Q3 2018 Results - Aktiespararna...2019/01/17 · Centers for Disease Control and Prevention....

Aktiespararna Sundsvall

17 January 2019

Linda Holmström, Senior IR Manager

Swedish Orphan Biovitrum AB (Publ) (SobiTM)

Forward looking statements

1

In order to utilise the ‘Safe Harbor’ provisions of the United States Private Securities Litigation Reform Act of 1995, Swedish Orphan Biovitrum AB (publ) is providing the following cautionary statement. This presentation contains forward-looking statements with respect to the financial condition, results of operations and businesses of Swedish Orphan Biovitrum AB (publ), By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, the loss or expiration of patents, marketing exclusivity or trade marks; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; the impact of any failure by third parties to supply materials or services; the risk of delay to new product launches; the difficulties of obtaining and maintaining governmental approvals for products; the risk of failure to observe ongoing regulatory oversight; the risk that new products do not perform as we expect; and the risk of environmental liabilities.


A long history of innovation

2

Pharmacia

Kabi/Kabi Pharmacia

Biovitrum

Sobi

Swedish Orphan

Sobi in brief

• Business areas; Haemophilia, Immunology and Specialty Care

• Integrated biopharma company with a focus on rare diseases

• Including R&D and in-house production of biological drug substances

• Delivering treatments to patients in over 70 countries world wide

• SEK 6,511 M in revenues 2017, SEK 6,568 M Jan-Sep 2018

• About 850 employees

3

4

Life-threatening and chronic

EU : 1 on 2 000

US : Less than 200 000 people

More than 7 000 know diagnosis

400 approved treatments

Roughly 400 million people worldwide could be affected by a rare disease (1 of 15)

Worldwide Orphan Drug Sales forecast to grow +11% 2018-2024 to USD 262 Bn., double the rate forecast for the non-orphan drug market*

Why rare diseases?

*EvaluatePharma Orphan Drug Report 2018


Product portfolio

Haemophilia Specialty CareImmunology

5

Sobi’s vision is to become global leaders in rare diseases

Increasing access to our treatments for haemophilia

Enlarging our Specialty Care franchise

Expanding our position in EMENAR,

and growing in North America

Strengthening R&D pipeline

6

Vision

To be recognised as a

global leader in

providing innovative

treatments that

transform lives for

individuals with rare

diseases


Strong growth over the past years

7

Main growth drivers

• Extremely successful Haemophilia

launch

• Kineret strong double-digit growth

Growth opportunities

• Further growth opportunities in

Haemophilia and penetration and

internationalisation

• Increase US market presence and

footprint

• Broaden Specialty Care portfolio in

areas of expertise

Sobi revenue1

SEK M

2013

3,228

2014

2,177

20172015 2016

2,607

5,204

6,511

33% p.a.

2018E

8,900-9,0002

1. Sobi Annual Reports 2013–2017

2. Revised outlook published on 31 October 2018

Haemophilia

8


Haemophilia – the most common rare disease in the world

• A a genetic disorder in which the ability of a person’s blood to clot is impaired.

• Haemophilia A occurs in about one in 5,000 male births annually, and more rarely in females.

• Haemophilia B occurs in about one in 28,000 male births annually, and more rarely in females.

• Estimated that 185,000 people are currently diagnosed with haemophilia world-wide

• People with haemophilia A or B experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening haemorrhages.

9

1. World Federation of Hemophilia. Report on the Annual Global Survey 2016. Available at: http://www1.wfh.org/publications/files/pdf-1690.pdf. Accessed on: 6 March 2018


A strong heritage within Haemophilia

10

ITIBIVV001BIVV002

Haemophilia – Global vs. Sobi territory market

• Sobi’s European Haemophilia A market estimated at 3.5 Bn. USD today

• Sobi’s European Haemophilia B market estimated at 0.5 Bn. USD

11

Source: EvaluatePharma

Top 5 global haemophilia A product sales

estimated at $ 4.6 bn(2018e)

$9.3 bnby 2024

+100%

Haemophilia A is hereditary and the most common of rare diseases


A distinctive position in Haemophilia with Elocta and Alprolix

• Well established safety and efficacy profiles - real-world experience from thousands of patients

• Replacing the missing factor – fundamental in haemophilia treatment

• Standard of care in many countries

• Suitability for all patient groups and ages and flexibility to truly match treatment to outcomes

• Creates possibilities to live an active life with less worry about the safety and effectiveness of their therapy

12


A year of prophylactic treatment with conventional FVIII vs EHL

13

Convential FVIII is usually dosed 3-4 times a week1, 2, 3

* Bild från M. Carcao1. Meunier et al. International Society on Thrombosis and Haemostasis, 29 June–4 July 2013, Amsterdam, Netherlands; 2. Hay et al. International Society on Thrombosis and Haemostasis, 20–25 June 2015, Toronto, Canada;3. Ahnström et al. Haemophilia 2004

Median dosing frequency with rFVIIIFc in the A-LONG study was 2times a week1

http://www.google.ca/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&docid=aDwpdtRyKEi8cM&tbnid=wHKh2Z5LELvuWM:&ved=0CAUQjRw&url=http://www.iihl.org/&ei=EW9lU7OWLcvTsATGg4CoDg&bvm=bv.65788261,d.aWw&psig=AFQjCNFzIbb7yf5F9lnCGgOySGg-yTnKQg&ust=1399242813627739

http://www.google.ca/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&docid=aDwpdtRyKEi8cM&tbnid=wHKh2Z5LELvuWM:&ved=0CAUQjRw&url=http://www.iihl.org/&ei=EW9lU7OWLcvTsATGg4CoDg&bvm=bv.65788261,d.aWw&psig=AFQjCNFzIbb7yf5F9lnCGgOySGg-yTnKQg&ust=1399242813627739


Haemophilia – continued strong sales growth

14

• Total Haemophilia Jan-Sep revenues of SEK 4,260 M (2,568)

• Revenue growth of 66 per cent (60 per cent increase at CER)

• Elocta Jan-Sep product revenues of SEK 2,316 M1 (1,018)

▪ Revenue growth of 128 per cent (115 per cent at CER)

• Alprolix Jan-Sep product revenues of SEK 671 M (232)


Total Revenues (SEK M)

0

200

400

600

800

1 000

1 200

1 400

1 600

1 800

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3

2016 2017 2018

Product revenues Royalty

Manufacturing One-time items

1 Revenues as well as EBITA were positively affected by SEK 56 M, in Q3 2018, related to adjusted pharmaceutical taxes in France from 2017, whereof SEK 52 M relates to Elocta.

Haemophilia growth strategy

Capitalise on strong position and substantial potential

• Achieve a leadership position in Europe, the Middle East and Africa

• Expand access to patients in markets where treatment not yet available

• Research into follow-on compounds and advancing care

• Strengthen and broaden R&D pipeline

15


Reaching patients in 40 countriesDonation statistics July 2015 to December 2017

16

By year-end 2017, Sobi and Bioverativ had donated

262million IUs of Elocta and Alprolix enabling the treatment of

15,000+people in

40countries by addressing

79,400bleeds and almost

1,500surgical procedures

Specialty Care

17

Lifecycle management & indication expansione.g. turnaround of Kineret to solid 10%+ p.a. growth

18

Active strategic partnership management in order to continuously introduce novel therapies into our key markets: moving from distribution to ownership

Expand portfolio by strengthening R&D pipeline and business development efforts in order to further drive growth of the Specialty Care business

Specialty Care – active portfolio management


Products

Specialty CareImmunology

19


Specialty Care - solid performance across portfolio

20

• Total Specialty Care Jan-Sep revenues SEK 2,308 M (2,068)

• Revenue growth of 12 per cent (9 per cent at CER)

• Kineret Jan-Sep revenues SEK 985 M (835)


• Orfadin Jan-Sep revenues SEK 645 M (594)

▪ Revenue growth of 9 per cent (decrease of 4 per cent at CER)

Sales Revenues (SEK M)

0

1 000

2 000

3 000

4 000

0

250

500

750

1 000

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3

2016 2017 2018

Quarterly 4Q-rolling

Strategic transactions to further drive growth

21


Expansive strategy to build Immunology franchise and strengthen US business

22

Develop

Specialty

Care

Expand

US business

Strengthen

R&D

pipeline

Drive Haemophilia

Penetration


Components of the Synagis transaction

• Perpetual rights to Synagis® (palivizumab) in

the US

• Synagis, the only approved respiratory

syncytial virus (RSV) prophylaxis for high-risk

infants

• Clinical studies have shown reduced risk of RSV-related hospitalisations in high-risk infants (pre-mature, and/or cardiopulmonary disease)

• Access to a proven US commercial

infrastructure

• Right to participate in 50 per cent of the future

earnings in the US

• A follow-on candidate to Synagis being

investigated for the prevention of lower

respiratory tract infection (LRTI) caused by

RSV in a larger patient population

• Currently in an ongoing Phase IIb study

• The current development plan includes initiation of a Phase III trial in healthy full-term and late pre-term infants

15

MEDI8897

RSV infection may be associated with significant morbidity

• Respiratory syncytial virus (RSV) is a major cause of respiratory illness in young children

• Almost all children have been infected by 4 years of age

• Symptoms may be like common cold and can develop into bronchiolitis and pneumonia

• Severe disease in children most often occurs in premature children and/or children with cardiopulmonary disease

• For the care of high-risk infants, prevention is critical

24Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV): Trends and Surveillance;Hall CB et al. The burden of respiratory syncytial virus infection in young children. New Engl J Med. 2009.Merck Manual 2018.


The main theses of the transaction

Build a business on the combination of a unique biologic with access to the 50% of earnings of a follow on compound in a much broader patient population

Synagis is a product that connects with our DNA, meaning focus on rare conditions and expertise in the paediatric field

Double our commercial footprint in the US –allowing Sobi to expand its presence beyond Synagis

25

Longitudinal earnings stream

Synagis connects with Sobi’s DNA

Access to talent poolto build US platform


Pro forma financial impact

26

Revenues

EBITA3 Margin

Key Financials

FY2018E (SEK)

8.95 billion1 2.4 billion2 11.4 billion

>40%

Combined

Pro forma

38-39%1

Enhances financial capacity

1. Revised outlook published on 31 October 2018. EBITA expected in the range of SEK 8.9-9.0 M.

2. Based on Synagis US LTM 30 June 2018 revenues reported by AstraZeneca, converted at a USD/SEK FX of 9.05

3. Financial measure not defined according to IFRS (alternative performance measure). EBITA is earnings before interest, tax and amortisation

>60%

Key Financials

LTM 30 June 2018 (SEK)


Emapalumab - a highly attractive late stage orphan drug candidate

• Strategic partnership to develop and commercialise emapalumab

• A fully human monoclonal antibody that targets IFN-gamma, a central mediator of inflammation

• Addresses a high unmet medical need in Haemophagocytic lymphohistiocytosis (HLH)

• Emapalumab in review for rare disease primary HLH

• FDA approval 20 November 2018

• MAA filing to EMA validated Aug 2018

• Near-term commercial opportunity with sales potential from 2019 onwards

• Purchase price of CHF 450 M (CHF 50 M cash upon signing)

• The license agreement to emapalumab is expected to add of around SEK 200 M to the Sobi cost base in 2018 preparing for a successful launch

27

Haemophagocytic lymphohistiocytosis (HLH)

19

High unmet medical need

• Fatal with median survival of <2 months without

treatment

• No approved drug treatments

• Current widely accepted treatment protocols

apply a combination of dexamethasone and

chemo-immunotherapy (incl. etoposide)

HLH is a rare and life-threatening

syndrome of extreme immune activation

ca. 5,000+Patients in the

US, EU and Japan

(primary and

secondary HLH)

Two patient segments

Primary HLH (pHLH)

genetic disease

Secondary HLH (sHLH)

to infections, autoimmune

diseases or malignancyInitial filing

Source: [patient population data]


Emapalumab – an excellent fit with our strategy

Late stage orphan drug in the Immunology area

Provides an attractive near-term commercial opportunity with USD 300 M peak sales potential

Expected to support sustainable sales growth from 2019 onwards

Full global rights to emapalumab

Utilises Sobi’s strengths in market access and product launch

Potential to significantly expand sales in the US market

PDUFA date 20 November 2018MAA filing to EMA validated Aug 2018

A late stage asset with studies in follow-on indications planned

29

Builds Immunology franchise and long-term

earnings streams

Expands

US business and

extend position in

EMENAR

Strengthens R&D pipeline


Strategic rationale

30

Diversify Sobi’s

revenue base

into Immunology

Accelerate build

up of Sobi’s US

commercialisation

platform

Enhance

financial

capacity

R&D pipeline

31

1 Extension trial for an already approved indication 2 PUP – Previously Untreated Patients

3 A Bioverativ, a Sanofi-company, development programme. Sobi has elected to add the programmes to the collaboration agreement with Bioverativ but has not yet opted-in. 4. Pending regulatory acceptance of acquisition.

A rare disease pipeline with increasing valueTherapeutic area / Indication

MPSIIIA

Anti-C5

Anti-IL-1

Haemophilia B

Pre-clinical

Haemophilia A

Phase 1

Acute gout

Phase 2

Haemophilia A

Haemophilia B

Still’s disease

Alkaptonuria

Phase 3

Haemophilia A

Haemophilia A

Haemophilia A

Haemophilia A and B

Product / Project

SOBI003

SOBI005

SOBI006

BIVV0023/EXTEN-B

BIVV0013/EXTEN-A

Anakinra/anaGO

Elocta/PUP1,2

Alprolix/B-YOND1

Alprolix/PUP12

Anakinra/anaSTILLs

Nitisinone/SONIA2

Elocta/ASURE

Elocta/reITIrate

Elocta/verITI8

Elocta/Alprolix/PREVENT

Phase 4

Haemophilia B

Primary HLH Emapalumab

Secondary HLH Emapalumab

HA

EMO

PH

ILIA

SPEC

IALT

Y C

AR

E

RSV Prevention MEDI88974

SOBI003 for Mucopolysaccharidosis IIIA (MPS IIIA)

• A rare systemic disease with a significant CNS component due to incomplete breakdown and increased lysosomal storage of heparan sulfate(HS)

• Increased morbidity and mortality

• Caused by mutations in gene for sulfamidaseenzyme

• Up to about 2000 people are estimated to live with MPS IIIA in the EU and US

• There is currently no treatment available for MPS IIIA

• SOBI003: a recombinant sulfamidase using proprietary Modifa™ technology with potential to address an unmet needs in MPS IIIA

33

SOBI003 - chemically modified recombinant human sulfamidase

Summary

34

Strong growth and positive outlook in the rare disease market segment

35

HAEMOPHILIA

Strong product offering

Continued market expansion

High entry barriers limit

competition

SPECIALTY CARE

Move towards proprietary

drugs and drug candidates

Acquisitions to

- Leverage European platform

- Create synergies with existing

portfolio

- Expand North American

footprint

LONG TERM VALUE

CREATION

Profitable growth

Strong cash flow

Increasing financial

flexibility

WORLD WIDE COMMERCIAL PLATFORM

• Proven track record of bringing Haemophilia products to the market

• Robust marketing and distribution infrastructure

Sobi’s vision is to become global leaders in rare diseases

Further internationalisationand commercialisation of Haemophilia

Build Specialty Care as the preferred partner

Strengthen positionin the US and EMENAR

Build pipeline and self-sustained R&D

36

Vision

To be recognised as a

global leader in

providing innovative

treatments that

transform lives for

individuals with rare

diseases


Executive Committee

37

Ramin LevinHead of North America

Guido OelkersCEO

Torbjörn HallbergGeneral Counsel, Head of Legal Affairs

Fredrik WetterlundHead of HR

Henrik StenqvistCFO

Philip WoodHead of Haemophilia

Norbert OppitzHead of Specialty Care

Milan ZdravkovicHead of R&D, CMO

Armin ReiningerHead of Medical and Scientific Affairs

Christian DregerHead of NorthernEurope, Middle East& Russia

Anne Marie de Jonge SchuermansHead of Technical Operations

Paula TreutigerHead ofCommunications and IR

Sofiane FahmyHead of Southern and Western Europe & North Africa

Thank you – questions?Linda Holmström

[email protected]

0708-734095

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