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
Total revenue in 2019 increased to CHF 134.4 million (2018: CHF 132.6 million). Together, product revenue and contract revenue increased to CHF 114.4 million (2018: CHF 105.9 million). Revenue contributions from the two marketed brands Cresemba and Zevtera increased 39% to CHF 114.3 million (2018: CHF 82.0 million), of which CHF 68.7 million (2018: CHF 50.5 million) relate to non-deferred revenue and CHF 45.6 million (2018: CHF 31.5 million) to deferred revenue recognition. Deferred revenue is recognized for upfront, development and regulatory milestone payments received in prior years from partners. The company was able to fully offset the impact from the completion of the non-cash deferred revenue recognition related to Toctino in 2018 (2018: CHF 23.9 million). Other revenue amounted to CHF 19.7 million (2018: CHF 26.5 million). This included CHF 18.5 million BARDA reimbursements (2018: CHF 25.9 million), which are offsetting a substantial portion of the ceftobiprole phase 3 development expenses. The BARDA reimbursements decreased in line with the reduced development expenses after the successful completion of the ceftobiprole phase 3 skin infection study.
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.
