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Photocure ASA

Investor Presentation Nov 8, 2023

3714_rns_2023-11-08_33ae6009-2a52-4d03-b6df-e97545095671.pdf

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Photocure ASA 3rd Quarter 2023 Results

November 8, 2023

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.

3rd Quarter 2023 Highlights:

Growth limited as flexible BLC phase down continues; positive milestones achieved in Q3

Product Revenue +11%

Unit sales -1% year-over-year

21 SaphiraTowers Installed Q3:

  • ⁻ 15 new accounts opened in U.S.
  • ⁻ 6 upgrades of existing accounts
  • ⁻ 64 Saphira™ towers placed YTD U.S.
  • ⁻ 100+ quotes outstanding

Executing on Plan in Europe

  • ⁻ 130 image quality upgrades YTD
  • ⁻ 15 new accounts opened YTD
  • ⁻ 27 Saphira™ POs pending

Ongoing challenges:

  • ⁻ Phase down of flex BLC utilization
  • ⁻ Staffing shortages slowly resolving

EBITDA NOK 3.3 million

NOK 3.9M ex-BD expense

OPEX mostly level excluding FX & BD last 8 quarters; Continued investment behind Hexvix/Cysview

Biz Dev expense NOK 0.6 million

Strong Balance Sheet

NOK 255 million in cash and equivalents; term debt fully paid off in Q2 2023

Key news and milestone events

Asieris' Cevira® Phase III trial met primary endpoint: Plans to present data at a medical conference

Hexvix Phase III trial met primary endpoint: high statistically significant results from 1st randomized clinical trial using high def. BLC equip.

Citizen's Petition* to re-classify BLC equipment: Stryker submits public comment, process ongoing

Budget Impact Model Publication in France applying AFU guidelines: concludes insignificant cost difference between WL and BLC use

Segment Trends

North America and Europe markets

Loss of Flex in U.S. Pressured Growth, Europe Steady

Regional Unit Sales Year-Over-Year by Quarter

North America Europe

Q3 2023 Trends in North America

  • Q3 revenues increased 2%, in-market unit sales declined 9%; Phase down of flexible BLC usage outweighed Cysview sales growth in the TURBT segment
  • Continued expansion of blue light tower installed base: 15 new Saphira™ installations, 6 upgrades in Q3 (100+ quotes)
  • Demand for rigid blue light towers remains strong, BLC a key topic in urology: Robust pipeline for new towers, Karl Storz extended promo through year-end, active AUA meeting, strong interest in Photocure's U.S. Bladder Cancer Registry (>3,000 patients)

Key initiatives to improve unit sales growth

  • Increase Cysview kit usage in existing account base for TURBTs / Accelerate kit adoption of new accounts initiating use of blue light
  • Reactivate low users or inactive accounts through upgrades
  • Continue to expand BL penetration throughout the U.S. VA system leveraging VA BRAVO study data
  • Maintain as many of the 30 Flex accounts as possible for continued U.S. registry data collection and potential flex BLC reintroduction

Citizen's Petition for BLC reclassification

  • Recent supportive public comment from Stryker Corp. backing BLC reclassification*
  • If FDA approved, would enable expedited pathway to expand the number of BLC equipment manufacturers in the U.S.
  • Flex tower discontinuation highlights the need for BLC reclassification

SUNA UroLogic Conference, October 26-29, 2023

Saphiranow 35% of rigid BLC installed base in U.S.

21 installations in Q3 2023: 15 new account placements & 6 upgrades

New Account Tower Installations Q4 2022: 31 installations (24 Rigid & 7 Flex) Q1 2023: 18 installations (Rigid only) Q2 2023: 8 installations (Rigid only) Q3 2023: 15 installations (Rigid only)

120 Saphira™ towers installed since Q3 2022 launch; 71 New & 49 Upgrades

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

Q3 2023 Trends in Europe

  • Q3 revenues increased 17% year-over-year, driven by the positive effect of price increases, continued growth in Germany and more broadly the DACH region, as well as a benefit from foreign exchange in the quarter. Unit sales volume increased 2% compared to the same period in 2022.
  • Blue light continues to gain traction in urology community; Strong KOL support, high visibility at national urology congresses such as DGU; EAU guidelines strengthened with additional data in 2023
  • Photocure 2023 Bladder Cancer Bus Tour: Successful roadshow in Q3 with 15 stops in Germany and Austria
  • Key initiatives to improve 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 (130 YTD 22% of targeted clinics)
    • 15 new blue light accounts opened YTD 2023; 27 Saphira™ POs pending

Significant progress with our partner Asieris

Hexvix China

Q3 & 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
Expect China NDA
Submission
Before YE 2023
Photocure
eligible for
additional
milestones
-------------------------------------------- ------------------------------------------------------------------------------------------- ------------------------------------------------------------------------------------ -------------------------------------------------- ------------------------------------------------------- --

Cevira

Q3 & Recent News

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

Primary Endpoint Successfully Met

Going forward

Positive Results to be Presented at Future Medical Conference (TBD)

Asieris Communication with Regulatory Authorities in Coming Months

Going forward

& royalties upon Asieris' regulatory achievements, market authorizations, & potential sales

Q3 Financials

Consolidated Income Statement Third Quarter 2023

Amounts
in
NOK
million
Q3 '23 Q3 '22 Change YTD '23 YTD '22 Change
Hexvix/Cysview Revenue 107.3 96.9 11% 329.1 278.2 18%
Other Revenue 0.3 9.8 29.0 10.8
Total Revenue 107.5 106.8 1% 358.1 288.9 24%
Gross Profit 100.7 101.0 0% 337.9 271.9 24%
Operating Expenses excl BD -96.7 -91.3 6% -302.0 -266.7 13%
Business Development
Expenses
-0.6 -5.0 -10.3 -13.0
EBITDA –
excluding BD
3.9 9.7 35.8 5.2
EBITDA –
including BD
3.3 4.7 25.6 -7.8
Depreciation & Amortization -7.2 -6.1 -20.2 -18.1
EBIT -3.9 -1.4 5.3 -25.9
Net Financial Items -4.8 -4.8 -12.1 -16.7
Earnings before Tax -8.7 -6.3 -6.8 -42.6
Tax Expenses 3.8 -3.7 -5.4 -7.8
Net earnings -4.8 -9.9 -12.2 -50.4

Revenue

  • Q3 total revenue increased YoY 1%. Q3 2022 revenue was positively impacted by a USD 1.0 million milestone payment from Asieris
  • Q3 Hexvix/Cysview revenue increased 11% vs. last year, driven by price and FX
    • Consolidated volume impacted negatively by the phase down of Cysview usage in the flexible BLC setting

Operating Expenses

  • Q3 operating expenses excluding business development costs increased 6% YoY, mainly due to FX and inflation
  • Operating expenses within business development projects relate to life cycle management for Hexvix/Cysview

EBITDA

Q3 EBITDA including business development expenses NOK 3.3 million (NOK 3.9 million ex-BD expense)

Net Financial Items

Includes Ipsen earn-out payments

Segment Performance Third Quarter 2023

North America Segment

in
NOK
million
Amounts
Q3 '23 Q3 '22 Change YTD '23 YTD '22 Change
Total revenues 43.6 42.9 2% 132.0 112.1 28%
Gross profit 42.2 41.4 2% 127.7 108.5 28%
%
of
revenue
97% 97% 97% 97%
Direct costs -34.2 -38.8 -12% -122.6 -116.9 13%
Contribution (1) 8.0 2.7 5.2 -8.5
EBITDA, excl BD -2.2 -7.1 -24.2 -35.6
of
%
revenue
-5% -17% -18% -32%
  • Q3 revenue growth 2% driven by price increases and FX, partially offset by phase down of Cysview usage in the flexible BLC setting
    • In-market unit sales decreased 9%, USD appreciated 5%, price increase 5% in US
  • Q3 direct costs decreased, despite negative impact of FX
  • Contribution improved NOK 5.3 million YoY driven by cost containment

Europe Segment

million
Amounts
in
NOK
Q3 '23 Q3 '22 Change YTD '23 YTD '22 Change
Total revenues 63.4 54.0 17% 196.7 165.6 19%
Gross profit 58.2 50.0 17% 181.9 152.9 20%
of
%
revenue
92% 92% 92% 92%
Direct costs -29.1 -25.6 14% -85.7 -73.5 17%
Contribution (1) 29.1 24.3 96.3 79.5
EBITDA, excl BD 10.4 7.2 43.5 31.3
%
of
revenue
16% 13% 22% 19%

Q3 revenue increased 17% YoY

  • In-market unit sales increased 2% YoY, EUR appreciated 13%, price increases across several countries contributed remaining 2%
  • Expenses were driven by negative impact of FX
  • Contribution improved NOK 4.8 million YoY, driven by higher revenue

Cash Flow & Balance Sheet Third Quarter 2023

NOK
million
Amounts
in
Q3 '23 Q3 '22 YTD '23 YTD '22
Operations Cash Flow 8.7 21.3 28.7 -2.7
Earnings before tax -8.7 -6.3 -6.8 -42.6
Depreciation & amortization 7.2 6.1 20.2 18.1
Working capital 1.8 5.6 -10.0 -14.6
Other 8.4 15.9 25.2 36.2
Investments Cash Flow -2.5 -0.3 -1.8 -2.3
Financing Cash Flow -10.0 -10.2 -39.9 -34.0
Net Change in Cash -3.9 10.8 -13.0 -39.0
NOK
million
Amounts
in
30.09.23 31.12.22
Non-current assets 347.7 360.8
Inventory & receivables 102.8 90.2
Cash & short-term deposits 255.1 268.1
Equity 468.9 462.7
Long-term liabilities 157.3 167.1

Current liabilities 79.3 89.2 Total balance 705.6 719.0

Cash Flow

  • Net cash flow from operations in Q3 NOK 8.7 million, driven by EBITDA adjusted for non-cash cost items
  • Net investment cash flow includes capitalization of certain medical expenses in the U.S.
  • Net cash flow from financing NOK -10.0 million relates mainly to earnout payments to Ipsen
    • Term loan was fully repaid in Q2
  • Net cash flow in Q3 NOK -3.9 million, cash balance end of Q3 NOK 255.1 million

Financial position

  • Non-current assets include intangibles and goodwill from Ipsen transaction totaling NOK 260.7 million
  • Long-term liabilities includes deferred Ipsen earnout totaling NOK 128.7 million
  • Equity NOK 468.9 million, 66% of total assets

Summary

Summary of Q3 results

  • 11% revenue growth / -1% unit sales growth YoY; several initiatives to reaccelerate unit sales momentum
  • 21 Saphira™ towers installed in U.S. (15 new, 6 upgrades)
  • Saphira™ now 35% of rigid towers in U.S.; Strong pipeline for HD BLC equipment remains, 100+ quotes issued
  • EBITDA of NOK 3.3 million (NOK 3.9 million excl. BD); Commercial business EBITDA-positive in the quarter
  • Cash balance strong at NOK 255 million; no term debt
  • BLC awareness continues to rise in urology community, KOL support, and equipment/image quality upgrades
  • Refined guidance; continued challenges from flex phase-down, staffing shortages, capital budget pressures
  • Stryker submits public comment supporting Karl Storz's Citizen's Petition; Potential re-classification of BLC equipment could "unlock" the market for Cysview in the U.S.

Anticipated Milestones & Corporate Objectives

  • 2023 Guidance: 65-75 new Saphira™ blue light tower installations assuming delivery of an anticipated large PO in Q4; consolidated product revenue growth in the range of 17-20% including the impact of FX and the ongoing flexible BLC phase down; and positive EBITDA anticipated in the range of NOK 45-50 million excluding BD spending
  • Continue to grow the base of rigid blue light towers in North America, upgrade BLC® image quality throughout Europe, and 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
  • Continue to geographically expand commercial business by penetrating untapped European markets, and through additional Hexvix® licensing agreements ROW
  • Present/publish additional data from patient registries and other studies on the use of BLC® with Hexvix/ Cysview
  • Continued progress for Asieris Assets: Cevira Phase III data expected at upcoming medical congress, potential for Hexvix regulatory submission in China end of 2023/Cevira in 2024, anticipated milestone payments/future royalties

Leading change in bladder cancer

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