Earnings Release • Nov 8, 2017
Earnings Release
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RESULTS FOR THIRD QUARTER AND FIRST NINE MONTHS 2017
8 NOVEMBER 2017
Kjetil Hestdal, MD, President & CEO Erik Dahl, CFO
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 2016. 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.
Increase growth of Cysview in US based on increased investment in US commercial operation
Increase Hexvix / Cysview global inmarket unit sales
Obtain regulatory approval for market expansion of Cysview into surveillance market
With courtesy of Dr. Dirk Zaak
Global in-market value NOK mill (LTM)
Of the total 1.4 million cystoscopies performed in the US each year approximately 40-50% estimated to be performed in surveillance of patients with high and medium risk NMIBC
7 1. Carcinoma in Situ; 2. Transurethral Resection of Bladder Tumour
| MEDICARE REIMBURSEMENT OF AN ADDITIONAL USD 1,000 PER TURBT FROM 2018 Medicare (~55% of TURBT) Private payer (~45% of TURBT) • Procedure fee for cystoscopy • Procedure fee for cystoscopy • Cysview paid at contracted rate (ASP +6 to Cystoscopy • Cysview paid at ASP* +6% 15%) • No change from 2017 • No change from 2017 • Hospital Outpatient Depts. will receive an additional \$1,000 to cover the complexity of using Cysview and Blue Light Cystoscopy procedure for • Procedure fee for TURBT – varies by type the following codes: 52204, 52214 & • Cysview paid at (Average Selling Price -ASP +6 TURBT 5224 to 15%) • No change from 2017 • Bundled into ambulatory payment classification (APC – varies by TURBT type)1 for the higher procedure codes of 52234, 52235 and 52240 |
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|---|---|---|
| Note: 1) Exceptions: Cancer centers, state of Maryland (Medicare exception), Critical access hospitals (rural classified as critical access) receive incremental Professional fees for cystoscopy/TURBT remain the same, additional reimbursement for specific TURBT procedures; *Average Sales Price |
payment; |
8
| Totals (inpatient & | ||
|---|---|---|
| Metropolitan statistical area | outpatient TURBT | |
| procedures*): Total | ||
| New York, Newark, Jersey Chicago, Naperville, Elgin |
21,284 9,649 |
|
| Philadelphia, Camden, Wilmington |
6,256 | |
| Los Angeles, Long Beach, Anaheim | 5,994 | |
| Miami, Fort Lauderdale, West Palm Beach |
5,436 | |
| Tampa, St. Petersburg, Clearwater |
5,010 | |
| Boston, Cambridge, Newton |
4,768 | |
| Detroit, Warren, Dearborn | 4,054 | |
| Phoenix, Mesa, Scottsdale | 3,998 | |
| Baltimore, Columbia, Towson | 2,862 | |
| Houston, The Woodlands, Sugar Land |
2,763 | |
| Washington, Arlington, Alexandria |
2,700 | |
| St. Louis | 2,535 | |
| Orlando, Kissimmee, Sanford | 2,339 | |
| Atlanta, Sandy Springs, Roswell |
2,136 | |
| Dallas, Fort Worth, Arlington |
2,076 | |
| Cleveland, Elyria |
1,937 | |
| Cincinnati | 1,923 | |
| Cape Coral, Fort Myers | 1,712 | |
| Pittsburgh | 1,685 | |
| North Port, Sarasota, Bradenton |
1,672 | |
| Jacksonville | 1,671 | |
| Providence, Warwick Minneapolis, St. Paul, Bloomington |
1,613 1,544 |
|
| Nashville, Davidson, Murfreesboro, Franklin | 1,535 | |
| 9 | ||
| *TURBT numbers as per Medicare coding data | ||
Maximizing the US Cysview opportunity is essential to Photocure's strategy to create a Specialty Pharmaceutical Company in Urology
Its medical benefits align with TURBT key objectives
highest in Denmark and Norway
11 Source: QuintilesMS Note: 1) Respondents DK 17, FI 18, NO 11, SE 20
«Real-life experience: recurrence rate at 3 years with Hexvix® photodynamic prospective controlled study» Gallagher K et al, World J Urology; 2017 (published online 12 August 2017)
| A randomized study of hexaminolevulinate photodynamic therapy in patients with |
||
|---|---|---|
| cervical intraepithelial neoplasia 1/2 Fred Millensons, 1971 President Carrie, 1412 14996 Audi United Franz, 1484 |
||
| Mark H. Hondales, Mills MA | Theliane Dramsk, MDI (Slow Industrie). MDI (The Litk Insteam, 1470) | |
| URAPER | Leasend Managers of APR 1979 compared by 27% 21% palental in the plansker price at it, member. The bearings area adds to use START DESIGN This was a studie-twice conti- the test words of a patient will precedure the lost and centrated state-feeling study that traducer is long of 1927 and Drug Evaluation |
day to Ba. 34.102.9 |
| EXPERT OPINION |
Topical hexaminolevulinate photodynamic therapy for the treatment of persistent human papilloma virus infections and cervical intraepithelial neoplasia |
4 Source 0.463 |
| SEGMENT PERFORMANCE | |||||
|---|---|---|---|---|---|
| THIRD QUARTER 2017 | |||||
| Commercial franchise: | MNOK | Q3 '17 | Q3 '16 | YTD '17 | YTD '16 |
| • Hexvix/Cysview total revenue increased YoY 12% in the |
Commercial Franchise | ||||
| third quarter, driven by continued strong US revenues | Nordic revenues | 9.0 | 8.7 | 30.4 | 29.4 |
| • Third quarter own revenues, Nordic and US, increased 23%, |
US revenues Partner revenues |
11.3 15.2 |
7.8 15.1 |
32.3 47.0 |
22.4 47.5 |
| while partner revenues, Ipsen, increased 1% | Hexvix / Cysview | 35.5 | 31.6 | 109.6 | 99.4 |
| • Hexvix/Cysview revenues increased 10% YTD (in constant |
Other revenues Total revenues |
0.2 35.6 |
3.6 35.2 |
1.9 111.5 |
6.2 105.5 |
| currencies 12%) | Gross profit | 32.6 | 33.1 | 102.9 | 98.9 |
| • Increased operating expenses in quarter and YTD driven by |
Operating expenses | -32.8 | -25.0 | -93.5 | -79.6 |
| sales & marketing in US | EBITDA recurring | -0.2 | 8.0 | 9.4 | 19.3 |
| Development Portfolio | |||||
| Development portfolio: | Operating expenses | -9.4 | -9.7 | -27.7 | -27.0 |
| • Activities related to regulatory work and intellectual |
EBITDA recurring | -9.4 | -9.7 | -27.7 | -27.0 |
| property. Cysview post marketing commitment phase 3 capitalized |
Total | ||||
| EBITDA recurring | -9.6 | -1.6 | -18.3 | -7.7 | |
| • One-off items (first quarter): Write down of Nedax lamp inventory and components |
One-Off items EBITDA |
0.0 -9.6 |
0.0 -1.6 |
-4.0 -22.3 |
0.0 -7.7 |
| 17 |
| CONSOLIDATED INCOME STATEMENT THIRD QUARTER 2017 Q3 '17 Q3 '16 YTD '17 YTD '16 MNOK Total revenue increases YoY 1% third quarter and 6% YTD Hexvix / Cysview revenues 35.5 31.6 109.6 99.4 Operating expenses increase YoY 22% third quarter Other revenues 0.2 3.6 1.9 6.2 Total revenues 35.6 35.2 111.5 105.5 and 14% YTD Gross profit 32.6 33.1 102.9 98.9 – R&D YTD increase 9% – Sales & marketing YTD increase 23%, driven by US Research & Development -4.7 -3.9 -13.3 -12.2 Sales & Marketing -25.6 -19.1 -73.0 -59.2 investments and flex preparations Other Opex -12.0 -11.6 -34.9 -35.2 – Other Opex YTD decrease 1% Operating expenses -42.2 -34.7 -121.2 -106.6 Recurring EBITDA at NOK -9.6 million third quarter and EBITDA recurring -9.6 -1.6 -18.3 -7.7 NOK -18.3 million YTD One-Off items - - -4.0 - One-off items: Write down of Nedax lamp inventory and Depreciation & Amortization -4.3 -1.6 -8.8 -4.8 components EBIT -13.9 -3.2 -31.1 -12.5 Depreciation and amortization driven by amortization of Net financial items 0.4 -0.0 2.7 1.2 Profit/loss(-) before tax -13.5 -3.3 -28.4 -11.3 Cysview phase 3 investments Tax expenses 3.5 3.3 6.7 28.7 Net profit/loss(-) -10.1 0.1 -21.7 17.5 |
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| 18 |
| MNOK | Q3 '17 | Q3 '16 | YTD '17 | YTD '16 |
|---|---|---|---|---|
| Cash flow from: - Operations |
-3.4 | -8.6 | -31.1 | -30.7 |
| - Investments | -10.6 | -2.9 | -15.1 | -11.1 |
| - Financing Net change in cash |
0.0 -13.9 |
1.0 -10.5 |
0.0 -46.1 |
1.7 -40.1 |
| Ending cash balance | 123.1 | 93.9 | 123.1 | 93.9 |
| MNOK | 30.09 | 31.12 | 30.09 |
|---|---|---|---|
| 2017 | 2016 | 2016 | |
| Non-current assets | 89.1 | 74.1 | 82.0 |
| Inventory & receivables | 47.4 | 43.0 | 81.4 |
| Cash & equivalents | 123.1 | 169.2 | 93.9 |
| 259.6 | 286.3 | 257.3 | |
| Total assets | |||
| Shareholders equity | 230.7 | 251.9 | 234.1 |
| Long term liabilities | 4.5 | 3.8 | 3.4 |
| Current liabilities | 24.3 | 30.6 | 19.8 |
| Total equity & liabilities | 259.6 | 286.3 | 257.3 |
| Equity ratio | 89 % | 88 % | 91 % |
Increase Hexvix / Cysview global inmarket unit sales
Obtain regulatory approval for market expansion of Cysview into surveillance market
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