Summit Therapeutics
plc(‘Summit’, the ‘Company’ or the ‘Group’)
Summit Therapeutics Reports Financial
Results and Operational Progress for the First Quarter Ended
30 April 2019
Oxford, UK, and Cambridge, MA, US, 12
June 2019 - Summit Therapeutics plc (NASDAQ: SMMT, AIM:
SUMM) today reports its financial results and provides an update on
its operational progress for the first quarter ended 30 April
2019.
“As global leaders are sounding the alarm for
new antibiotics, we are proud to be taking a leadership role in
discovering and developing new classes of antibiotics with the
potential to help combat the rising threat posed by antibiotic
resistance," said Mr Glyn Edwards, Chief Executive Officer
of Summit. "We believe these new class antibiotics have
the potential to transform patient lives and that it is possible to
show clear advantages over standard of care treatments and cost
effectiveness during development. With this differentiated
approach, we believe we will have the opportunity to be
commercially successful.
“Ridinilazole is the exemplar of this strategy.
It is a precision, microbiome preserving antibiotic that aims to
sustain cures of C. difficile infection to improve outcomes for
patients. We were excited to initiate our landmark Ri-CoDIFy Phase
3 clinical programme in February 2019. If successful, we believe
our two Phase 3 clinical trials of ridinilazole will deliver
clinical and economic data to support ridinilazole as the new
standard of care for patients with C. difficile infection.
“Our Discuva Platform is enabling us to expand
our leadership role as innovators in infectious disease. In
April2019, we announced the addition to our pipeline of another new
class antibiotic programme targeting Enterobacteriaceae infections.
With this new discovery-stage programme, our preclinical programme
for N. gonorrhoeae and ridinilazole for C. difficile, our pipeline
now targets the three most urgent bacterial threats as defined by
the US Centers for Disease Control and Prevention with new classes
of antibiotics.”
Programme Highlights
Strategy
- Through its scientific focus,
Summit is discovering new classes of antibiotics to treat serious
infectious diseases. Through creative development programmes,
Summit aims to show its new classes of antibiotics offer
significant advantages over current standards of care. Through
demonstrating economic advantages, Summit aims to provide
compelling value for payors and healthcare systems and achieve
commercial success.
Ridinilazole for C. difficile Infection
(‘CDI’)
- RiCoDIFy Phase 3 clinical trial
programme initiated in February 2019, which aims to support
adoption of ridinilazole as the new standard of care treatment for
C. difficile infection.
- These landmark design clinical
trials aim to: i) show superiority over the current standard of
care, vancomycin, using a composite endpoint measuring sustained
clinical response; ii) generate health economic data to help
support the commercial launch, if approved; and iii) undertake deep
microbiome analysis that aims to show ridinilazole’s preservation
of the gut microbiome.
- Recruitment of patients into the two Phase 3 clinical trials is
ongoing, and the programme remains on-track for expected reporting
of top-line data in H2 2021.
- Clinical and regulatory development of ridinilazole is
supported by a BARDA contract worth up to $62 million.
SMT-571 for Gonorrhoea
- SMT-571 is a new class antibiotic that is designed to treat
infections caused by Neisseria gonorrhoeae.
- In February 2019, preclinical data
was published in the Journal of Antimicrobial Chemotherapy that
showed SMT-571 had consistently high potency across over 200
clinically relevant strains of N. gonorrhoeae, including numerous
multi-drug resistant and extensively-drug resistant strains.
- IND-enabling
studies are ongoing and expected to continue through the second
half of the year. The Phase 1 clinical trial is no longer expected
to initiate in H2 2019. Summit is evaluating the design of a
clinical trial programme with the potential to shorten the overall
clinical development timeline of SMT-571, subject to regulatory
approvals. Further updates on the design and timelines for the
start of the clinical programme to be provided when available.
- SMT-571 development is being
supported by an award of up to $4.5 million from CARB-X.
DDS-04 for Enterobacteriaceae
- Identification of DDS-04 compound
series, a new class of antibiotics that acts via the novel
bacterial target LolCDE with the potential to treat infections
caused by the gram-negative bacteria, Enterobacteriaceae.
- In vivo proof of concept
demonstrated with a DDS-04 series compound cured infection in a
translationally-relevant animal model of urinary tract infection,
while therapeutic concentrations were also achieved in the lungs
and bloodstream showing potential to treat other major
Enterobacteriaceae infection sites. These data were presented at
the 20th European Congress of Clinical Microbiology &
Infectious Diseases.
Financial Highlights
- Cash and cash equivalents at
30 April 2019 of £28.3 million compared to £26.9 million
at 31 January 2019.
- Loss for the three months ended
30 April 2019 of £4.0 million compared to a loss of £5.8
million for the three months ended 30 April 2018.
This announcement contains inside information
for the purposes of Article 7 of EU Regulation 596/2014 (MAR).
About Summit TherapeuticsSummit
Therapeutics is a leader in antibiotic innovation. Our new
mechanism antibiotics are designed to become the new standards of
care for the benefit of patients and create value for payors and
healthcare providers. We are currently developing new mechanism
antibiotics to treat infections caused by C. difficile, N.
gonorrhoeae and Enterobacteriaceae and are using our proprietary
Discuva Platform to expand our pipeline. For more information,
visit www.summitplc.com and follow us on Twitter @summitplc.
For more information:
SummitGlyn Edwards / Richard Pye (UK
office)Michelle Avery (US office) |
Tel: +44 (0)1235 443 951 +1 617 225
4455 |
Cairn
Financial Advisers LLP (Nominated Adviser)Liam Murray /
Tony Rawlinson |
Tel: +44 (0)20 7213 0880 |
N+1
Singer (Joint Broker)Aubrey Powell / Jen Boorer, Corporate
FinanceTom Salvesen, Corporate Broking |
Tel: +44 (0)20 7496 3000 |
Bryan
Garnier & Co Limited (Joint Broker)Phil Walker /
Dominic Wilson |
Tel: +44 (0)20 7332 2500 |
MSL
Group (US)Jon Siegal |
Tel: +1 781 684 6557
summit@mslgroup.com |
Consilium
Strategic Communications (UK) Mary-Jane Elliott / Sue
Stuart / Jessica Hodgson / Lindsey Neville |
Tel: +44 (0)20 3709 5700
summit@consilium-comms.com |
Forward Looking StatementsAny
statements in this press release about the Company’s future
expectations, plans and prospects, including but not limited to,
statements about the potential benefits and future operation of the
BARDA or CARB-X contract, including any potential future payments
thereunder, the clinical and preclinical development of the
Company’s product candidates, the therapeutic potential of the
Company’s product candidates, the potential of the Discuva
Platform, the potential commercialisation of the Company’s product
candidates, the sufficiency of the Company’s cash resources, the
timing of initiation, completion and availability of data from
clinical trials, the potential submission of applications for
marketing approvals and other statements containing the words
"anticipate," "believe," "continue," "could," "estimate," "expect,"
"intend," "may," "plan," "potential," "predict," "project,"
"should," "target," "would," and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: the ability of
BARDA or CARB-X to terminate our contract for convenience at any
time, the uncertainties inherent in the initiation of future
clinical trials, availability and timing of data from ongoing and
future clinical trials and the results of such trials, whether
preliminary results from a clinical trial will be predictive of the
final results of that trial or whether results of early clinical
trials or preclinical studies will be indicative of the results of
later clinical trials, expectations for regulatory approvals, laws
and regulations affecting government contracts, availability of
funding sufficient for the Company’s foreseeable and unforeseeable
operating expenses and capital expenditure requirements and other
factors discussed in the "Risk Factors" section of filings that the
Company makes with the Securities and Exchange Commission,
including the Company’s Annual Report on Form 20-F for the fiscal
year ended 31 January 2019. Accordingly, readers should not place
undue reliance on forward-looking statements or information. In
addition, any forward-looking statements included in this press
release represent the Company’s views only as of the date of this
release and should not be relied upon as representing the Company’s
views as of any subsequent date. The Company specifically disclaims
any obligation to update any forward-looking statements included in
this press release.
FINANCIAL REVIEW
Revenue
Revenue was £0.2 million for the three months
ended 30 April 2019 compared to £3.9 million for the
three months ended 30 April 2018. This decrease was
principally due to the reduction in revenue related to the Sarepta
licence and collaboration agreement following the Group’s decision
to discontinue development of ezutromid in June 2018. Revenue
recognised during the three months ended 30 April 2019
relating to the cost-share arrangement under the Sarepta agreement
amounted to £0.1 million.
The Group also recognised £0.1 million of
revenue during the three months ended 30 April 2019
relating to the receipt of a $2.5 million (£1.9 million) upfront
payment in respect of the licence and commercialisation agreement
signed with Eurofarma Laboratórios SA ('Eurofarma') in December
2017.
Other Operating Income
Other operating income was £4.9 million for the
three months ended 30 April 2019, as compared to £3.5
million for the three months ended 30 April 2018. This
increase resulted primarily from the recognition of operating
income from Summit’s funding contract with BARDA for the
development of ridinilazole, which was £4.6 million for the three
months ended 30 April 2019 as compared to £3.3 million
for the three months ended 30 April 2018.
The Group also recognised operating income of
£0.2 million during the three months ended 30 April 2019
related to the Group's CARB-X award supporting the development of
SMT-571 for the treatment of gonorrhoea.
Operating Expenses
Research and Development Expenses
Research and development expenses decreased by
£3.3 million to £8.3 million for the three months ended
30 April 2019 from £11.6 million for the three months
ended 30 April 2018.
Expenses related to the CDI programme increased
by £0.8 million to £5.8 million for the three months ended
30 April 2019 from £5.0 million for the three months
ended 30 April 2018. This increase primarily related to
clinical and manufacturing activities related to the Ri-CoDIFy
Phase 3 clinical trials of ridinilazole that commenced in February
2019.
Investment in the Group's antibiotic pipeline
development activities was £0.7 million for the three months ended
30 April 2019 compared to £0.2 million for the three
months ended 30 April 2018. This increase primarily
related to preclinical development activities for SMT-571 for the
treatment of gonorrhoea and the DDS-04 series for the treatment of
Enterobacteriaceae infections.
Expenses related to the Duchenne muscular
dystrophy ('DMD') programme decreased by £4.1 million to £0.1
million for the three months ended 30 April 2019 from
£4.2 million for the three months ended 30 April 2018, as
a result of the discontinuation of the development of ezutromid in
June 2018. The Group does not expect to incur further significant
cost for this programme.
Other research and development expenses
decreased by £0.5 million to £1.7 million during the three months
ended 30 April 2019 as compared to £2.2 million during
the three months ended 30 April 2018, which was driven by
a decrease in staffing and facilities costs reflecting
implementation of cost-cutting measures following the decision to
discontinue development of ezutromid in June 2018.
General and Administration Expenses
General and administration expenses decreased by
£0.6 million to £1.7 million for the three months ended
30 April 2019 from £2.3 million for the three months
ended 30 April 2018. This decrease was driven by a
reduction in staff related costs and legal and professional fees,
offset by a net negative movement in exchange rate variances.
Finance Costs
Finance costs recognised during the three months
ended 30 April 2019 relate to lease liability interest
payable and the unwinding of the discount associated with
provisions. Finance costs were £0.1 million for the three
months ended 30 April 2019 compared to £0.2 million
for the three months ended 30 April 2018. This decrease
relates to the cessation of the unwinding of the discount following
the remeasurement of the financial liabilities on funding
arrangements relating to DMD-related US not for profit
organisations to £nil in June 2018.
Taxation
The income tax credit for the three months ended
30 April 2019 was £0.8 million as compared to
£0.9 million for the three months ended
30 April 2018. This net decrease was driven by a decrease
in the Group's accrued UK research and development tax credit,
reflecting lower research and development expenditure, offset by a
net positive movement in taxes relating to the US operations and
the release of deferred tax liabilities associated with the
amortisation of intangible assets.
Losses
Loss before income tax was £4.9 million for the
three months ended 30 April 2019 compared to a loss
before income tax of £6.8 million for the three months ended
30 April 2018. Net loss for the three months ended
30 April 2019 was £4.0 million with a basic loss per
share of 3 pence compared to a net loss of £5.8 million for the
three months ended 30 April 2018 with a basic loss per
share of 8 pence.
Cash Flows
The Group had a net cash inflow of £1.3 million
for the three months ended 30 April 2019 as compared to
£7.2 million for the three months ended
30 April 2018.
Operating ActivitiesFor the three months ended
30 April 2019, net cash generated from operating
activities was £1.4 million compared to net cash used in operating
activities of £7.0 million for the three months ended
30 April 2018. This net positive movement of £8.4 million
was driven by an increase in cash received from licensing
agreements and funding arrangements of £3.8 million and an increase
in taxation cash inflows of £4.9 million due to the timing of
receipt of the Group's research and development tax credits
receivable on qualifying expenditure in respect of financial years
ended 31 January 2017 and 2018, offset by an increase in operating
costs of £0.3 million.
Investing ActivitiesNet cash used in investing
activities for the three months ended 30 April 2019 and
30 April 2018 represents amounts paid to acquire
property, plant and equipment and intangible assets, net of bank
interest received on cash deposits.
Financing ActivitiesNet cash used in financing
activities for the three months ended 30 April 2019 of
£0.1 million primarily relates to lease liability repayments of
£0.1 million. Net cash generated from financing activities for the
three months ended 30 April 2018 of £14.2 million
included £14.1 million of proceeds, net of transaction costs,
received following the Group’s equity placing on the AIM market of
the London Stock Exchange in March 2018 and £0.1 million received
following the exercise of restricted stock units and share options,
offset by lease liability repayments of £0.1 million.
Financial Position and Cash Runway
Guidance
As at 30 April 2019, total cash and
cash equivalents held were £28.3 million (31 January 2018: £26.9
million).
The Group believes that its existing cash and
cash equivalents, anticipated payments from BARDA under its
contract for the development of ridinilazole and anticipated
payments from CARB-X under its contract for the development of its
gonorrhoea antibiotic candidate, will be sufficient to enable the
Group to fund its operating expenses and capital expenditure
requirements through 31 January 2020.
Glyn Edwards |
|
|
Chief Executive Officer |
|
|
|
|
|
12 June 2019 |
|
|
FINANCIAL STATEMENTS
Condensed Consolidated Statement of Comprehensive
Income (unaudited) For the three months ended
30 April 2019
|
|
Three months ended 30 April 2019 |
Three months ended 30 April 2019 |
Three months ended 30 April 2018 |
|
|
|
|
(Adjusted*) |
|
Note |
$000s |
£000s |
£000s |
|
|
|
|
|
Revenue |
|
324 |
|
249 |
|
3,874 |
|
|
|
|
|
|
Other
operating income |
|
6,347 |
|
4,871 |
|
3,455 |
|
|
|
|
|
|
Operating expenses |
|
|
|
|
Research and development |
|
(10,780 |
) |
(8,273 |
) |
(11,590 |
) |
General and administration |
|
(2,156 |
) |
(1,655 |
) |
(2,328 |
) |
Total operating expenses |
|
(12,936 |
) |
(9,928 |
) |
(13,918 |
) |
Operating loss |
|
(6,265 |
) |
(4,808 |
) |
(6,589 |
) |
|
|
|
|
|
Finance
income |
|
3 |
|
2 |
|
1 |
|
Finance
costs |
|
(79 |
) |
(61 |
) |
(200 |
) |
Loss before income tax |
|
(6,341 |
) |
(4,867 |
) |
(6,788 |
) |
|
|
|
|
|
Income
tax |
|
1,097 |
|
842 |
|
946 |
|
Loss for the period |
|
(5,244 |
) |
(4,025 |
) |
(5,842 |
) |
|
|
|
|
|
Other
comprehensive income |
|
|
|
|
Items that may be
reclassified subsequently to profit or loss |
|
|
|
|
Exchange
differences on translating foreign operations |
|
4 |
|
3 |
|
7 |
|
Total comprehensive loss for the period |
|
(5,240 |
) |
(4,022 |
) |
(5,835 |
) |
|
|
|
|
|
Basic and diluted loss per ordinary share from
operations |
2 |
(4) cents |
(3) pence |
(8) pence |
* See Note 1 - ‘Basis of Accounting - Adoption
of IFRS 16 ‘Leases’’
Condensed Consolidated Statement of Financial
Position (unaudited) As at 30 April 2019
|
|
30 April 2019 |
30 April 2019 |
31
January 2019 |
|
|
|
|
(Adjusted*) |
|
|
$000s |
£000s |
£000s |
ASSETS |
|
|
|
|
Non-current assets |
|
|
|
|
Goodwill |
|
2,364 |
|
1,814 |
|
1,814 |
|
Intangible
assets |
|
13,547 |
|
10,397 |
|
10,604 |
|
Property, plant
and equipment |
|
1,812 |
|
1,391 |
|
1,540 |
|
|
|
17,723 |
|
13,602 |
|
13,958 |
|
Current
assets |
|
|
|
|
Trade and other
receivables |
|
12,324 |
|
9,458 |
|
13,491 |
|
Current tax
receivable |
|
2,967 |
|
2,277 |
|
6,328 |
|
Cash and cash
equivalents |
|
36,894 |
|
28,315 |
|
26,858 |
|
|
|
52,185 |
|
40,050 |
|
46,677 |
|
Total assets |
|
69,908 |
|
53,652 |
|
60,635 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
Non-current liabilities |
|
|
|
|
Lease
liabilities |
|
(739 |
) |
(567 |
) |
(647 |
) |
Deferred
revenue |
|
(920 |
) |
(706 |
) |
(831 |
) |
Provisions for
other liabilities and charges |
|
(2,480 |
) |
(1,903 |
) |
(1,851 |
) |
Deferred tax
liability |
|
(2,141 |
) |
(1,643 |
) |
(1,675 |
) |
|
|
(6,280 |
) |
(4,819 |
) |
(5,004 |
) |
Current
liabilities |
|
|
|
|
Trade and other
payables |
|
(8,804 |
) |
(6,757 |
) |
(8,733 |
) |
Lease
liabilities |
|
(466 |
) |
(358 |
) |
(358 |
) |
Deferred
revenue |
|
(3,186 |
) |
(2,445 |
) |
(3,374 |
) |
Contingent consideration |
|
(819 |
) |
(629 |
) |
(629 |
) |
|
|
(13,275 |
) |
(10,189 |
) |
(13,094 |
) |
Total liabilities |
|
(19,555 |
) |
(15,008 |
) |
(18,098 |
) |
Net assets |
|
50,353 |
|
38,644 |
|
42,537 |
|
|
|
|
|
|
EQUITY |
|
|
|
|
Share
capital |
|
2,091 |
|
1,605 |
|
1,604 |
|
Share premium
account |
|
120,926 |
|
92,806 |
|
92,806 |
|
Share-based
payment reserve |
|
1,316 |
|
1,010 |
|
1,148 |
|
Merger
reserve |
|
3,944 |
|
3,027 |
|
3,027 |
|
Special
reserve |
|
26,051 |
|
19,993 |
|
19,993 |
|
Currency
translation reserve |
|
77 |
|
59 |
|
56 |
|
Accumulated
losses reserve |
|
(104,052 |
) |
(79,856 |
) |
(76,097 |
) |
Total equity |
|
50,353 |
|
38,644 |
|
42,537 |
|
* See Note 1 - ‘Basis of Accounting - Adoption
of IFRS 16 ‘Leases’’
Condensed Consolidated Statement of Cash flows
(unaudited)
For the three months ended
30 April 2019
|
Three months ended 30 April 2019 |
Three months ended 30 April 2019 |
Three months ended 30 April 2018 |
|
|
|
(Adjusted*) |
|
$000s |
£000s |
£000s |
Cash flows from operating activities |
|
|
|
Loss before
income tax |
(6,341 |
) |
(4,867 |
) |
(6,788 |
) |
|
(6,341 |
) |
(4,867 |
) |
(6,788 |
) |
Adjusted
for: |
|
|
|
Finance
income |
(3 |
) |
(2 |
) |
(1 |
) |
Finance
costs |
79 |
|
61 |
|
200 |
|
Foreign
exchange gain |
(201 |
) |
(154 |
) |
(457 |
) |
Depreciation |
186 |
|
143 |
|
160 |
|
Amortisation
of intangible fixed assets |
270 |
|
207 |
|
208 |
|
Loss on
disposal of assets |
13 |
|
10 |
|
— |
|
Research and
development expenditure credit |
— |
|
— |
|
(65 |
) |
Share-based
payment |
167 |
|
128 |
|
545 |
|
Adjusted loss from operations before changes in working
capital |
(5,830 |
) |
(4,474 |
) |
(6,198 |
) |
|
|
|
|
Decrease /
(increase) in prepayments and other receivables |
5,272 |
|
4,047 |
|
(1,426 |
) |
Decrease in
deferred revenue |
(1,373 |
) |
(1,054 |
) |
(2,339 |
) |
(Decrease) /
increase in trade and other payables |
(2,633 |
) |
(2,021 |
) |
3,007 |
|
Cash used in operations |
(4,564 |
) |
(3,502 |
) |
(6,956 |
) |
Taxation
received |
6,381 |
|
4,897 |
|
— |
|
Net cash generated from operating activities |
1,817 |
|
1,395 |
|
(6,956 |
) |
|
|
|
|
Investing activities |
|
|
|
Purchase of property, plant and
equipment |
(5 |
) |
(4 |
) |
(25 |
) |
Purchase of intangible assets |
— |
|
— |
|
(5 |
) |
Interest received |
3 |
|
2 |
|
1 |
|
Net cash used in investing activities |
(2 |
) |
(2 |
) |
(29 |
) |
|
|
|
|
Financing activities |
|
|
|
Proceeds from
issue of share capital |
— |
|
— |
|
15,000 |
|
Transaction
costs on share capital issued |
— |
|
— |
|
(858 |
) |
Proceeds from
exercise of share options |
1 |
|
1 |
|
99 |
|
Repayment of lease liabilities |
(116 |
) |
(89 |
) |
(84 |
) |
Net cash used in financing activities |
(115 |
) |
(88 |
) |
14,157 |
|
|
|
|
|
Increase in cash and cash equivalents |
1,700 |
|
1,305 |
|
7,172 |
|
Effect
of exchange rates in cash and cash equivalents |
198 |
|
152 |
|
411 |
|
Cash
and cash equivalents at beginning of the period |
34,996 |
|
26,858 |
|
20,102 |
|
Cash and cash equivalents at end of the
period |
36,894 |
|
28,315 |
|
27,685 |
|
* See Note 1 - ‘Basis of Accounting - Adoption
of IFRS 16 ‘Leases’’
Condensed Consolidated Statement of
Changes in Equity (unaudited) Three months ended
30 April 2019
Group |
Share capital£000s |
Share premium account£000s |
Share-based payment reserve£000s |
Merger reserve£000s |
Special reserve£000s |
Currencytranslationreserve£000s |
Accumulated losses reserve£000s |
Total £000s |
At 31 January 2019 (as previously
reported) |
1,604 |
|
92,806 |
|
1,148 |
|
3,027 |
|
19,993 |
|
56 |
|
(76,092 |
) |
42,542 |
|
|
Change in accounting policy (full
retrospective application IFRS 16) |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
(5 |
) |
(5 |
) |
|
At 31 January 2019 (Adjusted*) |
1,604 |
|
92,806 |
|
1,148 |
|
3,027 |
|
19,993 |
|
56 |
|
(76,097 |
) |
42,537 |
|
|
Loss for the period |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
(4,025 |
) |
(4,025 |
) |
|
Currency translation adjustment |
— |
|
— |
|
— |
|
— |
|
— |
|
3 |
|
— |
|
3 |
|
|
Total comprehensive loss for the
period |
— |
|
— |
|
— |
|
— |
|
— |
|
3 |
|
(4,025 |
) |
(4,022 |
) |
|
Share options exercised |
1 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
1 |
|
|
Share-based payment |
— |
|
— |
|
128 |
|
— |
|
— |
|
— |
|
— |
|
128 |
|
|
Transfer |
— |
|
— |
|
(266 |
) |
— |
|
— |
|
— |
|
266 |
|
— |
|
|
At 30 April 2019 |
1,605 |
|
92,806 |
|
1,010 |
|
3,027 |
|
19,993 |
|
59 |
|
(79,856 |
) |
38,644 |
|
|
Year ended 31 January 2019
Group |
Share capital£000s |
Share premium account£000s |
Share-based payment reserve£000s |
Merger reserve£000s |
Special reserve£000s |
Currencytranslationreserve£000s |
Accumulated losses reserve£000s |
Total £000s |
At 31 January 2018 (as previously
reported) |
736 |
|
60,237 |
|
6,743 |
|
3,027 |
|
19,993 |
|
37 |
|
(93,957 |
) |
(3,184 |
) |
Change
in accounting policy (full retrospective application IFRS 16) |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
32 |
|
32 |
|
At 31
January 2018 (Adjusted*) |
736 |
|
60,237 |
|
6,743 |
|
3,027 |
|
19,993 |
|
37 |
|
(93,925 |
) |
(3,152 |
) |
Profit for the year (Adjusted*) |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
7,490 |
|
7,490 |
|
Currency translation adjustment |
— |
|
— |
|
— |
|
— |
|
— |
|
19 |
|
— |
|
19 |
|
Total comprehensive profit for the
period (Adjusted*) |
— |
|
— |
|
— |
|
— |
|
— |
|
19 |
|
7,490 |
|
7,509 |
|
New share capital issued |
864 |
|
33,784 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
34,648 |
|
Transaction costs on share capital
issued |
— |
|
(1,313 |
) |
— |
|
— |
|
— |
|
— |
|
— |
|
(1,313 |
) |
Share options exercised |
4 |
|
98 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
102 |
|
Share-based payment |
— |
|
— |
|
4,743 |
|
— |
|
— |
|
— |
|
— |
|
4,743 |
|
Transfer |
— |
|
— |
|
(10,338 |
) |
— |
|
— |
|
— |
|
10,338 |
|
— |
|
At 31 January 2019 (Adjusted*) |
1,604 |
|
92,806 |
|
1,148 |
|
3,027 |
|
19,993 |
|
56 |
|
(76,097 |
) |
42,537 |
|
Three months ended 30 April 2018
Group |
Share capital£000s |
Share premium account£000s |
Share-based payment reserve£000s |
Merger reserve£000s |
Special reserve£000s |
Currencytranslationreserve£000s |
Accumulated losses reserve£000s |
Total £000s |
At 31 January 2018 (as previously
reported) |
736 |
|
60,237 |
|
6,743 |
|
3,027 |
|
19,993 |
|
37 |
|
(93,957 |
) |
(3,184 |
) |
Change in accounting policy (full
retrospective application IFRS 16) |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
32 |
|
32 |
|
At 31 January 2018 (Adjusted*) |
736 |
|
60,237 |
|
6,743 |
|
3,027 |
|
19,993 |
|
37 |
|
(93,925 |
) |
(3,152 |
) |
Loss for the period (Adjusted*) |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
(5,842 |
) |
(5,842 |
) |
Currency translation adjustment |
— |
|
— |
|
— |
|
— |
|
— |
|
7 |
|
— |
|
7 |
|
Total comprehensive loss for the
period (Adjusted*) |
— |
|
— |
|
— |
|
— |
|
— |
|
7 |
|
(5,842 |
) |
(5,835 |
) |
New share capital issued |
83 |
|
14,917 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
15,000 |
|
Transaction costs on share capital
issued |
— |
|
(858 |
) |
— |
|
— |
|
— |
|
— |
|
— |
|
(858 |
) |
Share options exercised |
1 |
|
98 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
99 |
|
Share-based payment |
— |
|
— |
|
545 |
|
— |
|
— |
|
— |
|
— |
|
545 |
|
At 30 April 2018 (Adjusted*) |
820 |
|
74,394 |
|
7,288 |
|
3,027 |
|
19,993 |
|
44 |
|
(99,767 |
) |
5,799 |
|
* See Note 1 - ‘Basis of Accounting - Adoption of IFRS 16
‘Leases’’
The accompanying notes form an integral part of
these condensed consolidated interim financial statements.
NOTES TO THE FINANCIAL INFORMATION
For the three months ended
30 April 2019
1. Basis of Accounting
The unaudited condensed consolidated interim
financial statements of Summit Therapeutics plc ('Summit') and its
subsidiaries (together, the ‘Group’) for the three months ended
30 April 2019 have been prepared in accordance with
International Financial Reporting Standards ('IFRS') and
International Financial Reporting Interpretations Committee
(‘IFRIC’) interpretations as issued by the International Accounting
Standards Board and with those parts of the Companies Act 2006
applicable to companies reporting under IFRS including those
applicable to accounting periods ending 31 January 2020 and the
accounting policies set out in Summit’s consolidated financial
statements. There have been no changes to the accounting policies
as contained in the annual consolidated financial statements as of
and for the year ended 31 January 2019 other than as described
below. These condensed consolidated interim financial statements do
not include all information required for full statutory accounts
within the meaning of section 434 of Companies Act 2006 and should
be read in conjunction with the consolidated financial statements
of the Group as at 31 January 2019 (the ‘2019 Accounts’). The 2019
Accounts, on which the Company’s auditors delivered an unqualified
audit report, are available on the Group's website at
www.summitplc.com and will be delivered to the Registrar of
Companies following the 2019 Annual General Meeting. The auditor’s
report did not contain any statement under section 498 of the
Companies Act 2006 but did contain a statement from the
auditors drawing the shareholders’ attention to the Group’s need to
raise additional capital as noted below.
Whilst the financial information included in
this announcement has been prepared in accordance with IFRS and
IFRIC interpretations as issued by the International Accounting
Standards Board and with those parts of the Companies Act 2006
applicable to companies reporting under IFRS, this announcement
does not itself contain sufficient information to comply with
IFRSs.
The interim financial statements have been
prepared assuming the Group will continue on a going concern basis.
Based on management's forecasts, the Group's existing cash and cash
equivalents, anticipated payments from BARDA under its contract for
the development of ridinilazole and anticipated payments from
CARB-X under its contract for the development of its gonorrhoea
antibiotic candidate are expected to be sufficient to enable the
Group to fund its operating expenses and capital expenditure
requirements through 31 January 2020. The Group will need to raise
additional funding in order to support, beyond this date, its
planned research and development efforts, potential
commercialisation related activities, if any of its product
candidates receive marketing approval, as well as to support
activities associated with operating as a public company in the
United States and the United Kingdom. Should the Group be unable to
raise additional funding, management has the ability to take
mitigating action to fund its operating expenses and capital
expenditure requirements in relation to its clinical development
activities for only a short period beyond 12 months from the date
of issuance of these financial statements. These circumstances
represent a material uncertainty which may cast and raise
significant doubt on the Group’s ability to continue as a going
concern. The interim financial statements do not contain any
adjustments that might result if the Group was unable to continue
as a going concern.
The Group is evaluating various options to
finance its cash needs through a combination of some, or all, of
the following: equity offerings, collaborations, strategic
alliances, grants and clinical trial support from government
entities, philanthropic, non-government and not-for-profit
organisations and patient advocacy groups, debt financings, and
marketing, distribution or licensing arrangements. Whilst the Group
believes that funds would be available in this manner before the
end of January 2020, there can be no assurance that the Group will
be able to generate funds, on terms acceptable to the Group, on a
timely basis or at all, which would impact the Group’s ability to
continue as a going concern. The failure of the Group to obtain
sufficient funds on acceptable terms when needed could have a
material adverse effect on the Group’s business, results of
operations and financial condition.
The financial information for the three month
periods ended 30 April 2019 and 2018 are unaudited.
Solely for the convenience of the reader, unless
otherwise indicated, all pound sterling amounts stated in the
Consolidated Statement of Financial Position as at 30 April 2019
and the Consolidated Statement of Comprehensive Income and
Consolidated Statement of Cash Flows for the three months ended 30
April 2019 have been translated into US dollars at the rate on 30
April 2019 of $1.303 to £1.00. These translations should not be
considered representations that any such amounts have been, could
have been or could be converted into US dollars at that or any
other exchange rate as at that or any other date.
The Board of Directors of the Company approved
this statement on 12 June 2019.
Adoption of IFRS 16
'Leases'
IFRS 16 specifies how to recognise, measure,
present and disclose leases. The standard provides a single lessee
accounting model, requiring lessees to recognise assets and
liabilities for all leases unless the lease term is 12 months or
less or the underlying asset has a low value. The standard is
effective for reporting periods beginning on or after 1 January
2019 and replaces the accounting standard IAS 17 'Leases'. Two
adoption methods are permitted for transition: retrospectively to
all prior reporting periods presented in accordance with IAS 8
'Accounting Policies, Changes in Accounting Estimates and Errors',
with certain practical expedients permitted; or retrospectively
with the cumulative effect of initially applying the standard
recognised at the date of initial application.
Accounting policy
At inception of a contract, the Group assesses
whether a contract is, or contains, a lease based on whether the
contract conveys the right to control the use of an identified
asset for a period of time in exchange for consideration. The Group
recognises a right-of-use asset within property, plant and
equipment and a lease liability at the lease commencement date. The
right-of-use asset is initially measured based on the initial
amount of the lease liability adjusted for any lease payments made
at or before the commencement date, plus any initial direct costs
incurred and an estimate of costs to dismantle and remove the
underlying asset or to restore the underlying asset or the site on
which it is located, less any lease incentives received. The assets
are depreciated to the earlier of the end of the useful life of the
right-of-use asset or the lease term using the straight-line
method. The lease term includes periods covered by an option to
extend if the Group is reasonably certain to exercise that option
and periods covered by an option to terminate if it is reasonably
certain not to exercise that option. The lease liability is
initially measured at the present value of the lease payments that
are not paid at the commencement date, discounted using the
interest rate implicit in the lease or, if that rate cannot be
readily determined, the Group's incremental borrowing rate. The
lease liability is subsequently measured at amortised cost using
the effective interest method and is remeasured when there is a
change in future contractual lease payments or if the Group changes
its assessment of whether it will exercise a purchase, extension or
termination option.
The Group adopted this new standard effective 1
February 2019, as required, using the full retrospective transition
method in accordance with IAS 8 'Accounting Policies, Changes in
Accounting Estimates and Errors'. Under this method, the Group
will adjust its results for the years ended 31 January 2018, and
2019, and applicable interim periods, as if IFRS 16 had been
effective for those periods. The Group has assessed the effect
of adoption of this standard as it relates to its UK leased
properties in Oxford and Cambridge and has concluded that any other
contracts are not within the scope of IFRS 16 or are of low value,
for which the Group has elected not to apply the requirement of
IFRS 16.
Due to the adoption of IFRS 16, the Group has
recognised both right-of-use assets and lease liabilities related
to its UK leased properties. The Group no longer recognises a lease
incentive accrual and has reclassified some costs from research and
development expenses and general and administration expenses to
finance costs, being the interest expense on lease liabilities. In
addition, some amounts previously presented as cash outflows from
operating activities in the Group's Consolidated Statement of Cash
Flows are now presented as cash flows from investing or financing
activities.
This change in accounting policy has been reflected
retrospectively in the comparative Statement of Financial Position
for the year ended 31 January 2019, the comparative Statement of
Comprehensive Income, Statement of Cash Flows and Statement of
Changes in Equity for the three months ended 30 April 2018,
including the opening accumulated losses reserve at 1 February 2018
and 1 February 2019.
During the year ended 31 January 2019, the Group
re-assessed the allocation of staff related expenses, totalling
£0.3 million, previously reported as general and administration
expenses during the three months ended 30 April 2018. These are now
presented as research and development expenses.
The impact of the change in accounting policy to
IFRS 16 and the allocation of the staff related expenses discussed
above on the comparatives to the unaudited condensed consolidated
interim financial statements is disclosed in the following
tables.
Impact
on Unaudited Condensed Consolidated |
OriginalYear ended 31 January
2019 |
AdjustedYear ended 31 January
2019 |
Impact |
Statement of Financial Position |
£000s |
£000s |
£000s |
Non-current assets |
|
|
|
Property, plant and equipment |
616 |
|
1,540 |
|
924 |
|
Current assets |
|
|
|
Trade and other receivables |
13,547 |
|
13,491 |
|
(56 |
) |
Non-current liabilities |
|
|
|
Lease liabilities |
— |
|
(647 |
) |
(647 |
) |
Current liabilities |
|
|
|
Trade and other payables |
(8,865 |
) |
(8,733 |
) |
132 |
|
Lease liabilities |
— |
|
(358 |
) |
(358 |
) |
Equity |
|
|
|
Accumulated losses reserve |
(76,092 |
) |
(76,097 |
) |
(5 |
) |
Impact
on Unaudited Condensed Consolidated |
OriginalThree
monthsended30 April
2018 |
Adjusted Three months ended30 April
2018 |
Impact |
Statement of Comprehensive Income |
£000s |
£000s |
£000s |
Operating expenses |
|
|
|
Research and development |
(11,254 |
) |
(11,590 |
) |
(336 |
) |
General and administration |
(2,669 |
) |
(2,328 |
) |
341 |
|
Operating loss |
(6,594 |
) |
(6,589 |
) |
5 |
|
Finance costs |
(188 |
) |
(200 |
) |
(12 |
) |
Loss for the period |
(5,835 |
) |
(5,842 |
) |
(7 |
) |
Impact
on Unaudited Condensed Consolidated |
OriginalThree months
ended30 April 2018 |
AdjustedThree months
ended30 April 2018 |
Impact |
Statement of Cash Flows |
£000s |
£000s |
£000s |
Loss before income tax |
(6,781 |
) |
(6,788 |
) |
(7 |
) |
Adjusted for: |
|
|
|
Finance
costs |
188 |
|
200 |
|
12 |
|
Depreciation |
77 |
|
160 |
|
83 |
|
Increase in trade and other receivables |
(1,434 |
) |
(1,426 |
) |
8 |
|
Increase in trade and other payables |
3,019 |
|
3,007 |
|
(12 |
) |
Financing activities |
|
|
|
Repayment of lease liabilities |
— |
|
(84 |
) |
(84 |
) |
Impact on net cash flows |
|
|
— |
|
The Group will continue to monitor
interpretations released by the IFRS Interpretations Committee and
amendments to IFRS 16 and, as appropriate, will adopt these from
the effective dates.
2. Loss per Share Calculation
The loss per share has been calculated using the
loss for the period and dividing this by the weighted average
number of ordinary shares in issue during the three months ended
30 April 2019: 160,398,130 (for three months ended
30 April 2018: 76,571,101).
Since the Group has reported a net loss, diluted
loss per ordinary share is equal to basic loss per share.
3. Issue of Share Capital
On 23 April 2019, 104,877 ordinary shares were issued
following the exercise of restricted stock units ('RSUs'). This
exercise of RSUs raised net proceeds of £1,049.
The new ordinary shares issued in connection
with the RSUs exercised rank pari passu with existing ordinary
shares.
As of 30 April 2019, the number of
ordinary shares in issue was 160,494,758.
-END-
Summit Therapeutics (NASDAQ:SMMT)
Historical Stock Chart
From Jun 2024 to Jul 2024
Summit Therapeutics (NASDAQ:SMMT)
Historical Stock Chart
From Jul 2023 to Jul 2024