Xbrane Biopharma AB · OMXSTO:XBRANE
Xbrane Biopharma AB — Investor Presentation (February 2019)
22 slides from Xbrane Biopharma AB's investor presentation, Feb 19, 2019
Slide 1: Lead candidate in phase III with annual sales potential of EUR 300m with STADA
Lead%candidate%in%phase%III% with%annual%sales%potential%of%EUR%300m%with%STADA%as%commercial%partner% Q1#2019
Slide 2: Important Information
IMPORTANT)INFORMATION You)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
Slide 3: Xbrane Biopharma
Xbrane Biopharma Our strategy Strategy The only biosimilar developer with a commercialization partner on Develop high quality and cost efficient biosimilars the lead candidate targeting Lucentis® • Focusing on niched drugs with few competitors • High yield technology platform leading to high margins
Slide 4: Biosimilar drugs enjoy high margins despite several competitors on the market
Biosimilar drugs enjoy high margins despite several competitors on5the5market Traditional Pharma – Chemical drugs Biological Drugs Small molucular drugs Large molucular drugs Generics Originator5drugs Biosimilars Originator5drugs After&loss&of&exclusivity After&loss&of&exclusivity 95generics at590%5
Slide 5: The biosimilar market at an inflection point
The$biosimilar$market$at$an$infliction$point Biosimilar market expected to grow with 30% 2017-2022 Market driven by strong fundamental drivers Biologics market • Loss of exclusivity of originators: +EUR100bn to be 400 exposed 2022 30% • Regulatory clarity: 51 biosimilars approved in 300 Europe, 19 i
Slide 6: Lead candidate in phase III and 5 pre-clinical assets
Lead%candidate%in%phase%III%and%5%pre0clinical%assets Xlucane (targeting Lucentis®) 5 pre-clinical assets • Late stage clinical candidate • 1 asset with signed partnership, (MAA anticipated 2020) • Study design acceptance from FDA (2019-01-15) • 4 pre-clinical assets in pipeline targeting drugs with
Slide 7: Xlucane
Xlucane
Slide 8: Macular degeneration – a common cause of blindness
Macular'degeneration'– a'common'cause'of'blindness' • Macular degeneration is one of the most common cause of blindness • wAMD, Wet Age-Related Macular Degeneration, typically occurs in the older population due to damage to the macula of the retina • DME, Diabetic Macular Edema, occurs when the bloo
Slide 9: Treatment options
Treatment(options Lucentis® Eylea® Avastin® Treatment • Designed to treat macular • Designed to treat macular • Anti-body used to treat different degenerations degenerations types of cancers (off-label) Efficacy • 7 – 11 letters 1 (vision'improvement after • 7 – 11 letters 1 • Non-inferiority to Luc
Slide 10: Approximately 18m+ individuals affected
Approximately-18m+-Individuals-affected Over-5m+-affected-eyes-in-EU-and-US-in-wAMD/DME Many-affected-individuals-go-untreated-in-emerging-markets Prevalence(of(wAMD and(DME(in(EU(and(US((number(of(eyes,(million) Prevalence(of(wAMD and(DME(in(Rest(of(world((number(of(eyes,(million) 5,2 Avastin&is&an
Slide 11: Sales potential of EUR 300-350m (only in EU and US)
Sales*potential*of*EUR*3006350m*(ONLY*IN*EU*AND*US) Potential of reaching currently untreated patients Potential of gaining market in emerging markets with share from off-label usage of lower priced product Avastin providing a safer treatment option at reasonable cost 1400,0 Potential of 50% increas
Slide 12: Biosimilar pioneer STADA to sell and market Xlucane
Biosimilar'pioneer'STADA'(~EUR'5bn'market'cap)'to'sell'and'market'Xlucane o Summary'of'the'co.development'partnership'with'STADA Experienced'in'successfully'launching'biosimilars 2018 • STADA is a German pharma company, specialising in the production and sales of Equal share of profit at EBIT level
Slide 13: Strong similarity to originator demonstrated by Xlucane
Strong'similarity'to'originator'demonstrated'by'Xlucane Primary%structure Higher%order%structure Binding Potency Purity The(sequence(of(amino(acids The(way(the(amino(acid(sequence( The(ability(of(the(protein(to(bind(to( The(actual(biological(effect(on( The(percentage(of(the(actual( has(folded the(sp
Slide 14: Similar tolerability and PK profile to originator in vivo
Similar'tolerability'and'PK'profile'to'originator'in4vivo Study'design • Two groups with 8 rabbits (16 eyes) in each group recieving intravitral injection of Xlucane and Lucentis respectively • Serum concentration of ranibizumab analyzed at hour 4, 8 and 48 • Eye inflammations observed throughout th
Slide 15: Xbrane has the support of a top tier global Key Opinion Leader
Xbrane has)the)support)of)a)top)tier)global)Key)Opinion)Leader Chair of TAU's Department of Ophthalmology and Vice Dean of the Sackler Faculty of Medicine • Anat is a retina specialist, expert in retinal toxicity, and has a strong research interest in the early detection of retinal disease . • Named
Slide 16: Phase III study design acceptance enabling marketing authorization
Phase&III&study&design&acceptance&– enabling&marketing&authorization&across&key& markets&globally&before&launch Recruitment,9,months Treatment,12,months Start o • Multi-regional clinical trial with 150 sites across EU, US, India, China and Russia Xlucane 290 patients • Enable Marketing Authorization
Slide 17: Public peers and candidate development
Public'peers and'candidate development Overview'of'conducted'clinical'trials Key take-away Commercialisation Other biosimilars Market Cap. Candidate (target) Developer Partner under development (SEK in million) Other Partners Few Competitors Momenta Copaxone (approved) Eylea Phase III Pharmaceutical
Slide 18: Strategic Outlook
Strategic Outlook
Slide 19: Important milestones reached in 2018
Important)milestones)reached)in)2018 Signed partnership with CR Pharma (China) Anders Tullgren joined the board as Chariman Signed commercialization deal with STADA STADA paid EUR 7.5m in up-front payment Strategic decision to focus on Biosimilars Positive feedback from the FDA phase III Xplore meet
Slide 20: Significant value drivers ahead
Significant value drivers*ahead Development*timeline Other Xlucane Candidates Phase III CTA submission MAA/BLA 100% Recruited Submission Phase III Phase III/Xplore Approval CTA approval 25/50/75% Recruited Phase III/Xplore Interim Phase III/Xplore First Patient Clinical Data Recruited Phase III/Xplo
Slide 21: Experienced board and management owning approx. 15% of the company
Experienced*board*and*management*owning*approx.*15%*of*the*company Board*of*Directors Shareholder*overview* KARIN%WINGSTRAND GIORGIO%CHIRIVI Shareholder (%) Board Member Board*Member Serendipity*Group 10.8 Paolo%Sarmientos 6.3 Shares:% 7,900 Shares:% 2,000 Avanza%Pension 5.5 Warrants:% 3,000 Warrant
Slide 22: Summary
Summary Late2stage2candidate2 Xlucane,*XBrane’s lead candidate,*a*Lucentis®*biosimilar,*has*received*FDA*acceptance of* entering2phase2III initiation*for*Phase2III2clinical2trials.2Clinical+design+available+at+Clinicaltrails.gov* Historical2low2risk Biosimilars*have*higher probability of*success (95
Xbrane Biopharma — Investor Presentation (February 2019) on 6ix