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Photocure ASA

Investor Presentation Feb 21, 2024

3714_rns_2024-02-21_f1040452-e51d-4faf-bbd2-51b9f87ff8ab.pdf

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Photocure ASA 4th Quarter 2023 Results

February 21, 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 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.

4th Quarter 2023 Highlights:

Continued growth and execution on key initiatives despite flexible BLC phase down

Product Revenue +20%

Unit sales +4% year-over-year

Expanding U.S. Saphirafootprint

  • ⁻ 10 new accounts opened
  • ⁻ 7 upgrades from existing accounts
  • ⁻ 51 Saphira™ towers placed in 2023

Executing on plan in Europe

  • ⁻ 146 image quality upgrades in 2023
  • ⁻ 23 new accounts opened

Ongoing challenges:

  • ⁻ Phase down of flex BLC utilization
  • ⁻ Single manufacturer in the U.S.
  • ⁻ Delay of Olympus' upgraded BL equipment launch in Europe

EBITDA NOK 29.9 million

NOK 29.6M ex-BD expense

OPEX mostly level excl. FOREX & BD last 8 quarters; Continued investment behind Hexvix/Cysview

Biz Dev expense not material

Strong Balance Sheet

NOK 260 million in cash and equivalents; no term debt

Key news and milestone events

7 accepted abstracts at major conferences in FY2023. In Q4:

  • ⁻ SUO 2023 Meeting: New RWE shows major decrease in Risk of BCa recurrence with BLC
  • ⁻ Clinical Results for Hexvix Phase III trial in China presented at SIU Congress: 1st randomized clin. trial using HD BLC equipment

Asieris' NDA for Hexvix accepted for regulatory review in China (Nov 2023)

Large order of rigid BLC Towers still anticipated; now expected in Q2 2024

Citizen's Petition* to re-classify BLC equipment: Pacific Edge posts supportive comment on Feb 16, 2024; process ongoing

Segment Trends

North America and Europe markets

Hexvix/Cysview Growth In 2023

Regional In-Market Unit Sales Year-Over-Year by Quarter

North America Europe

Saphiranow 39% of rigid BLC installed base in U.S.

17 installations in Q4 2023: 10 new account placements & 7 upgrades

Cumulative Installed Base in U.S. (Rigid Only)

Q4 2023 Trends in Europe

  • Q4 revenues increased 19% year-over-year driven by unit growth and a benefit from foreign exchange in the quarter. In-market unit sales increased 4% compared to the same period in 2022.
  • Investment in priority growth markets paying off. UK and Italy both demonstrating consistent double-digit growth in Q4 from significant negative trend when first acquired in 2020. Significant image quality upgrades in France during 2023 and current pipeline expected to yield similar durable turn-around trend going forward.
  • Blue light continues to gain traction in urology community across Europe; Significant increase in KOL support, EAU guidelines strengthened with additional data, strong presence at congresses, events and workshops – a total of 165 in 2023.
  • Key initiatives to accelerate unit sales growth
  • 1,400 TURBT-performing centers, approximately 50% have BL equipment
  • Actively targeting 590 hospitals/clinics; approximately 2/3 still underpenetrated
  • Continuing to execute image quality upgrades (146 in 2023 25% of targeted clinics)
  • 23 new blue light accounts opened in 2023

Photocure Booth at AFU, Paris, Nov 2023

Top French KOLs visiting Photocure booth at AFU congress:

Prof. Morgan Rouprêt:

  • Chief of French Urology onco-committees
  • Member of the EAU Guidelines on bladder
  • Chief Edito of the European Onco Urology Journal

Dr. Benjamin Pradère

  • Member of the French Bladder committee
  • Member of the EAU Guidelines on Bladder

Dr. Gauthier Marcq

• Member of the French Bladder committee

Significant progress with our partner Asieris

Hexvix China

Phase III Trial
Enrollment
Completed

Primary Endpoint Successfully Met;

Data presented at SIU Congress 12 Oct 2023

Primary Endpoint Successfully Met

Strong Results (p<0.0001)

First RCT Trial Conducted with High Def. BLC

Recent News Going forward

NDA Submitted November 2023; Chinese FDA (NMPA) Review Time Typically 18 Months

Photocure eligible for additional milestones & royalties upon Asieris' regulatory achievements, market authorizations, & potential sales

Cevira

1st Non-Invasive Candidate for Cervical HSIL; Phase III Results China & Europe

Recent News Going forward

Phase III Results to be Presented at the EUROGIN 2024 HPV Congress (March 13-16)

Asieris Communication with Regulatory Authorities in Coming Months

Q4 Financials

Consolidated Income Statement Fourth Quarter 2023

Amounts
in
NOK
million
Q4 '23 Q4 '22 Change FY '23 FY '22 Change
Hexvix/Cysview Revenue 114.2 94.9 20% 443.3 373.0 19%
Other Revenue 28.4 9.3 57.4 20.1
Total Revenue 142.5 104.2 37% 500.7 393.1 27%
Gross Profit 136.7 98.6 39% 474.5 370.4 28%
Operating Expenses excl BD -107.1 -105.4 2% -409.1 -372.1 10%
Business Development
Expenses
0.3 -10.0 -9.9 -23.0
EBITDA –
excluding BD
29.6 -6.8 65.4 -1.6
EBITDA –
including BD
29.9 -16.9 55.5 -24.6
Depreciation & Amortization -7.4 -6.2 -27.7 -24.4
EBIT 22.5 -23.1 27.8 -49.0
Net Financial Items -5.9 -5.5 -18.1 -22.1
Earnings before Tax 16.6 -28.6 9.7 -71.1
Tax Expenses -4.1 7.1 -9.5 -0.7
Net earnings 12.5 -21.5 0.3 -71.9

Revenue

  • Q4 total revenue increased YoY 37%. The revenue increase is driven by 20% product sales growth and a milestone payment received from Asieris of USD 2.5 million
  • Q4 Hexvix/Cysview revenue increased 20% vs. last year, driven by unit and price increases, and FX
  • Consolidated volume impacted negatively by the phase down of Cysview usage in the flexible BLC setting

Operating Expenses

  • Q4 operating expenses excluding business development costs increased 2% YoY, mainly due to FX which was offset by cost containment
  • Operating expenses within business development projects relate to life cycle management for Hexvix/Cysview

EBITDA

Q4 EBITDA including BD expenses NOK 29.9 million

Net Financial Items

Includes Ipsen earn-out payments

Segment Performance Fourth Quarter 2023

North America Segment

million
Amounts
in
NOK
Q4 '23 Q4 '22 Change FY '23 FY '22 Change
Total revenues 46.7 38.7 21% 178.6 150.8 18%
Gross profit 45.0 37.5 2% 172.8 145.9 18%
of
%
revenue
97% 97% 97% 97%
Direct costs -41.1 -46.0 -11% -163.6 -162.9 0%
Contribution (1) 4.0 -8.5 9.1 -16.9
EBITDA, excl BD -5.3 -17.5 -29.5 -49.5
of
%
revenue
-11% -45% -16% -33%
  • Q4 revenue growth 21% driven by volume and price increases, and FX, partially offset by phase down of Cysview usage in the flexible BLC setting
  • In-market unit sales increased 7%, USD appreciated 6%, price increase 5% in US
  • Q4 direct costs decreased, despite negative impact of FX
  • Contribution improved by NOK 12.5 million YoY driven by revenue growth and cost containment

Europe Segment

in
NOK
million
Amounts
Q4 '23 Q4 '22 Change FY '23 FY '22 Change
Total revenues 66.8 56.2 19% 263.5 221.8 19%
Gross profit 62.3 52.1 20% 244.3 205.0 19%
%
of
revenue
93% 93% 93% 92%
Direct costs -37.1 -29.5 26% -122.8 -102.9 19%
Contribution (1) 25.2 22.6 121.5 102.1
EBITDA, excl BD 8.8 5.7 52.4 42.2
of
%
revenue
13% 10% 20% 19%
  • Q4 revenue increased 19% YoY
  • In-market unit sales increased 4% YoY and EUR appreciated 12%. In addition, the net of price, stocking and mix contributed positively to the growth
  • Q4 Expenses were driven by the negative impact of FX and one-off costs
  • Contribution improved by NOK 2.6 million YoY, driven by revenue growth

Cash Flow & Balance Sheet Fourth Quarter 2023

million
Amounts
in
NOK
Q4 '23 Q4 '22 FY '23 FY '22
Operations Cash Flow 19.6 0.7 48.3 -2.0
Earnings before tax 16.6 -28.6 9.7 -71.1
Depreciation & amortization 7.4 6.2 27.7 24.4
Working capital -8.2 13.2 -18.1 -1.4
Other 3.8 10.0 29.0 42.2
Investments Cash Flow 1.2 0.8 -0.6 -1.5
Financing Cash Flow -16.4 -17.3 -56.3 -51.3
Net Change in Cash 4.4 -15.8 -8.6 -54.8
million
Amounts
in
NOK
31.12.23 31.12.22
Non-current assets 338.8 360.8
Inventory & receivables 112.9 90.2
Cash & short-term deposits 259.5 268.1
Equity 482.1 462.7
Long-term liabilities 151.6 167.1
Current liabilities 77.5 89.2
Total balance 711.3 719.0

Cash Flow

  • Q4 net cash flow from operations in Q4 was NOK 19.6 million, driven by EBITDA adjusted for non-cash cost items and working capital
  • Q4 net investment cash flow includes interest received offsetting investments in tangible and intangible assets
  • Q4 net cash flow from financing NOK -16.4 million includes earnout payments to Ipsen
  • Term loan was fully repaid in Q2 2023
  • Net cash flow in Q4 was NOK 4.4 million, cash balance end of Q4 was NOK 259.5 million

Financial position

  • Non-current assets include intangibles and goodwill from Ipsen transaction totaling NOK 256.5 million
  • Long-term liabilities includes deferred Ipsen earnout totaling NOK 127.7 million
  • Equity NOK 482.1 million, 68% of total assets

Summary

Summary of Q4 results

  • 20% Product rev. gr. / 4% unit sales growth YoY; several initiatives to accelerate unit sales momentum in 2024
  • EBITDA of NOK 29.9 million; Commercial business contribution-positive in Q4
  • 17 Saphira™ towers installed in U.S. (10 new, 7 upgrades); Large rigid tower order anticipated in Q2
  • Installed base of 137 Saphira™ towers since launch; now represents 39% 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 and starting to show double-digit growth
  • BLC attention continues to rise in urology community, growing KOL support & equipment/image quality upgrades
  • Cash balance strong at NOK 259.5 million; no term debt

Anticipated Milestones & Corporate Objectives

  • 2024 Guidance: 6-9% product revenue growth (constant currency), positive EBITDA, 40-70 Saphira™ installs (new + upgrades)
  • Increase Hexvix®/Cysview® kit throughput, continue to grow rigid BLC tower base in U.S. and image quality upgrades in Europe, 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, 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
  • Progress for Asieris Assets: Cevira Phase III data presentation anticipated at EUROGIN in March, potential regulatory submission in 2024, Hexvix (China) undergoing regulatory review, add'l. milestones anticipated
  • Continue to geographically expand commercial business by penetrating untapped European markets, and through additional Hexvix licensing agreements ROW

Leading change in bladder cancer

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