Earnings Release • Aug 22, 2024
Earnings Release
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COPENHAGEN, Denmark, August 22, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today its interim financial results and business progress for the first half of 2024 and released its financial calendar for 2025.
| DKK million | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | 2024 Guidance |
|---|---|---|---|---|---|
| Revenue | 1,427 | 1,987 | 2,259 | 3,239 | ~5,300 |
| EBITDA | 420 | 690 | 441 | 1,171 | ~1,350 |
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We are pleased to report strong developments for Bavarian Nordic during the first half of 2024. Unfortunately, mpox is again making global headlines as a result of the record number of cases reported in Africa. The situation has urged the African CDC and the WHO to declare public health emergencies and Bavarian Nordic is working closely with all stakeholders to ensure the equitable access to our mpox vaccine. Importantly, we have built a strong partnership with the Africa Centers of Disease Control (CDC), both on exploring supply, but also expanding our manufacturing network to include Africa. We are also working with the WHO on a regulatory path to ensure access to all countries, while in parallel seeking approval for use in adolescents and also conducting clinical studies in Africa to further expand the use to children. A recent order for MVA-BN was secured by an undisclosed European country, and this was anticipated as part of the 2024 guidance and as such, has no impact on the remaining vaccine capacity. Indeed, in response to recent events the company plans to ramp-up vaccine manufacturing to ensure the continued equitable access to our mpox vaccine. Consequently, we have the capacity to manufacture 10 million doses by the end of 2025, in addition to our current orders, and could already supply up to 2 million doses this year. Bavarian Nordic is prepared to work with the international community to play our role in protecting and saving lives around the World and to contain the latest outbreak."
| 2024 Annual Report | March 5, 2025 |
|---|---|
| Annual General Meeting | April 9, 2025 |
| Three-month report (Q1) | May 9, 2025 |
| Half-year report (Q2) | August 22, 2025 |
| Nine-month report (Q3) | November 14, 2025 |
The management of Bavarian Nordic will host an investor/analyst call today at 2 pm CEST (8 am EDT) to present the interim results followed by a Q&A session. A listen-only version of the call and presentation slides can be accessed via https://bit.ly/bavaQ22024. To join the Q&A session, please register in advance via https://bit.ly/bavaQ22024reg.
Europe: Rolf Sass Sørensen, Vice President Investor Relations, [email protected], Tel: +45 61 77 47 43 US: Graham Morrell, Paddock Circle Advisors, [email protected], Tel: +1 781 686 9600
Company Announcement no. 25 / 2024
Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. For more information visit www.bavarian-nordic.com.
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
| DKK thousand | 1/4-30/6 2024 | 1/4-30/6 2023 | 1/1-30/6 2024 | 1/1-30/6 2023 1/1-31/12 2023 | |
|---|---|---|---|---|---|
| Income statements | |||||
| Revenue | 1,427,497 | 1,986,627 | 2,258,969 | 3,238,680 | 7,062,340 |
| Production costs | 707,547 | 683,729 | 1,273,784 | 1,112,126 | 2,459,294 |
| Sales and distribution costs | 120,395 | 72,374 | 209,088 | 138,004 | 331,579 |
| Research and development costs | 209,587 | 503,629 | 394,694 | 801,647 | 2,228,080 |
| Administrative costs | 124,057 | 180,685 | 244,405 | 270,938 | 540,848 |
| Income before interest and taxes (EBIT) | 265,893 | 546,210 | 136,998 | 915,965 | 1,502,539 |
| Financial items, net | 97 | (3,552) | 14,851 | 3,173 | (19,596) |
| Income before company tax | 265,990 | 542,658 | 151,849 | 919,138 | 1,482,943 |
| Net profit for the period | 261,128 | 538,079 | 146,677 | 914,446 | 1,475,189 |
| Balance sheet | |||||
| Total non-current assets | 8,883,912 | 10,578,155 | 8,950,162 | ||
| Securities, cash and cash equivalents | 2,237,184 | 1,384,899 | 1,867,481 | ||
| Other current assets | 3,153,349 | 3,030,187 | 3,535,570 | ||
| Total assets | 14,274,445 | 14,993,241 | 14,353,213 | ||
| Equity | 10,436,717 | 9,685,751 | 10,339,932 | ||
| Non-current liabilities | 188,328 | 2,381,071 | 1,225,412 | ||
| Current liabilities | 3,649,400 | 2,926,419 | 2,787,869 | ||
| Cash flow statements | |||||
| Cash flow from operating activities | 1,066,095 | 227,786 | 1,119,206 | ||
| Cash flow from investment activities | (1,695,588) | (701,583) | (945,564) | ||
| Cash flow from financing activities | (37,221) | 734,168 | 735,832 | ||
| Financial Ratios1) | |||||
| EBITDA | 419,539 | 689,670 | 441,377 | 1,171,166 | 2,614,543 |
| Earnings (basic) per share of DKK 10 | 1.9 | 12.1 | 19.2 | ||
| Net asset value per share | 133.6 | 124.3 | 132.4 | ||
| Share price at period-end | 173 | 194 | 177 | ||
| Share price/Net asset value per share | 1.3 | 1.6 | 1.3 | ||
| Number of outstanding shares at period-end (thousand) | 78,117 | 77,929 | 78,098 | ||
| Equity share | 73% | 65% | 72% | ||
| Number of employees, converted to full-time, at period-end | 1,381 | 1,354 | 1,379 |
1) Earnings per share (EPS) is calculated in accordance with IAS 33 "Earning per share". Other financial ratios have been calculated in accordance with the guidelines from the Danish Society of Financial Analysts.
| Reconciliation of EBITDA | |||||
|---|---|---|---|---|---|
| Income before interest and tax (EBIT) | 265,893 | 546,210 | 136,998 | 915,965 | 1,502,539 |
| Amortization | 77,756 | 71,817 | 155,923 | 140,050 | 298,529 |
| Depreciation + amortization of developed product processes | 75,890 | 71,643 | 148,456 | 115,151 | 255,792 |
| Impairment loss | - | - | - | - | 557,683 |
| EBITDA | 419,539 | 689,670 | 441,377 | 1,171,166 | 2,614,543 |
Bavarian Nordic is a leading global provider of travel vaccines and a preferred partner with governments and international organizations on delivering vaccines for improving public preparedness, such as mpox/smallpox vaccines.
The company employs nearly 1,400 people across its research and development facilities in Germany and the USA, manufacturing sites in Denmark and Switzerland and with a global commercial organization present in strategic markets across Europe and the USA.
Bavarian Nordic is listed on the Nasdaq Copenhagen exchange under the ticker symbol BAVA.
| Rabipur/RabAvert is indicated for both pre- and post exposure vaccination against rabies. The vaccine is marketed globally in 20 countries. |
|---|
| Encepur is a vaccine against tick-borne-encephalitis (TBE) and is marketed in 12 countries in the EU. |
| Vivotif is an oral typhoid vaccine approved in 25 countries. |
| Vaxchora is an oral cholera vaccine approved in 27 countries and is the only FDA-approved cholera vaccine. |
| Third-party products which are marketed and distributed in selected markets by Bavarian Nordic: |
| IXIARO® is a Japanese encephalitis vaccine and DUKORAL® is a cholera vaccine, both from Valneva, and marketed and distributed by Bavarian Nordic in Germany and Switzerland |
| HEPLISAV-B® is a vaccine against hepatitis B from Dynavax, marketed and distributed by Bavarian Nordic in |
Germany.

JYNNEOS/IMVANEX/IMVAMUNE is a vaccine against both mpox and smallpox.
JYNNEOS is primarily sold to governments and organizations, but has also been launched in the U.S. in April 2024 to expand access to populations at-risk of mpox infections
| Q2 sales | |||
|---|---|---|---|
| mDKK | Q2 2024 | Q2 2023 | Growth |
| Travel health | |||
| Rabipur/RabAvert | 333 | 313 | 6% |
| Encepur | 202 | 211 | -4% |
| Vivotif | 55 | 271 | 100% |
| Vaxchora | 21 | 7 1 |
204% |
| Third-party products | 60 | 38 | 59% |
| 671 | 597 | 12% | |
| Public preparedness | |||
| JYNNEOS/IMVANEX/IMVAMUNE | 680 | 1,334 | -49% |
| Other revenue | 76 | 56 | 36% |
| Total | 1,427 | 1,987 | -28% |
Comparative figures for 2023 are shown in brackets. Where market shares are mentioned, these are measured by value.
Revenue from sale of Rabipur/RabAvert in the second quarter increased by 6% to DKK 333 million (DKK 313 million), reflecting a strong demand from key markets in the U.S. and Germany.
For the first half year revenue from sale of Rabipur/RabAvert amounted to DKK 568 million (DKK 555 million).
In the second quarter, the U.S. market grew by 8% versus the prior year and RabAvert market share increased by 1pp to 71%. The German market dropped by 18% in the second quarter versus the prior year, driven by a temporary stockout of both Rabipur and the competitor's product, which was resolved during the second quarter. The stockout negatively impacted Rabipur market share but has since seen strong signs of recovery reaching 82% for the quarter.
The transfer of the fill and finish process for Rabipur/RabAvert has been completed and approved by the regulators and product manufactured at Bavarian Nordic is now being sold within the market. The transfer of bulk manufacturing process is currently being reviewed by the regulators, but approval expected later this year. This will complete the full manufacturing process transfer within four years, as planned and on budget, for one of the most complicated commercial live vaccines currently on the market. The completion of the manufacturing transfer will see a gross margin improvement already in 2026 and with a full 15-20pp impact in 2027 as the remaining stock from GSK is depleted.
Revenue from sale of Encepur in the second quarter was DKK 202 million (DKK 211 million). The decrease is attributed to higher sales during the first quarter driven by a milder winter and earlier start of the TBE season.
For the first half, revenue from sale of Encepur increased by 10% to DKK 327 million (DKK 299 million).
Encepur market share was 29%, 2pp higher than in the first quarter.
Revenue from sale of Vivotif in the second quarter was DKK 55 million (DKK 27 million) and revenue from sale of Vaxchora was DKK 21 million (DKK 7 million).
For the first half year revenue from sale of Vivotif amounted to DKK 98 million (DKK 27 million) and revenue from sale of Vaxchora amounted to DKK 33 million (DKK 7 million).
| H1 sales | |||
|---|---|---|---|
| mDKK | H1 2024 | H1 2023 | Growth |
| Travel health | |||
| Rabipur/RabAvert | 568 | 555 | 2% |
| Encepur | 327 | 299 | 10% |
| Vivotif | 98 | 271 | 256% |
| Vaxchora | 33 | 7 1 |
367% |
| Third-party products | 93 | 81 | 14% |
| 1,119 | 969 | 15% | |
| Public preparedness | |||
| JYNNEOS/IMVANEX/IMVAMUNE | 1,024 | 2,182 | -53% |
| Other revenue | 116 | 87 | 33% |
| Total | 2,259 | 3,239 | -30% |
1 Includes only revenue from mid-May 2023 from the time when the acquisition of the vaccines was completed.
Comparative figures for both products only include revenue from mid-May 2023 from the time of completion of the acquisition from Emergent BioSolutions.
Both products are being relaunched with an ambition to drive combined annual peak revenue to a level of USD 100 million.
Revenue from sale of third-party products in the second quarter was DKK 60 million (DKK 38 million).
For the first half year revenue from sale of third-party products amounted to DKK 93 million (DKK 81 million).
Vaccines within this sector are typically manufactured to order, to ensure the longest shelf-life and are also impacted by outbreaks and or larger orders from time to time, often referred to as spike demand/orders, which make quarterly or annual comparisons more challenging. However, the sales for 2024 are fully aligned with the Company's expectations and the inventory on hand will ensure that the remaining anticipated orders for 2024 can be supplied in the second half of the year.
Revenue from sale of JYNNEOS/IMVANEX/IMVAMUNE in the second quarter was DKK 680 million (DKK 1,334 million) and includes revenue from ongoing contracts with the U.S. government as well as contracts entered with various other governments and organizations.
For the first half year revenue from sale of JYNNEOS/IMVANEX/IMVAMUNE amounted to DKK 1,024 million (DKK 2,182 million).
In response to the updated U.S. CDC recommendations for routine use of JYNNEOS in individuals s 18 years and older with certain risk factors, Bavarian Nordic launched the vaccine in the U.S. in April 2024 to expand access to at-risk populations. Initial focus has been to increase market access through distributors, wholesalers and pharmacies, as well as increasing reimbursement coverage through insurance companies while at the same time raising the awareness in the market through marketing activities. Initial JYNNEOS sales have largely been driven by filling up the supply chain and pull-through sales have been limited by the fact that doses were still freely available through public health channels. This availability will end during the third quarter of 2024, thus further priming the sales through private channels.
For the full year, total JYNNEOS/IMVANEX/IMVAMUNE revenue of approximately DKK 3,000 million is now expected and is now all largely secured by contracts.
Other revenue in the second quarter was DKK 76 million (DKK 56 million), mainly stemming from ongoing contracts with the U.S. government, including the contract to develop an MVA-BN-based vaccine against equine encephalitis viruses.
Following the global mpox outbreak in 2022-2023, Bavarian Nordic continues to support governments and supranational organizations, fulfilling orders from both existing and new customers, including larger contracts from the USA, Canada and the EU. These partnerships will remain a significant part of the Company's public preparedness business.
Bavarian Nordic has an ongoing contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) valued at USD 299 million to supply freeze-dried doses of JYNNEOS® . This contract allows the production of freeze-dried doses prior to the licensure of the formulation and the Company has started to manufacture vaccines under this contract in the first quarter of 2024, aiming to fulfil the first USD 119 million contract option this year. Additional options valued at USD 180 million are pending exercise by BARDA.
The bulk product for manufacturing the freeze-dried vaccines was initially manufactured under previous contracts, however a significant part of this inventory was repurposed for manufacturing of liquid-frozen doses during the 2022/2023 mpox outbreak and would thus need to be replaced via new orders to enable fulfilment of the remaining freeze-dried option.
A new order was received from BARDA in August 2024. The total value of this contract is USD 156.8 million, of which USD 135.7 million will cover the manufacture of new bulk product to partly replenish the inventory required for fulfilment of the freezedried contract. This represents the second bulk replenishment order following a USD 120 million order last year and combined these do not fully replace all the bulk vaccine required to fulfill the remaining freeze-dried option.
In May, Bavarian Nordic submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a freeze-dried formulation of JYNNEOS® for prevention of smallpox and mpox.
Following the U.S. Center for Disease Control and Prevention's (CDC) recommendation to vaccinate the at-risk populations, Bavarian Nordic launched JYNNEOS in the U.S. in April 2024 to expand access to populations at risk of mpox infections.
In April 2024, the EU extended their commitment through the award of a contract valued at EUR 65 million to supply smallpox vaccines to rescEU in 2025. This third, and larger order follows two previous orders, received in 2023 and delivered in 2024, for smallpox vaccines to rescEU stockpiles across Europe and will help to expand the EU's capability to respond to future biological threats and emergencies by enabling rapid deployment of medical countermeasures to its member states.
Bavarian Nordic has also entered bilateral supply contracts with certain European countries. In August, a new order to supply 440,000 doses of smallpox and mpox vaccines was received from a non-disclosed European country. The order was anticipated as
For the first half year other revenue amounted to DKK 116 million (DKK 87 million).
part of the 2024 guidance and has no impact on the remaining 2024/25 capacity for our smallpox and mpox vaccine.
In July 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommended approval of a type II variation for IMVANEX® (MVA-BN) smallpox and mpox vaccine, which includes real-world effectiveness data from the use of the vaccine during the global 2022 mpox outbreak in the marketing authorization. These realworld data demonstrated vaccine effectiveness against mpox of up to 90% after two MVA-BN doses and a significant reduction of the risk of mpox-related hospitalizations.
In August 2024, Bavarian Nordic submitted clinical data to the European Medicines Agency (EMA) to support the extension of the IMVANEX indication to include adolescents 12 to 17 years of age. The submission is based on interim results from a clinical study sponsored by the U.S. National Institutes of Health (NIH) in 315 adolescents 12-17 years of age and 211 adults aged 18 years and older, demonstrating non-inferiority of the immune responses, as well as a similar safety profile, between both age groups after vaccination with two standard doses of the MVA-BN vaccine. Following review of the data by EMA, the Marketing Authorisation for IMVANEX could be extended to include use of the vaccine for adolescents during the fourth quarter of 2024.
Africa is currently tackling one of the largest and deadliest known mpox outbreak to date, caused by the clade I virus – a more severe variant than the clade II, which was the cause of the recent global outbreak. Since the beginning of 2024, over 18,000 mpox cases and more than 500 deaths have been reported from 12 countries as of mid-August 2024, with the vast majority (>95%) of cases and deaths occurring in the Democratic Republic of Congo (DRC). The escalating situation led the Africa CDC to declare a Public Health Emergency of Continental Security on August 13, 2024, followed by a declaration by the WHO on the next day, that the current mpox outbreak constitutes a Public Health Emergency of International Concern.
These declarations will help to strengthen the public health response, and among others will help facilitate broader access to vaccines across the African continent. Currently, only two African countries, including the DRC, have authorized Bavarian Nordic's vaccine for emergency use in individuals at risk of mpox, currently limiting access of the vaccine. However, upon the recent request from the WHO, as part of their Emergency Use Listing (EUL) program, the vaccine could obtain emergency use authorization in countries, where national regulatory approvals are not yet in place.
Bavarian Nordic is working with global partners to increase access to the vaccine in Africa. Through a recent agreement with the European Health Emergency Preparedness and Response Authority (HERA), a total of 215,420 doses will be donated to Africa CDC, comprising of 175,420 doses procured by HERA from Bavarian Nordic and 40,000 doses donated by the Company.
Bavarian Nordic has also pledged 15,000 doses which along with donations from other sources will be coordinated and deployed by a consortium of organizations, including Gavi, WHO and UNICEF in affected areas in Africa.
Bavarian Nordic is furthermore working with the Coalition for Epidemic Preparedness Innovations (CEPI), who have provided
During the first half of 2024, Bavarian Nordic completed submissions to U.S. and EU regulatory authorities, seeking approval of the CHIKV VLP vaccine for immunization against chikungunya virus infection in individuals 12 years of age and older – the first chikungunya vaccine candidate seeking approval for adolescents.
In June, the Company completed the rolling submission process, which was initiated in April 2024 with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for the CHIKV VLP vaccine. In August, the FDA accepted the BLA and granted it Priority Review, thus initiating their formal review with an aim to complete this within six months. The Prescription Drug User Free Act (PDUFA) target action date is February 14, 2025.
In June, the Company also submitted a Marketing Authorization Application (MAA) for the CHIKV VLP vaccine to the European Medicines Agency (EMA). The application has been granted accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP), which may reduce the review time, thus potentially supporting an approval of the vaccine by the European Commission in the first half of 2025. The centralized review procedure began in July upon EMA's acceptance and validation of the MAA.
The BLA and MAA submissions are based on, among others, two completed Phase 3 studies of CHIKV VLP vaccine (NCT05072080 and NCT05349617). Both studies met their primary endpoints, demonstrating that CHIKV VLP vaccine induced high levels of neutralizing antibodies against chikungunya in individuals 12
In May, Bavarian Nordic announced the departure of Laurence de Moerlooze as Executive Vice President and Chief Medical Officer, who had chosen to pursue new opportunities. A search process to identify the next Chief Medical Officer has been initiated.
By January 1, 2024, Bavarian Nordic's share capital was DKK 780,978,340, comprising 78,097,834 shares of a nominal value of DKK 10 each.
In May, 18,702 new shares were issued as a consequence of employees' exercise of warrants, raising gross proceeds of DKK 2.7 million.
funding for a clinical trial to investigate the MVA-BN vaccine in African children aged 2-12 years. Results from this study could support an extension of the current regulatory approvals for use of the vaccine in adults to also include children 2-12 years of age. Importantly, the study will also generate evidence on the vaccine in endemic African populations.
years and above, with antibody titers equal to or above the threshold agreed with authorities as a marker of seroprotection.
The CHIKV VLP vaccine was well-tolerated across both studies and adverse events were mainly mild or moderate in nature.
The long-term immunogenicity of CHIKV VLP vaccine is currently being evaluated in a follow-up Phase 3 study (NCT06007183) in healthy adults and adolescents from the previous Phase 3 study (NCT05072080). The new study will evaluate both the safety and long-term immunogenicity of a single dose of CHIKV VLP vaccine in up to 5 years after vaccination and antibody responses after a booster vaccination with CHIK VLP vaccine administered 3, 4, or 5 years post-initial vaccination.
Bavarian Nordic has an ongoing partnership with the U.S. Department of Defense (DOD) to develop MVA-BN® WEV, a prophylactic vaccine candidate against Western, Eastern and Venezuelan equine encephalitis virus.
After having concluded a Phase 1 clinical trial, Bavarian Nordic was awarded a contract by the DOD in 2022 to advance the development of MVA-BN WEV. The base agreement of USD 64 million has been secured for the period 2023-2026 and covers the costs for a clinical Phase 2 dose finding study, further nonclinical studies, process development and manufacturing of clinical trial material. Options under this contract are valued at USD 28 million and could support Phase 3 preparations.
Preparations are ongoing to initiate the Phase 2 study in the fourth quarter of 2024.
By June 30, 2024, Bavarian Nordic's share capital was DKK 781,165,360, comprising 78,116,536 shares of a nominal value of DKK 10 each.
Nine-month report (Q3) November 15, 2024 2024 Annual Report March 5, 2025 Annual General Meeting* April 9, 2025 Three-month report (Q1) May 9, 2025 Half-year report (Q2) August 22, 2025 Nine-month report (Q3) November 14, 2025
* Pursuant to Article 12 of the Articles of Association, shareholders who wish to submit a request for proposals for consideration at the annual general meeting must lodge this with the Company no later than Tuesday, February 25, 2025.
Financial statements for the period January 1 – June 30, 2024 are un-audited. Comparison figures for the same period 2023 are stated in brackets.
Revenue for the period was DKK 2,259 million (DKK 3,239 million) and was composed of DKK 1,119 million (DKK 969 million) from the travel health business, DKK 1,024 million (DKK 2,182 million) from the public preparedness business and finally DKK 116 million (DKK 87 million) from contract work. All products contributed to the growth in the travel health portfolio, however with main contributions driven by strong Encepur sales DKK 327 million (DKK 299 million) and considerable growth in sale of Vivotif and Vaxchora DKK 131 million (DKK 35 million) acquired from Emergent BioSolutions as of May 15, 2023. The lower public preparedness revenue compared with 2023 is explained by the 2023 revenue impact of the mpox outbreak that started in 2022. Revenue reported for the three months ended June 30, 2024, was DKK 1,427 million (DKK 1,987 million) with the decline all explained by the 2023 public preparedness revenue.
Production costs totaled DKK 1,274 million (DKK 1,112 million). Costs related directly to revenue amounted to DKK 780 million (DKK 835 million), of which cost of goods sold totaled DKK 694 million (DKK 770 million). Contract costs totaled DKK 86 million (DKK 65 million). Amortization of product rights was recognized as part of the production costs with a total of DKK 156 million (DKK 140 million). Amortization of product rights mainly relates to Rabipur/RabAvert and Encepur, DKK 136 million (DKK 136 million), whereas amortization of Vivotif and Vaxchora amounted to DKK 20 million (DKK 4 million). Other production costs totaled DKK 338 million (DKK 138 million). The increase in other production costs relates to temporary close-down of bulk production due to water damage in Kvistgaard in January and inclusion of other production costs from the Bern site, mainly due to cost of idle capacity in Q1. In the second quarter of 2024, production costs were DKK 708 million (DKK 684 million).
Sales and distribution costs totaled DKK 209 million (DKK 138 million) divided between costs for distribution of products of DKK 30 million (DKK 27 million) and costs for running the commercial organization and activities of DKK 179 million (DKK 111 million). The increase in running costs for the commercial organization and activities is mainly related to the acquired activities from Emergent BioSolutions.
Research and development costs totaled DKK 395 million (DKK 802 million). During the first six months of 2023 the main costs were related to the Phase 3 study for RSV (approx. DKK 530 million). As such, total costs have been reduced for 2024, even when considering the chikungunya Phase 3 study and the running cost for the R&D facility in San Diego taken over from Emergent BioSolutions. The amount excludes R&D costs of DKK 86 million (DKK 64 million) recognized as production costs, see note 5.
Administrative costs totaled DKK 244 million (DKK 271 million). Costs related to the acquisition of subsidiaries and activities from Emergent BioSolutions was expensed by DKK 64 million in second quarter of 2023, and excluding these expenses, the underlying increase in administrative costs compared to 2023 mainly relates to an increase in headcounts and costs within administrative functions following the acquired activities from Emergent BioSolutions. Furthermore, integration costs have also incurred in both periods.
Income before interest and tax (EBIT) was a profit of DKK 137 million, compared to a profit of DKK 916 million in the first six months of 2023, following the lower revenue and gross profit for the period. 2023 was positively impacted by high mpox vaccine revenue resulting from the outbreak.
EBITDA was a profit of DKK 441 million (profit of DKK 1,171 million). Amortization of product rights and developed production processes amounted to DKK 156 million (DKK 140 million) whereas depreciation on other fixed assets amounted to DKK 148 million (DKK 115 million). The increase in depreciations relates to the Bern production site (acquired as per May 15, 2023) and depreciations on the rebuilt plant in Kvistgaard.
Financial items totaled a net income of DKK 15 million (net income of DKK 3 million) and consisted of interest income of DKK 26 million (DKK 15 million), net gains on derivative financial instruments DKK 1 million (net gain of DKK 15 million), financial net income from securities of DKK 22 million (net income of DKK 30 million), and net foreign exchange rate gain of DKK 37 million (loss of DKK 7 million) due to increase in USD exchange rate. This is partly offset by interest expense on debt of DKK 3 million (DKK 7 million) and net value adjustment of deferred consideration of DKK 66 million (DKK 42 million) from the acquisition of Encepur and Rabipur/RabAvert and Vivotif and Vaxchora.
The net value adjustment of deferred consideration was an expense of DKK 66 million (DKK 42 million) and consists of three components; Adjustment of deferred consideration due to change in estimated timing of payments of DKK 8 million expense (income of DKK 7 million), currency adjustments of DKK 18 million expense (expense of DKK 4 million) and unwinding of the discounting effect related to deferred consideration of DKK 40 million (DKK 45 million), see note 6 and note 7.
Income before company tax was a gain of DKK 152 million (gain of DKK 919 million).
Tax on income was DKK 5 million (DKK 5 million). The effective tax rate is 3.4% for the Group. No tax has been recognized for the Parent Company due to a substantial non-recognized tax asset which can be utilized to reduce future income tax payables.
For the first six months of 2024, Bavarian Nordic reported a net profit of DKK 147 million (net gain of DKK 914 million).
Product rights recognized in the balance sheet totaled DKK 4,822 million (DKK 4,791 million as of December 31, 2023) and relates to Rabipur/RabAvert, Encepur, Vaxchora and Vivotif. In June 2024, based on higher than expected sales of Rabipur and Encepur during the second quarter of 2024, Management assessed it likely that Bavarian Nordic would reach the trigger for the sales milestone included in the Asset Purchase Agreement concluded in 2019 and this was finally confirmed by end of July 2024. The sales milestone of DKK 186 million has been recognized as an addition to the product rights and the deferred consideration.
Acquired rights and development in progress consist of the acquired chikungunya Phase 3 study and stood at DKK 1,287 million (DKK 1,287 million as of December 31, 2023). The chikungunya development asset consists of the initial calculated fair value of DKK 876 million, including the net present value of probable future development milestones, DKK 499 million.
Developed production processes relates to the technology transfer from GSK to Bavarian Nordic of the manufacturing process for Rabipur/RabAvert and Encepur and is recognized in the balance sheet with DKK 362 million. The transfer project has been running for the past 4 years in a staged process, starting with packaging then filling and ending with the transfer of bulk manufacturing. The Company has capitalized incurred costs related mainly to internal labor and consultancy work on the technology transfer process. The asset was finalized beginning of 2024 with an initial value of DKK 375 million and will be amortized over 10 years. The amortization costs will be included as part of the cost for future manufactured vaccines.
Securities, cash and cash equivalents were DKK 2,237 million as of June 30, 2024 (DKK 1,867 million as of December 31, 2023).
Cash flow generated by operating activities was positive by DKK 1,066 million (DKK 228 million). Cash flow from working capital increased by DKK 519 million (decreased by DKK 952 million), primarily following a very high receivable position at year-end 2023. Compared to December 31, 2023, the receivable position was brought down by DKK 706 million during first half of 2024. The payable position also contributed with a positive cash impact of DKK 165 million. As of December 31, 2023, the accounts payable position included received milestone invoices from GSK and AdaptVac in total of DKK 298 million. Both invoices were paid in January. As of June 30, 2024, the accounts payable position included a received milestone invoice from GSK of DKK 596 million. The invoice was paid in July. The positive cash impact from incoming customer payments and a higher payable position was partly offset by cash spend on building up of higher inventory position, DKK 349 million.
Cash flow from investment activities amounted to DKK 1,696 million (DKK 702 million) and related to investment in short term securities of DKK 1 billion and milestone payment to GSK following the completion of the transfer of the drug substance production process for Encepur, DKK 596 million.
The acquisition of subsidiaries and activities from Emergent BioSolutions in May 2023 amounted to DKK 1.8 billion.
Cash flow from financing activities was negative by DKK 37 million (positive by DKK 734 million), primarily related to purchase of treasury shares, DKK 28 million.
The net cash flow for the first six months of 2024 was negative by DKK 667 million compared to a positive cash contribution of DKK 260 million in first six months of 2023. Adjusted for the investment in securities of DKK 1 billion, the net cash flow for the first six months of 2024 was positive by DKK 364 million.
The Group's equity as of June 30, 2024, stood at DKK 10,437 million (DKK 10,340 million as of December 31, 2023).
Deferred consideration to GSK for purchase of product rights amounted to DKK 1,496 million and consists of likely milestone payments to GSK dependent on operational steps in the ongoing technology transfer of the Encepur and Rabipur related production activities and the sales milestone. Following the completion of the transfer of the drug substance production process for Encepur in June a milestone payment invoice of DKK 596 million was received and offset against the deferred consideration.
Deferred consideration to Emergent BioSolutions for purchase of their travel health business amounted to DKK 537 million and consists of milestone payments related to submission and approval of Biologics License Application (BLA) to FDA and Marketing Authorization Application to EMA.
All the above milestone payments are expected to be payable within the following 12 months.
The Company retains a yet undrawn sustainability-linked loan (SLL) of DKK 1 billion with Danske Bank and Nordea, which provides additional financial flexibility, e.g., to absorb fluctuations in working capital or to fulfil periodic significant milestone payments related to previous acquisitions.
Bavarian Nordic faces a number of risks and uncertainties, common for the biotech/pharma industry. These relate to operations, research and development, manufacturing, commercial and financial activities. For further information about risks and uncertainties which Bavarian Nordic faces, refer to page 37-39 "Risk Management" in the 2023 Annual Report.
Bavarian Nordic confirms its new guidance for the full year at the upper end of the range, with aggregated revenue of approximately DKK 5,300 million and EBITDA of approximately DKK 1,350 million.
The expected revenue of approximately DKK 5,300 million consists of approximately DKK 3,000 million from Public Preparedness, now largely all secured by contracts, approximately DKK 2,100 million from Travel Health and approximately DKK 200 million from contract work.
Travel Health anticipates a 12% growth, driven by a mix of continued market growth and market share gains.
Research and development costs of approximately DKK 850 million are expected, of which the chikungunya program represents nearly half. Similarly, the chikungunya program will impact manufacturing costs negatively by approximately DKK 240 million due to manufacturing of drug substance batches as part of the preparations for commercial launch in 2025. Pending approval of the vaccine, it is expected that these costs will be reversed and capitalized in 2025. Adjusting the implicit 2024 EBITDA margin for this effect would give an EBITDA margin range of 27-30%.
Net working capital is expected to increase by approximately DKK 900 million due to final inventory build-up before completion of tech-transfer of rabies and TBE manufacturing.
Other tangible investments of approximately DKK 300 million are expected.
Cash outflow in 2024 further includes milestone payments of approximately DKK 2,000 million to GSK and Emergent BioSolutions.
The outlook is based on the following assumptions on currency exchange rates of DKK 6.90 per 1 USD and DKK 7.45 per 1 EUR.
| DKK thousand | Note | 1/4-30/6 2024 | 1/4-30/6 2023 | 1/1-30/6 2024 | 1/1-30/6 2023 | 1/1-31/12 2023 |
|---|---|---|---|---|---|---|
| Revenue | 3 | 1,427,497 | 1,986,627 | 2,258,969 | 3,238,680 | 7,062,340 |
| Production costs | 4 | 707,547 | 683,729 | 1,273,784 | 1,112,126 | 2,459,294 |
| Gross profit | 719,950 | 1,302,898 | 985,185 | 2,126,554 | 4,603,046 | |
| Sales and distribution costs | 120,395 | 72,374 | 209,088 | 138,004 | 331,579 | |
| Research and development costs | 5 | 209,587 | 503,629 | 394,694 | 801,647 | 2,228,080 |
| Administrative costs | 124,075 | 180,685 | 244,405 | 270,938 | 540,848 | |
| Total operating costs | 454,057 | 756,688 | 848,187 | 1,210,589 | 3,100,507 | |
| Income before interest and tax (EBIT) | 265,893 | 546,210 | 136,998 | 915,965 | 1,502,539 | |
| Financial income | 6 | 26,894 | 26,363 | 78,842 | 66,709 | 112,784 |
| Financial expenses | 7 | 26,797 | 29,915 | 63,991 | 63,536 | 132,380 |
| Income before company tax | 265,990 | 542,658 | 151,849 | 919,138 | 1,482,943 | |
| Tax on income for the period | 4,862 | 4,579 | 5,172 | 4,692 | 7,754 | |
| Net profit for the period | 261,128 | 538,079 | 146,677 | 914,446 | 1,475,189 | |
| Earnings per share (EPS) - DKK | ||||||
| Basic earnings per share of DKK 10 | 3.3 | 7.1 | 1.9 | 12.1 | 19.2 | |
| Diluted earnings per share of DKK 10 | 3.3 | 7.1 | 1.9 | 12.1 | 19.2 |
| DKK thousand | 1/4-30/6 2024 | 1/4-30/6 2023 | 1/1-30/6 2024 | 1/1-30/6 2023 | 1/1-31/12 2023 |
|---|---|---|---|---|---|
| Net profit for the period | 261,128 | 538,079 | 146,677 | 914,446 | 1,475,189 |
| Other comprehensive income | |||||
| Remeasurements of defined benefit plans | - | - | - | - | (32,555) |
| Income tax | - | - | - | - | 4,505 |
| Items that will not be reclassified to the income statement | - | - | - | - | (28,050) |
| Recycled to financial items | - | - | - | - | (31,894) |
| Change in fair value of financial instruments entered into to hedge future cash flows |
8,924 | 15,774 | (27,429) | (19,452) | 45,887 |
| Exchange rate adjustments on translating foreign operations | (6,146) | (1,421) | (44,645) | (3,355) | 34,489 |
| Items that will be reclassified to the income statement | 2,778 | 14,353 | (72,074) | (22,807) | 48,482 |
| Other comprehensive income after tax | 2,778 | 14,353 | (72,074) | (22,807) | 20,432 |
| Total comprehensive income | 263,906 | 552,432 | 74,603 | 891,639 | 1,495,621 |
| DKK thousand | 1/1 - 30/6 2024 | 1/1 - 30/6 2023 | 1/1-31/12 2023 |
|---|---|---|---|
| Net profit for the period | 146,677 | 914,446 | 1,475,189 |
| Adjustment for non-cash items: | |||
| Financial income | (78,842) | (66,709) | (112,784) |
| Financial expenses | 63,991 | 63,536 | 132,380 |
| Tax on income for the period | 5,172 | 4,692 | 7,754 |
| Depreciation, amortization and impairment losses | 304,380 | 255,201 | 1,111,504 |
| Share-based payment | 46,936 | 31,596 | 55,477 |
| Changes in inventories | (348,979) | (459,811) | (599,015) |
| Changes in receivables | 706,301 | (780,209) | (1,345,427) |
| Changes in provisions | (3,087) | (371) | 24,744 |
| Changes in current liabilities | 164,831 | 288,400 | 368,739 |
| Cash flow from operations (operating activities) | 1,007,380 | 250,771 | 1,118,561 |
| Received financial income | 74,448 | 30,901 | 63,260 |
| Paid financial expenses | (10,016) | (50,550) | (52,412) |
| Paid company taxes | (5,717) | (3,336) | (10,203) |
| Cash flow from operating activities | 1,066,095 | 227,786 | 1,119,206 |
| Investments in products rights | (596,454) | - | (298,117) |
| Investments in other intangible assets | (11,601) | (376,738) | (536,763) |
| Investments in property, plant and equipment | (49,887) | (183,391) | (142,525) |
| Cash used for acquisition of businesses | - | (1,835,449) | (1,831,573) |
| Investments in/disposal of financial assets | (7,019) | (35,781) | (38,706) |
| Investments in securities | (1,047,586) | (10,832) | (10,834) |
| Disposal of securities | 16,959 | 1,740,608 | 1,912,954 |
| Cash flow from investment activities | (1,695,588) | (701,583) | (945,564) |
| Payment on loans | (947) | (1,104,614) | (1,105,545) |
| Proceeds from loans | - | 240,000 | 240,000 |
| Repayment of lease liabilities | (11,556) | (12,981) | (34,270) |
| Proceeds from warrant programs exercised | 2,741 | 21,459 | 45,517 |
| Proceeds from capital increase through private placement | - | 1,641,913 | 1,641,913 |
| Cost related to issue of new shares | - | (42,621) | (42,795) |
| Purchase of treasury shares | (27,459) | (8,988) | (8,988) |
| Cash flow from financing activities | (37,221) | 734,168 | 735,832 |
| Cash flow of the period | (666,714) | 260,371 | 909,474 |
| Cash as of 1 January | 1,477,234 | 575,407 | 575,407 |
| Currency adjustments 1 January | 5,882 | (3,976) | (7,647) |
| Cash end of period | 816,402 | 831,802 | 1,477,234 |
| DKK thousand | Note | 30/6 2024 | 30/6 2023 | 31/12 2023 |
|---|---|---|---|---|
| Assets | ||||
| Product rights | 4,821,957 | 5,360,221 | 4,791,442 | |
| Acquired rights and development in progress | 1,286,749 | 2,169,752 | 1,286,749 | |
| Developed production processes | 362,362 | - | - | |
| Software | 8,205 | 18,141 | 12,443 | |
| Intangible assets in progress | 27,706 | 356,162 | 391,102 | |
| Intangible assets | 6,506,979 | 7,904,276 | 6,481,736 | |
| Land and buildings | 955,111 | 933,098 | 987,013 | |
| Leasehold improvements | 21,431 | 22,950 | 25,047 | |
| Plant and machinery | 388,968 | 407,603 | 412,674 | |
| Fixtures and fittings, other plant and equipment | 659,822 | 716,105 | 696,060 | |
| Assets under construction | 224,223 | 242,948 | 206,721 | |
| Property, plant and equipment | 2,249,555 | 2,322,704 | 2,327,515 | |
| Right-of-use assets | 104,618 | 100,925 | 125,170 | |
| Other receivables | 9,445 | 12,156 | 11,185 | |
| Prepayments | 13,315 | 236,371 | 4,556 | |
| Financial assets | 22,760 | 248,527 | 15,741 | |
| Deferred tax assets | - | 1,723 | - | |
| Total non-current assets | 8,883,912 | 10,578,155 | 8,950,162 | |
| Inventories | 8 | 1,992,715 | 1,508,403 | 1,643,736 |
| Trade receivables | 9 | 1,059,820 | 1,310,244 | 1,778,104 |
| Tax receivables | 84 | 84 | 84 | |
| Other receivables | 10 | 46,074 | 33,824 | 95,136 |
| Prepayments | 54,656 | 177,632 | 18,510 | |
| Receivables | 1,160,634 | 1,521,784 | 1,891,834 | |
| Securities | 1,420,782 | 553,097 | 390,247 | |
| Cash and cash equivalents | 816,402 | 831,802 | 1,477,234 | |
| Securities, cash and cash equivalents | 2,237,184 | 1,384,899 | 1,867,481 | |
| Total current assets | 5,390,533 | 4,415,086 | 5,403,051 | |
| Total assets | 14,274,445 | 14,993,241 | 14,353,213 |
| DKK thousand Note |
30/6 2024 | 30/6 2023 | 31/12 2023 |
|---|---|---|---|
| Equity and liabilities | |||
| Share capital | 781,165 | 779,286 | 780,978 |
| Treasury shares | (2,843) | (1,537) | (1,537) |
| Retained earnings | 9,461,138 | 8,766,964 | 9,330,002 |
| Other reserves | 197,257 | 141,038 | 230,489 |
| Equity | 10,436,717 | 9,685,751 | 10,339,932 |
| Deferred consideration for product rights | - | 1,415,870 | 1,016,856 |
| Prepayment and loan from Government | - | 806,420 | - |
| Debt to credit institutions | 14,188 | 16,053 | 15,135 |
| Retirement benefit obligations | 77,645 | 55,617 | 80,732 |
| Deferred tax liabilities | 27,957 | 27,421 | 29,068 |
| Lease liabilities | 68,538 | 59,690 | 83,621 |
| Non-current liabilities | 188,328 | 2,381,071 | 1,225,412 |
| Deferred consideration for product rights | 2,033,052 | 1,737,888 | 1,360,133 |
| Debt to credit institutions | 1,913 | 1,924 | 1,913 |
| Lease liabilities | 39,973 | 44,044 | 44,633 |
| Prepayment from customers | 35 | 111 | - |
| Trade payables | 1,124,787 | 764,233 | 954,142 |
| Company tax | 6,929 | 7,469 | 7,205 |
| Other liabilities 11 |
442,711 | 370,750 | 419,843 |
| Current liabilities | 3,649,400 | 2,926,419 | 2,787,869 |
| Total liabilities | 3,837,728 | 5,307,490 | 4,013,281 |
| Total equity and liabilities | 14,274,445 | 14,993,241 | 14,353,213 |
| Reserves for | Reserves for fair value of |
||||||
|---|---|---|---|---|---|---|---|
| DKK thousand | Share capital | Treasury shares |
Retained earnings |
currency adjustment |
financial instruments |
Share-based payment |
Equity |
| Equity as of January 1, 2024 | 780,978 | (1,537) | 9,330,002 | 10,932 | 45,887 | 173,670 | 10,339,932 |
| Comprehensive income for the period | |||||||
| Net profit | - | - | 146,677 | - | - | - | 146,677 |
| Other comprehensive income | |||||||
| Exchange rate adjustments on translating foreign operations |
- | - | - | (27,429) | - | - | (27,429) |
| Change in fair value of financial instruments entered into to hedge future cash flows |
- | - | - | - | (44,645) | - | (44,645) |
| Total comprehensive income for the period | - | - | 146,677 | (27,429) | (44,645) | - | 74,603 |
| Transactions with owners | |||||||
| Share-based payment | - | - | - | - | - | 46,937 | 46,937 |
| Warrant program exercised | 187 | - | 3,227 | - | - | (673) | 2,741 |
| Cost related to issue of new shares | - | - | (37) | - | - | - | (37) |
| Purchase of treasury shares | - | (1,623) | (25,836) | - | - | - | (27,459) |
| Transfer regarding restricted stock units | - | 317 | 7,105 | - | - | (7,422) | - |
| Total transactions with owners | 187 | (1,306) | (15,541) | - | - | 38,842 | 22,182 |
| Equity as of June 30, 2024 | 781,165 | (2,843) | 9,461,138 | (16,497) | 1,242 | 212,512 | 10,436,717 |
| DKK thousand | Share capital | Treasury shares |
Retained earnings |
Reserves for currency adjustment |
Reserves for fair value of financial instruments |
Share-based payment |
Equity |
|---|---|---|---|---|---|---|---|
| Equity as of January 1, 2023 | 707,354 | (1,463) | 6,300,575 | (23,557) | 31,894 | 135,184 | 7,149,987 |
| Comprehensive income for the period | |||||||
| Net profit | - | - | 914,446 | - | - | - | 914,446 |
| Other comprehensive income | |||||||
| Exchange rate adjustments on translating foreign operations |
- | - | - | (3,355) | - | - | (3,355) |
| Change in fair value of financial instruments entered into to hedge future cash flows |
- | - | - | - | (19,452) | - | (19,452) |
| Total comprehensive income for the period | - | - | 914,446 | (3,355) | (19,452) | - | 891,639 |
| Transactions with owners | |||||||
| Share-based payment | - | - | - | - | - | 32,362 | 32,362 |
| Warrant program exercised | 1,464 | - | 25,613 | - | - | (5,618) | 21,459 |
| Capital increase through rights issue | 70,468 | - | 1,571,445 | - | - | - | 1,641,913 |
| Cost related to issue of new shares | - | - | (42,621) | - | - | - | (42,621) |
| Purchase of treasury shares | - | (440) | (8,548) | - | - | - | (8,988) |
| Transfer regarding restricted stock units | - | 366 | 6,054 | - | - | (6,420) | - |
| Total transactions with owners | 71,932 | (74) | 1,551,943 | - | - | 20,324 | 1,644,125 |
| Equity as of June 30, 2023 | 779,286 | (1,537) | 8,766,964 | (26,912) | 12,442 | 155,508 | 9,685,751 |
The interim financial statements are prepared in accordance with IAS 34, Interim Financial Reporting, as adopted by EU and the additional Danish requirements for submission of interim reports for companies listed on Nasdaq Copenhagen. The interim report has not been audited or reviewed by the Company's auditors.
The interim financial statements are presented in Danish Kroner (DKK), which is considered the primary currency of the Group's activities and the functional currency of the parent company.
The accounting policies used in the interim financial statements are consistent with those used in the consolidated financial statements for 2023 and in accordance with the recognition and measurement policies in the International Financial Reporting Standards (IFRS) as adopted by EU.
As of June 30, 2024, the Company has implemented all new or amended accounting standards and interpretations as adopted by the EU and applicable for the 2024 financial year. None of the new or amended standards or interpretations are assessed to have significant impact on the consolidated financial statements.
In the preparation of the interim financial statements according to IAS 34, Interim Financial Reporting, as adopted by the EU, Management is required to make certain estimates as many financial statement items cannot be reliably measured but must be estimated. Such estimates comprise judgments made on the basis of the most recent information available at the reporting date. It may be necessary to change previous estimates as a result of changes to the assumptions on which the estimates were based or due to supplementary information, additional experience or subsequent events.
Similarly, the value of assets and liabilities often depends on future events that are somewhat uncertain. In that connection, it is necessary to set out e.g. a course of events that reflects Management's assessment of the most probable course of events.
Further to the key accounting estimates, assumptions and uncertainties, which are stated in the Annual Report 2023, the Management has not changed key estimates and judgments regarding recognition and measurement.
| DKK thousand | 1/4 - 30/6 2024 |
1/4 - 30/6 2023 |
1/1 - 30/6 2024 |
1/1 - 30/6 2023 |
1/1-31/12 2023 |
|---|---|---|---|---|---|
| 3. Revenue | |||||
| Travel health | |||||
| Rabipur/RabAvert | 333,476 | 312,671 | 568,439 | 555,142 | 1,161,162 |
| Encepur | 201,745 | 211,487 | 327,253 | 298,557 | 416,756 |
| Vivotif | 54,935 | 27,496 | 97,925 | 27,496 | 118,885 |
| Vaxchora | 21,321 | 7,024 | 32,809 | 7,024 | 23,736 |
| Other product sale | 60,473 | 37,928 | 92,795 | 81,117 | 156,533 |
| 671,950 | 596,606 | 1,119,221 | 969,336 | 1,877,072 | |
| Public preparedness | |||||
| Mpox/smallpox vaccine sale | 679,652 | 1,334,340 | 1,023,500 | 2,182,185 | 5,027,001 |
| Sale of goods | 1,351,602 | 1,930,946 | 2,142,721 | 3,151,521 | 6,904,073 |
| Contract work | 75,895 | 55,681 | 116,248 | 87,159 | 158,267 |
| Sale of services | 75,895 | 55,681 | 116,248 | 87,159 | 158,267 |
| Revenue | 1,427,497 | 1,986,627 | 2,258,969 | 3,238,680 | 7,062,340 |
| Total revenue includes: | |||||
| Fair value adjustment concerning financial instruments entered into to hedge revenue |
1,493 | - | 15,561 | - | - |
| 4. Production costs | |||||
| Cost of goods sold | 444,377 | 502,003 | 693,511 | 770,077 | 1,608,263 |
| Contract costs | 56,272 | 39,647 | 86,336 | 64,487 | 126,877 |
| Other production costs | 129,142 | 71,818 | 338,014 | 137,510 | 426,125 |
| Amortization product rights | 77,756 | 70,261 | 155,923 | 140,052 | 298,029 |
| Production costs | 707,547 | 683,729 | 1,273,784 | 1,112,126 | 2,459,294 |
| 5. Research and development costs | |||||
| Research and development costs occurred in the period | 265,859 | 543,276 | 481,030 | 866,134 | 1,797,274 |
| Of which: | |||||
| Contract costs recognized as production costs | (56,272) | (39,647) | (86,336) | (64,487) | (126,877) |
| Impairment loss of ABNCoV2 development program | - | - | - | - | 557,683 |
| Research and development costs | 209,587 | 503,629 | 394,694 | 801,647 | 2,228,080 |
| Impairment loss of ABNCoV2 development program | |||||
| Acquired rights and development in progress | - | - | - | - | 1,403,264 |
| Intangible assets in progress | - | - | - | - | 26,224 |
| Prepayments Prepayment and loan from Government |
- - |
- - |
- - |
- - |
456,551 (806,420) |
| Deferred consideration | - | - | - | - | (521,936) |
| Impairment loss of ABNCoV2 development program | - | - | - | - | 557,683 |
| 6. Financial income | |||||
| Financial income from bank and deposit contracts1 | 9,549 | 11,908 | 26,361 | 15,217 | 40,214 |
| Financial income from securities | 12,652 | 2,301 | 19,226 | 8,308 | 14,340 |
| Fair value adjustments on securities | 2,994 | (6,302) | 2,994 | 21,282 | 30,777 |
| Adjustment of deferred consideration due to change in estimated timing of payments |
(2,004) | 7,552 | (8,160) | 6,815 | 13,759 |
| Currency adjustment deferred consideration | - | - | - | - | 2,563 |
| Net gains on derivative financial instruments at fair value | |||||
| through the income statement (held for trading) | - | 10,904 | 907 | 15,087 | 11,131 |
| Net foreign exchange gains | 3,703 | - | 37,514 | - | - |
| Financial income | 26,894 | 26,363 | 78,842 | 66,709 | 112,784 |
1 Interest income on financial assets measured at amortized cost
| DKK thousand | 1/4 - 30/6 2024 |
1/4 - 30/6 2023 |
1/1 - 30/6 2024 |
1/1 - 30/6 2023 |
1/1-31/12 2023 |
|---|---|---|---|---|---|
| 7. Financial expenses | |||||
| Interest expenses on debt1 | 1,250 | 793 | 2,866 | 7,032 | 3,558 |
| Fair value adjustments on securities Unwinding of the discounting effect related to deferred |
(1,121) | - | - | - | - |
| consideration | 20,142 | 21,359 | 40,285 | 45,344 | 101,961 |
| Currency adjustment deferred consideration | 5,339 | (390) | 17,884 | 3,825 | - |
| Financial expenses, other | 1,187 | - | 2,956 | - | 11,469 |
| Net foreign exchange losses | - | 8,153 | - | 7,335 | 15,392 |
| Financial expenses | 26,797 | 29,915 | 63,991 | 63,536 | 132,380 |
1 Interest expenses on financial liabilities measured at amortized cost
| DKK thousand | 30/6 2024 | 30/6 2023 | 31/12 2023 |
|---|---|---|---|
| 8. Inventories | |||
| Raw materials and supply materials | 309,891 | 433,510 | 317,392 |
| Work in progress | 1,168,140 | 908,130 | 1,231,857 |
| Manufactured goods and commodities | 718,253 | 309,083 | 319,102 |
| Write-down on inventory | (203,569) | (142,319) | (224,615) |
| Inventories | 1,992,715 | 1,508,403 | 1,643,736 |
| Write-down on inventory 1 January | (224,615) | (162,419) | (162,419) |
| Additions from acquisition of businesses | - | - | (14,498) |
| Write-down during the period | (49,938) | - | (75,300) |
| Use of write-down | 50,984 | 20,100 | 27,602 |
| Reversal of write-down | 20,000 | - | - |
| Write-down end of period | (203,569) | (142,319) | (224,615) |
| 9. Trade receivables | |||
| Trade receivables from public preparedness business | 377,915 | 838,062 | 1,660,604 |
| Trade receivables from travel health business | 681,082 | 469,485 | 110,832 |
| Trade receivables from contract work | 823 | 2,697 | 6,668 |
| Trade receivables | 1,059,820 | 1,310,244 | 1,778,104 |
| 10. Other receivables | |||
| Receivable VAT and duties | 29,522 | 17,444 | 46,585 |
| Derivative financial instruments at fair value | 4,328 | 12,442 | 45,887 |
| Interest receivables | 12,224 | 3,933 | 2,664 |
| Other receivables | - | 5 | - |
| Other receivables | 46,074 | 33,824 | 95,136 |
| 11. Other liabilities | |||
| Liability relating to phantom shares | - | 1,814 | - |
| Payable salaries, holiday accrual etc. | 175,470 | 151,919 | 212,122 |
| Gross to net deduction accrual | 221,838 | 169,560 | 159,802 |
| Other accrued costs | 45,403 | 47,457 | 47,919 |
| Other liabilities | 442,711 | 370,750 | 419,843 |
Fair value hierarchy for financial instruments measured at fair value
| DKK thousand | Level 1 | Level 2 | Total |
|---|---|---|---|
| Securities | 1,420,782 | - | 1,420,782 |
| Derivative financial instruments at fair value through the income statement | |||
| (currency) | - | 3,086 | 3,086 |
| Financial assets measured at fair value through the income statement | 1,420,782 | 3,086 | 1,423,868 |
| Derivative financial instruments to hedge future cash flow (currency) | - | 75 | 75 |
| Derivative financial instruments to hedge future cash flow (interest) | - | 1,167 | 1,167 |
| Financial assets/liabilities used as hedging instruments | - | 1,242 | 1,242 |
| DKK thousand | Level 1 | Level 2 | Total |
|---|---|---|---|
| Securities | 390,247 | - | 390,247 |
| Financial assets measured at fair value through the income statement | 390,247 | - | 390,247 |
| Derivative financial instruments to hedge future cash flow (currency) | - | 44,784 | 44,784 |
| Derivative financial instruments to hedge future cash flow (interest) | - | 1,103 | 1,103 |
| Financial assets/liabilities used as hedging instruments | - | 45,887 | 45,887 |
| Outstanding as of January 1 |
Additions | Warrants exercised |
Annulled Terminated | Trans ferred |
Outstanding as of June 30 |
||
|---|---|---|---|---|---|---|---|
| Corporate Management | 669,064 | - | - | - | - | - | 669,064 |
| Other Executive Management | 484,041 | - | - | - | - | (129,050) | 354,991 |
| Other employees | 2,916,601 | - | (18,702) | (128,229) | - | (98,416) | 2,671,254 |
| Resigned employees | 451,209 | - | - | - | - | 227,466 | 678,675 |
| Total | 4,520,915 | - | (18,702) | (128,229) | - | - | 4,373,984 |
| Weighted average exercise price | 226 | - | 147 | 254 | - | - | 226 |
| Weighted average share price at exercise |
175 | ||||||
| Numbers of warrants which can be exercised as of June 30, 2024 | 1,567,390 | ||||||
| at a weighted average exercise price of DKK | 188 |
The total recognized cost of the warrant programs was DKK 30.1 million in the first six months of 2024 (DKK 23.8 million).
| DKK | Nov 2019 |
Jan 2020 |
Nov 2020 |
Nov 2021 |
Apr 2022 |
Dec 20223) |
Dec 20233 |
|---|---|---|---|---|---|---|---|
| Average share price | 154.05 | 171.20 | 179.84 | 307.20 | 171.35 | 224.70 | 172.40 |
| Average exercise price at grant | 185.40 | 197.00 | 206.82 | 353.06 | 190.11 | 270.91 | 191.58 |
| Average exercise price at grant - Executive Management Average exercise price determined at date of rights issue March 30, |
- | - | - | - | - | 224.70 | 172.40 |
| 2020 (DKK) | 146.60 | 155.80 | - | - | - | - | - |
| Applied volatility rate2 | 52.2% | 53.0% | 39.8% | 41.8% | 42.3% | 46.6% | 53.3% |
| Expected life (years) | 3.0 | 3.0 | 3.0 | 3.0 | 3.0 | 3.0 | 3.0 |
| Expected dividend per share | - | - | - | - | - | - | - |
| Risk-free interest rate p.a. | -0.69% | -0.65% | -0.66% | -0.53% | 0.39% | 2.04% | 2.55% |
| Fair value at grant1 | 45 | 53 | 41 | 76 | 47 | 64 | 62 |
| Fair value at grant - Executive Management1 |
78 | 68 |
1 Fair value of each warrant applying the Black-Scholes model
2 The applied volatility is based on the historical volatility of the Bavarian Nordic share, except for November 2020, November 2021 and April 2022 programs where the volatility is based on the volatility for a peer group.
3 The December 2022 and December 2023 programs have two set of exercise conditions. Executive Management can subscribe future shares at a exercise price of DKK 224.70/DKK 172.40 per share equivalent to the market price of Bavarian Nordic's shares at the time of grant. Vesting of the warrants is subject to prior fulfilment of KPI's as determined by the Board of Directors. Other employees can subscribe future shares at a exercise price of DKK 270.91/DKK 191.58 per share, determined as the average market price (closing price) of the Company's shares on Nasdaq Copenhagen over a period of 15 business days prior to grant plus 15%.
No significant changes in contingent liabilities and other contractual obligations have occurred since December 31, 2023.
On July 18, 2024, Bavarian Nordic announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA), which was submitted in June 2024 for CHIKV VLP, the Company's vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older.
On August 8, 2024, Bavarian Nordic announced a new order valued at USD 156.8 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to manufacture additional bulk product for JYNNEOS® , the company's smallpox/mpox vaccine.
On August 13, 2024, Bavarian Nordic announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for CHIKV VLP, the Company's vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older.
On August 13, 2024, Bavarian Nordic announced a new order for 175,420 doses of the Company's mpox vaccine from the European Health Emergency Preparedness and Response Authority (HERA) for donation to the Africa CDC, in addition to 40,000 doses donated by Bavarian Nordic.
On August 21, 2024, Bavarian Nordic received a new order to supply 440,000 doses of smallpox and mpox vaccines to a non-disclosed European country.
The unaudited condensed consolidated interim financial statements were approved by the Board of Directors and Corporate Management and authorized for issue on August 22, 2024.
The Board of Directors and Corporate Management have, today reviewed and approved the Bavarian Nordic A/S interim report for the period January 1 to June 30, 2024.
The interim report has been prepared in accordance with IAS 34 "Interim Financial Reporting" as adopted by the EU and additional Danish disclosure requirements for interim reports of listed companies, including those of Nasdaq Copenhagen.
In our opinion, the interim report gives a true and fair view of the group's assets and liabilities and financial position as of June 30, 2024, and the results of the group's activities and cash flows for the period January 1 to June 30, 2024.
In our opinion, the management's review provides a true and fair description of the development in the group's activities and financial affairs, the results for the period and the group's financial position as a whole as well as a description of the most important risks and uncertainty factors faced by the group.
Hellerup, August 22, 2024
Corporate Management:
Paul John Chaplin Henrik Juuel
President & CEO Executive Vice President & CFO
Board of Directors:
Chairman of the Board Deputy Chairman
Anne Louise Eberhard Johan van Hoof Heidi Hunter Montse Montaner
Employee-elected Employee-elected Employee-elected Employee-elected
Luc Debruyne Anders Gersel Pedersen Frank A.G.M. Verwiel
Thomas Alex Bennekov Anja Gjøl Karen Merete Jensen Linette Munksgaard Andersen
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