Lipidor publishes interim report for H1 2021
Summary of the interim report – second quarter 2021
Lipidor has had an intense first half year with success in many areas. At the beginning of the year, we signed a license agreement with Cannassure Therapeutics (for topical medical cannabis products based on Lipidor's AKVANO® technology), we submitted an application during the first quarter for the start of the Phase III study for our combination drug for psoriasis (AKP02), and our subsidiary Emollivet received a grant from Vinnova to prepare for the launch of veterinary drugs.
| Second quarter (Apr-Jun) 2021 | Reporting period (Jan-Jun) 2021 |
| Net sales 2 KSEK (461) Operating income –7 470 KSEK (-2 876) Result per share prior to and after dilution -0,26 SEK (-0,12) |
Net sales 104 tkr (461) Operating income –12 732 tkr (-5 800) Result per share prior to and after dilution -0,45 SEK (-0,25) |
Significant events during the second quarter (Jan-Mar)
- On 22nd April Lipidor provided an update on the planned Phase lll study of the company’s drug candidate AKP02 for the treatment of psoriasis.
- On 23rd April it was announced that Lipidor’s subsidiary Emollivet AB had taken the next step towards launching and was to receive funding of SEK 300,000 from Vinnova.
Significant events during the reporting period
- On 18th January, it was announced that Lipidor had entered into an exclusive agreement with Cannassure Therapeutics Ltd in Israel for medical cannabis products based on Lipidor's AKVANO® technology. Lipidor will receive double-digit royalties from upcoming product sales as well as a milestone payment for a certain sales volume achieved up to a maximum of €350,000 EUR.
Significant events after the reporting period
- On 1st July we announced that Lipidor has signed a licence agreement under which Lipidor grants RELIFE S.r.l., part of leading international pharmaceutical company, Menarini Group, exclusive rights to register, promote, distribute, and market drug candidates for the treatment of psoriasis in EU, Turkey, UK, Switzerland, CIS, and Balkan countries. The total potential value of this agreement is up to MEUR 70.
Selected financial data
| 000’s | 2021 apr-jun |
2020 apr-jun |
2021 jan-jun |
2020 jan-jun |
2020 jan-dec |
| Net sales | 2 | 461 | 104 | 461 | 620 |
| Operating income | -7 470 | -2 876 | -12 732 | -5 800 | -16 264 |
| Income after tax | –7 470 | –2 876 | –12 732 | –5 800 | -16 204 |
| Total assets | 55 443 | 22 545 | 55 443 | 22 545 | 65 877 |
| Cash flow for the period | -6 187 | -3 223 | -11 177 | -2 970 | 37 190 |
| Cash flow per share (SEK) | -0.22 | -0.14 | -0.39 | -0.13 | 1.51 |
| Cash | 53 126 | 20 920 | 53 126 | 20 920 | 64 303 |
| Result per share prior to dilution (SEK) | -0.26 | -0.12 | -0.45 | -0.25 | -0.66 |
| Result per share after dilution (SEK) | -0.26 | -0.12 | -0.45 | -0.25 | -0.66 |
| Shareholder’s equity per share (SEK) | 1.79 | 0.89 | 1.79 | 0.89 | 2.24 |
| Equity ratio, % | 91.85 | 93.26 | 91.85 | 93.26 | 96.63 |
Lipidor in Brief
Lipidor AB, Org. Nr. 556779-7500 is a Swedish limited company based in Stockholm. The company address is: Lipidor AB, Fogdevreten 2, 175 21 Solna.
Lipidor is a drug development company with a pipeline of drug development projects in the preclinical and clinical phase. The company develops drugs for the treatment of skin diseases such as psoriasis, bacterial skin infections and atopic dermatitis.
In 2019, the subsidiary Emollivet AB was formed, with a focus on veterinary care products based on AKVANO.
Statement from Lipidor’s CEO
The first six months of the year were intense with several important advancements for Lipidor. Great focus and intense efforts were devoted to the negotiations regarding an agreement for future commercialization of our two initial pharmaceutical candidates for psoriasis, AKP01 and AKP02. The outcome was announced on July 1st when we reported that Lipidor had signed an exclusive license agreement with RELIFE S.r.l., a part of the Menarini group, which has strong presence in both Europe and as well in the global market. The deal marks an important milestone for Lipidor, and we look forward to a successful commercial cooperation.
The agreement grants exclusive rights to register, promote, distribute, and market in EU, Turkey, UK, Switzerland, CIS (independent nations commonwealth of former Soviet states), and Balkan countries. The agreement stipulates that future development and related costs for AKP01 and AKP02, subsequent to concluded phase lll-study, in essence are assumed by our new partner. Lipidor will contribute its expertise and knowledge in specific issues related to the pharmaceutical candidates.
Lipidor filed a study application initiation with AKP02 to the Indian authorities during the second quarter. We expect to be able to present results from the study during the first half of 2022. Our partner is Aurena Laboratories, one of Lipidor’s two major industrial shareholders, which will manage commercial production of the products. Market launch by RELIFE within the agreement is expected during the second half of 2013.
Licensing in other markets
We conducted an extensive evaluation process regarding licensing partners, and our choice fell Menarini Group which is a solid partner with distribution capacity and resilience in order to establish the pending products in the contracted markets. We now continue our efforts in evaluating licensing in other markets along with Menarini Group as well as other potential partners.
External validation of AKVANO®
External validation provides a vitamin-injection for us at Lipidor. That supports us in our vision to establish AKVANO® as a leading development platform in development of topical pharmaceuticals, and in our ambition to improve every-day life for millions of individuals with skin diseases.
Early this year we entered into an exclusive licensing agreement with Cannassure Therapeutics for topical medicinal cannabis products based on Lipidor’s AKVANO®-technology. The agreement is an important external validation of our patented formulating platform and it demonstrates that cannabinoids also may be incorporated in AKVANO®.
During the second quarter our subsidiary Emollivet AB received a grant from Sweden’s innovation authority, Vinnova. Emollivet develops animal-care products based on AKVANO®. This financing will be used for a project in which Emollivet by interaction with animal owners and entities in the animal care market, gathers support ahead of the pending launch of animal care products.
Eventful fall
Lipidor’s AKVANO® technology currently has both medicinal proof-of-concept (the phase lll-study in AKP01) and commercial proof-of-concept (license agreements with Cannassure and Menarini). Along with existing liquidity and milestone payments, including among others a signing fee, the company’s operations under current plans are financed for the foreseeable future. Furthermore, we have the reserves to ramp up speed in both our preclinical, and clinical development. Our ambition is to develop additional pharmaceutical candidates based on AKVANO in areas estimated to indicate strong demand for improved products. Our ambition is to enter into additional license agreements over the coming years and to generate a portfolio generating income from several products.
I am expectant and optimistic for Lipidor’s future growth. In the near future, I look forward to an eventful fall and, among other, updates regarding the cooperation with Cannassure, developments within animal care in Emollivet, initiation of the phase lll-study in AKP02, and updates regarding Lipidor’s clinical programs.
Stockholm, August 24, 2021
Ola Holmlund
CEO
Financial Calendar
Interim report January – September 25th November 2021
Year-end report January – December 2021 17th November 2021
Interim report January – March 2022 5th May 2022
Information
The information was provided for publication through the office of Lipidor’s CEO on 24th August 2021 at 8.30am (CEST).
