AI Terminal

MODULE: AI_ANALYST
Interactive Q&A, Risk Assessment, Summarization
MODULE: DATA_EXTRACT
Excel Export, XBRL Parsing, Table Digitization
MODULE: PEER_COMP
Sector Benchmarking, Sentiment Analysis
SYSTEM ACCESS LOCKED
Authenticate / Register Log In

Photocure ASA

Investor Presentation Oct 29, 2025

3714_rns_2025-10-29_49f8ca2f-4203-41a0-8e11-5283fd58e356.pdf

Investor Presentation

Open in Viewer

Opens in native device viewer

Photocure ASA 3rd Quarter 2025 Results

October 29, 2025

Dan 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 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 2024. 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.

Strategic Priorities & Initiatives

Continue to grow Hexvix®/Cysview® sales and increase Company profitability

  • Provide and deliver on financial guidance, continue generating operating leverage
  • Accelerate ForTec Mobile BLC usage
  • Drive additional account reactivations in U.S. and image quality upgrades in Europe
  • Increase penetration in Priority Growth Markets in Europe
  • Leverage Olympus' launch of new HD BLC system in Nordics/EU

Establish BLC® as the definitive diagnostic standard in bladder cancer care and improve access

  • Position blue light cystoscopy (BLC) as the primary diagnostic tool to facilitate earlier use of new NMIBC therapeutics
  • Support reclassification of BLC equipment in the U.S.: Citizen's petition/Partnerships
  • Collaborate with BLC equipment manufacturers who plan to enter the U.S.
  • Build adoption for Richard Wolf's interim Flex BLC solution in Europe; launch new HD Flex BLC system globally once developed

Expand and diversify global product portfolio in uro-oncology

  • Asses new opportunities in NMIBC and adjacent uro-oncology indications, including biomarkers, AI, and emerging precision medicine technologies
  • Leverage Photocure's established global commercial infrastructure to expand into precision diagnostics within the broader urooncology segment

3

3rd Quarter 2025 Highlights:

Continued growth and execution on key initiatives

Product Revenue +12%

Product Revenue +6% NOK 134.1 million

Regional Performance YoY

⁻ North America product revenue up 12%, units up 14%, the Mobile Solution growth and pricing favorably impact the increase, flex decline and FX partly offsets growth.

Unit sales level in Q2 YoY; +3% YTD

⁻ European revenue up 11%, units up 4%. Favorably impacted by timing of shipments to wholesale markets

Increasing number of U.S. accounts: 373 (+23% YoY)

  • ⁻ 7 new account towers installed
  • ⁻ 7 upgrades from existing accounts
  • ⁻ ForTec mobile BLC strategy: 6 new towers (total 24) further supporting strong growth

Executing on plan in Europe

⁻ 49 Olympus BLC Visera Elite-III systems installed since launch (in Q1 2025)

EBITDA NOK 10.2 million

EBITDA NOK 27.8 million NOK 14.1 million ex-BD & ex milestone

Continue forecasting improved operating leverage for FY 2025 and investing in revenue growth opportunities

NOK 29.2 million ex-BD expense

Biz Dev expense NOK 3.9 million

Strong Balance Sheet

NOK 247.8 million in cash and equivalents, completed buy-back program of 500,000 shares; no term debt

Recent news and key milestone events

First national recommendation on blue-light cystoscopy from the Italian society of urology: recommended for 1st TURB, 2nd resection and recurrent NMIBC in populations at higher risk (September)

EU Roundtable on Bladder cancer: Report of recommendations

published in Sept 2025, including Photocure expert's contribution

Partner news:

In August, Asieris announced that Cevira (APL-1702), had advanced to the second round of technical review.

Photocure and ISC partner on development of AI for blue light cystoscopy (Oct 15, post-period)

AI-Powered Blue Light Cystoscopy

Intelligent Scopes Corporation (ISC)

is a US-based subsidiary of Claritas HealthTech; delivering cutting-edge AI-assisted diagnostic solutions for bladder cancer detection

Strategic Partnership Overview:

  • Photocure + ISC are developing AI software for real-time tumor detection using BLC
  • 200 BLC procedures/80,000+ images → strong performance in detecting high-risk/early-stage lesions
  • Joint development underway; ENAiBLE clinical study initiated in the U.S. and Europe
  • FDA and CE submissions planned following development phase

Strategic Rationale & Value Creation:

  • Strengthen Photocure's position as the reference for next-generation cystoscopy
  • Leverage AI + BLC synergy to improve detection accuracy, diagnosis and resection completeness
  • Expand Photocure's technology moat towards data-driven precision care
  • Exclusive global commercialization rights to Photocure post-clearance

North America and Europe markets

Strong Unit Sales Performance in Both Regions

Quarterly Hexvix/Cysview Unit Sales by Region (Last 3 Years)

Q3 2025 Trends in North America and Europe

North America

  • Strong Mobile performance more than offsetting the decline in sales to flex accounts
  • Q3 2025 revenues increased 12%, in-market unit sales increased 14%
  • ForTec mobile BLC rollout in U.S. continues to gain traction: +6 Towers, 121 Unique accounts have used the service since roll-out

  • Installed base of rigid BLC equipment continues to expand; 14 Saphira installs (7 new towers, 7 upgrades)
  • Active accounts in U.S. up 23% YoY in Q3
  • Access to BLC and reclassification of blue light cystoscopes in U.S. remains a high priority

Europe

  • Q3 revenues increased 11% year-over-year, in-market unit sales grew 4%
  • Increases in unit sales driven primarily by strong growth in DACH 4% and Nordics 11%
  • Priority growth markets performed well with double-digit growth in UK and Italy
  • Olympus upgrading to include blue light: 49 Visera Elite III systems installed across Europe since launch in Q1 with healthy pipeline of new towers to be added throughout remainder of 2025
  • YTD there have also been 53 upgrades of other equipment

Significant Growth in U.S. Accounts Actively Using Cysview

23% growth in Q3 YoY

*Active account is defined as an account with at least one order during the last 12 months accounts include rigid-only, multi- or dual-towers, flex-only, mobile tower, and evaluation

U.S. is a Highly Underpenetrated Market for BLC with Potential Exponential Upside

Bladder Cancer Market Access

U.S. incidence1: ~85K patients/year U.S. prevalence2: 730K+ patients

350K+ TURBTs/year in U.S3

1.2M+ surveillance cystoscopies/year in U.S3

* Active account is defined as an account with at least one order during the last 12 months accounts include rigid-only, multi- or dual-towers, flex-only, mobile tower, and evaluation 1.) ACS (American Cancer Society) 2025 Cancer Facts and Figures Annual Report. 2.) SEER Cancer Stat Facts: Bladder Cancer. https://seer.cancer.gov/statfacts/html/urinb.html 3) Proprietary internal CPT claims data

Growth initiatives

Growth initiatives

Accelerating BLC through Mobile Capability in the U.S.: ForTec

  • Nationwide sales collaboration doubling BLC's footprint with new ForTec customers
  • On Demand capability: Ondemand utilization of BLC via operating budgets
  • 24 Mobile towers deployed and building demand, 121 accounts and over 185 MDs have used service since launch in mid-2024
  • Teams leveraging both partners' customer infrastructure

Flexible BLC equipment to unlock the global surveillance market: Richard Wolf (RW)

  • Strategic agreement to jointly develop and commercialize a next generation 4K LED HD reusable flexible blue light cystoscope
  • IP and Regulatory responsibilities remain with RW
  • Estimated Total Addressable Global Market: 1.3B USD 1

Positioning BLC as the precision diagnostic in the rapidly evolving NMIBC treatment landscape

  • BLC to play an important role in supporting new "bladder sparing" therapies: patient selection, staging, marker lesion identification
  • 5 new FDA approved products and multiple drug companies conducting 20+ clinical trials: multiple MOAs & drug targets
  • Tumor resection, biopsies and pathology will still be required for definitive staging and grading

Value-generating Asieris Programs:

Hexvix: Commercial partnership in China

Phase III Trial Endpoint successfully met.

1st Data presented at SIU Congress in Oct 2023

Strong Results (p<0.0001)

First RCT Trial Conducted with High Def. BLC equipment

Past Progress Recent News & Expectations

Chinese Authorities' (NMPA) Review of NDA ongoing since Nov 2023 (Typically 18 Months!)

Market Authorization Granted Early in China (November 5, 2024)

Awaiting regulatory Approval of BL Equipment

Commercialization

Potential for Photocure

Photocure/Asieris Joint Steering Committee Development of Hexvix Brand in China/Taiwan Milestone, Royalty, and Manufacturing Revenue on Sales

Cevira: Out-licensed worldwide rights to Asieris for development/commercialization

1st Non-Invasive Candidate for Cervical HSIL;

Phase III Endpoint met. Results China & Europe

Phase III Trial Results presented at the EUROGIN 2024 HPV Congress in March 2024

Past Progress Recent News & Expectations

NDA accepted in China May 2024, review by NMPA ongoing

Regulatory review and commercialization in China

U.S. FDA discussions and EU pre-submission discussions took place in Q4 2024

Potential for Photocure

Regulatory Milestones; Royalties and Sales Milestones, for primary and secondary indications

Q3 Financials

Consolidated Income Statement Third Quarter 2025

Amounts
in
NOK
million
Q3 '25 Q3'24 Change YTD '25 YTD '24 Change
Hexvix/Cysview Revenue 134.1 120.1 12% 395.0 359.3 10%
Milestones and Other Revenue 0.9 0.1 0.9 24.4
Total Revenue 135.0 120.2 12% 395.9 383.7 3%
Gross Profit 123.1 112.4 10% 364.8 360.5 1%
Operating Expenses excl BD -109.0 -106.1 2% -324.6 -316.4 2%
Business Development
Expenses
-3.9 -1.2 -13.5 -3.3
EBITDA –
Reported
10.2 5.0 26.8 40.7
EBITDA –
Ex BD ex
Milestones
14.1 6.3 40.3 22.5
Depreciation & Amortization -7.3 -7.2 -22.0 -21.5
EBIT 2.8 -2.2 4.8 19.2
Net Financial Items -3.3 -2.8 -12.0 -12.0
Earnings before Tax -0.4 -4.9 -7.3 7.2
Tax Expenses 4.4 1.5 13.7 -6.2
Net earnings 4.0 -3.5 6.4 1.0

Revenue

Q3 Hexvix/Cysview product revenue increased 12% YoY driven by higher kit sales and average pricing in the US and Europe. The expected decline of kits used for flexible cystoscopy in US and FX movements negatively impacted the product revenue growth.

Operating Expenses

  • Total Operating expenses including Business Development expenses increased YoY NOK 5.6 million to NOK NOK 112.9 million. The increase was driven by business development expenses, and merit and inflation
  • Operating expenses within business development, NOK 3.9 million in Q3, relate mainly to life cycle management for Hexvix/Cysview and efforts that can diversify our business

EBITDA

Q3 EBITDA ex BD and ex Milestones was NOK 14.1 million, up from NOK 6.3 million in Q3 2024

Net Financial Items

Ipsen earn-out payment offset mainly by interest income and FX gain

Segment Performance Third Quarter 2025

North America Segment

million
Amounts
in
NOK
Q3 '25 Q3 '24 Change YTD '25 YTD '24 Change
Total revenues 54.8 49.0 12% 160.9 146.9 10%
Gross profit 52.0 47.3 10% 153.1 142.3 8%
of
%
revenue
95% 97% 95% 97%
Direct costs -42.1 -42.7 -2% 132.1 -129.2 2%
Contribution (1) 9.9 4.6 21.1 13.2
EBITDA -1.9 -6.9 -12.2 -17.1
of
%
revenue
-4% -14% -8% -12%
  • Q3 revenue growth was 12%, but was partially offset by the negative impact of FX
  • In-market unit sales increased 14%, average price increased 5%
  • Q3 direct costs decreased 2% YoY
  • Q3 Contribution NOK 9.9 million, more than doubling the contribution margin versus Q3 2024

Europe Segment

million
Amounts
in
NOK
Q3 '25 Q3 '24 Change YTD '25 YTD '24 Change
Total revenues 79.3 71.1 11% 233.9 212.4 10%
Gross profit 70.9 65.0 9% 211.4 194.4 9%
of
%
revenue
89% 91% 90% 92%
Direct costs -32.8 -30.0 9% -93.0 -87.1 7%
Contribution (1) 38.2 35.1 118.4 107.3
EBITDA 19.7 15.3 64.2 53.1
%
of
revenue
25% 21% 27% 25%
  • Q3 revenue increased 11% YoY, growth mainly driven by DACH and the Nordics
  • In-market unit sales increased 4% (4% in DACH and 11% in Nordics)
  • Q3 direct costs decreased 9% YoY driven by FTE adjustments
  • Q3 Contribution NOK 38.2 million, 48% of revenue

Cash Flow & Balance Sheet Third Quarter 2025

Amounts
in
NOK
million
Q3 '25 Q3 '24 YTD '25 YTD '24
Operations Cash Flow 29.2 34.5 26.4 61.3
Earnings before tax -0.4 -4.9 -7.3 7.2
Depreciation & amortization 7.3 7.2 22.0 21.5
Working capital 15.5 23.9 -6.3 5.3
Other 6.8 8.3 18.0 27.3
Investments Cash Flow -8.5 2.4 -7.2 3.1
Financing Cash Flow -12.1 -12.9 -65.3 -32.8
Net Change in Cash 8.7 24.1 -46.1 31.5
Amounts
in
NOK
million
30.09.25 31.12.24
Non-current assets 322.1 315.1
Inventory & receivables 126.8 130.1
Cash & short-term deposits 247.8 293.9
Equity 486.6 501.7
Long-term liabilities 122.0 139.7
Current liabilities 88.1 97.7
Total balance 696.7 739.1

Cash Flow

  • Q3 cash flow from operations was NOK 29.2 million, driven by EBITDA adjusted for non-cash expenses and working capital
  • Q3 cash flow from investments includes interest received and paid, and investments in tangible and intangible assets, including partnerships with ISC and Richard Wolf
  • Q3 cash flow from financing of NOK 8.5 million includes earnout payments to Ipsen of NOK 10.5 million
  • Net cash flow in Q3 was NOK 8.7 million, cash balance end of Q3 was NOK 247.8 million

Financial position

  • Non-current assets include intangibles and goodwill from Ipsen transaction totaling NOK 322.1 million
  • Long-term liabilities includes deferred Ipsen earnout totaling NOK 104.3 million
  • Equity on 30 September 2025 was NOK 486.6 million, 70% of total assets

Summary of Q3 2025 results

  • 12% global product rev. growth YoY; executing on key initiatives to increase sales growth.
  • EBITDA NOK 10.2M (NOK 14.1M Ex-BD ex Milestones); forecasting increased operating leverage while funding growth initiatives.
  • 20% Rigid kit sales growth in U.S., outweighing Flex headwinds; ForTec mobile tower momentum.
  • 23% active account growth in U.S. for rolling 12 months through Q3 2025 (unit sales 14% growth)
  • 11% rev. growth in EU (unit sales: 4% in DACH, 11% in Nordics, double digit growth in UK & Italy).
  • Strong momentum for BLC; KOL and new guidelines support; new data positioning BLC as the leading precision diagnostic in the rapidly evolving NMIBC treatment landscape.
  • Cash balance of NOK 247.8M at end of Q3 2025; buy-back of 500,000 shares completed; no term debt.
  • Advancing several business development initiatives in next-generation precision diagnostics, including a partnership with Intelligent Scope Corporation/Claritas to develop AI software for BLC.

Anticipated Milestones & Corporate Objectives

  • Financial guidance: 8-10% product revenue growth on a constant currency basis (compared to 7 to 11% previously) and YoY EBITDA improvement in 2025. The Company also expects continued operating leverage flowthrough in its commercial business and significant potential growth in milestones this year.
  • Continue increasing Hexvix/Cysview kit throughput and tower upgrades & installations; collaborate with ForTec on mobile tower national rollout in U.S.; focus on growth markets & Olympus equipment launch in Europe.
  • Advance partnership with Richard Wolf to develop and commercialize a next-generation, state-of-the-art, 4k/High Definition Flexible BLC system for the global markets as soon as possible.
  • Present/publish additional data from real world evidence patient registries and other studies supporting the use of BLC with Hexvix/Cysview; leverage Photocure's U.S. registry with NMIBC therapeutic companies.
  • Increase access to BLC by supporting additional equipment manufacturers to enter the U.S. market (Citizen's Petition, other expedited pathways to market entry).
  • Asieris progress: Hexvix early approval in China awaiting BLC equipment approval; NDA for Cevira in regulatory review.

Q&A

Talk to a Data Expert

Have a question? We'll get back to you promptly.