SUMMARY OF ANNUAL REPORT 2022 Dicot AB (publ) 559006-3490
Året i siffror Contents Management Report....................................................................................................................3 Income Statement............................................................................................................................6 Balance Sheet.........................................................................................................................................7 Cash Flow Statement.................................................................................................................8 Notes......................................................................................................................................................................9
Dicot’s vision
Increase quality of life and well-being with innovations that enhance sexual health
Dicot AB (559006-3490) S:t Olofsgatan 11A 753 21 Uppsala www.dicot.se
Management report The Board of Directors and the Chief Executive Officer of Dicot AB (publ), company registration number 559006-3490, hereby submit the annual report for the financial year 2022. The annual report has been prepared in Swedish kronor, SEK. The company has its registered office in Uppsala.
General about the business Dicot is a pharmaceutical company within sexual health that develops the candidate LIB-01 into a new modern potency drug for the world market. The ambition is to create a drug that has a longer duration of action and fewer side effects than those on the market today. In this way, Dicot wants to drastically improve the treatment of erectile dysfunctions and give affected men and couples a better sex life and improved quality of life. The goal is to develop LIB-01 to become the first choice of treatment for erectile dysfunction and premature ejaculation. The global market for drugs for erectile dysfunction was worth SEK 44 billion in 2021 and for premature ejaculation SEK 31 billion, totalling SEK 75 billion. Global demand is growing rapidly. Dicot’s main strategy for LIB-01 is to develop it under its own auspice until clinical phase 2a study and thereafter in partnership with major established pharmaceutical companies to finance and develop LIB-01 into a registered drug on the world market. At the end of the year, about ten people were engaged in Dicot on a part-time basisand the company had two full-time employees. All except the CEO and the CSO, Chief Scientific Officer, are employed on a consultancy basis.
Significant events during the financial year At the beginning of the year, Dicot was able to successfully change the administration route for LIB-01 from subcutaneous to oral, i.e., from being given by syringe to ingestion by mouth. Having an oral drug candidate before the start of clinical trials is considered to have a great positive significance from both a market and valuation perspective. In June, it was noted that good effect was achieved with this new oral formulation, with statistically confirmed effect on all studied parameters seven days after the last dose. In October, good results were also obtained from the preclinical toxicology programme, showing that LIB-01 is well-tolerated in the studies conducted so far, with a good safety profile and no signs of
side effects. In November a study of the mechanism of action of LIB-01 showed that it differs from PDE5 inhibitors such as Viagra, indicating that LIB-01 can be assumed to represent a new generation of potency drugs. The focus during 2022 has been on the preclinical studies and other preparatory activities to be able to start clinical studies in humans. During the autumn, procurement of CRO services took place, i.e., the partner who will conduct the first studies in humans. In November, the first of two meetings with the Swedish Medical Products Agency was held, prior to an application to start a clinical trial. For a pharmaceutical company, patent rights are of utmost importance. In February, Dicot announced the strengthening of its IP portfolio through the identification and documentation of ten new potential patentable assets that could extend the intellectual property protection until at least 2042. In June, work began on a patent application to protect new production methods and various chemical compounds used in the manufacture of the drug substance in LIB-01 and in October this application was submitted to the relevant patent authority. A research collaboration was initiated in May with Uppsala University and the W. Szafer Institute of Botany at the Polish Academy of Sciences with the aim of investigating new technology for the production of starting materials for the drug substance. Simultaneously, work was done to improve logistics and reduce costs in the manufacturing process, which led to the extraction process being moved to South Africa, where the starting material is already handled. On 1 April, Elin Trampe took over as CEO of Dicot, replacing Göran Beijer, who remains on a consultancy basis as a part-time strategic business developer. Prior, Elin was COO and deputy CEO at Dicot. During the year, the organization was reinforced with Charlotte Gauffin as Chief Scientific Officer and Björn Petersson as CFO. The Board was strengthened at the annual general meeting in May with Fredrik Buch and Michael Zell, two experienced members with solid track records. The subscription period for warrants of the TO3 series took place in June when 34,202,814 options were exercised, corresponding to 90% subscription. Thus, Dicot received SEK 10.0 million before issue costs. In December, the decision was made to carry out a rights issue in January 2023 of a total of SEK 54.8 million and two warrant programmes. The purpose of the issue is primarily to secure financing of the clinical phase 1 study.
ANNUAL REPORT 2022 – Dicot AB 559006-3490
3
Significant events after the financial year The rights issue in January 2023 was oversubscribed to 109.5%. Subsequently no issue guarantees had to be utilised and 87% of the underwriters chose to receive compensation in the form of units via a offset instead of monetary compensation. Dicot thus received net SEK 49.9 million after costs. In connection with this, a reduction of the share capital was carried out, which led to a better balance between share capital and total equity. The decision on the rights issue and the reduction of share capital was taken at an extraordinary general meeting on January 9, 2023. Prior to the clinical phase 1 study, Clinical Trial Consultants was contracted in January to conduct the study and Thermo Fisher for GMP manufacturing of the study drug. In February, Thermo Fisher started manufacturing, which was fully in line with the schedule. The last meeting with the Swedish Medical Products Agency before the application to start the study was held in March, and the agency was favourable to Dicot’s proposals on design and other matters. In January, it was also announced that Dicot is proceeding with a patent application covering the oral formulation developed in 2022. In April, the toxicology programme prior to clinical phase 1 was completed with good results.
Dependence on key individuals Dicot’s future growth is deemed to be highly dependent on the knowledge, experience, and commitment of the company’s management, the Board of Directors and other key individuals. If one or more key persons leave Dicot, this may have negative consequences for the business and its results, as well as if new qualified key persons cannot be recruited to the desired extent. Profitability and capital requirements It cannot be ruled out that it will take longer than expected before Dicot achieves continuous, stable profitability. In addition, it cannot be ruled out that Dicot in the future will have a greater capital requirement than what is currently deemed necessary. There are no guarantees that such an increased capital requirement can be acquired on terms acceptable to the shareholders and the market. A deterioration in profitability may also have a negative impact on the company’s market value. Protection of intellectual property rights and know-how Intellectual property rights are an important part of Dicot and its operations. There is a risk that Dicot cannot fully utilise or protect its rights. There is also a risk that new products are developed that circumvent Dicot’s current and potential future intellectual property rights. Furthermore, Dicot is dependent on know-how, and it cannot be ruled out that competitors develop corresponding know-how or that Dicot fails to protect its knowledge or brand in an effective manner. Such a development could have a negative impact on the company.
Financing and liquidity Significant risks For a detailed account of risk factors, please read Dicot’s EU growth prospectus, January 9, 2023. Preclinical and clinical studies The outcome of preclinical and clinical studies cannot be guaranteed. The clinical studies may show that the expected effect based on the chosen study profile does not occur or may show side effects. This may lead to more extensive and/or costly studies. Worst case, it may mean that market authorisation is not obtained and that the studies are discontinued. Collaboration partners A large part of Dicot’s development takes place in collaboration with CROs (clinical research organizations) and CMOs (contract manufacturing organizations) and in the future in the form of expected alliances with pharmaceutical companies. There is a risk of delays in finding suitable partners. There is also a risk that pharmaceutical companies demand additional studies before entering into an agreement. This could increase Dicot’s costs. Dependence on raw materials Dicot uses suppliers to deliver the raw material used in the production of LIB-01. There is a risk that Dicot’s suppliers will not be able to deliver ordered raw materials or that the raw materials can no longer be produced. If this risk occurs, it will have a negative impact on Dicot’s production of LIB-01 and, by extension, on Dicot’s operations, earnings, and financial position.
4
In June, Dicot raised SEK 10.0 million before issue costs (net SEK 9.0 million) by exercising 34,202,814 warrants of series TO3 2021, corresponding to 90% subscription at a price of SEK 0.29 per share. In December, an interest-bearing bridge loan of SEK 2.1 million was raised to be repaid in early February 2023. The purpose of the loan was to strengthen working capital pending the issue proceeds. After the end of the year, in January 2023, Dicot received SEK 54.8 million before issue costs through a unit issue, resulting in net proceeds of SEK 49.9 million, including the set-off of guarantee compensation in a subsequent directed issue. At the end of the year, equity was less than half of the registered share capital. When subscription guarantees and subscription commitments, which together far exceeded the shortfall, were received in early December, the Board of Directors was able to conclude that the equity was intact and that there was no need for an initial meeting for liquidation purposes. After the issue was registered with the Swedish Companies Registration Office in February 2023, the Board of Directors could establish that the capital was restored in its entirety.
ANNUAL REPORT 2022 – Dicot AB 559006-3490
To ensure Dicot’s continued development and management, the Board and management continuously evaluate various financing options. These could be through the company obtaining grant funding, a new shares issue or other types of capital contribution. The company is also able to limit costs and commitments if necessary.
During 2023, a redemption period will take place for warrants of series TO4 (June 1-15) and of series TO5 (November 1-15), which together can provide up to SEK 101.4 million before issue costs. The Board and Management assess that Dicot’s working capital is sufficient for the next 12 months.
Cap table as of December 31, 2022 Name
Number of shares
Number of votes (%)
Avanza Pension
17,563,779
12.8%
Bertil Lindkvist (Ålandsbanken)
4,141,155
3.0%
Skyddsprodukter i Sverige Finans AB
4,000,000
2.9%
Rune Löderup
2,974,303
2.2%
Jarl Wikberg via bolag Dicotyledon AB
2,879,272
2.1%
Nordnet Pensionsförsäkring
2,738,020
2.0%
Michael Zell
2,030,000
1.5%
Christian Lentz
1,577,110
1.2%
Gryningskust Holding AB
1,483,032
1.1%
Göran Thorstensson
1,325,984
1.0%
Other
96,390,365
70.3%
Total
137,103,020
100.0%
Multi-year comparison KSEK
2022
2021
2020
2019
2018
2017
0
0
0
0
0
0
-31,756
-27,175
-17,541
-13,396
-6,343
-1,517
43.3
89.2
91.0
91.0
83.1
-15.3
Net sales Result after financial items Equity ratio (%) Refer to notes for key ratio definitions
Proposal for appropriation of profits At the disposal of the Annual General Meeting: Loss brought forward -66,178,700 Share premium reserve 86,154,417 Net profit for the year -31,755,698 Total
-11,779,981
The Board of Directors proposes that -11,779,981 will be carried over in the accounts. For further information regarding the company’s financial results and position, please refer to the subsequent income statement and balance sheet, along with accompanying notes.
ANNUAL REPORT 2022 – Dicot AB 559006-3490
5
Income Statement SEK
Note
2022
2021
2
120,414
79,402
Total operating income
120,414
79,402
Operating income Other operating income
Operating expenses Other external expenses
3
-26,612,038
-23,852,012
Personnel
4
-5,053,057
-3,275,963
Depreciation of tangible fixed assets
-7,553
-7,553
Other operating expenses
-170,388
-114,895
Total operating expenses
-31,843,036
-27,250,423
Operating profit/loss
-31,722,622
-27,171,021
Financial income
0
29
Financial expenses
-33,076
-3,870
Total financial items
-33,076
-3,841
Net profit/loss after financial items
-31,755,698
-27,174,862
-31,755,698
-27,174,862
SEK 2022
2021
Financial items
Net profit/loss for the year
Earnings per share Earnings after tax
-31,755,698
-27,174,862
Number of shares on the balance sheet date
137,103,020
102,900,206
Average number of shares, before dilution
120,235,879
64,133,066
Average number of shares, after dilution
121,348,979
69,324,987
Earnings per average number of shares before and after dilution
-0.26
-0.42
6
ANNUAL REPORT 2022 – Dicot AB 559006-3490
Balance Sheet SEK
Note
Dec 31, 2022
Dec 31, 2021
Assets FIXED ASSETS Tangible fixed assets Equipment
5
20,842
28,395
Total fixed assets
20,842
28,395
CURRENT ASSETS Inventory Raw materials and supplies
1,488,575
0
Current receivables Other receivables
1,143,654
1,013,197
Prepaid expenses and accrued income
341,784
402,221
Total current receivables
1,485,438
1,415,418
Cash and cash equivalents
9,376,413
30,328,275
Total current assets
12,350,426
31,743,693
Total assets
12,371,268
31,772,088
Equity and Liabilities EQUITY Restricted equity Share capital
6
17,137,878
12,862,526
Unrestricted equity Share premium reserve
86,154,417
81,667,198
Losses brought forward
-66,178,700
-39,003,838
Net profit/loss for the year
-31,755,698
-27,174,862
Total unrestricted equity
-11,779,981
15,488,498
Total equity
5,357,897
28,351,024
Current liabilities Accounts payable
3,419,876
2,575,319
Other liabilities
2,405,460
189,784
Accrued expenses and deferred income
1,188,035
655,961
Total current liabilities
7,013,371
3,421,064
12,371,268
31,772,088
Total equity and liabilities
ANNUAL REPORT 2022 – Dicot AB 559006-3490
7
Cash Flow Statement SEK 2022
2021
Operating Activities Operating profit/loss before financial items Adjustment for depreciation Financial items related to operations Cash flow from operating activities before change in working capital Change in inventories Change in current receivables Change in accounts payable Change in other current operating liabilities Cash flow from operating activities
-31,722,622 7,553 -33,076 -31,748,145
-27,171,021 7,553 -3,841 -27,167,309
-1,488,575 -70,020 844,557 2,747,750 -29,714,433
0 -164,243 1,087,348 378,536 -25,865,668
0 0
0 0
New shares issue Cash flow from financing activities
8,762,571 8,762,571
35,866,606 35,866,606
Cash Flow for the year Cash and cash equivalents at start of year
-20,951,862 30,328,275
10,000,938 20,327,337
Cash and cash equivalents at end of year
9,376,413
30,328,275
Investing Activities Investments in fixed assets Cash flow from investing activities
Financing Activities
The bridge loan of 2.15 million SEK for the period December 2022 to February 2023 is considered a short-term operating liability in the cash flow statement.
Change in Equity SEK Share Capital
Share Premium Reserve
Other Unrestricted Equity
Total Equity
Opening balance January 1, 2021 5,458,550 53,204,567 -39,003,837 19,659,280 Warrant program 9,000 9,000 Shares issue 7,403,976 33,011,172 40,415,148 Issue costs -4,557,542 -4,557,542 Net loss for the year -27,174,862 -27,174,862 Closing balance December 31, 2021 12,862,526 81,667,197 -66,178,699 28,351,024 Opening balance January 1, 2022 12,862,526 81,667,198 -66,178,700 28,351,024 Shares issue 4,275,352 5,643,464 9,918,816 Issue costs -1,156,245 -1,156,245 Net loss for the year -31,755,698 -31,755,698 Closing balance December 31, 2022 17,137,878 86,154,417 -97,934,398 5,357,897 Unconditional shareholder’s contributions as of the balance sheet date amount to SEK 1,331,159 (1,331,159). 8
ANNUAL REPORT 2022 – Dicot AB 559006-3490
Notes Note 1 - Accounting and valuation principles The annual report has been prepared in accordance with the Annual Accounts Act and BFNAR 2012:1 Annual report and consolidated accounts (K3). The accounting principles are unchanged compared to the previous year.
Valuation principles Receivables Receivables have been recognised at the amounts at which they are expected to be received. Other assets, provisions, and liabilities Other assets, provisions, and liabilities have been measured at their acquisition cost unless otherwise stated below. Revenue recognition Revenues have been recognised at the fair value of what has been or will be received and is recognised to the extent that it is probable that the economic benefits will be realised by the company and the revenue can be calculated reliably. Government grants Government grants are recognised at fair value when there is reasonable assurance that the grant will be received and that the company will fulfil all related conditions. Grants received are recognised as other operating income in the income statement. Intangible fixed assets The company uses the cost model for internally generated intangible assets. This means that all development costs are expensed as incurred.
Tangible fixed assets Property, plant and equipment are recognised at cost less accumulated depreciation and any impairment losses. The assets are depreciated on a straight-line basis over the assets’ estimated useful life. The useful life is reassessed at each balance sheet date. The following useful lives are applied: Equipment, tools and machinery: 5 years Borrowing costs The borrowing costs incurred when the company borrows capital are recognised in the in the income statement in the period in which they arise. Income tax Current tax is the income tax for the current financial year which relates to the taxable profit for the year and that part of the previous financial year’s income tax that has not yet been recognised. Current tax is assessed at the probable amount based on the tax rates and tax regulations applicable on the balance sheet date. Deferred tax relating to future tax effects is not recognised in the income statement and balance sheet. The total unutilised deficit amounts to 117,501 (84,628) KSEK. Considering that the company has consistently reported losses, and there is some uncertainty when tax surpluses arise, no deferred tax asset related to the loss carryforward is recognized.
Note 2 – Other Operating Income SEK 2022
2021
Other operating income broken down by type of income Profit on the disposal of fixed assets
-
29,500
Foreign exchange gains
79,045
49,902
Other
41,369
-
Total other operating income
120,414
79,402
ANNUAL REPORT 2022 – Dicot AB 559006-3490
9
Note 3 – Remuneration to Auditors SEK 2022
2021
Öhrlings PricewaterhouseCoopers AB: Audit fees
207,575
116,240
By audit fees, we mean the auditor’s work for statutory audits and by audit services various types of quality assurance services. Any other services are those not included in audit engagements, audit services, or tax advisory services.
Note 4 – Staff SEK 2022
2021
Average number of employees The average number of employees is based on hours paid by the company related to normal working hours.
The average number of employees has been
2
2
of whom are female
2
1
of whom are male
0
1
Salaries, Compensation, etc. Salaries, compensation, social costs, and pension costs have been incurred as follows: Board of Directors and CEO Salaries and compensation
2,771,386
2,346,102
Pension costs
244,787
0
3,016,173
2,346,102
Salaries and compensation
796,901
398,240
Pension costs
144,759
74,050
941,660
472,290
Social costs
887,844
425,212
Total for the Board, CEO, and others
4,845,677
3,243,604
Other employees
Gender Distribution Number of board members
6
6
of whom are female
2
3
of whom are male
4
3
Number of key executives
4
3
of whom are female
2
2
of whom are male
2
1
10
ANNUAL REPORT 2022 – Dicot AB 559006-3490
SEK Board Members and Senior Executives
Basic Salary / Board Fees 2022 2021
Consulting Fees 2022 2021
Eva Sjökvist Saers, Chairman of the Board
170,000
69,167
-
-
Mikael von Euler-Chelpin, Director
75,000
50,000
30,400
-
Per-Göran Gillberg, Director
75,000
-
106,959
42,230
Lena Söderström, Director
75,000
50,000
2,600
4,550
Ebba Florin Robertsson, Former Director
75,000
50,000
45,600
87,400
Claes Post, Former Director
75,000
50,000
-
-
Lars O Jonsson, Former Director
-
83,333
-
-
Jarl Wikberg, Former Director
-
25,000
-
42,750
1,178,944
-
-
-
Göran Beijer, Former CEO
791,855
1,964,436
-
-
Other Senior Executives
736,541
380,000
2,638,744
910,938
3,252,340
2,721,936
2,824,303
1,087,868
Elin Trampe, CEO
Total The agreement with the CEO includes a mutual notice period of six months.
Note 5 – Equipment SEK 2022
2021
Opening acquisition cost
37,764
37,764
Purchases for the year
0
0
Closing accumulated acquisition costs
37,764
37,764
Opening depreciation
-9,369
-1,816
Depreciation for the year
-7,553
-7,553
Closing accumulated depreciation
-16,922
-9,369
20,842
28,395
Closing book value
ANNUAL REPORT 2022 – Dicot AB 559006-3490
11
Note 6 – Information on Share Capital SEK
Number of Shares
Quota Value per Share
At opening of the year
102,900,206
0.125
Shares issue TO3 2021
34,202,814
0.125
At closing of the year
137,103,020
0.125
The number of shareholders at the end of the year was 3,377, an increase of 21% since the beginning of the year. The stock has been listed on the Spotlight Stock Market under the name Dicot since June 20, 2018.
There are a total of seven outstanding incentive programs in Dicot. The exercise price for the options and future subscription price are based on the Black & Scholes model.
There are no benefits for option holders, and therefore no attributable costs to the company.
Incentive Program
Increase in share capital (SEK)
Exercise price (SEK)
Number of Number of warrants new shares (where of issued)
Time for share subscription
2018/2023
3,100
248,000
31,000
14.25
2018-05-08 – 2023-04-30
2019/2024
110,000
110,000
13,750
20.00
2019-07-03 – 2024-05-16
(80,000)
2020/2025
350,000
(250,000)
2021/2026
350,000
- styrelse
(300,000)
2021/2026
650,000
- övriga
(450,000)
2022/2027
700,000
- styrelse 2022/2027 - övriga Totalt
350,000 350,000 650,000 700,000
43,750 43,750 81,250 87,500
7.50 4.10 4.10 0.91
2020-06-11 - 2025-05-26 2024-06-01 – 2026-06-01 2024-06-01 – 2026-06-01 2025-06-01 – 2027-06-01
0 700,000
700,000
87,500
0.91
2025-06-01 – 2027-06-01
0 2,863,100
3,108,000
388,500
(1,083,100)
12
ANNUAL REPORT 2022 – Dicot AB 559006-3490
Note 7 – Definition of Key Ratios Key Ratios Equity Ratio (%)
Adjusted equity (equity and untaxed reserves, net of deferred tax) as a percentage of total assets
Net Sales
The main revenues of the business, invoiced costs, incidental revenues, and revenue adjustments.
Result After Financial Items
Results after financial income and expenses but before taxes.
Note 8 - Significant events after the end of the financial year The rights issue in January 2023 was oversubscribed to 109.5%. Subsequently no issue guarantees had to be utilised and 87% of the underwriters chose to receive compensation in the form of units via a offset instead of monetary compensation. Dicot thus received net SEK 49.9 million after costs. In connection with this, a reduction of the share capital was carried out, which led to a better balance between share capital and total equity. The decision on the issue and the reduction of share capital was taken at an extraordinary general meeting on January 9, 2023. Prior to the clinical phase 1 study, Clinical Trial Consultants was contracted in January to conduct the study and Thermo Fisher for GMP manufacturing of the study drug. In February, Thermo Fisher started manufacturing, which was fully in line with the schedule. The last meeting with the Swedish Medical
Products Agency before the application to start the study was held in March, and the agency was favourable to Dicot’s proposals on design and other matters. In January, it was also announced that Dicot is proceeding with a patent application covering the oral formulation developed in 2022. In April, the toxicology programme prior to clinical phase 1 was completed with good results.
ANNUAL REPORT 2022 – Dicot AB 559006-3490
13
Michael Zell
Per-Göran Gillberg
Eva Sjökvist Saers
Mikael von Euler-Chelplin
Lena Söderström
Fredrik Buch
Uppsala, on the day indicated by our electronic signatures Eva Sjökvist Saers
Fredrik Buch
Mikael von Euler-Chelpin
Chairman of the Board
Director
Director
Per-Göran Gillberg
Lena Söderström
Michael Zell
Director
Director
Director
Elin Trampe Chief Executive Officer
Our audit report has been issued on the day indicated by our electronic signatures. Öhrlings PricewaterhouseCoopers AB Lars Kylberg Authorized Public Accountant
14
ANNUAL REPORT 2022 – Dicot AB 559006-3490
www.dicot.se
Dicot AB S:t Olofsgatan 11A 753 21 Uppsala Sweden