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Bactiguard Holding

Earnings Release Oct 24, 2024

3004_10-q_2024-10-24_d9a2e33e-58d2-4752-a31c-424efcd21778.pdf

Earnings Release

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INTERIM REPORT THIRD QUARTER 2024

Bactiguard delivers positive EBITDA and initiates review of 2028 financial targets due to previously announced agreement termination

Third quarter 2024 (July – September)

  • Total revenue amounted to SEK 73.9 (49.5) million, an increase of SEK 24.5 million corresponding to 49.4%.
  • Net sales amounted to SEK 67.3 (45.5) million, an increase of SEK 21.9 million corresponding to 48.1%. Adjusted for currency effects of SEK -4.2 million, net sales increased by 57.5%.
  • Operating loss amounted to SEK 1.9 (21.6) million.
  • EBITDA amounted to SEK 9.9 (-9.5) million.
  • Net loss for the period amounted to SEK 4.7 (24.6) million.
  • Loss per share, before and after dilution, amounted to SEK 0.13 (0.70).
  • Cash flow from operating activities amounted to SEK 8.3 (-35.0) million corresponding to SEK 0.24 (-1.00) per share.

The period January – September 2024

  • Total revenue amounted to SEK 193.6 (161.8) million, an increase of SEK 31.8 million corresponding to 19.6%.
  • Net sales amounted to SEK 178.6 (145.3) million, an increase of SEK 33.3 million corresponding to 22.9%. Adjusted for currency effects of SEK -1.2 million, net sales increased by 23.9%.
  • Operating loss amounted to SEK 25.7 (108.1) million.*
  • EBITDA amounted to SEK 9.6 (-71.8) million.*
  • Net loss for the period amounted to SEK 28.9 (111.2) million.*
  • Loss per share, before and after dilution, amounted to SEK 0.82 (3.17).
  • Cash flow from operating activities amounted to SEK 6.1 (-62.4) million corresponding to SEK 0.17 (-1.78) per share.

* The difference mainly pertained to the SEK 42 million provision for inventory, accounts receivables, and project related items, made in the second quarter 2023.

Key figures Jul-Sep Jan-Sep Full year RTM
2024 2023 2024 2023 2023 2023/24
Total revenue¹,MSEK 73.9 49.5 193.6 161.8 223.2 255.0
Operating profit/loss¹,MSEK -1.9 -21.6 -25.7 -108.1 -131.9 -49.4
EBITDA²,MSEK 9.9 -9.5 9.6 -71.8 -76.1 5.3
EBITDA margin²,% 13.4 -19.3 5.0 -44.4 -34.1 2.1
Net profit/loss for the period¹,MSEK -4.7 -24.6 -28.9 -111.2 -138.4 -56.1
Earnings per share¹,SEK -0.13 -0.70 -0.82 -3.17 -3.95 -1.60
Cash flow from operating activities ¹,MSEK 8.3 -35.0 6.1 -62.4 -52.3 16.2
Cash flow from operating activities, per share²,SEK 0.24 -1.00 0.17 -1.78 -1.49 0.46
Equity ratio²,% 48.6 54.8 48.6 54.8 53.3 48.6
Net debt²,MSEK 129.0 111.5 129.0 111.5 109.9 129.0

1 Defined according to IFRS.

2 Alternative performance measure. For definition and reconciliation, see pages 15-16.

CEO statement

Bactiguard delivers positive EBITDA and initiates review of 2028 financial targets due to previously announced agreement termination

Total revenue for Q3 amounted to SEK 73.9 million (Q3 2023: SEK 49.5 million), including net sales of SEK 67.3 million (Q3 2023: SEK 45.5 million), and EBITDA amounted to SEK 9.9 million (Q3 2023: SEK -9.5 million). OPEX totaled SEK 56.9 million for Q3 (Q3 2023: SEK 49.8 million) and the anticipated cost savings of SEK 25 million related to the strategic shift from 2023 are expected to be delivered on a full-year basis. Total cash flow for the quarter amounted to SEK 1.6 million (Q3 2023: SEK -38.7 million).

Solid growth in global BD partnership a main driver of EBITDA

Total license revenues amounted to SEK 47.5 million (Q3 2023: SEK 20.8 million) and were mainly driven by increased revenues from the BD partnership which amounted to SEK 33.3 million (Q3 2023: SEK 9.2 million). Our partnership now has a more global approach, where we work closely together on the expansion of Bactiguardcoated Foley catheters into both existing and new markets. The BD relationship demonstrates how the license focused strategy is proving itself. Our collaboration has shifted into a close partner cooperation where Bactiguard now engages with BD across the entire value chain, from technology through go-to-market. In short, BD's success is our success.

Revenues in the third quarter from the Zimmer Biomet partnership amounted to SEK 10.7 million (Q3 2023: SEK 11.6 million) and consisted of both license revenues from royalties and application development revenues. Notably, most of the Zimmer Biomet revenues are related to the continuing trauma agreement.

Our Wound Management portfolio had a strong third quarter with revenues of SEK 17.9 million (Q3 2023: SEK 17.5 million) and continues to grow profitably. Revenues from the BIP portfolio decreased and amounted to SEK 1.9 million (Q3 2023: SEK 7.1 million), which is in line with our expectations following the decision to discontinue our own product portfolio and transition the BIP Foley markets to BD.

With an EBITDA of SEK 9.9 million for the third quarter (Q3 2023: SEK -9.5 million), we have turned profitable on an EBITDA level both for the quarter and year-to-date. The profitability was delivered from a combination of increased license revenues and a disciplined approach to costs.

Termination of Zimmer Biomet multiple orthopedic products agreement, while trauma agreement remains in effect – review of 2028 financial targets initiated

The termination of the multiple orthopedic product segment agreement in early October was a disappointment, but the trauma agreement remains in effect. Zimmer Biomet informed us that they were not prepared to commit to a more complex and lengthier US FDA pathway than initially expected for the other orthopedic product segments. However, Zimmer Biomet are strong believers in the importance of infection prevention and in our technology. We continue working together in the trauma segment where the infection rate, and therefore medical need, is significantly higher compared to, for instance, reconstructive procedures. This collaboration includes, among other things, work with regulatory processes in Europe and the US. In addition, the commercialization activities for the ZNN Bactiguard trauma nail, especially in Europe, continues.

We are in close dialogue with Zimmer Biomet to evaluate further details and analyze the longer-term financial impact of the termination of the multiple orthopedic agreement. As a consequence, we have decided to review our 2028 financial targets, set in October 2023, and the outcome of the review will be announced during Q1 2025.

Outlook – exploring technology application across multiple therapeutic areas

13 September was World Sepsis Day. Nearly 50 million people contract sepsis when an infection goes astray, and more than 11 million die each year. These data points put the need for infection prevention into perspective and for Bactiguard, this drives home our mission to work with leading MedTech companies to enable differentiated medical devices to be brought to the market. We see an increased interest in our infection prevention technology, and we are actively exploring its application across multiple therapeutic areas. Our R&D team is currently working with potential MedTech partners in early-stage testing on different medical devices, surfaces, and materials to demonstrate the performance of our technology. When early-stage projects with potential partners convert into exclusivity and license partnerships, we will announce to the market accordingly.

A year has passed since Bactiguard embarked on the journey to a sharpened license focused strategy and we have been through a fundamental transformation, from being a medical device company to a licensing partnership and knowledge organization. We have reached EBITDA profitability for 2024 already in the third quarter serving as evidence that our strategy and business model are effective. Regardless, we remain humble about the complexities in creating strategic long-term partnerships with leading global MedTech companies. We will continue to work relentlessly on advancing our current partnerships as well as continue to strengthen the knowledge and specialist areas within the organization further. This will enable us to deliver future partnerships in therapeutic areas where there is a strong unmet medical need for infection prevention.

Christine Lind, CEO

Business model

Bactiguard is a global MedTech company developing safe and biocompatible technology to prevent medical device related infections. The company's unique technology is based on an ultra-thin noble metal coating that prevents bacterial adhesion and biofilm formation on medical devices.

Bactiguard's infection prevention solutions decrease patient suffering, save lives, and unburden healthcare resources while also fighting against antimicrobial resistance, one of the most serious threats to global health and modern medicine.

Bactiguard operates through license partnerships with leading global MedTech companies that apply the technology to their medical devices and sell them under their own brand or co-branded with Bactiguard. The company also has a portfolio of wound management products.

Three partnership phases

Bactiguard's revenues have two main components: firstly, charging license partners for the right to use our coating technology on their medical devices within a specific application and geographical area, and secondly, royalties; a variable remuneration once the license partners' products reach the market. Bactiguard's business model is scalable and has a high-margin potential. The revenues are generated across three phases of partnerships: application development partners, exclusivity partners and license partners.

An application development partner participates in a development project where we test the coating technology to different medical devices, surfaces, and materials. Bactiguard's coating development team works in close collaboration with the partner. Some application development projects will not materialize, and this is a natural part of our business.

An exclusivity partner gets an exclusive right to apply our coating technology to a certain medical device but has no products in the market yet, for instance due to pending regulatory approvals.

A license partner has the right to market and sell medical devices with Bactiguard's coating technology, in a certain region or globally. Most of our revenues are generated through partnerships at this phase. BD and Zimmer Biomet (their trauma implant ZNN Bactiguard) are examples of license partners.

Not all partnerships will follow all three phases. An agreement with a partner can generate revenues from different phases and streams simultaneously.

Partnerships Application area Market*
Becton Dickinson & Company (BD) Urinary catheters (Foley) Global excl. China
Zimmer Biomet Trauma implants Global excl. Southeast Asia, China,
India, and South Korea
Zimmer Biomet** Orthopedic implants Global excl. Southeast Asia, China,
India, and South Korea.
Well Lead Medical Urinary catheters China

*Black: With approved products on these markets, Green = rights.

** Zimmer Biomet informed Bactiguard in October 2024 that they terminate the agreement for multiple orthopedic product segments.

Development in the third quarter

Revenue

Jul-Sep
MSEK 2024 2023
Total license revenue 47.5 20.8
License partners 46.6 18.0
Exclusivity partners - 2.7
Application development partners 0.9 0.2
Wound Management portfolio 17.9 17.5
BIP portfolio 1.9 7.1
Net sales 67.3 45.5
Other operating revenues 6.6 4.0
Total revenue 73.9 49.5

Total revenue for the third quarter amounted to SEK 73.9 (49.5) million, an increase of SEK 24.4 million, corresponding to 49.4 percent. Adjusted for currency effects of SEK 0.4 million, revenue increased by 48.7 percent.

Net sales amounted to SEK 67.3 (45.5) million, an increase of SEK 21.9 million, corresponding to 48.1 percent. Adjusted for currency effects of SEK -4.2 million, net sales increased by 57.5 percent.

Total license revenue amounted to SEK 47.5 (20.8) million, an increase of SEK 26.7 million, corresponding to 128.3 percent. Adjusted for currency effects of SEK -4.2 million, license revenues increased by 148.7 percent. Revenues from Becton Dickinson & Company (BD) amounted to SEK 33.3 (9.2) million, an increase of SEK 24.1 million, corresponding to 262.3 percent. Adjusted for currency effects of SEK 0.2 million, revenues from BD increased by 265.5 percent. The increase pertained to the stock adjustments made by BD during Q2 and Q3 last year. Revenues from Zimmer Biomet amounted to SEK 10.7 (11.6) million, a decrease of SEK 0.9 million, corresponding to 7.8 percent. Adjusted for currency effects of SEK -0.6 million, revenues from Zimmer Biomet decreased by 2.7 percent. These revenues consist of license revenues from royalties, incl. minimum royalties, and application development revenues. Notably, most of the Zimmer Biomet revenues are related to the continuing trauma agreement.

Revenues from license partners amounted to SEK 46.6 (18.0) million, an increase of SEK 28.7 million, corresponding to 159.7 percent. Adjusted for currency effects of SEK -4.3 million, revenues from license partners increased by 183.4 percent.

Revenues from exclusivity partners amounted to SEK 0.0 (2.7) million, a decrease of SEK 2.7 million.

Revenues from application development partners amounted to SEK 0.9 (0.2) million, an increase of SEK 0.7 million.

Revenues from Wound Management portfolio amounted to SEK 17.9 (17.5) million, an increase of SEK 0.4 million, corresponding to 2.2 percent with and without currency effects.

Revenues from the BIP portfolio amounted to SEK 1.9 (7.1) million, a decrease of SEK 5.2 million, corresponding to 72.9 percent with and without currency effects. The BIP portfolio revenue will continue to decrease as our inventory depletes and we cease production.

Other revenues amounted to SEK 6.6 (4.0) million, an increase of SEK 2.6 million, corresponding to 64.1 percent. Currency effects amounted to SEK 4.6 (2.0) million and the remaining revenue primarily relates to rent income.

Result

Costs for raw materials and consumables for the third quarter amounted to SEK -6.9 (-10.5) million, a decrease of SEK 3.7 million, corresponding to 34.7 percent. Other external costs amounted to SEK -27.8 (-21.6) million, an increase of SEK 6.3 million, corresponding to 29.1 percent. The increase mainly pertained to external costs to consulting, regulatory and legal services. Personnel costs amounted to SEK -24.9 (-25.0) million, a decrease of SEK 0.1 million, corresponding to 0.3 percent. Other operating expenses are related to currency exchange losses/gains, which amounted to SEK -4.1 (-3.2) million. Total operating expenses (OPEX) amounted to SEK -56.9 (-49.8) million, an increase of SEK 7.1 million, corresponding to 14.2 percent.

The operating loss amounted to SEK 1.9 (21.6) million, a decrease of SEK 19.6 million, corresponding to 91.0 percent. The improved operating result mainly pertained to the increase in total license revenues while keeping costs under control.

EBITDA for the third quarter amounted to SEK 9.9 (-9.5) million, an increase of SEK 19.4 million. The EBITDA margin was 13.4 (-19.3) percent.

Depreciation and amortisation amounted to SEK -11.8 (-12.1) million, a decrease of SEK 0.2 million, corresponding to 2.0 percent. Amortization of intangible assets amounted to SEK -7.0 (-8.2) million, attributable primarily to amortization of SEK -6.4 (-6.4) million related to Bactiguard's technology. Depreciation of fixed assets amounted to SEK -4.8 (-3.8) million, primarily attributable to depreciation on leasing of SEK -3.7 (-2.8) million.

Financial items amounted to SEK -4.2 (-4.4) million. Financial income amounted to SEK -0.4 (2.2) million which pertained mainly to exchange rate effects. Financial expenses amounted to SEK -3.8 (-6.6) million which mainly pertained to interest expenses of SEK -3.5 (-3.9) million.

Tax for the period amounted to SEK 1.5 (1.4) million. Change in deferred tax amounted to SEK 1.5 (1.4) million attributable to the intangible assets and leases, which is calculated at the Swedish tax rate of 20.6 percent. Income tax in foreign subsidiaries is calculated on the basis of a tax rate of 24.0 percent.

Net loss for the third quarter of 2024 amounted to SEK 4.7 (24.6) million.

Development during the period January - September

Revenue

Jan-Sep Full year RTM
MSEK 2024 2023 2023 2023/24
Total license revenue 120.5 85.0 117.2 152.6
License partners 114.2 74.8 104.3 143.7
Exclusivity partners 5.3 7.1 9.7 7.9
Application development partners 1.0 3.2 3.2 1.0
Wound Management portfolio 45.3 39.9 53.8 59.2
BIP portfolio 12.8 20.4 30.5 23.0
Net sales 178.6 145.3 201.5 234.9
Other operating revenues 15.0 16.5 21.6 20.1
Total revenue 193.6 161.8 223.2 255.0

Total revenue for the period January to September amounted to SEK 193.6 (161.8) million, an increase of SEK 31.8 million, corresponding to 19.6 percent. Adjusted for currency effects of SEK 7.6 million, revenue increased by 15.0 percent.

Net sales amounted to SEK 178.6 (145.3) million, an increase of SEK 33.3 million, corresponding to 22.9 percent. Adjusted for currency effects of SEK -1.2 million, net sales increased by 23.9 percent.

Total license revenue amounted to SEK 120.5 (85.0) million, an increase of SEK 35.4 million, corresponding to 41.7 percent. Adjusted for currency effects of SEK -1.0 million, license revenues increased by 43.0 percent. Revenues from Becton Dickinson & Company (BD) amounted to SEK 88.9 (64.0) million, an increase of SEK 24.9 million, corresponding to 38.9 percent. Adjusted for currency effects of SEK -4.0 million, revenues from BD increased by 45.3 percent. Revenues from Zimmer Biomet amounted to SEK 24.1 (18.4) million, an increase of SEK 5.7 million, corresponding to 31.2 percent. Adjusted for currency effects of SEK -0.7 million, revenues from Zimmer Biomet increased by 34.7 percent. These revenues consist of license revenues from royalties, exclusivity revenues and application development revenues.

Revenues from license partners amounted to SEK 114.2 (74.8) million, an increase of SEK 39.4 million, corresponding to 52.7 percent. Adjusted for currency effects of SEK -1.0 million, revenues from license partners increased by 54.1 percent.

Revenues from exclusivity partners amounted to SEK 5.3 (7.1) million, a decrease of SEK 1.8 million, corresponding to 25.5 percent. Adjusted for currency effects of SEK -0.1 million, revenues from exclusivity partners decreased by 24.8 percent.

Revenues from application development partners amounted to SEK 1.0 (3.2) million, a decrease of SEK 2.2 million, corresponding to 68.5 percent with and without currency effects.

Revenues from Wound Management portfolio amounted to SEK 45.3 (39.9) million, an increase of SEK 5.4 million, corresponding to 13.6 percent with and without currency effects.

Revenues from the BIP portfolio amounted to SEK 12.8 (20.4) million, a decrease of SEK 7.5 million, corresponding to 37.0 percent with and without currency effect. The BIP portfolio revenue will continue to decrease as our inventory depletes and we cease production.

Other revenues amounted to SEK 15.0 (16.5) million, a decrease of SEK 1.5 million, corresponding to 9.2 percent. Currency effects amounted to SEK 8.8 (9.6) million and the remaining revenue primarily relates to rent income.

Result

Costs for raw materials and consumables for the period January to September amounted to SEK -30.2 (-49.8) million, a decrease of SEK 19.6 million, corresponding to 39.4 percent. Other external costs amounted to SEK -65.9 (-75.9) million, a decrease of SEK 13.2 million, corresponding to 10.0 percent. Personnel costs amounted to SEK -81.5 (-98.4) million, a decrease of SEK 16.9 million, corresponding to 17.2 percent. Other operating expenses are related to currency exchange losses/gains, which amounted to SEK -6.2 (-10.8) million. In total operating expenses (OPEX) amounted to SEK -153.5 (-185.1) million, a decrease of SEK 31.6 million, corresponding to 17.1 percent.

The operating loss amounted to SEK 25.7 (108.1) million, a decrease of SEK 82.5 million, corresponding to 76.3 percent. The decrease mainly pertained to the SEK 42 million provision made in the second quarter 2023, and the increase in total license revenues, as well as decrease in total operating expenses (OPEX).

EBITDA for the period January to September amounted to SEK 9.6 (-71.8) million, an increase of SEK 81.4 million. EBITDA margin was 5.0 (-44.4) percent.

Depreciation and amortisation amounted to SEK -35.2 (-36.3) million, a decrease of SEK 1.1 million, corresponding to 3.0 percent. Amortization of intangible assets amounted to SEK -21.3 (-24.9) million, attributable primarily to amortization of SEK -19.1 (-19.1) million related to Bactiguard's technology. Depreciation of fixed assets amounted to SEK -14.0 (-11.4) million, primarily attributable to depreciation on leasing of SEK -10.9 (-8.5) million.

Financial items amounted to SEK -8.6 (-8.0) million. Financial income amounted to SEK 3.7 (9.9) million which pertained mainly to exchange rate effects. Financial expenses amounted to SEK -12.3 (-17.9) million which mainly pertained to interest expenses of SEK -10.8 (-9.9) million.

Tax for the period amounted to SEK 5.3 (5.0) million. Change in deferred tax amounted to SEK 5.3 (4.8) million attributable to the intangible assets and leases, which is calculated at the Swedish tax rate of 20.6 percent. Income tax in foreign subsidiaries is calculated on the basis of a tax rate of 24.0 percent.

Net loss for the period January to September 2024 amounted to SEK 28.9 (111.2) million.

Cash flow

Cash flow from operating activities for the quarter amounted to SEK 8.3 (-35.0) million and for the period January to September to SEK 6.1 (-62.4) million. Change in working capital for the quarter amounted to SEK -6.0 (-18.1) million and for the period January to September to SEK 4.9 (5.4) million. Cash flow from investing activities for the quarter amounted to SEK -2.9 (-0.7) million and for the period January to September to SEK -13.1 (-2.6) million. Cash flow from financing activities for the quarter amounted to SEK -3.9 (-3.0) million and for the period January to September to -13.6 (-8.0). Cash flow for the quarter amounted to SEK 1.6 (-38.7) million and for the period January to September to SEK -20.5 (-73.0) million. Cash and cash equivalents at the end of the period of 30 September 2024 amounted to SEK 106.4 (124.4) million.

Financial position

Equity on 30 September 2024 amounted to SEK 328 (384) million and net debt to SEK 129 (112) million. Total assets on 30 September 2024 amounted to SEK 676 (700) million.

As of 30 September 2024, the parent company's liabilities with SEB amounted to SEK 171 (171) million. As of 30 September 2024, the approved overdraft facility from SEB of SEK 30 million was not utilized. As of 30 September 2024, foreign subsidiaries had debts with credit institutions amounting to SEK 3.6 (9.2) million.

The parent company has a bank loan of SEK 171 million with a term until May 2025. Discussions are currently ongoing with SEB with the aim of extending this loan during Q1 2025. To manage the liquidity risk, the parent company has a shareholder-issued liquidity guarantee until June 2026, which was signed on October 18, 2024. This guarantee means that the shareholder undertakes to repay the loan to SEB (including the remaining overdraft facility if it has been utilised), in case the company is unable to repay it when it matures in May 2025 in exchange for the shareholder issuing a loan with similar terms. The Board of Directors assesses that there is no material risk of a liquidity shortage for the next 12-month period.

Employees

Full-time equivalents in the Group during the period January to September averaged to 182 (219) of which 111 (134) are women. On 30 September 2024, the number of full-time equivalents was 163.

The share and share capital

Bactiguard's B share is listed on Nasdaq Stockholm with the short name "BACTI B". The closing price for the B share was SEK 55.6 (64.9) on 30 September 2024 and the market capitalization amounted to SEK 1,948 (2,274) million.

The share capital in Bactiguard on 30 September 2024 amounted to SEK 0.9 (0.9) million divided into 31,043,885 Class B shares with one vote each (31,043,885 votes) and 4,000,000 Class A shares with ten votes each (40,000,000 votes). The total number of shares and votes in Bactiguard on 30 September 2024 was 35,043,885 shares and 71,043,885 votes.

Ownership

Shareholders No. of A
shares
No. of B shares Total number % of capital % of votes
TomBact AB¹ 2,000,000 4,443,787 6,443,787 18.4 34.4
GIDL Invest AB² 2,000,000 4,179,326 6,179,326 17.6 34.0
Jan Ståhlberg 3,605,150 3,605,150 10.3 5.1
Nordea Funds 3,524,877 3,524,877 10.1 5.0
The Fourth Swedish National Pension Fund 3,475,992 3,475,992 9.9 4.9
Handelsbanken Fonder 2,080,726 2,080,726 5.9 2.9
TomEnterprise Public Capital AB¹ 1,885,384 1,885,384 5.4 2.7
AMF - försäkring och fonder 1,706,340 1,706,340 4.9 2.4
Insurance company Avanza Pension 1,246,737 1,246,737 3.6 1.8
Lancelot Asset Management AB 465,000 465,000 1.3 0.7
Total, major shareholders 4,000,000 26,613,319 30,613,319 87.4 93.7
Total, others 4,430,566 4,430,566 12.6 6.3
Total number of shares 4,000,000 31,043,885 35,043,885 100.0 100.0

1 Company controlled by Thomas von Koch.

2 Company controlled by Christian Kinch.

Per 30 September 2024 Bactiguard had 3,061 (3,627) shareholders.

Key events

Key events during the quarter

No events during the quarter.

Key events after the end of the quarter

Zimmer Biomet has informed Bactiguard that they terminate the license agreement signed in 2022 covering multiple orthopedic product segments. The reason stated is the more complex and lengthier path with the US Food and Drug Administration (FDA) than initially expected by Zimmer Biomet. The partnership with Zimmer Biomet within the trauma product segment, related to the agreement signed in 2019, remains in effect.

Financial targets

The company's financial targets relate to growth and profitability and are expected to be delivered by year-end 2028. The financial and strategic targets should not be perceived as a forecast but rather reflect what

Bactiguard's Board of Directors and Executive Management consider to be reasonable mid-term expectations given the sharpened license focused strategy.

Due to the termination of the multiple orthopedic agreement by Zimmer Biomet, we have decided to review our 2028 financial targets, set in October 2023, and the outcome of the review will be announced during Q1 2025.

Other information

Accounting and valuation principles

The consolidated financial statements are prepared in accordance with the International Financial Reporting Standards (IFRS). The interim report has been prepared in accordance with IAS 34 Interim Reporting and the Annual Accounts Act. Disclosures in accordance with IAS 34 Interim Reporting are submitted both in notes and elsewhere in the interim report. The parent company's financial statements have been prepared in accordance with the Annual Accounts Act and the Financial Reporting Board's recommendation, RFR 2 Accounting for Legal Entities.

Accounting and valuation principles are stated in the annual report 2023. The accounting principles are unchanged from previous periods, except for a new assessment model of clients' risk classification, where more clients are assessed individually as a consequence of the change.

Segment reporting

An operating segment is a component of an entity that engages in business activities from which it may derive revenues and incur expenses, whose operating results are regularly reviewed by the chief operating decision maker and for which there is separate financial information. The company's reporting of operating segments is consistent with the internal reporting provided to the chief operating decision maker. The chief operating decision maker is the function that assesses the operating segment performance and decides how to allocate resources. The company has determined that the Group's executive management constitutes of the chief operating decision maker. The company is considered in its entirety to operate within one business segment.

Parent company

During the period, the parent company has received compensation for services and interest on its receivables from group companies. No investments were made during the period.

Risk factors

Companies within the Group are exposed to various types of risk through their activities. Bactiguard continually engages in a process of identifying all risks that may arise and assessing how each of these risks shall be managed. The Group is working to create an overall risk management program that focuses on minimizing potential adverse effects on the company's financial results. The company is primarily exposed to market related risks, operational risks, and financial risks. A description of these risks can be found on page 16 and 45–47 in the annual report 2023. In addition to the liquidity and financing risk stated, the parent company has a credit facility with SEB with a term until May 2025, which is set to be extended during Q1 2025. In addition, the parent company has a shareholder-issued Liquidity Guarantee until June 2026.

The geopolitical situation and macro trends

In addition to identified risks, the macro situation and its impact is continuously monitored. The global healthcare challenges have a significant impact on society. The need for more efficient and safe healthcare is driven by both economic and demographic developments, as well as increased political unrest, conflicts, wars, and natural disasters. Particularly prominent are healthcare-associated infections and antimicrobial resistance where we see an increased interest in infection prevention.

Bactiguard does not have suppliers in or sales to any of Russia, Belarus, or Ukraine. However, the global economy is affected by the situation of the war, and we follow developments closely and continuously evaluate the operational and financial effects as the global situation may change and affect the company's financial position. Bactiguard has a subsidiary in Israel. We are closely following the developments there and our primary focus is to ensure the staff's well-being and security. We make the assessment that the conflict in Israel will have a negligible effect on the group's result and financial position.

While we see falling inflation levels, inflation and higher prices can continue to affect the company negatively as it is not always possible to change the price to the customers, all of which can affect the financial position negatively. The falling inflation levels can lead to lower interest rates, which can positively impact the interest costs. Some countries are now in or close to recession, which can lead to a decreased ability for customers to pay their invoices. The company also has a large exposure to the USD and EUR, see the annual report 2023.

Group consolidated income statement

Jul-Sep Jan-Sep Full year RTM
TSEK Note 2024 2023 2024 2023 2023 2023/24
Revenues 1
Net sales 67,325 45,456 178,604 145,293 201,545 234,857
Other operating revenue 6,611 4,029 15,018 16,546 21,628 20,101
Sum 73,936 49,485 193,622 161,839 223,174 254,958
Change in inventory of finished goods and
products in progress
-334 732 -290 732 1,000 -22
Capitalized production - 555 - 555 563 8
Raw materials and consumables -6,865 -10,520 -30,220 -49,837 -65,572 -45,955
Other external expenses -27,844 -21,562 -65,852 -75,888 -97,854 -87,818
Personnel costs -24,902 -24,973 -81,498 -98,422 -123,456 -106,532
Depreciation and amortization -11,820 -12,063 -35,243 -36,316 -55,865 -54,792
Other operating expenses -4,114 -3,246 -6,175 -10,805 -13,923 -9,293
Sum -75,879 -71,077 -219,278 -269,981 -355,107 -304,404
Operating profit/loss -1,943 -21,592 -25,656 -108,142 -131,933 -49,447
Profit/loss from financial items
Financial income -399 2,208 3,737 9,931 13,428 7,234
Financial expenses -3,790 -6,585 -12,303 -17,910 -28,649 -23,042
Sum -4,189 -4,377 -8,566 -7,979 -15,221 -15,808
Profit/loss before tax -6,132 -25,969 -34,222 -116,121 -147,154 -65,255
Current tax - -1 0 167 -136 -303
Deferred tax 1,458 1,368 5,329 4,790 8,910 9,447
NET PROFIT/LOSS FOR THE PERIOD -4,674 -24,602 -28,893 -111,164 -138,382 -56,111
Attributable to:
The parent company´s shareholders -4,674 -24,602 -28,893 -111,164 -138,382 -56,111
Earnings per share, before and after dilution,
SEK
-0.13 -0.70 -0.82 -3.17 -3.95 -1.60

Condensed statement of comprehensive income

Jul-Sep Jan-Sep Full year RTM
TSEK Note 2024 2023 2024 2023 2023 2023/24
Net profit/loss for the period -4,674 -24,602 -28,893 -111,164 -138,382 -56,111
Other comprehensive income:
Items that will not be reclassified to profit or
loss for the year
- - - - - -
Items that will be reclassified to profit or loss
for the year
Translation differences 4,563 172 4,093 -979 -4,149 923
Other comprehensive income, after tax 4,563 172 4,093 -979 -4,149 923
TOTAL COMPREHENSIVE INCOME FOR
THE PERIOD
-111 -24,430 -24,800 -112,143 -142,531 -55,188
Attributable to:
The parent company´s shareholders -111 -24,430 -24,800 -112,143 -142,531 -55,188
Number of shares at the end of period ('000) 35,044 35,044 35,044 35,044 35,044 35,044
Weighted average number of shares ('000) 35,044 35,044 35,044 35,044 35,044 35,044

Group condensed statement of financial position

TSEK Note 2024-09-30 2023-09-30 2023-12-31
ASSETS
Non-current assets
Intangible fixed assets
Goodwill 252,158 249,790 248,103
Technology 54,244 79,861 73,304
Brands 25,621 25,774 25,729
Customer relationships 4,039 5,551 5,107
Capitalized development expenditure 1,895 10,795 2,953
Patents 1,345 1,442 1,345
Sum 339,302 373,213 356,541
Tangible assets
Right of use lease assets 56,329 52,697 50,426
Buildings 26,037 14,650 13,766
Improvements, leasehold 5,174 5,143 4,991
Machinery and other technical plant 8,115 18,529 15,583
Equipment, tools and installations 18,435 6,156 9,092
Sum 114,090 97,175 93,858
Financial assets
Other non-current accounts receivable 2,966 1,398 2,885
Sum 2,966 1,398 2,885
Deferred tax assets 16,056 6,578 10,763
Total non-current assets 472,414 478,364 464,047
Current assets
Inventories
Accounts receivable
27,971 41,786 29,646
Other current receivables
2
36,158
16,405
30,928
6,152
17,249
8,118
Prepaid expenses and accrued income 16,789 18,042 19,898
Cash and cash equivalents 106,421 124,415 123,217
Total current assets 203,744 221,323 198,127
TOTAL ASSETS 676,158 699,687 662,174
EQUITY AND LIABILITIES
Equity attributable to shareholders of the parent
Share capital 876 876 876
Translation reserve 3,238 2,315 -855
Other capital 930,680 930,680 930,680
Retained earnings including net profit for the period -606,417 -550,305 -577,523
Total equity 328,377 383,565 353,178
Non-current liabilities
Liabilities to credit institutions - 179,150 -
Leasing liability 44,471 44,870 42,306
Provisions 5,257 5,257 5,257
Other long-term liabilities 10 - 28
Total non-current liabilities 49,738 229,277 47,590
Current liabilities
Liabilities to credit institutions 174,850 - 178,569
Leasing liability 16,061 11,928 12,224
Accounts payable 31,798 17,628 16,695
Provisions 19,684 16,138 10,256
Other current liabilities
2
3,831 5,045 4,570
Accrued expenses and prepaid income 51,819 36,106 39,093
Total current liabilities 298,043 86,845 261,406
TOTAL LIABILITIES 347,781 316,122 308,996
TOTAL EQUITY AND LIABILITIES 676,158 699,687 662,174

Group condensed statement of changes in equity

Retained
earnings
including net
TSEK Share
capital
Other
capital
Reserves profit for the
period
Total equity
Opening balance 2023-01-01 876 930,680 3,294 -439,141 495,709
Net profit/loss for the period -111,164 -111,164
Other comprehensive income:
Translation differences -979 -979
Total comprehensive income after tax -979 -111,164 -112,143
Closing balance 2023-09-30 876 930,680 2,315 -550,305 383,565
Opening balance 2024-01-01 876 930,680 -855 -577,523 353,178
Net profit/loss for the period -28,893 -28,893
Other comprehensive income:
Translation differences 4,093 4,093
Total comprehensive income after tax 4,093 -28,893 -24,800
Closing balance 2024-09-30 876 930,680 3,238 -606,417 328,377

Group condensed statement of cash flows

Jul-Sep Jan-Sep Full year RTM
TSEK Note 2024 2023 2024 2023 2023 2023/24
Net profit/loss for the period -4,674 -24,601 -28,894 -111,164 -138,382 -56,112
Adjustments for depreciation and amortization
and other non-cash items
19,028 7,680 30,159 43,352 72,288 59,095
Increase/decrease inventory 12,029 -2,219 6,957 -1,280 8,252 16,489
Increase/decrease accounts receivable -1,569 -1,840 -18,255 8,855 28,455 1,345
Increase/decrease other current receivables -9,274 -1,578 -10,553 -5,604 -10,450 -15,399
Increase/decrease accounts payable -6,729 2,110 15,103 -15,470 -17,127 13,446
Increase/decrease other current liabilities -468 -14,560 11,612 18,870 4,632 -2,626
Cash flow from changes in working capital -6,011 -18,087 4,864 5,371 13,762 13,255
Cash flow from operating activities 8,342 -35,008 6,129 -62,441 -52,331 16,239
Investments in intangible assets - -902 - -1,420 -1,420 0
Investments in tangible assets -2,890 194 -13,074 -1,148 -7,189 -19,115
Cash flow from investing activities -2,890 -708 -13,074 -2,568 -8,609 -19,115
Amortization of financial leasing liability -3,642 -2,796 -9,849 -8,333 -11,139 -12,655
Amortization of loan -255 288 -3,719 - -696 -4,415
Change in bank overdraft - -258 - 332 - -332
Other financing activities - -252 - - - 0
Cash flow from financing activities -3,897 -3,018 -13,568 -8,001 -11,835 -17,402
Cash flow for the period 1,555 -38,734 -20,513 -73,010 -72,775 -20,278
Cash and cash equivalents at the beginning of
the period
105,275 163,333 123,217 197,727 197,727 124,413
Exchange difference in cash and cash
equivalents
-410 -186 3,715 -303 -1,735 2,282
Cash and cash equivalents at end of period 106,421 124,415 106,421 124,415 123,217 106,419

Condensed parent company income statement

Jul-Sep Jan-Sep 2023 2023/24
TSEK
Note
2024 2023 2024 2023 Full year RTM
Net sales 262 902 2,172 1,748 3,062 3,486
Sum 262 902 2,172 1,748 3,062 3,486
Other external expenses -700 -692 -3,203 -2,497 -3,176 -3,883
Personnel costs -759 -740 -2,354 -2,543 -3,295 -3,106
Sum -1,459 -1,432 -5,557 -5,040 -6,471 -6,989
Operating profit/loss -1,197 -530 -3,385 -3,292 -3,409 -3,503
Interest income and similar profit/loss items 5,160 5,324 16,087 14,026 19,625 21,686
Interest expenses and similar profit/loss items -3,165 -3,545 -9,878 -8,749 -12,016 -13,145
Sum 1,995 1,779 6,209 5,278 7,609 8,541
Income after financial items 798 1,249 2,824 1,986 4,200 5,038
Deferred tax - - - 0 10 10
Net profit/loss for the period 798 1,249 2,824 1,986 4,210 5,048

The parent company presents no separate statement of comprehensive income since the company has no items in 2024 or 2023 recognized in other comprehensive income. Net profit/loss for the period for the parent company thereby also constitutes of the comprehensive income for the period.

Condensed parent company balance sheet

TSEK
Note
2024-09-30 2023-09-30 2023-12-31
ASSETS
Non-current assets
Financial assets
Shares in subsidiaries 625,191 525,191 575,191
Receivables from group companies 356,768 371,814 368,803
Deferred tax assets 15,255 15,255 15,255
Total non-current assets 997,214 912,260 959,249
Current assets
Current receivables
Other current receivables 721 49 1,639
Prepaid expenses and accrued income 48,482 27,431 32,806
Sum 49,203 27,481 34,445
Cash and bank balances 2,398 3,535 1,811
Total current assets 51,601 31,016 36,256
TOTAL ASSETS 1,048,814 943,276 995,506
EQUITY & LIABILITIES
Equity
Restricted equtiy
Share capital 876 876 876
Total restricted equity 876 876 876
Non-restricted equity
Retained earnings -29,347 694,413 -33,556
Non-restricted share premium 727,969 0 727,969
Net profit/loss for the period 2,824 1,986 4,210
Total non-restricted equity 701,446 696,399 698,623
Total equity 702,322 697,275 699,499
Non-current liabilities
Liabilities to credit institutions - 170,941 -
Total non-current liabilities - 170,941 -
Current liabilities
Liabilities to credit institutions 170,941 - 170,941
Liabilities to group companies 174,000 74,000 124,000
Accounts payable 31 89 86
Other current liabilities 175 122 407
Accrued expenses and prepaid income 1,345 849 572
Total current liabilities 346,492 75,060 296,007
Total liabilities 346,492 246,001 296,007
Total equity and liabilities 1,048,814 943,276 995,506

Definitions of alternative key performance indicators

Bactiguard presents certain financial measures in its annual report that have not been defined in line with IFRS (referred to as alternative key performance indicators as set forth in the ESMA guidelines). It is the opinion of the company that these measures provide useful supplementary information to investors and the company's management as they allow for the evaluation of the company's performance. Since not all companies calculate the measures in the same way, these are not always comparable to measures used by other companies. These performance measures should therefore not be considered a substitute for measures as defined under IFRS.

The definitions and tables below describe how the performance measures are calculated. The measures are alternative in accordance with ESMA's guidelines unless otherwise stated.

EBITDA

EBITDA presents the company's earning capacity from ongoing operations irrespective of capital structure and tax situation. The key figure is used to facilitate comparisons with other companies in the same industry. The company considers this performance measure to be the most relevant, since the company's technology is depreciated by large amounts, which does not impact cash flow negatively. Bactiguard's patented, unique technology can be applied to a broad range of products in the licensing business.

The company defines EBITDA as operating profit/loss excluding depreciation and amortization of tangible and intangible assets.

Jul-Sep Jan-Sep Full year RTM
TSEK 2024 2023 2024 2023 2023 2023/24
Operating profit/loss -1,943 -21,592 -25,656 -108,142 -131,933 -49,447
Depreciation 11,820 12,063 35,243 36,316 55,865 54,792
EBITDA 9,877 -9,529 9,587 -71,826 -76,068 5,345

EBITDA margin

Presents the company's earning capacity from ongoing operations, irrespective of capital structure and tax situation, in relation to revenues. The key figure is used to facilitate analysis of the company's result in comparison with comparable companies.

Jul-Sep Jan-Sep Full year RTM
TSEK 2024 2023 2024 2023 2023 2023/24
EBITDA 9,877 -9,529 9,587 -71,826 -76,068 5,345
Revenues 73,936 49,485 193,622 161,839 223,174 254,958
EBITDA margin % 13.4 -19.3 5.0 -44.4 -34.1 2.1

Net debt

Net debt is a measure used to describe the Group's indebtedness and its ability to repay its debt with cash generated from the Group's operating activities if the debts matured today. The company considers this key figure interesting for creditors who want to understand the Group's debt situation.

The company defines net debt as interest-bearing liabilities minus cash and cash equivalents at the end of the period.

Jan-Sep Full year
TSEK 2024 2023 2023
Non-current liabilities to credit institutions - 179,150 -
Current liabilities to credit institutions 174,850 - 178,569
Short-term lease debt 44,471 44,870 42,306
Long-term lease debt 16,061 11,928 12,224
Interest-bearing debt 235,382 235,948 233,099
Cash and cash equivalents -106,421 -124,415 -123,217
Net debt 128,961 111,533 109,882

Equity ratio

Equity ratio is a measure the company considers important for creditors who want to understand the company's long-term ability to pay. The company defines equity ratio as equity and untaxed reserves (less deferred tax), in relation to the balance sheet total.

Jan-Sep Full year
TSEK 2024 2023 2023
Equity 328,377 383,565 353,178
Balance sheet total 676,158 699,687 662,174
Equity ratio, % 48.6 54.8 53.3

Cash flow from operating activities per share

Cash flow per share calculated as the cash flow from operating activities divided by the average number of shares outstanding during the period. The key figure is presented because it is used by analysts and other stakeholders to evaluate the company – it shows operating cash flow per share.

Profit/loss from financial items

Financial income minus financial expenses. Direct reconciliation against financial report is possible.

RTM/Rolling 12 months

This performance measure implies the twelve months before and including a certain date.

Note 1 Revenue distribution

Jul-Sep
Jan-Sep
Full year RTM
TSEK 2024 2023 2024 2023 2023 2023/24
License partners 46,639 17,961 114,192 74,779 104,322 143,736
Exclusivity partners - 2,696 5,269 7,071 9,710 7,908
Application development partners 866 152 997 3,164 3,163 997
Wound Management portfolio 17,880 17,501 45,313 39,900 53,817 59,230
BIP portfolio 1,939 7,148 12,832 20,381 30,533 22,984
Sum 67,323 45,458 178,603 145,296 201,545 234,854
Time for revenue recognition
Performance commitment is met at a certain
time
66,458 42,611 172,337 135,060 188,672 225,950
Performace commitment is met during a
period of time
866 2,848 6,266 10,235 12,873 8,905
Sum 67,323 45,458 178,603 145,296 201,545 234,854

Note 2 Financial assets and liabilities at fair value

The table below shows the breakdown of financial assets and financial liabilities recognized at fair value in the consolidated balance sheet. Distribution of how fair value is determined is based on three levels.

Level 1: according to prices quoted on an active market for the same instrument.

Level 2: based on directly or indirectly observable market data not included in level 1.

Level 3: based on input data that is not observable on the market.

For description of how real values have been calculated, see annual report 2023, note 4. Fair value of financial assets and liabilities is estimated to be substantially consistent with posted values. The group holds derivative instruments for foreign exchange contracts which are recognized at fair value through profit or loss, considering the current exchange rate on the foreign exchange market and the remaining maturity of respective instruments. The balance sheet contains receivables and liabilities from the business that are held to maturity. These are reported at amortized cost, which also constitutes an approximation to fair value.

Quarterly information

TSEK Q3 2024 Q2 2024 Q1 2024 Q4 2023 Q3 2023 Q2 2023 RTM 23/24
License partners 46,639 35,129 32,424 29,544 17,960 19,141 143,736
Exclusivity partners - 2,678 2,591 2,639 2,696 4,376 7,908
Application development partners 866 - 131 - 153 1,304 997
Wound Management portfolio 17,880 14,700 12,733 13,917 17,501 11,229 59,230
BIP portfolio 1,939 4,847 6,046 10,152 7,148 8,139 22,984
Other operating revenues 6,611 3,540 4,867 5,083 4,029 7,006 20,101
Total revenue 73,936 60,893 58,793 61,334 49,486 51,193 254,958
EBITDA 9,877 1,211 -1,501 -4,242 -9,529 -55,682 5,345
EBITDA margin (%) 13.4 2.0 -2.6 -6.9 -19.3 -108.8 2.1
EBIT -1,943 -10,846 -12,867 -23,791 -21,592 -67,844 -49,447
Net profit/loss for the period -4,674 -14,318 -9,901 -27,218 -24,602 -64,464 -56,111
Earnings per share, before and
after dilution, SEK
-0.13 -0.41 -0.28 -0.78 -0.70 -1.84 -1.60
Operating cash flow 8,342 16,843 -19,056 10,110 -35,008 -19,746 16,239
Operating cash flow per share, SEK 0.24 0.48 -0.54 0.29 -1.00 -0.56 0.46
Net debt 128,961 134,020 145,690 109,882 111,533 75,794 128,961
Total shares (pcs) 35,043,885 35,043,885 35,043,885 35,043,885 35,043,885 35,043,885 35,043,885

Signatories of the report

The Board of Directors and the CEO certify that the interim report, to the best of their knowledge, provides a fair overview of the parent company's and the Group's operations, financial position and results and describes the material risks and uncertainties faced by the parent company and the companies included in the Group.

Stockholm 24 October 2024

Thomas von Koch Richard Kuntz Chairman of the Board Board Member

Board Member Board Member

Anna Martling Magdalena Persson

Jan Ståhlberg Christine Lind Board Member CEO

The interim report has been reviewed by the company auditors.

This information is information that Bactiguard Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out below on 24 October 2024, at 07.00 a.m. CET.

This is a translation of the Swedish Interim report. In the event of any discrepancy, the Swedish version applies.

About Bactiguard

Bactiguard is a global MedTech company developing safe and biocompatible technology to prevent medical device related infections. The company's unique technology is based on an ultra-thin noble metal coating that prevents bacterial adhesion and biofilm formation on medical devices.

Bactiguard's infection prevention solutions decrease patient suffering, save lives, and unburden healthcare resources while also fighting against antimicrobial resistance, one of the most serious threats to global health and modern medicine.

Bactiguard operates through license partnerships with leading global MedTech companies that apply the technology to their medical devices and sell them under their own brand or cobranded with Bactiguard. The company also has a portfolio of wound management products.

Bactiguard is headquartered in Stockholm and listed on Nasdaq Stockholm.

Read more about Bactiguard bactiguard.com

Follow Bactiguard on LinkedIn

Forthcomming disclosures of information

6 February 2025 Year-end report 1 January – 31 December 2024
17 April 2025 Annual Report 2024
24 April 2025 Interim report first quarter 1 January – 31 March 2025
15 July 2025 Interim report second quarter 1 April – 30 June 2025
23 October 2025 Interim report third quarter 1 July – 30 September 2025

Contacts

For additional information, please contact: Patrick Fruergaard Bach, CFO: +46 8 440 58 80 Nina Nornholm, Head of Communication & Investor Relations: +46 708 550 356

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