(GlobeNewswire) - Midatech Pharma (AIM: MTPH; Nasdaq: MTP), the international specialty pharmaceutical company focused on commercialising and developing products in oncology, immunology and other therapeutic areas, today announces its interim results for the six months ended 30 June 2016.
Successful integration and good sales performance from newly acquired US commercial business, Midatech Pharma US Inc. (formerly DARA BioSciences, Inc.)
US launch of anti-nausea product Zuplenz in April 2016, with encouraging early uptake helping drive the increasing revenues
Gelclair continues to consolidate its brand and market leadership in the US for oral mucositis
Positive progress has continued for lead Q-Octreotide product for the treatment of Acromegaly and Carcinoid Syndrome. Plans for human bio-equivalence studies in H1 2017 are on track, which, in the case of positive results, could lead to the potential filing for first marketing authorisations by end 2017/beginning of 2018
Investment for scale up of manufacturing for the launch of Q-Octreotide and collaboration with Ophthotech has commenced and is on time and budget
Product candidate testing and selection in vivo for glioblastoma and hepatocellular carcinoma on track for completion by the end of 2016
Dosing due to commence in Q3 2016 in first immunotherapy (MTX102) Phase I study using Midatech`s gold nanoparticle ("GNP") technology in type 1 diabetes
Further positive progress seen in the period in the Company`s OpsiSporin and MTX110/111 (DIPG) programmes
Total revenue grew from 0.32 million in H1 2015 to 3.80 million (up 1,088%)
Research and development costs of 2.05 million, a 13% increase from 1.82 million in H1 2015
Administrative expenses increased from 3.77 million in H1 2015 to 6.82 million (up 81%), primarily due to the Company`s enlarged commercial infrastructure from the acquisition of Midatech Pharma US
Net cash outflow used in operations (after changes in working capital) was 8.25 million, up 55% from 5.31 million in H1 2015. The cash balance at 30 June 2016 was 7.23 million
Loss per share increased by 39% to 25p (H1 2015: 18p)
Commenting on the interim results Dr. Jim Philips, CEO of Midatech Pharma, said: "Midatech has made good performance in the first half of 2016 and our commercial business is well placed to deliver continued revenue growth in the second half of 2016. We continue to carefully invest in our platform technologies and candidate pipeline and the remainder of 2016 with 2017 are set to deliver results from a variety of our exciting R&D programmes. Notwithstanding the challenging recent market conditions globally, we continue to look at opportunities to build value for shareholders and look to the future with optimism."
Conference callDr. Jim Phillips, Chief Executive Officer and Nick Robbins-Cherry, Finance Director, will host a conference call for analysts at 14.00 BST today.
UK: +44 1452 555 566USA: +1 866 966 9439Conference ID: 63728744
A replay of the call will be available for 30 days after the event, and can be accessed through the numbers below.
UK: +44 1452 550 000USA: +1 866 247 4222Conference ID: 63728744
The results presentation will be made available on the Investors section of the Midatech website shortly before the call.
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Notes for Editors
About Midatech Pharma PLCMidatech 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 StatementCertain statements in this press release may constitute "forward-looking statements" within the meaning of legislation in the United Kingdom and/or United States. Such forward-looking statements include, but are not limited to, statements regarding the ability of Midatech to successfully test, manufacture, produce or commercialize products for conditions using the nanoparticle and sustained release drug delivery platforms, and the ability for products in development to achieve positive clinical results, and the ability to meet or achieve timelines associated with pre-clinical studies, clinical trials or regulatory submissions. Any 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.
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.
CHAIRMAN AND CHIEF EXECUTIVE`S REVIEW
We are pleased to report that during the first half of 2016 Midatech has continued to make good progress on a number of fronts.
In December 2015, we completed the acquisition of the US-based oncology supportive care business, DARA BioSciences, Inc., which has since been renamed Midatech Pharma US, Inc. ("MTPUS"). This was rapidly followed with the acquisition of the anti-nausea product Zuplenz. MTPUS brought with it three cancer supportive care products, Gelclair, Oravig and Soltamox as well as an established oncology focussed, sales and marketing capability in the United States.
Midatech`s commitment to build on its product portfolio within the chosen therapeutic areas was demonstrated with the MTPUS acquisition which has provided an excellent opportunity for the Group by providing a knowledgeable and established commercial infrastructure in its primary target area of oncology. Following the Zuplenz addition to the MTPUS portfolio our US salesforce has a comprehensive range of cancer supporting care products with which to target the US market. The market share for these products currently remains modest so we believe there is significant opportunity for expansion.
Performance from our MTPUS commercial business for the first six months of 2016 has been good: overall, total Group revenue was 3.80 million (H1 2015: 0.32 million) with 3.19 million coming from product sales in the US (H1 2015: nil). Prior to its acquisition, DARA Biosciences, Inc. had revenue from product sales of $2.24m in the comparable six months to 30 June 2015. This represents an encouraging growth rate on the equivalent period last year. Gelclair continues to grow, Oravig is in its early growth phase having been added in October 2015 and Zuplenz was launched in the US in April where performance has, so far, been encouraging.
We are pleased to report that the integration of the US business was completed quickly, successfully and according to plan.
We continue to invest in the Group`s infrastructure, and are in the process of expanding our manufacturing capability in Bilbao to include the Group`s lead development product, Q-Octreotide, and the products coming from our collaboration with Ophthotech. By investing in the scale up of our sustained release technology this will enable us to manufacture most of our own products to commercial scale in-house in the future. This work is on-going and is expected to be completed in late 2016.
In May, we received data from the joint venture insulin legacy programme (MTD101, MidaformTM) following its Phase IIa study. The study failed to demonstrate the release profile seen in prior studies and we are moving to close this programme down. Importantly for the Company, the oral delivery system used for this trial was a novel and unique application of Midatech`s GNP technology and it is not used in any of the Group`s other GNP programmes; all other GNP programmes are delivered via injection or infusion, which we believe is the optimal delivery system for our GNP programmes.
All of our other programmes continue to move forward with encouraging data coming in, in particular from our lead Q-Octreotide programme (MTD201) for the treatment of acromegaly and carcinoid syndrome. Midatech plans to submit an IND application to the FDA for Q-Octreotide and begin bio-equivalence or therapeutic equivalence studies by late 2016/early 2017, with a potential US launch in 2018 or 2019 (depending on clinical trial outcomes). The market each year for chronic treatment of acromegaly and metastatic carcinoid syndrome is estimated by the Directors to amount
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