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Moberg Pharma
Annual Report • Feb 11, 2025
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Annual Report
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Year-end report 2024
Moberg Pharma AB (Publ)
TERCLARA CONTINUES TO LEAD THE MARKET AND EXPANDS TO NORWAY
"The success continues in Sweden, with Terclara® solidifying its position as the market leader. Building on this momentum, we are now taking the next step by launching in Norway. A new terbinafine supplier has been secured, eliminating a key bottleneck for future market launches. After publishing the topline data, we reevaluated our U.S. plans and made a strategic decision to focus on the European markets, where strong momentum and the approval of our effective daily dosing regimen in 13 EU countries present the best opportunities for near-term growth," says Anna Ljung, CEO of Moberg Pharma.
THE YEAR (JAN-DEC 2024)
- Net revenue SEK 9.8 million (0)
- EBITDA SEK -23.5 million (-25.4)
- Operating profit (EBIT) SEK -324.8 million (-27.5)
- Total profit SEK -255.1 million (-21.1)
- Diluted earnings per share SEK -6.74 (-1.33)
- Cash and cash equivalents amounted to SEK 293.3 million (60.6)
FOURTH QUARTER (OCT-DEC 2024)
- Net revenue SEK 1.0 million (0)
- EBITDA SEK -7.8 million (-8.0)
- Operating profit (EBIT) SEK -308.1 million (-8.2)
- Total profit SEK -243.3 million (-6.4)
- Diluted earnings per share SEK -5.21 (-0.23)
- Cash and cash equivalents amounted to SEK 293.3 million (60.6)
SIGNIFICANT EVENTS DURING THE FOURTH QUARTER
- Terclara® continues to be the market leader in Sweden.
- A new terbinafine supplier has been secured for Terclara®/MOB-015. As a result, terbinafine availability is no longer a limiting factor for the company's launch plans.
- Topline data from the Phase 3 study has been reported. MOB-015 did not meet the primary endpoint using 8 weeks of daily dosing followed by weekly maintenance dosing. The company's focus going forward will be on the effective daily dosing regimen approved in 13 EU countries.
- Moberg Pharma and Bayer have mutually terminated the license agreement, where Moberg Pharma has regained full rights to MOB-015 in the EU and maintains previous milestone payments.
SIGNIFICANT EVENTS AFTER THE QUARTER
• The launch of Terclara® (MOB-015) is beginning in Norway. The experience from Sweden inspires confidence in the Norwegian market, and the launch of Terclara® in Norway follows the same approach as in Sweden. In February, the first deliveries were made to Norwegian pharmacies, followed by targeted information campaigns for pharmacy staff and healthcare professionals. In parallel, consumer marketing will intensify ahead of the peak season, when the demand for nail fungus treatment traditionally increases.
CONFERENCE CALL
CEO Anna Ljung will present the report at a telephone conference today, February 11th, 2025, at 3:00 p.m. CET. Telephone: SE 010 884 80 16, US +1 646 664 1960 Access code: 223155
CEO COMMENTS
Terclara® continues to lead the Swedish market, solidifying its position as the market leader. Building on this momentum, we are now taking the next step by expanding to Norway. A new terbinafine supplier has been secured, eliminating a key bottleneck for future market launches. After publishing the North American phase 3 topline data, we reevaluated our U.S. plans and made a strategic decision to focus on the European markets, where strong momentum and the approval of our effective daily dosing regimen in 13 EU countries present the best opportunities for growth.
For the full-year 2024, Terclara® achieved a market share in Sweden of 31% in value and 25% in units in pharmacy sales to end consumers, despite consumer marketing only beginning in April.1 Notably, Q4 figures reached 33% in value and 26% in units – remarkable growth within a limited time period.
Refined Strategy Following Phase 3 Study Results
In December, the topline data from the North American Phase 3 study for MOB-015 were published. In line with previous announcements, it was confirmed that the primary endpoint was not met with 8 weeks of daily dosing followed by weekly maintenance dosing. Mycological cure (fungus-free) was lower than observed in previous studies. The North American study reduced the dosage compared to the company's commercial product with daily dosage throughout the treatment period. EU approval is based on previous studies and is not impacted by the new study results.
As predicted, the lower dosage reduced discoloration of the nails2 , but it also resulted in a lower mycological cure rate. Our analysis is that 8 weeks of daily dosing did not deliver sufficient terbinafine into the nail to kill the fungus before switching to weekly maintenance treatment. Our hypothesis has not changed, that there is a trade-off between delivering enough terbinafine and avoiding overhydration/white discoloring of the nails. While overhydration is temporary, it makes it difficult to assess the clinical cure in a clinical study. One possible solution to the problem is an additional study with a longer follow-up and/or a different combination of daily treatment and maintenance treatment, with the potential to generate stronger efficacy data.
Our view is that additional clinical data needs to be generated before we can apply for approval in the U.S. This means a delay of the expected U.S. launch, and the company's board of directors has decided therefore to recognize an intangible asset impairment. Moberg Pharma has a long-term ambition to implement an additional clinical study in the U.S. to secure FDA approval, strengthen global marketing claims, and support our ongoing patent application. In the near term, the company's priority is firmly on the European markets, where MOB-015 is already approved. By showcasing the product's market-leading potential through successful EU launches, we are building a strong foundation for growth before considering a new study in the U.S. or investing in marketing outside of Europe.
Strategic Realignment and Partnership Changes
We mutually agreed with Bayer to terminate our partnership, due to strategic considerations and the study results. This means that we regained full rights to MOB-015 in Europe while maintaining previous milestone payments from Bayer. Our partnership in the Republic of Korea has concluded as well. Due to the highly competitive and structurally unique nature of the Korean market—where Jublia (efinaconazole) has gone generic, OTC and Rx channels are blurred, and pricing and reimbursement dynamics are unfavorable—we have decided not to pursue further collaboration in Korea at this time as it does not set us up for success. These changes gives us an opportunity to manage our activities and investments in Europe and Asia according to our priorities and the company's long-term strategy for value creation.
As a first step, we have decided to take a more active role in commercialization, establishing a stronger direct presence in the EU, including ownership of the trademark, to enhance margins. Discussions with potential partners in Europe are underway to support this strategy, and I look forward to sharing updates as plans take shape.
1 Source: IQVIA MIDAS, Pharmacy Sell-Out data, January - December 2024
2 In previous phase 3 studies, whitish nails were noted after 12 weeks daily treatment in ~70% of patients, with the new dosing less than 50% of patients seemed affected by whitish nails at 12 weeks
We intend to use a commercialization model similar to the one we previously successfully implemented in the U.S. by positioning Terclara as a premium brand complemented by additional products through acquisitions. Historically, we have been successful in identifying, acquiring, and developing smaller brands from larger companies, which has created economies of scale and valuable brand equity.
Expanding Momentum Across Europe
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A new terbinafine supplier was secured during the quarter, which means that terbinafine availability is no longer a limiting factor for our launch plans, enabling us to plan further expansion with confidence.
In February 2025, we proudly announced the launch of Terclara® in Norway – a significant step in our European expansion strategy. Initial deliveries have been made to Norwegian pharmacies with pharmacy and healthcare staff education and targeted consumer marketing planned in the lead-up to high season. We see great potential for Terclara® to become established as the market leader in Norway as well, building on our remarkable success in Sweden.
With approval in 13 EU markets, we are on track for additional rollouts in 2026, fueled by the success of the Swedish launch. Terclara® not only emerged as the market leader in Sweden but also expanded the total market, demonstrating the strength of our marketing message. In two large phase 3 studies, 76% of patients became fungus-free - world-leading outcomes that far surpass any other topical treatment. The success validates our strategy and provides a strong foundation as we expand into new markets and continue driving growth in Europe.
We remain energized and optimistic about the future, as Moberg Pharma continues to set new benchmarks for innovation, performance and market leadership.
Anna Ljung, CEO Moberg Pharma
ABOUT MOBERG PHARMA AND MOB-015
Moberg Pharma is committed to establishing MOB-015 as the world's leading treatment for nail fungus while building a specialty pharmaceutical company with direct sales in select European markets and strategic partnerships in other key regions. With MOB-015 as its core, the company plans to expand its portfolio with complementary products in adjacent therapeutic areas.
MOB-015 represents the next generation of onychomycosis (nail fungus) treatments. Phase 3 clinical trials, involving over 800 patients, have demonstrated a remarkable antifungal effect, positioning the product as a future market leader. Moberg Pharma has secured licensing agreements in Scandinavia, Canada and Israel, and the product has received regulatory approval in 13 European countries. The global annual sales potential for MOB-015 is estimated at USD 250–500 million.
| MOB-015 (Terclara® in Sweden) |
|---|
| World-leading anti-fungal effect · 76% mycological cure in Phase 3 · Topical terbinafine for treatment of nail fungus · Negligible systemic levels of terbinafine |
| Potential to be the global market leader · Partners in Scandinavia, Canada and Israel · Estimated global sales potential USD 250-500 million · Terclara® is now available in Swedish and Norwegian pharmacies, additional European rollout to follow 2026 · Nail fungus affects 10%, more common among older people |
| Market leader in Sweden under brand name Terclara® · National marketing authorization approvals received in 13 European countries, whereof 7 granted OTC status ® Launch ongoing in Sweden and Norway under brand name Terclara® · Phase 3 studies completed in North America, n=365, and Europe, n=452. Primary endpoints reached without serious side effects |
| 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 |
ADDRESSING A SIGNIFICANT MEDICAL NEED: OVER 100 MILLION PATIENTS IN THE EU AND U.S. SUFFER FROM NAIL FUNGUS
Nail fungus affects one in ten people worldwide, yet there currently aren't any good treatment alternatives available. Oral terbinafine, the most effective treatment, is associated with the risk of liver damage and interactions with other drugs. Dermatologists globally recognize the need for better topical treatments without the risk of systemic side effects. In a U.S. survey, 72% of responding physicians avoid prescribing oral terbinafine due to patient concerns about side effects, while 62% would prefer a product with MOB-015's intended target profile over other existing topical treatments. Only 6-15% of responding physicians would continue to prescribe current topical treatments.3
3 Survey of 89 U.S. physicians (dermatologists and podiatrists), LifeSci Physician Survey, April 4, 2017
RESULTS FROM TWO PHASE 3 STUDIES SHOW THAT MOB-015 HAS UNIQUE ANTIFUNGAL EFFECT
In December 2019, results from the North American study, the first of two Phase 3 clinical studies for MOB-015 were presented, followed by the results of the European study in June 2020. Both studies met their primary endpoint. The North American study included 365 patients, showing superiority versus vehicle. The European Phase 3 study included 452 onychomycosis patients, showing noninferiority versus topical ciclopirox. Mycological cure (eradication of fungal infection) was achieved in 76% of patients (70% of the patients in the North American study and 84% of the patients in the European study), far exceeding the 30-54%4 rates of other existing topical treatments. Furthermore, the onset of the antifungal effect is rapid, with MOB-015 delivering 55–78% mycological cure at six months and 37–46% as early as three months.
The company also conducted a North American study with a reduced dosage5 compared to the commercial product with daily dosage throughout the treatment period. The analysis concluded that the daily treatment period did not deliver sufficient terbinafine to kill the fungus before transitioning to weekly maintenance treatment.
MOB-015 is the first topical treatment to achieve a mycological cure rate at the same level as oral terbinafine - the current gold standard for onychomycosis treatment. Before the completion of the clinical Phase 3 studies, it was considered unrealistic for a topical treatment to reach a 70% mycological cure rate. Furthermore, compared to what has been reported for oral terbinafine, MOB-15's pharmacological profile is highly favorable: 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 – ideal characteristics for an effective tropical treatment without systemic exposure.
MARKET APPROVAL IN THE EU
In March 2022, Moberg Pharma submitted the registration application for MOB-015 in Europe through the Decentralized Procedure. Following a positive outcome in June 2023, MOB-015 was recommended for national approval in 13 European countries for the treatment of mild to moderate fungal nail infections in adults. All national approvals have now been received with the last country approving the product in May 2024.
The following EU countries are included: Austria (OTC), Belgium (OTC), Czech Republic (Rx), Denmark (Rx), Finland (Rx), France (Rx), Hungary (OTC), Ireland (Rx), Italy (OTC), Netherlands (OTC), Norway (OTC), Spain (Rx) and Sweden (OTC).
ROLLOUT PROGRESS AND MARKET TRACTION
Since February 2024, MOB-015 is available in Swedish pharmacies under the brand name Terclara®. Within its first month of consumer marketing, the product achieved a market-leading position, which it has maintained to this day. Terclara® was awarded "Best launch of 2024" at both Kronan pharmacy's and Doz pharmacy's supplier meetings. In February 2025, the company announced that the launch of Terclara® has also begun in Norway. This launch marks an important step in the company's European expansion strategy and builds on the success in Sweden. These early launches in Sweden and Norway enables Moberg Pharma to gain valuable insights into consumer behavior, and provide user data supporting direct sales without a prescription or conversion to OTC status in more countries. The Norwegian commercialization strategy and launch is, as in Sweden, being executed in collaboration with the company's partner Allderma, managed by the commercial leaders responsible for the successful Nordic launch of Nalox® - Moberg Pharma's first-generation nail fungus product.
In 2024, Moberg Pharma qualified a new terbinafine manufacturer with an authorized EU Certificate of Suitability (CEP), which means that terbinafine availability is no longer a limiting factor for the company's launch plans. Moberg Pharma aims to increase its influence over the value chain in Europe by establishing a stronger direct presence, including ownership of the trademark. To implement this strategy, Moberg Pharma is holding discussions with potential partners in Europe to identify an optimal way forward where MOB-015 reaches patients and where the company takes an active role in the commercialization, allowing for greater control over branding, distribution and profitability, ahead of the pan-European rollout.
4 Source: U.S. prescribing information for each drug
5 8 weeks of daily treatment followed by weekly maintenance treatment
Currently, three commercial partnership agreements are in place for MOB-015: Cipher Pharmaceuticals (Canada), Allderma (Scandinavia) and Padagis (Israel). The agreements grant exclusive marketing and sales rights to MOB-015 to each partner, in each respective market, while Moberg Pharma is responsible for production and supply. Under the framework of these agreements Moberg Pharma can receive milestone payments upon successful development and commercialization, in addition to royalties and compensation for delivered products.
In December 2024, Moberg Pharma and Bayer mutually agreed to conclude their partnership due to strategic considerations and the study results. As a result, Moberg Pharma has regained full European rights to MOB-015 while maintaining previous milestone payments from Bayer. This transition allows the company greater control over the commercialization strategy, higher returns on direct investments, and enable a more direct presence in Europe which will enhance margins and profitability.
We intend to use a commercialization model similar to the one we previously successfully implemented in the U.S. by positioning Terclara as a premium brand complemented by an expanded portfolio through targeted acquisitions. The company has a successful precedence of identifying, acquiring, and developing smaller brands from larger companies, generating economies of scale and strengthening valuable brand equity. By leveraging this expertise, Moberg Pharma aims to enhance its market position and drive long-term growth.
THE LONG TERM U.S. OBJECTIVE REMAINS
The U.S remains a key strategic objective, but Moberg Pharma's view is that additional clinical data needs to be generated before applying for FDA approval, leading to an extended timeline for the expected U.S. launch. Moberg Pharma's long-term ambition is to conduct an additional clinical study in the U.S. to secure FDA approval, strengthen the product's clinical evidence, reinforce global marketing claims, and support the company's ongoing patent application. In the near term, the company's priority is firmly on the European markets, where MOB-015 is already approved. Moberg Pharma intend to showcase the product's market-leading potential through successful EU launches before considering a new study in the U.S. or investing in marketing outside of Europe.
PROVEN MODEL FOR SUCCESS
Moberg Pharma successfully commercialized its first-generation nail fungus product – Kerasal Nail® – building an OTC business with an annual revenue of SEK 440 million and sales in more than 30,000 sales locations, including major U.S. chains CVS, Walgreens and Walmart. In 2019, this OTC business was successfully divested for SEK 1.4 billion.
The company now aims to repeat this success by leveraging a strong clinical foundation, a proven commercial track record, and a clear strategic roadmap to establish MOB-015 as a market leader in onychomycosis treatment.
COMPANY EVENTS
The Annual General Meeting on May 14, 2024 elected Jonas Ekblom to the Board of Directors. Jonas Ekblom has worked for three decades in research and development of pharmaceuticals and medtech products. Jonas has held board and management positions in public and privately held life science companies in Sweden, Switzerland and the U.S. He has served as CEO of BOWS Pharmaceuticals SA, Pergamum AB and Promore Pharma AB. Today, Jonas is chairman of the board of CombiGene AB and Oblique Therapeutics AB, and is a board director of Emplicure AB and Ziccum AB.
In May, 832,213 class C shares were issued to fulfill the company's commitments under the long-term incentive program LTI 2024 resolved by the Annual General Meeting on May 14, 2024. The shares are intended to secure the commitments under the incentive program and are owned by Moberg Pharma. On June 24, the company announced that 17,776,856 warrants of series 2023:1 ("TO 2") were exercised for subscription of 17,776,856 ordinary shares for approximately SEK 320 million, corresponding to a subscription rate of approximately 98%. The exercise price for the warrants was set at 70% of the average volume-weighted trading price of the company's ordinary share on Nasdaq Stockholm during the period from May 20, 2024 to May 31, 2024. Thus, the subscription price was set at SEK 18.00 per share. Subscription and top guarantee commitments had been made, free of charge, with certain external professional investors in TO 2, and the Board of Directors resolved on June 24 on a directed issue of 863,333 ordinary shares for approximately SEK 16 million to the top guarantors to fulfil the top guarantee commitments. Through the exercise of TO 2 and the share issue, Moberg Pharma thus received approximately SEK 336 million before issue costs.
FINANCIAL OVERVIEW
REVENUES AND PROFIT
Fourth quarter (October - December 2024)
Terclara® continues to lead the market in Sweden, even during off season – the fourth quarter. Growth in the category is clearly tied to Terclara®. Net revenue for the quarter was SEK 1.0 million (0.0).
As a consequence of the topline date in the North American study announced on 10 December 10, the company's view is that additional clinical data needs to be generated before Moberg Pharma can apply for approval in the U.S. This means a delay of the expected U.S. launch, and the company has decided therefore to recognize an intangible asset impairment of SEK 300 million; see note 2. The largest expense items in the quarter consist of the impairment of development expenses within intangible assets of SEK 300 million (0), followed by business development and administration expenses of SEK 5.9 million (6.3) and selling expenses of SEK 1.0 million (1.2). Profit for the quarter was SEK -243.3 million (-6.4).
Full-year (January - December 2024)
Net revenue was SEK 9.8 million (0), of which product sales accounted for SEK 8.1 million and milestone payments for SEK 1.7 million. Operating profit for the year was SEK -324.8 million (-27.5), where the largest expense item other than the impairment of SEK 300 million was business development and administration expenses of SEK 21.8 million (21.6).
CASH FLOW
Fourth quarter (October - December 2024)
Cash flow from operating activities before changes in working capital was SEK -2.0 million (-5.6) and SEK 3.2 million (-7.3) after changes in working capital. Cash flow from investments was SEK -18.5 million (-33.2) and relates to capitalized expenses for MOB-015. Cash flow from financing activities was SEK -0.3 million (-0.4), which refers to repaid leasing liabilities.
The total change in cash and cash equivalents in the quarter was SEK -15.7 million (-40.9). Cash and cash equivalents amounted to SEK 293.3 million (60.6) at the end of the period.
Full-year (January - December 2024)
Cash flow from operating activities was SEK -16.5 million (-33.2). Cash flow from investments was SEK -73.6 million (-124.1). Cash flow from financing activities was SEK 322.8 million (92.3), of which an inflow of SEK 324 million from issuance linked to TO2. The total change in cash and cash equivalents during the year was SEK 232.7 million (-65.0).
INVESTMENTS
Investments in intangible assets relate to capitalized expenses for development work on MOB-015 of SEK 18.5 million (33.2) in the quarter.
| R&D expenses (costs and investments) | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
|---|---|---|---|---|
| (SEK thousand) | 2024 | 2023 | 2024 | 2023 |
| R&D expenses (in statement of comprehensive income) | -300,814 | -1,037 | -302,230 | -3,657 |
| Capitalized R&D investments | -18,526 | -33,215 | -73,553 | -124,116 |
| Depreciation/amortization booked to R&D expenses | 300,188 | 150 | 300,762 | 1,276 |
| Change in R&D investments (in statement of financial position) | 281,662 | -33,065 | 227,209 | -122,840 |
| Total R&D expenditure | -19,152 | -34,102 | -75,021 | -126,497 |
LIABILITIES
As at the balance sheet date, the Group has no interest-bearing liabilities (excluding leasing liabilities).
CHANGES IN EQUITY
SHAREHOLDER INFORMATION
The company's largest shareholders per December 31, 2024:
| Shareholder | Number of shares | % of votes and capital |
|---|---|---|
| IBKR Financial Services | 8,046,813 | 16.8% |
| Östersjöstiftelsen | 2,527,380 | 5.3% |
| Avanza Pension | 2,305,097 | 4.8% |
| SEB Life International Assurance | 1,481,022 | 3.1% |
| CBNY-Charles Schwab FBO Customer | 1,371,279 | 2.9% |
| CBNY-National Financial Services LL | 1,337,803 | 2.8% |
| Pershing Securities Limited | 1,200,000 | 2.5% |
| Moberg Pharma AB (publ) | 1,186,522 | 2.5% |
| Nordnet Pensionsforsakring AB | 1,053,996 | 2.2% |
| Swedbank Försäkring | 605,799 | 1.3% |
| Zachau, Styrbjorn | 500,000 | 1.0% |
| UBS AG London Branch, W8IMY | 400,000 | 0.8% |
| SAXO Bank A/S | 359,595 | 0.8% |
| Nordea Livförsäkring Sweden AB | 358,228 | 0.8% |
| Blom, Fredrik | 355,000 | 0.7% |
| Morgan Stanley & Co | 353,493 | 0.7% |
| Handelsbanken Liv Försäkringsaktiebolag | 309,171 | 0.7% |
| Chen, Chance | 306,275 | 0.6% |
| SEB Sweden Indexnara | 302,695 | 0.6% |
| Eriksson, Mats | 301,331 | 0.6% |
| TOTAL, 20 LARGEST SHAREHOLDERS | 24,661,499 | 51.5% |
| Other shareholders | 23,218,355 | 48.5% |
| TOTAL | 47,879,854 | 100.0% |
SHARES
The number of shares and votes increased by 18,609,069 in June 2024 and by 832,213 in July 2024 to a total of 47,879,854. The change was due to the exercise of warrants of series 2023:1 (TO 2), which increased the number of ordinary shares and votes by 17,776,856, and the long-term incentive program LTI 2024 resolved by the Annual General Meeting on May 14, 2024, which increased the number of ordinary shares and votes by 832,213. The directed issue to the investors, which included the top guarantee commitments in connection with TO 2, was registered in July and comprised 863,333 shares.
Share capital at the end of the period was SEK 47,879,854, where the total number of registered shares outstanding was 47,879,854 ordinary shares with a quotient value of SEK 1. Moberg Pharma holds 1,186,522 repurchased ordinary shares at the end of the quarter.
SHARE-BASED COMPENSATION PLANS
As at the reporting date, the number of outstanding instruments was 1,688,247 performance share units (which entitle holders to not more than 1,061,127 shares), with a maximum potential dilution of 2.2%. In the second quarter, the performance share rights program 2021:1 became vested for affected employees; 91,665 own shares have been allocated to employees after evaluating performance relative to the company-wide and individual targets set by the Board of Directors.
9
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 2023 Annual Report.
PARENT COMPANY
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 2024, operating profit was SEK -324.8 million (-27.5), while profit after financial items was SEK -320.5 million (-25.4). Profit after tax was SEK -255.1 million (-21.1). Cash and cash equivalents amounted to SEK 293.3 million (60.6) at the end of the period.
OTHER INFORMATION
ORGANIZATION
Per December 31, 2024, Moberg Pharma had 9 employees, of whom 78% were women. All were employees of the parent company.
RISK FACTORS
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 2023 Annual Report on page 32.
OUTLOOK
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 have now been received in all countries, with the last country approving the product in May 2024. Moberg Pharma has active license agreements with partners in Scandinavia, Canada and Israel and will continue to work closely with partners with local registration processes and commercialization.
The company has initiated the launch in Sweden and Norway under the brand name Terclara® and is already the market leader in Sweden. In 2024, Moberg Pharma qualified a new terbinafine manufacturer with an authorized EU Certificate of Suitability (CEP), which means that terbinafine availability is no longer a limiting factor for the company's launch plans.
The company aims to increase its influence over the value chain in Europe by establishing a stronger direct presence, including ownership of the trademark. To implement this strategy, Moberg Pharma is holding discussions with potential partners in Europe to identify an optimal way forward where MOB-015 reaches patients and where the company takes an active role in the commercialization ahead of the pan-European rollout.
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
|---|---|---|---|---|
| (SEK thousand) | 2024 | 2023 | 2024 | 2023 |
| Net revenue | 1,027 | - | 9,811 | - |
| Cost of goods sold | -1,165 | - | -3,496 | - |
| Gross profit | -138 | - | 6,315 | - |
| Selling expenses | -956 | -1,167 | -7,131 | -3,257 |
| Business development and administrative expenses | -5,854 | -6,288 | -21,841 | -21,603 |
| Research and development expenses | -300,814 | -1,037 | -302,230 | -3,657 |
| Other operating income | - | 257 | 57 | 1,054 |
| Other operating expenses | -369 | - | - | - |
| Operating profit (EBIT) | -308,131 | -8,235 | -324,830 | -27,463 |
| Interest income and similar items | 2,230 | 799 | 4,584 | 2,303 |
| Interest expenses and similar items | -53 | -52 | -228 | -260 |
| Profit after financial items from continuing operations (EBT) | -305,954 | -7,488 | -320,474 | -25,420 |
| Tax on profit for the period | 62,647 | 1,043 | 65,363 | 4,327 |
| PROFIT FOR THE PERIOD | -243,307 | -6,445 | -255,111 | -21,093 |
| TOTAL PROFIT FOR THE PERIOD | -243,307 | -6,445 | -255,111 | -21,093 |
| Profit for the period attributable to parent company shareholders | -243,307 | -6,445 | -255,111 | -21,093 |
| Total profit attributable to parent company shareholders | -243,307 | -6,445 | -255,111 | -21,093 |
| Basic earnings per share | -5.21 | -0.23 | -6.74 | -1.33 |
| Diluted earnings per share 6 | -5.21 | -0.23 | -6.74 | -1.33 |
| EBITDA FROM CONTINUING OPERATIONS | -7,800 | -7,975 | -23,511 | -25,364 |
| Depreciation/amortization | -300,331 | -260 | -301,319 | -2,099 |
| Operating profit (EBIT) | -308,131 | -8,235 | -324,830 | -27,463 |
6 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.
CONSOLIDATED STATEMENT OF FINANCIAL POSITION IN BRIEF
| (SEK thousand) | 2024-12-31 | 2023-12-31 |
|---|---|---|
| Assets | ||
| Intangible non-current assets7 | 305,773 | 532,220 |
| Tangible non-current assets | - | - |
| Right-of-use assets | 4,420 | 4,942 |
| Deferred tax asset | 95,783 | 28,077 |
| Total non-current assets | 405,976 | 565,239 |
| Inventories | 4,295 | 7,115 |
| Trade receivables and other receivables | 2,530 | 1,823 |
| Cash and cash equivalents | 293,289 | 60,555 |
| Total current assets | 300,114 | 69,493 |
| TOTAL ASSETS | 706,090 | 634,732 |
| Equity and liabilities | ||
| Equity attributable to parent company's shareholders | 686,820 | 610,725 |
| Total equity | 686,820 | 610,725 |
| Non-current leasing liabilities | 2,548 | 3,467 |
| Non-current non-interest-bearing liabilities | - | - |
| Total non-current liabilities | 2,548 | 3,467 |
| Current leasing liabilities | 1,595 | 1,270 |
| Current non-interest-bearing liabilities | 15,127 | 19,270 |
| Total current liabilities | 16,722 | 20,540 |
| TOTAL EQUITY AND LIABILITIES | 706,090 | 634,732 |
7Refers to capitalized development expenses, see note 2.
CONSOLIDATED STATEMENT OF CASH FLOWS IN BRIEF
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
|---|---|---|---|---|
| (SEK thousand) | 2024 | 2023 | 2024 | 2023 |
| Operating activities | ||||
| Operating profit before financial items | -308,131 | -8,235 | -324,830 | -27,463 |
| Financial items, received and paid | 4,353 | 1,788 | 4,356 | 2,006 |
| Taxes paid | - | - | - | - |
| Adjustments: | ||||
| Depreciation/amortization and capital gains | 300,331 | 260 | 301,319 | 2,099 |
| Employee share-based adjustments to equity 8 | 1,428 | 625 | 4,715 | 2,308 |
| Cash flow before changes in working capital | -2,019 | -5,562 | -14,440 | -21,050 |
| Change in working capital | ||||
| Increase (-)/Decrease (+) in inventories | 2,580 | -7,115 | 2,820 | -7,115 |
| Increase (-)/Decrease (+) in operating receivables | 438 | 778 | -707 | 424 |
| Increase (+)/Decrease (-) in operating liabilities | 2,173 | 4,551 | -4,143 | -5,464 |
| OPERATING CASH FLOW | 3,172 | -7,348 | -16,470 | -33,205 |
| Investing activities | ||||
| Net investments in intangible assets | -18,526 | -33,215 | -73,553 | -124,116 |
| CASH FLOW FROM INVESTING ACTIVITIES | -18,526 | -33,215 | -73,553 | -124,116 |
| Financing activities | ||||
| Repayment of leases | -320 | -118 | -1,390 | -2,425 |
| Issue of new shares less transaction costs | - | -268 | 324,147 | 94,751 |
| CASH FLOW FROM FINANCING ACTIVITIES | -320 | -386 | 322,757 | 92,326 |
| Change in cash and cash equivalents | -15,674 | -40,949 | 232,734 | -64,995 |
| Cash and cash equivalents at the beginning of period | 308,963 | 101,504 | 60,555 | 125,550 |
| Cash and cash equivalents at the end of period | 293,289 | 60,555 | 293,289 | 60,555 |
8 Note that revaluation of estimated costs for social security contributions for employee stock options is recognized in change in operating liabilities.
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
| (SEK thousand) | Share capital | Other capital contributions |
Accumulated profit/loss |
Total equity |
|---|---|---|---|---|
| January 1 – December 31, 2024 | ||||
| Opening balance, January 1, 2024 | 27,961 | 921,297 | -338,533 | 610,725 |
| Total profit | ||||
| Profit for the period | -255,111 | -255,111 | ||
| Transactions with shareholders | ||||
| New shares issued | 18,732 | 316,792 | 335,524 | |
| Transaction costs | -9,033 | -9,033 | ||
| Share-based incentive program | 4,715 | 4,715 | ||
| CLOSING BALANCE, DECEMBER 31, 2024 | 46,693 | 1,233,771 | -593,644 | 686,820 |
| (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 |
KEY RATIOS FOR THE GROUP
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
|---|---|---|---|---|
| (SEK thousand) | 2024 | 2023 | 2024 | 2023 |
| Net revenue | 1,027 | - | 9,811 | - |
| Gross margin % | -13% | - | 64% | - |
| EBITDA | -7,800 | -7,975 | -23,511 | -25,364 |
| Operating profit (EBIT) | -308,131 | -8,235 | -324,830 | -27,463 |
| Profit after tax | -243,307 | -6,445 | -255,111 | -21,093 |
| Cash and cash equivalents | 293,289 | 60,555 | 293,289 | 60,555 |
| Balance sheet total | 706,090 | 634,732 | 706,090 | 634,732 |
| Equity/assets ratio | 97% | 96% | 97% | 96% |
| Return on equity | -35% | -1% | -37% | -3% |
| Diluted earnings per share, SEK | -5.21 | -0.23 | -6.74 | -1.33 |
| Equity per share, SEK | 14.71 | 21.84 | 14.71 | 21.84 |
| Basic average number of shares | 46,693,322 | 27,961,478 | 37,847,729 | 15,871,799 |
| Diluted average number of shares | 47,754,449 | 47,610,579 | 38,908,856 | 35,520,899 |
| Number of shares at the end of the period | 46,693,322 | 27,961,478 | 46,693,322 | 27,961,478 |
| Share price on balance sheet date, SEK | 10.17 | 15.20 | 10.17 | 15.20 |
DEFINITIONS OF KEY RATIOS
Moberg Pharma presents certain financial performance measures in the interim report that are not defined in accordance with IFRS. In Moberg Pharma's opinion, these performance measures provide valuable additional information to investors and company management as they enable an evaluation of the company's performance. These financial performance measures 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 measures defined in accordance with IFRS.
| Gross margin | Gross profit as a percentage of net revenue |
|---|---|
| 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 |
PARENT COMPANY INCOME STATEMENT SUMMARY
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
|---|---|---|---|---|
| (SEK thousand) | 2024 | 2023 | 2024 | 2023 |
| Net revenue | 1,027 | - | 9,811 | - |
| Cost of goods sold | -1,165 | - | -3,496 | - |
| Gross profit | -138 | - | 6,315 | - |
| Selling expenses | -956 | -1,167 | -7,131 | -3,257 |
| Business development and administrative expenses | -5,854 | -6,288 | -21,841 | -21,603 |
| Research and development expenses | -300,814 | -1,037 | -302,230 | -3,657 |
| Other operating income | -369 | 257 | 57 | 1,054 |
| Other operating expenses | - | - | - | - |
| Operating profit | -308,131 | -8,235 | -324,830 | -27,463 |
| Interest income | 2,230 | 799 | 4,584 | 2,303 |
| Interest expenses | -53 | -52 | -228 | -260 |
| Profit after financial items | -305,954 | -7,488 | -320,474 | -25,420 |
| Tax on profit for the period | 62,647 | 1,043 | 65,363 | 4,327 |
| PROFIT | -243,307 | -6,445 | -255,111 | -21,093 |
PARENT COMPANY BALANCE SHEET SUMMARY
| (SEK thousand) | 2024-12-31 | 2023-12-31 |
|---|---|---|
| Assets | ||
| Intangible non-current assets | 305,773 | 532,220 |
| Tangible non-current assets | - | - |
| Right-of-use assets | 4,420 | 4,942 |
| Non-current financial assets | 100 | 100 |
| Deferred tax asset | 95,783 | 28,077 |
| Total non-current assets | 406,076 | 565,339 |
| Inventories | 4,295 | 7,115 |
| Trade receivables and other receivables | 2,530 | 1,823 |
| Cash and cash equivalents | 293,289 | 60,555 |
| Total current assets | 300,114 | 69,493 |
| TOTAL ASSETS | 706,190 | 634,832 |
| Equity and liabilities | ||
| Equity | 686,821 | 610,726 |
| Non-current leasing liabilities | 2,548 | 3,467 |
| Non-current non-interest-bearing liabilities | - | - |
| Total non-current liabilities | 2,548 | 3,467 |
| Liabilities to Group companies | 99 | 99 |
| Current leasing liabilities | 1,595 | 1,270 |
| Current non-interest-bearing liabilities | 15,127 | 19,270 |
| Total current liabilities | 16,821 | 20,639 |
| TOTAL EQUITY AND LIABILITIES | 706,190 | 634,832 |
PARENT COMPANY CASH FLOW STATEMENT SUMMARY
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
|---|---|---|---|---|
| (SEK thousand) | 2024 | 2023 | 2024 | 2023 |
| Operating activities | ||||
| Operating profit before financial items | -308,131 | -8,235 | -324,830 | -27,463 |
| Financial items, received and paid | 4,353 | 1,788 | 4,356 | 2,006 |
| Adjustments: | ||||
| Depreciation/amortization and capital gains | 300,331 | 260 | 301,319 | 2,099 |
| Expenses for share-based incentive program | 1,428 | 625 | 4,715 | 2,308 |
| Cash flow before changes in working capital | -2,019 | -5,562 | -14,440 | -21,050 |
| Change in working capital | ||||
| Increase (-)/Decrease (+) in inventories | 2,580 | -7,115 | 2,820 | -7,115 |
| Increase (-)/Decrease (+) in operating receivables | 438 | 778 | -707 | 424 |
| Increase (+)/Decrease (-) in operating liabilities | 2,173 | 4,551 | -4,143 | -5,464 |
| OPERATING CASH FLOW | 3,172 | -7,348 | -16,470 | -33,205 |
| Investing activities | ||||
| Net investments in intangible assets | -18,526 | -33,215 | -73,553 | -124,116 |
| CASH FLOW FROM INVESTING ACTIVITIES | -18,526 | -33,215 | -73,553 | -124,116 |
| Financing activities | ||||
| Repayment of leases | -320 | -118 | -1,390 | -2,425 |
| Issue of new shares less transaction costs | - | -268 | 324,147 | 94,751 |
| CASH FLOW FROM FINANCING ACTIVITIES | -320 | -386 | 322,757 | 92,326 |
| Change in cash and cash equivalents | -15,674 | -40,949 | 232,734 | -64,995 |
| Cash and cash equivalents at the beginning of the period | 308,963 | 101,504 | 60,555 | 125,550 |
| Cash and cash equivalents at the end of the period | 293,289 | 60,555 | 293,289 | 60,555 |
NOTE 1 ACCOUNTING POLICIES AND MEASUREMENT PRINCIPLES
The interim report was prepared in accordance with IAS 34 and the Swedish Annual Accounts Act. The consolidated financial statements were, like the annual accounts for 2023, 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 2023.
MOB-015 continues to develop. The product now has market approval in 13 countries and more approvals are expected. The launch in the European markets is expected primarily in 2026, linked to the securing of long-term terbinafine availability and launch preparations. The launch is beginning in Sweden and Norway. The development of MOB-015 is not complete, because of which amortization of development expenses has not begun.
NOTE 2 SPECIFICATION OF MAJOR INTANGIBLE NON-CURRENT ASSETS
| (SEK thousand) | 2024-12-31 | 2023-12-31 |
|---|---|---|
| Capitalized expenditure for MOB-015 | 305,773 | 532,220 |
| TOTAL CAPITALIZED EXPENDITURE FOR DEVELOPMENT WORK | 305,773 | 532,220 |
As a consequence of the topline date in the North American study announced on 10 December 10, the company's view is that additional clinical data needs to be generated before Moberg Pharma can apply for approval in the U.S. This means a delay of the expected U.S. launch, and the company has decided therefore to recognize an intangible asset impairment of SEK 300 million.
NOTE 3 SEGMENT REPORTING
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.
NOTE 4 RELATED PARTY TRANSACTIONS
No material changes have occurred in the nature and scope of transactions with related parties compared to disclosures in the Annual Report.
INFORMATION AND FINANCIAL CALENDAR
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 2025 May 13, 2025 Interim report for January–June 2025 August 12, 2025 Interim report for January–September 2025 November 11, 2025
The Annual General Meeting of Moberg Pharma will be held on May 22, 2025. The last date for shareholders to request to have a matter considered at the Annual General Meeting is April 3, 2025. The Annual Report will be available no later than April 18, 2025 on the company's website at www.mobergpharma.se
FOR FURTHER INFORMATION, PLEASE CONTACT
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.
DECLARATION
The undersigned hereby declare that the interim 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.
Stockholm, February 11, 2025
Kerstin Valinder Strinnholm Chairman
Jonas Ekblom Board member
Håkan Wallin Board member Anna Ljung CEO
Nikolaj Sörensen Board member