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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended December 31, 2015
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from ______________ to _______________
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SHELL COMPANY PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Date of event requiring this shell company report_________________
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Title of each class
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Name of each exchange on which registered
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Ordinary Shares, nominal value 005p each
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American Depositary Shares, each representing two
ordinary shares
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NASDAQ Capital Market
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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U.S. GAAP
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International Financial Reporting Standards as issued by the
International Accounting Standards Board
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Other
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PART I
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| 6 | |
| 6 | |
| 6 | |
| 42 | |
| 83 | |
| 83 | |
| 97 | |
| 111 | |
| 114 | |
| 117 | |
| 119 | |
| 123 | |
| 124 | |
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PART II
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| 128 | |
| 128 | |
| 128 | |
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ITEM 16. [RESERVED]
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| 129 | |
| 129 | |
| 129 | |
| 130 | |
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| 130 | |
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PART III
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| 132 | |
| 132 | |
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Phase I
clinical trials involve the assessment of the safety, pharmacodynamics and pharmacokinetics of a drug candidate in a small group of human subject (typically 20 to 100 patients).
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Phase la
is a Phase I single ascending dose study, where a small number of participants receive a single dose, before ascending to the next dose once safety is determined.
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Phase lb
is a Phase I multiple ascending dose study, where a number of participants receive multiple low doses before escalating the dose for further groups to a predetermined level.
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Phase ll
clinical trials involve the assessment in patients of a drug to determine its safety, dose range and preliminary efficacy (typically 100 to 300 patients).
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Phase lla
is a form of Phase II study designed specifically to assess dosing requirements.
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Phase llb
is a form of Phase II study specifically designed to study efficacy.
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Phase lll
is a clinical trial involving the assessment of the efficacy and safety of a drug, usually in comparison with a marketed product or a placebo, in the patient population for which it is intended (typically 1,000 to 3,000 patients).
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our estimates regarding losses, expenses, future revenues, capital requirements and needs for additional financing;
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the successful commercialization and manufacturing of our licensed products, products originally licensed to DARA, and any future product we may commercialize;
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the success and timing of our preclinical studies and clinical trials;
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the difficulties in obtaining and maintaining regulatory approval of our product candidates, and the labeling under any approval we may obtain;
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the success and timing of the potential commercial development of our product candidates and any product candidates we may acquire in the future;
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our plans and ability to develop and commercialize our product candidates and any product candidates we acquire in the future;
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the rate and degree of market acceptance of any of our product candidates;
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the successful development of our commercialization capabilities, including sales and marketing capabilities;
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obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology;
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the success of competing therapies and products that are or become available;
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the success of any future acquisitions;
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the potential we will incur financial obligations to former DARA stockholders;
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the difficulties of integrating DARA’s former business into our own;
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the outcome of the Company’s remediation plan and approach to the material weakness in internal control over financial reporting;
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the impact of government laws and regulations;
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regulatory and political developments in the United Kingdom, the United States and other foreign countries;
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the difficulties doing business internationally;
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the ownership of our Ordinary Shares and Depositary Shares;
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our failure to recruit or retain key scientific or management personnel or to retain our executive officers;
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the impact and costs and expenses of any litigation we may be subject to now or in the future; and
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the performance of third parties, including joint venture partners, our sales force, our collaborators, third-party suppliers and parties to our licensing agreements.
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IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISORS.
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OFFER STATISTICS AND EXPECTED TIMETABLE.
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KEY INFORMATION.
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A.
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Selected Financial Data.
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(£’s in thousands, except share and per share data; all from continuing operations)
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As of and for the
Year Ended
December 31,
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2015
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2014
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2013
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Consolidated Statement of Comprehensive Income Data:
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Total revenue
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1,375 | 157 | 147 | |||||||||
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Loss from operations
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(12,918 | ) | (9,947 | ) | (4,499 | ) | ||||||
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Loss before tax
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(11,232 | ) | (10,100 | ) | (4,883 | ) | ||||||
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Loss after tax attributable to the owners of the parent
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(10,099 | ) | (9,082 | ) | (4,084 | ) | ||||||
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Total other comprehensive income, net of tax
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399 | (151 | ) | 5 | ||||||||
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Total comprehensive loss attributable to the owners of the parent
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(9,700 | ) | (9,233 | ) | (4,079 | ) | ||||||
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Loss Per Share Data:
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Basic and diluted loss per ordinary share—pence
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(36p | ) | (101p | ) | (71p | ) | ||||||
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Cash dividends declared per ordinary share
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— | — | — | |||||||||
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Weighted average number of ordinary shares used
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28,229,814 | 9,026,347 | 5,715,576 | |||||||||
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Consolidated Statement of Financial Position Data:
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Non-Current assets
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43,710 | 15,035 | 1,079 | |||||||||
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Current assets
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20,331 | 31,628 | 4,095 | |||||||||
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Cash and cash equivalents
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16,175 | 30,325 | 2,387 | |||||||||
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Total assets
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64,041 | 46,663 | 5,174 | |||||||||
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Non-Current liabilities
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8,055 | 1,842 | 2,119 | |||||||||
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Borrowings
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1,508 | 1,488 | 2,119 | |||||||||
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Current liabilities
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9,099 | 2,832 | 2,295 | |||||||||
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Total liabilities
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17,154 | 4,674 | 4,414 | |||||||||
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Total equity
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46,887 | 41,989 | 760 | |||||||||
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Total equity and liabilities
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64,041 | 46,663 | 5,174 | |||||||||
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High ($)
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Low ($)
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|||||
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Recent Monthly Data
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||||||
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April 2016 (through April 1, 2016)
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1.4204 | 1.4204 | ||||
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March 2016
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1.4514 | 1.3948 | ||||
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February 2016
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1.4580 | 1.3926 | ||||
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January 2016
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1.4686 | 1.4167 | ||||
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December 2015
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1.5213 | 1.4746 | ||||
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November 2015
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1.5428 | 1.5040 | ||||
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October 2015
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1.5475 | 1.5162 | ||||
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Average
Rate ($) (1)
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Annual Data (12-month period ended December 31)
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||||
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2015
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1.5250 | |||
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2014
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1.6461 | |||
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2013
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1.5667 | |||
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2012
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1.5924 | |||
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2011
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1.6105 | |||
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(1)
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The average rates were calculated by taking the simple average of the daily noon buying rates, as published by the Federal Reserve Bank of New York, on the last day of each month during the period.
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B.
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Capitalization and Indebtedness
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C.
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Reasons for the Offer and Use of Proceeds
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D.
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Risk Factors
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successfully complete development activities, including preclinical development and clinical trials for its product candidates;
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complete and submit new drug applications to the European Medicines Agency (the “EMA”), the Medicines and Healthcare Products Regulatory Agency in the United Kingdom (the “MHRA”), the United States Food and Drug Administration (the “FDA”), and any other foreign regulatory authorities, and obtain regulatory approval for testing and for products for which there is a commercial market;
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set a commercially viable price for its products;
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obtain commercial qualities of its products at acceptable cost levels;
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develop a commercial organization capable of sales, marketing and distribution in its markets; and
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obtain adequate reimbursement from third-parties, including government, departments and healthcare payors.
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the success of products acquired in connection with the acquisition of DARA and the commercialization of other assets;
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the initiation, progress, timing, costs and results of clinical trials for its product candidates and future product candidates it may in-license or acquire;
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the attainment of milestones and the need to make any royalty payments on any of its product candidates or any other future product candidates;
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the number and characteristics of product candidates it in-license or acquires and develop;
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the outcome, timing and cost of regulatory approvals by the EMA, the MHRA, the FDA and any other comparable foreign regulatory authorities, including the potential for such regulatory authorities to require that Midatech perform more studies than those it currently expects;
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the cost of filing, prosecuting, defending and enforcing any patent claims or other intellectual property rights;
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the effect of competing technological and market developments; and
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the cost of establishing sales, marketing and distribution capabilities for any product candidates for which it may receive regulatory approval.
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$0.07 per CVR if gross sales of Oravig and Gelclair, two drugs acquired in the acquisition of DARA, equal or exceed $15.0 million but are less than $16.5 million, in the aggregate, for the fiscal year ending December 31, 2016;
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$0.09 per CVR if gross sales of Oravig and Gelclair equal or exceed $16.5 million but are less than $18.0 million, in the aggregate, for the fiscal year ending December 31, 2016; or
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$0.11 per CVR if gross sales of Oravig and Gelclair equal or exceed $18.0 million, in the aggregate, for the fiscal year ending December 31, 2016.
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$0.11 per CVR if gross sales of Oravig and Gelclair, two drugs acquired in the acquisition of DARA, equal or exceed $15.0 million but are less than $16.5 million, in the aggregate, for the fiscal year ending December 31, 2017;
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$0.13 per CVR if gross sales of Oravig and Gelclair equal or exceed $16.5 million but are less than $18.0 million, in the aggregate, for the fiscal year ending December 31, 2017; or
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·
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$0.16 per CVR if gross sales of Oravig and Gelclair equal or exceed $18.0 million, in the aggregate, for the fiscal year ending December 31, 2017.
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delay or failure in reaching agreement with the applicable regulatory authorities on a trial design that Midatech is able to execute;
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delay or failure in obtaining authorization to commence a trial or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical study;
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delay or failure in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”), and clinical trial providers and sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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delay or failure in obtaining institutional review board approval (“IRB”) or the approval of other reviewing entities, including regulatory authorities, to conduct a clinical trial at each site;
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withdrawal of clinical trial sites from Midatech’s clinical trials as a result of changing standards of care or the ineligibility of a site to participate in Midatech’s clinical trials;
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delay or failure in recruiting and enrolling suitable subjects to participate in a trial;
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delay or failure in having subjects complete a trial or return for post-treatment follow-up;
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clinical sites and investigators deviating from trial protocol, failing to conduct the trial in accordance with regulatory requirements, or dropping out of a trial;
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inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication;
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failure of Midatech’s third party clinical trial managers to satisfy their contractual duties or meet expected deadlines;
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failure to receive the recommendation of the United Kingdom National Institute for Health and Care Excellence (“NICE”);
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delay or failure in adding new clinical trial sites;
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ambiguous or negative interim results, or results that are inconsistent with earlier results;
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feedback from the EMA, the MHRA, the FDA, the IRB, data safety monitoring boards, or other regulatory authority, or results from earlier stage or concurrent preclinical and clinical studies, which might require modification to the protocol;
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decisions by the EMA, the MHRA, the FDA, the IRB, other regulatory authorities, or Midatech, or recommendation by a data safety monitoring board or other regulatory authority, to suspend or terminate clinical trials at any time for safety issues or for any other reason;
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unacceptable risk-benefit profile or unforeseen safety issues or adverse side effects;
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failure to demonstrate a benefit from using a drug;
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manufacturing, including manufacturing or obtaining from third parties sufficient quantities of a product candidate for use in clinical trials; or
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changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.
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disagreement with the design or implementation of Midatech’s clinical trials;
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failure to demonstrate that a product candidate is safe and effective for its proposed indication;
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failure of clinical trials to meet the level of statistical significance required for approval;
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failure to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
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disagreement with Midatech’s interpretation of data from preclinical studies or clinical trials;
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the insufficiency of data collected from clinical trials of Midatech’s product candidates to support the submission and filing of a new drug application or other submission or to obtain regulatory approval;
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disapproval of the manufacturing processes or facilities of third party manufacturers, if any, with whom Midatech contracts for clinical and commercial supplies; or
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changes in the approval policies or regulations that render Midatech’s preclinical and clinical data insufficient for approval.
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Midatech may suspend marketing of such product;
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regulatory authorities may withdraw approvals of such product or may require additional warnings on the label;
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Midatech may be required to develop a Risk Mitigation Strategy for each product or, if a strategy is already in place, to incorporate additional requirements;
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Midatech may be required to conduct post-market studies; and
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Midatech could be sued and held liable for harm caused to subjects or patients.
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issue warning letter or untitled letters;
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mandate modifications to, or the withdrawal of, marketing and promotional materials or require Midatech to provide corrective information to healthcare practitioners;
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require Midatech to enter into a consent decree, which can include the imposition of various fines against Midatech, reimbursements of inspection costs, required due dates for specific actions and penalties for noncompliance;
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seek an injunction or impose civil or criminal penalties or monetary fines;
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suspend or withdraw its regulatory approval;
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suspend any ongoing clinical studies;
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refuse to approve pending applications or supplements to applications filed;
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suspend or impose restrictions on operations, the products, manufacturing or Midatech itself;
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require Midatech to change its product labeling; or
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seize or detain products, refuse to permit the import or export of products or require Midatech to initiate a product recall.
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Zuplenz, the only FDA-approved oral soluble film indicated for
moderately emetogenic chemotherapy-induced nausea and vomiting (“CINV”), radiotherapy-induced nausea and vomiting (“RINV”), and post-operative nausea and vomiting (“PONV”)
;
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Gelclair, an FDA-cleared product indicated for the management and relief of pain due to oral mucositis;
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Oravig, an orally dissolving buccal tablet approved for oral thrush; and
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Soltamox, an FDA-approved oral liquid solution of tamoxifen citrate, for the prevention of breast cancer.
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the prevalence and severity of any side effects;
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the efficacy and potential advantages of alternative treatments;
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price;
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the willingness of physicians to prescribe Midatech’s products; and
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sufficient coverage or reimbursement by the Centers for Medicare and Medicaid Services and third party payers.
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Directive 2001/83/EC of 6 November 2001 on the European Community code as regards medicinal products for human use;
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Commission Directive 2003/94/EC of October 8, 2003 enforcing principles and guidelines of
good manufacturing practice as they related to medicinal products and investigational medicinal products for human use;
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Commission Directive 2005/28/EC of April 8, 2005 establishing the principles and guidelines for good clinical practice relating to investigational medicinal products for human use, and the authorization requirements for the manufacturing or import thereof; and
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Council Directive 89/105/EEC, of December 21, 1988, addressing the transparency of measures that regulate pricing of medicinal products for human use and their inclusion in national health insurance systems.
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the scope of Midatech’s patents provides and will provide Midatech with exclusivity with respect to any or all of its products and technologies, as well as any other technologies and/or products that address the same problems as Midatech’s technologies and products by a different means, whether in the same manner as Midatech or not;
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pending or future patent applications will be issued as patents;
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Midatech’s patents, and/or those patents to which Midatech is licensed, are and will remain valid and enforceable and will not be subject to invalidity or revocation proceedings and that such proceedings will not result in a complete or partial loss of rights;
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Midatech’s entitlement to exploit patents from time to time (including patents registered solely in Midatech or its affiliates’ name or in the joint names of Midatech or an affiliate and a third party or patents which are licensed to Midatech) is and will be sufficient to protect Midatech’s core intellectual property rights against third parties, its commercial activities from competition or to support comprehensively its ability to develop and market its proposed products either now or in the future;
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the lack of any particular patents or rights to exploit any particular patents, and the scope of Midatech’s patents, will not have a material adverse effect on Midatech’s ability to develop and market its proposed products, either now or in the future;
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Midatech has or will have the resources to pursue any infringer of: (i) patents registered in its name (whether solely or jointly with a third party) from time to time; or (ii) patents licensed to Midatech where Midatech or an affiliate has the financial responsibility to bring such infringement actions pursuant to the relevant license agreement;
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Midatech will develop technologies or products which are patentable, either alone or in conjunction with third parties;
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the ownership, scope or validity of any patents registered in Midatech’s name (either solely or jointly) from time to time will not be challenged by third parties, including parties with whom Midatech, or any affiliate, has entered into collaboration projects or co-ownership arrangements and that any such challenge will not be successful;
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any patent or patent application owned solely or jointly by Midatech will not be challenged on grounds that Midatech failed to identify the correct inventors or that Midatech failed to comply with its duty of disclosure to the United States Patent and Trademark Office or any equivalent office in a foreign jurisdiction having a disclosure requirement;
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any issued patent in Midatech’s sole or joint name from time to time will not be challenged in one or more post-grant proceedings, including but not limited to
inter partes
review, derivation proceedings, interferences, and that like; and that any such challenge will not result in a complete or partial loss of rights to such issued patent or patents;
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any patent applications in Midatech’s sole or joint name from time to time will not be opposed by any third party, including parties to collaboration, co-existence and any other contractual relationship with Midatech or any of its members;
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the license agreements between Midatech and third parties are and will be valid and subsisting in the future or until their expiry dates, and that Midatech has complied with its contractual obligations under the license agreements;
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all intellectual property capable of being commercialized that is or has been generated pursuant to collaboration agreements between Midatech and third parties will be or has been identified;
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all intellectual property generated pursuant to collaboration agreements and to which Midatech has a contractual entitlement or generated by employees has been lawfully assigned into Midatech’s sole name (or to one of its subsidiaries);
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in respect of all intellectual property generated pursuant to a collaboration agreement between Midatech and a third party to which Midatech and that third party have a joint contractual entitlement, that such intellectual property has been lawfully assigned into joint names and the rights between Midatech and that third party are properly regulated by a co-ownership agreement; and
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beyond contractual warranties, the licensors of intellectual property to Midatech or affiliate own the relevant patents and that those patents have not and will not be the subject of, or subject to, infringement, invalidity or revocation actions.
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decreased demand for any product candidates or product that Midatech may develop;
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·
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termination of clinical trial sites or entire trial programs;
|
|
|
·
|
significant negative media attention and injury to Midatech’s reputation;
|
|
|
·
|
withdrawal of clinical trial participants;
|
|
|
·
|
significant costs to defend the related litigation;
|
|
|
·
|
substantial monetary awards to trial subjects or patients;
|
|
|
·
|
loss of revenue;
|
|
|
·
|
diversion of management and scientific resources from Midatech’s business operations; and
|
|
|
·
|
the inability to commercialize any products that Midatech may develop.
|
|
|
·
|
have economic or business interests or goals that are inconsistent with those of Midatech and be in a position to take or influence actions contrary to Midatech’s interests and plans, which may create impasses on decisions and affect Midatech’s ability to implement its strategies;
|
|
|
·
|
veto proposals in respect of joint venture operations;
|
|
|
·
|
be unable or unwilling to fulfill their obligations under the joint venture or other agreements; or
|
|
|
·
|
experience financial or other difficulties.
|
|
|
·
|
the federal healthcare anti-kickback statute prohibits any person from, among other things, knowingly and willfully offering, paying, soliciting, or receiving remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchasing, leasing, ordering or arranging for or recommending of any good or service for which payment may be made, in whole or in part, under federal and state healthcare programs such as Medicare and Medicaid. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand, and prescribers, purchasers, and formulary managers on the other. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly and practices that involve remuneration to those who prescribe, purchase, or recommend pharmaceutical and biological products, including certain discounts, or engaging consultants for as speakers or consultants, may be subject to scrutiny if they do not fit squarely within the exemption or safe harbor. Midatech’s practices may not in all cases meet all of the criteria for safe harbor protection from anti-kickback
liability. Moreover, there are no safe harbors for many common practices, such as educational and research grants or patient assistance programs;
|
|
|
·
|
the federal civil False Claims Act imposes civil penalties, and provides for whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, claims for payment of government funds that are false or fraudulent, or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government, or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government. In recent years, several pharmaceutical and other healthcare companies have faced enforcement actions under the federal False Claims Act for, among other things, allegedly submitting false or misleading pricing information to government health care programs and providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies have faced enforcement actions for causing false claims to be submitted because of the company’s marketing the product for unapproved, and thus non-reimbursable, uses. In addition, violation of the federal anti-kickback statute may be actionable under the federal civil False Claims Act. Criminal prosecution is possible for making or presenting a false or fictitious or fraudulent claim to the federal government;
|
|
|
·
|
the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act, among other things, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. HIPAA also prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services;
|
|
|
·
|
the federal Physician Payment Sunshine Act, being implemented as the Open Payments Program, requires certain manufacturers of drugs, devices, biologics and medical supplies to engage in extensive tracking of payments and other transfers of value to physicians and teaching hospitals, including physician ownership and investment interests, and to publicly report such data. Pharmaceutical and biological manufacturers with products for which payment is available under Medicare, Medicaid or the State Children’s Health Insurance Program started tracking such payments in August 2013, and must submit a report on or before the 90th day of each calendar year disclosing reportable payments made in the previous calendar year; and
|
|
|
·
|
analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by nongovernmental third party payors, including private insurers. Several states also require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products in those states and to report gifts and payments to individual health care providers in those states. Some of these states also prohibit certain marketing-related activities, including the provision of gifts, meals, or other items to certain health care providers. In addition, several states require pharmaceutical companies to implement compliance programs or marketing codes.
|
|
·
|
currency exchange rate fluctuations;
|
|
·
|
restrictions on repatriation of earnings;
|
|
·
|
efforts to develop an international sales, marketing and distribution organization, which may increase
Midatech’s expenses, divert management’s attention from the acquisition or development of product
candidates or cause it to forgo profitable licensing opportunities in these geographies;
|
|
·
|
unexpected changes in foreign laws and regulatory requirements, including pharmaceutical
regulations;
|
|
·
|
difficulty of effective enforcement of contractual provisions in local jurisdictions;
|
|
·
|
inadequate intellectual property (including confidentiality) protection in foreign countries;
|
|
·
|
trade-protection measures, import or export licensing requirements and fines, penalties or suspension
or revocation of export privileges; and
|
|
·
|
changes in a specific country’s or a region’s political or economic conditions, particularly in
emerging markets.
|
|
|
·
|
issue stock that would dilute its stockholders’ percentage of ownership;
|
|
|
·
|
incur debt and assume liabilities; and
|
|
|
·
|
incur amortization expenses related to intangible assets or incur large and immediate write-offs.
|
|
|
·
|
problems integrating the purchased business, products or technologies, including the failure to achieve the expected benefits and synergies;
|
|
|
·
|
increases to Midatech’s expenses;
|
|
|
·
|
the failure to have discovered undisclosed liabilities of the acquired asset or company;
|
|
|
·
|
diversion of management’s attention from their day-to-day responsibilities;
|
|
|
·
|
harm to Midatech’s operating results or financial condition;
|
|
|
·
|
entrance into markets in which Midatech has limited or no prior experience; and
|
|
|
·
|
potential loss of key employees, particularly those of the acquired entity.
|
|
|
·
|
the progress of preclinical development, laboratory testing and clinical trials of Midatech’s product candidates;
|
|
|
·
|
the results from Midatech’s clinical programs and any future trials Midatech may conduct;
|
|
|
·
|
developments in the clinical trials of potentially similar competitive products;
|
|
|
·
|
European Medicines Agency, U.S. Food and Drug Administration or international regulatory actions;
|
|
|
·
|
failure of any of Midatech’s product candidates, if approved, to achieve commercial success;
|
|
|
·
|
announcements of the introduction of new products by Midatech or its competitors;
|
|
|
·
|
market conditions in the pharmaceutical and biotechnology sectors;
|
|
|
·
|
developments concerning intellectual property rights;
|
|
|
·
|
litigation or public concern about the safety of Midatech’s products;
|
|
|
·
|
market research and comments by securities analysts;
|
|
|
·
|
actual and anticipated fluctuations in Midatech’s operating results;
|
|
|
·
|
deviations in Midatech’s operating results from the estimates of securities analysts;
|
|
|
·
|
rumors relating to Midatech or its competitors;
|
|
|
·
|
additions or departures of key personnel;
|
|
|
·
|
third party reimbursement policies;
|
|
|
·
|
developments concerning current or future collaborations, strategic alliances, joint ventures or similar relationships; and
|
|
|
·
|
reviews of long-term values of Midatech’s assets, which could lead to impairment charges that could reduce Midatech’s earnings.
|
|
·
|
the requirement to file periodic reports and financial statements with the SEC as frequently or as promptly as United States companies with securities registered under the Exchange Act;
|
|
·
|
the requirement to file financial statements prepared in accordance with GAAP;
|
|
·
|
the proxy rules, which impose certain disclosure and procedural requirements for proxy solicitations; and
|
|
·
|
the requirement to comply with Regulation FD, which imposes certain restrictions on the selective disclosure of material information.
|
|
|
·
|
The deficiency in the design and operating effectiveness of internal controls related to the accounting treatment for a non-routine, complex transaction relating to the fair value of share options and warrants assumed by Midatech being required to be treated as a derivative financial liability rather than as an equity instrument. The assumption of these options and warrants was associated with the acquisition of DARA.
|
|
INFORMATION ON THE COMPANY.
|
|
A.
|
History and Development of the Company
|
|
|
·
|
the fit-out and equipping of new laboratory and office facilities at the Group’s headquarters facility near Oxford, United Kingdom, costing £0.42 million;
|
|
|
·
|
an upgrade of the Group’s information technology infrastructure, including the acquisition of a new accounting and enterprise resource planning software, costing £0.14 million; and
|
|
|
·
|
ongoing development of commercial scale manufacturing equipment for the Group’s sustained release technology, costing £0.18 million.
|
|
B.
|
Business Overview
|
|
|
·
|
Zuplenz
®
(ondansetron) Oral Soluble Film
, the only FDA-approved oral soluble film indicated for CINV, RONV and PONV;
|
|
|
·
|
Gelclair® oral rinse gel
, an FDA-cleared product indicated for the management and relief of pain due to oral mucositis;
|
|
|
·
|
Oravig® (miconazole)
, an orally dissolving buccal tablet approved for oral thrush; and
|
|
|
·
|
Soltamox®
, an FDA-approved oral liquid solution of tamoxifen citrate, for the prevention of breast cancer.
|
|
Year ended December 31,
|
||||||||||||
|
(£’s in thousands)
|
2015
|
2014
|
2013
|
|||||||||
|
Revenue (United States)
|
677 | -- | 147 | |||||||||
|
Revenue (Europe) (1)
|
98 | 25 | -- | |||||||||
|
Grant revenue (2)
|
600 | 132 | -- | |||||||||
|
Total Revenue
|
1,375 | 157 | 147 | |||||||||
|
|
_______________
|
|
|
(1)
|
Including the United Kingdom.
|
|
|
(2)
|
Grant revenue is not analyzed by geography.
|
|
|
Midatech’s business model has four components:
|
|
|
·
|
In-House Products.
Development and commercialization of products is done in-house without engaging partners to support the product. This applies particularly to oncology applications.
|
|
|
·
|
Partner Products.
Development and commercialization of Midatech’s partner-supported and licensed products, principally in diabetes, ophthalmology and neuroscience.
|
|
|
·
|
Acquisitions
. Acquisitions of later stage, strategic opportunities with complementary focused portfolios, such as DARA; or complementary technologies that are synergistic to that of Midatech, accelerate revenue, and are value accretive.
|
|
|
·
|
Establish Worldwide Commercial Organization
. Build on to Midatech’s U.S. commercial operations and establish a European commercial organization upon approval of its own product candidates.
|
|
|
·
|
Research and Development Collaborations
. In the near term, revenues are anticipated to be driven by collaborations such as those that currently exist and with new potential customers using Midatech’s technologies to address their pharmaceutical challenges.
|
|
|
·
|
Commercial Operations
. Midatech expects that the main growth driver in the period from 2016 to 2018 will be the Midatech US business, with sales coming from its existing commercial product portfolio.
|
|
|
·
|
Partner Licensing and Royalty Deals.
In the period from 2016 to 2018, revenue growth is anticipated to be supported by licensing transactions from those partnerships outlined herein, as well as new potential partnerships, with possible product royalties realized from 2016 to 2017.
|
|
|
·
|
In-House Products Commercialization.
In the third stage of Midatech’s evolution, expected to be from 2018 to 2019, Midatech’s own products are anticipated to reach market in the specialized orphan sector, and Midatech’s commercial sales organization to be deployed initially in the United States and then in Europe, to drive sales and revenue growth from Midatech’s own product launches.
|
|
|
·
|
Acquisitional.
In support of and in addition to above, Midatech may from time to time seek value accretive and synergistic target companies, such as DARA, and portfolios, such as Zuplenz, that would accelerate its own product recurring revenues and profitability via products in market.
|
|
|
Midatech believes the key potential advantages of its core GNP platform technology are:
|
|
|
·
|
Solubility.
Carbohydrate properties of the GNP drug conjugates enable the transport of non-soluble and lipid soluble compounds to sites of disease.
|
|
|
·
|
Releasability.
GNP drug conjugates are designed to release the active compound inside the cell as a result of chemistry that keeps the compound stable in plasma, but dissociates and delivers the payload in the cell.
|
|
|
·
|
Mobility.
Due to the size and charge of the drug conjugates, compounds may be transported to sites of disease that are otherwise very difficult to reach, including across membranes, between cells and through cells to invading tumor margins.
|
|
|
·
|
Targetability.
Flexible functionalization of GNP chemistry and multiple binding sites provides a platform for several therapeutics and targeting agents all on a single nanoparticle which, together with solubility and mobility characteristics, may enable targeting of disease sites.
|
|
|
·
|
Stability.
Peptides may be stabilized by GNP drug conjugates due to the fact that the peptides have less freedom to degrade when bound to the fixed platform.
|
|
|
·
|
Excretability
. Due to their small size, GNP drug conjugates are believed to exit cells and become eliminated via the kidneys and liver.
|
|
|
·
|
Compatibility.
As a result of their inertness, biocompatibility and small size, GNP drug conjugates are believed to evade and not disturb the immune system since they are likely not recognized by such cells.
|
|
|
·
|
Scalability.
Midatech, as a result of having its own cGMP certified manufacturing facility, can execute rapidly, at scale, from discovery through to clinical development.
|
|
|
·
|
Protected.
Midatech patents and trade secrets currently secure its position within the field of GNPs.
|
|
|
·
|
Oncology and Endocrinology
—a lead program in acromegaly, an endocrine disorder in which the body produces too much growth hormone, and a second program in carcinoid syndrome, an oncologic disorder of neuro-endocrine tumors; and
|
|
|
·
|
Ophthalmology
—in uveitis (inflammation of the eye).
|
|
|
·
|
Acromegaly and Carcinoid Syndrome.
Octreotide is an existing, immediate-release injection product used to decrease the production of growth hormone in people suffering acromegaly. It is also the most important form of treatment for carcinoid syndrome that occurs with carcinoid tumors (hormone producing cell tumors in the body). Midatech is looking to develop a sustained release version of this product, called “Q-Octreotide” that will compete with the market leader Sandostatin (marketed by Novartis). This project is undergoing a final formulation optimization and in vivo studies, and is expected to commence a Phase I pharmacokinetic trial in humans at the end of 2016. This will then lead to potential filings in 2017 and subsequent product sales in the United States and the European Union in 2018. Midatech will look to partner this program prior to commercialization.
|
|
|
·
|
Uveitis.
Uveitis is an inflammatory process affecting the iris, the ciliary body, the choroid layer or all or part of these structures of the eye. Significant vision loss can occur in up to 35% of children and adults with uveitis and total blindness as a result of uveitis accounts for 10% to 15% of all cases. Cyclosporine is an immunosuppressant compound that is marketed by Allergan for use of chronic dry eye syndromes. Current treatments for uveitis such as systemic or local immunosuppressants and corticosteroids have limited efficacy and poor side effect profile. A treatment that permanently controls inflammation, with a good short- and long-term safety profile, has yet to be developed. Midatech is pursuing in-house development of “Q-Cyclosporin” sustained release treatment for uveitis. This internally funded project is in its formulation phase and is anticipated to reach clinical stage in the second half of 2017. Clinical development is likely to be conducted through Phase Ib and Phase II studies, with marketing authorization filings potentially being approved in 2019.
|
|
|
·
|
concluding a license agreement with a third party in respect of any of the intellectual property rights comprising the subject matter of the agreement;
|
|
|
·
|
demonstrating therapeutic and/or diagnostic efficacy in an animal model derived from research sponsored by Midatech (or its affiliated companies);
|
|
|
·
|
demonstration of a diagnostic product in Phase I clinical trials arising from intellectual property rights; or
|
|
|
·
|
selling products made by Midatech, affiliated companies or licensees exploiting the intellectual property rights comprising the subject matter of the agreement which generate net sales royalties or net revenue royalties for CSIC.
|
|
Sales Amount
|
Royalty
|
|||
|
Net Sales to €1 million
|
6 | % | ||
|
Net Sales between €1 million and €9,999,999
|
5 | % | ||
|
Net Sales between €10 million and €99,999,999
|
4 | % | ||
|
Net Sales €100 million and above
|
3 | % | ||
|
|
·
|
Drug conjugate technology:
Midatech’s core platform is a pioneering drug conjugate delivery system based on GNPs (a class of carbohydrate-coated gold nanoparticles) combined with approved drugs for targeted release at specific organs, cells or sites of disease; and
|
|
|
·
|
Sustained release technology:
Midatech’s secondary platform (previously developed at Midatech Wales) involves the consistent and precise encapsulation of active drug compounds within polymer microspheres that are designed to release drugs and drug compounds into the body in a highly controlled manner over a prolonged period of time.
|
|
|
·
|
Endocrinology.
Seven patent families, with expiration dates ranging from 2031 to 2035. These patent families include eight granted patents and 29 pending patent applications in Key Markets protecting products in Midatech’s pipeline for the treatment of diabetes, in particular, GNP-insulin, GNP-GLP-1 and GNP-combination (insulin and GLP-1).
|
|
|
·
|
Oncology.
Seven patent families, which have predicted expiration dates ranging from 2025 to 2036. These patent rights include 11 granted patents and 16 pending applications in Key Markets relating to products and methods for treating and imaging cancers. In addition to the radiative and immune-based therapies contemplated by many of these patent families, Midatech’s pipeline of GNP-drug conjugates for oncology benefits from protection by the foundation GNP patents of patent family 1.
|
|
|
·
|
Neuroscience.
An early patent family directed to use of GNPs for drug delivery across the blood brain barrier to the central nervous system. Midatech’s pipeline of GNP-drug conjugates for neuroscience also benefits from protection by the foundation GNP patents of patent family 1. The patent family includes seven pending applications.
|
|
|
·
|
KRN5500
. Four issued U.S. patents directed to spicamycin and derivatives thereof, including KRN5500, and their use in methods of decreasing or preventing pain; two pending U.S. patent applications and one pending U.S. provisional patent application directed to formulations of spicamycin derivatives, including KRN5500, and their use in methods of treating or preventing pain or treating liquid tumors; fourteen issued foreign patents and five pending foreign applications directed to spicamycin and derivatives thereof, including KRN5500, and their use in methods of decreasing or preventing pain.
|
|
|
·
|
DB959
. Three issued U.S. patents and one pending U.S. patent application with corresponding foreign patents and patent applications and one pending PCT application related to indane acetic acid derivative compounds and use thereof for treating type 2 diabetes, obesity, cardiovascular disease, liver disorders, Alzheimer’s disease, autoimmune disorders, psoriasis and other diseases, and the process and intermediates for preparing compounds. The patents and patent applications related to DB959 were licensed by DARA to T3D Therapeutics, Inc. in 2013.
|
|
·
|
completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice (“GLP”) regulations;
|
|
·
|
submission to the FDA of an investigational new drug application, which must take effect before human clinical trials may begin;
|
|
·
|
approval by an independent institutional review board (“IRB”), representing each clinical site before each;
|
|
·
|
potential initiation of a clinical trial;
|
|
·
|
performance of adequate and well-controlled human clinical trials in accordance with good clinical practices (“GCP”) to establish the safety and efficacy of the proposed drug product for each indication;
|
|
·
|
preparation and submission to the FDA of a new drug application (“NDA”);
|
|
·
|
review of the product by an FDA advisory committee, where appropriate or if applicable;
|
|
·
|
satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with cGMP requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity;
|
|
·
|
satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data;
|
|
·
|
payment of user fees and securing FDA approval of the NDA; and
|
|
·
|
compliance with any post-approval requirements, including Risk Evaluation and Mitigation Strategies (“REMS”), and post-approval studies required by the FDA.
|
|
·
|
Phase I.
The drug is initially introduced into healthy human subjects or, in certain indications such as cancer, patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness and to determine optimal dosage.
|
|
·
|
Phase II.
The drug is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.
|
|
·
|
Phase III.
The drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the product, and to provide adequate information for the labeling of the product.
|
|
·
|
restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
|
|
·
|
fines, warning letters or holds on post-approval clinical trials;
|
|
·
|
refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product license approvals;
|
|
·
|
product seizure or detention, or refusal to permit the import or export of products; or
|
|
·
|
injunctions or the imposition of civil or criminal penalties.
|
|
·
|
the required patent information has not been filed;
|
|
·
|
the listed patent has expired;
|
|
·
|
the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or
|
|
·
|
the listed patent is invalid, unenforceable or will not be infringed by the new product.
|
|
·
|
preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the applicable European Union Good Laboratory Practice regulations;
|
|
·
|
submission to the relevant national authorities of a clinical trial application (“CTA”) which must be approved before human clinical trials may begin;
|
|
·
|
performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication;
|
|
·
|
submission to the relevant competent authorities of a marketing authorization application (“MAA”) which includes the data supporting safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed labelling;
|
|
·
|
satisfactory completion of an inspection by the relevant national authorities of the manufacturing facility or facilities, including those of third parties, at which the product is produced to assess compliance with strictly enforced current cGMP;
|
|
·
|
potential audits of the non-clinical and clinical trial sites that generated the data in support of the MAA; and
|
|
·
|
review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product.
|
|
·
|
a streamlined application procedure via a single entry point, the European Union portal;
|
|
·
|
a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures that will spare sponsors from submitting broadly identical information separately to various bodies and different member states;
|
|
·
|
a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is assessed jointly by all member states concerned. Part II is assessed separately by each member state concerned;
|
|
·
|
strictly defined deadlines for the assessment of clinical trial application; and
|
|
·
|
the involvement of the ethics committees in the assessment procedure in accordance with the national law of the member state concerned but within the overall timelines defined by the Regulation (EU) No 536/2014.
|
|
·
|
medicinal products developed by means of one of the following biotechnological processes:
|
|
o
|
recombinant DNA technology;
|
|
o
|
controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells; and
|
|
o
|
hybridoma and monoclonal antibody methods;
|
|
·
|
advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No. 1394/2007 on advanced therapy medicinal products;
|
|
·
|
medicinal products for human use containing a new active substance that, on the date of effectiveness of this regulation, was not authorized in the European Union, and for which the therapeutic indication is the treatment of any of the following diseases:
|
|
o
|
acquired immune deficiency syndrome (AIDS);
|
|
o
|
cancer;
|
|
o
|
neurodegenerative disorder;
|
|
o
|
diabetes;
|
|
o
|
auto-immune diseases and other immune dysfunctions; and
|
|
o
|
viral diseases; and
|
|
·
|
medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.
|
|
·
|
The decentralized procedure allows applicants to file identical applications to several European Union member states and receive simultaneous national approvals based on the recognition by European Union member states of an assessment by a reference member state.
|
|
·
|
The national procedure is only available for products intended to be authorized in a single European Union member state.
|
|
·
|
A mutual recognition procedure similar to the decentralized procedure is available when a marketing authorization has already been obtained in at least one European Union member state.
|
|
·
|
the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare program such as Medicare and Medicaid;
|
|
·
|
the federal False Claims Act imposes civil penalties, and provides for civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
|
|
·
|
the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
|
|
·
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
|
·
|
the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;
|
|
·
|
the federal transparency requirements under the Health Care Reform Law requires manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to payments and other transfers of value to physicians and teaching hospitals and physician ownership and investment interests; and
|
|
·
|
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.
|
|
·
|
brentuximab vedotin, marketed as Adectris by Seattle Genetics and Millennium Pharmaceuticals/Takeda Oncology, is an antibody drug conjugate directed to the protein CD30, and is used to treat lymphoma;
|
|
·
|
trastuzumab emtansine, marketed as Kadcyla by Genentech Inc., a subsidiary of F. Hoffman-La Roche AG, is an antibody drug conjugate used for the treatment of metastatic breast cancer;
|
|
·
|
Abraxane, marketed by Celegene Corporation, consists of paclitaxel protein-bound particles for injectivable suspension, and is used for treating breast, lung, pancreatic and various other cancers;
|
|
·
|
Doxil, marketed by Janssen Products, is a doxorubicin HCI liposome injection used for ovarian cancer, kaposi sarcoma (a form of cancer that develops from the cells that line lymph or blood vessels) and multiple myeloma;
|
|
·
|
ThermoDox, a variant of Doxil, is marketed by Celsion Corporation, is a lyso-thermosensitive liposomal doxorubicin, and is used for treating breast and liver cancer. A variant of ThermoDox, called DaunXome, marketed by Galen Pharmaceuticals, is a liposomal daunoubicin, and is used to treat karposi sarcoma;
|
|
·
|
Marquibo, marketed by Spectrum Pharaceuticals, is a liposome-encapsulated vincristine, and is used to treat certain forms of leukemia.
|
|
C.
|
Organizational Structure
|
|
Subsidiaries
|
Country of Incorporation
|
Voting Interest
|
|
Subsidiaries of Midatech Pharma PLC
|
||
|
Midatech Pharma (Wales) Limited
|
England and Wales
|
100%
|
|
Midatech Limited
|
England and Wales
|
100%
|
|
Midatech Pharma US Inc.
|
United States (Delaware)
|
100%
|
|
Midatech Pharma Pty Limited
|
Australia
|
100%
|
|
Joint Ventures with Midatech Limited
|
||
|
MidaSol Therapeutics GP (1)
|
Cayman Islands
|
50%
|
|
Syntara LLC (2)(3)
|
United States (Delaware)
|
50%
|
|
Subsidiaries of Midatech Limited
|
||
|
Midatech Pharma Espana SL
|
Spain
|
100%
|
|
Midatech Andalucia SL (3)
|
Spain
|
100%
|
|
Pharmida AG (3)
|
Switzerland
|
100%
|
|
Subsidiaries of Midatech Pharma US Inc.
|
||
|
DARA Therapeutics, Inc.
|
United States (North Carolina)
|
100%
|
|
(1)
|
Joint venture between Midatech Limited and MonoSol.
|
|
(2)
|
Joint venture between Midatech Limited and Immunotope Inc. The percentage ownership of the entity is d
etermined by reference to the partnership agreement and varies from time to time depending on capital committed. While 50% is the economic interest, Midatech Limited can currently direct 49% of the voting rights.
|
|
(3)
|
Dormant entity or entities in the process of being wound-down.
|
|
D.
|
Property, Plant and Equipment
|
|
UNRESOLVED STAFF COMMENTS.
|
|
OPERATING AND FINANCIAL REVIEW AND PROSPECTS.
|
|
A.
|
Operating Results.
|
|
|
·
|
future expected cash flows from in-process research and development;
|
|
|
·
|
the fair value of the property, plant and equipment; and
|
|
|
·
|
discount rates.
|
|
|
·
|
volatility is estimated based on the average annualized volatility of a number of publicly traded peer companies in the biotech sector;
|
|
|
·
|
the estimated life of the option is estimated to be until the first exercise period, which is typically the month after the option vests; and
|
|
|
·
|
the dividend return is estimated by reference to our historical dividend payments. Currently, this is estimated to be zero as no dividend has been paid in the prior periods.
|
|
|
•
|
identify the contract(s) with a customer;
|
|
|
•
|
identify the performance obligations in the contract;
|
|
|
•
|
determine the transaction price;
|
|
|
•
|
allocate the transaction price to the performance obligations in the contract; and
|
|
|
•
|
recognize revenue when (or as) the entity satisfies a performance obligation.
|
|
Year Ended
December 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
(£ in thousands)
|
||||||||
|
Revenue
|
775 | 25 | ||||||
|
Grant revenue
|
600 | 132 | ||||||
|
Total revenue
|
1,375 | 157 | ||||||
| Cost of Sales | (70 | ) | --- | |||||
| Gross Profits | 1,305 | 157 | ||||||
|
Research and development costs
|
(5,920 | ) | (5,439 | ) | ||||
|
Distribution costs, sales and marketing
|
(374 | ) | --- | |||||
|
Administrative costs
|
(7,929 | ) | (4,665 | ) | ||||
|
Loss from operations
|
(12,918 | ) | (9,947 | ) | ||||
|
Finance income
|
1,691 | 8 | ||||||
|
Finance expense
|
(5 | ) | (161 | ) | ||||
|
Loss before tax
|
(11,232 | ) | (10,100 | ) | ||||
|
Taxation
|
(1,133 | ) | 1,018 | |||||
|
Loss after tax attributable to the owners of the parent
|
(10,099 | ) | (9,082 | ) | ||||
|
|
·
|
the listing of the Depositary Shares on NASDAQ and the registration of such Depositary Shares, and the Ordinary Shares underlying them, with the SEC, the acquisition of Midatech US and Zuplenz and related professional fees of £2.99 million; and
|
|
|
·
|
an increase in the average number of staff employed by the Group from 36 to 74, as opposed to 38 in 2014, and the associated increase in payroll costs by £1.45 million to £4.52 million in the aggregate, as opposed to £3.07 million in the aggregate in 2014.
|
|
Year Ended
December 31,
|
||||||||
|
2014
|
2013
|
|||||||
|
(£ in thousands)
|
||||||||
|
Revenue
|
157 | 147 | ||||||
|
Research and development costs
|
(5,439 | ) | (2,840 | ) | ||||
|
Administrative costs
|
(4,665 | ) | (1,806 | ) | ||||
|
Loss from operations
|
(9,947 | ) | (4,499 | ) | ||||
|
Finance income
|
8 | 1 | ||||||
|
Finance expense
|
(161 | ) | (385 | ) | ||||
|
Loss before tax
|
(10,100 | ) | (4,883 | ) | ||||
|
Taxation
|
1,018 | 799 | ||||||
|
Loss after tax attributable to the owners of the parent
|
(9,082 | ) | (4,084 | ) | ||||
|
|
·
|
the incurrence of professional fees and other costs of £1.05 million in connection with Midatech’s initial public offering and admission onto AIM;
|
|
|
·
|
the acquisition of Midatech Wales and related professional fees of £0.17 million; and
|
|
|
·
|
an increase in the average number of staff employed by 9 to 38, as opposed to 29 in 2013, and the associated increase in payroll costs £0.47m to £2.81 million in the aggregate, as opposed to £2.34 million in the aggregate in 2013 (which includes 23 days of Midatech Wales’ payroll costs).
|
|
B.
|
Liquidity and Capital Resources.
|
|
Year ended December 31,
|
||||||||||||
|
2015
|
2014
|
2013
|
||||||||||
|
(£’s in thousands)
|
||||||||||||
|
Cash used in operating activities
|
(12,421 | ) | (5,455 | ) | (4,436 | ) | ||||||
|
Cash used in investing activities
|
(1,533 | ) | (907 | ) | (50 | ) | ||||||
|
Cash (used) provided by financing activities
|
(219 | ) | 34,300 | 6,740 | ||||||||
|
Net (decrease) increase in cash and equivalents
|
(14,173 | ) | 27,938 | 2,254 | ||||||||
|
Year Ended
December 31,
|
||||||||||||
|
2015
|
2014
|
2013
|
||||||||||
|
(£’s in thousands)
|
||||||||||||
|
Current Assets
|
20,331 | 31,628 | 4,095 | |||||||||
|
Current Liabilities
|
9,099 | 2,832 | 2,295 | |||||||||
|
Working Capital
|
11,232 | 28,796 | 1,800 | |||||||||
|
·
|
providing resources to accelerate research and development on Midatech’s target products and key collaborations, and to further develop its technology platforms;
|
|
|
·
|
enhancing Midatech’s profile among current and prospective partners, suppliers and customers;
|
|
|
·
|
providing the potential to access capital to fund Midatech’s future growth and support further any potential expansion plans;
|
|
|
·
|
providing a platform for potential further acquisitions of companies, products and intellectual property; and;
|
|
|
·
|
providing opportunities for Midatech to attract, retain and incentivize high caliber employees.
|
|
C.
|
Research and Development, Patents and Licenses, Etc.
|
|
D.
|
Trend Information.
|
|
E.
|
Off-Balance Sheet Arrangements.
|
|
F.
|
Tabular Disclosure of Contractual Obligations.
|
|
Payments due by period
|
||||||||||||||||||||
|
Total
|
Less than 1 year
|
1-3 years
|
3-5 years
|
More than 5 years
|
||||||||||||||||
|
(£’s in thousands)
|
||||||||||||||||||||
|
Long-Term Debt Obligations
|
31 | 9 | 9 | 13 | -- | |||||||||||||||
|
Capital Lease Obligations
|
161 | 78 | 27 | 56 | -- | |||||||||||||||
|
Government Research Loans
|
1,716 | 388 | 195 | 644 | 755 | |||||||||||||||
|
Total
|
1,908 | 475 | 231 | 713 | 755 | |||||||||||||||
|
G.
|
Safe Harbor
|
|
DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES.
|
|
A.
|
Directors and Senior Management
|
|
Name
|
Age at
12/31/2015
|
Position/Title
|
||
|
Directors:
|
||||
|
James Phillips, MB, ChB (3) (4)
|
53
|
Chief Executive Officer, Director
|
||
|
Nicholas Robbins-Cherry (3) (4)
|
46
|
Chief Financial Officer, Director
|
||
|
Rolf Stahel (2) (3)
|
71
|
Non-Executive Chairman of the Board of Directors
|
||
|
John Johnston (1) (3) (4)
|
57
|
Non-Executive Director
|
||
|
Michele Luzi (2) (3)
|
58
|
Non-Executive Director
|
||
|
Pavlo (Paul) Protopapa (1) (3)
|
49
|
Non-Executive Director
|
||
|
Simon Turton, Ph.D. (1) (2) (3)
|
48
|
Senior Independent Non-Executive Director
|
||
|
Sijmen (Simon) de Vries, M.D. (2) (3)
|
56
|
Non-Executive Director
|
||
|
Executive Officers (5):
|
||||
|
Craig Cook, MB, BCH
|
49
|
Chief Operating Officer and Chief Medical Officer
|
||
|
David Benharris (6)
|
51
|
President, Midatech Pharma US, Inc.
|
|
(1)
|
Audit Committee member
|
|
(2)
|
Remuneration Committee member
|
|
(3)
|
Nominations Committee member
|
|
(4)
|
Disclosure Committee member
|
|
(5)
|
Other than directors who are also executive officers.
|
|
(6)
|
Mr. Benharris was not an executive officer of Midatech in 2015. Mr. Benharris was appointed as President of Midatech Pharma US, Inc. in January 2016.
|
|
B.
|
Compensation
|
|
Name
|
Fees Earned or
Paid in Cash
(£)(1)
|
All Other
Compensation
(£)
|
Total
(£)
|
|||
|
Rolf Stahel
|
50,000
|
57,640 (2)
|
107,640
|
|||
| Jeff Brown (4) |
—
|
46,667 (5) | 46,667 (5) | |||
|
John Johnston
|
35,000 (3)
|
—
|
35,000
|
|||
|
Michele Luzi
|
35,000
|
—
|
35,000
|
|||
|
Pavlo Protopapa
|
35,000
|
—
|
35,000
|
|||
|
Simon Turton
|
35,000 (3)
|
—
|
35,000
|
|||
|
Sijmen de Vries
|
35,000
|
—
|
35,000
|
|
|
(1)
|
Includes annual fees, committee chairpersonship fees and meeting fees.
|
|
|
(2)
|
Includes fees paid to Mr. Stahel in connection with a consultancy agreement with Chesyl Pharma Limited, a company wholly owned by Mr. Stahel.
|
|
|
(3)
|
A portion of the compensation paid to each of Messrs. Johnston and Turton for their services on the Board are paid to consulting firms owned by each of Mr. Johnston and Mr. Turton, respectively; however, Midatech does not receive any consulting services from Messrs. Johnston or Turton or their respective consulting firms.
|
|
(4)
|
Mr. Brown resigned from the Midatech Board of Directors effective April 30, 2015.
|
|
(5)
|
Includes pro rated annual fees and meeting
fees, as well as
£35,000 paid upon Mr. Brown’s resignation.
|
|
Name
|
Number of Options |
Grant Date
|
Exercise Price
per Share
(£)
|
Expiration
Date
|
||||||
|
Michele Luzi (1)
|
18,796 | (2) |
4/20/2012
|
4.19 |
4/20/2022
|
|||||
|
Sijmen de Vries
|
3,000 | (2) |
12/31/2008
|
1.425 |
12/31/2018
|
|||||
| 4,000 | (2) |
4/20/2012
|
4.19 |
4/20/2022
|
||||||
| 10,000 | (3) |
6/30/2014
|
0.075 |
6/30/2024
|
||||||
|
(1)
|
Stock options held by Mr. Luzi were granted as part of a prior investment in Midatech Limited in 2011 and not for service as a non-executive director.
|
|
(2)
|
The stock options are fully vested.
|
|
(3)
|
The stock options vest in the following installments: (i) 50% of the stock options vest when Midatech’s share price is £5.31 share, (ii) a further 25% of the stock options vest when Midatech’s share price is £13.72 a share and (iii) the remaining 25% of the stock options vest when Midatech’s share price is £18.86 a share.
|
|
·
|
by either party giving at least three months prior written notice;
|
|
·
|
by the Midatech Board of Directors reasonably determining that Mr. Stahel’s acceptance of any other employment, engagement, appointment, interest or involvement with any business or person competes or conflicts with his appointment and would result in a serious conflict of interest or Mr. Stahel reasonably determines such interest would result in a serious conflict of interest, and Mr. Stahel accepts such employment, engagement, appointment, interest or involvement; or
|
|
·
|
in accordance with Midatech’s articles of association or applicable law.
|
|
·
|
as to 244,880 shares held by Mr. Stahel (the “Relevant Shares”), Mr. Stahel is under an obligation not to dispose of such shares, subject to one-eighth of the Relevant Shares being released from such disposal restriction on each of the first, second, third and fourth anniversaries of March 1, 2014 (the “Appointment Date”), such that by the fourth anniversary of the Appointment Date, 50% of the Relevant Shares will no longer be subject to any disposal restriction. In the event of termination by Midatech of Mr. Stahel’s appointment as a non-executive director in certain circumstances for cause prior to such fourth anniversary, any shares which remain restricted will be able to be purchased by Midatech at a price of £0.075p per ordinary share, referred to as the Relevant Price. On the occurrence of other circumstances of termination, the restrictions shall cease to apply to the Relevant Shares. As of March 1, 2016, approximately 61,220 of the Relevant Shares are no longer subject to any disposal restrictions;
|
|
·
|
as to 122,440 of such Relevant Shares held by Mr. Stahel, Mr. Stahel has agreed not to dispose of such shares until the first to occur of (i) Midatech achieving a target measured by the average market capitalization of Midatech on any public market over a 30 day period of at least £184.7 million, provided the Share Increase Hurdle (as defined below) applies or a trade sale or a valuation carried out by an independent valuer (collectively, the “Trigger Events”); or (ii) the fourth anniversary of the Appointment Date, whereupon Midatech has the right to repurchase such shares at the Relevant Price if no Trigger Event at or above such value has occurred;
|
|
·
|
as to a further 122,440 of such Relevant Shares held by Mr. Stahel, Mr. Stahel has agreed not to dispose of such shares until the first to occur of (i) Midatech achieving a target measured by the average capitalization of Midatech on any public market over a 30 day period of at least £240.9 million provided the Share Increase Hurdle applies on a Trigger Event; or (ii) the fourth anniversary of the Appointment Date, whereupon Midatech has the right to repurchase such shares at the Relevant Price if no Trigger Event at or above such value has occurred; and
|
|
·
|
the Relevant Shares that are subject to disposal restrictions are unable to be voted upon by Mr. Stahel during the periods described above in respect of the amount of such shares which remain under restriction.
|
|
·
|
is found guilty of any misconduct, gross negligence or dishonesty or acts in a manner which is materially adverse to the interests of Midatech;
|
|
·
|
commits any serious or repeated breach or non-observance of his obligations to Midatech;
|
|
·
|
becomes bankrupt, has an interim order made against him under the United Kingdom Insolvency Act 1986 or makes any composition or enters into any deed of arrangement with his creditors or the equivalent of any of these under any other jurisdictions;
|
|
·
|
becomes of unsound mind, becomes a patient under any statute relating to mental health or is unable, due to any accident, illness or injury, to undertake his duties for Midatech for a period of more than six consecutive months;
|
|
·
|
is convicted of a criminal offense (other than a motoring offense for which a non-custodial penalty is imposed);
|
|
·
|
is disqualified by law or an order of a court of competent jurisdiction from holding office; or
|
|
·
|
has failed to submit his resignation as Chairman and as a director of Midatech when required to so pursuant to the terms of the Stahel Appointment Agreement.
|
|
Name
|
Salary
(£)
|
Bonus
(1)(£)
|
All Other
Compensation
(2)(£)
|
Total
(£)
|
||||
|
Dr. James Phillips
|
242,880
|
104,125
|
30,284
|
377,289
|
||||
|
Chief Executive Officer
|
||||||||
|
Nicholas Robbins-Cherry
|
145,696
|
38,360
|
15,583
|
199,639
|
||||
|
Chief Financial Officer
|
||||||||
|
All executive officers as a group (3 persons) (3)
|
597,617
|
191,985
|
65,784
|
855,386
|
|
(1)
|
The Service Agreements also include a bonus target for Dr. Phillips and Mr. Robbins-Cherry of 50% and 33%, respectively, of their annual base salary, which bonus is payable upon attainment of objectives as determined in the subjective judgment of Midatech’s Board of Directors or a committee thereof, taking into account various factors without any preassigned weighting. For 2015, all of the executive officers received approximately 80% of their bonus target.
|
|
(2)
|
The amounts reflect the value of benefits payable pursuant to pension plans.
|
|
(3)
|
Compensation information for David Benharris
is not included in this table, as he was not considered an executive officer of Midatech in 2015.
|
|
Name
|
Number of
Options
|
Grant Date
|
Exercise
Price per
Share (£)
|
Expiration
Date
|
||||
|
James Phillips
|
400,000 (1)
|
6/30/2014
|
0.075
|
6/30/2024
|
||||
|
200,000 (2)
|
5/9/2014
|
0.075
|
5/1/2023
|
|||||
|
Nick Robbins-Cherry
|
60,000 (1)
|
6/30/2014
|
0.075
|
6/30/2024
|
||||
|
All executive officers as a group (3 persons) (3)
|
1,020,000 (1) (4)
|
(5)
|
0.075
|
(6)
|
|
(1)
|
Stock options held by Messrs. Phillips, Robbins-Cherry and Cook vest in the following installments: (i) 50% of the stock options vest when Midatech’s share price is £5.31 share, (ii) a further 25% of the stock options vest when Midatech’s share price is £13.72 a share and (iii) the remaining 25% of the stock options vest when Midatech’s share price is £18.86 a share. In connection with the acquisition of DARA, stock options issued to Mr. Benharris exercisable for shares of DARA common stock were assumed by Midatech and became exercisable for Ordinary Shares (subject to certain adjustments based upon the exchange ratio for DARA common stock in the merger). All Ordinary Shares issuable upon exercise of such options are to be delivered in the form of Depositary Shares.
|
|
(2)
|
The stock options are fully vested.
|
|
(3)
|
Option award information for Mr. Benharris is not included in this table, as he was not considered an executive officer in 2015.
|
|
(4)
|
200,000 stock options are fully vested.
|
|
(5)
|
The grant dates range from May 9, 2014 to July 1, 2014.
|
|
(6)
|
The stock options expire between May 1, 2023 and July 1, 2024.
|
|
·
|
is guilty of serious misconduct or any other misconduct which affects, or is likely to affect, prejudicially the interests of Midatech or any of its subsidiaries;
|
|
·
|
fails or neglects to efficiently and diligently discharge his duties or commits any serious or repeated breach or non-observance of any of the provisions of the Service Agreement or any share dealing code adopted by Midatech or any of its subsidiaries;
|
|
|
·
|
has an interim receiving order made against him, becomes bankrupt or makes any composition or enters into any deed of arrangement with his creditors;
|
|
|
·
|
is charged with an arrestable criminal offense (other than a road traffic offense in the United Kingdom or elsewhere for which a fine or non-custodial penalty is imposed);
|
|
|
·
|
is disqualified from holding office in any company by reason of an order of a court of competent jurisdiction;
|
|
|
·
|
becomes of unsound mind or becomes a patient under any statute relating to mental health;
|
|
|
·
|
is convicted of an offense under the United Kingdom’s Criminal Justice Act 1993 in relation to insider dealings or under any other present or future statutory enactment or regulations relating to insider dealings;
|
|
|
·
|
is in breach of the Model Code on directors’ dealings in listed securities, including securities trading on AIM, published by the London Stock Exchange; or
|
|
|
·
|
commits any other act warranting summary termination at common law including, but not limited to, any act justifying dismissal without notice in the terms of Midatech’s generally applicable disciplinary rules.
|
|
C.
|
Board Practices
|
|
D.
|
Employees
|
| As of December 31, | ||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
Business functional area:
|
|
|
||||||||
|
Research and development
|
52
|
|
26
|
|
|
22
|
|
|||
|
Sales and marketing
|
7
|
|
--
|
|
|
--
|
|
|||
|
General and administration
|
23
|
|
10
|
|
7
|
|
||||
|
|
|
|||||||||
|
Total
|
82
|
36
|
|
29
|
|
|||||
| As of December 31, | ||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
|
Geography:
|
|
|
||||||||
|
United Kingdom
|
40
|
|
12
|
|
|
9
|
|
|||
|
North America
|
14
|
|
--
|
|
|
--
|
|
|||
|
Spain
|
28
|
|
24
|
|
|
20
|
|
|||
|
|
|
|||||||||
|
Total
|
82
|
36
|
|
29
|
||||||
|
E.
|
Share Ownership
|
|
MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS.
|
|
A.
|
Major Shareholders
|
|
|
·
|
each person that is known by Midatech to be a beneficial owner of 3% or more of Midatech ordinary shares ( based on information in our share register and information provided by such persons);
|
|
|
·
|
each member of Midatech’s Board of Directors;
|
|
|
·
|
each of Midatech’s executive officers; and
|
|
|
·
|
all members of Midatech’s Board of Directors and its executive officers, taken as a group.
|
|
Name of Beneficial Owner
|
Amount and
Nature
Of Ownership (1)
|
Percent
of class
|
||||||
|
Major Stockholders:
|
||||||||
|
Woodford Fund Management Limited (2)
|
6,791,689 | 20.3 | % | |||||
|
Ferracom Establishment (3)
|
3,043,164 | 9.1 | % | |||||
|
Ippon Capital SA (4)
|
1,649,334 | 4.9 | % | |||||
|
Finance Wales (5)
|
1,531,136 | 4.6 | % | |||||
|
Disruptive Capital Finance (6)
|
1,524,294 | 4.6 | % | |||||
|
Promida Holdings (7)
|
1,118,266 | 3.3 | % | |||||
|
Nanoline L.P. (8)
|
1,052,878 | 3.1 | % | |||||
|
Legal & General Investment Management (9)
|
1,043,500 | 3.1 | % | |||||
|
Directors and Executive Officers:
|
||||||||
|
David Benharris
|
3,808 | * | ||||||
|
Craig Cook, MB, BCH
|
— | — | ||||||
|
Sijmen (Simon) de Vries, M.D.
|
15,802 | * | ||||||
|
John Johnston
|
14,981 | * | ||||||
|
Michele Luzi (10)
|
209,522 | * | ||||||
|
James N. Phillips, MB, ChB
|
233,339 | * | ||||||
|
Pavlo (Paul) Protopapa (11)
|
1,649,334 | 4.9 | % | |||||
|
Nicholas Robbins-Cherry
|
500 | * | ||||||
|
Rolf Stahel
|
527,215 | 1.6 | % | |||||
|
Simon Turton, Ph.D.
|
215,328 | * | ||||||
|
Directors and executive officers as a group (10
persons) |
2,869,829 | 8.6 | % |
|
*
|
Less than one percent of the outstanding Ordinary Shares.
|
|
(1)
|
Includes the following Ordinary Shares subject to outstanding stock options exercisable within 60 days of February 16, 2016: Dr. de Vries—7,000; Mr. Luzi—18,796; Dr. Phillips—200,000; Mr. Benharris—3,808; and all current directors and executive officers as a group—229,604.
|
|
(2)
|
The principal business address of Woodford Fund Management Limited is 9400 Garsington Road, Oxford, OX4 2HN, United Kingdom.
|
|
(3)
|
The principal business address of Ferracom Establishment is Landstrasse 99, FL 9494, Schaan, Liechtenstein.
|
|
(4)
|
Pavlo (Paul) Protopapa, one of Midatech’s directors, is a director of Ippon Capital SA. The principal business address of Ippon Capital SA is 7 Rue de Chantepoulet, 1211 Geneva 1, Switzerland.
|
|
(5)
|
The principal business address of Finance Wales Investments Limited is 1 Capital Quarter, Tyndall Street, Cardiff, Wales CF10 4BZ.
|
|
(6)
|
The principal business address of Disruptive Capital Finance LLP is Vestry House, Laurence Pountney Hill, London, United Kingdom EC4R OEH.
|
|
(7)
|
The principal business address of Promida Holdings is Hawksford House, Caledonia Place, St. Helier, Jersey JE4 8QP.
|
|
(8)
|
The principal business address of Nanoline L.P. is 201 Main Street, Suite 2600, Fort Worth, Texas 76102 United States of America.
|
|
(9)
|
The principal business address of Legal & General Investment Management Limited is 1 Coleman St, London, United Kingdom EC2R 5AA.
|
|
(10)
|
Includes 69,382 Ordinary Shares held by JTC Trustees Limited, of which Mr. Luzi is a beneficiary.
|
|
(11)
|
Includes 1,649,334 Ordinary Shares directly held by Ippon Capital SA. Mr. Protopapa, a director of Ippon Capital SA, disclaims beneficial ownership of all shares held directly by Ippon Capital SA except to the extent of his pecuniary interest therein, if any.
|
|
B.
|
Related Party Transactions
|
|
C.
|
Interests of Experts and Counsel
|
|
FINANCIAL INFORMATION.
|
|
A.
|
Consolidated Statements and Other Financial Information
|
|
B.
|
Significant Changes
|
|
THE OFFER AND LISTING.
|
|
A.
|
Offer and Listing Details.
|
|
Price Per Ordinary Share
|
Price Per Ordinary Share | ||||||
|
£
|
$ | ||||||
|
High
|
Low
|
High
|
Low
|
||||
|
Annual Information
|
|||||||
|
Year Ended December 31, 2014 (1)
|
2.85
|
2.60
|
|
4.20
|
3.83
|
||
|
Year Ended December 31, 2015
|
3.30
|
1.50
|
|
4.87
|
2.21
|
||
|
Quarterly Information:
|
|||||||
|
Fourth Quarter 2014 (1)
|
2.85
|
2.60
|
4.20
|
3.83
|
|||
|
First Quarter 2015
|
3.30
|
2.65
|
|
4.87
|
3.91
|
||
|
Second Quarter 2015
|
3.20
|
2.60
|
|
4.72
|
3.83
|
||
|
Third Quarter 2015
|
3.05
|
2.65
|
|
4.50
|
3.91
|
||
|
Fourth Quarter 2015
|
2.85
|
1.50
|
|
4.20
|
2.21
|
||
|
First Quarter 2016
|
2.05
|
1.33
|
|
3.02
|
1.96
|
||
|
Monthly Information:
|
|||||||
|
October 2015
|
2.65
|
2.57
|
3.91
|
3.79
|
|||
|
November 2015
|
2.85
|
2.58
|
|
4.20
|
3.80
|
||
|
December 2015
|
2.68
|
1.50
|
|
3.95
|
2.21
|
||
|
January 2016
|
2.05
|
1.70
|
|
3.02
|
2.51
|
||
|
February 2016
|
1.74
|
1.70
|
|
2.57
|
2.51
|
||
|
March 2016
|
1.72
|
1.33
|
2.54
|
1.96
|
|||
|
April 2016 (through April 8, 2016)
|
1.75
|
1.42
|
2.58
|
2.09
|
|||
|
(1)
|
The Ordinary Shares began trading on AIM on December 8, 2014. Prior to that, no established market for Ordinary Shares existed.
|
|
Price Per Depositary Share
|
|||
|
$
|
|||
|
High
|
Low
|
||
|
Annual Information
|
|||
|
Year Ended December 31, 2015 (1)
|
8.09
|
|
4.09
|
|
Quarterly Information:
|
|||
|
Fourth Quarter 2015
|
8.09
|
|
4.09
|
|
First Quarter 2016
|
5.72
|
|
3.33
|
|
Monthly Information:
|
|||
|
December 2015
|
8.09
|
|
4.09
|
|
January 2016
|
5.72
|
|
4.33
|
|
February 2016
|
4.72
|
|
4.55
|
|
March 2016
|
4.67
|
3.33
|
|
|
April 2016 (through April 8, 2016)
|
5.44
|
4.30
|
|
|
(
1)
|
The Depositary Shares began trading on the NASDAQ Capital Market on December 7, 2015. Prior to that, no established market for the Depositary Shares existed.
|
|
B.
|
Plan of Distribution
|
|
C.
|
Markets
|
|
D.
|
Seller Shareholders
|
|
E.
|
Dilution
|
|
F.
|
Expenses of the Issue
|
|
ADDITIONAL INFORMATION.
|
|
A.
|
Share Capital
|
|
B.
|
Memorandum and Articles of Association
|
|
C.
|
Material Contracts
|
|
D.
|
Exchange Controls
|
|
E.
|
Taxation
|
|
|
·
|
an individual who is a citizen or resident of the United States;
|
|
|
·
|
a corporation or other entity taxable as a corporation that is created or organized in the United States or under the laws of the United States or any state thereof or the District of Columbia;
|
|
|
·
|
an estate the income of which is subject to U.S. federal income taxation regardless of its source; or
|
|
|
·
|
any trust if (a) a court within the United States is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have the authority to control all substantial decisions of the trust, or (b) such trust has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.
|
|
F.
|
Dividends and Payment Agents
|
|
G.
|
Statements by Experts
|
|
H.
|
Documents on Display
|
|
I.
|
Subsidiary Information
|
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
|
|
DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES.
|
|
A.
|
Debt Securities
|
|
B.
|
Warrants and Rights
|
|
C.
|
Other Securities
|
|
D.
|
American Depositary Shares
|
|
Service
|
|
Fees
|
|
·
to any person to whom Depositary Shares are issued or to any person to whom a distribution is made in respect of Depositary Share distributions pursuant to stock dividends or other free distributions of stock, bonus distributions, stock splits or other distributions (except where converted to cash)
|
|
Up to US$0.05 per Depositary Share issued
|
|
·
to any person surrendering Depositary Shares for withdrawal of deposited securities or whose Depositary Shares are cancelled or reduced for any other reason including, inter alia, cash distributions made pursuant to a cancellation or withdrawal
|
|
Up to US$0.05 per Depositary Share cancelled
|
|
·
Distribution of cash dividends
|
|
Up to US$0.05 per Depositary Share held
|
|
·
Distribution of cash entitlements (other than cash dividends) and/or cash proceeds, including proceeds from the sale of rights, securities and other entitlements
|
|
Up to US$0.05 per Depositary Share held
|
|
·
Distribution of Depositary Shares pursuant to exercise of rights.
|
|
Up to US$0.05 per Depositary Share held
|
|
·
Depositary services
|
|
Up to US$0.05 annually per Depositary Share held on the applicable record date(s) established by the depositary bank
|
|
|
·
|
taxes (including applicable interest and penalties) and other governmental charges;
|
|
|
·
|
such registration fees as may from time to time be in effect for the registration of Ordinary Shares or other deposited securities with Midatech’s share registrar and applicable to transfers of Ordinary Shares or other deposited securities to or from the name of the custodian, the Depositary or any nominees upon the making of deposits and withdrawals, respectively;
|
|
|
·
|
such cable, telex, facsimile and electronic transmission and delivery expenses as are expressly provided in the deposit agreement to be at the expense of the person depositing or withdrawing Ordinary Shares or Depositary Share holders and beneficial owners of Depositary Shares;
|
|
|
·
|
the expenses, fees and other charges incurred by the Depositary in the conversion of foreign currency, including, without limitation, the expenses, fees and other charges imposed by any affiliate of the Depositary (which may, in its sole discretion, act in a principal capacity in such transaction) that may be utilized in connection therewith;
|
|
|
·
|
such fees and expenses as are incurred by the Depositary in connection with compliance with exchange control regulations and other regulatory requirements applicable to Ordinary Shares, deposited securities, Depositary Shares and American Depositary Receipts;
|
|
|
·
|
the fees and expenses incurred by the Depositary in connection with the delivery of deposited securities, including any fees of a central depository for securities in the local market, where applicable; and
|
|
|
·
|
any fees, charges, costs or expenses that may be incurred from time to time by the Depositary and/or any of the Depositary’s agents, including the custodian, and/or agents of the Depositary’s agents in connection with the servicing of Ordinary Shares, deposited securities and/or Depositary Shares, the sale of securities (including, without limitation, deposited securities), the delivery of deposited securities or otherwise in connection with the Depositary’s or its custodian’s compliance with applicable law, rule or regulation (such fees, charges, costs or expenses to be assessed against Depositary Share holders of record as at the date or dates set by the Depositary as it sees fit and collected at the sole discretion of the Depositary by billing such Depositary Share holders for such fee or by deducting such fee from one or more cash dividends or other cash distributions).
|
|
DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES.
|
|
MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS.
|
|
CONTROLS AND PROCEDURES.
|
|
A.
|
Disclosure Controls and Procedures
|
|
●
|
The deficiency in the design and operating effectiveness of internal controls related to the accounting treatment for a non-routine, complex transaction relating to the fair value of share options and warrants assumed by Midatech being required to be treated as a derivative financial liability rather than as an equity instrument. The assumption of these options and warrants was associated with the acquisition of DARA
.
|
|
B.
|
Management
’
s Annual Report on Internal Control Over Financial Reporting
|
|
C.
|
Attestation Report of the Registered Public Accounting Firm
|
|
D.
|
Changes in Internal Control Over Financing Reporting
|
|
AUDIT COMMITTEE FINANCIAL EXPERT.
|
|
CODE OF ETHICS.
|
|
PRINCIPAL ACCOUNTANT FEES AND SERVICES.
|
|
2015
|
2014
|
|||||||
|
(£’s in thousands)
|
||||||||
|
Audit Fees(1)
|
674 | 351 | ||||||
|
Audit-Related Fees(2)
|
— | — | ||||||
|
Tax Fees(3)
|
7 | 27 | ||||||
|
All Other Fees(4)
|
— | — | ||||||
|
Total
|
681 | 378 | ||||||
|
(1)
|
Audit fees consist of the aggregate fees billed in connection with the audit of Midatech’s annual consolidated financial statements and internal controls, the issuance of comfort letters, interim reviews of our half-yearly financial information
and the listing of the Depositary Shares on NASDAQ
.
|
|
(2)
|
Audit-related fees are fees for services that are traditionally performed by the independent accountants, including consultations concerning financial accounting and reporting, and employee benefit plan audits, and due diligence on mergers or acquisitions.
|
|
(3)
|
Represents the aggregate fees billed for tax compliance, tax advice and tax consulting services.
|
|
(4)
|
Represents the aggregate fees billed for all products and services provided that are not included under “audit fees”, “audit related fees or “tax fees,” including, but not limited to, fees billed for services relating to mergers, acquisitions and the listing of Midatech’s Ordinary Shares on AIM.
|
|
EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES.
|
|
PURCHASE OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS.
|
|
CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANTS.
|
|
CORPORATE GOVERNANCE.
|
|
|
·
|
Midatech does not follow NASDAQ’s requirements applicable to independent director oversight of director nominations, which require that director nominees either be selected or recommended by independent directors. In accordance with United Kingdom law and practice, the Company’s directors are nominated by the Nominations Committee, which is comprised of all of the directors of the company.
|
|
|
·
|
Midatech does not follow NASDAQ’s requirement that the compensation committee be comprised of Independent Directors, as defined under Rule 5605(a)(2). One of the members of Midatech’s compensation committee, Mr. Stahel, is not considered independent under the applicable NASDAQ rule. He is, however, considered to be independent under United Kingdom law and practice.
|
|
|
·
|
Midatech does not require that the compensation committee consider the specific factors affecting consultant independence that are set forth in NASDAQ Rule 5605(d)(3)(D). Midatech’s compensation committee may engage independent compensation consultants at its discretion.
|
|
|
·
|
Midatech does not follow NASDAQ’s requirements that non-executive directors meet on a regular basis without management present. Midatech’s Board of Directors may choose to meet in executive session at their discretion.
|
|
|
·
|
Midatech does not follow NASDAQ’s quorum requirements for stockholder meetings. In accordance with United Kingdom law and practice, Midatech’s Articles of Association provide alternative quorum requirements that are generally applicable to meetings of shareholders.
|
|
|
·
|
Midatech does not follow NASDAQ’s requirements to seek shareholder approval for the implementation of certain equity compensation plans and issuances of ordinary shares. In accordance with the AIM Rules, Midatech is not required to seek shareholder approval in such circumstances.
|
|
MINE SAFETY DISCLOSURE.
|
|
FINANCIAL STATEMENTS.
|
|
FINANCIAL STATEMENTS.
|
|
EXHIBITS.
|
|
Exhibit
Number
|
Title
|
|
1.1
|
Articles of Association of Midatech Pharma PLC (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
2.1
|
Specimen certificate representing ordinary shares of Midatech Pharma PLC (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
2.2
|
Form of Deposit Agreement by and among Midatech Pharma PLC, Deutsche Bank Trust Company Americas, as depositary, and all owners and holders from time to time of American Depositary Shares thereunder (incorporated by reference to Exhibit 99A to the Company’s Registration Statement on Form F-6/A (File No. 333-207186), filed with the SEC on October 27, 2015).
|
|
2.3
|
Form of American Depositary Receipt (included in Exhibit 2.2).
|
|
2.4
|
Form of Warrant Assumption Agreement by and between Midatech Pharma PLC and DARA BioSciences, Inc. (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
2.5
|
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4 to DARA BioSciences, Inc.’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, filed with the SEC on May 14, 2010).
|
|
2.6
|
Form of Class B Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.3 to DARA BioSciences, Inc.’s Current Report on Form 8-K filed with the SEC on December 29, 2010).
|
|
2.7
|
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.2 to DARA BioSciences, Inc.’s Current Report on Form 8-K filed with the SEC on January 18, 2012).
|
|
2.8
|
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.2 to DARA BioSciences, Inc.’s Current Report on Form 8-K filed with the SEC on April 9, 2012).
|
|
2.9
|
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to DARA BioSciences, Inc.’s Current Report on Form 8-K filed with the SEC on October 22, 2013).
|
|
2.10
|
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to DARA BioSciences, Inc.’s Current Report on Form 8-K filed with the SEC on February 12, 2014).
|
|
2.11
|
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.2 to DARA BioSciences, Inc.’s Current Report on Form 8-K filed with the SEC on May 30, 2014).
|
|
2.12
|
Form of “Phase 2b” Common Stock Purchase Warrant issued to General Hospital Corporation d/b/a Massachusetts General Hospital (incorporated by reference to Exhibit 4.1 to DARA BioSciences, Inc.’s Current Report on Form 8-K filed with the SEC on December 15, 2014).
|
|
2.13
|
Form of “FDA Approval” Common Stock Purchase Warrant issued to General Hospital Corporation d/b/a Massachusetts General Hospital (incorporated by reference to Exhibit 4.2 to DARA BioSciences, Inc.’s Current Report on Form 8-K filed with the SEC on December 15, 2014).
|
|
4.1
|
Form of Contingent Value Rights Agreement by and among Midatech Pharma PLC, DARA BioSciences, Inc., Shareholder Representative Services LLC and American Stock Transfer & Trust Company, LLC, as rights agent (incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.2#
|
Midatech Pharma PLC 2014 Enterprise Management Incentive Scheme (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.3#
|
Form of Option Agreement (included in Exhibit 4.2).
|
|
4.4
|
Form of Warrant Exchange Agreement dated as of November 28, 2014, by and between Midatech Pharma PLC and certain warrantholders of Midatech Limited (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.5
|
Nominated Advisor and Broker Agreement, dated as of December 2, 2014, by and between Midatech Pharma PLC and Panmure Gordon (UK) Limited (incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.6
|
Form of Lock-in Agreement, dated as of December 3, 2014, by and among Midatech Pharma PLC, Panmure Gordon (UK) Limited and certain stockholders of Midatech Pharma PLC (incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.7
|
Form of Lock-in Agreement, dated as of December 3, 2014, by and among Midatech Pharma PLC, Panmure Gordon (UK) Limited and certain directors, related parties and employees of Midatech Pharma PLC (incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.8
|
Patent and Know-How Agreement, dated June 21, 2002, as amended on October 14, 2004, by and between Consejo Superior de Investigaciones Cientificas and Midatech Limited (incorporated by reference to Exhibit 10.10 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.9†
|
Joint Venture Agreement, dated as of December 15, 2011, by and between MonoSol RX LLC and Midatech Limited (incorporated by reference to Exhibit 10.11 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.10
|
Collaboration and License Agreement dated as of October 27, 2008, by and between MonoSol RX LLC and Midatech Limited (incorporated by reference to Exhibit 10.12 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.11
|
Research Collaboration Agreement, dated as of February 16, 2012, by and between Middlesex University and Midatech Limited (incorporated by reference to Exhibit 10.13 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.12
|
Research Collaboration Agreement, dated as of December 14, 2012, by and between The Open University and Midatech Limited (incorporated by reference to Exhibit 10.14 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.13
|
Consortium Agreement, dated as of June 25, 2012, by and among Midatech Limited, Cardiff University, Inserm-Transfert SA, Nanopass Technologies Ltd., Leiden University Medical Center, Kings College London, Institut National de la Sante et de la Recherche Medicale, Marseille and Linkopings University (incorporated by reference to Exhibit 10.15 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.14
|
Supply Agreement, dated as of July 9, 2013, by and between Q Chip Limited and Nova Laboratories Limited (incorporated by reference to Exhibit 10.16 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.15†
|
Formulation Feasibility Agreement, dated as of August 12, 2015, by and between Midatech Pharma PLC and Ophthotech Corporation (incorporated by reference to Exhibit 10.24 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.16*† †
|
Asset Purchase Agreement, dated as of December 17, 2015, by and between Galena Biopharma, Inc. and Midatech Pharma PLC.
|
|
4.17*† †
|
License and Supply Agreement dated as of July 17, 2014, by and between MonoSol RX, LLC and Galena Biopharma, Inc.
|
|
4.18*† †
|
License and Supply Transfer Agreement dated as of December 16, 2015, by and between MonoSol RX, LLC and Galena Biopharma, Inc.
|
|
4.19*† †
|
Distribution and Licence Agreement dated as of September 7, 2012, by and between Helsinn Healthcare SA and DARA BioSciences, Inc.
|
|
4.20*† †
|
Commercialization Agreement dated as of March 9, 2015, by and between Onxeo S.A. and DARA BioSciences, Inc.
|
|
4.21*† †
|
Master Service Agreement, dated as of October 25, 2013, by and between DARA Biosciences, Inc. and Alamo Pharma Services, Inc. including the Sales Representative Sharing Agreement by and among DARA Biosciences Inc., Alamo Pharma Services, Inc. and Mission Pharmacal Company (attached as Exhibit A), and the Co-Promotion Agreement by and among DARA BioSciences, Inc., Alamo Pharma Services, Inc. and Mission Pharmacal Company (attached as Attachment B) (incorporated by reference to Exhibit 10.1 to DARA BioSciences, Inc.’s Quarterly Report on Form 10-Q, as filed with the SEC on November 13, 2013).
|
|
4.22#
|
Consultancy Agreement, dated as of April 15, 2014, by and between Midatech Limited and Chesyl Pharma Limited (incorporated by reference to Exhibit 10.17 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.23#
|
Service Agreement dated as of December 3, 2014, by and between Midatech Pharma PLC and Dr. James Phillips (incorporated by reference to Exhibit 10.18 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.24#
|
Service Agreement dated as of December 3, 2014, by and between Midatech Pharma PLC and Nicholas Robbins-Cherry (incorporated by reference to Exhibit 10.19 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.25*#
|
Executive Employment Agreement dated as of January 1, 2016, by and between Midatech Pharma US, Inc. and David Benharris.
|
|
4.26#
|
Appointment Agreement, dated as of April 15, 2014, by and between Midatech Limited and Rolf Stahel (incorporated by reference to Exhibit 10.20 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.27#
|
Revised Appointment Agreement, dated as of December 2, 2014, by and between Midatech Pharma PLC and Rolf Stahel (incorporated by reference to Exhibit 10.21 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.28#
|
Form of Appointment Letter between Midatech Pharma PLC and certain directors of Midatech Pharma PLC (incorporated by reference to Exhibit 10.22 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
|
4.29#
|
Deed of Indemnity dated August 5, 2015 (incorporated by reference to Exhibit 10.23 to the Company’s Registration Statement on Form F-4 (File No. 333-206305), originally filed with the SEC on August 11, 2015, as amended).
|
| 4.30*# | Contract of Employment dated September 1, 2014 by and between Midatech Limited and Craig Cook. |
|
8.1*
|
Subsidiaries of Midatech Pharma PLC
|
|
12.1*
|
Certification of Chief Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to §302 of the Sarbanes-Oxley Act of 2002.
|
|
12.2*
|
Certification of Chief Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to §302 of the Sarbanes-Oxley Act of 2002.
|
|
13.1*
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002.
|
|
15.1*
|
Consent of BDO LLP.
|
|
MIDATECH PHARMA PLC
|
|||
|
(Registrant)
|
|||
|
By:
|
/s/ James N. Phillips
|
||
|
Name:
|
James N. Phillips
|
||
|
Title:
|
Chief Executive Officer
|
||
|
Page
|
|
|
F-2
|
|
|
F-3
|
|
|
F-4
|
|
|
F-5
|
|
|
F-6
|
|
|
F-9
|
|
Note
|
2015
|
2014
|
2013
|
|||||||||||||
| £'000 |
£'000
|
£'000
|
||||||||||||||
|
Revenue
|
3 | 775 | 25 | 147 | ||||||||||||
|
Grant revenue
|
600 | 132 | - | |||||||||||||
|
Total revenue
|
1,375 | 157 | 147 | |||||||||||||
|
Cost of sales
|
(70 | ) | - | - | ||||||||||||
|
Gross profit
|
1,305 | 157 | 147 | |||||||||||||
|
Research and development costs
|
(5,920 | ) | (5,439 | ) | (2,840 | ) | ||||||||||
|
Distribution costs, sales and marketing
|
(374 | ) | - | - | ||||||||||||
|
Administrative costs
|
4 | (7,929 | ) | (4,665 | ) | (1,806 | ) | |||||||||
|
Loss from operations
|
(12,918 | ) | (9,947 | ) | (4,499 | ) | ||||||||||
|
Finance income
|
6 | 1,691 | 8 | 1 | ||||||||||||
|
Finance expense
|
6 | (5 | ) | (161 | ) | (385 | ) | |||||||||
|
Loss before tax
|
(11,232 | ) | (10,100 | ) | (4,883 | ) | ||||||||||
|
Taxation
|
7 | 1,133 | 1,018 | 799 | ||||||||||||
|
Loss after tax attributable to the owners of the parent
|
(10,099 | ) | (9,082 | ) | (4,084 | ) | ||||||||||
|
Other comprehensive income:
|
||||||||||||||||
|
Items that will or may be reclassified subsequently to profit
or loss when specific conditions are met:
|
||||||||||||||||
|
Exchange (losses)/gains arising on translation of foreign
operations
|
399 | (151 | ) | 5 | ||||||||||||
|
Total other comprehensive income/(loss), net of tax
|
399 | (151 | ) | 5 | ||||||||||||
|
Total comprehensive loss attributable to the owners of
the parent |
(9,700 | ) | (9,233 | ) | (4,079 | ) | ||||||||||
|
Loss per share
|
||||||||||||||||
|
Basic and diluted loss per ordinary share - pence
|
8 | (36p | ) | (101p | ) | (71p | ) | |||||||||
|
Note
|
2015
|
2014
|
2013
|
|||||||||||||
|
Assets
|
£’000
|
£’000
|
£’000
|
|||||||||||||
|
Non-current assets
|
||||||||||||||||
|
Property, plant and equipment
|
9 | 1,984 | 1,516 | 684 | ||||||||||||
|
Intangible assets
|
10 | 41,339 | 13,094 | 4 | ||||||||||||
|
Investment in equity accounted joint venture
|
- | - | 12 | |||||||||||||
|
Other receivables due in greater than one year
|
17 | 387 | 425 | 379 | ||||||||||||
| 43,710 | 15,035 | 1,079 | ||||||||||||||
|
Current assets
|
||||||||||||||||
|
Inventories
|
19 | 459 | - | - | ||||||||||||
|
Trade and other receivables
|
17 | 2,496 | 462 | 909 | ||||||||||||
|
Taxation
|
1,201 | 841 | 799 | |||||||||||||
|
Cash and cash equivalents
|
18 | 16,175 | 30,325 | 2,387 | ||||||||||||
| 20,331 | 31,628 | 4,095 | ||||||||||||||
|
Total assets
|
64,041 | 46,663 | 5,174 | |||||||||||||
|
Liabilities
|
||||||||||||||||
|
Non-current liabilities
|
||||||||||||||||
|
Borrowings
|
21 | 1,508 | 1,488 | 2,119 | ||||||||||||
|
Deferred tax liability
|
24 | 6,547 | 354 | - | ||||||||||||
| 8,055 | 1,842 | 2,119 | ||||||||||||||
|
Current liabilities
|
||||||||||||||||
|
Trade and other payables
|
20 | 7,084 | 2,341 | 1,047 | ||||||||||||
|
Borrowings
|
21 | 442 | 491 | 1,248 | ||||||||||||
|
Derivative financial liability – equity settled
|
22 | 1,573 | - | - | ||||||||||||
| 9,099 | 2,832 | 2,295 | ||||||||||||||
|
Total liabilities
|
17,154 | 4,674 | 4,414 | |||||||||||||
|
Issued capital and reserves attributable to owners of the
parent
|
||||||||||||||||
|
Share capital
|
25 | 1,002 | 1,001 | - | ||||||||||||
|
Share premium
|
26 | 31,643 | 31,643 | 21,018 | ||||||||||||
|
Merger reserve
|
26 | 52,803 | 37,776 | - | ||||||||||||
|
Shares to be issued
|
26 | 200 | 800 | - | ||||||||||||
|
Foreign exchange reserve
|
26 | 390 | (9 | ) | 142 | |||||||||||
|
Accumulated deficit
|
26 | (39,151 | ) | (29,222 | ) | (20,400 | ) | |||||||||
|
Total equity
|
46,887 | 41,989 | 760 | |||||||||||||
|
Total equity and liabilities
|
64,041 | 46,663 | 5,174 | |||||||||||||
|
Note
|
2015
|
2014
|
2013
|
|||||||||||||
|
£’000
|
£’000
|
£’000
|
||||||||||||||
|
Cash flows from operating activities
|
||||||||||||||||
|
Loss for the year after tax
|
(10,099 | ) | (9,082 | ) | (4,084 | ) | ||||||||||
|
Adjustments for:
|
||||||||||||||||
|
Depreciation of property, plant and equipment
|
9 | 501 | 321 | 246 | ||||||||||||
|
Amortisation of intangible fixed assets
|
10 | 236 | 1 | 1 | ||||||||||||
|
Loss on disposal of fixed assets
|
- | 89 | - | |||||||||||||
|
Net Interest (income)/expense
|
(1,686 | ) | 153 | 384 | ||||||||||||
|
Impairment of IPRD
|
- | 1,800 | - | |||||||||||||
|
Gain on bargain purchase
|
13 | (165 | ) | - | - | |||||||||||
|
Share based payment expense
|
170 | 260 | - | |||||||||||||
|
Taxation
|
(1,133 | ) | (1,018 | ) | (799 | ) | ||||||||||
|
Cash flows from operating activities before changes in
working capital
|
(12,176 | ) | (7,476 | ) | (4,252 | ) | ||||||||||
|
Increase in inventories
|
(62 | ) | - | - | ||||||||||||
|
(Increase)/decrease in trade and other receivables
|
(1,540 | ) | 761 | (442 | ) | |||||||||||
|
Increase/(decrease) in trade and other payables
|
711 | 466 | (330 | ) | ||||||||||||
|
Cash used in operations
|
(13,067 | ) | (6,249 | ) | (5,024 | ) | ||||||||||
|
Taxes received
|
646 | 794 | 588 | |||||||||||||
|
Net cash used in operating activities
|
(12,421 | ) | (5,455 | ) | (4,436 | ) | ||||||||||
|
Investing activities
|
||||||||||||||||
|
Purchases of property, plant and equipment
|
(922 | ) | (1,030 | ) | (47 | ) | ||||||||||
|
Purchase of intangibles
|
(3 | ) | - | (3 | ) | |||||||||||
|
Acquisition of subsidiary, net of cash acquired
|
12 | 1,867 | 115 | - | ||||||||||||
|
Acquisition of business, net of cash acquired
|
13 | (2,528 | ) | - | - | |||||||||||
|
Interest received
|
53 | 8 | - | |||||||||||||
|
Net cash used in investing activities
|
(1,533 | ) | (907 | ) | (50 | ) | ||||||||||
|
Financing activities
|
||||||||||||||||
|
Interest paid
|
(5 | ) | (48 | ) | (15 | ) | ||||||||||
|
Payments to finance lease creditors
|
(49 | ) | (48 | ) | (93 | ) | ||||||||||
|
Repayment of borrowings
|
(165 | ) | (346 | ) | (200 | ) | ||||||||||
|
Issue of convertible debt
|
- | - | 1,251 | |||||||||||||
|
Loan finance raised
|
- | 890 | - | |||||||||||||
|
Share issues net of costs
|
- | 33,852 | 5,797 | |||||||||||||
|
Net cash (used in)/generated from financing activities
|
(219 | ) | 34,300 | 6,740 | ||||||||||||
|
Net (decrease)/increase in cash and cash equivalents
|
(14,173 | ) | 27,938 | 2,254 | ||||||||||||
|
Cash and cash equivalents at beginning of year
|
30,325 | 2,387 | 133 | |||||||||||||
|
Exchange gains on cash and cash equivalents
|
23 | - | - | |||||||||||||
|
Cash and cash equivalents at end of year
|
18 | 16,175 | 30,325 | 2,387 | ||||||||||||
|
Share
capital
|
Share
premium
|
Merger reserve
|
Shares to be
issued
|
Foreign
exchange
reserve
|
Accumulated
deficit
|
Total
equity
|
||||||||||||||||||||||
|
£'000
|
£'000
|
£ ’000 | £ ’000 |
£'000
|
£'000
|
£'000
|
||||||||||||||||||||||
|
At 1 January 2015
|
1,001 | 31,643 | 37,776 | 800 | (9 | ) | (29,222 | ) | 41,989 | |||||||||||||||||||
|
Loss for the year
|
- | - | - | - | - | (10,099 | ) | (10,099 | ) | |||||||||||||||||||
|
Foreign exchange translation
|
- | - | - | - | 399 | - | 399 | |||||||||||||||||||||
|
Total comprehensive loss
|
- | - | - | - | 399 | (10,099 | ) | (9,700 | ) | |||||||||||||||||||
|
Transactions with owners
|
||||||||||||||||||||||||||||
|
Shares issued on exercise of
share options
|
1 | - | - | - | - | - | 1 | |||||||||||||||||||||
|
Shares, warrants and share
options issued as consideration
for a business combination – 4
December 2015
|
- | - | 14,427 | - | - | - | 14,427 | |||||||||||||||||||||
|
Share option charge
|
- | - | - | - | - | 170 | 170 | |||||||||||||||||||||
|
Shares issued as deferred
consideration for business
combination
|
- | - | 600 | (600 | ) | - | - | - | ||||||||||||||||||||
|
Total contribution by and
distributions to owners
|
1 | - | 15,027 | (600 | ) | - | 170 | 14,598 | ||||||||||||||||||||
|
At 31 December 2015
|
1,002 | 31,643 | 52,803 | 200 | 390 | (39,151 | ) | 46,887 | ||||||||||||||||||||
|
Share
capital
|
Share
premium
|
Merger reserve
|
Shares to be
issued
|
Foreign
exchange
reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||||||||
|
£'000
|
£'000
|
£’000 |
£'000
|
£'000
|
£'000
|
£'000
|
||||||||||||||||||||||
|
At 1 January 2014
|
- | 21,018 | - | - | 142 | (20,400 | ) | 760 | ||||||||||||||||||||
|
Loss for the year
|
- | - | - | - | - | (9,082 | ) | (9,082 | ) | |||||||||||||||||||
|
Foreign exchange translation
|
- | - | - | - | (151 | ) | - | (151 | ) | |||||||||||||||||||
|
Total comprehensive loss
|
- | - | - | - | (151 | ) | (9,082 | ) | (9,233 | ) | ||||||||||||||||||
|
Issue of Midatech Limited shares - pre-share for
share exchange
|
- | 3,202 | - | - | - | - | 3,202 | |||||||||||||||||||||
|
Transfer to merger reserve on the merger of
Midatech Pharma plc and Midatech Limited – 31
October 2014
|
- | (24,220 | ) | 24,220 | - | - | - | - | ||||||||||||||||||||
|
Transfer of A Preference shares from liability to
equity (28 October 2014) and subsequent
conversion to Deferred shares – 8 December 2014
|
1,000 | - | - | - | - | - | 1,000 | |||||||||||||||||||||
|
Issue of shares to settle A Preference share
accrued dividend – 8 December 2014
|
- | 994 | - | - | - | - | 994 | |||||||||||||||||||||
|
Shares issued as consideration for a business
combination – 8 December 2014
|
- | - | 13,556 | - | - | - | 13,556 | |||||||||||||||||||||
|
Shares to be issued as consideration for a business
combination – 8 December 2014
|
- | - | - | 800 | - | - | 800 | |||||||||||||||||||||
|
Issue of shares on placing – 8 December 2014
|
1 | 32,000 | - | - | - | - | 32,001 | |||||||||||||||||||||
|
Costs associated with share placing
|
- | (1,351 | ) | - | - | - | - | (1,351 | ) | |||||||||||||||||||
|
Share based payment
|
- | - | - | - | - | 260 | 260 | |||||||||||||||||||||
|
Total contribution by and distributions to
owners
|
1,001 | 10,625 | 37,776 | 800 | - | 260 | 50,462 | |||||||||||||||||||||
|
At 31 December 2014
|
1,001 | 31,643 | 37,776 | 800 | (9 | ) | (29,222 | ) | 41,989 | |||||||||||||||||||
|
Share
capital
|
Share
premium
|
Merger reserve
|
Shares to be
issued
|
Foreign
exchange
reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||||||||
|
£'000
|
£'000
|
£ ’000 | £ ’000 |
£'000
|
£'000
|
£'000
|
||||||||||||||||||||||
|
1 January 2013
|
- | 11,966 | - | - | 137 | (17,194 | ) | (5,091 | ) | |||||||||||||||||||
|
Loss for the year
|
- | - | - | - | - | (4,084 | ) | (4,084 | ) | |||||||||||||||||||
|
Foreign exchange translation
|
- | - | - | - | 5 | - | 5 | |||||||||||||||||||||
|
Total comprehensive income/(loss)
|
- | - | - | - | 5 | (4,084 | ) | (4,079 | ) | |||||||||||||||||||
|
Transaction with owners
|
||||||||||||||||||||||||||||
|
Conversion of convertible loan notes
|
- | - | - | - | - | 584 | 584 | |||||||||||||||||||||
|
Issue of shares
|
- | 9,093 | - | - | - | - | 9,093 | |||||||||||||||||||||
|
Cost of share issues
|
- | (41 | ) | - | - | - | - | (41 | ) | |||||||||||||||||||
|
Capital contribution
|
- | - | - | - | - | 294 | 294 | |||||||||||||||||||||
|
Total contribution by and distributions to
owners
|
- | 9,052 | - | - | - | 878 | 9,930 | |||||||||||||||||||||
|
31 December 2013
|
- | 21,018 | - | - | 142 | (20,400 | ) | 760 | ||||||||||||||||||||
|
1
|
Accounting policies
|
|
•
|
Identify the contract(s) with a customer;
|
|
•
|
Identify the performance obligations in the contract;
|
|
•
|
Determine the transaction price;
|
|
•
|
Allocate the transaction price to the performance obligations in the contract; and
|
|
•
|
Recognize revenue when (or as) the entity satisfies a performance obligation.
|
|
Entity
|
Summary description
|
|
Midatech Pharma PLC
|
Ultimate holding company
|
|
Midatech Limited
|
Trading company
|
|
Midatech Pharma (Espana) SL (formerly Midatech Biogune SL)
|
Trading company
|
|
Midatech Andalucia SL
|
Dormant
|
|
PharMida AG
|
Trading company
|
|
Midatech Pharma (Wales) Limited (formerly Q Chip Limited)
|
Trading company
|
|
Midatech Pharma US, Inc. (formerly DARA Biosciences, Inc.)
|
Trading company
|
|
Dara Therapeutics, Inc.
|
Dormant
|
|
Midatech Pharma Pty
|
Trading company
|
|
·
|
the fair value of the consideration transferred to the seller, plus
|
|
·
|
the amount of any non-controlling interest in the acquiree, plus
|
|
·
|
if the business combination is achieved in stages, the fair value of the existing equity interest in the acquiree re-measured at the acquisition date, less
|
|
·
|
the fair value of the net identifiable assets acquired and assumed liabilities.
|
|
Goodwill
|
- | Indefinite life |
|
IPRD
|
-
|
In process, not yet amortising
|
|
IT and website costs
|
-
|
4 years
|
|
Product and marketing rights
|
-
|
Between 2 and 13 years
|
|
·
|
Completion of the asset is technically feasible so that it will be available for use or sale;
|
|
·
|
The Group intends to complete the asset and use or sell it;
|
|
·
|
The Group has the ability to use or sell the asset and the asset will generate probable future economic benefits (over and above cost);
|
|
·
|
There are adequate technical, financial and other resources to complete the development and to use or sell the asset, and
|
|
·
|
The expenditure attributable to the asset during its development can be measured reliably.
|
|
·
|
Joint ventures: where the Group has rights to only the net assets of the joint arrangement; or
|
|
·
|
Joint operations: where the Group has both the rights to assets and obligations for the liabilities of the joint arrangement.
|
|
·
|
The structure of the joint arrangement;
|
|
·
|
The legal form of joint arrangements structured through a separate vehicle;
|
|
·
|
The contractual terms of the joint arrangement agreement; and
|
|
·
|
Any other facts and circumstances (including any other contractual arrangements).
|
|
·
|
Borrowings are initially recognised at fair value net of any transaction costs directly attributable to the issue of the instrument. Such interest bearing liabilities are subsequently measured at amortised cost using the effective interest rate method, which ensures that any interest expense over the period to repayment is at a constant rate on the balance of the liability carried in the consolidated statement of financial position. Interest expense in this context includes initial transaction costs and premium payable on redemption, as well as any interest or coupon payable while the liability is outstanding.
|
|
·
|
Government loans received on favourable terms below market rate are discounted at a market rate of interest. The difference between the present value of the loan and the proceeds is held as a government grant within deferred revenue and is released to research and development expenditure in line with when the asset or expenditure is recognised in the income statement.
|
|
·
|
Redeemable preference shares are classified as liabilities as they accrued fixed interest payable in cash when distributable profits are available and confer no right to assets or equity distributions of the Company.
|
|
·
|
Trade payables and other short-term monetary liabilities are initially recognised at fair value and subsequently carried at amortised cost using the effective interest method.
|
|
·
|
Ordinary shares of £0.00005 each are classified as equity instruments; and
|
|
·
|
Deferred shares of £1 each are classified as equity instruments.
|
|
·
|
including any market performance conditions (including the share price);
|
|
·
|
excluding the impact of any service and non-market performance vesting conditions (for example, remaining an employee of the entity over a specified time period); and
|
|
·
|
including the impact of any non-vesting conditions (for example, the requirement for employees to save).
|
|
·
|
the initial recognition of goodwill;
|
|
·
|
the initial recognition of an asset or liability in a transaction which is not a business combination and at the time of the transaction affects neither accounting or taxable profit; and
|
|
·
|
investments in subsidiaries and jointly controlled entities where the Group is able to control the timing of the reversal of the difference and it is probable that the difference will not reverse in the foreseeable future.
|
|
Fixtures and fittings
|
-
|
25% per annum straight line
|
|
Leasehold improvements
|
-
|
10% per annum straight line
|
|
Computer equipment
|
-
|
25% per annum straight line
|
|
Laboratory equipment
|
-
|
15% per annum straight line
|
|
2
|
Critical accounting estimates and judgements
|
|
·
|
future expected cash flows from in-process research and development;
|
|
·
|
the fair value of the property, plant and equipment; and
|
|
·
|
discount rates.
|
|
·
|
Volatility is estimated based on the average annualized volatility of a number of publicly traded peer companies in the biotech sector.
|
|
·
|
The estimated life of the option is estimated to be until the first exercise period, which is typically the month after the option vests.
|
|
·
|
The dividend return is estimated by reference to our historical dividend payments. Currently, this is estimated to be zero as no dividend has been paid in the prior periods.
|
|
3
|
Segment Information
|
|
2015
|
2014
|
2013
|
||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
United Kingdom
|
-
|
25
|
- | |||||||||
|
Turkey
|
73
|
-
|
-
|
|||||||||
|
Austria
|
25 | - | - | |||||||||
|
United States
|
677 | - | 147 | |||||||||
| 775 | 25 | 147 | ||||||||||
|
·
|
Pipeline Research and Development: The Pipeline Research and Development (“Pipeline R&D”) segment seeks to develop products using the Group’s nanomedicine and sustained release technology platforms.
|
|
·
|
Commercial: The Commercial segment distributes and sells the Group’s commercial products. Midatech Pharma US promotes the Group’s commercial, cancer supportive care products in the US market, in which the Group has exclusive licenses to Soltamox, Oravig and Zuplenz, an exclusive license to distribute, promote and market Gelclair, and a marketing agreement to co-promote two other products: Ferralet 90 and Aquoral. As and when new products are introduced the Commercial segment will include revenues from the marketing of these commercial products.
|
|
Pipeline R&D
|
Commercial
|
Unallocated
Costs
(1)
|
Consolidated
|
|||||||||||||
| £ ’000 | £ ’000 | £ ’000 | £ ’000 | |||||||||||||
|
Revenue
|
273 | 502 | - | 775 | ||||||||||||
|
Grant revenue
|
600 | - | - | 600 | ||||||||||||
|
Total revenue
|
873 | 502 | - | 1,375 | ||||||||||||
|
Cost of sales
|
- | (70 | ) | - | (70 | ) | ||||||||||
|
Research and development costs
|
(5,811 | ) | (109 | ) | - | (5,920 | ) | |||||||||
|
Distribution costs, sales and marketing
|
- | (374 | ) | (374 | ) | |||||||||||
|
Other administrative costs
|
(3,983 | ) | (218 | ) | (2,991 | ) | (7,192 | ) | ||||||||
|
Depreciation
|
(500 | ) | (1 | ) | - | (501 | ) | |||||||||
|
Amortisation
|
(5 | ) | (231 | ) | - | (236 | ) | |||||||||
|
Segmental result/operating loss
|
(9,426 | ) | (501 | ) | (2,991 | ) | (12,918 | ) | ||||||||
|
Finance income
|
1,691 | |||||||||||||||
|
Finance expense
|
(5 | ) | ||||||||||||||
|
Loss before tax
|
(11,232 | ) | ||||||||||||||
|
Taxation
|
1,133 | |||||||||||||||
|
Loss after tax
|
(10,099 | ) | ||||||||||||||
|
2015
|
2014
|
2013
|
||||||||||
|
£’000
|
£’000
|
£’000
|
||||||||||
|
Spain
|
1,433 | 1,578 | 951 | |||||||||
|
United Kingdom
|
14,019 | 13,457 | 128 | |||||||||
|
United States
|
28,258 | - | - | |||||||||
| 43,710 | 15,035 | 1,079 | ||||||||||
|
4
|
Loss from operations
|
|
2015
|
2014
|
2013
|
||||||||||
|
Loss from operations is stated after charging/(crediting):
|
£' 000 |
£'000
|
£'000
|
|||||||||
|
Changes in inventories of finished goods and work in
progress
|
62 | - | - | |||||||||
|
Depreciation of property, plant and equipment
|
501 | 321 | 246 | |||||||||
|
Amortisation of intangible assets
|
236 | 1 | 1 | |||||||||
|
Impairment of IPRD
|
- | 1,800 | - | |||||||||
|
Operating lease expense:
|
||||||||||||
|
-
Property
|
246 | 97 | 194 | |||||||||
|
-
Plant and machinery
|
86 | 57 | - | |||||||||
|
Foreign exchange (gain)/loss
|
(23 | ) | (37 | ) | 28 | |||||||
|
IPO costs
|
- | 763 | - | |||||||||
|
Acquisition costs
|
2,991 | 172 | - | |||||||||
|
Loss on disposal of property, plant and equipment
|
- | 89 | - | |||||||||
|
Gain on bargain purchase
|
(165 | ) | - | - | ||||||||
|
5
|
Staff costs
|
|
2015
|
2014
|
2013
|
||||||||||
| £ ’000 |
£'000
|
£'000
|
||||||||||
|
Staff costs (including directors) comprise:
|
||||||||||||
|
Wages and salaries
|
3,731 | 2,322 | 1,866 | |||||||||
|
Defined contribution pension cost (note 28)
|
183 | 169 | 177 | |||||||||
|
Social security contributions and similar taxes
|
431 | 322 | 295 | |||||||||
|
Share based payment
|
170 | 260 | - | |||||||||
| 4,515 | 3,073 | 2,338 | ||||||||||
|
2015
|
2014
|
2013
|
||||||||||
| £ ’000 |
£'000
|
£'000
|
||||||||||
|
Research and development
|
45 | 28 | 22 | |||||||||
|
General and administration
|
22 | 10 | 7 | |||||||||
|
Sales and marketing
|
7 | - | - | |||||||||
| 74 | 38 | 29 | ||||||||||
|
2015
|
2014
|
2013
|
||||||||||
| £ ’000 |
£'000
|
£'000
|
||||||||||
|
Wages and salaries
|
850 | 546 | 561 | |||||||||
|
Defined contribution pension cost
|
59 | 36 | 55 | |||||||||
|
Payments made to third parties
|
223 | 184 | - | |||||||||
|
Social security contributions and similar taxes
|
88 | 78 | 72 | |||||||||
|
Benefits in kind
|
7 | 36 | 7 | |||||||||
|
Share based payment
|
170 | 260 | - | |||||||||
| 1,397 | 1,140 | 695 | ||||||||||
|
6
|
Finance income and expense
|
|
2015
|
2014
|
2013
|
||||||||||
|
Finance income
|
£ ’000 |
£'000
|
£'000
|
|||||||||
|
Interest received on bank deposits
|
53 | 8 | 1 | |||||||||
|
Gain on equity settled derivative financial liability
|
1,638 | - | - | |||||||||
|
Total finance income
|
1,691 | 8 | 1 | |||||||||
|
2015
|
2014
|
2013
|
||||||||||
|
Finance expense
|
£ ’000 |
£'000
|
£'000
|
|||||||||
|
Bank loans
|
2 | 126 | 3 | |||||||||
|
Other loans
|
3 | - | 50 | |||||||||
|
Interest on convertible loans
|
- | 35 | 195 | |||||||||
|
Non-equity preference shares
|
- | - | 137 | |||||||||
|
Total finance expense
|
5 | 161 | 385 | |||||||||
|
7
|
Taxation
|
|
2015
|
2014
|
2013
|
||||||||||
| £ ’000 |
£'000
|
£'000
|
||||||||||
|
Current tax credit
|
||||||||||||
|
Current tax credited to the income statement
|
1,002 | 663 | 799 | |||||||||
|
Taxation payable in respect of foreign subsidiary
|
- | (5 | ) | - | ||||||||
| 1,002 | 658 | 799 | ||||||||||
|
Deferred tax credit
|
||||||||||||
|
Reversal of temporary differences
|
131 | 360 | - | |||||||||
|
Total current tax and tax credit
|
1,133 | 1,018 | 799 | |||||||||
|
2015
|
2014
|
2013
|
||||||||||
| £ ’000 |
£'000
|
£'000
|
||||||||||
|
Loss before income tax
|
(11,232 | ) | (10,100 | ) | (4,883 | ) | ||||||
|
Expected tax credit based on the standard rate of United
Kingdom corporation tax at the domestic rate of 20.25%
(2014: 21.49%, 2013:20%)
|
(2,274 | ) | (2,170 | ) | (977 | ) | ||||||
|
Fixed asset differences
|
- | 12 | 4 | |||||||||
|
Expenses not deductible for tax purposes
|
185 | 440 | 67 | |||||||||
|
Adjustments to brought forward values
|
(8 | ) | 33 | - | ||||||||
|
Additional deduction for R&D expenditure
|
(789 | ) | (566 | ) | (811 | ) | ||||||
|
Surrender of tax losses for R&D tax refund
|
406 | 419 | 653 | |||||||||
|
Adjust deferred tax opening/closing rate
|
- | 59 | - | |||||||||
|
Income not taxable
|
- | (44 | ) | - | ||||||||
|
Difference in capital allowances and
depreciation/amortisation
|
- | - | 5 | |||||||||
|
Other short term timing differences
|
- | - | 23 | |||||||||
|
Unrelieved tax losses and other deductions arising in the
period
|
(78 | ) | (35 | ) | 237 | |||||||
|
Deferred tax not recognised
|
1,425 | 834 | - | |||||||||
|
Total tax credited to the income statement
|
(1,133 | ) | (1,018 | ) | (799 | ) | ||||||
|
8
|
Loss per share
|
|
Total
|
Total
|
Total
|
||||||||||
|
2015
|
2014
|
2013
|
||||||||||
|
Numerator
|
£ ’000 |
£'000
|
£'000
|
|||||||||
|
Loss used in basic EPS and diluted EPS
|
(10,099 | ) | (9,082 | ) | (4,084 | ) | ||||||
|
Denominator
|
||||||||||||
|
Weighted average number of ordinary shares used in basic
EPS
|
28,229,814 | 9,026,347 | 5,715,576 | |||||||||
|
Basic and diluted loss per share - pence
|
(36p | ) | (101p | ) | (71p | ) | ||||||
|
9
|
Property, plant and equipment
|
|
Fixtures
|
Leasehold
|
Computer
|
Laboratory
|
|||||||||||||||||
|
and fittings
|
improve-
ments |
equipment
|
equipment
|
Total
|
||||||||||||||||
|
£'000
|
£'000
|
£'000
|
£'000
|
£'000
|
||||||||||||||||
|
Cost
|
||||||||||||||||||||
|
At 1 January 2013
|
716 | 746 | 147 | 161 | 1,770 | |||||||||||||||
|
Additions
|
16 | 15 | 15 | 1 | 47 | |||||||||||||||
|
Exchange differences
|
16 | 6 | 3 | - | 25 | |||||||||||||||
|
At 31 December 2013
|
748 | 767 | 165 | 162 | 1,842 | |||||||||||||||
|
At 1 January 2014
|
748 | 767 | 165 | 162 | 1,842 | |||||||||||||||
|
Additions
|
524 | 259 | 18 | 229 | 1,030 | |||||||||||||||
|
Acquired through acquisition of
subsidiary |
3 | 19 | 15 | 207 | 244 | |||||||||||||||
|
Exchange differences
|
(42 | ) | (41 | ) | (3 | ) | - | (86 | ) | |||||||||||
|
Disposals
|
(31 | ) | (124 | ) | - | (15 | ) | (170 | ) | |||||||||||
|
At 31 December 2014
|
1,202 | 880 | 195 | 583 | 2,860 | |||||||||||||||
|
At 1 January 2015
|
1,202 | 880 | 195 | 583 | 2,860 | |||||||||||||||
|
Additions
|
183 | 283 | 173 | 385 | 1,024 | |||||||||||||||
|
Acquired through acquisition of
subsidiary |
- | - | - | 16 | 16 | |||||||||||||||
|
Exchange differences
|
(66 | ) | (51 | ) | (14 | ) | (1 | ) | (132 | ) | ||||||||||
|
At 31 December 2015
|
1,319 | 1,112 | 354 | 983 | 3,768 | |||||||||||||||
|
9
|
Property, plant and equipment
(continued)
|
|
Fixtures
|
Leasehold
|
Computer
|
Laboratory
|
|||||||||||||||||
|
and fittings
|
improve-
ments |
equipment
|
equipment
|
Total
|
||||||||||||||||
|
£'000
|
£'000
|
£'000
|
£'000
|
£'000
|
||||||||||||||||
|
Accumulated depreciation
|
||||||||||||||||||||
|
At 1 January 2013
|
321 | 400 | 94 | 79 | 894 | |||||||||||||||
|
Charge for the year
|
102 | 86 | 22 | 36 | 246 | |||||||||||||||
|
Exchange differences
|
7 | 9 | 2 | - | 18 | |||||||||||||||
|
At 31 December 2013
|
430 | 495 | 118 | 115 | 1,158 | |||||||||||||||
|
At 1 January 2014
|
430 | 495 | 118 | 115 | 1,158 | |||||||||||||||
|
Charge for the year
|
102 | 67 | 24 | 128 | 321 | |||||||||||||||
|
Exchange differences
|
(22 | ) | (33 | ) | (2 | ) | 3 | (54 | ) | |||||||||||
|
Disposals
|
(31 | ) | (50 | ) | - | - | (81 | ) | ||||||||||||
|
At 31 December 2014
|
479 | 479 | 140 | 246 | 1,344 | |||||||||||||||
|
At 1 January 2015
|
479 | 479 | 140 | 246 | 1,344 | |||||||||||||||
|
Charge for the year
|
3 | 282 | 48 | 168 | 501 | |||||||||||||||
|
Exchange differences
|
(24 | ) | (28 | ) | (8 | ) | (1 | ) | (61 | ) | ||||||||||
|
At 31 December 2015
|
458 | 733 | 180 | 413 | 1,784 | |||||||||||||||
|
Net book value
|
||||||||||||||||||||
|
At 31 December 2015
|
861 | 379 | 174 | 570 | 1,984 | |||||||||||||||
|
At 31 December 2014
|
723 | 401 | 55 | 337 | 1,516 | |||||||||||||||
|
At 31 December 2013
|
318 | 272 | 47 | 47 | 684 | |||||||||||||||
|
At 1 January 2013
|
395 | 346 | 53 | 82 | 876 | |||||||||||||||
|
10
|
Intangible assets
|
|
In-process
research and development |
Product and
marketing rights |
Goodwill
|
IT/Website
costs |
Total
|
||||||||||||||||
|
£'000
|
£'000
|
£'000
|
£'000
|
£'000
|
||||||||||||||||
|
Cost
|
||||||||||||||||||||
|
At 1 January 2013
|
- | - | - | 9 | 9 | |||||||||||||||
|
Additions
|
- | - | - | 3 | 3 | |||||||||||||||
|
At 31 December 2013
|
- | - | - | 12 | 12 | |||||||||||||||
|
At 1 January 2014
|
- | - | - | 12 | 12 | |||||||||||||||
|
Acquired in business combinations
|
12,600 | - | 2,291 | - | 14,891 | |||||||||||||||
|
At 31 December 2014
|
12,600 | - | 2,291 | 12 | 14,903 | |||||||||||||||
|
At 1 January 2015
|
12,600 | - | 2,291 | 12 | 14,903 | |||||||||||||||
|
Additions
|
- | - | - | 3 | 3 | |||||||||||||||
|
Acquired in business combinations
|
- | 17,989 | 9,952 | - | 27,941 | |||||||||||||||
|
Foreign exchange
|
- | 332 | 213 | - | 545 | |||||||||||||||
|
At 31 December 2015
|
12,600 | 18,321 | 12,456 | 15 | 43,392 | |||||||||||||||
|
10
|
Intangible assets
(continued)
|
|
In-process
|
Product and
|
Goodwill
|
IT/Website
|
|||||||||||||||||
|
research and
|
marketing
|
Costs
|
Total
|
|||||||||||||||||
|
development
|
rights
|
|||||||||||||||||||
|
£'000
|
£'000
|
£'000
|
£'000
|
£'000
|
||||||||||||||||
|
Accumulated amortisation
|
||||||||||||||||||||
|
At 1 January 2013
|
- | - | - | 7 | 7 | |||||||||||||||
|
Amortisation charge for the
year
|
- | - | - | 1 | 1 | |||||||||||||||
|
At 31 December 2013
|
- | - | - | 8 | 8 | |||||||||||||||
|
At 1 January 2014
|
- | - | - | 8 | 8 | |||||||||||||||
|
Amortisation charge for the
year
|
- | - | - | 1 | 1 | |||||||||||||||
|
Impairment charge for year
|
1,800 | - | - | - | 1,800 | |||||||||||||||
|
At 31 December 2014
|
1,800 | - | - | 9 | 1,809 | |||||||||||||||
|
Amortisation charge for the
year
|
- | 235 | - | 1 | 236 | |||||||||||||||
|
Foreign exchange
|
- | 8 | - | - | 8 | |||||||||||||||
|
At 31 December 2015
|
1,800 | 243 | - | 10 | 2,053 | |||||||||||||||
|
Net book value
|
||||||||||||||||||||
|
At 31 December 2015
|
10,800 | 18,078 | 12,456 | 5 | 41,339 | |||||||||||||||
|
At 31 December 2014
|
10,800 | - | 2,291 | 3 | 13,094 | |||||||||||||||
|
At 31 December 2013
|
- | - | - | 4 | 4 | |||||||||||||||
|
At 1 January 2013
|
- | - | - | 2 | 2 | |||||||||||||||
|
Carrying amount
|
Remaining amortisation period
|
|||||||||||||||||||||||
|
2015
|
2014
|
2013
|
2015
|
2014
|
2013
|
|||||||||||||||||||
| £ ’000 | £ ’000 | £ ’000 |
(years)
|
(years)
|
(years)
|
|||||||||||||||||||
|
Midatech Pharma (Wales)
Limited acquired IPRD
|
10,800 | 10,800 | - |
n/a in
process
|
n/a in
process
|
- | ||||||||||||||||||
|
Midatech Pharma US, Inc.,
product and marketing rights
|
15,570 | - | - |
Between 2
and 5
|
- | - | ||||||||||||||||||
|
Zuplenz product and
marketing rights
|
2,508 | - | - | 13 | - | - | ||||||||||||||||||
| 28,878 | 10,800 | - | ||||||||||||||||||||||
|
11
|
Prior year - acquisition of Q Chip Limited – revised provisional values
|
|
a)
|
Add controlled-release technology to Midatech gold nano-particle and portfolio
|
|
b)
|
Expand the number of development projects
|
|
c)
|
Q-Chip’s product portfolio offered Midatech a lower risk profile than Midatech’s own technology thereby mitigating against potential future failure
|
|
Final fair value
|
||||
| £ ’000 | ||||
|
Identifiable intangible assets:
|
||||
|
In-process research and development
|
12,600 | |||
|
Property, plant and equipment
|
244 | |||
|
Receivables and other debtors
|
314 | |||
|
Payables and other liabilities
|
(494 | ) | ||
|
Deferred tax
|
(714 | ) | ||
|
Cash
|
115 | |||
|
Total net assets
|
12,065 | |||
|
Equity instruments (5,077,122 ordinary shares)
|
13,556 | |||
|
Deferred Equity instruments (299,624 deferred consideration shares
held as shares to be issued) |
800 | |||
|
Total consideration – non cash movement
|
14,356 | |||
|
Goodwill on acquisition
|
2,291 | |||
|
12
|
Acquisition of Midatech Pharma US, Inc.
|
|
Provisional fair
value
|
||||
| £ ’000 | ||||
|
Identifiable intangible assets:
|
||||
|
Product and marketing rights
|
15,477 | |||
|
Property, plant and equipment
|
16 | |||
|
Receivables and other debtors
|
515 | |||
|
Stock
|
152 | |||
|
Payables and other liabilities
|
(4,150 | ) | ||
|
Deferred tax
|
(6,191 | ) | ||
|
Cash
|
2,289 | |||
|
Total net assets
|
8,108 | |||
|
Equity instruments (5,422,028 ordinary shares)
Deferred Equity instruments
|
14,427 | |||
|
-
Share options*
|
1,056 | |||
|
-
Warrants*
|
2,155 | |||
|
-
Preference share redemption**
|
422 | |||
|
Total consideration
|
18,060 | |||
|
Goodwill on acquisition
|
9,952 | |||
| £’000 | ||||
|
Cash paid on completion – preferred share redemption
|
(422 | ) | ||
|
Net cash acquired
|
2,289 | |||
| 1,867 | ||||
|
13
|
Acquisition of Zuplenz
|
|
Provisional fair
value
|
||||
| £’000 | ||||
|
Identifiable intangible assets:
|
||||
|
Product and marketing rights
|
2,512 | |||
|
Stock
|
231 | |||
|
Total net assets
|
(2,743 | ) | ||
|
Cash consideration
|
2,528 | |||
|
Contingent consideration*
|
50 | |||
|
Total consideration
|
2,578 | |||
|
Negative goodwill on acquisition
|
(165 | ) | ||
|
|
*
|
The contingent consideration relates to various milestone payments which are dependent on the quarterly sales achieved in calendar years 2016 and 2017 and annual sales from 2018 to 2022 exceeding specified sales targets.
|
|
The net cash outflow in the year in respect of the business acquisition comprised:
|
||||
| £’000 | ||||
|
Cash paid on completion
|
2,528 | |||
|
14
|
Impairment testing
|
|
IPRD carrying amount
|
Goodwill carrying amount
|
Valuation
Basis
|
|||
|
Name
|
2015
|
2014
|
2015
|
2014
|
|
|
£’000
|
£000
|
£’000
|
£000
|
£’000
|
|
|
CGU – Midatech Pharma (Wales) Ltd
|
10,800
|
10,800
|
2,291
|
2,291
|
Value in use
|
|
Assumptions
|
2015
CGU – Q Chip
Limited and
subsidiaries
|
2014
CGU –
Q Chip
Limited and
subsidiaries
|
|
Pre-tax discount rate
|
17.7-19.5%
|
17.7-19.5%
|
|
Cumulative probability of success of projects
|
46% to 69%
|
23% to 57%
|
|
2015
CGU – Q Chip
Limited and
subsidiaries
|
|
|
Pre-tax discount rate for all projects
|
increase to 23.9%
|
|
Cumulative probability of success of all projects
|
44%
|
|
Name
|
Goodwill
carrying
amount 2015
|
Product and
marketing
rights carrying
amount 2015
|
Valuation basis
|
|||
|
£000
|
£000
|
|||||
|
CGU – Midatech Pharma US, Inc.
|
9,952
|
15,477
|
Value in use
|
|
Assumptions
|
2015
CGU – Midatech Pharma US, Inc.
|
|
|
Pre-tax discount rate
|
23.2%
|
|
15
|
Subsidiaries
|
|
Country of
|
Nature of
|
|||||
|
Name
|
incorporation
|
Business
|
Notes
|
|||
|
Midatech Limited
|
United Kingdom
|
Trading company
|
||||
|
Midatech Pharma (Espana) SL
|
Spain
|
Trading company
|
(a)
|
|||
|
Midatech Andalucia SL
|
Spain
|
Dormant
|
||||
|
PharMida AG
|
Switzerland
|
Trading company
|
(b)
|
|||
|
Midatech Pharma (Wales) Limited
|
United Kingdom
|
Trading company
|
(c)
|
|||
|
Midatech Pharma US, Inc.
|
USA
|
Trading company
|
(d)
|
|||
|
Dara Therapeutics, Inc.
|
USA
|
Dormant
|
||||
|
Midatech Pharma PTY
|
Australia
|
Trading company
|
(e)
|
|
(a)
|
Midatech Biogune SL was renamed Midatech Pharma (Espana) Limited on 16 April 2015.
|
|
(b)
|
PharMida AG became dormant in January 2016.
|
|
(c)
|
Q Chip Limited was renamed Midatech Pharma (Wales) Limited on 23 January 2015.
|
|
(d)
|
DARA Bio Sciences, Inc. was acquired on 4 December 2015 through a merger with a specially incorporated subsidiary of Midatech Pharma PLC. This merger subsidiary was renamed Midatech Pharma US, Inc. on 4 December 2015.
|
|
(d)
|
Midatech Pharma PTY was incorporated on 16 February 2015.
|
|
16
|
Joint arrangements
|
|
Country of
|
|||
|
Name
|
incorporation
|
Nature of business
|
Type of arrangement
|
|
Syntara LLC
|
USA
|
Dormant
|
Joint venture
|
|
MidaSol
Therapeutics GP |
Cayman Islands
|
Research and development partner
|
Joint operation
|
|
2015
|
2014
|
2013
|
||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
Research and development spend on MidaSol Therapeutics
|
776 | 248 | 542 | |||||||||
|
Year-end receivable due from joint operation partner
|
219 | - | 146 | |||||||||
|
17
|
Trade and other receivables
|
|
2015
|
2014
|
2013
|
||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
Trade receivables
|
985 | 189 | 160 | |||||||||
|
Prepayments
|
685 | 49 | 68 | |||||||||
|
Other receivables
|
1,213 | 649 | 1,060 | |||||||||
|
Total trade and other receivables
|
2,883 | 887 | 1,288 | |||||||||
|
Less: non-current portion (rental deposit and bond)
|
(387 | ) | (425 | ) | (379 | ) | ||||||
|
Current portion
|
2,496 | 462 | 909 | |||||||||
|
18
|
Cash and cash equivalents and cash flow supporting notes
|
|
2015
|
2014
|
2013
|
||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
Cash at bank available on demand
|
16,175 | 30,325 | 2,387 | |||||||||
|
Significant non-cash transactions are as follows:
|
||||||||||||
| 2015 | 2014 | 2013 | ||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
Financing activities
|
||||||||||||
|
Conversion of convertible local notes into equity
|
- | - | 3,255 | |||||||||
|
Share issues net of costs – cash transactions
|
||||||||||||
| 2015 | 2014 | 2013 | ||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
Funds raised on the Initial Public Offering
|
- | 32,000 | - | |||||||||
|
Costs of raising funds on Initial Public Offering/listing
|
- | (1,350 | ) | - | ||||||||
|
Issue of shares in Midatech Limited pre flotation
|
- | 3,202 | 5,797 | |||||||||
| - | 33,852 | 5,797 | ||||||||||
|
19
|
Inventories
|
|
2015
|
2014
|
2013
|
||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
Work in progress
|
230 | - | - | |||||||||
|
Finished goods
|
229 | - | - | |||||||||
|
Total inventories
|
459 | - | - | |||||||||
|
20
|
Trade and other payables
|
|
2015
|
2014
|
2013
|
||||||||||
|
Current
|
£’000 |
£'000
|
£'000
|
|||||||||
|
Trade payables
|
2,285 | 981 | 522 | |||||||||
|
Other payables
|
35 | 177 | 177 | |||||||||
|
Accruals
|
3,101 | 732 | 58 | |||||||||
|
Total financial liabilities, excluding loans and
borrowings, classified as financial liabilities measured at
amortised cost
|
5,421 | 1,890 | 757 | |||||||||
|
Tax and social security
|
183 | 274 | 78 | |||||||||
|
Deferred revenue
|
1,480 | 177 | 212 | |||||||||
|
Total trade and other payables
|
7,084 | 2,341 | 1,047 | |||||||||
|
21
|
Loans and borrowings
|
|
2015
|
2014
|
2013
|
||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
Current
|
||||||||||||
|
Bank loans
|
9 | 9 | - | |||||||||
|
Finance lease
|
70 | 37 | 47 | |||||||||
|
Government and research loans
|
363 | 445 | 138 | |||||||||
|
Preference share dividends payable
|
- | - | 1,063 | |||||||||
|
Total
|
442 | 491 | 1,248 | |||||||||
|
Non-current
|
||||||||||||
|
Bank loans
|
20 | 31 | - | |||||||||
|
Government and research loans
|
1,420 | 1,457 | 1,006 | |||||||||
|
Preference shares
|
- | - | 1,075 | |||||||||
|
Finance lease
|
68 | - | 38 | |||||||||
|
Total
|
1,508 | 1,488 | 2,119 | |||||||||
|
22
|
Derivative financial liability - current
|
|
2015
|
2014
|
2013
|
||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
Equity settled derivative financial liability
|
1,573 | - | - | |||||||||
| On aquisition — 5 December 2015 | 3,211 | - | - | |||||||||
|
Gain recognized in finance income within
the consolidated statement of comprehensive income |
(1,638 | ) | - | - | ||||||||
| At 31 December | 1,573 | - | - | |||||||||
|
23
|
Financial instruments - risk management
|
|
·
|
Credit risk
|
|
·
|
Foreign exchange risk
|
|
·
|
Liquidity risk
|
|
·
|
Trade and other receivables;
|
|
·
|
Cash and cash equivalents;
|
|
·
|
Trade and other payables;
|
|
·
|
Accruals;
|
|
·
|
Loans and borrowings; and
|
|
·
|
Derivative financial liability.
|
|
2015
|
2014
|
2013
|
||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
Cash and cash equivalents
|
16,175 | 30,325 | 2,387 | |||||||||
|
Trade receivables
|
985 | 189 | 160 | |||||||||
|
Other receivables
|
1,213 | 649 | 1,060 | |||||||||
|
Total financial assets
|
18,373 | 31,163 | 3,607 | |||||||||
|
2015
|
2014
|
2013
|
||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
Trade payables
|
2,285 | 981 | 522 | |||||||||
|
Other payables
|
35 | 177 | 177 | |||||||||
|
Accruals
|
3,101 | 732 | 58 | |||||||||
|
Loans and borrowings
|
1,950 | 1,979 | 3,367 | |||||||||
|
Total financial liabilities - amortised cost
|
7,371 | 3,869 | 4,124 | |||||||||
|
2015
|
2014
|
2013
|
||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
Equity settled derivative financial liability
|
1,573 | - | - | |||||||||
|
•
|
Level 1: quoted (unadjusted) prices in active markets for identical assets and liabilities;
|
|
•
|
Level 2: other techniques for which all inputs which have a significant effect on the recorded fair value are observable, either directly or indirectly; and
|
|
•
|
Level 3: techniques which use inputs that have a significant effect on the recorded fair value that are not based on observable market data.
|
|
Financial
liabilities
|
Fair value
as at
31/12/2015
|
Fair value
hierarchy
|
Valuation
technique(s)
and key
input(s)
|
Significant unobservable
input(s)
|
Relationship of
unobservable inputs to
fair value
|
|||||
|
Equity
settled
financial
derivative
liability
|
£1,573
|
Level 3
|
Black Scholes option pricing model
|
Volatility rates between a range of 59% and 76% determined using historical volatility of comparable companies.
|
The higher the volatility the higher the fair value.
|
|||||
|
|
Expected life between a range of 0.1 and 8.6 years determined using the remaining life of the share options.
|
The shorter the expected life the lower the fair value.
|
||||||||
|
|
Risk-free rate between a range of 0.44% and 1.81% determined using the expected life assumptions.
|
The higher the risk-free rate the higher the fair value.
|
|
2015
|
Up to 3
months
|
Between
3 and 12
months
|
Between
1 and 2
years
|
Between
2 and 5
years
|
Over
5 years
|
|||||||||||||||
| £’000 | £’000 | £’000 | £’000 | £’000 | ||||||||||||||||
|
Trade and other payables
|
5,421 | — | — | — | — | |||||||||||||||
|
Bank loans
|
2 | 7 | 9 | 13 | — | |||||||||||||||
|
Finance leases
|
7 | 71 | 27 | 56 | — | |||||||||||||||
|
Government research loans
|
36 | 352 | 195 | 644 | 755 | |||||||||||||||
|
Total
|
5,466 | 430 | 231 | 713 | 755 | |||||||||||||||
|
2014
|
Up to 3
months
|
Between
3 and 12
months
|
Between
1 and 2
years
|
Between
2 and 5
years
|
Over
5 years
|
|||||||||||||||
| £’000 | £’000 | £’000 | £’000 | £’000 | ||||||||||||||||
|
Trade and other payables
|
1,890 | — | — | — | — | |||||||||||||||
|
Bank loans
|
2 | 7 | 9 | 24 | — | |||||||||||||||
|
Finance leases
|
11 | 27 | — | — | — | |||||||||||||||
|
Government research loans
|
— | 485 | 207 | 891 | 351 | |||||||||||||||
|
Total
|
1,903 | 519 | 216 | 915 | 351 | |||||||||||||||
|
2013
|
Up to 3
months
|
Between
3 and 12
months
|
Between
1 and 2
years
|
Between
2 and 5
years
|
Over
5 years
|
|||||||||||||||
| £’000 | £’000 | £’000 | £’000 | £’000 | ||||||||||||||||
|
Trade and other payables
|
757 | — | — | — | — | |||||||||||||||
|
Finance leases
|
12 | 35 | 38 | — | — | |||||||||||||||
|
Government research loans
|
— | 159 | 169 | 535 | 445 | |||||||||||||||
|
Preference shares
|
— | — | — | — | 1,075 | |||||||||||||||
|
Preference share dividends payable
|
1,063 | — | — | — | — | |||||||||||||||
|
Total
|
1,832 | 194 | 207 | 535 | 1,520 | |||||||||||||||
|
•
|
Trade and payables – Note 20
|
|
•
|
Loans and borrowings – Note 21
|
|
•
|
to safeguard the entity’s ability to continue as a going concern, and
|
|
•
|
to have sufficient resource to take development projects forward towards commercialisation.
|
|
24
|
Deferred tax
|
|
2015
|
2014
|
|||||||
| £’000 |
£'000
|
|||||||
|
Liability at 1 January
|
354 | - | ||||||
|
Arising on business combination
|
6,191 | 714 | ||||||
|
Credited to income on impairment of IPRD
|
- | (360 | ) | |||||
|
Credited to income statement
|
(131 | ) | - | |||||
|
Foreign exchange gain
|
133 | - | ||||||
|
Liability at 31 December
|
6,547 | 354 | ||||||
|
Gross losses
|
Unrecognised
deferred tax
asset
|
|||||||
| £’000 | £’000 | |||||||
|
31 December 2013
|
13,004 | 2,601 | ||||||
|
31 December 2014
|
16,017 | 3,203 | ||||||
|
31 December 2015
|
23,286 | 4,191 | ||||||
|
2015
|
Asset
|
Liability
|
Net
|
|||||||||
| £’000 | £’000 |
£'000
|
||||||||||
|
Business Combinations
|
1,625 | (8,172 |
)
|
(6,547 | ) | |||||||
|
2014
|
Asset
|
Liability
|
Net
|
|||||||||
| £’000 | £’000 |
£'000
|
||||||||||
|
Business Combinations
|
1,806 | (2,160 | ) | (354 | ) | |||||||
|
25
|
Share capital
|
|
2015
|
2015
|
2014
|
2014
|
2013
|
2013
|
|||||||||||||||||||
|
Allotted and fully paid – classified as equity
|
Number
|
£ |
Number
|
£ |
Number
|
£ | ||||||||||||||||||
|
At 1 January
|
||||||||||||||||||||||||
|
Ordinary shares of 0.005p each
|
33,467,504 | 1,673 | 27,794,258 | 1,390 | 2,889,229 | 289 | ||||||||||||||||||
|
Deferred shares of £1 each
|
1,000,001 | 1,000,001 | 1,000,001 | 1,000,001 | - | - | ||||||||||||||||||
|
C preference shares of 0.01p each
|
- | - | - | - | 565,064 | 57 | ||||||||||||||||||
|
Total
|
1,001,674 | 1,001,391 | 346 | |||||||||||||||||||||
| 2015 | 2015 | 2014 | 2014 | 2013 | 2013 | |||||||||||||||||||
|
Allotted and fully paid up – classified as liabilities
|
Number
|
£ |
Number
|
£ |
Number
|
£ | ||||||||||||||||||
|
A 7.5% preference shares of £1 each
|
- | - | - | - | 1,000,000 | 1,000,000 | ||||||||||||||||||
|
B 15% preference shares of £1 each
|
- | - | - | - | 75,000 | 75,000 | ||||||||||||||||||
| - | - | 1,075,000 | ||||||||||||||||||||||
|
|
·
|
To receive notice of, to attend and to vote at all general meetings of the Company, in which case shareholders shall have one vote for each share of which they are the holder.
|
|
|
·
|
To receive such dividend as is declared by the Board on each share held.
|
|
|
·
|
C preference shareholders to receive original issue price;
|
|
|
·
|
A and B preference shareholders to receive an agreed amount per share as set out in the Company’s Articles; and
|
|
|
·
|
C preference and ordinary shareholders to receive remaining capital and rank pari passu.
|
|
|
·
|
To receive notice of, to attend and to vote at all general meetings of the Company, in which case shareholders shall have one vote for each share of which he is the holder.
|
|
|
·
|
To receive such dividend as is declared by the Board on each share held.
|
|
|
·
|
shall not be entitled to receive notice of or to attend or speak at any general meeting of the Company or to vote on any resolution to be proposed at any general meeting of the Company; and
|
|
|
·
|
shall not be entitled to receive any dividend or other distribution of out of the profits of the Company.
|
|
25
|
Share Capital
(continued)
|
|
Date of Issue
|
Type of Share Issue
|
Ordinary
Shares
|
A Preference
Shares
|
B Preference
Shares
|
C Preference
Shares
|
Share Price
|
Total
consideration
|
||||||||||||||||||
|
Number
|
Number
|
Number
|
Number
|
£ | £’000 | ||||||||||||||||||||
|
2013
|
|||||||||||||||||||||||||
|
As at 1 January 2013
|
Brought forward
|
2,457,493 | 1,000,000 | 75,000 | - | - | - | ||||||||||||||||||
|
11 February 2013
|
Convertible loan
|
234,196 | - | - | 8.38 | 1,963 | |||||||||||||||||||
|
21 February 2013
|
Subscription option
|
16,489 | - | - | - | 13.70 | 226 | ||||||||||||||||||
|
27 February 2013
|
Subscription option
|
133,808 | - | - | - | 8.38 | 1,120 | ||||||||||||||||||
|
30 April 2013
|
Subscription option
|
5,474 | - | - | - | 13.70 | 75 | ||||||||||||||||||
|
10 May 2013
|
Subscription option
|
4,806 | - | - | - | 13.70 | 66 | ||||||||||||||||||
|
03 June 2013
|
Subscription option
|
962 | - | - | - | 13.70 | 13 | ||||||||||||||||||
|
18 June 2013
|
Subscription option
|
5,715 | - | - | - | 17.50 | 100 | ||||||||||||||||||
|
04 July 2013
|
Subscription option
|
14,286 | - | - | - | 17.50 | 250 | ||||||||||||||||||
|
15 July 2013
|
Subscription option
|
5,715 | - | - | - | 17.50 | 100 | ||||||||||||||||||
|
05 August 2013
|
Subscription option
|
2,857 | - | - | - | 17.50 | 50 | ||||||||||||||||||
|
08 August 2013
|
Subscription option
|
1,428 | - | - | - | 17.50 | 25 | ||||||||||||||||||
|
26 September 2013
|
Subscription option
|
3,000 | - | - | - | 17.50 | 53 | ||||||||||||||||||
|
27 September 2013
|
Subscription option
|
3,000 | - | - | - | 17.50 | 53 | ||||||||||||||||||
|
05 December 2013
|
Convertible
|
- | - | - | 144,552 | 8.95 | 1,294 | ||||||||||||||||||
|
05 December 2013
|
Share issue
|
- | - | - | 420,512 | 8.81 | 3,705 | ||||||||||||||||||
|
Total 2013
|
2,889,229 | 1,000,000 | 75,000 | 565,064 | 9,093 | ||||||||||||||||||||
|
Date of Issue
|
Type of Share Issue
|
Ordinary
Shares
|
A
Preference
Shares
|
B
Preference
Shares
|
C
Preference
Shares
|
Deferred
Shares
|
Share Price
|
Total
considera-
tion
|
||||||||||||||||||||||
|
Number
|
Number
|
Number
|
Number
|
Number
|
£ | £’000 | ||||||||||||||||||||||||
|
2014
|
||||||||||||||||||||||||||||||
|
As at 1 January 2014
|
2,889,229 | 1,000,000 | 75,000 | 565,064 | - | - | 9,093 | |||||||||||||||||||||||
|
30 January 2014
|
Equalisation round
|
39,853 | - | - | - | - | - | - | ||||||||||||||||||||||
|
19 April 2014
|
Subscription option
|
244,881 | - | - | - | - | 0.15 | 37 | ||||||||||||||||||||||
|
13 June 2014
|
Subscription option
|
8,250 | - | - | - | - | 0.15 | 1 | ||||||||||||||||||||||
|
4 September 2014
|
Rights issue
|
105,314 | - | - | 511,738 | - | 5.13 | 3,165 | ||||||||||||||||||||||
|
12 September 2014
|
Share redemption
|
- | - | (75,000 | ) | - | - | - | - | |||||||||||||||||||||
|
Total pre-share for share exchange –
Midatech Limited |
3,287,527 | 1,000,000 | - | 1,076,802 | - | 12,296 | ||||||||||||||||||||||||
|
12 September 2014
|
Subscriber share – Midatech Pharma plc
|
1 | 1.0000 | - | ||||||||||||||||||||||||||
|
13 November 2014
|
Share for share exchange
|
3,287,527 | 1,000,000 | - | 1,076,802 | - | - | - | ||||||||||||||||||||||
|
13 November 2014
|
Sub-division of subscriber share
|
9,999 | - | - | - | - | 0.0001 | - | ||||||||||||||||||||||
|
28 November 2014
|
Warrant exchange share issue
|
628,356 | - | - | - | - | 0.0001 | - | ||||||||||||||||||||||
|
28 November 2014
|
Share conversion
|
(10,000 | ) | - | - | - | 1 | - | - | |||||||||||||||||||||
|
28 November 2014
|
Share conversion
|
1,076,802 | - | - | (1,076,802 | ) | - | - | - | |||||||||||||||||||||
|
|
Total ordinary shares pre-subdivision
|
4,992,685 | ||||||||||||||||||||||||||||
|
28 November 2014
|
Share sub division
|
9,985,370 | - | - | - | - | - | - | ||||||||||||||||||||||
|
8 December 2014
|
Share issue on acquisition of Q Chip Limited
|
5,077,122 | - | - | - | - | 2.67 | - | ||||||||||||||||||||||
|
8 December 2014
|
Public offering
|
11,985,019 | - | - | - | - | 2.67 | 32,000 | ||||||||||||||||||||||
|
8 December 2014
|
Share conversion
|
746,747 | (1,000,000 | ) | - | - | 1,000,000 | - | - | |||||||||||||||||||||
| 27,794,258 | - | - | - |
1,000,001
|
32,000
|
|||||||||||||||||||||||||
|
Ordinary
Shares
|
A
Preference
Shares
|
B
Preference
Shares
|
C
Preference
Shares
|
Deferred
Shares
|
Share Price
|
Total
considera-
tion
|
||||||||||||||||||||||||
|
Number
|
Number
|
Number
|
Number
|
Number
|
£ | £’000 | ||||||||||||||||||||||||
|
2015
|
||||||||||||||||||||||||||||||
|
As at 1 January 2015
|
27,794,258 | - | - | - | 1,000,001 | 32,000 | ||||||||||||||||||||||||
|
24 April 2015
|
Exercise of employee share options
|
16,500 | - | - | - | - | 0.00005 | - | ||||||||||||||||||||||
|
25 September 2015
|
Exercise of employee share options
|
10,000 | - | - | - | - | 0.00005 | - | ||||||||||||||||||||||
|
4 December 2015
|
Share issue on acquisition of DARA BioSciences, Inc.
|
5,422,028 | - | - | - | - | 2.63 | 14,240 | ||||||||||||||||||||||
|
23 December 2015
|
Deferred consideration re: acquisition of Q
Chip Limited |
224,718 | - | - | - | - | 2.67 | 600 | ||||||||||||||||||||||
|
As at 31 December
2015
|
33,467,504 | - | - | - | 1,000,001 | 46,840 | ||||||||||||||||||||||||
|
26
|
Reserves
|
|
Reserve
|
Description and purpose
|
|
|
Share premium
|
Amount subscribed for share capital in excess of nominal value.
|
|
|
Merger reserve
|
Represents the difference between the fair value and nominal value of shares issued on the acquisition of subsidiary companies where the company has elected to take advantage of merger relief. This is added to the share premium of Midatech Limited prior to the merger as set out in note 1.
|
|
|
Shares to be issued
|
Shares for which consideration has been received but which are not yet issued and which form part of consideration in a business combination.
|
|
|
Foreign exchange reserve
|
Gains/losses arising on retranslating the net assets of overseas operations into sterling.
|
|
|
Accumulated deficit
|
All other net gains and losses and transactions with owners (e.g. dividends) not recognised elsewhere.
|
|
27
|
Leases
|
|
Land and
|
||||||||
|
buildings
|
Other
|
|||||||
|
2015
|
£'000
|
£'000
|
||||||
|
Expiring In one year or less
|
313 | 1 | ||||||
|
Expiring Between one and five years
|
410 | 2 | ||||||
| 723 | 3 | |||||||
|
Land and
|
||||||||
|
buildings
|
Other
|
|||||||
|
2014
|
£'000
|
£'000
|
||||||
|
Expiring In one year or less
|
150 | 79 | ||||||
|
Expiring Between one and five years
|
159 | - | ||||||
| 309 | 79 | |||||||
|
Land and
|
||||||||
|
Buildings
|
Other
|
|||||||
|
2013
|
£'000
|
£'000
|
||||||
|
Expiring In one year or less
|
48 | 67 | ||||||
|
Expiring Between one and five years
|
50 | 56 | ||||||
| 98 | 123 | |||||||
|
28
|
Retirement benefits
|
|
2015
|
2014
|
2013
|
||||||||||
| £’000 |
£'000
|
£'000
|
||||||||||
|
Defined contribution pension scheme
|
183 | 169 | 177 | |||||||||
|
29
|
Share-based Payments
|
|
Date of grant
|
At 1
January
2015
|
Granted in
2015
|
Exercised
in 2015
|
Forfeited in
2015
|
At 31
December
2015
|
Exercise
Price
|
||||||||||||||||||
|
31 December 2008
|
26,122 | - | - | - | 26,122 | £1.425 | ||||||||||||||||||
|
31 December 2008
|
15,500 | - | - | - | 15,500 | £3.985 | ||||||||||||||||||
|
1 April 2010
|
25,110 | - | - | - | 25,110 | £4.00 | ||||||||||||||||||
|
20 August 2010
|
59,666 | - | - | (17,900 | ) | 41,766 | £4.19 | |||||||||||||||||
|
13 September 2011
|
3,000 | - | - | - | 3,000 | £4.19 | ||||||||||||||||||
|
20 April 2012
|
35,796 | - | - | - | 35,796 | £4.19 | ||||||||||||||||||
|
3 April 2014
|
26,500 | - | (26,500 | ) | - | - | £0.075 | |||||||||||||||||
|
9 May 2014
|
200,000 | - | - | - | 200,000 | £0.075 | ||||||||||||||||||
|
30 June 2014
|
880,000 | - | - | - | 880,000 | £0.075 | ||||||||||||||||||
|
11 July 2014
|
11,000 | - | - | (6,000 | ) | 5,000 | £0.075 | |||||||||||||||||
| 1,282,694 | - | (26,500 | ) | (23,900 | ) | 1,232,294 | ||||||||||||||||||
|
Options exercisable at 31 December 2015
|
366,044 | |||
|
Weighted average exercise price of outstanding options at 31 December 2015
|
£0.502 | |||
|
Weighted average exercise price of options exercised in 2015
|
£0.075 | |||
|
Weighted average exercise price of options forfeited in 2015
|
4.19 | |||
|
Weighted average exercise price of options granted in 2015
|
n/a | |||
|
Weighted average remaining contractual life of outstanding options at 31 December 2015
|
7.8 years
|
|||
|
Date of grant
|
At 1
January
2014
|
Granted in
2014
|
Exercised
in 2014
|
Forfeited in
2014
|
At 31
December
2014
|
Exercise
Price
|
||||||||||||||||||
|
31 December 2008
|
44,622 | - | - | (18,500 | ) | 26,122 | £1.425 | |||||||||||||||||
|
31 December 2008
|
15,500 | - | - | - | 15,500 | £3.985 | ||||||||||||||||||
|
1 September 2009
|
12,500 | - | - | (12,500 | ) | - | £3.985 | |||||||||||||||||
|
13 November 2009
|
25,000 | - | - | (25,000 | ) | - | £4.00 | |||||||||||||||||
|
1 April 2010
|
25,110 | - | - | - | 25,110 | £4.00 | ||||||||||||||||||
|
20 August 2010
|
59,666 | - | - | - | 59,666 | £4.19 | ||||||||||||||||||
|
13 September 2011
|
3,000 | - | - | - | 3,000 | £4.19 | ||||||||||||||||||
|
20 April 2012
|
47,796 | - | - | (12,000 | ) | 35,796 | £4.19 | |||||||||||||||||
|
1 May 2013
|
100,000 | - | - | (100,000 | ) | - | £6.85 | |||||||||||||||||
|
3 April 2014
|
- | 43,000 | (16,500 | ) | - | 26,500 | £0.075 | |||||||||||||||||
|
9 May 2014
|
- | 200,000 | - | - | 200,000 | £0.075 | ||||||||||||||||||
|
30 June 2014
|
- | 880,000 | - | - | 880,000 | £0.075 | ||||||||||||||||||
|
11 July 2014
|
- | 11,000 | - | - | 11,000 | £0.075 | ||||||||||||||||||
| 333,194 | 1,134,000 | (16,500 | ) | (168,000 | ) | 1,282,694 | ||||||||||||||||||
|
Options exercisable at 31 December 2014
|
125,847 | |||
|
Weighted average exercise price of outstanding options at 31 December 2014
|
£0.54 | |||
|
Weighted average exercise price of options forfeited in 2014
|
£5.43 | |||
|
Weighted average exercise price of options granted in 2014
|
£0.08 | |||
|
Weighted average remaining contractual life of outstanding options at 31 December 2014
|
8.5 years
|
|||
|
Date of grant
|
At 1 January
2013
|
Granted in
2013
|
Exercised
in 2013
|
Forfeited in
2013
|
At 31
December
2013
|
Exercise
Price
|
||||||||||||||||||
|
31 December 2008
|
46,222 | - | - | (1,600 | ) | 44,622 | £1.425 | |||||||||||||||||
|
31 December 2008
|
15,500 | - | - | - | 15,500 | £3.985 | ||||||||||||||||||
|
25 March 2009
|
25,000 | - | - | (25,000 | ) | - | £3.985 | |||||||||||||||||
|
1 September 2009
|
12,500 | - | - | - | 12,500 | £3.985 | ||||||||||||||||||
|
13 November 2009
|
25,000 | - | - | - | 25,000 | £4.00 | ||||||||||||||||||
|
1 April 2010
|
25,110 | - | - | - | 25,110 | £4.19 | ||||||||||||||||||
|
20 August 2010
|
59,666 | - | - | - | 59,666 | £4.19 | ||||||||||||||||||
|
13 September 2011
|
3,000 | - | - | - | 3,000 | £4.19 | ||||||||||||||||||
|
20 April 2012
|
47,796 | - | - | - | 47,796 | £4.19 | ||||||||||||||||||
|
1 May 2013
|
- | 100,000 | - | - | 100,000 | £6.85 | ||||||||||||||||||
| 259,794 | 100,000 | - | (26,600 | ) | 333,194 | |||||||||||||||||||
|
Options exercisable at 31 December 2013
|
148,528 | |||
|
Weighted average exercise price of outstanding options at 31 December 2013
|
£4.57 | |||
|
Weighted average exercise price of options forfeited in 2013
|
£3.83 | |||
|
Weighted average exercise price of options granted in 2013
|
£6.85 | |||
|
Weighted average remaining contractual life of outstanding options at 31 December 2013
|
6.0 years
|
|||
|
|
·
|
25,000 vested immediately;
|
|
|
·
|
25,000 vest on 1 May 2015, a further 25,000 on 1 May 2016 and a further 25,000 on 1 May 2017;
|
|
|
·
|
50,000 vest when the ordinary price of a share reaches £13.70;
|
|
|
·
|
50,000 vest when the ordinary price of a share reaches £27.40; and
|
|
|
·
|
on the event of an initial public offering all of the options vest immediately and have therefore vested.
|
|
|
·
|
50% vest when the share price reaches £5.31 per share;
|
|
|
·
|
a further 25% vests when the share price reaches £13.72; and
|
|
|
·
|
the remaining 25% when the share price reaches £18.86.
|
|
2014
|
||
|
Number of options
|
1,134,000
|
|
|
Option pricing models used
|
Black Scholes/ Monte Carlo
|
|
|
Share price
|
£2.67*
|
|
|
Exercise price of options issued in
year
|
7.5p
|
|
|
Contractual life
|
9 -10 years
|
|
|
Volatility
|
60%**
|
|
|
Expected dividend yield
|
0%
|
|
|
Risk free rate
|
1.51%
|
|
*
|
The share price used in the determination of the fair value of the options granted in 2014 was the price of ordinary shares issued at initial public offering in December 2014.
|
|
**
|
Volatility was calculated with reference to the historic share price volatility of comparable companies measured over a four-year period.
|
|
29
|
Share-based payment
(continued)
|
|
|
·
|
A subscription option of 29,833 ordinary shares exercisable over 5 years at an exercise price of £8.38 per share. On 5 December 2013 the expiry date of part of this option over 20,883 ordinary shares was extended to 20 August 2020.
|
|
|
·
|
A subscription option of up to a maximum of 417,660 ordinary shares exercisable over 6 months from 19 December 2010 at an exercise price of £8.38 per share. On 19 June 2011, pursuant to the exercise of this option, 251,635 ordinary shares of 0.01p each were issued for a cash consideration of £2.1 million.
|
|
|
·
|
Two subscription options of up to a maximum of 417,660 ordinary shares each at an exercise price of £8.38 per share exercisable on a “follow on” basis to match any exercise of the above option. Following the exercise of the above option, the two options of 251,635 ordinary shares each were to be exercised by 19 December 2011. On 5 December 2011, 119,332 options were exercised and the remaining options over 383,938 shares were exercised on 19 December 2011.
|
|
|
·
|
On 29 October 2012 the Company issued subscription options over 119,332 ordinary shares at an exercise price of £8.38 per share and over 182,482 ordinary shares at an exercise price of £13.70 per share. Both options were valid until 30 June 2013. On 31 January 2013 options over 16,489 ordinary shares were exercised for an aggregate cash consideration of £225,899.
|
|
30
|
Capital commitments
|
|
31
|
Related party transactions
|
|
32
|
Contingent liabilities
|
|
33
|
Ultimate controlling party
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|