Page 1 of 19
Bavarian Nordic A/S
Philip Heymans Alle 3 Tel. +45 33 26 83 83 CVR-no. 16 27 11 87
DK-2900 Hellerup www.bavarian-nordic.com LEI Code: 2138006JCDVYIN6INP51
Company Announcement
Bavarian Nordic Announces Interim Results for the First Three Months of 2021
COPENHAGEN, Denmark, May 27, 2021 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results and
business progress for the first three months of 2021.
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “It has been an eventful quarter for Bavarian Nordic with
continued progress in the commercialization of the Company. This is driven by the acquired product portfolio from GSK, our smallpox
vaccine business, and several new supply contracts, but importantly, also with significant advances in our pipeline. We have initiated the
human challenge trial of the RSV vaccine as planned and look forward to results later this year. Following the announcement of encouraging
preclinical results for the COVID-19 vaccine, which demonstrated the potential for a broad protection against emerging SARS-CoV2 variants,
we will soon advance the project by initiating a larger phase 2 trial and are working to secure funding for phase 3 development towards
licensure. We remain optimistic about the gradual reopening of the society and maintain our financial guidance for 2021, although markets
are still uncertain due to COVID-19.”
Financial highlights from the first quarter
• Revenue was DKK 535 million comprised of DKK 515 million from combined product sales and DKK 20 million from contract work.
• EBITDA was DKK 1 million.
• Strong cash position of DKK 2,589 million at end of the period, excluding unutilized credit facilities of DKK 244 million.
• Full-year guidance maintained with expected revenue between DKK 1,900-2,200 million, EBITDA between DKK 100-250 million and
securities, cash and cash equivalents at year-end between DKK 1,400-1,600 million. The guided ranges reflect the uncertainty
created by COVID-19 in the rabies and tick-bore encephalitis markets.
DKK million
Q1 2021
Q1 2020
2021 Guidance
Revenue
535
365
1,900 - 2,200
EBITDA
1
641*
100 - 250
Securities, cash and cash equivalents
2,589
2,205
1,400 - 1,600
* EBITDA in Q1 2020 was positively impacted by the sale of the Priority Review Voucher.
Other highlights
• In January, Bavarian Nordic announced contracts with three European countries for the supply of smallpox vaccines. Deliveries
occurred during the first quarter 2021.
• In March, Bavarian Nordic received a new order from the Canadian Government for smallpox vaccines valued at USD 31 million for
delivery in 2022 and 2023. The order was made under an existing contract with the Public Health Agency of Canada.
• In March, Bavarian Nordic reported encouraging preclinical data for the COVID-19 vaccine candidate, ABNCoV2 and subsequently
raised DKK 1.1 billion through a private placement to, among others, advance the clinical development of the vaccine towards
licensure.
Events after the reporting date
• In April, new preclinical results for the COVID-19 vaccine candidate, ABNCoV2 were announced, confirming its potential to offer
broad protection against variants of the SARS-CoV2 virus.
• In April, Bavarian Nordic received a new Ebola supply order from Janssen, valued at approximately USD 28 million. Manufacturing
and delivery will occur during 2021. The Johnson & Johnson Ebola vaccine regimen, which includes Mvabea
®
from Bavarian Nordic
also received Prequalification from the World Health Organization, which along with the July 2020 approval from the European
Commission, will help accelerate its registration in countries where Ebola is a persistent public health threat.
• In May, the US government exercised the final USD 12 million option remaining under the USD 202 million order for JYNNEOS
®
awarded in April 2020.
• In May, Bavarian Nordic entered an agreement with Dynavax on marketing and distribution of their HEPLISAV B
®
hepatitis B vaccine
in Germany
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 1 pm CET (7 am ET) 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=6095. To
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 2 of 19
Company Announcement no. 20 / 2021
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 3319667.
Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600
Company Announcement no. 20 / 2021
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacture 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.
Forward-looking statements
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.
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 3 of 19
Company Announcement no. 20 / 2021
Consolidated Key Figures (unaudited)
DKK thousand
1/1 - 31/3 2021
1/1 - 31/3 2020
1/1-31/12 2020
Income statements
Revenue
535,253
365,405
1,852,383
Production costs
377,341
243,084
1,195,094
Sales and distribution costs
51,035
74,847
285,783
Research and development costs
122,140
66,081
341,420
Administrative costs
72,730
51,452
278,145
Other operating income
-
627,647
627,647
Income before interest and taxes (EBIT)
(87,993)
557,588
379,588
Financial items, net
(41,738)
(42,001)
(97,612)
Income before company tax
(129,731)
515,587
281,976
Net profit for the period
(130,845)
514,578
277,521
Balance sheet
Total non-current assets
6,405,533
6,374,683
6,378,017
Securities, cash and cash equivalents
2,588,622
2,205,150
1,669,607
Other current assets
754,279
425,438
711,440
Total assets
9,748,434
9,005,271
8,759,064
Equity
5,920,743
5,110,553
4,894,353
Non-current liabilities
2,378,114
3,184,714
2,912,401
Current liabilities
1,449,577
710,004
952,310
Cash flow statements
Cash flow from operating activities
(119,535)
432,027
571,911
Cash flow from investment activities
(1,069,407)
(630,145)
(1,911,532)
- Investment in intangible assets
(14,513)
(32,499)
(501,877)
- Investment in property, plant and equipment
(81,177)
(22,787)
(204,833)
- Net investment in securities
(973,277)
(572,679)
(1,202,145)
Cash flow from financing activities
1,146,119
1,363,041
1,334,874
Financial Ratios
1)
EBITDA after Other operating income
1,264
641,205
739,736
EBITDA before Other operating income
1,264
13,558
112,089
Earnings (basic) per share of DKK 10
(2.2)
12.6
5.1
Net asset value per share
92.9
87.7
83.7
Share price at period-end
286
109
187
Share price/Net asset value per share
3.1
1.2
2.2
Number of outstanding shares at period-end (thousand)
2)
63,737
58,300
58,450
Equity share
61%
57%
56%
Number of employees, converted to full-time, at period-end
711
552
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)
(87,993)
557,588
379,588
Depreciation and amortization
89,257
83,617
360,148
EBITDA after Other operating income
1,264
641,205
739,736
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 4 of 19
Company Announcement no. 20 / 2021
Management’s Review
Sales and other income
Comparative figures for 2020 are shown in brackets. Where
market shares are mentioned, these are measured by value.
Q1 sales
mDKK
Q1 2021
Q1 2020
Growth
Rabipur/RabAvert
80
218
-63%
Encepur
98
103
-5%
JYNNEOS
336
-
Contract work
20
44
-55%
Total
535
365
Rabipur/RabAvert revenue amounted to DKK 80 million (DKK 218
million) for the quarter. The 63% decrease versus the prior year
was caused by COVID-19 and wholesaler inventory build-up in Q1
2020.
Due to COVID-19, the US market declined by 21% year-over-year
whereas the German market declined by 91% in the same period.
For the first quarter, the US market share was approximately 5
percentage points lower compared with prior year where the
main competitor faced a temporary out-of-stock situation.
Encepur revenue amounted to DKK 98 million (DKK 103 million)
for the quarter, i.e. a decrease of 5% versus prior year primarily
caused by wholesaler inventory fluctuations.
The German market grew by nearly 8% versus prior year and the
Encepur market share grew by 0.2 percentage points in the
German market.
Revenue from the sale of JYNNEOS/IMVANEX/IMVAMUNE in the
first quarter was DKK 336 million (DKK 0 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 contract work was DKK 20 million (DKK 44 million),
mainly related to qualification and validation activities relating
to the new 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.
Update on strategic priorities
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
During first quarter, 11 markets for Rabipur/RabAvert and
Encepur were transferred from GSK in addition to the 6 markets
transferred in 2020, and more than 90% of the product revenue is
now covered by Bavarian Nordic or its partners’ distribution.
Remaining markets are expected to be transferred by first half of
2021.
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 fourth quarter of
2021. 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.
R&D innovation
Several key pipeline projects have advanced during the first
quarter, supporting the Company’s strategy to develop innovative
life-saving vaccines.
RSV
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. The trial will generate the first efficacy data against RSV
during second half of 2021 and potentially further de-risk the
Phase 3 efficacy trial, which has been postponed into 2022 due to
COVID-19.
COVID-19 vaccine
The first-in-human study of ABNCoV2, the capsid virus like
particle (cVLP) COVID-19 vaccine candidate licensed from
AdaptVac, was initiated in March 2021 at the Radhoud University
Medical Centre in the Netherlands. The phase 1/2 open label,
dose-escalation trial, which is supported by a Horizon 2020 EU
grant, will assess the safety and tolerability of two doses of
ABNCoV2, formulated with and without adjuvant, in up to 42
healthy, adult, SARS-CoV-2-naïve volunteers. Results from the
study are expected in the third quarter of 2021.
In parallel, Bavarian Nordic has conducted a preclinical study,
demonstrating that two doses of non-adjuvanted ABNCoV2 led to
>50-fold higher titers of neutralizing antibodies against the wild-
type (Wuhan) virus when compared to titers measured in
convalescent human samples, and this translated into protection
from a challenge with wild-type virus. Additionally, a
neutralization test of samples from the study has confirmed
similarly high levels of neutralizing antibodies against the SARS-
CoV2 variants B.1.1.7 (British) and B.1.351 (South African). These
are highly encouraging results as it has been reported that high
levels of neutralizing antibodies are highly predictive of
protection.
Bavarian Nordic will further advance the development of the
vaccine by investing in a larger phase 2 clinical trial to
investigate the ability of ABNCoV2 to boost existing immunity
through prior vaccination, to create a more durable immune
response that could protect against the current circulating
variants of COVID-19. The study is planned for initiation in the
second quarter of 2021.
Additionally, the Company will, through contract manufacturers,
scale up manufacturing to phase 3 volume levels in preparation
for further clinical development towards licensure.
The Company continues to seek funding to further progress the
candidate through Phase 3 towards licensure.
MVA-BN smallpox, freeze-dried
During 2021, the Company expects to complete the Phase 3 trial
(lot consistency trial) of freeze-dried MVA-BN smallpox vaccine,
with subsequent submission of a supplement to the Biologics
License Application (BLA) to extend the approval for both
formulations of MVA-BN, anticipated in 2022.
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 5 of 19
Company Announcement no. 20 / 2021
Immuno-oncology
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, expectedly in the second half of 2021.
See full pipeline below.
Manufacturing
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 bulk
vaccine of MVA-BN Filo (Ebola) for Janssen.
Pending final qualification and validation, Bavarian Nordic will
initiate the first commercial manufacturing at its new fill and
finish facility later in 2021 when transferring the final drug
production of the liquid-frozen JYNNEOS smallpox vaccine to the
line.
Additionally, the expansion of the bulk facility to support
technology transfer of Rabipur/RabAvert and Encepur have
progressed timely.
Other matters
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 planned 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.
Our marketed products
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
Our clinical pipeline
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 planned with data read-out in 2021 and
subsequent Phase 3 initiation in 2022.
ABNCoV2
COVID-19
Phase 1/2 study ongoing. Phase 2 planned in Q2, 2021
TAEK-VAC
Cancer
Phase 1/2 study ongoing
MVA-BN WEV
Equine encephalitis
Phase 1 dose finding study completed.
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 6 of 19
Company Announcement no. 20 / 2021
Financial review
Financial statements for the period January 1 – March 31, 2021
are un-audited. Comparison figures for the same period 2020 are
stated in brackets.
Revenue
Revenue generated for the three months ending March 31, 2021
was DKK 535 million (DKK 365 million). Revenue was composed of
DKK 179 million (DKK 321 million) from sale of the two new
products Rabipur/RabAvert and Encepur, DKK 246 million (DKK 0
million) from sale of MVA-BN smallpox vaccine bulk drug
substance to US government, DKK 90 million (DKK 0 million) sale
of MVA-BN smallpox vaccines to rest of World, and DKK 20 million
(DKK 44 million) from contract work.
Production costs
Production costs totaled DKK 377 million (DKK 243 million). Costs
related directly to revenue amounted to DKK 219 million (DKK
172 million), of which cost of goods sold totaled DKK 205 million
(DKK 142 million). Contract costs totaled DKK 13 million (DKK 29
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 68 million (DKK 68
million). Other production costs totaled DKK 90 million (DKK 3
million). In first quarter of 2021 the production facility was
mainly used for production of RSV Phase 3 clinical trial material,
which gives a much lower utilization of the capacity for
commercial manufacturing leading to low absorption of indirect
production costs causing higher other production costs.
Sales and distribution costs
Sales and distribution costs totaled DKK 51 million (DKK 75
million) split between costs for distribution of products DKK 4
million (DKK 39 million) and costs for running the commercial
organization and activities DKK 47 million (DKK 36 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
Research and development costs totaled DKK 122 million (DKK 66
million). The increase compared to 2020 was driven by
manufacturing of RSV phase 3 material and activities related to
support technology transfer of Rabipur/RabAvert and Encepur.
The amount excludes R&D costs of DKK 13 million (DKK 29
million) classified as production costs.
Administrative costs
Administrative costs totaled DKK 73 million (DKK 51 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
Other operating income for 2020 related to the sale of the
Priority Review Voucher, DKK 628 million.
EBIT/EBITDA
Income before interest and tax (EBIT) was a loss of DKK 88
million, compared to a gain of DKK 558 million in first quarter
2020 following the sale of the Priority Review Voucher.
EBITDA was a gain of DKK 1 million (gain of DKK 641 million).
Amortization of product rights related to Rabipur/RabAvert and
Encepur amounted to DKK 68 million (DKK 68 million) whereas
1
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.
depreciation on other fixed assets amounted to DKK 21 million
(DKK 16 million).
Financial items
Financial items totaled a net expense of DKK 42 million (DKK 42
million) and consisted of interest expense on debt of DKK 5
million (DKK 18 million), net value adjustment of deferred
consideration of DKK 26 million (DKK 21 million), a net expense
from securities of DKK 13 million (DKK 6 million) and a net loss on
derivative financial instruments of DKK 1 million (DKK 3 million),
partly offset by net foreign exchange rate gains of DKK 3 million
(DKK 6 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 0 million (income of
DKK 9 million), currency adjustments of DKK 1 million income
(income of DKK 1 million) and unwinding
1
of the discounting
effect related to deferred consideration DKK 28 million (DKK 31
million), see note 6 and 7.
Income before company tax was a loss of DKK 130 million (gain of
DKK 516 million).
Tax
Tax on income was DKK 1 million (DKK 1 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.
Net profit
For the first three months of 2021, Bavarian Nordic reported a
net loss of DKK 131 million (net gain of DKK 515 million).
Product rights
Product rights recognized in the balance sheet totaled DKK 5,147
million (DKK 5,186 million as of December 31, 2020) and relates
to Rabipur/RabAvert and Encepur.
Securities, cash and cash equivalents
Securities, cash and cash equivalents were DKK 2,589 million as of
March 31, 2021 (DKK 1,670 million as of December 31, 2020). 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.
Cash flow
Cash flow generated by operating activities was negative by DKK
120 million (positive by DKK 432 million), primarily due to the
negative result for the period. Cash flow from investment
activities was negative by DKK 1,069 million (negative by DKK 630
million) following net investments in securities of DKK 973 million
(net investment of DKK 573 million). Cash flow from investment
activities also include DKK 81 million (DKK 23 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 intangible assets
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 7 of 19
Company Announcement no. 20 / 2021
amounted to DKK 15 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 1,146 million (DKK 1,363 million), following
the proceeds from capital increase through private placement.
The net change in cash and cash equivalents was negative by DKK
43 million (contribution of DKK 1,165 million).
Equity
The Group’s equity as of March 31, 2021 stood at DKK 5,921
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
Deferred consideration for product rights amounted to DKK 2,849
million, an increase of DKK 26 million compared to December 31,
2020, due to the adjustment of net present value following the
unwinding of the discounting effect.
Debt to credit institutions
Debt to credit institutions decreased by DKK 1 million compared
to December 31, 2020.
Significant risks and uncertainties
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.
Outlook for 2021
Bavarian Nordic maintains the financial guidance for 2021 with
expected revenue between DKK 1,900 million and DKK 2,200
million and an EBITDA between DKK 100 million and DKK 250
million. Cash and cash equivalents at year-end are expected to
be between DKK 1,400 million and DKK 1,600 million.
The low end of the revenue range reflects a scenario where a
lockdown due to COVID-19 continues beyond Q1 in key markets
like the US and Germany. The higher end of the revenue range
reflects a scenario where a gradual reopening will happen in key
markets during Q2 and where travel starts picking up again in Q3
and Q4 of 2021.
The smallpox and Ebola business are not expected to be
impacted by COVID-19.
The key assumptions for the guidance remain largely unchanged
since the publication of guidance in the 2020 Annual Report.
Financial calendar 2021
Half-year report (Q2) August 25, 2021
Nine-month report (Q3) November 12, 2021
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 8 of 19
Company Announcement no. 20 / 2021
Financial statements
Unaudited Condensed Consolidated Income Statements for the Periods Ended March 31, 2021 and 2020 and
December 31, 2020
DKK thousand
Note
1/1 - 31/3 2021
1/1 - 31/3 2020
1/1-31/12 2020
Revenue
3
Production costs
4
Gross profit
Sales and distribution costs
Research and development costs
5
Administrative costs
Total operating costs
Other operating income
Income before interest and tax (EBIT)
(87,993 )
Financial income
6
Financial expenses
7
Income before company tax
(129,731 )
Tax on income for the period
Net profit for the period
(130,845 )
Earnings per share (EPS) - DKK
Basic earnings per share of DKK 10
(2.2 )
Diluted earnings per share of DKK 10
(2.2 )
Unaudited Condensed Consolidated Statements of Comprehensive Income for the Periods Ended March 31,
2021 and 2020 and December 31, 2020
DKK thousand
1/1 - 31/3 2021
1/1 - 31/3 2020
1/1-31/12 2020
Net profit for the period
(130,845 )
Items that might be reclassified to the income statement:
Exchange rate adjustments on translating foreign operations
(61 )
(3,082 )
Change in fair value of financial instruments entered into to hedge future cash
flows
(12,956 )
(3,569 )
(3,096 )
Other comprehensive income after tax
(9,122 )
(3,630 )
(6,178 )
Total comprehensive income
(139,967 )
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 9 of 19
Company Announcement no. 20 / 2021
Unaudited Condensed Consolidated Statements of Cash Flow for the Periods Ended March 31, 2021 and
2020 and December 31, 2020
DKK thousand
1/1 - 31/3 2021
1/1 - 31/3 2020
1/1-31/12 2020
Net profit for the period
(130,845 )
Adjustment for non-cash items:
Financial income
(6,912 )
(16,779 )
(97,922 )
Financial expenses
Tax on income for the period
Depreciation, amortization and impairment losses
Share-based payment
Changes in inventories
(31,749 )
(86,002 )
(420,320 )
Changes in receivables
(10,409 )
(138,665 )
(88,094 )
Changes in current liabilities
(96,743 )
Cash flow from operations (operating activities)
(111,400 )
Received financial income
Paid financial expenses
(8,620 )
(9,337 )
(40,034 )
Paid company taxes
(175 )
(3,944 )
Cash flow from operating activities
(119,535 )
Investments in products rights
(21,671 )
(393,992 )
Investments in other intangible assets
(14,513 )
(10,828 )
(107,885 )
Investments in property, plant and equipment
(81,177 )
(22,787 )
(204,833 )
Investments in financial assets
(440 )
(2,180 )
(2,677 )
Investments in securities
(1,062,058 )
(671,190 )
(2,343,828 )
Disposal of securities
Cash flow from investment activities
(1,069,407 )
(630,145 )
(1,911,532 )
Payment on loans
(544 )
(1,382,918 )
(1,375,598 )
Repayment of lease liabilities
(4,853 )
(3,548 )
(17,799 )
Proceeds from warrant programs exercised
Proceeds from rights issue
Proceeds from capital increase through private placement
Cost related to issue of new shares
(25,179 )
(99,983 )
(103,184 )
- hereof accrued costs
-
Sale of preemptive rights - treasury shares
Purchase of treasury shares
(11,099 )
Cash flow from financing activities
Cash flow of the period
(42,823 )
(4,747 )
Cash as of 1 January
Currency adjustments 1 January
(7,311 )
Cash end of period
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 10 of 19
Company Announcement no. 20 / 2021
Unaudited Condensed Consolidated Statements of Financial Position - Assets as of March 31, 2021 and 2020
and December 31, 2020
DKK thousand
Note
31/3 2021
31/3 2020
31/12 2020
Assets
Product rights
Acquired patents and licenses
Software
Intangible assets in progress
Intangible assets
Land and buildings
Leasehold improvements
Plant and machinery
Fixtures and fittings, other plant and equipment
Assets under construction
Property, plant and equipment
Right-of-use assets
14
Other receivables
Financial assets
Total non-current assets
Inventories
8
Trade receivables
9
Tax receivables
Other receivables
10
Prepayments
Receivables
Securities
Cash and cash equivalents
Securites, cash and cash equivalents
Total current assets
Total assets
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 11 of 19
Company Announcement no. 20 / 2021
Unaudited Condensed Consolidated Statements of Financial Position - Equity and Liabilities as of March 31,
2021 and 2020 and December 31, 2020
DKK thousand
Note
31/3 2021
31/3 2020
31/12 2020
Equity and liabilities
Share capital
Treasury shares
(946 )
(599 )
(1,077 )
Retained earnings
Other reserves
Equity
Deferred consideration for product rights
Debt to credit institutions
11
Lease liabilities
14
Non-current liabilities
Deferred consideration for product rights
Debt to credit institutions
11
Lease liabilities
14
Prepayment from customers
12
Trade payables
Company tax
Other liabilities
13
Current liabilities
Total liabilities
Total equity and liabilities
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 12 of 19
Company Announcement no. 20 / 2021
Unaudited Condensed Consolidated Statements of Changes in Equity for the Periods March 31, 2021 and
2020
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
(1,077 )
(40,640 )
(809 )
Comprehensive income for the period
Net profit
(130,845 )
(130,845 )
Other comprehensive income
Exchange rate adjustments on translating foreign
operations
Change in fair value of financial instruments entered
into to hedge future cash flows
(12,956 )
(12,956 )
Total comprehensive income for the period
(130,845 )
(12,956 )
(139,967 )
Transactions with owners
Share-based payment
Warrant program exercised
(7,498 )
Capital increase through private placement
Cost related to issue of new shares
(25,179 )
(25,179 )
Transfer regarding restricted stock units
(2,534 )
Total transactions with owners
Equity as of March 31, 2021
(946 )
(36,806 )
(13,765 )
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, 2020
(684 )
(37,558 )
Comprehensive income for the period
Net profit
Other comprehensive income
Exchange rate adjustments on translating foreign
operations
(61 )
(61 )
Change in fair value of financial instruments entered
into to hedge future cash flows
(3,569 )
(3,569 )
Total comprehensive income for the period
(61 )
(3,569 )
Transactions with owners
Share-based payment
Capital increase through rights issue
Cost related to issue of new shares
(99,983 )
(99,983 )
Transfer regarding restricted stock units
(2,474 )
Sale of preemptive rights - treasury shares
Total transactions with owners
Equity as of March 31, 2020
(599 )
(37,619 )
(1,282 )
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 13 of 19
Company Announcement no. 20 / 2021
Notes
1. Significant accounting policies
2. Significant accounting estimates, assumptions and uncertainties
3. Revenue
4. Production costs
5. Research and development costs
6. Financial income
7. Financial expenses
8. Inventories
9. Trade receivables
10. Other receivables
11. Debt to credit institutions
12. Prepayment from customers
13. Other liabilities
14. Right-of-use assets and lease liabilities
15. Financial instruments
16. Warrants
17. Significant changes in contingent liabilities and other contractual obligations
18. Significant events after the balance sheet date
19. Approval of the unaudited condensed consolidated interim financial statements
1. Significant accounting policies
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 March 31, 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.
2. Significant accounting estimates, assumptions and uncertainties
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 Interim Results for the First Three Months of 2021 Page 14 of 19
Company Announcement no. 20 / 2021
DKK thousand
1/1 - 31/3 2021
1/1 - 31/3 2020
1/1-31/12 2020
3. Revenue
MVA-BN smallpox vaccine sale
336,211
186
540,769
Rabipur/RabAvert
80,332
218,140
627,699
Encepur
98,480
102,770
455,012
Sale of goods
515,023
321,096
1,623,480
Milestone payments
-
-
66,553
Contract work
20,230
44,309
162,350
Sale of services
20,230
44,309
228,903
Revenue
535,253
365,405
1,852,383
Total revenue includes:
Fair value adjustment concerning financial instruments entered into to
hedge revenue
269
-
13,146
4. Production costs
Cost of goods sold
205,411
142,295
584,574
Contract costs
13,486
29,253
104,409
Amortization product rights
68,234
68,234
272,935
Other production costs
90,210
3,302
233,176
Production costs
377,341
243,084
1,195,094
5. Research and development costs
Research and development costs occurred in the period
135,626
95,334
445,829
Of which:
Contract costs recognized as production costs
(13,486)
(29,253)
(104,409)
Research and development costs
122,140
66,081
341,420
6. Financial income
Financial income from bank and deposit contracts
41
188
193
Interest income from financial assets measured at amortized cost
41
188
193
Financial income from securities
2,291
1,153
8,756
Fair value adjustments on securities
-
-
6,783
Adjustment of deferred consideration due to change in estimated timing of
payments
335
8,670
67,719
Currency adjustment deferred consideration
1,366
954
11,900
Adjustment of net present value of provisions
-
-
-
Net gains on derivative financial instruments at fair value through the
income statement
-
-
2,571
Net foreign exchange gains
2,879
5,814
-
Financial income
6,912
16,779
97,922
7. Financial expenses
Interest expenses on debt
4,662
18,457
31,853
Interest expenses on financial liabilities measured at amortized cost
4,662
18,457
31,853
Fair value adjustments on securities
14,849
6,921
-
Unwinding of the discounting effect related to deferred consideration
28,129
30,818
145,149
Net loss on derivative financial instruments at fair value through the income
statement
1,010
2,584
-
Net foreign exchange losses
-
-
18,532
Financial expenses
48,650
58,780
195,534
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 15 of 19
Company Announcement no. 20 / 2021
DKK thousand
31/3 2021
31/3 2020
31/12 2020
8. Inventories
Raw materials and supply materials
74,086
48,761
73,919
Work in progress
60,044
237,686
201,601
Manufactured goods and commodities
450,329
336
309,099
Write-down on inventory
(31,628)
(100,019)
(63,537)
Inventories
552,831
186,764
521,082
Write-down on inventory as of January 1
(63,537)
(104,056)
(104,056)
Write-down during the period
(2,451)
-
(25,692)
Use of write-down
34,360
3,854
65,672
Reversal of write-down
-
183
539
Write-down end of period
(31,628)
(100,019)
(63,537)
9. Trade receivables
Trade receivables from smallpox vaccine sale
12,011
36
-
Trade receivables from Encepur and Rabipur/RabAvert
138,725
183,792
121,355
Trade receivables from contract work
8,451
26,776
17,937
Other receivables
159,187
210,604
139,292
10. Other receivables
Receivable VAT and duties
18,216
15,391
31,486
Derivative financial instruments at fair value
-
-
606
Interest receivables
5,199
2,792
3,767
Other receivables
1
-
1,475
Other receivables
23,416
18,183
37,334
11. Debt to credit institutions
Mortgage
22,703
24,869
23,247
European Investment Bank (loan in DKK)
372,195
372,195
372,195
Repo transactions
-
-
-
Debt to credit institutions
394,898
397,064
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
(1,656)
(593)
(9,469)
Prepayments from customers end of period
72,691
28,117
74,347
13. Other liabilities
Financial instruments at fair value
13,764
1,282
1,414
Liability relating to phantom shares
16,246
352
4,849
Payable salaries, holiday accrual etc.
67,722
57,046
101,229
Gross to net deduction accrual
24,261
-
26,355
Other accrued costs
24,225
21,183
17,967
Other liabilities
146,218
79,863
151,814
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 16 of 19
Company Announcement no. 20 / 2021
14. Right-of-use assets and lease liabilities
Right-of-use assets
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
-
523
-
523
Modifications
20,040
-
38
20,078
Depreciations
(4,454)
(400)
(112)
(4,966)
Exchange rate adjustments
8
36
(0)
44
Right-of-use assets as of March 31, 2021
84,525
2,471
670
87,666
Lease liabilities
DKK thousand
31/3 2021
Non-current
69,481
Current
20,890
Lease liabilities
90,371
Amounts included in the income statement
DKK thousand
1/1 - 31/3 2021
Interest expense leases
492
Depreciation recognized on right-of-use assets
4,966
Cost recognized for short term leases (less than 12
months)
132
In the first three months of 2021 the total cash outflow relating to lease was DKKt 5,345 split between interests of DKKt 492 and repayment
of DKKt 4,853.
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 17 of 19
Company Announcement no. 20 / 2021
15. Financial instruments
Method and assumption to determine fair value
The Group has financial instruments measured at fair value at level 1 and level 2.
Securities (level 1)
The portfolio of publicly traded government bonds and publicly traded mortgage bonds is valued at listed prices and price quotas.
Derivative financial instruments (level 2)
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.
Fair value hierarchy for financial instruments measured at fair value
As of March 31, 2021
DKK thousand
Level 1
Level 2
Total
Securities
2,342,787
-
2,342,787
Financial assets measured at fair value through the income statement
2,342,787
-
2,342,787
Derivative financial instruments to hedge future cash flow (currency)
-
(12,712)
(12,712)
Derivative financial instruments to hedge future cash flow (interest)
-
(1,052)
(1,052)
Financial assets/liabilities used as hedging instruments
-
(13,764)
(13,764)
Liability relating to phantom shares
-
(16,246)
(16,246)
Financial liabilities measured at fair value through the income statement
-
(16,246)
(16,246)
As of December 31, 2020
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)
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 18 of 19
Company Announcement no. 20 / 2021
16. Warrants
Outstanding warrants as of March 31, 2021
Outstanding
as of
January 1
Addition
during the
period
Warrants
exercised
Annulled
Terminated
Trans-
ferred
Outstanding
as of
March 31
Corporate Management
439,402
-
-
-
-
-
439,402
Other Executive Management
723,326
-
-
-
-
(215,328)
507,998
Other employees
2,062,360
-
(110,559)
(75,479)
-
(43,243)
1,833,079
Resigned employees
167,901
-
(26,133)
-
-
258,571
400,339
Total
3,392,989
-
(136,692)
(75,479)
-
-
3,180,818
Weighted average exercise price
188
-
207
192
-
-
187
Weighted average share price at exercise
-
-
302
-
-
-
-
Numbers of warrants which can be exercised as of March 31, 2021
689,512
at a weighted average exercise price of
DKK
230
The total recognized cost of the warrant programs was DKK 10.5 million in the first three months of 2021 (DKK 4.8 million).
Specification of parameters for Black-Scholes model
DKK
Dec
2016
Jul
2017
Nov
2017
Nov
2018
Nov
2019
Jan
2020
Nov
2020
Average share price
222.50
383.50
259.50
159.00
154.05
171.20
179.84
Average exercise price at grant
260.20
430.40
303.00
179.60
185.40
197.00
206.82
Average exercise price determined at
date 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 grant
1)
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
17. Significant changes in contingent liabilities and other contractual obligations
No significant changes in contingent liabilities and other contractual obligations have occurred since December 31, 2020.
18. Significant events after the balance sheet date
On May 27, Bavarian Nordic announced an agreement with Dynavax on marketing and distribution of their HEPLISAV B® hepatitis B vaccine in
Germany.
On May 7, 2021, Bavarian Nordic announced that the US government had exercised the final USD 12 million option remaining under the USD
202 million order for JYNNEOS
®
awarded in April 2020.
On April 29, 2021, Bavarian Nordic reported additional preclinical data for the capsid virus-like particle (cVLP) COVID-19 vaccine candidate,
ABNCoV2, confirming its ability to induce neutralizing antibodies against SARS-CoV-2 variants.
On April 6, 2021, Bavarian Nordic announced that the Company had received a new supply order from Janssen Pharmaceutica NV, part of the
Janssen Pharmaceutical Companies of Johnson & Johnson, valued at approximately USD 28 million for manufacturing and delivery of bulk drug
substance of MVA-BN® Filo vaccine.
19. Approval of the unaudited condensed consolidated interim financial statements
The unaudited condensed consolidated interim financial statements were approved by the Board of Directors and Corporate Management and
authorized for issue on May 27, 2021.
Bavarian Nordic Announces Interim Results for the First Three Months of 2021 Page 19 of 19
Company Announcement no. 20 / 2021
Statement from the Board of Directors and Corporate Management
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 March 31, 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 March 31, 2021,
and the results of the group’s activities and cash flows for the period January 1 to March 31, 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.
Hellerup, May 27, 2021
Corporate Management:
Paul John Chaplin Henrik Juuel
President & CEO Executive Vice President & CFO
Board of Directors:
Gerard W.M. van Odijk Anders Gersel Pedersen Erik Gregers Hansen Peter H. Kürstein-Jensen
Chairman of the Board Deputy Chairman
Frank A.G.M. Verwiel Elizabeth McKee Anderson Anne Louise Eberhard
Thomas Alex Bennekov Anja Gjøl Karen Merete Jensen Linette Munksgaard Andersen
Employee-elected Employee-elected Employee-elected Employee-elected