PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY
RESULTS OF THIRD QUARTER AND FIRST NINE MONTHS 2016
15 NOVEMBER 2016
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 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.
DELIVERING ON KEY OBJECTIVES
KEY OBJECTIVES 3Q/YTD2016 KEY ACHIEVEMENTS
Commercial Update
HEXVIX/CYSVIEW A SIGNIFICANT GLOBAL SPECIALTY BRAND
- Value of in-market sales of Hexvix/Cysview in the quarter increased YoY 12% to NOK 57 million. Year to date at NOK 181 million (+16%)
- Hexvix/Cysview global in-market volume increased YoY 3% in the quarter and 5% year to date
- Overall franchise EBITDA year to date at NOK 19.3 million, EBITDA margin of 18%
Global in-market unit sales (by Q)
Global in-market value NOK mill (LTM)
HEXVIX/CYSVIEW PROVIDES SIGNIFICANT CLINICAL BENEFITS
- New publications show that Blue Light Cystoscopy with Hexvix/Cysview significantly improves detection of bladder cancer, reduces progression of bladder cancer and can be used repeatedly
- Significantly reduces progression of bladder cancer (Gakis et al, August)
- Repeated use of Blue Light Cystoscopy with Hexvix/Cysview do not increase the frequency of adverse events (Lane et al, September)
- Using Blue Light Cystoscopy with Hexvix/Cysview in German clinical practice increase the detection of bladder cancer lesions (Back et al, August)
6
HEXVIX/CYSVIEW PERFORMANCE IN NORDICS AND USA
- Photocure own sales revenue in the US and Nordics increased YoY 22% in the quarter and 23% year to date to NOK 51.9 million
- US revenue increased YoY 46% in the quarter and 43% year to date
- Driven by YoY in-market volume growth of 37% in third quarter and 27% year to date
- Permanent Blue Light Cystoscope placements of 81 at the end of the quarter (2015 year end 65)
- The bill to provide separate and additional payments to hospitals has gained significant support and a possible resolution may occur in November or December
- Nordic revenue increased YoY 7% in the quarter and 12% year to date
- In-market volume growth of 1% year to date with a decrease (14%) in the quarter compared to last year
- In-market volume growth in Sweden 11% year to date
Own Hexvix/Cysview in-market unit sales Nordic and US
HEXVIX/CYSVIEW PARTNER PROGRESS
- Partner revenue increased YoY 12% in the quarter and 17% year to date to NOK 47.5 million
- End user YoY volume growth 4% in the quarter and 5% year to date
- New territories & partners
- BioSyent Pharma in Canada
- Commercial sale behind expectations due to timing of outplacement of scopes
- Juno Pharmaceuticals in Australia and New Zealand
- MAA approved in Australia, Milestone received of EUR 0.25 million
Hexvix Partner Unit Sales Per Quarter
Pipeline Update
HEXVIX/CYSVIEW EXPANDING INTO THE SURVEILLANCE SEGMENT
- Surveillance following initial diagnosis represents a significant growth opportunity with a total market size 2-3 times current TURB segment
- Patient enrollment in Hexvix/Cysview Phase 3 market expansion trial continued to be strong in third quarter
- Expect lower than planned total study cost
- Study results expected in 2017
- Secured alignment with FDA on study design necessary to obtain label extension
CEVIRA & VISONAC PHASE 3 READY PRODUCTS WITH SIGNIFICANT SALES POTENTIAL
- Cevira Breakthrough single use and fully integrated drug-device technology to satisfy high need for novel non-surgical therapies to treat global epidemic of HPV/HSIL populations
- Visonac Novel topical non-antibiotic/non-isotretinoin treatment to satisfy high unmet medical need among patients with inflammatory, severe acne (IGA 4)
- Cevira and Visonac both phase 3 ready with Special Protocol Agreement on phase 3 program with FDA
- Cevira and Visonac both addressing large patient populations with significant unmet medical needs
- Cevira with blockbuster sales potential based on premium pricing opportunity in large patients populations
- Cevira and Visonac have granted patents with extensive patent life and additional patent applications can provide additional extension
- Ongoing discussions and due diligence with potential partners for development and commercialization
Financials
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
- Total revenue increase YoY 5% year to date
- Negatively impacted by sales of API and reduced milestone revenues
- Operating expenses increase YoY 3% year to date
- R&D reduction 40%
- Sales & marketing increase 13%
- Other Opex increase 15%
- EBITDA at NOK -1.6 million for the quarter, NOK -7,7 million year to date
- EBIT impacted by amortization of phase 3 Cysview
- Tax net income (non-cash) year to date driven by change in transfer pricing method
| MNOK |
Q3 '16 |
YTD '16 |
YTD '15 |
| Hexvix / Cysview revenues |
31.6 |
99.4 |
82.6 |
| Other sales revenues (API) |
-0.0 |
-0.0 |
6.5 |
| Signing fees and 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 |
| Research & Development |
-3.9 |
-12.2 |
-20.5 |
| Sales & Marketing |
-19.1 |
-59.2 |
-52.4 |
| Other Opex |
-11.6 |
-35.2 |
-30.5 |
| Operating expenses |
-34.7 |
-106.6 |
-103.4 |
| EBITDA |
-1.6 |
-7.7 |
-9.4 |
| Depreciation & Amortization |
-1.6 |
-4.8 |
-2.4 |
| EBIT |
-3.2 |
-12.5 |
-11.8 |
| Net financial items excl PCI |
-0.0 |
1.2 |
4.5 |
| Profit/loss(-) before PCI & Tax |
-3.3 |
-11.3 |
-7.3 |
| Impairment loss shares PCI |
- |
- |
-7.7 |
| Tax expenses |
3.3 |
28.7 |
-11.8 |
| Net profit/loss(-) |
0.1 |
17.5 |
-26.7 |
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 |
| Net change in cash |
-10.5 |
-40.1 |
-25.8 |
| Ending cash balance |
93.9 |
93.9 |
139.5 |
- 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 postmarketing 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
- 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
- No interest bearing debt
- Shareholder's equity of NOK 234.1 million. Equity ratio of 91%
- Photocure held 809 own shares at end of the quarter
| 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% |
Outlook
DELIVERING ON KEY OBJECTIVES
KEY OBJECTIVES 3Q/YTD2016 KEY ACHIEVEMENTS
- Increase Hexvix/Cysview global in-market unit
- sales growth rate Hexvix/Cysview in-market value increased YoY 16% to NOK 181 million year to date
- Hexvix/Cysview global in-market volume increased YoY 5% year to date; we expect full year growth to be approximately 5% impacted by lower growth in mature European markets
- Cysview in-market volume increased YoY 37% in third quarter and 27% year to date
- Marketing authorization obtained in Australia
- Three new independent publications in the third quarter on the long term 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
- 18 • Secure Partnership for further development and commercialization of Visonac and Cevira reflecting the product potential
- Discussions ongoing with potential partners