RESULTS OF THE FIRST QUARTER 2014 PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY
7 MAY 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 2013. 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 FIRST QUARTER 2014
- Hexvix/Cysview sales revenues increased 33% to NOK 19.3 million in 1Q 2014, driven by strong customer demand across major markets
- Hexvix/Cysview global in-market unit sales increased 20%
- Value of global in-market sales increased 36% to NOK 46 million
- Photocure's own sales revenues in US and Nordics increased 39% to NOK 8.9 million
- Partner sales revenues increased 29% to NOK 10.4 million
- Positive support from major European regulatory authorities for the proposed Phase 3 program of Cevira in women with CIN2
- Operating loss of NOK 13.7 million, improvement of 42% over prior year, driven by restructuring and tight cost control
- Cash and cash equivalents of NOK 150 million
Commercial Update
HEXVIX/CYSVIEW STRONG GROWTH IN ALL MARKETS
- Hexvix/Cysview global in-market volume growth 20% YOY
- Value of in-market sales of Hexvix/Cysview increased 36% YOY
Global in-market unit sales (by Q)
Global in-market value NOK mill (LTM)
HEXVIX/CYSVIEW SOLID PERFORMANCE IN NORDICS
- Photocure own sales revenues in the US and Nordics increased 39% in 1Q 2014 to NOK 8.9 million
- Key drivers include strong customer demand and price increases
- Nordic revenue growth of 40% in 1Q 2014
- Volume growth of 16%
- Double digit growth in Sweden, Norway and Denmark
- Increasing both number and productivity of blue light cystoscopies
- Price increase in Norway effective in May
Own Hexvix/Cysview in-market unit sales
HEXVIX/CYSVIEW GOOD PERFORMANCE IN US
- US 1Q 2014 revenue growth of 36%
- Key drivers include volume growth of 13%, price increases and Fx
- Despite limited 2014 CMS reimbursement policy, Blue Light Cystoscope placements increased to 43 in 1Q 2014
- Continued progress towards securing sustainable reimbursement
- Multiple stakeholders engaged including US Urologists, KOLs, AUA, KSEA, ACS, Patients, BCAN, interested members of US Congress
HEXVIX IPSEN STRONG PERFORMANCE IN EUROPE
- Partner revenue increased 29% in 1Q 2014 Hexvix Partner Unit Sales Per Quarter to NOK 10.4 million
- Strong customer demand with end user volume growth of 21%
- Double digit growth in France, Germany, Belgium and Netherlands
- Price increase in Germany effective in April
- Successful execution of Hexvix activities at the European Association of Urology Congress held in Stockholm
Pipeline Update
CREATING VALUE DIVERSE PRODUCT PORTFOLIO
|
Technology |
Indication |
Phase 1 |
Phase 2 |
Phase 3 |
Status |
| Lumacan® |
PDD |
Detection of
colorectal
cancer |
|
|
|
Worldwide license with Salix
Phase 1 / 2 Clinical trial
underway |
| Visonac® |
PDT |
Treatment of
moderate to
severe acne |
|
|
|
Positive Phase 2b results
SPA approved
Exploring partnerships |
| Cevira® |
PDT |
Treatment of
precursors of
cervical cancer |
|
|
|
Positive Phase 2b results
In discussion with Health
Authorities on phase 3 program
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
- High level of interest from potential partners for development and commercialization
CEVIRA A MAJOR OPPORTUNITY
- High unmet medical need for novel therapies to treat global epidemic of HPV/CIN populations
- Breakthrough single use and fully integrated drug-device technology
- 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
- Securing agreement with Regulators on phase 3 design and target patient population
- Re-evaluation of the Phase 2b clinical data progressing as planned in advance of continuing discussions with the FDA
- Positive Scientific Advice meetings completed with
- major European regulators
12
Financials
HEXVIX/CYSVIEW - CONTINUED GROWTH
•
Revenue from own sales of Hexvix/
Cysview increased
39% in 1Q 2014 |
SALES - MNOK |
Q1 '14 |
–
Nordic revenue increased 40%
•
Driven by end user volume growth of 16%, |
Hexvix own sales
YoY growth |
8,9
39 % |
inventory 7% , price and FX impact
–
US revenue increased 36% |
Hexvix partner sales
YoY growth |
10,4
29 % |
•
Driven by end user volume growth of 13%,
price increase of 10% and FX impact |
Total Photocure
YoY growth |
19,3
33 % |
•
Partner 1Q 2014 revenue increased
29% |
|
|
–
In-market volume growth of 21% |
Revenue in-market (*)
YoY growth |
46,0
36 % |
•
Total in market sales value increased 36%
in 1Q 2014 to NOK 46 million |
Units in-market (*)
YoY growth |
13 388
20 % |
•
LTM value NOK 163 million compared to |
|
|
(*) Calculated in-market sales
NOK 151 million at year end
PROFIT & LOSS FIRST QUARTER 2014
- Revenue increase of 32%
- Milestones revenues relate to accrued revenue from Galderma
- Operating expenses down 13%
- R&D expenses at NOK 8.7 million in 1Q 2014. Main activity related to re-analysis of clinical data for Cevira
- 1Q 2014 S&M expenses at NOK 14.1 million, in line with previous two quarters.
- 1Q 2014 recurring operating loss at NOK 13.7 million
- Improvement of NOK 9.9 million from last year
| MNOK |
Q1 '14 |
Q1 '13 |
| Hexvix / Cysview revenues |
19,3 |
14,6 |
| Other sales revenues |
0,2 |
- |
| Signing fee and milestones |
1,2 |
1,0 |
| Total revenues |
20,7 |
15,7 |
| Gross profit |
19,1 |
14,3 |
| Operating expenses |
-32,9 |
-38,0 |
| Operating profit/loss(-) |
-13,7 |
-23,6 |
| Net financial profit/loss(-) |
0,7 |
2,2 |
| Profit/loss(-) before tax |
-13,0 |
-21,4 |
Operating expenses NOK mill
CASH FLOW FIRST QUARTER 2014
- 1Q 2014 cash flow from operations NOK -18.7 million
- Quarter working capital changes negative NOK 5.6 million, compared to last year negative NOK 3.4 million
- Quarter end cash balance at NOK 149.7 million
| MNOK |
Q1 '14 |
Q1 '13 |
| Cash flow from: |
|
|
| - Operations |
-18,7 |
-26,7 |
| - Investments |
1,1 |
1,8 |
| - Financing activities |
0,0 |
-0,6 |
| Net change in cash |
-17,5 |
-25,5 |
| Ending cash balance |
149,7 |
277,3 |
BALANCE SHEET PER 31 MARCH 2014
- Non current assets includes NOK 47.9 million in shares in PCI Biotech and deferred tax asset of NOK 49.1 million
- No interest bearing debt
- Shareholder's equity of NOK 272.9 million
- Equity ratio of 91%
- Photocure held 72,976 own shares at quarter end
| MNOK |
31.03
2014 |
31.12
2013 |
| Non-current assets |
120,6 |
104,8 |
| Inventory & receivables |
29,7 |
29,7 |
| Cash & equivalents |
149,7 |
167,3 |
| Total assets |
300,1 |
301,7 |
|
|
|
| Shareholders equity |
272,9 |
269,1 |
| Long term liabilities |
2,5 |
2,3 |
| Current liabilities |
24,7 |
30,3 |
| Total equity & liabilities |
300,1 |
301,7 |
|
|
|
| Equity ratio |
91 % |
89 % |
Summary and Outlook
GOOD PROGRESS MADE TOWARDS 2014 GOALS
| KEY 2014 OBJECTIVES |
1Q ACHIEVEMENTS |
Hexvix/Cysview global in-market unit sales growth of
≥10% |
20%
growth |
| Obtain sustainable reimbursement solution in US |
Established
broad
support |
Secure partnership for development and
commercialization of Visonac |
Established
high
interest
with
key
dermatology
players |
Secure regulatory alignment on Cevira
clinical
development
to progress partner discussions |
Positive Scientific Advice
meetings with key EU regulators
on Cevira
phase 3 program
Re-analysis of Cevira
data |
|
progressing as planned |
End of year cash reserve ≥ NOK 105 million, excluding
milestone payments |
Cash
of NOK 150 million at end
of 1Q |