Full Press Release Details
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.
Ridinilazole for C. difficile Infection ( CDI )
| Quarter | Number of patients enrolled | |||
| Q1 2019 | 9 | |||
| Q2 2019 | 21 | |||
| Q3 2019 | 43 | |||
| Q4 2019 | 78 | |||
| Q1 2020 | 101 |
Key Operational Updates
Financial Highlights
About C. difficile Infection
Clostridioides 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 Enterobacteriaceae
Enterobacteriaceae are a family of bacteria responsible for severe and often deadly infections. They account for 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.
There 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
About Summit Therapeutics
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
Forward Looking Statements
Any 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 |
This 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 $000s | December 31, 2019 000s | January 31, 2019 (Adjusted*) 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 |
Consolidated Statement of Cash flows (derived from audited information)
For the eleven months ended December 31, 2019
| Year ended 31 December 2019 $000s | Year ended 31 December 2019 000s | Year ended 31 January 2018 (Adjusted*) 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 |
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 | Currency translation reserve 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 | Currency translation reserve 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 |