NEEDHAM & COMPANY'S 18TH ANNUAL HEALTHCARE CONFERENCE, NEW YORK APRIL 9, 2019 - Bavarian Nordic
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NEEDHAM & COMPANY’S
18TH ANNUAL HEALTHCARE CONFERENCE, NEW YORK
APRIL 9, 2019
1
FORWARD-LOOKING STATEMENTS 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
OUR STORY IN BRIEF
Unlocking the power of the immune system to improve public health, with
a focus on high unmet medical needs
Proven vaccine development expertise
• Approved smallpox vaccine
Validated platform powering robust pipeline
• Broad infectious disease vaccine portfolio
• Targeted immuno-oncology programs for orphan and large indications
Strong relationship with US Government and Big Pharma
• $1.8B in contracts with the USG
• Potential for ~$1B in milestones and royalties from Janssen
Strong financial position
• $356M in cash (as of 12/31/18)
Commercial scale vaccine manufacturing capabilities
• Additional finish & fill facility under construction
3
UNLOCKING THE POWER OF THE IMMUNE SYSTEM…
to improve public health with focus on high unmet medical needs
RSV
CV301 + checkpoint inhibitors
protection against diseases
potentially curing cancer
with no approved therapies
HIV
Brachyury
INFECTIOUS Hepatitis
improving CANCER
survival
DISEASES seeking a
functional cure
Smallpox / Ebola
HPV
preparedness against global
preventing cancer
pandemic threats
4
OUR VISION & STRATEGY
INVESTING FOR THE FUTURE
By 2023 we aspire to be a leading and profitable biotech company that through harnessing
the power of the immune system will develop, manufacture and commercialize products for
infectious disease and cancer
MAINTAIN global leadership of • Finalize development of smallpox vaccine
our smallpox vaccine business • Secure broader sales
EXPAND and rapidly ADVANCE • Launch RSV vaccine
the pipeline of infectious • Advance partnered programs
disease programs • Advance infectious disease pipeline
• Explore combination therapies with vaccines and standard of
ESTABLISH a broad and deep care
cancer immunotherapy portfolio
• Explore more advanced combinations
• Take advantage of core manufacturing capabilities and
EXPAND the commercial capacity
footprint and capabilities
• Build commercial infrastructure to drive profitable growth
5A SOLID FOUNDATION FOR GROWTH
Key pipeline assets Partnerships
Infectious diseases
MVA-BN Revenue driver – now and in the future
Smallpox
MVA-BN RSV Blockbuster market, no vaccine available
Janssen Seeking functional cure in major diseases
Immuno-oncology
Brachyury Potential registration trial in ultra-rare cancer
CV301 Combination therapy addressing major cancers
IV-IT Next-gen IV and intra-tumoral administrations
6INFECTIOUS DISEASES 7
SMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES
MVA-BN PARTNERSHIP WITH U.S. GOVERNMENT
USD 1.8 BILLION ALREADY AWARDED TO DATE
U.S. strategic long-term
stockpiling goal
Liquid-frozen Freeze-dried
Pre-approval (EUA)
28M doses delivered
To protect 10 million at ~13M doses ordered
to date
risk U.S. citizens
20M doses Phase 3 safety
Phase 3 completed
(initiate 2019)
BLA filing accepted Supplement to BLA
(H2, 2018) (2021)
Post approval
FDA licensure To protect 66 million FDA licensure
(2019) citizens with a safer (2022)
smallpox vaccine
Priority Review
Voucher (2019)
132M doses
8SMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES
A GROWING NEED FOR PREPAREDNESS
FUTURE OPPORTUNITIES FOR MVA-BN
• Recent cases of human monkeypox in the U.K. and Israel Monkeypox
highlight the need for preparedness plans; update of
stockpiles with safest alternatives and vaccination of first • Zoonotic disease
line responders (transmission from
• 3 cases in U.K. and 1 in Israel, all related to current Nigeria
animals to humans),
outbreak – 1 case of a health care worker with mortality rate
ranging from 1-10%
• U.K. authorities chose IMVANEX* over currently stockpiled,
replicating smallpox vaccines for vaccination of healthcare • Human-to-human
workers
transmission
• Post MVA-BN licensure for the general adult population a
number of new opportunities beyond national stockpile • No approved
vaccines, but
• Current recommendation for smallpox vaccination are military
personnel in S. Korea smallpox vaccines
• Future: All troops entering basic training historically showed
• Future: All active duty military personnel efficacy in
• U.S. smallpox vaccination guidelines (2002): preventing
• 0.5M to up to 10M healthcare workers monkeypox
• Other civilians who wish to be vaccinated
* IMVANEX (MVA-BN) is not approved for the prevention of monkeypox
9SMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES
INVESTING FOR THE FUTURE
• Fill and Finish facility
• Up to 8M freeze-dried & 40M liquid doses per
year
• Expands our manufacturing capability
• Key driver in securing higher smallpox
revenues in the years to come
• Support new partnerships
• Launch RSV
• Licensing of pipeline assets
• Manufacturing for partners/collaborators
Project timeline
Mar-18 Nov-18 Jun-19 Oct-19 Jan-20 Oct-20 end 2020
Outer All Equipment PQ
Construction Initiation of
Groundbreaking building equipment commissioned activities
finalized production
completed installed and qualified completed
10SMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES
OUR COLLABORATION WITH JANSSEN
A LONG-TERM VALUE DRIVER
4 license agreements in place
• The combination of Janssen’s AdVac + MVA-BN
has demonstrated robust and sustained immune
responses in humans
• The synergistic benefit of combining our
technology has been key to establishing
collaborations in blockbuster indications
• Equity investments have made JNJ a major
shareholder with ownership of 5.77%
MVA-BN Filo (Ebola) Phase 3 ongoing
MVA-BN HPV Phase 1/2a ongoing Potential milestone
payments of
MVA-BN HIV Phase 1/2a in 2019 ~$1BN + royalties
MVA-BN HBV
11RSV – A LARGE UNMET MEDICAL NEED
RSV Influenza
No approved $5.4B USD
prophylactic vaccine global market
RSV Influenza
Infections Hospitalizations Deaths
Initial target population: Elderly and At-Risk Adults
• ~180,000 hospitalizations in the US per year
• ~14,000 deaths in the US per year
• Similar in the EU
12SMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES
AT THE FOREFRONT OF RSV VACCINE DEVELOPMENT
Novel Vaccine Design MVA-BN RSV
• Encodes 5 distinct targets of RSV to stimulate a
broad protective immune response (T-cell and
antibody response).
F(A)
• The vaccine is mimicking a natural response to an
RSV infection that is believed to induce protection
for at least a year. G(A)
Competitive Advantages
• Induction of a broad T-cell and antibody response G(B)
against RSV
• Induction of mucosal immunity N
• Durable immune response lasting a year in the
majority of subjects M2
• Based on MVA-BN – live virus adjuvant with a
favorable safety profile
13Our story Smallpox vaccine Infectious disease Cancer immunotherapy Financials Selected milestones
PHASE 2 MVA-BN RSV MAIN AND BOOSTER STUDIES
▪ Phase 2 Main Study demonstrated:
• Good Safety profile consistent with platform history
• Induction of a significant and broad antibody and T cell response
• Induction of a mucosal immune response that may be important for
protection against RSV
• Immunity against both RSV subtypes (A&B)
▪ Established that only a single booster vaccination is required
▪ Phase 2 Booster Study confirmed the long-term durability of the
immune response and yearly vaccination regimen
• Durable and elevated antibody and T cell levels after 1 year
• Immediate and significant increases in RSV-specific antibodies and T
cells following booster
• Strongest mucosal antibody responses observed in subjects with the
weakest immunity
Currently discussing requirements of potential Phase 3 trial with FDA
14SMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES
RSV PHASE 3 CONSIDERATIONS
• Ongoing dialogue with the FDA regarding requirements for
licensure of MVA-BN RSV
• Current Phase 3 considerations:
• Phase 3 in 12,000 - 18,000 depending on statistical plan to be finalized with the
FDA in 2019
• Study will start in 2020
• Potentially could conduct a Phase 3 over 2 RSV seasons including a futility analysis
after season 1
• Estimated Phase 3 trial cost: USD 80-120 M
Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul
RSV season
IND/Reg. authority Months of vaccination Results
15IMMUNO-ONCOLOGY 16
SMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES
HOW HAS OUR I-O STRATEGY EVOLVED?
Augmented dosing regimen
2 priming doses in 4 different areas (as compared with prior
constructs), which appears to increase the quantity of
antigen-specific T cells in vaccinated patients
Trafficking of Vastly enhanced immunogenicity and
T cells to
tumors
improved antigen selection
Priming and PROSTVAC induced PSA-specific T cell
activation activation in less than 30% of patients
Infiltration of
T cells
into tumors CV301 and BN-Brachyury demonstrated
T cell activation targeting CEA, MUC-1
and Brachyury in >90% of vaccinated
patients
Cancer antigen Recognition Provided the body with more weapons
presentation of cancer cells
by T cells Combining BN-Brachyury and CV301
with checkpoint inhibitors, radiation
and/or chemotherapy is believed to
Release of cancer Killing of
cell antigens cancer cells amplify the body’s ability to recognize,
infiltrate and kill cancer cells
17SMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES
BRACHYURY
- NEW FRONTIERS IN TREATING METASTATIC CANCERS
Brachyury • BN-Brachyury vaccine candidate utilizes a prime-
boost regimen that has been optimized to include
• Tumor-associated
the gene for brachyury and other molecules known
antigen that is
overexpressed in to increase immune activation
major solid tumor
indications and • Phase 1 data demonstrated that BN-Brachyury vaccine
several ultra-rare could safely target brachyury and induce brachyury-
orphan cancers specific T-cell responses
• Expression is highly • Ongoing Phase 2 trial in chordoma
correlated with
metastatic disease, • Received orphan drug status from the FDA
multi-drug
resistance and • Potential for Breakthrough Designation
decreased survival
rates
18SMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES
PIVOTAL TRIAL ONGOING IN CHORDOMA
ULTRA-ORPHAN CANCER WITH LIMITED TREATMENT OPTIONS
• Multi-site trial to assess the effectiveness of BN-Brachyury
vaccine and current standard of care, radiation therapy, in
patients with advanced chordoma
• Radiation has been shown to inflame the tumor, releasing Chordoma
cancer antigens, increasing the targeting of brachyury • Rare cancer that occurs
in the skull base and
• Patients will receive 2 primer vaccinations with MVA-BN spine that universally
Brachyury followed by boosters with (fowlpox virus) FPV- overexpresses
Brachyury and radiation therapy brachyury
• Establish if combo therapy results in a clinically-meaningful • 1,000 new cases in the
ORR U.S. and E.U. annually
• Stage 1 enrollment completed in January 2019 • Historical objective
response rate (ORR)
with radiation aloneSMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES CV301 THREE PHASE 2 COMBINATION TRIALS ONGOING • Investigator sponsored studies and studies that employ adaptive trial designs to provide a capital-efficient, rapid proof of concept • Patients receive 2 priming doses on MVA-BN-CV301 in four different injection sites, followed by multiple boosters of FPV-CV301 at tapering intervals for the duration of checkpoint inhibitor therapy Bladder cancer Colorectal cancer Colorectal & Pancreatic CV301 + TECENTRIQ CV301 + OPDIVO CV301 + IMFINZI (atezolizumab) (nivolumab) & chemotherapy (durvalumab) Primary Endpoint: Primary Endpoint: Primary Endpoint: Objective Response Rate Overall Survival (OS) Progression Free Survival (ORR) (PFS) N=68 (27 in stage 1) N=78 N=52 (26 for each disease) Bavarian Nordic-sponsored Sponsored by Rutgers Sponsored by Georgetown trial University University 20
SMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES
INTRA-TUMORAL AND INTRAVENOUS ADMINISTRATION
Strengthening our immuno-oncology platform
Developing intra-tumoral (IT) and intravenous (IV) administration of cancer
immunotherapies as a potent approach to activate both arms of the immune system
and alter the suppressive tumor microenvironment (TME)
Trafficking of
T cells to tumors
Preclinical data of IT and IV
immunotherapy demonstrate: Priming and
activation Infiltration of
• Strong activation of innate T cells
and adaptive immune into tumors
mechanisms
• Inflammatory responses in
the TME
• Tumor-specific T cell
recruitment into the tumor Cancer antigen
tissue presentation Recognition of
cancer cells by
T cells
• Control of tumor growth
• Synergies with immune Killing of
checkpoint blockade Release of cancer
cancer cells
cell antigens
21FINANCIALS AND OUTLOOK 22
SMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES
FINANCIAL OUTLOOK 2019
Revenue 2019
• Majority of 2019 revenue expected from
mDKK
bulk smallpox vaccine contract (50 mUSD)
• R&D costs of approx. 570 mDKK
(420 mDKK in P&L) Smallpox sales US + RoW
280
• Investments in FnF of approx. 270 mDKK 320
R&D Contracts
(peak year)
• Sale of Priority Review Voucher has not
been included in guidance
mUSD
2018 2019 2018 2019
mDKK actual guidance actual guidance
Revenue 501 600 77 92
EBIT (354) (360) (54) (54)
Cash preparedness at year-end 2,314 1,600 355 246
USD/DKK = 6.5
Cash preparedness includes cash, cash equivalents, investments in securities and the aggregate amount of undrawn credit lines.
23SMALLPOX INFECTIOUS DISEASE CANCER IMMUNOTHERAPY COMMERCIAL FINANCIALS OBJECTIVES
2019 PRIORITIES AND GOALS
MAINTAIN global leadership of our smallpox EXPAND and rapidly ADVANCE the pipeline of
vaccine business infectious disease programs
• FDA approval of liquid-frozen MVA-BN • Finalize RSV development plan
• Award of Priority Review Voucher • Initiate Phase 1/2a study of HIV vaccine with
Janssen
• Initiate Phase 3 study of freeze-dried MVA-BN
• Initiate Phase 1 dose finding study of equine
encephalitis virus vaccine
ESTABLISH a broad and deep cancer EXPAND the commercial footprint and
immunotherapy portfolio capabilities
• Initiate Phase 1 study of intra-tumoral • Finalize construction of fill and finish facility
administration of CV301 in solid tumors
• Initiate Phase 1 study of intravenous
administration of BN-Brachyury
• Report initial ORR results from CV301 in
combination with atezolizumab in bladder
cancer
• Report initial ORR results from Phase 2 study
of BN-Brachyury in chordoma
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