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Photocure ASA

Investor Presentation • Aug 23, 2017

3714_rns_2017-08-23_28a08bbb-2fba-4d9c-9774-e296b80a6f80.pdf

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PHOTOCURE ASA

RESULTS FOR SECOND QUARTER AND FIRST HALF YEAR 2017

23 AUGUST 2017

Kjetil Hestdal, MD, President & CEOErik Dahl, CFO

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 2016. 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.

KEY OBJECTIVES AND ACHIEVEMENTS

KEY OBJECTIVES

2Q/FIRST HALF YEAR KEY ACHIEVEMENTS

  • • Increase growth of Cysview in the US based on an increased investment in the US commercial operations •
  • • In the US Cysview in-market volume increased YoY 37% in second quarter and 33% YTD
  • In July, CMS proposed new coding and reimbursement of Blue Light Cystoscopy (BLC) with Cysview for use in hospital outpatient departments
  • •Increase in activities in accordance with US strategic investment plan

•Increase Hexvix/Cysview global in-market unit sales

Obtain regulatory approval for market expansion of Cysview into

  • • Hexvix/Cysview in-market volume in own markets increased YoY 13 % in second quarter, while partner unit sales declined 6% to an overall YoY 2% decline in-market volume in second quarter
  • •Hexvix/Cysview in-market unit sales increased 4% YTD
  • •Patient enrollment completed in January
  • • Strong clinical data from phase 3 study presented in the Late Breaking Plenary Session at AUA in May
  • • Supplemental NDA filed in August for Blue Light Flexible Cystoscopy (BLFC) with Cysview

surveillance market

•

Hexvix/Cysview Update

HEXVIX/CYSVIEWA SIGNIFICANT GLOBAL SPECIALTY BRAND

  • • Value of in-market sales of Hexvix/Cysview in the second quarter increased 4% to NOK 66 million and YTD 6% to NOK 131 million
  • • Hexvix/Cysview global in-market volume decreased YoY 2% in the second quarter, with own unit sales increase of 13% while partner unit sales Ipsen declined 6%
  • • Overall franchise EBITDA YTD at NOK 9.6 million, EBITDA margin of 13%

With courtesy of Dr. Dirk Zaak

5

HEXVIX/CYSVIEWREDUCED RECURRENCE RATE AT 3 YEARS IN REAL-LIFE EXPERIENCE STUDY

  • • A «Real-life experience» study performed at single center in UK enrolled 808 bladder cancer patients
  • – 345 patients qualified for long term follow up after bladder cancer resection (TURBT) with Blue Light Cystoscopy (BLC) with Hexvix or standard White Light Cystoscopy (WLC)
  • • The overall recurrence rates at 3 years were significantly (p=0.02) less in patients who received BLC with Hexvix(39.0%) compared to WLC resection (53.3%)
  • The benefit on the recurrence rate was most pronounced in patients with high-risk disease (52.1% recurrence at year 3 with BLC with Hexvix versus 80% with WLC; p=0.01)
  • There was a significantly (p=0.001) longer mean recurrence free survival in patients who received BLC with Hexvix (52.9 months) compared to patients with WLC resections (42.5 months)

«Real-life experience: recurrence rate at 3 years with Hexvix® photodynamic diagnosis-assisted TURBT compared with good quality white light TURBT in new NMIBC - a prospective controlled study» Gallagher K et al, World J Urology; 2017 (published online 12 August 2017)

6

HEXVIX/CYSVIEWPROGRESS UPDATE IN US

  • • Photocure own sales revenue in the US in 2Q increased 55%
  • Driven by YoY in-market volume growth of 37% in second quarter
  • • Permanent Blue Light Cystoscope placements of 93 at the end of quarter, increase of 10 since end of 2016
  • • US strategic investment plan is on track and we have doubled our sales organization, increased medical headcount and targeted marketing investments
  • • Our increased investments have started yielding positive results as seen by the increased growth and awareness
  • Focused local awareness marketing campaign in Nashville has resulted in 342K TV Viewers and 1,6 million digital impressions in the market
  • Increased number of hospitals are actively promoting the availability of Blue light Cystoscopy (BLC) with Cysview utilizing multiple media outlets
  • Increased awareness among urologists through several presentations of new clinical data at regional urology conferences across the US 7

Maximizing the US Cysview opportunity is essential to Photocure's strategy to create a Specialty Pharmaceutical Company in Urology

US MEDICARE PROPOSED NEW REIMBURSMENT OF BLC WITH CYSVIEW

Background

  • • For Medicare patients BLC with Cysview has been reimbursed similar to white light cystoscopy, where the cost of Cysview is bundled in with the cost of the procedure
  • • For private insured patients Cysview is reimbursed in addition to the procedure reimbursement

Efforts

  • • The new AUA guidelines emphasize the clinical benefits of BLC with Cysview and recommend a broader application of BLC with Cysview
  • • Health care providers including major cancer hospitals, key bladder cancer urologists, AUA, as well as bladder cancer patients, have approached CMS as well as key members of the congress to secure broader access to technology that improves management of bladder cancer patients

Conclusion

  • • In July, CMS proposed separate codes for BLC with Cysview recognizing the clinical benefits and additional hospital cost related to the improved procedure
  • • The new BLC with Cysview codes will be implemented by January 1, 2018
  • • If implemented, this will provide additional foundation for increased utilization

HEXVIX/CYSVIEWsNDA FILED BASED ON STRONG CLINICAL PHASE 3 SURVEILLANCE STUDY RESULTS

Phase 3 Surveillance Study Conclusions

  • Blue Light Flexible Cystoscopy (BLFC) with Cysview significantly improves the detection of patients with recurrent bladder cancer (20.6%, p<0.0001)
  • • Blue Light Cystoscopy (BLC) with Cysview significantly improves the detection of patients with CIS (34.6%, p<0.0001)
  • • Tumor detection was improved in 46.2% of patients who underwent repeat BLC with Cysview
  • •Repeat use of Cysview is safe
  • • Patients found it worthwhile to undergo BLFC with Cysview (92.7%) and BLC with Cysview (87.0%) and would recommend it to others
  • • BLFC with Cysview should be used for patients in surveillance of their bladder cancer recurrence and for management in the OR

Supplemental NDA

Objective of the supplemental NDA

  • • Approval of the use of BLFC with Cysview during surveillance cystoscopy
  • • Improved label and approval of BLC with Cysview for improved detection of all Non-muscle invasive bladder cancer lesions (NMIBC) including Carcinoma in Situ (CIS)
  • •Improved label and approval of repeat use of Cysview

EXPANSION INTO LARGER SEGMENTS:MARKET OPPORTUNITY IN THE SURVEILLANCE SEGMENT

  • •Expansion with Blue Light Flexible Cystoscopy with Cysview
  • •For office settings (surveillance) that utilize flexible cystoscopes

10

HEXVIXPERFORMANCE NORDICS

  • • Photocure own sales revenue in the Nordics increased YoY 10% in second quarter with 3% increase YTD
  • YoY in-market unit sales increase of 4% in second quarter with a decrease of 3% YTD
  • The negative trend in Denmark observed in previous quarters has been reversed in second quarter
  • Blue Light Flex Cystoscopy with Hexvix gets a foothold in the Nordic countries
  • Positive IIT study published from Herlev and Gentofte University Hospital, Copenhagen University, Denmark in the Scandinavian Journal of Urology.
    • • Blue Light Flexible Cystoscopy with Hexvix in outpatient setting provides same ability to detect and obtain biopsy of aggressive flat bladder cancer lesions (CIS) as rigid cystoscopy in the operating room, significantly improving the quality of life (QoL) for patients

•

HEXVIX/CYSVIEWPARTNER PROGRESS

  • • Partner revenue declined 9% YoY in second quarter
  • In-market unit sales declined 6% due to reduced unit sales in June in key markets including Germany and France
  • • Recently formed partnerships: BioSyent in Canada and Juno in Australia/New Zealand
  • Significant support from urological community in both locations.
  • Roll-out of new equipment Karl Storz Image 1S has started
  • Applications for re-imbursement have been submitted; decisions are expected by the end of the year.

Cost of Bladder Cancer represents € 4.9 bn (Leal et al, 2016)

Cevira/Visonac Update

CEVIRA & VISONACPHASE 3 READY PRODUCTS WITH SIGNIFICANT SALES POTENTIAL

  • • Cevira - Breakthrough single use and fully integrated drug-device technology to satisfy high need for novel non-surgical therapies to treat global epidemic of HPV/HSIL populations
  • • Visonac – Novel topical non-antibiotic/non-isotretinoin treatment to satisfy high unmet medical need among patients with inflammatory, severe acne (IGA 4)
  • • Cevira and Visonac both phase 3 ready with Special Protocol Agreement on phase 3 program with FDA
  • • Cevira and Visonac both addressing large patient populations with significant unmet medical needs
  • • After a non-conclusive comprehensive partnering process, PHO will initiate a broad review of possible strategic alternatives for Cevira and Visonac

Financials

SEGMENT PERFORMANCESECOND QUARTER 2017

Commercial franchise:

  • • Hexvix/Cysview total revenue increased YoY 10% in the second quarter, driven by strong US revenues.
  • • Second quarter own revenues, Nordic and US, increased 28%, while partner revenues, Ipsen, declined 9%.
  • •Year to date YoY increase of 9% (in constant currencies 12%)
  • • Increased operating expenses in quarter and YTD driven by sales & marketing in US
  • •EBITDA margin YTD at 13%

Development portfolio:

  • • Activities related to regulatory work and intellectual property. Cysview post marketing commitment phase 3 capitalized
  • • One-off items (first quarter): Write down of Nedax lamp inventory and components
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CONSOLIDATED INCOME STATEMENTSECOND QUARTER 2017

  • • Total revenue increases YoY 1% second quarter and 8% YTD
  • • Operating expenses increase YoY 15% second quarter and 10% YTD
  • –R&D YTD increase 5%
  • Sales & marketing YTD increase 18%, driven by US investments
  • –Other Opex YTD decrease 3%
  • • Recurring EBITDA at NOK -4.4 million for the secondquarter and NOK -8.7 million YTD
  • • One-off items
  • – Write down of Nedax lamp inventory and components
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17

CASH FLOWSECOND QUARTER 2017

  • • Cash flow from operations second quarter NOK -16.9 million, YTD NOK -27.7 million
  • Working capital impact YTD NOK -16.9 million (YTD 2016 NOK -15.7 million)
  • • Cash flow from investments second quarter NOK -1.5 million and YTD NOK -4.5 million (YTD 2016 NOK -8.3million)
  • – Includes investments YTD of NOK 5.9 million in development expenses
  • • Net cash flow YTD NOK -32.2 million (YTD 2016 NOK - 29.6 million)
  • •Quarter end cash balance at NOK 137.0 million
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BALANCE SHEETPER 30 JUNE 2017

  • • Non current assets include NOK 29.6 million in investments in tangible and intangible assets and deferred tax asset of NOK 49.3 million
  • •No interest bearing debt
  • • Shareholder's equity of NOK 241.0 million. Equity ratio of 89%
  • • Photocure held 809 own shares at end of the quarter
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Summary

STRENGTHENING BOARD AND MANAGEMENT TEAM

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KEY OBJECTIVES AND ACHIEVEMENTS

KEY OBJECTIVES

2Q/FIRST HALF YEAR KEY ACHIEVEMENTS

  • • Increase growth of Cysview in the US based on an increased investment in the US commercial operations •
  • • In the US Cysview in-market volume increased YoY 37% in second quarter and 33% YTD
  • In July, CMS proposed new coding and reimbursement of Blue Light Cystoscopy (BLC) with Cysview for use in hospital outpatient departments
  • •Increase in activities in accordance with US strategic investment plan

•Increase Hexvix/Cysview global in-market unit sales

Obtain regulatory approval for market expansion of Cysview into

  • • Hexvix/Cysview in-market volume in own markets increased YoY 13 % in second quarter, while partner unit sales declined 6% to an overall YoY 2% decline in-market volume in second quarter
  • •Hexvix/Cysview in-market unit sales increased 4% YTD
  • • Patient enrollment completed in January
  • • Strong clinical data from phase 3 study presented in the Late Breaking Plenary Session at AUA in May
  • • Supplemental NDA filed in August for Blue Light Flexible Cystoscopy (BLFC) with Cysview

surveillance market

•

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