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Photocure ASA

Investor Presentation Feb 19, 2025

3714_rns_2025-02-19_3d5508eb-930b-4ab8-981c-368ef889a447.pdf

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Photocure ASA 4th Quarter and Full Year 2024 Results

February 19, 2025

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 2023. 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. Photocure – Presentation of Q4 2024 Results

Strategic Priorities & Initiatives

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

- Provide and deliver on financial guidance, continue generating operating leverage

  • 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

Develop BLC's role as a definitive diagnostic in bladder cancer care / Improve access

  • Position 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 product portfolio / Diversify global product offering in bladder cancer / uro-oncology

  • Continue to assess opportunities within NMIBC & other uro-oncology indications: Biomarkers, AI, new technologies
  • Leverage existing global commercial infrastructure in broader uro-oncology segment

4th Quarter 2024 Highlights: ⁻ N America revenue up 20%, units up 12% ⁻ European revenue up 9%, units up 11% ⁻ 3 new account towers installed ⁻ 3 upgrades from existing accounts

Continued growth and execution on key initiatives⁻ 44 image quality upgrades in Q4 2024 ⁻ Priority growth markets up 9% in 2024

Unit sales level in Q2 YoY; +3% YTD

Product Revenue +13% ⁻ Phase down of flex BLC utilization ⁻ Single manufacturer in the U.S.

Strong Regional Performance YoY

-

Expanding U.S. Saphira footprint

-

Executing on plan in Europe

-

Ongoing challenges:

-

EBITDA NOK 8.5 million

Product Revenue +6% EBITDA NOK 27.8 million Q4 unit sales +11% NOK 13.6 million ex-BD expense

Continuing to generate operating

NOK 29.2 million ex-BD expense

leverage and investing in revenue growth opportunities

Biz Dev expense NOK 5.1 million

Strong Balance Sheet

Photocure – Presentation of Q4 2024 Results from NOK 260 million at year-end 2023; No term debt

Recent news and key milestone events

Richard Wolf Flex Agreement: Flexible BLC interim solution availability announced February 2024 (Post period)

NOK 294 million in cash and equivalents, up Olympus equipment upgrade features blue light, broadening access to Blue Light Cystoscopy for NMIBC patients in Europe ForTec Mobile BLC Strategy: Asieris Progress: Early approval of

National rollout in U.S. showing good momentum with 44 accounts using the service in 2024

Hexvix in China. Cevira data presented at IPVC Conference (both in November)

Segment Trends

North America and Europe markets

Strong Unit Sales Performance in Both Regions in Q4

Quarterly Hexvix/Cysview Unit Sales by Region (Last 2 Years)

0 2 000 4 000 6 000 8 000 10 000 12 000 14 000 16 000 2023 2024 0 500 1 000 1 500 2 000 2 500 3 000 3 500 4 000 4 500 Q1 Q2 Q3 Q4 2023 2024 Photocure – Presentation of Q4 2024 results

North America Europe

6

Q4 2024 Trends in North America

  • Q4 2024 revenues increased 20%, in-market unit sales rose 12%. Higher average price benefited revenues. Cysview unit sales in the rigid segment grew 12% during 2024. ForTec mobile BLC rollout in U.S. continues to gain traction:
  • Installed base of rigid BLC equipment continues to expand; 6 Saphira installs (3 new towers, 3 upgrades).
  • Active accounts in U.S. up 11.3% YoY in Q4 on a rolling 12-month basis
  • 44 accounts have used the service as of year-end 2024.
  • Access to BLC and reclassification in U.S. remains a focus Public comment period for Karl Storz Citizen's Petition closed by FDA on December 10th, Awaiting FDA to publish a proposed order in The Federal Register 7 Photocure – Presentation of Q4 2024 Results

Photocure sponsor of the BCAN Patient Fall Summit on November 1, 2024 in Philadelphia

Saphira now 49% of rigid BLC installed base in U.S.

6 tower installations in Q4 2024 (3 new accounts, 3 upgrades); 55 Saphira systems placed YTD

Cumulative Installed Rigid Tower Base in U.S.

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

Solid Growth in U.S. Accounts Actively Using Cysview

11.3% growth in Q4 YoY (12 months rolling average)

350

• Active account is defined as an account with at least one order during the last 12 months

• Accounts include rigid-only, multior dual-towers, flex-only, mobile tower, and evaluation

Q4 2024 Trends in Europe

  • Q4 revenues increased 9% year-over-year, in-market unit sales grew 11%. Increases driven primarily by strong growth in Germany. Higher Q4 unit sales outperformed revenue due to wholesaler stock and ordering patterns.
  • Executing on plan to grow Priority Growth Markets. Unit sales in Priority Growth Markets increased 9% in 2024 vs. 2.7% in 2023.
  • Olympus upgrading to include blue light: Regulatory approval granted in December for the enablement of Olympus's Visera Elite III system with 4K blue light capability
  • Continuing support to KOLs and medical education: EAU UROwebinar on "Nightmare cases in Bladder Cancer" on Nov 5th drew record number of participants & questions
  • Key initiatives to accelerate unit sales growth:
    • 1,400 TURBT-performing centers, approximately 50% have BL equipment
    • Over 200 image quality upgrades since 2023 to date in target accounts; 79 in 2024
    • Expected account upgrade momentum in 2025 given Olympus new BL offering

Hexvix/Cysview Annual Sales Revenue

Global Sales Revenue by Segment (NOK '000)

Growth initiatives

Growth initiatives

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

  • Nationwide sales collaboration doubling BLC's footprint with new
  • On Demand capability: Ondemand utilization of BLC via operating budgets
  • 18 Towers deployed and building demand, 44 accounts used service in 2024 Photocure – Presentation of Q4 2024 Results
    • Teams leveraging both partners' customer infrastructure

Flexible BLC equipment to unlock the global surveillance market: Richard Wolf ForTec customers

  • 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
  • Interim solution bringing flexible BLC to international centers while developing optimized solution
    • Estimated Total Addressable Market: 1.3B USD

Leverage opportunities stemming from the rapidly evolving NMIBC treatment landscape

  • 3 new FDA approved products / 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
  • © Photocure Confidential 13 • BLC to play an important role in supporting new "bladder sparing" therapies: patient selection, staging, marker lesion identification

Value-generating Asieris Programs:

Strong Results

(p<0.0001)

Conducted with High Def. BLC equipment

First RCT Trial

Hexvix: Commercial partnership in China

Potential for Photocure

Market Authorization Granted Early in China (November 5, 2024) Regulatory Approval of BL Equipment Commercialization Photocure/Asieris Joint Steering Committee Development of Hexvix Brand in China/Taiwan Milestone, Royalty, and Manufacturing Revenue on Sales

Photocure – Presentation of Q4 2024 Results 14 Cevira: Out-licensed worldwide rights to Asieris for development/commercialization

Nov 2023

Chinese Authorities' (NMPA) Review of NDA ongoing since

(Typically 18 Months!)

Past Progress

Past Progress

1st Non-Invasive Candidate for Cervical HSIL;

Phase III Trial Endpoint

successfully met.

1st Data presented at SIU Congress in Oct

2023

Phase III Endpoint met. Results China & Europe Recent News & Expectations

Recent News & Expectations

Potential for Photocure

EU Pre-MAA submission and US FDA discussions anticipated in Q4,

ongoing Commercialization in China / Potential MAs in other regions

Regulatory Milestones; Royalties and Sales Milestones

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

NDA accepted in China May 2024, review by NMPA

Q4 Financials Photocure – Presentation of Q4 2024 Results

Consolidated Income Statement Fourth Quarter 2024

flexible BLC setting in U.S.
Operating Expenses
adjustment, merit, inflation and FX
can diversify our business
Net Financial Items

Revenue

  • Q4 Hexvix/Cysview product revenue increased 13% YoY, driven by unit sales increase of 12% in North America and 11% in Europe
    • Consolidated volume impacted by phase down of Cysview usage in the flexible BLC setting in U.S.
  • Other revenue YTD includes Asieris milestone payments in both years

Operating Expenses

  • Q4 total operating expenses excluding BD increased 13% YoY including investments in medical activities, indirect inventory cost adjustment, merit, inflation and FX
  • Operating expenses within business development projects relate mainly to life cycle management for Hexvix/Cysview and efforts that can diversify our business

EBITDA

Q4 EBITDA including BD expenses was NOK 8.5 million

Net Financial Items

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

Segment Performance Fourth Quarter 2024

North America Segment

Amounts in NOK million
Total revenues
Q4 '24 North America Segment Europe Segment
Q4 '23 Change FY '24 FY '23 Change Amounts in NOK million Q4 '24 Q4 '23 Change FY '24 FY '23 Change
55.5 46.7 20% 202.3 178.6 13%
Gross profit 54.1 45.0 20% 196.4 172.8 14%
%
of
revenue
98% 97% 97% 97% %
of
revenue
93% 93% 92% 93%
Direct costs -46.3 -41.1 13% -175.5 -163.6 7%
Contribution (1) 7.8 4.0 21.0 9.1 Contribution (1) 31.7 25.2 139.0 121.5
EBITDA -4.0 -5.3 -21.1 -29.5 EBITDA 11.0 8.8 64.1 52.4
%
of
revenue
-7% -11% -10% -16% %
of
revenue
15% 13% 22% 20%
Q4 revenue growth of 20% was driven by unit sales growth in
the rigid BLC setting
and higher average price, partially offset by
the phase down of Cysview usage in the flexible BLC setting
In-market unit sales increased 12%, average price increased 5%
Q4 direct costs increased 13% YoY including investments in
medical activities, merit, inflation and FX
Q4 Contribution improved YoY by NOK 3.8 million and FY
Q4 revenue increased 9% YoY
In-market unit sales increased 11%, wholesaler stock and order
patterns temporarily impacted revenue growth
Q4 direct costs decreased 2% YoY
Q4 Contribution improved YoY by NOK 6.5 million and FY
by NOK 17.5 million, driven by revenue growth and cost
containment
NOK 11.9 million YoY by
  • Q4 revenue growth of 20% was driven by unit sales growth in the phase down of Cysview usage in the flexible BLC setting
    • In-market unit sales increased 12%, average price increased 5%
  • Q4 direct costs increased 13% YoY including investments in medical activities, merit, inflation and FX
  • NOK 11.9 million YoY

Europe Segment

Amounts in NOK million Q4 '24 Q4 '23 Change FY '24 FY '23 Change
Total revenues 73.1 66.8 9% 285.6 263.5 8%
Gross profit 67.9 62.3 9% 262.3 244.3 7%
of
%
revenue
93% 93% 92% 93%
Direct costs -36.3 -37.1 -2% -123.4 -122.8 0%
Contribution (1) 31.7 25.2 139.0 121.5
EBITDA 11.0 8.8 64.1 52.4
of
%
revenue
15% 13% 22% 20%
  • Q4 revenue increased 9% YoY
    • In-market unit sales increased 11%, wholesaler stock and order patterns temporarily impacted revenue growth
  • Q4 direct costs decreased 2% YoY
  • Q4 Contribution improved YoY by NOK 6.5 million and FY by NOK 17.5 million, driven by revenue growth and cost containment

Cash Flow & Balance Sheet Fourth Quarter 2024

Amounts in NOK million Q4 '24 Q4 '23 FY '24 FY '23 Cash Flow
Operations Cash Flow 15.4 19.6 76.8 48.3
Earnings before tax 1.2 16.6 8.4 9.7
Depreciation & amortization 7.3 7.4 28.8 27.7
Working capital -2.3 -11.9 3.0 -21.9
Other 9.3 7.6 36.6 32.8
Investments Cash Flow -1.6 1.2 1.4 -0.6
Financing Cash Flow -11.0 -16.4 -43.8 -56.3
Net Change in Cash 2.8 4.4 34.4 -8.6
Depreciation & amortization
7.3
7.4
28.8
27.7
Working capital -11.9 3.0 -21.9
Other 9.3 7.6 36.6 32.8
Investments Cash Flow -1.6 1.2 1.4 -0.6
Financing Cash Flow -11.0 -16.4 -43.8 -56.3
Net Change in Cash 2.8 4.4 34.4 -8.6
Amounts in NOK million 31.12.24 31.12.23
Non-current assets 313.6 339.5
Inventory & receivables 125.9 112.9
Cash & short-term deposits 293.9 259.5
Equity 500.2 482.8
Long-term liabilities 139.7 151.6
Current liabilities 93.5 77.5
Total balance 733.4 712.0
Photocure –
Presentation of Q4 2024 Results

Cash Flow

  • Q4 cash flow from operations was NOK 15.4 million, driven by EBITDA adjusted for non-cash expenses and working capital
  • Q4 cash flow from investments includes interest received and paid, and investments in tangible and intangible assets 293.9 million
  • Q4 cash flow from financing of NOK -11.0 million includes earnout payments to Ipsen of NOK 9.6 million
    • Term loan was fully repaid in Q2 2023
  • Net cash flow in Q4 was NOK 2.8 million, cash balance end of Q4 was NOK

Financial position

  • Non-current assets include intangibles and goodwill from Ipsen transaction totaling NOK 239.9 million
  • Long-term liabilities includes deferred Ipsen earnout totaling NOK 117.1 million
  • Equity at December 31, 2024 was NOK 500.2 million, 68% of total assets

Summary

Summary of Q4 2024 results

  • 13% product rev. growth, unit sales up 11% YoY; executing on key initiatives to increase sales growth
  • EBITDA of NOK 8.5M (NOK 13.6 Ex-BD); Delivered operating leverage, while funding new growth initiatives
  • Growth of rigid (TURBT) kit sales in U.S. outweighed Flex headwinds, ForTec mobile tower momentum building Photocure – Presentation of Q4 2024 Results 20
  • Over 11% active account growth in U.S. for rolling 12 months through Q4 2024
  • Installed base of 192 Saphira towers since launch, now representing 49% of rigid towers in U.S.
  • Priority Growth Markets in Europe responding well to turn-around efforts, 9% growth in 2024 vs. 2.7% in 2023
  • Strong momentum for NMIBC & BLC; KOL support/equipment upgrades/new NMIBC therapies coming to market
  • Cash balance of NOK 294M at year-end 2024, up from NOK 260M in prior year period; no term debt

Anticipated Milestones & Corporate Objectives

  • Financial guidance: 7-11% product revenue growth and YoY EBITDA improvement in 2025. The Company also expects continued operating leverage flow-through in its commercial business and significant 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 BLC® with Hexvix/Cysview; leverage Photocure's U.S. registry with NMIBC therapeutic companies Asieris progress: Hexvix early approval in China; NDA for Cevira undergoing regulatory review.
  • Advance partnership with Richard Wolf to develop and commercialize a next-generation Flexible BLC system for the global markets as soon as possible. Drive early adoption of Richard Wolf interim "Flex" solution in Europe Photocure – Presentation of Q4 2024 Results 21
  • Present/publish additional data from real world evidence patient registries and other studies supporting the use of
  • Proactively support the Citizen's Petition for the U.S. FDA to reclassify BLC equipment from Class 3 to Class 2, potentially creating an expedited pathway for additional blue light equipment manufacturers to enter the U.S. market

Leading change in bladder cancer

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