Earnings & Revenue Estimates
Earnings Call Transcripts
Operator: Good morning, and welcome to the Akers Biosciences Conference Call to discuss 2017 Earnings. As a reminder, this conference call is being recorded. I would now like to introduce your host for today’s conference, Ben Simons with Akers Corporate Communications team. Ben, please go ahead.
Ben Simons: Thank you, Tracy and good morning everyone. Thank you for joining us for this short commentary regarding the company’s performance in 2017 and an opportunity to ask questions to John Gormally the Company’s CEO; and Gary Rauch, VP of Finance. Following the Safe Harbor statement, which I will read very shortly, John will provide an overview of 2017 and then Gary will provide a summary of the financial results before we open up the call for questions. Before we get underway, I’d like to ask everyone to take note of the Safe Harbor paragraph that appears at the end of the News Release detail in the company’s financial results which were published this morning. This paragraph states that any forward-looking statements that the company makes, speak only as of the date made, are subject to inherent risks and uncertainties, including those described in the company’s reports filed with the Securities and Exchange Commission and should not be unduly relied upon. Except as otherwise required by the Federal Securities laws, the company disclaims any obligation or undertaking to publicly release any updates or revisions to any forward-looking statements contained herein or elsewhere to reflect any change in our expectations with regard to any changes in events, conditions or circumstances on which any such statement is based. Thank you for listening to that and I’d now like to hand over the call over to Akers Bio CEO, John Gormally.
John Gormally: Thank you and good morning everyone. As I wrote in my commentary published this morning, 2017 was a year of strengthening the company. We strengthened our Board of Directors with the appointments of highly experienced directors in the fields of healthcare, medical device, finance and capital markets. We strengthened our domestic commercial team with new talent, especially in sales and distribution. We strengthened our product position across core products, including PIFA Heparin and OxiChek which I’ll talk about in a moment; and finally we strengthened our balance sheet with net proceeds from Public Offerings, our Private Placement and the conversion of warrants during the course of the year were approximately $10.5 million. Putting these building blocks in place will I believe enable the company to accelerate revenue growth in the months and years ahead. Now a key product of the future which we worked hard to position optimally during 2017 is KetoChek, the first commercialized product from the Akers Wellness line aimed at the large and growing health and wellness market. OxiChek is a rapid breath test for oxidative stress which is a good indicator of a person’s overall health and wellbeing. It works with BreathScan Lync, a Bluetooth-enabled reading device which enables users to track the results through an app on a mobile device. In addition to anti-aging, functional and integrative health and wellness treatment practitioners, we are also marketing to the chiropractic sector. Sales of this product are small, in context of overall revenues. However, as a part of our three year strategic plan, we knew that the physician approval of our science was a key component of supporting our strategies within the network or multi level marketing target arena. This segment represents the significant opportunity of profitable growth to the company. Our goal remains to secure strategic partnership agreements. We’ve initiated discussions during the year and continue meaningful dialog. We will update you when appropriate as the strategy develops. OxiChek is a part of the MPC Biosensor platform family of proprietary breath testing technology. MPC sales grew overall by 237% to just under $1 million and were a major contributor sales growth over prior year. It is also notable that sales of BreathScan Alcohol Breathalyzer products, another commercialized product in this category enjoyed a stronger year, boosted by a $0.25 million initial stocking order from Australia and New Zealand. Now some of our medical tests are designed only for use in the clinical study. It’s been a please to walk down the aisle of a major drug store change and find our rapid test for cholesterol in the shelves under the First Check brand. We are encouraged by continued end user demand and we’ve already received orders that will be shipped in 2Q, 2018. Moving on to our main revenue generator today, the test which accounts for around 70% of revenues in 2017, including associated component sales is our rapid antibody test for an allergy to a widely-used blood thinner, heparin. Now this test is called the PIFA Heparin/PF4 Rapid Assay. The condition in test four is heparin-induced thrombocytopenia or HIT and is a life and limb threatening potential complication of heparin therapy. Heparin as you know is the most widely used blood thinner in the world because it is inexpensive. Our test is significantly faster than existing alternatives and many as you know, the speed of diagnosis is paramount to good decision marking in medicine and also key to ultimately saving money. Although we reported only moderate revenue growth of 6% in sales on these tests or the related components, we remain encouraged with our future. Now that the third wave of our strategy, which many of you will remember is physician awareness is beginning to unfold. We believe we are only scratching the surface of this eventual market potential for these assets. Accordingly, we have adjusted our market strategy to target large integrated delivery network customers in the U.S. These IDNs have taken longer to penetrate than the smaller individual hospitals, but we believe they refer much bigger prizes when eventfully converted. We are devoting a lot of attention to the awareness campaign and a strategic focus on clinical end users, particularly cardiac and orthopedic surgeons, and we expect to announce a number of exciting partnerships in this area in the coming months. While I’m talking about PIFA Heparin, it is appropriate to mention that Pamela Hibler who joined the company in 2017 as the Vice President of Sales and Distribution for North America is a major driving force behind our strategy to take PIFA to the next level. I worked with Pamela prior to Akers Bio. She has more than 25 years of success in medical device sector sales and I’m excited about the work that she and our expanding team of regional sales representatives are doing. Now I’m sure you will have seen last month our announcement on the three year National Distribution Agreement with Diagnostica Stago for the sale of whole blood version of this test in the US. Stago is a global leader in hemostasis, with a specialized sales team. They have a large and established customer base to leverage and we believe this could be a valuable additional channel to market in the years ahead. Our most advanced products in the development pipeline are the PIFA Chlamydia Rapid Assay, KetoChek and PulmoHealth which is our Enzymatic Assay. Each of these products has considerable market potential. A new focused process, to manage the various stage or product innovation through commercialization is in practice at Akers Bio and has been for the last 18 months. Decisions embraced by my leadership team are based on customer requirements and return on investments. PulmoHealth or Enzymatic Assay will require a 510(k) submission, is slightly within this process but future development is required. KetoChek however is our next product under consideration for launch and we are rapidly working though this process to make this happen. As with all new products there are no timing guarantees for commercial launch or customer adoption. Details will be appropriately shared as we work through customer requirements and our unwavering commitment to meet and exceed the industry’s highest quality standards. Shareholders have regularly been contacting the company to ask about the status with the 510(k) submission for PIFA Chlamydia. We are delighted by your enthusiasm for this test because we believe that has exceptional potential. PIFA Chlamydia Rapid Assay is the first rapid blood test for this highly prevalent sexually transmitted disease. Subject to regulatory approval, we believe it will be highly appealing to our targeted markets which include Planned Parenthood, ambulatory care, health clinics and college campus clinics. In May 2017, the company submitted PIFA Chlamydia to the FDA for 510(k) approval. The company continues to work proactively with the FDA to advance the approval process. The company is in communication with the FDA regarding a potential requirement for additional data. In the event that the FDA requires additional data to support this application, the company is committed to completing further studies as expeditiously as possible in order to complete the FDA 510(k) process. Now I want to stop here for moment and say, this commentary is the extent of which we are prepared to comment on the Chlamydia PIFA Assay at this point in time. Now I’d like to hand over the call to Gary Rauch our VP of Finance for a brief summary on the financial performance.
Gary Rauch: Thank you, John. Total revenue was up by a third to just shy $4 million during 2017. PIFA Heparin/PF4 Rapid Assay products or components associated with that product continue to account for majority of that revenue. However the growth over 2017 was driven primarily by the BreathScan Alcohol Breathalyzers, OxiChek and the re-introduction of the Tri-Cholesterol test. Gross profit margin remained consistently strong at 63% leading to a gross profit of $2.5 million. We are still maintaining very tight controls over expenses, but despite this major expense categories increased 17% overall. This was mainly because of general administrative expenses which increased by 36% to $4.1 million, which was a result of increased personnel expense and because the company has begun to take a more conservative approach to debt collectability and reserve $500,000 for doubtful accounts during the year, which is included in the G&A. Sales and marketing costs were stable at $2 million and research and development expenses were up slightly at 6% to $1.25 million. The company’s net loss for the year ended December 31, 2017 was approximately $5.8 million. Several events impacted the result, including the cost of raising capital, ongoing legal fees associated with litigation and this new conservative approach in respect to managing overdue receivables. Importantly in 2017, Akers Bio took steps to strengthen its balance sheet, raising net proceeds of $10.5 million during the year from public offerings, private placements and the execution of warrants. This led to a cash and marketable securities position at year end of a little under $5.5 million and this places the company at a much more robust financial position from which to accelerate our sales growth and new product commercialization. During the year ended December 31, the company’s average weekly cash burn rate increased to 97.7 [ph] as compared to 82.53 [ph]. Once again the results from payments to vendors and subcontractors that were included in the year end of 2016, at which point our cash flow position was soft, legal settlement costs, higher personnel costs and other contractual obligation. The company anticipates the cash requirements to remain in the range of $97,000 to $100,000 per week through 2018. Now I’ll turn it back over to John.
John Gormally: Hey, thanks Gary. So haven taken the necessary steps to strengthen our business across key areas of 2017, our goal is to leverage that platform to materially accelerate the rate of revenue growth. Over the past two years our product revenue growth has more than doubled and I can attest that the Akers Bio leadership team and its new Board of Directors remains focused on improving our efficiency, our productivity and ultimately our profitability. There are a number of ways that we can achieve goals to enable shareholder value. We have defined key pillars of success that plot our path forward. The potential for the PIFA Heparin Rapid Manual Assay growth remains significant, especially when our physician awareness strategy and our newly developed relationship with Stago developed market traction. Another key pillar of our success this year resides in the development and successful launch of a strategic partnership agreement on OxiChek within the network marketing arena. And finally, I believe we can further enhance company valuation with the introduction of new products, subject to regulatory approvals such as PIFA Chlamydia which I know we are all very excited about. You know at this point, I would happy to take any questions that you might have. Thank you.
Operator: Thank you, sir. [Operator Instructions]. We will now take our first question from [Inaudible]. Please go ahead.
Unidentified Analyst: Congratulations guys on a tremendous quarter.
John Gormally: Thank you very much. We are excited about that.
Unidentified Analyst: I just have some quick question. I know we can’t go into too much color regarding the 510(k) with the PIFA Chlamydia. However are there additional requirements that they did request from the company?
John Gormally: So the commentary Mark that I made in the performance discussion that we just had is the extent in which the company is prepared to comment on. The FDA has a series of protocols that they follow and it is not unusual for them to come back to a company and to ask questions about submissions. We are in that stage of discussion with them, but my message back to the market on this is very clear, that we are committed to resolve any number of questions that they may have, as expeditiously as possible, and because we feel quite confident that this product that we hope to launch is going to provide a un-met need in a very profitable segment of the market.
Unidentified Analyst: Tremendous! I really do appreciate it and keep up the great work guys.
John Gormally: Thank you, Mark.
Operator: We will now take our next question from [Inaudible] a Private Investor. Please go ahead. He appears to have stepped away. We’ll now take our next question from James Terwilliger from Paulson Investment Co. Please go ahead.
James Terwilliger: Hey guys, can you hear me?
John Gormally: Loud and clear.
James Terwilliger: Okay. Congratulations on all of your accomplishments. I don’t mean the Eagles or Villanova. I mean just the revenue growth, getting your deals done and because that’s a lot. It’s amazing how you were able to run the business and help the capital markets. Just real quick and I’ll jump back in queue. The cash balance at the end of the year, is it approximately $5 million?
Gary Rauch: Yes.
James Terwilliger: And can you give you’re…
Gary Rauch: Go ahead.
James Terwilliger: No, no I’m sorry, go ahead. I didn’t mean to interrupt you.
Gary Rauch: I was finished.
James Terwilliger: Okay. And then I’m just working on my model to kind of catch up to you guys, because I got to do some changes here. Can you give me the full diluted shares outstanding for the quarter?
Gary Rauch: I’ll have John take the next question here and I’ll look it up real quick.
James Terwilliger: And when we look at your business, I mean is there some seasonality here where the fourth quarter is kind of – from the seasonality perspective at 30,000 feet, did you get some large distribution orders that as I look at my model going into next year that we shouldn’t expect. How do I think of the seasonality of your business and I believe there would be some within being in the healthcare field and dealing with distributors, both U.S. and international.
John Gormally: Sure. I wouldn’t use the word seasonality, because that suggests to me that certain tests like as an example FLU A and FLU B during the fall and the winter seasons tends to spike, and that would be a seasonality component. I think what happened is, is that because of our size and dealing with the large distributors out there that are committed to on-time delivery of their orders to the end user, we work with them and we make sure that they have sufficient inventory on hand to meet the growing new demand that we’ve created on our PIFA Heparin product. However, the jump from third quarter to fourth quarter in terms of our overall performance on the top line was dedicated to strategic initiatives that candidly we have been working very diligently around the globe to realize and they just came to term if you will in the fourth quarter. We always anticipated this happening, but sometimes when you are working outside of the United States and quite candidly within the States, they tend to happen at the customers pace. So we were delighted about what had happen in our initiatives in Australia and New Zealand. We were very excited about the advancements that have been made on the PIFA Heparin product in the fourth quarter, specifically as a result of our awareness campaign and the initiative being driven with the physician community on their awareness of us having the only 510(k) approved product, you know obviously domestically for the HIT. So again, very excited about that. Gary, were you able to find…
Gary Rauch: Okay, so as of year-end outstanding shares was $52,620,552. The weighted average at that point $94,977 [ph]. We have issued 20-Plus million shares through the first quarter, which bring us up to around 83 million shares; I don’t have that exact number with me. And of course the weighted average is going to go up proportionally.
James Terwilliger: Yeah, that’s great detail. And then lastly, so as much as I’m focused on Heparin, which is your number one product it was really your BreathScan and your Cholesterol that kind of really hit the growth button here in this quarter. Okay, I’ll jump back in queue and lets some other people take some questions. Nice job guys, both in terms of your capital structure and in terms of your core business.
John Gormally: Thank you very much James. We really do appreciate the support that you have given us. Thank you.
Operator: [Operator Instructions] We will not take our next question from [Inaudible]. Please go ahead.
Unidentified Analyst: Good morning, thank you John how are you?
John Gormally: Hey, good morning to you. Thank you, Keith [ph].
Unidentified Analyst: Two questions; one would be what’s your quarterly revenue to achieve break even cash flow positive?
Gary Rauch: The annualized number is approximately $5.2 million. We’re – breaking that down by quarter would be what, about $1.4 million in that neighborhood, $1.6 million.
Unidentified Analyst: Is it fair to say the goal this year would be to achieve your cash flow break even positive?
John Gormally: Yeah Keith, this is John Gormally. I would just want to correct Gary. It’s been a lot of preparation for this whole year and its $6.2 million, so…
Unidentified Analyst: So its $2 million annual.
John Gormally: Yeah, that’s on an annualized basis. So it’s about $1.8 million to break even and you know ultimately that is our goal, there are no guarantees associated with that. We have a go-to-market strategic that the leadership team has put together for this year. Clearly as you get out of the gates, that’s your objective, that’s what you want to do. I just want to caution again that there are no guaranties due to unforeseen market conditions that may come up and we are – we have the plan and now we are working the plan to make that happen, and as things unfold on the performance goals that we had every quarter, I will make sure that everybody is updated and also Press Releases as well, you know giving people status updates on this objective. Thank you.
Unidentified Analyst: Great, next question. Congratulations on the Stago agreement. When will shipments being for that agreement and are there any quotas, max, mins associated with it and/or what are you expecting on an annual basis?
John Gormally: Yeah, so the answer to the first part of that question is, yes, there is a provision in the agreement where there is an initial stocking order and that will take place in the first – excuse me, in the second quarter of 2018. The contract as you know was signed in the last week of the first quarter of 2018. We had received their forecast – we are delighted with their forecast based on turning this product over to their very confident and capable sales organization and we have a proprietary you know confidential discussion with them. What we are disclosing to the markets, Stago as you know is a privately held company and at this point we are not disclosing what we believe the annual revenue from this are, but it is robust and very encouraging.
Unidentified Analyst: And I would assume then you’ll recognize revenue in Q2 from that agreement.
John Gormally: Absolutely, absolutely that is the plan.
Unidentified Analyst: Thank you. I’ll get back in line and keep going.
John Gormally: Thank you very much Keith.
Operator: We will now take our next question from Marc Robin from Catalyst Research. Please go ahead.
Marc Robin: Thank you for taking my call. Good morning gentlemen.
John Gormally: Hey Marc, how are you? Good to hear your voice.
Marc Robin: Yeah perfect, thank you. Help me out a little bit here with the breath based product that you have. With OxiChek and the alcohol detection, is there anything else that’s in there baked that I missed?
John Gormally: On a global perspective under MPC, which stands for Micro Partial Catalyzed Bio Sensor, there is the METRON product as well that is sold outside of the United States. What you have is the BreathScan; it’s the OxiChek cartage and the link reader and then METRON.
Marc Robin: Okay, and you include the Link Reader in that, okay.
John Gormally: Yes, yes Marc.
Marc Robin: Okay, thank you. And then additionally with the OxiChek we chatted about having a – I’m going to call it a – what is it, an MLM Multi Level Market, MLM yeah right. Now that would not be like your vitamin sales people. It would go more directly to the fitness clubs and so forth or am I wrong in that?
John Gormally: You’re partially correct. Well, I may even say you are more than partially correct, better put.
Marc Robin: It’s better to be generally correct than specifically wrong you know.
John Gormally: So, the network marketing or the multilevel market arena are the series of companies that are out promoting an antioxidant supplement. And what we are doing – yes, what we are doing is we are going to be used when successful, if successful, I don’t want to jinx myself by any stretch here or overstate our position. We are going to be working with targeted companies that would help them use our product as a sales tool to advance the sale of their antioxidant supplement. And we are laser focused on candidly working with identified targeted customers in this market segment and that is a major initiative, one our pillars of success here at Akers Bio.
Marc Robin: Have the discussions proceeded sufficiently that you are talking about pricing to the MLM network. And my real question is, are they beating the jeepers out of you on margin?
John Gormally: You know, I can’t unfortunately discuss anything related to the specifics because of the arrangements that we have. However, I would consider these conversations that we are having is extremely professional, very restricted and both parties view the other parties as strategic business partners. So it’s a symbiotic type of relationship and again, very, very, very professionally conducted.
Marc Robin: That’s a good sign. Alright, let’s turn towards the piece I hit then. What Blue Sky – tell me what the – what do you think the world demand could be or before you price a hit. I think we talked in the past about $60 million is at stake. Is that kind of the same size for Europe and possibly the same size for Asia or am I goofy on that?
John Gormally: No, I wouldn’t say you’re goofy by any stretch of imagination. I think what the $60 million market potential in the United States is definitely spot on. You know Western Europe is approximately half of that and the potential in the developed regions around the globe, this is where many companies run into challenges and they start putting unit volume down on targeted markets. You got to get into these markets and you got to meet, you got to understand what the unmet customer needs are. And as what we had in the developed regions around the world and trying to force fit that into those markets is where a lot of companies run into challenges. So here at Akers Bio we’ve taken a very strategic approach about sitting down with our partners outside the U.S. and working with them as a starting point with what we have. But listen intently with what they need to get the product; you know to take off in their served markets. So I’m not going to comment on what the potential is in China or India or our PIFA Heparin, or Heparin induced thrombocytopenia test. But I will tell you that we remain engaged with them and we are working strategically to help them get to the point where they are demonstrating profitable growth for Akers Bio.
Marc Robin: Okay and then lastly, let’s change direction just a little bit on your test for, I’m going to call it hear attacks, I can’t use the fancy language. That to me has complete tremendous potential as a triaging product. I guess my question is can you say anything about how trials will go to prove capability and performance of the device?
John Gormally: Yeah, well we anticipate obviously that this is a Class 2 medical device that would require FDA approval, 510(k) approval if you will. We have a very dynamic and rigid process that we use for product innovation, you know concept all the way to being able to commercialize it and to start recording revenue on the books here at Akers Bio, and that task is in the process that we use. I apologize Marc; off the top of my head, I don’t have the – we call it the pace calendar. I don’t have that in front of me. But that is slotted in the distant future for development. And what we are doing here in this process is that we are managing the cash very conservatively to make sure that it is great market potential and it is something that we can quickly capture you know a return on investment. 2017 was a year in which we had to make a lot of changes to strengthen the go-forward strategy for the company, and in doing so we had to make some challenging choices. Now that we are properly positioned with a healthy balance sheet, again we will continue to manage this cash extremely diligently and apply it in the areas that are laser focused and maybe not a sharp turn approach. You know, let’s get something adopted and build from there.
Marc Robin: Very good, I’ll let you go. Thanks so much for all your help.
John Gormally: Thank you, Marc.
Operator: We have time for one more question. [Operator Instructions]. We will now take our next question from Michael Clark [ph] a Private Investor. Please go ahead.
John Gormally: Michael?
Operator: Please go ahead.
Michael Clark: I’m sorry, I was on mute. I wanted to just talk about three, four months ago and very, very happy with my returns. A couple of things besides the new things that are coming out with the FDA approval; it’s all really exciting things. Has there been some kind of quiet period or something for anybody that did not make it inside of purchases and/or do you see the company upgrading anybody else’s compensation package until we get an updated approval or do the stocks appreciate so much that we can afford your new compensation package? I just want to get down. But we buy in open market and we are totally exposed with no information and I see whereas there are companies that upgrade themselves with a compensation package and that’s guaranteed no matter what the stock does. And I’m just wondering how will you understand that, and how you balance that and how you just make all your shareholders happy?
John Gormally: Yeah, that’s a challenging question there Michael. So right now, insiders here at Akers Bio, we have an insider trading policy that all of the leadership team and employees of the company are required to sign and we are at the blackout period. And that blackout period takes us through the middle of May; Gary just provided me with that data. So, that’s the first part of your question. And very genuine, honest, with the new board of directors and the leadership team here, you know we are on a mission and that mission was articulated in my discussion earlier this morning. We had people that are patriots to the organization. They are focused on the goals that are outlined in our 2018 go-to-market strategy and at this point in time the Board of Directors has made it very clear, and I sit on the Board, that we are looking for stabilization in the organization and that was the capital raise, the SI capital raise that took place back in December, making sure that we have enough working capital to initiate the strategies that we have a strong commitment on, and at some point in the future I suspect this will be brought up as a topic and we would do what was in the best interest of the shareholders and the companies and to reward those people that candidly are delivering on performance. We have a pay for performance monitor here at Akers Bio and we live by it. So hopefully that Michael…
Michael Clark: Yeah, I totally agree with that. And I’ve gone to – I’ve had my own business. When I stated up I lived on peanut butter and jelly sandwiches and crackers for a long time until I got to my business to where it was and I could reward myself and it’s a lot of bouncing around here, a lot of misinformation on what we are buying on, really innuendo and hopefulness for the future and I’m not saying it’s not fair, don’t get me wrong. What I’m saying – do you anticipate any new compensation packages before there is another major event that may cause the stock to go up to at least to get us well over $1 for 10 days.
John Gormally: You know I wish my – I’m not trying to be evasive here Michael. I wish my crystal ball was a little cleaner on that. I’m not aware of that thing at this point in time, so...
Ben Simons: Michael, its Ben here. And John I think we have been on the call now for about 40 minutes, so I think it’s probably time to wrap up. But I think you very much everyone who dialed in and if we haven’t got around to everybody’s question, I apologize, but I hope that the presentation and the Q&A session have covered all of the main areas. And the company will continue to keep shareholders updated through press releases and filings as usual and we look forward to speaking with you again for the Q1 earnings review call in the not too distant future. Thank you very much everyone.
John Gormally: Thank you.
Operator: This concludes today’s call. Thank you for your participation ladies and gentlemen. You may now disconnect.
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