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Photocure ASA

Earnings Release Feb 23, 2022

3714_rns_2022-02-23_043789f2-a58f-4f1b-8485-d763237a5249.pdf

Earnings Release

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Photocure ASA Results for 4th Quarter 2021

February 23, 2022

Daniel Schneider, President and CEO

Erik Dahl, CFO

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 2020. 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.

Fourth Quarter 2021 Highlights: Progress in both commercial regions despite Covid-19

2 U.S. Registry Publications:

• "Role of BLC in Detecting Invasive Bladder Tumor" in the BJUI

• "Utility of Blue Light Cystoscopy for Post-BCG Bladder Cancer Recurrence Detection…" in The

Journal of Urology

growth and launch of upgraded BLC system in U.S.

China: Asieris initiates Hexvix early access program in Hainan region in December.

of January 1, 2022)

COVID-19 Update Access restrictions continued with Delta/Omicron Variants

Restrictions continued in parts of the U.S. during Q4

  • Leveraged community urology practices while hospital access remained limited
  • Hospitals working through Covid-related staffing shortages
  • Continue to anticipate normalized access and procedure volumes in Q2 2022

Outlook both regions

Covid-19 interruptions expected to continue to limit growth in 1Q 2022

Europe

  • Restrictions returned in Q4 due to Omicron wave
  • Access limited to approximately half of hospitals during Q4 in Europe
  • Staffing shortages in clinics had additional impact
  • Majority of hospitals still expect gradual normalization from Q2 2022 onwards

Segment Trends

U.S. and Europe markets

Q4 2021 Momentum in U.S.

  • Continued business growth during Covid-19 restrictions
  • Unit volume up 11% in Q4 2021, up 16% for FY 2021 year-over-year
  • Cysview uptake in the clinic was a focus in Q4; flexible cystoscopy momentum rising
  • Contracting continues to be key growth driver with accounts taking advantage of volume-based programs
  • OR access and staffing shortages remain a challenge nationwide
  • Strong demand for both rigid and flexible BLC capital equipment continues

Increase in U.S. Market Penetration During 2-year Covid-19 Pandemic

Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Q3 2021 Q4 2021

Market Volume (TURBTs) Sales for Cysview Kits

*Source: Definitive Health monthly claims data; commercial data through 12/21, Medicare data through 6/21. Medicare FY 2021 claims are projected Notes: (1) TURBTs = CPT 52204-52240; (2) 2019-2021 = full year; (4) 2021 = Jan to Dec factored to full year and includes projections for Medicare data; (5) Total Cysview units factored 95% TURBTs

Photocure – Presentation of Q4 2021 Results

Market Volume

Growth Trend Continues in U.S.

Despite surge of COVID-19 variants in Q4 2021

Monthly Unit Sales Trend

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Q1 Q2 Q3 Q4

U.S. continued blue light cystoscope placements

9 Tower installations in Q4 as customers await launch of upgraded Karl Storz system

Annual New Installations Cumulative install base continues strong trend

The New Blue Light will "Elevate the Standard"

Improving the BLC experience with state-of-the-art image quality and practical features to make the technology more user friendly

Key Features and Benefits

Feature Benefit
High Definition Enabling
precision Blue Light and razor-sharp
quality in all visualization modes
New LED Light
Source with
30,000-Hour Life
Providing more consistent light which won't
degrade over time
New Fiber Light
Cable
Giving HCPs convenient autoclave (sterilization)
options
CHROMA Red
Contrast
Enhancement
Allowing more visualization of vascularity
Ergonomic
Integrated Camera
Head
Enabling "Blue Light Intensity Control" with an
easy toggle between visualization modes and
blue light output

Key Initiatives to Drive Growth in the U.S.

CONTRACTING

Ongoing contracting with key health systems and community-based Urology Groups

REFRESHED CYSVIEW CAMPAIGN

New campaign tailored to key physician segments & to educate on the clinical benefits of using BLC

VETERANS AFFAIRS

Recent tower installations, pipeline building interest and demand with key VAs in the United States

PEER-TO-PEER

Virtual and on-site programs have increased access and surge of interest in Blue Light

PATIENT DEMAND

Cysview website locator map serving as a useful tool to get physicians to notice patients are looking for BLC locally

NON-PERSONAL PROMOTION

Expanding brand awareness, opening doors for sales reps through advertisements, mailers etc.

Q4 2021 Trends in Europe

  • Fourth Quarter unit volume up 12% vs. Q4 2020; Positive development in Germany & priority growth markets (France, U.K., Italy), Covid-19 volatility was a factor in 2020 period
  • Full Year unit volume up 3% vs. 2020; Commercial execution first full year after take-over despite pressure from Covid-19 impact
  • Successful bladder cancer bus tour through Europe; ~63% of hospitals involved requested testing of new equipment
  • Photocure European KOL Faculty cooperated on first UROwebinar "Bladder Cancer TURB" highlighting the use of BLC® with Hexvix; over 1,000 views to date

Europe positioned for growth after first full year

Continuing improvement despite multiple COVID-19 surges

Monthly Unit Sales Trend

Large Untapped Potential in European Market

Established Hexvix Markets

Nordics: ~40% penetration

Active Hexvix Markets

DACH region: ~30% penetration France: ~10% penetration Benelux: ~10% penetration

Untapped Large EU Markets

UK, Italy, Spain, Poland ~0% penetration

Untapped Small EU Markets

Baltics, Czech Rep, Hungary, Ireland, Greece, Portugal ~0% penetration

Change of Trend*

Large European Future Growth Markets First Full Year After Take-Over Despite Covid

from -12% in 2020 to +11% in 2021

Italy

from -25% in 2020 to +13% in 2021

UK

from -37% in 2020 to +44% in 2021

Key Initiatives to Drive Growth in Europe

ESTABLISH ADVOCACY

Identify the strongest advocates for BLC among European top experts and leverage their experience

HEXVIX (RE)LAUNCH CAMPAIGN

Impactful campaign to clarify potential misconceptions about Hexvix in formerly neglected/new territories

BLC EQUIPMENT SUPPLIERS

Leverage cooperation opportunities with Equipment Suppliers realizing common business interests

KEY OPINION LEADER FACULTY

Group of experts to educate about BLC supported by developing Centers of Excellence across Europe

ORGANIZATION

Consistently meet opportunity with the right resource and competence level as the commercial situation develops in Europe

BUILD CUSTOMER INSIGHT

Build a strong customer data base in new territories identifying the hot spots for growth and execute

Q4 2021 Financials

Segment Performance Fourth Quarter 2021

U.S. Segment

in
NOK
million
Amounts
Q4 '21 Q4 '20 Change FY '21 FY '20 Change
Total revenues 34.6 41.1 -16% 125.2 113.2 11%
Gross profit 33.5 39.6 -15% 121.3 107.7 23%
%
of
revenue
97% 95% 97% 95%
Direct costs -34.0 -32.2 6% -128.6 -130.7 -2%
Contribution (2) -0.5 7.4 -7.3 -23.0
EBITDA -8.8 3.1 -35.2 -38.1
of
%
revenue
-25% 8% -28% -34%
  • Q4 revenue growth 11% excluding FX impact and one-off (reversed accrual in Q4 '20)
  • Sequential growth 9% in constant currency
  • Unit volume increase Q4: 11% YoY
  • Q4 direct costs growth as planned, full year below prior year

Europe Segment

million
Amounts
in
NOK
Q4 '21 Q4 '20 Change FY '21 FY '20 Change
Total revenues (1) 59.4 56.6 5% 225.8 141.6 59%
Gross profit 53.2 51.3 4% 207.3 129.4 60%
%
of
revenue
90% 91% 92% 91%
Direct costs -26.9 -18.1 -88.7 -30.4
Contribution (2) 26.2 33.2 118.6 98.9
EBITDA 9.6 16.8 63.8 48.4
%
of
revenue
16% 30% 28% 34%
  • Q4 revenue growth 12% in constant currencies
  • FX impact Q4: -7%
  • Unit volume increase Q4: 12% YoY. Main drivers Germany, France, UK
  • Headcount and expense increase as access to care improves
  • (1) Europe revenue includes own revenue from Q4 '20 and partner (Ipsen) revenue Q1-3 '20

(2) Contribution = revenue – COGS – direct/local sales, marketing, medical and G&A costs

Consolidated Income Statement Fourth Quarter 2021

million
Amounts
in
NOK
Q4 '21 Q4 '20 Change FY '21 FY '20 Change
Hexvix/Cysview Revenue 94.2 97.7 -4% 351.4 255.2 38%
Other Revenue 0.3 0.2 9.2 1.3
Total Revenue 94.5 97.9 -3% 360.5 256.5 41%
Gross Profit 87.0 91.0 -4% 336.5 238.0 41%
Operating Expenses -92.5 -75.8 22% -318.2 -241.9 32%
EBITDA before Restructuring -5.5 15.2 18.3 -3.9
Depreciation & Amortization -6.0 -7.7 -24.1 -19.3
EBIT before Restructuring -11.5 7.5 -5.8 -23.2
Restructuring Expenses - -2.5 - -12.9
Net Financial Items -21.5 -5.4 -25.8 2.8
Earnings before Tax -33.0 -0.4 -31.7 -33.2
Tax Expenses 4.9 10.6 0.8 10.8
Net earnings -28.2 10.2 -30.9 -22.4

Revenue

  • Q4 total revenue driven by organic growth in both European and U.S. operations, offset by negative FX impact (~-5%) and a one-off reversed accrual in Q4 '20
  • Q4 growth 11% excl. FX impact & accrual reversal in Q4'20

Operating Expenses

Q4 operating expenses increased YoY mainly due to investment in the European commercial operation

EBITDA

Decline in Q4 EBITDA driven by the one-off reversed accrual in Q4 '20. EBITDA level with prior year adjusted for the one-off accrual reversal and FX

Net financial items

Q4 and FY driven mainly by the Ipsen earnout payment and currency gain in addition to a non-cash valuation adjustment in Q4 of the earnout liability due to higher expected future sales in Europe

Cash Flow & Balance Sheet Fourth Quarter 2021

Amounts
in
NOK
million
Q4 '21 Q4 '20 FY '21 FY '20
Operations Cash Flow 6.3 11.1 23.9 15.6
Earnings before tax -33.0 -0.4 -31.7 -33.2
Depreciation & amortization 6.0 7.7 24.1 19.3
Adjustment earnout liability 17.2 - 17.2 -
Contract receivable (Asieris) - 10.6 - 23.0
Working capital 8.6 -16.1 -3.2 -5.9
Other 7.5 9.2 17.4 12.5
Investments Cash Flow 0.1 0.3 -1.9 -166.2
Financing Cash Flow -13.7 1.7 -34.0 360.2
Net Change in Cash -7.2 13.0 -12.0 209.6
million
Amounts
in
NOK
31.12.21 31.12.20
Non-current assets 376.5 363.8
Inventory & receivables 90.3 77.4
Cash & short-term deposits 322.9 334.9
Equity 502.6 508.1
Long-term liabilities 185.0 188.1
Current liabilities 102.0 79.8
Total balance 789.6 776.0

19 Photocure – Presentation of Q4 2021 Results

Cash Flow

  • Net cash flow in Q4 NOK -7.2 million includes loan repayment of NOK 6.3 million and earnout payments of NOK 7.8 million, partly offset by working capital development of NOK 6.6 million
  • Full year net cash flow includes loan repayment of NOK 12.5 million and earnout payments of NOK 28.8 million. The loan will be fully repaid in 2023
  • FY net cash flow NOK -12.0 million, cash end of 2021 NOK 322.9 million

Financial position

  • Non-current assets includes intangibles and goodwill from Ipsen transaction totaling NOK 89.9 million
  • Long-term liabilities includes deferred Ipsen earnout (NOK 139.4 million) and long-term portion of bank term loan (NOK 12.5 million)

Strategy for Shareholder Value Creation

Hexvix®/Cysview® – ambition to become standard of care in a \$1.9 billion total addressable market**

KEY SUCCESS FACTORS

*AUA, EAU, SUO, AFU, NICE, DGU guidelines **TAM = estimation of total addressable market U.S. and EU5 ¹Source: Photocure internal patient-based model built on Globocan 2019 EU5 data. Photocure – Presentation of Q4 2021 Results

Anticipated Milestones & Corporate Priorities

  • Regain prior sales momentum once Covid-19 is in significant decline
  • Co-launch Karl Storz's upgraded Blue Light system and expand base of BLC capital equipment in the U.S. and European markets
  • Further execute on contracting with GPOs and large Hospital/Health Systems in the U.S.
  • Continue geographic expansion by penetrating untapped European and Canadian markets, and through additional Hexvix licensing agreements ROW
  • Present/publish additional clinical data on the use of BLC® with Hexvix®/Cysview®
  • Report on the progress of partnered companies and license agreements
  • Continue evaluating strategic product or business opportunities

Summary

Continuing to execute despite ongoing Covid-19 & pending Karl Storz BLC launch

  • Delivered strong Hexvix/Cysview volume growth in Q4 2021 despite Covid-19 challenges
  • Strong new account pipeline; customers anticipating new Karl Storz Blue Light system
  • 9 new towers placed in the U.S. during Q4; demand for flexible BLC equipment increasing
  • New Karl Storz system FDA approved in February; National launch expected in H1 2022
  • Continuing to drive key initiatives in both commercial regions and with licensing partners
  • Photocure is well-positioned for strong growth post-pandemic

Leading change in bladder cancer

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