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Photocure ASA

Investor Presentation May 15, 2024

3714_rns_2024-05-15_c6e25437-7a0e-4955-87ed-208d48c2adfa.pdf

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Photocure ASA 1st Quarter 2024 Results

May 15, 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.

1st Quarter 2024 Highlights:

Continued growth and execution on key initiatives

Product Revenue +10%

Unit sales +6% year-over-year

Expanding U.S. Saphira footprint

  • ⁻ 6 new accounts opened
  • ⁻ 5 upgrades from existing accounts
  • ⁻ 6 mobile Saphira towers

Executing on plan in Europe

  • ⁻ Priority Growth Markets responding to turn-around initiatives
  • ⁻ Nordics stabilized, awaiting BL upgrade in H2 2024

Ongoing challenges:

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

EBITDA NOK 7.9 million

NOK 8.6 million ex-BD expense

OPEX mostly level excl. FOREX & BD last 9 quarters; Continued investment behind Hexvix/Cysview

Biz Dev expense NOK 0.8 million

Strong Balance Sheet

NOK 258 million in cash and equivalents; no term debt

Recent news and key milestone events

Hexvix Phase III trial in China:

new data from RCT with high def. BLC equip. presented at ASCO-GU & EAU

Post-period:

VA Bravo II data at AUA: results show BLC use associated with positive impact on recurrence, progression, and overall survival

Asieris' Cevira®: positive Phase III data unveiled at EUROGIN/SGO; NDA acceptance in China announced May 12, 2024

ForTec Mobile BLC Strategy: Plans to expand and rollout nationally in H2 2024

Reclassification of BLC equipment: Olympus posts supportive comment to Citizen's Petition* in April 2024

Segment Trends

North America and Europe markets

Photocure – Presentation of Q1 2024 Results

Monthly Hexvix/Cysview

North America Europe

Unit Sales by Region Last 3 Years

Q1 2024 Trends in North America

Q1 revenues increased 13%, in-market unit sales rose 2% (~12% rigid growth); Cysview growth again outpaces flexible BLC phase down

  • Installed base of rigid BLC continues to grow despite recent Saphira backorders; 17 Saphira installed (6 new accounts, 5 upgrades and 6 mobile towers). Temporary backorder affected 5 new account POs in Q1
  • Other Q1 wins: 9 accounts reactivated in Q1 (18 reactivated in 2023), Cysview label strengthened in Canada, ForTec mobile tower strategy expansion initiated
  • 2024 AUA meeting focuses on NMIBC – VA Bravo II data show positive recurrence, progression and OS data, many new drug treatments for NMIBC coming to market where BLC can play a key role, positive momentum with KOLs
  • Interest in proprietary U.S. Registry remains strong
  • 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

ForTec Website Featuring BLC Mobile Equipment

Saphira now 42% of rigid BLC installed base in U.S.

17 blue light tower placements in Q1 2024: 6 new accounts, 5 upgrades, 6 mobile units

Cumulative Installed Rigid Tower Base in U.S.

Q1 2024: 12 installations (6 New, 6 Mobile)

Q1 2024 Trends in Europe

  • Q1 revenues increased 9% year-over-year driven primarily by 8% in-market unit growth compared to Q1 2023.
  • Executing on plan to increase penetration in Priority Growth Markets. UK and Italy both demonstrated double-digit growth in Q1 after showing double digit growth in Q4 2023. Significant image quality upgrades in France plus current pipeline expected to yield increased momentum this year.
  • Strong BLC presence at 2024 EAU Congress. Two abstract presentations (Hexvix in China and Laser III data); Many KOLs present at Photocure booth; BLC towers prominently 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 hospitals/clinics; approximately 2/3 still underpenetrated
    • 153 image quality upgrades in target accounts providing strong base for unit sales growth in 2024
    • Prepare for co-launch of Olympus upgraded blue light anticipated in H2 2024

Photocure Booth at EAU, Paris, April 2024

Executing on European Growth Opportunity

Steady Growth in DACH continuesNordics stable since Q3'23Olympus BL equipment upgrade in Nordics anticipated H2 2024 9 Established Markets Nordic (excl. DK)/DACH 26% to 58% range of penetration Priority Growth Markets Untapped EU Markets Spain, Poland, Baltics, Czech Rep, Hungary, Ireland, Greece, Portugal: ~0% penetration France, UK, Italy, Be/Ne 2% to 14% penetration • Continuous Investment in Commercial Excellence • Good Penetration, Guidelines & Procedure Funding • Germany/Austria (70% of EU unit sales) consistently increasing market share YoY • Outdated Olympus towers still a challenge in Nordics • Active Pipeline for Image Quality Upgrades (Reactivation) & New Installations • Good installed base of equipment but dated & underpenetrated. Significant progress made in image quality upgrades in 2023, continues into 2024 • Returning to growth after stabilization of decline during COVID years Q1 2024Evaluating key launch factors in each territory: - Availability of capital equipment - Local treatment guidelines - KOL engagement - Coverage/reimbursement - Decision on direct/distribution strategy • 13% Growth in Q1 2024, first time organic double-digit growth since IPSEN transitionSpain pilot in cooperation with Karl Storz has started Photocure – Presentation of Q1 2024 Results

Significant progress with our partner Asieris

Hexvix China

Recent News

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

Going forward

NDA Accepted November 2023; Chinese Authorities (NMPA) Review ongoing (Typically 18 Months)

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)

Going forward

NDA accepted in China May 2024, EU Pre-MAA Communication anticipated in Q3, discussions with U.S. FDA in H2

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

Q1 Financials

Consolidated Income Statement First Quarter 2024

NOK
million
Amounts
in
Q1 '24 Q1 '23 Change FY '23
Hexvix/Cysview Revenue 116.8 105.9 10% 443.3
Other Revenue 1.1 0.3 57.4
Total Revenue 118.0 106.2 11% 500.7
Gross Profit 110.3 99.8 11% 474.5
Operating Expenses excl BD -101.7 -100.9 1% -409.1
Business Development Expenses -0.8 -0.1 -9.9
EBITDA –
excluding BD
8.6 -1.1 65.4
EBITDA –
including BD
7.9 -1.2 55.5
Depreciation & Amortization -7.1 -7.4 -27.7
EBIT 0.7 -7.7 27.8
Net Financial Items -4.8 -2.4 -18.1
Earnings before Tax -4.0 -10.1 9.7
Tax Expenses -3.9 -1.6 -8.8
Net earnings -7.9 -11.7 1.0

Revenue

  • Q1 total revenue increased YoY 11%
  • The increase was primarily due to Hexvix/Cysview product revenue growth of 10% driven by increases in unit volumes, price increases and a benefit from foreign exchange.
    • Consolidated volume impacted negatively by the phase down of Cysview usage in the flexible BLC setting

Operating Expenses

  • Q1 operating expenses excluding business development costs increased 1% 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

Q1 EBITDA including BD expenses NOK 7.9 million

Net Financial Items

Includes Ipsen earn-out payments

Segment Performance First Quarter 2024

North America Segment

million
Amounts
in
NOK
Q1 '24 Q1 '23 Change FY '23
Total revenues 47.5 42.1 13% 178.6
Gross profit 46.1 40.7 13% 172.8
of
%
revenue
97% 97% 97%
Direct costs -41.8 -43.5 -4% -163.6
Contribution (1) 4.3 -2.7 9.1
EBITDA, excl BD -5.1 -11.6 -29.5
%
of
revenue
-11% -28% -16%
  • Q1 revenue growth 13% 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 2%, USD appreciated 3%, price increase 5% in US. In addition, the effect of mix further contributed to growth in the quarter
  • Q1 direct costs decreased, despite negative impact of FX
  • Contribution improved by NOK 7.0 million YoY driven by revenue growth and cost containment

Europe Segment

Amounts
in
NOK
million
Q1 '24 Q1 '23 Change FY '23
Total revenues 69.3 63.3 9% 263.5
Gross profit 63.4 58.6 8% 244.3
%
of
revenue
92% 92% 93%
Direct costs -27.3 -29.0 -6% -122.8
Contribution (1) 36.1 29.6 121.5
EBITDA, excl BD 19.0 13.7 52.4
%
of
revenue
27% 22% 20%

Q1 revenue increased 9% YoY

  • In-market unit sales increased 8% YoY and EUR appreciated 4%. In addition, timing of stocking tempered growth in the quarter
  • Q1 direct costs decreased, despite negative impact of FX
  • Contribution improved by NOK 6.5 million YoY, driven by revenue growth and cost containment

Cash Flow & Balance Sheet First Quarter 2024

in
NOK
million
Amounts
Q1 '24 Q1 '23 FY '23
Operations Cash Flow 5.1 -9.1 48.3
Earnings before tax -4.0 -10.1 9.7
Depreciation & amortization 7.1 6.5 27.7
Working capital -7.0 -10.7 -18.1
Other 8.9 5.2 29.0
Investments Cash Flow 0.2 0.6 -0.6
Financing Cash Flow -6.5 -13.5 -56.3
Net Change in Cash -1.2 -22.0 -8.6
Amounts
in
NOK
million
31.03.24 31.03.23 31.12.23
Non-current assets 333.8 357.0 339.5
Inventory & receivables 122.6 102.9 112.9
Cash & short-term deposits 258.3 246.1 259.5
Equity 483.1 455.3 482.8
Long-term liabilities 151.3 165.6 151.6
Current liabilities 231.5 250.6 77.5

Cash Flow

  • Q1 cash flow from operations was NOK 5.1 million, driven by EBITDA adjusted for non-cash cost items and working capital
  • Q1 cash flow from investments includes interest received offsetting investments in tangible and intangible assets
  • Q1 cash flow from financing NOK -6.5 million includes earnout payments to Ipsen
    • Term loan was fully repaid in Q2 2023
  • Net cash flow in Q1 was NOK -1.2 million, cash balance end of Q1 was NOK 258.3 million

Financial position

  • Non-current assets include intangibles and goodwill from Ipsen transaction totaling NOK 252.4 million
  • Long-term liabilities includes deferred Ipsen earnout totaling NOK 126.1 million
  • Equity NOK 483.1 million, 68% of total assets

Summary

Summary of Q1 2024 results

  • 10% Product rev. growth, 6% unit sales growth YoY; executing against key initiatives to increase unit sales
  • EBITDA of NOK 7.9M (NOK 8.6M Ex-BD); Commercial businesses contribution-positive in Q1
  • 17 Saphira towers installed in U.S. (6 new, 5 upgrades, 6 mobile); ForTec mobile tower expansion expected H2
  • Installed base of 154 Saphira towers since launch; these now represent 42% 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, UK/IT sustaining double-digit growth
  • Strong momentum for NMIBC & BLC ; KOL support/equipment upgrades/many new NMIBC therapies launching
  • Cash balance strong at NOK 258 million; no term debt

Anticipated Milestones & Corporate Objectives

  • Reiterated 2024 guidance: 6-9% product revenue growth (constant currency), positive EBITDA, 40-70 Saphira installs (new + upgrades)
  • Increase Hexvix®/Cysview® kit throughput, continue growing BLC tower base in U.S. and penetration of EU priority growth markets, facilitate ForTec mobile tower strategy, pursue Flex BLC equipment reintroduction
  • 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
  • Asieris Assets progress: NDAs for both Cevira and Hexvix in China undergoing regulatory review. Cevira EU Pre-MAA application anticipated in Q3, FDA discussions anticipated H2 2024.

Leading change in bladder cancer

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