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Photocure ASA

Earnings Release Nov 8, 2018

3714_rns_2018-11-08_b2832890-dc74-4876-b908-d2e3c29986cb.pdf

Earnings Release

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PHOTOCURE ASA

RESULTS FOR THIRD QUARTER AND THE FIRST NINE MONTHS 2018

8 November 2018

Daniel Schneider, President and CEO Ambaw Bellete, President, Photocure Inc. and Head, US Cancer Commercial Operations 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


Q3 US sales revenue up 42% in US\$ YOY, driven by in-market volume increase
in Q3 of 35%. YTD revenue growth 45% in US\$

43% growth YOY in installed blue light enabled cystoscopes in market to 137 by
end of Q3

Improved reimbursement has positively impacted sales development including
new account install base

Our launch priority is focused on the accounts that participated in the BL Flex
trial, current existing targeted accounts and the top large Urology groups in the
US

Our pipeline of potential new accounts continues to grow driven by customer and
patient demand

Total Hexvix/Cysview revenue increased 26% YOY to NOK 43.5 million in Q3,
highest ever. YTD growth of 16% (proforma)

Total in-market unit sales increased 8% in Q3. YTD increase of 2% driven by US

STRATEGIC FOCUS ON TRANSFORMING BLADDER CANCER MANAGEMENT

Strategic focus on bladder cancer detection & management core products, including potential new, complementary products

NON-CORE PIPELINE PRODUCTS:

Visonac® (Acne treatment)

Cevira® (Cervical disease treatment)

Partner out

Assess partnering opportunities Expansion and strategic alternatives

Strategy built on leveraging our unique know-how and capabilities

Hexvix/Cysview Update

CYSVIEW CONTINUED STRONG MOMENTUM IN US

  • 42% increase in U.S. Cysview sales revenue driven by in market volume growth from both current and new accounts.
  • Year to date U.S. revenues increased 45% and unit growth of 38%
  • 43% YoY increase in permanent Blue Light Cystoscope placements finishing with 137 installed Blue Light scopes including 6 Blue Light flex scopes
  • Positive reimbursement for BLC with Cysview continues to drive sales volume and install base for BLC with Cysview in multiple settings of care
  • In November CMS announced a permanent A Code for Cysview for use in the physician office and clinic starting in January 1st 2019 and an additional \$1,187 / case reimbursement for certain BLC with Cysview procedures
  • Increasing awareness on BLC with Cysview coming from new clinical publications, CME symposium and podium presentations at multiple international, national and regional medical meetings.
  • US strategic investment plan is on track with additional sales resources that are positively impacting productivity

6

US LAUNCH OF CYSVIEW IN SURVEILLANCE OF BLADDER CANCER PATIENTS PRESENTS A LARGE MARKET OPPORTUNITY

  • BLC with Cysview for surveillance launch strategy is focused on the accounts that participated in the BL Flex trial, current existing BL enabled accounts and the top large Urology groups in the US in the top MSA's
  • Building on the positive clinical data published in Urologic Oncology Journal and British Journal of International Urology
  • Continually assess the opportunities within flex and appropriately align our resources against those targets.
  • Market opportunity is ~4 times the size of the TURBT market
  • BLC with Cysview with flexible cystoscopes current install base of six centers

7 accounts

– Customer and Patient demand has resulted in a robust pipeline of potential flex accounts and rapidly working to close those

BLUE LIGHT CYSTOSCOPY WITH CYSVIEW FOR SURVEILLANCE

Video clip from UT Southwestern in Dallas, TX

2018 MEDIA PROGRAMS

NEW POSITIVE 2019 REIMBURSEMENT CODING, COVERAGE AND PAYMENT

Medicare Private payer
Coding,
Coverage and
Payment
Cystoscopy
Procedure fee for cystoscopy

Cysview paid at ASP +6% in clinic or
Physician Office setting with the new A
Code for Cysview –
A9589

Procedure fee for cystoscopy

Cysview paid at contracted rate (ASP +6
to
15%)
TURBT
Hospital Outpatient Depts. Will receive
an additional \$1,187 to cover the
complexity of using Cysview®
and Blue
Light Cystoscopy procedure for the
following codes: 52204 & 52224

Bundled into ambulatory payment
classification (APC –
varies by TURBT type)
* For the following procedure codes 52214,
52234, 52235 and 52240

Add in code for Cysview –
A9589

Procedure fee for TURBT –
varies by type

Cysview paid at (Average Selling Price -ASP +6
to 15%)

New Medicare reimbursement accounts for ~50% of TURBT Medicare market and 100% of the Physician Office / Clinic use

CYSVIEW SIGNIFICANT GROWTH OPPORTUNITY WITH NEW US LABEL

BLC with
Cysview
Market
segment
Total Number of
Cystoscopy
Procedures
Number of
Procedures
in top 25
MSA*
Market
potential in
top 25
MSAs*
TURBT 324,094 130 000 130 MUSD
Surveillance
Cystoscopy
1.2 -
1.4 million
540 000 540 MUSD
  • Our focus is to establish and build BLC with Cysview business in the top 25 TURBT and Surveillance markets utilizing the MSA Strategy
  • BLC with Cysview has achieved significant market penetration in In the top 10 MSA's: New York , Los Angeles, Houston, Chicago and Washington DC in the last 18 months
  • Large install base in TURBT segment has set a great stage for the surveillance BLC with Cysview opportunity
  • Focused investment of commercial and medical resources is driving our growth

BLUE LIGHT CYSTOSCOPY WITH CYSVIEW

New Standard of Care for Bladder Cancer

hospitals and institutions 130 and counting! Over

BLC with Cysview – A New Standard of Care in 74% of NCCN Designated Cancer Centers

BLC with Cysview is in 39 of the NCI Designated Cancer Centers

A New Standard of Care in 74% of the top 25 of Best Hospitals in Adult Urology as per US News and World Report

CYSVIEW PUSH & PULL STRATEGIES

Drive continued growth in the US in the TURBT segment and successfully launch in the surveillance market

HEXVIX NORDIC UPDATE

  • Third quarter revenue increased 19% YoY. The increase was driven by higher billing compared to last year as distributors third quarter last year reduced their inventory
  • Impact of inventory reduction in the third quarter 2017 approx. NOK 0.5 million
  • YTD revenue increased 10% to NOK 33.5 million (NOK 30.4 million). In constant currencies, the increase was 9%
  • In-market unit sales declined 3% YTD, partly due to large deliveries to hospitals at the end of the fourth quarter 2017. Third quarter in-market unit sales was at level with last year
  • In August we signed an exclusive distribution agreement for Combat Medical's HIVEC for the Nordic region leveraging our existing Hexvix infrastructure
  • Commercial sales to commence in the first quarter of 2019.

HEXVIX/CYSVIEW PARTNER UPDATE

  • Partner in-market unit sales increased 6% YoY in the third quarter. YTD decline of 1%
  • Germany at level with last year.
  • Decline in France caused by loss of very favorable reimbursement since Q2'17; decline counteracted by strong guideline recommendation
  • Other countries in total at level with last year
  • Revenue decline (proforma) YTD of 2% in constant currencies

In-market unit sales (by Q)

Financials

SEGMENT PERFORMANCE - PROFORMA THIRD QUARTER 2018

Commercial Franchise

  • Strong revenue growth in US, third quarter revenue growth in US\$ 42%, YTD 45%
  • Continued progress in Nordic, third quarter revenue growth 19%, impacted by inventory decreases last year. YTD growth 9% in constant currencies
  • Ipsen improvements in third quarter, rebound driven mainly by Germany and France. YTD revenue decline 2% in constant currencies (proforma) driven by unit sales
  • Increased operating expenses in quarter and full year driven by commercial organization in US

Development Portfolio

• Significant cost reduction YOY driven by activity level and capacity reductions

MNOK Q3 '18 ProF
Q3 '17
YTD '18 ProF
YTD '17
Commercial Franchise
Nordic revenues 10.6 9.0 33.5 30.4
US revenues 16.5 11.3 45.3 32.3
Partner revenues 16.4 14.3 47.8 46.7
Hexvix / Cysview 43.5 34.6 126.6 109.3
Other revenues 0.9 1.0 5.1 4.4
Total revenues 44.4 35.6 131.6 113.8
Operating expenses -39.0 -32.7 -112.4 -93.5
EBITDA recurring 1.3 -0.2 7.1 11.7
Development Portfolio
Operating expenses -4.4 -9.4 -13.5 -27.7
EBITDA recurring -4.4 -9.4 -13.5 -27.7
Total
EBITDA recurring -3.1 -9.6 -6.4 -16.1

CONSOLIDATED INCOME STATEMENT - PROFORMA THIRD QUARTER 2018

  • Recurring EBITDA significantly improved from third quarter and YTD last year
  • Increased revenue driven by US
  • Increased sales & marketing expenses, partly offset by decline in R&D and other operating expenses
  • Depreciation and amortization driven by amortization of Cysview phase 3 investments and IFRS 15 adjustments
  • Restructuring expenses NOK 13.1 million, headcount reductions and organizational changes in second quarter
MNOK Q3 '18 ProF
Q3 '17
YTD '18 ProF
YTD '17
Hexvix / Cysview revenues
Other revenues
Total revenues
43.5
0.9
44.4
34.6
1.0
35.6
126.6
5.1
131.6
109.3
4.4
113.8
Operating expenses -43.4 -42.2 -125.9 -121.2
EBITDA recurring -3.1 -9.6 -6.4 -16.1
Depreciation & amortization
Restructuring expenses
One-Off items
-3.3
-
-
-4.5
-
-
-9.8
-13.1
-
-9.5
-
-4.0
EBIT -6.4 -14.2 -29.3 -29.6
Net financial items
Profit/loss(-) before tax
Tax expenses
0.0
-6.3
1.5
0.4
-13.8
3.5
-0.0
-29.4
4.6
2.7
-26.9
6.7
Net earnings -4.8 -10.3 -24.7 -20.2

CASH FLOW THIRD QUARTER 2018

  • Cash flow from operations third quarter at NOK -5.3 million, an improvement from first and second quarter 2018
  • NOK -2 million related to Q2 restructuring
  • Cash flow from investments third quarter NOK +0.2 million, an improvement of NOK 10.8 million from same period 2017
  • Decline driven by investments in development projects as Cysview phase 3 project is finalized
  • Quarter end cash balance at NOK 92.8 million
MNOK Q3 '18 Q3 '17 YTD '18 YTD '17
Cash flow from:
- Operations -5.3 -3.4 -35.3 -31.1
- Investments 0.2 -10.6 -0.7 -15.1
- Financing - - -0.6 -
Net change in cash -5.1 -13.9 -36.5 -46.1
Ending cash balance 92.8 123.1 92.8 123.1

BALANCE SHEET 30 SEPTEMBER 2018

  • Non current assets include NOK 27.2 million in investments in tangible and intangible assets and deferred tax asset of NOK 57.5 million
  • No interest bearing debt
  • Shareholder's equity of NOK 182.6 million. Equity ratio of 80%
MNOK 30.09 31.12 30.09
2018 2017 2017
Non-current assets 85.8 87.5 78.9
Inventory & receivables 49.9 46.2 47.4
Cash & equivalents 92.8 129.4 123.1
Total assets 228.5 263.1 259.6
Shareholders equity 182.6 218.1 230.7
Long term liabilities 5.2 4.8 4.5
Current liabilities 40.7 40.3 24.3
Total equity & liabilities 228.5 263.1 259.6
Equity ratio 80 % 83 % 89 %

Summary and Outlook

DELIVERING ON KEY 2018 OBJECTIVES

Significant growth of Cysview®
in
US TURBT market

Q3 US sales revenue up 42% in US\$ YOY, driven by in-market volume increase
in Q3 of 35%. YTD revenue growth 45% in US\$

43% growth YOY in installed blue light enabled cystoscopes in market to 137 by
end of Q3

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 the 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 26% YOY to NOK 43.5 million in Q3,
highest ever. YTD growth of 16% (proforma)

Total in-market unit sales increased 8% in Q3. YTD increase of 2% driven by US

Attachments

INCOME STATEMENT THIRD QUARTER REPORTED

MNOK Q3 '18 Q3 '17 YTD '18 YTD '17
Commercial Franchise
Nordic revenues
US revenues
Partner revenues
Hexvix / Cysview
Other revenues
Total revenues
10.6
16.5
16.4
43.5
0.9
44.4
9.0
11.3
15.2
35.5
0.2
35.6
33.5
45.3
47.8
126.6
5.1
131.6
30.4
32.3
47.0
109.6
1.9
111.5
Operating expenses
EBITDA recurring
-39.0
1.3
-32.8
-0.2
-112.4
7.1
-93.5
9.4
EBITDA % 3 % -1 % 5 % 8 %
Development Portfolio
Operating expenses
-4.4 -9.4 -13.5 -27.7
EBITDA recurring -4.4 -9.4 -13.5 -27.7
Total

EBITDA recurring -3.1 -9.6 -6.4 -18.3

Income Statement - Segment Income Statement - Consolidated

MNOK Q3 '18 Q3 '17 YTD '18 YTD '17
Hexvix / Cysview revenues
Other revenues
Total revenues
43.5
0.9
44.4
35.5
0.2
35.6
126.6
5.1
131.6
109.6
1.9
111.5
Operating expenses -43.4 -42.2 -125.9 -121.2
EBITDA recurring -3.1 -9.6 -6.4 -18.3
Depreciation & amortization
Restructuring expenses
One-Off items
-3.3
-
-
-4.3
-
-
-9.8
-13.1
-
-8.8
-
-4.0
EBIT -6.4 -13.9 -29.3 -31.1
Net financial items
Earnings before tax
Tax expenses
0.0
-6.3
1.5
0.4
-13.5
3.5
-0.0
-29.4
4.6
2.7
-28.4
6.7
Net earnings -4.8 -10.1 -24.7 -21.7

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