PHOTOCURE ASA
RESULTS FOR FOURTH QUARTER AND FULL YEAR 2017
27 FEBRUARY 2018
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 2017 OBJECTIVES
Increase growth of Cysview® in US based on increased investment in US commercial operation
Obtain regulatory approval for market expansion of Cysview® into surveillance market
Increase Hexvix® / Cysview® global inmarket unit sales
- US sales revenue up 27% YoY in 4Q and 39% FY, driven by in-market volume increase in 4Q of 21% and 31% FY
- New increased CMS reimbursement for Blue Light Cystoscopy (BLC™) with Cysview for use in hospital outpatient departments, starting in from January 2018
- Twenty-five percent growth in blue light enabled cystoscopes in market to over 100 cystoscopes installed by end of LY
- Clinical results from pivotal phase 3 study announced May 2017 at AUA meeting
- Supplemental NDA filed in August for Blue Light Flexible Cystoscopy (BLFC) with Cysview
- sNDA granted Priority review by US FDA in October
- In February 2018, FDA approved the supplemental NDA
- Total Hexvix/Cysview sales revenue increased 25% to NOK 39.4 million in 4Q
- Hexvix revenue in Nordic in 4Q was record high, 35% growth YoY
- In-market volume in own markets increased YoY 16 % in 4Q and 12% FY
- Total in-market unit sales increased 2% FY, impacted by decline in partner inmarket unit sales declined 9% in 4Q and 1% FY
Hexvix/Cysview Update
HEXVIX/CYSVIEW TWO SIGNIFICANT MILESTONES REACHED
fulfil the US post marketing commitments in 2015
Note: 1) US Center for Medicare & Medicaid Services
EXPANDED US MARKET OPPORTUNITY THROUGH SUPPLEMENTAL NEW DRUG APPROVAL
- February 2018 obtained US FDA approval of an extension of the Cysview indication
- Blue Light Cystoscopy (BLC) with Cysview indicated to be used in bladder cancer patients undergoing surveillance cystoscopy for bladder cancer
- Blue Light Cystoscopy (BLC) with Cysview indicated for use in detection of carcinoma in situ (CIS) in the bladder
- Blue Light Cystoscopy (BLC) with Cysview allowed to be used repetitively
- Blue Light Cystoscopy (BLC) with Cysview indicated for use after intravesical immunotherapy (BCG) and chemotherapy
APPROVED NEW CYSVIEW INDICATION
MEDICARE REIMBURSEMENT OF AN ADDITIONAL USD 1,000 PER TURBT FROM 2018*
|
Medicare (~55% of TURBT) |
Private payer
(~45% of TURBT) |
| Cystoscopy |
•
Procedure fee for cystoscopy
•
Cysview paid at ASP** +6%
•
No
change from 2017 |
•
Procedure fee for cystoscopy
•
Cysview paid at contracted rate (ASP** +6
to
15%)
•
No change from 2017 |
| TURBT |
•
Hospital
Outpatient Depts. will
receive an additional \$1,000 to cover
the complexity of using Cysview
and
Blue Light Cystoscopy procedure for
the following codes:
52204, 52214 &
52224
•
Bundled into ambulatory payment
classification (APC –
varies by TURBT
type)1
for the higher procedure codes of
52234, 52235
and 52240 |
•
Procedure fee for TURBT –
varies by type
•
Cysview
paid at (Average Selling Price -ASP +6
to 15%)
•
No change from 2017 |
New Medicare reimbursement accounts for ~50% of TURBT Medicare market
Note: 1) Exceptions: Cancer centers, state of Maryland (Medicare exception), Critical access hospitals (rural classified as critical access) receive incremental payment; *Professional fees for cystoscopy/TURBT remain the same, additional reimbursement for specific TURBT procedures; **Average Sales Price
MAXIMIZING SALES EFFICIENCY TARGETING TOP 25 US MARKETS – FOCUS ON 400 MAJOR HOSPITALS
- Focus efforts to establish and build Cysview business in top 25 TURBT markets (MSAs)
- 400 major hospitals represents ~40% of total US TURBT market
- Established 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
- Adding sales resources as we expand installed base in target areas; currently 18 sales regions
- Supported by medical experts and reimbursement/training managers
TURBT Heat Map and current BLC accounts
Sales Efficiency Mature
Market (Nordic) |
Sales Efficiency
Immature
Market (USA) |
6 direct
sales employee |
18 direct sale employee |
~ 1500 Cysview kits per
year per employee |
~ 400 kits per year per
employee |
INCREASING MARKET AWARENESS OF BLC WITH CYSVIEW AMONG BLADDER CANCER PATIENTS
| Patient Survey Questions? |
January
2018 |
January
2017 |
|
Number of patients
participated in the survey* |
550 |
568 |
|
Percentage
of patients received BLC with Cysview |
87% |
79% |
|
Percentage of patients where BLC
with Cysview
helped in managing their cancer |
88% |
81% |
|
Percentage
of patients where BLCC with Cysview
improved the confidence in the treatment that they
received |
89% |
37% |
|
Percentage
of patients that once diagnosed sought
institutions that offered BLCC |
87% |
74% |
|
Percentage of patients confirmed the importance of
having BLCC as part of their disease management |
95% |
91% |
|
Increased Marketing budget has allowed for execution of a number of local and national awareness programs that is yielding results with increased interest for BLC with Cysview
HEXVIX/CYSVIEW SIGNIFICANT GROWTH OPPORTUNITY WITH NEW US LABEL
BLC with
Cysview
Market
segment |
Total Number
of Cystoscopy
Procedures |
Number of
Procedures
in top 25
MSA* |
Market
potential in
top 25
MSAs* |
Peak sales value with
5% market share in
top 25 MSAs* |
Peak sales value with
10% market share in
top 25 MSAs* |
Peak sales value with
20% market share in top
25 MSAs* |
| TURBT |
324,094 |
130 000 |
130 MUSD |
6.5 MUSD |
13 MUSD |
26 MUSD |
Surveillance
Cystoscopy |
1.2 -
1.4 million |
540 000 |
540 MUSD |
27 MUSD |
54 MUSD |
108 MUSD |
The new approved label for both TURBT and surveillance flexible cystoscopy constitute a significant new market opportunity in the US
HEXVIX/CYSVIEW CONTINUED STRONG MOMENTUM IN US
- Photocure own sales revenue in the US in 2017 increased 39% YoY
- Driven by YoY in-market volume growth of 31%
- Permanent Blue Light Cystoscope placements of 104 at the end of the year, increase of 21 since end of 2016
- High penetration in many major and recognized US cancer hospitals
- US strategic investment plan is on track
- Doubled the sales organization, increased medical headcount and targeted marketing investments to impact the hospital bladder cancer programs
HEXVIX/CYSVIEW RECORD HEXVIX SALES REVENUE IN NORDIC IN 4Q2017
- Photocure own sales revenue in the Nordics increased YoY 35% in fourth quarter to NOK 12.9 MNOK and 11% FY
- Driven by growth in Norway and Denmark, with Denmark reversed following the decline earlier in 2017
- In market unit growth of 14% in 4Q
- Survey among 66 urologists at 41 hospitals in Nordic:
- The survey confirms the high awareness of Hexvix in the Nordic
- The use of Hexvix is expected to increase in all countries, both in the TURBT and surveillance setting, highest in Sweden
HEXVIX/CYSVIEW PARTNER UPDATE
- Partner revenue increased 17% YoY in fourth quarter, driven by inventory build-up
- In-market unit sales declined 9% partly due to uneven purchase patterns and partly to declined demand. Germany at level with 4Q 2016
- Full year revenue growth of 3% and in-market unit sale decline of 1%
In-market unit sales (by Q)
Financials
SEGMENT PERFORMANCE FOURTH QUARTER 2017
Commercial Franchise:
- Hexvix/Cysview total revenue increased YoY 25% in the fourth quarter. Growth in all regions, partly driven by inventory increases at customers and partners
- Fourth quarter own revenues, Nordic and US, increased YoY 31%, while partner revenues increased YoY 17%
- Full year Hexvix/Cysview total revenue increased YoY 14%
- Increased operating expenses in quarter and full year driven by sales & marketing in US
Development Portfolio:
- Activities related to regulatory work and intellectual property. Cysview post marketing commitment phase 3 capitalized
- One-off items (first quarter): Write down of Nedax lamp inventory and components
| MNOK |
Q4 '17 |
Q4 '16 |
FY '17 |
FY '16 |
| Commercial Franchise |
|
|
|
|
| Nordic revenues |
12.9 |
9.6 |
43.3 |
39.0 |
| US revenues |
10.2 |
8.0 |
42.4 |
30.5 |
| Partner revenues |
16.3 |
14.0 |
63.3 |
61.5 |
| Hexvix / Cysview |
39.4 |
31.6 |
149.0 |
131.0 |
| Other revenues |
0.0 |
6.5 |
1.9 |
12.7 |
| Total revenues |
39.4 |
38.1 |
150.9 |
143.6 |
| Gross profit |
36.0 |
35.4 |
138.9 |
134.3 |
| Operating expenses |
-35.1 |
-24.6 |
-128.5 |
-104.2 |
| EBITDA recurring |
0.9 |
10.7 |
10.4 |
30.0 |
| Development Portfolio |
|
|
|
|
| Operating expenses |
-11.8 |
-11.1 |
-39.5 |
-38.1 |
| EBITDA recurring |
-11.8 |
-11.1 |
-39.5 |
-38.1 |
| Total |
|
|
|
|
| EBITDA recurring |
-10.8 |
-0.3 |
-29.1 |
-8.0 |
| One-Off items |
0.0 |
0.0 |
-4.0 |
0.0 |
| EBITDA |
-10.8 |
-0.3 |
-33.1 |
-8.0 |
|
|
|
|
|
CONSOLIDATED INCOME STATEMENT FOURTH QUARTER 2017
- Total revenue increases YoY 3% fourth quarter and 5% full year
- Strong growth for Hexvix/Cysview partly offset by reduction in milestone revenues and sale of API
- Operating expenses increase YoY 18% full year
- Significant increase in US sales & marketing expenses, increased 35% in fourth quarter and 29% full year
- Recurring EBITDA at NOK -10.8 million fourth quarter and NOK -29.1 million full year
- Depreciation and amortization driven by amortization of Cysview phase 3 investments
| MNOK |
Q4 '17 |
Q4 '16 |
FY '17 |
FY '16 |
| Hexvix / Cysview revenues |
39.4 |
31.6 |
149.0 |
131.0 |
| Other sales revenues (API) |
0.0 |
5.2 |
0.2 |
5.2 |
| Signing fees and milestones |
- |
1.2 |
1.7 |
7.4 |
| Total revenues |
39.4 |
38.1 |
150.9 |
143.6 |
| Gross profit |
36.0 |
35.4 |
138.9 |
134.3 |
| Operating expenses |
-46.8 |
-35.7 |
-168.0 |
-142.3 |
| EBITDA recurring |
-10.8 |
-0.3 |
-29.1 |
-8.0 |
| One-Off items |
- |
- |
-4.0 |
- |
| Depreciation & Amortization |
-3.3 |
-3.1 |
-12.1 |
-7.9 |
| EBIT |
-14.1 |
-3.4 |
-45.2 |
-15.9 |
| Net financial items |
1.0 |
27.4 |
3.6 |
28.6 |
| Profit/loss(-) before tax |
-13.2 |
24.0 |
-41.6 |
12.8 |
| Tax expenses |
0.2 |
-6.2 |
6.9 |
22.5 |
| Net profit/loss(-) |
-13.0 |
17.9 |
-34.7 |
35.3 |
CASH FLOW FOURTH QUARTER 2017
- Cash flow from operations fourth quarter NOK 7.5 million, full year NOK -23.6 million
- Working capital impact full year NOK 6.4 million (FY 2016 NOK -8.8 million)
- Prior year driven by settlement of deferred revenue Metvix of NOK NOK 37.2 million
- Cash flow from investments fourth quarter NOK -1.2 million, full year NOK -16.3 million (FY 2016 NOK 13.9 million)
- Includes investments full year of NOK 17.5 million in development expenses
- Prior year includes sale proceeds shares and subscription rights of NOK 33.2 million
- Year end cash balance at NOK 129.4 million
| MNOK |
Q4 '17 |
Q4 '16 |
FY '17 |
FY '16 |
| Cash flow from: |
|
|
|
|
| - Operations |
7.5 |
49.9 |
-23.6 |
19.2 |
| - Investments |
-1.2 |
25.0 |
-16.3 |
13.9 |
| - Financing |
0.0 |
0.4 |
0.0 |
2.1 |
| Net change in cash |
6.3 |
75.3 |
-39.9 |
35.2 |
| Ending cash balance |
129.4 |
169.2 |
129.4 |
169.2 |
BALANCE SHEET 31 DECEMBER 2017
- Year end working capital at NOK 6.0 million (2016: NOK 12.4 million)
- Non current assets include NOK 34.6 million in investments in tangible and intangible assets and deferred tax asset of NOK 52.9 million
- No interest bearing debt
- Shareholder's equity of NOK 218.1 million. Equity ratio of 83%
| MNOK |
31.12 |
31.12 |
|
2017 |
2016 |
| Non-current assets |
87.5 |
74.1 |
| Inventory & receivables |
46.2 |
43.0 |
| Cash & equivalents |
129.4 |
169.2 |
| Total assets |
263.1 |
286.3 |
| Shareholders equity |
218.1 |
251.9 |
| Long term liabilities |
4.8 |
3.8 |
| Current liabilities |
40.3 |
30.6 |
| Total equity & liabilities |
263.1 |
286.3 |
| Equity ratio |
83 % |
88 % |
Summary and Outlook
DELIVERING ON KEY 2017 OBJECTIVES
Increase growth of Cysview® in US based on increased investment in US commercial operation
- US sales revenue up 27% YoY in 4Q and 39% FY, driven by in-market volume increase in 4Q of 21% and 31% FY
- New increased CMS reimbursement for Blue Light Cystoscopy (BLC™) with Cysview for use in hospital outpatient departments, starting from January 2018
- Twenty-five percent growth in blue light enabled cystoscopes in market to over 100 cystoscopes installed by end of LY
Obtain regulatory approval for market expansion of Cysview® into surveillance market
Increase Hexvix® / Cysview® global inmarket unit sales
- Clinical results from pivotal phase 3 study announced May 2017 at AUA meeting
- Supplemental NDA filed in August for Blue Light Flexible Cystoscopy (BLFC) with Cysview
- sNDA granted Priority review by US FDA in October
- In February 2018, FDA approved the supplemental NDA
- Total Hexvix/Cysview sales revenue increased 25% to NOK 39.4 million in 4Q
- Hexvix revenue in Nordic in 4Q was record high, 35% growth YoY
- In-market volume in own markets increased YoY 16 % in 4Q and 12% FY
- Total in-market unit sales increased 2% FY, impacted by decline in partner inmarket unit sales declined 9% in 4Q and 1% FY
FOCUS & OBJECTIVES 2018
Increase growth of Cysview® in US TURBT market market
- Continue investment in the US operations to increase Cysview revenues and achieve 2020 revenue target
- Expand the number of hospitals with blue light enabled scopes
- Continue to increase the awareness of the medical benefits of BLC™ with Cysview among health care providers and patients
- Take full benefit of improved CMS reimbursement for Blue Light Cystoscopy (BLC) with Cysview for use in hospital outpatient departments
Launch Cysview® in US flexible cystoscopy surveillance market
• Following the FDA approval of the label extension, launch BLC™ with Cysview for improved surveillance of bladder cancer patients by mid year 2018
Increase Hexvix® / Cysview® global inmarket unit sales
- Continue to increase the market share of Hexvix in the Nordic Region
- Focus on development in Europe to stop decline and drive turn-around