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Photocure ASA

Earnings Release Nov 8, 2017

3714_rns_2017-11-08_71a16abe-f72a-4661-8c73-ece2d50bff4f.pdf

Earnings Release

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PHOTOCURE ASA

RESULTS FOR THIRD QUARTER AND FIRST NINE MONTHS 2017

8 NOVEMBER 2017

Kjetil Hestdal, MD, President & CEO Erik Dahl, CFO

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 2016. 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.

DELIVERING ON KEY OBJECTIVES

Increase growth of Cysview in US based on increased investment in US commercial operation

Increase Hexvix / Cysview global inmarket unit sales

  • US sales revenue up 45% YoY in 3Q and 44% YTD, driven by in-market volume increase in 3Q of 39% and 35% YTD
  • Improved CMS reimbursement for Blue Light Cystoscopy (BLC) with Cysview for use in hospital outpatient departments, from January 2018
  • US marketing and sales activities on track
  • In-market volume in own markets increased YoY 17 % in 3Q, while partner unit sales declined 1% to an overall YoY 3% increase in 3Q

Obtain regulatory approval for market expansion of Cysview into surveillance market

  • In-market unit sales increased 4% YTD Supplemental NDA filed in August for Blue Light Flexible Cystoscopy
  • (BLFC) with Cysview In October, FDA accepted the supplemental NDA for Cysview on a priority review with expected decision H1 2018

Hexvix/Cysview Update

HEXVIX/CYSVIEW A SIGNIFICANT GLOBAL SPECIALTY BRAND

  • Value of in-market sales of Hexvix/Cysview in the third quarter increased 8% YoY to NOK 61 million and 7% YTD to NOK 193 million
  • Hexvix/Cysview global in-market volume increased YoY 3% in the third quarter, with own unit sales increase of 17% while
  • partner unit sales Ipsen declined 1% Overall franchise EBITDA YTD amounted to NOK 9.4 million with a corresponding EBITDA margin of 8%

With courtesy of Dr. Dirk Zaak

Global in-market value NOK mill (LTM)

HEXVIX/CYSVIEW TWO SIGNIFICANT MILESTONES REACHED IN 2017

EXPANDED US MARKET OPPORTUNITY THROUGH SUPPLEMENTAL NEW DRUG APPLICATION • Seeking approval for expanded use including: ― Combination of Cysview with Karl Storz Flexible

  • Videoscope System, in addition to current Rigid Scope System, for surveillance cystoscopies of patients diagnosed with Non Muscle Invasive Bladder Cancer (NMIBC)
  • ― Improved detection of CIS1 in the rigid scope setting (TURBT2 )
  • ― Repeated use of Cysview in the TURBT and surveillance scope setting
  • In October, FDA designated priority review for the sNDA
  • ― Expected response from FDA 1H2018

KARL STORZ FLEXIBLE BLUE LIGHT VIDESOSCOPE

Of the total 1.4 million cystoscopies performed in the US each year approximately 40-50% estimated to be performed in surveillance of patients with high and medium risk NMIBC

7 1. Carcinoma in Situ; 2. Transurethral Resection of Bladder Tumour

MEDICARE REIMBURSEMENT OF AN ADDITIONAL USD 1,000 PER TURBT FROM 2018* Medicare (~55% of TURBT) Private payer (~45% of TURBT)

MEDICARE REIMBURSEMENT OF AN ADDITIONAL USD 1,000 PER
TURBT FROM 2018
Medicare (~55% of TURBT)
Private payer
(~45% of TURBT)

Procedure fee for cystoscopy

Procedure fee for cystoscopy

Cysview paid at contracted rate (ASP
+6
to
Cystoscopy

Cysview paid at ASP
* +6%
15%)

No
change from 2017

No change from 2017

Hospital
Outpatient Depts. will
receive an additional \$1,000 to cover
the complexity of using Cysview
and
Blue Light Cystoscopy procedure for

Procedure fee for TURBT –
varies by type
the following codes:
52204, 52214 &

Cysview
paid at (Average Selling Price -ASP +6
TURBT
5224
to 15%)

No change from 2017

Bundled into ambulatory payment
classification (APC –
varies by TURBT
type)1
for the higher procedure codes of
52234, 52235
and 52240
Note: 1) Exceptions: Cancer centers, state of Maryland (Medicare exception), Critical access hospitals (rural classified as critical access) receive incremental
Professional fees for cystoscopy/TURBT remain the same, additional reimbursement for specific TURBT procedures; *Average Sales Price
payment;

8

MAXIMIZING SALES EFFICIENCY TARGETING TOP 25 US MARKETS – FOCUS ON 400 MAJOR HOSPITALS New York, Newark, Jersey 21,284 Chicago, Naperville, Elgin 9,649 Philadelphia, Camden, Wilmington 6,256 Top 25 markets – TURBT rank Example anchor accounts

Totals (inpatient &
Metropolitan statistical area outpatient TURBT
procedures*): Total
New York, Newark, Jersey
Chicago, Naperville, Elgin
21,284
9,649
Philadelphia, Camden,
Wilmington
6,256
Los Angeles, Long Beach, Anaheim 5,994
Miami, Fort Lauderdale, West
Palm Beach
5,436
Tampa, St.
Petersburg, Clearwater
5,010
Boston,
Cambridge, Newton
4,768
Detroit, Warren, Dearborn 4,054
Phoenix, Mesa, Scottsdale 3,998
Baltimore, Columbia, Towson 2,862
Houston, The Woodlands,
Sugar Land
2,763
Washington,
Arlington, Alexandria
2,700
St. Louis 2,535
Orlando, Kissimmee, Sanford 2,339
Atlanta,
Sandy Springs, Roswell
2,136
Dallas, Fort
Worth, Arlington
2,076
Cleveland,
Elyria
1,937
Cincinnati 1,923
Cape Coral, Fort Myers 1,712
Pittsburgh 1,685
North Port,
Sarasota, Bradenton
1,672
Jacksonville 1,671
Providence, Warwick
Minneapolis, St. Paul, Bloomington
1,613
1,544
Nashville, Davidson, Murfreesboro, Franklin 1,535
9
*TURBT numbers as per Medicare coding data

Comments

  • Focus efforts to establish and build Cysview business in top 25 TURBT markets
  • 400 major hospitals represents ~40% of total US TURBT market
  • Establish well known academic hospitals as anchor and referral
  • accounts Expand by targeting and establishing new accounts in reachable proximity to the anchor accounts • Utilize marketing and sales resources in
  • a focused and efficient way

HEXVIX/CYSVIEW CONTINUED STRONG MOMENTUM IN US • Photocure own sales revenue in the US in 3Q increased th quarter with QoQ sales revenue growth in the US,

  • 45% YoY
  • Driven by YoY in-market volume growth of 39% in third quarter
  • 6
  • despite seasonality Permanent Blue Light Cystoscope placements of 96 at the end of quarter, increase of 13 since end of 2016
  • US strategic investment plan is on track and we have doubled our sales organization, increased medical headcount and targeted marketing investments

Maximizing the US Cysview opportunity is essential to Photocure's strategy to create a Specialty Pharmaceutical Company in Urology

HEXVIX/CYSVIEW SOLID POSITION IN NORDICS CONFIRMED BY SURVEY – It is the treatment of choice in Denmark – The share of NMIBC patients receiving TURBT with Hexvix is – The use of Hexvix is expected to increase in all countries, both in

  • Survey among 66 urologists at 41 hospitals in Nordic indicated Hexvix:
  • Is used regularly by all urologists in Denmark and 67-73% in the other countries in a surgery/operating room setting
  • Its medical benefits align with TURBT key objectives

  • highest in Denmark and Norway

  • the TURBT and surveillance setting, highest in Sweden
  • Blue Light FLEX Cystoscopy gaining a foothold in Nordics
  • Positive IIT study published in Scandinavian Journal of Urology. Photocure own sales revenue in the Nordics increased YoY 3% in third quarter and 3% YTD
  • Driven by growth in Sweden and Finland combined with reversal of negative trend observed in Denmark in prior quarters

11 Source: QuintilesMS Note: 1) Respondents DK 17, FI 18, NO 11, SE 20

HEXVIX/CYSVIEW

  • PARTNER UPDATE Partner revenue increased 1% YoY in third quarter
  • In-market unit sales declined 1% due to reduced unit sales all markets except Germany and Austria
  • Juno in Australia/New Zealand
  • Significant support from urological community in both locations
  • started
  • Applications for reimbursement have been submitted; decisions are expected by the end of the year/early next year
  • Juno Pharmaceuticals obtained regulatory approval of Hexvix in New Zealand in October

CONTINUED FLOW OF CLINICAL PUBLICATIONS ON MEDICAL BENEFITS OF HEXVIX/CYSVIEW – BLC with Hexvix showed reduced disease recurrence rate at 3 years

  • A «Real-life experience» study performed at single center in UK enrolled 808 bladder cancer patients published in World Journal of Urology
  • compared to standard WLC resection (39.0% vs 53.3%; p=0.02)
  • US Bladder Cancer Registry Study including results from 533 patients on 641 BLC with Cysview procedures were presented at the recent International Congress of Urology (SIU)
  • The increased detection led to change in management in 13% of the bladder cancer patients
  • Hospital, Copenhagen University, Denmark in the Scandinavian Journal of Urology
  • Blue Light Flexible Cystoscopy with Hexvix in outpatient setting provides similar detection quality as rigid scopes, significantly improving the quality of life (QoL) for patients

«Real-life experience: recurrence rate at 3 years with Hexvix® photodynamic prospective controlled study» Gallagher K et al, World J Urology; 2017 (published online 12 August 2017)

Cevira/Visonac Update

CEVIRA & VISONAC PHASE 3 READY PRODUCTS WITH SIGNIFICANT SALES POTENTIAL • Cevira - Breakthrough single use and fully integrated drug-device • Visonac – Novel topical non-antibiotic/non-isotretinoin treatment to severe acne (IGA 4) • Cevira and Visonac both phase 3 ready with Special Protocol • Cevira and Visonac both addressing large patient populations with

  • technology to satisfy high need for novel non-surgical therapies to treat global epidemic of HPV/HSIL populations
  • satisfy high unmet medical need among patients with inflammatory,
  • Agreement on phase 3 program with FDA
  • significant unmet medical needs After a non-conclusive comprehensive partnering process, PHO continues to review of possible strategic alternatives for Cevira and Visonac
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Financials

SEGMENT PERFORMANCE THIRD QUARTER 2017 • Hexvix/Cysview revenues increased 10% YTD (in constant

Commercial franchise:

  • Hexvix/Cysview total revenue increased YoY 12% in the third quarter, driven by continued strong US revenues
  • Third quarter own revenues, Nordic and US, increased 23%, while partner revenues, Ipsen, increased 1%
  • currencies 12%)
  • Increased operating expenses in quarter and YTD driven by sales & marketing in US

Development portfolio:

  • Activities related to regulatory work and intellectual property. Cysview post marketing commitment phase 3 capitalized
  • inventory and components
SEGMENT PERFORMANCE
THIRD QUARTER 2017
Commercial franchise: MNOK Q3 '17 Q3 '16 YTD '17 YTD '16

Hexvix/Cysview total revenue increased YoY 12% in the
Commercial Franchise
third quarter, driven by continued strong US revenues Nordic revenues 9.0 8.7 30.4 29.4

Third quarter own revenues, Nordic and US, increased 23%,
US revenues
Partner revenues
11.3
15.2
7.8
15.1
32.3
47.0
22.4
47.5
while partner revenues, Ipsen, increased 1% Hexvix / Cysview 35.5 31.6 109.6 99.4

Hexvix/Cysview
revenues increased 10% YTD (in constant
Other revenues
Total revenues
0.2
35.6
3.6
35.2
1.9
111.5
6.2
105.5
currencies 12%) Gross profit 32.6 33.1 102.9 98.9

Increased operating expenses in quarter and YTD driven by
Operating expenses -32.8 -25.0 -93.5 -79.6
sales & marketing in US EBITDA recurring -0.2 8.0 9.4 19.3
Development Portfolio
Development portfolio: Operating expenses -9.4 -9.7 -27.7 -27.0

Activities related to regulatory work and intellectual
EBITDA recurring -9.4 -9.7 -27.7 -27.0
property. Cysview post marketing commitment phase 3
capitalized
Total
EBITDA recurring -9.6 -1.6 -18.3 -7.7

One-off items (first quarter): Write down of Nedax
lamp
inventory and components
One-Off items
EBITDA
0.0
-9.6
0.0
-1.6
-4.0
-22.3
0.0
-7.7
17

CONSOLIDATED INCOME STATEMENT THIRD QUARTER 2017

  • Total revenue increases YoY 1% third quarter and 6% YTD
  • Operating expenses increase YoY 22% third quarter and 14% YTD
  • R&D YTD increase 9%
  • Sales & marketing YTD increase 23%, driven by US investments and flex preparations
  • Recurring EBITDA at NOK -9.6 million third quarter and NOK -18.3 million YTD
  • components
  • Depreciation and amortization driven by amortization of Cysview phase 3 investments
CONSOLIDATED INCOME STATEMENT
THIRD QUARTER 2017
Q3 '17
Q3 '16
YTD '17
YTD '16
MNOK
Total revenue increases YoY 1% third quarter and 6%
YTD
Hexvix / Cysview revenues
35.5
31.6
109.6
99.4
Operating expenses increase YoY 22% third quarter
Other revenues
0.2
3.6
1.9
6.2
Total revenues
35.6
35.2
111.5
105.5
and 14% YTD
Gross profit
32.6
33.1
102.9
98.9

R&D YTD increase 9%

Sales & marketing YTD increase 23%, driven by US
Research & Development
-4.7
-3.9
-13.3
-12.2
Sales & Marketing
-25.6
-19.1
-73.0
-59.2
investments and flex preparations
Other Opex
-12.0
-11.6
-34.9
-35.2

Other Opex
YTD decrease 1%
Operating expenses
-42.2
-34.7
-121.2
-106.6
Recurring EBITDA at NOK -9.6 million third quarter and
EBITDA recurring
-9.6
-1.6
-18.3
-7.7
NOK -18.3 million YTD
One-Off items
-
-
-4.0
-
One-off items: Write down of Nedax
lamp inventory and
Depreciation & Amortization
-4.3
-1.6
-8.8
-4.8
components
EBIT
-13.9
-3.2
-31.1
-12.5
Depreciation and amortization driven by amortization of
Net financial items
0.4
-0.0
2.7
1.2
Profit/loss(-) before tax
-13.5
-3.3
-28.4
-11.3
Cysview phase 3 investments
Tax expenses
3.5
3.3
6.7
28.7
Net profit/loss(-)
-10.1
0.1
-21.7
17.5
18

CASH FLOW THIRD QUARTER 2017

  • Cash flow from operations third quarter NOK -3.4 million, YTD NOK -31.1 million
  • Working capital impact YTD NOK -10.7 million (YTD 2016 NOK -22.9 million)
  • Cash flow from investments third quarter NOK -10.6 million and YTD NOK -15.1 million (YTD 2016 NOK - 11.1 million)
  • Includes investments YTD of NOK 16.7 million in development expenses
  • Net cash flow YTD NOK -46.1 million (YTD 2016 NOK -40.1 million)
  • Quarter end cash balance at NOK 123.1 million
MNOK Q3 '17 Q3 '16 YTD '17 YTD '16
Cash flow from:
- Operations
-3.4 -8.6 -31.1 -30.7
- Investments -10.6 -2.9 -15.1 -11.1
- Financing
Net change in cash
0.0
-13.9
1.0
-10.5
0.0
-46.1
1.7
-40.1
Ending cash balance 123.1 93.9 123.1 93.9

BALANCE SHEET 30 SEPTEMBER 2017

  • Non current assets include NOK 36.3 million in investments in tangible and intangible assets and deferred tax asset of NOK 52.7 million
  • No interest bearing debt
  • Shareholder's equity of NOK 230.7 million. Equity ratio of 89%
  • Photocure held 809 own shares at end of the quarter
MNOK 30.09 31.12 30.09
2017 2016 2016
Non-current assets 89.1 74.1 82.0
Inventory & receivables 47.4 43.0 81.4
Cash & equivalents 123.1 169.2 93.9
259.6 286.3 257.3
Total assets
Shareholders equity 230.7 251.9 234.1
Long term liabilities 4.5 3.8 3.4
Current liabilities 24.3 30.6 19.8
Total equity & liabilities 259.6 286.3 257.3
Equity ratio 89 % 88 % 91 %

Summary

DELIVERING ON KEY OBJECTIVES

Increase growth of Cysview in US based on increased investment in US commercial operation

Increase Hexvix / Cysview global inmarket unit sales

  • US sales revenue up 45% YoY in 3Q and 44% YTD, driven by in-market volume increase in 3Q of 39% and 35% YTD
  • US marketing and sales activities on track
  • Improved CMS reimbursement for Blue Light Cystoscopy (BLC) with Cysview for use in hospital outpatient departments, from January 2018
  • Increased the 2020 Annual US Cysview Sales Ambition to USD 20-25 Million
  • In-market volume in own markets increased YoY 17 % in 3Q, while partner unit sales declined 1% to an overall YoY 3% increase in 3Q

Obtain regulatory approval for market expansion of Cysview into surveillance market

  • In-market unit sales increased 4% YTD Supplemental NDA filed in August for Blue Light Flexible Cystoscopy
  • (BLFC) with Cysview In October, FDA accepted the supplemental NDA for Cysview on a priority review with expected decision H1 2018

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