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Photocure ASA

Investor Presentation May 10, 2023

3714_rns_2023-05-10_2054a8e4-f9e0-46f9-83be-7c255d2bbdbd.pdf

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Photocure ASA 1st Quarter 2023 Results

May 10, 2023

Dan Schneider, President and CEO

Erik Dahl, CFO

David Moskowitz, VP Investor Relations

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 ASA (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 acknowledges 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.

The Presentation will be used during an oral presentation and is therefore not a complete summary of the presentation held. Further, it is not the intention to provide, and the Recipient may not rely on the Presentation as providing, a complete or comprehensive analysis of the Company's financial or trading position or prospects. Several factors could adversely affect the business, legal or financial position of the Company or the value of its securities. For a further description of other relevant risk factors, we refer to the Company's annual report for 2022. Should one or more of these or other risks and uncertainties materialize, actual results may vary significantly from those described in this Presentation.

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. Forward-looking statements concern future circumstances and results and other statements that are not historical facts. 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.

1st Quarter 2023 Highlights:

Return to growth in both regions, continuing to execute on key initiatives

+30% Revenue growth 8% Hexvix®/Cysview® unit growth

Hexvix/Cysview sales up 12% sequentially from Q4 2022

Installed base of blue light continues to expand and improve: 18 new Saphira™ towers installed in Q1 + 12 upgrades from existing accounts; standard definition towers relocated within 4 accounts to create new blue light user facilities

Navigating ongoing market challenges: staffing shortages, hospital budget constraints improving but still present

EBITDA NOK -1.2 million Improvement of NOK 12.7 million YoY

Commercial investment to support Hexvix/Cysview growth and launch of upgraded blue light system

Business Development spend back to base-line levels

NOK 246 million in cash and equivalents; expect to retire remainder of term debt in Q2 2023

Key news and events

Citizen's Petition (CP)* to reclassify BLC equipment: multiple public comments submitted to FDA support increasing the number of BLC equipment manufacturers in the U.S.; Karl Storz "Flex" discontinuation highlights the public health need

High visibility of Blue Light Cystoscopy at EAU, ASCO-GU, and AUA: Four abstracts presented, several well-attended scientific sessions included discussions on BLC.

Peer-reviewed publication backing health economics of BLC in Q1 2023

Segment Trends

North America and Europe markets

Global Healthcare Delivery: Pockets of Volatility Remain

Staffing Shortages/Strikes

  • Continued impact to procedure volumes in both U.S. & Europe (strikes UK, France & Germany)

Hosp. Budget Pressures

  • Elevated staffing costs & general inflation resulting in prioritization of activities

Constraints easing but still present in both sales territories

Q1 Return to Growth in Both Commercial Territories

Monthly Hexvix/Cysview Unit Sales by Region Last 3 Years

North America Europe

Q1 2023 Trends in North America

  • Q1 revenues & in-market unit sales increased 38% & 16%, respectively; Unit sales also up 9% sequentially Q1'23/Q4'22; Recovery in procedure volumes, pull through of new tower installations, and staffing shortage pressure beginning to ease drove the unit sales increase
  • Continued expansion of blue light tower installed base: 18 new Saphira™ installations, 12 upgrades; 4 new user facilities created with relocation of legacy standard definition equipment
  • Demand for new blue light equipment remains strong: New Tower pipeline remains robust, Karl Storz recently increased number of evaluation towers to support demand
  • Contracting & improved reimbursement: Remain a key focus for adoption of BLC
  • Strong advocacy for Citizen's Petition to reclassify blue light equipment; if approved, would enable an expedited pathway to expand the number of capital equipment manufacturers in the U.S.
  • Public comments by Photocure, KOLs, BCAN (U.S. Patient Advocacy), Equipment Manufacturers, Health systems, and others
  • Flex tower discontinuation highlights the need for BLC reclassification
  • Potential for Karl Storz to receive FDA feedback on Citizen's Petition with 210-day response period (May 25)

Karl Storz SAPHIRA™ Blue Light System

April 2023: Satellite Symposium + AUA congress booth

Saphiranow 25% of rigid BLC installed base in U.S.

80 Saphira™ Towers installed since Q4 2022 launch; 40 New & 40 Upgrades

Q1 2023: 18 new placements, 12 upgrades, 4 std. definition tower relocations

Cumulative Installed Base in U.S.

*2012 – 17 of the 23 installations were converted clinical sites upon Cysview approval

Q3 2022: 10 installations (6 Rigid & 4 Flex) Q4 2022: 31 installations (24 Rigid & 7 Flex) Q1 2023: 18 Installations (Rigid only)

New Account Installations Q2 2022: 5 Installations (5 Flex)

Q1 2023 Trends in Europe

  • Q1 revenues & in-market unit sales increased 26% & 6%, respectively: Continuing to increase penetration despite ongoing challenges of staffing shortages, strikes, hospital budget constraints
  • 2023 is first year where access is fully open since re-acquiring the territory in Oct. 2020 (focused on the 80% of existing accounts that are underpenetrated)
  • Blue light gaining traction in urology community Increasing KOL support broadly, high visibility at EAU, Additional data strengthens EAU guidelines
  • Karl Storz Saphira™ system rollout gaining traction; image quality upgrades a key initiative in 2023
  • Photocure 2023 Bladder Cancer Bus Tour: high demand from German hospitals interested in BLC

September 2022: Bladder Cancer Bus with BLC at DGU to recruit hospitals for 2023 tour

Growth acceleration in Europe expected

10

Q1 2023
Established Business
Nordic (excl. DK)/DACH
26% to 58% range of
penetration

Continuous Investment in Commercial
Excellence

Good Penetration, Guidelines & Procedure Funding

Germ/Austria (70% of EU unit sales) consistently
increasing market share YoY

Addressing DK situation pulling down Nordics

Steady Growth in
DACH continues

Nordic Stable
(except DK)
Priority Growth
Markets
France, UK, Italy, Be/Ne
2% to 14% penetration

Active Pipeline for Image Quality Upgrades
(Reactivation) & New Installations

Mostly good installed base of equipment but dated,
underpenetrated, clinical practice & awareness differs

Stabilized sales during the pandemic after years of
decline before re-acquisition

France & Be/Ne
first markets to
move from
stabilization to
growth
Untapped EU Markets
Spain, Poland, Baltics,
Czech Rep, Hungary, Ireland,
Greece, Portugal:
~0% penetration

Evaluating key launch factors in each territory:
-
Availability of capital equipment
-
Local treatment guidelines
-
KOL engagement
-
Coverage/reimbursement
-
Decision on direct/distribution strategy

Spanish market
top priority

Investments in medical & data generation activities driving awareness/growth opportunities for BLC

Additional activities:

  • Supported conversations for potential company collaborations (Pharma: 2nd line therapeutics & Dx: biomarker tests )
  • Paved the way to potential new relationships with KOLs of interest
  • Provided a springboard for debate that has kept BLC in conversation

Q1 Financials

Consolidated Income Statement First Quarter 2023

million
Amounts
in
NOK
Q1 '23 Q1 '22 Change FY '22
Hexvix/Cysview Revenue 105.9 81.4 30% 373.0
Other Revenue 0.3 0.3 20.1
Total Revenue 106.2 81.6 30% 393.1
Gross Profit 99.8 75.6 32% 370.4
Operating Expenses excl BD -100.5 -86.9 16% -375.3
Business Development Expenses -0.4 -2.6 -19.8
EBITDA –
excluding BD
-0.8 -11.3 -4.8
EBITDA –
including BD
-1.2 -13.9 -24.6
Depreciation & Amortization -6.5 -6.0 -24.4
EBIT -7.7 -19.9 -49.0
Net Financial Items -2.4 -7.4 -22.1
Earnings before Tax -10.1 -27.3 -71.1
Tax Expenses -1.6 5.3 -0.7
Net earnings -11.7 -22.0 -71.9

Revenue

  • Q1 Hexvix/Cysview revenue 30% above last year, driven by volume, price and FX
  • Consolidated volume increased YoY 8% and sequentially from Q4 2022 9%

Operating Expenses

  • Q1 operating expenses excluding business development costs increased 16% YoY, mainly due to FX and inflation. Sequentially, from Q4 2022 the operating expenses excluding business development costs decreased 6%
  • Operating expenses within business development are related to the objective to increase the Company's product offering

EBITDA

Q1 EBITDA including business development expenses improved NOK 12.7 million YoY, driven by revenue. Positive impact from FX NOK 1 million

Net financial items

Q1 for both years driven by the Ipsen earnout; partly offset by FX gains and interest income in 2023

Segment Performance First Quarter 2023

North America Segment

million
Amounts
in
NOK
Q1 '23 Q1 '22 Change FY '22
Total revenues 42.1 30.5 38% 150.8
Gross profit 40.7 29.3 39% 145.9
of
%
revenue
97% 96% 97%
Direct costs -43.5 -38.0 15% -162.9
Contribution (1) -2.8 -8.6 -16.9
EBITDA, excl BD -11.6 -17.5 -49.4
of
%
revenue
-28% -57% -33%
  • Q1 revenue growth 38% driven by volume, price increases and FX.
  • In-market unit sales increased 16%, USD appreciated 15%, price increase 3% in US
  • Q1 direct costs development as planned in local currencies
  • Contribution improved NOK 5.8 million YoY driven by revenue

Europe Segment

Amounts
in
NOK
million
Q1 '23 Q1 '22 Change FY '22
Total revenues 63.6 50.4 26% 221.8
Gross profit 58.6 45.7 28% 205.0
%
of
revenue
92% 91% 92%
Direct costs -29.0 -21.5 35% -102.9
Contribution (1) 29.6 24.2 102.1
EBITDA, excl BD 13.7 8.2 42.4
%
of
revenue
22% 16% 19%
  • Q1 revenue increased 26% YoY. EUR appreciated 10%
  • In-market unit sales increased 6% YoY; 9% sequential growth from Q4 2022
  • Expenses were driven by activity (phasing) and FX impact
  • Contribution improved NOK 5.4 million YoY, driven by revenue

Cash Flow & Balance Sheet First Quarter 2023

million
Amounts
in
NOK
Q1 '23 Q1 '22 FY '22
Operations Cash Flow -9.1 -22.1 -2.0
Earnings before tax -10.1 -27.3 -71.1
Depreciation & amortization 6.5 6.0 24.4
Working capital -10.7 -8.5 -0.2
Other 5.2 7.7 44.9
Investments Cash Flow 0.6 0.5 -1.5
Financing Cash Flow -13.5 -15.8 -51.3
Net Change in Cash -22.0 -37.4 -54.8
Amounts
in
NOK
million
31.01.23 31.03.22 31.12.22
Non-current assets 357.0 375.9 360.8
Inventory & receivables 102.9 76.7 90.2
Cash & short-term deposits 246.0 285.5 268.1
Equity 455.3 481.0 462.7
Long-term liabilities 165.6 176.8 167.1
Current liabilities 85.0 80.3 89.2
Total balance 706.0 738.1 719.0

Cash Flow

  • Net cash flow from operations in Q1 NOK -9.1 million, impacted by EBITDA including Business Development expenses of NOK -1.2 million and working capital of NOK -10.7 million
  • Net cash flow from financing NOK -13.5 million includes loan repayment of NOK 6.3 million and earnout payments of NOK 8.0 million
  • Remaining term loan NOK 6.3 million, will be fully repaid in Q2 2023
  • Net cash flow in Q1 NOK -22.0 million, cash balance end of Q1 NOK 246.0 million

Financial position

  • Non-current assets includes intangibles and goodwill from Ipsen transaction totaling NOK 269.0 million
  • Long-term liabilities includes deferred Ipsen earnout totaling NOK 133.1 million
  • Equity NOK 455.3 million, 64% of total assets

Summary

Summary of results

  • 30% rev. growth/8% unit growth in Q1; 12% sequential rev. growth highlights rebound from Q4 anomaly
  • 30 Saphira™ towers installed in U.S. in Q1 (18 new, 12 upgrades)
  • Saphira™ high-definition equipment now 25% of rigid tower base in U.S.; Pipeline remains strong
  • Continuing to drive key initiatives in both commercial regions and with licensing partners
  • Healthcare delivery/hospital budgets still under some constraints globally but improving
  • BLC awareness rising with clinical data, KOL support, and equipment/image quality upgrades
  • Potential re-classification of BLC equipment could "unlock" the market for Cysview in the U.S.

2023 Anticipated Milestones & Corporate Objectives

  • Deliver 65-75 Saphira™ installs, product revenue growth above 20%, and generate positive EBITDA in 2023
  • Continue to grow the base of rigid blue light towers in North America, upgrade BLC® image quality throughout Europe, and pursue strategy to establish a durable solution for flexible BLC equipment globally
  • Proactively support the Citizen's Petition for the U.S. FDA to reclassify BLC equipment from Class 3 to Class 2, creating an expedited pathway for additional BLC manufacturers to enter the U.S. market
  • Continue to geographically expand commercial business by penetrating untapped European and Canadian markets, and through additional Hexvix® licensing agreements ROW
  • Present/publish additional data from patient registries and other studies on the use of BLC® with Hexvix/Cysview
  • Evaluate strategic product or business opportunities that leverage organizational strengths

Leading change in bladder cancer

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