Close

Summit Therapeutics Reports Financial Results for the Fourth Period and Eleven Months Ended December 31, 2019, and Operational Progress

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.

QuarterNumber of patients enrolled
Q1 20199 
Q2 201921 
Q3 201943 
Q4 201978 
Q1 2020101 

Discuva Platform

Enterobacteriaceae

Gonorrhea

Key Operational Updates

Financial Highlights

* 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 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.

About Gonorrhea
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 urgently needed.

About Summit Therapeutics
Summit 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 Officeinvestors@summitplc.com

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, 2019Eleven months ended December 31, 2019 Year ended January 31, 2019
   (Adjusted*)
 $000s£000s£000s
    
Revenue774 583 43,012 
    
Other operating income20,120 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 income5 4 2,788 
Finance costs(303)(228)(467)
(Loss) / profit before income tax(33,910)(25,556)4,994 
    
Income tax4,676 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) pence9 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, 2019December 31, 2019January 31, 2019
   (Adjusted*)
 $000s£000s£000s
ASSETS   
Non-current assets   
Goodwill2,407 1,814 1,814 
Intangible assets13,203 9,950 10,604 
Property, plant and equipment1,548 1,167 1,540 
 17,158 12,931 13,958 
Current assets   
Trade and other receivables10,769 8,116 13,491 
Current tax receivable4,855 3,659 6,328 
Cash and cash equivalents64,245 48,417 26,858 
 79,869 60,192 46,677 
Total assets97,027 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 capital4,457 3,359 1,604 
Share premium account171,316 129,110 92,806 
Share-based payment reserve1,724 1,299 1,148 
Merger reserve4,017 3,027 3,027 
Special reserve26,529 19,993 19,993 
Currency translation reserve74 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 costs303 228 467 
Unrealized foreign exchange loss / (gain)722 544 (408)
Depreciation695 524 644 
Amortization of intangible fixed assets1,008 760 829 
Loss on disposal of assets14 10 43 
Increase / (decrease) in provisions2 1 19 
Impairment of goodwill and intangible assets  3,985 
Share-based payment878 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 receivables6,186 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 received8,272 6,234 159 
Research and development expenditure credit received685 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 received5 4 4 
Net cash used by investing activities(349)(263)(121)
    
Financing activities   
Proceeds from issue of share capital50,000 38,759 34,648 
Transaction costs on share capital issued(930)(701)(1,313)
Proceeds from exercise of share options1 1 102 
Repayment of lease liabilities(435)(328)(281)
Repayment of lease interest(40)(30)(43)
Net cash generated from financing activities48,59637,701 33,113 
    
Increase / (decrease) in cash and cash equivalents27,46021,771 6,329 
Effect of exchange rates on cash and cash equivalents1,147 (212)427 
Cash and cash equivalents at beginning of the period / year35,638 26,858 20,102 
Cash and cash equivalents at end of the period / year64,245 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

GroupShare 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 issued1,754 37,005      38,759 
Transaction costs on share capital issued (701)     (701)
Warrant expense  15     15 
Share options exercised1       1 
Share-based payment  646     646 
Transfer  (510)   510  
At December 31, 20193,359 129,110 1,299 3,027 19,993 56 (97,619)59,225 

Year ended January 31, 2019

GroupShare 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, 2018736 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 issued864 33,784      34,648 
Transaction costs on share capital (1,313)     (1,313)
Share options exercised4 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.

Primary Logo