NASDAQ FIRST NORTH GROWTH MARKET: REDW.ST, redwoodpharma.se
1 January – 31 December 2021
- The company’s net revenue for the period totaled SEK 0 (0).
- Operating profit for the period amounted to SEK -20,480M (-14,523).
- Earnings per share for the period were SEK -0.71 (-0.97).
Fourth quarter, 1 October – 31 December 2021
- The company’s net revenue for the period totaled SEK 0 (0).
- Operating profit for the period amounted to SEK -3,597M (-4,311).
- Earnings per share for the period were SEK -0.17 (-0.28).
Important events during the period
- The company carried out a rights issue which ended on 8 February. The share issue was subscribed to a total of 146.5 per cent, of which 67.7 per cent with the support of subscription rights and 78.8 per cent without the support of subscription rights. Redwood Pharma received approximately SEK 34.2 million before administrative costs.
- Redwood Pharma moved its share listing to Nasdaq First North Growth Market to increase visibility and prepare for the company’s future growth under the Nasdaq brand.
- Redwood Pharma announced a strategic change with the accelerated development of RP501, the company’s IntelliGel-based dry eye disease (DED) topical therapy.
Important events after the end of the period
- Redwood Pharma received approval from the ethics committee in Austria prior to start of clinical trial of RP501.
“A clinical trial is expected to begin soon to support the CE mark required to market a medical device in the EU.”
2021 was a challenging year in many ways, especially in light of the spread of Covid-19. During the year, Redwood Pharma added resources to build on positive clinical results for IntelliGel (RP501) for the treatment of dry eyes that emerged in the Phase II trial for RP101, in which RP501 showed significant safety and clinical efficacy. We plan to position RP501 as the next generation of first-line treatment for men and women of all ages who suffer from dry eyes, i.e., a self-care product. The study showed that RP501 stays on the front of the eye for longer periods, which increases patient comfort and offers significant commercial potential. Our goal is to be able to bring RP501 to market in 2023.
The year began with a successful funding round of SEK 34.2 million to finance investment in our development programs for dry eyes. RP501 is now being prepared for approval as a medical device in Europe. Preparations for the development of processes for obtaining regulatory approval and commercialization of a medical device are now well underway. A clinical trial is expected to be launched shortly, among other things to investigate how RP501 is tolerated by contact lens wearers. We were recently pleased to report that the study has received ethical approval, which is the first of two regulatory approvals required to begin recruiting patients for the study. A positive outcome from the study brings us closer to a larger self-care market and a broader indication of our CE mark and medical approval.
I would like to thank our shareholders for their continued support, and I look forward to being able to get back to you about progress in the coming year.
Martin Vidaeus, CEO
About Redwood Pharma and its market
Redwood Pharma AB develops ophthalmic drugs in areas where considerable medical demand exists. The company has two programs for the development of treatments for people suffering from different forms of dry eye disease (DED).
RP501 is being developed to help patients suffering from mild eye dryness through treatment with IntelliGel without active substance. IntelliGel can probably also be used to improve the dosage of other established and new drugs in ophthalmology. Our second program, RP101, concerns the development of a product for the treatment of moderate to severe chronic dry eyes in postmenopausal women with a biologically active drug substance. Redwood Pharma focuses on clinical development at an early stage.
RP501: a medtech treatment for temporary relief for anyone suffering from mild DED
With an aging population and increased screen time in front of computers and mobile devices, people are increasingly suffering from temporary dry eye disease. Where existing products on the market, such as artificial tears, must be used several times a day to be effective, RP501 has recently been shown in a clinical trial to help those with dry eye problems with just one or two treatments a day. RP501 has the potential to provide temporary relief to men and women of all ages.
RP101: a drug treatment for moderate to severe chronic DED in post-menopausal women
The company is developing a low-dose, estrogen-based local eye treatment for chronically dry eyes in post-menopausal women who suffer from DED. Currently, no sufficiently reliable treatments exist for women with moderate to severe symptoms. We believe that RP101 will be the first hormone treatment of DED in this patient group. It targets specific underlying biological mechanisms and increases production of tear fluid. RP101 has recorded confirmed results from two previous clinical Phase II trials in the US. And in Redwood Pharma’s recently completed Phase II trial in Europe exhibited safety and efficacy with doses of up to twice a day.
Size of the global dry eye disease market
The total global DED market is estimated at USD 5 billion and is expected to grow to USD 7 billion by 2025 according to TMR 2020.
IntelliGel drug delivery platform
Redwood Pharma owns the global rights to the IntelliGel platform within ophthalmology. IntelliGel is a so-called drug delivery platform that controls the release of a drug and gives its active ingredients the opportunity to act for a longer period which in turn results in a reduction of the number of instillations. The platform also creates additional business opportunities in that several ophthalmic drugs can hopefully be reformulated and dosed more efficiently and in a way that is perceived as more convenient and perhaps also increase the safety of patients.
There are several reasons why the market is expected to grow. The main reasons are the lack of effective drugs that provide patients with effective relief from chronic dry eye disease and an aging population in which chronic dry eye disease is more prevalent.
There are several types of chronic dry eye and a common medical solution for all types of these problems does not currently exist. New products are under development. However, these are aimed at inflammation in the eye that can be a consequence of too little tear fluid. Product development is also expected to contribute to overall market growth.
Today, there is also a pronounced need for drug formulations that minimize the number of doses that need to be taken per day. As a drug delivery platform, IntelliGel therefore constitutes a market opportunity in and of itself.
The company’s core competence lies within drug development. To develop RP501, RP101 and new ophthalmic drugs, the company uses its extensive network of experts in manufacturing, pre-clinical and clinical development as well as experts in ophthalmology, endocrinology, and women’s health.
The company has completed Phase II clinical trials of RP101 and now intends to identify a commercial partner to maximize value. The company is currently evaluating future strategies regarding RP501.
Through business agreements with major drug companies, the company will receive payments for achieving milestones and as future royalties. Such agreements may mean that the company receives an initial payment upon signing an agreement and subsequently for achieved milestones such as completion of Phase III clinical trials, market approvals, and initial sales. Redwood Pharma is, however, open to other types of agreement to maximize the value of the company.
Revenues and expenses
The company did not generate any income between 1 January – 31 December 2021. Reported Other Operating Income refers to exchange rate gains. The company’s expenses are primarily related to development, project-related, and administrative costs.
Operating profit for the period 1 January – 31 December 2021 was SEK -20,480M (-14,523). Operating profit for the period 1 October – 31 December 2021 was SEK -3,597M (-4,311).
Financial position and liquidity
As of 31 December 2021, the company’s liquid assets amounted to SEK 14,793M (6,606). The ratio of shareholder equity to total assets was 75% (55). The company’s shareholder equity amounted to SEK 15,894M (7,080).
Cashflow from day-to-day operations for the period amounted to SEK -21,466M (-11,010).
During the period 1 January – 31 December 2021, the company did not invest in tangible or intangible fixed assets.
The Board of Directors proposes that no dividend is paid.
This interim report has been prepared in line with the Annual Accounts Act (1995:1554) and Swedish Accounting Standards Board’s BFNAR 2012:1 guidelines, Annual Accounts and Corporate Auditing (“K3”).
Risks and uncertainty
In conjunction with the preferential rights issue that was completed in February 2021, a detailed review of the risks associated with the company’s operations was carried out. No new risks have subsequently been identified. Risks and uncertainty are reported in the information memorandum produced in conjunction with the issue and has been published on the Redwood Pharma website, redwoodpharma.com.
Change in the number of outstanding shares
|Opening balance January 1 2020||14,698,693|
|Share subscription exchange in June||293,716|
|Rights issue registered in November||866,654|
|Closing balance December 31 2020||15,859,063|
|Share subscription exchange in February||4,879,708|
|Closing balance December 31 2021||20,738,771|
This quarterly report has not been audited by the company’s auditors.
For further information, please contact:
Martin Vidaeus, CEO, on +46 (0) 70 232 29 29, or email@example.com.
This is information that Redwood Pharma AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person mentioned above on 16 February 2021.
About Redwood Pharma
Redwood Pharma develops ophthalmic products for unmet medical needs. The Company’s first project is the development of drug candidate RP101 with a known active substance against chronic dry eye in postmenopausal women who have moderate to severe symptoms. With the drug delivery platform IntelliGel the release of active substances is controlled. Through the use of IntelliGel, Redwood Pharma can also improve dosing of other established drugs. Redwood Pharma’s strength lies in formulation and early clinical development. Revenues will be generated through licensing agreements with pharmaceutical companies that have capabilities to manufacture and sell commercial products worldwide.
Redwood Pharma AB (publ.) is listed on Nasdaq First North Growth Market, REDW, (ISIN: SE0008294789).
For more information visit: www.redwoodpharma.com