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.