Immunovia AB
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Immunovia |
First NCI collaboration in the diabetes opportunity |
Company update |
Healthcare equipment & services |
20 December 2016 |
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Immunovia is a research client of Edison Investment Research Limited |
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Immunovia has taken key steps in both opportunities being pursued for its IMMray PanCan-d test for the early detection of pancreatic cancer. In diabetes, a collaboration with the Early Detection Research Network (EDRN), part of the US National Cancer Institute (NCI), is an important step forwards as it could lead to the start of the required clinical study. Diabetes is the larger of the two indications with 3.4 million newly diagnosed diabetes patients every year in the US and EU. In high-risk pancreatic cancer patients, Immunovia has now started a prospective clinical trial, as expected. This is a smaller opportunity (c 200k patients) but could generate initial revenues in 2018. Our valuation remains SEK155.2/share.
Year |
Revenue (SEKm) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/14 |
0.36 |
(8.86) |
(0.80) |
0.0 |
N/A |
N/A |
12/15 |
0.21 |
(7.38) |
(0.65) |
0.0 |
N/A |
N/A |
12/16e |
0.20 |
(10.25) |
(0.69) |
0.0 |
N/A |
N/A |
12/17e |
0.20 |
(10.68) |
(0.64) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles and exceptional items.
Immunovia delivers agreement with NCI
Immunovia has made important first steps towards its strategy of pursuing new onset diabetic patients by signing a memorandum of understanding (MoU) with the NCI EDRN. The goal of the collaboration with EDRN is to validate biomarkers to improve early diagnosis of pancreatic cancer, in particular in patients over 50 years old with new onset diabetes. These patients have eight times more risk to develop pancreatic cancer. We believe that this collaboration could lead to the start of a formal clinical trial to test IMMray PanCan-d in this population in order to gain regulatory approvals for the test. We anticipate that any such trial could involve 5,000 to 10,000 patients, analysed at least twice a year over three years. Immunovia recently raised c SEK218.6m to advance the diabetic opportunity.
Start of clinical trial in high-risk PC group announced
As expected, the company has announced the start of a three-year prospective clinical trial in 1,000 patients at high risk of pancreatic cancer (those with a family history of pancreatic cancer, hereditary pancreatitis, chronic pancreatitis or genetic diseases). The risk of developing pancreatic cancer is 32 to 132 times higher for these patients. At SEK5,000 per test and two tests per year for c 200,000 potential patients, we estimate this is an opportunity of c SEK2bn in the EU and US.
Valuation: No change to rNPV of SEK155.2/share
We have made no changes to our financial forecasts and maintain our rNPV valuation of SEK155.2 per share (SEK149.6 diluted), assuming a penetration rate of 35% in patients at high risk of pancreatic cancer and 5% in newly diagnosed diabetic patients, which targets total peak sales of c SEK2.1bn for both groups. The start of the formal clinical trial in diabetes could lead to an increase in our current 60% probability of success in this opportunity.
Heading towards a sizeable opportunity
Immunovia announced in September 2016 that it was holding talks with a large consortium focused on diabetes and pancreatic cancer. The company has effectively executed on this by signing an MoU with the NCI EDRN, which establishes the framework of a collaboration to identify, develop and validate biomarkers for early detection of pancreatic cancer, in particular in the risk group of patients over 50 years old with new onset diabetes.
We believe this is a positive step towards the development of a test for the early diagnosis of pancreatic cancer in the diabetes population and this collaboration could lead to a clinical trial in this group. As we mentioned in our initiation report, patients over 50 years of age diagnosed with diabetes have an up to eight times higher risk of pancreatic cancer. The Rochester study conducted in 2,122 diabetic subjects showed 1% of those over 50 years old were diagnosed with pancreatic cancer three years after diagnosis. To investigate this, public bodies like the NCI have created and funded the Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer (CPDPC), which includes leading US academic centres, with the aim of gaining insights into the epidemiology of chronic pancreatitis and the association between pancreatic cancer and diabetes.
IMMray PanCan-d could be a first filter to diagnose early-stage pancreatic cancer that would be confirmed later. Applying it to around 3.4 million patients diagnosed with diabetes every year in the EU and the US, with two tests per year for three years at a price of SEK5,000/test, represents an opportunity of SEK34bn per year.
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