Lipidor publishes interim report for period 1 January – 30 September and Q3 2021
Summary of the interim report – third quarter 2021
The quarter saw Lipidors most important milestone to date when we entered into an exclusive commercial agreement for registration, marketing, sales and distribution of AKP01 and AKP02 with RELIFE S.r.L. – part of the pharmaceutical giant, Menarini Group. In connection with the signing of this agreement, Lipidor received the first milestone compensation amounting to EUR € 1.5 million. The potential value of the agreement amounts to at least EUR € 70 million.
During the period, Lipidor's most valuable project, AKP02, was also approved for the initiation of a clinical phase III study, with topline results expected as soon as the second quarter of 2022. We have also announced progress in the collaboration with Cannassure, where positive results led to a new patent application being filed, and the collaboration is being taken on to the clinical phase.
|Third quarter (Jul-Sep) 2021||Reporting period (Jan-Sep) 2021|
|Net sales 15 270 KSEK (0)
Operating income 3 384 KSEK (-4 915)
Result per share prior to and after dilution 0,12 SEK (-–0,21)
|Net sales 15 376 tkr (455)
Operating income –9 348 tkr (-10 715)
Result per share prior to and after dilution -0,33 SEK (-0,45)
Selected financial data
|Net sales||15 270||–||15 376||455||620|
|Operating income||-3 384||-4 915||-9 348||-10 715||-16 264|
|Income after tax||–3 456||–4 874||-9 276||–10 674||-16 204|
|Total assets||61 692||51 132||61 692||51 132||65 877|
|Cash flow for the period||6 418||28 614||-4 759||22 421||37 190|
|Cash flow per share (SEK)||0.23||1.21||-0.17||0.95||1.51|
|Cash||59 544||49 534||59 544||49 534||64 303|
|Result per share prior to dilution (SEK)||0.12||-0.21||-0.33||-0.45||-0.66|
|Result per share after dilution (SEK)||0.12||-0.21||-0.33||-0.45||-0.66|
|Shareholder’s equity per share (SEK)||1.91||1.86||1.91||1.86||2.24|
|Equity ratio, %||88.15||96.14||88.15||96.14||96.63|
Lipidor in Brief
Lipidor AB (publ), org. nr. 556779-7500 is a Swedish limited company based in Stockholm. The company address is: Lipidor AB, Svärdvägen 13, 182 33 Danderyd.
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.
Significant events during the third quarter (Jul-Sep)
- On 1st July, we announced that Lipidor has signed a license agreement under which Lipidor grants RELIFE S.r.l., the right to sell drug candidates for the treatment of psoriasis.
- On 27th September, we announced that Lipidor has received approval for the study start of a clinical Phase III study of the psoriasis candidate AKP02.
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.
- On April 23, it was announced that Lipidor's subsidiary Emollivet AB had taken the next step towards launch and received a grant of SEK 300,000 from Vinnova.
Significant events after the reporting period
- The CEO and employees have redeemed all warrants during the month of October. Through the exercise, the number of shares and votes in the company will increase by 580,000.
- On October 29, it was announced that Lipidor has filed a new patent application for medical cannabis products based on its AKVANO® technology.
Statement from Lipidor’s CEO
The quarter contained Lipidor's most important milestone to date when on July 1st we announced that Lipidor had entered into an exclusive commercial agreement to register, market, sell and distribute AKP01 and AKP02. Our partner is RELIFE S.r.l., a company focused on dermatological indications and products. RELIFE is a part of the pharmaceutical Menarini group. Menarini Group is a leading international pharmaceutical company, headquartered in Italy, that has representation in 140 countries globally. The Menarini Group generates annual income in excess of USD 4.2bn and is thus one of the largest pharmaceutical companies in Europe. The agreement allows RELIFE to assume responsibility for registration, marketing, sales and distribution of the psoriasis products in the EU, Turkey, Switzerland and the Balkan countries.
The potential value of the agreement amounts to at least EUR € 70 million, which mainly comprises income based on estimated sales, as well as one-time payments based on achieved milestones. The initial payment upon signing of the agreement amounted to EUR 1.5 million.
Our application to initiate the clinical phase lll-study with the AKP02 substance for psoriasis was approved in September. The primary objective of the study is to compare the therapeutic effect of AKP02 for mild to medium-severe psoriasis with the market leading Enstilar. The study will also measure quality of life and patient satisfaction with the aim of demonstrating advantages in these aspects with AKP02. In our estimation the prospects of positive outcome in the study is high. Results are expected during the second quarter of 2022.
Efforts continue as planned to enter into additional agreements with the psoriasis candidates AKP01 and AKP02 in additional markets. The markets we view particularly positively are Asia, including China, as well as Brazil and Canada. However, it is premature to mention specific targets regarding when such discussions may generate agreements.
We are also pleased that the cooperation with Cannassure in development of topical medicinal cannabis products is progressing well and according to plan. After the end of the reporting period, at the end of October, we filed a new patent application based on data generated thus far in the project. In turn, this means that the cooperation agreement with Cannassure has now expanded to also include the new patent family. Cannassure’s therapeutic focus has primarily been on psoriasis and pain. We hope to file an application for clinical study during the first half of 2022, with results during the first half of 2023.
Under current plans, the agreement with RELIFE, along with existing liquidity, will fully finance operations for the foreseeable future. In addition, there is room to increase the pace of both our preclinical and clinical work. We have our sights set on developing additional topical pharmaceutical candidates based on AKVANO® with continued focus on dermatology. It is a therapeutic field in which we assess significant demand for products with improved treatment results, and thereby increased patient advantages.
Stockholm, 25th November 2021
Year-end report January – December 2021 23rd February 2022
Interim report January – March 2022 5th May 2022
Interim report January – June 2022 24th August 2022
Interim report January – September 2022 23rd November 2022
The information was provided for publication through the office of Lipidor’s CEO on 25th November 2021 at 8.00am (CET).