Summit Therapeutics
plc(‘Summit’, the ‘Company’ or the ‘Group’)
Summit Therapeutics Reports Financial
Results for the Fourth Period and Eleven Months Ended December 31,
2019, and Operational Progress
Oxford, UK, and Cambridge, MA, US, April
30, 2020 - Summit Therapeutics plc (NASDAQ: SMMT) today
reports its financial results for the fourth period* and eleven
months ended December 31, 2019, and provides an update on its
operational progress.
Program Highlights
Ridinilazole for C. difficile Infection (‘CDI’)•
As of March 31, 2020, the Company had
enrolled a total of 252 patients into its Phase 3 Ri-CoDIFy
clinical trials. Below is a table outlining the enrollment
statistics by calendar quarter since the opening of the trials in
February 2019. The Company expects to report quarterly enrollment
updates going forward.
Quarter |
Number of patients enrolled |
Q1 2019 |
9 |
|
Q2 2019 |
21 |
|
Q3 2019 |
43 |
|
Q4 2019 |
78 |
|
Q1 2020 |
101 |
|
- Due to the uncertainties surrounding COVID-19, the Company is
withdrawing the expected timing of completion for the clinical
trials.
- The Ri-CoDIFy clinical trials aim to support registration of
the precision antibiotic ridinilazole in the US and other
territories resulting in its intended adoption as a first-line
treatment for CDI by:
- testing for superiority over the current standard of care,
vancomycin, in the primary endpoint of sustained clinical response
at 30 days after treatment has ended;
- generating health economic data to help support ridinilazole's
commercial launch, if approved; and
- undertaking deep microbiome analysis that aims to show
ridinilazole’s preservation of the gut microbiome.
- BARDA increased the total value of its award in June 2019 and
again in January 2020. The total award is now worth up to $72.5
million, with $62.4 million of that committed to date. As of
December 31, 2019, an aggregate of £29.1 million ($38.6 million) of
the total committed BARDA funding had been received.
Discuva Platform
Enterobacteriaceae
- DDS-04 compound series is a new class of antibiotics in lead
optimization to treat infections caused by the Gram-negative
bacteria, Enterobacteriaceae.
- Presented in vivo proof of concept data in pneumonia, sepsis
and urinary tract infection at medical conferences in 2019.
Gonorrhea
- Developing a new mechanism antibiotic for the treatment of
gonorrhea with published preclinical data showing compounds from
the series had consistently high potency across over 200 clinically
relevant strains of Neisseria gonorrhoeae, including numerous
multi-drug resistant and extensively-drug resistant strains.
- Program supported by an award of up to $5.7 million from
CARB-X.
Key Operational Updates
- In light of the COVID-19 pandemic, Summit's employees are
currently working remotely with the Company's IT infrastructure
helping maintain high levels of connectivity enabling the majority
of day to day business operations to continue. Summit's own
laboratory facilities are temporarily closed, and management
continues to evaluate plans that may allow resumption of activities
while not compromising the safety of the researchers. There has
been a slowing of patient enrollment into the Ri-CoDIFy clinical
trials, which the Company expects to continue during the
pandemic.
- Mr. Robert W. Duggan was appointed as Chief Executive Officer,
Dr. Elaine Stracker was appointed Interim Chief Operating Officer
and Dr. Ventzislav Stefanov was appointed Executive Vice President
and President of Discuva in April 2020. Mr. Glyn Edwards stepped
down as Chief Executive Officer in April 2020, and he remains on
the board as a Non-Executive Director.
- Dr. David Powell was promoted to Chief Scientific Officer from
his previous position as Head of Research and Development in March
2020.
- Ms. Divya Chari was appointed as Head of Global Clinical
Operations in March 2020. She has over 16 years of experience in
clinical operations working with data management, supporting
multiple successful New Drug Applications and Supplemental New Drug
Applications across therapeutic areas. Ms. Chari most recently led
large, global partnership clinical trials at Pharmacyclics, Inc.,
an AbbVie company.
- The Company's six-member board consists of Mr. Robert W.
Duggan, Mr. Manmeet Soni, Dr. Elaine Stracker, Dr. Ventzislav
Stefanov, Mr. Glyn Edwards and Mr. Rainer Erdtmann.
Financial Highlights
- Net proceeds of $49.1 million (£38.1 million) received from the
sale of the Company's ordinary shares in a placement that completed
in December 2019.
- Loss for the eleven months ended December 31, 2019, of £22.0
million compared to a profit of £7.5 million for the year ended
January 31, 2019.
- Cash and cash equivalents at December 31, 2019, of £48.4
million compared to £26.9 million at January 31, 2019.
- In December 2019, the Company changed its fiscal year end from
January 31 to December 31. As a result, the Company is presenting
financial results for the eleven months ended December 31,
2019.
* The fourth period ended December 31, 2019,
covered the two months from November 2019 to December 2019 and was
due to the change in fiscal year end made in December 2019.
About C. difficile
InfectionClostridioides difficile, or C. difficile,
infection (CDI) is a bacterial infection of the colon that produces
toxins causing inflammation of the colon and severe diarrhea. CDI
can also result in more serious disease complications, including
pseudomembranous colitis, bowel perforation, toxic megacolon and
sepsis. CDI represents a serious healthcare issue in hospitals,
long-term care homes and in the wider community. Summit estimates
there are over one million cases of CDI each year in the United
States and Europe, based on an epidemiology report on CDI that was
published in 2015 by Decision Resources, a healthcare research and
consulting company. In addition, from 2011-2017, CDI was associated
with over 20,000 deaths each year in the United States, according
to a study published in the New England Journal of Medicine in
April 2020. The Healthcare Cost and Utilization Project, a family
of databases developed through a federal-state-industry
partnership, sponsored by the Agency for Healthcare Research and
Quality of the US Department of Health and Human Services, reported
an approximate 3.5-fold increase in hospital stays associated with
CDI between 2000 and 2008. The economic impact of CDI is
significant. A study published in 2016 in BMC Infectious Diseases
estimated that the total costs attributable to the management of
CDI were approximately $6.3 billion per year.
About
EnterobacteriaceaeEnterobacteriaceae are a family of
bacteria responsible for severe and often deadly infections. They
accountfor a significant number of cases across a number of
conditions including bloodstream infections, urinary tract
infections and hospital-acquired pneumonias. Summit estimates that
there are more than one million infections in the United States
annually caused by Enterobacteriaceae across these three conditions
based on data published in 2018 in the Journal of Antimicrobial
Chemotherapy, 2016 in the Journal of Molecular Science, 2014 in the
National Healthcare Safety Network, 2014 and 2018 in the New
England Journal of Medicine, 2015 in Nature Reviews Microbiology,
2012 in World Journal of Urology and 2014 in PLOS One. Mechanisms
of antibiotic resistance to Enterobacteriaceae are listed as both
urgent and serious threats by the CDC.
About GonorrheaThere is an
urgent unmet need for the development of new antibiotics against
gonorrhea, which is a sexually transmitted infection caused by an
overgrowth of the bacteria Neisseria gonorrhoeae (N. gonorrhoeae).
N. gonorrhoeae can cause infection of the genitals, throat, and
eyes. Untreated infections may spread to the rest of the body,
especially the joints, and in women may cause pelvic inflammatory
disease and possible infertility. It is estimated by the WHO that
there are approximately 78 million new cases of gonorrhea globally
per year. N gonorrhoeae has consistently developed resistance to
each class of antibiotics recommended for the treatment of
gonorrhea infections, and there is now only one treatment that is
recommended by the CDC, a combination of the cephalosporin
antibiotic ceftriaxone and the macrolide antibiotic azithromycin.
The WHO ranks gonorrhea as a “high” priority for research and
development while the CDC states that additional treatment options
are urgently needed.
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, subject to regulatory approvals,
and create value for payors and healthcare providers. We are
currently developing new mechanism antibiotics to treat infections
caused by C. difficile, Enterobacteriaceae and N. gonorrhoeae and
are using our proprietary Discuva Platform to expand our pipeline.
For more information, visit www.summitplc.com and follow us on
Twitter @summitplc.
Contacts:
Summit Press
Office |
investors@summitplc.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 commercialization 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, the impact of the COVID-19 pandemic 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 the
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 preclinical studies and clinical
trials and the results of such preclinical studies and clinical
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, legal, regulatory, political and economic risks arising
from or relating to global public health crises that reduce
economic activity (including the recent coronavirus COVID-19
outbreak) and the enrollment in and completion of clinical trials,
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 January 31, 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.
The financial information in the Company’s
financial statements has been prepared assuming the Company will
continue on a going concern basis. Based on management's forecasts,
the Company's existing cash and cash equivalents, anticipated
payments from BARDA under its contract for the development of
ridinilazole, anticipated payments from CARB-X under its contract
for the development of its gonorrhea antibiotic program, and
anticipated milestone payments from its license and
commercialization agreement with Eurofarma are expected to be
sufficient to enable the Company to fund its operating expenses and
capital expenditure requirements through January 31, 2021. The
Company will need to raise additional funding in order to support,
beyond this date, its planned research and development efforts, its
preparatory commercialization related activities should
ridinilazole receive marketing approval, as well as to support
activities associated with operating as a public company in the
United States. The failure of the Company to obtain sufficient
funds on acceptable terms when needed could have a material adverse
effect on the Company’s business, results of operations and
financial condition, and may cast and raise significant doubt on
the Company’s ability to continue as a going concern.
FINANCIAL STATEMENTS
Consolidated Statement of Comprehensive Income
(derived from audited information) For the eleven months
ended December 31, 2019, and year ended January 31,
2019
|
Eleven months ended December 31, 2019 |
Eleven months ended December 31, 2019 |
Year ended January 31, 2019 |
|
|
|
(Adjusted*) |
|
$000s |
£000s |
£000s |
|
|
|
|
Revenue |
774 |
|
583 |
|
43,012 |
|
|
|
|
|
Other
operating income |
20,120 |
|
15,163 |
|
15,156 |
|
|
|
|
|
Operating expenses |
|
|
|
Research and development |
(41,401 |
) |
(31,201 |
) |
(39,182 |
) |
General and administration |
(13,106 |
) |
(9,877 |
) |
(12,328 |
) |
Impairment of goodwill and intangible assets |
— |
|
— |
|
(3,985 |
) |
Total operating expenses |
(54,507 |
) |
(41,078 |
) |
(55,495 |
) |
Operating (loss) / profit |
(33,613 |
) |
(25,332 |
) |
2,673 |
|
|
|
|
|
Finance
income |
5 |
|
4 |
|
2,788 |
|
Finance
costs |
(303 |
) |
(228 |
) |
(467 |
) |
(Loss) / profit before income tax |
(33,910 |
) |
(25,556 |
) |
4,994 |
|
|
|
|
|
Income
tax |
4,676 |
|
3,524 |
|
2,496 |
|
(Loss) / profit for the period |
(29,234 |
) |
(22,032 |
) |
7,490 |
|
|
|
|
|
Other
comprehensive income / (loss) |
|
|
|
Items that may be
reclassified subsequently to profit or loss |
|
|
|
Exchange
differences on translating foreign operations |
— |
|
— |
|
19 |
|
Total comprehensive (loss) / profit for the
period |
(29,234 |
) |
(22,032 |
) |
7,509 |
|
|
|
|
|
Basic and diluted (loss) / earnings per ordinary share from
operations |
(18) cents |
(13) pence |
9 pence |
* Please refer to the Company’s annual report as
filed on Form 20-F for accompanying notes to these consolidated
financial statements.
The financial information for the eleven months
ended December 31, 2019, and for the year ended January 31, 2019,
does not constitute the statutory financial statements for the
respective years within the meaning of Sections 434-436 of the
Companies Act 2006 and is an extract from the financial
statements.
Consolidated Statement of Financial Position
(derived from audited information) As at December
31, 2019
|
December 31, 2019 |
December 31, 2019 |
January 31, 2019 |
|
|
|
(Adjusted*) |
|
$000s |
£000s |
£000s |
ASSETS |
|
|
|
Non-current assets |
|
|
|
Goodwill |
2,407 |
|
1,814 |
|
1,814 |
|
Intangible
assets |
13,203 |
|
9,950 |
|
10,604 |
|
Property,
plant and equipment |
1,548 |
|
1,167 |
|
1,540 |
|
|
17,158 |
|
12,931 |
|
13,958 |
|
Current assets |
|
|
|
Trade and
other receivables |
10,769 |
|
8,116 |
|
13,491 |
|
Current tax
receivable |
4,855 |
|
3,659 |
|
6,328 |
|
Cash and cash
equivalents |
64,245 |
|
48,417 |
|
26,858 |
|
|
79,869 |
|
60,192 |
|
46,677 |
|
Total assets |
97,027 |
|
73,123 |
|
60,635 |
|
|
|
|
|
LIABILITIES |
|
|
|
Non-current liabilities |
|
|
|
Deferred
revenue |
(496 |
) |
(374 |
) |
(831 |
) |
Lease
liabilities |
(424 |
) |
(320 |
) |
(647 |
) |
Provisions for
other liabilities and charges |
(2,720 |
) |
(2,050 |
) |
(1,851 |
) |
Deferred tax
liability |
(2,070 |
) |
(1,560 |
) |
(1,675 |
) |
|
(5,710 |
) |
(4,304 |
) |
(5,004 |
) |
Current liabilities |
|
|
|
Trade and
other payables |
(10,643 |
) |
(8,020 |
) |
(8,733 |
) |
Lease
liabilities |
(475 |
) |
(358 |
) |
(358 |
) |
Deferred
revenue and income |
(1,507 |
) |
(1,136 |
) |
(3,374 |
) |
Contingent consideration |
(106 |
) |
(80 |
) |
(629 |
) |
|
(12,731 |
) |
(9,594 |
) |
(13,094 |
) |
Total liabilities |
(18,441 |
) |
(13,898 |
) |
(18,098 |
) |
Net assets / (liabilities) |
78,586 |
|
59,225 |
|
42,537 |
|
|
|
|
|
EQUITY |
|
|
|
Share
capital |
4,457 |
|
3,359 |
|
1,604 |
|
Share premium
account |
171,316 |
|
129,110 |
|
92,806 |
|
Share-based
payment reserve |
1,724 |
|
1,299 |
|
1,148 |
|
Merger
reserve |
4,017 |
|
3,027 |
|
3,027 |
|
Special
reserve |
26,529 |
|
19,993 |
|
19,993 |
|
Currency
translation reserve |
74 |
|
56 |
|
56 |
|
Accumulated
losses reserve |
(129,531 |
) |
(97,619 |
) |
(76,097 |
) |
Total equity / (deficit) |
78,586 |
|
59,225 |
|
42,537 |
|
* Please refer to the Company’s annual report as
filed on Form 20-F for accompanying notes to these consolidated
financial statements
Consolidated Statement of Cash flows (derived
from audited information)
For the eleven months ended December
31, 2019
|
Year ended 31 December 2019 |
Year ended 31 December 2019 |
Year ended 31 January 2018 |
|
|
|
(Adjusted*) |
|
$000s |
£000s |
£000s |
Cash flows from operating activities |
|
|
|
(Loss) / profit before income tax |
(33,910 |
) |
(25,556 |
) |
4,994 |
|
|
(33,910 |
) |
(25,556 |
) |
4,994 |
|
Adjusted for: |
|
|
|
Gain on remeasurement or derecognition of financial liabilities on
funding arrangements |
— |
|
— |
|
(539 |
) |
Loss on recognition of contingent consideration payable |
— |
|
2 |
|
754 |
|
Finance income |
(5 |
) |
(4 |
) |
(2,788 |
) |
Finance costs |
303 |
|
228 |
|
467 |
|
Unrealized foreign exchange loss / (gain) |
722 |
|
544 |
|
(408 |
) |
Depreciation |
695 |
|
524 |
|
644 |
|
Amortization of intangible fixed assets |
1,008 |
|
760 |
|
829 |
|
Loss on disposal of assets |
14 |
|
10 |
|
43 |
|
Increase / (decrease) in provisions |
2 |
|
1 |
|
19 |
|
Impairment of goodwill and intangible assets |
— |
|
— |
|
3,985 |
|
Share-based
payment |
878 |
|
661 |
|
4,743 |
|
Adjusted (loss) / profit from operations before changes in
working capital |
(30,293) |
(22,830 |
) |
12,743 |
|
|
|
|
|
Decrease / (increase) in trade and other receivables |
6,186 |
|
4,662 |
|
(2,210 |
) |
(Decrease) / increase in deferred revenue |
(3,577 |
) |
(2,696 |
) |
(36,898 |
) |
(Decrease) / increase in trade and other payables |
(1,332 |
) |
(1,004 |
) |
68 |
|
Cash used by operations |
(29,016 |
) |
(21,868 |
) |
(26,297 |
) |
|
|
|
|
Contingent consideration paid |
(728 |
) |
(549 |
) |
(192 |
) |
Taxation received |
8,272 |
|
6,234 |
|
159 |
|
Research and development expenditure credit received |
685 |
|
516 |
|
(333 |
) |
Net cash used by operating activities |
(20,787) |
(15,667 |
) |
(26,663 |
) |
|
|
|
|
Investing activities |
|
|
|
Purchase of property, plant and equipment |
(212 |
) |
(160 |
) |
(119 |
) |
Purchase of intangible assets |
(142 |
) |
(107 |
) |
(6 |
) |
Interest received |
5 |
|
4 |
|
4 |
|
Net cash used by investing activities |
(349) |
(263 |
) |
(121 |
) |
|
|
|
|
Financing activities |
|
|
|
Proceeds from issue of share capital |
50,000 |
|
38,759 |
|
34,648 |
|
Transaction costs on share capital issued |
(930 |
) |
(701 |
) |
(1,313 |
) |
Proceeds from exercise of share options |
1 |
|
1 |
|
102 |
|
Repayment of lease liabilities |
(435 |
) |
(328 |
) |
(281 |
) |
Repayment of lease interest |
(40 |
) |
(30 |
) |
(43 |
) |
Net cash generated from financing activities |
48,596 |
37,701 |
|
33,113 |
|
|
|
|
|
Increase / (decrease) in cash and cash
equivalents |
27,460 |
21,771 |
|
6,329 |
|
Effect of exchange rates on cash and cash
equivalents |
1,147 |
|
(212 |
) |
427 |
|
Cash and cash equivalents at beginning of the period /
year |
35,638 |
|
26,858 |
|
20,102 |
|
Cash and cash equivalents at end of the period /
year |
64,245 |
|
48,417 |
|
26,858 |
|
* Please refer to the Company’s annual report as
filed on Form 20-F for accompanying notes to these consolidated
financial statements.
Consolidated Statement of Changes in
Equity (derived from audited information)
Eleven months ended December
31, 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 February 1, 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 15) |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
(5 |
) |
(5 |
) |
At February 1, 2019 (Adjusted*) |
1,604 |
|
92,806 |
|
1,148 |
|
3,027 |
|
19,993 |
|
56 |
|
(76,097 |
) |
42,537 |
|
Loss for the period |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
(22,032 |
) |
(22,032 |
) |
Total comprehensive loss for the
period |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
(22,032 |
) |
(22,032 |
) |
New share capital issued |
1,754 |
|
37,005 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
38,759 |
|
Transaction costs on share capital
issued |
— |
|
(701 |
) |
— |
|
— |
|
— |
|
— |
|
— |
|
(701 |
) |
Warrant expense |
— |
|
— |
|
15 |
|
— |
|
— |
|
— |
|
— |
|
15 |
|
Share options exercised |
1 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
1 |
|
Share-based payment |
— |
|
— |
|
646 |
|
— |
|
— |
|
— |
|
— |
|
646 |
|
Transfer |
— |
|
— |
|
(510 |
) |
— |
|
— |
|
— |
|
510 |
|
— |
|
At December 31, 2019 |
3,359 |
|
129,110 |
|
1,299 |
|
3,027 |
|
19,993 |
|
56 |
|
(97,619 |
) |
59,225 |
|
Year ended January 31, 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 February 1, 2018 |
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 February 1, 2018 (Adjusted*) |
736 |
|
60,237 |
|
6,743 |
|
3,027 |
|
19,993 |
|
37 |
|
(93,925 |
) |
(3,152 |
) |
Profit for the year |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
7,490 |
|
7,490 |
|
Currency translation adjustment |
— |
|
— |
|
— |
|
— |
|
— |
|
19 |
|
— |
|
19 |
|
Total comprehensive profit for the
year |
— |
|
— |
|
— |
|
— |
|
— |
|
19 |
|
7,490 |
|
7,509 |
|
New share capital issued |
864 |
|
33,784 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
34,648 |
|
Transaction costs on share capital |
— |
|
(1,313 |
) |
— |
|
— |
|
— |
|
— |
|
— |
|
(1,313 |
) |
Share options exercised |
4 |
|
98 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
102 |
|
Share-based payment |
— |
|
— |
|
4,743 |
|
|
— |
|
— |
|
— |
|
4,743 |
|
Transfer |
|
|
(10,338 |
) |
|
|
|
10,338 |
|
— |
|
At January 31, 2019 (Adjusted*) |
1,604 |
|
92,806 |
|
1,148 |
|
3,027 |
|
19,993 |
|
56 |
|
(76,097 |
) |
42,537 |
|
* Please refer to the Company’s annual report as filed on Form
20-F for accompanying notes to these consolidated financial
statements.
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