CHF 46.1 million (+26% year-on-year) non-deferred Cresemba and Zevtera revenue, includingCHF 23.6 million royalty income (+27% year-on-year) reflecting continued commercial success of marketed brands- Strong operational performance led to 18% improvement in net cash used in operating activities
- Operating result improved by 40% year-on-year, excluding the one-off profit from HQ property sale in H1 2020 and deferred revenue
CHF 164.7 million cash and investments at half-year 2021- 2021 full-year guidance increased; higher revenue expectations leading to better operating result
Ad hoc announcement pursuant to Art. 53 LR
He continued: “We also continue to manage our cost base. We were able to keep our total cost and operating expenses at a stable level in spite of the growth of our commercial business and the continued progress in our drug development portfolio. The strong underlying operational performance is positively reflected in our operating result, which improved 40% year-on-year, when excluding the one-off profit from the sale of our headquarters property in the first half-year 2020 and the deferred revenue recognition in both periods.”
Financial summary
Total revenue in the first half-year 2021 was CHF 54.2 million (H1 2020: CHF 69.3 million), reflecting the already anticipated decrease in the recognition of deferred revenue to CHF 1.3 million (H1 2020:
In the first half of 2021, investments in the pipeline resulted in research and development expenses of CHF 41.7 million (H1 2020: CHF 43.9 million). Such expenses were mainly driven by costs for the phase 3 program for ceftobiprole, the costs related to the ongoing preclinical and clinical programs for derazantinib and lisavanbulin, as well as to the ongoing pediatric programs for ceftobiprole and isavuconazole.
Selling, general and administrative expenses amounted to CHF 14.4 million (H1 2020: CHF 14.5 million). In line with increasing sales of products to partners, cost of products sold increased to CHF 13.5 million (H1 2020: CHF 13.1 million).
In the first half-year of 2021, the operating loss amounted to CHF 15.4 million (H1 2020: operating profit of CHF 12.8 million). The operating result H1 2020 was positively impacted by
Net cash used in operating activities in H1 2021 was reduced by 18.1% to CHF 27.2 million as compared to CHF 33.2 million in H1 2020. This improvement is a result, on the one hand of the significant increase in cash inflow, based on the growth of Cresemba and Zevtera non-deferred revenue contributions and on the other hand, of Basilea’s continued focus on managing operating expenses, by continuously optimizing investments into the preclinical and clinical portfolio and improving the cost base through strategic transactions. Cash and investments amounted to CHF 164.7 million as of
Key financial figures
(in CHF million, except per share data) | H1 2021 | H1 2020 |
Product revenue | 13.6 | 30.5 |
Contract revenue | 33.8 | 31.5 |
Revenue from R&D services | 0.2 | 0.2 |
Other revenue | 6.6 | 7.1 |
Total revenue | 54.2 | 69.3 |
Cost of products sold | (13.5) | (13.1) |
Research & development expenses, net | (41.7) | (43.9) |
Selling, general & administrative expenses | (14.4) | (14.5) |
Total cost and operating expenses | (69.6) | (71.5) |
Profit from sale of assets | - | 15.0 |
Operating loss/profit | (15.4) | 12.8 |
Net loss/profit | (19.9) | 9.9 |
Net cash used in operating activities | (27.2) | (33.2) |
Basic loss/earnings per share, in CHF | (1.84) | 0.92 |
Diluted loss/earnings per share, in CHF | (1.84) | 0.91 |
(In CHF million) | ||
Cash and investments | 164.7 | 167.3 |
Note: Consolidated figures in conformity with
The unaudited, condensed consolidated interim financial statements of
FY 2021 financial guidance
Basilea increases its revenue guidance and expects a better operating result for full-year 2021:
- Non-deferred revenue contributions from Cresemba and Zevtera are expected to grow to
CHF 115 - 125 million (+47% to +60% y-o-y), reflecting the continued significant growth of in-market sales by its partners and several potential milestone events in the second half of 2021. - Total R&D and SG&A expenses are expected to remain approximately stable. Cost of products sold is expected to increase in line with higher product deliveries to partners.
- The anticipated operating loss amounts to CHF 7 - 17 million, which is below the operating loss reported for FY 2020, excluding the one-off positive impact from the sale of the headquarters property.
- Cash and investments are expected to be approximately CHF 165 - 170 million at year-end 2021, excluding any impact from a reduction of 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
Private placement: provides further financial flexibility and opens up a number of strategic opportunities for the further development of oncology drug candidates
In
Continued reduction of 2022 convertible bond further improves debt ratio
Since the beginning of the year, Basilea reduced the convertible bond maturing in
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 derazantinib1: 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
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
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
Cresemba has reached
In
Zevtera (ceftobiprole): expanding commercial partnerships and making progress in key study for potential
In July, Basilea announced another distribution agreement, with
Innovative anti-infectives: received CARB-X grant for development of novel antibiotic
In May, Basilea was awarded an up to
Conference call and webcast
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Replay
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About Basilea
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in
Disclaimer
This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning
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Phone | +41 61 606 1102 |
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This ad hoc announcement can be downloaded from www.basilea.com.
References
- Basilea has in-licensed derazantinib from ArQule Inc., a wholly-owned subsidiary of Merck & Co., Inc.,
Kenilworth, N.J. , U.S.A. - FIDES-01 study: ClinicalTrials.gov identifier NCT03230318
- FIDES-02 study: ClinicalTrials.gov identifier NCT04045613
- FIDES-03 study: ClinicalTrials.gov identifier NCT04604132
- ClinicalTrials.gov identifier NCT02490800
- B. M. Alexander, T. F. Cloughesy. Adult Glioblastoma.
Journal of Clinical Oncology 2017 (35), 2402-2409 - IQVIA,
March 2021 . In-market sales reported as moving annual total (MAT) inU.S. Dollar corrected for currency fluctuations. - Clinicaltrials.gov identifier NCT03471988
- Basilea's ceftobiprole phase 3 program is funded in part (up to
USD 134.2 million , which is approximately 70% of the total potential program costs) with federal funds from theU.S. Department of Health and Human Services ;Office of the Assistant Secretary for Preparedness and Response;Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. - TARGET study: Clinicaltrials.gov identifier NCT03137173. J. S. Overcash.
C. Kim ,R. Keech et al. Ceftobiprole compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections: results of a phase 3, randomized, double-blind trial (TARGET). Clinical Infectious Diseases 2020, ciaa974; https://doi.org/10.1093/cid/ciaa974 - ERADICATE study: Clinicaltrials.gov identifier NCT03138733.
K. Hamed ,M. Engelhardt , M. E. Jones et al. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, phase III trial. Future Microbiology 2020 (15), 35-48; https://doi.org/10.2217/fmb-2019-0332
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