Trading Statement

Trading Update

Immunodiagnostic Systems Holdings PLC 

20 April 2018

Immunodiagnostic Systems Holdings PLC

Trading update for the year ended 31 March 2018 and change of Non-Executive Directorate

Immunodiagnostic Systems Holdings PLC ("the Group"), a specialist producer of manual and automated diagnostic testing kits and instruments for the clinical market, today provides a trading update for the financial year ended 31 March 2018 ("FY18").

Unaudited Group revenue is expected to be approximately £37.9m, a decrease of 5% on the previous year (and a decline of 8% at constant exchange rates "CER"). The majority of the decline was due to the loss of royalty income from a major customer, as communicated previously. Revenues in the Laboratory business (comprising the Automated and Manual business units) are expected to be £35.2m, unchanged on the previous year at CER, with growth in the automated business offsetting declines in the manual business.

1. Automated Business

Revenues in our automated CLIA business are expected to be approximately £22.9m, 4% higher than FY17 at CER (compared to 3% growth in FY17 v FY16). An overview of the key revenue streams in this business is set out below:

· Automated 25OH Vitamin D revenue of approximately £6.3m represents a decline of around 9% at CER compared to the prior year. The rate of this decline is lower than seen in previous years.

· Automated Speciality Endocrinology revenue of approximately £13.6m represents a growth of around 5% at CER compared to the prior year.

· Automated Autoimmune and Infectious Disease revenue of approximately £1.0m represents growth of 24% at CER. As previously announced, we have reached agreement with Technogenetics SRL to enable IDS to sell their range of circa fifty autoimmune ("AI") and infectious disease ("ID") assays globally. We expect all of these assays will be available under the IDS brand by autumn.

During the year IDS launched three new automated assays for the IDS analyzer. Combined with the IDS branded AI and ID offering, we now have a CE marked automated assay panel of 72 assays, 22 of which are produced by IDS (FY17 : 19). The assay menu in the US and China remains unchanged compared to the previous year, at ten and four respectively.

Annual gross placements of analysers in markets with direct sales organizations were 34 (FY17: 40). The number of returns were 25 (FY17: 24), meaning net placements in the year were 9 (FY17: 16). Gross placements of 16 during H2 FY18 were disappointing, being lower than the 18 achieved in H1. This was mainly due to a high staff and management turnover in one region. We have been able to fill most of these positions by now and therefore expect gross new placements of analysers to resume growth again.

In contrast to our direct sales business, our distribution business performed strongly, with sales of 36 analysers in the year (FY17: 12). This strong performance puts IDS in a good position to grow distribution revenue during FY19.

The average number of assays run on an IDS analyser increased to 4.7 (FY17: 4.3) which reflects the upselling activities performed by the sales organisation. The increase in this metric demonstrates that IDS analysers are becoming more widely used within our laboratory customers, which gives us increased confidence that contracts will more likely be renewed at the end of their term.

2. Manual Business

Manual assay revenues are expected to be approximately £12.4m, 6% lower than FY17 at CER (FY17vFY16: 11% decline). The rate of decline has slowed due to a strong performance in our Diametra business, which offset the continued declines in the legacy IDS Manual business.

During H2 FY18 we completed the recruitment of the Manual business unit commercial team. The new team has already developed a pipeline of OEM sales opportunities, as well as being at advanced negotiations to on-board at least 10 new distributors. We anticipate that we will start to see the financial benefit of these actions during H2 FY19.

3. Licensing and Technology Business

Licensing and Technology revenues are expected to be approximately £2.7m, a decline of around 55% at CER compared to the prior year. The majority of the decline is due to the loss in royalty income from one major customer, as announced in June 2016. Revenues from this customer were £2.8m in the prior year, but are minimal during FY18. Thus moving forward this issue will no longer drag down the overall group growth rates.

4. Other Metrics

As of 31 March 2018 the Group employed 281 staff and contractors on a full time employment basis (31 March 2017: 284).

Closing cash and cash equivalents are expected to be around £28.5m (31 March 2017: £31.5m).

5. Board Changes

Till Campe informed the Company today that he will step down from the Board, effective from 30 June 2018, to focus on his activities at Forum Family Office. The Board would like to thank Till for his contributions during his time with IDS, particularly in relation to our corporate development efforts.

6. Automated Business - New Allergy Products

We are pleased to announce that we have recently signed an exclusive agreement to distribute globally 51 allergy assays which have been developed by our partner, Omega Diagnostics. These assays will be branded as IDS Allersys.

We only anticipate modest revenues from these assays in the next 1 - 2 years, as a much larger panel of assays, and related screening tests, are required to place new analyzers in labs with a focus on allergy testing. The incumbent providers feature menus with over 100 tests. Revenues in the next couple of years will thus largely be limited to upsells into the existing IDS analyzer installations. Encouragingly feedback from initial trials is that the IDS / Omega solution is more flexible and easy to use than existing systems available for small to mid-size laboratories.

7. Outlook

Within our Automated business we still have a number of actions to undertake to strengthen our direct sales team, which we aim to complete during the first quarter of FY19. This is vital to allow us to accelerate the number of gross analyser placements, and accelerate the disappointing growth levels we witnessed in our Specialty Endocrinology business. We are encouraged by the performance of our distribution business in FY18. We will deploy additional resources in this area if necessary to capitalise on this growth opportunity. Finally the potential presented as a result of the deal with Technogenetics is very exciting. Our combined AI and Endocrinology panel, coupled with the ease of use of the IDS analyser platform, give us a compelling proposition for laboratories which we need to exploit during FY19.

Within our Manual business, we are pleased to see the new commercial team generating a pipeline of revenue opportunities. We now have to convert these to firm orders, and target an improvement in the revenue trend of this business during H2 FY19.

Preliminary results for the year ended 31 March 2018 will be announced on 20 June 2018.

For further information:

Immunodiagnostic Systems Holdings plc Tel : +44 (0)191 5190660

Jaap Stuut, Chief Executive Officer

Paul Martin, Group Finance Director

Peel Hunt LLP  Tel : +44 (0)207 418 900

James Steel

Oliver Jackson