PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY
RESULTS OF THE FOURTH QUARTER AND FULL YEAR 2013
27 February 2014
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 2012. 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.
HIGHLIGHTS FOURTH QUARTER AND FULL YEAR 2013
- Hexvix/Cysview sales revenues increased 28% in 4Q 2013, 16% for FY 2013, driven by strong customer demand across major markets
- Photocure's own sales revenues in US and Nordics increased 34% in 4Q 2013, 29% for FY 2013
- Partner sales revenues increased 23% in 4Q 2013, 5% for FY 2013
- Value of global in-market sales reach NOK 150 million for FY 2013
- Agreement with Galderma (Nestle Skin Care) triggers exploration of potential development and commercialization partners for Visonac
- CMS packaged payment policy including Cysview announced in 4Q 2013, effective 01 Jan 2014
- Discussions with the US FDA on appropriate Cevira Phase 3 population initiated post response to Fast Track Application
- Operating loss (excl. restructuring and one offs) of NOK 10.5 million 4Q 2013, NOK 63.0 million FY 2013
- Cash and cash equivalents of NOK 167 million
Commercial Update
HEXVIX/CYSVIEW SOLID PERFORMANCE IN NORDICS
- Photocure own sales revenues in the US and Nordics increased 34% in 4Q 2013 and 29% for FY 2013
- Key drivers include strong customer demand and price increases in Nordics
- Nordic revenue growth of 33% in 4Q 2013 and 21% for FY 2013
- Volume growth of 10% in 4Q 2013 and 8% for FY 2013
- Volume growth in Sweden was 47% in 4Q, and 38% for FY 2013
- Regional market share increased to 38% of TURBs
- Increasing both number and productivity of blue light cystoscopies
Own Hexvix/Cysview in-market unit sales
HEXVIX/CYSVIEW CMS RULING HINDERS US GROWTH
- US 4Q 2013 revenue growth of 37% and 68% for FY 2013
- Volume growth of 19% in 4Q 2013 and 51% for FY 2013
- CMS packaged payment policy released in 4Q 2013 and includes Cysview into overall procedure payment without increasing payment for cost of drug
- Impacts growth of BLCs, exit year at 36 permanent installations, 3 under evaluation and 10 awaiting capital approval
- Photocure working with all key stakeholders to secure sustainable reimbursement
- Urologists, KOLs, AUA, ACS, Patients, BCAN, interested members of US Congress
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TEGORIES
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Access to Blue Light Cystoscopy |
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December 5, 2013
by Monica Smith |
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Over the past few days, you may have heard about the issue regarding reimbursement of blue light cystoscopy. As all of you |
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know, there are very few treatments and innovations for bladder cancer. It is BCAN's position that everyone should have
equal access to all treatments, tests and innovations that have been approved by the FDA. |
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When reimbursement is restricted, it limits access for patients to care that may improve their quality of life. As a patient |
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a man a considerable a field for an inspection theory for the and the following assumption that the construction |
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HEXVIX IPSEN STRONG PARTNER IN EUROPE
- Partner revenue increased 23% in 4Q 2013 and 5% for FY 2013
- Volume growth of 15% in 4Q 2013, and 10% for FY 2013
- Double digit growth in key markets
- Strong customer demand
- Germany represents 68% of total revenue
- Positive momentum leading into 2014 with 4Q 2013 reimbursement gains in Italy and France
Hexvix Partner Unit Sales Per Quarter
Pipeline Update
CREATING VALUE DIVERSE PRODUCT PORTFOLIO
|
Technology |
Indication |
Phase 1 |
Phase 2 |
Phase 3 |
Status |
| Lumacan® |
PDD |
Detection of
colorectal
cancer |
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|
Worldwide license with Salix
Phase 1 / 2 Clinical trial
underway |
| Visonac® |
PDT |
Treatment of
moderate to
severe acne |
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Positive Phase 2b results
SPA approved
Exploring partnerships |
| Cevira® |
PDT |
Treatment of
precursors of
cervical cancer |
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|
Positive Phase 2b results
In discussion with FDA on Phase
3 patient population
Exploring partnerships |
VISONAC PHASE 3 READY ASSET
- High unmet need for novel treatments for moderate/ severe acne
- 1st Photodynamic treatment for inflammatory acne
- Broad geographic fit
- Positive Phase 2b results
- Significant reduction in inflammatory lesions
- Overall improvement in acne severity
- Well tolerated regimen
- Phase 3 Ready
- SPA agreed in 2Q 2013
- Development and regulatory risks significantly reduced
- Agreement with Galderma (Nestlè Skin Care) in 4Q 2013 allows Photocure freedom to explore early partnerships
- Outreach to potential partners for development and commercialization initiated in 4Q 2013
CEVIRA A MAJOR OPPORTUNITY
- High unmet medical need for novel therapies to treat global epidemic of HPV/CIN populations
- Single use and integrated drug-device
- Breakthrough technology allows for convenience and simplicity which can be integrated in even under-developed healthcare systems
- Results of the Phase 2b trial are significant
- Significant overall response in CIN 2
- High clearance of HPV, including highly oncogenic HPV 16/18
- Excellent tolerability and high physician & patient acceptance
CEVIRA STATUS OF REGULATORY INTERACTIONS
- In 4Q 2013 FDA transferred review responsibility to Division of Bone, Reproductive and Urologic Products (DBRUP) from Oncology Division
- Photocure initiated discussion with DBRUP, focused on recently published diagnostic and clinical management guidelines
- The recently published diagnostic guidelines classify cervical lesions in a two tiered system rather than the previous three tiers
- Low-grade Squamous Intraepithelial Lesions (LSIL), previously classified as CIN1
- High-grade Squamous Intraepithelial Lesions (HSIL), previously classified as CIN2 and CIN3
- The recently published management guidelines include the updated diagnostic guidelines, while recognizing the need to manage women of child bearing potential with CIN2 differently, due to the serious morbidities associated with surgery
- Photocure will re-evaluate the Phase 2b clinical data in accordance with recently published diagnostic guidelines and continue discussions with the FDA to align on the Phase 3 patient population
- Fast Track application not approved at this time
- Potential partner discussions continue concurrently
Financials
STRONG VOLUME GROWTH
•
Revenue from own sales of Hexvix/ Cysview
increased 34% in 4Q 2013 |
SALES - MNOK |
Q4 '13 |
FY '13 |
|
–
Nordic revenue increased 33%. In-market unit
sales to pharmacies increased 10% |
Hexvix own sales
YoY growth |
13,0
34 % |
38,1
29 % |
|
–
US revenue increased 37% driven by end user
volume growth of 19%, price increase of 10%
and FX impact |
Hexvix partner sales
YoY growth |
11,5
23 % |
39,8
5 % |
|
•
Partner 4Q 2013 revenue increased 23% |
Total Photocure
YoY growth |
24,5
28 % |
77,9
16 % |
|
–
In-market volume growth of 15%
–
Supply to partner compared to deliveries in
2012 and FX impact |
Revenue in-market (*)
YoY growth |
44,0
28 % |
150,9
18 % |
|
•
Total in market sales increased 28% in 4Q 2013
and 18% for FY 2013 to NOK 150 million |
Units in-market (*)
YoY growth |
12 496
14 % |
45 916
11 % |
|
(*) Calculated in-market sales to hospitals/pharmacies
TIGHT FISCAL MANAGEMENT
- R&D expenses at NOK 9.8 million in 4Q 2013
- Main activity related to development of Cevira and Visonac as well as ongoing regulatory work for Hexvix/Cysview
- 4Q 2013 S&M expenses at NOK 14.8 million
- In line with 3Q 2013
- A decline from 1H 2013 level due to cessation of marketing support program with partner
- FY 2013 reduction of 3% compared to FY 2012
- Other OPEX down FY 14% excluding one offs
- Restructuring finalized
- One-off related to payment to Galderma of USD 1.5 million
| MNOK |
Q4 '13 |
FY '13 |
Change |
Research & Development
Sales & Marketing
Other Opex |
9,8
14,8
10,3 |
34,0
68,4
37,4 |
-32 %
-3 %
-14 % |
| Operating expenses |
34,9 |
139,8 |
-15 % |
| Restructuring |
-0,3 |
3,7 |
|
| One-Off items |
8,9 |
8,9 |
|
| Total |
43,5 |
152,3 |
-7 % |
PROFIT & LOSS FOURTH QUARTER 2013
| MNOK |
Q4 '13 |
Q4 '12 |
Change |
FY '13 |
FY '12 |
Change |
| Hexvix / Cysview revenues |
24,5 |
19,1 |
28 % |
77,9 |
67,8 |
15 % |
| Other sales revenues |
0,7 |
0,6 |
9 % |
1,4 |
7,3 |
-81 % |
| Signing fee and milestones |
1,1 |
27,6 |
-96 % |
4,3 |
58,7 |
-93 % |
| Total revenues |
26,3 |
47,3 |
-44 % |
83,6 |
133,8 |
-38 % |
| Gross profit |
24,4 |
45,6 |
-46 % |
76,8 |
124,4 |
-38 % |
| Operating expenses |
-34,9 |
-43,1 |
-19 % |
-139,8 |
-163,7 |
-15 % |
| Operating profit/loss(-) recurring |
-10,5 |
2,5 |
|
-63,0 |
-39,2 |
60 % |
| Restructuring expenses |
0,3 |
- |
|
-3,7 |
- |
|
| One-Off items |
-8,9 |
- |
|
-8,9 |
- |
|
| Net profit/loss(-) |
-9,2 |
3,3 |
|
-59,0 |
-47,9 |
23 % |
- Total revenues for 4Q 2013 NOK 26.3 million, decreased 44% from prior year driven by lower milestone revenues and sales of API
- FY 2013 recurring operating loss excluding milestones at NOK 67.3 million compared to last year NOK 97.9 million
CASH FLOW FOURTH QUARTER 2013
| MNOK |
Q4 '13 |
Q4 '12 |
FY '13 |
FY '12 |
| Cash flow from: |
|
|
|
|
| - Operations |
-17,8 |
27,5 |
-99,7 |
-54,9 |
| - Investments |
0,9 |
1,7 |
4,5 |
9,1 |
| - Financing activities |
1,9 |
-0,2 |
-40,4 |
-6,5 |
| Net change in cash |
-15,0 |
29,0 |
-135,6 |
-52,4 |
| Ending cash balance |
167,3 |
302,8 |
167,3 |
302,8 |
- 4Q 2013 cash flow from operations NOK -17.8 million, including payment to Galderma of NOK 8.9 million
- FY 2013 operational cash flow negatively impacted by significant non-recurring working capital changes
- Dividend payment of NOK 42.4 million in 2Q 2013
- Year end cash balance at NOK 167.3 million
BALANCE SHEET PER 31 DECEMBER 2013
•
Non current assets includes NOK |
MNOK |
31.12 |
31.12 |
| 32.6 million in shares in PCI Biotech |
|
2013 |
2012 |
| and deferred tax asset of NOK 49.1 |
Non-current assets |
104,8 |
104,9 |
| million |
Inventory & receivables |
29,7 |
25,3 |
•
No interest bearing debt |
Cash & equivalents |
167,3 |
302,8 |
|
Total assets |
301,7 |
433,0 |
•
Shareholder's equity of NOK 269.1 |
|
|
|
| million |
Shareholders equity |
269,1 |
380,3 |
|
Long term liabilities |
2,3 |
1,6 |
•
Equity ratio of 89% |
Current liabilities |
30,3 |
51,1 |
•
Photocure held 72,976 own shares
at year end |
Total equity & liabilities |
301,7 |
433,0 |
|
Equity ratio |
89 % |
88 % |
Summary and Outlook
EXECUTING OUR STRATEGY
- Build a speciality pharma company, focused on cancer and dermatology
- Maximize the potential of the company's Photodynamic Technology Platform Photocure Technology™
- Leverage our experience to develop, register and commercialize new products based on Photocure Technology™
- Build a strong commercial platform in select territories
Key Achievements FY 2013:
- Strong Nordic and Partner sales of Hexvix
- Built momentum in own sales of Cysview
- SPA approved and EU Scientific Advice aligned for Visonac Phase 3 program
- Galderma agreement reached allowing for early exploration of partnerships for Visonac
- Successful completion of Phase 2b trial of Cevira
- Tight fiscal management
20
OUTLOOK & TARGETS 2014
- Hexvix/Cysview global in-market unit sales growth of ≥10%
- Obtain sustainable reimbursement solution in US
- Secure partnership for development and commercialization of Visonac
- Secure regulatory alignment on Cevira clinical development to progress partner discussions
- End of year cash reserve ≥ NOK 105 million, excluding milestone payments