Annual Report • Feb 13, 2024
Annual Report
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"MOB-015 is now on the shelves of pharmacies around Sweden under the brand name Terclara® – a milestone we have been working towards at Moberg Pharma for some time. It is especially gratifying to see the great interest in the product among the pharmacies," says Anna Ljung, CEO of Moberg Pharma.
• The sale of MOB-015 in Sweden under the brand name Terclara® has begun and the product is now available at the majority of pharmacies around the country.
MOB-015 is now on the shelves of pharmacies around Sweden under the brand name Terclara® – a milestone we have been working towards at Moberg Pharma for some time. It is especially gratifying to see the great interest in the product among the pharmacies.
We are now in the midst of the rollout to pharmacies of Terclara®, the brand name that MOB-015 is being launched under in Sweden by our partner Allderma. Production and inselling to pharmacy chains has been completed on schedule, so that the pharmacies can get the product now during the "February window," one of three times during the year when the chains reset their shelves. At the same time as pharmacies fill up the shelves, work is ongoing to inform doctors and pharmacy staff about the unique advantages of Terclara®. We're also conducting tests and fine-tuning marketing materials to ensure that it effectively communicates the product's superior features to our target groups. This is followed by targeted marketing to consumers, including digital marketing starting from March and TV commercials from April onwards. This means that MOB-015 is now available to Swedish patients ahead of high season in Q2 for those who want to begin the journey towards attractive, fungus-free nails before sandal season and the summer holiday.
We have received national approvals in a total of ten countries to date and are awaiting approvals in the remaining three countries included in the DCP process. We are dialoguing with the countries - Italy, Belgium and the Netherlands - that have not yet approved the product, where the approval decisions are taking time mainly due to the limited resources and heavy workload of the regulatory authorities. It is worth noting that all the countries have approved the product within the DCP process. National approvals affect only national adjustments, such as the translation of the product literature to the national language and whether the product will be approved for over-the-counter (OTC) or prescription (Rx) sales in each country.
Sweden is the priority market for Moberg Pharma as we have limited access to terbinafine in the near term. We have made progress in our efforts to secure a long-term supply of terbinafine ahead of the planned pan-European rollout together with our partner Bayer. We continue to work together with our intended terbinafine supplier, with an anticipated application submission expected shortly. In addition, we are actively working to secure another terbinafine supplier and have ordered terbinafine from alternative manufacturers. Upon delivery, we will have a small batch of MOB-015 manufactured for the stability studies required for the regulatory process to include a new terbinafine manufacturer. We thus have two parallel tracks to ensure a stable supply of terbinafine.
An important event during the quarter was the conclusion of patient enrollment in North America in early October by a wide margin thanks to the outstanding efforts of the team and engaged investigators. A total of 384 patients have been randomized at 33 study centers in the U.S. and Canada. The completion of the recruitment has also resulted in an outflow of cash linked to this milestone and we expect lower expenses for the study going forward. The timing when the last patient is enrolled in the study determines the timeline when data can be presented, and thanks to the fact that enrollment was completed in October, we expect to be able to present topline results as soon as January 2025. Maintaining a dialogue with the investigators in the study and key opinion leaders is important to both our ongoing clinical work and so that medical personnel will receive the product in the best way, and we look forward to again meeting many of our investigators at the annual meeting of the American Academy of Dermatology (AAD) in March.
Now in the first quarter we see that the preconditions for a successful launch are in place, with pharmacies filling up their shelves, and we look forward to launching our marketing to the consumer when high season is approaching and interest in treating nail fungus peaks. The Swedish launch is an important springboard to realize our vision – to make MOB-015 the leading nail fungus treatment worldwide.
Anna Ljung, CEO of Moberg Pharma
Moberg Pharma's goal is to make MOB-015 the world's leading treatment for nail fungus and to build a specialty pharmaceutical company with its own sales in the U.S. and sales through partners in other markets. With MOB-015 as an anchor, the company intends to expand the product portfolio with additional products in adjacent areas either developed inhouse or acquired.
MOB-015 is a next-generation treatment for onychomycosis (nail fungus), and the high antifungal effect shown in clinical Phase 3 studies with more than 800 patients indicates that the product has the potential to become the future market leader in nail fungus. Moberg Pharma has signed license agreements with partners in Europe, Canada, Israel and the Republic of Korea for MOB-015, and the product is approved in ten European countries with approvals expected in three additional European countries. The global annual sales potential for MOB-015 is estimated at USD 250–500 million.
| MOB-015 |
|---|
| Nail fungus affects 10%, more common among older people Topical terbinafine for treatment of nail fungus Target profile: Rapid, visible improvement, superior cure rate and shorter treatment time |
| World-leading anti-fungal effect 76% mycological cure in Phase 3 1000x higher concentration of terbinafine in the nail compared to oral terbinafine 40x higher concentration of terbinafine in the nail bed compared to oral terbinafine Negligible systemic levels of terbinafine |
| Estimated global sales potential USD 250-500 million per annum Partners in Europe, Canada, Israel and the Republic of Korea Two-step launch plan, beginning in Scandinavia followed by pan-European launch |
| Launch initiated in Sweden under brand name Terclara® National marketing authorization approvals received in 10 European countries, recommended for approval in additional 3 EU countries Phase 3 studies completed in North America, n=365, and Europe, n=452. Primary ٠ endpoints reached without serious side effects New Phase 3 study for North America ongoing, n=384, topline results expected Jan 2025 |
| Patent protection until 2032 and additional ongoing patent applications Patents granted in major markets, including the U.S., the EU, Canada, Japan and China Patents include new topical formulations of allylamines (including terbinafine) and treatment methods for nail fungus using the new formulations |
Despite that one out of every ten people suffers from nail fungus, there currently aren't any good treatment alternatives available. The most effective treatment is oral terbinafine, which is associated with the risk of liver damage and interaction with other drugs. Dermatologists around the world agree on the great need for better topical treatments without the risk of systemic side effects. In a survey in the U.S., 72% of responding physicians avoid prescribing oral terbinafine due to their
patients' concern about side effects, and 62% would prefer a product with MOB-015's intended target profile to current topical treatments. Only 6-15% of responding physicians would continue to prescribe current topical treatments. 1
In December 2019, the results were presented from the first of two clinical studies in the Phase 3 program for MOB-015, followed by the results of the European study in June 2020. Both studies met the primary endpoint. Mycological cure (eradicating the fungal infection) was achieved in 76 percent of the patients (70 percent of the patients in the North American study and 84 percent of the patients in the European study), which is substantially higher than reported for other topical treatments (30-54 percent). Furthermore, the onset of the antifungal effect is more rapid than for oral terbinafine, with MOB-015 delivering 55–78 percent mycological cure at 6 months (vs 40 percent for oral terbinafine) and 37–46 percent already at 3 months (vs 15 percent for oral terbinafine).
MOB-015 is the first topical treatment with a mycological cure rate at the same level as oral terbinafine, the current gold standard for treatment of onychomycosis. Before the completed clinical Phase 3 studies with MOB-015, it appeared unrealistic that a topical treatment would achieve a mycological cure rate of 70 percent. Furthermore, the concentration of terbinafine has been shown to be 1000X higher in the nail, 40x higher in the nail bed and 1000X lower in plasma compared to oral terbinafine – ideal characteristics for an effective tropical treatment without systemic exposure.
In March 2022, Moberg Pharma submitted the registration application for MOB-015 in Europe through the decentralized process. In June 2023, the Decentralized Procedure ended with a positive outcome and MOB-015 recommended for national approval in 13 European countries for the treatment of mild to moderate fungal infections of the nails in adults. The following EU countries are included: Austria, Belgium, Czech Republic, Denmark, Finland, France, Hungary, Ireland, Italy, Netherlands, Norway, Spain and Sweden. Next steps include national implementation in each country and OTC approvals when applicable. The national approvals are expected to follow in the upcoming months and timelines may vary between countries. As at the date of this report, Moberg Pharma has received national approvals in the following countries: Austria (OTC), Czech Republic (Rx), Denmark (Rx), Finland (Rx), France (Rx), Hungary (OTC), Ireland (Rx), Norway (OTC), Spain (Rx) and Sweden (OTC).
Our commercialization rollout will be a two-step process and has now begun in our home market. As of February 2024, MOB-015 is available in pharmacies under the brand name Terclara®, and at the present time the majority of pharmacies around Sweden have decided to sell Terclara®. This early launch in Sweden enables us to gain valuable insights into consumer behavior, collect patient feedback and provide user data to support a direct Rx to OTC switch in more countries. The launch is taking place in collaboration with our partner Allderma, managed by the commercial leaders who were responsible for the successful Nordic launch of Nalox®, Moberg Pharma's first-generation nail fungus product. Step 2 of the launch will be a pan-European rollout together with our partner Bayer, following the results of the ongoing North American study, which we believe has the potential to strengthen product claims further, including a shorter dosing regimen. The timing is also driven by our need to secure sufficient API (active pharmaceutical ingredient) for a pan-European launch.
For market approval in the U.S., the FDA normally requires two studies that demonstrate superiority (statistically superior to the comparator) for the primary endpoint. An additional North American study is ongoing to enable registration in the U.S. market. Moberg Pharma submitted documentation on the new study to the FDA in March 2022, the first patient was enrolled in May 2022 and the enrollment of 384 patients was completed in October 2023. Topline results are expected in January 2025. The randomized, vehicle-controlled, multicenter Phase 3 study is being conducted at 33 study centers in the U.S. and Canada. The patients are being evaluated over 52 weeks and the primary endpoint will be the proportion of subjects achieving complete cure of their target nail. The study design builds on the experience gained from the previous Phase 3 studies and Moberg Pharma is cooperating with the same CRO, same lead investigator and high-performance clinics from the previous
1 Survey of 89 U.S. physicians (dermatologists and podiatrists), LifeSci Physician Survey, April 4, 2017
North American study. The purpose of the new study is to facilitate market approval in the U.S. as well as strengthen the product's clinical evidence and marketing claims globally.
In total, five agreements are in place with commercial partners for MOB-015: Cipher Pharmaceuticals for Canada; DongKoo, the market leader in dermatology in the Republic of Korea; Allderma in Scandinavia; Padagis in Israel; and the Consumer Health division of Bayer AG, a world leader in OTC fungus treatments with the brand Canesten, for Europe.
The agreements give these partners exclusive rights to market and sell MOB-015 in each respective market, while Moberg Pharma is responsible for production and supply. Within the framework of the agreements Moberg Pharma can receive milestone payments of up to a total USD 70 million upon successful development and commercialization, in addition to royalties and compensation for delivered products.
Previously, Moberg Pharma has successfully commercialized products in the U.S. and retained the rights to MOB-015 for the U.S. market. The aim is to repeat the journey taken with Kerasal Nail®, where Moberg Pharma combined direct sales in the U.S. with strategic collaborations in other major territories. The most important markets for MOB-015 are expected to be the U.S., EU, Japan, Canada and China, all with patent protection until 2032. In addition to granted patents, the company also has ongoing patent applications which, if approved, could provide significantly longer patent protection.
Moberg Pharma commercialized its first-generation nail fungus product – Kerasal Nail® – and built an OTC business with an annual revenue of SEK 440 million, a 30% market share in the U.S. and more than 30,000 sales locations, including the major chains CVS, Walgreens and Walmart. In 2019, the OTC business was successfully divested for SEK 1.4 billion. The company's aim is now to repeat this journey with MOB-015, a product with much greater potential.
The Annual General Meeting on May 16 elected Håkan Wallin to the Board of Directors. Håkan has many years of both operative and financial experience from advisory positions as well as from board and management positions in both listed and non-listed life science companies. Previous positions include responsible partner on the corporate finance side for the life science sector at ABG Sundal Collier, EVP Corporate Development at Medivir and Chairman of the Board of Palette Life Sciences (previously PharmanestAB). Håkan is today CFO at NP3 Fastigheter AB.
In November, the organization was strengthened following market approval earlier this year and ahead of the upcoming launch. The management team has added two new members in Christina Erixon, Head of Pharmaceutical Innovation & Operations, who succeeds Agneta Larhed, and Robert Ehrl, Head of Supply, who succeeds Jesper Lind. Both roles have been expanded from part-time consultants to full-time positions. Agneta Larhed is stepping down from the management team but remaining a part-time consultant to the company with unchanged scope. Jesper Lind is remaining for a period as a consultant to the company.
Christina Erixon has extensive experience from development, regulatory issues and pharmaceutical quality within the pharmaceutical industry. Dr. Erixon has held leading positions within the pharmaceutical industry and at regulatory authorities, including roles as the manager of clinical trials at the Swedish Medical Products Agency, senior product developer at AstraZeneca, business manager and associate director for Pharmaceutical Development at APL, and most recently as the director of Drug Development at SDS Life Science. Dr. Erixon is pharmacist with a PhD in Pharmaceutics from Uppsala University.
Robert Ehrl holds a PhD in organic chemistry with over 20 years of experience from the pharmaceutical industry. He has held leadership positions at AstraZeneca and Valneva Sweden AB, primarily in process development, supply, and manufacturing. Dr. Ehrl has worked with both small molecule and biological drugs/vaccines, from active pharmaceutical ingredient (API) to final packed product.
On June 28, the Board of Directors resolved to carry out a new issue of ordinary shares and warrants with preferential rights for existing shareholders of approximately SEK 100 million. The Board of Directors also resolved on a directed issue to guarantors in the rights issue. The Board of Directors' resolutions were approved by the Extraordinary General Meeting on August 8 and the Extraordinary General Meeting on October 9. The rights issue was oversubscribed with a subscription rate of 130% and provided the company with approximately SEK 100 million before transaction costs. The net proceeds will mainly be used for clinical and regulatory activities for MOB-015 and preparations ahead of launch.
Moberg Pharma's operations consist of research and development, business development and administrative functions. The majority of the development expenditure incurred is directly attributable to the development project MOB-015 and is capitalized. The largest expense items in the quarter therefore consist of business development and administration expenses of SEK 6.3 million (5.2), pre-launch selling expenses of SEK 1.2 million (0.5), followed by research and development expenses of SEK 1.0 million (0.2). Profit for the quarter was SEK -6.4 million (-3.1).
Selling expenses increased in pace with the upcoming launch of MOB-015 to SEK 3.3 million (1.0). Business development and administrative expenses increased due to several business development activities tied to the ongoing approvals in several markets to SEK 21.6 million (20.1). Research and development expenses include fees related to market approvals as well as regulatory registrations of SEK 3.7 million (1.2). Profit for the year was SEK -21.1 million (-15.7).
Cash flow from operating activities was SEK -5.6 million (-4.4) before changes in working capital and SEK -7.3 million (-3.3) after changes in working capital. A large share of the total cash flow from operating activities relates to stock procurement ahead of the upcoming launch. Cash flow from investments was SEK -33.2 million (-13.6) and relates to capitalized expenditure for the ongoing North American Phase 3 study. The success in enrolling patients, where the last patient was enrolled during the quarter, has also meant a large cash outflow to pay for enrollment activities and the CRO. This is the main reason for the increase in R&D expenditure during the quarter and we expect lower R&D expenditures going forward. Cash flow from financing activities was SEK -0.3 million (-0.8). The total change in cash and cash equivalents in the quarter was SEK -40.9 million (-16.9). Cash and cash equivalents amounted to SEK 60.6 million (125.5) at the end of the period.
Cash flow from operating activities before changes in working capital was SEK -21.1 (-15.5) million. Cash flow from investments was SEK -124.1 million (-68.1). Cash flow from financing activities was SEK 92.3 million (107.8). The total change in cash and cash equivalents during the year was SEK -65.0 million (22.9).
Investments in intangible assets relate to capitalized expenses for development work on MOB-015, mainly the ongoing North American Phase 3 study, of SEK 33.2 million (26.6) in the quarter.
| R&D expenses (costs and investments) | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
|---|---|---|---|---|
| (SEK thousand) | 2023 | 2022 | 2023 | 2022 |
| R&D expenses (in statement of comprehensive income) | -1,037 | -225 | -3,657 | -1,177 |
| Capitalized R&D investments | -33,215 | -26,612 | -124,116 | -81,062 |
| Depreciation/amortization booked to R&D expenses | 150 | 430 | 1,276 | 1,683 |
| Change in R&D investments (in statement of financial position) | -33,065 | -26,182 | -122,840 | -79,379 |
| Total R&D expenditure | -34,102 | -26,407 | -126,497 | -80,556 |
As at the balance sheet date, the Group has no interest-bearing liabilities (excluding leasing liabilities).
Share capital at the end of the period was SEK 28,407,452, where the total number of shares outstanding was 28,407,452 ordinary shares with a quotient value of SEK 1. Moberg Pharma holds 445,974 repurchased ordinary shares at the end of the year.
The Annual General Meeting on May 16, 2023 resolved on a reverse share split, through which ten (10) existing shares were consolidated into one (1) new share. The share's quotient value increased from SEK 0.1 to SEK 1.0.
In June 2023, 187,000 class C shares were issued to ensure that the company can fulfil its commitments under the long-term incentive program LTI 2023 resolved by the Annual General Meeting on May 16, 2023. The shares are intended for use in securing the commitments under the incentive program and are owned by Moberg Pharma.
In September 2023, Moberg Pharma completed a rights issue of units, comprised of 17,470,149 ordinary shares and warrants of series 2023:1, as resolved by the Board of Directors on June 28, 2023, as well as a directed issue of units, corresponding to 664,370 ordinary shares and warrants of series 2023:1, to the guarantors in the rights issue who have chosen to receive their guarantee commission in the form of newly issued units. Each warrant of series 2023:1 entitles the holder to subscribe for one (1) new ordinary share in the company during the period June 5, 2024 up to and including June 19, 2024. The subscription price for subscription of ordinary shares with the support of warrants of series 2023:1 will correspond to 70 percent of the volume-weighted average price of the company's ordinary share during the period from and including May 20, 2024 up to and including May 31, 2024. However, the subscription price can at minimum amount to the quota value of the share, corresponding to approximately SEK 1.0 per ordinary share. The rights issue was oversubscribed and Moberg Pharma was provided with proceeds of approximately SEK 100 million before deducting transaction costs.
As at the reporting date, the number of outstanding instruments was 1,851,000 performance share units (which entitle holders to not more than 1,522,988 shares), with a maximum potential dilution of 5.1%. Performance share units are issued and held in trust, where the actual number of shares that can be transferred varies depending on the individual targets and whether the company meets its business goals over several years. For detailed information on the incentive programs, see the 2022 Annual Report.
The company's largest shareholders per December 31, 2023:
| Shareholder | Number of shares | % of votes and capital |
|---|---|---|
| Östersjöstiftelsen | 3,266,477 | 11.5 |
| Avanza Pension | 1,825,734 | 6.4 |
| Nordnet Pensionsforsakring AB | 656,696 | 2.3 |
| Kjelsmark Holding ApS | 500,000 | 1.8 |
| Moberg Pharma AB (publ) | 445,974 | 1.6 |
| The Bank of New York Mellon SA/NV, W8IMY | 419,232 | 1.5 |
| Iveland, Beatrice | 390,000 | 1.4 |
| Swedbank Försäkring | 358,111 | 1.3 |
| Clearstream Banking S.A., W8imy | 344,383 | 1.2 |
| IBKR Financial Services AG, W8IMY | 335,348 | 1.2 |
| JS Erhvervs Consult Aps | 329,811 | 1.2 |
| Blom, Fredrik | 320,000 | 1.1 |
| Zachau, Styrbjorn | 317,246 | 1.1 |
| Chen, Chance | 307,671 | 1.1 |
| Nordea Livförsäkring Sweden Ab | 296,798 | 1.0 |
| Asberg, Fredrik Erik | 231,345 | 0.8 |
| Handelsbanken Liv Försäkringsaktiebolag | 222,773 | 0.8 |
| Eriksson, Mats | 213,143 | 0.8 |
| SEB Life International Assurance | 211,010 | 0.7 |
| SEB Investment Management | 198,631 | 0.7 |
| TOTAL, 20 LARGEST SHAREHOLDERS | 11,190,383 | 39.4 |
| Other shareholders | 17,217,069 | 60.6 |
| TOTAL | 28,407,452 | 100 |
Moberg Pharma AB (publ), corp. reg. no. 556697-7426, is the parent company of the Group. The operations of the Group are primarily conducted in the parent company and consist of research and development, business development and administrative functions. For the period January to December 2023, the parent company's operating profit was SEK -27.5 million (-20.2), while profit after financial items was SEK -25.4 million (-19.5). Profit after tax was SEK -21.1 million (15.7). Cash and cash equivalents amounted to SEK 60.6 million (125.6) at the end of the period.
Per December 31, 2023, Moberg Pharma had 10 employees, of whom 80% were women. All were employees of the parent company.
Commercialization and development of pharmaceuticals are capital-intensive activities exposed to significant risks. Risk factors considered to be of particular significance for Moberg Pharma's future development are linked to the results of clinical trials,
regulatory actions, patents and trademarks, key personnel, sensitivity to economic fluctuations, future capital requirements, and financial risk factors. A description of these risks can be found in the company's 2022 Annual Report on page 21.
Moberg Pharma's goal is to create value and provide attractive shareholder returns through the successful commercialization of its pipeline assets.
In June 2023, the Decentralized Procedure ended with a positive outcome and MOB-015 recommended for national approval in 13 European countries for the treatment of mild to moderate fungal infections of the nails in adults. National approvals are now underway in each country, where 10 countries have approved the product to date, as well as OTC approvals when applicable.
Moberg Pharma is also conducting a North American Phase 3 study, where patient enrollment was completed in October 2023 and topline results are expected in January 2025. The study has the potential to enable drug registration in the U.S. and further strengthen the product claims.
The company have initiated the launch in Sweden and as of February 2024, MOB-015 is available at pharmacies under the brand name Terclara®. Pharmacies are now filling their shelves, after which marketing to the consumer will begin ahead of high season – as summer and the sandal season approach, interest in treating nail fungus peaks. The Swedish launch is an important springboard to realize our vision – to make MOB-015 the leading nail fungus treatment worldwide.
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
|---|---|---|---|---|
| (SEK thousand) | 2023 | 2022 | 2023 | 2022 |
| Net revenue | - | - | - | 207 |
| Cost of goods sold | - | - | - | - |
| Gross profit | - | - | - | 207 |
| Selling expenses | -1,167 | -540 | -3,257 | -1,014 |
| Business development and administrative expenses | -6,288 | -5,160 | -21,603 | -20,057 |
| Research and development expenses | -1,037 | -225 | -3,657 | -1,177 |
| Other operating income | 257 | 1,326 | 1,054 | 1,815 |
| Other operating expenses | - | - | - | - |
| Operating profit (EBIT) | -8,235 | -4,599 | -27,463 | -20,226 |
| Interest income and similar items | 799 | 786 | 2,303 | 786 |
| Interest expenses and similar items | -52 | -13 | -260 | -72 |
| Profit after financial items from continuing operations (EBT) | -7,488 | -3,826 | -25,420 | -19,512 |
| Tax on profit for the period | 1,043 | 713 | 4,327 | 3,802 |
| PROFIT FOR THE PERIOD | -6,445 | -3,113 | -21,093 | -15,710 |
| TOTAL PROFIT FOR THE PERIOD | -6,445 | -3,113 | -21,093 | -15,710 |
| Profit for the period attributable to parent company shareholders | -6,445 | -3,113 | -21,093 | -15,710 |
| Total profit attributable to parent company shareholders | -6,445 | -3,113 | -21,093 | -15,710 |
| Basic earnings per share | -0.23 | -0.32 | -1.33 | -2.07 |
| Diluted earnings per share 2 | -0.23 | -0.32 | -1.33 | -2.07 |
| EBITDA FROM CONTINUING OPERATIONS | -7,975 | -3,954 | -25,364 | -17,644 |
| Depreciation/amortization | -260 | -645 | -2,099 | -2,582 |
| Operating profit (EBIT) | -8,235 | -4,599 | -27,463 | -20,226 |
2 In periods when the Group reports a loss, no dilution effect arises. A dilution effect is only recognized when a potential conversion to ordinary shares would result in lower earnings per share.
| (SEK thousand) | 2023-12-31 | 2022-12-31 |
|---|---|---|
| Assets | ||
| Intangible non-current assets3 | 532,220 | 408,104 |
| Tangible non-current assets | 0 | 0 |
| Right-of-use assets | 4,942 | 5,984 |
| Deferred tax asset | 28,077 | 22,575 |
| Total non-current assets | 565,239 | 436,663 |
| Inventories | 7,115 | - |
| Trade receivables and other receivables | 1,823 | 2,210 |
| Cash and cash equivalents | 60,555 | 125,550 |
| Total current assets | 69,493 | 127,760 |
| TOTAL ASSETS | 634,732 | 564,423 |
| Equity and liabilities | ||
| Equity attributable to parent company's shareholders | 610,725 | 533,584 |
| Total equity | 610,725 | 533,584 |
| Non-current leasing liabilities | 3,467 | 3,988 |
| Non-current non-interest-bearing liabilities | - | 65 |
| Total non-current liabilities | 3,467 | 4,053 |
| Current leasing liabilities | 1,270 | 2,117 |
| Current non-interest-bearing liabilities | 19,270 | 24,669 |
| Total current liabilities | 20,540 | 26,786 |
| TOTAL EQUITY AND LIABILITIES | 634,732 | 564,423 |
3Refers to capitalized development expenses, see note 2.
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
|---|---|---|---|---|
| (SEK thousand) | 2023 | 2022 | 2023 | 2022 |
| Operating activities | ||||
| Operating profit before financial items | -8,235 | -4,599 | -27,463 | -20,226 |
| Financial items, received and paid | 1,788 | 775 | 2,006 | 717 |
| Taxes paid | - | - | - | - |
| Adjustments: | ||||
| Depreciation/amortization and capital gains | 260 | 645 | 2,099 | 2,582 |
| Employee share-based adjustments to equity 4 | 625 | 535 | 2,308 | 1,458 |
| Cash flow before changes in working capital | -5,562 | -4,411 | -21,050 | -15,469 |
| Change in working capital | ||||
| Increase (-)/Decrease (+) in inventories | -7,115 | - | -7,115 | - |
| Increase (-)/Decrease (+) in operating receivables | 778 | -792 | 424 | -210 |
| Increase (+)/Decrease (-) in operating liabilities | 4,551 | 155 | -5,464 | -1,163 |
| OPERATING CASH FLOW | -7,348 | -3,281 | -33,205 | -16,842 |
| Investing activities | ||||
| Net investments in intangible assets | -33,215 | -13,622 | -124,116 | -68,072 |
| CASH FLOW FROM INVESTING ACTIVITIES | -33,215 | -13,622 | -124,116 | -68,072 |
| Financing activities | ||||
| Repayment of leases | -118 | 0 | -2,425 | -1,873 |
| Issue of new shares less transaction costs | -268 | 0 | 94,751 | 109,682 |
| CASH FLOW FROM FINANCING ACTIVITIES | -386 | 0 | 92,326 | 107,809 |
| Change in cash and cash equivalents | -40,949 | -16,903 | -64,995 | 22,895 |
| Cash and cash equivalents at the beginning of period | 101,504 | 142,453 | 125,550 | 102,655 |
| Cash and cash equivalents at the end of period | 60,555 | 125,550 | 60,555 | 125,550 |
4 Note that revaluation of estimated costs for social security contributions for employee stock options is recognized in change in operating liabilities.
| (SEK thousand) | Share capital | Other capital contributions |
Accumulated profit/loss |
Total equity |
|---|---|---|---|---|
| January 1 – December 31, 2023 | ||||
| Opening balance, January 1, 2023 | 9,827 | 841,197 | -317,440 | 533,584 |
| Total profit | ||||
| Profit for the period | -21,093 | -21,093 | ||
| Transactions with shareholders | ||||
| New shares issued | 18,134 | 82,319 | 100,453 | |
| Transaction costs | -4,527 | -4,527 | ||
| Share-based incentive program | 2,308 | 2,308 | ||
| CLOSING BALANCE, DECEMBER 31, 2023 | 27,961 | 921,297 | -338,533 | 610,725 |
| (SEK thousand) | Share capital | Other capital contributions |
Accumulated profit/loss |
Total equity |
|---|---|---|---|---|
| January 1 – December 31, 2022 | ||||
| Opening balance, January 1, 2022 | 4,405 | 731,376 | -301,730 | 434,051 |
| Total profit | ||||
| Profit for the period | -15,710 | -15,710 | ||
| Transactions with shareholders | ||||
| New shares issued | 5,422 | 124,168 | 129,590 | |
| Transaction costs | -15,805 | -15,805 | ||
| Share-based incentive program | 1,458 | 1,458 | ||
| CLOSING BALANCE, DECEMBER 31, 2022 | 9,827 | 841,197 | -317,440 | 533,584 |
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
|---|---|---|---|---|
| (SEK thousand) | 2023 | 2022 | 2023 | 2022 |
| Net revenue | 0 | 0 | 0 | 207 |
| EBITDA | -7,975 | -3,954 | -25,364 | -17,644 |
| Operating profit (EBIT) | -8,235 | -4,599 | -27,463 | -20,226 |
| Total profit | -6,445 | -3,113 | -21,093 | -15,710 |
| Cash and cash equivalents | 60,555 | 125,550 | 60,555 | 125,550 |
| Balance sheet total | 634,732 | 564,423 | 634,732 | 564,423 |
| Equity/assets ratio | 96% | 95% | 96% | 95% |
| Return on equity | -1% | -1% | -3% | -3% |
| Diluted earnings per share, SEK | -0.23 | -0.32 | -1.33 | -2.07 |
| Equity per share, SEK | 21.84 | 54.30 | 21.84 | 54.30 |
| Basic average number of shares | 27,961,478 | 9,826,959 | 15,871,799 | 7,587,166 |
| Diluted average number of shares | 46,640,128 | 10,179,997 | 34,550,449 | 7,752,320 |
| Number of shares at the end of the period excluding repurchased own shares |
27,961,478 | 9,826,959 | 27,961,478 | 9,826,959 |
Moberg Pharma presents certain financial performance measurements in the interim report that are not defined in accordance with IFRS. In Moberg Pharma's opinion, these performance measurements provide valuable additional information to investors and company management as they enable an evaluation of the company's performance. These financial performance measurements are not always comparable with those used by other companies since not all companies calculate them in the same manner. Accordingly, these financial measurements are not to be regarded as a substitute for the performance measurements defined in accordance with IFRS.
| EBITDA | Operating profit before depreciation/amortization and impairment of intangible |
|---|---|
| assets and property, plant, and equipment | |
| Equity/assets ratio | Equity at the end of the period in relation to balance sheet total |
| Return on equity | Profit for the period divided by closing equity |
| Earnings per share* | Profit after tax divided by the diluted average number of shares |
| Equity per share | Equity divided by the number of shares outstanding at the end of the period |
* Defined in accordance with IFRS
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
|---|---|---|---|---|
| (SEK thousand) | 2023 | 2022 | 2023 | 2022 |
| Net revenue | - | - | - | 207 |
| Cost of goods sold | - | - | - | - |
| Gross profit | - | - | - | 207 |
| Selling expenses | -1,167 | -540 | -3,257 | -1,014 |
| Business development and administrative expenses | -6,288 | -5,160 | -21,603 | -20,057 |
| Research and development expenses | -1,037 | -225 | -3,657 | -1,177 |
| Other operating income | 257 | 1,326 | 1,054 | 1,815 |
| Other operating expenses | - | - | - | - |
| Operating profit | -8,235 | -4,599 | -27,463 | -20,226 |
| Interest income | 799 | 786 | 2,303 | 786 |
| Interest expenses | -52 | -13 | -260 | -72 |
| Profit after financial items | -7,488 | -3,826 | -25,420 | -19,512 |
| Tax on profit for the period | 1,043 | 713 | 4,327 | 3,802 |
| PROFIT | -6,445 | -3,113 | -21,093 | -15,710 |
| (SEK thousand) | 2023-12-31 | 2022-12-31 |
|---|---|---|
| Assets | ||
| Intangible non-current assets | 532,220 | 408,104 |
| Tangible non-current assets | - | - |
| Right-of-use assets | 4,942 | 5,984 |
| Non-current financial assets | 100 | 100 |
| Deferred tax asset | 28,077 | 22,575 |
| Total non-current assets | 565,339 | 436,763 |
| Inventories | 7,115 | - |
| Trade receivables and other receivables | 1,823 | 2,210 |
| Cash and cash equivalents | 60,555 | 125,550 |
| Total current assets | 69,493 | 127,760 |
| TOTAL ASSETS | 634,832 | 564,523 |
| Equity and liabilities | ||
| Equity | 610,726 | 533,585 |
| Non-current leasing liabilities | 3,467 | 3,988 |
| Non-current non-interest-bearing liabilities | - | 65 |
| Total non-current liabilities | 3,467 | 4,053 |
| Liabilities to Group companies | 99 | 99 |
| Current leasing liabilities | 1,270 | 2,117 |
| Current non-interest-bearing liabilities | 19,270 | 24,669 |
| Total current liabilities | 20,639 | 26,885 |
| TOTAL EQUITY AND LIABILITIES | 634,832 | 564,523 |
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
|---|---|---|---|---|
| (SEK thousand) | 2023 | 2022 | 2023 | 2022 |
| Operating activities | ||||
| Operating profit before financial items | -8,235 | -4,599 | -27,463 | -20,226 |
| Financial items, received and paid | 1,788 | 775 | 2,006 | 717 |
| Adjustments: | ||||
| Depreciation/amortization and capital gains | 260 | 645 | 2,099 | 2,582 |
| Expenses for share-based incentive program | 625 | 535 | 2,308 | 1,458 |
| Cash flow before changes in working capital | -5,562 | -2,644 | -21,050 | -15,469 |
| Change in working capital | ||||
| Increase (-)/Decrease (+) in inventories | -7,115 | - | -7,115 | - |
| Increase (-)/Decrease (+) in operating receivables | 778 | -792 | 424 | -210 |
| Increase (+)/Decrease (-) in operating liabilities | 4,551 | 155 | -5,464 | -1,163 |
| OPERATING CASH FLOW | -7,384 | -3,281 | -33,205 | -16,842 |
| Investing activities | ||||
| Net investments in intangible assets | -33,215 | -13,622 | -124,116 | -68,072 |
| CASH FLOW FROM INVESTING ACTIVITIES | -33,215 | -13,622 | -124,116 | -68,072 |
| Financing activities | ||||
| Repayment of leases | -118 | - | -2,425 | -1,873 |
| Issue of new shares less transaction costs | -268 | - | 94,751 | 109,682 |
| CASH FLOW FROM FINANCING ACTIVITIES | -386 | - | 92,326 | 107,809 |
| Change in cash and cash equivalents | -40,949 | -16,903 | -64,995 | 22,895 |
| Cash and cash equivalents at the beginning of the period | 101,504 | 142,453 | 125,550 | 102,655 |
| Cash and cash equivalents at the end of the period | 60,555 | 125,550 | 60,555 | 125,550 |
The year-end report was prepared in accordance with IAS 34 and the Swedish Annual Accounts Act. The consolidated financial statements were, like the annual accounts for 2022, prepared in accordance with the International Financial Reporting Standards (IFRS) as adopted by the EU and the Swedish Annual Accounts Act. The parent company financial statements were prepared in accordance with Swedish Annual Accounts Act and Recommendation RFR 2 of the Swedish Financial Reporting Board, Financial Statements for Legal Entities.
Amounts are presented in Swedish kronor and rounded to the nearest thousand unless otherwise stated. Rounding to the nearest thousand may mean that certain amounts do not match when added up. Amounts and figures in parentheses refer to comparable figures for the corresponding period in 2022.
| (SEK thousand) | 2023-12-31 | 2022-12-31 |
|---|---|---|
| Capitalized expenditure for MOB-015 | 532,220 | 408,104 |
| TOTAL CAPITALIZED EXPENDITURE FOR DEVELOPMENT WORK | 532,220 | 408,104 |
Moberg Pharma's operations comprise only one area of operation: the commercialization and development of medical products. The statement of comprehensive income and statement of financial position as a whole therefore comprise one operating segment.
No material changes have occurred in the nature and scope of transactions with related parties compared to disclosures in the Annual Report.
This information is such that Moberg Pharma AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation and the Securities Market Act.
Interim report for January–March 2024 May 7, 2024 Interim report for January–June 2024 August 13, 2024 Interim report for January–September 2024 November 12, 2024
The Annual General Meeting of Moberg Pharma will be held on May 14, 2024. The last date for shareholders to request to have a matter considered at the Annual General Meeting is March 26, 2024. The Annual Report will be available no later than April 16, 2024 on the company's website at www.mobergpharma.se
Anna Ljung, CEO, tel. 08-522 307 01, [email protected] Mark Beveridge, VP Finance, tel. 076 - 805 82 88, [email protected]
For more information on Moberg Pharma's business, please see the company's website, www.mobergpharma.com.
The year-end report has not been reviewed by the Company's auditors.
The undersigned hereby declare that the year-end report provides a true and fair overview of the operations, financial position, and results of the parent company and Group, as well as a fair description of significant risks and uncertainties faced by the parent company and Group companies
Bromma, February 13, 2024
Kerstin Valinder Strinnholm Chairman
Anders Lundmark Board member
Nikolaj Sörensen Board member
Håkan Wallin Board member Anna Ljung CEO
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