PRESS RELEASE

November 14, 2018

Financial highlights

Jan – Sep 2018 (Jan - Sep 2017)

  • Net revenues were SEK 52.7 M (16.1 M)
  • EBIT was SEK -19.9 M (-40.6 M)
  • Net profit/loss was SEK -17.7 M (-34.4)
  • Earnings per share were SEK -0.80 (-1.62)
  • Diluted earnings per share were SEK -0.80 (-1.62)

Q3 2018 (Q3 2017)

  • Net revenues were SEK 44.6 M (4.2 M)
  • EBIT was SEK 19.9 M (-15.1 M)
  • Net profit/loss was SEK 15.3 M (-13.4)
  • Earnings per share were SEK 0.68 (-0.61)
  • Diluted earnings per share were SEK 0.68 (-0.61)

Business highlights in Q3 2018

  • Saniona received a research milestone payment of € 4 million (SEK 41.8 million) as a result of the candidate selection by Boehringer Ingelheim. According to the agreement, Saniona may receive up to €90 million in milestone payments. In addition, Saniona is entitled to tiered royalties on net sales of any potential products commercialized by Boehringer Ingelheim as a result of this collaboration. As of today, Saniona have received a total of €9 million under the collaboration.

Significant events after the reporting period

  • Saniona completed recruitment of adolescents for the second part of its Phase 2a study of Tesomet in patients with Prader Willi Syndrome (PWS). The trial is expected to be completed in early 2019 with topline results available in Q1 2019.
  • Saniona’s spin-out company Scandion Oncology was listed on the Spotlight Stock Market on November 8, 2018 and received total proceeds of SEK 26 million before issuance costs through an Initial Public Offering.
  • Saniona has entered into a 1-year option agreement with Initiator Pharma A/S, where Initiator Pharma obtains the right to acquire the AN788 program under certain conditions.
  • Saniona’s partner Medix has initiated the data-lock procedure in the Phase 3 study for tesofensine in obesity after the last patient has completed the 3-month follow-up visit. Top-line results are expected to be available in December 2018.

Comments from the CEO         

"We have made significant progress on our preclinical and clinical programs during the third quarter. We received a significant milestone payment from Boehringer Ingelheim and are now looking forward to report results and topline date from five ongoing clinical studies within the next few months including a pivotal Phase 3 study and two Phase 2 studies,” says Jørgen Drejer, 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

The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CET on November 14, 2018.

About Saniona

Saniona is a research and development company focused on drugs for diseases of the central nervous system, autoimmune diseases, metabolic diseases and treatment of pain. The company has four programs in clinical development. Saniona intends to develop and commercialize treatments for orphan indications such as Prader-Willi syndrome and hypothalamic obesity on its own. The research is focused on ion channels and the company has a broad portfolio of research programs. Saniona has partnerships with Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V and Cadent Therapeutics. Saniona is based in Copenhagen, Denmark, and the company’s shares are listed at Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com.

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