Bavarian Nordic Receives USD 156.8 Million from the U.S. Government for Additional Smallpox/Mpox Vaccine Production
August 08 2024 - 12:49AM
- The contract will help replenish inventory of bulk vaccine
required for future manufacturing and supply of freeze-dried
vaccines.
COPENHAGEN, Denmark, August 8,
2024 – Bavarian Nordic A/S (OMX: BAVA) today
announced that it has received a new order valued at USD 156.8
million from the Biomedical Advanced Research and Development
Authority (BARDA), part of the Administration for Strategic
Preparedness and Response within the U.S. Department of Health and
Human Services, to manufacture additional bulk product for
JYNNEOS®, the company’s smallpox/mpox vaccine.
The bulk product, representing USD 139.7 million
of the contract value, will be manufactured and invoiced in 2024
and will partly replenish the inventory used to manufacture
vaccines in response to the mpox outbreak in 2022. Replenishment of
the bulk inventory is necessary to fulfil the company’s existing
contract to supply a next-generation, freeze-dried version of the
vaccine for U.S. smallpox preparedness.
The contract also includes approximately USD 17
million for additional services in the period 2025-2027, including
storage of vaccine doses in the U.S.
“Our smallpox/mpox vaccine represents a key
component in the U.S. biological preparedness, as demonstrated
during the 2022 mpox outbreak. JYNNEOS was also the first smallpox
vaccine successfully developed under Project BioShield, a program
created by the U.S. Congress in 2004 to accelerate the research,
development, procurement, and availability of medical
countermeasures against biological, chemical, radiological, and
nuclear (CBRN) agents through public-private partnerships. We
applaud the U.S. government’s steadfast commitment to maintaining a
robust preparedness and are proud to continue providing vaccines to
protect its citizens against current and future public health
threats,” said Paul Chaplin, President & CEO of
Bavarian Nordic.
While the contract will not impact the company’s
overall financial guidance for 2024, the order will increase the
value of secured contracts in the Public Preparedness business this
year from approximately DKK 1,600 million to approximately DKK
2,500 million. A total of DKK 2,700–3,000 million is expected from
this business in 2024 with the residual primarily driven by a few
additional government contracts anticipated later this year.
Revenue for the year furthermore comprises
approximately DKK 2,100 million from Travel Health vaccines and
approximately DKK 200 million from contract work, thus totaling an
expected DKK 5,000-5,300 million. The EBITDA is expected to reach
DKK 1,100-1,350 million.
All full year revenue and earnings estimates
mentioned are in line with previous guidance.
About our vaccine contracts with the
U.S. governmentSince 2003, Bavarian Nordic has worked with
the U.S. government on the development, manufacturing and supply of
a non-replicating smallpox vaccine to ensure all populations can be
protected from smallpox, including people with weakened immune
systems who are at high risk of adverse reactions to traditional
smallpox vaccines, which are based on replicating vaccinia virus
strains. The vaccine was approved by the FDA in 2019 under the
trade name JYNNEOS®, indicated for the prevention of both smallpox
and mpox infection.
Prior to approval, Bavarian Nordic had supplied
nearly 30 million doses of the liquid-frozen version to the U.S.,
with the vast majority being delivered for emergency use - and now
expired.
BARDA has supported the development of a
freeze-dried version of the vaccine with longer shelf-life to
replace the stockpile and in 2017 awarded the company a ten-year
contract for supply of freeze-dried vaccines. Under this contract
Bavarian Nordic had previously manufactured bulk vaccine,
corresponding to approximately 13 million doses, pending filling
and supply. However, the request from BARDA in 2022 to supply the
liquid-frozen version of the vaccine to mitigate the mpox outbreak
reduced the inventory of bulk, thus calling for a replenishment to
enable Bavarian Nordic to fulfill its contract for the freeze-dried
version. The first replenishment contract was awarded in 2023,
allowing for the initiation of manufacturing and supply of the
first freeze-dried doses in 2024.
This project has been supported in part with
federal funds from the Department of Health and Human Services
(HHS); Administration for Strategic Preparedness and Response
(ASPR); Biomedical Advanced Research and Development Authority,
under contract HHSO100201700019C.
About the smallpox
vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic
(marketed under the brand names JYNNEOS®, IMVANEX® and IMVAMUNE®)
is a non-replicating smallpox and mpox vaccine. The vaccine is
approved by the FDA, EC, Health Canada, MHRA and Swissmedic and has
also obtained emergency use authorization in other territories for
use during the mpox outbreak. The vaccine was originally developed
in collaboration with the U.S. government to ensure supply of a
smallpox vaccine for the entire population, including
immunocompromised individuals who are not recommended vaccination
with traditional replicating smallpox vaccines.
About Bavarian NordicBavarian
Nordic is a fully integrated vaccine company with a mission to
protect and save lives through innovative vaccines. We are a global
leader in smallpox and mpox vaccines, supplied to governments to
enhance public health preparedness and have a strong portfolio of
vaccines for travelers and endemic diseases. For more information
visit www.bavarian-nordic.com.
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.
ContactsEurope: Rolf Sass
Sørensen, Vice President Investor Relations,
rss@bavarian-nordic.com, Tel: +45 61 77 47 43US: Graham Morrell,
graham@paddockcircle.com, Tel: +1 781 686 9600
Company Announcement no. 21 / 2024