PHOTOCURE ASA
BUILDING A SPECIALTY PHARMA COMPANY
APRIL, 2015
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 2014. 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.
Investment Highlights
- World leader in photodynamic technology
- Hexvix® commercialized globally
- Robust product pipeline
- Growing in-market sales +19% at NOK 180M (\$28.6M)1
- Driven by Hexvix®/Cysview® for improved detection of bladder cancer and patient management
- Significant Hexvix /Cysview growth opportunities in new market segments
- Profitable Hexvix/Cysview commercial franchise
- Commercial operations in Nordic region and United States
- Strategic partnership with Ipsen in EU
- High potential pipeline addressing significant unmet medical needs
- Cevira® Phase 3 ready targeting HPV and pre-cancerous lesions of the cervix
- Visonac® Phase 3 ready for the treatment of Acne
Creating Value Diverse Product Portfolio
|
Indication |
Phase
1 |
Phase
2 |
Phase
3 |
Market |
Status |
Hexvix® (EU)
Cysview® (US) |
Optical imaging
agent for
improved
bladder cancer
detection and
management |
|
|
|
|
Marketed as adjunct to white light
cystoscopy
Phase 3 trial for expansion to
surveillance market initiated |
| Cevira® |
Treatment of
precursors of
cervical cancer |
|
|
|
|
Positive Phase 2b results
Submit US SPA by mid 2015
Exploring partnerships |
| Visonac® |
Treatment of
moderate to
severe acne |
|
|
|
|
Positive Phase 2b results
SPA and PIP approved
Exploring partnerships |
Hexvix/Cysview
First significant advance for the improved detection and management of bladder cancer in >50 years
Bladder Cancer Prevalent, Recurring, Progressing and Expensive
• 5th most common cancer type
- ‒ Most expensive cancer: \$96-187K/patient1
- ‒ > 200,000 new patients annually
- ‒ 75% of patients diagnosed with NMIBC2
- Key therapeutic aim is to avoid progression from NMIBC to muscle invasive disease
- ‒ ~ 6 million cystoscopies annually
- ‒ ~ 600,000 procedures (TURBs3) annually
- ‒ 10 30% progression rate
• Regular ongoing surveillance required
‒ Recommend follow up cystoscopies every 3-9 months
Hexvix/Cysview1 Seeing Bladder Cancer in a Different Light
White Light Cystoscopy (WLC)
- Standard procedure used in the detection and monitoring of bladder cancer
- Key Challenges:
- − Detectionrate
- − High recurrence and progression rate
- − Cost
Hexvix / Cysview (Blue LC)
- Optical imaging agent + blue light adjunct for known/suspected bladder cancer
- Key Attributes:
- − Improved detection rates
- − Reduced recurrence rate
- − Beneficial impact on costs
Hexvix/Cysview Medical Benefits Validated
- Landmark Meta-Analysis published in European Urology (2013)1
- significantly improves the detection of bladder cancer
- reduces the risk of recurrence
- Continued positive data flow fuels forward momentum
- World Journal of Urology (2015) publication validating positive impact on overall and progression free survival2
- Transforming clinical practice
- Included in European and National Guidelines in several EU countries
- Recommended use in 50-70% of TURB procedures3
Hexvix/Cysview A Significant Global Specialty Brand
- Value of in-market sales of Hexvix/Cysview increased YOY 11% in the quarter and 19% FY 2014 to NOK 180M (\$28.6M)
- Hexvix/Cysview global in-market volume growth 10% FY 2014
- Continued growth by increased market share of TURBs across all regions
- Increased momentum in the US
- Revenue growth of 60% in 4Q2014 and 49% FY 2014
- Increased number of new key hospitals with permanent Blue Light Cystocopes to 51 at end of 2014
- Continued progress towards sustainable reimbursement
- Overall franchise operating profit FY 2014 at NOK 10.4M (\$1.7M) 9
Global in-market value NOK mill (LTM)
Hexvix/Cysview Future Growth Drivers
- Volume growth in existing markets
- Increased penetration in the US
- Incorporation in national guidelines (EU & US); publication of expert opinions
- Expand into new markets and territories
- Surveillance following initial diagnosis represents significant opportunities
- Positive early clinical experience with flexible cystoscope
- Clinical trials (Phase 3 and IITs) planned/underway
- Cysview approved by Health Canada and evaluation of commercial options ongoing
- Improve profitability of Hexvix/Cysview franchise
- Increase productivity of cystoscopes
- Pricing strategy
Cevira
Novel treatment for HPV related diseases of the cervix
Cevira1
Addressing unmet needs in cervical disease
- Oncogenic Human Papilloma Virus (HPV) is a highly prevalent sexually transmitted disease
- Well established cause of Cervical Intraepithelial Neoplasia (CIN) and cervical cancer
- Close association of HPV induced cell changes and invasive cancer
- 30 million women globally with low grade lesions/CIN1; 10 million with high grade lesions/CIN2
- High unmet medical need for novel therapies
- Breakthrough single use, disposable intravaginal device
- Obviates clinical and commercial barriers
- Easy to use; simple application in office setting
- Phase 3 ready , SPA submission in 1H2015
Cevira Phase 2b Trial Results
- Significant overall response in HSIL(CIN2)
- High clearance of HPV, including highly oncogenic HPV 16/18
- Excellent tolerability and high physician & patient acceptance
Cevira Significant Sales Potential
- HSIL Initial Target Segment
- Preserves fertility and avoids the morbidities of invasive surgery
- Large patient population based on biopsy confirmed histology
- 100-110M pap cytology tests performed annually, 1M cases HSIL annually in US & West EU1
- ~1% of all pap tests histologically confirmed CIN2/32
- Upside exists in Latin America, Asia and East EU, where burden of HPV is higher
-
Simplicity of Cevira ideal for use in most healthcare systems, rural areas, and by physician extenders/PCPs
-
Premium pricing potential3
- At premium price levels, cost impact model demonstrates cost savings / benefit to the US health care system as compared to current treatment practice
- Additional significant savings when avoidance of costs associated with preterm births factored in
- LCM Opportunity High Risk HPV
- Overall prevalence of hrHPV is 13-15%4 of women undergoing routine cervical screening
14
- Solomon 2007, Antilla 2009 2. Stoler 2011, Wright 2012 3. Internal assessment perfomed by Bridgehead 4. Wright 2012, Dunne 2007
Visonac
Novel non-antibiotic treatment of acne
Visonac1
• Late Stage Development Compound
- Phase 3 ready
- Development and regulatory risks significantly reduced
• High Market Need
- Current treatment options, antibiotics and isotretinoin, hampered by possible development of antibiotic resistance and major safety issues
- Need to improve patient compliance through MD controlled treatment options
- Large unsatisfied patient population with >2 million patients in EU and USA in need of second line treatment options
- Payers and patients willingness to pay due to limited effective and safe treatment options
Visonac Strong Phase 2b Results
- Solid Phase 2b results
- Significant reduction in inflammatory lesions
- Overall improvement in acne severity
- Well tolerated regimen
• Ready for Phase 3 registration trials
- Clinical Phase 3 program in place and SPA obtained from FDA
- Patent coverage across major markets to 2025
- Partner search for development and commercialization ongoing
17
Visonac Significant Sales Potential
- \$900M USD Market in Moderate-Severe Acne
- Dermatologists are main prescriber of oral antibiotics and retinoids
- Visonac positioned as second line alternative
- Over 2M patients in need of second line treatment options (U.S. and EU)
- Favorable risk profile compared to existing treatment options
- Sustained efficacy allows for premium price
Financials & Outlook
Financials 2012-2014
- Financial run rates reflecting PHO growth within specialty pharma
- Commercial activities profitable from 2014
- YoY sales revenue growth 18% (measured in NOK)
- Significant reductions in operational expenses
- R&D spending still significant given strong product pipeline
- R&D 25% of total Opex
| MUSD |
2012
FY |
2013
FY |
2014
FY |
| Hexvix / Cysview revenues |
11,6 |
13,2 |
14,6 |
| Other sales revenues |
1,3 |
0,2 |
0,3 |
| Total sales revenues |
12,9 |
13,5 |
14,9 |
| Signing fee and milestones |
10,3 |
0,7 |
5,7 |
| Total revenues |
23,2 |
14,2 |
20,6 |
| Gross profit |
21,6 |
13,0 |
19,5 |
| Operating expenses |
-28,6 |
-25,6 |
-20,2 |
| EBIT recurring |
-7,0 |
-12,6 |
-0,8 |
| Profit/loss(-) before tax |
-5,5 |
-11,7 |
0,3 |
Net change in Cash
- Incl. FX impact YE cash bal. |
-4,9
3,9 |
-26,9
-2,6 |
-5,3
-4,9 |
| Ending cash balance |
54,4 |
27,5 |
22,2 |
| USD/NOK - Average |
0,172 |
0,170 |
0,159 |
| Outlook |
|
| FINANCIAL |
•
Hexvix/Cysview
global in-market unit sales growth of ≥10% in 2015 |
| CLINICAL |
•
Submit Special Protocol Assessment Request (SPAR) by mid-2015
•
Initiate Phase 3 clinical trial to expand the use of Hexvix/Cysview
into the surveillance market and fulfill the US post marketing
commitments
in 2015 |
| PARTNERSHIP |
•
Secure partnership for further development and commercialization
of Visonac
and Cevira
reflecting the product potential |
Attachment
Share Information
| Account |
|
|
|
|
|
|
|
| Shareholder |
type |
Citizen |
No of shares |
% |
|
|
|
| J.P. MORGAN CHASE BANK N.A. LONDON |
NOM |
GBR |
2 957 334 |
13,82 % |
|
|
|
| RADIUMHOSPITALETS FORSKNINGSSTIFTELSE |
|
NOR |
2 029 000 |
9,48 % |
|
|
|
| FONDSFINANS SPAR |
|
NOR |
1 731 371 |
8,09 % |
|
|
|
| KLP AKSJE NORGE VPF |
|
NOR |
1 279 984 |
5,98 % |
|
|
|
| KOMMUNAL LANDSPENSJONSKASSE |
|
NOR |
940 000 |
4,39 % |
|
|
|
| MP PENSJON PK |
|
NOR |
850 000 |
3,97 % |
|
|
|
| SKAGEN VEKST |
|
NOR |
626 466 |
2,93 % |
|
|
|
| BERGEN KOMMUNALE PENSJONSKASSE |
|
NOR |
500 000 |
2,34 % |
|
|
|
| DANSKE INVEST NORSKE INSTIT. II. |
|
NOR |
422 703 |
1,98 % |
|
|
|
| VERDIPAPIRFONDET EIKA NORGE |
|
NOR |
406 517 |
1,90 % |
|
|
|
| VERDIPAPIRFONDET DNB SMB |
|
NOR |
392 810 |
1,84 % |
|
|
|
| DANSKE INVEST NORSKE AKSJER INST |
|
NOR |
360 714 |
1,69 % |
|
|
|
| VICAMA AS |
|
NOR |
345 384 |
1,61 % |
|
|
|
| FONDSFINANS FARMASI |
|
NOR |
310 000 |
1,45 % |
|
|
|
| HOLMEN SPESIALFOND |
|
NOR |
300 000 |
1,40 % |
|
|
|
| VERDIPAPIRFONDET DNB NORGE (IV) |
|
NOR |
287 193 |
1,34 % |
|
|
|
| RUL AS |
|
NOR |
281 475 |
1,32 % |
|
|
|
| POLAR CAPITAL GLOBAL HSBC BANK PLC. |
|
GBR |
254 537 |
1,19 % |
|
|
|
| ARTAL AS |
|
NOR |
233 000 |
1,09 % |
|
|
|
| MYNA AS |
|
NOR |
215 000 |
1,00 % |
|
|
|
| Total 20 largest shareholders |
|
|
14 723 488 |
68,82 % |
|
|
|
| Total other shareholders |
|
|
6 669 813 |
31,18 % |
|
|
|
| Total number of shares |
|
|
21 393 301 |
100,00 % |
|
|
|
For Investor Relations information, please contact:
Erik Dahl (CFO): [email protected] Kathleen Deardorff (COO): [email protected]