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Midatech will host a conference call and live Q&A session today (Wednesday 13 April 2016) at 1300 BST / 0800 EDT for analysts and investors to discuss the Annual Results. Dr Jim Phillips, Chief Executive Officer, and Nic

Key Takeaway: Midatech will host a conference call and live Q&A session today (Wednesday 13 April 2016) at 1300 BST / 0800 EDT for analysts and investors to discuss the Annual Results. Dr Jim Phillips, Chief Executive Officer, and Nick Robbins-Cherry, Chief Financial Officer, will participate.

Full Press Release Details

Midatech will host a conference call and live Q&A session today (Wednesday 13 April 2016) at 1300 BST / 0800 EDT for analysts and investors to discuss the Annual Results. Dr Jim Phillips, Chief Executive Officer, and Nick Robbins-Cherry, Chief Financial Officer, will participate. Dial-in details are: UK: +44 20 3427 1913, US: +1646 254 3360, ID: 9558747.
("Midatech" or the "Company")
Audited financial results for the year ended 31 December 2015
Midatech Pharma (AIM: MTPH; Nasdaq: MTP), the international specialty pharmaceutical company focused on commercialising and developing products in oncology and other therapeutic areas, today announces its audited financial results for the twelve month period ended 31 December 2015.
Operational highlights including post period end highlights
Financial highlights
Commenting on the Annual Results for 2015, Midatech's Chairman, Rolf Stahel, said: "In its first full year since IPO, Midatech has rapidly assembled the building blocks for becoming an outstanding specialty pharma. It now has a revenue-generating commercial operation in the US selling marketed oncology support products, including Zuplenz, launched this week, and an ambitious pipeline using Midatech's proprietary right place, right time technology, targeting high-value niche indications.
"The highly driven management team has successfully executed on its stated claims as laid out at the time of the IPO with acquisitions, revenues and pipeline developments; and the Board of Directors looks forward to continuing this success through 2016 and beyond."
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About Midatech Pharma PLC
Midatech is an international specialty pharmaceutical company focused on oncology and other therapeutic areas with a commercial platform and four marketed products in the US. Midatech's strategy is to develop products in-house in oncology and with partners in other indications, and to accelerate growth organically and through strategic acquisitions. The Company's R&D activities are supported by two breakthrough drug delivery technologies. The Group, listed on AIM: MTPH and Nasdaq: MTP, employs c.100 staff in four countries. For further company information see: www.midatechpharma.com
Forward-Looking Statement
Certain statements in this press release may constitute "forward-looking statements" within the meaning of legislation in the United Kingdom and/or United States. These forward-looking statements are based on currently available competitive, financial and economic data together with management's views and assumptions regarding future events and business performance as of the time the statements are made and are subject to risks and uncertainties. We wish to caution you that there are some known and unknown factors that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements, including but not limited to risks related to: (i) our estimates regarding losses, expenses, future revenues, capital requirements and needs for additional financing; (ii) the successful commercialisation and manufacturing of licensed products, products originally licensed to DARA, and any future products we may commercialise; (iii) the success and timing of our preclinical studies and trials; (iv) the difficulties in obtaining and maintaining regulatory approval of our product candidates and any product candidates we may acquire in the future; (v) our plans and ability to develop and commercialise our product candidates and any product candidates we acquire in the future; (vi) the rate and degree of market acceptance of any of our product candidates; (vii) the successful development of our commercialisation capabilities, including sales and marketing capabilities; (viii) obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology; (ix) the success of competing therapies and products that are or become available; (x) the success of any future acquisition; (xi) the potential we will incur financial obligations to former DARA stockholders; (xii) the difficulties of integrating DARA's former business into our own; (xiii) the outcome of our remediation plan and approach to the material weakness in our internal control over financial reporting; (xiv) the impact of government laws and regulations; (xv) regulatory and political developments in the United Kingdom, the United States and other foreign countries; (xvi) the difficulties of doing business internationally; (xvii) the ownership of our ordinary share and ADRs; (xviii) our failure to recruit or retain key scientific or management personnel or to retain our executive officers; (xix) the impact and costs and expenses of any litigation we may be subject to now or in the future; and (xx) the performance of third parties, including joint venture partners, our sales force, our collaborators, third-party suppliers and parties or out licensing agreements.
Reference should be made to those documents that Midatech shall file from time to time or announcements that may be made by Midatech in accordance with the London Stock Exchange AIM Rules for Companies ("AIM Rules"), the Disclosure and Transparency Rules ("DTRs") and the rules and regulations promulgated by the US Securities and Exchange Commission, which contains and identifies other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Midatech are expressly qualified in their entirety by the cautionary statements above. Except as may be required under the AIM Rules or the DTRs or by relevant law in the United Kingdom or the United States, Midatech does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or otherwise arising.
Midatech has come a long way in the two years that I have worked with the Company. I joined Midatech because I was excited by the potential of its gold nanoparticle technology, but back in early 2014 there was a lot of work to be done. By the end of 2014 the Company had a new management team, a clear, commercially-focussed strategy and, with the acquisition of the former Q Chip business, it had a second platform technology and a number of sustained release pipeline products that were closer to market than Midatech's own. Finally, thanks to a successful IPO and listing on AIM, Midatech went into 2015 with the funds to build on these technologies.
2015 has been no less exciting as the Company has continued to develop rapidly.
The main highlight of the year followed the announcement in June that Midatech intended to acquire the US-based pharmaceutical sales organisation DARA BioSciences Inc., which, following completion in December 2015, was renamed Midatech Pharma US, Inc. ("MTPUS"). I am a strong supporter of this transaction as it de-risks Midatech and expands the business in a number of directions.
Most obvious is the addition of three cancer supportive care products, Gelclair , Oravig and Soltamox along with an established oncology focussed, sales and marketing capability in the biggest and most profitable pharmaceuticals market in the world. This is an essential part of the commercial development of Midatech as it will provide an established, specialised sales channel for the Company's oncology products currently under development. Subject to regulatory approval, they could reach the market as early as 2018/19. MTPUS adds solid top-line line revenue and good growth potential that management believes will bring forward the Group's monthly profitability.
The MTPUS purchase further enabled us to acquire the anti-nausea product Zuplenz . This product is highly complementary to MTPUS's existing US product portfolio and is an excellent opportunity to leverage the sales and marketing capabilities of this promising US business. In tandem with the conclusion of the MTPUS deal, in December Midatech listed its shares on NASDAQ through the issue of American Depositary Receipts ("ADRs"). This dual-listing is another exciting development and, with the fundamental strength of the Midatech business and the wide range of anticipated news flow over the next few months, which is expected to bring the opportunity to open up the US investor base as well as further expand the UK one.
2015 also saw significant progress for both of Midatech's platform technologies; gold nanoparticle nanotechnology, and sustained release microsphere, where we continue to move forward with a broad range of programmes.
In summary, in a little over a year Midatech has completed three acquisitions as well as listing on AIM and on NASDAQ through the issue of ADRs. Furthermore, excellent progress has been made on the development pipeline. Management has demonstrated its ability to execute the Company's strategy as presented during the IPO and I am confident that they will continue to do so over the forthcoming months and years.
On behalf of the Board I should like to thank Midatech's shareholders, the Board, management and staff for their continuing support and I look forward to further successes in 2016 and beyond.
CHIEF EXECUTIVE'S STATEMENT
Rapid profitable growth trajectory
Our commercialisation strategy is intended to swiftly build a long-term, profitable and commercially focused enterprise.
With our infrastructure in the US we are focussed on building our commercial business through product acquisitions, such as Zuplenz in December 2015, and by launching our wholly-owned products, leveraging the capabilities of our own sales force and thus ensuring the quickest path to those products becoming highly profitable. Core to our business model is to deliver strong revenue growth that allows the organisation to become sustainably profitable in the shortest reasonable time.
Niche market potential
We are advancing a pipeline of product candidates in clinical and pre-clinical development for diseases for which there are currently few or no treatment options available.
Each of our niche cancer therapies, currently in research and development, has revenue potential of well over $100m per year and in some cases much more than this. We have multiple programmes that allow us to defray development risks and thus be in a position to deliver benefits to patients, healthcare professionals and to deliver high growth revenue for the company.
Intellectual property
The Group has developed a strong intellectual property base and has a wide IP portfolio of 150 granted patents, 92 applications in process and 34 patent families covering a range of technologies.
The foundation of our IP is on two core platform technologies, which have allowed multiple patent filings and we continue to strive to protect our future revenues and assets using our technology advantages; delivered by actively managing our patent portfolio and know-how.
Balanced risk reward profile
Our robust portfolio of collaborations and internal product pipeline positions Midatech for multiple shots on goal.
Midatech has differentiated its risk as a business through having a balanced mix of fast-growth marketed oncology products, different types of development programmes at different stages of progress and an approach to research that reduces risk by using known chemical entities where we improve the way they work as medicines.
Ambitious leadership
Significant experience and track record in the pharmaceutical industry creating value out of high growth companies.
From our Board of Directors Chaired by Rolf Stahel (former CEO of Shire plc) through to the global, senior leadership team (comprised of 11 executives), all of our senior staff have been successful leaders in their area of responsibility and bring their knowledge and experience to bear in order to ensure success at Midatech.
2015 marked a year of transformational progress in Midatech Pharma plc's delivery against the objectives set around the time of the IPO in 2014, and we are now being recognised as a leading emerging specialty pharma company, globally. In 2015, progress was seen across all areas of the Group and 2016 has already commenced with a strong tailwind both operationally and financially. Our key focus is now moving towards oncology.
Total revenues for 2015 were 1.38m, comfortably above market expectations, and our operating expenses were in line with expectations. During 2015, the business incurred certain non-recurring expenses relating to the two acquisitions, and we ended the year with strong cash reserves of 16.18m. Our negative EBIT, which is fully expected for a company with some development pipeline, was (subject to exceptional items) marginally better than the market view.
Products and pipeline
Our M&A strategy delivered two acquisitions in 2015, the first of which (DARA BioSciences Inc. "DARA") has given us a commercial platform to launch our own products into the key US market. DARA also brought a portfolio of products that are in commercial launch or market growth phases. After acquiring DARA, we moved swiftly to acquire a complementary product, Zuplenz , to add to our sales platform. Zuplenz is a treatment for chemotherapy and radiotherapy induced nausea and vomiting and is highly complementary to DARA's existing cancer supportive care product portfolio. The acquisition cost was approximately one fold historic (un-promoted) sales, with some additional milestone payments that are only triggered once sales exceed our current expectations for the product. We are therefore anticipating accelerating our revenue growth for 2016 and beyond in line with our original strategic objectives. Midatech's full launch of this product was announced on 11 April 2016.
Our platform technologies continued to deliver new potential products and collaborations in 2015, the most important of which was the collaboration with the US company, Ophthotech, to work on two products it has in development. This ongoing work follows-on from previous collaborations, affirming confidence in our technology's capabilities. Our MidaSol joint venture in diabetes completed a small Phase II trial in type 1 diabetes with the transbuccal insulin strip.
Elsewhere, our in-house programmes all proceeded well, with Q-Octreotide, the closest to market, completing product formulation work, and Q-Opsisporin giving a good response to treatment in pre-clinical testing.
Our work in targeted cancer therapies continued apace and, in Q3 2015, led to the first compassionate use request for a Midatech treatment to be used in a condition called Diffuse Intra Pontine Glioma (DIPG) one of the rarest brain cancers in children. This programme has brought forward our product development and will lead to patient treatments and possibly a clinical trial in 2016. In March 2016, the University of California, San Francisco, requested use of our treatment and Midatech will continue to manufacture in line with demand.
At the year-end the Group had 81 employees plus a further 20 dedicated, outsourced sales force across the US, UK and Spain, and we have been fortunate to attract more high quality people to work with us in all departments. This means that in a Group like Midatech, where business execution is the key to success, we are in a great place to be able to deliver continuing growth and positive news throughout 2016 and beyond.
CEO's summary and outlook
Midatech has successfully evolved in line with strategy into a revenue generating, US commercial-facing high-growth specialty pharmaceutical business.
In the first three months of 2016 we have seen strong revenues from our marketed products and as a result the Group is trading slightly ahead of market expectations. In addition, our clinical and preclinical pipelines are advancing well and showing great promise to patients.
Our supportive shareholders and strong team of international staff make our future very bright as we look forward to continuing to build the business on all fronts throughout 2016 and beyond.
Chief Executive Officer
The Group is commercialising oncology treatments and supportive care products through its US commercial organisation, Midatech Pharma US. In Europe, the Group is principally engaged in the discovery and development of pharmaceutical products in the fields of nanomedicine and sustained release technology.
Midatech's business model has four components:
Midatech also aims to expand its vertical integration by leveraging its integrated manufacturing capabilities.
The Directors believe that Midatech's key strengths include:
Our strategy and outlook
Midatech's business and commercialisation strategy is based on maturing its technology platforms with a clear focus on its key therapeutic areas of oncology, endocrinology and neuroscience (including ophthalmology), along with strategic late stage product focused acquisitions. Together, these are expected to drive a commercial pipeline of products with improved essential parameters, over and above the currently marketed source compound, including safety, tolerability, efficacy and compliance profiles. The Board believes that its management team has significant industry and technical experience and is highly capable of and committed to building the value of Midatech.
Midatech's commercialisation strategy intends to build a long term, profitable and commercially focused enterprise with revenues generated as follows:
In diabetes, Midatech, alongside its MidaSol Therapeutics joint venture partner MonoSol, has completed a Phase IIa clinical trial with its MidaForm -Insulin-PharmFilm in humans with type 1 diabetes. Subject to results, due in Q2 2016, Midatech will look for potential out-licensing deals given this asset is non-core to the Group's strategy.
In oncology, Midatech believes that it has the opportunity to leverage its own commercial capabilities in the US and roll out similar infrastructure in Europe around the market entry of its orphan oncology program products. Midatech believes that the acquisition of Zuplenz and DARA will accelerate its progress towards achieving this objective. These products require small, dedicated specialty pharmaceutical sales forces. Midatech will also look for further in-licensing acquisition opportunities to grow revenues in this sector.
In neuroscience/ophthalmology, commercialisation will focus on products for the treatment of uveitis and other conditions of the eye, Parkinson's disease, Alzheimer's disease and multiple sclerosis. Midatech aims to achieve this through partnerships with leading specialty pharmaceutical companies and academic institutions, where Midatech would seek to earn license payments, manufacturing revenue and royalties.
The oncology and supportive care products marketed by Midatech Pharma US are:
An orally-dissolving buccal tablet indicated for the local treatment of oropharyngeal candidiasis in adults.
An oral gel indicated for the management and relief of pain due to oral mucositis and other oral lesions that can occur with common cancer treatments.
An anti-emetic which does not need to be injected or swallowed, offering patients a differentiated alternative.
The only liquid form of tamoxifen, is indicated for the treatment of metastatic breast cancer, the adjuvant treatment of node-positive breast cancer in premenopausal women, the reduction in risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS), and for the reduction of the incidence of breast cancer in women at high risk for breast cancer.
An artificial saliva spray that is intended to provide relief from chemotherapy/radiation therapy-induced dry mouth.
A prescription iron supplement indicated for the treatment of all anaemias that are responsive to oral iron therapy.
Midatech Pharma US has an exclusive license to Soltamox and Oravig , an exclusive license to distribute, promote and market Gelclair , and a marketing agreement to co-promote two Mission products: Ferralet 90 and Aquoral . In addition, Midatech also holds the exclusive license to Zuplenz .
Midatech Pharma plc (the "Company") is a company domiciled in England and was incorporated on 12 September 2014. The Midatech Group was formed on 31 October 2014 when Midatech Pharma plc acquired the entire issued share capital of Midatech Limited and its wholly owned subsidiaries.
On 4 December 2015, the Company acquired the entire issued share capital of U.S. based, DARA BioSciences, Inc. ("DARA"), an oncology supportive care pharmaceutical company, through the issue of 5,422,028 ordinary shares valued at 14.43m. These shares were delivered to former DARA stockholders in the form of American Depositary Receipts ("ADRs") with each ADR representing the right to receive two ordinary shares. The ADRs were admitted to trading on the NASDAQ Stock Market LLC trading platform ("NASDAQ") on 4 December 2015. Additional consideration was paid in the form of a preference share settlement and the assumption of share options and warrants.
DARA stockholders also received one contingent value right ("CVR"), which represents the right to receive contingent payments if specified sales milestones are achieved for the years ended 31 December 2016 and 2017. Cash of up to $0.27 per CVR, or $5.7 million in aggregate will be payable upon the achievement of the stringent sales milestones however this amount has not been accrued as the Board, as at the time of the transaction, expected the targets to not be achieved.
DARA provides the Group with an attractive portfolio of cancer supportive care products and an established commercial platform in the U.S. market with a field sales organisation. Subsequent to the acquisition the name of DARA was changed to Midatech Pharma US.
The acquisition of DARA included intangibles comprising 15.48m of product sales and marketing rights' and 9.95m of goodwill.
On 24 December 2015, the Company acquired Zuplenz (ondansetron), a marketed anti-emetic oral soluble film from Galena Biopharma, Inc. (Nasdaq: GALE) for the prevention of chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV) for up front consideration of $3.75 million in cash. Further cash payments, totalling up to $26 million, will become payable if certain sales milestones are achieved, the milestone period expires 31 December 2022, however the Board does not expect these to be achieved. These further payments, if they become payable, are expected to be self-financed by milestone-generated cash flow.
The acquisition of Zuplenz was treated as a business combination under the scope of IFRS 3 and included intangibles comprising 2.51m product sales and marketing rights' and 0.17m of negative goodwill.
Key performance indicators
2015 2014 Change
Total revenue 1.38 m 0.16 m 763 %
R&D costs 5.92 m 5.44 m 9 %
R&D as % of operating costs (before listing and a cquisition expenses) 55 % 61 % -
Loss from operations ( 12.92 m) ( 9.69 m) 33 %
Net cash (outflow)/inflow for the year ( 14.17 m) 27.94 m n/a
Average headcount 74 38 95 %
To date, Midatech's KPIs have been focussed on the key areas of cash management and operating results and, most recently, R&D spend. KPIs relating to Midatech's recently acquired US commercial operation and non-financial KPIs, including further KPIs in respect of the research and development programmes, will be formalised in due course.
For the year ended 31 December 2015, Midatech generated consolidated total revenue of 1.38m (2014: 0.16m), an increase of 763% on the prior year and ahead of expectation.
Net cash outflows for the year were 14.17m (2014: 5.91m excluding proceeds from share issues) which was in line with the forecast for the year adjusted for the costs of the DARA and Zuplenz acquisitions as well as the ADR listing on NASDAQ. Cash management remains a major focus for management.
Administrative costs
Midatech's administrative costs increased on the prior year to 7.93m (2014: 4.41m), in part due to costs associated with the acquisition of DARA and listing ADRs on NASDAQ:
Research and development expenditure
Research and development costs also increased on the previous year to 5.92m (2014: 5.44m, including a charge of 1.80m relating to the impairment of IPRD acquired with Q Chip Limited) reflecting a significant increase in the number of active programmes. Activities in the year included:
Last updated: Apr 13, 2016