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Photocure ASA

Investor Presentation Mar 3, 2021

3714_rns_2021-03-03_63b717c6-5126-4d0b-9c3a-bd698ca81130.pdf

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Photocure ASA Results for End of Year & 4th Quarter 2020

3 March 2021

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 2019. 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.

Over half a million bladder cancer patients across the world have received our breakthrough product

Our Mission: Delivering transformative solutions to improve the lives of bladder cancer patients

Photocure's four step strategy to deliver on our mission & vision

Photocure's global commercial bladder cancer platform will be the foundation for transformative deals and value growth

Highlights in fourth quarter 2020 and subsequent events:

Cash balance end of Q4 2020: NOK 334.9M

Bladder cancer has been chronically underserved

1) Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: https://gco.iarc.fr/today, accessed [December 2019]. 2) Sievert KD et al. World J Urol 2009;27:295–300 and Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html. 3) Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011;103(2):117-28. 4) Sylvester RJ et al. Eur Urol 2006; 49:466-467 Global Data: Bladder Cancer Report

Hexvix®/Cysview® For better detection and management of NMIBC

Blue Light Cystoscopy: Creating a New Standard of Care "You cannot treat what you cannot see!"

Bladder cancer seen under white light (left) and using Hexvix®/Cysview® blue light cystoscopy® (right) - Courtesy of Professor Dirk Zaak; Traunstein, Germany.

Hexvix/Cysview detected 21%of recurrent patients that were assessed as disease-free under WLC alone in followup/surveillance of non-muscle invasive bladder cancer (NMIBC)2

Key benefits

  • Hexvix/Cysview with BLC offers improved detection and more complete surgical resection leading to a reduced risk of recurrence vs. white light cystoscopy alone1–4,6–9
  • Enables more accurate risk classification leading to better management of disease
  • Offers improved patient monitoring with surveillance cystoscopy for long-term disease management

In the OR, Hexvix/Cysview found 35% of patients with CIS (high-grade NMIBC) that were missed with WLC alone.2

Summary of product characteristics: https://www.hexvix.com/safety-information/ Cysview prescribing information: https://packageinsert.s3.us-east-2.amazonaws.com/Cysview+PI+2020.pdf References: 1. Hermann GG et al. BJU Int 2011; 108(8 Pt 2):E297–E303. 2. Daneshmand S et al. J Urol 2018; 199(5):1158–1165. 3. Stenzl A et al. J Urol 2010; 184(5):1907–1913. 4. Burger M et al. Eur Urol 2013; 64(5):846–854. 5. Hexvix® (hexaminolevulinate hydrochloride) 85 mg Summary of Product Characteristics. 2019. 6. Drejer D et al. Urology 2020; 137:91–96. 7. Gallagher KM et al. World J Urol 2017; 35(12):1871–1877. 8. Geavlete B et al. BJU Int 2012; 109(4):549–556. 9. Grossman HB et al. J Urol 2012; 188(1):58–62.

Supportive environment for becoming the standard of care for the detection & management of bladder cancer

Recommended in global & national guidelines:

The Patient Journey: Characterized by long term follow-up with repeat procedures

Strategic commercial organization

~35 Management / Field Force in the U.S.

Growing Global Countries Footprint

with Distribution / Marketing Partnerships in Canada, Chile, China and Australia/NZ

Management / Field Force in Major European

~27

Photocure Direct Sales & Marketing Partner Sales & Marketing

Partner Marketing Authorization in Process

Q4 2020 Financials

Segment Performance

Fourth Quarter 2020

NOK
million
Amounts
in
Q4 '20 Q4 '19 Change FY '20 FY '19 Change
Commercial Franchise
U.S. Revenue 41.1 27.8 48% 113.2 98.7 15%
Europe Revenue (1) 56.6 30.8 83% 141.6 113.9 24%
Partner Revenue - 0.1 0.4 0.7
Total Hexvix®/Cysview® 97.7 58.8 66% 255.2 213.2 20%
Other Revenue 0.2 0.3 1.0 3.2
Total Revenue 97.9 59.1 66% 256.2 216.4 18%
Operating Expenses -73.0 -49.7 47% -233.7 -186.6 25%
EBITDA before restr. 17.9 1.6 4.2 7.3
Development Portfolio
Total Revenue - 56.4 0.3 65.1
Operating Expenses -2.7 -3.3 -16% -8.2 -13.5 -39%
EBITDA before Restructuring -2.7 53.2 -8.1 51.6
Total Photocure
EBITDA before Restructuring 15.2 54.8 -3.9 58.9

(1) Europe revenue includes own revenue Q4 and partner (Ipsen) revenue Q1-3

Commercial Franchise

  • Revenue: 66% growth in Q4, full year at 20%
  • U.S.: Q4 revenue growth of 48%. Q4 unit sales 11% above Q4 2019, impacted by Covid-19
  • Release of accrual NOK 8 million in Q4, balance of Q2 accrual for discounts
  • Europe: Q4 revenue growth of 83%, driven by inclusion of the former Ipsen business
  • Unit sale 11% below Q4 2019, impacted by Covid-19 including inventory imbalances at customers
  • EBITDA: Q4 at NOK 17.9 million (18% of revenue), full year at NOK 4.2 million
    • Full year negatively impacted by costs associated with the transition of the European business; NOK 7.9 million

Development Portfolio

  • Revenue in Q4 and full year 2019 is sign-on fee and milestones from Asieris
  • Operating expenses in Q3 reduced YOY 39%

Consolidated Income Statement

Fourth Quarter 2020

million
Amounts
in
NOK
Q4 '20 Q4 '19 Change FY '20 FY '19 Change
Hexvix®/Cysview®
Revenue
97.7 58.8 66% 255.2 213.2 20%
Other Revenue 0.2 56.8 1.3 68.3
Total Revenue 97.9 115.6 -15% 256.5 281.6 -9%
Gross Profit 91.0 107.7 -16% 238.0 259.0 -8%
Operating Expenses -75.8 -52.9 43% -241.9 -200.1 21%
EBITDA before Restructuring 15.2 54.8 -3.9 58.9
Depreciation & Amort. -7.7 -3.8 -19.3 -16.2
EBIT before Restructuring 7.5 51.0 -23.2 42.7
Restructuring Expenses -2.5 - -12.9 -
Net Financial Items -5.4 2.3 2.8 3.2
Earnings before Tax -0.4 53.3 -33.2 45.9
Tax Expenses 10.6 -10.7 10.8 -14.1
Net earnings 10.2 42.5 -22.4 31.8

Revenue, Significant One-off Items

  • Excluding one-off's in Q4, YoY revenue increased 52%
  • Q4 2020: Release of accrual NOK 8 million
  • Q4 2019: Sign-on fee & milestones from Asieris of NOK 56.5 million

Operating Expenses

  • Q4 increased mainly due to investment in the European commercial operation
  • Successful transition of the Ipsen territories

EBITDA

Excluding one-off's in Q4, YoY EBITDA increased by NOK 8.9 million

Restructuring Expenses

One-off costs related to transition of the Ipsen territories

Cash Flow

Fourth quarter 2020

in
NOK
million
Amounts
Q4 '20 Q4 '19 FY '20 FY '19
Operations Cash Flow 11.1 30.4 15.6 20.7
Earnings before Tax -0.4 53.3 -33.2 45.7
Contract receivable 10.6 -23.0 23.0 -23.0
Working Capital -16.1 3.1 -5.9 -7.1
Other 16.9 -3.0 31.7 4.8
Investments Cash Flow -0.3 - -166.8 0.6
Fixed & Intangible Assets -0.2 -0.4 -1.6 -1.1
Return of Marketing Rights - - -166.7 -
Other -0.1 0.4 1.6 1.7
Financing Cash Flow 2.3 -1.0 360.8 -2.8
Private Placements - - 301.7 -
Loan -0.3 - 49.7 -
Other 2.6 -1.0 9.4 -2.8
Net Change in Cash 13.0 29.4 209.6 18.5
Ending Cash Balance 334.9 125.3 334.9 125.3

Cash Flow from Operations

  • Comparison with Q4 2019 driven by sign-on and milestones from Asieris in Q4 2019 of NOK 56.5 million
  • Working capital increased in Q4 2020 due to the transition of the Ipsen territories

Cash Flow from Investments

Full year includes acquisition of marketing rights from Ipsen, EUR 15 million

Cash Flow from Financing

Full year net proceeds from private placements of NOK 302 million as well as a loan provided of NOK 50 million

Cash Balance Year End

Year end cash balance at 335 million after net cash inflow in Q4 of NOK 13 million

Balance Sheet

December 31, 2020

Amounts
in
NOK
million
2020
Dec. 31
2019
Dec. 31
Non-Current Assets 363.8 70.5
Customer relationship 162.6 -
Goodwill 144.0 -
Tax
Asset
49.9 38.3
Other 7.4 32.1
Current
Assets
412.2 186.9
Inventory & receivables 77.4 61.6
Cash & equivalents 334.9 125.3
Total Assets 776.0 257.4
Shareholders' equity 508.1 208.6
Earn-out liability 143,7 -
Loan 50.0 -
Other long-term liabilities 7.0 10.0
Current liabilities 67.3 38.7
Total Equity & Liabilities 776.0 257.4

Non-Current Assets

  • Ipsen transaction
  • Accounted for in accordance with IFRS 3. Total Assets includes up-front payment (EUR 15 million) and capitalized value of estimated future earn-out payments
  • Customer relationship NOK 162.6 million, amortized in Q4 NOK 4.2 million
  • Goodwill, based on purchase price allocation
  • Deferred tax asset of NOK 49.9 million, relates to parent company only
  • Other items include impact from adoption of IFRS 16 (Leases) as well as net investments. Reduction due to the Cysview Phase 3 project being fully amortized in 2020, and payments of milestones from Asieris during 2020

Current Assets

Inventory & receivables increased YoY, mainly driven by inventory return from Ipsen and increased receivables due to the inclusion of European revenues

Equity & Liabilities

  • Shareholders' equity of NOK 508.1 million. Equity ratio of 65%
  • Three-year term loan of NOK 50 million, floating interest rate (2.7% in 2020)
  • Earn-out liability: Capitalized value of assumed future earn-out payments

U.S. Positioned for Growth

Cysview Performance: Kit Volume Last 3 Years

Covid-19 volatility in 2020; significant impact in Q2 & Q4

U.S.: Continued blue light cystoscope placements

despite challenges of pandemic

Surgical & Surveillance Approvals Inclusion in Guidelines New Commercial Team/Leadership Improved Reimbursement

Q1 2020: 12 installations (11 Rigid & 1 Flex) Q2 2020: 11 installations (8 Rigid & 3 Flex) Q3 2020: 7 installations (4 Rigid & 3 Flex) Q4 2020: 15 installations (10 Rigid & 5 Flex)

Annual New Installations Cumulative Installed Base

Hexvix® European Operations

Large Untapped Potential in the 150 Mill EUR 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

Europe: 165,000 new cases and more than 50,000 deaths annually1 EU5: 360,000 TURBTs Ave. Hexvix® price ~ EUR 420 Germany: current penetration, >3,500 units per sales FTE, growing Major markets like UK, Spain were not pursued, very limited resources in Italy, France US: 82,500 new cases and more than 18,000 deaths annually1 US: 315,000 TURBTs Ave. Cysview® price ~ USD 1071 Penetration 5-10% Growth rate in excess of 35% Y-o-Y Increased commercial investment and focus delivering results Europe U.S.

Resources Committed for Hexvix® Growth in Europe

  • Direct promotion initiated 1 October 2020
  • Expanded Photocure EU commercial organization from 7 employees to 27 from July 2020 through Feb. 2021
  • 5 experienced Country Managers covering priority regions
  • Distribution channels built across all of Europe
  • Will continue to invest in commercial team opportunistically after Covid -19 has lifted
  • EBITDA -positive segment

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.

Cevira® License Agreement

CEVIRA®: Value From License of Non-Core Asset to Asieris

USD 250M potential in total: Asieris is a Chinese subsidiary focused on genito-urinary diseases, with their own product candidate in clinical development in China and the U.S. for the treatment of NMIBC 1B

CEVIRA® – CERVICAL CANCER

  • Breakthrough, single use, integrated drug-device technology.
  • Potential to fill high unmet need for non-surgical treatment of HPV/CIN populations
  • Potential to treat high grade cervical dysplasia independent of HPV genotype

License Agreement terms:

USD 5M UP-FRONT SIGNING FEE

USD 18M FOR APPROVAL OF 1ST INDICATION IN CHINA (EST 2024) AND USD 36M FOR APPROVAL OF 1ST INDICATION IN U.S./EUROPE (EST 2026)

PAYMENTS UP TO USD 14M FOR SECOND INDICATIONS IN CHINA, U.S. AND EUROPE

ROYALTIES AND MILESTONES ON SALES IN ALL MARKETS

Q3 / Q4 NEWS ON CEVIRA:

  • November 2020: First patient dosed in Phase 3 study in China, \$1.5M milestone payment received
  • October 2020: New EP 2983780 Patent in Europe covering the commercial Cevira device in Europe until 2034
  • July 2020: Asieris received China NMPA's approval to start global Phase 3 clinical trial for APL-1702 (Cevira)

Summary and outlook

Summary & Guidance

Continuing to execute; positioned for growth

  • Hexvix/Cysview sales increased in Q4 and FY 2020 YoY, despite Covid-19 pandemic
  • Added 45 new cystoscope towers in 2020, Installations continuing into early 2021 in both the U.S. and Europe
  • Delivered positive EBITDA in Q4; Cash position grew to NOK 335M from NOK 322M in Q4 vs. Q3 2020
  • Integrated Ipsen acquisition and consolidated rights to Hexvix/Cysview in major markets
  • Managed well through a challenging year, maintained full U.S. commercial team and launched commercial organization in Europe in Q4 2020 to remain prepared for future growth
  • Pandemic not yet resolved; long-term ambition guidance suspended
  • New guidance to be issued when Covid-19 becomes better managed and is in decline
  • Photocure is well-positioned for strong growth post-pandemic

Investment Highlights

Leading change in bladder cancer

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