In its recent financial results, Basilea's partner Astellas reported Cresemba (isavuconazole, antifungal) Q2/2019 US sales of $37m, taking H1/2019 US sales to $67m (+26% YoY), slightly above our $65.5m forecast. The company also stated that it projects FY2019E (April 2019 - March 2020) sales to reach $143m, in line with our estimate for Astellas's fiscal year. This increases our confidence in our peak sales forecasts for Cresemba of nearly $230m in the US and $645m globally by 2026E, of which we expect Basilea to receive close to 40% over the life of the agreements with commercialisation partners. Basilea shares are trading well below our sum-of-theparts ("SoTP") derived fair value of CHF108 per share, of which Cresemba in marketed regions including the US and Europe accounts for CHF49 (46%). Hence, we feel that the shares are undervalued and see room for upside as the company continues to achieve upcoming milestones, including first Phase III data for anti-MRSA antibiotic ceftobiprole in the US in H2/2019E. We reiterate our OUTPERFORM recommendation.
We forecast H1/2019E revenues of CHF57.4m, including CHF44.3m from Cresemba and Zevtera (ceftobiprole, marketed ex-US) and CHF13m in reimbursements from BARDA related to the US Phase III clinical trial programme for ceftobiprole. Our expectation for a c.4% revenue decline is due to the lack of deferred revenue from Toctino, which totalled CHF18.8m in H1/2018 (the last CHF5.1m were booked in H2/2018). We forecast an operating loss of CHF19.5m broadly in line with CHF20.4m in the prior year, with a small increase in CoGS offset by a c.8% decline in R&D expenses, as H1/2018 included a $10m one-off payment to ArQule for the in-licensing of oncology drug derazantinib.
The key upcoming datapoint is top-line data from the Phase III trial testing ceftobiprole in severe skin infections ("ABSSSI") in H2/2019E, which we expect to be positive. Basilea intends to use the results from this study together with the ongoing trial in Staph. aureus bacteraemia ("SAB", expected in August 2021E) to file for US FDA approval (we remind investors that BARDA reimburses c.70% of the costs). The US is by far the largest market for MRSA antibiotics. Hence this region accounts for $227m of our c.$400m peak sales forecast for ceftobiprole. Other key datapoints this year include first Cresemba sales in APAC and top-line data from the ongoing Phase IIa trial of oncology asset BAL101553 in platinum-resistant or refractory ovarian cancer and recurrent glioblastoma.