Bavarian Nordic MARCH 2021
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Bavarian Nordic MARCH 2021 1
Disclaimer This presentation 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 regarding our short-term objectives and opportunities, financial expectations for the full year and financial preparedness as of year end, as well as 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. 2
Bavarian Nordic – a fully integrated vaccine company
By 2025, we aspire to be one of the largest
pure play vaccine companies improving and
saving lives by excelling in R&D innovation,
manufacturing and commercialization
4 Commercial
650 marketed
products
scale Commercial
manufacturing infrastructure
employees
rabies
facility supporting key RSV Profitable
+32% with inhouse markets in US late-stage vaccine
ii 2020 fill and finish and EU vaccine business
TBE
being added candidate
smallpox during 2021 in blockbuster
indication
Ebola
3
Products & pipeline
Products Pipeline
Rabipur/RabAvert Phase 1 Phase 2 Phase 3
Smallpox
Rabies
MVA-BN freeze-dried
Phase 3 lot-consistency study ongoing with anticipated completion in 2021
Respiratory Syncytial Virus (RSV)
Encepur MVA-BN RSV
Tick-borne encephalitis (TBE) Human challenge study planned for 2021, followed by Phase 3 in 2022.
Immuno-oncology
TAEK-VAC
Phase 1/2 study ongoing
JYNNEOS/IMVANEX/IMVAMUNE
Smallpox & monkeypox Equine encephalitis
MVA-BN WEV
Phase 1 dose finding study completed
COVID-19
ABNCoV2
MVABEA
Ebola Phase 1/2 study planned for initiation Q1 2021. Licensed from AdaptVac
Licensed to Janssen
Products 5
JYNNEOS - smallpox vaccine
Expanding the smallpox market
FDA approved vaccine
• JYNNEOS® is the first and only FDA approved non-replicating vaccine for the prevention of smallpox and monkeypox
• Smallpox vaccines approved in Canada and EU under trade names IMVAMUNE® and IMVANEX®
US national stockpiling opportunity
• U.S. Government new 10-year contract worth up to USD 539m awarded in 2017 to replace expired stockpile
• Freeze-dried well positioned to fulfil U.S. Government long-term stockpiling requirements
Pre-approval (EUA) Post-approval
To protect 10 million citizens at risk in the To protect 66 million citizens
event of an emergency (contraindicated to ACAM2000 and their
household contacts)
20m doses, liquid-frozen 132m doses, freeze-dried
Smallpox beyond national stockpiling
• Market opportunities for general adult population expanded beyond national stockpile
• Current recommendation: Military personnel in South Korea (50,000 p.a.)
• Future potential: All troops entering basic training (~240k p.a.); all active duty military personnel (~3m)
• Seek to re-invoke 2002 US smallpox vaccination guidelines: 0.5m to up to 10m healthcare workers; other civilians
who wish to be vaccinated
6
Smallpox vaccine contract and development with USG
• New JYNNEOS order from the U.S. government – bulk & liquid-frozen
• Positive Phase 3 topline results for freeze-dried version reported in August 2020
• FDA approval expected in 2022 unlocking value of USD 299M contract option
• 2020 JYNNEOS order from USG valued up to USD 202 million
• Covers two years of performance and includes the manufacturing of additional bulk vaccine and the
supply of up to 1.4 million doses of liquid frozen JYNNEOS
• USD 106 million secured in Apr 2020 and USD 83M in Dec 2020 to be invoiced in 2021
• Ensures the availability of a licensed, non-replicating smallpox vaccine in the U.S. Strategic
National Stockpile (SNS) for potential use by first-line responders
Timelines
2016-2019 2020 2021 2022-2024
Bulk orders, manufactured/invoiced $333M
New order, bulk and final doses (LF) $202M
Freeze-dried delivery, 13M doses $299M
7
Rabipur/RabAvert – rabies vaccine
Rabipur/RabAvert #1 position in major and high growth Western markets
Rabies – market characteristics Rabipur/RabAvert
• Well established life-saving vaccine with 30 years of
market experience, supported by extensive clinical and
safety evidence
59,000 deaths1
Annual global mortalities from rabies indicating Product & market dynamics
significance of disease
• First launched in 1985
• Sterile, freeze dried vaccine indicated for both pre exposure and post
exposure prophylaxis in all age groups
• Focused on major Western regulated markets and traveller population
• Market shares highly supply driven; leading players appear to spend very low
100% effectiveness or no effort on promotion
Pre- and post-exposure effectiveness of
Rabipur/RabAvert vaccine • Rabipur / RabAvert is a market leader in major Western markets
• US and Germany account for the majority of product revenues
• EU/US market size approximately €170m
Low risk awareness
Of travellers to endemic areas, leading to an
extremely low coverage
Source: 1. https://www.cdc.gov/rabies/location/world/index.html.
8
Rabipur/RabAvert sales – strong US performance
mDKK
Q3 2020 Q3 2019 Growth 9M 2020 9M 2019 Growth mDKK
188 257 -27% 548 692 -21% 300
250
Competitor was out-of-stock in the beginning of the year 200
Post-exposure segment is more resilient and less impacted by COVID-19. US market 150
decline limited to 14% vs LY
100
Market share gain in US market (61% in 1Q19 to 79% in 3Q20)
50
US revenue growth of more than 30% vs LY
0
Pre-exposure (travel) market heavily impacted - down by 92% in Germany in Q1 Q2 Q3 Q4 *
(July/August 2020 versus prior year) 2019 2020
* Q4 2019 significantly positively impacted by
competitor’s out of stock situation; nearly DKK 150
million higher than expected
Sales figures from 2019 have been provided by GSK and are presented for comparison only.
9
Encepur – tick-borne encephalitis (TBE) vaccine
TBE a growing public health issue in Europe
Encepur #2 position in markets with high underlying growth
TBE – market characteristics Encepur
• Unique dosing flexibility supported by proven efficacy,
effectiveness and long-term persistence data
10-20% paralysis1
Rate of paralysis amongst those infected in Product & market dynamics
addition to 1-2% mortality rate • Product launched in 1991
• Vaccine against TBE. Administered in a three dose regimen over a one year or
one month period
• Commercialized in major European markets
• High competitive dynamics. Pfizer has a market leader position
5k-13k cases p.a.2 • Encepur has an established market presence limited historical marketing efforts
Reported cases with majority originating from provide attractive upside potential
Russia and Central & Eastern Europe
• Encepur holds a #2 position in major European markets
• Germany and Sweden account for majority of product revenues
• EU market size approximately €220m
Three patient segments
Living in endemic areas, traveling to endemic
areas, occupationally at risk
Source: 1. https://www.cdc.gov/vhf/tbe/pdf/factsheet.pdf; 2. https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-related-infectious-diseases/tickborne-encephalitis.
10Encepur sales – sign of market rebound
mDKK
Q3 2020 Q3 2019 Growth 9M 2020 9M 2019 Growth mDKK
250
110 97 14% 406 484 -16%
200
Year-over-year decline was caused by inventory movements in the supply chain and
150
COVID-19 impact in key markets due to limited access to physicians
Largest market, Germany slightly declined in July/August, but showing signs of 100
recovery
50
Market share remains stable around 30%
Encepur growth of 14% in Q3 vs LY 0
Q1 Q2 Q3 Q4
2018 2019 2020
Sales figures from 2018 and 2019 have been provided by GSK and are presented for comparison only.
11MVA-BN Filo - Ebola vaccine
i
• In 2019, the WHO recommended deployment of the Janssen/Bavarian 2021 Re-emergence
Nordic Ebola vaccine to combat the outbreak in the DRC, Rwanda and In February, the governments
Uganda of the DRC and Guinea
announced a new outbreak of
• An EMA was granted in July 2020 for active immunization for the Ebola in their countries.
prevention of disease caused by the Ebola virus in individuals aged one
year and above, triggering a $10M milestone payment from Janssen
• Janssen entered into a new supply contract with BN, worth ~$14M to be
recognized in 2021, in addition to the +2M doses that have previously
been manufactured
Guinea
Uganda
DR Congo Rwanda
Ebola vaccine – a Janssen partnership
Janssen’s AdVac + MVA-BN showed robust and sustained immune responses.
Synergistic benefit of combining our technology has been key to establishing
collaborations in blockbuster indications
12Update on manufacturing expansion Single-bulk facility transforming into a fully-fledged manufacturing plant Fill and finish ✓ Construction completed ✓ Validation & qualification completed ✓ Ready for first commercial manufacturing Bulk manufacturing ✓ Construction work ongoing for expansion of facility to allow for simultaneous bulk manufacturing of multiple products 13
Pipeline 14
COVID-19 vaccine program
• AdaptVac is planning the initiation COVID-19 vaccine candidate Flexible platform adaptive to mutations
of a first-in-human study, supported • Capsid virus like particle (cVLP) based SARS-
by a Horizon 2020 EU grant. Initial CoV-2 subunit vaccine
data expected during Q1 2021. • Designed to fulfil WHO’s criteria for a COVID-
19 vaccine during outbreak (e.g. rapid onset
• Bavarian Nordic-sponsored NHP of protection, suitable for all ages)
study ongoing with preliminary • Licensed from AdaptVac
results confirming AdaptVac’s
immunogenicity data in mice.
Additional data expected during Q1
2021.
• Accelerated development plan
including Phase 3 design has been
NHP study cVLP SARS-CoV2
developed. Preliminary results show that the cVLP vaccine vaccine in patients
induces high levels of neutralizing antibodies,
comparable with the levels detected in the
NHP
convalescent sera of SARS-CoV2 patients.
High Low High Low
dose dose titers titers
15RSV – a new approach
• MVA-BN RSV encodes 5 distinct targets of RSV to stimulate a broad protective immune response (T cells &
antibodies)
• MVA-BN RSV mimics the natural response to an RSV infection and is believed to induce protection for at least
one year
MVA-BN RSV
• The Phase 2 main study and booster study demonstrated: F(A)
o Safe, durable immune response
o Significant and broad antibody & T cell responses G(A)
o Strong mucosal immune response
o Immunity against both subtypes (A&B) G(B)
N
M2
16RSV – de-risking Phase 3 with planned human challenge trial
Human challenge trial Phase 3 in older adults
• Human challenge trial in 2021 will
• Assessing the effect of vaccination with • Randomized, placebo-controlled trial with
provide efficacy insights ahead of MVA-BN-RSV vaccine, in reducing the RSV an adaptive design enrolling 12,000 -
Phase 3 viral loads due to the challenge strain 14,000 subjects over two seasons (6,000
when compared to placebo for the first season, 6,000-8,000 for the
• Postponing Phase 3 study initiation by • Other predefined outcome measures, such second season)
one year into 2022 due to anticipated as symptoms scores will also be evaluated
• After passing the first season threshold
COVID-19 impact there would be a ~75% chance of
successfully reaching the efficacy
endpoint of the trial
• Estimated costs to determine futility after
the first season will be USD 40m. Second
season will cost an additional USD 50-70m
2021 2022 2023 2024
Human challenge trial Phase 3 (season 1) Phase 3 (season 2)
Vaccination Results Futility
Vaccination RSV season Vaccination RSV season Results
analysis
17MVA-BN WEV - equine encephalitis an emerging disease
i
• A new vaccine program targeting three separate strains of the The virus
equine encephalitis virus Transmitted to humans via
mosquitos
• Eastern (EEEV) While EEEV, VEEV and WEEV vary
in infection rates and severity of
• Venezuelan (VEEV)
disease, all three pathogens are
• Western (WEEV) associated with risks of flu-like
symptoms, potential central
• Multi-year agreement with U.S. Department of Defense of up to nervous disorders, and death
USD 36m
• A Phase 1 dose-ranging trial (N=45) has been completed, showing No vaccine
favorable safety and immunogenicity Currently no preventative
vaccines available
• Funding being sought with US agencies to support further
preclinical, clinical development and manufacturing to support
licensure. U.S. outbreak
In 2019, 38 EEEV cases, including
15 deaths were reported, mostly
in north-eastern parts of the
U.S., making it the worst
outbreak yet
18Financials 19
Financial Results
Preliminary Financial Results for 2020 were released on January 28, 2021
The annual report, including financial guidance, is expected to be published on March 12, 2021
▪ Revenue for the full year is expected to be approximately DKK 1,852 million:
• DKK 1,082 million from combined sale of Rabipur/RabAvert and Encepur
• DKK 704 million from US Government sale, including JYNNEOS revenue and contract work
• DKK 66 million from the milestone payment from Janssen (Ebola vaccine approval)
▪ EBITDA is expected at approximately DKK 740 million:
• Including other operating income of DKK 628 million from the sale of Priority Review Voucher
▪ Cash position at year-end was approximately DKK 1,670 million, excluding unutilized credit facilities of DKK
244 million
FY2020 FY2019
Prelim mDKK Actual
Revenue 1,852 662
EBITDA 740 (271)
Securities, Cash and Cash Equivalents 1,670 716
2021
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