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Edesa Biotech, Inc. (EDSA)

Q4 2015 Earnings Call· Fri, Dec 18, 2015

$14.32

+28.20%

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Transcript

Operator

Operator

Good day, ladies and gentlemen. Thank you for standing by. Welcome to the Stellar Biotechnologies Year-end 2015 Corporate Update Conference Call and Webcast. This conference is being recorded today, Tuesday, December 15, 2015. During today's call all parties will be in a listen-only mode. Following the presentation the conference will be open for questions. [Operator Instructions] I would now like to turn the conference over to Mark McPartland, Vice President of Corporate Development at Stellar Biotechnologies. Please go ahead, sir.

Mark McPartland

Analyst

Thank you, operator and good day everyone. We'd like to thank you for joining us today for Stellar Biotechnologies' year-end 2015 corporate update conference call and webcast and our first call as a NASDAQ listed company. Joining me on the call today from Stellar Biotechnologies' senior management team are Mr. Frank Oakes, our CEO and President; Ms. Kathi Niffenegger, our Chief Financial Officer; and Dr. Catherine Brisson, our Chief Operating Officer. Mr. Oakes will provide update on Stellar operations, review our recent achievements, growth opportunities and Ms. Niffenegger will review our consolidated financial results. After the formal presentation, we will be available for answer your questions from the dial-in callers and as the operator has already indicated from the webcast participants as well. I would also like to note that in addition to our press release issued yesterday afternoon, our 10-K annual report for the period ending September 30, 2015, was also filed and is available through the U.S. SEC filing system on EDGAR and the Canadian SEDAR filing system. All documents are also available under the investors section of our website at stellarbiotech.com. Now before I begin, I would like to remind our listeners that today's conference call may include forward-looking statement based on current expectations. Such statements, other than purely historical factual information, including statements relating to revenues or profits or the Company's future plans and objectives or expected sales, cash flows, and capital expenditures constitute forward-looking statements. Forward-looking statements are based on numerous assumptions and subject to all the risks and uncertainties inherent in, among other things, the Company's availability of funds and resources to pursue research and development projects, the successful and timely completion of preclinical or clinical studies by third parties in which the Company's products are utilized, the degree of market acceptance for the…

Frank Oakes

Analyst

Thank you, Mark, and good day, everyone. Thank you for joining us here today for the Stellar Biotechnologies 2015 year-end corporate update conference call. I want to start with a brief reminder of Stellar's business and our industry position. Stellar is the leader in the sustainable manufacture of Keyhole Limpet Hemocyanin or KLH. KLH as many of you know is an important immune-stimulating molecule used in wide-ranging therapeutic and diagnostic markets. KLH is both an active pharmaceutical ingredient in many new immunotherapies and development as well as a finished product for measuring immune status. We are positioning Stellar to be the leading company supplying the long-term demand for KLH in the immunotherapy field. We began fiscal 2015 with a specific objective of strengthening and expanding our core KLH business. I am pleased to report on the strong progress we made and to recap highlights from what we believe has been a very successful year for Stellar Biotechnologies. On November 5th, Stellar's common shares began trading on the NASDAQ capital market under the symbol SBOT. NASDAQ up-listing is a testimony not only to our growth and maturation as a public company but also to the hard work of Stellar's team and our commitment to supporting shareholder value. We believe that the NASDAQ listing offers a number of advantages, including broader visibility to the investment community and the potential for increased shareholder liquidity. In addition to NASDAQ listing, Stellar's common shares will continue to trade on the TSX Venture Exchange in Canada. I am pleased to point out that revenue for fiscal 2015 increased by over 100% from the prior year. This growth was driven primarily by increase in production, sales associated with core customers, greater volume, sales under supply agreements, and the promising advancement of clinical trials conducted by our customers.…

Kathi Niffenegger

Analyst

Thank you, Frank, and thank you, everyone, for joining us on the call today. I will be discussing our fiscal year-end September 30, 2015, financial information. We generated revenue of $759,000 for the fiscal year ended September 30, 2015, an increase of 104% compared to $372,000 for fiscal 2014. The increase in revenue resulted from an increase in the number of customers and associated increase in sales volume, including sales under supply agreements and custom manufactured products. Our expenses for fiscal 2015 decreased to $5.1 million, as compared to $6.1 million incurred in fiscal ‘14. Cost of sales and contract services increased to $581,000 for fiscal 2015, as compared to $469,000 for the prior year, consistent with the increased sales and contract services revenue. We reclassified aquaculture costs to present them separately from cost of sales and contract services since those operating costs are incurred regardless of sales levels. We also began recording inventory on our balance sheet for the first time beginning September 2014, and continuing in fiscal 2015. Due to the early stage of our development in fiscal 2014, all manufacturing costs of production were expensed during that year, increasing the cost of sales and contract services relative to revenue. There were no grant expenses for fiscal 2015, as compared to 37,000 in the prior year due to the closeout of our NSF Phase II/IIb grants in November 2013. Research and development expense was 1.1 million for fiscal 2015, as compared to 2.5 million for fiscal 2014. The decrease was the result of our planned decreased use contract research organization due to a realignment of our focus from internal research and process development to manufacturing our Stellar KLH products in response to increased customer demand. General and administrative expenses increased to 3.2 million for fiscal 2015, as compared…

Frank Oakes

Analyst

Thank you, Kathi. I would like to just reiterate key points of our presentation. Growth in revenues continued in 2015, we increased KLH sales, and our business development efforts continued to bring in new customers. Our transition in 2015 to a fully reporting US domestic issuer culminated in the uplist to the NASDAQ capital market, a move that we think was important for our shareholders, both for broader outreach and improved liquidity. Our cash position remains strong and we see an excellent opportunity for Company growth in the year to come. I am very excited by the prospects for Stellar Biotechnologies and want to thank our employees, partners, and shareholders for your part in successful 2015.

Mark McPartland

Analyst

Operator, this concludes our formal comments at this time and we would like to open up the call for questions, if you would start the Q&A portion of the call, please.

Operator

Operator

Thank you, Mark. We will now begin the question-and-answer session. [Operator Instructions] And we will take our first question from Jason McCarthy with Maxim Group.

Jason McCarthy

Analyst

It sounds like you guys had a very good year, the up listing to the NASDAQ and sales are growing, just a couple of questions. Can you give us a sense for 2016, what KLH sales could look like, maybe some guidance on grams that you are thinking for the next year? And could you give us a sense of what the consumption rate is for a company like Neovacs who are -- they are in a Phase IIb and they are going to initiate several other studies in the coming months. How much KLH do you consume at the Phase II level? And then, maybe what a company like that in lupus consume in a Phase III?

Frank Oakes

Analyst

As a public company, we can't speculate on future events, in particular those things that are under the control of our partners, like Neovacs. I think you can look to Neovacs, I know that they have given indications through press releases of the expanding -- their expanding Phase IIb lupus trial. And I do know that they have forecasts of their own for the demands. Those are proprietary, but there are two indicators as to why we're confident in our core KLH business and the potential for fast growth. One is that our sales growth reflects really the increasing demand of KLH as companies advance their clinical trials, companies like our partner Araclon as well as Neovacs. Also, if you look at the pipeline of companies with KLH based immunotherapies in clinical trials and then imagine how many more there may be in preclinical stages, you'll see that the reason that we are excited about the prospect for growing demand. And I think for indications of specific requirements of companies like Neovacs, I think you would have to look to their press releases to get public information with regard to what each one of those trials would require.

Jason McCarthy

Analyst

And I just want to shift gears. A week or two ago, you had data or an announcement of a poster presentation of a KLH therapeutic vaccine for C. diff which I thought was great data. It was really interesting. And I am curious if -- indications in infectious diseases, these in-house therapeutic vaccines, if you would, is something that Stellar is going to continue to pursue and can we look forward to more preclinical then ultimately clinical data in these other indications, aside from being a KLH supplier to other vaccine companies?

Frank Oakes

Analyst

We think that the data from our investment in developing the C. diff immunotherapy is a positive indicator both of the value of that asset and we are in discussions that could result in partnering relationships to further advance that asset. It's also a great indication of the strength that Stellar has in its R&D program to identify preclinical assets, incorporate KLH into an immunotherapy using those targets for specific disease indications and we think that we will continue to work in that to identify potential drug candidates and partners to help advance those drug candidates into clinical development.

Mark McPartland

Analyst

Operator, with that, now I am going to take one of our calls from the -- or one of our questions from the webcast participants. And the question is with regard to our expansion in Mexico. Under your current expansion plans in Mexico, can you give us any more detail why this is relevant? And Frank, would you take that question?

Frank Oakes

Analyst

Yes, that's a good question. It was, we think, one of the highlights of 2015. As I hope our investors and stakeholders can appreciate, Stellar has advanced its technology for aquaculture production of the source animal. In Ventura County, California, we've developed a state-of-the-art aquaculture facility but there is always inherent risk in being single-site dependent. So both for long-term growth strategy, as well as site redundancy, we think it was critical to acquire a second facility. We are going to go methodically through a two to three year feasibility assessment at that site before we make substantial capital commitments to actually build out commercial scale production facilities, and we hope that site would be available and could be developed coincident with commercial launch of one or more of our partners' drug products so that we can assure both scalability and site security with two production sites. So we think it's a critical asset and a third point from a competitive strategy, we think we have spent a lot of time looking for an appropriate second site. We think this is one of the best sites that we have seen along the coast of North America, and we think having control of that site clearly gives us competitive advantage because it's not available to a competitor. So, we think both for offensive and defensive strategy, we think it was an excellent move both for our shareholders, as well as for our customers.

Mark McPartland

Analyst

And then as a follow-up to that, there was an additional. How challenging is the environment in Mexico regarding the government acceptance?

Frank Oakes

Analyst

Obviously, working in a foreign jurisdiction, there are always cross-border issues, but at this site in Baja California, our partner, Ostiones Guerrero, has great relationship with the local municipalities and officials, and we have cultivated our own relationships with individuals, such as the Mexican National Secretary of Fisheries and Aquaculture and the regional aquaculture director, to build out very strong political alliances, as well as commercial alliances, to ensure that we can grow in an expeditious manner and have all of the support both, as I said, both commercial and political support to develop this site, and I think there is a great deal of enthusiasm amongst the partners and stakeholders in Baja California to see biotechnology assets developed in that region. So, we think the climate is excellent and political relationships are well established.

Mark McPartland

Analyst

With that, Operator, we would like to turn the call back to live call-in participants, if you would start to poll for questions again?

Operator

Operator

[Operator Instructions] And we’ll take our next question from Brian Marckx with Zacks Investment Research.

Brian Marckx

Analyst · Zacks Investment Research.

Good afternoon, guys, and congratulations on all the great progress. The 10-K notes Axon Neurosciences contributed, I believe it was, 16% of revenue for the year. Does that relate to their Phase I study for their Alzheimer's candidate?

Frank Oakes

Analyst · Zacks Investment Research.

Mark, thanks. I am glad to see that people are reading our 10-K in detail. But yes, Axon was a significant contributor to the growth in Stellar's revenue. And although I can't speak specifically to that relationship, as you can appreciate, many of our commercial relationships are under NDA, but I can point you to Axon's news with regard to what they thought were very promising results from a Phase I clinical trial and the announcement that they intend to pursue their tau protein target for Alzheimer's disease in a Phase II trial that they expect to launch in 2016, and I would think that acquisition of KLH would be more forward thinking toward a Phase II trial, rather than a Phase I trial that has already been completed.

Brian Marckx

Analyst · Zacks Investment Research.

Okay, okay, that's great. Thanks, Frank. That's all I had.

Frank Oakes

Analyst · Zacks Investment Research.

Okay, great, and we appreciate the comments.

Mark McPartland

Analyst · Zacks Investment Research.

Operator, with that, I'm going to take a couple more questions from our webcast participants and we're coming up on the cut-off time we had originally scheduled for the call. But we will take a couple more questions from the webcast participants and then transition from there. So, the next question relates to our margins and looking for some more clarity on our margins. So with that, I am going to pass that to Kathi to address that specific regarding our margins.

Kathi Niffenegger

Analyst · Zacks Investment Research.

Okay. Thank you for that question. I appreciate the opportunity to explain it a little bit more, because I am asked that fairly regularly, looking back at our comparative financial statements. And I mentioned that in 2014 and prior, we certainly have had sales at that point, but we had not had the level and consistency of sales of particular products that, under accounting rules, we would be able to support the assurance of recoverability in the future. So we did not put inventory onto our balance sheet. That means that as we had production, all those costs flowed to cost of sales and contract services, whether or not the products had been sold. And so, it actually would look like a negative margin. I think now in the fiscal 2015 where we are recording inventory on our books, that is a much better assessment of -- you can see the sales and the cost of sales, so that's a better assessment of our margin. Of course, it will vary with the product mix, but you can definitely see that there is positive margin at that point in time and hopefully that explains that for people.

Mark McPartland

Analyst · Zacks Investment Research.

That's great. Yes, I think that covers that. That is very good. So we will take one final question from the webcast participants and this should wrap the call for this time. But the next question is, when will companies that you are working with have positive inflection points and when should we expect such future announcements?

Frank Oakes

Analyst · Zacks Investment Research.

Thank you, Mark. This is Frank and I will take that question. Of course, as I said earlier, we can't speak for other companies, of course, and we can't speculate on future events, but the indicators that we believe are important are these. First, look at the agreements that we have in place now -- long-term contracts, clinical-stage companies in a variety of serious diseases. These show our ability to convert customer inquiries into partnerships. Second, our sales are increasing, which points to growing demand for Stellar KLH. And lastly, look at the pipeline of dozens of KLH-based immunotherapies in clinical trials. All of these will need a reliable, scalable source of GMP-grade KLH. We see this as virtually untapped market potential and we are positioning to be the Company that supplies that market through our own manufacturing capabilities, our site expansion, and growing relationships and alliances with customers. So we think all of these things are great indicators of the future potential for Stellar and its KLH products.

Mark McPartland

Analyst · Zacks Investment Research.

Thank you, Frank. With that, Frank, I would like to just turn it back to you for closing comments, and then the operator, you can take us from there.

A - Frank Oakes

Analyst · Zacks Investment Research.

Okay. Thank you, Operator. Once again, I would like to thank all our shareholders and key stakeholders who have participated in today's conference call. If you have any additional questions, please feel free to contact either Mark McPartland or myself. Thank you for your continued support and interest in Stellar Biotechnologies over the last year, and we look forward with great excitement to providing future updates on Stellar's progress. Operator?