OREANDA-NEWS. Avita Medical Announces Financial Results for Fourth Quarter Fiscal 2016

Avita Medical Ltd., a regenerative medicine company specializing in the treatment of wounds and skin defects, today announced its financial results and business update for the fourth quarter of fiscal 2016 which concluded on June 30, 2016.

Q4 Financial Highlights

·      Total cash inflows of $1.1m for the quarter and $4.4m for the year

·      Cash receipts from BARDA totalled $2.1m for the year

·      Net operating cash outflows of $2.6m for the quarter and $10.2m for the year

·      Total ReCell® revenue for the full 2016 fiscal year increased 2% over the previous year

·      Device utilization increased 135%, 70%, and 44% for Germany, UK, and France, respectively

·      Awarded extension deal from BARDA which provides an additional $USD7.96 million for the support of its US product launch and commercialization

·      Cash of $4.17m at the end of the quarter with an additional $9m raised the first week of July

In recent months, Avita has been very active on various fronts: financial, business operations, clinical and regulatory. The company has continued to execute its strategy by strengthening its balance sheet, expanding its leadership team, and growing its distribution network. It also progressed its clinical development program, and further engaged with the medical community for the use of its regenerative medicine technology. The sale of its respiratory business in February of this year has allowed the Company to give its complete focus to building recurrent sales of its regenerative family of devices.

Avita announced during the quarter that its BARDA contract had been increased with an extra ~US$8 million of non-dilutive financing. This takes the contract total to US$61.9 million, of which US$24.9 is fully committed by the US federal disaster preparedness agency, with the balance to be provided should various options be exercised. The extra $8 million of funds will be deployed to directly support the Company's build-out of its US operations in support of the FDA PMA submission towards approval in advance of a launch in the lucrative US market. Avita is in close contact with BARDA to fulfil the terms of their mutual contract, and the Company regards the extended funding as a strong validation of its strategy and progress in the US. The Company also raised AUD$9 million, pre costs, in a Rights Issue, which will provide further financing for its commercial objectives in the US and global markets.

The company reported total cash inflows of $1.1m for the quarter and $4.4m for the year. Net operating cash outflows reached $2.6m for the quarter and $10.2m for the full financial year, in-line with expectations. Receipts from customers for the year equalled $2.2m vs last fiscal year of $2.6m; the drop off due to the divestiture of the respiratory product line in early February, leaving nearly five months void of revenues from the discontinued operations. The impact of this was offset by cash received from BARDA, which started coming through in Q3, and totalled $2.1m for the year. The Company reported that device utilization was on the increase in its key European markets, being up 135%, 70% and 44% in Germany, the UK and France respectively. However, as Avita has moved from a direct sales to a distributor sales model in these markets, this has entailed a reduced margin, resulting in total Regenerative revenues over the fiscal year increasing by a modest 2%.

"Increasing the usage of our devices is the fundamental first step in our commercialization programme," said Avita CEO Adam Kelliher. "We know that once medical professionals experience the first-hand clinical and health-economic benefits from using the device, and see the transformative outcomes in their patients, they will buy recurrently. So we are putting great efforts to create this virtuous cycle. The increased device usage shows that we are on the right track and we will keep working on this steady build. "

To support this fundamental activity, Avita has made several strategic hires, including the appointment of Troy Barring to the role of COO, a position he assumed from Tim Rooney, who will now be focused solely on his role as CFO. To further improve its commercialization efforts, Avita added a new VP of sales and marketing, Ross Saunders. These two hires were specified by their prior experience in developing markets which require specialist training; this continues the trend of adding human capital that is adept at building the infrastructure required to properly launch the Company's commercialization strategy. The addition of these two industry veterans will be valuable as the Company rolls out the strategy with an emphasis on regional deployment of educational and clinical resources to develop Centres of Excellence to drive recurrent product usage and position Avita for long-term success.

The Company has recognised that a key reason why previous sales strategies in various territories have achieved limited traction is due to the lack of in-market training and support. To achieve stronger recurrent sales, the focus now is to ensure each key market has a Preceptorship Programme, a Centre of Excellence as a reference centre for Peer to Peer support and sufficient clinical and health economic data to support reimbursement activities. In addition, we will add clinical support resources for thorough training of sales representatives, in-servicing of each new customer, and maintaining close contact with a growing group of Key Opinion Leaders. This emphasis is expected to lead to a more rapid product acceptance and building a pattern of repeat sales. This activity in the US will be directly supported by BARDA, which is funding an education strategy to ensure leading burns surgeons are adept at Avita's approach. BARDA is also funding a premier health economics agency to investigate how Avita's devices may save money by reducing patient's length of stay and saving on other costs typically associated with the current standard of care.

As part of its focus on Asian markets, the Company conducted a series of conferences in China, in which experts from Europe and Australia addressed some 300 Chinese clinicians on the benefits of using ReCell® for the skin condition, Vitiligo. Avita's distributor in China, Sinopharm, pushed ahead with its activity plan focused on Beijing, Shanghai, Guangzhou, and Xian, with the appointment of regional sub-distributors, and the commencement of clinical evaluations in leading hospitals. Avita signed on a Malaysian distributor and appointed distributors in Japan and South Korea who made progress towards regulatory approval. Distributors are allowing the Company to quickly put additional feet on the ground in the target markets, freeing the Avita team to focus its investment on building user experience and developing Key Opinion Leaders.

The Company's clinical programme continued apace, with the enrolment of the first patient in a study of ReGenerCell™, exploring how the device may treat Diabetic Foot Ulcers (DFUs). This UK-based study takes the Company into a treatment area of massive significance, given the growing global incidence of diabetes. Elsewhere, the Company entered into the final safety observation period of its multi-centre FDA approval study for burns, now that the enrolment and treatment periods have been completed. Once fully collated, the data will be submitted under the PMA approval pathway, and the Company reports that it is on track for approval in the second half of calendar 2017.

Avita provided supporting data for its technology in presentations at various industry conferences, and in peer-reviewed journals. At the American Burn Association's (ABA) 48th Annual Meeting, results from a UK study confirmed that ReCell® effectively reduces the occurrence of long-term scarring and itching symptoms associated with paediatric burn treatment, compared to various treatment modalities. In addition, a randomised clinical trial from Germany published in the peer-reviewed journal, Burns, demonstrated that the combination of medical needling with a suspension of epithelial cells provided by ReNovaCell™ can restore pigment on burn scars. At the Charing Cross Symposium in London, leading UK vascular surgeons who are experienced users of the medical device presented findings showing that early intervention with ReGenerCell™ can kick-start the closure of hard-to-heal Venous Leg Ulcers, and save public health bodies significant money. The journal Regenerative Medicine published a wrap-up of the various studies and data presented at the Company's Skin Regeneration Symposium, held in April in Cambridge, UK. The data showed consistent positive outcomes in the three key treatment areas of Avita's focus: burns, chronic wounds and aesthetics.