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Basilea reports significant revenue growth from marketed products and pipeline progress for full-year 2019
Basel, Switzerland, February 18, 2020 – Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today its financial results for the financial year ended December 31, 2019. David Veitch, Chief Executive Officer, said: “Basilea made significant progress in 2019. Revenue contributions from our two marketed brands, Cresemba and Zevtera, increased by 39 percent year-on-year. At the same time, we continued to manage closely our expenses, leading to a further reduction of our net cash consumption, and a 29 percent improvement of our operating result. Cresemba sales by our partners continued to grow significantly, both in established markets and new markets, which triggered two sales milestone payments based on sales in Europe. Our commercialization partners doubled the number of launched countries during 2019 and we expect that Cresemba will be available in about 60 countries by the end of 2021.” He continued: “Important progress was also made for lisavanbulin and derazantinib, our most advanced oncology programs. We have identified a potentially response-predictive biomarker approach for lisavanbulin and decided to move the drug candidate forward into a targeted phase 2 study in patients with glioblastoma. For derazantinib, we have started a phase 1/2 study in patients with urothelial cancer and are planning to further expand the clinical development program into gastric cancer. In both studies, derazantinib will be explored as a single drug and in combination with Roche’s immune checkpoint inhibitor, atezolizumab. Preclinical profiling of derazantinib indicated that it may make tumors more susceptible to immunotherapy. For our antibiotic ceftobiprole, we have successfully completed the first of the two phase 3 studies which are necessary to support a regulatory filing in the U.S., the commercially most important market for novel branded hospital antibiotics. We expect continued strong global sales uptake for Cresemba while we remain focused on carefully managing our expenses and are convinced that we are very well positioned to take our next value-generating steps.” Financial summary In 2019, investments in Basilea’s pipeline resulted in research and development expenses of CHF 102.7 million (2018: CHF 104.9 million). Such expenses were mainly driven by costs for the two phase 3 studies for the antibiotic ceftobiprole, the costs related to the ongoing preclinical and clinical program for derazantinib, the phase 1/2a development of oncology drug candidate lisavanbulin and the ongoing pediatric programs for ceftobiprole and isavuconazole. Selling, general and administrative expenses remained flat at CHF 30.0 million (2018: CHF 31.4 million). Cost of products sold, which includes manufacturing costs, capacity reservation costs, shipping and handling costs as well as certain one-off items amounted to CHF 18.9 million (2018: CHF 20.3 million). In 2019, the operating loss amounted to CHF 17.2 million (2018: CHF 24.1 million). Net loss in 2019 was significantly reduced to CHF 22.4 million (2018: CHF 31.4 million), resulting in a basic and diluted loss per share of CHF 2.08 (2018: CHF 2.89). Net cash consumption from operating activities in 2019 was reduced by 19% to CHF 63.8 million as compared to CHF 79.2 million in 2018. This is a result, on the one hand of the significant increase in cash inflow from Cresemba and Zevtera revenue and, on the other hand, of Basilea’s continued focus on managing its operating expenses by continuously optimizing its preclinical and clinical portfolio and targeting its investments into its R&D pipeline. Combined cash and investments amounted to CHF 161.0 million as of December 31, 2019, compared to CHF 223.9 million as of December 31, 2018. Key financial figures
1 Contract revenue in 2019 include none (2018: CHF 23.9 million) related to Toctino® deferred revenue recognition. The consolidated financial statements of Basilea Pharmaceutica Ltd. for the financial year 2019 can be found on the Company’s website at https://www.basilea.com/financial-reports. 2020 Outlook For 2020 Basilea will focus on:
Considering these key priorities, Basilea provides the following financial guidance for 2020:
Portfolio – Important progress in clinical pipeline and accelerated commercialization of marketed brands throughout 2019 In-market sales of our two marketed brands, Cresemba and Zevtera, continued to increase significantly In 2019, Basilea’s partners doubled the number of countries in which Cresemba is launched. To date, Cresemba is launched in more than 40 countries. According to the latest available public data, global in-market sales of Cresemba reached approximately USD 190 million in the 12 months to the end of September 2019.1 Zevtera is currently launched in 18 countries. Zevtera sales continued to increase and sales growth is expected to further accelerate through the increasing contributions from the newly launched countries inside and outside of Europe. Expanding derazantinib data package In August 2019, we started a phase 1/2 study, FIDES-02, to explore the FGFR kinase inhibitor, derazantinib, in patients with advanced urothelial cancer with FGFR genetic aberrations, alone and in combination with Roche’s atezolizumab (Tecentriq®), a PD-L1 checkpoint inhibitor.2 As announced early in 2020, we are also planning a biomarker-driven multi-cohort phase 1/2 study, FIDES-03, in advanced gastric cancer patients with FGFR genetic aberrations, which is expected to start in the third quarter of 2020. This study, too, will assess derazantinib alone and in combination therapy with atezolizumab. The rationale for the combination is based on the activity of derazantinib to inhibit the colony-stimulating factor-1-receptor (CSF1R), which differentiates derazantinib from other FGFR kinase inhibitors in clinical development. CSF1R kinase inhibition has the potential to enhance the response to atezolizumab’s immune-checkpoint inhibition. Roche is providing clinical supply of atezolizumab for the FIDES-02 and FIDES-03 studies. Following the reporting of positive interim results from FIDES-01, a registrational phase 2 study with derazantinib in patients with intrahepatic cholangiocarcinoma (iCCA) and FGFR2 gene fusions, an additional cohort was opened in patients with FGFR2 gene mutations and amplifications in order to further profile derazantinib in this indication.3 Tumor checkpoint controller lisavanbulin shows clinical efficacy in glioblastoma In 2019, we concluded patient enrolment into two phase 1/2 studies with lisavanbulin (formerly BAL101553) with daily oral dosing and weekly 48-hour i.v. infusion, respectively.4, 5 We observed clinical activity in glioblastoma in both studies, including two patients with profound clinical responses with more than 80% reduction of the tumor area. We decided to advance the development of the oral formulation to a targeted, biomarker-driven, phase 2 study in recurrent glioblastoma and potentially additional tumor types. This study is anticipated to start in glioblastoma patients mid-2020. In addition, a separate phase 1 study with daily oral dosing of lisavanbulin in combination with radiotherapy in patients with newly diagnosed glioblastoma is ongoing.6 This study is conducted in collaboration with the U.S. Adult Brain Tumor Consortium, and patient enrolment into the study could be completed by mid-2020. Positive topline results from phase 3 study with ceftobiprole (Zevtera®) support U.S. strategy In August 2019, Basilea reported positive topline results from the phase 3 TARGET study, which evaluated ceftobiprole in the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI).7 Ceftobiprole met primary and secondary efficacy endpoints and was well tolerated with the overall rates of drug-related adverse events being similar between ceftobiprole and the control group. For a future regulatory filing in the U.S., positive results from a second phase 3 study, ERADICATE, would also be required.8 ERADICATE is exploring ceftobiprole in patients with bloodstream infections (bacteremia) caused by Staphylococcus aureus bacteria and is on track to report topline results in the second half of 2021. The ceftobiprole phase 3 program is funded in part (up to USD 128 million, which is approximately 70% of the total estimated program costs) with federal funds from the U.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 No. HHSO100201600002C. Conference call and webcast Via audio webcast with presentation: Via phone: +41 (0) 58 310 5000 (Europe and RoW) Replay: About Basilea Basilea Pharmaceutica Ltd. is a commercial-stage biopharmaceutical company, focused on the development of products that address the medical challenges in the therapeutic areas of oncology and infectious diseases. With two commercialized drugs, the company is committed to discovering, developing and commercializing innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com. 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 Basilea Pharmaceutica Ltd. and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact:
This press release can be downloaded from www.basilea.com. References 1 IQVIA, September 2019. In-market sales reported as moving annual total (MAT) in U.S. Dollar corrected for currency fluctuations. Attachment |