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Photocure ASA

Earnings Release Feb 27, 2019

3714_rns_2019-02-27_387fa3bd-8087-41c9-96a7-2d80b1f93ffa.pdf

Earnings Release

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PHOTOCURE ASA

RESULTS FOR FOURTH QUARTER AND FULL YEAR 2018

27 February 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 2017. 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 2018 OBJECTIVES

Significant growth of Cysview® in US TURBT market

  • Q4 revenue growth in US\$ 76%, full year 53%, driven by in-market volume increase in Q4 of 69%, full year 45%
  • 51% growth YOY in installed blue light enabled cystoscopes in market to 157 by end of year, including 8 Flex cystoscopes
  • Improved reimbursement has positively impacted sales development including new account install base

Launch Cysview® in US flexible cystoscopy surveillance market

  • Our launch priority is focused on the accounts that participated in the BL Flex trial, current existing targeted accounts and top large Urology groups in the US
  • Our pipeline of potential new accounts continues to grow driven by customer and patient demand

Increase Hexvix® / Cysview® global in-market unit sales

  • Total Hexvix/Cysview revenue increased 28% YOY to NOK 46.3 million in Q4, highest ever. Full year growth of 19% (proforma)
  • Total in-market unit sales increased 11% in Q4. Full year increase of 5% driven by US

STRATEGIC FOCUS ON 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

* Total In Market Sales including US, Nordic and Partners

Hexvix/Cysview Update

NON-MUSCLE INVASIVE BLADDER CANCER IS ONE OF THE MOST COMMON CANCERS WITH 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

EXPANDING INTO FLEX IS ONE OF OUR BIG NEXT STEPS

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

HEXVIX® / CYSVIEW® IS A TRANSFORMATIVE SOLUTION TO IMPROVE THE LIVES OF PATIENTS WITH BLADDER CANCER

Additional tumors found in 1 out of 4 patients1

1Burder 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

50% INCREASE IN CUSTOMER FACING ROLES IN 2019 75% MSA COVERAGE

Commercial Role 2016 2017 2018 2019
Surgical Sales Executives 11 15 21 27
Corp Account Mgrs.
(LUGPA and IDHN)
0 0 0 4
Total FTEs 11 15 21 31
Total Account Coverage 275 375 525 750+

INCREASING PATIENT AWARENESS & DEMAND NOV/DEC 2018 MEDIA PROGRAMS: HCP & PATIENT

USA Today Nov 29

PATIENTS WANT BLUE LIGHT CYSTOSCOPY AND CYSVIEW®

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

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

CYSVIEW® TO BECOME THE NEW STANDARD OF CARE FOR THE DETECTION AND MANAGEMENT OF BLADDER CANCER IN THE USA

Supportive environment

Strongly recommended by national guidelines and expert panels New reimbursement (Jan '19) for Medicare patients

High adoption rate in leading sites Established in >140 key cancer hospitals and leading institutions and the numbers are growing

in 74% NCCN centers

in 56% of NCI centers

in 74% of top 25 Best Hospitals

HEXVIX® TO BECOME THE NEW STANDARD OF CARE FOR THE DETECTION AND MANAGEMENT OF BLADDER CANCER IN EUROPE

Supportive environment

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

25% to 70% penetration rate

Continued growth in the Nordics

9% revenue growth during full year 2018 Further leverage commercial infrastructure – Combat Medical

Improve penetration in Rest of Europe

Well established in Germany with 30% penetration rate Opportunity to increase penetration in rest of Europe

Financials

SEGMENT PERFORMANCE - PROFORMA FOURTH QUARTER 2018

Amounts
in NOK million
Q4 '18 Prof
Q4 '17
Change FY '18 Prof
FY '17
Change
Commercial Franchise
Nordic revenue 13.5 12.9 5% 47.0 43.3 9%
US revenue 18.4 10.2 81% 63.7 42.4 50%
Partner revenue 14.4 13.2 9% 62.2 59.9 4%
Total Hexvix/Cysview 46.3 36.3 28% 172.9 145.6 19%
Other
revenue
3.5 0.8 8.6 5.3
Total revenue 49.9 37.1 34% 181.5 150.9 20%
Operating expenses -43.6 -35.0 24% 156.0 128.5 21%
EBITDA recurring 1.3 -1.3 8.4 10.4
Development Portfolio
Operating expenses -5.4 -11.8 -54% -18.9 -39.5 -52%
EBITDA recurring -5.4 -11.8 -18.9 -39.5
TOTAL
EBITDA recurring -4.1 -13.1 -10.5 -29.1

The statement is prepared on the proforma basis as if the accounting principles IFRS 15 and IFRS 9 had been adopted 1 Jan '17

Commercial Franchise

  • Strong revenue growth in US, fourth quarter revenue growth in US\$ 76%, full year 53%
  • Installed base of BLC year end at 157, increased 51% for the full year
  • Continued growth in Nordic, 5% in Q4
  • Partner revenue Q4 growth 9%, driven by Canada (BioSyent) and Germany (Ipsen)
  • Increased operating expenses driven by commercial investments in US

Development Portfolio

• Significant cost reduction – activity level and capacity reductions

CONSOLIDATED INCOME STATEMENT - PROFORMA FOURTH QUARTER 2018

Amounts
in NOK million
Q4 '18 Prof
Q4 '17
Change FY '18 Prof
FY '17
Change
Hexvix/Cysview revenue 46.3 36.3 28% 172.9 145.6 19%
Other
revenue
3.5 0.8 8.6 5.3
Total revenue 49.9 37.1 34% 181.5 150.9 20%
Gross profit 44.9 33.7 33% 164.4 138.9 18%
Operating expenses -49.0 -46.8 5% -174.9 -168.0 4%
EBITDA recurring -4.1 -13.1 -10.5 -29.1
Depreciation
& Amort.
-3.4 -3.6 -13.2 -13.1
Restructuring
expenses
-1.1 -14.2
One-off
items
-4.0
EBIT -8.6 -16.6 -37.9 46.2
Net financial
items
1.2 1.0 1.2 3.6
Earnings
before
tax
-7.3 -15.7 -36.7 -42.6
Tax
expenses
-4.6 0.2 0.0 6.9
Net earnings -12.0 -15.5 -36.7 -35.7
  • Recurring EBITDA significantly improved from last year. Improvement is revenue driven while expense growth is limited
  • Increased Hexvix/Cysview revenue driven by US
  • Increased sales & marketing expenses, partly offset by decline in R&D and other operating expenses, net growth 4%
  • Depreciation and amortization driven by amortization of Cysview phase 3 investments
  • Restructuring expenses NOK 14.2 million, headcount reductions and organizational changes in second quarter

The statement is prepared on the proforma basis as if the accounting principles IFRS 15 and IFRS 9 had been adopted 1 Jan '17

CASH FLOW FOURTH QUARTER 2018

Amounts
in NOK million
Q4 '18 Prof
Q4 '17
FY '18 Prof
FY '17
Operations cash flow 11.2 7.5 -24.1 -23.6
EBITDA, recurring -4.1 -10.8 -10.5 -29.1
Working
capital
11.9 17.1 1.4 6.4
Other 3.3 1.2 -15.0 -0.9
Investments cash flow -0.4 -1.2 -1.1 -16.3
Development exp. - -0.8 -0.6 -17.5
Other -0.4 -0.4 -0.5 1.3
Financing
cash flow
3.2 - 2.7 -
Share
capital
6.3 - 6.3 -
Other -3.1 - -3.7 -
Net change
in cash
14.0 6.3 -22.5 -39.9
Ending cash balance 106.8 129.4 106.8 129.4
  • Cash flow from operations fourth quarter at NOK 11.2 million, full year NOK -24.1 million
  • Working capital positive in the quarter, main drivers are funds from Skattefunn (tax incentive scheme) and increased payables.
  • Cash flow from investments fourth quarter NOK -0.4 million, full year NOK -1.1 million
  • Full year improvement of NOK 15.2 million from 2017. Decline driven by investments in development projects as Cysview phase 3 project is finalized
  • Year end cash balance at NOK 106.8 million

BALANCE SHEET 31 DECEMBER 2018

Amounts
in NOK million
31.12
2018
31.12.
2017
Non current
assets
77.8 87.5
Investments 24.6 34.6
Tax
asset
52.4 52.9
Other 0.7 -
Inventory & receivables 46.6 46.2
Cash & equivalents 106.8 129.4
Total assets 231.2 263.1
Shareholders
equity
176.3 218.1
Long term liabilities 2.5 4.8
Current
liabilities
52.3 40.3
Total equity & liabilities 231.2 263.1
Equity ratio 76% 83%
  • Investments of NOK 24.6 million in tangible and intangible assets is driven by investments in Cysview phase 3 project
  • Deferred tax asset of NOK 52.4 million at level with YE 2017, tax rate reduced from 23% to 22%
  • No interest bearing debt
  • Shareholder's equity of NOK 176.3 million. Equity ratio of 76%

Summary and Outlook

OUTLOOK

Growth drivers USA

  • 50% Larger customer facing commercial team
  • Target 700 largest reference center hospitals and LUGPAs
  • BLC Recommended in AUA & NCCN bladder cancer treatment guidelines
  • Improved permanent favorable reimbursement
  • Accelerated penetration into large untapped surveillance market

Growth drivers Europe

  • Strongly recommended by European and national guidelines
  • Strengthened customer facing commercial team in Nordic
  • Penetration into European surveillance market

Financial guidance

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

Attachments

INCOME STATEMENT FOURTH QUARTER REPORTED

MNOK Q4 '18 Q4 '17 FY '18 FY '17
Commercial Franchise
Nordic revenues
US revenues
13.5
18.4
12.9
10.2
47.0
63.7
43.3
42.4
Partner revenues 14.4 16.3 62.2 63.3
Hexvix / Cysview
Other revenues
Total revenues
Operating expenses
46.3
3.5
49.9
-43.6
39.4
-
39.4
-35.1
172.9
8.6
181.5
-156.0
149.0
1.9
150.9
-128.5
EBITDA recurring 1.3 0.9 8.4 10.4
Development Portfolio
Operating expenses
-5.4 -11.8 -18.9 -39.5
EBITDA recurring -5.4 -11.8 -18.9 -39.5
Total
EBITDA recurring -4.1 -10.8 -10.5 -29.1

Income Statement - Segment Income Statement - Consolidated

MNOK Q4 '18 Q4 '17 FY '18 FY '17
Hexvix / Cysview revenues 46.3 39.4 172.9 149.0
Other revenues 3.5 0.0 8.6 1.9
Total revenues 49.9 39.4 181.5 150.9
Gross profit 44.9 36.0 164.4 138.9
Operating expenses -49.0 -46.8 -174.9 -168.0
EBITDA recurring -4.1 -10.8 -10.5 -29.1
Depreciation & amortization -3.4 -3.3 -13.2 -12.1
Restructuring expenses -1.1 - -14.2 -
One-Off items - - - -4.0
EBIT -8.6 -14.1 -37.9 -45.2
Net financial items 1.2 1.0 1.2 3.6
Earnings before tax -7.3 -13.2 -36.7 -41.6
Tax expenses -4.6 0.2 0.0 6.9
Net earnings -12.0 -13.0 -36.7 -34.7

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