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Photocure ASA

Earnings Release Apr 27, 2020

3714_rns_2020-04-27_cdff4083-e564-4b25-961b-580ab6e447b1.pdf

Earnings Release

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PHOTOCURE ‒ COMPANY UPDATE

27 April 2020

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").

The presentation has been prepared by the Company for information purposes only and does not constitute, and should not be construed as, an offer to sell or a solicitation of an offer to buy any securities 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 information contained in this Presentation has not been independently verified. This Presentation contains information which has been sourced from third parties believed to be reliable, but without independent verification. None of the Company or any of its subsidiary undertakings or affiliates, or any directors, officers, employees, advisors or representatives (collectively "Representatives") of any of the aforementioned make any representation or warranty (express or implied) whatsoever as to the accuracy, completeness or sufficiency of any information contained herein, and nothing contained in this Presentation is or can be relied upon as a promise or representation by the Company or any of its Representatives.

None of the Company or any of its Representatives shall 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 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 content of this Presentation are not to be construed as legal, business, investment or tax advice or other professional advice. The Recipient should consult with its own professional advisers for any such matter and advice.

An investment in the Company involves significant risk, and several factors could adversely affect the business, legal or financial position of the Company or the value of its securities. Such risks include but are not limited to economic and market conditions in the geographic areas and markets where the Company is or will be operating, IP risks, clinical development risks, regulatory risks, fluctuations in currency exchange rates, and changes in governmental regulations. For a description of relevant risk factors it is referred 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. An investment in the Company is suitable only for investors who understand the risk factors associated with this type of investment and who can afford a loss of all or part of their investment.

DISCLAIMER (CONTINUED)

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, sometimes identified by the words "believes", "expects", "predicts", "intends", "projects", "plans", "estimates", "aims", "foresees", "anticipates", "targets", and similar expressions.

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 forwardlooking statements. None of the Company or its Representatives provides 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 contains financial information derived from the Company's audited consolidated financial statements, as well as the Company's un-audited interim financial reports. To obtain complete information of the Company's financial position, operational results and cash flow, the financial information in this Presentation must be read in conjunction with the Company's audited financial statements and other financial information made public by the Company.

This Presentation contains information about views and opinions regarding the Company's performance, products and prospective products, including the usage, potential usage, competitiveness and results of such products, and the markets in which the Company operates. In the absence of exhaustive industry or market reports, the Company has assembled information about its markets through formal and informal contacts with industry professionals, its competitors as well as its own experiences. These estimates have not been verified by independent experts, and there is no guarantee that these estimates are accurate or complete, or free from errors.

This Presentation speaks as at the date set out on herein. Neither the delivery of this Presentation nor any further discussions of the Company or its Representatives with the Recipient shall, under any circumstances, create any implication that there has been no change in the market or the affairs of the Company since such date. Neither the Company nor its Representatives assumes 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.

PHOTOCURE AT A GLANCE

Oslo (HQ)

Norwegian commercial-stage pharmaceutical company focused on bladder cancer with commercial operations in Nordics and USA. Partners in Europe, Canada, Australia and New Zealand

Princeton (NJ)

CORE PRODUCT ON MARKET

Bladder cancer detection & management

Accelerating revenue growth:

+23% total sales revenue growth in 2019

NOK 1.5 billion Market cap**

NOK 330M global in-market sales*

500 000+ patients treated with Hexvix / Cysview worldwide

650K Avg daily volume YTD**

Oslo Stock Exchange: IPO May 2000

* Total In Market Sales including US, Nordic and Partners ** 24/04/2020

PHOTOCURE BEFORE AND NOW

Global Leader in Photodynamic Therapy (PDT)

As of 1997

New strategic focus:

The Bladder Cancer Company

2018

Continue success of Hexvix/Cysview

Expand portfolio of bladder cancer assets

2020 + beyond

OUR MISSION IS TO DELIVER TRANSFORMATIVE SOLUTIONS WHICH IMPROVE THE LIVES OF BLADDER CANCER PATIENTS

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

"YOU CANNOT TREAT WHAT YOU CANNOT SEE!"

  • Risk that 20-35% of cancer patients will be missed, if Blue Light Cystoscopy is NOT used1,2
  • Risk of wrong risk-classification leading to mismanagement of disease, if Blue Light Cystoscopy is NOT used
  • Incomplete resection of bladder tumors leading to increased risk of recurrence and progression to more advanced disease, if Blue Light Cystoscopy is NOT used

  • Burger et al. Eur. Urol. 2013

  • Daneshmand S et al. The Journal of Urology, Vol.199, 1158-1165, May 2018

Expand and Acquire World Wide Rights to Hexvix

. . . . . . . . . . . . .

KEY DEAL CONSTRUCTS

  • Agreement with Ipsen for the return of Hexvix® sales, marketing and distribution rights in Europe and other markets currently controlled by Ipsen
  • Photocure will commence the commercial operations with Hexvix in Europe from 1 October 2020
  • Countries not currently partnered or commercialized by Ipsen will be returned to Photocure upon signing
  • Photocure will pay Ipsen EUR 15 million in acquisition cost on the date of transfer
  • To be funded through equity issue and cash balance
  • Ipsen will book sales up until 30 September 2020. After transition Ipsen will receive earn-out payments in the range of 10-15% of sales (years 1-7) and 7.5% of sales (years 8-10) in the current Ipsen markets
  • The costs associated with the return of Hexvix® sales, marketing and distribution rights in Europe and other markets currently controlled by Ipsen is to be financed through a combination of cash, debt and/or equity
  • Received offers from debt providers, and agreements on financing may be entered into to ensure completion of the settlement 1

PHOTOCURE UNLOCKS TREMENDOUS POTENTIAL IN EUROPE

  • Apply commercial success & strong growth in the Nordic and the U.S. markets to the European region
  • Deep knowledge of our product and the disease state
  • Minimal learning curve needed
  • Leveraging our international expertise
  • Expanding our global footprint
  • Build a scalable business platform for future acquisitions and growth
  • Building upon our credibility in the bladder cancer space

Strategic opportunity Value-creation opportunity

  • After transition year targeting 20-30% annual revenue growth in current Ipsen territories
  • Revenue in the range of NOK 1 billion (2023)
  • Expected to be EBITDA1 accretive from full-year 2021
  • EBITDA margin approximately 40% (2023)
  • Current EU penetration (except DACH) is <5% Opportunity to reach Nordic penetration level of 40%
  • Focused EU investment maximizing revenue returns

LARGE UNTAPPED POTENTIAL IN THE EUR 150 MILL EUROPEAN MARKET (CURRENT EU PENETRATION (EXCEPT DACH) <5% WITH OPPORTUNITY TO REACH NORDIC LEVEL OF 40%)

0% penetration

Europe U.S.
Europe: 165,000 new
cases, 550,000
prevalent cases, and
more than 50,000
deaths annually1
US: 82,500 new cases,
280,000 prevalent
cases, and more than
18,000 deaths
annually1
EU5: 360,000 TURBTs US: 315,000 TURBTs
Ave. Hexvix price ~
415€
Ave. Hexvix price ~
USD 1070
Germany: 30% current
penetration, >3,500
units per sales FTE,
growing
Penetration 5-10%
Growth rate in excess
of 35% Y-o-Y
Major markets like UK,
Spain not pursued, very
limited resources in
Italy, France
Increased commercial
investment and focus
delivering results

SYNERGISTIC OPPORTUNITY LEVERAGING OUR INTERNAL EXPERTISE:

Get people in place with competencies and skills to address challenges and opportunities

EU General Manager recruited to lead initial organization of 20 FTEs

Supported by global functions with established training, medical and marketing programs and tools

Drive use of Hexvix in existing clinics Expand the number of clinics Leverage Photocure's relationship with equipment suppliers Increase KOL advocacy & engagement Improve market access & reimbursement Build strong Patient Advocacy relationships as in U.S.

Leverage infrastructure, synergies, global approach and consistent global brand

Implement Best practices

Leverage investment in U.S. marketing and medical – scalable into global platforms

Accelerate / Expand / Acquire / Transform:

Establish global bladder cancer footprint in line with our strategy

Ambitions – driving change in our area of expertise

Continuity – dedicated team and performance-based culture

Q1 update and guidance

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1 ST QUARTER HIGHLIGHTS CONTRIBUTING TO PHOTOCURE STRATEGY IMPLEMENTATION

Financial growth highlights:

  • Positive growth rate in Q1, Hexvix/Cysview revenue growth of 6%
  • Some impact of Covid-19 during the last weeks of the quarter
  • Q1 revenue growth YoY in U.S. was 21% in USD, driven by 17% growth in unit sales
  • US accounts for 52% of our total sales revenue
  • Installed base of rigid and flex BLC +14 Rigid, +1 Flex
  • Cost reduction initiatives to reduce impact of Covid-19

Partnership highlights:

• Asieris payment of USD 1.5 million in Q1, according to license agreement

Product highlights:

  • U.S. patent for neoadjuvant therapy for patients scheduled for cystectomy (Expiry 2036)
  • Traction for the procedure on regional Fox News channel: Fox 11 LA program in January 2020 on Blue Light Technology in Bladder Cancer

COVID-19 ORGANIZATION RESPONSE

  • Transparency: Informing the markets early on (for details, see Market Update #2, April 7, 2020)
  • Market & Demand situation: Bladder cancer treatments are prioritized procedures but there are short-term postponements of procedures
  • Priority on the health and welfare of all Photocure employees and stakeholders: remote work arrangements & travel policies across locations/functions
  • Financial situation: Cost saving measures taken during Q2 to counteract COVID-19 impact
  • Uninterrupted supply chain: production & inventory satisfactory
  • Outlook: Experiencing some COVID-19 impact in the short-term but long-term outlook remains strong
  • Continuing to update the markets as the situation evolves

OPTIMISTIC TO REBOUND FROM COVID-19 IMPACT IN H2

BLCTM with Hexvix®/Cysview® can play an integral part in this situation: postponed procedures* do not postpone aggressive cancer progression

  • Patient safety through better detection of bladder cancer tumors, in spite of the potential longer check-up intervals during the COVID-19 crisis
  • Low and medium-risk patient categories in particular could be treated in the office/flex setting:
  • less restrictive for the patients
  • performing flexible Blue Light Cystoscopies in the office setting frees up hospital capacity
  • Less recurrence and avoiding progression to muscle-invasive bladder cancer stages
  • The ministry of health in several countries urging hospitals to start addressing the backlog of procedures and surgeries as soon as possible

17 * Low and medium-risk patients category will be postponed, not the high-risk patient category. According to this, roughly 45% of patients should not be postponed and they represent close to 50% of TURBTs Internal data: USA, EU5 & Nordics figures: Please note market breakout 30% TURBTs and 70% Cystoscopies.

SEGMENT PERFORMANCE FIRST QUARTER 2020

Amounts in NOK million Q1 '20 Q1 '19 Change FY '19
Commercial Franchise
US revenue 28.2 21.2 33% 98.7
Nordic revenue 12.2 13.1 -7% 48.2
Partner revenue 14.0 17.0 -18% 66.3
Total Hexvix/Cysview 54.4 51.2 6% 213.2
Other revenue 0.3 1.0 3.2
Total revenue 54.7 52.2 5% 216.4
Operating expenses -54.0 -45.1 20% -186.6
EBITDA -5.2 1.7 7.3
Development Portfolio
Total revenue 0.3 - 65.1
Operating expenses -1.5 -3.2 -53% -13.5
EBITDA -1.4 -3.2 51.6
TOTAL
EBITDA -6.7 -1.5 58.9
18

Commercial Franchise

  • US: Strong revenue growth 33%. Growth in USD 21%, driven by unit sales and price
  • Impact of Covid-19 on unit sales from last two weeks of quarter
  • Installed base of rigid and flex BLC 238 at quarter end, and increase of 15 units in the quarter. Increased 39% YOY
  • Nordic: Q1 revenue decline 7%, mainly driven by reduced unit sales in Denmark due to stock up at hospitals end of 2019
  • Partner: Revenue decline in Q1 18%. Largest driver is billing of COGS to partner (Ipsen)
  • Increased operating expenses, Q1 at 20% YOY, sales and marketing programs in general and commercial investments in US

Development Portfolio

• Operating expenses Q1 reduced YOY 53%

CONSOLIDATED INCOME STATEMENT & CASH POSITION FIRST QUARTER 2020

Amounts in NOK million Q1 '20 Q1 '19 Change FY '19
Hexvix/Cysview revenue 54.4 51.2 6% 213.2
Other revenue 0.6 1.0 68.3
Total revenue 55.0 52.2 5% 281.6
Gross profit 48.8 46.8 4% 259.0
Operating expenses -55.5 -48.3 15% -200.1
EBITDA -6.7 -1.5 58.9
Depreciation & Amort. -3.9 -4.2 -16.2
EBIT -10.5 -5.8 42.7
Net financial items 5.7 -0.2 3.2
Earnings before tax -4.8 -6.0 45.9
Tax expenses -12.9 1.0 -14.1
Net earnings -17.7 -4.9 31.8
Net change
in cash
2.2 -15.4 18.5
Ending cash balance 127.6 91.4 125.3

19

  • Operating expenses, increase driven by
  • Planned investments in US commercial operations (sales & marketing) as well as program spending
  • Significant FX impact, approximately 8%
  • Net financial items driven by FX on receivables (Asieris license agreement)
  • Tax expense, non cash: Net income in parent company due to FX drives release of tax asset. No tax payable
  • Strong cash position, NOK 128 million at quarter end
  • Net inflow NOK 2.2 in Q1, including USD 1.5 million from Asieris

Operating expenses, quarterly (NOK million)

GUIDANCE: APPROXIMATELY 1BN REVENUE IN 2023

• Current-year guidance:

  • Q1 revenue growth YoY in U.S. at 21% in USD, driven by 17% growth in unit sales
  • Near term temporary pressure on revenue due to COVID-19 impact
  • Rebound in H2: steady return expected
  • 2023 guidance:
  • Group revenues ambitions in the range of NOK 1 billion
  • EBITDA margins approximately 40%

Positioned for growth

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HEXVIX®/CYSVIEW® – KEY ENABLERS IN PLACE AND READY FOR GROWTH

SUPPORTIVE ENVIRONMENT & INCREASING AWARENESS FOR BECOMING THE STANDARD OF CARE FOR THE DETECTION AND MANAGEMENT OF BLADDER CANCER

Inclusion in Bladder Cancer treatment guidelines

BLC™ with Hexvix® /Cysview® is strongly recommended by US, European and national guidelines as well as expert panels.

  • 80% adoption rate in top Cancer centers and growing Established in >170 key US cancer hospitals and leading institutions
  • Patient preference

growing awareness and active preference as shown in recent BCAN survey

  • Favorable and Permanent US Reimbursement 2019
  • Partnering with prominent Patient Associations especially BCAN in the US and the new World Bladder Cancer Patient Coalition

US: ACCELERATED MOMENTUM INSTALLED BASE OF CYSTOSCOPES IN THE US

US: THE INVESTMENT MADE WILL DELIVER ACCELERATED RETURNS

Strategy – Target Key Hospitals in the 30 largest MSAs in the US

2018/19 – We have built the Commercial Foundation

  • Sales team focused on top 700+ centers that influence bladder cancer care in their regions
  • Team is composed of 28 Surgical Sales Executives ("hunters" sell to new accounts) and 5 Clinical Support Specialists ("farmers" – increase utilization of current accounts)
  • Average territory for sales rep at peak sales: USD 1.5 2 mill in revenues
  • Future investment would be predicated on gaining optimal account coverage with similar ROI
  • Continuous improvement to build a performance driven culture

HEXVIX®/CYSVIEW® FUTURE POTENTIAL: THERAPEUTIC PATENT SECURED

Recent early stage studies show a potential treatment effect of Blue Light Cystoscopy (BLC™) with Hexvix1

Study results: a treatment effect could be related to

  • direct anti-tumor effect
  • immune cell activation
  • Photocure has the intention to further explore areas of utility of Hexvix/Cysview
  • Therapeutic effect

US Patent issued Feb 11th 2020 covering the use of Hexvix as a neoadjuvant agent in the treatment of patients scheduled for cystectomy

– Other areas of early investigation include enhancing the detection and physician experience and the use of Hexvix/Cysview in combination therapy

IP Strategy

DRUG-DEVICE COMBINATION ‒ HURDLES TO MARKET ENTRY NO PDT PRODUCTS HAVE EXPERIENCED GENERIC COMPETITION (VISUDYNE, METVIX) TO DATE

IP*/Intellectual Property

Review multiple patents, regulatory data protection in the US with market exclusivity for office use/flex

2

1

Desk research/Market size

No straightforward access to sales data and performance – different hospital distribution paths, ATC classification "Other diagnostics"

Technical/Manufacturing hurdles

3

API manufacturing or sourcing – meet EU/US pharmacopeia monograph specifications

Freeze dry API under aseptic conditions. Solvent in vial or prefilled syringe. Manual/semi manual packaging/labeling

Photocure exclusivity with only commercial medical API supplier in the world

4

5

Regulatory hurdles

A drug-device combination product. ANDA1 for drug, PMA2 for device. Multiple FDA offices. Participation by 2 companies, requires device manufacturer relationship and coordinated process

No clear drug approval standard: How to document "bioequivalence?"

Note: 1) Abbreviated new drug application; 2) Premarket approval

Commercial challenges

Active product support incl. training of physicians and nurses, facilitate workflow

* European patent expired September 2019, US patent valid until November 2020, Data exclusivity on flex valid until February 2021 PDT patent in the US granted until December 2036, Additional patents pending

IN ADDITION, PHOTOCURE IS CONTINUOUSLY FOCUSING ON KEY STRATEGIC INITIATIVES TO FURTHER STRENGTHEN ITS LONG-TERM COMPETITIVENESS

Cevira® License Agreement

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. . . . . . . . . . . . . . .

CEVIRA®: LICENSE AGREEMENT WITH ASIERIS

ASIERIS MEDITECH CO., Ltd.

  • Asieris is a subsidiary of the China-based Jiangsu Yahong Meditech Co., Ltd., a specialty pharma company
  • Strong development capabilities in genitourinary diseases (GU) area in China, rapidly expanding its global capability
  • Leading drug candidate for treating non-muscle invasive bladder cancer, is in a registrational clinical trial in China and Phase Ib trial in the US

CEVIRA® – CERVICAL CANCER

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

License Agreement terms: USD 250 mill potential in total:

  • Under the License Agreement, Photocure has received a total signing fee of USD 5 million in 2019
  • 1 st milestone payment of USD 1.5 million in Q1 2020
  • Approval of the initial indication will result in USD 18 million in China (est 2024) and USD 36 million in US/EU (est 2026)
  • A second indication in China, the US and the EU would result in payments of up to USD 14 million
  • Sales royalties and milestones will apply in all markets

Summary and outlook

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OUR OPPORTUNITY FOR INCREASING MOMENTUM

6- This is why we maintain the long-term guidance 1- Increased global focus on health post Covid-19. Opportunities to improve dialogue with healthcare authorities and enhance public awareness about bladder cancer

5- The need for Bladder Cancer diagnosis and treatment is unchanged in the long-term

2- BLCTM with Hexvix®/Cysview® offers superior detection and management. "Postponed patients" should benefit from BLC as "the new normal": cancer progression hasn't stopped

4- Solid financial position & strong underlying sales momentum (U.S.) providing a platform for long-term growth 3- Office setting using a flexible cystoscope: less restrictive for patients and freeing hospital resources

CREATING THE LEADING BLADDER CANCER COMPANY

Ambition of world wide revenues in range of NOK 1 Billion in 2023

Appendix

THE PATIENT JOURNEY – CHARACTERIZED BY LONG TERM FOLLOW-UP WITH REPEAT PROCEDURES

Hexvix®/Cysview®: Use for the 1st TURBT and for all intermediate and high-risk NMIBC patients during surgical treatment and surveillance / follow-up

*TURBT: trans-urethral resection of bladder tumors

HEXVIX®/CYSVIEW® FOR BETTER DETECTION AND MANAGEMENT OF NMIBC

A Drug Device combination for better visual contrast between benign and malignant cells

Hexvix / Cysview is used with a blue light enabled cystoscope, from Karl Storz, Wolf or Olympus

BLUE LIGHT CYSTOSCOPY CAN PROVIDE AN ACCURATE AND COMPLETE 1ST TURBT – CRITICAL FOR PATIENT OUTCOMES

Bladder Cancer Progression and Recurrence

Key therapeutic aim is to avoid progression from non-muscle invasive bladder cancer ("NMIBC") to muscle invasive bladder cancer ("MIBC")

  • The first TURBT is essential for patient outcomes: correct diagnosis, complete removal of all lesions.2
  • The two most important factors for progression to MIBC:
  • presence of CIS*, the flat and hard to detect lesions with a high tendency to progress
  • presence of high grade tumor

For the same patient having CIS more than doubles their probability to progress to MIBC

40 Sources: All: Global Data: Bladder Cancer Report, Sylvester RJ et al. Eur Urol 2006

Note: 1) Stages from tumor growing into the perivesical tissue and until it has spread to the prostate, uterus or vagina; 2) The tumor has spread to the pelvic wall or the abdominal wall except

2: Babjuk M et al. EAU Guidelines Non-muscle-invasive Bladder Cancer 2018 http://uroweb.org/guideline/ non-muscle-invasive-bladder-cancer/

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