Earnings Release • May 14, 2019
Earnings Release
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14 May 2019
Daniel Schneider, President and CEO Erik Dahl, CFO
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Significant growth of Cysview® in US TURBT market
Accelerate Cysview® in US flexible cystoscopy surveillance market
Increase Hexvix® / Cysview® global inmarket unit sales
Create opportunities vis-à-vis our strategic partnerships
US (1000 NOK)
4
2013 2014 2015 2016 2017 2018 Q1 2019
Profitable commercial franchise
Hexvix®/Cysview® ~\$35M global in-market sales* (FY'18) Over 500k patients treated with Hexvix®/Cysview® worldwide
Strong competitive position Unique and complex drug-device procedure Leading regulatory, manufacturing & commercial expertise
Significant growth prospects Grow in existing markets like the US & expand into new regions FLEX label extension accessing a larger market opportunity
Scalable for partnerships and in-licensing opportunities
~650K
surgical procedures annually in USA and EU ~2.2M
surveillance cystoscopies annually in USA and EU
50% disease recurrence 10% – 30% disease progression
\$3.7 Billion in direct medical costs/year1
Picture: Mayo Clinic; Researchgate.net 1. Direct medical costs in USA in 2001: The health economics of bladder cancer: a comprehensive review of the published literature. Botteman MF et al. Pharmacoeconomics 2003;21 (8), 1315-1330
with Hexvix® / Cysview®
Additional tumors found in 1 out of 4 patients1
1 Burger et al, Eur. Urol. 2013 WLC: White Light Cystoscopy; BLC: Blue Light Cystoscopy™ + Cysview®
Key feature Better visual contrast between benign and malignant cells
Key benefits Improve diagnostic accuracy Achieve optimal surgical results
Significant reduction of disease recurrence Reduction in disease progression Potential for reduction in cystectomies Improved and cost-effective health outcomes
The global flexible surveillance market is approximately 3X bigger than the rigid TURBT market
Supportive environment Strongly recommended by European and national guidelines as well as expert panels
Strongly recommended by US guidelines and expert panels
• Expert Consensus Statement: Blue light flexible cystoscopy with Cysview (hexaminolevulinate) in nonmuscle-invasive bladder cancer
• The prognostic impact of hexaminolevulinate-based bladder tumor resection in patients with primary nonmuscle invasive bladder cancer treated with radical cystectomy
Established in >140 key cancer hospitals and leading institutions The numbers will grow with optimized US commercial footprint
High Adoption Rates
in 74% NCCN centers
in 56% of NCI centers
in 74% of top 25 Best Hospitals
Jan. 2016 n=222, Jan. 2017 n=568, Jan. 2018 n=550, Jan. 2019 n=600
BLC™ with Cysview® was featured in several sessions at the AUA meeting, including:
• Dr. Yair Lotan, M.D., Professor of Urology, University of Texas Southwestern Medical Center presented on "Blue Light Flexible Cystoscopy with Hexaminolevulinate for Surveillance of Bladder Cancer".
Targeting top 750 Reference Centers and major LUGPA and IDNs
Re-focused Existing Headcount
| Amounts in NOK million |
Q1 '19 | Q1 '18 | Change | FY '18 |
|---|---|---|---|---|
| Commercial Franchise | ||||
| Nordic revenue | 13.1 | 12.1 | 8% | 47.0 |
| US revenue | 21.2 | 12.7 | 66% | 63.7 |
| Partner revenue | 17.0 | 15.8 | 7% | 62.2 |
| Total Hexvix/Cysview | 51.2 | 40.7 | 26% | 172.9 |
| Other revenue |
1.0 | 0.9 | 8.6 | |
| Total revenue | 52.2 | 41.6 | 26% | 181.5 |
| Operating expenses | -45.1 | -37.3 | 21% | 156.0 |
| EBITDA recurring | 1.7 | 0.9 | 8.4 | |
| Development Portfolio | ||||
| Operating expenses | -3.2 | -5.0 | -36% | -18.9 |
| EBITDA recurring | -3.2 | -5.0 | -18.9 | |
| Total | ||||
| EBITDA recurring | -1.5 | -4.0 | -10.5 |
• Significant cost reductions continuing from last year – activity level and capacity reductions
| Amounts in NOK million |
Q1 '19 | Q1 '18 | Change | FY '18 |
|---|---|---|---|---|
| Hexvix/Cysview revenue | 51.2 | 40.7 | 26% | 172.9 |
| Other revenue |
1.0 | 0.9 | 8.6 | |
| Total revenue | 52.2 | 41.6 | 26% | 181.5 |
| Gross profit | 46.8 | 38.2 | 22% | 164.4 |
| Operating expenses | -48.3 | -42.2 | 14% | -174.9 |
| EBITDA recurring | -1.5 | -4.0 | -10.5 | |
| Depreciation & Amort. |
-4.2 | -3.2 | -13.2 | |
| Restructuring expenses |
-14.2 | |||
| EBIT | -5.8 | -7.3 | -37.9 | |
| Net financial items |
-0.2 | -0.2 | 1.2 | |
| Earnings before tax |
-6.0 | -7.5 | -36.7 | |
| Tax expenses |
1.0 | 4.5 | 0.0 | |
| Net earnings | -4.9 | -3.0 | -36.7 |
| Amounts in NOK million |
Q1 '19 | Q1 '18 | FY '18 |
|---|---|---|---|
| Operational cash flow |
-15.7 | -18.5 | -24.1 |
| EBITDA, recurring | -1.5 | -4.0 | -10.5 |
| Working capital |
-12.5 | -11.0 | 1.4 |
| Other | -1.6 | -3.5 | -15.0 |
| Investment cash flow | 0.5 | -0.1 | -1.1 |
| Development exp. | - | -0.4 | -0.6 |
| Other | 0.5 | 0.3 | -0.5 |
| Financing cash flow |
-0.2 | - | 2.7 |
| Share capital |
0.6 | - | 6.3 |
| Other | -0.9 | - | -3.7 |
| Net change in cash |
-15.4 | -18.6 | -22.5 |
| Ending cash balance | 91.4 | 110.7 | 106.8 |
| Amounts in NOK million |
31.03 2019 |
31.12 2018 |
|---|---|---|
| Non current assets |
84.9 | 77.8 |
| Investments | 21.5 | 24.6 |
| Tax asset |
53.4 | 52.4 |
| Other | 10.0 | 0.7 |
| Inventory & receivables | 56.1 | 46.6 |
| Cash & equivalents | 91.4 | 106.8 |
| Total assets | 232.4 | 231.2 |
| Shareholders equity |
171.8 | 176.3 |
| Long term liabilities | 12.1 | 2.5 |
| Current liabilities |
48.6 | 52.3 |
| Total equity & liabilities | 232.4 | 231.2 |
| Equity ratio | 74% | 76% |
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