscape for some of these next generation FGFR2/3 inhibitors that are making their way through the pipeline, for example, Relay Therapeutics or Kinnate? Thank you. Yeah. Thank you for the question. Adesh, do you want to take the first one on the iCCA sort of opportunity and how we're thinking about that? Then Marc, you could comment maybe on the future FGFR compounds. Yeah, sure. I think we are not looking at iCCA in isolation, but I think it is a good case for the point that we believe strongly in differentiation. When it comes to iCCA, for instance, as you correctly pointed out, I think from the perspective of clinical benefit, a relevant factor is progression-free survival. As such, we are actually quite pleased with the outcome of the FIDES-01 study that we have just announced with PFS of 6.6 months. Far, we believe we are in the range of what has been reported with other FGFR inhibitors, generally speaking, as a class. Really differentiation as a monotherapy in iCCA would from our perspective, be driven by the safety and tolerability profile of derazantinib, where we believe that the profile is actually quite competitive. If you look at the space, it's quite favorable. Potentially the differentiation through the cohort two, which is still ongoing, which is in other genetic aberrations than FGFR2 gene fusions, which is a patient population that is smaller than the gene fusion patient population, but clearly would provide a differentiation versus, for instance, you mentioned pemigatinib, but also other FGFR inhibitors that are in more advanced clinical development. In essence, it is really about differentiation, but also, to be quite honest, our strategy is not necessarily to position derazantinib as an iCCA drug, but we believe that the scope for derazantinib is far beyond iCCA. Therefore, we are looking at the urothelial cancer indication where Marc previously indicated that based on the unique kinase inhibition profile, we believe that there is scope for differentiation, especially in combination with immune checkpoint inhibitors. There's also scope for differentiation on the safety and tolerability profile. In gastric cancer, where we have a potential first-in-class opportunity. We are looking broader at derazantinib than just looking at the iCCA opportunity. Maybe, on your second question, I would hand over to Marc. I think the newer FGFR inhibitors that we're seeing now coming to clinical study, I think there's a number of them tested mainly in China, but also, as you mentioned, RLY-4008. I think there's little published data on these inhibitors out there. I think the Relay compound is supposed to be very selective for FGFR2. We'll need to see how these play out, how much selectivity really plays a role also in terms of maybe the toxicity profile. It's too early to say I would make a statement at this point. We really need to see the clinical data, whether these compounds provide comparable efficacy, and especially whether the higher selectivity has an impact on the safety profile. One part maybe for the derazantinib differentiation perspective. As I said in response to the first question, our differentiation, part of our differentiation is really based on the activity to other kinases, especially CSF1R and also FGFR2, where we think when used in combination, actually, this may provide advantages and unique profiling against other FGFR inhibitors. It will be interesting to see how the very selective FGFR2 inhibitors, for example, how their benefit risk is in the end. Thank you. Next question comes from John Priestner from Edison Research. Please go ahead. Hi. Congratulations on the progress, and thank you for taking my questions. I have three. The first is really, what are the key sales catalysts for Cresemba and Zevtera over the next few years that we should really be looking out for? The second, I understand that Astellas and the University of San Diego have initiated a phase III trial with Cresemba, for the treatment of COVID-19-associated pulmonary aspergillosis. Can you really discuss the potential implications and benefits for Basilea if this trial was successful? My final question really is, given the evolving standard of care in gastric cancer, how important is the ramucirumab paclitaxel derazantinib cohort, and how does this really expand the potential patient population for derazantinib? Okay. Thank you for those questions. I'll address the first one, the one around the sales catalyst. In terms of, obviously, as you've seen from the data that Adesh has talked about, we're actually in the existing markets. We've launched Cresemba and Zevtera, and sales are going well. We've highlighted before the majority of our sales are coming from Cresemba, and Cresemba actually is growing in all markets that it's in. We have continued growth there. In terms of new catalysts for the future, clearly two markets that are very important that Adesh actually alluded to is China and the launch in China and also Japan. Obviously China, as he said, we've had accepted our two marketing applications by the regulators. We don't know yet how long that will take and whether we are required to do additional studies or not. The good news is that that regulatory process by our partner, Pfizer, is underway. Japan, where we did have to do a phase III, and as I said, that's actually completed enrollment now, and we expect the results later this year. If they're positive, then we begin, or our partner, Eisai, begins the regulatory process in Japan. They would be two very strategically important markets for us because they represent, we believe, about 25% of the global potential of the compound. They would be two major events. For Zevtera, Ceftobiprole, it's clear the approval we got for China is important. The launch in China, in 2022, end of this year, is very important. Also the most important, though, is the U.S., and Marc mentioned that. The opportunity for Zevtera, we believe, is the U.S., obviously then the next major event there is completing the phase III study, as he said, at the end of this year. Then the results of that in the first half of next year. If that's positive, then obviously every focus we will have is on seeking the regulatory approval in the important U.S. market. That's sort of the answer to the major catalyst for the crizanlizumab-Zevtera. Marc, can you comment on the Astellas San Diego collaboration with regard to looking at it in terms of COVID-19? I can comment, but cannot provide a lot of detail to this because it is not in our territories. We know also from Germany about case series of COVID-19 patients who acquired an invasive aspergillosis and the use of Cresemba. I think Cresemba is particularly optic to this because of the pharmacological profile and also the drug-drug interaction profile, which allows to alleviate concerns regarding interactions with other compounds. The percentage of patients with severe COVID-19 lung infections that suffer then from invasive aspergillosis, I am not sure whether that is entirely clear. Because of the relatively high prevalence of COVID-19, this may be a sizable number, but I do not know whether there is a clear prevalence estimate of this. I would consider this really, that the invasive aspergillosis in these patients is secondary, and that an antifungal treatment which has shown to work in pulmonary invasive aspergillosis, like isavuconazole, is very well suited to treat these infections. I think the other question was the value of the ramucirumab-paclitaxel-derazantinib cohort. I would approach this from a perspective that ramucirumab-paclitaxel is a key treatment standard in the second-line metastatic setting of gastric cancer, and that's quite a large group of patients. I think it's quite important to, in the group of about 10% of FGFR alterations in gastric cancer patients, to target these patients or may improve their outcomes by adding an FGFR inhibitor to this combination. In our viewpoint, the ramucirumab-paclitaxel combination is quite well established. I also think it will stay a standard in second-line treatment, even if the treatment landscape may shift a little bit. That could be in the perioperative setting. docetaxel is now increasingly used in the context of the FLOT regimen. If these patients recur early, there may be a concern of re-exposing them to paclitaxel, but this is probably a relatively limited group. While if the first-line treatment changed from a 5-FU platinum to a 5-FU- platinum- immunotherapy combination, I think that would not necessarily impact the second line. We're also running an atezolizumab-durvalumab combination cohort, which may actually help us in these data were positive to rationalize going in gastric cancer metastatic setting first line. I'm not sure whether that answers the question. If you have any other questions about it, bring them on. No, that's great. Thank you. Thanks for answering all my questions. Thank you. The next question comes from Brian White from Calvine Partners. Please go ahead. Yeah, thanks. I've got a couple of questions, actually. I was a bit confused on the strategy for lisavanbulin in terms of development. Looking at EB1, it sounds about 5% of GBM patients. Is the intention then to move on to other biomarkers? There certainly appears to be other relevant ones to look at. Is it to move on to all-comers or to look at other tumors where EB1 is relevant and the intention to conquer those? Secondly, just again, I hate to ask another question about differentiation of derazantinib. It's very clear that resistance is going to be an increasing issue for the FGFR inhibitor class in general. I wondered if there was any merit in the additional activities in the CSF1R pathway, perhaps, which may help in terms of having potentially a better resistance profile than some of the competing already commercially available products. Thank you. Yeah. I think, Marc, why don't you kick off and then I'll come back. In terms of the EB1, the strategy, and the approach there. Yeah, certainly. I think EB1, to us, is a biomarker that we've known about for a long time. We've run animal experiments over this biomarker back in 2016, and we've seen that this was a responsive biomarker in glioblastoma in animal models. The EB1 is a protein on the microtubules, which has a function regulating the dynamic of the microtubules. There has been descriptions also from other authors that have shown that this is potentially a prognostic marker, for example, breast cancer. Looking at the evidence we have in terms of animal models, it was quite, I think, intuitive to say that this biomarker really is on the pathophysiological pathway, so it makes sense. We have then proposed a relatively high threshold for EB1 positivity based on the clinical data we've seen in a couple of patients. With this threshold, we are now selecting about 5% of EB1 positive patients into our phase II study, and this will provide a proof of concept. We have not published, but we know that EB1 positivity also occurs in other cancer types, but we have submitted this for publication later this year, so we can provide a more detailed update then and talk about other cancer types. This could go down either a tumor-specific role, if we see EB1 positive in a low percentage of the larger cancer types or even in an agnostic role. What we do in parallel is that we are sequencing all patients who go into our study and are EB1 positive. There could be a refinement of the biomarker in the sense that we may see in this EB1 positive population, responders and non-responders, and that may refine the signature further. For now, the program is really directed towards EB1, but of course, we try to get a deep understanding how EB1 is genetically characterized and whether the biomarker signature can be further developed. Just to add one thing on the EB1 strategy. What's clear, though, is we're not planning on starting up the next non-GBM studies until we've proven the concept that it works, the EB1 is a response predictive biomarker in GBM. If we prove that and it works, and we'll know that we predict in the second half of before the end of this year, then we could look at moving into other tumor types in the way Marc described. Clearly, if it doesn't work, then obviously the program will stop. Just to be clear on that point. In terms of, though, the other point about your differentiation of derazantinib and whether maybe the resistance could be different having FGFR1 and CSF1R, et cetera. Maybe, Marc, that's another question for you. Best to answer that. I think it's a very interesting thinking, and I think recently, people have talked more about that the FGFR just located such a central place in the signaling cascade. The FGFR inhibition may be involved also in modulating resistance to other tyrosine kinase inhibitors. Certainly, if we could show that the CSF1R inhibition really changes the tumor immune microenvironment, I think that would just be an additional component to it. Yes, that certainly the FGFR inhibition itself and the inhibition of other kinases like FGFR2 and CSF1R could play a role in modulating resistance to other kinase inhibitors. Okay. That's helpful. Thanks, Marc. The next question comes from Paul Verbraeken from Research Partners. Please go ahead. I have a few questions on Cresemba. First, it comes based on the Astellas numbers, in which they give an outlook for Q1 of this calendar year, which is quite cautious, seeing a year-on-year decline. The question is, are they just being cautious, or is there still a corona effect, or are there some underlying causes there? That would be the first one. The second is also on Cresemba in the U.S. If I understand correctly, the in-market sales were up some 9% last year. Can you give a little bit of a feeling of the development of the number of prescriptions versus average price development? I can imagine if people are unemployed, the reimbursement goes through public rather than private health insurance. What was the effect of that influence last year? The last one, if I may, on the handover of the manufacturing of Cresemba to Pfizer, is it now completed? What was the impact on the numbers in 2020? Thanks. Thank you for the questions. In terms of the U.S., what I would say is that to look at one quarter to the next is sometimes always not that meaningful. There's a little bit of a sore tooth effect from one quarter to the next. I can't comment on whether Astellas is being conservative, but what I can say is that the gross sales growth in last year for the full year, if my memory serves me correctly, is around 13%. It's healthy from a gross sales point of view. You are correct, by the way, in your comment about the channel and the discounts, because obviously more people in 2020 were out of employment, and there was more Medicare, Medicaid, lower, bigger discount channels used. That's obviously, hopefully, if COVID starts to be managed at a different level than 2020, that's sort of one-off effects, and that will affect gross to net. What we tend to look at is the underlying health being the gross sales. In our most mature, established market, the U.S., the double-digit growth last year is what we focus on in terms of showing the underlying health of the business. Post-COVID, we hope that the gross to net will also go back to what it was before. That's the view on Cresemba in terms of the U.S. One other factor that obviously was a factor that I think we made a comment in a previous either half year or a different press release, where we talked about obviously the U.S. dollar to Swiss franc exchange rate. That was another factor that actually affects Basilea when the exchange rate goes in favor of the Swiss franc, because obviously Astellas is selling in dollars. There are a couple of factors that you hope are more like one-off events rather than constant events. Which is why I say we tend to look at the volume growth, the organic volume growth, and that's looking very healthy in the U.S. even though it's been launched a number of years. That's my comment on Cresemba. In terms of the transfer to Pfizer of the supply, Adesh, do you want to take that question? First, where do we stand? We're expecting in 2021 to actually keep on supplying Pfizer with API and with some bulk vials, and the bulk vial supply would extend to 2023. In essence, the handover is partially completed. On the API level, it will be completed by the end of the year. Then we may be carrying on supplying them with some Cresemba vials for another couple of years. On the impact perspective, some numbers have been disclosed, some haven't. What we have disclosed in our financial report is that product sales to Pfizer amounted to about CHF 38 million in 2020. That CHF 38 million included CHF 20 million or CHF 21 million in deferred revenue. The actual product sales were, in essence, the CHF 17 million difference between the deferred revenues and the total product revenues or product sales related to Pfizer. That gives you sort of a perspective on 2020. As indicated in 2021, this will continue. In 2022, we would, of course, expect this to sort of fade away. This will have a positive impact in turn on our cost of product sold, because as you know, on the product sales to Pfizer, we have sort of limited margin because the margin is coming through the royalty payments and the milestones that we get from Pfizer on their sales. Does this answer your question, Paul? Yeah. It's clear. Thank you very much. Thank you. The next question comes from Kieran Bunge from ODDO Partners. Please go ahead. Hi, gentlemen. Thank you for taking my question. Just two from me quickly. I know, firstly, you don't break out the Zevtera versus Cresemba mix, but could you give a sort of indication onto whether Zevtera was better or worse than it did in the previous financial year? I think it sort of slightly underperformed versus your expectations. Secondly, could you provide a little commentary on how you think the reimbursement environment for antibiotics is changing, especially in the U.S. ahead of the Zevtera launch? Thank you. Yeah. Adesh, do you want to comment on the product revenues? What we can say. Yeah The environment. With regard to Zevtera, I think there are two separate points. One is the in-market performance, which generally speaking increased year-on-year. The other point is that unlike with Cresemba, for Zevtera, we are only doing product sales to our partners, so we don't have royalties. Hence, our revenues do not necessarily reflect exactly how the product is doing in the market in a given period. As we are not breaking it out, we can't comment on how our Zevtera revenues have been doing. In-market demand in key markets has actually increased in 2020 versus previous years. An important factor there is, of course, the approval in China, which will have a significant impact or is expected to have a significant impact forward looking, as China is probably the second most important market after the U.S. from a commercial perspective or commercial opportunity perspective. Yeah. The segue to your sort of second question, because they're linked, is that we believe that up to about 90% of the potential, the revenue potential of Zevtera, is in the U.S. looking at other analogs. The U.S. opportunity is significant for us, and your question's a good one in terms of could the environment, the external environment in the U.S. particularly, given our opportunity there, could it improve? We know our standard answer to that question is that as of today, the environment is what it is. We think there seems to be momentum in terms of moving, in terms of change in legislation that could impact and separate out, provide more of a pull incentive for antibiotics and make them more commercially viable in the U.S. market. The two pieces of legislation are the DISARM Act, and even more importantly, I think the PASTEUR Act. We don't know if they'll become law or when they would become law. What we do know is that there seems to be an increase in visibility that something needs to change, and we believe that in the U.S., something will happen, in this area. We don't know exactly when. That can only then improve the environment for us with Zevtera. Obviously, what you've got to bear in mind is that we're not given the timelines we talked about earlier. If we have the results of our phase III SAB study in the first half of 2022, we're not going to be filing until, if it's positive, filing until the Q3, Q4 2022, and then that will be in approval sometime in 2023. At which point, with the QIDP, we would have 10 years of exclusivity following the approval date. That's the sort of timeline. In one respect, we've got some time for the external environment to improve, and if it did improve, that would obviously could only help us with regard to our future Ceftobiprole revenue potential. Okay, thank you. The next question comes from Bob Pooler from valuationLAB. Please go ahead. Good afternoon, gentlemen. Congrats again on the excellent results for 2020, especially in the face of COVID-19 and also the negative currency translation effect. Just on COVID-19, do you expect the COVID-19 pandemic to have a lasting impact on your future operations? You had to work from home, less traveling. Do you see anything, going forward in the future, potentially where there's also cost savings or hiring people abroad, not based in Basel, et cetera? Yeah. No, thanks for the question. It's a good question. It's probably maybe a standard answer you might get from a lot of companies, but I think clearly it's shown us, like a lot of companies, that we can work effectively by being remote. There are certain roles in our company, like for example, lab workers, whether they be researchers or analytical people in our company who actually need to have lab use. There are some roles that can't, but the majority of our people, I think it's taught us that we can work effectively from home. We've changed our practices. We've changed our, like a lot of companies, SOPs and things to align with remote working, and I think an element of that will absolutely stay. I think that also plays to your question about could we be more flexible with employment? I think, yes, we've proved that it's not where you sit, it's the job you do that's important. Yeah. I think the easy answer to that is yes, there will be some sort of things that stay on after COVID hopefully has disappeared or reduced to a much lower level. Okay, thank you. On your pipeline, do you expect to extend that soon, and would it be internally or externally, and also, rather anti-infectives or oncology? What we said earlier was that we have this compound that we talked about earlier that we hope, as long as the IND-enabling studies are successful this year, we hope to move that into the clinic. That's an oncology. It's a kinase we talked about, we can obviously, as we said, give more details of that as we're around that time, beginning of 2022. We hope to put that into the clinic. We've also got other oncology and anti-infective agents in different degrees of preclinical stages that we're trying to push towards the clinic, that they're not quite so close as this last one I just mentioned. We are also continually looking, Adesh can comment because he's responsible for this, we're also looking for external assets that fulfill our criteria in oncology and anti-infectives. I think the nature of the number of assets that are out there'll be more oncology than anti-infectives. Maybe Adesh, you want to comment on our external strategy? There's not really much more to add. We are being selective about what we are looking at in order to make sure that we can actually add value. It's more about ensuring that opportunities fit to our external expertise, where we believe we could create value, which we can then later on really pass on and potentially even partner if needed. That's actually the only other element that I would add to this. My final question. You're seeing that your revenues are going up. You're still heavily investing also in your oncology portfolio products there next to Zevtera. It seems that potentially you're going to break even. Would that be possible next year? Adesh, do you want to take that one? Yep. For sure. As you're saying, I think what we have now consistently demonstrated over the course of the last two or three years, our cash outflow is under control. We have stable expenses on the R&D and SG&A side. Our cash inflow reflected by the non-deferred revenues from Cresemba and Zevtera is constantly going up. As such, it is now controlled to some degree. You could also say whether or not, or when do we actually reach profitability. In response to your question, I would say it is purely a function of what our choices are going to be related to our oncology pipeline. We are working towards a number of different readouts in the course of 2021 and the early part of 2022. Based on the readouts, as David indicated, we will have to make decisions around partnering, taking things forward ourselves, and that will, at the end of the day, indicate or will drive whether we break even or when do we break even. Okay. Yeah, also there the main drive is adding value, and maximizing profitability depending on the indication areas there. Right. We are looking at things from a perspective of creating value. Very clear. Thank you. Thanks, Adesh. Yeah. Thank you. Thanks for the question. The next question comes from Victor Floc'h from Bryan Garnier. Please go ahead. Hi, guys. Victor Floc'h from Bryan Garnier. Thanks a lot for taking my question. Actually, most of my question has already been answered, but I still have one regarding the iCCA indication. Do you believe that the interim results from the second cohort expected in H1 will be enough to give you confidence to move on? Is there a possibility that you will wait for the top-line results expected next year? Thanks a lot. Yeah. You mean in terms of a regulatory progression, a regulatory process, do you mean, for iCCA? Yeah. Definitely. Yeah. Yeah. No, our view on this is that you're right, that with regard to iCCA, we need initially the top-line results in the first half of this year, but also in terms of our overall regulatory strategy for derazantinib, because we've got a number of data points as we've explained in quite quick succession across different tumor types, across gastric and across urothelial and iCCA. If we didn't have so many points, we'd probably come to a different conclusion, but we want to see how the data evolves across those different tumor types to understand what's the best overall regulatory strategy. Because these are quite quick succession, we think because we're focused on differentiation rather than just speed. Yeah. Speed's useful, but also differentiation's useful. We want to see how these different datas play out over the next 12 months to understand what is the best approach from a sort of regulatory point of view for the compound as a whole. Okay. Got it. Thanks a lot. Gentlemen, so far there are no more questions. Okay. Well, thank you all of you for your questions and your continued interest in Basilea. Enjoy the rest [inaudible].