Interim / Quarterly Report • Aug 25, 2021
Interim / Quarterly Report
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Company Announcement
COPENHAGEN, Denmark, August 25, 2021 – Bavarian Nordic A/S (OMX: BAVA) announced today its interim financial results and business progress for the first half of 2021 and releases its financial calendar for 2022.
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We are very pleased to confirm the successful execution of our commercial strategy with nearly 30 Rabipur/RabAvert and Encepur markets now transferred to Bavarian Nordic. Our objective during this transition was to stop the historical market share losses before the acquisition of these products, start gaining more ground and increase the awareness of Bavarian Nordic among health care professionals and we are pleased that we today can tick all these boxes, despite that the markets are still impacted by COVID-19. Both the rabies and TBE markets are still suffering from a low level of international travel and limited availability of physicians for non-COVID vaccinations in certain markets and due to this alone, we are firming up our financial guidance for 2021 to reflect the lower end of the previously guided intervals.
So far this year, we also received new orders for our Ebola and smallpox vaccines and saw very important advancements in our pipeline assets with our promising COVID-19 vaccine candidate, ABNCoV2 entering Phase 2 after reporting highly promising clinical results. The recent agreement with the Danish Ministry of Health to provide aid for developing ABNCoV2 is a strong recognition of the technology and Bavarian Nordic to develop a highly promising general booster against COVID-19. With this funding, together with our existing commitment to fund the program to the end of Phase 2, we have sufficient funds to execute the existing plans to develop ABNCoV2 through to licensure. We look forward to reporting the Phase 2 results for ABNCoV2, as well as additional pivotal results from the RSV human challenge trial later this year."
| DKK million | Q2 2021 | Q2 2020 | H1 2021 | H1 2020 | 2021 Guidance |
|---|---|---|---|---|---|
| Revenue | 370 | 700 | 905 | 1,065 | ~1,900 |
| EBITDA | (9) | 197 | (8) | 839* | ~100 |
| Securities, cash and cash equivalents | 2,208** | 2,380 | 2,208** | 2,380 | ~1,400 |
* EBITDA in H1 2020 was positively impacted by the sale of the Priority Review Voucher (DKK 628 million). ** Repo pledged securities deducted.
The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am EST) to present the interim results followed by a Q&A session. A listen-only version of the call can be accessed via https://www.bavarian-nordic.com/investor/events.aspx?event=6096. To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495. Participant code is 8569159.
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43 US: Graham Morrell, Paddock Circle Advisors, [email protected], Tel: +1 781 686 9600
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. government of a non-replicating smallpox vaccine, which has been approved by the FDA under the trade name JYNNEOS® , also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe under the trade name IMVANEX® and in Canada under the trade name IMVAMUNE® . Our commercial product portfolio furthermore contains the market-leading vaccine Rabipur®/RabAvert® against rabies and Encepur® against tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN® , we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, Mvabea® , which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine based on an in-licensed capsid virus-like particle technology. The vaccine candidate, ABNCoV2, is currently being investigated in clinical trials. 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 2021 | 1/4 - 30/6 2020 | 1/1 - 30/6 2021 | 1/1 - 30/6 2020 | 1/1-31/12 2020 |
|---|---|---|---|---|---|
| Income statements | |||||
| Revenue | 369,999 | 699,575 | 905,252 | 1,064,980 | 1,852,383 |
| Production costs | 249,301 | 379,486 | 626,642 | 622,570 | 1,195,094 |
| Sales and distribution costs | 47,061 | 75,017 | 98,096 | 149,864 | 285,783 |
| Research and development costs | 97,077 | 57,978 | 219,217 | 124,059 | 341,420 |
| Administrative costs | 83,200 | 74,881 | 155,930 | 126,333 | 278,145 |
| Other operating income | - | - | - | 627,647 | 627,647 |
| Income before interest and taxes (EBIT) | (106,640) | 112,213 | (194,633) | 669,801 | 379,588 |
| Financial items, net | (41,493) | (223) | (83,231) | (42,224) | (97,612) |
| Income before company tax | (148,133) | 111,990 | (277,864) | 627,577 | 281,976 |
| Net profit for the period | (150,258) | 111,275 | (281,103) | 625,853 | 277,521 |
| Balance sheet | |||||
| Total non-current assets | 6,426,395 | 6,354,989 | 6,378,017 | ||
| Securities, cash and cash equivalents | 2,513,448 | 2,379,907 | 1,669,607 | ||
| Other current assets | 1,068,535 | 507,814 | 711,440 | ||
| Total assets | 10,008,378 | 9,242,710 | 8,759,064 | ||
| Equity | 5,788,550 | 5,251,149 | 4,894,353 | ||
| Non-current liabilities | 2,391,883 | 3,256,008 | 2,912,401 | ||
| Current liabilities | 1,827,945 | 735,553 | 952,310 | ||
| Cash flow statements | |||||
| Cash flow from operating activities | (377,266) | 672,281 | 571,911 | ||
| Cash flow from investment activities | (1,179,496) | (1,944,953) | (1,911,532) | ||
| - Investment in intangible assets | (41,633) | (52,000) | (501,877) | ||
| - Investment in property, plant and equipment | (171,411) | (66,261) | (204,833) | ||
| - Net investment in securities | (965,891) | (1,824,178) | (1,202,145) | ||
| Cash flow from financing activities | 1,454,979 | 1,351,992 | 1,334,874 | ||
| Financial Ratios1) | |||||
| EBITDA after Other operating income | (9,249) | 197,413 | (7,985) | 838,618 | 739,736 |
| EBITDA before Other operating income | (9,249) | 197,413 | (7,985) | 210,971 | 112,089 |
| Earnings (basic) per share of DKK 10 | (4.6) | 12.6 | 5.1 | ||
| Net asset value per share | 90.7 | 89.8 | 83.7 | ||
| Share price at period-end | 259 | 181 | 187 | ||
| Share price/Net asset value per share | 2.9 | 2.0 | 2.2 | ||
| Number of outstanding shares at period-end (thousand)2) |
63,817 | 58,450 | 58,450 | ||
| Equity share | 58% | 57% | 56% | ||
| Number of employees, converted to full-time, at period-end |
730 | 604 | 690 |
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.
2) Number of shares increased by 5,150,000 at completion of private placement March 2021.
| Reconciliation of EBITDA | |||||
|---|---|---|---|---|---|
| Income before interest and tax (EBIT) | (106,640) | 112,213 | (194,633) | 669,801 | 379,588 |
| Depreciation and amortization | 97,391 | 85,200 | 186,648 | 168,817 | 360,148 |
| EBITDA after Other operating income | (9,249) | 197,413 | (7,985) | 838,618 | 739,736 |
Comparative figures for 2020 are shown in brackets. Where market shares are mentioned, these are measured by value.
| Q2 sales | |||
|---|---|---|---|
| mDKK | Q2 2021 | Q2 2020 | Growth |
| Rabipur/RabAvert | 127 | 142 | -10% |
| Encepur | 146 | 193 | -24% |
| JYNNEOS | - | 320 | - |
| Mvabea (Ebola) | 89 | - | - |
| Contract work | 8 | 45 | -83% |
| Total | 370 | 700 | |
Rabipur/RabAvert revenue amounted to DKK 127 million (DKK 142 million) for the second quarter. The 10% decrease versus the prior year was primarily caused by expected market share loss from competition being back after a temporary stock-out.
The US market grew by 5-6% compared with last year in the period January to May, but the market is still significantly below the pre-COVID-19 level. The US market share end of May was approximately 68%, which is approximately 7 percentage points higher than the level prior to the competitor out-of-stock situation.
European revenue remains very low due to COVID-19 and the impact on travelling to endemic rabies countries. The market is down approximately 90% compared to the pre-COVID-19 market.
For the first half year Rabipur/RabAvert revenue amounted to DKK 207 million (DKK 360 million), i.e. a decrease of 42%.
Encepur revenue amounted to DKK 146 million (DKK 193 million) for the second quarter, i.e. a decrease of 24% versus prior year primarily caused by a significant market decline in Germany.
The Q2 2021 German market declined by nearly 26%, due to lack of resources for TBE vaccinations as general practitioners were focused on COVID-19 vaccinations. This decline followed a promising first quarter with an 8% market growth. The German market share was 32% by end of June, which is in line with prior year.
| H1 sales | |||
|---|---|---|---|
| mDKK | H1 2021 | H1 2020 | Growth |
| Rabipur/RabAvert | 207 | 360 | -42% |
| Encepur | 245 | 295 | -17% |
| JYNNEOS | 336 | 320 | 5% |
| Mvabea (Ebola) | 89 | - | - |
| Contract work | 28 | 90 | -69% |
| Total | 905 | 1,065 |
For the first half year Encepur revenue amounted to DKK 245 million (DKK 295 million), i.e. a decrease of 17%.
Revenue from the sale of JYNNEOS/IMVANEX/IMVAMUNE in the second quarter was DKK 0 million (DKK 320 million). For the first half year JYNNEOS/IMVANEX/IMVAMUNE revenue was DKK 336 million, of which DKK 246 million was related to orders from the US government and DKK 90 million was related to rest of World orders.
Revenue from the sale of Mvabea to Janssen was DKK 89 million in the second quarter and in the first half of the year (DKK 0 million/DKK 0 million). The revenue was all related to the order announced in June 2020.
Revenue from contract work in the second quarter was DKK 8 million (DKK 45 million), mainly stemming from qualification and validation activities relating to the fill-and-finish plant and the Phase 3 trial of the freeze-dried version of the smallpox vaccine, both under contracts with the US government. For the first half year revenue from contract work amounted to DKK 28 million (DKK 90 million).
| PRODUCT | INDICATION |
|---|---|
| Rabipur®/RabAvert® | Rabies |
| Encepur® | Tick-borne encephalitis (TBE) |
| JYNNEOS®/IMVAMUNE®/IMVANEX® (liquid-frozen) | Smallpox (and Monkeypox in the US) |
| Mvabea® (licensed to Janssen) | Ebola |
Bavarian Nordic's fundamental mission is to save and improve lives by unlocking the power of the immune system and in the medium term, we have established a bold vision and aspiration to become one of the largest pure play vaccine companies by developing innovative life-saving vaccines, excelling in commercialization and being a best-in-class vaccine manufacturer.
Commercial execution remains on track with the remaining markets for Rabipur/RabAvert and Encepur, except Japan, now transferred from GSK in accordance with plans and in record time. In addition, market shares have either been maintained or increased during the transition and the awareness of Bavarian Nordic among health care practitioners have increased in key markets.
In May, the Company entered an agreement with Dynavax on marketing and distribution of their HEPLISAV-B® hepatitis B vaccine in Germany with expected launch in the first half of 2022. The vaccine was granted marketing authorization by the European Commission in February 2021. The vaccine will complement and strengthen Bavarian Nordic's commercial portfolio in Germany, which, in addition to the Company's own vaccines for rabies and tick-borne encephalitis, also will include Valneva's vaccines for Japanese Encephalitis and cholera from 2022 as part of the mutual marketing and distribution agreement entered last year.
Several key pipeline projects have advanced during the first half, supporting the Company's strategy to develop innovative lifesaving vaccines.
In August, Bavarian Nordic advanced the development of ABNCoV2, the capsid virus like particle (cVLP) COVID-19 vaccine candidate licensed from AdaptVac, by initiating a Phase 2 clinical trial to investigate the potential of ABNCoV2 as a booster vaccine for individuals with previous COVID-19 disease or vaccination. The trial will enroll 150 healthy adults with existing immunity against SARS-CoV-2, acquired through previous disease or from prior immunization with approved COVID-19 vaccines, and will investigate the ability of a single vaccination with ABNCoV2 to boost existing levels of SARS-CoV-2 neutralizing antibodies across all groups. A second arm in the trial will enroll up to 60 healthy adults with no prior vaccination or disease who will receive two vaccinations for evaluation of neutralizing antibody levels from ABNCoV2 when used as a prime-boost vaccine. In both groups, neutralizing immune responses against circulating variants of SARS-CoV2 will be evaluated, as high levels of neutralizing antibodies have been reported as highly predictive of protection against COVID-191 . Initial trial results are expected in the fourth quarter of 2021.
In parallel with the Phase 2 trial, Bavarian Nordic is preparing for a Phase 3 trial of ABNCoV2 in 2022.
A funding agreement, valued at up to DKK 800 million, was entered with the Danish Ministry of Health in August to support the completion of the development of ABNCoV2 towards licensure. Under the agreement, which is subject to final approval by the Finance Committee of the Danish Parliament, Bavarian Nordic is entitled to an upfront payment of DKK 80 million, in addition to payments of up to DKK 720 million, which are contingent upon reaching a number of predefined milestones including among others completion of the ongoing Phase 2 trial, Phase 3 development milestones and milestones related to upscaling of manufacturing for commercial production of the vaccine.
All payments are potentially subject to repayment, however only upon successful marketing authorization of the vaccine by the European Commission. Repayment may occur via supply of vaccines and royalty payments from the sale of the vaccine to other customers. Royalty payments are only triggered upon reaching a certain volume in sales. The Danish Ministry of Health could be entitled to an additional, capped royalty payment if the sales reach a certain threshold above the sales volume for the ordinary royalty payment.
Earlier in August, initial data from the first-in-human study of ABNCoV2 were reported. The study was conducted by AdaptVac and the PREVENT-nCoV consortium under a Horizon 2020 EU grant. The Phase 1/2 dose-escalation trial enrolled 45 healthy SARS-CoV-2-naïve adult volunteers at the Radboud University Medical Centre in the Netherlands, who received two doses (dose ranges from 6- 70 μg) of ABNCoV2, formulated with and without adjuvant. The results demonstrate that the vaccine was well tolerated across all dose groups with no observed difference in the adverse event profile after first and second vaccinations. No serious adverse events were reported, and the safety profile was comparable to other vaccines based on recombinant protein-technology.
In all dose groups, antibody titers were significantly higher after the boost vaccination and were up to 12-fold higher than those measured in convalescent human samples and significantly higher than those reported for current approved COVID-19 vaccines. Importantly, high neutralization titers were demonstrated against all SARS-CoV-2 variants of concern, including the dominant Delta variant.
Final results from the study are expected later in the second half of 2021.
As planned, Bavarian Nordic initiated a Phase 2 human challenge trial of its RSV vaccine candidate, MVA-BN RSV in the first quarter of 2021. All subjects have been vaccinated and challenged, and the trial will generate the first efficacy data against RSV during second half of 2021. In parallel, activities to support a regulatory Phase 3 trial in 2022 are ongoing, pending results from the human challenge trial.
The tech transfer of the freeze-dried version of the MVA-BN smallpox vaccine to Bavarian Nordic's fill and finish line has been initiated, which, together with the completed Phase 3 trial (lot consistency trial) will form basis for submission of a supplement to the Biologics License Application (BLA) to extend the approval for both formulations of MVA-BN, anticipated in 2022.
During first quarter, Bavarian Nordic initiated a Phase 1/2 open label trial of intravenous administration of TAEK-VAC, a tumor antibody enhanced therapeutic vaccine targeting HER2 and brachyury, which has been generated from the MVA-BN platform. The first stage of the trial is investigating the safety and tolerability of escalating doses of the vaccine before advancing into stage 2, expected in the second half of 2021.
1 Khoury et al. doi.org/10.1101/2021.03.09.21252641
| VACCINE | INDICATION | PHASE 1 | PHASE 2 | PHASE 3 | STATUS / MILESTONE |
|---|---|---|---|---|---|
| MVA-BN freeze-dried | Smallpox | Phase 3 lot-consistency study ongoing with anticipated completion in 2021 | |||
| MVA-BN RSV | RSV | Human challenge trial ongoing with data read-out in 2021 and subsequent Phase 3 initiation in 2022. |
|||
| ABNCoV2 | COVID-19 | Phase 2 ongoing with expected data read-out in Q4 2021 | |||
| TAEK-VAC | Cancer | Phase 1/2 study ongoing | |||
| MVA-BN WEV | Equine encephalitis | Phase 1 dose finding study completed. |
The ongoing activities to expand Bavarian Nordic's manufacturing footprint are progressing as planned, while also running the planned production in parallel.
Key manufacturing activities in 2021 relate to the production of bulk vaccine for the US government, as well as production of Mvabea (Ebola) bulk vaccine for Janssen.
In June, the Kvistgaard manufacturing facility was inspected by the Danish Medicines Agency (DMA). In addition to the primary inspection of the new fill and finish facility, the existing bulk manufacturing facility was reinspected in accordance with the GMP requirements. Both inspections were successful and Bavarian Nordic expects to receive the formal approval of the entire facility from the DMA during the third quarter of 2021.
During first half, transfer and validation of the final drug production of the liquid-frozen JYNNEOS smallpox vaccine was completed and commercial production of the vaccine has been initiated at the new fill and finish facility.
Additionally, the expansion of the bulk facility to support technology transfer of Rabipur/RabAvert and Encepur have progressed timely.
Successful private placement strengthening the capital base and providing flexibility to advance COVID-19 vaccine candidate In March 2021, Bavarian Nordic announced and completed a directed issue and private placement of 5,150,000 new shares, generating gross proceeds of DKK 1,148 million. Part of the proceeds will be used to fund the Phase 2 clinical study and scale-up of manufacturing to accommodate potential future clinical development to support licensure of ABNCoV2. Additionally, the proceeds will be used to secure financial flexibility to strengthen the Company's manufacturing capabilities, ensure the strategic flexibility necessary to pursue an active M&A strategy, and to strengthen the Company's capital base and cash preparedness for general corporate purposes.
Page 6 of 20
Financial statements for the period January 1 – June 30, 2021 are un-audited. Comparison figures for the same period 2020 are stated in brackets.
Revenue generated for the six months ending June 30, 2021 was DKK 905 million (DKK 1,065 million). Revenue was composed of DKK 452 million (DKK 655 million) from sale of the two new products Rabipur/RabAvert and Encepur, DKK 246 million (DKK 320 million) from sale of MVA-BN smallpox vaccine bulk drug substance to US government, DKK 90 million (DKK 0 million) sale of smallpox vaccines to three European countries, DKK 89 million (DKK 0 million) sale of Mvabea to Janssen, and DKK 28 million (DKK 90 million) from contract work. Revenue reported for the three months ended June 30, 2021 was DKK 370 million (DKK 700 million).
Production costs totaled DKK 627 million (DKK 623 million). Costs related directly to revenue amounted to DKK 343 million (DKK 443 million), of which cost of goods sold totaled DKK 324 million (DKK 384 million). Contract costs totaled DKK 19 million (DKK 60 million). Amortization of product rights related to Rabipur/RabAvert and Encepur has also been recognized as part of the production costs with a total of DKK 136 million (DKK 136 million). Other production costs totaled DKK 147 million (DKK 43 million), part of which is related to production of RSV Phase 3 clinical trial material, which gave a much lower utilization of the capacity for commercial manufacturing leading to low absorption of indirect production costs causing higher other production costs.
In the second quarter of 2021, production costs were DKK 249 million (DKK 379 million).
Sales and distribution costs totaled DKK 98 million (DKK 150 million) split between costs for distribution of products of DKK 10 million (DKK 79 million) and costs for running the commercial organization and activities of DKK 88 million (DKK 71 million). In 2020 GSK handled the sale and distribution of Rabipur/RabAvert and Encepur for which the Group paid a distribution fee based on the revenue incurred, leading to much higher distribution costs in 2020 compared to 2021.
Research and development costs totaled DKK 219 million (DKK 124 million). The increase compared to 2020 was driven by manufacturing of RSV Phase 3 material. The amount excludes R&D costs of DKK 19 million (DKK 60 million) classified as production costs.
Administrative costs totaled DKK 156 million (DKK 126 million). The increase primarily relates to the ongoing transfer project for Rabipur/RabAvert and Encepur and the impact from the extension of the executive management during 2020.
Other operating income for 2020 related to the sale of the Priority Review Voucher, DKK 628 million.
Income before interest and tax (EBIT) was a loss of DKK 195 million, compared to a gain of DKK 670 million in first half of 2020.
EBITDA was a loss of DKK 8 million (gain of DKK 839 million). Amortization of product rights related to Rabipur/RabAvert and Encepur amounted to DKK 136 million (DKK 136 million) whereas depreciation on other fixed assets amounted to DKK 51 million (DKK 33 million).
Financial items totaled a net expense of DKK 83 million (DKK 42 million) and consisted of interest expense on debt of DKK 9 million (DKK 23 million), net value adjustment of deferred consideration of DKK 60 million (DKK 28 million), a net loss on derivative financial instruments of DKK 2 million (DKK 1 million) and a net expense from securities of DKK 18 million (income of DKK 7 million), partly offset by net foreign exchange rate gains of DKK 5 million (DKK 2 million).
The net value adjustment of deferred consideration consists of three components; Adjustment of deferred consideration due to change in estimated timing of payments DKK 6 million income (income of DKK 27 million), currency adjustments of DKK 2 million income (income of DKK 7 million) and unwinding2 of the discounting effect related to deferred consideration DKK 68 million (DKK 62 million), see note 6 and 7.
Income before company tax was a loss of DKK 278 million (gain of DKK 628 million).
Tax on income was DKK 3 million (DKK 2 million). The parent company's taxable income for the full year of 2021 is expected to be zero due to utilization of taxable amortization on the acquired product rights related to Rabipur/RabAvert and Encepur, leading to an effective tax rate close to 0% for the Group. We do not expect to use any tax loss carry forwards, hence the deferred tax asset on the balance sheet remains at DKK 0 million. The Company retains the right to use the tax losses carried forward that was written down in prior year, see note 14 in the Annual Report for 2020.
For the first six months of 2021, Bavarian Nordic reported a net loss of DKK 281 million (net gain of DKK 626 million).
Product rights recognized in the balance sheet totaled DKK 5,049 million (DKK 5,186 million as of December 31, 2020) and relates to Rabipur/RabAvert and Encepur.
Securities, cash and cash equivalents were DKK 2,513 million as of June 30, 2021, including repo pledged securities of DKK 305 million (DKK 1,670 million as of December 31, 2020, no repo pledged securities). The increase is primarily due to the capital increase in March 2021 which generated net proceeds of DKK 1.1 billion.
In addition to the current cash position, the Company has an undrawn loan with the European Investment Bank of EUR 30 million.
2 The deferred consideration for product rights is measured at net present value and the difference between the net present value and the amounts due is recognized in the income statement as a financial expense over the period until expected payment date using the effective interest method.
Cash flow generated by operating activities was negative by DKK 377 million (positive by DKK 672 million), primarily due to increase in inventories following the market take-overs from GSK and higher accounts receivables compared to year-end 2020. Cash flow from investment activities was negative by DKK 1,179 million (negative by DKK 1,945 million) following net investments in securities of DKK 966 million (net investment of DKK 1,824 million). Cash flow from investment activities also include DKK 171 million (DKK 66 million) of investments in property, plant and equipment related to the ongoing expansion of the bulk facility for future production of Rabipur/RabAvert and Encepur. Investment in other intangible assets amounted to DKK 42 million (DKK 30 million) and includes the ongoing Rabipur/RabAvert and Encepur technology transfer project and IT system investments. Cash flow from financing activities was a contribution of DKK 1,455 million (DKK 1,352 million), following the proceeds from capital increase through private placement and conclusion of repo transactions. The net change in cash and cash equivalents was negative by DKK 102 million (positive by DKK 79 million).
The Group's equity as of June 30, 2021 stood at DKK 5,789 million (DKK 4,894 million as of December 31, 2020). The capital increase through private placement increased the equity by DKK 1,148 million before costs.
Deferred consideration for product rights amounted to DKK 2,882 million, an increase of DKK 60 million compared to December 31, 2020, due to the adjustment of net present value following the unwinding of the discounting effect.
The Company has concluded repo transactions (further described in note 15) hence debt to credit institutions increased by DKK 306 million compared to December 31, 2020.
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 48-51 "Risk Management" in the 2020 Annual Report.
In addition to the risk factors stated in the annual report, the COVID-19 situation could impact Bavarian Nordic's business adversely by delaying projects, development or manufacturing or by negatively impacting demand for products.
Bavarian Nordic maintains the financial guidance for 2021, expecting to meet to the lower end of the previously guided ranges due to continued COVID-19 impact on the TBE and rabies markets. Thus, revenue of approximately DKK 1,900 million and an EBITDA of approximately DKK 100 million are expected. Cash and cash equivalents at year-end are expected to be approximately DKK 1,400 million.
The smallpox and Ebola business are not expected to be impacted by COVID-19.
Other key assumptions for the guidance remain largely unchanged.
The 2022 dates for announcement of the Company's financial reports and the annual general meeting have now been determined, and planned future reporting dates are as follows:
| Nine-month report (Q3) | November 12, 2021 |
|---|---|
| 2021 Annual Report | March 4, 2022 |
| Annual General Meeting* | April 5, 2022 |
| Three-month report (Q1) | May 9, 2022 |
| Half-year report (Q2) | August 24, 2022 |
| Nine-month report (Q3) | November 9, 2022 |
* 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 Monday, February 21, 2022.
| Unaudited Condensed Consolidated Income Statements for the Periods Ended June 30, 2021 and 2020 and | |||
|---|---|---|---|
| December 31, 2020 |
| DKK thousand | Note | 1/4 - 30/6 2021 | 1/4 - 30/6 2020 | 1/1 - 30/6 2021 | 1/1 - 30/6 2020 | 1/1-31/12 2020 |
|---|---|---|---|---|---|---|
| Revenue | 3 | 369,999 | 699,575 | 905,252 | 1,064,980 | 1,852,383 |
| Production costs | 4 | 249,301 | 379,486 | 626,642 | 622,570 | 1,195,094 |
| Gross profit | 120,698 | 320,089 | 278,610 | 442,410 | 657,289 | |
| Sales and distribution costs | 47,061 | 75,017 | 98,096 | 149,864 | 285,783 | |
| Research and development costs | 5 | 97,077 | 57,978 | 219,217 | 124,059 | 341,420 |
| Administrative costs | 83,200 | 74,881 | 155,930 | 126,333 | 278,145 | |
| Total operating costs | 227,338 | 207,876 | 473,243 | 400,256 | 905,348 | |
| Other operating income | - | - | - | 627,647 | 627,647 | |
| Income before interest and tax (EBIT) | (106,640) | 112,213 | (194,633) | 669,801 | 379,588 | |
| Financial income | 6 | 11,713 | 34,445 | 18,625 | 44,302 | 97,922 |
| Financial expenses | 7 | 53,206 | 34,668 | 101,856 | 86,526 | 195,534 |
| Income before company tax | (148,133) | 111,990 | (277,864) | 627,577 | 281,976 | |
| Tax on income for the period | 2,125 | 715 | 3,239 | 1,724 | 4,455 | |
| Net profit for the period | (150,258) | 111,275 | (281,103) | 625,853 | 277,521 | |
| Earnings per share (EPS) - DKK | ||||||
| Basic earnings per share of DKK 10 | (2.4) | 2.2 | (4.6) | 12.6 | 5.1 | |
| Diluted earnings per share of DKK 10 | (2.4) | 2.2 | (4.6) | 12.6 | 5.1 |
| DKK thousand | 1/4 - 30/6 2021 | 1/4 - 30/6 2020 | 1/1 - 30/6 2021 | 1/1 - 30/6 2020 | 1/1-31/12 2020 |
|---|---|---|---|---|---|
| Net profit for the period | (150,258) | 111,275 | (281,103) | 625,853 | 277,521 |
| Items that might be reclassified to the income statement: |
|||||
| Exchange rate adjustments on translating foreign operations |
157 | (200) | 3,991 | (261) | (3,082) |
| Change in fair value of financial instruments entered into to hedge future cash flows |
2,170 | 5,603 | (10,786) | 2,034 | (3,096) |
| Other comprehensive income after tax | 2,327 | 5,403 | (6,795) | 1,773 | (6,178) |
| Total comprehensive income | (147,931) | 116,678 | (287,898) | 627,626 | 271,343 |
| DKK thousand | 1/1 - 30/6 2021 | 1/1 - 30/6 2020 | 1/1-31/12 2020 |
|---|---|---|---|
| Net profit for the period | (281,103) | 625,853 | 277,521 |
| Adjustment for non-cash items: | |||
| Financial income | (18,625) | (44,302) | (97,922) |
| Financial expenses | 101,856 | 86,526 | 195,534 |
| Tax on income for the period | 3,239 | 1,724 | 4,455 |
| Depreciation, amortization and impairment losses | 186,647 | 168,817 | 360,147 |
| Share-based payment | 34,390 | 16,886 | 32,998 |
| Changes in inventories | (146,361) | (53,834) | (420,320) |
| Changes in receivables | (209,922) | (246,079) | (88,094) |
| Changes in current liabilities | (38,304) | 130,370 | 345,723 |
| Cash flow from operations (operating activities) | (368,183) | 685,961 | 610,042 |
| Received financial income | 4,480 | 1,365 | 5,847 |
| Paid financial expenses | (12,610) | (13,070) | (40,034) |
| Paid company taxes | (953) | (1,975) | (3,944) |
| Cash flow from operating activities | (377,266) | 672,281 | 571,911 |
| Investments in products rights | - | (21,672) | (393,992) |
| Investments in other intangible assets | (41,633) | (30,328) | (107,885) |
| Investments in property, plant and equipment | (171,411) | (66,261) | (204,833) |
| Investments in/disposal of financial assets | (561) | (2,514) | (2,677) |
| Investments in securities | (1,116,911) | (2,104,089) | (2,343,828) |
| Disposal of securities | 151,020 | 279,911 | 1,141,683 |
| Cash flow from investment activities | (1,179,496) | (1,944,953) | (1,911,532) |
| Payment on loans | (1,088) | (1,383,457) | (1,375,598) |
| Proceeds from loans | 306,706 | - | - |
| Repayment of lease liabilities | (9,745) | (8,360) | (17,799) |
| Proceeds from warrant programs exercised | 44,800 | 15,564 | 15,564 |
| Proceeds from rights issue | - | 2,824,326 | 2,824,326 |
| Proceeds from capital increase through private placement | 1,148,450 | - | - |
| Cost related to issue of new shares | (25,563) | (98,745) | (103,184) |
| Sale of preemptive rights - treasury shares | - | 2,664 | 2,664 |
| Purchase of treasury shares | (8,581) | - | (11,099) |
| Cash flow from financing activities | 1,454,979 | 1,351,992 | 1,334,874 |
| Cash flow of the period | (101,783) | 79,320 | (4,747) |
| Cash as of 1 January | 285,487 | 297,545 | 297,545 |
| Currency adjustments 1 January | 2,197 | 56 | (7,311) |
| Cash end of period | 185,901 | 376,921 | 285,487 |
| DKK thousand | Note | 30/6 2021 | 30/6 2020 | 31/12 2020 |
|---|---|---|---|---|
| Assets | ||||
| Product rights | 5,049,298 | 5,322,233 | 5,185,765 | |
| Acquired patents and licenses | 29,813 | - | 29,813 | |
| Software | 28,791 | 18,797 | 17,631 | |
| Intangible assets in progress | 81,969 | 32,255 | 57,543 | |
| Intangible assets | 5,189,871 | 5,373,285 | 5,290,752 | |
| Land and buildings | 361,054 | 161,306 | 366,232 | |
| Leasehold improvements | 3,313 | 2,357 | 3,713 | |
| Plant and machinery | 263,583 | 83,171 | 204,664 | |
| Fixtures and fittings, other plant and equipment | 219,071 | 26,295 | 223,238 | |
| Assets under construction | 301,398 | 620,966 | 213,309 | |
| Property, plant and equipment | 1,148,419 | 894,095 | 1,011,156 | |
| Right-of-use assets | 14 | 83,422 | 83,650 | 71,987 |
| Other receivables | 4,683 | 3,959 | 4,122 | |
| Financial assets | 4,683 | 3,959 | 4,122 | |
| Total non-current assets | 6,426,395 | 6,354,989 | 6,378,017 | |
| Inventories | 8 | 667,443 | 154,596 | 521,082 |
| Trade receivables | 9 | 339,955 | 318,286 | 139,292 |
| Tax receivables | - | 1,015 | - | |
| Other receivables | 10 | 27,837 | 24,001 | 37,334 |
| Prepayments | 33,300 | 9,916 | 13,732 | |
| Receivables | 401,092 | 353,218 | 190,358 | |
| Securities | 15, 16 | 2,327,547 | 2,002,986 | 1,384,120 |
| Cash and cash equivalents | 185,901 | 376,921 | 285,487 | |
| Securities, cash and cash equivalents | 2,513,448 | 2,379,907 | 1,669,607 | |
| Total current assets | 3,581,983 | 2,887,721 | 2,381,047 | |
| Total assets | 10,008,378 | 9,242,710 | 8,759,064 |
| DKK thousand | Note | 30/6 2021 | 30/6 2020 | 31/12 2020 |
|---|---|---|---|---|
| Equity and liabilities | ||||
| Share capital | 638,172 | 584,501 | 584,501 | |
| Treasury shares | (1,176) | (553) | (1,077) | |
| Retained earnings | 5,086,384 | 4,576,142 | 4,246,359 | |
| Other reserves | 65,170 | 91,059 | 64,570 | |
| Equity | 5,788,550 | 5,251,149 | 4,894,353 | |
| Deferred consideration for product rights | 1,934,498 | 2,789,858 | 2,464,932 | |
| Debt to credit institutions | 11 | 392,182 | 394,362 | 393,268 |
| Lease liabilities | 14 | 65,203 | 71,788 | 54,201 |
| Non-current liabilities | 2,391,883 | 3,256,008 | 2,912,401 | |
| Deferred consideration for product rights | 947,930 | 367,197 | 357,736 | |
| Debt to credit institutions | 11, 15 | 308,878 | 2,163 | 2,174 |
| Lease liabilities | 14 | 21,079 | 13,834 | 20,422 |
| Prepayment from customers | 12 | 51,435 | 26,472 | 74,347 |
| Trade payables | 298,545 | 201,496 | 345,320 | |
| Company tax | 1,461 | - | 497 | |
| Other liabilities | 13 | 198,617 | 124,391 | 151,814 |
| Current liabilities | 1,827,945 | 735,553 | 952,310 | |
| Total liabilities | 4,219,828 | 3,991,561 | 3,864,711 | |
| Total equity and liabilities | 10,008,378 | 9,242,710 | 8,759,064 |
| 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, 2021 | 584,501 | (1,077) | 4,246,359 | (40,640) | (809) | 106,019 | 4,894,353 |
| Comprehensive income for the period | |||||||
| Net profit | - | - | (281,103) | - | - | - | (281,103) |
| Other comprehensive income | |||||||
| Exchange rate adjustments on translating foreign operations |
- | - | - | 3,991 | - | - | 3,991 |
| Change in fair value of financial instruments entered into to hedge future cash flows |
- | - | - | - | (10,786) | - | (10,786) |
| Total comprehensive income for the period | - | - | (281,103) | 3,991 | (10,786) | - | (287,898) |
| Transactions with owners | |||||||
| Share-based payment | - | - | - | - | - | 22,989 | 22,989 |
| Warrant program exercised | 2,171 | - | 54,489 | - | - | (11,860) | 44,800 |
| Capital increase through private placement | 51,500 | - | 1,096,950 | - | - | - | 1,148,450 |
| Cost related to issue of new shares | - | - | (25,563) | - | - | - | (25,563) |
| Purchase of treasury shares | - | (317) | (8,264) | - | - | - | (8,581) |
| Transfer regarding restricted stock units | - | 218 | 3,516 | - | - | (3,734) | - |
| Total transactions with owners | 53,671 | (99) | 1,121,128 | - | - | 7,395 | 1,182,095 |
| Equity as of June 30, 2021 | 638,172 | (1,176) | 5,086,384 | (36,649) | (11,595) | 113,414 | 5,788,550 |
| Share | Treasury | Retained | Reserves for currency |
Reserves for fair value of financial instrument |
Share based |
||
|---|---|---|---|---|---|---|---|
| DKK thousand | capital | shares | earnings | adjustment | s | payment | Equity |
| Equity as of January 1, 2020 | 323,891 | (684) | 1,460,007 | (37,558) | 2,287 | 117,512 | 1,865,455 |
| Comprehensive income for the period | |||||||
| Net profit | - | - | 625,853 | - | - | - | 625,853 |
| Other comprehensive income | |||||||
| Exchange rate adjustments on translating foreign operations |
- | - | - | (261) | - | - | (261) |
| Change in fair value of financial instruments entered into to hedge future cash flows |
- | - | - | - | 2,034 | - | 2,034 |
| Total comprehensive income for the period | - | - | 625,853 | (261) | 2,034 | - | 627,626 |
| Transactions with owners | |||||||
| Share-based payment | - | - | - | - | - | 14,259 | 14,259 |
| Warrant program exercised | 1,498 | - | 17,514 | - | - | (3,448) | 15,564 |
| Capital increase through rights issue | 259,112 | - | 2,565,214 | - | - | - | 2,824,326 |
| Cost related to issue of new shares | - | - | (98,745) | - | - | - | (98,745) |
| Transfer regarding restricted stock units | - | 131 | 3,635 | - | - | (3,766) | - |
| Sale of preemptive rights - treasury shares | - | - | 2,664 | - | - | - | 2,664 |
| Total transactions with owners | 260,610 | 131 | 2,490,282 | - | - | 7,045 | 2,758,068 |
| Equity as of June 30, 2020 | 584,501 | (553) | 4,576,142 | (37,819) | 4,321 | 124,557 | 5,251,149 |
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 2020 and in accordance with the recognition and measurement policies in the International Financial Reporting Standards (IFRS) as adopted by EU.
As of June 30, 2021, the Company has implemented all new or amended accounting standards and interpretations as adopted by the EU and applicable for the 2021 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 significant accounting estimates, assumptions and uncertainties, which are stated in the Annual Report 2020, the Management has not changed significant estimates and judgments regarding recognition and measurement.
Bavarian Nordic Announces First Half 2021 Results Page 15 of 20
| DKK thousand | 1/4 - 30/6 2021 |
1/4 - 30/6 2020 |
1/1 - 30/6 2021 |
1/1 - 30/6 2020 |
1/1-31/12 2020 |
|---|---|---|---|---|---|
| 3. Revenue | |||||
| MVA-BN smallpox vaccine sale | 167 | 320,123 | 336,378 | 320,309 | 540,769 |
| Rabipur/RabAvert | 126,858 | 141,551 | 207,190 | 359,691 | 627,699 |
| Encepur | 146,180 | 192,629 | 244,660 | 295,399 | 455,012 |
| Other product sale | 89,079 | - | 89,079 | - | - |
| Sale of goods | 362,284 | 654,303 | 877,307 | 975,399 | 1,623,480 |
| Milestone payments | - | - | - | - | 66,553 |
| Contract work | 7,715 | 45,272 | 27,945 | 89,581 | 162,350 |
| Sale of services | 7,715 | 45,272 | 27,945 | 89,581 | 228,903 |
| Revenue | 369,999 | 699,575 | 905,252 | 1,064,980 | 1,852,383 |
| Total revenue includes: Fair value adjustment concerning financial instruments entered into to hedge revenue |
0 | - | 269 | - | 13,146 |
| 4. Production costs | |||||
| Cost of goods sold | 118,249 | 241,401 | 323,660 | 383,696 | 584,574 |
| Contract costs | 5,743 | 30,286 | 19,229 | 59,539 | 104,409 |
| Amortization product rights | 68,233 | 68,233 | 136,467 | 136,467 | 272,935 |
| Other production costs | 57,076 | 39,566 | 147,286 | 42,868 | 233,176 |
| Production costs | 249,301 | 379,486 | 626,642 | 622,570 | 1,195,094 |
| 5. Research and development costs | |||||
| Research and development costs occurred in the period | 102,820 | 88,264 | 238,446 | 183,598 | 445,829 |
| Of which: | |||||
| Contract costs recognized as production costs | (5,743) | (30,286) | (19,229) | (59,539) | (104,409) |
| Research and development costs | 97,077 | 57,978 | 219,217 | 124,059 | 341,420 |
| 6. Financial income | |||||
| Financial income from bank and deposit contracts Interest income from financial assets measured at |
56 | 5 | 97 | 193 | 193 |
| amortized cost | 56 | 5 | 97 | 193 | 193 |
| Financial income from securities | 3,174 | 2,540 | 5,465 | 3,693 | 8,756 |
| Fair value adjustments on securities | - | 10,724 | - | 3,803 | 6,783 |
| Adjustment of deferred consideration due to change in estimated timing of payments |
6,008 | 18,423 | 6,343 | 27,092 | 67,719 |
| Currency adjustment deferred consideration | 421 | 6,244 | 1,787 | 7,198 | 11,900 |
| Net gains on derivative financial instruments at fair value through the income statement |
- | - | - | - | 2,571 |
| Net foreign exchange gains | 2,054 | (3,491) | 4,933 | 2,323 | - |
| Financial income | 11,713 | 34,445 | 18,625 | 44,302 | 97,922 |
| 7. Financial expenses | |||||
| Interest expenses on debt | 4,222 | 4,689 | 8,884 | 23,146 | 31,853 |
| Interest expenses on financial liabilities measured at amortized cost |
4,222 | 4,689 | 8,884 | 23,146 | 31,853 |
| Fair value adjustments on securities Unwinding of the discounting effect related to deferred consideration |
8,147 39,760 |
- 31,070 |
22,996 67,889 |
- 61,887 |
- 145,149 |
| Net loss on derivative financial instruments at fair value | |||||
| through the income statement | 1,077 | (1,091) | 2,087 | 1,493 | - |
| Net foreign exchange losses | - | - | - | - | 18,532 |
| Financial expenses | 53,206 | 34,668 | 101,856 | 86,526 | 195,534 |
| DKK thousand | 30/6 2021 | 30/6 2020 | 31/12 2020 |
|---|---|---|---|
| 8. Inventories | |||
| Raw materials and supply materials | 69,770 | 51,094 | 73,919 |
| Work in progress | 78,046 | 217,007 | 201,601 |
| Manufactured goods and commodities | 529,530 | 336 | 309,099 |
| Write-down on inventory | (9,903) | (113,841) | (63,537) |
| Inventories | 667,443 | 154,596 | 521,082 |
| Write-down on inventory 1 January | (63,537) | (104,056) | (104,056) |
| Write-down during the period | (6,252) | (14,178) | (25,692) |
| Use of write-down | 59,886 | 3,854 | 65,672 |
| Reversal of write-down | - | 539 | 539 |
| Write-down end of period | (9,903) | (113,841) | (63,537) |
| 9. Trade receivables | |||
| Trade receivables from smallpox vaccine sale | 166 | - | - |
| Trade receivables from Encepur and Rabipur/RabAvert | 266,418 | 254,153 | 121,355 |
| Trade receivables from other product sale | 68,956 | - | - |
| Trade receivables from contract work | 4,415 | 64,133 | 17,937 |
| Trade receivables | 339,955 | 318,286 | 139,292 |
| 10. Other receivables | |||
| Receivable VAT and duties | 23,228 | 14,999 | 31,486 |
| Derivative financial instruments at fair value | - | 5,817 | 606 |
| Interest receivables | 4,609 | 3,185 | 3,767 |
| Other receivables | - | - | 1,475 |
| Other receivables | 27,837 | 24,001 | 37,334 |
| 11. Debt to credit institutions | |||
| Mortgage | 22,159 | 24,330 | 23,247 |
| European Investment Bank (loan in DKK) | 372,195 | 372,195 | 372,195 |
| Security lending (repo transactions) | 306,706 | - | - |
| Debt to credit institutions | 701,060 | 396,525 | 395,442 |
| 12. Prepayment from customers | |||
| Prepayments from customers as of January 1 | 74,347 | 6,631 | 6,631 |
| Prepayments received during the period | - | 22,079 | 77,185 |
| Recognized as revenue during the period | (22,912) | (2,238) | (9,469) |
| Prepayments from customers end of period | 51,435 | 26,472 | 74,347 |
| 13. Other liabilities | |||
| Financial instruments at fair value | 11,651 | 1,495 | 1,414 |
| Liability relating to phantom shares | 16,250 | 3,761 | 4,849 |
| Payable salaries, holiday accrual etc. | 80,511 | 93,055 | 101,229 |
| Gross to net deduction accrual | 63,175 | - | 26,355 |
| Other accrued costs | 27,030 | 26,080 | 17,967 |
| Other liabilities | 198,617 | 124,391 | 151,814 |
| DKK thousand | Rent facility | Car leasing | Equipment | Total |
|---|---|---|---|---|
| Right-of-use assets as of January 1, 2021 | 68,931 | 2,312 | 744 | 71,987 |
| Additions | - | 753 | - | 753 |
| Modifications | 20,503 | 111 | 38 | 20,652 |
| Depreciations | (8,967) | (796) | (225) | (9,988) |
| Exchange rate adjustments | (6) | 24 | - | 18 |
| Right-of-use assets as of June 30, 2021 | 80,461 | 2,404 | 557 | 83,422 |
| Lease liabilities | ||||
| DKK thousand | 30/6 2021 | |||
| Non-current | 65,203 | |||
| Current | 21,079 | |||
| Lease liabilities | 86,282 | |||
| Amounts included in the income statement | ||||
| DKK thousand | 1/1 - 30/6 2021 | |||
| Interest expense leases | 1,007 | |||
| Depreciation recognized on right-of-use assets | 9,988 | |||
| Cost recognized for short term leases (less than 12 months) | 220 | |||
| In the first six months of 2021 the total cash outflow relating to lease was DKKt 10,752 split between interests of DKKt 1,007 and repayment of DKKt 9,745. |
The Company has entered into transactions that transferred ownership of securities to a counterparty, while the Company retains the risks associated with the holding of the securities (repo transactions). As the Company retains all risks, the securities remain in the balance sheet, and the transactions are accounted for as loans received against collateral (securities lending). The transactions involve selling the securities to be repurchased at a fixed price at a later date. Counterparties are entitled to sell the securities or deposit them as collateral for loans.
| DKK thousand | 30/6 2021 | 30/6 2020 | 31/12 2020 |
|---|---|---|---|
| Carrying amount of transferred securities | 305,050 | - | - |
| Carrying amount of associated liabilities (repo transactions) | (306,706) | - | - |
| Net position | (1,656) | - | - |
The Group has financial instruments measured at fair value at level 1 and level 2.
The portfolio of publicly traded government bonds and publicly traded mortgage bonds is valued at listed prices and price quotas.
Currency forward contracts, currency option contracts and currency swap contracts are valued according to generally accepted valuation methods based on relevant observable swap curves and exchange rates.
| DKK thousand | Level 1 | Level 2 | Total |
|---|---|---|---|
| Securities | 2,022,497 | - | 2,022,497 |
| Transferred securities that are not derecognized | 305,050 | - | 305,050 |
| Financial assets measured at fair value through the income statement | 2,327,547 | - | 2,327,547 |
| Derivative financial instruments to hedge future cash flow (currency) | - | (10,681) | (10,681) |
| Derivative financial instruments to hedge future cash flow (interest) | - | (914) | (914) |
| Financial assets/liabilities used as hedging instruments | - | (11,595) | (11,595) |
| Derivative financial instruments at fair value through the income statement (currency) |
- | (56) | (56) |
| Security lending (repo transactions) | (306,706) | - | (306,706) |
| Liability relating to phantom shares | - | (16,250) | (16,250) |
| Financial liabilities measured at fair value through the income statement | (306,706) | (16,306) | (323,012) |
| DKK thousand | Level 1 | Level 2 | Total |
|---|---|---|---|
| Securities | 1,384,120 | - | 1,384,120 |
| Financial assets measured at fair value through the income statement | 1,384,120 | - | 1,384,120 |
| Derivative financial instruments to hedge future cash flow (currency) | - | 606 | 606 |
| Derivative financial instruments to hedge future cash flow (interest) | - | (1,414) | (1,414) |
| Financial assets/liabilities used as hedging instruments | - | (808) | (808) |
| Liability relating to phantom shares | - | (4,849) | (4,849) |
| Financial liabilities measured at fair value through the income statement | - | (4,849) | (4,849) |
Outstanding warrants as of June 30, 2021
| Outstanding as of January 1 |
Addition during the period |
Warrants exercised |
Annulled Terminated | Trans ferred |
Outstanding as of June 30 |
||
|---|---|---|---|---|---|---|---|
| Corporate Management | 439,402 | - | - | - | - | - | 439,402 |
| Other Executive Management | 723,326 | - | (12,191) | - | - | (215,328) | 495,807 |
| Other employees | 2,062,360 | - | (164,969) | (141,518) | - | (43,243) | 1,712,630 |
| Resigned employees | 167,901 | - | (39,976) | - | - | 258,571 | 386,496 |
| Total | 3,392,989 | - | (217,136) | (141,518) | - | - | 3,034,335 |
| Weighted average exercise price | 188 | - | 206 | 192 | - | - | 187 |
| Weighted average share price at exercise | - | - | 295 | - | - | - | - |
| Numbers of warrants which can be exercised as of June 30, 2021 | 595,009 | ||||||
| at a weighted average exercise price of DKK | 233 |
The total recognized cost of the warrant programs was DKK 16.4 million in the first six months of 2021 (DKK 10.3 million).
| DKK | Dec | Jul | Nov | Nov | Nov | Jan | Nov |
|---|---|---|---|---|---|---|---|
| 2016 | 2017 | 2017 | 2018 | 2019 | 2020 | 2020 | |
| Average share price | 222.50 | 383.50 | 259.50 | 159.00 | 154.05 | 171.20 | 179.84 |
| Average exercise price at grant Average exercise price determined at date |
260.20 | 430.40 | 303.00 | 179.60 | 185.40 | 197.00 | 206.82 |
| of rights issue March 30, 2020 (DKK) | 205.80 | 340.40 | 239.60 | 142.00 | 146.60 | 155.80 | - |
| Applied volatility rate | 44.6% | 44.1% | 52.4% | 53.3% | 52.2% | 53.0% | 39.8% |
| 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. | -0.48% | -0.46% | -0.55% | -0.43% | -0.69% | -0.65% | -0.66% |
| Fair value at grant1) | 54 | 98 | 80 | 52 | 45 | 53 | 41 |
The applied volatility is based on the historical volatility of the Bavarian Nordic share, except for November 2020 program where the volatility is based on the volatility for a peer group.
1) Fair value of each warrant applying the Black-Scholes model
No significant changes in contingent liabilities and other contractual obligations have occurred since December 31, 2020.
On August 9, 2021, Bavarian Nordic reported initial results from the first-in-human trial of ABNCoV2, showing that the COVID-19 vaccine candidate was well tolerated and induced a strong antibody response, superior to current approved vaccines. Importantly, a strong neutralization response was demonstrated against SARS-CoV2 variants, including the Delta variant.
On August 23, 2021, Bavarian Nordic announced the initiation of a Phase 2 clinical trial of ABNCoV2 to investigate the vaccine's potential as a universal booster vaccine for individuals with existing immunity from prior COVID-19 disease or vaccination.
On August 23, 2021, Bavarian Nordic announced a funding agreement with the Danish Ministry of Health to further advance the development of ABNCoV2. The agreement is valued at up to DKK 800 million and aims to support the completion of the development towards licensure of ABNCoV2 as a booster vaccine.
The unaudited condensed consolidated interim financial statements were approved by the Board of Directors and Corporate Management and authorized for issue on August 25, 2021.
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, 2021.
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, 2021, and the results of the group's activities and cash flows for the period January 1 to June 30, 2021.
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.
Corporate Management:
Paul John Chaplin Henrik Juuel
President & CEO Executive Vice President & CFO
Board of Directors:
Chairman of the Board Deputy Chairman
Employee-elected Employee-elected Employee-elected Employee-elected
Gerard W.M. van Odijk Anders Gersel Pedersen Erik Gregers Hansen Peter H. Kürstein-Jensen
Frank A.G.M. Verwiel Elizabeth McKee Anderson Anne Louise Eberhard
Thomas Alex Bennekov Anja Gjøl Karen Merete Jensen Linette Munksgaard Andersen
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