Xbrane Biopharma releases interim report for January – March 2020

Financial summary first quarter 2020

• Revenues amounted to SEK 0 M (0).
• Gross margin amounted to 0 percent (0).
• Other operating income amounted to SEK 4.9 M (1.2).
• EBITDA amounted to SEK -47.0 M (-31.2).
• R&D expenses amounted to SEK 44.6 M (26.5) representing 86 percent (82) of total operating expenses.
• Loss for the period amounted to SEK 48.9 M (-33.3).
• Earnings per share of SEK -3.17 SEK (-5.26).
• Cash and cash equivalents amounted to SEK 84.5 M (44.3) by the end of the first quarter.

Significant events during the first quarter 2020

• In February, 50 percent of the patients in the Xplore study had been recruited, which represents an important milestone.

• To better equip the management group for the upcoming commercialization of our biosimilars, it has been strengthened with the addition of Maria Edebrink, Head of Regulatory Affairs and Anders Wallström, Head of Manufacturing and Supply Chain, both of whom have been employed at Xbrane since early 2019. Furthermore, Xiaoli Hu has been recruited to the position of Head of Business Development and is a part of the management as of May 1, 2020. As a result of Xbrane’s strategic focus on biosimilars, Paolo Sarmientos, Head of Long-acting injectables, is no longer part of the management group.

• Finchimica S.p.A., parent company of the contract manufacturer ICI S.p.A, which Primm Pharma uses to manufacture Spherotide, went bankrupt in early 2020. Primm Pharma is taking the appropriate action to safeguard its interests in the future production of Spherotide.

• Board member Maris Hartmanis has announced that he has declined re-election in 2020.

Significant events after the period

• In April the company announced how the ongoing COVID-19 pandemic, had affected Xbrane’s operations. Xbrane has adapted its operations to comply with local government health guidelines. This has resulted in cancelled trips, switching to digital meetings and that the majority of employees are working from home. The Xplore study remains open for recruiting new patients and treating patients already included in the study. The work on Xplore follows local authority guidelines as well as those from the European Medicines Agency (“EMA”) and the US Food and Drug Administration (“FDA”). Safety for patient and clinical staff is our first priority. The rapid development of the COVID-19 pandemic makes it difficult to predict future recruitment rates at this stage. Although we expect Xplore be fully recruited by third quarter 2020 and thereby still moving towards market approval before Lucentis® loses its patent protection in the EU in July 2022.

• In May, Xbrane and STADA announced that they had formed a partnership with Bausch + Lomb for the commercialization of Xlucane in the United States and Canada. Under the agreement, Bausch + Lomb will pay a license fee consisting of a mid single-digit million USD up-front payment upon signing and milestone payments at regulatory approval and launch as well as sharing the gross profits from sales with Xbrane and STADA. Xbrane and STADA will equally share all income from Bausch + Lomb from the commercialization of Xlucane in the United States and Canada.