Axe Compute Inc. (AGPU) Q3 2016 Earnings Report, Transcript and Summary

Welcome to the Skyline Medical Third Quarter 2016 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following management’s prepared remarks, we will hold a Q&A session. [Operator Instructions] As a reminder, this conference is being recorded, Tuesday, November 15, 2016. I would now like to turn the conference over to Kim Golodetz. Please go ahead, ma’am.

Thank you. This is Kim Golodetz with LHA. Thank you all for participating in today’s call. Joining me from Skyline Medical are Dr. Carl Schwartz, Executive Chairman and Peter Alex, Vice President of Sales. We are also joined by Richard Gabriel, the COO of GLG Pharma. Joining us for the Q&A portion of today’s call, we also will have Bob Myers, Chief Financial Officer. Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements regarding the operations and future results of Skyline Medical. I encourage you to review the company’s filings with the Securities and Exchange Commission, including without limitation the company’s Forms 10-K and 10-Q which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Factors that may affect the company’s results include, but are not limited to product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks. All forward-looking statements speak only as of today’s date, November 15, 2016 and except as required by law, the company assumes no obligation to update these forward-looking statements whether as a result of any information, future events, changed circumstances or otherwise. With that said, I would like to turn the call over to Dr. Carl Schwartz. Carl?

Thank you, Kim and my thanks to each of you for joining us today. Since our successful Special Meeting of Stockholders almost exactly 2 months ago, Kim, my colleagues and I have received questions from many shareholders asking in essence what’s next. During today’s call, my colleagues and I are going to update you on all the work that has been underway of Skyline Medical and discuss our near term and longer term plans. Leading up to that stockholders meeting, Skyline was very active in reaching out to our investors both to tell you why we are so excited about our future and to solicit your votes. As you know, we ultimately receive the votes we needed to pass all three proposals as that would allow us to continue running this company and we do so with renewed energy and optimism. Let me begin the remarks today by extending deepest gratitude to fellow stockholders for voting in favor of our company’s future. I also want to assure you we intend to uphold the same level of transparency in the future as we did leading up to the proxy vote. Rest assured that when we – the Skyline is in a period of relatively quiet, it is not because of a lack of progress, but rather simply a reflection of the process that must proceed tangible results. In terms of our plans and progress, the third quarter in recent weeks have been extremely active as we took a number of decisive steps to support Skyline’s growth and to establish a foundation for highly significant longer term opportunities. Today, I am going to talk briefly about our financial results and then discuss the ways in which we are leveraging the exciting opportunities we have in front of us. From a financial perspective, revenue for the third quarter of 2016 was $134,605, which was up sharply 57% in fact compared with revenue of $85,792 in the third quarter of 2015. Revenue this past quarter was derived from the sale of two STREAMWAY systems as well as sales of disposable products, whereas revenue a year ago also included system sales and disposable products. These two sales in the 2016 period represented the sixth and seventh units purchased by a renowned institution for their headquarters location. So clearly, the STREAMWAY system is an important part of the operating room devices there. The purchase of multiple units at one institution is a terrific vote of confidence for STREAMWAY. Gross profit for the third quarter of 2016 was $108,124 or 80% of revenue and these figures are up from $66,019 gross profit and 77% gross margin a year ago. This is the first quarter in which we have improved our margins following the installation of new systems. Recall that our reported gross margin had declined due to the replacement of original STREAMWAY units with latest generation product at no charge to customers. This replacement is now complete and the gross margin for 2016 is expected to be higher than the gross margin for 2015. Total operating expenses for the third quarter of 2016 and 2015 held steady at about $1.2 million each quarter. During the 2016 quarter, lower G&A expenses were partially offset by higher sales and marketing expense and higher operations expense. The net loss available to common shareholders for the third quarter of 2016 was $1.1 million or $0.32 per share and this compares with a net loss available to common shareholders a year ago of $1.1 million or $7.09 per share. The share count was significantly differed between the two periods with about 3.2 million shares in the current quarter and about 157,000 shares a year ago on a split adjusted basis. The company had cash, cash equivalents and marketable securities of $1.2 million as of September 30, 2016 and this is down from about $4.9 million as of December 31, 2015. We used about $3.7 million in cash to fund the operations during the first nine months of 2016. We will require additional funding to finance operating expenses to invest in our sales organization and new product development and to enter the international marketplace. We are exploring various alternatives for this financing. We have recently had a shelf registration statement declared effective by the SEC which increases our flexibility. Let me now turn to some exciting developments of Skyline. As discussed on previous calls, we have broadened our management team with the hiring of Peter Alex as Vice President of Sales and more recently we appointed world class accomplished advisors and board members, Dr. Paul Sweetnam, Tim Krochuk and Mel Engle. Collectively, these additions will improve our sales channels and pipeline the potential products, strengthen our governance and open new opportunities for Skyline Medical. Dr. Sweetnam who joined our medical advisory board has more than 25 years of executive and entrepreneurial experience in the pharmaceutical and biotechnology industries. In addition, he has established an extensive network of scientific collaborators within academia, the government and industry. Tim Krochuk, one of our new board members is the CEO of CHP Clean Energy. A full service provider of biogas powered combined heat and power systems for wastewater treatment facilities with anaerobic digesters, which he founded in 2009. He is also a Managing Director of GRT Capital Partners, an investment advisor based in Boston and as a portfolio manager, a managing partner for GRT BioEdge Ventures Fund, a fund focused on equity investments in privately held emerging healthcare and biopharmaceutical companies. Mr. Engle, our other new board member has worked in the healthcare industry for the past three decades. He is Chairman of the Board of Windgap Medical, a startup medical device firm focused on unique drug delivery applications and is held executive positions at prominent companies, including Chairman and CEO of ThermoGenesis, Regional Head/Director, North America at Merck Generics, President and Chief Executive Officer of Dey, and Senior Vice President, U.S. Sales at Allergan. In addition to this new talent, we signed a partnership with GLG Pharma and a letter of intent for joint venture with EOR events that hold potentially be transformative to our company when completed. In GLG Pharma, we have a partner with distribution capability in Europe and a pipeline of products in development for rapid diagnostic tests that utilized fluid and tissue collected by the STREAMWAY system during procedures in a few moments. Richard Gabriel who will be – I am sorry in a few moments Richard Gabriel, who has served as the Chief Operating Officer of GLG of the past 7 years will provide some comments on the opportunities he sees. EOR brings to the joint venture advantageous position in terms of ownership and certifications. Their partner contracts with NIH, Department of Defense are expected to provide Skyline with access to bid on procurement contracts for up to 550 million or more in federal funds budgeted for health, security, life safety system support, humanitarian assistance and disaster preparedness, and in particular mobile operating rooms. We are working to finalize this agreement hopefully by the end of the year. Subsequent to the quarter’s end, we effected a 1-for-25 reverse stock split. This is an important step to maintaining our listing on NASDAQ as it brings our stock price above the $1 minimum bid requirement. We are working to cure our stockholders’ equity shortfall as well and we are pleased stockholders voted to increase our authorized share capital as this gives us additional flexibility to raise funds. We have requested a meeting with the NASDAQ hearing panel to request an extension and present our plan to regaining compliance. Looking to our near-term milestones, we expect to receive clearance to market STREAMWAY in Canada in the coming weeks followed by of receipt of the CE Mark potentially during the first quarter which would allow the company to sell and distribute in Europe. Peter Alex has redoubled our sales efforts and have generated a vastly improved backlog of product enquiries. We will also hear from Peter shortly. As we previously discussed Munro Enterprises is working to distribute the STREAMWAY System to the U.S. federal government including United States Department of Veterans Affairs, U.S. Department of Defense and U.S. Health and Human Services facilities. They expect to make progress now that a new federal government fiscal year has begun. Those are a few of the highlights of our recent accomplishments. And now I will turn the conference over to Peter Alex, who will provide some color in our sales and marketing initiatives. Pete?

Thanks, Carl. It’s a pleasure to be speaking with all of you today. Short of any successful sales and marketing campaign, our product benefits from strategic vision and we are in a powerful position to succeed with STREAMWAY because it offers tangible benefits to all constituents including healthcare professionals, patients and healthcare facilities. Continued confidence in the STREAMWAY System is reaffirmed by extremely positive industry feedback over the past several months. Today, I am going to update you on my initial 9-point plan for the STREAMWAY System that answer is to you in September in the framework of a comprehensive undertaking for success which includes the following. Current and prospective customers, first, the best customers are current customer and to that end we are looking to expand our install base where we are generally and only a single department now include the institutions entire facility and health system. This also supports our customers’ needs to standardize care system wide and improves purchase economies of scale. Accounts are being quoted and are budgeting for new and additional units in 2017 in both our commercial and VA government sectors. We are in contract negotiations with three of the largest GPOs or group purchasing organizations to get the STREAMWAY on contract which will streamline and accelerate our sales process with current and prospective customers to grow sales in 2017 through 2019. We expect our first set of contracts to begin as early as January 1, 2017. Disposables, STREAMWAY disposables are Skyline Medical’s annuity business and also allows the daily interaction with customers. In fact disposable sales contributed to our year-over-year third quarter revenue increase and we project disposable sales growing as we continue targeting higher volume opportunities and as we develop the expansion of the STREAMWAY platform with GLG Pharma. We are receiving tremendous customer feedback in combining our disposables as a kit to drive infection control for clients. All these drivers will keep us focused on patient outcomes, procedural efficiency and deliver ROI and long-term savings to our customers operating budgets and total cost of ownership. Service and preventive maintenance, on September 1, we launched a simple, yet comprehensive service and preventive maintenance plan that will provide customers with a valuable option to ensure the highest level of uptime with their STREAMWAY System. Greater uptime, of course drives further sales of disposables, reinforces the brand and has attributed to a higher degree of customer satisfaction. Our preventive maintenance and service plans are competitively price and we have begun to securing contacts for these contracts. We expect this part of our business to grow as more strategic supplier and installed units and as our field service and sales infrastructure expands, feedback from clinical engineering biomed departments has been favorable. Installation, the STREAMWAY Systems novel direct to drink concept has freed installation phases to advance to sale. We are now engaging third-party installers and facilities engineering departments at the onset of our sales process which will support new construction, renovation and retrofit opportunities to identify total project costs and foster cost contained installations. We had developed an engineering cut sheet for engineers and contractors to provide accurate job estimation. Interest from third-party installers and facility engineering departments has been promising and the end users have embraced the project implementation strategy. Product acquisition and purchase alternatives, we are continuing to promote and expand our purchase methods for STREAMWAY to allow a purchase to fall under facility’s operating budget and not as a capital of equipment expenditure which is a lengthier process. This includes opportunities for a pay per procedure model, placement agreement, rental program in addition to our current capital purchase and lease options. Our goal is two-fold. First to provide solutions to put a facility’s procedure generative revenue more aligned with the equipment and disposable costs. And second to partner with supply chains and other ROI and outcome based models. We are looking at these methods to reduce the timeline between the demonstration or trial to the time of order. Account feedback has been collaborative to identify purchase options that capitalize on contingency funds and budget cycles. Sales leads, we continue to look for cost effective and wide audience digital marketing efforts on social media and through a variety of clinical society websites. In fact the number of sales leads and active quotes generated since July of this year have exceeded all of 2015 in the first half of 2016 by nearly 5x. We are evaluating this data to determine targets and have generated notable sales opportunities via this strategy. As budgets permit, we will expand our digital marketing, traditional marketing, tradeshow attendance, support of light favors in clinical trials to build on our brand. Direct sales model, we intend to increase our direct sales efforts with the hiring of additional reps as soon as resources allow. This would provide us with direct territory coverage to expand our install base and also to develop a new regional business approach to drive sales and distribution initiatives. Distributor sales model, in parallel to direct sales, our distributor sales we are actively reviewing further U.S. regional distributors and are into the review process for Canadian and European distributors that complement our strategy to leverage sales. As Carl mentioned GLG Pharma represents a partner with distribution capability in Europe that we will build on with the STREAMWAY. We expect to market STREAMWAY in Canada in the coming weeks followed by receipt of the CE Mark allowing the company to sell in Europe potentially in the first quarter of next year. Munro Enterprise has recently attended the National Veterans Small Business Engagement, Minneapolis and presented STREAMWAY’s capabilities to more than 40 decision makers across the VA network. Regions across the U.S. or Vizient’s are actively working with Munro regarding acquisition steps and active quotes are pending approval. Our distribution sales model has been a complement to our direct sales efforts and we are aligned in similar and sales processes. GPO contracts, lastly and as I mentioned earlier a critical piece to our success will be working with various GPOs to get STREAMWAY on contract. In late September, we attended Vizient’s Innovative Technology Exchange in Dallas. The feedback and the response to the STREAMWAY System was exceptional. We are now in active contract negotiations with three large and prominent GPOs that represent over 15,000 members including hospitals and outpatient surgery centers. Getting on contract will dramatically broaden our STREAMWAY value, differentiate us from our competition, simplify the purchasing process and drive greater brand awareness for innovative novel solution. We continue to remain focused on positioning our STREAMWAY for growth is in streamlined and focused strategies that meet today’s changing healthcare model and tomorrow’s value based requirements. Over time and with additional products, we will be creating new demand for our solutions in growing our top line. Our passion remains bringing fluid management solutions to patients, clinicians and healthcare facilities. And now I would like to introduce Richard Gabriel, the COO of GLG Pharma to speak about our new partnership. Richard?

Thanks Pete. It’s a pleasure to have the opportunity to speak today to the Skyline Medical’s stockholders. We are all very excited at GLG about our new relationship with Skyline, notably because STREAMWAY Systems will become the platform for GLG diagnostics, cell capturing technologies that we are developing for oncology applications. One of the first opportunities we have identified is ovarian cancer and the collection of ovarian cancer cells as well as the use of markers to identify the state of cancer and the level of metastasis that is evidenced in the ascites fluid. The STREAMWAY system is the only commercial system we at GLG have seen with capability for collection, identification and safe disposal potentially has for this material, all in the operating room. We believe that GLG will be able to help our partnership reach a unique position in the EOR with our combined efforts to expand the utility of STREAMWAY by adding products that will allow oncologists to more accurately treat patients. While improvements in ovarian cancer treatment have increased the 5-year survival rate from 20% to 30% of patients up to 50% today, a lot of work still needs to be done. GLG’s STAT3 diagnostic and other markers plugged into the STREAMWAY system will give OR clinicians near real-time information to stratify patient risk. Ovarian cancer is usually diagnosed, because the patient is expressing pain, discomfort, loss of appetite or other symptoms. And on ultrasound it reveals ascites fluid in the abdomen. Early testing is essential to help diagnose the cancer before it progresses even further. In the future, using the same technologies we will look at other fluid collection, for example, from the lung area, which is usually the result of lung, breast or other cancers. Again, developing the panel of diagnostic tests, cell capture and safe waste disposal is a unique function that GLG will be developing for Skyline. In addition to oncology, GLG will also develop diagnostics for infectious diseases and metabolic disorders that will bring the diagnostic closer and faster to the physician and the patient. The technology will not eliminate further testing, but what it will do is alert the physician that more testing will need to be done sooner rather than later. In addition to GLG’s development of new technologies with Skyline, we will be distributing the STREAMWAY System in Central Europe and also the UK once the CE Mark has been obtained. GLG is currently setting up operations in Poland for Central Europe and will be setting up operations in the UK shortly thereafter. What’s important is in both of these market areas we will focus on oncology centers and the types of centers that Skyline has typically targeted in the U.S. The prospects for the STREAMWAY System in oncology, is we believe very compelling and we will be looking to starting up sales operations as soon as possible. With the market for STREAMWAY – I am sorry, while the market for STREAMWAY systems in the U.S. is much larger, there are nearly 3,600 operating rooms in Poland alone and another 3,400 operating rooms in the UK. We see both geographic opportunities as excellent channels, not only for the direct sale of the STREAMWAY product with its disposables, but also as a platform for expanding add-on diagnostics faster. Both the UK and Central Europe have generous programs for non-dilutive funding for companies developing improved oncology treatments whether it is a device, a diagnostic or a drug. We look forward to tapping into those non-dilutive resources. Thank you.

I think with those comments, operator, we are ready to take some questions.

[Operator Instructions] Your first question comes from Barry Krosch [ph] with Beck Corporate.

Good afternoon, gentlemen.

Good afternoon.

First of all, congratulations on the sale of two units, the last time we spoke we hadn’t quite got there yet, but in the case of regular time to build the building, so congrats on that. I have a couple of questions for Richard Gabriel.

Sure.

First, I researched on your company online and I had most of the information like it is in Polish and Google Translate just doesn’t it do it for me. How many people does your company employ currently?

There are – well, the number of people, I have got 3 that are coming through this call. There are number of people in Poland. There is a link on the top of page that allows you to convert to English. So, that should be active. So, you can either listen to it in English, I mean, you can either see it in English or you can see it in Polish. The Polish operation has $2.7 million grant and that grant will employ when we are fully operational we just started in November will employ about 12 people in Poland, there is 8 people in the U.S. So, that’s about 20 people total and then our UK operation will once its funded and up and running we will also employ somewhere around 10 people.

So, as the funding comes in, you will be growing I would presume your sales team, because that’s what it sounds like you guys are going to be in charge of here is a lot of the overseas sales?

Well, we are focused on Central Europe starting with Poland and also the UK and the answer is yes.

Okay. And just one other question, would you be able to provide me with the name of your international sales manager, because I can’t find anything on any kind of sales staff that you have, that is just personally for myself and maybe for other stockholders, we like to do all this research on past performance and schooling whatnot see what types of things that they have done in the industry?

Well, the individual to head up to sales, we don’t have the CE Mark yet. So, we have not heard the individual as Peter Alex is for the operation in Europe. As soon as we do we will publicly release that.

Okay, great. I just have one more comment in general for Skyline Medical, you have great plans and I am looking the direction that you are taking have you ever considered possibly doing the 10 minute segment on 60 minutes, because your product in the public line would sell itself?

That’s an interesting point. And the answer is no, I haven’t considered that, but we certainly will do anything to help our oncology cancer patients. We are very patient focused. We would do anything to help Skyline and also promote the integration of the system, because it gets the diagnostic close to the operating room. The closer you can get to the operating room the faster you can get results to the patients and the oncologists and the better off the patients will be. So, that’s the primary drive that we have. That’s why we are so excited about this system. And I might add so we are making on….

I just think is that all you really need now to be really successful is exposure and something like that nationwide on a program like 60 minutes where you have the 10-minute segment and medical professionals will be watching, because that’s what they do and this product would sell itself.

Well, thank you….

Thanks very much for taking my call.

Yes. If I could comment a little further on that, in addition to oncology, I mean, media outlets such as 60 minutes or just broader level media outlets are a great way to get the message out. We do have a significant brand story to tell with our product. There is a ton of passion behind it. Our customers feel it. They feel it from an environmental standpoint. They feel it from an infection control and cross-contamination of their staff. They recognized it from a patient standpoint and facilities and infrastructure people love our product as its actually part of the wall versus more of the mobile solution and it increases footprint. So, thank you for the question and that will definitely complement hopefully your answer.

We have a new President in the U.S. and I think he is going to really like that product. I hope you do very well, because I am heavily invested.

Thank you.

Thanks very much.

Your next question comes from Betty Kendall with Individual Investment.

My questions regard to NASDAQ compliance, I know you have a meeting towards December timeframe that’s what we are looking for? No, since we are at a $1 or actually above $1 for the last 10 days also we can get compliance before that meeting?

This is Bob Myers. I will answer that question for you. The answer to that is no, we cannot necessarily get compliant before that meeting, because it’s a special hearing panel that is independent body of individuals that do not work for NASDAQ and make the decision and they need to see our plan unfolding in front of them along with the fact that we have been above the $1 mark. However, there is possibility that if we satisfy the listing notification for our equity problem that we could possibly avoid the hearing panel and become compliant in advance, the timing is difficult and I don’t see that happening before next month, but we are working to try to do that and we are working very diligently to provide a plan to the hearing panel that will be acceptable. We have hired a top firm in the country, Donohue & Donohue that I was representing this with the hearing panel and I feel very confident that we will be successful.

Thank you.

You are welcome.

[Operator Instructions] Your next question comes from William Klein with Private Investor.

Yes. Good afternoon gentlemen and thank you for the update provided today. My hope is that we get progress report on the EOR contract being fully executed and why it hasn’t progressed past the letter of intent stage that we heard about months ago?

This is Bob Myers and I will take that again if it’s alright and Carl if you wish to amplify you may.

No, go ahead Bob.

Okay. We are in the middle of negotiating with EOR on both – on a number of levels, one, to setup a joint venture that we are looking to do in the future and two, to establish a sales network now where we do a joint selling project to the VA and to their customers based on their contracts. The reason that we have not included that deal is that we are still under the NASDAQ compliancy for the hearing and we need to settle that before we can go ahead and formulate a finalization to the deal. We expect to do that in the middle of December and then therefore you could look to CEO or finalize on what’s sometimes shortly thereafter?

Thank you very much.

Yes.

Your last question comes from Rafael Phase with Private Investor.

Hello. Hi, I just wanted to I guess piggyback off the EOR JV, joint venture in regards to it’s consumption [ph], I know you just said after December 15 we could possibly hear some news, when will contracts via EOR would be announced or when can they be forecasted to have something solidified in regards to that?

That is something we are working on currently and that might occur prior to December, but I can’t answer what I don’t know and that I don’t have a definitive answer on. They have contracts out there for bid and they are working with on a reseller agreement so that we can take advantage of that now. They have already represented us in various hospitals and VAs already and we just haven’t concluded anything at this point. I am sorry that that’s not a direct answer, but it’s the best I can do without finalizing the deal.

Great. And I may if I can piggyback one more time in regards to is the Munro Industries or Enterprises, is that similar to the potential joint venture with EOR, I know this is a veteran disadvantage company and similar concept to EOR, is it something similar in regards to utilizing this company in order to pool in the government contracts they have access to?

It’s similar, but not the same. We have a distribution contract already in existence with Munro that we signed a couple of months ago. They have been actively working as a sole distributor for us in the VA and they are now since October started the cycle for funding for the VA they have been putting out quotes and looking to fulfill orders and hopefully we will get some of those in the fourth quarter or certainly the first quarter. They will complement what is going to go on with EOR and should we conclude with EOR and we will work with both Munro and EOR at that point in time.

Perfect. Thanks so much for the clarification. I am heavily invested as well. Best of luck to you guys and we are definitely pushing for the stock price to blow and put a lot [indiscernible]. Best of luck.

Thank you.

There are no further questions at this time. Please proceed with your presentation or any closing remarks.

So anyway thank you very much. So in closing I want to thank you all for your time today and for your interest in our company. We have a lot of exciting opportunities in front of us which I trust we have conveyed during this call. We look forward to executing on our plan and to keeping you informed of our progress. Have a good day. Thank you.

Ladies and gentlemen, that concludes your conference call for today. We thank you for your participation and ask that you please disconnect your lines.