PHOTOCURE ASA
BUILDING A SPECIALTY PHARMA COMPANY
AUGUST 28, 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 +17% LTM 2Q2015 at NOK 195 MNOK
- Driven by Hexvix®/Cysview® for improved detection of bladder cancer and patient management
- Significant Hexvix /Cysview growth opportunities in new territories and 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 targeting HPV and pre-cancerous lesions of the cervix
- Visonac® Phase 3 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 |
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|
|
Marketed as adjunct to white light cystoscopy Phase 3 trial for expansion to surveillance market initiated |
| Cevira® |
Treatment of precursors of cervical cancer |
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Positive Phase 2b results SPA approved 3Q Exploring partnerships |
| Visonac® |
Treatment of moderate to severe acne |
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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:
- − Detection rate
- − 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 17% LTM 2Q2015 to NOK 195 MNOK
- Hexvix/Cysview global in-market volume growth 15% 2Q215
- Continued growth by increased market share of TURBs across all regions
- Increased momentum in the US
- Revenue growth YOY of 117% 1H2015, driven by inmarket volume growth of 57% as well as price increases and Fx
- Increased number of new key hospitals with permanent Blue Light Cystoscopes to 58 at end of Q2 2015
- Continued progress towards sustainable reimbursement
- Overall franchise operating profit year to date at NOK 14.1 million, improvement of NOK 8.7 million from prior year 9
Global in-market unit sales (by Q)
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
- Surveillance following initial diagnosis represents significant opportunities
- Positive early clinical experience with flexible cystoscope
- Clinical trials (Phase 3 and IITs) planned/underway
• Expand into new territories
- In May, distribution agreement with Juno Pharmaceuticals for Hexvix in Australia and New Zealand with potential of 25 000 bladder cancer resections (TURBs) each year
- In August, distribution agreement with BioSyent Pharmaceuticals for Cysview in Canada with potential of 25 000 bladder cancer resections (TURBs) each year
- Recent approval of Hexvix in Russia
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
CEVIRA A Major Opportunity
- Breakthrough single use and fully integrated drug-device technology to satisfy high need for novel therapies to treat global epidemic of HPV/CIN populations
- A well tolerated non-systemic treatment option for patients which preserves fertility and avoids the morbidities of invasive surgery
- Results of the Phase 2b trial are significant
- Statistically significant HSIL (CIN2,3) regression in the FDA agreed phase 3 patient population (p=0.004)
- Statistically significant virologic clearance of oncogenic HPV at 9 months after first treatment (p=0.045)
- Excellent tolerability and high physician & patient acceptance
- Achieved Special Protocol Agreement with FDA in August for patients with HSIL
- Alignment on clinical phase 3 program of two similar double blind, placebo controlled studies with ~200 patients in each study with primary efficacy end point 6 months after treatment
| GYNECOLOGY |
A randomized study of hexaminolevulinate photodynamic therapy in patients with cervical intraepithelial neoplasia 1/2 |
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|
| Mark H. Einstein, MD, MS |
Peter Hillemanns, MD; Francisco Garcia, MD, MPH; Karl Ulrich Petry, MD; Vladimir Dvorak, MD; Oliver Sadovsky, MD; Ole-Erik Iversen, MD; OBJECTIVE: The objective of the study was to investigate the efficacy |
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clear dose effect with a statisticaly significant response in |
| procram. |
and safety of hexaminoleyulinate (HAL) photodynamic therapy (PDT), a novel therapy for women with cervical intraepithelial neoplasia (CIN) 1/2, to define the appropriate population and endpoints for a phase 3. STUDY DESIGN: This was a double-blind, randomized, placebo- controlled, dose-finding study that induded a total of 262 women with biopsy-confirmed CIN 1/2 based on local pathology. Patients received 1 or 2 topical traatments of HAL hydrochioride 0.2%, 1%, 5% |
spotting were reported. |
the HAL 5% group of 95% (18/19 patients) compared to 57% (12/21 patients) in the placebo group $\langle P < .001 \rangle$ was observed at 3 months in women with CIN2, including an encouraging 83% (5/6) patients) dearance of HPV 16/18 compared to 33% (2/6 patients) in the placebo group at 6 months. The treatment was easy to use and well accepted by patients and gynecologists. Only local self- limiting adverse reactions including discharge, discomfort, and |
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Drug Evaluation |
rapy that shows promise in the e of oncogenic HPV, but not of ce maies HAL PDT a tissue- childbearing age who with to |
EXPERT OPINION |
Topical hexaminolevulinate photodynamic therapy for the treatment of persistent human papilloma virus infections and cervical intraepithelial neoplasia |
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lies are planned. cclasia, hexaminolevulinate, therapy |
Introduction Treatment review Condusion |
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patients with cervical intraepithelial |
| Expert opinion |
Peter Hillemanns 1 , Mark H Einstein & Ole Erik Ivenen |
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CEVIRA Significant Sales Potential
- Large patient population based on biopsy confirmed histology of HSIL
- ~1M cases HSIL annually in US & West EU1,2 detected through routine cervical screening programs; 50% of these are caused by HPV strain 16 or 183
- ~30% risk of progress to cervical cancer4
- Upside exists in Latin America, Asia and East EU, where burden of HPV is higher
- LCM Opportunity for clearance of oncogenic HPV in patients with normal cytology/LSIL
- It is estimated that ~35M are HPV infected in US & EU, with a prevalence of HPV strains 16 or 18 of 32% (~11M)
- 10-15M cases oncogenic HPV annually in US & West EU6 detected through routine cervical screening programs
- Persistent infection occurs in 10-20% of the cases7
• Blockbuster sales potential based on premium pricing opportunity
- At premium price levels, cost impact model demonstrates cost savings / benefit to the US health care system as compared to current treatment practice5
- Additional significant savings when avoidance of costs associated with preterm births factored in5
- 14 • Continued discussions with potential partners for development and commercialization
1.Solomon 2007, Antilla 2009 2. Stoler 2011, Wright 2012 3. Smith 2007 4. Stanley 2010 5. Internal assessment perfomed by Bridgehead 6. Wright 2012, Dunne 2007 7. Moscicki 1998
Visonac
Novel non-antibiotic treatment of acne
Visonac1
First Photodynamic Treatment for Inflammatory Acne
• 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
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
Financials 2012-2015
• Financial run rates reflecting PHO growth within specialty pharma • Commercial activities profitable from 2014 – Q2 2015 LTM sales revenue growth YoY 26% (measured in NOK) – Significant reductions in operational expenses • R&D spending still significant given strong product pipeline – R&D 23% of total Opex 2012 2013 2014 Q2 '15 MNOK FY FY FY LTM Hexvix own revenues 29,5 38,1 45,7 54,3 Hexvix partner revenues 38,3 39,8 46,3 50,1 Hexvix / Cysview revenues 67,8 77,9 92,0 104,4 Other sales revenues 7,3 1,4 1,6 5,1 Total sales revenues 75,1 79,3 93,6 109,6 Signing fee and milestones 58,7 4,3 35,4 37,6 Total revenues 133,8 83,6 129,0 147,1 Cost of goods sold -9,4 -6,8 -7,0 -7,6 Gross profit 124,4 76,8 122,0 139,5 Other income 2,2 1,6 - -0,0 Research & Development -50,1 -34,0 -32,6 -31,4 Sales & Marketing -70,2 -68,4 -54,6 -61,3 Other Opex -45,6 -47,8 -40,5 -42,1 Operating expenses -163,7 -148,6 -127,6 -134,8 EBIT recurring -39,2 -71,8 -5,6 4,7
Segments and Profit/Loss Second quarter 2015
• Commercial franchise
- Continued improvement in revenues (+39% year to date) and EBIT
- EBIT margin year to date at 22%
• Development portfolio:
- Activities related to Cevira SPA
- Cysview post marketing commitment phase 3 capitalized
• Total Opex increased 12% in year to date
– Increased investment in S&M and FX impact
| MNOK |
Q2 '15 |
Q2 '14 |
YTD '15 |
YTD '14 |
LTM |
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|
|
| Commercial Franchise |
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|
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|
|
|
|
| Total revenues |
34,8 |
25,5 |
64,4 |
46,2 |
116,4 |
|
|
|
Gross profit Operating expenses |
32,6 -22,7 |
23,5 -18,1 |
60,2 -46,1 |
42,6 -37,2 |
108,8 -84,1 |
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|
|
| EBIT |
9,9 |
5,4 |
14,1 |
5,4 |
24,6 |
|
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|
| Development Portfolio |
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|
|
|
|
| Total revenues |
0,0 |
0,0 |
0,0 |
0,0 |
0,0 |
|
|
|
Gross profit Operating expenses |
0,0 -11,8 |
0,0 -11,0 |
0,0 -23,2 |
0,0 -24,8 |
0,0 -50,7 |
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|
|
| EBIT |
-11,8 |
-11,0 |
-23,2 |
-24,8 |
-50,7 |
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| Total |
|
|
|
|
|
|
|
|
| EBIT |
-1,9 |
-5,7 |
-9,1 |
-19,4 |
-26,0 |
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| (*) One-Off's excluded |
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| Salix termination fee |
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30,8 |
|
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Operating loss (EBIT) at NOK 1.9 million in 2Q and NOK 9.1 million year to date
Improvements of NOK 10 million from first half last year
Cash balance of NOK 147 million at end of 2Q2015
Outlook
Outlook
Q&A
Attachments
Largest Shareholders
|
Account |
|
|
|
| Shareholder |
type |
Citizen |
No of shares |
% |
| J.P. MORGAN CHASE BANK N.A. LONDON |
NOM |
GBR |
3 153 874 |
14,72 % |
| RADIUMHOSPITALETS FORSKNINGSSTIFTELSE |
|
NOR |
1 929 000 |
9,00 % |
| FONDSFINANS NORGE |
|
NOR |
1 475 000 |
6,88 % |
| KLP AKSJE NORGE VPF |
|
NOR |
1 279 984 |
5,97 % |
| KOMMUNAL LANDSPENSJONSKASSE |
|
NOR |
950 000 |
4,43 % |
| MP PENSJON PK |
|
NOR |
825 000 |
3,85 % |
| SKAGEN VEKST |
|
NOR |
626 466 |
2,92 % |
| DANSKE INVEST NORSKE INSTIT. II. |
|
NOR |
422 703 |
1,97 % |
| VERDIPAPIRFONDET EIKA NORGE |
|
NOR |
406 517 |
1,90 % |
| ARTAL AS |
|
NOR |
381 118 |
1,78 % |
| BERGEN KOMMUNALE PENSJONSKASSE |
|
NOR |
370 000 |
1,73 % |
| DANSKE INVEST NORSKE AKSJER INST |
|
NOR |
360 714 |
1,68 % |
| FONDSFINANS GLOBAL HELSE |
|
NOR |
357 806 |
1,67 % |
| VICAMA AS |
|
NOR |
345 384 |
1,61 % |
| VERDIPAPIRFONDET DNB NORGE (IV) |
|
NOR |
287 193 |
1,34 % |
| RUL AS |
|
NOR |
281 475 |
1,31 % |
| POLAR CAPITAL GLOBAL HSBC BANK PLC. |
|
GBR |
254 537 |
1,19 % |
| SVENSKA HANDELSBANKEN |
|
SWE |
250 000 |
1,17 % |
| VERDIPAPIRFONDET DNB SMB |
|
NOR |
217 500 |
1,02 % |
| HOLMEN SPESIALFOND |
|
NOR |
200 000 |
0,93 % |
| Total 20 largest shareholders |
|
|
14 374 271 |
67,09 % |
| Total other shareholders |
|
|
7 051 194 |
32,91 % |
| Total number of shares |
|
|
21 425 465 |
100,00 % |
Profit & Loss Second Quarter 2015
| MNOK |
Q2 '15 |
Q2 '14 |
Change |
YTD '15 |
YTD '14 |
Change |
| Hexvix / Cysview revenues |
28,9 |
23,8 |
21 % |
55,6 |
43,2 |
29 % |
| Other sales revenues |
2,6 |
0,5 |
>100% |
4,3 |
0,7 |
>100% |
| Signing fee and milestones |
3,3 |
1,1 |
>100% |
4,5 |
2,3 |
96 % |
| Total revenues |
34,8 |
25,5 |
36 % |
64,4 |
46,2 |
39 % |
| Gross profit |
32,6 |
23,5 |
39 % |
60,2 |
42,6 |
41 % |
| Operating expenses |
-34,5 |
-29,2 |
18 % |
-69,2 |
-62,0 |
12 % |
| EBIT / Operating profit/loss(-) |
-1,9 |
-5,7 |
-67 % |
-9,1 |
-19,4 |
-53 % |
| Profit/loss(-) before PCIB and tax |
-0,4 |
-4,2 |
-90 % |
-7,4 |
-17,2 |
-57 % |
- Total revenue increase YoY 36% in 2Q and 39% year to date
- Operating expenses increase YoY 18% in 2Q and 12% year to date
- Mainly driven by planned activities in sales and marketing, as well as FX impact
- Operating loss (EBIT) at NOK 1.9 million in 2Q and NOK 9.1 million year to date
- Significant improvements from last year
Hexvix/Cysview Continued Growth in Second Quarter 2015
- Revenue from own sales of Hexvix/ Cysview increased YoY 42% in 2Q and 43% year to date
- Nordic 2Q revenue growth of 19%
- US 2Q revenue growth of 118%
- Partner 2Q revenue increased YoY 3% and year to date with 16%
- Changed timing of supply to partner compared to the same period in 2014
- Total in market sales value increased YoY 26% in 2Q and 17% year to date
- LTM value NOK 195 million
| SALES - MNOK |
Q2 '15 |
YTD '15 |
| Hexvix - Nordic |
10,0 |
18,2 |
| YoY growth |
19 % |
20 % |
| Cysview - US |
5,8 |
10,3 |
| YoY growth |
118 % |
117 % |
| Hexvix own sales |
15,7 |
28,6 |
| YoY growth |
42 % |
43 % |
| Hexvix partner sales |
13,2 |
27,0 |
| YoY growth |
3 % |
16 % |
| Total Photocure |
28,9 |
55,6 |
| YoY growth |
21 % |
29 % |
|
|
|
| Revenue in-market (*) |
53,8 |
104,4 |
| YoY growth |
26 % |
17 % |
| Units in-market (*) |
14 043 |
27 257 |
| YoY growth |
15 % |
6 % |
(*) Calculated in-market sales
Cash Flow Second Quarter 2015
| MNOK |
Q2 '15 |
Q2 '14 |
YTD '15 |
YTD '14 |
| Cash flow from: |
|
|
|
|
| - Operations |
-2,5 |
-9,8 |
-14,4 |
-28,5 |
| - Investments |
-1,5 |
0,8 |
-5,1 |
1,9 |
| - Financing |
0,9 |
0,0 |
0,9 |
0,0 |
| Net change in cash |
-3,1 |
-9,0 |
-18,6 |
-26,5 |
| Ending cash balance |
146,7 |
140,7 |
146,7 |
140,7 |
- 2Q cash flow from operations NOK -2.5 million, year to date NOK -14.4 million
- Year to date improvement of NOK 14.1 million from last year.
- Year to date cash flow from investments NOK -5.1 million.
- Includes investments of NOK 7.0 million in intangible assets mainly related to the initiation of the phase 3 post-marketing commitment trial for Cysview
- Quarter end cash balance at NOK 147 million
Balance Sheet Per 30 June 2015
- Non current assets includes NOK 8.9 million in shares in PCI Biotech and deferred tax asset of NOK 24.3 million
- No interest bearing debt at quarter end
- Shareholder's equity of NOK 220.9 million
- Equity ratio of 89%
- Photocure held 35,476 own shares at end of quarter
| MNOK |
30.06 2015 |
31.12 2014 |
| Non-current assets |
70,0 |
76,5 |
| Inventory & receivables |
32,8 |
28,8 |
| Cash & equivalents |
146,7 |
165,2 |
| Total assets |
249,5 |
270,6 |
| Shareholders equity |
220,9 |
240,1 |
| Long term liabilities |
3,5 |
3,1 |
| Current liabilities |
25,1 |
27,5 |
| Total equity & liabilities |
249,5 |
270,6 |
| Equity ratio |
89 % |
89 % |