Photocure ASA 2nd Quarter 2024 Results
August 7, 2024
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 Q2 2024 Results
Strategic Priorities & Initiatives




Continue to grow Hexvix®/Cysview® sales and increase Company profitability
- Deliver on our guidance for revenue, EBITDA and new tower placements
- Collaborate with ForTec on Mobile BLC rollout
- 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 new BLC manufacturers entering the U.S. post-reclassification
- Reintroduce Flex BLC with state-of-the-art system via partnership with Richard Wolf
Expand product portfolio / Diversify global product offering in bladder cancer / uro-oncology
- Continue to assess opportunities within NMIBC & other bladder cancer indications: Biomarkers, AI, new technologies
- Leverage existing global commercial infrastructure in broader uro-oncology segment
2nd Quarter 2024 Highlights: ⁻ 5 new account towers installed ⁻ 3 upgrades from existing accounts ⁻ 12 mobile Saphira towers ⁻ 2 of 3 Priority Growth Markets consistently ⁻ Nordics stable since Q3'23, hospital
Continued growth and execution on key initiatives⁻ Phase down of flex BLC utilization
Unit sales level in Q2 YoY; +3% YTD

Product Revenue +6% Unit sales level in Q2 YoY; +3% YTD
Expanding U.S. Saphira footprint
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Executing on plan in Europe
- growing double-digit ⁻ Single manufacturer in the U.S. ⁻ Delay of Olympus' upgraded BL to H2
- strikes in Sweden impacted Q2'24
Ongoing challenges:
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Product Revenue +6% EBITDA NOK 27.8 million
NOK 29.2 million ex-BD expense
OPEX mostly level excl. FOREX & BD last 10 quarters; Continued investment behind Hexvix/Cysview
NOK 29.2 million ex-BD expense
Biz Dev expense NOK 1.3 million
Strong Balance Sheet
up from NOK 260 million at year-end 2023. No term debt
EBITDA NOK 27.8 million Recent news and key milestone events
Photocure – Presentation of Q2 2024 Results *Link to FDA CP Public Comments for BLC Re-classification NOK 267 million in cash and equivalents, Richard Wolf Flex Agreement (postperiod): Partnership to develop & commercialize state-of-the-art HD flexible BLC system globally ForTec Mobile BLC Strategy: National
rollout in U.S. underway
VA Bravo II data at AUA: results show BLC use associated with positive impact on recurrence, progression, and overall survival
Asieris' Cevira®: after positive Phase III data presented in Q1, NDA acceptance in China announced May 12, 2024
Reclassification of BLC equipment: Olympus and Richard Wolf post supportive comments to Citizen's Petition* in April/May
Segment Trends
North America and Europe markets

Flex Phase-Down in U.S. & Timing of Customer Orders in Europe Mainly Affected Q2 Unit Sales
Q1 & Q2 Monthly Hexvix/Cysview Unit Sales by Region (Last 3 Years)

North America


6
First Half 2024 Unit Sales in Europe

H1 Hexvix unit volume last 3 years

- First half 2024 unit sales in Europe increased 4% vs. prior year
- Long-term trend has resumed in early Q3
Q2 2024 Trends in North America
- Q2 revenues increased 9%, in-market unit sales rose 1%. Higher average price benefited revenues, Cysview growth in rigid segment outpaces flexible BLC phase down again (11% rigid sales growth H1'24)
- Installed base of rigid BLC equipment continues to increase; 20 Saphira installs (5 new towers, 3 upgrades and 12 mobile). Karl Storz rolling out new promotional program for all customers in H2 2024 ForTec mobile tower national rollout is underway in U.S.
- 4 accounts reactivated in Q2; 22 reactivations since mid-2023
- Activities continue around potential U.S. BLC reclassification
- Public comments so far by KOLs, BCAN (U.S. Patient Advocacy), health systems, Pacific Edge (biomarkers), Richard Wolf, Stryker and Olympus
- BLC special controls posted by Karl Storz on Citizen's Petition website, Letter submitted to FDA's Oncology Center of Excellence, 3 new patient testimonials recently posted

New Cysview.com website 2024

Saphira now 46% of rigid BLC installed base in U.S.

20 blue light tower installations in Q2 2024: 5 new accounts, 3 upgrades, 12 mobile units

38 51 29 2024 25 36 51 65 83 104 150 197 230 263 301 352 381 0 50 100 150 200 250 300 350 400 450 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Q2 2024 Photocure – Presentation of Q2 2024 Results
Cumulative Installed Rigid Tower Base in U.S.
*2012 –17 of the 23 installations were converted clinical sites upon Cysview approval
Q2 2024 Trends in Europe
- Q2 revenues increased 3% year-over-year, in-market unit sales -1%. Revenue increase was mainly due to wholesaler order timing. Unit sales in Q3 primarily impacted by customer order fluctuations in DACH and healthcare strike in Sweden. Resumption of longterm unit volume trend in early Q3; H1 2024 Unit sales growth +4% in Europe
- Executing on plan to increase penetration in Priority Growth Markets. UK and Italy both demonstrated double-digit growth in Q2, trend sustained since Q4 2023. Significant image quality upgrades in France & current pipeline expected to yield increased momentum later this year.
- Strong BLC presence at 2024 EAU Congress. Two abstract presentations (Hexvix in China displayed at all capital equipment suppliers' booths.
Key initiatives to accelerate unit sales growth:
- 1,400 TURBT-performing centers, approximately 50% have BL equipment
- Actively targeting 590 key hospitals/clinics; approximately 2/3 still underpenetrated
- 23 image quality upgrades in Q2; 176 since 2023 to date in our target accounts
- Added 29 new accounts in 2023 and 2024 YTD


Photocure Booth at EAU, Paris, April 2024
Growth Initiatives

Accelerating BLC through Mobile Capability
Focus on Utilization / National U.S. Rollout in Q3 2024



- Focused on bringing Blue Light Cystoscopy (BLC) to accounts that currently do not have equipment
- Partnership will more than double the number of fieldbased account managers
- Photocure, ForTec and KARL STORZ will collaborate to ensure seamless BLC experience
ForTec can reach 93%+ of U.S. Capability
- On-demand utilization of BLC via operating budgets
- Operating Rooms within 3 hours

White Glove service: equipment prep & set up, technical support, disposables & accessories, zero down-time model

On Demand Customer
ForTec accounts and National GPO access provides leverage to increase use of BLC with





Photocure – Richard Wolf agreement: Next generation Flexible BLC equipment to unlock the surveillance market globally

1.0M – 1.5M USD, Specific financial Terms of the Agreement
- Strategic agreement to develop and commercialize 4K LED HD reusable flexible blue light cystoscope; executed and announced 15 July 2024 Photocure – Presentation of Q2 2024 Results
- Future equipment based on Richard Wolf's System blue technology
- Photocure and Richard Wolf are coinvesting in the development of the new flexible BLC system
- terms undisclosed
- 24-30 months estimated development period
Photocure investment between
- Intellectual property owned by Richard Wolf
- Richard Wolf will develop, manufacture, obtain regulatory clearances, and be market authorization holder globally
- Photocure will provide guidance to Richard Wolf based on extensive knowledge of surveillance procedures and urology customers' needs
- Photocure and Richard Wolf will copromote globally
- Governance through Joint Development and Joint Commercialization Committees

1.65M Surveillance Procedures in U.S. & EU5 Countries
Estimated Total Addressable Market (TAM) 1.3B USD
Significant Pharmaceutical Industry Investment
Expected to drive higher demand for precision diagnostics, procedures & therapeutics

Rapidly Evolving NMIBC Treatment Landscape

Earlier detection of CIS lesions/BCG-refractory/recurrent disease key to new therapeutic utilization
New therapeutics to treat NMIBC were the major topic at AUA 2024
• 3 new FDA approved products, multiple drug companies conducting 20+ clinical trials, multiple MOAs/drug targets being pursued
Tumor resection, biopsies and pathology will continue to be required for definitive staging and grading Photocure – Presentation of Q2 2024 Results
• Missing early recurrence of high-risk tumors (HG T1, CIS) may delay use of newer second-line therapies and increase the risk of poor outcomes1
BLC is positioned to play an important role in supporting new "bladder sparing" therapies
- Guideline recommended to detect, confirm & monitor high-risk NMIBC tumors2
- 4 Kamat J Everyday Urology Oncology Insights 2018 • Significant body of clinical evidence including RCTs and large realworld evidence NMIBC registries demonstrating improved detection of BCG-unresponsive tumors, a requirement for patients to be eligible for novel bladder sparing drugs3
- Recommended (if available) to enhance therapeutic response monitoring by the International Bladder Cancer Group (IBCG)4
- FDA recognizes CIS lesions as "markers" to track therapeutic response5
- Monitoring response to novel bladder sparing NMIBC therapies is a regulatory requirement
3 Morelli 2021 J Endo Uro
- 5 Gofrit et al. Marker lesion in Bca. J Urol 2010
1 Williams et al JAMA Network Open. 2021, van den Bosch S. Eur Urol. 2011, Morelli 2021 J Endourol 2 Witjes et al 2014
| Asieris Programs: |
Two candidates under regulatory review |
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Hexvix China Recent News |
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Going forward |
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Phase III Trial Enrollment Completed |
Primary Endpoint Successfully Met; Data presented at SIU Congress 12 Oct 2023 |
Strong Results (p<0.0001) First RCT Trial Conducted with High Def. BLC |
NDA Accepted November 2023; Chinese Authorities (NMPA) Review ongoing (Typically 18 Months) |
Photocure eligible for significant milestones & royalties upon |
Cevira Recent News 1st Non-Invasive Candidate for Cervical HSIL; Phase III Results China & Europe |
Primary Endpoint Successfully Met |
Phase III Results presented at the EUROGIN 2024 HPV Congress (March 2024) |
forward Going NDA accepted in China May 2024, EU Pre-MAA Communication anticipated in Q3, discussions with U.S. FDA in H2 |
Asieris' regulatory achievements, market authorizations, & potential sales |
Q2 Financials Photocure – Presentation of Q2 2024 Results


Consolidated Income Statement Second Quarter 2024
Consolidated Income Statement Second Quarter 2024 |
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| Amounts in NOK million |
Q2 '24 |
Q2 '23 |
Change |
YTD '24 |
YTD '23 |
Change |
Revenue |
| Hexvix/Cysview Revenue |
122.4 |
115.9 |
6% |
239.2 |
221.8 |
8% |
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| Other Revenue |
23.0 |
28.4 |
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24.3 |
28.7 |
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| Total Revenue |
145.4 |
144.3 |
1% |
263.5 |
250.6 |
5% |
|
| Gross Profit |
137.8 |
137.4 |
0% |
248.1 |
237.2 |
5% |
|
| Operating Expenses excl BD |
-108.6 |
-104.4 |
4% |
-210.3 |
-205.3 |
2% |
periods |
Business Development Expenses |
-1.3 |
-9.6 |
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-2.1 |
-9.7 |
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EBITDA – excluding BD |
29.2 |
33.0 |
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37.8 |
31.9 |
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Operating Expenses |
EBITDA – including BD |
27.8 |
23.4 |
|
35.7 |
22.2 |
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business development expense |
| Depreciation & Amortization |
-7.2 |
-6.6 |
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-14.3 |
-13.1 |
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| EBIT |
20.7 |
16.8 |
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21.4 |
9.2 |
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| Net Financial Items |
-4.5 |
-4.9 |
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-9.2 |
-7.3 |
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EBITDA |
| Earnings before Tax |
16.2 |
12.0 |
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12.2 |
1.8 |
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| Tax Expenses |
-3.8 |
-7.6 |
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-7.7 |
-9.3 |
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Net Financial Items |
| Net earnings |
12.3 |
4.3 |
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4.4 |
-7.4 |
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Includes Ipsen earn-out payments |
Photocure – Presentation of Q2 2024 Results |
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Revenue
- Hexvix/Cysview product revenue increased 6% driven by higher unit sales and average price in the U.S. and the timing of shipments to wholesalers in certain European markets Consolidated volume impacted by phase down of Cysview usage in the flexible Other revenue includes Asieris milestone payments in 2023 and 2024
- BLC setting and customer order fluctuations in DACH and a strike in Sweden
- periods
Operating Expenses
- Q2 total operating expenses declined 4% YoY mainly driven by business development expense
- Operating expenses within business development projects relate to life cycle management for Hexvix/Cysview
EBITDA
Q2 EBITDA including business development expenses NOK 27.8 million
Net Financial Items
Includes Ipsen earn-out payments

Segment Performance Second Quarter 2024
North America Segment
| Amounts in NOK million |
Q2 '24 |
Q2 '23 |
Change |
YTD '24 |
YTD '23 |
Change |
Amounts in NOK million |
Q2 '24 |
Q2 '23 |
Change |
YTD '24 |
YTD '23 |
Change |
| Total revenues |
50.4 |
46.2 |
9% |
97.9 |
88.3 |
11% |
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| Gross profit |
49.0 |
44.8 |
9% |
95.1 |
85.5 |
11% |
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of % revenue |
97% |
97% |
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97% |
97% |
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of % revenue |
92% |
93% |
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92% |
93% |
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| Direct costs |
-44.6 |
-44.8 |
0% |
-86.5 |
88.4 |
-2% |
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| Contribution (1) |
4.3 |
-0.0 |
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8.6 |
-2.8 |
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Contribution (1) |
36.1 |
37.6 |
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72.2 |
67.2 |
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| EBITDA, excl BD |
-5.1 |
-10.3 |
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-10.2 |
-22.0 |
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EBITDA, excl BD |
18.8 |
19.5 |
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37.8 |
33.2 |
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% of revenue |
-10% |
-22% |
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-10% |
-25% |
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% of revenue |
26% |
28% |
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27% |
25% |
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average price, partially offset by phase down of Cysview usage in the flexible BLC setting In-market unit sales increased 1%, price increase 5%, customer mix also further contributed to growth in Q2 Q2 direct costs level |
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In-market unit sales level YoY and EUR depreciated 0.8%. Timing of wholesaler stocking added to revenue growth in the quarter Q2 direct costs increased driven mainly by timing of project expenses |
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Q2 Contribution improved by NOK 4.3 million YoY driven by revenue growth and cost containment. YTD contribution increased by NOK 11.4 million YoY |
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Q2 Contribution mostly level YoY, YTD contribution increased by NOK 5.0 million YoY driven by revenue growth and cost containment |
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Photocure – Presentation of Q2 2024 Results |
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(1) Contribution = revenue – |
COGS – |
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direct/local sales, marketing, medical and G&A costs |
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- Q2 revenue growth 9% driven by both higher volume and average price, partially offset by phase down of Cysview usage in the flexible BLC setting
- In-market unit sales increased 1%, price increase 5%, customer mix also further contributed to growth in Q2
- Q2 direct costs level
- Q2 Contribution improved by NOK 4.3 million YoY driven by revenue growth and cost containment. YTD contribution increased by NOK 11.4 million YoY

Europe Segment
| Amounts in NOK million |
Q2 '24 |
Q2 '23 |
Change |
YTD '24 |
YTD '23 |
Change |
| Total revenues |
72.0 |
69.7 |
3% |
141.3 |
133.3 |
6% |
| Gross profit |
66.0 |
65.2 |
1% |
129.4 |
123.7 |
5% |
% of revenue |
92% |
93% |
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92% |
93% |
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| Direct costs |
-29.8 |
-27.6 |
8% |
-57.1 |
56.6 |
1% |
| Contribution (1) |
36.1 |
37.6 |
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72.2 |
67.2 |
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| EBITDA, excl BD |
18.8 |
19.5 |
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37.8 |
33.2 |
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% of revenue |
26% |
28% |
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27% |
25% |
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- Q2 revenue increased 3% YoY
- In-market unit sales level YoY and EUR depreciated 0.8%. Timing of wholesaler stocking added to revenue growth in the quarter
- Q2 direct costs increased driven mainly by timing of project expenses
- Q2 Contribution mostly level YoY, YTD contribution increased by NOK 5.0 million YoY driven by revenue growth and cost containment
Cash Flow & Balance Sheet Second Quarter 2024
| Amounts in NOK million |
Q2 '24 |
Q2 '23 |
YTD '24 |
YTD '23 |
Cash Flow |
| Operations Cash Flow |
19.5 |
29.1 |
27.9 |
20.0 |
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| Earnings before tax |
16.2 |
12.0 |
12.2 |
1.9 |
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| Depreciation & amortization |
7.2 |
6.5 |
14.3 |
13.1 |
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| Working capital |
-11.6 |
-1.1 |
-18.6 |
-10.7 |
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| Other |
7.7 |
11.7 |
20.0 |
15.8 |
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| Investments Cash Flow |
0.5 |
0.1 |
0.6 |
0.7 |
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| Financing Cash Flow |
-11.3 |
-16.3 |
-21.1 |
-29.8 |
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| Net Change in Cash |
8.7 |
12.9 |
7.5 |
-9.1 |
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-1.1 11.7 0.1 -16.3 12.9 |
-18.6 20.0 0.6 -21.1 7.5 30.06.24 326.0 120.6 |
-10.7 15.8 0.7 -29.8 -9.1 31.12.23 339.5 112.9 |
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267.0 |
259.5 |
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499.7 |
482.8 |
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147.3 |
151.6 |
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66.7 |
77.5 |
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713.6 |
712.0 |
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Cash Flow
- Q2 cash flow from operations was NOK 19.5 million, driven by EBITDA adjusted for non-cash expenses and working capital
- Q2 cash flow from investments includes interest received, partially offset by investments in tangible and intangible assets Q2 cash flow from financing of NOK -11.3 million includes earnout
- payments to Ipsen of NOK 9.1 million
- Term loan was fully repaid in Q2 2023
- Net cash flow in Q2 was NOK 8.7 million, cash balance end of Q2 was NOK 267.0 million
Financial position
- Non-current assets include intangibles and goodwill from Ipsen transaction totaling NOK 248.2 million
- Long-term liabilities includes deferred Ipsen earnout totaling NOK 123.0 million
- Equity NOK 499.7 million, 70% of total assets
Summary


Summary of Q2 2024 results
- 6% Product rev. growth, unit sales level YoY; executing on key initiatives to increase unit sales
- EBITDA of NOK 27.8M (NOK 29.2M Ex-BD); Commercial businesses contribution-positive in Q2 & prior 3 quarters 20 Saphira towers installed in U.S. (5 new, 3 upgrades, 12 mobile); ForTec national mobile rollout underway
- Installed base of 176 Saphira towers since launch; these now represent 46% of rigid towers in U.S.
- Flex phase-down remains a challenge, but growth of rigid (TURBT) towers & kit sales outweighed Flex pressure Photocure – Presentation of Q2 2024 Results 22
- Priority Growth Markets in Europe responding well to turn-around efforts, UK/IT sustaining double-digit growth
- Strong momentum for NMIBC & BLC ; KOL support/equipment upgrades/new NMIBC therapies coming to market
- Cash balance strong at NOK 267 million, up from NOK 260 million at year-end 2023; no term debt
Anticipated Milestones & Corporate Objectives
- 2024 financial guidance reiterated: 6-9% product revenue growth (constant currency), positive EBITDA. Raised 2024 tower guidance range to 55-70 Saphira installs (new + upgrades)
- Increase Hexvix®/Cysview® kit throughput, continue growing BLC tower base in U.S. and penetration of priority growth markets in Europe, collaborate with ForTec on mobile tower national rollout in U.S.
- 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 BLC manufacturers to enter the U.S. market Photocure – Presentation of Q2 2024 Results 23
- 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
- Advance partnership with Richard Wolf to develop and commercialize a next-generation Flexible BLC system for the global markets
- Asieris Assets progress: NDAs for both Cevira and Hexvix in China undergoing regulatory reviews. Anticipated Q3 Pre-MAA discussions for Cevira in EU, FDA discussions on regulatory requirements in H2 2024.
Leading change in bladder cancer

