+ All Categories
Home > Documents > April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high...

April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high...

Date post: 11-Oct-2020
Category:
Upload: others
View: 0 times
Download: 0 times
Share this document with a friend
19
1 Science for High quality Biosimilars April 2020
Transcript
Page 1: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

1

Science for High quality BiosimilarsApril 2020

Page 2: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

2

IMPORTANT INFORMATIONYou must read the following before continuing. The following applies to this document and the information provided in this presentation by Xbrane Biopharma AB (publ) (the “Company”) or any person on behalf of the Company and any other material distributed or statements made in connection with such presentation (the “Information”), and you are therefore advised to carefully read the statements below before reading, accessing or making any other use of the Information. In accessing the Information, you agree to be bound by the following terms and conditions.

The Information does not constitute or form part of, and should not be construed as, an offer or invitation to subscribe for, underwrite or otherwise acquire, any securities of the Company or a successor entity or any existing or future subsidiary or affiliate of the Company, nor should it or any part of it form the basis of, or be relied on in connection with, any contract to purchase or subscribe for any securities of the Company or any of such subsidiaries or affiliates nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. Specifically, this presentation does not constitute a “prospectus” within the meaning of the U.S. Securities Act of 1933, as amended.

The Information may not be reproduced, redistributed, published or passed on to any other person, directly or in directly, in whole or in part, for any purpose. The Information is not directed to, or intended for distribution to or use by, any person or entity that is a citizen or resident of, or located in, any locality, state, country or other jurisdiction where such distribution or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction. The Information is not for publication, release or distribution in the United States, the United Kingdom, Australia, Canada or Japan, or any other jurisdiction in which the distribution or release would be unlawful.

All of the Information herein has been prepared by the Company solely for use in this presentation. The Information contained in this presentation has not been independently verified. No representation, warranty or undertaking, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the Information or the opinions contained herein. The Information contained in this presentation should be considered in the context of the circumstances prevailing at that time and has not been, and will not be, updated to reflect material developments which may occur after the date of the presentation. The Company may alter, modify or otherwise change in any manner the content of this presentation, without obligation to notify any person of such revision or changes.

This presentation may contain certain forward-looking statements and forecasts which relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on the Company’s operations, financial position and earnings. The terms “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “may”, “might”, “plans”, “should”, “projects”, “will”, “would” or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realised. Factors that could cause these differences include, but are not limited to, implementation of the Company’s strategy and its ability to further grow, risks associated with the development and of the Company’s products, ongoing research and development, the ability to commercialize the Company’s products, technology changes and new products in the Company’s potential market and industry, the ability to develop new products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors. While the Company always intends to express its best judgment when making statements about what it believes will occur in the future, and although the Company bases these statements on assumptions that it believe to be reasonable when made, these forward-looking statements are not a guarantee of its performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the Company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this presentation are made only as of the date hereof. The Company does not undertake, and specifically decline, any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.

Page 3: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

3

XBRANE BIOPHARMA – THE ONLY NORDIC BIOSIMILAR DEVELOPER

Low-risk high potential lead

phase III biosimilar

• Xlucane (Lucentis® biosimilar) is a low-risk product partnered in 50/50 profit share deal with STADA addressing a €10.4b market expected to generate +€100m in annual income to Xbrane three years after its launch mid-2022

• Xlucane will deliver near term triggers: • 2020: Licence deals together with STADA (particularly North America)• Q3 2020: Phase III fully recruited• Q1 2021: Phase III top-line data • Q2 2021: MAA/BLA filing • Mid-2022: MAA/BLA approval and launch

• Pipeline biosimilar candidates addressing €8.7b of originator sales based on flexible, patented high-yield platform technology

Near term triggers

Strong pipeline biosimilar candidates

Page 4: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

4

BIOSIMILARS ARE SIMILAR BUT NOT IDENTICAL TO ORIGINATOR BIOLOGICS

Biological originator drug:

• Gene introduced to cell instructing it to produce a protein

• Separation of the protein as active substance in drug

Biosimilar: • Gene instructing cell to produce identical protein as originator product

• Can be demonstrated as highly similar but not identical to originator product

Gene Living cell Protein

Page 5: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

5

Xlucane used in treatment of severe eye diseases Xlucane binds to growth factor VEGFa

Binds to growth factor VEGFa and thereby inhibits growth of abnormal blood vessels causing the

deteriorating vision

Growth ofabnormal

blood vessels

Intravitrealinjection of

VEGFainhibitor

Normal visionAffected vision

Leads to deterioration of vision and in worst case blindness

Wet age-related macular degeneration (“wAMD”) and Diabetes related macular edema (“DME”)

XLUCANE IS A BIOSIMILAR TO LUCENTIS® BINDING TO GROWTH FACTOR VEGFaAND THEREBY RESTORES VISION

Page 6: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

6

1

10

100

0 8 16 24 32 40 48

Mea

n (n

g/m

L)

Time (hr)1 mg/total Lucentis1 mg/total Xlucane

Xlucane demonstrates similar PK pattern in vivo

70%

80%

90%

100%

110%

120%

130%

+/- 3 Standard Deviations of Lucentis®

Commercial Scale Xlucane Batches

Bioactivity VEGFa (Reporter Gene Assay)

Xlucane binds equivalently to VEGFa as Lucentis®

”The preliminary physicochemical and biological similarity assessment, confirms a high degree of biosimilarity. All defined acceptance criteria are met.” – EMA tailored scientific advice

February 2020

Source: Xbrane pre-clinical package

VEGFa 165 VEGFa 110 VEGFa 189 VEGFa 121

XLUCANE BINDS EQUIVALENTLY TO VEGFa AS LUCENTIS®

Page 7: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

7

XPLORE IS A PIVOTAL PHASE III WITH OBJECTIVE TO DEMONSTRATE EQUIVALENCE OF XLUCANE VS. LUCENTIS®

Equivalence margin agreed with EMA and FDA

MARINA clinical trial (Lucentis® vs. placebo)

PlaceboLucentis® 0.5 mgLucentis® 0.3 mg

Xlucane290 patients

Objective to demonstrate equivalence vs. Lucentis®Xplore is a pivotal phase III equivalence trial

Lucentis®290 patients

Weeek 8Primary end-point

Weeek 52End of treatment

Page 8: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

8

14%

3%

20%

0

100

200

300

400

500

600

Recruited patients Active clinics

10%

3%42%

Eastern Europe

8%

APRIL 2019 MARCH 2020

AS PER END OF MARCH APPROXIMATELY 355 OF 580 PATIENTS RECRUITED 1.5K INJECTIONS PERFORMED WITH NO SAFETY NOR EFFICACY ABNORMALITY IN BLINDED ASSESSMENTS

% of recruitedpatients

LPI Q2

COVID-19 impact

Pre- COVID

-19

LPI Q3

Page 9: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

9

Xlucane Pivotal Phase III Trial

Study close down

First patient inApril 2019

Last patient in (LPI)

MAA/BLA

Submission(based on 6 month

data)

Approval

2019 2020 2021

LoE EUJuly 2022

2022

Top-line data

XLUCANE LAUNCH EXPECTED AT LUCENTIS® LOSS OF EXCLUSIVITY MID 2022 –MULTIPLE TRIGGERS EXPECTED BEFORE

Xlucane launchJuly 2022

Page 10: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

10

XLUCANE ADRESSES A €10.4 B MARKET GROWING AT 10% PER YEAR

VEGFa Inhibitors Ophthalmic Use (€ B)

Source: Novartis, Regeneron and Roche financials

3,0 3,1 3,5 3,6

0,035

4,6 5,15,9

6,8

7,68,2

9,4

10,4

0,0

2,0

4,0

6,0

8,0

10,0

12,0

2016 2017 2018 2019

Page 11: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

11

5.2

1,1

0.6

0.8

0

1

2

3

4

5

6

Affected TreatedEylea® Lucentis® Avastin®

Number of affected Eyes Europe and US (M)

HUGE GLOBAL UNMET MEDICAL NEED FOR XLUCANE

2.5

12.9

0.10.10.6 0

2

4

6

8

10

12

14

Affected TreatedEylea® Lucentis® Avastin®

Number of affected Eyes Rest of World (M)

approx. 0.5 - 1.0

On-label

On-label

Off-label

Page 12: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

12

COMMERCIAL PARTNER: STADA – BIOSIMILAR LEADER

STADA – a biosimilar leader Strong partnership

201820172016

• Biosimilars key value creation driver for PE ownersBain Capital and Cinven

• Portfolio of 14 Biosimilars – 4 on the market• Dedicated Biosimilar Team of 200+ Professionals• EPO (Silapo®/Erypo®) Biosimilar Developed

In-House, Annual EU Sales of €200m

Xlucane co-development deal – 50/50 development and profit split

€4m equity investment in 2019

Ongoing evaluation of collaboration around Xcimzane and Xdivane (ROFR for Europe granted)

Page 13: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

13

Sales target Total

Xlucane annual net-sales target of €350m three years after launch with significant further upsideExpected annual income of €100m after cost deduction and profit sharing for Xbrane

€350m

Annualnet-sales

target

Potential upside

Annualnet-sales

target

Market expansion through more patients and doses per patient

in Europe and US

Taking market share from

Eylea

Target untreated

patients in rest of world

Taking 25% share ofLucentis in EU/US at

price discount ofup to 50%

XLUCANE EXPECTED TO GENERATE ANNUAL NET-SALES OF €350 M THREE YEARS AFTER LAUNCH OUT OF WHICH €100M INCOME FOR XBRANE

Page 14: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

14

0%

25%

50%

75%

100%

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Rituximab (EU)

Infliximab (EU)

Etanercept (EU)

Peg-filgrastim(US)

Trastuzumab(EU)

Year 1 Year 2Time after launch

BIOSIMILARS WITH +€400M IN ANNUAL SALES TWO YEARS AFTER LAUNCH

40%2 years

42%2 years

60%2 years

40%2 years25%

1.5 years

Leading biosimilar Annual sales

€400m (Y2)

€440m (Y2)

€410m (Y3)

€317m (Y1)

Average Biosimilar Volume Market Share vs. Originator

Source: IQVIA, - The impact of biosimilar competition in Europe, Morgan Stanley – Biosimilars infancy to Youth

Page 15: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

15

LIMITED COMPETITION – ONLY TWO COMPETING BIOSIMILARS

Developer Partner Deal for developer

€7.5m up-front50/50 development cost and profit split

Global excluding China

Single digit €m up-frontMilestones of +€100m

No royaltiesGlobal

USD 310 m license fee Un-disclosed royalty

Europe and USAlso including Eylea biosoimilar

Overview of phase III Lucentis Biosimilar Developers

1) Data as per 2020-[-] (capitaliq.com)

*Global developmentpartner

*US Commercial partner

Page 16: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

16

ADDITIONAL LICENSE DEALS WITH XLUCANE EXPECTED DURING 2020

€3.3b

€6.2b Ongoing out-licensing to US**

€0.1b Ongoing establishment of distribution partners**

€0.1b Ongoing out-licensing (Xbrane)

€0.7b Discussion with regulatory authority

* Combined annual sales for Eylea and Lucentis** Together with STADA

Market 2019*

Xlucane only remaining

available Lucentis biosimilar in

North America

Page 17: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

17

OUR PORTFOLIO: TARGET APPROXIMATELY € 12 BILLION IN ORIGINATOR SALES

Commercialization Partner

Candidate / Product

Originator Product Indication Development

PhasePlanned Launch

Xlucane

Xcimzane

Lucentis®(Roche)

Cimzia®(UCB)

Age related macular degeneration, Diabetic

macular edema, Diabetic related retinopathy

Rhematoid arthrisis, psoriatic arthrisis,

ankylosing spondylotis, psoriasis and Crohn’s

disease

At patent expiry

Primary Patent Expiry

2020 / 2022

(US) / (EU)

2025/2024 (EU/USA)

Global Annual Sales

€3.6b

€1.7b At patent expiry

Ongoing Phase III

Pre-clinical

Xoncane Oncaspar®(Servier)

Acute Lymphotic (ALL) Expired €0.2b Pre-clinical

Decapeptyl®(Debiopharm

/ Ipsen / Ferring)

Prostate cancer, Breast cancer, Endometriosis and

MyomaExpired €0.4b Pre-clinical

Total €12.3b

Opdivo®(BMS)

Lung, liver, head & neck, kidney, colorectal cancer

and melanoma2026-2030 €6.4b

At patent expiryPre-clinicalXdivane

Spherotide

Ongoing evaluation by

STADA

Ongoing evaluation by

STADA

Term-sheet with STADA

Pre-clinical trial

Phase completed

Ongoing phase III

Remaining

Source: Year end reports, IQVIA

Page 18: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

18

EXPERIENCED AND DEDICATED TEAM

Management Board of Directors

Martin ÅmarkCEO

Siavash BashiriCOO

Susanna HelgesenCFO

David VikströmCTO

Anders Tullgren Chairman of the Board

Eva NilsagårdDirector of the Board

Karin WingstrandDirector of the Board

Dina JurmanHead of Clinical

Affairs

Maria EdebrinkHead of Regulatory

Affairs

Anders WallströmHead of

Manufacturing & Supply Chain

Peter EdmanDirector of the Board

Giorgio ChiriviDirector of the Board

Ivan Cohen-TanugiDirector of the Board

Xiaoli HuHead of Business

Development

Maris HartmanisDirector of the Board

Page 19: April 2020 - XBrane · 3 XBRANE BIOPHARMA –THE ONLY NORDIC BIOSIMILAR DEVELOPER Low-risk high potential lead phase III biosimilar •Xlucane (Lucentis®biosimilar) is a low-riskproduct

19

Science for High quality Biosimilars


Recommended