the outstanding convertible bonds (H1 2021: CHF 13 million), and assuming 
      that the cash-inflow from certain milestone events expected in H2 2021 
      will only occur in early 2022. 
 
(in CHF million)             FY 2021e (updated)  FY 2021e (previous)  FY 2020a 
---------------------------  ------------------  -------------------  -------- 
           Cresemba & 
            Zevtera revenue 
            (non-deferred)            115 - 125            108 - 118      78.2 
---------------------------  ------------------  -------------------  -------- 
           Cresemba & 
            Zevtera revenue 
            (deferred)                      2.5                  2.5      33.8 
---------------------------  ------------------  -------------------  -------- 
Total revenue                         134 - 144            128 - 138     127.6 
---------------------------  ------------------  -------------------  -------- 
           Total cost and 
            operating 
            expenses                  149 - 154            149 - 154     150.9 
---------------------------  ------------------  -------------------  -------- 
           Profit from sale 
            of assets                         0                    0      15.0 
---------------------------  ------------------  -------------------  -------- 
Operating loss                           7 - 17              13 - 23       8.2 
---------------------------  ------------------  -------------------  -------- 
 
Cash and investments 
 (year-end)                          165 - 170*           155 - 160*     167.3 
---------------------------  ------------------  -------------------  --------

* Excluding any impact from a reduction of the outstanding convertible bonds

Corporate events: divestment of Chinese R&D subsidiary -- private placement with institutional investors

Divestment of Basilea Pharmaceutica China: increases flexibility in the procurement of external research and development services and helps to better adapt the cost structure to the respective project portfolio.

In April 2021, Basilea announced that it has completed the divestment of its Chinese research and development subsidiary to the U.S.-based custom manufacturing organization PHT International Inc. for an initial payment of USD 2.5 million (CHF 2.3 million). In addition, Basilea is entitled to receive additional payments of USD 3.8 million (CHF 3.6 million) over the next three years.

Private placement: provides further financial flexibility and opens up a number of strategic opportunities for the further development of oncology drug candidates

In February 2021, Basilea carried out a strategic capital increase in the form of a private placement with institutional investors, which generated gross proceeds of around CHF 46 million.

Continued reduction of 2022 convertible bond further improves debt ratio

Since the beginning of the year, Basilea reduced the convertible bond maturing in December 2022 (ISIN CH0305398148) by CHF 12.4 million.

Portfolio progress: three clinical studies expected to report topline results until mid-2022 -- clinical pipeline expansion expected -- significant progress made in commercialization of marketed brands

FGFR inhibitor derazantinib(1) : further strengthened differentiated efficacy and safety profile

Encouraging topline results have been reported for cohort 1 (FGFR2 fusion-positive iCCA) of the FIDES-01 phase 2 study in February 2021.(2) These data further matured during patient follow-up and with data cut-off in April 2021 showed a median progression-free survival (PFS) of 7.8 months, which is in the upper range reported for this endpoint with FGFR inhibitors in this patient population.(2) This further supports the clinically relevant efficacy for derazantinib monotherapy in this indication. For cohort 2 of FIDES-01 (iCCA with FGFR2 mutations/amplifications), positive interim results were published in March and topline results for this cohort are expected in the first half of 2022. In the FIDES-02 urothelial cancer study, interim results for the cohort with patients who failed to respond to other FGFR inhibitors are expected in the second half of 2021, both for monotherapy with derazantinib and in combination with Roche's atezolizumab.(3) In May 2021, Basilea decided to also explore higher daily doses for mono- as well as combination therapy in the FIDES-02 and FIDES-03 studies (FGFR-driven urothelial and gastric cancer, respectively).(4) Initial results from cohorts receiving this intensified dose regimen are expected in the first half of 2022.

Lisavanbulin: potential expansion of lisavanbulin into other tumors based on biomarker signature -- orphan drug designation granted

Basilea is currently investigating its tumor checkpoint controller lisavanbulin in patients with glioblastoma.(5) Glioblastoma is the most common type of primary brain cancer and one of the most lethal types of cancer.(6) Two patients from the phase 1 part of the ongoing clinical study, whose tumors tested positive on the potential response-predictive biomarker EB1, are showing a long-lasting clinical benefit and have been successfully treated for more than two years. One of these patients even experienced a reduction of tumor size of more than 80%. In the phase 2 part of the study, only EB1-positive glioblastoma patients are being enrolled and Basilea expects interim results at the end of 2021 and topline results in the first half of 2022. If these results provide a clinical proof-of-concept in glioblastoma, this would support exploring the selection of patients based on EB1-positivity in other tumor types as well, such as melanoma, breast, colorectal and lung cancers, or rare cancer types such as medulloblastomas or neuroblastomas. Approximately 5% of glioblastoma tissue samples were found to be EB1-positive.

In July 2021, the U.S. Food and Drug Administration (FDA) granted lisavanbulin Orphan Drug Designation for the treatment of malignant glioma, which includes glioblastoma. This is positive news as the designation qualifies for various incentives, including longer regulatory market exclusivity.

Pipeline expansion: new oncology drug candidate expected to enter clinical studies early 2022

Basilea is making encouraging progress in final preclinical studies with a potential first-in-class small-molecule kinase inhibitor, which was in-licensed in 2018. If successfully completed, Basilea plans to file an IND (Investigational New Drug) application later this year. If the IND is granted, first-in-human clinical studies could be initiated in early 2022.

Cresemba (isavuconazole): global "in-market" sales continue to increase -- progress in Japan and China

Cresemba has reached USD 266 million global "in-market" sales for the 12 months to the end of March 2021.(7) This is an increase of 18% year-on-year. Cresemba is currently approved in almost 60 countries and has been launched in 53 countries. Thus, Basilea is well on track to achieve the target of 60 launched countries by the end of this year and is targeting to increase this to approximately 70 countries by the end of 2022.

In January 2021, the last patient was enrolled in a phase 3 study in deep-seated mycoses, conducted by Basilea's partner Asahi Kasei Pharma.(8) At the end of July, Asahi Kasei Pharma announced that the study was successfully completed and that they are planning to file a New Drug Application (NDA) for the marketing authorization of Cresemba in Japan. In China, the review of the marketing authorization applications which were accepted for review in May and October 2020 (for mucormycosis and for invasive aspergillosis respectively), is ongoing.

Zevtera (ceftobiprole): expanding commercial partnerships and making progress in key study for potential U.S. approval

In July, Basilea announced another distribution agreement, with Moscow-based JSC Lancet for Russia and the other countries of the Eurasian Economic Union. In order to gain market access to the commercially most important U.S. market, Basilea is conducting a phase 3 program of two cross-supportive studies.(9) The program was agreed with the FDA in a Special Protocol Assessment. The first of the two studies, the TARGET study that explored ceftobiprole for the treatment of complicated skin infections, was successfully completed in 2019.(10) The second study, the ERADICATE study in Staphylococcus aureus bacteremia (SAB), is on track to complete patient enrolment around the end of 2021, with topline results in the first half of 2022.(11)

Innovative anti-infectives: received CARB-X grant for development of novel antibiotic

In May, Basilea was awarded an up to USD 2.7 million research grant from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global partnership dedicated to supporting the early development of antibacterial products, for the development of DXR inhibitors, a novel class of antibiotics targeting drug-resistant Gram-negative bacteria such as carbapenem-resistant Enterobacterales, Acinetobacter baumannii and multidrug-resistant Pseudomonas aeruginosa.

Conference call and webcast

Basilea Pharmaceutica Ltd. will host a conference call and webcast today, Tuesday, August 17, 2021, at 4 p.m. (CEST), to discuss the Company's financial and operating results.

Via audio webcast with presentation

The live audio webcast of the results presentation can be followed here https://www.globenewswire.com/Tracker?data=zsNC3u1TOzyn3WhUUR_hFvOBT0H3sIPlE96C9SiP9yFPzyX7__1LUEmGcGGZFn50LAWszU6rbz2VM6q9HxrMMT_Qf0EsEiMt6pofF88wfOOFYlXLFswaWcJXqiWlDNa8S5obdZZsbSjxtYLFerbhqg== . Please note that there is no function to ask questions via webcast. For questions, please additionally dial-in via phone (see below).

Via phone

To listen by phone and ask questions, please use the dial-in details below. To ensure prompt access, please call approximately five minutes prior to the scheduled start of the call. 


 
+41 (0) 58 310 50   (Europe and RoW) 
 00 
+1 (1) 866 291 41   (USA) 
 66 
+44 (0) 207 107 06  (U.K.) 
 13

Replay

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August 17, 2021 01:15 ET (05:15 GMT)