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Photocure ASA

Earnings Release Jan 9, 2017

3714_rns_2017-01-09_8e4be05e-ab7b-41a5-96f8-6c40462e03ee.pdf

Earnings Release

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Photocure ASA

JANUARY 2017

Disclaimer

The information included in this Presentation contains certain forward-looking statements that address activities, events or developments that Photocure ASA ("the Company") expects, projects, believes or anticipates will or may occur in the future. These statements are based on various assumptions made by the Company, which are beyond its control and are subject to certain additional risks and uncertainties. The Company is subject to a large number of risk factors including but not limited to economic and market conditions in the geographic areas and markets where Photocure is or will be operating, IP risks, clinical development risks, regulatory risks, fluctuations in currency exchange rates, and changes in governmental regulations. For a further description of other relevant risk factors we refer to Photocure's Annual Report for 2015. As a result of these and other risk factors, actual events and our actual results may differ materially from those indicated in or implied by such forward-looking statements. The reservation is also made that inaccuracies or mistakes may occur in this information given above about current status of the Company or its business. Any reliance on the information above is at the risk of the reader, and Photocure disclaims any and all liability in this respect.

Photocure – Investment Highlights

Commercial-stage company focused on Urology

  • Hexvix®/Cysview® for improved detection and management of bladder cancer
  • ─ Improved detection, reduced disease recurrence and progression rates with cost benefits
  • ─ ~USD 30M global in market sales (LTM); EBITDA USD 2.8 million (LTM)
  • Specialist salesforce established in US and Nordic region and additional emerging operations in other high value territories through partners
  • ─ Ipsen (EU), Juno Pharmaceuticals (Australia/New Zealand), BioSyent Pharma (Canada)

Value building opportunities anticipated in next 12 – 24 months

  • Large untapped potential for Hexvix/Cysview in existing and new market segments/territories
  • ─ New clinical data in Flex scope/surveillance use with potential label extension in the US; clarity on reimbursement in US
  • Partnering opportunities for non-urology assets
  • ─ Cevira® (cervical disease) and Visonac® (Acne)
  • Exploring expansion of urology portfolio to leverage commercial infrastructure

Hexvix/Cysview

.
.
.

The Current State of Bladder Cancer

Bladder Cancer is 5th most common cancer type

  • Most expensive cancer: \$96-187K/patient1
  • 200,000 new patients annually

  • 75% of patients diagnosed with NMIBC2
  • 16,000 will die from bladder cancer in US in 2016

Key therapeutic aim is to avoid progression from NMIBC to muscle invasive disease

  • ~ 6 million cystoscopies for initial screening annually worldwide
  • ~ 600,000 surgical procedures (TURBs3 ) annually worldwide
  • 10% 30% progression rate

Regular ongoing surveillance required

  • Recommend follow up cystoscopies every 3-9 months
  • 2M follow up surveillance cystoscopies annually worldwide

5

Unmet Medical Needs

Bladder cancer is associated with a high risk of

  • Recurrence:1
  • ─ Up to 61% at 1 year
  • ─ Up to 78% at 5 years for NMIBC
  • Progression to muscle-invasive disease:1
  • ─ Up to 17% at 1 year
  • ─ Up to 45% at 5 years
  • ─ Common in patients with CIS, which are often difficult to detect2

High rate of residual tumor after TURBT:

• 34–76% of patients have evidence of tumor on repeat TURBT at 2–6 weeks3-5

Patients with incomplete initial resection are at high risk of recurrence4

  • Continued growth of microscopic lesions which were not observed at initial TURBT6
  • New growth of small residual traces of tumor, often at surgical margins7

Improving Bladder Cancer Management

Blue Light Cystoscopy (BLC) with Hexvix® (EU) / Cysview ® (US) for improved detection and management of bladder cancer

  • Hexvix/Cysview is a colorless contrast solution that is used with a blue-light cystoscope
  • First approved drug-device procedure; launched in US in 2012
  • Recommended use in 50-70% of TURB's (bladder cancer resection procedures); included in AUA guidelines

Utilizes the body's own biology to detect malignant cells

  • Hexvix/Cysview contains precursors which are converted inside the cell to form an endogenous photoactive entity (PpIX)
  • The solution is administered into the bladder directly and accumulates in cancerous cells, which then fluoresce red when blue-light is shone upon them

View of Bladder with use of WLC

Same view using Blue Light Cystoscopy with Hexvix/Cysview

A Significant Global Specialty Brand

Value of in-market sales of Hexvix/Cysview in the quarter increased YoY 11% to USD 7 million

  • YTD in-market sales at USD 22 million (+10%)
  • Hexvix/Cysview global in-market volume increased YoY 3% in the quarter and 5% year to date

US revenue increased year to date YoY 35%

  • YoY in-market volume growth of 27%
  • Services 81 hospitals and urology centers at the end of Q3 (2015 year end 65)
  • We are working on a Congressional bill to give additional separate reimbursement for Medicare patients.

Partner revenue increased 10% year to date YoY to USD 5.6 million

  • End user YoY volume growth 5% year to date
  • BioSyent Pharma: Preparing launch
  • Juno Pharmaceuticals: MAA approval in Australia received

Global in-market unit sales (by Q)

Global in-market value USD mill (LTM)

Increasing Exposure in Medical Community

Continued positive data flow fuels forward momentum

  • New publications in Bladder Cancer show Blue Light Cystoscopy (BLC) with Hexvix/Cysview significantly improves long time outcomes
  • ─ Significantly prolongs time to progression of bladder cancer (Kamat et al, April)
  • ─ Significantly reduces progression of bladder cancer (Gakis et al, August)
  • Publication in The Journal of Urology shows BLC with Hexvix/Cysview has no increase in adverse events when a one-off procedure to compared to repeats 1
  • New study in World Journal of Urology shows that BLC with Hexvix/Cysview significantly improves detection of NMIBC 2

Inclusion in National Guidelines

Transforming clinical practice

  • US Guidelines: Use of Blue Light Cystoscopy with Hexvix/Cysview receives highest level of recommendation in the new AUA/SUO bladder cancer guideline
  • ─ Recommended based on the large body of evidence supporting both increased detection and reduced recurrence of non-muscle invasive bladder cancer
  • Included in European and National Guidelines in several EU countries
  • ─ Strong recommendation recently received within French National Guidelines for Blue Light Cystoscopy with Hexvix
  • ─ EAU altered guidelines to include the use of Hexvix as a preferential diagnosis procedure
  • ─ NICE recommended the use of cystoscopies and that photodynamic diagnosis should be offered to patients
  • Recommended use in 50-70% of TURB procedures 1
Urological
Association
Advancing Urology"
ABOUT US EDUCATION
RESEARCH
ADVOCACY INTERNATIONAL PRACTICE RESOURCES
EDUCATION > Guidelines & Policies > Guidelines > Non-Muscle Invasive Bladder Cancer
Guidelines AUA University
All your educational needs, all in one place!
Now, enhanced access and resources just for AUA members. Learn More
NON-MUSCLE INVASIVE BLADDER CANCER
Download the unabridged version of this quideline [pdf]
Download Non-Muscle Invasive Bladder Cancer Treatment Algorithm [pdf]
AUA/SUO GUIDELINE DIAGNOSIS AND TREATMENT OF NON-MUSCLE INVASIVE BLADDER CANCER:
M. McKiernan, MD Sam S. Chang, MD, MBA; Stephen A. Boorjian, MD; Roger Chou, MD; Peter E. Clark, MD; Siamak
Daneshmand, MD; Badrinath R. Konety, MD, FACS, MBA; Raj Pruthi, MD, FACS; Diane Z. Quale;
Chad R. Ritch, MD, MBA; John D. Seigne, MD; Eila Curlee Skinner, MD; Norm D. Smith, MD; James
Purpose The survival rate for the majority of patients with non-muscle invasive bladder cancer (NMIBC) is
favorable; however, the rates of recurrence and progression to muscle-invasive bladder cancer
(MIBC) are important surrogate endpoints for overall prognosis, as these are major determinants
Membership Events Education Guidelines
Research
Sections
EAU GUIDELINES ON NON-MUSCLE INVASIVE (Ta,
(Limited text update March 2016) T1, CIS) BLADDER CANCER
S. Shariat, R. Sylvester, R. Zigeuner
Guidelines Associates: O. Capoun, D. Cohen, V. Hernández, V. Soukup
M. Babjuk (Chair), A. Böhle, M. Burger, E. Compérat, E. Kaasinen, J. Palou, B.W.G. van Rhijn, M. Rouprêt,
Eur Urol 2011 Apr;59(4):584-94
Eur Urol 2013 Oct;64(4):639-53

Cysview US - Significant Growth Opportunity

Number of bladder cancer resections (TURBs) > 300 000 per year in the US

  • Majority of TURBT's done at 400 centers in the US with more than 100 MUSD potential
  • BLC with Cysview available at 81 centers up from 65 in 2017 as of Q3 2016
  • Obtained market share of over 20% across current accounts

Foundation for continued growth

  • Inclusion of BLC with Cysview in the AUA guidelines validated the high unmet medical needs
  • Established a major bladder cancer patient registry with over 500 patients providing data on clinical benefits from real world clinical of BLC with Cysview
  • Increased awareness with support from leading urologists
  • Broaden coverage with increased sales and marketing resources 11

Concentration of Top - TURBT & Cystoscopy Targets

Expanding into the Surveillance Segment

Surveillance following initial diagnosis represents a significant growth opportunity of 2-3 times current TURB segment

US Surveillance Study

Overview

  • Compare use of Blue Light Cystoscopy with Cysview and White Light using the blue light enabled Flexible cytoscope device (Karl Storz)
  • 100mg of Cysview as intravesical solution will be instilled in the bladder and the patient will wait an hour before the Cystoscopy

Endpoints

  • 1°endpoint is to look at the rate at which malignancy is detected with Cysview compared to white light using flexible scopes
  • 2°endpoint (1) is to look at the proportion of patients with adverse events from the procedure after repeated administration
  • 2°endpoint (2) is to compare the amount of patients with one or more CIS (Carcinoma in situ; flat, aggressive lesions) lesions that are detected with Cysview when white light detects none

Current Status

  • Secured alignment with FDA on study design necessary to obtain label extension on three significant areas (use in combination with flexible scope, repeated use, increased detection of CIS)
  • Study results expected in 2017

Longer Term Potential for Urology Franchise

Photocure's strategy is to create a Specialty Pharmaceutical Company maximizing its commercial presence and the opportunity of its flagship brand Hexvix/Cysview in urology

Non-Urology Pipeline

.
.
.
.
.

Cevira – A Major Opportunitunity in Cervical disease

Breakthrough single use and fully integrated drug-device technology to satisfy high need for novel non-surgical therapies to treat global epidemic of HPV/CIN populations

Results of the Phase 2b trial are significant in HSIL patients

  • Statistically significant (p=0.004) HSIL (CIN2,3) regression
  • Statistically significant (p=0.045) virologic clearance of oncogenic HPV
  • Excellent tolerability and high physician & patient acceptance

Achieved SPA on Phase 3 program with FDA for patients with HSIL

Blockbuster sales potential based on premium pricing opportunity in large patients populations

  • ~1M cases HSIL annually in US & West EU with additionally 10-15M cases oncogenic HPV annually in US & West EU detected through routine cervical screening programs
  • At premium price levels, cost impact model demonstrates cost savings/benefit to the US health care system

Further strengthened patent portfolio with issuance on new patents

Ongoing discussions and due diligence with potential partners for development and commercialization

Visonac – Addressing a Need for Newer, Safer Acne Therapies

As documented in scientific literature and dermatology guidelines high unmet medical need for non-antibiotic, non-retinoid treatments in severe acne segment

  • Mono therapy with oral antibiotics (tetracyclines) effectiveness not well documented
  • Combinations of oral antibiotics plus topical agents or systemic retinoids only currently available effective treatment options
  • Toxicities of available agents/combination of agents make them unsuitable for long term use

Positive Phase 2b results published in British Journal of Dermatology

• Significant reduction in inflammatory lesions and improvement of overall acne severity as a topical monotherapy

Phase 3 Ready with significantly reduced regulatory risk

• SPA (US) and PIP (EU) agreed for global registration program

Further strengthened patent portfolio with issuance of new patents

Ongoing discussions and due diligence with potential partners for development and commercialization

Financials & Outlook

Financial Snapshot (Third Quarter 2016)

Commercial franchise

  • Continued revenue growth for Hexvix/Cysview, YoY quarter growth 16%, year to date 13% (in constant FX: 13%)
  • EBITDA margin at 18% year to date
  • ─ Increased operating expenses, sales & marketing in US and trials to support surveillance market

Total

• EBITDA at USD -0.2 million for the quarter, USD -0.9 million year to date

Cash Flow

  • Quarter end cash balance at USD 11.7 million
  • ─ Payment from Galderma 2016.12.31 of EUR 4.0 million (USD 4.2 million)
  • ─ Sale of shares in PCI Biotech in December, NOK 32.5 million (USD 3.8 million)

Delivering on Key Objectives

Key Objectives 9M 2016 Key Achievements

Increase
Hexvix/Cysview global in-market unit
sales growth rate

Hexvix/Cysview global in-market volume
increased YoY 5%

Hexvix/Cysview in-market value increased
YoY 10% to USD 22 million

BLC
with Cysview recommended in new
American Urology Association bladder
cancer guidelines

Continuous stream of publications on the
benefits of BLC with Hexvix/Cysview

Finalize
recruitment and reporting of clinical
results of Hexvix/Cysview phase 3 market
expansion study in 2017

Strong patient enrollment in third quarter

Lower total project costs than originally
planned

Secure Partnership for further development
and commercialization of Visonac
and Cevira
reflecting the product potential

Discussions ongoing with potential partners

21

Photocure – Investment Highlights

Commercial-stage company focused on Urology

  • Hexvix®/Cysview® for improved detection and management of bladder cancer
  • ─ Improved detection, reduced disease recurrence and progression rates with cost benefits
  • ─ ~USD 30M global in market sales (LTM); EBITDA USD 2.8 million (LTM)
  • Specialist salesforce established in US and Nordic region and additional emerging operations in other high value territories through partners
  • ─ Ipsen (EU), Juno Pharmaceuticals (Australia/New Zealand), BioSyent Pharma (Canada)

Value building opportunities anticipated in next 12 – 24 months

  • Large untapped potential for Hexvix/Cysview in existing and new market segments/territories
  • ─ New clinical data in Flex scope/surveillance use with potential label extension in the US; clarity on reimbursement in US
  • Partnering opportunities for non-urology assets
  • ─ Cevira® (cervical disease) and Visonac® (Acne)
  • Exploring expansion of urology portfolio to leverage commercial infrastructure

Appendix

.
.
.
.
.

Segments - Third Quarter 2016

Commercial franchise

  • Hexvix/Cysview total revenue growing YoY 17% in the quarter and year to date 20% (in constant FX: 13%)
  • Total revenues negatively impacted by API revenues and milestone revenues
  • Increased operating expenses; sales & marketing in US and investigator initiated trials to support surveillance market in Nordics
  • EBITDA margin at 18% year to date

Development portfolio

• Activities related to regulatory work and intellectual property. Cysview post marketing commitment phase 3 capitalized

MNOK Q3
'16
YTD
'16
YTD
'15
Commercial
Franchise
Nordic
revenues
8
7
29
4
26
4
US
revenues
7
8
22
4
15
7
Partner
revenues
15
1
47
5
40
5
Hexvix
/
Cysview
31
6
99
4
82
6
API
revenues
0
0
0
0
6
5
Signing
fee
&
milestones
3
6
6
2
11
1
Total
revenues
35
2
105
5
100
2
Cost
of
goods
sold
-2
2
-6
6
-6
2
Gross
profit
33
1
98
9
94
0
Operating
expenses
-25
0
-79
6
-69
8
EBITDA 8
0
19
3
24
2
Development
Portfolio
Operating
expenses
-9
7
-27
0
-33
5
EBITDA -9
7
-27
0
-33
5
Total
EBITDA -1
6
-7
7
-9
3

Profit & Loss - Third Quarter 2016

Revenue and Expenses

MNOK Q3
'16
YTD
'16
YTD
'15

Total revenue increase YoY 5% year to
date

Negatively impacted by sales of API and
reduced milestone revenues
/
Cysview
Hexvix
revenues
Other
sales
(API)
revenues
Signing
fees
and
milestones
Total
revenues
31
6
-0
0
3
6
35
2
99
4
-0
0
6
2
105
5
82
6
6
5
11
1
100
2

Operating expenses increase YoY 3%
Cost
of
goods
sold
Gross
profit
-2
2
33
1
-6
6
98
9
-6
2
94
0
year to date

R&D reduction 40%

Sales & marketing increase 13%

Other Opex
increase 15%
Research
&
Development
Sales
&
Marketing
Other
Opex
Operating
expenses
-3
9
-19
1
-11
6
-34
7
-12
2
-59
2
-35
2
-106
6
-20
5
-52
4
-30
5
-103
4
Earnings EBITDA -1
6
-7
7
-9
4

EBITDA at NOK -1.6 million for the
quarter, NOK -7,7 million year to date
Depreciation
&
Amortization
EBIT
-1
6
-3
2
-4
8
-12
5
-2
4
-11
8

EBIT impacted by amortization of phase 3
Cysview
PCI
Net
financial
items
excl
Profit/loss(-)
PCI
before
&
Tax
Impairment
loss
shares
PCI
-0
0
-3
3
-
1
2
-11
3
-
4
5
-7
3
-7
7

Tax net income (non-cash) year to date
driven by change in transfer pricing
Tax
expenses
profit/loss(-)
Net
3
3
0
1
28
7
17
5
-11
8
-26
7

method

Cash Flow - Third Quarter 2016

MNOK Q3
'16
YTD
'16
YTD
'15
Cash
flow
from:
Operations
-
8
6
-
30
7
-
19
2
-
Investments
-
2
9
-
11
1
-
9
0
-
Financing
-
1
0
1
7
2
4
in
Net
change
cash
10
5
-
40
1
-
25
8
-
Ending
cash
balance
93
9
93
9
139
5

Comments

  • Year to date cash flow from operations at NOK -30.7 million (prior year NOK -19.2 million)
  • ─ Change in working capital NOK -22.9 million (prior year NOK -9,6 million) year to date. Increased outflow driven by reduced payables
  • Year to date cash flow from investments NOK -11.1 million, includes investments of NOK 10.8 million in development expenses mainly related to the initiation of the phase 3 post-marketing commitment trial for Cysview
  • Quarter end cash balance at NOK 93.9 million
  • ─ Payment from Galderma 2016.12.31 of EUR 4.0 million

Balance Sheet per 30 September 2016

• Shareholder's equity of NOK 234.1

• Photocure held 809 own shares at end

million. Equity ratio of 91%

of the quarter

Assets • Non current assets include NOK 22.5 million in investments in tangible and intangible assets, NOK 7.4 million in shares in PCI Biotech and deferred tax asset of NOK 52.2 million • Current assets include NOK 35.1 million in remaining settlement for sale of Metvix, due 31.12.2016 Equity and Liabilities • No interest bearing debt MNOK 30.09 31.12 2016 2015 Non-current assets 82.0 43.6 Inventory & receivables 81.4 70.4 Cash & equivalents 93.9 134.0 Total assets 257.3 248.1 Shareholders equity 234.1 210.1 Long term liabilities 3.4 4.0 Current liabilities 19.8 34.0 Total equity & liabilities 257.3 248.1 Equity ratio 91% 85%

Shareholders

Shareholder Acc
type
Citizen No
of
shares
%
HIGH
SEAS
AS
NOR 3,350,000 15.54
%
J
P
MORGAN
CHASE
BANK
NOM GBR 3,155,822 14.64
%
AKSJENORGE
KLP
NOR 1,218,130 5.65
%
RADIUMHOSPITALETS
FORSKNINGSSTIFTELSE
NOR 1,112,916 5.16
%
KOMMUNAL
LANDSPENSJONSKASSE
NOR 838,272 3.89
%
FONDSFINANS
NORGE
NOR 825,000 3.83
%
MP
PENSJON
PK
NOR 810,000 3.76
%
DANSKE
INVEST
NORSKE
C/O
DANSKE
CAPITAL
NOR 422,603 1.96
%
SKAGEN
VEKST
NOR 399,267 1.85
%
EIKA
NORGE
NOR 366,001 1.70
%
VICAMA
AS
NOR 329,530 1.53
%
DANSKE
INVEST
NORSKE
NOR 322,414 1.50
%
FONDSFINANS
GLOBAL
HELSE
NOR 320,000 1.48
%
POLAR
CAPITAL
GLOBAL
HSBC
BANK
PLC
GBR 254,537 1.18
%
RUL
AS
NOR 224,451 1.04
%
WLH
INVEST
AS
NOR 201,537 0.93
%
BERGEN
KOMMUNALE
PENSJONSKASSE
NOR 200,000 0.93
%
EGELAND
HOLDING
AS
NOR 195,000 0.90
%
AKSJENORGE
INDEKS
KLP
NOR 188,492 0.87
%
AS
ARTAL
NOR 177,349 0.82
%
Total
20
largest
shareholders
14,911,321 69.17
%
Total
other
shareholders
6,646,589 30.83
%
of
Total
number
shares
21,557,910 100.00
%

Contact Information

Erik Dahl Chief Financial Officer Tel: + 47 45055000 [email protected]

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