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Photocure ASA

Earnings Release Dec 15, 2015

3714_iss_2015-12-15_a6e927e5-150f-4c3a-9c28-6a952a844e7a.pdf

Earnings Release

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PHOTOCURE ASA

DNB'S 6TH ANNUAL HEALTH CARE CONFERENCE

DECEMBER 15, 2015

Disclaimer

The information included in this Presentation contains certain forward-looking statements that address activities, events or developments that Photocure ASA ("the Company") expects, projects, believes or anticipates will or may occur in the future. These statements are based on various assumptions made by the Company, which are beyond its control and are subject to certain additional risks and uncertainties. The Company is subject to a large number of risk factors including but not limited to economic and market conditions in the geographic areas and markets where Photocure is or will be operating, IP risks, clinical development risks, regulatory risks, fluctuations in currency exchange rates, and changes in governmental regulations. For a further description of other relevant risk factors we refer to Photocure's Annual Report for 2014. As a result of these and other risk factors, actual events and our actual results may differ materially from those indicated in or implied by such forward-looking statements. The reservation is also made that inaccuracies or mistakes may occur in this information given above about current status of the Company or its business. Any reliance on the information above is at the risk of the reader, and Photocure disclaims any and all liability in this respect.

Investment Highlights

  • World leader in photodynamic technology
  • Hexvix® commercialized globally
  • Robust product pipeline
  • Growing in-market sales +17% LTM 3Q2015 at NOK 204 MNOK
  • Driven by Hexvix®/Cysview® for improved detection of bladder cancer and patient management
  • Significant Hexvix /Cysview growth opportunities in new territories and market segments
  • Profitable Hexvix/Cysview commercial franchise
  • Commercial operations in Nordic region and United States
  • Strategic partnership with Ipsen in EU
  • High potential pipeline addressing significant unmet medical needs
  • Cevira® Phase 3 targeting HPV and pre-cancerous lesions of the cervix
  • Visonac® Phase 3 for the treatment of Acne

Creating Value Diverse Product Portfolio

Indication Phase
1
Phase
2
Phase
3
Market Status
Hexvix® (EU)
Cysview® (US)
Optical imaging
agent for
improved
bladder cancer
detection and
management
Marketed as adjunct to white light
cystoscopy
Phase 3 trial for expansion to
surveillance market initiated
Cevira® Treatment of
precursors of
cervical cancer
Positive Phase 2b results
SPA approved 3Q
Exploring partnerships
Visonac® Treatment of
moderate to
severe acne
Positive Phase 2b results
SPA and PIP approved
Exploring partnerships

Hexvix/Cysview

First significant advance for the improved detection and management of bladder cancer in >50 years

Bladder Cancer Prevalent, Recurring, Progressing and Expensive

5 th most common cancer type

  • ‒ Most expensive cancer: \$96-187K/patient1
  • ‒ > 200,000 new patients annually
  • ‒ 75% of patients diagnosed with NMIBC2
  • Key therapeutic aim is to avoid progression from NMIBC to muscle invasive disease
  • ‒ ~ 6 million cystoscopies annually
  • ‒ ~ 600,000 procedures (TURBs3 ) annually
  • ‒ 10 30% progression rate
  • Regular ongoing surveillance required
  • ‒ Recommend follow up cystoscopies every 3-9 months

Hexvix/Cysview Medical Benefits Validated

  • Landmark Meta-Analysis published in European Urology (2013)1
  • significantly improves the detection of bladder cancer
  • reduces the risk of recurrence
  • Continued positive data flow fuels forward momentum
  • World Journal of Urology (2015) publication validating positive impact on overall and progression free survival2
  • Transforming clinical practice
  • Included in European and National Guidelines in several EU countries
  • Recommended use in 50-70% of TURB procedures3

Hexvix/Cysview A Significant Global Specialty Brand

  • Value of in-market sales of Hexvix/Cysview increased YoY 19% year to date to NOK 204 million LTM
  • Hexvix/Cysview global in-market volume increased YoY 8% in the quarter, and 7% year to date
  • Overall franchise EBIT year to date at NOK 23.1 million, improvement of NOK 12.0 million from prior year

Global in-market value NOK mill (LTM)

Hexvix/Cysview Future Growth Drivers

  • Volume growth in existing markets
  • Increased penetration in the US
  • Incorporation in national guidelines (EU & US); publication of expert opinions
  • Expand into new markets
  • Surveillance following initial diagnosis represents significant opportunities
  • Positive early clinical experience with flexible cystoscope
  • Clinical trials (Phase 3 and IITs) planned/underway

Expand into new territories

  • In May, distribution agreement with Juno Pharmaceuticals for Hexvix in Australia and New Zealand with potential of 25 000 bladder cancer resections (TURBs) each year
  • In August, distribution agreement with BioSyent Pharmaceuticals for Cysview in Canada with potential of 25 000 bladder cancer resections (TURBs) each year
  • Recent approval of Hexvix in Russia

Cevira

Novel treatment for HPV related diseases of the cervix

Cevira1 Addressing Unmet Needs in Cervical Disease

  • Oncogenic Human Papilloma Virus (HPV) is a highly prevalent sexually transmitted disease
  • Well established cause of Cervical Intraepithelial Neoplasia (CIN) and cervical cancer
  • Close association of HPV induced cell changes and invasive cancer
  • 30 million women globally with low grade lesions/CIN1; 10 million with high grade lesions/CIN2
  • High unmet medical need for novel therapies

CEVIRA A Major Opportunity

  • Breakthrough single use and fully integrated drug-device technology to satisfy high need for novel therapies to treat global epidemic of HPV/CIN populations
  • A well tolerated non-systemic treatment option for patients which preserves fertility and avoids the morbidities of invasive surgery
  • Results of the Phase 2b trial are significant
  • Statistically significant HSIL (CIN2,3) regression in the FDA agreed phase 3 patient population (p=0.004)
  • Statistically significant virologic clearance of oncogenic HPV at 9 months after first treatment (p=0.045)
  • Excellent tolerability and high physician & patient acceptance
  • Achieved Special Protocol Agreement with FDA in August for patients with HSIL
  • Alignment on clinical phase 3 program of two similar double blind, placebo controlled studies with ~200 patients in each study with primary efficacy end point 6 months after treatment

CEVIRA Significant Sales Potential

  • Large patient population based on biopsy confirmed histology of HSIL
  • ~1M cases HSIL annually in US & West EU1,2 detected through routine cervical screening programs; 50% of these are caused by HPV strain 16 or 183
  • ~30% risk of progress to cervical cancer4
  • Upside exists in Latin America, Asia and East EU, where burden of HPV is higher
  • LCM Opportunity for clearance of oncogenic HPV in patients with normal cytology/LSIL
  • It is estimated that ~35M are HPV infected in US & EU, with a prevalence of HPV strains 16 or 18 of 32% (~11M)
  • 10-15M cases oncogenic HPV annually in US & West EU6 detected through routine cervical screening programs
  • Persistent infection occurs in 10-20% of the cases7

Blockbuster sales potential based on premium pricing opportunity

  • At premium price levels, cost impact model demonstrates cost savings / benefit to the US health care system as compared to current treatment practice5
  • Additional significant savings when avoidance of costs associated with preterm births factored in5
  • 13 • Continued discussions with potential partners for development and commercialization

1.Solomon 2007, Antilla 2009 2. Stoler 2011, Wright 2012 3. Smith 2007 4. Stanley 2010 5. Internal assessment perfomed by Bridgehead 6. Wright 2012, Dunne 2007 7. Moscicki 1998

Visonac

Novel non-antibiotic treatment of acne

Visonac1

First Photodynamic Treatment for Inflammatory Acne

Late Stage Development Compound

  • Phase 3 ready
  • Development and regulatory risks significantly reduced

High Market Need

  • Current treatment options, antibiotics and isotretinoin, hampered by possible development of antibiotic resistance and major safety issues
  • Need to improve patient compliance through MD controlled treatment options
  • Large unsatisfied patient population with >2 million patients in EU and USA in need of second line treatment options
  • Payers and patients willingness to pay due to limited effective and safe treatment options

Visonac Strong Phase 2b Results

  • Solid Phase 2b results
  • Significant reduction in inflammatory lesions
  • Overall improvement in acne severity
  • Well tolerated regimen
  • Ready for Phase 3 registration trials
  • Clinical Phase 3 program in place and SPA obtained from FDA
  • Patent coverage across major markets to 2025
  • Partner search for development and commercialization ongoing

Visonac Significant Sales Potential

  • \$900M USD Market in Moderate-Severe Acne
  • Dermatologists are main prescriber of oral antibiotics and retinoids
  • Visonac positioned as second line alternative
  • Over 2M patients in need of second line treatment options (U.S. and EU)
  • Favorable risk profile compared to existing treatment options
  • Sustained efficacy allows for premium price

Financials

Results by Segment Third Quarter 2015

  • Commercial franchise:
  • Continued improvement in revenues and EBIT
  • EBIT margin year to date at 23%
  • Total in market sales value increased YoY 22% in 3Q and 19% year to date
  • Development portfolio:
  • Activities related to Cevira
  • Cysview post marketing commitment phase 3 capitalized
  • Quarter end cash balance at NOK 139.5 million
MNOK Q3 '15 Q3 '14 YTD '15 LTM
Commercial Franchise
Total revenues 35,9 26,1 100,2 72,2 126,2
Gross profit
Operating expenses
33,9
-24,8
24,5
-18,8
94,0
-70,9
67,1
-56,0
118,2
-90,2
EBIT 9,0 5,7 23,1 11,1 28,0
Development Portfolio
Total revenues 0,0 0,0 0,0 0,0 0,0
Gross profit
Operating expenses
0,0
-11,7
0,0
-12,6
0,0
-34,9
0,0
-37,4
0,0
-49,8
EBIT -11,7 -12,6 -34,9 -37,4 -49,8
Total
EBIT -2,7 -6,9 -11,8 -26,4 -21,8
(*) One-Off's excluded
Salix termination fee 30,8 0,0

Outlook

Outlook

FINANCIAL CLINICAL PARTNERSHIP • Hexvix/Cysview global in-market unit sales growth of 10% in 2015 • Initiate necessary documentation for the Cevira device to ensure readiness for the Phase 3 trial following the SPA approval • Reporting of clinical results of Hexvix/Cysview phase 3 market expansion study in 2017 • Secure partnership for further development and commercialization of Visonac and Cevira reflecting the product potential

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