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Research: Healthcare
Photocure announced results for Q117 with 9% growth for the Hexvix/Cysview franchise compared to Q116. The US was a major driver, up 32% to NOK10m, though the Nordics fell by 4% to NOK9.7m due to currency and weakness in Denmark. Importantly, the company also recently announced that its Phase III trial in the bladder cancer surveillance market was successful, which should enable it to receive marketing authorisation in that market.
Written by
Photocure |
A strong quarter in the US |
Financial update |
Pharma & biotech |
6 June 2017 |
Share price performance
Business description
Next events
Analysts
Photocure is a research client of Edison Investment Research Limited |
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Photocure announced results for Q117 with 9% growth for the Hexvix/Cysview franchise compared to Q116. The US was a major driver, up 32% to NOK10m, though the Nordics fell by 4% to NOK9.7m due to currency and weakness in Denmark. Importantly, the company also recently announced that its Phase III trial in the bladder cancer surveillance market was successful, which should enable it to receive marketing authorisation in that market.
Year end |
Revenue (NOKm) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/15 |
134.7 |
(17.4) |
(0.82) |
0.0 |
N/A |
N/A |
12/16 |
143.6 |
12.8 |
0.59 |
0.0 |
46.3 |
N/A |
12/17e |
145.5 |
(48.9) |
(2.26) |
0.0 |
N/A |
N/A |
12/18e |
242.5 |
5.8 |
0.26 |
0.0 |
105.0 |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
US sales continue to be strong
Sales in the US increased 32% to NOK10.0m driven mainly by volume growth and price increases, though there was also a minor currency headwind. Unit sales increased 28% and six additional units were installed over the quarter, bringing the total installed base to 89. The company is in the process of increasing the size of the US salesforce, which may enable it to maintain the fast pace of growth and take advantage of the recent Phase III data in the surveillance setting.
Surveillance trial data potentially transformational
Data from the 304-patient Phase III trial of Hexvix/Cysview in the surveillance setting showed that the product increased detection of patients with recurrence and that 21.5% (p<0.0001) of the patients with recurrence had one that was only detected with Hexvix/Cysview. Hexvix/Cysview sales may have significant upside if the product successfully expands into the US bladder cancer surveillance market, which has 1.2m procedures per year, compared to its current market of 250,000 transurethral resection of the bladder (TURB) procedures.
Nordic segment continues to struggle
2016 was a relatively difficult year for Photocure in the Nordic region due to staffing issues on its salesforce and the franchise only grew 1% over the course of the year. Q117 Nordic revenues fell 4% to NOK9.7m (though on a constant currency basis they were up 1%) and in-market unit sales were down 8%. Results were especially weak in Denmark due to the reorganisation of hospitals in the Copenhagen region.
Valuation: NOK947m or NOK44 per share
We have adjusted our valuation to NOK947m or NOK44 per basic share, from NOK943m or NOK44 per basic share, mainly due to rolling over our NPV model to Q117. We expect approval for the US surveillance market and profitability in 2018. The company ended Q117 with NOK155m in cash, and we do not expect it to require further financing.
First quarter results
Photocure reported total revenue of NOK36.5m for Q117, representing 5% growth over Q116. This was driven by 9% year-on-year growth of revenues from Hexvix/Cysview (NOK36.5m vs NOK33.5m), offset by a lack of milestone revenue compared to NOK1.3m in Q116.
Exhibit 1: Q117 Hexvix/Cysview sales
Revenue (NOKm) |
Y-o-y |
Q-o-q |
Units |
Y-o-y |
Q-o-q |
|
Hexvix sales Nordic |
9,731 |
-4% |
1% |
2,271 |
-8% |
-7% |
Cysview sales US |
10,041 |
32% |
25% |
1,276 |
28% |
22% |
Total own sales |
19,772 |
12% |
12% |
3,547 |
2% |
2% |
Partner sales |
16,742 |
6% |
20% |
11,908 |
12% |
10% |
Total Hexvix/Cysview |
36,514 |
9% |
16% |
15,455 |
9% |
8% |
Source: Photocure
End user unit sales were especially strong in the US (up 28%), which was driven by an increase in the number of permanent blue light cystoscopes installed and by an increase in the usage per centre. The ongoing expansion of the US salesforce may help improve the already positive dynamics there even further. Nordic sales were hampered by weak results across Scandinavia but mainly due to a reorganisation of hospitals in the Copenhagen region. Growth in partnered areas was hampered by the delayed placement of scopes and reimbursement issues in the new markets of Australia and Canada.
|
Exhibit 2: Hexvix/Cysview in-market sales |
|
|
Source: Photocure |
SG&A for Q1 was slightly higher than recent quarters at NOK33.5m (compared to NOK30.3m in Q4). SG&A will likely increase in 2017 and 2018 due in large part to an increase in the number of salespeople in the US. This will enable them to penetrate additional metropolitan areas and lay the groundwork in preparation for the surveillance market launch. R&D expenses were up (to NOK8.5m from NOK5.0m), mainly due to a NOK4.0m write-down of Nedax lamp inventory (the lamp is associated with the Visonac product).
Improving bladder cancer surveillance
Photocure presented new clinical results of Hexvix/Cysview at the American Urological Association (AUA) meeting on 14 May 2017. The results are from the Phase III clinical study measuring the utility of Hexvix/Cysview for the ongoing surveillance of patients with non-muscle invasive bladder cancer (NMIBC). After diagnosis, patients with NMIBC typically undergo a TURB procedure, in which tumours are resected using a cystoscope. Hexvix/Cysview is already approved for use during TURB procedures to improve the identification of lesions for removal. These patients are then followed with routine surveillance for recurrence, which is high with NMIBC. The AUA recommends surveillance every three to six months for the first three years after diagnosis and yearly thereafter.
The clinical trial enrolled 304 patients at 17 institutions in the US. It only enrolled patients with a high probability of recurrence as identified by having multiple tumours, a previous recurrence, and/or high-grade tumours in previous procedures. Patients on the study underwent both blue light and white light cystoscopy and the ability of the two techniques to identify recurrence events was compared. The primary end point of the trial was the number of patients with recurrences who were identified using Hexvix/Cysview who were missed with white light cystoscopy. In addition to the experimental portion of the trial, 68 patients were included for training purposes to acclimatise physicians to blue light cystoscopy.
A total of 220 patients were in the experimental portion of the trial and available for evaluation. From this population, 103 patients were referred to the operating room for a TURB procedure based on initial surveillance cystoscopy, and 65 had a confirmed recurrence. 14 patients (21.5% p<0.0001) were referred to the operating room using Hexvix/Cysview and would have been missed using white light cystoscopy alone. This is significant evidence that Hexvix/Cysview can improve the surveillance in this population. Moreover, of these 65 patients with recurrence, almost half (30 patients, 46.2%) had additional lesions detected using Hexvix/Cysview over white light cystoscopy alone. In particular, Hexvix/Cysview improved the identification of carcinoma in situ (CIS). CIS is a small flat lesion in the early stages of its growth before it is generally considered a tumour with high risk of progression. Of the patients on the trial, 26 had confirmed CIS, of which nine (34.6%, p<0.0001) were diagnosed with Hexvix/Cysview and would have otherwise been missed.
The use of Hexvix/Cysview did substantially increase the number of false positive diagnoses of recurrence. It doubled the number of patients from 19 to 38 (8.6% to 17.2%) that were referred for TURB who turned out to not have a malignancy. The total number of patients referred for TURB increased by 47% (from 70 to 103) when using Hexvix/Cysview; however, we consider this increase in procedures justified considering that 42% of the new referrals had disease that would have otherwise been missed.
We believe that these data are supportive of approval for the US surveillance market. In addition, the safety data on repeated use of Hexvix/Cysview, as well as significantly improved detection of CIS obtained in the current study, should expand the current label to include improved detection of CIS and remove the current label restrictions on repeated use.
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Exhibit 3: Blue light cystoscopy with Hexvix/Cysview increases bladder cancer detection |
|
|
Source: Photocure |
Expansion into the surveillance market is essential to the continued growth of Hexvix/Cysview, particularly in the US. The product is currently approved in the US and Europe for TURB, of which there are approximately 250,000 and 300,000 respective procedures annually. However, surveillance procedures are far more common than TURB, with approximately 1.2m procedures in the US and 750,000 in Europe per year.
Valuation
We have adjusted our valuation to NOK947m or NOK44 per basic share, from NOK943m or NOK44 per basic share, mainly due to rolling over our NPV model to Q117. We expect approval for the US surveillance market and profitability in 2018. We may adjust our valuation in the future to reflect the initial sales trajectory of the product, as well as changes to spending associated with new marketing.
Exhibit 4: Valuation of Photocure
Product |
Main indication |
Status |
Probability of commercialisation |
Launch year |
Peak sales (NOKm) |
Patent protection |
Economics |
rNPV (NOKm) |
|
Hexvix/Cysview |
Bladder cancer detection |
Market |
100% |
Launched |
344 |
2019-20 |
Fully owned – US and Nordics; partner with Ipsen in EU (35% royalty) |
537 |
|
Cevira |
HPV-related diseases |
Phase III |
20% |
2020 |
2,399 |
2030 |
17.5% |
136 |
|
Visonac |
Acne |
Phase III |
20% |
2020 |
2,175 |
2028 |
17.5% |
118 |
|
Total |
|
|
|
|
|
|
|
792 |
|
Cash and cash equivalents (Q117) |
155 |
||||||||
Total firm value |
947 |
||||||||
Total basic shares (m) |
21.6 |
||||||||
Value per basic share (NOK) |
44 |
||||||||
Options (Q117, m) |
0.1 |
||||||||
Total number of shares (m) |
21.6 |
||||||||
Diluted value per share (NOK) |
44 |
||||||||
Source: Edison Investment Research
Financials
We are maintaining our estimates for the most part though we have increased our 2017 sales estimate by NOK1.5m and increased our 2017 and 2018 R&D expense estimates by NOK2.3m and NOK2.4m, respectively. We continue to expect that the company will become profitable in 2018, although we expect cash flows to be negative until 2019. The company ended Q117 with NOK155m in cash, and we do not expect it to require further financing.
Exhibit 5: Financial summary
NOK'000s |
2015 |
2016 |
2017e |
2018e |
||
Year end 31 December |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
||||||
Revenue |
|
|
134,717 |
143,627 |
145,499 |
242,457 |
Cost of Sales |
(8,221) |
(9,337) |
(11,572) |
(16,947) |
||
Gross Profit |
126,496 |
134,291 |
133,927 |
225,510 |
||
Sales, General and Administrative Expenses |
(115,025) |
(124,647) |
(155,241) |
(194,052) |
||
Research and Development Expense |
(29,558) |
(17,652) |
(20,800) |
(21,632) |
||
EBITDA |
|
|
(18,087) |
(8,008) |
(42,114) |
9,827 |
Operating Profit (before amort. and except) |
(21,986) |
(15,861) |
(53,660) |
827 |
||
Intangible Amortisation |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
0 |
0 |
||
Exceptionals |
0 |
0 |
0 |
0 |
||
Operating Profit |
(21,986) |
(15,861) |
(53,660) |
827 |
||
Net Interest |
4,553 |
28,640 |
4,742 |
4,932 |
||
Other |
(9,771) |
(366) |
(313) |
0 |
||
Profit Before Tax (norm) |
|
|
(17,434) |
12,779 |
(48,918) |
5,758 |
Profit Before Tax (FRS 3) |
|
|
(27,205) |
12,414 |
(49,231) |
5,758 |
Tax |
0 |
(0) |
0 |
0 |
||
Deferred tax |
(0) |
(0) |
(0) |
(0) |
||
Profit After Tax (norm) |
(17,434) |
12,779 |
(48,918) |
5,758 |
||
Profit After Tax (FRS 3) |
(27,205) |
12,413 |
(49,231) |
5,758 |
||
Average Number of Shares Outstanding (m) |
21.4 |
21.5 |
21.6 |
21.9 |
||
EPS - normalised (ore) |
|
|
(82) |
59 |
(226) |
26 |
EPS - FRS 3 (ore) |
|
|
(127) |
58 |
(228) |
26 |
Dividend per share (ore) |
0.0 |
0.0 |
0.0 |
0.0 |
||
BALANCE SHEET |
||||||
Fixed Assets |
|
|
76,394 |
74,070 |
73,368 |
71,970 |
Intangible Assets |
50,615 |
26,390 |
23,684 |
22,088 |
||
Tangible Assets |
2,288 |
1,660 |
1,286 |
1,484 |
||
Other |
23,490 |
46,020 |
48,398 |
48,398 |
||
Current Assets |
|
|
171,670 |
212,268 |
167,971 |
177,884 |
Stocks |
13,800 |
17,955 |
14,436 |
27,990 |
||
Debtors |
23,844 |
12,323 |
14,660 |
24,246 |
||
Cash |
134,026 |
169,239 |
123,571 |
110,344 |
||
Other |
0 |
12,750 |
15,304 |
15,304 |
||
Current Liabilities |
|
|
(34,039) |
(30,637) |
(28,267) |
(28,267) |
Creditors |
(34,039) |
(30,637) |
(28,267) |
(28,267) |
||
Short term borrowings |
0 |
0 |
0 |
0 |
||
Long Term Liabilities |
|
|
(3,960) |
(3,758) |
(3,955) |
(4,351) |
Long term borrowings |
0 |
0 |
0 |
0 |
||
Other long term liabilities |
(3,960) |
(3,758) |
(3,955) |
(4,351) |
||
Net Assets |
|
|
210,064 |
251,943 |
209,118 |
217,236 |
CASH FLOW |
||||||
Operating Cash Flow |
|
|
(21,030) |
19,193 |
(38,207) |
(5,626) |
Net Interest |
0 |
0 |
0 |
0 |
||
Tax |
0 |
0 |
0 |
0 |
||
Capex |
(14,930) |
(21,715) |
(8,469) |
(8,650) |
||
Acquisitions/disposals |
0 |
33,213 |
0 |
0 |
||
Financing |
0 |
0 |
0 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
||
Other |
2,326 |
2,394 |
1,008 |
1,048 |
||
Net Cash Flow |
(33,634) |
33,085 |
(45,668) |
(13,227) |
||
Opening net debt/(cash) |
|
|
(165,245) |
(134,026) |
(169,239) |
(123,571) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
||
Exchange rate movements |
2 |
0 |
0 |
0 |
||
Other |
2413 |
2129 |
0 |
0 |
||
Closing net debt/(cash) |
|
|
(134,026) |
(169,239) |
(123,571) |
(110,344) |
Source: Photocure accounts, Edison Investment Research
|
|
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