Immunovia — Update 10 November 2016

Immunovia — Update 10 November 2016

Immunovia

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Immunovia

Getting the immune system to work in diagnostics

Initiation of coverage

Healthcare equipment
& services

10 November 2016

Price

SEK90

Market cap

SEK1,504m

SEK8.36/US$

Net cash (SEKm) at 30 June 2016 plus September-October 2016 raise

278.3

Shares in issue

16.8m

Free float

58%

Code

IMMUNOV

Primary exchange

NASDAQ FN Stockholm

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(4.3)

(24.8)

N/A

Rel (local)

(2.9)

(25.6)

N/A

52-week high/low

SEK73.5

SEK26.1

Business description

Immunovia is a Swedish diagnostics company based in Lund’s Medicon Village. It specialises in diagnostics for oncology and autoimmune diseases. Its main product is IMMray PanCan-d, an antibody microarray based on its proprietary IMMray platform. A prospective trial in high-risk patients will start in Q416. The company expects to generate initial out-of-pocket sales in 2018.

Next events

Start prospective trial

YE16

Commence commercial operations

2017

First revenues

2018

Complete prospective trial, registration

2019

Analysts

Juan Pedro Serrate

+44 (0)20 3681 2534

Jonas Peciulis

+44 (0)20 3077 5728

Immunovia is a research client of Edison Investment Research Limited

Immunovia is ready to validate its test for the early diagnosis of pancreatic cancer from its IMMray platform. Pancreatic cancer is rare and difficult to treat, with a five-year survival rate of c 5%; early diagnosis could improve this to c 50%. This would make an accurate diagnostic test cost-effective in higher-risk patient groups. A prospective trial will start in Q416, with first out-of-pocket sales in 2018 before reimbursement is achieved. Screening of patients newly diagnosed with type 2 diabetes provides additional upside. We value Immunovia at SEK2.6bn or SEK155.2/share.

Year
end

Revenue (SEKm)

PBT*
(SEKm)

EPS*
(SEK)

DPS
(SEK)

P/E
(x)

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, exceptional items and share-based payments.

The immune system as early sensor for disease

Immunovia’s products are antibody microarrays originated from its proprietary IMMray technology platform. The result is a signature of antibodies able to discriminate between ill and healthy subjects by detecting disease-specific biomarkers present in blood. IMMray products can detect disease at early stages, allowing for early diagnosis and treatment. The platform combines its own antibody library with algorithm and bioinformatics for data analysis and interpretation.

Initial data support conducting a prospective study

Data from several retrospective studies indicate the test can be used to differentiate between healthy subjects and pancreatic cancer patients, with high sensitivity and specificity, even at early stage. In a 1,400-sample Scandinavian study, IMMray PanCan-d discriminated healthy individuals from those with pancreatic cancer with 96% accuracy. In Q416, the company intends to start a prospective trial that will run for three years in 1,000 at-risk patients.

Significant market opportunity and upside

Immunovia plans to start commercial activities in 2017 with first revenues in 2018. It will first target patients with a family history of pancreatic cancer, or other pancreatic diseases with increased risk of cancer (estimated at 200,000 in the EU/US) followed by patients diagnosed with type 2 diabetes (T2D, estimated at 3.4 million new patients per year) after completing a clinical trial. Use in other patient groups/indications could provide upside.

Valuation: rNPV of SEK155.2 per basic share

We believe there is upside to SEK155.2 per share (SEK149.6 diluted), assuming a penetration rate of 35% in high-risk patients and 5% in T2D patients, which results in targeting total peak sales of c SEK2.1bn for both groups. During September-October 2016, Immunovia raised c SEK218.6m at a price of SEK87 per share to fund a clinical trial in the T2D group. Continued business execution and expansion to further indications should unlock further value.

Investment summary

Company description: Diagnosing early-stage disease

Immunovia AB is a technology platform and product development company headquartered in Lund, Sweden. It is based in the Medicon Village, a biomedical cluster that harbours some 100 organisations employing 1,400 people. Immunovia was founded in 2007 based on research from Lund University and the Centre for Translational Cancer Research (CREATE Health) in Lund. Its proprietary technology platform IMMray utilises antibody microarrays to detect biomarkers of early disease thereby allowing rapid treatment. The system is complemented with proprietary antibody libraries, antibody production and purification as well as software and clinical algorithms. The IMMray system has the potential to allow for monitoring of cancer treatment, predicting disease progression and assessing response to therapy. The company’s main product is IMMray PanCan-d, a blood-based test for early detection of pancreatic cancer. Detection at stage I or II would allow resection and improve survival rates.

Valuation: Risk-adjusted NPV of SEK2.6bn or SEK155.2/share

Our DCF valuation is SEK2.6bn or SEK155.2/share (SEK149.6 diluted), based on a risk-adjusted NPV analysis using a 12.5% discount rate. We assume a price of SEK5,000 per test, and peak sales of c SEK2.1bn in the EU and US. We project a 35% penetration rate in the c 200,000 population of patients at increased risk of pancreatic cancer and 5% in the 3.4 million newly diagnosed diabetic patients, which represent a combined opportunity of SEK36bn per year.

Financials: Business execution to drive cash burn

In December 2015 the company completed a listing on Nasdaq First North in Stockholm, offering 2.6m shares at SEK18.50 per share, raising SEK60m. The offering was five times oversubscribed. This added to the SEK43m grant that Immunovia received from the EU and national programmes, of which SEK12m was used in 2015.

At June 2016 Immunovia had SEK59.7m cash plus SEK28m in EU funding from Horizon 2020. As a result of the initiation of prospective trials in high-risk individuals and newly diagnosed T2D patients and the first commercial operations, we expect operating expenses to increase in 2017-20 to a peak of SEK60m in 2019. To cover the costs of these trials Immunovia has raised SEK218.6m in September and October 2016 in a combined direct and rights issue offering.

Sensitivities: A numbers game

The key sensitivity is market penetration, in particular the large, but yet untested, market of newly diagnosed T2D patients. Sensitivity (true positives) and specificity (true negatives) need to be measured in the context of the population; that is, the predictive value. The test needs to properly detect those patients with the disease and keep the false negatives to a minimum, avoiding expensive secondary testing with ultrasound, magnetic resonance imaging (MRI) or computerised tomography (CT) scan, to get reimbursement and become commercially successful. Successful commercialisation will require managing price sensitive healthcare authorities in each country. In the US, Immunovia will market its product as a laboratory developed test (LDT) validated by a Clinical Laboratory Improvement Amendments-(CLIA) accredited laboratory; however, that may severely limit its ability to distribute its test beyond the CLIA-certified lab and may mean a slow ramp-up in revenues and a lower probability of reimbursement. FDA approval, which requires additional resources, would increase the chances of getting reimbursement. As an example, Exact Sciences’s Cologuard was only reimbursed after FDA approval. True acceptance will likely only come after full reimbursement and inclusion in various cancer screening guidelines.

A signature for early diagnosis of cancer

Immunovia develops blood-based tests for the early detection of cancer. In most types of cancer, early detection is critical to improve outcomes. Cancer is classified according to progression, with stages I and II being localised and amenable to surgical resection, while stages III and IV have spread to lymph nodes and other internal organs. In the case of pancreatic cancer, symptoms do not appear until the disease has spread and it is too late for full resection. As a result, less than 5% of patients are alive five years after diagnosis. Early detection at stage I or II, when the tumour can be removed with surgery, could improve five-year survival rates to c 50%. In addition to patients at high risk of pancreatic cancer and newly onset diabetic patients, the company has ongoing projects in other indications such as systemic lupus erythematosus (SLE), prostate and breast cancer.

To support clinical development and commercialisation, Immunovia works in association with key opinion leaders and top cancer research centres such as the OHSU Knight Cancer Institute (which received a $1bn donation in 2015 to fund research for early detection of cancer), Liverpool University Hospital, University of Michigan, Mount Sinai Hospital, the USCF Medical Center and the Karolinska Institute.

The IMMray technology platform

Immunovia’s IMMray technology platform covers the production of arrays and the laboratory work needed for analysis of samples and results. IMMray’s key assets are its antibody library, its bioinformatics and its simplicity of use. One of the main problems of antibody-based arrays is stability due to the inherent complex structure of antibodies and susceptibility to changes in the environment. Immunovia’s IMMray technology uses small fragments termed single-chain variable fragments (scFv) that retain specificity and are optimised to be stable on a solid surface. Immunovia has an in-house antibody production and purification facility.

The resulting product of the platform is a slide made of 14 antibody arrays. Arrays are a collection of antibodies fixed to a solid surface in a particular order where they interact with labelled biological samples and generate a signal. The discovery arrays that Immunovia uses have 17,136 data points, while the commercial product is fine-tuned to 3,584 data points per slide in 14 arrays per slide. Slides are scanned, generating an image that is processed by its proprietary bioinformatics algorithm, providing a snapshot of the patient’s disease status. This is valuable information that can be used to assess the patient’s responsiveness to therapy, diagnostics, disease follow up and monitoring.

Exhibit 1: IMMray platform process

Source: Immunovia

Pancreatic cancer: Diagnose early to improve outcomes

The pancreas is a gland located in the upper abdomen, behind the stomach and in front of the spine. Through exocrine pancreatic cells, digestive enzymes are released into the small intestine. The endocrine islet cells (or islets of Langerhans) secrete hormones such as insulin and glucagon that help control sugar levels in the blood. Most tumours form in exocrine cells and usually do not cause symptoms until disease has advanced into later stages. Pancreatic cancer is the 12th most common type of cancer; however, it is one of the most lethal with 53,000 new cases in the US in 2016 and an estimated 41,780 deaths, according to SEER. In the EU-27, there were 78,654 new cases and 77,958 deaths in 2012 according to EUCAN.

Pancreatic cancer is split into stages according to the following criteria:

Stage I: the cancer is completely into the pancreas and has not spread to other tissues and is smaller than 2cm (stage IA) or larger than 2cm (stage IB).

Stage II: cancer has grown into nearby tissues, but there is no cancer in large blood vessels of lymph nodes (stage IIA); if cancer has spread to lymph nodes, but no large blood vessels are involved, it is termed stage IIB.

Stage III: cancer spreads outside the pancreas; it may or may not have grown into lymph nodes.

Stage IV: the cancer has grown into other organs such as the liver or lungs.

Both stage I and II are considered amenable for surgery, ie resectable. Stages III and IV are considered unresectable. Surgery, chemotherapy and radiotherapy may all be used in the treatment of pancreatic cancer. Surgery is mostly used in early stages when the cancer is small and has not spread. In locally advanced cancer, chemotherapy and/or radiotherapy may be given to control cancer. When the disease has spread to other parts of the body, palliative therapy is administered.

The fact that there are not noticeable symptoms or that they are vague (weight loss, abdominal pain, jaundice) make pancreatic cancer difficult to detect at early stages and therefore difficult to treat and deadly. Hence, five-year survival rates are around 5% for advanced pancreatic cancer. Early detection could significantly increase this rate.

Assessing the value of diagnostic methods

The value of a diagnostic test is predicated on its accuracy and predictive value. In terms of accuracy, sensitivity is the probability that a test result will be positive when the disease is present, also known as the true positive rate; specificity is the probability that a test result will be negative when the disease is not present, also known as the true negative rate.

Predictive values are the positive predictive value (PPV), that is, the probability that the disease is present when the test is positive; and the negative predictive value (NPV), which measures the probability that the disease is not present when the test is negative.

IMMray’s algorithms select a combination of markers that aim to provide the optimal balance between sensitivity and specificity. Biomarkers are selected on the basis of the additional information that they contain; hence, the test can be balanced towards high sensitivity at the expense of specificity or vice versa. Sensitivity and specificity are independent of the population subjected to the test, while PPV and NPV are dependent on the prevalence of the disease in the population tested. It is important to choose the appropriate test depending on the objectives. When false negatives need to be avoided, a test with high sensitivity and high NPV is chosen. On the other hand, when false positives need to be avoided, a test with high specificity and high PPV is recommended, which is the case of pancreatic cancer. A good diagnostic test for pancreatic cancer needs to show that a positive result is actually a positive. Therefore, a high specificity and high PPV will ultimately determine the value of the test for this condition and influence reimbursement decisions.

IMMray PanCan-d: Early diagnosis of pancreatic cancer

IMMray PanCan-d is Immunovia’s first product and is a blood-based diagnostic test for early detection of pancreatic cancer. It leverages Immunovia’s IMMray technology to produce a micro-array with a 25-protein signature. It has been tested in a number of retrospective studies and is due to be confirmed in a prospective trial.

The company also holds strong IP rights over the combination of its tests’ markers. It has four groups of patents; one of them covers IMMray PanCan-d entirely with five different patent families. Protection extends beyond 2030.

Existing data allow for progress

Immunovia has conducted seven retrospective trials testing different biomarker signatures from the IMMray technology. The main endpoint of these trials has been the area under the receiver operating characteristic (ROC) curve (AUROCC or AUC), which reflects how good the test is at differentiating between patients with and without a given condition. In this case, it has been able to differentiate pancreatic cancer patients at different stages from healthy individuals and other conditions of the pancreas. The greater the AUC, the better the test. For instance, an AUC of 1 means 100% specificity and sensitivity.

The IMMray technology has proved effective in discriminating between pancreatic cancer patients and healthy individuals and patients with other conditions of the pancreas, at variable rates, as shown in Exhibit 2. In the Scandinavian study (n=1,355) IMMray PanCan-d was able to differentiate between stage I and II pancreatic cancer and healthy subjects at a rate of 96%, with 98% for stages I to IV and healthy subjects. The rate was 96% in the US validation study (see Exhibit 2). Rates are lower when discriminating between pancreatic cancer and other pancreatic diseases; 85% in one study, 70% in another (Exhibit 2).

From these data, the company has developed a signature of 35 biomarkers that discriminates pancreatic cancer from healthy samples and other pancreatic diseases.

Exhibit 2: Retrospective studies of IMMray PanCan-d

Study

Number of samples

Data

Ingvarsson J et al. Proteomics 2008 8(11):2211-9

44

AUC=1 PC vs healthy individuals

Wingren et al. Cancer Res. 2012 15;72(10):2481-90

103

AUC=0.95 PC vs healthy individuals

AUC=0.86 PC vs pancreatitis

AUC=0.99 PC vs autoimmune pancreatitis

AUC=0.85 PC vs combined healthy, pancreatitis and immune pancreatitis

Sandström et al. Proteomics Clin. Appl. 2012, 6, 486–496.

113

AUC=1 acute pancreatitis vs healthy controls

AUC=0.96 chronic pancreatitis vs healthy controls

AUC=0.98 autoimmune pancreatitis vs healthy controls

Gerdtsson et al. Int Journal of Proteomics 2015;2015:587250

338

PC vs healthy controls: average AUC 0.98, sensitivity 99%, specificity 80%. Average PPV of 96% and NPV of 95%.

PC vs other pancreatic disease: average AUC 0.7, 62% sensitivity, 80% specificity, 73% PPV, 71% NPV.

Gerdtsson et al. Chinese study.

213

AUC value of 0.80 for early-stage disease (stage I/II) and 0.96 for late-stage disease (stage three/four) vs normal controls, respectively.

South Scandinavian study

1,355

AUC value of 0.96 for stage I and II PC vs normal controls

AUC value of 0.98 for all PC vs normal controls

North American validation study

429

AUC=0.96 for PC stage I and II vs normal controls

Source: Edison Investment Research, Immunovia. Note: PC = pancreatic cancer. AUC = area under the ROC Curve. PPV = positive predictive value. NPV = negative predictive value.

One of the most important parameters for physicians is positive predictive value, which applies sensitivity and specificity to the population. A high sensitivity rate means most cases will be correctly detected in the population. However, unless specificity is very high and the disease is prevalent in the test population, there will be many false positives (people who do not have the disease, but test positive). Clinicians expect a test to be reliably positive when it renders a positive result. If the false positive rate is high, many patients would need expensive confirmatory tests, increasing the cost burden to health services. Therefore, it is important to find the population groups in which the disease is more prevalent.

Next steps: Start prospective trial and marketing

To confirm its findings, Immunovia plans to run a prospective study in approximately 1,000 at-risk subjects in some of the top hospitals in Europe and the US. The study will start by the end of 2016 and run for three years. Immunovia plans to start selling to out-of-pocket customers (without reimbursement) in 2017 with first revenues starting in 2018, although at a cost of SEK5,000 we expect uptake to be slow until there is reimbursement.

This trial intends to show the clinical utility of the test by discriminating between people who have pancreatic cancer and those who do not, even at early stages.

To commence commercial activities in 2017, Immunovia is working to obtain a CE mark following the 98/97/EC directive of In Vitro Diagnostic Medical Devices in Europe. In the US, the company will market its product as a laboratory developed test (LDT), regulated by the CLIA, which reviews the analytical validation of the LDT. Immunovia will also obtain the ISO/IEC 17025 accreditation for clinical laboratories. These activities will be completed by mid-2017. The prospective study will be important for reimbursement discussions. The company will market the test to pancreatologists (around 400) with its own salesforce.

Furthermore, Immunovia plans to pursue patients diagnosed with type 2 diabetes. Diabetologists are becoming increasingly aware of the risk of pancreatic cancer (up to eight times higher) for patients that have been diagnosed with T2D and need to be followed up. The Consortium to Study Chronic Pancreatitis, Diabetes and Pancreatic Cancer was formed by leading US academic centres to gain insights into the epidemiology of chronic pancreatitis and the association between pancreatic cancer and diabetes.

Developing a cost-effective test

To obtain reimbursement for the test, it is necessary to run an economic evaluation of cost-effectiveness that takes into account measures such as quality-adjusted life years (QALY) and the incremental cost-effectiveness ratio (ICER).

QALY combines the quantity and quality of life for a patient following a particular treatment or intervention. It is calculated by estimating the years of life remaining for a patient and weighting each year with a score that describes quality of life; one QALY is a year in perfect health.

As part of the examination of the costs associated with health outcomes, the ICER represents the additional cost of one unit of outcome gained by a given intervention compared with another. Willingness to pay, or cost-effectiveness threshold, is defined by monetary units per QALY gained, and varies by country. For instance, in Europe it is c €50,000 per QALY gained, while the UK’s National Institute for Health and Care Excellence has a threshold of £20,000 per QALY. Cost per QALY can be calculated by dividing the difference in cost of each intervention by the difference in benefits in QALY terms. Depending on the cost of the test (the company guides for €400-1,000/test) and the incidence of the target population, the ICER varies, being more cost-effective the higher the incidence and the cheaper the test, as shown in Exhibit 3:

Exhibit 3: Cost-effectiveness analysis

Source: Immunovia. Note: The red line represents the willingness to pay per QALY gained.

In assessing the cost-effectiveness of a test, the sensitivity and specificity must be estimated. These values would be combined with the estimated prevalence of the condition being tested for, to get an estimation of the number of true positives, true negatives, false positives and false negatives.

The pancreatic cancer screening market

There are no official screening guidelines for pancreatic cancer but, according to the consensus reached at the International Cancer of the Pancreas Screening Consortium summit, screening is not recommended for the general population. Instead, the groups recommended for screening are:

People with two or more blood relatives, and at least one first-degree relative, with pancreatic cancer.

Carriers of p16, PALB2, or BRCA2 mutations with a first-degree relative with pancreatic cancer.

Patients with Peutz-Jeghers syndrome.

People with Lynch syndrome and a first-degree relative with pancreatic cancer.

Those with two first-degree relatives with pancreatic cancer have a 6.4-fold greater risk of pancreatic cancer (8-12% lifetime risk) than the general population. Those with three or more first-degree relatives with pancreatic cancer have a 32-fold greater risk (40% lifetime risk).1

  Canto et al., Gut 2012; 0:1-9

As previously mentioned, to make an economically justified and cost-effective case, it is necessary to target population subgroups with an increased risk of pancreatic cancer. High prevalence of the disease in the population will increase PPV. In particular, Immunovia plans to address the following population subgroups:

Patients at increased risk of pancreatic cancer. These are patients with a family history of pancreatic cancer, hereditary pancreatitis, chronic pancreatitis or genetic diseases such as Peutz-Jeghers syndrome. They have increased risk of pancreatic cancer, from up to 32 times for patients with a family history of pancreatic cancer, to 132 times for patients with Peutz-Jeghers syndrome. The company estimates that 200,000 people would be in this group, which also corresponds with our estimations. At a cost of SEK5,000/test and two tests per year as this population needs to be closely monitored, this is a total opportunity of around SEK2bn in the EU and US.

Newly diagnosed type 2 diabetes (T2D) patients. T2D patients have an up to eight times increased risk of pancreatic cancer. The prevalence of pancreatic cancer in T2D patients is around 1% to 2.2%, according to different studies. The Rochester study conducted in 2,149.6 diabetic subjects shows 1% of those over 50 years old being diagnosed with pancreatic cancer three years after diagnosis. IMMray PanCan-d could be a first filter to diagnose early-stage pancreatic cancer that would be later confirmed. Applying it to around 3.4 million patients diagnosed with T2D 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.

Current screening methods

As previously mentioned, IMMray PanCan-d intends to be a first filter in the screening for pancreatic cancer. At present, people who are considered high risk due to a strong family history of pancreatic cancer or with a genetic disease that significantly increases their risk undergo an endoscopic ultrasound (EUS). This test is done with an endoscope that has a small probe on its tip and can take biopsies if necessary. EUS has sensitivity of 89% and specificity of 96% and costs approximately $500 unless covered by insurance. It requires sedation and sometimes general anaesthesia. It involves the insertion of a tube into the mouth, down to the stomach and into the first part of the small intestine. Risks are bleeding and gastrointestinal perforation, and sometimes infection. So, while accurate, it is far from perfect or consumer friendly and many patients drop out after the first visit. Other techniques are CT scan, which is useful in assessing pancreatic cancer and other conditions of the pancreas, and magnetic resonance imaging, which can help exclude or detect cancer in patients with pancreas abnormalities; this is the method of choice in the US. The potential benefit of Immunovia’s blood-based screening is clear: the easier it is to screen, the more screening will take place, which will help detect cancer earlier when it is more treatable and chances of survival are higher.

CEA (carcinoembryonic antigen) and CA 19-9 (carbohydrate antigen 19-9) are two tumour markers commonly used to follow patients with known cancers. Serum CA 19-9 is more commonly used and although it is not particularly useful in the diagnosis of pancreatic cancer, it may be used to monitor the evolution of disease, watch for recurrence and help differentiate between pancreatic cancer and others conditions such as pancreatitis.

Immunovia’s network of key opinion leaders (KOLs) will play a crucial role in the commercialisation of IMMray PanCan-d. They have participated in the research studies conducted by the company and have influence over a broad group of stakeholders that comprise patient organisations, hospitals, top research centres and payers. Moreover, Immunovia has signed an agreement with the Knight Cancer Institute of Oregon Health and Science University (OHSU) to run a retrospective trial to confirm in the US population the findings of previous studies, which have been conducted in European and Chinese populations. After the test has confirmed these data, OHSU Knight Diagnostic Laboratories will validate it. The OHSU Knight Diagnostic Laboratories is CLIA certified and recently received $1bn in funding for cancer research.

Geographically, the company will first target the US, Germany and the Nordics. In a second wave, the UK, Spain and Italy will be targeted.

Sensitivities

As previously discussed, the key sensitivity is market penetration, in particular the large, but yet untested, market of newly diagnosed T2D patients. Regarding sensitivity and specificity, it is important to reduce false positives as much as possible for a critical condition like pancreatic cancer. Therefore, to secure payers’ acceptance, the test will need to demonstrate a high specificity with high positive predictive value. This will reduce the need for expensive secondary testing. For example, since the incidence of pancreatic cancer is low (c 13 cases per 100,000 people), screening in the general population is not a feasible strategy. A test with 99% specificity and 99% sensitivity in a population with low incidence of a disease (like the 0.013% of pancreatic cancer) used to screen 100,000 individuals would detect nearly all patients with the disease, but would classify 1,000 healthy individuals as having the disease. This would result in a PPV of just 1.3%, which is too low to justify screening the general population. That is why it is important to focus on particular subgroups with increased incidence of pancreatic cancer. In the at-risk population, it is estimated that the incidence is around 2.2%, which is a PPV of c 60%, assuming the test has 99% sensitivity and specificity rates.

Initial out-of-pocket sales may gain certain traction in the US where this market is more developed, but acceptance will come after positive data from the prospective study, regulatory approval and full reimbursement is granted. The company plans on getting the CE mark in Europe and market its product as an LDT under the CLIA waiver programme in the US. The tentative timeline for both is mid-2017. Nonetheless, we believe that true acceptance will come after a full reimbursement and inclusion in various cancer screening guidelines. This may involve the need of FDA approval.

Expansion to other population subgroups such as patients with vague gastrointestinal symptoms, additional products targeting SLE, in current development, and other cancer indications could provide upside.

Exhibit 4: Competitors and current tests

Company

Product

Status

Description

Data

Cost per test ($)

Interpace

PancraGen TM

Market

Assesses the risk of cancer in precursor lesions. No direct competitor. Retrospective data. Reimbursed, but small sales due to invasiveness and inconclusive data

Sensitivity: 47%-83%

Specificity: 81%-100%

PPV: 55%-100%

NPV: 50%-97%

Not disclosed

Myriad

Panexia

Market

Identifies patients with higher risk to develop cancer. Not competitive, but complementary to Immunovia

Sensitivity: 99%

Specificity: 99%

3,025

Natimab

EZR/ENOA Abs

Clinical development

Blood-based two marker test for prognosis and detection of pancreas cancer

Sensitivity: 100%

Specificity: 92.3%

AUC: 0.96

NA

VolitionRx

NuQ

Clinical development

Blood test based on the NuQ nucleosome technology

Sensitivity: 84%

Specificity: 92%

40-80

Trovagene

Trovera KRAS ctDNA

Pre-clinical

Liquid biopsy. Measures ctDNA KRAS mutations

Sensitivity: 30%-50%

Specificity: 90%

NA

Current tests

Various

EUS

Market

Endoscopy ultrasound

Sensitivity: 89%

Specificity: 96%

500

Various

CA-19-9

Market

Blood marker for follow up

Sensitivity: 79%

Specificity: 82%

20-40

Source: Edison Investment Research, Immunovia

Valuation: Risk-adjusted NPV of SEK155.2/basic share

The company’s share price has risen almost 400% since IPO. This increase has been supported by strong demand from investors, a successful business plan execution (agreements with major cancer centres and KOLs), clinical data and pipeline expansion to autoimmune diseases (SLE). We value Immunovia at SEK155.2 per share (SEK149.6/share fully diluted), using a 12.5% discount rate. We have projected future free cash flows according to the following assumptions:

We estimate IMMray PanCan-d will generate the first out-of-pocket sales in 2018 in the US and in 2019 in the EU with a probability of 70%. We are modelling sales in the high-risk population of 200,000 patients, with an initial slow ramp-up in revenues that increases in 2020 when the company believes the test will be fully approved and reimbursed. Peak sales in 2025 are SEK707m assuming a base price tag of SEK5,000 per test in all regions and 35% market share in Europe and the US, used twice a year.

We assume Immunovia starts a trial in the diabetic population in 2018, which runs for three years and starts selling the test in this group in 2021. We model two tests for a potential population of 3.4 million new patients per year, which is 6.8m tests and represents a total market opportunity of SEK34bn at SEK5,000/test. To reflect the risk of this untested population we apply a 60% success rate, which is lower than the high-risk group, and a slower ramp up to peak sales in 2028. Furthermore, we model two scenarios: one scenario in which reimbursement is achieved and IMMray PanCan-d gets 5% market share, which results in peak sales of SEK1.4bn in EU and US in 2028; in this case valuation is SEK155.2 per basic share (shown as Scenario 1 in Exhibit 5). In case reimbursement is not achieved, we model a lower penetration rate of 1% and peak sales of SEK275m; in this case our valuation is SEK81.7 per basic share (shown as Scenario 2 in Exhibit 5). We will update these assumptions as more information on the clinical trial is disclosed.

Although we are not including the segment of patients with vague gastrointestinal symptoms in our model nor additional indications, we believe this represents further upside.

Exhibit 5: Valuation summary

Scenario 1

Scenario 2

US$m

SEKm

US$m

SEKm

Peak sales in T2D patients (US and EU in 2028)

151

1,373

30

275

Peak sales in at risk patients (US and EU in 2025)

78

707

78

707

PV of explicit FCF forecast (2017-2028)

111

1,009

49.2

447

Terminal Value (2.5% TGR)

599.3

5,448

294.4

2,676

PV of Terminal Value

145.8

1,326

71.6

651

Total NPV

256.8

2,334.6

120.8

1,098.5

Add net cash (FY16e)

30.1

273.5

30.1

273.5

Implied equity value

286.9

2,608.1

150.9

1,372.1

Number of shares (m)

16.8

16.8

16.8

16.8

Per basic share

$17.1

SEK155.2

$1.85

SEK81.7

Source: Edison Investment Research. Note: SEK/US$ exchange rate 0.11.

Financials

In September and October 2016 Immunovia raised a total of SEK218.6m in two tranches. First, a direct offering of almost 2.2m shares at SEK87 per share that resulted in gross proceeds of SEK189.9m. Second, a preferential rights issue of 329,451 shares at SEK87 per share raised an additional SEK28.7m. Due to increased demand from shareholders, the rights issue was oversubscribed by 43%.

At June 2016 cash and equivalents were SEK59.7m plus SEK28m in EU funding from Horizon 2020 and SEK218.6m from the recent offering. Thus, we expect 2016 net cash of c SEK273.6m, following our cash consumption projections and taking into account the equity raise proceeds.

Following Immunovia’s guidance, we project first sales of SEK13.5m in 2018, with increased sales from 2020 onwards as the company obtains approval and reimbursement for IMMray PanCan-d in the two target indications. We model increasing operating costs to cover clinical trials, starting in 2017 for the at-risk population, and 2018 for the T2D population; both running for three years and consuming SEK40m and SEK90m respectively. We also model an increase in marketing costs to cover the salesforce expenses.

At end 2015, Immunovia had SEK13.88m as intangible assets, the majority of which wascapitalised as development costs. According to Immunovia’s accounting rules, development costs can be capitalised and reduce the net loss. These costs are included in the balance sheet as intangible assets, which will be amortised according to our model.

Exhibit 6: Financial summary

SEK000s

2013

2014

2015

2016e

2017e

2018e

Year end 31 December

GAAP

GAAP

GAAP

GAAP

GAAP

GAAP

PROFIT & LOSS

Revenue

 

 

1,179

359

205

200

200

9,444

Cost of Sales

0

0

0

0

0

(6,611)

Gross Profit

1,179

359

205

200

200

2,833

Operating expenses

(1,875)

(7,549)

(17,377)

(22,058)

(20,882)

(43,333)

Personnel

(417)

(1,382)

(6,749)

(12,308)

(12,001)

(15,499)

EBITDA

 

 

(1,114)

(8,701)

(7,136)

(10,401)

(10,813)

(55,999)

Operating Profit (before GW and except.)

(1,614)

(8,960)

(7,424)

(10,932)

(11,334)

(56,510)

Intangible Amortisation

0

0

0

0

0

0

Exceptionals/Other

0

0

0

0

0

0

Operating Profit

(1,614)

(8,960)

(7,424)

(10,932)

(11,334)

(56,510)

Net Interest

17

101

40

683

651

496

Exceptionals/Other

0

0

0

0

0

0

Profit Before Tax (norm)

 

 

(1,596)

(8,859)

(7,384)

(10,249)

(10,683)

(56,014)

Profit Before Tax (IFRS)

 

 

(1,596)

(8,859)

(7,384)

(10,249)

(10,683)

(56,014)

Tax

0

0

0

0

0

0

Discontinued operations

0

0

0

0

0

0

Profit After Tax (norm)

(1,596)

(8,859)

(7,384)

(10,249)

(10,683)

(56,014)

Profit After Tax (IFRS)

(1,596)

(8,859)

(7,384)

(10,249)

(10,683)

(56,014)

Average Number of Shares Outstanding (m)

6.24

11.05

11.42

14.93

16.80

16.80

EPS - normalised (SEK)

 

 

(0.26)

(0.80)

(0.65)

(0.69)

(0.64)

(3.33)

EPS - IFRS (SEK)

 

 

(0.26)

(0.80)

(0.65)

(0.69)

(0.64)

(3.33)

Dividend per share (SEK)

0.00

0.00

0.00

0.00

0.00

0.00

Gross Margin (%)

N/A

N/A

N/A

N/A

N/A

N/A

EBITDA Margin (%)

N/A

N/A

N/A

N/A

N/A

N/A

Operating Margin (before GW and except.) (%)

N/A

N/A

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

3,596

6,209

14,556

26,563

26,042

25,532

Intangible Assets

3,596

5,469

13,885

22,615

22,094

21,584

Tangible Assets

0

740

671

3,948

3,948

3,948

Other

0

0

0

0

0

0

Current Assets

 

 

3,869

32,664

76,959

274,893

262,531

201,746

Stocks

0

0

0

0

1,050

1,322

Debtors

228

464

814

733

733

1,889

Cash

3,607

31,804

75,767

273,559

260,452

198,239

Other

34

396

378

601

296

296

Current Liabilities

 

 

(2,526)

(3,131)

(7,713)

(9,464)

(7,264)

(1,983)

Creditors

(969)

(1,164)

(1,252)

(1,600)

(3,764)

(1,983)

Short term borrowings

0

0

0

0

0

0

Deferred revenues

0

0

0

0

0

0

Other short term liabilities

(1,557)

(1,967)

(6,461)

(7,864)

(3,500)

0

Long Term Liabilities

 

 

0

0

0

0

0

0

Long term borrowings

0

0

0

0

0

0

Deferred revenues

0

0

0

0

0

0

Other long term liabilities

0

0

0

0

0

0

Net Assets

 

 

4,939

35,742

83,802

291,992

281,309

225,294

CASH FLOW

Operating Cash Flow

 

 

(1,111)

(8,291)

(2,844)

(8,109)

(13,107)

(62,212)

Net Interest

0

0

0

0

0

0

Tax

0

0

0

0

0

0

Capex

0

(3,175)

(8,636)

(9,182)

0

0

Acquisitions/disposals

0

0

0

0

0

0

Financing

4,042

39,663

55,441

215,083

0

0

Dividends

0

0

0

0

0

0

Other

(17)

0

0

0

0

0

Net Cash Flow

2,914

28,197

43,961

197,792

(13,107)

(62,212)

Opening net debt/(cash)

 

 

(693)

(3,607)

(31,804)

(75,767)

(273,559)

(260,452)

HP finance leases initiated

0

0

0

0

0

0

Exchange rate movements

0

0

0

0

0

0

Other

0

1

2

0

(0)

0

Closing net debt/(cash)

 

 

(3,607)

(31,804)

(75,767)

(273,559)

(260,452)

(198,239)

Source: Edison Investment Research, Immunovia accounts

Contact details

Revenue by geography

Immunovia
Medicon Village
SE-223 81 Lund
Sweden
+46 46 275 60 00
www.immunovia.com

N/A

Contact details

Immunovia
Medicon Village
SE-223 81 Lund
Sweden
+46 46 275 60 00
www.immunovia.com

Revenue by geography

N/A

Management team

CEO: Mats Grahn

CSO: Rolf Ehrnström

Mr Grahn has been the CEO of Immunovia since 2012. Mr Grahn holds an MSc in engineering physics from Lund University, Sweden. Mr Grahn has more than two decades of experience in the healthcare industry, where he has held different positions, including: VP of product management and VP of marketing at GE Healthcare; CVP marketing at Dako A/S; VP marketing Amersham Biosciences; VP laboratory separations at Pharmacia Biotech; and VP at Prevas Bioinformatics.

Mr Ehrnström holds an MSc in biochemistry & biotechnology engineering from the Royal Institute of Technology, Stockholm, Sweden. He has held leadership positions at medtech and diagnostic companies, including: CSO at Dako-Agilent, CVP of R&D at Dako A/S, VP of R&D at Gyros AB, science director Amersham Biosciences, senior scientific advisor Amersham Pharmacia Biotech, senior program manager MicroArrays Amersham-Pharmacia Biotech and director R&D molecular biology Pharmacia Biotech.

CTO: Christer Wingren

CFO: Hans Liljenborg

Dr Wingren is a lecturer at Lund University’s CREATE centre. Dr Wingren holds a BSc in chemistry and a PhD in biochemistry from Lund University. He conducted his postdoctoral training in structural biology at the laboratory of Professor Ian Wilson at the Scripps Research Institute, La Jolla, US. His research focus is the development of recombinant antibody microarrays for high-throughput disease proteomics, with a particular focus on oncoproteomics and autoimmunity. Dr Wingren joined Immunovia in 2007.

Mr Liljenborg has a BSc in business and mathematics from Lund University. He has held different roles in finance management at biomedical companies. He was finance director at Physio Control and Jolife AB. Mr Liljenborg was finance manager at Vivoline Medical AB. He has also been CFO at QuickCool AB and finance manager at Pharma Visions Systems AB.

Management team

CEO: Mats Grahn

Mr Grahn has been the CEO of Immunovia since 2012. Mr Grahn holds an MSc in engineering physics from Lund University, Sweden. Mr Grahn has more than two decades of experience in the healthcare industry, where he has held different positions, including: VP of product management and VP of marketing at GE Healthcare; CVP marketing at Dako A/S; VP marketing Amersham Biosciences; VP laboratory separations at Pharmacia Biotech; and VP at Prevas Bioinformatics.

CSO: Rolf Ehrnström

Mr Ehrnström holds an MSc in biochemistry & biotechnology engineering from the Royal Institute of Technology, Stockholm, Sweden. He has held leadership positions at medtech and diagnostic companies, including: CSO at Dako-Agilent, CVP of R&D at Dako A/S, VP of R&D at Gyros AB, science director Amersham Biosciences, senior scientific advisor Amersham Pharmacia Biotech, senior program manager MicroArrays Amersham-Pharmacia Biotech and director R&D molecular biology Pharmacia Biotech.

CTO: Christer Wingren

Dr Wingren is a lecturer at Lund University’s CREATE centre. Dr Wingren holds a BSc in chemistry and a PhD in biochemistry from Lund University. He conducted his postdoctoral training in structural biology at the laboratory of Professor Ian Wilson at the Scripps Research Institute, La Jolla, US. His research focus is the development of recombinant antibody microarrays for high-throughput disease proteomics, with a particular focus on oncoproteomics and autoimmunity. Dr Wingren joined Immunovia in 2007.

CFO: Hans Liljenborg

Mr Liljenborg has a BSc in business and mathematics from Lund University. He has held different roles in finance management at biomedical companies. He was finance director at Physio Control and Jolife AB. Mr Liljenborg was finance manager at Vivoline Medical AB. He has also been CFO at QuickCool AB and finance manager at Pharma Visions Systems AB.

Principal shareholders

(%)

Carl Borrebaeck

11.37

Vincent Saldell

5.95

Sara Andersson Ek

5.77

Per Mats Ohlin

5.77

Christer Wingren

5.77

Försäkringsbolaget Avanza Pension

4.64

Companies named in this report

Interpace Diagnostics (IDXG, US), Myriad (MYGN, US), NatiMab Therapeutics, Trovagene (TROV, US), VolitionRx (VNRX, US), Exact Sciences (EXAS).

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2016 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Immunovia and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.
Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (ie without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2016. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Contact details

Revenue by geography

Immunovia
Medicon Village
SE-223 81 Lund
Sweden
+46 46 275 60 00
www.immunovia.com

N/A

Contact details

Immunovia
Medicon Village
SE-223 81 Lund
Sweden
+46 46 275 60 00
www.immunovia.com

Revenue by geography

N/A

Management team

CEO: Mats Grahn

CSO: Rolf Ehrnström

Mr Grahn has been the CEO of Immunovia since 2012. Mr Grahn holds an MSc in engineering physics from Lund University, Sweden. Mr Grahn has more than two decades of experience in the healthcare industry, where he has held different positions, including: VP of product management and VP of marketing at GE Healthcare; CVP marketing at Dako A/S; VP marketing Amersham Biosciences; VP laboratory separations at Pharmacia Biotech; and VP at Prevas Bioinformatics.

Mr Ehrnström holds an MSc in biochemistry & biotechnology engineering from the Royal Institute of Technology, Stockholm, Sweden. He has held leadership positions at medtech and diagnostic companies, including: CSO at Dako-Agilent, CVP of R&D at Dako A/S, VP of R&D at Gyros AB, science director Amersham Biosciences, senior scientific advisor Amersham Pharmacia Biotech, senior program manager MicroArrays Amersham-Pharmacia Biotech and director R&D molecular biology Pharmacia Biotech.

CTO: Christer Wingren

CFO: Hans Liljenborg

Dr Wingren is a lecturer at Lund University’s CREATE centre. Dr Wingren holds a BSc in chemistry and a PhD in biochemistry from Lund University. He conducted his postdoctoral training in structural biology at the laboratory of Professor Ian Wilson at the Scripps Research Institute, La Jolla, US. His research focus is the development of recombinant antibody microarrays for high-throughput disease proteomics, with a particular focus on oncoproteomics and autoimmunity. Dr Wingren joined Immunovia in 2007.

Mr Liljenborg has a BSc in business and mathematics from Lund University. He has held different roles in finance management at biomedical companies. He was finance director at Physio Control and Jolife AB. Mr Liljenborg was finance manager at Vivoline Medical AB. He has also been CFO at QuickCool AB and finance manager at Pharma Visions Systems AB.

Management team

CEO: Mats Grahn

Mr Grahn has been the CEO of Immunovia since 2012. Mr Grahn holds an MSc in engineering physics from Lund University, Sweden. Mr Grahn has more than two decades of experience in the healthcare industry, where he has held different positions, including: VP of product management and VP of marketing at GE Healthcare; CVP marketing at Dako A/S; VP marketing Amersham Biosciences; VP laboratory separations at Pharmacia Biotech; and VP at Prevas Bioinformatics.

CSO: Rolf Ehrnström

Mr Ehrnström holds an MSc in biochemistry & biotechnology engineering from the Royal Institute of Technology, Stockholm, Sweden. He has held leadership positions at medtech and diagnostic companies, including: CSO at Dako-Agilent, CVP of R&D at Dako A/S, VP of R&D at Gyros AB, science director Amersham Biosciences, senior scientific advisor Amersham Pharmacia Biotech, senior program manager MicroArrays Amersham-Pharmacia Biotech and director R&D molecular biology Pharmacia Biotech.

CTO: Christer Wingren

Dr Wingren is a lecturer at Lund University’s CREATE centre. Dr Wingren holds a BSc in chemistry and a PhD in biochemistry from Lund University. He conducted his postdoctoral training in structural biology at the laboratory of Professor Ian Wilson at the Scripps Research Institute, La Jolla, US. His research focus is the development of recombinant antibody microarrays for high-throughput disease proteomics, with a particular focus on oncoproteomics and autoimmunity. Dr Wingren joined Immunovia in 2007.

CFO: Hans Liljenborg

Mr Liljenborg has a BSc in business and mathematics from Lund University. He has held different roles in finance management at biomedical companies. He was finance director at Physio Control and Jolife AB. Mr Liljenborg was finance manager at Vivoline Medical AB. He has also been CFO at QuickCool AB and finance manager at Pharma Visions Systems AB.

Principal shareholders

(%)

Carl Borrebaeck

11.37

Vincent Saldell

5.95

Sara Andersson Ek

5.77

Per Mats Ohlin

5.77

Christer Wingren

5.77

Försäkringsbolaget Avanza Pension

4.64

Companies named in this report

Interpace Diagnostics (IDXG, US), Myriad (MYGN, US), NatiMab Therapeutics, Trovagene (TROV, US), VolitionRx (VNRX, US), Exact Sciences (EXAS).

Edison, the investment intelligence firm, is the future of investor interaction with corporates. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. We provide services to more than 400 retained corporate and investor clients from our offices in London, New York, Frankfurt, Sydney and Wellington. Edison is authorised and regulated by the Financial Conduct Authority. Edison Investment Research (NZ) Limited (Edison NZ) is the New Zealand subsidiary of Edison. Edison NZ is registered on the New Zealand Financial Service Providers Register (FSP number 247505) and is registered to provide wholesale and/or generic financial adviser services only. Edison Investment Research Inc (Edison US) is the US subsidiary of Edison and is regulated by the Securities and Exchange Commission. Edison Investment Research Limited (Edison Aus) [46085869] is the Australian subsidiary of Edison and is not regulated by the Australian Securities and Investment Commission. Edison Germany is a branch entity of Edison Investment Research Limited [4794244]. www.edisongroup.com

DISCLAIMER
Copyright 2016 Edison Investment Research Limited. All rights reserved. This report has been commissioned by Immunovia and prepared and issued by Edison for publication globally. All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report. Opinions contained in this report represent those of the research department of Edison at the time of publication. The securities described in the Investment Research may not be eligible for sale in all jurisdictions or to certain categories of investors. This research is issued in Australia by Edison Aus and any access to it, is intended only for "wholesale clients" within the meaning of the Australian Corporations Act. The Investment Research is distributed in the United States by Edison US to major US institutional investors only. Edison US is registered as an investment adviser with the Securities and Exchange Commission. Edison US relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. As such, Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions. The information that we provide or that is derived from our website is not intended to be, and should not be construed in any manner whatsoever as, personalised advice. Also, our website and the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. This document is provided for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.
Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report. The value of securities mentioned in this report can fall as well as rise and are subject to large and sudden swings. In addition it may be difficult or not possible to buy, sell or obtain accurate information about the value of securities mentioned in this report. Past performance is not necessarily a guide to future performance. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (ie without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision. To the maximum extent permitted by law, Edison, its affiliates and contractors, and their respective directors, officers and employees will not be liable for any loss or damage arising as a result of reliance being placed on any of the information contained in this report and do not guarantee the returns on investments in the products discussed in this publication. FTSE International Limited (“FTSE”) © FTSE 2016. “FTSE®” is a trade mark of the London Stock Exchange Group companies and is used by FTSE International Limited under license. All rights in the FTSE indices and/or FTSE ratings vest in FTSE and/or its licensors. Neither FTSE nor its licensors accept any liability for any errors or omissions in the FTSE indices and/or FTSE ratings or underlying data. No further distribution of FTSE Data is permitted without FTSE’s express written consent.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Trifast — Update 9 November 2016

Trifast

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