February 7, 2020
Financial highlights
Jan – Dec 2019 (Jan – Dec 2018)
Net revenues were SEK 2.7 M (54.9 M)
EBIT was SEK -103.9 M (-54.2 M)
Net profit/loss was SEK -75.8 M (-41.1 M)
Earnings per share were SEK -2.95 (-1.84)
Diluted earnings per share were SEK -2.95 (-1.84)
Q4 2019 (Q4 2018)
Net revenues were SEK 0.0 M (2.2 M)
EBIT was SEK -28.1 M (-34.3 M)
Net profit/loss was SEK -3.4 M (-23.3 M)
Earnings per share were SEK -0.12 (-1.02)
Diluted earnings per share were SEK -0.12 (-1.02)
Business highlights in Q4 2019
Saniona recruited the last patient in the Phase 2a clinical study for Tesomet in hypothalamic obesity (HO). Patients will receive either Tesomet or placebo for 24 weeks followed by an open-label extension study where all patients will receive Tesomet for 24 weeks resulting in a total treatment period of 48 weeks. Saniona expects to report top line results from double-blind part of the study in Q2 2020.
Saniona’s partner Medix submitted a new drug application to the Mexican food and drug administration (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS) for approval of tesofensine for the treatment of patients with obesity. Medix expects to launch the product in Mexico in 2020, which will lead to double digit royalties on product sales.
Significant events after the reporting period
Saniona appointed Rami Levin as President and Chief Executive Officer. Rami Levin will oversee the transition of Saniona to a fully-fledged biopharmaceutical company. He has extensive commercial experience in CNS and rare diseases, both in U.S and globally. Jørgen Drejer, previous CEO, will continue in the role of Chief Scientific Officer.
Saniona completed a private placement of SEK 25 million and proposed a financing of up to SEK 158 million comprising a combination of the directed issue and rights issue of warrants totaling SEK 111 million – 133 million at a strike price of SEK 25 – 30 per share as well as a loan facility of SEK 25 million.
Comments from the CEO
“Saniona has reached an important inflection point in its development, poised for the approval and commercialization of Tesomet in the rare CNS disorders Prader-Willi Syndrome (PWS) and Hypothalamic Obesity (HO). We made significant progress towards our strategic targets in 2019, with positive and encouraging Phase 2a results with Tesomet in PWS and a continuing Phase 2 trial in HO. This underpins our commitment to bringing Tesomet to the market and to becoming a leading rare disease company, focusing on diseases of the central nervous system by developing new treatments that address significant unmet medical needs,” says Rami Levin, President & CEO of Saniona.
Read the complete Interim Report attached below.
For more information, please contact
Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail: tf@saniona.com
This information is such information as Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CET on February 7, 2020.
About Saniona
Saniona (OMX: SANION) focuses on research and development of drugs to treat rare diseases of the central nervous system. Saniona intends to independently develop and commercialize treatments for orphan indications such as Prader-Willi syndrome and hypothalamic obesity. The company currently has three proprietary programs in clinical development and four clinical development programs in partnership. Saniona’s drug discovery platform is focused on ion channel research and the company has a broad portfolio of early stage programs. Saniona’s partners include Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V and Cadent Therapeutics.
