TIDMCIR

RNS Number : 5190F

Circassia Group Plc

22 March 2022

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 ("MAR"), and is disclosed in accordance with the Company's obligations under Article 17 of MAR. The persons taking responsibility for this announcement are the Company contacts named below.

CIRCASSIA GROUP PLC

("Circassia" or the "Company" and, together with its subsidiaries, the "Group")

PRELIMINARY RESULTS FOR THE YEARED 31 DECEMBER 2021

Oxford, UK - 22 March 2022: Circassia Group plc ("Circassia" or "the Group"; AIM: CIR), a medical device company focused on point of care asthma diagnosis and management, today announces its audited results for the year ended 31 December 2021.

Financial highlights

-- Revenues were up 17% to GBP27.9 million (20% on a constant currency basis), approximately 84% being recurring consumable revenues

-- Group adjusted EBITDA positive for the first time at GBP0.6 million, ahead of upgraded consensus estimates

-- Profit for the financial year GBP3.6 million after a deferred tax credit of GBP4.4 million (2020: loss of GBP33.5 million)

   --      Net cash GBP12.6 million (31 December 2020: GBP7.4 million) 

Financial progress

 
            Audited                                          2021                2020 
                                                             GBPm                GBPm 
                                               ------------------  ------------------ 
            Revenue                                          27.9                23.9 
                                               ------------------  ------------------ 
            Gross margin                                      68%                 68% 
                                               ------------------  ------------------ 
            Total expenditure(1)                           (18.4)              (25.4) 
                                               ------------------  ------------------ 
            Adjusted EBITDA(2)                                0.6               (9.1) 
                                               ------------------  ------------------ 
            Operating loss                                  (4.3)              (17.3) 
                                               ------------------  ------------------ 
            Loss before tax                                 (2.1)              (18.4) 
                                               ------------------  ------------------ 
            Profit/ (loss) for the year 
             from discontinued operations                     1.3               (6.7) 
                                               ------------------  ------------------ 
            Profit/ (loss) for the financial 
             year                                             3.6              (33.5) 
                                               ------------------  ------------------ 
            Cash(3) at year end                              12.6                 7.4 
                                               ------------------  ------------------ 
 (1) Excludes depreciation, amortisation, impairment 
  and share option charge. 
  (2) Earnings before interest, tax, depreciation, 
  amortisation, impairment and share option charge. 
  (3) Includes cash and cash equivalents. 
 

Operational highlights

   --      Solid recovery in revenues despite continuing Covid-19 disruption 

-- Ongoing transition to distributor-led business model with new arrangements in the USA and China expected to drive scalable revenue growth

   --      Transition period for COPD business complete 
   --      Global Health & Pharma Awards named Circassia as Global Leaders in FeNO testing in 2021 

-- Updated American Thoracic Society guidelines recommend FeNO testing for diagnosis and ongoing management of asthma

Ian Johnson, Circassia's Executive Chairman, said: "The Group passed some significant milestones in 2021, achieving positive adjusted EBITDA and a profit after tax for the first time, as well as generating positive cash flow from our operating activities. The Group is debt free and has the cash resources to continue implementing its business strategy of accessing a large and underserved population of patients suffering from asthma.

We anticipate the global pandemic will continue to have some impact on our markets, however, the much-reduced cost base, high levels of recurring revenues and high gross margins will continue to provide a considerable degree of resilience going forward. The business has made a positive start to 2022 with NIOX(R) clinical revenues up 24% in the first two months of the year on the equivalent period in 2021 and has continued to generate positive operating cash flow. The Board believes that the ongoing transition to a distributor led business model will drive top line growth and deliver further shareholder value over the medium term."

Contacts

Circassia

Ian Johnson, Executive Chairman via Singer Capital Markets

Michael Roller, Chief Financial Officer

Singer Capital Markets (Nominated Adviser and Broker)

Aubrey Powell/ Jen Boorer Tel: +44 (0) 20 7496 3000

About Circassia

Our ambition is to improve the quality of life of millions of people suffering from asthma. Circassia is a medical device company focused on point of care asthma diagnosis and management. Our market-leading NIOX(R) products are used by physicians around the world to improve asthma diagnosis and management and also by leading research organisations conducting clinical studies on behalf of pharmaceutical companies. At present, Circassia provides products and services in around 50 countries. For more information please visit www.circassia.com .

Forward-looking statements

This press release contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of Circassia. The use of terms such as "may", "will", "should", "expect", "anticipate", "project", "estimate", "intend", "continue", "target" or "believe" and similar expressions (or the negatives thereof) are generally intended to identify forward-looking statements. These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors that could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Nothing contained in this press release should be construed as a profit forecast or profit estimate. Investors or other recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. Circassia undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.

Executive Chairman's statement

A year of significant progress

Following the wide-ranging business and management changes in 2020, 2021 saw both the continued implementation of the strategy to focus on the Group's market-leading NIOX(R) business and the final hand back of the COPD business to AstraZeneca in line with the agreement signed in April 2020.

The NIOX(R) business was significantly affected by the impact of the Covid-19 pandemic in Q2 2020, however, although revenues have built back steadily since then, they have not yet recovered to the levels achieved in 2019, thanks to ongoing disruption associated with the pandemic. Despite this, the restructuring of the cost base and associated restructuring of the sales model has permitted the achievement of profitability at the adjusted EBITDA level for the Group as a whole. As the effects of the pandemic wane, and the new distribution arrangements put in place in the US and China begin to take effect, we envisage consistent sales growth without the need to add significant fixed costs.

Management continues to focus on building a profitable business around its NIOX(R) products and has a clear strategy to grow the business. The Company intends to drive revenues in its core medical and clinical trials markets with the VERO(R) device and is examining the possibility of launching additional products for patients to self-test at home.

Equity financing

On 24 March 2021, the Company announced it had raised an additional GBP5 million by way of a subscription for new ordinary shares, by three major shareholders at a price of 25 pence per share to strengthen its balance sheet. Given the successful reduction of costs and close ongoing controls on operating expenditure, the Company is well financed for its anticipated needs.

NIOX(R) business

Revenues for the continuing NIOX(R) business for the year ended 31 December 2021 were up 17% to GBP27.9 million (2020: GBP23.9 million), and up 20% on a constant currency basis. H1 revenues were GBP14.6 million, benefitting from a one-off revenue item of GBP0.6 million in China and a strong Q1 for research sales driven by the start of clinical trials that were delayed in 2020 due to Covid-19, with H2 revenues of GBP13.3 million. Given the geographically diverse nature of the NIOX(R) business, different markets suffered disruption from lockdowns and other pandemic effects at different times during the year.

After reducing the cost base significantly in 2020, further cost reductions were effected in the current year, principally in the area of sales and marketing costs. This was mostly the result of the move to a distributor led model for sales. Group headcount, which started the year at 156, ended the year at 111. While management will remain alert to the possibility of further cost reductions where these can be identified, the bulk of the cost savings have now been achieved.

Discontinued operations

The transfer of the COPD products back to AstraZeneca completed on 31 March 2021. In the first three months of 2021, this business made an operating profit / EBITDA of GBP1.3 million. Circassia retains legal liability for rebates payable to third parties (primarily Medicare) for the period during which it operated the COPD business. GBP4.2 million of rebates have been paid since 31 March 2021 and an accrual for additional rebates of GBP3.7 million remains in the Group's balance sheet at 31 December 2021. Rebate claims totalling GBP0.8 million have been received since 31 December 2021.

Circassia also retains legal liability for returns of product sold during the period when it operated the COPD business. An accrual of GBP1.9 million has been included to cover this eventuality in the Group's balance sheet at 31 December 2021. The value of returns to date has been very low, but this liability remains with Circassia until late 2023.

Russia and Ukraine

Circassia has no operations in Russia and generates no revenue in Russia. In 2021, revenues derived from Ukraine were less than 1% of Group revenues.

BeyondAir

On 26 May 2021 we announced that our dispute with Beyond Air Inc. relating to the Group's rights to their LungFit (R) product had been settled. Upon FDA approval of the product, which to date has not been received, a total of $10.5 million is payable to Circassia in stage payments and up to a further $6 million in royalties on future sales.

Employees

On behalf of the Board, I would like to thank all employees within the Group for their hard work and commitment during what has been another difficult year for everyone. For a second consecutive year, I would like to offer particular thanks to those employees who continued to attend our offices and logistics facilities to ensure the continued smooth operation of the business during periods of lockdown.

Summary and outlook

The Group passed some significant milestones in 2021, achieving positive EBITDA and a profit after tax for the first time, as well as generating positive cash flow from our operating activities. The Group is debt free and has the cash resources to continue implementing its business strategy of accessing a large and underserved population of patients suffering from asthma.

We anticipate the global pandemic will continue to have some impact on our markets, however, the much-reduced cost base, high levels of recurring revenues and high gross margins will continue to provide a considerable degree of resilience going forward. The business has made a positive start to 2022 with NIOX(R) clinical revenues up 24% in the first two months of the year on the equivalent period in 2021 and has continued to generate positive operating cash flow. The Board believes that the ongoing transition to a distributor led business model will drive top line growth and deliver further shareholder value over the medium term.

OPERATING REVIEW

Key strategic drivers of the Group

The opportunity

Asthma affects over 340 million people worldwide with a further 100 million estimated to be affected by 2025. There are an estimated 1,000 deaths globally due to asthma every day. In some 50% of cases, asthma is either not diagnosed or misdiagnosed, which leads to a delay in asthma patients receiving the care that they need. Following a diagnosis of asthma, it is important to be able to regularly monitor the condition and ensure the correct medication is taken.

FeNO

Asthma is a condition that is characterised by inflammation of the airways and lungs. Nitric oxide is produced by inflammatory cells and can be precisely measured in exhaled breath, this is known as FeNO (fraction of exhaled nitric oxide). Measuring FeNO helps understand the level of inflammation in the lungs of an asthmatic and is a precise biomarker of type 2 airway inflammation. Clinicians use FeNO measurements to diagnose and manage asthma in order to improve quality of life of asthma sufferers.

The American Thoracic Society (ATS) recommended that FeNO testing should be part of the ongoing care of asthmatics as well as being used as a tool for diagnosing asthma. This is the latest example from an increasing body of highly credible, influential evidence based medical guidelines around the world that have recommended the use of FeNO testing as a routine part of diagnosing and managing asthma. The guidelines are based on a substantial body of published clinical trials that demonstrate the benefits of FeNO testing.

Further impetus is coming from a new class of biologic anti-inflammatory medicines for the treatment of type 2 inflammatory asthma. These medicines have the potential to replace or reduce the use of inhaled steroids, which have long been the standard of care for inflammatory asthma. Biologic medicines are targeted at asthmatics with increased inflammation and therefore elevated FeNO. The cost of these new medicines is significant. This means that some pharmaceutical companies are investing resources to raise the awareness and usage of FeNO testing in order to identify the patients that are most likely to respond to treatment as they seek to establish this new class of drugs as an effective line of therapy.

Our products

The Company's NIOX VERO(R) is the market leading device for measuring FeNO. This is a non-invasive, point-of-care system which accurately measures the patient's FeNO level. It is quick, easy to use and reliable. The system comprises a small portable device and test kits containing sensors and individual disposable mouthpieces. The quality and innovation of NIOX VERO(R) has been recognised with several awards over recent years, most recently the Global Health & Pharma Awards, where Circassia was named as Global Leaders in FeNO Testing 2021.

NIOX(R) is registered and reimbursed in all major markets and available in more than 50 countries via Circassia's international network of distribution partners.

Our business

The NIOX VERO(R) dominates FeNO testing currently with approximately 17,000 devices and with over 40 million FeNO tests sold to date.

NIOX(R) revenues in 2021 for medical diagnosis and management of asthma were GBP23.4 million (2020: GBP21.5 million). Approximately 90% of these revenues are from recurring sales of consumables (test kits) used for routine testing.

In addition to routine use by clinicians, the NIOX VERO(R) is almost exclusively specified as the device of choice by clinical research organisations (CROs) who manage clinical trials on behalf of large pharma. Our principal CRO customer established a number of new trials in the early part of the year, after a slowdown in sales in 2020 during the early stages of the pandemic.

Revenues in 2021 from CROs were GBP4.5 million (2020: GBP2.4 million). Approximately 55% of these revenues are from sales of consumables (test kits) driven by the length of the trial and the number of patients recruited and are not classified as recurring.

Principal challenges

Today around 5% of eligible asthmatics receive a FeNO test, meaning that there is a huge untapped potential in the FeNO testing market. The primary challenge the NIOX(R) business faces is to increase the awareness and usage of FeNO testing, particularly in the medical community that treat asthma on a day to day basis (e.g. primary care or general practice). The customer base is inherently conservative, and their adoption of new technology or techniques tends to reflect this.

The Company continues to engage with respiratory professionals to promote the use of FeNO tests in new and under-served customer segments such as primary care settings and pharmacies. Use by CROs also raises the profile of FeNO testing and NIOX(R) in particular.

Management intends to expand the number of distribution partners in our major markets, such as the US and China, to further raise awareness and levels of education regarding the benefits of FeNO testing and to make NIOX(R) more easily available.

Covid-19 impact

During 2021 the impact of the Covid-19 pandemic was less severe than 2020, however, it continued to affect our major markets in varying degrees. The overall effect has been to disrupt routine testing of asthma patients, with revenues for the year reaching approximately 85% of pre-pandemic levels. As time passes our sales patterns indicate that different healthcare systems are developing strategies to reduce the level of disruption to routine healthcare services.

Conclusion

Our ambition is to improve the quality of life of millions of people suffering from asthma. The Group has a robust strategy in place to expand the business and generate profitable growth from this large underserved market; this includes the ongoing evaluation of a product for home use.

FINANCIAL REVIEW

This has been a significant year for Circassia. Despite the performance of the NIOX(R) business still being affected by the impact of the Covid-19 pandemic on the level of FeNO testing carried out by our customers, the Group achieved positive adjusted EBITDA for the first time. The continuing activities of the Group also generated GBP1.3 million in cash.

On 27 May 2020, the Group handed back the rights to its COPD products to AstraZeneca, and as such the results of the COPD business are classified as a discontinued operation in the table below. The NIOX(R) business represents the continuing operations of the Group.

 
                                            2021     2020 
                                            GBPm     GBPm 
======================================   =======  ======= 
 Revenue                                    27.9     23.9 
 Cost of sales                             (8.9)    (7.6) 
 Gross profit                               19.0     16.3 
 Gross margin                                68%      68% 
 Research and development costs            (4.6)    (6.8) 
 Sales and marketing costs                (11.9)   (16.6) 
 Administrative expenses                   (6.8)   (10.2) 
 Adjusted EBITDA(1)                          0.6    (9.1) 
 Operating loss                            (4.3)   (17.3) 
 Other gains and (losses) - net              1.6    (0.9) 
 Other income                                0.9        - 
 Net finance costs                         (0.3)    (0.2) 
 Loss before tax                           (2.1)   (18.4) 
 Taxation                                    4.4    (8.4) 
 Profit/(loss) for the financial year 
  from continuing operations                 2.3   (26.8) 
 Profit/ (loss) for the financial 
  year from discontinued operations          1.3    (6.7) 
 Profit/(loss) for the financial year        3.6   (33.5) 
---------------------------------------  -------  ------- 
 Cash and cash equivalents                  12.6      7.4 
---------------------------------------  -------  ------- 
 

(1) Earnings before interest, tax, depreciation, amortisation, impairment and share option charge.

Revenue

NIOX(R) revenue for the year was GBP27.9 million (2020: GBP23.9 million) which includes clinical revenue of GBP23.4 million (2020: GBP21.5 million) and research revenue of GBP4.5 million (2020: GBP2.4 million). NIOX(R) c linical revenue represents sales to physicians and hospitals for use in clinical practice and to the Company's distributors, while research revenue is from pharmaceutical companies and contract research organisations (CROs) for use in clinical studies.

The increase in NIOX(R) revenue was due to the recovery following the Covid-19 pandemic, combined with the implementation of the Company's business strategy to focus efforts entirely on the NIOX(R) product.

Gross profit

Gross profit on NIOX(R) revenue was GBP19.0 million (2020: GBP16.3 million), with a gross margin of 68% (2020: 68%). Gross margin was in line with prior year. A higher proportion of relatively high margin revenue in China was largely offset by a higher proportion of lower margin research revenue.

Research and development

Research and development costs decreased to GBP4.6 million (2020: GBP6.8 million). Included in this category are GBP1.2 million of Device Development costs (2020: GBP1.5 million), GBP0.6 million of Quality costs (2020: GBP1.3 million), GBP0.4 million of Medical Affairs costs (2020: GBP0.6 million), GBP0.3 million of Regulatory costs (2020: GBP0.5 million) and GBP2.1 million of depreciation, amortisation and impairment (2020: GBP2.9 million).

The prior year costs include a GBP0.9 million impairment charge against internal device development costs due to a change in the strategic roadmap for product development. Excluding depreciation, amortisation and impairment, research and development costs decreased to GBP2.5 million (2020: GBP3.9 million) which is mainly due to lower headcount.

Sales and marketing

Sales and marketing costs decreased markedly to GBP11.9 million (2020: GBP16.6 million) which was mainly due to a reduction in the number of dedicated NIOX(R) sales representatives across the Group as a result of the switch to a distributor led sales model, in particular in the US and China, combined with lower third-party marketing costs incurred during the Covid-19 pandemic. Given that the full impact of the headcount reductions did not impact 2021, but will impact 2022, we expect sales and marketing costs in the aggregate to continue to fall in 2022, notwithstanding a modest increase in third-party marketing costs as the impact of the Covid-19 pandemic eases.

Administrative expenditure

Administrative expenditure, which includes overheads relating to corporate functions, centrally managed support functions and corporate costs, decreased to GBP6.8 million (2020: GBP10.2 million). This was mainly due to lower salary costs as a result of lower headcount.

Other income

Other income includes a GBP0.7 million grant received from the US government under the Payment Protection Program (2020: GBPnil). There are no contingencies or conditions attaching to this grant, and the amounts are not repayable.

Taxation

Taxation for the year was a credit of GBP4.4 million (2020: GBP8.4 million charge) which arose due to an increase in the amount of recognised carried-forward tax losses in the Group generated in Sweden by Circassia AB.

Earnings per share

Basic and diluted profit per share for the year was 1p (2020: 9p loss) reflecting a profit of GBP3.6 million (2020: GBP33.5 million loss), with the increase mainly as a result of the reduction in the cost base of the Group. Basic and diluted profit per share from continuing operations was 1p (2020: 7p loss) reflecting a profit for the financial year of GBP2.3 million (2020: GBP26.8 million loss).

Profit/(loss) from discontinued operations

Profit from discontinued operations was GBP1.3 million (2020: GBP6.7 million loss).

The transitional run-off period of the discontinued COPD business ended in March 2021, during which time minimal operating expenditure was incurred. The prior period includes several one-off items including the AstraZeneca loan write-off, offset by the associated impairment charge of the COPD licence assets.

Other comprehensive income/(expense)

The Group's other comprehensive expense of GBP7.8 million (2020: GBP7.8 million income) relates to exchange differences on the translation of foreign operations into British pound sterling.

The current year expense is mainly due to the strengthening of the British pound against the Swedish krona. The expense consists of a GBP3.7 million loss (2020: GBP4.3 million gain) on the translation of intangible assets, a GBP3.6 million loss (2020: GBP3.0 million gain) on the translation of overseas subsidiaries' net assets, and a GBP0.5 million loss (2020: GBP0.5 million gain) on the translation of goodwill.

Statement of financial position

The Group's net assets at 31 December 2021 were GBP66.8 million (2020: GBP66.1 million).

Current liabilities at the end of the year were GBP10.8 million (2020: GBP26.7 million). The decrease is mainly due to lower trade payables, in particular lower rebate accruals relating to the discontinued COPD business.

Cash flow

The Group's cash position (including cash and cash equivalents) increased from GBP7.4 million at 31 December 2020 to GBP12.6 million at 31 December 2021.

Cash generated from operations during the year aggregated GBP1.5 million, of which GBP0.2 million was generated in the COPD discontinued operations.

Cash generated from/(used in) operations in the year by business unit was as follows:

 
                                  NIOX (R)   COPD (Discontinued)  Head office  Group 
 
                                                            GBPm 
                                      GBPm                               GBPm   GBPm 
-------------------------------  ---------  --------------------  -----------  ----- 
 Adjusted EBITDA                       2.4                   1.0        (1.8)    1.6 
 Net working capital movements         0.2                 (0.8)            -  (0.6) 
 Other non-cash movements                -                     -          0.5    0.5 
 Cash generated from/(used 
  in) operations by business 
  unit                                 2.6                   0.2        (1.3)    1.5 
-------------------------------  ---------  --------------------  -----------  ----- 
 

Non-operating cash movements aggregated GBP3.7 million (2020: GBP4.3 million):

 
                                                2021     2020 
                                                GBPm     GBPm 
--------------------------------------------  ------  ------- 
 Cash generated from/(used in) operations        1.5   (23.9) 
 Interest paid                                 (0.1)    (0.2) 
 Tax credit received                               -      0.2 
 Payments for property, plant and equipment    (0.1)    (0.1) 
 Payments for intangible assets                (0.1)    (0.4) 
 Proceeds from issue of shares net of share 
  issue transaction costs                        4.9      5.0 
 Principal elements of lease payments          (0.8)    (0.7) 
 Exchange (losses)/gains on cash and cash 
  equivalents                                  (0.1)      0.5 
--------------------------------------------  ------  ------- 
 Net increase/(decrease) in cash and cash 
  equivalents                                    5.2   (19.6) 
--------------------------------------------  ------  ------- 
 

Michael Roller

Chief Financial Officer

22 March 2022

Consolidated statement of comprehensive income

for the year ended 31 December 2021

 
                                                          2021     2020 
                                                Notes     GBPm     GBPm 
 Continuing operations 
 
 Revenue from contracts with customers                    27.9     23.9 
 Cost of sales                                           (8.9)    (7.6) 
---------------------------------------------  ------  -------  ------- 
 Gross profit                                             19.0     16.3 
 
 Research and development costs                          (4.6)    (6.8) 
 Sales and marketing costs                              (11.9)   (16.6) 
 Administrative expenses                                 (6.8)   (10.2) 
 Operating loss                                   4      (4.3)   (17.3) 
 
 Other gains and (losses) - net                            1.6    (0.9) 
 Other income                                              0.9        - 
 Finance costs                                    5      (0.3)    (0.3) 
 Finance income                                   5          -      0.1 
 Loss before tax                                         (2.1)   (18.4) 
 
 Taxation                                         7        4.4    (8.4) 
---------------------------------------------  ------  -------  ------- 
 Profit/(loss) from continuing operations                  2.3   (26.8) 
---------------------------------------------  ------  -------  ------- 
 
 Profit/(loss) from discontinued 
  operations (attributable to equity 
  holders of Circassia Group plc)                 6        1.3    (6.7) 
 
 Profit/(loss) for the year                                3.6   (33.5) 
---------------------------------------------  ------  -------  ------- 
 
 Other comprehensive (expense)/income 
 Items that may be subsequently reclassified 
  to profit or loss 
 Exchange differences on translation 
  of foreign operations                          12      (7.8)      7.8 
 Other comprehensive (expense)/income 
  for the year, net of tax                               (7.8)      7.8 
---------------------------------------------  ------  -------  ------- 
 Total comprehensive expense for 
  the year                                               (4.2)   (25.7) 
---------------------------------------------  ------  -------  ------- 
 

Earnings per share attributable to owners of the parent during the year (expressed in GBP per share)

 
                                                   2021     2020 
 Basic earnings per share                           GBP      GBP 
--------------------------------------------      -----  ------- 
 Basic earnings per share for profit/(loss) 
  from continuing operations                   8   0.01   (0.07) 
 Basic earnings per share for profit/(loss) 
  for the year                                 8   0.01   (0.09) 
--------------------------------------------      -----  ------- 
 
 
                                                     2021     2020 
 Diluted earnings per share                           GBP      GBP 
----------------------------------------------      -----  ------- 
 Diluted earnings per share for profit/(loss) 
  from continuing operations                     8   0.01   (0.07) 
 Diluted earnings per share for profit/(loss) 
  for the year                                   8   0.01   (0.09) 
----------------------------------------------      -----  ------- 
 

The notes below are an integral part of these financial statements.

Consolidated statement of financial position

as at 31 December 2021

 
                                             2021      2020 
                                  Notes      GBPm      GBPm 
-------------------------------  ------  --------  -------- 
 Assets 
 Non-current assets 
 Property, plant and equipment                0.2       0.1 
 Right-of-use assets                          1.2       1.3 
 Goodwill                           9         4.8       5.3 
 Intangible assets                 10        37.3      45.1 
 Deferred tax assets                         23.1      21.6 
                                             66.6      73.4 
-------------------------------  ------  --------  -------- 
 
 Current assets 
 Inventories                                  2.7       4.0 
 Trade and other receivables                  4.5      18.3 
 Cash and cash equivalents                   12.6       7.4 
-------------------------------  ------  --------  -------- 
                                             19.8      29.7 
-------------------------------  ------  --------  -------- 
 Total assets                                86.4     103.1 
-------------------------------  ------  --------  -------- 
 
   Equity 
 Share capital                                0.3       0.3 
 Share premium                              640.3     635.4 
 Other reserves                    12        16.7      24.5 
 Accumulated losses                       (590.5)   (594.1) 
 Total equity                                66.8      66.1 
-------------------------------  ------  --------  -------- 
 
   Liabilities 
   Non-current liabilities 
 Lease liabilities                            0.9       0.8 
 Deferred tax liabilities                     7.9       9.5 
                                              8.8      10.3 
-------------------------------  ------  --------  -------- 
 
 Current liabilities 
 Trade and other payables          11        10.4      25.6 
 Lease liabilities                            0.4       0.8 
 Contingent consideration                       -       0.3 
                                             10.8      26.7 
-------------------------------  ------  --------  -------- 
 Total liabilities                           19.6      37.0 
-------------------------------  ------  --------  -------- 
 Total equity and liabilities                86.4     103.1 
-------------------------------  ------  --------  -------- 
 

The notes below are an integral part of these financial statements.

Ian Johnson Michael Roller

Executive Chairman Chief Financial Officer

Circassia Group plc Circassia Group plc

Registered number: 05822706

Consolidated statement of cash flows

for the year ended 31 December 2021

 
 
                                                                           2021     2020 
                                                                  Notes    GBPm     GBPm 
---------------------------------------------------------------  ------  ------  ------- 
 Cash flows from operating activities 
 Cash generated from/(used in) operations                          13       1.5   (23.9) 
 Interest paid                                                      5     (0.1)    (0.2) 
 Tax credit received                                                7         -      0.2 
---------------------------------------------------------------  ------  ------  ------- 
 Net cash generated from/(used in) operating activities                     1.4   (23.9) 
---------------------------------------------------------------  ------  ------  ------- 
 
 Cash flows from investing activities 
 Payments for property, plant and equipment                               (0.1)    (0.1) 
 Payments for intangible assets                                    10     (0.1)    (0.4) 
 Grant of loans to subsidiary undertakings                                    -        - 
 Net cash used in investing activities                                    (0.2)    (0.5) 
---------------------------------------------------------------  ------  ------  ------- 
 
 Cash flows from financing activities 
 Proceeds from issue of shares                                              5.0      5.0 
 Share issue transaction costs                                            (0.1)        - 
 Principal elements of lease payments                                     (0.8)    (0.7) 
 Net cash generated from financing activities                               4.1      4.3 
---------------------------------------------------------------  ------  ------  ------- 
 
 Net increase/(decrease) in cash and cash equivalents                       5.3   (20.1) 
 Cash and cash equivalents at 1 January                                     7.4     27.0 
 Effects of exchange rate changes on cash and cash equivalents            (0.1)      0.5 
---------------------------------------------------------------  ------  ------  ------- 
 Cash and cash equivalents at 31 December                                  12.6      7.4 
---------------------------------------------------------------  ------  ------  ------- 
 

The notes below are an integral part of these financial statements.

Consolidated statement of changes in equity

for the year ended 31 December 2021

 
                                          Share      Share          Other   Accumulated     Total 
                                        capital    premium    reserves(1)        losses    equity 
                               Notes       GBPm       GBPm           GBPm          GBPm      GBPm 
----------------------------  ------  ---------  ---------  -------------  ------------  -------- 
 At 1 January 2020                          0.3      630.4           14.7       (560.6)      84.8 
 Loss for the year                            -          -              -        (33.5)    (33.5) 
 Exchange differences 
  on translation of foreign 
  operations                    12            -          -            7.8             -       7.8 
----------------------------  ------  ---------  ---------  -------------  ------------  -------- 
 Total comprehensive 
  income/(expense)                            -          -            7.8        (33.5)    (25.7) 
 Transactions with owners: 
 Issue of new shares                          -        5.0              -             -       5.0 
 Employee share scheme 
  issues                                      -          -            2.0             -       2.0 
----------------------------  ------  ---------  ---------  -------------  ------------  -------- 
 At 31 December 2020                        0.3      635.4           24.5       (594.1)      66.1 
----------------------------  ------  ---------  ---------  -------------  ------------  -------- 
 At 1 January 2021                          0.3      635.4           24.5       (594.1)      66.1 
 Profit for the year                          -          -              -           3.6       3.6 
 Exchange differences 
  on translation of foreign 
  operations                    12            -          -          (7.8)             -     (7.8) 
 Total comprehensive 
  (expense)/income                            -          -          (7.8)           3.6     (4.2) 
 
 Transactions with owners: 
 Issue of new shares                          -        4.9              -             -       4.9 
 At 31 December 2021                        0.3      640.3           16.7       (590.5)      66.8 
----------------------------  ------  ---------  ---------  -------------  ------------  -------- 
 

(1) Other reserves include share option reserve, translation reserve, treasury shares reserve, and transactions with NCI reserve.

The notes below are an integral part of these financial statements.

Notes to the financial statements

   1.             General information 

Basis of preparation

The consolidated financial statements of Circassia Group plc have been prepared on the going concern basis and in accordance with EU adopted International Financial Reporting Standards (IFRS), IFRIC interpretations and the Companies Act 2006 applicable to companies reporting under IFRS. The consolidated financial statements have been prepared under the historical cost convention.

The financial information set out in this preliminary announcement does not constitute the Company's statutory financial statements for the years ended 31 December 2021 or 2020 but is derived from those financial statements. Statutory financial statements for 2020 have been delivered to the registrar of companies and those for 2021 will be delivered in due course. The auditors have reported on those financial statements; their reports were (i) unqualified (ii) did not include a reference to any matters to which the auditor drew attention by way of emphasis without qualifying their report and (iii) did not contain a statement under section 498 (2) or (3) of the Companies Act 2006.

The preliminary announcement will be published on the Company's website. The maintenance and integrity of the website is the responsibility of the directors. The work carried out by the auditors does not involve consideration of these matters. Legislation in the United Kingdom governing the preparation and dissemination of financial statements may differ from legislation in other jurisdictions.

   2.             Operating segments 

The chief operating decision-maker, the Executive Chairman, examines the Group's performance from a product perspective, and has identified two reportable segments of the business:

- NIOX(R) relates to the portfolio of products used to improve asthma diagnosis and management by measuring fractional exhaled nitric oxide (FeNO); and

- COPD relates to the Tudorza(R) and Duaklir(R) Pressair(R) products marketed in the United States, where they are indicated for the maintenance treatment of patients with COPD.

The COPD business has been classified as a discontinued operation. Information about the results of this segment is provided in note 6; information regarding its assets is presented below.

The table below presents operating loss information regarding the Group's operating segments for the years ended 31 December 2021 and 2020. Only the results for the Group's continuing activities are included in order to aid comparison.

Segment operating loss

 
 Year ended 31 December 2021                                                    NIOX(R)   Head office    Total 
                                                                                   GBPm          GBPm     GBPm 
-----------------------------------------------------------------------------  --------  ------------  ------- 
 Revenue (from external customers, based on the destination of the customer) 
 US                                                                                 7.1             -      7.1 
 UK                                                                                 1.7             -      1.7 
 EU                                                                                 8.2             -      8.2 
 Asia Pacific                                                                      10.6             -     10.6 
 Rest of world                                                                      0.3             -      0.3 
-----------------------------------------------------------------------------  --------  ------------  ------- 
 Total segment revenue                                                             27.9             -     27.9 
 
 Cost of sales                                                                    (8.9)             -    (8.9) 
-----------------------------------------------------------------------------  --------  ------------  ------- 
 
 Research and development costs                                                   (4.6)             -    (4.6) 
 Sales and marketing costs                                                       (11.9)             -   (11.9) 
 Administrative expenses                                                          (5.0)         (1.8)    (6.8) 
 Operating loss from continuing operations                                        (2.5)         (1.8)    (4.3) 
-----------------------------------------------------------------------------  --------  ------------  ------- 
 
 Depreciation, amortisation and impairment included above                         (4.9)             -    (4.9) 
-----------------------------------------------------------------------------  --------  ------------  ------- 
 
 
 Year ended 31 December 2020                                                    NIOX(R)   Head office    Total 
                                                                                   GBPm          GBPm     GBPm 
-----------------------------------------------------------------------------  --------  ------------  ------- 
 Revenue (from external customers, based on the destination of the customer) 
 US                                                                                 6.5             -      6.5 
 UK                                                                                 1.3             -      1.3 
 EU                                                                                 6.9             -      6.9 
 Asia Pacific                                                                       8.9             -      8.9 
 Rest of world                                                                      0.3             -      0.3 
-----------------------------------------------------------------------------  --------  ------------  ------- 
 Total segment revenue                                                             23.9             -     23.9 
 
 Cost of sales                                                                    (7.6)             -    (7.6) 
-----------------------------------------------------------------------------  --------  ------------  ------- 
 
 Research and development costs                                                   (6.8)             -    (6.8) 
 Sales and marketing costs                                                       (16.6)             -   (16.6) 
 Administrative expenses                                                          (5.9)         (4.3)   (10.2) 
 Operating loss from continuing operations                                       (13.0)         (4.3)   (17.3) 
-----------------------------------------------------------------------------  --------  ------------  ------- 
 
 Depreciation, amortisation and impairment included above                         (6.2)             -    (6.2) 
-----------------------------------------------------------------------------  --------  ------------  ------- 
 

Assets by segment

 
 As at 31 December 2021           NIOX(R)              COPD   Total 
                                             (Discontinued) 
                                     GBPm              GBPm    GBPm 
-------------------------------  --------  ----------------  ------ 
 Cash and cash equivalents           12.6                 -    12.6 
 Property, plant and equipment        0.2                 -     0.2 
 Right-of-use assets                  1.2                 -     1.2 
 Goodwill                             4.8                 -     4.8 
 Intangible assets                   37.3                 -    37.3 
 Deferred tax assets                 23.1                 -    23.1 
 Inventories                          2.7                 -     2.7 
 Trade and other receivables          4.3               0.2     4.5 
 Total assets                        86.2               0.2    86.4 
-------------------------------  --------  ----------------  ------ 
 
 As at 31 December 2020           NIOX(R)              COPD   Total 
                                             (Discontinued) 
                                     GBPm              GBPm    GBPm 
-------------------------------  --------  ----------------  ------ 
 Cash and cash equivalents            7.4                 -     7.4 
 Property, plant and equipment        0.1                 -     0.1 
 Right-of-use assets                  1.3                 -     1.3 
 Goodwill                             5.3                 -     5.3 
 Intangible assets                   45.1                 -    45.1 
 Deferred tax assets                 21.6                 -    21.6 
 Inventories                          3.0               1.0     4.0 
 Trade and other receivables          6.4              11.9    18.3 
 Total assets                        90.2              12.9   103.1 
-------------------------------  --------  ----------------  ------ 
 
   3.             Employees and directors 

Average number of people employed

 
 Monthly average number of people (including Executive and Non-Executive Directors) employed: 
                                                                                             2021      2020 
                                                                                           Number    Number 
------------------------------------------------------------------------   ----------------------  -------- 
 Office and management                                                                         31        38 
 Sales and marketing                                                                           81       184 
 Research and development                                                                      16        25 
-------------------------------------------------------------------------  ----------------------  -------- 
 Total average headcount                                                                      128       247 
-------------------------------------------------------------------------  ----------------------  -------- 
 

Average headcount includes 1 (2020: 44) sales and marketing and 1 (2020: 4) research and development person employed solely for the discontinued operation.

The Group's total headcount at 31 December 2021 was 111 (2020: 156).

Employee benefit costs

 
                                  2021    2020 
                                  GBPm    GBPm 
------------------------------  ------  ------ 
 Wages and salaries               10.6    14.5 
 Social security costs             1.2     1.5 
 Other pension costs               0.5     0.8 
 Share option charge                 -     2.0 
------------------------------  ------  ------ 
 Total employee benefit costs     12.3    18.8 
------------------------------  ------  ------ 
 

Key management personnel

Key management personnel during the year included directors (Executive and Non-Executive), Regional VP APAC, Regional VP Americas, VP Product Development, VP Supply Chain and Technical Operations, Regional VP EMEA, VP Research Business and Senior VP Global Human Resources. Key management personnel in the prior year also included the VP Global Marketing. The compensation paid or payable to key management is set out below.

 
                                                                2021    2020 
                                                                GBPm    GBPm 
------------------------------------------------  ------------------  ------ 
 Short-term employee benefits (including bonus)                  3.0     2.9 
 Post-employment benefits                                          -     0.1 
 Share based payment                                             0.3     0.3 
 Total                                                           3.3     3.3 
------------------------------------------------  ------------------  ------ 
 
   4.             Breakdown of expenses by nature 
 
                                                         Notes                        2021    2020 
                                                                                      GBPm    GBPm 
------------------------------------------------------  ------  --------------------------  ------ 
 Employee benefit costs                                    3                          12.3    18.8 
 Depreciation charge of property, plant and equipment                                    -     0.3 
 Depreciation charge of right-of-use assets                                            0.8     0.8 
 Amortisation charge of intangible assets                 10                           4.1     4.2 
 Impairment of intangible assets                          10                             -     0.8 
 Impairment of property, plant and equipment                                             -     0.1 
 Loss on disposal of property, plant and equipment                                       -     0.1 
------------------------------------------------------  ------  --------------------------  ------ 
 
   5.             Finance costs and income 
 
                                            2021    2020 
                                            GBPm    GBPm 
----------------------------------------  ------  ------ 
 Finance costs: 
 Bank charges                              (0.2)   (0.2) 
 Interest charges for lease liabilities    (0.1)   (0.1) 
 Total finance costs                       (0.3)   (0.3) 
----------------------------------------  ------  ------ 
 
 Finance income: 
 Bank interest receivable                      -     0.1 
 Total finance income                          -     0.1 
----------------------------------------  ------  ------ 
 
 
   6.             Discontinued operations 

On 9 April 2020, Circassia signed an agreement to hand back the Tudorza(R) and Duaklir(R) licences to AstraZeneca and as such, the results of the COPD operating segment are reported as a discontinued operation. There were no assets or liabilities classified as held for sale in relation to the discontinued operation.

 
 Profit/(loss) for the year 
                                                                         2021      2020 
                                                                         GBPm      GBPm 
-----------------------------------------------------------  ----  ----------  -------- 
 Revenue                                                                  2.5      22.1 
 Cost of sales                                                          (0.3)     (6.4) 
-----------------------------------------------------------------  ----------  -------- 
 Gross profit                                                             2.2      15.7 
-----------------------------------------------------------------  ----------  -------- 
 
 Expenditure                                                            (1.2)    (20.0) 
 Goodwill and intangible asset impairment                                   -   (114.0) 
-----------------------------------------------------------------  ----------  -------- 
 Operating profit/(loss)                                                  1.0   (118.3) 
-----------------------------------------------------------------  ----------  -------- 
 
 Other gains and (losses) - net                                           0.3     114.8 
 Finance costs                                                              -     (3.2) 
-----------------------------------------------------------------  ----------  -------- 
 Profit/(loss) from discontinued operations                               1.3     (6.7) 
-----------------------------------------------------------------  ----------  -------- 
 
 Cash flow                                                               2021      2020 
                                                                         GBPm      GBPm 
------------------------------------------------------------  ---  ----------  -------- 
 Net cash inflow/(outflow) from operating activities                      0.2     (9.8) 
 Net cash generated from/(used in) discontinued operations                0.2     (9.8) 
------------------------------------------------------------  ---  ----------  -------- 
 
 

Other gains and losses includes a GBPnil (2020: GBP123.1 million) gain relating to the forgiveness of the AstraZeneca loan and accrued interest, GBPnil (2020: GBP8.3 million) loss on foreign exchange, and GBP0.3 million (2020: GBPnil) gain on the change in fair value of the contingent royalty consideration.

Finance costs include GBPnil (2020: GBP3.0 million) of interest charged on the loan from AstraZeneca , and GBPnil (2020: GBP0.2 million) relating to the unwinding of discounts on amounts payable to AstraZeneca.

   7.             Taxation 
 
                                                     2021    2020 
                                                     GBPm    GBPm 
-------------------------------------------------  ------  ------ 
 Deferred tax 
 (Increase)/decrease in deferred tax assets         (2.8)     8.2 
 (Decrease)/increase in deferred tax liabilities    (1.6)     0.2 
-------------------------------------------------  ------  ------ 
 Total deferred tax (credit)/charge                 (4.4)     8.4 
-------------------------------------------------  ------  ------ 
 
 Tax is attributable to: 
 Loss from continuing operations                    (4.4)     8.4 
-------------------------------------------------  ------  ------ 
 

The tax credit (2020: charge) for the year is lower (2020: higher) than the standard rate of corporation tax in the UK of 19.00% (2020: 19.00%). The differences are explained below:

 
                                                                      2021     2020 
                                                                      GBPm     GBPm 
 Loss from continuing operations before tax                          (2.1)   (18.4) 
 Profit/(loss) from discontinued operations before tax                 1.3    (6.7) 
------------------------------------------------------------------  ------  ------- 
 Loss before tax                                                     (0.8)   (25.1) 
------------------------------------------------------------------  ------  ------- 
 Tax at the UK tax rate of 19.00% (2020: 19.00%)                     (0.2)    (4.8) 
 Expenses not deductible for tax purposes                            (0.2)        - 
 Employee share options                                              (0.1)      0.4 
 Tax losses for which no deferred income tax asset was recognised    (3.9)     12.8 
 Tax (credit)/charge for the year                                    (4.4)      8.4 
------------------------------------------------------------------  ------  ------- 
 

At 31 December 2021, the Group has tax losses to be carried forward of approximately GBP541.7 million (2020: GBP513.7 million). These can be utilised against future taxable profits. A proportion of these tax losses have been recognised as a deferred tax asset.

At 31 December 2021, Circassia Group plc and Circassia Limited had tax losses to be carried forward of approximately GBP166.3 million (2020: GBP162.6 million). These losses have no expiry date, however, the utilisation of these losses will be restricted to 50% of profits generated in the United Kingdom.

   8.             Earnings per share 
 
 Basic earnings per share                       2021     2020 
                                                 GBP      GBP 
---------------------------------------------  -----  ------- 
 From continuing operations                     0.01   (0.07) 
 From discontinued operations                   0.00   (0.02) 
---------------------------------------------  -----  ------- 
 Total basic earnings per share attributable 
  to the ordinary equity holders of the 
  company                                       0.01   (0.09) 
---------------------------------------------  -----  ------- 
 
 
 Diluted earnings per share                       2021     2020 
                                                   GBP      GBP 
-----------------------------------------------  -----  ------- 
 From continuing operations                       0.01   (0.07) 
 From discontinued operations                     0.00   (0.02) 
-----------------------------------------------  -----  ------- 
 Total diluted earnings per share attributable 
  to the ordinary equity holders of the 
  company                                         0.01   (0.09) 
-----------------------------------------------  -----  ------- 
 
 
 Reconciliation of earnings used in calculating         2021     2020 
  earnings per share                                    GBPm     GBPm 
----------------------------------------------------  ------  ------- 
 Basic and diluted earnings per share 
 Profit/(loss) attributable to the ordinary 
  equity holders of the company used in calculating 
  basic and dilutive earnings per share: 
            From continuing operations                   2.3   (26.8) 
            From discontinued operations                 1.3    (6.7) 
                                                         3.6   (33.5) 
----------------------------------------------------  ------  ------- 
 

The earnings used in calculating basic and diluted earnings per share is the same.

 
 Weighted average number of shares                              2021                     2020 
----------------------------------------------  --------------------  ----------------------- 
 Weighted average number of ordinary shares 
  used as the denominator in calculating 
  basic earnings per share                               412,604,673              381,859,840 
 Adjustments for calculation of diluted 
  earnings per share: 
            Share options                                 23,212,517                        - 
            Deferred shares                                  823,467                        - 
 Weighted average number of ordinary shares 
  and potential ordinary shares used as the 
  denominator in calculating diluted earnings 
  per share                                              436,640,657              381,859,840 
----------------------------------------------  --------------------  ----------------------- 
 

As net losses are recorded in the previous financial year, there are no dilutive potential shares in that year.

   9.             Goodwill 
 
                              2021     2020 
                              GBPm     GBPm 
-------------------------  -------  ------- 
 At 1 January 
 Cost                         88.3     87.8 
 Accumulated impairment     (83.0)   (83.0) 
-------------------------  -------  ------- 
 Net book amount               5.3      4.8 
-------------------------  -------  ------- 
 
 Year ended 31 December 
-------------------------  -------  ------- 
 Opening net book amount       5.3      4.8 
 Impairment                   83.0        - 
 Disposal                   (83.0)        - 
 Exchange differences        (0.5)      0.5 
-------------------------  -------  ------- 
 Closing net book amount       4.8      5.3 
-------------------------  -------  ------- 
 
 At 31 December 
-------------------------  -------  ------- 
 Cost                          4.8     88.3 
 Accumulated impairment          -   (83.0) 
-------------------------  -------  ------- 
 Net book amount               4.8      5.3 
-------------------------  -------  ------- 
 

Following the cessation of the run-off period on 31 March 2021, the fully impaired COPD goodwill assets have been disposed of.

The carrying value of goodwill is allocated to the NIOX(R) CGU and was generated in June 2015 on the acquisition of Aerocrine. The recoverable amount of a CGU is assessed using a value in use model. The value in use for the NIOX(R) CGU was calculated over a five-year period using a discount factor of 11.5% (being a weighted average cost of capital rate for the CGU). The calculations use post-tax cash flow projections. Cash flows over five years have been considered appropriate based on the product lifecycle. Cash flows beyond the five-year period were extrapolated using the estimated terminal growth rate stated below. The growth rate does not exceed the long-term average growth rate for the business. The discount rate used is post-tax and reflects specific risks relating to the Group and uncertainties surrounding the cash flow projections.

The key assumptions used for the valuation of the NIOX(R) CGU are as follows:

 
 Assumption                                 Approach used to determine values 
-----------------------------------------  --------------------------------------------------------------------------- 
 Valuation basis                            Value in use 
-----------------------------------------  --------------------------------------------------------------------------- 
 Sales                                      Based on past performance and management's expectations of market 
                                            development. Sales in 2022 
                                            are expected to return towards pre-pandemic levels. The growth rate for 
                                            2023-2026 reflects 
                                            a more cautious growth level than historic CAGR. 
-----------------------------------------  --------------------------------------------------------------------------- 
 Gross margin                               Based on past performance and management's expectations for the future 
-----------------------------------------  --------------------------------------------------------------------------- 
 Operating costs                            Management forecasts these costs based on the current structure of the 
                                            business, adjusting for inflationary increases but not reflecting any 
                                            future 
                                            restructurings or cost-saving measures 
-----------------------------------------  --------------------------------------------------------------------------- 
 Period of specified projected cash flows   2021 - 5 years 
                                             2020 - 5 years 
-----------------------------------------  --------------------------------------------------------------------------- 
 Long-term growth rate                      Terminal growth rates based on management's estimate of future long-term 
                                            average growth rate 
                                            2021 - 1% 
                                            2020 - 1% 
-----------------------------------------  --------------------------------------------------------------------------- 
 Discount rate                              Reflects specific risks relating to the relevant segments and the 
                                            countries in which they 
                                            operate 
                                            2021 - 11.5% 
                                            2020 - 11.5% 
-----------------------------------------  --------------------------------------------------------------------------- 
 

Impact of possible changes in key assumptions - NIOX(R) CGU

If the budgeted NIOX(R) sales in the value in use calculation had been 25% lower than management's estimates at 31 December 2021, the Group would have had to recognise an impairment against the carrying amount of goodwill and intangible assets of GBP3.8 million. This steep hypothetical reduction in sales represents a slower recovery post the Covid-19 pandemic.

   10.          Intangible assets 
 
                                                                                                      Total intangible 
                                           Customer                        Intellectual                         assets 
                           CMP        relationships     Technology             property     Other 
                          GBPm                 GBPm           GBPm                 GBPm      GBPm                 GBPm 
--------------------  --------  -------------------  -------------  -------------------  --------  ------------------- 
 At 1 January 2020 
 Cost                    259.3                 34.6           50.3                 44.0       3.9                392.1 
 Accumulated 
  amortisation and 
  impairment           (141.6)               (11.3)         (30.6)               (44.0)     (1.6)              (229.1) 
--------------------  --------  -------------------  -------------  -------------------  --------  ------------------- 
 Net book amount         117.7                 23.3           19.7                    -       2.3                163.0 
--------------------  --------  -------------------  -------------  -------------------  --------  ------------------- 
 
 Year ended 31 
 December 2020 
 Opening net book 
  amount                 117.7                 23.3           19.7                    -       2.3                163.0 
 Additions                   -                    -              -                    -       0.4                  0.4 
 Amortisation charge     (3.7)                (1.8)          (2.0)                    -     (0.4)                (7.9) 
 Impairment                  -                    -              -                    -     (0.8)                (0.8) 
 Disposal              (114.0)                    -              -                    -         -              (114.0) 
 Exchange 
  differences                -                  2.5            2.0                    -     (0.1)                  4.4 
--------------------  --------  -------------------  -------------  -------------------  --------  ------------------- 
 Closing net book 
  amount                     -                 24.0           19.7                    -       1.4                 45.1 
--------------------  --------  -------------------  -------------  -------------------  --------  ------------------- 
 
 At 31 December 2020 
 Cost                    259.3                 34.4           31.2                 44.0       4.3                373.2 
 Accumulated 
  amortisation and 
  impairment           (259.3)               (10.4)         (11.5)               (44.0)     (2.9)              (328.1) 
--------------------  --------  -------------------  -------------  -------------------  --------  ------------------- 
 Net book amount             -                 24.0           19.7                    -       1.4                 45.1 
--------------------  --------  -------------------  -------------  -------------------  --------  ------------------- 
 
 Year ended 31 
 December 2021 
 Opening net book 
  amount                     -                 24.0           19.7                    -       1.4                 45.1 
 Additions                   -                    -              -                    -       0.1                  0.1 
 Amortisation charge         -                (1.8)          (1.9)                    -     (0.4)                (4.1) 
 Impairment              259.3                    -              -                 44.0         -                303.3 
 Disposal              (259.3)                    -              -               (44.0)         -              (303.3) 
 Exchange 
  differences                -                (2.1)          (1.7)                    -         -                (3.8) 
--------------------  --------  -------------------  -------------  -------------------  --------  ------------------- 
 Closing net book 
  amount                     -                 20.1           16.1                    -       1.1                 37.3 
--------------------  --------  -------------------  -------------  -------------------  --------  ------------------- 
 
 At 31 December 2021 
 Cost                        -                 31.4           28.5                    -       4.4                 64.3 
 Accumulated 
  amortisation and 
  impairment                 -               (11.3)         (12.4)                    -     (3.3)               (27.0) 
--------------------  --------  -------------------  -------------  -------------------  --------  ------------------- 
 Net book amount             -                 20.1           16.1                    -       1.1                 37.3 
--------------------  --------  -------------------  -------------  -------------------  --------  ------------------- 
 

The amortisation charge of GBP4.1 million (2020: GBP7.9 million) is included on the face of the statement of comprehensive income. GBP2.0 million (2020: GBP2.0 million) is included within research and development costs, GBP1.8 million (2020: GBP1.8 million) is included within sales and marketing costs, GBP0.3 million (2020: GBP0.4 million) is included within administrative expenses and GBPnil (2020: GBP3.7 million) is included within profit/(loss) from discontinued operations.

The Group tests at least annually whether intangible assets have suffered any impairment. Key assumptions and sensitivities used in the impairment review at a CGU level are disclosed in note 9.

Currently marketed products ("CMP")

CMP comprises the Tudorza(R) and Duaklir(R) products. The CMP assets were partially impaired in 2019 following an underperformance in sales of Tudorza(R) and Duaklir(R), and subsequently fully impaired in the 2020 financial year as the licences were handed back to AstraZeneca on 27 May 2020. Following the cessation of the run-off period on 31 March 2021, the fully impaired assets have been disposed of.

Customer relationships

Customer relationships represent the existing customers as at June 2015, being the date of the acquisition of Aerocrine, that are expected to continue to support the NIOX(R) business. A remaining useful life of 18 years was determined at acquisition. Amortisation has been calculated on a straight-line basis over this period from the date of acquisition.

Technology

Aerocrine developed its technology to measure fractional exhaled nitric oxide ("FeNO") in the mid-1990s. The company was the first to develop an instrument for the measurement of FeNO as a valuable tool in the management of airway inflammation. This technology is used by the Group in its NIOX(R) devices. The valuation of the Technology was based on a pre-determined hypothetical royalty rate attributable to the use of the Technology. A remaining useful life of 15 years was determined at acquisition in June 2015. Amortisation has been calculated on a straight-line basis over this period from the date of acquisition.

Intellectual property

Intellectual property comprises the LungFit(R) licence which was acquired from Beyond Air Inc. in 2019. The asset was initially valued at GBP44.0 million, being the fair value of consideration. This includes GBP8.0 million paid upfront in the form of shares and contingent milestone and royalty payments valued at GBP36.0 million.

The intellectual property was fully impaired following an announcement made by Beyond Air Inc. in December 2019 purporting to terminate the agreement for the commercial licence of LungFit(R). During the year, Circassia settled its contractual dispute with Beyond Air Inc and surrendered its right to the LungFit(R) product in exchange for consideration and therefore the fully impaired asset was disposed of.

Other

Other intangible assets relate to software and internally generated capitalised device development costs. Amortisation on the ERP software has been calculated on a straight-line basis over the period from which the software was fully developed and operational. An impairment loss of GBP0.8 million was recognised in the prior year against the capitalised device development costs following a change in the strategic roadmap for product development.

   11.          Trade and other payables 
 
                                     2021    2020 
                                     GBPm    GBPm 
---------------------------------  ------  ------ 
 Trade payables                       0.5     5.2 
 Social security and other taxes      0.6     0.5 
 Accruals                             9.0    18.9 
 Other payables                       0.3     1.0 
 Total trade and other payables      10.4    25.6 
---------------------------------  ------  ------ 
 

Trade payables are unsecured and are usually paid within 30 days of recognition.

The carrying amounts of trade and other payables are considered to be the same as their fair values, due to their short-term nature.

   12.          Other reserves 
 
                                                                                 Transactions with 
                          Share option                         Treasury shares     non-controlling 
                               reserve         Translation             reserve           interests         Total other 
                                                   reserve                                                    reserves 
------------------ 
                                  GBPm                GBPm                GBPm                GBPm                GBPm 
------------------  ------------------  ------------------  ------------------  ------------------  ------------------ 
 At 1 January 2020                13.0                 8.7               (0.9)               (6.1)                14.7 
 Employee share 
  option scheme                    2.0                   -                   -                   -                 2.0 
 Exchange 
  differences on 
  translation of 
  foreign 
  operations                         -                 7.8                   -                   -                 7.8 
 At 31 December 
  2020                            15.0                16.5               (0.9)               (6.1)                24.5 
 Exchange 
  differences on 
  translation of 
  foreign 
  operations                         -               (7.8)                   -                   -               (7.8) 
 At 31 December 
  2021                            15.0                 8.7               (0.9)               (6.1)                16.7 
------------------  ------------------  ------------------  ------------------  ------------------  ------------------ 
 

Treasury shares

Treasury shares are shares in Circassia Group plc that are held by the Circassia Pharmaceuticals plc Employee Benefit Trust for the purpose of issuing shares under the various employee share schemes. Shares issued to employees are recognised on a first in, first out basis.

The number of shares acquired by the Trust is as follows:

 
 
  Scheme                                                      Nominal value of shares     Amount of consideration paid 
                                         Number of shares 
                                                                                  GBP                             GBPm 
------------------------------------  -------------------  --------------------------  ------------------------------- 
 DSBP 2014                                        110,845                      0.0008                              0.3 
 DSBP 2015                                        156,036                      0.0008                              0.4 
 DSBP 2017                                        251,377                      0.0008                              0.2 
 DSBP 2018                                        412,706                      0.0008                                - 
 Total as at 31 December 2020 and 31 
  December 2021                                   930,964                      0.0008                              0.9 
------------------------------------  -------------------  --------------------------  ------------------------------- 
 

The shares to satisfy the DSBP 2018 scheme were allotted as new ordinary shares in Circassia Group plc, rather than being purchased by the Trust.

   13.          Cash generated from/(used in) operations 

Reconciliation of profit/(loss) before tax to net cash used in operations:

 
                                                          Notes     2021      2020 
                                                                    GBPm      GBPm 
-------------------------------------------------------  ------  -------  -------- 
 (Loss)/profit from continuing operations before tax               (2.1)    (18.4) 
 Profit/(loss) from discontinued operations before tax      6        1.3     (6.7) 
-------------------------------------------------------  ------  -------  -------- 
 (Loss)/profit before tax                                          (0.8)    (25.1) 
 Adjustments for: 
 Finance income                                             5          -     (0.1) 
 Finance costs                                              5        0.1       3.5 
 Depreciation charge of property, plant and equipment                  -       0.3 
 Depreciation charge of right-of-use assets                          0.8       0.8 
 Amortisation charge of intangible assets                  10        4.1       7.9 
 Impairment of intangible assets                           10          -       0.8 
 Impairment of property, plant and equipment                           -       0.1 
 Loss on disposal of intangible assets                     10          -     114.0 
 Gain on loan write off                                                -   (123.0) 
 Share based payment charge                                 3          -       2.0 
 Foreign exchange on non-operating cash flows                      (2.1)       8.7 
 Changes in working capital: 
 Decrease/(increase) in trade and other receivables                 13.4     (3.9) 
 Decrease in inventories                                             1.1       2.9 
 Decrease in trade and other payables                             (15.1)    (12.8) 
-------------------------------------------------------  ------  -------  -------- 
 Cash generated from/(used in) operations                            1.5    (23.9) 
-------------------------------------------------------  ------  -------  -------- 
 
   14.          Related party transactions 

There is no ultimate controlling party of the Group as ownership is split between the Company's shareholders. The most significant shareholders as at 31 December 2021 and 2020 are as follows:

 
                         Ownership interest 
 Name                        2021       2020 
---------------------  ----------  --------- 
 Griffiths R I             29.88%     28.15% 
 Harwood Capital LLP       18.59%     17.62% 
 AstraZeneca PLC           16.99%     17.88% 
 
 

On 24 March 2021, the Company executed a Subscription for a total of GBP5 million in additional equity finance at a price of 25.0p per share with three of its major institutional shareholders, being North Atlantic Smaller Companies Investment Trust plc (to which Harwood Capital LLP acts as investment adviser/manager), Richard Griffiths and Lombard Odier Asset Management (Europe) Limited. Each of the investments by Harwood Capital LLP and Richard Griffiths constituted a related party transaction under the AIM Rules for Companies and was disclosed as such at the time.

On 2 June 2020, the Company executed an equity financing facility for up to GBP5 million of additional equity finance at a price of 24.6p per share with two of its major institutional shareholders, being North Atlantic Small Companies Investment Trust plc (to which Harwood Capital LLP acts as investment adviser/manager) and Richard Griffiths, to provide the Company with access to additional liquidity should it be required. On 17 September 2020 the Board decided to draw down this equity financing. The foregoing equity financing facility constitutes a related party transaction under the AIM Rules for Companies.

Employee benefit trust

In 2014 the Company set up an employee benefit trust for the purposes of buying and selling shares on the employees' behalf. Nothing was paid into the Trust by the Company during the year ended 31 December 2021 and 2020.

No shares were purchased by the Trust during the years ended 31 December 2021 and 31 December 2020. No shares were allotted to the Trust (2020: 412,706) during the year ended 31 December 2021.

   15.          Events occurring after the reporting date 

No events occurred after the reporting date.

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END

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(END) Dow Jones Newswires

March 22, 2022 03:00 ET (07:00 GMT)

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