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Photocure ASA

Earnings Release May 14, 2019

3714_rns_2019-05-14_ce490f16-b08a-4876-91d7-d006021850e5.pdf

Earnings Release

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PHOTOCURE ASA

RESULTS FOR FIRST QUARTER 2019

14 May 2019

Daniel Schneider, President and CEO Erik Dahl, CFO

DISCLAIMER

By reading this company presentation (the "Presentation"), or attending any meeting or oral presentation held in relation thereto, you (the "Recipient") agree to be bound by the following terms, conditions and limitations.

The Presentation has been produced by Photocure (the "Company") for information purposes only and does not in itself constitute, and should not be construed as, an offer to sell or a solicitation of an offer to buy any securities of the Company in any jurisdiction. The distribution of this Presentation may be restricted by law in certain jurisdictions, and the Recipient should inform itself about, and observe, any such restriction. Any failure to comply with such restrictions may constitute a violation of the laws of any such jurisdiction.

The Recipient acknowledge that it will be solely responsible for its own assessment of the Company, the market and the market position of the Company and that it will conduct its own analysis and be solely responsible for forming its own view of the potential future performance of the Company's business. The Company shall not have any liability whatsoever (in negligence or otherwise) arising directly or indirectly from the use of this Presentation or its contents, including but not limited to any liability for errors, inaccuracies, omissions or misleading statements in this Presentation, or violation of distribution restrictions.

An investment in the Company involves significant risk, and several factors could adversely affect the business, legal or financial position of the Company or the value of its securities. For a description of relevant risk factors we refer to the Company's annual report for 2018. Should one or more of these or other risks and uncertainties materialize, actual results may vary significantly from those described in this Presentation. An investment in the Company is suitable only for investors who understand the risk factors associated with this type of investment and who can afford a loss of all or part of their investment.

This Presentation contains certain forward-looking statements relating to inter alia the business, financial performance and results of the Company and the industry in which it operates. Any forward-looking statements contained in this Presentation, including assumptions, opinions and views of the Company or cited from third party sources, are solely opinions and forecasts and are subject to risks, uncertainties and other factors that may cause actual results and events to be materially different from those expected or implied by the forward-looking statements. The Company cannot provide any assurance that the assumptions underlying such forward-looking statements are free from errors nor do any of them accept any responsibility for the future accuracy of opinions expressed in this Presentation or the actual occurrence of forecasted developments.

This Presentation speaks as at the date set out on herein. Neither the delivery of this Presentation nor any further discussions of the Company shall, under any circumstances, create any implication that there has been no change in the affairs of the Company since such date. The Company does not assume any obligation to update or revise the Presentation or disclose any changes or revisions to the information contained in the Presentation (including in relation to forward-looking statements).

This Presentation is subject to Norwegian law, and any dispute arising in respect of this Presentation is subject to the exclusive jurisdiction of Norwegian courts.

DELIVERING ON KEY 2019 OBJECTIVES

Significant growth of Cysview® in US TURBT market

Accelerate Cysview® in US flexible cystoscopy surveillance market

Increase Hexvix® / Cysview® global inmarket unit sales

Create opportunities vis-à-vis our strategic partnerships

  • Q1 revenue growth in US\$ 52%, in-market volume increase in Q1 of 44%
  • Highest unit & revenue quarter to date
  • 51% growth YOY in installed blue light enabled cystoscopes in market
  • Total of 171 cystoscopes including 11 Flex cystoscopes
  • Total Hexvix®/Cysview® revenue increased 26% YOY to NOK 51.2 million
  • Highest quarter ever. 6 consecutive quarters with increases QOQ sales!
  • Total in-market unit sales increased 7% in Q1
  • Highest in-market unit sales ever

ACCELERATED MOMENTUM 5 CONSECUTIVE QUARTERS OF RECORD REVENUES IN US

US (1000 NOK)

4

ACCELERATED MOMENTUM INSTALLED BASE OF CYSTOSCOPES IN THE US

2013 2014 2015 2016 2017 2018 Q1 2019

STRATEGIC FOCUS TRANSFORMING BLADDER CANCER DETECTION AND MANAGEMENT

Profitable commercial franchise

Hexvix®/Cysview® ~\$35M global in-market sales* (FY'18) Over 500k patients treated with Hexvix®/Cysview® worldwide

Strong competitive position Unique and complex drug-device procedure Leading regulatory, manufacturing & commercial expertise

Significant growth prospects Grow in existing markets like the US & expand into new regions FLEX label extension accessing a larger market opportunity

Scalable for partnerships and in-licensing opportunities

Hexvix®/Cysview® Update

NON-MUSCLE INVASIVE BLADDER CANCER SIGNIFICANT RECURRENCE RATE AND HIGH DISEASE BURDEN

~650K

surgical procedures annually in USA and EU ~2.2M

surveillance cystoscopies annually in USA and EU

50% disease recurrence 10% – 30% disease progression

\$3.7 Billion in direct medical costs/year1

Picture: Mayo Clinic; Researchgate.net 1. Direct medical costs in USA in 2001: The health economics of bladder cancer: a comprehensive review of the published literature. Botteman MF et al. Pharmacoeconomics 2003;21 (8), 1315-1330

HEXVIX® / CYSVIEW® A DRAMATIC IMPACT ON BLADDER CANCER PATIENT CARE

with Hexvix® / Cysview®

Additional tumors found in 1 out of 4 patients1

1 Burger et al, Eur. Urol. 2013 WLC: White Light Cystoscopy; BLC: Blue Light Cystoscopy™ + Cysview®

Key feature Better visual contrast between benign and malignant cells

Key benefits Improve diagnostic accuracy Achieve optimal surgical results

Significant reduction of disease recurrence Reduction in disease progression Potential for reduction in cystectomies Improved and cost-effective health outcomes

TREMENDOUS OPPORTUNITY IN THE US CYSVIEW® READY FOR ACCELERATED GROWTH!

OUR AMBITION: MAKE HEXVIX®/CYSVIEW® THE STANDARD OF CARE

Keys to Success – The Five A's

APPROVAL EXPANDED INDICATIONS: SURVEILLANCE, REPEAT USE, AND CIS

The global flexible surveillance market is approximately 3X bigger than the rigid TURBT market

ACCEPTANCE INCLUDED PROMINENTLY IN MAJOR WORLD GUIDELINES

Supportive environment Strongly recommended by European and national guidelines as well as expert panels

Strongly recommended by US guidelines and expert panels

ACCEPTANCE GROWING SIGNIFICANT PUBLICATIONS 2019 INCLUDING FLEX!

Nature Reviews Urology:

Expert Consensus Statement: Blue light flexible cystoscopy with Cysview (hexaminolevulinate) in nonmuscle-invasive bladder cancer

World Journal of Urology:

• The prognostic impact of hexaminolevulinate-based bladder tumor resection in patients with primary nonmuscle invasive bladder cancer treated with radical cystectomy

ACCEPTANCE KEY REFERENCE CENTERS ACROSS THE US

Established in >140 key cancer hospitals and leading institutions The numbers will grow with optimized US commercial footprint

High Adoption Rates

in 74% NCCN centers

in 56% of NCI centers

in 74% of top 25 Best Hospitals

ACCESS FAVORABLE AND PERMANENT US REIMBURSEMENT 2019

Commercial Payers

  • Cysview is separately reimbursed normally at ASP + 6% to 15% depending on the contracted rates for all sites of care
  • Coding: A9589 Cysview (hexaminolevulinate acetate)

Medicare

  • Office / Clinic: Cysview is separately reimbursed at ASP + 6% (coding: A9589)
  • Hospital Outpatient Dept (HOPD): Additional reimbursement \$1,187/case for certain TURBT procedures with a BLC with Cysview Complexity adjustment
  • ASC: Reimbursement is bundled into the procedure payment and Cysview coding A9589 should be added
  • Inpatient Operating Room: Cysview is separately reimbursed at ASP + 6%

BLC with Cysview Codes:

  • A9589 Cysview (hexaminolevulinate acetate)
  • C9738 BLC with Cysview Complexity Adjustment Code for Medicare results in an additional payment of \$1,187 for certain TURBT procedure codes

"ACTIVATED" AWARENESS 99% OF BLADDER CANCER PATIENTS SEEK BLC™ WITH CYSVIEW® !

  1. Survey of self-selected patients completed through the Bladder Cancer Advocacy Network (BCAN) sponsored by Photocure.

Jan. 2016 n=222, Jan. 2017 n=568, Jan. 2018 n=550, Jan. 2019 n=600

"ACTIVATED" AWARENESS AUA 2019 – A SUCCESS

BLC™ with Cysview® was featured in several sessions at the AUA meeting, including:

  • Blue Light Cystoscopy for the diagnosis of Bladder Cancer - Dr. Badrinath Konety, University of Minnesota
  • Surgical Techniques: Tips & Tricks: Oncology - Dr. Yair Lotan, UTSW, presented on BLC with Cysview for surveillance
  • Poster presentation of data from the Nordic Blue Light Flexible Cystoscopy registry
  • UroToday coverage

"ACTIVATED" AWARENESS EAU 2019 – BLUE LIGHT FLEX CYSTOSCOPY ON THE MAIN STAGE

• Dr. Yair Lotan, M.D., Professor of Urology, University of Texas Southwestern Medical Center presented on "Blue Light Flexible Cystoscopy with Hexaminolevulinate for Surveillance of Bladder Cancer".

"ACTIVATED" AWARENESS MEDIA/ADVERTISING PROGRAMS: PROVIDERS

HCP UroToday UroCare Live: LUGPA

ACCELERATE OPTIMIZED AND FOCUSED US COMMERCIAL FOOTPRINT

Targeting top 750 Reference Centers and major LUGPA and IDNs

Re-focused Existing Headcount

  • 27 Sales Reps Key Hospitals
  • 4 Key Account Managers LUGPA & IDNs (Integrated Delivery Networks)
  • 4 Regional Managers

Financials

SEGMENT PERFORMANCE FIRST QUARTER 2019

Amounts
in NOK million
Q1 '19 Q1 '18 Change FY '18
Commercial Franchise
Nordic revenue 13.1 12.1 8% 47.0
US revenue 21.2 12.7 66% 63.7
Partner revenue 17.0 15.8 7% 62.2
Total Hexvix/Cysview 51.2 40.7 26% 172.9
Other
revenue
1.0 0.9 8.6
Total revenue 52.2 41.6 26% 181.5
Operating expenses -45.1 -37.3 21% 156.0
EBITDA recurring 1.7 0.9 8.4
Development Portfolio
Operating expenses -3.2 -5.0 -36% -18.9
EBITDA recurring -3.2 -5.0 -18.9
Total
EBITDA recurring -1.5 -4.0 -10.5

Commercial Franchise

  • Continued strong revenue growth in US, first quarter revenue growth in US\$ 52%
  • Installed base of rigid and flex BLC 171 at quarter end, increased 51% YOY
  • Nordic revenue growth at 8% in Q1, strong development in Denmark
  • Q1 growth in partner revenue at 7%, driven by Germany (Ipsen)
  • Increased operating expenses, 21% YOY, commercial investments in US

Development Portfolio

• Significant cost reductions continuing from last year – activity level and capacity reductions

CONSOLIDATED INCOME STATEMENT FIRST QUARTER 2019

Amounts
in NOK million
Q1 '19 Q1 '18 Change FY '18
Hexvix/Cysview revenue 51.2 40.7 26% 172.9
Other
revenue
1.0 0.9 8.6
Total revenue 52.2 41.6 26% 181.5
Gross profit 46.8 38.2 22% 164.4
Operating expenses -48.3 -42.2 14% -174.9
EBITDA recurring -1.5 -4.0 -10.5
Depreciation
& Amort.
-4.2 -3.2 -13.2
Restructuring
expenses
-14.2
EBIT -5.8 -7.3 -37.9
Net financial
items
-0.2 -0.2 1.2
Earnings
before
tax
-6.0 -7.5 -36.7
Tax
expenses
1.0 4.5 0.0
Net earnings -4.9 -3.0 -36.7
  • Recurring EBITDA significantly improved from last year. Improvement is revenue driven
  • Increased Hexvix/Cysview revenue driven by US
  • Increased sales & marketing expenses, partly offset by decline in R&D and other operating expenses, YOY increase 14%

CASH FLOW FIRST QUARTER 2019

Amounts
in NOK million
Q1 '19 Q1 '18 FY '18
Operational
cash flow
-15.7 -18.5 -24.1
EBITDA, recurring -1.5 -4.0 -10.5
Working
capital
-12.5 -11.0 1.4
Other -1.6 -3.5 -15.0
Investment cash flow 0.5 -0.1 -1.1
Development exp. - -0.4 -0.6
Other 0.5 0.3 -0.5
Financing
cash flow
-0.2 - 2.7
Share
capital
0.6 - 6.3
Other -0.9 - -3.7
Net change
in cash
-15.4 -18.6 -22.5
Ending cash balance 91.4 110.7 106.8
  • Cash flow from operations first quarter at NOK -15.7 million, improvement from Q1 last year of NOK 2.8 million
  • Improvement driven by improved EBITDA
  • Main drivers for working capital development was payments related to the 2018 restructuring (NOK 3.2 million), accounts payables and accounts receivables
  • Cash flow from investments first quarter NOK 0.5 million, improvement from Q1 last year of NOK 0.6 million
  • Improvement driven by reduced investments in development projects
  • Quarter end cash balance at NOK 91.4 million

BALANCE SHEET 31 MARCH 2019

Amounts
in NOK million
31.03
2019
31.12
2018
Non current
assets
84.9 77.8
Investments 21.5 24.6
Tax
asset
53.4 52.4
Other 10.0 0.7
Inventory & receivables 56.1 46.6
Cash & equivalents 91.4 106.8
Total assets 232.4 231.2
Shareholders
equity
171.8 176.3
Long term liabilities 12.1 2.5
Current
liabilities
48.6 52.3
Total equity & liabilities 232.4 231.2
Equity ratio 74% 76%
  • Non current assets
  • Investments of NOK 21.5 million in tangible and intangible assets is driven by investments in Cysview phase 3 project
  • Deferred tax asset of NOK 53.4 million
  • Other items includes impact from adoption of IFRS 16 (Leases) from 1 January 2019
  • Inventory & receivables driven by large volumes shipped at the end of the quarter
  • No interest bearing debt
  • Shareholder's equity of NOK 171.8 million. Equity ratio of 74%

Summary and Outlook

2019 OUTLOOK

Growth drivers USA

  • Optimized customer facing commercial team
  • Target 750 largest reference center hospitals and LUGPAs
  • BLC™ Recommended in bladder cancer treatment guidelines
  • Improved permanent favorable reimbursement
  • Accelerate penetration into large untapped surveillance market

Growth drivers Europe

  • Strongly recommended by European/National guidelines
  • Strengthened customer facing commercial team in Nordic
  • Increase penetration into European rigid and surveillance markets

Financial guidance

  • 2020 revenue outlook (U.S.) is \$20-25 million
  • Significant continued revenue growth and profit opportunities in the U.S. market beyond 2020

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