Earnings Labs

Atossa Therapeutics, Inc. (ATOS)

Q3 2014 Earnings Call· Wed, Nov 12, 2014

$5.52

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Transcript

Operator

Operator

Good afternoon and welcome to the Atossa Genetics' Third Quarter 2014 Earnings Conference Call. All participants will be in listen-only mode. (Operator instructions) After today’s presentation, there will be an opportunity to ask questions. (Operator instructions) Please note this event is being recorded. I would now like to turn the conference over to Scott Gordon, President of CorProminence. Please go ahead, sir.

Scott Gordon

Management

Thank you, Laura, and thank you for joining today’s conference call to discuss Atossa Genetics’ corporate development and financial results for the third quarter ended September 30, 2014. With us today are Dr. Steven Quay, Chairman, CEO and President; and Mr. Kyle Guse, CFO and General Counsel. At 4:01 PM Eastern Time today, Atossa released financial results for the third quarter ended September 30, 2014. If you have not received Atossa’s earnings release, please visit www.atossagenetics.com. Before we begin, I would like to note that comments made during this call may include forward-looking statements regarding future events or the future financial performance of the company. Such statements are predictions only and actual events or results could differ materially from those made in any forward-looking statements due to a number of risks and uncertainties, including assumptions about the future events based on current expectations, plans, business development efforts, near and long-term objectives, regulatory actions, potential new business, strategies or organizational changes, changing markets, future business performance and outlook. Please see Atossa’s most recent filings with the SEC, including without limitations Form 10-K, 10-Q and 8-K. I will now turn the call over to Dr. Quay.

Steven Quay

Management

Thank you, Scott, and good afternoon. We are the breast health company. Our mission is to improve breast health to the development and commercialization of proprietary specimen collection devices, laboratory test and pharmaceutical treatments. Our laboratory tests are being developed and commercialized by our subsidiary the National Reference Lab for Breast Health or NRLBH. Before I provide an update on our products and services, kyle will summarize our third quarter financial results.

Kyle Guse

Management

Thank you, Dr. Quay, and good afternoon everybody. Revenue for the three and nine months ended September 30, 2014, totaled $3,000 and $37,000 consisting of additional cash collected in excess of the amounts we previously accrued at the Medicare rates. Total revenue for the three and nine months ended September 30, 2013, were $77,000 and $585,000. Cost of revenue was $0 for the three and nine months ended September 30, 2014, compared to $26,000 and $315,000 in the same periods in 2013. For the three and nine months ended September 30, 2014, gross profit totaled $3,000 and $37,000, compared to $51,000 and $271,000 in the same period in 2013. Total operating expenses for the three months ended September 30, 2014, were $3.2 million consisting of G&A expenses of $2 million, R&D expenses of $923,000 and selling expenses of $282,000 representing a decrease of $304,000 or 9% from $3.6 million in the same period in 2013, which consisted of G&A expenses of $2.9 million, R&D of $321,000 and selling expenses of $373,000. Operating expenses for the nine months ended September 30, 2014, were $8.9 million, consisting of G&A expenses of $3.6 million, pardon me, $6.3 million, R&D expenses of $1.9 million and selling expenses of $744,000. Operating expenses increased $583,000 or 7% from $8.3 million for the same period in 2013 which consisted of $6.6 million in G&A expense, $731,000 in R&D expense and $965,000 in selling expenses. G&A expenses decreased primarily as a result of lower capital raising expenses, lower recall expenses, lower consulting fees, lower advertising and marketing fees and lower bad debt expenses, which were offset by higher regulatory fees, higher legal fees, higher salaries and director fees and higher employee benefits. Our selling expenses decreased primarily as a result of our reduced sales and marketing efforts after…

Steven Quay

Management

Thank you, Kyle. I'll first talk about the businesses we are in and then I'll talk in more detail about our products and services, our business strategy and our near term milestones. Atossa Genetics is focused on breast health and more specifically developing and commercializing a suite of medical devices, laboratory tests and therapeutics, with the goal of improving breast health. As you know we own a clear certified laboratory called the National Reference Laboratory for Breast Health or NRLBH located here in Seattle, which is developing and providing the laboratory tests that we offer. Separate from our laboratory tests, we're also developing medical devices to collect specimens from the breast and we intend to develop pharmaceuticals to treat various breast health conditions, including the treatment of precancerous hyperplasia conditions. Ultimately, we plan for our devices and laboratory tests to be used as companion diagnostics to the pharmaceuticals that we intend to develop. So there are three distinct aspects to our business; medical devices, laboratory tests and pharmaceuticals, all targeted at breast health. I’d like to say a few words about each of these. The [receptor] [ph] laboratory test, the NRLBH has historically been focused on NAF cytology testing. In 2013, we were recognizing $600 on average per patient in insurance reimbursement for the NAF cytology testing performed in our laboratory. As you know, the laboratory in its state-of-the-art equipment and highly trained personal is a valuable tactical asset for Atossa, which is a critical part of our overall financial strategy. In this context, we are continuously evaluating new tests that could potentially be offered by the NRLBH, with the goal of complementing our other test under development and providing a positive financial contribution to our business. We've been seeing a strong demand for pharmacogenomic testing, which are genetic tests…

Operator

Operator

We will now begin the question-and-answer session. (Operator instructions) And our first question will come from Marc Steinberg of Dawson James Securities.

Marc Steinberg - Dawson James Securities

Analyst

Good afternoon. I just had actually two quick questions. The first one had to do with any kind of update or additional information that you can provide with regards to [Magellan] [ph] ThermoFisher Scientific with commercialization of either the ForeCYTE in Europe or the FullCYTE here in the U.S.?

Steven Quay

Management

Okay Marc, yes I thought two questions. Good afternoon. With respect to Magellan and ThermoFisher to key points, number one is those are U.S. partners and we do not currently believe we would use them for distribution purposes outside of the United States. And as has been the case for almost a year now, they remain our partners, they remain in the wings until we get clearance or ready to launch these products and we believe when we are ready with product in warehouses and ready to go, that we can re-approach them and establish a launch plan that will use their extensive distribution networks Magellan with respect to OB/GYN offices and ThermoFisher with respect to the hospital suites.

Marc Steinberg - Dawson James Securities

Analyst

And that would be anticipated Dr. Quay in the first quarter of 2015.

Steven Quay

Management

That is correct.

Marc Steinberg - Dawson James Securities

Analyst

Okay. Thank you. And just one last question, any kind of update with the inspection of the Seattle facility?

Steven Quay

Management

Yes, so a good question Marc, we appreciate that. we have continued to work with the FDA both in written communications and in face to face meetings to move the process along to clear our facility with respect to the observations made in the warning letter in February 2013. And we believe that in the next three to six months, we should be able to put a period at the end of the settings on that. We feel comfortable at this time saying that we think we've answered all of their questions and at this time, we don't have any outstanding issues with respect to the FDA and their inspection and observations at our facility.

Marc Steinberg - Dawson James Securities

Analyst

I see. Okay, well thank you. Thank you for the information.

Steven Quay

Management

Thanks Marc.

Operator

Operator

[Operator Instructions] And this concludes our question-and-answer session. I would like to turn the conference back over to Dr. Quay for any closing remarks.

Steven Quay

Management

Well thank you very much for your attention here this afternoon and your questions. In closing, we're very optimistic about the future of Atossa. The traction we're seeing with our new pharmacogenomic test looks very promising. We hope it will have a positive financial contribution to our business. We now have our CE Mark for foresight and are driving towards a Q1 launch in select EU countries. We're also planning to launch the FullCYTE aspirator in the first quarter of 2015 and we've been making significant progress towards commercializing our products and services and expect to achieve several important milestones as we finish the year and into the first part of 2015. We appreciate your patience and your continued support.

Operator

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.