REG - Allergy Therapeutics - Interim Results and Lifting Suspension in Trading
19/06/2023 07:15
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RNS Number : 0740D Allergy Therapeutics PLC 19 June 2023
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company" or the "Group")
Interim Results for the six months ended 31 December 2022
and Lifting of Suspension in Trading
19 June 2023: Allergy Therapeutics plc (AIM: AGY), the integrated commercial
biotechnology company specialising in allergy vaccines, announces its
unaudited interim results for the six months ended 31 December 2022 and
expected restoration of trading in the Company's ordinary shares on AIM with
effect from 7.30am today.
Financial Review
Revenue for the first half of the financial year was 18% lower at £39.9m
(2022 H1: £48.7m) as a consequence of the short-term pause in production in
October 2022.
Cost of sales increased to £14.1m (2022 H1: £12.8m), with an ongoing
programme of continuous improvement across the supply chain and quality
systems, together with higher labour costs.
Gross profit decreased by 28% to £25.8m (2022 H1: £35.9m), which represents
a gross margin of 65% (2022 H1: 74%), reflecting reduced absorption of fixed
production overheads on lower revenue.
Sales, marketing and distribution costs were slightly higher at £13.2m (2022
H1: £13.1m) as a result of higher labour costs offset by cost savings.
Administrative expenses increased to £11.9m (2022 H1: £10.6m), resulting
from increased IT spend to improve productivity and security. Research and
development costs increased to £8.5m (2022 H1: £5.0m), including initiation
of the G306 Pollinex Quattro grass study. Exceptional costs were £0.4m (2022
H1: £nil) from the ongoing review of funding options.
The operating profit pre-R&D of £0.5m (2022 H1: £12.5m) reflects the
decline in revenue caused by the short-term pause in production, together with
increased manufacturing, administrative and exceptional costs.
Research and development costs increased to £8.5m (2022 H1: £5.0m), mainly
due to initiation of the G306 Pollinex Quattro grass study and preparation for
the P101 peanut study.
The operating loss was £8.0m (2022 H1: £7.4m, profit), and the loss before
tax was £8.2m (2022 H1: £7.3m, profit). The tax charge of £0.3m (2022
H1: £0.6m) relates to the overseas subsidiaries. The basic loss per share
was 1.29 pence per share (2022 H1: 1.04 pence per share, gain).
Property, plant and equipment increased to £22.1m (30 June 2022: £20.2m),
mainly as a result of ongoing construction of the energy centre in the UK,
offset by depreciation.
The investment in the retirement benefit asset increased to £7.0m (30 June
2022: £6.0m), reflecting investment returns and corporate contributions.
Retirement benefit obligations relating to the German pension scheme were
slightly lower at £8.2m (30 June 2022: £8.3m).
Net assets excluding cash have increased to £22.8m (30 June 2022: £17.9m),
mainly due to capital investment and changes to pension assets and
liabilities.
There was an operating cash outflow of £7.5m caused by the decline in
profitability. After capital expenditure of £2.9m, gross share proceeds of
£7.0m, financing costs of £0.5m and repayment of loans of £0.5m, there was
a net decrease in cash and cash equivalents of £5.4m.
At 31 December 2022, the Group had cash of £15.2m (30 June 2022: £20.5m)
and debt of £2.0m (30 June 2022: £2.4m).
Pursuant to the subscription and debt financing announced in September 2022,
the Company received £6.5m of net share proceeds from the issue of new
ordinary shares in October 2022 and received £10m from the issue of loan
notes on 28 February 2023, together with the issue of 33,333,332 warrants to
subscribe for new ordinary shares at a warrant exercise price of 30 pence per
warrant.
On 6 April 2023, the Group entered into a senior secured facility agreement
in an aggregate principal amount of £40.75m to refinance the existing £10
million loan notes issued on 28 February 2023, to continue key clinical
trials, to finance trading and to provide working capital. The NatWest
revolving credit facility has been cancelled to provide security for the new
funding.
In conjunction with the senior secured facility agreement, the Company also
entered into an equity commitment agreement to raise gross proceeds of
£40.75m, which will be principally used to repay the amounts owed pursuant to
the senior secured facility agreement.
The Company also entered into an agreement with the lenders to pay a
substantial finance premium on the principal amount outstanding in the event
that there is a successful G306 data read-out, and the Company intends to
complete the equity financing and repay all amounts outstanding under the
facility agreement to avoid the contingent payment, subject to various
conditions.
The Directors have applied the going concern principle in preparing the
interim results for the six months ended 31 December 2022, however there is
material uncertainty for the following reasons:
- the need for additional near-term funding;
- the risk that existing investors are unwilling or unable to provide
further funds;
- the risk that foreign direct investment clearance required for the
equity raise is not obtained meaning that the Group is unable to repay the
loan or the contingent payment for the successful G306 read-out.
- the risk that the results of the G306 read-out are unsuccessful
meaning that the required additional near-term funding is not able to be
raised;
Outlook
Owing to the seasonality of the pollen allergy market, approximately one third
of revenue is generated in the second half of the financial year. Compared to
the prior comparable period, the Group expects sales for the second half year
to 30 June 2023 to continue at a slightly improved trend when compared with
the trend seen for the first half of the year, with correspondingly lower
gross margins. Overheads before R&D and exceptionals are expected to be
similar to the first half year.
As a result of the manufacturing capacity that needs to be allocated to
clinical batches, sales for the financial year to 30 June 2024 are expected to
be slightly lower than the comparable period, with consequently reduced gross
margins, while overheads before R&D and exceptionals are expected to be
similar. The investment in clinical trials for the G306 grass study, G308
paediatric study, B302 birch study and P101 peanut study will result in a
stepped increase in R&D costs. Further investment in plant and equipment
is planned to support the continuing improvements in manufacturing and
quality.
With over 90% of revenues and approximately 50% of costs (excluding research
and development costs) denominated in euros, and approximately 60% of research
and development costs denominated in US dollars, movements in the currency
markets have an effect on the Group's operational finances, which are
partially managed in the near-term by foreign currency forward contracts.
Notwithstanding the recent loan funding and planned equity refinancing of the
loan, the Group expects that additional funding will be required from around
September 2023 onwards for trading, working capital, capital expenditure and
continuing R&D programmes. Discussions have commenced with certain
shareholders on providing additional funding; these discussions are at an
early stage with no binding arrangements but have been positive.
Lifting of Suspending in Trading
As a result of publication of the 2022 Annual Report and Accounts and
publication of these Interim Results, trading in the Company's ordinary shares
on AIM is expected to be restored with effect from 7.30am today.
This announcement contains inside information for the purposes of the UK
Market Abuse Regulations.
- ENDS -
For further information, please contact:
Allergy Therapeutics
Manuel Llobet, Chief Executive Officer
Martin Hopcroft, Interim Chief Financial Officer
+44 (0)1903 845 820
Panmure Gordon (Nominated Adviser and Broker)
Freddy Crossley, Emma Earl, Corporate Finance
Rupert Dearden, Corporate Broking
+44 (0)20 7886 2500
Consilium Strategic Communications
Mary-Jane Elliott / David Daley / Davide Salvi
+44 (0)20 3709 5700
allergytherapeutics@consilium-comms.com
(mailto:allergytherapeutics@consilium-comms.com)
About Allergy Therapeutics
Allergy Therapeutics is an international commercial biotechnology company,
headquartered in the UK, focussed on the treatment and diagnosis of allergic
disorders, including aluminium free immunotherapy vaccines that have the
potential to cure disease. The Group sells proprietary and third-party
products from its subsidiaries in nine major European countries and via
distribution agreements in an additional ten countries. Its broad pipeline of
products in clinical development includes vaccines for grass, tree, house dust
mite and peanut. For more information, please see www.allergytherapeutics.com
(http://www.allergytherapeutics.com) .
ALLERGY THERAPEUTICS PLC
Consolidated income statement
6 months to 6 months to 12 months to
31 Dec 2022 31 Dec 2021 30 Jun 2022
£'000 £'000 £'000
Unaudited Unaudited Audited
Revenue 39,901 48,696 72,768
Cost of sales (14,118) (12,786) (23,262)
Gross profit 25,783 35,910 49,506
Sales, marketing and distribution costs (13,237) (13,080) (26,004)
Administration expenses (11,863) (10,630) (20,828)
Research and development costs (8,498) (5,033) (15,659)
Exceptional costs (424) - -
Other income 282 250 740
Operating (loss)/profit (7,957) 7,417 (12,245)
Finance income 155 53 257
Finance expense (398) (204) (669)
(Loss)/profit before tax (8,200) 7,266 (12,657)
Income tax (306) (595) (1,119)
(Loss)/profit for the period (8,506) 6,671 (13,776)
(Loss)/earnings per share
Basic (pence per share) (1.29)p 1.04p (2.14)p
Diluted (pence per share) (1.29)p 0.97p (2.14)p
Consolidated statement of comprehensive income
6 months to 6 months to 12 months to
31 Dec 2022 31 Dec 2021 30 Jun 2022
£'000 £'000 £'000
Unaudited Unaudited Audited
(Loss)/profit for the period (8,506) 6,671 (13,776)
Items that will not be reclassified subsequently to profit or loss:
Remeasurement of net defined benefit liability 479 (498) 3,094
Remeasurement of investments-retirement benefit assets 661 (58) (193)
Total other comprehensive income/(loss) 1,140 (556) 2,901
Items that may be reclassified subsequently to profit or loss:
Exchange differences on translation of foreign operations 414 1 265
Total comprehensive (loss)/income (6,952) 6,116 (10,610)
ALLERGY THERAPEUTICS PLC
Consolidated balance sheet
31 Dec 2022 31 Dec 2021 30 Jun 2022
£'000 £'000 £'000
Unaudited Unaudited Audited
Assets
Non-current assets
Property, plant and equipment 22,096 18,992 20,190
Intangible assets - goodwill 3,407 3,374 3,347
Intangible assets - other 1,202 791 1,688
Investment - retirement benefit asset 7,042 5,726 5,962
Total non-current assets 33,747 28,883 31,187
Current assets
Inventories 10,971 10,602 11,410
Trade and other receivables 11,697 10,773 10,468
Cash and cash equivalents 15,197 41,385 20,515
Derivative financial instruments - 330 -
Total current assets 37,865 63,090 42,393
Total assets 71,612 91,973 73,580
Liabilities
Current liabilities
Trade and other payables (14,299) (14,942) (15,669)
Current borrowings (775) (1,008) (952)
Lease liabilities (1,132) (654) (1,316)
Derivative financial instruments (847) - (116)
Total current liabilities (17,053) (16,604) (18,053)
Net current assets 20,812 46,486 24,340
Non-current liabilities
Retirement benefit obligations (8,179) (11,590) (8,319)
Deferred taxation liability (402) (387) (406)
Non-current provisions (152) (150) (144)
Lease liabilities (6,669) (6,398) (6,764)
Long term borrowings (1,199) (1,870) (1,497)
Total non-current liabilities (16,601) (20,395) (17,130)
Total liabilities (33,654) (36,999) (35,183)
Net assets 37,958 54,974 38,397
Equity
Capital and reserves
Issued share capital 689 652 654
Share premium 119,029 112,576 112,576
Merger reserve 40,128 40,128 40,128
Reserve - share based payments 2,824 3,015 2,799
Revaluation reserve 1,073 1,073 1,073
Foreign exchange reserve (509) (1,187) (923)
Retained earnings (125,276) (101,283) (117,910)
Total equity 37,958 54,974 38,397
ALLERGY THERAPEUTICS PLC
Consolidated statement of changes in equity
Issued share Capital Share premium Merger reserve Reserve - share based payment Foreign exchange reserve Retained earnings Total equity
Revaluation reserve
£'000 £'000 £'000 £'000 £'000 £'000 £'000 £'000
At 31 December 2021 652 112,576 40,128 3,015 1,073 (1,187) (101,283) 54,974
- - - - - 264 - 264
Exchange differences on translation of foreign operations
Valuation gains taken to equity (land and buildings) - net of deferred tax - - - - - - - -
Remeasurement of net defined benefit liability - - - - - - 3,592 3,592
Remeasurement of investments - retirement benefit assets - - - - - - (135) (135)
Total other comprehensive income - - - - - 264 3,457 3,721
Loss for the period - - - - - - (20,447) (20,447)
Total comprehensive income - - - - - 264 (16,990) (16,726)
Share based payments - - - 147 - - - 147
Shares issued 2 - - - - - - 2
Transfer of lapsed options - - - (363) - - 363 -
To retained earnings
Transfer of depreciation on revalued property - - - - - - - -
At 30 June 2022 654 112,576 40,128 2,799 1,073 (923) (117,910) 38,397
- - - - - 414 - 414
Exchange differences on translation of foreign operations
Remeasurement of net defined benefit liability - - - - - - 479 479
Remeasurement of investments - retirement benefit assets - - - - - - 661 661
Total other comprehensive income - - - - - 414 1,140 1,554
Loss for the period - - - - - - (8,506) (8,506)
Total comprehensive income - - - - - 414 (7,366) (6,952)
Share based payments - - - 25 - - - 25
Shares issued 35 6,965 - - - - - 7,000
Share issue costs - (512) - - - - - (512)
At 31 December 2022 689 119,029 40,128 2,824 1,073 (509) (125,276) 37,958
ALLERGY THERAPEUTICS PLC
Consolidated cash flow statement
6 months to 6 months to 12 months to
31 Dec 2022 31 Dec 2021 30 Jun 2022
£'000 £'000 £'000
Unaudited Unaudited Audited
Cash flows from operating activities
(Loss)/profit before tax (8,200) 7,266 (12,657)
Adjustments for:
Finance income (155) (53) (257)
Finance expense 398 204 669
Non-cash movements on defined benefit pension plan (142) 29 (23)
Depreciation and amortisation 2,102 2,400 4,166
Net monetary value of above the line R&D tax credit (282) (250) (740)
Charge for share based payments 25 322 469
Movement in fair value of derivative financial instruments 731 150 641
(Profit)/loss on disposal of fixed asset - - 8
(Increase) in trade and other receivables (1,042) (4,971) (4,246)
Decrease/(increase) in inventories 611 32 (572)
(Decrease) in trade and other payables (1,405) (1,385) (1,067)
Net cash (used)/generated by operations (7,359) 3,744 (13,609)
Income tax (paid)/received (92) 119 (213)
Net cash (used)/generated by operating activities (7,451) 3,863 (13,822)
Cash flows from investing activities
Interest received 18 53 58
Payments for retirement benefit investments - (87) (179)
Payments for intangible assets (630) (151) -
Payments for property plant and equipment (2,255) (996) (3,056)
Net cash used in investing activities (2,867) (1,181) (3,177)
Cash flows from financing activities
Net proceeds from issue of equity shares 6,488 1 3
Repayment of bank loan borrowings (533) (466) (957)
Interest paid on bank loan borrowings (137) (204) (168)
Repayment of principal on lease liabilities (761) (878) (1,311)
Interest paid on lease liabilities (160) (140) (373)
Net cash generated/(used) in financing activities 4,897 (1,687) (2,806)
Net (decrease)/ increase in cash and cash equivalents (5,421) 995 (19,805)
Effects of exchange rates on cash and cash equivalents 103 117 47
Cash and cash equivalents at the start of the period 20,515 40,273 40,273
Cash and cash equivalents at the end of the period 15,197 41,385 20,515
1. Interim financial information
The unaudited consolidated interim financial information is for the six months
ended 31 December 2022. The financial information does not include all the
information required for full annual financial statements and should be read
in conjunction with the consolidated financial statements of the Group for the
year ended 30 June 2022, which were prepared under International Financial
Reporting Standards (IFRS) in issue as adopted by the UK and with those parts
of the Companies Act 2006 that are relevant to the Group preparing its
accounts in accordance with UK-adopted IFRS.
The interim financial information has not been audited nor has it been
reviewed under ISRE 2410 of the Auditing Practices Board. The financial
information set out in this interim report does not constitute statutory
accounts as defined in Section 434 of the Companies Act 2006.
The annual report and accounts for the year ended 30 June 2022 included a
qualification for limitation of scope in respect of the carrying value of
insurance policy assets related to the pension scheme of the Group's German
subsidiary. The Board of Directors made relevant enquiries of the scheme's
insurer and were unable to obtain all of the relevant information required
under IAS (UK) 500 about the controls and valuation of the underlying assets
at 30 June 2022, therefore were unable to obtain sufficient, appropriate audit
evidence.
2. Basis of preparation
As permitted, this Interim Report has been prepared in accordance with the AIM
rules and not in accordance with IAS 34 "Interim Financial Reporting". The
accounting policies adopted in this report are consistent with those in the
annual financial statements for the year to 30 June 2022. There are no
accounting standards that have become effective in the current period that
would have a material impact upon the financial statements.
Going Concern
The financial statements have been prepared on a going concern basis after
considering the Group's and the Company's current cash position and reviewing
budgets and cash flow forecasts for a period of at least 12 months from the
date of approval of these financial statements.
On 4 October 2022, the Group announced that it had proactively paused
production at the Freeman facility, part of its Worthing, UK manufacturing
site, in order to accelerate ongoing site improvements and to maintain
regulatory compliance. The pause in manufacturing occurred during a period of
peak production prior to the start of the pollen season in the Spring. As a
consequence, the production pause will have a material impact upon the Group's
revenue and cashflow for the year ending 30 June 2023.
Despite the completion of the £7m equity raise and £10m of loan notes
announced on 17 October 2022, the manufacturing pause resulted in the Group
requiring additional funding to continue with the planned R&D clinical
trials. In addition, at the expected reduced levels of underlying profit,
excluding research and development costs, the terms of the £10m NatWest
revolving credit facility would not allow use of the facility.
As a result, on 6 April 2023, the Group announced it had signed a loan
agreement with certain shareholders for £40.75m, incurring interest at 18%
per annum and with full repayment of the principal outstanding and any accrued
interest in December 2025. The loan is fully secured against substantially all
assets of the Company and its subsidiaries incorporated in England and Wales
by way of an English-law governed debenture. The NatWest revolving credit
facility has been cancelled to release the necessary security.
The Directors have prepared cash flow forecasts for the period to 30 June
2024, which assume that the Group will be able to undertake a planned equity
financing of £40.75m during the going concern period to re-finance the
£40.75m shareholder loan, however the Group expects that additional financing
will be required from around September 2023 onwards.
The Directors acknowledge that a material uncertainty exists over the Group's
ability to access additional sources of finance, which will be required
regardless of the outcome of the Phase III G306 trial and regardless of the
planned equity financing after obtaining the necessary foreign direct
investment ("FDI") regulatory approvals.
Under the terms of a contingent payment letter entered into with the lenders
of the shareholder loan, the Group will be obligated to pay a substantial
finance premium ("G306 contingent payment") equal to 250% of the principal
amount of the loan outstanding on a successful data read-out of the Phase III
G306 trial, if any principal remains outstanding under the terms of the loan
agreement at 6 January 2024.
The planned equity financing for £40.75m is conditional on obtaining certain
foreign direct investment ("FDI") regulatory approvals and completing the
equity refinancing by 6 January 2024 and, if not obtained prior to the
read-out of the Phase III G306 trial, the equity financing is also conditional
on a successful Phase III G306 outcome. Should the equity financing not
proceed, it is unlikely that the Group will be able to pay the G306 contingent
payment should it crystallise. If the Group is unable to secure an alternative
funding solution to repay the amounts due under the shareholder loan, the
Group may be subject to, inter alia, possible insolvency and loss of ownership
of its assets, over which security has been granted pursuant to the loan.
The Directors have reasonable expectations that the Phase III G306 trial will
be successful and that appropriate additional financing can be obtained for
the Group and Company. Accordingly, they have prepared these financial
statements on a going concern basis.
There are, however, currently no binding arrangements in place for additional
funding over and above the equity financing and no guarantees that existing
shareholders will be willing, or able, to provide further funds.
It is therefore considered that material uncertainties exist which may cast
significant doubt on the Group's and the Company's ability to continue as a
going concern and therefore they may be unable to realise their assets and
discharge their liabilities in the normal course of business. The financial
statements do not include any adjustments that would result from the basis of
preparation being inappropriate.
3. (Loss)/earnings per share
6 months to 6 months to 12 months to
31 Dec 2022 31 Dec 2021 30 Jun 2022
Unaudited Unaudited Audited
(Loss)/profit after tax attributable to equity shareholders (£'000) (8,506) 6,671 (13,776)
Issued ordinary shares at start of the period ('000) 644,105 641,773 641,773
Ordinary shares issued in the period ('000) 35,000 1,824 2,332
Issued ordinary shares at end of the period ('000) 679,105 643,597 644,105
Weighted average number of shares in issue for the period 661,605 641,794 642,990
Weighted average number of shares for diluted earnings 661,605 686,135 642,990
Basic earnings per ordinary share (pence) (1.29)p 1.04p (2.14)p
Diluted earnings per ordinary share (pence) (1.29)p 0.97p (2.14)p
The diluted loss per share for 2022 does not differ from the basic loss per
share as the exercise of share options would have the effect of reducing the
loss per share and is therefore not dilutive under the terms of IAS 33.
4. Contingent liabilities
In a letter dated 3 February 2023, the Group's German subsidiary received
notification from the German national health insurance association which
indicated that manufacturer's rebates are due on sales of certain products
launched on the market from 1 September 2017. After taking legal advice, the
Group considers the likelihood of any payment of a rebate or other cash
outflow in relation to this matter, in respect of the period prior to 30 June
2022, to be below 50% and no provision has been made in the financial
statements for the six months ended 31 December 2022. In respect of net
revenue relating to certain products, there is a risk that up to £13.6m
cumulative revenue recognised in periods up to and including 31 December 2022
may be reversed due to the level of rebate being applied.
5. Events after the balance sheet date
On 6 April 2023, the Company entered into a senior secured facility agreement
pursuant to which the Company's existing substantial shareholders ZQ Capital
Management Limited (acting through its affiliate SkyGem International Holdings
Limited) and Southern Fox Investments Limited, agreed to make available to the
Company a secured term loan facility in an aggregate principal amount of
£40.75 million. The purpose of the facility was to refinance the existing
£10 million loan notes issued on 28 February 2023, to facilitate the
continuation of the Group's pivotal Phase III G306 trial for Grass MATA MPL,
to continue other key clinical trial activities including the Phase I study
for Peanut allergy and to finance trading and provide working capital. The
NatWest revolving credit facility has been cancelled to facilitate the new
funding.
In conjunction with the facility agreement, the Company also entered into an
equity commitment agreement with ZQ Capital Management Limited (acting through
its affiliate SkyGem International Holdings Limited) and Southern Fox
Investments Limited to conditionally subscribe for new ordinary shares of 0.1
pence each in the capital of the Company at an issue price of 1 pence per new
share to raise gross proceeds of £40.75 million. The equity financing is
comprised of a direct subscription by each of ZQ Capital Management Limited
and Southern Fox Investments Limited for, in aggregate, 3,385,510,000 new
shares at the issue price and an open offer, where qualifying shareholders
(excluding the three largest shareholders ZQ Capital Management Limited,
Southern Fox Investments Limited and Abbott Laboratories (together Abbott
Laboratories (Chile) Holdco SPA and Yissum Holdings Limited)) will be offered
the opportunity to subscribe for up to 689,490,000 new shares at the issue
price. The proceeds of the equity financing will be principally used to repay
the amounts owed under the facility agreement, including principal amounts and
accrued interest.
Under the terms of a contingent payment letter entered into between the
Company and the Lenders in connection with the facility agreement, the Company
will be obligated to pay a substantial finance premium equal to 250 per cent
of the principal amount of the loan outstanding under the facility to the
Lenders on a successful G306 data read-out if at such time any principal
remains outstanding under the terms of the facility agreement. The Company
therefore intends, subject to satisfaction (or waiver, if capable of being
waived) of the equity conditions, to complete the equity financing and repay
all amounts outstanding under the facility agreement within nine months of the
date of the facility agreement, thereby avoiding the contingent payment being
triggered.
On 27 April 2023, the Company received shareholder approval for the issue of
equity, but the equity funding remains conditional on FDI clearances.
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