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Photocure ASA

Investor Presentation Nov 13, 2024

3714_rns_2024-11-13_a2095f3b-7b93-4e16-af97-acf412fa82f9.pdf

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Photocure ASA 3rd Quarter 2024 Results

November 13, 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.

Strategic Priorities & Initiatives

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

  • Deliver on our guidance for product 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 BLC equipment manufacturers who plan to enter the U.S.
  • 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 uro-oncology indications: Biomarkers, AI, new technologies
  • Leverage existing global commercial infrastructure in broader uro-oncology segment

3rd Quarter 2024 Highlights:

Continued growth and execution on key initiatives

Product Revenue +12%

Product Revenue +6% Q3 unit sales +8%

Expanding U.S. Saphira footprint

Unit sales level in Q2 YoY; +3% YTD

  • ⁻ 6 new account towers installed
  • ⁻ 6 upgrades from existing accounts

Executing on plan in Europe

  • ⁻ Priority Growth Markets grew 12% in Q3
  • ⁻ Largest region, DACH countries maintaining good growth

Ongoing challenges:

  • ⁻ Phase down of flex BLC utilization
  • ⁻ Single manufacturer in the U.S.
  • ⁻ Delay of Olympus' upgraded BL to Q4 2024

EBITDA NOK 5.0 million

EBITDA NOK 27.8 million NOK 6.3 million ex-BD expense

NOK 29.2 million ex-BD expense

Photocure continues to contain expense growth and invest behind Hexvix/Cysview

Biz Dev expense NOK 1.3 million

Strong Balance Sheet

NOK 291 million in cash and equivalents, up from NOK 260 million at year-end 2023. No term debt

Recent news and key milestone events

Richard Wolf Flex Agreement:

Partnership to develop & commercialize stateof-the-art HD flexible BLC system globally (July)

ForTec Mobile BLC Strategy:

National rollout in U.S. showing good momentum

Named Patient Program (NPP):

Enables bladder cancer patients in South Africa access to BLC with Hexvix (Sept.)

Asieris Progress: Early approval of Hexvix in China (November). Cevira® Phase III data presentations at 2024 PDT & PD Conference & CSCO Annual Meeting in Q3.

Segment Trends

North America and Europe markets

Solid Unit Sales Performance in Both Regions in Q3

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

North America Europe

Q3 2024 Trends in North America

Q3 2024 revenues increased 12%, in-market unit sales rose 6%. Higher average price benefited revenues, Cysview growth in rigid segment outpaces flexible BLC phase down again (10% sales growth in rigid segment through Q3 2024)

  • Installed base of rigid BLC equipment continues to increase; 12 Saphira installs (6 new towers, 6 upgrades). Karl Storz BLC tower promotional program to remain in effect through year-end 2024.
  • ForTec mobile BLC national rollout gaining traction in U.S.: 18 towers deployed as of August 2024; 30 accounts have used the service as of Sept. 30.

Photocure advertorial with KOL interviews in AUA News starting July 2024

Access to BLC and reclassification in U.S. remains a focus Comments unanimously support the Citizen's Petition*, including those from KOLs, BCAN (U.S. Patient Advocacy), health systems, Pacific Edge (biomarkers), Richard Wolf, Stryker and Olympus

Saphira now 48% of rigid BLC installed base in U.S.

since Q3 2022 launch; 98 New, 70 Upgrades and

18 Mobile towers

12 tower installations in Q3 2024 (6 new accounts, 6 upgrades); 49 Saphira systems placed YTD

New & Mobile Rigid Tower Installations Q4 2023: 10 installations Q1 2024: 12 installations (6 New, 6 Mobile) Q2 2024: 17 installations (5 New, 12 Mobile) Q3 2024: 6 installations

Cumulative Installed Rigid Tower Base in U.S.

Q3 2024 Trends in Europe

  • Q3 revenues increased 12% year-over-year, in-market unit sales grew 9%. Revenue increase was mainly due to growth in Germany and Priority Growth Markets
  • Executing on plan to increase Priority Growth Market penetration UK continues to have strong double-digit growth, France achieved 9% growth, Italy trending well
  • Strong BLC presence at national congresses in Italy and Germany in Q3. Continuing support to KOLs and medical education
  • 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
      • 44 image quality upgrades in Q3; 220 since 2023 to date in our target accounts
      • Added 29 new accounts in 2023 and 2024 YTD
      • Preparing for co-launch of Olympus upgraded blue light system anticipated Q4 2024

Photocure after work with Olympus equipment exhibit at DGU, Leipzig, Germany, September 2024

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
  • 18 Towers deployed and building demand
  • Teams leveraging both partners' customer infrastructure

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

  • Strategic agreement to develop and commercialize a next generation 4K LED HD reusable flexible blue light cystoscope
  • IP and Regulatory responsibilities remain with RW
  • Photocure and Richard Wolf will invest in development and copromote globally
  • 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
  • BLC to play an important role in supporting new "bladder sparing" therapies: patient selection, staging, marker lesion identification

Value-generating Asieris Programs:

Hexvix: Commercial partnership in China

Past Progress

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

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

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

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

Past Progress

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

NDA accepted in China May 2024, review by NMPA ongoing

Recent News & Expectations

Recent News & Expectations

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

Commercialization in China / Potential MAs in other regions

Potential for Photocure

Regulatory Milestones; Royalties and Sales Milestones

Q3 Financials

Consolidated Income Statement Third Quarter 2024

Amounts
in
NOK
million
Q3 '24 Q3'23 Change YTD '24 YTD '23 Change
Hexvix/Cysview Revenue 120.1 107.3 12% 359.3 329.1 9%
Other Revenue 0.1 0.3 24.4 29.0
Total Revenue 120.2 107.5 12% 383.7 358.1 7%
Gross Profit 112.4 100.7 12% 360.5 337.9 7%
Operating Expenses excl BD -106.1 -96.7 10% -316.4 -302.0 5%
Business Development
Expenses
-1.2 -0.6 -3.3 -10.3
EBITDA –
excluding BD
6.3 3.9 44.1 35.8
EBITDA –
including BD
5.0 3.3 40.7 25.6
Depreciation & Amortization -7.2 -7.2 -21.5 -20.2
EBIT -2.2 -3.9 19.2 5.3
Net Financial Items -2.8 -4.8 -12.0 -12.1
Earnings before Tax -4.9 -8.7 7.2 -6.8
Tax Expenses 1.5 3.9 -6.2 -5.4
Net earnings -3.5 -4.8 1.0 -12.2

Revenue

  • Hexvix/Cysview product revenue increased 12% YoY, driven by unit sales increase of 6% in U.S. and 9% in Europe. Higher average pricing in the U.S. further contributed to the revenue growth
    • 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

  • Q3 total operating expenses excluding BD increased 10% YoY mainly driven by the timing of expense capitalization in Q3 2023 and timing of project expenses in 2024.
  • Operating expenses within business development projects relate mainly to life cycle management for Hexvix/Cysview

EBITDA

Q3 EBITDA including BD expenses was NOK 5.0 million

Net Financial Items

Include Ipsen earn-out payments

Segment Performance Third Quarter 2024

North America Segment

Amounts
in
NOK
million
Q3 '24 Q3 '23 Change YTD '24 YTD '23 Change
Total revenues 49.0 43.6 12% 146.9 132.0 11%
Gross profit 47.3 42.2 12% 142.3 127.7 11%
%
of
revenue
97% 97% 97% 97%
Direct costs -42.7 -34.2 25% -129.2 -122.6 5%
Contribution (1) 4.6 8.0 13.2 5.2
EBITDA -6.9 -2.2 -17.1 -24.2
%
of
revenue
-14% -5% -12% -18%
  • Q3 revenue growth of 12% 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 6%, average price increase 5%
  • Q3 direct costs increased YoY mainly due to capitalization of registry expenses in Q3 2023 and the timing of project expenses in 2024
  • YTD contribution increased by NOK 8.0 million YoY

Europe Segment

NOK
million
Amounts
in
Q3 '24 Q3 '23 Change YTD '24 YTD '23 Change
Total revenues 71.1 63.4 12% 212.4 196.7 6%
Gross profit 65.0 58.2 12% 194.4 181.9 5%
of
%
revenue
91% 92% 92% 92%
Direct costs -30.0 -29.1 3% -87.1 85.7 2%
Contribution (1) 35.1 29.1 107.3 96.3
EBITDA 15.3 10.4 53.1 43.5
of
%
revenue
21% 16% 25% 22%
  • Q3 revenue increased 12% YoY
    • In-market unit sales increased 9%, impact of FX impact was approximately 3%
  • Q3 direct costs increased 3%YoY, mainly driven by FX
  • Q3 Contribution improved YoY by NOK 6.0 million and YTD by NOK 11.0 million, driven by revenue growth and cost containment

Cash Flow & Balance Sheet Third Quarter 2024

NOK
million
Amounts
in
Q3 '24 Q3 '23 YTD '24 YTD '23
Operations Cash Flow 34.5 8.7 61.3 28.7
Earnings before tax -4.9 -8.7 7.2 -6.8
Depreciation & amortization 7.2 7.2 21.5 20.2
Working capital 23.9 1.8 5.3 -10.0
Other 8.3 8.4 27.3 25.2
Investments Cash Flow 2.4 -2.5 3.1 -1.8
Financing Cash Flow -12.9 -10.0 -32.8 -39.9
Net Change in Cash 24.1 -3.9 31.5 -13.0
Amounts
in
NOK
million
30.09.24 31.12.23
Non-current assets 322.1 339.5
Inventory & receivables 107.3 112.9
Cash & short-term deposits 291.1 259.5
Equity 499.7 482.8
Long-term liabilities 143.5 151.6
Current liabilities 77.3 77.5
Total balance 720.5 712.0

Cash Flow

  • Q3 cash flow from operations was NOK 34.5 million, driven by EBITDA adjusted for non-cash expenses and working capital
    • Working capital decreased mainly due to lower receivables and non-cash items including accruals and cost of the Company's employee option program
  • Q3 cash flow from investments includes interest received, partially offset by investments in tangible and intangible assets
  • Q3 cash flow from financing of NOK -12.9 million includes earnout payments to Ipsen of NOK 9.8 million
    • Term loan was fully repaid in Q2 2023
  • Net cash flow in Q3 was NOK 24.1 million, cash balance end of Q3 was NOK 291.1 million

Financial position

  • Non-current assets include intangibles and goodwill from Ipsen transaction totaling NOK 244.0 million
  • Long-term liabilities includes deferred Ipsen earnout totaling NOK 120.3 million
  • Equity at September 30, 2024 was NOK 499.7 million, 69% of total assets

Summary

Summary of Q3 2024 results

  • 12% Product rev. growth, unit sales up 8% YoY; executing on key initiatives to increase sales growth
  • EBITDA of NOK 5.0M (NOK 6.3M Ex-BD); Commercial businesses contribution-positive in Q3 & prior 4 quarters
  • 12 Saphira towers installed in U.S. (6 new, 6 upgrades); ForTec national mobile rollout gaining traction
  • Installed base of 186 Saphira towers since launch; these now represent 48% of rigid towers in U.S.
  • Flex phase-down remains a challenge, but growth of rigid (TURBT) towers & kit sales outweighed Flex pressure
  • Priority Growth Markets in Europe responding well to turn-around efforts, 12% growth in these markets in Q3
  • Strong momentum for NMIBC & BLC ; KOL support/equipment upgrades/new NMIBC therapies coming to market
  • Cash balance strong at NOK 291 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 ex BD spend, and U.S. Saphira tower placements in the range to 55-70 (new + upgrades)
  • 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
  • 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
  • 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 as soon as possible
  • Asieris progress: Hexvix approved several months early in China; NDA for Cevira undergoing regulatory review. Pre-MAA submission for Cevira in EU and FDA discussions on U.S. filing requirements planned for Q4

Leading change in bladder cancer

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