Earnings Labs

Atossa Therapeutics, Inc. (ATOS)

Q2 2014 Earnings Call· Tue, Aug 12, 2014

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Transcript

Operator

Operator

Good afternoon and welcome to the Atossa Genetics Second Quarter 2014 Earnings Conference Call. All participants will be in a 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, Amy, and thank you everyone for joining today’s conference call to discuss Atossa Genetics’ corporate development and financial results for the second quarter ended June 30, 2014. With us today are Dr. Steven Quay, Chairman, CEO and President; and Mr. Guse, CFO and General Counsel. At 4:01 PM Eastern Time today, Atossa released financial results for the second quarter ended June 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 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. For those who may be new to Atossa Genetics and as a reminder to others, we are a healthcare company focused on improving breast health, through the development of laboratory developed tests, medical devices and therapeutics. Please note that our products and services are currently in the development stage and require regulatory clearance or approval prior to marketing and commercialization. I’d like to begin with a brief regulatory update. Many of you will recall that on December 23, 2013, we submitted a premarket 510(k) notification with the FDA seeking clearance of the ForeCYTE Breast Aspirator which includes the ForeCYTE breast pump and patient specimen collection kit. On February 28, 2014, we received questions about our submission from the FDA. We have until August 20 to submit a response to the FDA and so we will be announcing to you our submission within the next week. Once cleared by the FDA, we intend to relaunch the ForeCYTE Breast Aspirator to our own specialty sales force and through our existing distributors, including Fisher Healthcare and PSS McKesson. Subject to regulatory clearance, we hope to relaunch in the fourth quarter of this year. I’m pleased to report that we have now prepared the data and information necessary to respond to the FDA’s questions and we are on track to submitting this information and data to the FDA on or before the August 20 deadline. Because of the ongoing nature of the 510(k) process and our relationship with the FDA, we will not be discussing the content of our response today. Now I will turn the call over to Kyle Guse to discuss our second quarter 2014 financial results.

Kyle Guse

Management

Thank you, Dr. Quay, and good afternoon everybody. Revenue for the three and six months ended June 30, 2014 totaled $10,000 and $34,000 respectively consisting of additional cash collected in excess of the Medicare amounts we previously accrued at the Medicare rates. Total revenue for the three and six months ended June 30, 2013 was $326,000 and $509,000. Cost of revenue was $0 for the three and six months ended June 20, 2014 compared to $222,000 and $289,000 in the same periods in 2013. Because the recall of our lead device commenced on October of 2013, we have recognized virtually no cost of revenue during the six months ended June 30, 2014. For the three and six months ended June 30, 2014, gross profit totaled $10,000 and $34,000. This compares to $104,000 and $220,000 in the same periods in 2013. Total operating expenses for the three months ended June 30, 2014 were $3.2 million consisting of G&A expenses of $2.5 million, R&D expenses of $511,000 and selling expenses of $223,000. This represents an increase of $509,000 or 19% from the $2.7 million in the same period in 2013 which consisted of G&A expenses of $2.2 million, R&D expenses of $190,000 and selling expenses of $319,000. Operating expenses for the six months ended June 30, 2014 were $5.6 million, consisting of G&A expenses of $4.2 million, R&D expenses of $933,000 and selling expenses of $461,000. Operating expenses increased $887,000 or 19% from $4.7 million for the same period in 2013 which consisted of $3.7 million in G&A, $410,000 in R&D and $592,000 in selling expenses. Now we expect that our G&A and selling expenses will continue to increase in the foreseeable future. And if we successfully relaunch the ForeCYTE Breast Aspirator and also begin to market our laboratory tests, we would…

Steven Quay

Management

For those of you who are new to Atossa and as a brief reminder to everyone else, let me first talk about the business we’re in then I’ll talk in more detail about our products and services. Atossa Genetics is focused entirely on breast health. We own a CLIA-certified laboratory, the National Reference Laboratory for Breast Health or NRLBH which is located here in Seattle, Washington, which is developing a suite of laboratory tests to address each point in the breast healthcare pathway. Each of which represents a significant market opportunity. Separate from our laboratory tests, we are also developing medical devices to collect specimens from the breast and we are developing pharmaceuticals to treat various breast health 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. And I’d like to say a few words about each of these. Our leading laboratory test developed by the NRLBH is the nipple aspirate fluid cytology test. Our laboratory has historically tested NAF samples collected with our ForeCYTE Breast Aspirator and with a NAF collection device marketed by another company. In 2013, we were recognizing $600 an average per patient in insurance reimbursement for the NAF cytology testing performed at our laboratory. Our laboratory is also developing a NAF cytology test to study NAF collected through a ductal lavage process. This test is being developed for women who are identified by their physician as being at high risk for breast cancer. The specimens for this test are collected by a surgeon using microcatheters including our own patented microcatheters which are designed to collect NAF specimens from individual…

Operator

Operator

(Operator instructions) Our first question comes from Marc Steinberg of Dawson James Securities. Marc Steinberg – Dawson James Securities: Good afternoon. My question is that when you realized back in February that information needed to be submitted to the FDA and realizing that without the FDA clearance the company could not relaunch the ForeCYTE product. My question is why is it that the company has chosen to wait literally close to or on the very last day required by the FDA to resubmit to the FDA or to them back the information they requested?

Steven Quay

Management

Hi, Marc. Thanks for your question. We intend – we always intended to file them as quickly as possible. The amount of information we’re providing is very extensive. I haven’t seen the final pile of papers and compared it to the original filing. But they’re probably comparable in size, Marc. So rest assured that we’ve been working diligently since February on this submission process. Marc Steinberg – Dawson James Securities: Okay. And the company – just to be clear, the company anticipates that they will be submitting before or on the 20th of August?

Steven Quay

Management

Yes. That’s absolutely assured. We will be filing on or before the 20th of August. Marc Steinberg – Dawson James Securities: Okay. And if I understand correctly, how long does the FDA barring no additional questions, have to make a decision with regards to clearance?

Steven Quay

Management

Yes. We believe they have roughly 30 days from the date that we submit it to make their final decision. And as you’ve sort of alluded to in your question, they do have the opportunity to ask us small questions which we can answer rapidly or if I guess if they ask a substantial question, they would stop the clock and have the remaining days that they have. Those I think are the two options. Marc Steinberg – Dawson James Securities: Okay, thank you.

Steven Quay

Management

Thank you, Marc.

Operator

Operator

(Operator instructions) 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

Yes, in closing, I’d just like to reiterate that we continue to remain extremely optimistic about the future opportunities here at Atossa. We are developing and intend to commercialize laboratory tests, medical devices and pharmaceutical therapies which will significantly improve beast health. Each of our test addresses large market opportunities and could result in significant revenue streams over the coming years. We have been working extremely hard to gain FDA clearance of the ForeCYTE Breast Aspirator and we look to relaunch this product in the last quarter of this year. In addition, we’re moving as expeditiously as possible to complete validation testing and gain regulatory clearance for our other tests. Finally, we continue to manage our expenses and we have access to additional capital at our discretion through our arrangement with Aspire Capital should we choose to bring additional cash into the company. We appreciate your patience and continued support and we look forward to reporting a number of key milestones this year.

Operator

Operator

The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.