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Photocure ASA

Investor Presentation Aug 18, 2020

3714_rns_2020-08-18_21ed4598-46ff-491e-9f98-ceebcc231b75.pdf

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PHOTOCURE ASA RESULTS FOR 2ND QUARTER 2020

18 August 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 (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 acknowledge 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.

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. For a description of 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. 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.

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. 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.

2 ND QUARTER 2020 HIGHLIGHTS CONTRIBUTING TO PHOTOCURE STRATEGY IMPLEMENTATION

Company highlights:

  • Regaining worldwide rights to Hexvix®: final agreement signed
    • Commercial rights will be transferred to Photocure on 1 October 2020
    • Building the European Organization and Logistics
    • Transition activities with Ipsen are on track
    • Expected to be EBITDA1 accretive from full-year 2021
  • Photocure published its first sustainability report (ESG report)

Financial growth highlights:

  • Positive revenue growth rate in Q2, in spite of Covid-19 pandemic. Hexvix/Cysview revenue growth of 3%
  • Q2 revenue decline in US driven by Covid-19. YTD unit sales 2% below last year
    • Sales rebound from May. June unit sales 7% above last year
  • Significantly improved financial position, cash balance at NOK 499 million
  • Two private placements in April and June 2020, raising a net NOK 303 million
  • Photocure was granted a Covid-19 pandemic related government guaranteed loan of 50 million NOK

Product highlights:

• Key data published by the 2020 American Urological Association (AUA) Annual Virtual Meeting. Three abstracts featured Blue Light Cystoscopy with Cysview®, further supporting the role for Cysview in the office setting.

Partnership highlights:

  • Early July Asieris received China NMPA's Approval to start a Global Phase III Clinical Trial for APL-1702 (Cevira)
  • In August, Photocure appointed Genotests as the exclusive distributor for the commercialization of Hexvix in Chile

Photocure is experiencing Covid-19 impact in the short-term but reiterates its long-term outlook and ambitions

PHOTOCURE AT A GLANCE

  • Norwegian commercial-stage pharmaceutical company focused on bladder cancer.
  • Created in 1997 as a R&D focused company based on its photodynamic cancer therapy technology platform.

CORE PRODUCT ON MARKET

Bladder cancer detection & management

Accelerating revenue growth:

  • +23% total sales revenue growth in 2019
  • NOK 330M global in-market sales*
  • 500 000+ patients with Hexvix /Cysview worldwide
  • Regain European rights from 1 October

NOK 2.0 billion Market cap**

559% share turnover annualized**

Oslo Stock Exchange: IPO May 2000

* Total In Market Sales including U.S., Nordic and Partners ** 14/08/2020

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

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: CREATING A NEW STANDARD OF CARE "YOU CANNOT TREAT WHAT YOU CANNOT SEE!"

9

  • 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

  1. Burger et al. Eur. Urol. 2013

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

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

* Ta, T1, CIS: Non muscle invasive bladder cancer tumor types

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

5-Year Relative Survival Rate (%)

Stage Recurrence rate Progression to MBIC
Low grade Ta 70% 2%
High-grade Ta 50-80% 14-48%
T1 70% 30-50%
Cis 43-73% 50%

10 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/

Q2 2020 Financials

SEGMENT PERFORMANCE SECOND QUARTER 2020

Amounts in NOK million Q2 '20 Q2 '19 Change YTD '20 YTD '19 Change
Commercial Franchise
US revenue 21.5 24.5 -12% 49.8 45.6 9%
Nordic revenue 13.9 10.7 30% 26.1 23.8 10%
Partner revenue 20.4 16.9 21% 34.3 33.9 1%
Revenue adjustment
(*)
-2.3 -2.3
Total Hexvix/Cysview 53.5 52.1 3% 107.9 103.3 4%
Other revenue 0.2 0.9 0.5 1.9
Total revenue 53.7 53.0 1% 108.4 105.2 3%
Operating expenses -58.1 -46.9 24% -110.4 -92.0 20%
EBITDA before restr. -6.4 1.5 -10.0 3.2
Development Portfolio
Total revenue - - 0.3 -
Operating expenses -2.5 -4.1 -39% -3.8 -7.3 -48%
EBITDA before restr. -2.5 -4.1 -3.7 -7.3
TOTAL
EBITDA before restr. -8.9 -2.6 -13.7 -4.1

Commercial Franchise

  • U.S.: Q2 revenue decline driven by Covid-19. YTD unit sales 2% below last year
    • Sales rebound from May. June unit sales above last year
  • Nordic: Q2 revenue increased 30%, mainly driven by Covid-19 related safety stock ordered by Danish authorities. YTD revenue increase 10%, in constant currencies 1%
  • Partner: Revenue increase of 21% in Q2, driven by true-up of billing of COGS/royalty for Q1 to Ipsen
  • Revenue adjustment relates to revenue items incurred in previous years, accounted for in Q2
  • Increased operating expenses, YTD at 20% YOY, currency impact at approximately 10%

Development Portfolio

• Operating expenses YTD reduced YOY 48%

(*) Revenue adjustment: Revenue items for previous periods accounted for this period

CONSOLIDATED INCOME STATEMENT SECOND QUARTER 2020

Amounts in NOK million Q2 '20 Q2 '19 Change YTD '20 YTD '19 Change
Hexvix/Cysview revenue 53.5 52.1 3% 107.9 103.3 4%
Other revenue 0.2 0.9 0.8 1.9
Total revenue 53.7 53.0 1% 108.6 105.2 3%
Gross profit 51.7 48.5 7% 100.5 95.2 6%
Operating expenses -60.6 -51.0 19% -114.2 -99.3 15%
EBITDA before restr. -8.9 -2.6 -13.7 -4.1
Depreciation & Amort. -3.9 -4.2 -7.8 -8.5
EBIT before restr. -12.8 -6.8 -21.4 -12.6
Restructuring
expenses
-1.3 - -3.2 -
Net financial items 0.3 0.1 6.0 -0.1
Earnings before tax -13.8 -6.7 -18.7 -12.6
Tax expenses 5.1 1.5 -7.8 2.6
Net earnings -8.7 -5.2 -26.4 -10.1
  • Operating expenses, increase driven by
    • Significant FX impact, average approximately 10%
    • Costs related to share-based compensation, and scaling of U.S. and group organization
  • Restructuring expenses
    • Work related to the Ipsen agreement, including transition costs
  • Net financial items
    • YTD driven by FX on receivables
  • Tax expense, non cash
    • YTD release of tax asset driven by net income in parent company due to FX. No tax payable

CASH FLOW SECOND QUARTER 2020

Amounts in NOK million Q2 '20 Q2 '19 YTD '20 YTD '19
Operations cash flow 11.4 -4.0 14.4 -19.7
Earnings before tax -13.8 -6.7 -18.7 -12.6
Working capital 21.0 0.6 14.4 -12.0
Other 4.3 2.1 18.7 4.9
Investments cash flow 0.3 0.1 -0.1 0.7
Development exp. -0.2 - -0.4 -
Other 0.5 0.1 0.4 0.7
Financing cash flow 360.1 -0.9 359.7 -1.1
Private placements 303.0 - 303.0 -
Loan 50.0 - 50.0 -
Other 7.1 -0.9 6.8 -1.1
Net change in cash 371.9 -4.7 374.1 -20.2
Ending cash balance 499.4 86.7 499.4 86.7
  • Cash flow from operations in Q2 improved mainly due to working capital (accounts receivables, accruals) while YTD improvement was driven by milestone payment of USD 1.5 million from Asieris
  • Cash flow from financing includes net proceeds from private placements of NOK 303 million as well as a loan provided of NOK 50 million
  • Net change in cash YTD at NOK 374.1 million
  • Quarter end cash balance at NOK 499.4 million

BALANCE SHEET 30 JUNE 2020

Amounts in NOK million 30.06
2020
31.12
2019
Non-current assets 55.9 70.5
Investments 8.7 13.6
Tax asset 30.6 38.3
Other 16.6 18.5
Current
assets
556.3 186.9
Inventory & receivables 56.9 61.6
Cash & equivalents 499.4 125.3
Total assets 612.3 257.4
Shareholders equity 496.9 208.6
Loan 50.0 -
Other long-term liabilities 8.8 10.0
Current liabilities 56.6 38.7
Total equity & liabilities 612.3 257.4

• Non-current assets

  • Net investments of NOK 8.7 million, driven by investments in Cysview phase 3 project. This project will be fully amortized in 2020
  • Deferred tax asset of NOK 30.6 million. Reduced mainly due to foreign exchange movements in parent company
  • Other items includes impact from adoption of IFRS 16 (Leases) as well as the long-term part of the Asieris receivable
  • Inventory & receivables reduced, mainly driven by payment of the short-term part of the Asieris receivable
  • Shareholder's equity of NOK 496.9 million. Equity ratio of 81%
  • Three-year term loan of NOK 50 million, floating interest rate
  • Other long-term liabilities include impact from adoption of IFRS 16 (Leases)

SOLID FINANCIAL POSITION TO MEET OUR AMBITIONS – NOK 500 MILLION IN CASH AT HAND

  • Photocure had NOK 499.4 million in cash at the end of Q2
    • Positive net cash flow from operations
    • Private placements on 27 April and 24 June, raising a total net of NOK 303 million
    • Bank financing of NOK 50 million
  • Use of proceeds:
    • Create and scale up a world-class marketing, sales, and distribution infrastructure after transfer of the business previously owned and managed by Ipsen
    • Finance growth and working capital, including expansion in underserved countries and new geographies currently not served by Photocure or Ipsen
    • Explore new product opportunities / development, and new geographies for Hexvix/Cysview to expand and secure market position
    • General corporate purposes

Expand and Acquire Worldwide Rights to Hexvix

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
  • Expected to be EBITDA1 accretive from full-year 2021
  • 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%)

UNTAPPED EU/SAE MARKETS: UK, SPAIN, ITALY & OTHER COUNTRIES

~0% penetration

Europe U.S.
Europe: 165,000 new
cases and more than
50,000 deaths
annually1
US: 82,500 new cases
and more than 18,000
deaths annually1
EU5: 360,000 TURBTs US: 315,000 TURBTs
Ave. Hexvix price ~
EUR 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

Positioned for growth

U.S.: ACCELERATED MOMENTUM H1 2020 REVENUES EXCEED H1 2019 DESPITE COVID-19 IMPACT

U.S. ACCELERATED MOMENTUM: INSTALLATIONS FUEL FUTURE GROWTH

Annual New Installations Cumulative install base continues strong trend

HEXVIX®/CYSVIEW® – KEY MARKET ENABLERS IN PLACE: READY FOR GROWTH AND OUR AMBITION TO BECOME THE STANDARD OF CARE

GROWING INTEREST FROM THE SCIENTIFIC COMMUNITY FOR BLUE LIGHT CYSTOSCOPY WITH HEXVIX®/CYSVIEW®

IP Protection 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

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

1

2

Cevira® License Agreement

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

License Agreement terms: USD 250 mill potential in total:

New in July 2020: Asieris received China NMPA's Approval to start a Global Phase III Clinical Trial for APL-1702 (Cevira)

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 total USD 18 million in China (est 2024) and USD 36 million in US/EU (est 2026)
  • A second indication in China, the U.S. and the EU would result in payments of up to USD 16 million
  • Sales royalties and milestones will apply in all markets

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

Summary and outlook

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 asap

30 * 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.

GUIDANCE: APPROXIMATELY 1BN REVENUE IN 2023

• Current-year guidance:

  • Strong back-half of Q2 momentum continues
  • Temporary pressure on revenue due to COVID-19 impact
    • Postponed procedures / restricted access to OR
    • Unknown impact on installed base growth in near term: capital equipment budgets are being temporarily reprioritized.
  • Rebound in H2: steady return expected. Hospitals are better prepared in case there is a second wave of the pandemic

• 2023 guidance:

  • Group revenues ambitions in the range of NOK 1 billion
  • EBITDA margins approximately 40%

CREATING THE LEADING BLADDER CANCER COMPANY

Ambition of worldwide revenues in range of NOK 1 Billion in 2023 and approximate 40% EBITDA margin in 2023

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