Lipidor AB (publ) publishes year-end report for 2020
Summary of quarterly report – Q4 2020
A quarter of high activity and more important milestones including: redemption of warrants amounting to SEK 20 million, recruitment of a Chief Development Officer and entering into cooperation agreements with contract manufacturers.
|Q4 2020 (Oct-Dec) 2020
||Reporting period (Jan-Dec) 2020
|Net sales 160 KSEK (0)
Operating income -5 549 KSEK (-4 763)
Result per share prior to and after dilution SEK -0.20 (-0.20)
|Net sales 620 KSEK (0)
Operating income -16 264 KSEK (-13 808)
Result per share prior to and after dilution -0,66 SEK (-0,68)
Significant events during Q4 (Oct-Dec)
- On 1st October, it was announced that Anders Hagman had been recruited as Chief Development Officer.
- On 7th October, it was announced that Lipidor has appointed Erik Penser Bank AB as Certified Adviser.
- On 14th October, it was published that the subscription price would be set at SEK 9.95 for the company's warrants (of series TO1 2019).
- On 11th November, it was announced that the subscription period had expired on 3rd November, with the result that approximately 95.9% of the options had been exercised for subscription of shares. Through the subscription, Lipidor thus stood to receive approximately SEK 20.0 million. Through the exercise of the warrants, the number of shares in Lipidor was set to increase by 2,012,863 shares, from 26,384,000 to 28,396,863 shares. Share capital would therefore increase by SEK 100,643 from SEK 1,319,200 to SEK 1,419,843.
- On 16th December, Lipidor signed a cooperation agreement with Aurena Laboratories for the manufacture of Lipidor's pharmaceutical products. The agreement stipulates investments over a five-year period up to SEK 15 million.
Significant events during the reporting period (jan-dec)
- On 24th January, we announced positive results from the company's clinical phase III study of calcipotriol spray (AKP01) against psoriasis.
- In January, we announced that the Knowledge Foundation is funding collaborative projects for studies of how drug formulations affect the skin barrier. In collaboration with Malmö University, MediGelium AB, Larodan AB and ERCO Pharma AB, Lipidor has been granted research grants from the Knowledge Foundation for a joint project. The project extends over two years and aims to develop models and investigate how body-specific ceramides and other lipids can be used to create more effective formulations of dermatologicals and facilitate repair of damaged skin. The project comprises a total budget of SEK 4.6 million, of which SEK 0.7 million is co-financed by Lipidor through research initiatives.
- On 16th March, we announced that Aurena Laboratories AB has developed and launched a disinfectant spray in collaboration with Lipidor based on Lipidor's AKVANO® technology, whose sales began in March and generated commission income from April.
- On 7th May, Lipidor submitted an updated project plan and announced, among other things, the intention to initiate a fully self-funded phase III study regarding AKP02.
- On 30th June, it was announced that Lipidor and its subsidiary Emollivet AB have formalized their relationship by entering into a licence agreement that regulates Emollivet's right to use Lipidor's patented AKVANO® technology in the veterinary field.
- On 7th July, we announced that an agreement has been entered into with Cadila Pharmaceuticals, a leading Indian pharmaceutical company with extensive CRO capacity, to conduct a Phase III study with Lipidor's drug candidate AKP02. The study is expected to begin in Q1 2021 and be finalized in Q1 2022.
- On 7th July, we announced that the subsidiary Emollivet AB had recruited Stina Linge as CEO.
- On 10th July, we announced that Lipidor had signed an agreement with OY Medfiles Ltd for delivery of clinical trial material for the phase III study with the drug candidate AKP02 against psoriasis.
- On 11th September, it was announced that Lipidor had completed a directed new issue amounting to SEK 35.0 million before issue costs amounting to SEK 2.0 million.
- On 30th September, we published a positive outcome from the company's feasibility study in collaboration with Cannassure Therapeutics Ltd., for the development of medical cannabis products based on the company's AKVANO® technology.
Significant events after 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 EUR €350,000.
|Selected financial data||2020 Oct-Dec||2019 Oct-Dec||2020 Jan-Dec||2019 Jan-Dec|
|Net sales, KSEK (thousand kronor)||160||–||620||72|
|Operating income, KSEK||-5 549||-4 763||-16 264||-13 808|
|Income after tax, KSEK||-5 530||-4 761||-16 204||-13 807|
|Total assets, KSEK||65 877||28 298||65 877||28 298|
|Cash flow for the period, KSEK||14 769||-5 402||37 190||25 939|
|Cash flow per share (SEK)||0.54||-0.23||1.51||1.28|
|Cash, KSEK||64 303||27 113||64 303||27 113|
|Result per share prior to dilution (SEK)||-0.20||-0.20||-0.66||-0.68|
|Result per share after dilution (SEK)||-0.20||-0.20||-0.66||-0.68|
|Shareholders equity per share (SEK)||2.24||1.14||2.24||1.14|
|Equity ratio, %||96.63%||94.80%||96.63%||94.80%|
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
Our vision is to establish Lipidor's patent-protected drug delivery technology AKVANO® as the leading formulation platform in the development of dermatologicals. During the past year, we have taken several steps forward and we have good conditions for a successful 2021. Lipidor is today well equipped with two drug candidates in the late clinical phase, both for psoriasis. The leading candidate, AKP01, has delivered positive results from a completed Phase III study and discussions with potential licensees are ongoing. The Phase III study with AKP02, which is fully funded by Lipidor, is being initiated, which is completely in line with our original plan. We continue to maintain a close dialogue with our partners about the study and we take measures to minimize the risk of possible delays due to the ongoing pandemic.
Licensing remains a priority
Entering into a license agreement has the highest priority and discussions are ongoing. It is very gratifying that the pharmaceutical market has shown a clear interest in both AKP01 and AKP02. By financing the implementation of the phase III study with AKP02 ourselves, we will keep the entire upside of an upcoming outlicensing. We also see great potential in discussing both drug candidates in a package as this makes us a more attractive partner for a drug company. The licensee can thus take two complementary products by registering for sale, which creates synergy effects. An additional significant aspect in the discussions may be the product supply, i.e. access for the licensee to large-scale production of the pharmaceutical products in accordance with GMP requirements and other regulations.
New cooperation agreement secures GMP manufacturing
In December, we signed a new agreement with Aurena Laboratories AB, which is one of Lipidor's two strong industrial main owners. The agreement means that Lipidor will invest up to SEK 15 million in the new collaboration over a five-year period. Aurena in turn will build a production unit that meets the regulatory requirements for the manufacture of Lipidor's prescription drug products. Through the collaboration, Lipidor can offer potential licensees the opportunity for large-scale GMP production of the products based on our formulation platform AKVANO®. It is strategically important for us, in the ongoing interactions with potential licensees, to be able to show that the infrastructure is in place, that the production meets all regulatory requirements and that the facility has capacity for commercial production. Close dialogues with potential licensees are ongoing at the time of writing and we are sticking to our goal of being able to enter into commercial agreements regarding AKP01 and AKP02 during the first half of this year.
Achieved commercial milestone and external validation
In early 2020, we announced the positive outcome of the feasibility study for the development of topical, on the skin, medical cannabis products for the treatment of skin inflammations, including psoriasis. The study was conducted in collaboration with Cannassure Therapeutics. In the autumn, Cannassure announced that they intended to exercise their option. In January this year, a license agreement was signed which means that Cannassure has exclusive rights to the use of AKVANO® in medical cannabis products for psoriasis, atopic dermatitis, pain and wounds. We are very pleased with the license agreement as it is an important commercial milestone and an external validation of Lipidor's unique formulation platform which shows that cannabinoids can also be incorporated into AKVANO®. We have great faith in Cannassure and we have high expectations of the partnership, whose goal is for the new medical cannabis products to hit the market as quickly as possible.
With my commercial experience, I am optimistic about Lipidor's continued growth journey and we at Lipidor look forward to an exciting financial year.
Stockholm, 23rd February 2021
Annual report 2020 Published on the company’s website w/c 19th April 2021
Quarterly report Q1 (Jan-Mar) 2021 6th May 2021
Interim report H1 (Jan-Jun) 2021 24th August 2021
Quarterly report Q3 (Jan-Sep) 2021 17th November 2021
AGM 2021 8th June 2021
See the year-end report
The information was provided for publication by Lipidor’s CEO on 23rd February 2021 at 8.00am (CET).