Earnings Release • Apr 27, 2020
Earnings Release
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Daniel Schneider, President and CEO Erik Dahl, CFO
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Oslo (HQ)
Norwegian commercial-stage pharmaceutical company focused on bladder cancer with commercial operations in Nordics and USA. Partners in Europe, Canada, Australia and New Zealand
Princeton (NJ)
+23% total sales revenue growth in 2019
NOK 330M global in-market sales*
500 000+ patients treated with Hexvix / Cysview worldwide
650K Avg daily volume YTD**
Oslo Stock Exchange: IPO May 2000
* Total In Market Sales including US, Nordic and Partners ** 24/04/2020
Global Leader in Photodynamic Therapy (PDT)
As of 1997
New strategic focus:
The Bladder Cancer Company
2018
Continue success of Hexvix/Cysview
Expand portfolio of bladder cancer assets
2020 + beyond
Photocure's global commercial bladder cancer platform will be the foundation for transformative deals and value growth
Incomplete resection of bladder tumors leading to increased risk of recurrence and progression to more advanced disease, if Blue Light Cystoscopy is NOT used
Burger et al. Eur. Urol. 2013
Daneshmand S et al. The Journal of Urology, Vol.199, 1158-1165, May 2018
. . . . . . . . . . . . .
0% penetration
| Europe | U.S. |
|---|---|
| Europe: 165,000 new cases, 550,000 prevalent cases, and more than 50,000 deaths annually1 |
US: 82,500 new cases, 280,000 prevalent cases, and more than 18,000 deaths annually1 |
| EU5: 360,000 TURBTs | US: 315,000 TURBTs |
| Ave. Hexvix price ~ 415€ |
Ave. Hexvix price ~ USD 1070 |
| Germany: 30% current penetration, >3,500 units per sales FTE, growing |
Penetration 5-10% Growth rate in excess of 35% Y-o-Y |
| Major markets like UK, Spain not pursued, very limited resources in Italy, France |
Increased commercial investment and focus delivering results |
Get people in place with competencies and skills to address challenges and opportunities
EU General Manager recruited to lead initial organization of 20 FTEs
Supported by global functions with established training, medical and marketing programs and tools
Drive use of Hexvix in existing clinics Expand the number of clinics Leverage Photocure's relationship with equipment suppliers Increase KOL advocacy & engagement Improve market access & reimbursement Build strong Patient Advocacy relationships as in U.S.
Leverage infrastructure, synergies, global approach and consistent global brand
Implement Best practices
Leverage investment in U.S. marketing and medical – scalable into global platforms
Accelerate / Expand / Acquire / Transform:
Establish global bladder cancer footprint in line with our strategy
Ambitions – driving change in our area of expertise
Continuity – dedicated team and performance-based culture
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• Asieris payment of USD 1.5 million in Q1, according to license agreement
BLCTM with Hexvix®/Cysview® can play an integral part in this situation: postponed procedures* do not postpone aggressive cancer progression
17 * Low and medium-risk patients category will be postponed, not the high-risk patient category. According to this, roughly 45% of patients should not be postponed and they represent close to 50% of TURBTs Internal data: USA, EU5 & Nordics figures: Please note market breakout 30% TURBTs and 70% Cystoscopies.
| Amounts in NOK million | Q1 '20 | Q1 '19 | Change | FY '19 |
|---|---|---|---|---|
| Commercial Franchise | ||||
| US revenue | 28.2 | 21.2 | 33% | 98.7 |
| Nordic revenue | 12.2 | 13.1 | -7% | 48.2 |
| Partner revenue | 14.0 | 17.0 | -18% | 66.3 |
| Total Hexvix/Cysview | 54.4 | 51.2 | 6% | 213.2 |
| Other revenue | 0.3 | 1.0 | 3.2 | |
| Total revenue | 54.7 | 52.2 | 5% | 216.4 |
| Operating expenses | -54.0 | -45.1 | 20% | -186.6 |
| EBITDA | -5.2 | 1.7 | 7.3 | |
| Development Portfolio | ||||
| Total revenue | 0.3 | - | 65.1 | |
| Operating expenses | -1.5 | -3.2 | -53% | -13.5 |
| EBITDA | -1.4 | -3.2 | 51.6 | |
| TOTAL | ||||
| EBITDA | -6.7 | -1.5 | 58.9 | |
| 18 |
• Operating expenses Q1 reduced YOY 53%
| Amounts in NOK million | Q1 '20 | Q1 '19 | Change | FY '19 |
|---|---|---|---|---|
| Hexvix/Cysview revenue | 54.4 | 51.2 | 6% | 213.2 |
| Other revenue | 0.6 | 1.0 | 68.3 | |
| Total revenue | 55.0 | 52.2 | 5% | 281.6 |
| Gross profit | 48.8 | 46.8 | 4% | 259.0 |
| Operating expenses | -55.5 | -48.3 | 15% | -200.1 |
| EBITDA | -6.7 | -1.5 | 58.9 | |
| Depreciation & Amort. | -3.9 | -4.2 | -16.2 | |
| EBIT | -10.5 | -5.8 | 42.7 | |
| Net financial items | 5.7 | -0.2 | 3.2 | |
| Earnings before tax | -4.8 | -6.0 | 45.9 | |
| Tax expenses | -12.9 | 1.0 | -14.1 | |
| Net earnings | -17.7 | -4.9 | 31.8 | |
| Net change in cash |
2.2 | -15.4 | 18.5 | |
| Ending cash balance | 127.6 | 91.4 | 125.3 |
19
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• Inclusion in Bladder Cancer treatment guidelines
BLC™ with Hexvix® /Cysview® is strongly recommended by US, European and national guidelines as well as expert panels.
growing awareness and active preference as shown in recent BCAN survey
2018/19 – We have built the Commercial Foundation
Recent early stage studies show a potential treatment effect of Blue Light Cystoscopy (BLC™) with Hexvix1
Study results: a treatment effect could be related to
US Patent issued Feb 11th 2020 covering the use of Hexvix as a neoadjuvant agent in the treatment of patients scheduled for cystectomy
– Other areas of early investigation include enhancing the detection and physician experience and the use of Hexvix/Cysview in combination therapy
Review multiple patents, regulatory data protection in the US with market exclusivity for office use/flex
1
Desk research/Market size
No straightforward access to sales data and performance – different hospital distribution paths, ATC classification "Other diagnostics"
3
API manufacturing or sourcing – meet EU/US pharmacopeia monograph specifications
Freeze dry API under aseptic conditions. Solvent in vial or prefilled syringe. Manual/semi manual packaging/labeling
Photocure exclusivity with only commercial medical API supplier in the world
5
A drug-device combination product. ANDA1 for drug, PMA2 for device. Multiple FDA offices. Participation by 2 companies, requires device manufacturer relationship and coordinated process
No clear drug approval standard: How to document "bioequivalence?"
Note: 1) Abbreviated new drug application; 2) Premarket approval
Active product support incl. training of physicians and nurses, facilitate workflow
* European patent expired September 2019, US patent valid until November 2020, Data exclusivity on flex valid until February 2021 PDT patent in the US granted until December 2036, Additional patents pending
IN ADDITION, PHOTOCURE IS CONTINUOUSLY FOCUSING ON KEY STRATEGIC INITIATIVES TO FURTHER STRENGTHEN ITS LONG-TERM COMPETITIVENESS
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ASIERIS MEDITECH CO., Ltd.
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6- This is why we maintain the long-term guidance 1- Increased global focus on health post Covid-19. Opportunities to improve dialogue with healthcare authorities and enhance public awareness about bladder cancer
5- The need for Bladder Cancer diagnosis and treatment is unchanged in the long-term
2- BLCTM with Hexvix®/Cysview® offers superior detection and management. "Postponed patients" should benefit from BLC as "the new normal": cancer progression hasn't stopped
4- Solid financial position & strong underlying sales momentum (U.S.) providing a platform for long-term growth 3- Office setting using a flexible cystoscope: less restrictive for patients and freeing hospital resources
Hexvix®/Cysview®: Use for the 1st TURBT and for all intermediate and high-risk NMIBC patients during surgical treatment and surveillance / follow-up
*TURBT: trans-urethral resection of bladder tumors
A Drug Device combination for better visual contrast between benign and malignant cells
Hexvix / Cysview is used with a blue light enabled cystoscope, from Karl Storz, Wolf or Olympus
Key therapeutic aim is to avoid progression from non-muscle invasive bladder cancer ("NMIBC") to muscle invasive bladder cancer ("MIBC")
For the same patient having CIS more than doubles their probability to progress to MIBC
40 Sources: All: Global Data: Bladder Cancer Report, Sylvester RJ et al. Eur Urol 2006
Note: 1) Stages from tumor growing into the perivesical tissue and until it has spread to the prostate, uterus or vagina; 2) The tumor has spread to the pelvic wall or the abdominal wall except
2: Babjuk M et al. EAU Guidelines Non-muscle-invasive Bladder Cancer 2018 http://uroweb.org/guideline/ non-muscle-invasive-bladder-cancer/
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