Non Regulatory

Summary: Q4 and FY 2023

AcuCort publishes its financial statement in Swedish. This is a summary in English.

Numbers in parentheses indicate results for the corresponding period in 2022.

Fourth quarter October 1 – December 31, 2023

  • No turnover has occurred during the period.
  • Net profit amounted to -4,311 (-3,830) KSEK.
  • Earnings per share amounted to -0.14 (-0.12) SEK before dilution and -0.14 (-0.12) SEK after dilution.
  • Cash and cash equivalents at the end of the period amounted to 19,244 KSEK.

Period January 1 – December 31, 2023

  • No turnover has occurred during the period.
  • Net profit amounted to -13,691 (-14,789) KSEK.
  • Earnings per share amounted to -0.44 (-0.47) SEK before dilution and -0.44 (-0.47) SEK after dilution.

Significant events during the fourth quarter October 1 – December 31, 2023

  • On October 23, AcuCort announced that results from a survey study would be presented at the ISPOR Europe 2023 scientific conference.
  • On October 24, AcuCort AB was granted extended SME (Small or Medium-sized Enterprise) status by the European Medicines Agency (EMA).
  • On October 25, November 6, and December 11, AcuCort announced that the company obtained trademark protection for Zeqmelit® in China, Norway, and Japan, respectively.
  • On October 31, AcuCort disclosed the outcome of a rights issue. Through the rights issue, AcuCort raised a total of approximately 21.0 MSEK before issuance costs.
  • On December 20, AcuCort announced that the company was granted a wholesale distribution license by the Swedish Medical Products Agency.

Significant events after the end of the period

  • On January 23, AcuCort announced that the company had submitted an updated application to TLV regarding Zeqmelit®.
  • On January 26 and January 29, AcuCort announced that the company obtained trademark protection for Zeqmelit® in India and Switzerland, respectively.
  • On January 31, AcuCort announced that the first patient in the phase IV study ZEQ001 had received the Zeqmelit® oral film. The purpose of the study is to enhance marketing with practical experience from physicians and patients.
  • On February 13, AcuCort announced that the tenth allergy patient had received the oral film in the phase IV study ZEQ001 for Zeqmelit®.

CEO statement – On the threshold of launch

AcuCort is approaching one of the most important milestones in the company’s history; the first order of Zeqmelit®. The fourth quarter has been characterized by work to prepare for the commercialization of the company’s drug product Zeqmelit®.

Our medical goal is to enable a smart drug that provides a shorter time to treatment for severe allergies. After several years of development and preparation for commercialization, it is very gratifying to look forward to the Zeqmelit® oral film making a positive difference for individuals with severe or acute allergies and several other indications. During the quarter, a series of important news was published, pushing the process forward. In December, AcuCort was granted a wholesale distribution permit by the Swedish Medical Products Agency. The wholesale distribution permit means that AcuCort meets the regulatory requirements for trading in medicinal products. It is an important quality stamp on the company’s work to commercialize the drug product Zeqmelit®.

To finance the market launch, AcuCort has carried out a rights issue. The final outcome means that AcuCort will receive a total of approximately 21 million SEK before issuance costs.
AcuCort is working to increase awareness of Zeqmelit® and its properties. I want to highlight the scientific presentation* of our study at the ISPOR Europe 2023 international health conference* in November.

Full year

The year 2023 has been a preparatory year for the launch year 2024, and many important parts have fallen into place. A strategic milestone is the collaboration agreement with Unimedic Pharma regarding the sale of Zeqmelit® in Sweden, Norway, Denmark, and Finland.

Milestones and Priorities

  • The company assesses that the first commercial order will come in the first quarter of this year from Unimedic Pharma. With the first order, AcuCort takes the step from being a development company to becoming a commercial pharmaceutical company.
  • At the beginning of the year, we initiated a Phase IV patient study. It runs parallel to the Nordic market launch and aims to collect valuable scientific data on the use of Zeqmelit® from patients who have previously been prescribed corticosteroids in tablet form for self-treatment of acute allergic reactions. It is not a study necessary for the launch – all clinical studies and approvals required are in place – but a study that shows how real patients experience their treatment with Zeqmelit®.
  • AcuCort is awaiting a response from the US Food and Drug Administration (FDA) regarding the company’s updated preparatory documentation for market approval in the USA before submitting the application. • AcuCort has updated the price and reimbursement application to the Dental and Pharmaceutical Benefits Agency (TLV) regarding Zeqmelit®. We expect a response in the first half of 2024. Approval for a subsidized price means that the drug can be sold to end consumers at a lower price while still being covered by high-cost protection.

We continue the preparatory work, together with Unimedic, for the market launch of Zeqmelit® in the Nordic region. With the first order expected shortly, we have secured production capacity and developed a production plan. We are increasing awareness of Zeqmelit® ahead of the launch, including by participating in scientific meetings for healthcare professionals in the Nordics. In the spring, the extensive survey study, where patients suffering from severe or acute allergies answered questions about their experiences of the disease and treatment, will be presented in scientific journals.

A large part of the preparations for the launch are done in collaboration with Unimedic Pharma, which has more than 50 years of experience in launching drugs. We estimate that Zeqmelit® will be available in pharmacies in the Nordics during the summer of this year. I thank all our shareholders and AcuCort employees for making the development into a commercial pharmaceutical company possible.

Jonas Jönmark

For further information:

Jonas Jönmark, CEO AcuCort AB
Tel: +46 70 3655400
Email: jonas.jonmark@acucort.se

About AcuCort AB (publ)

AcuCort has developed and is commercializing Zeqmelit®, a new rapidly dissolving oral film placed on the tongue, based on the well-known cortisone substance dexamethasone. The drug is a smart product in a new, innovative, patented, and user-friendly administration form primarily for the treatment of severe and acute allergic reactions, croup in children, nausea and vomiting during chemotherapy, and for the treatment of patients with COVID-19 requiring supplemental oxygen therapy. Zeqmelit® is approved in Sweden, Denmark, Norway, and Finland. AcuCort (ticker: ACUC) is listed on the Spotlight Stock Market. Visit www.acucort.se for more information.