Q3 2019 Earnings Call
For 19, Investor and Analyst update conference call.
As a reminder, this conference call is being recorded I'd now like to turn the conference over to your host Brian .
Pokes, both senior Vice President and Chief Financial Officer. Please go ahead.
Thank you operator, and good afternoon, everyone welcome to post bio Sciences quarterly investor and analyst optical.
Joining me on the call today, or Devin you girls or President and Chief Executive Officer, and it ever our executive Vice President and general manager of Dermatology.
Our comments and responsible to your questions. During today's call reflect management's views as of today November seven 2019, only and will include forward looking statements. These include statements regarding our plans and expectations relating to regulatory clearance, including the processing and expected outcomes or commercial operational.
Scientific and clinical and financial projections.
The next including the USIS and applications of such products and other future events.
Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are described in detail in her most recent Form 10-Q filed with the FCC or FCC filings can be found through our website or at the Fccs website <unk>.
Investors are cautioned not to place undue reliance on forward looking statements.
Please note that this conference call will be available for audio replay on our website that pulls bio sciences dot com on the news and events section on our Investor Relations page.
In addition to press release was covering today's announced CFO transition and operational highlights and financial results for the third quarter ended September 30 had been posted on <unk> and are available on our website.
The format of today's call will consist of providing highlights of the third quarter 2019, followed by a question answer session with that I'd now like to turn the call over <unk>, President and Chief Executive Officer during your.
Thanks, Brian Good afternoon, everyone and thank you for taking time to join us on today's call.
Are driving focus it pull style sciences remains the near term commercialization of our proprietary sell effect system.
Sadek dermatology in pursuit of our mission to build a viable company that makes a meaningful difference for the betterment of patients and clinicians.
Today, I'll start with some important updates, including an update on our regulatory progress with <unk> and a change to our management team announced in the press release earlier today before turning the call over to add to update on our dermatology business, including recent presentations at the American Society of Dermatologic Surgeons annual scientific meeting in Chicago I'll then provide.
The additional updates on our clinical programs before turning the call over to Brian for financial update.
Turning first to our regulatory process as we have discussed previously necessary to commercializing or sell the tech system in the United States is obtaining clearance from the U.S. food and drug administration.
On our Q2 Investor call in August we communicated our plans to file formal responses to the April 30th FDIC additional information letter by the end of the third quarter unexpected resolution of the five 10-K submission in quarter four.
As planned we provided an FDA without a formal responses on September 23rd.
He reviewed those responses and an early October requested further clarification. The two additional questions related to our clinical data.
We provided responses to those questions three days after receiving them and had a follow up teleconference with FDIC to discuss those responses.
After the teleconference. We mutually agreed with FDA to put the review on a temporary hold to allow sufficient time for F. D. H a properly review these remaining responses in time for us to work with S.P.A. on completing the review process.
We continue to have regular and highly collaborative communication with the FDA and at this time are waiting for feedback on our recent responses. We continue to believe that there will be resolution to this five drinking submission by the end of the year and we're planning for a five 10-K clearance.
As a reminder, the originally I letter at 23 questions regarding the technology preclinical and clinical data, we provided or sell effects system is a new product candidate F.D.A. is doing a thorough job review in the technology and the clinical data and at this point. We believe there are two questions remaining that's a big considerable progress in key.
Aberration with the agency.
We will provide further updates on the process as appropriate.
Today, We also announced the appointment of Sandra Garden, as Paulsboro Sciences, Executive Vice President and Chief Financial Officer effective November 18th.
We're thrilled to have see any joined the pulse biocides his team at such pivotal time for the company.
She has over 30 years of experience in the life science industry with 20 years, specifically in the medical device field across multiple market segments.
Prior to pull style Sciences said he served as executive Vice President and Chief Financial Officer acute Terra publicly traded medical device company and global provider of laser light and other energy based aesthetic systems.
Prior to that Sandy served as vice President and Chief Financial Officer of tree of beauty medical device manufacturer of laser based aesthetic devices.
Prior to these rolled she held a series of Vice President and Chief Financial Officer positions with both publicly traded and privately held companies Sandy earned her being management economics from the University of California at Davis.
She brings a wealth of experience and expertise in the aesthetic procedure market at a global scale as test by a sciences prepares for commercialization pending enough gave regulatory clearance Sandy will play a key role in helping the company grow injury viable global commercial company.
I look forward you're in introducing all of you to sandy in the near future.
Brian Dal, our Chief Financial Officer over the last four years has resigned effective November 18, 29 team that has agreed to stay with the company in a transitional through December 31 2019.
Myself the board of directors and the management team impulse buys sciences have the utmost respect for Brian and what he has brought to you. This company during his tenure.
I personally want to thank Brian for everything is done to help us get to where we are today and wish him the best in his future endeavors.
You will hear from Brian and a few minutes first endeavors will provide an update on our dermatology activities, including scientific presentations at the recent STS annual meeting.
Thanks, Sarah and good afternoon, everyone I'm pleased to report that our MPS technology in the pulse Biothrax team continued to build a growing foundation from clinical and scientific acceptance and advocacy with a top clinicians and researchers in dermatology many of whom are among the 6100 numbers like American Society of.
Before I think surgery or F B S.
Our ongoing investment working closely with leading dermatology opinion leaders in conducting top quality clinical research and multiple high volume applications in dermatology is increasing our visibility credibility and potential anesthetic dermatology post has earned the owner of increased pulling the exposure by virtue of.
Our growing body <unk> personal clinical results and our unique MPS technology mechanism of action.
All of which were showcased at last month HST, Yes annual scientific meeting.
A meeting wasn't importantly, and successful on several fronts. First this meeting is one of the premier scientific meetings in all of dermatology, drawing key opinion leaders and conditions from around the world that specialize in complex surgical and new aesthetic procedures.
Secondly, I am pleased to report that arc NPS clinical data enjoyed marquee exposure in a number of formal scientific podium presentations by established leaders they ask us.
With that exposure comes a general awareness among top opinion leaders that are NPS technology and unique nom thermal mechanism a broad potential to be used across a wide variety of common skin problems that cannot be easily treated with current technologies and techniques.
Finally, the expanding scientific presentations led to a high volume of unsolicited request for participation in our future clinical trials and discussions of scientific research for new applications.
These physician request for Apollo affirmations that our multiple applications strategy.
Okay, well pulled him and advocacy has generated a broad appeal to a premier positions from all over the world. We're beginning to notice and appreciate the pulse the setting the stage for game changing technology that has global importance to the field of dermatology into their patients.
During the Sps meeting the fitness exposure for MPS took place in a plenary session in the main hall led by Pulse Scientific Advisory Board member and clinical investigator Dr. Thomas War was also a past president of the here, yes, yes.
Dr work because of the talk titled emerging therapies, and Dermatologic surgery and featured our proprietary none of poll stimulation technology covering the bio physics of the technology and a broad range of this potential applications in dermatology, both currently being investigated and future possible applications.
Dr weren't articulated the unique mechanism of action that distinguishes NPS from other thermal modalities and backed up those differences by starting results from clinical studies as examples of how some non thermal targeting a specific cellular lesions and structures Walt spring the surrounding nonsolar structure.
Can be broadly applied to lesions commonly encountered in dermatology.
Dr will share his positive experience when the MPS technology, along with data and photographs from recently completed clinical studies.
Session was very well received and led to multiple post presentation discussions with attendees.
Another important talk was delivered by Dr. Gilly Mona Valley, who is also one of our scientific Advisory Board members and a lead clinical investigators for several of our studies.
Because well attended presentation entitled a multicenter pivotal study using the now poll stimulation procedure to agree to treat sebaceous hyperplasia lesions provided long term follow up data on our initial passage study and interim data from a more recent dosing study evaluating the use of lower energy levels.
The long term follow up over initially I think studies show that the higher degree of efficacy in our original starting at two months was a durable out to at least a 12 month follow up time point.
This is obviously important data to physicians and patients were seeking long term clearance of the solutions.
[noise] stuck in little by Little Belly also presented interim data of a more recent message study using lower inventory levels.
This study has enrolled 66 patients with 330 SH lesions.
Based on the interim data Dr. Morbelli decided early efficacy results on 243 treated regions with an efficacy range of 86% to 96% of treated lesions readers as clear for most declare 60 days after the final MPS treatment.
Dr Little though it concluded his presentation by knowing that the excellent safety results.
Oh were accompanied by efficacy and significant improvements in recovery time can post.
Treatment skin pigment, especially in patients with sensitive for darker pigmented skin.
Another scientific abstracts submitted by lead clinical investigator Dr., Vic Ross and accepted for publication and presentation can the podium and whats entitled first clinical use of non thermal medical stimulation technology for treating cutaneous non general works.
Standing in for Dr., Ross the podium Dr. I'm Gonna Valley, a co investigator for this initial feasibility study presented the results.
From both our recently completed feasibility study and early data from our ongoing pivotal works study.
In the feasibility study he highlighted the 61% efficacy, which resulted in rapid and complete tissue recovery in the cleared works.
He noted that the positive what results in these very difficult to treat werent populations in the piece of this feasibility study was impressive.
Which led to our decision to conduct a larger pivotal study, which early results are now available.
At the time of the presentation 33 patients had been enrolled in this pivotal worked study with an enrollment goal of 60 patients.
Just 30 days after one NPS procedure, 36% of accrued works were cleared with over 50% of appeared works reduced by greater than 50%.
Dr. One of only completed just talk by pulling up that's the study protocol provides for additional optional MPS treatments have 30, 60 90 days later, but that multiple treatment cohort data is not yet available.
We remain excited by this early data and look forward to sharing updates as more data becomes available.
Finally, clinical investigator Dr. Mark Nustar presented.
Usability studies for the treatment of moderate to severe active on Paris of the back using nipples stimulation energy.
Dr Industry discussed early results from our ongoing active clinical study, noting that you have observed both a rapid and persistent reduction in back acting lesions compared to untreated control area lesions with the first two patients recruited.
Data was presented showing an 80% reduction and acting lesion counts when compared to baseline lesion counts that just 30 days post treatment, which significantly improved to 87.5 production projected production over baseline by 60 days post treatment.
He concluded by noting that the study was ongoing.
That reduced MPS energy levels are being evaluated for potential political modifications and our could be included in a larger study.
Beyond podium presentations at the STS meeting we have recently had multiple peer reviewed papers outlining our technology published or accepted for publication in the prestigious journal of Dermatologic surgery.
The first paper titled Safety and efficacy of Nanosecond poster luck feel treatment of sebaceous glands hyperplasia was submitted by lead author Dr. Gilly Little Valley and has been accepted and recently published online prior to its a parents in the official journal of the ask yes next month.
This pure newspaper offline to result findings and observations from our clinical studies evaluating the safety and efficacy of MPS for the treatment of sebaceous hyperplasia, showing an impressive efficacy rate for this difficult to treat but very common patient lesion.
We anticipate the publication of another paper entitled Safety and efficacy of nano second post electrical field treatment of separate care ptosis.
Submitted by the lead author Dr. George Who's out. This paper has been accepted for publication in the STS Journal and will be published in the near future.
This paper.
As a result findings and observations from our original clinical study of SK evaluating the safety and efficacy in Heaven, yes for the treatment of S. case, a very common vision Dr. roosa. The principal investigator for this study is the current president of American Academy of Dermatology, the largest professional society of dermatology.
In the world.
Again, both of these peer reviewed papers have been accepted for publication in the prestigious journal of Dermatologic surgery, and each demonstrates the growing foundation of scientific acceptance for our technology and multiple clinical applications by clinical opinion leaders and dermatology specialist.
Ross the interest of our target clinicians to these important peer reviewed medical journals.
As I have shared with you in the past our ongoing strategy for introducing and expanding the potential of our Celtic system and are not now post stimulation platform includes securing the affirmative support from Carol wells at the podium and in these peer reviewed publications providing sound.
Scientific evidence for the multiple applications in indications we are studying.
The growing level of interest in our NPS technology is partly based on the portfolio clinical applications that we're pursuing today, but also based on the underlying science and mechanism of our MPS technology, which both bode well for future applications that fit our unique nonthermal solve specific mechanism.
The communication of this important future value is a testimony to our clinical partners weapon instrumental in helping us develop and clinically demonstrate the advantages and opportunities of MPS in the clinic.
And then in forming and educating their peers to podium presentations and medical publications.
We'll continue to grow our foundation of key opinion leader acceptance and advocacy as we pursue a clearance from the F.D.A.
I will now turn the call back to there.
Thanks, Ed I will now provide a brief update on our clinical application pipeline.
First as we reported in the Q2 Investor update call. We initiated our investigational awards pivotal study earlier this year in non genital cutaneous warts Ed provided some additional information on that study and that we're pleased with how it is progressing we continue to believe this study will be completely enrolled by the end of the year.
Words represent a very difficult lesion for dermatologists to treat and we continued to be optimistic about the opportunity to treat the many patients physicians see with these words.
We also continue to move forward with our macular SK application. We currently have over 40 patients enrolled toward our goal of 50 patients and anticipate completing enrollment in this study by the end the year.
As we've communicated in the past we also have a number of feasibility studies going on at the current time, including an back acne as you heard from Ed describing Dr. nesters presentation at the Sds tattoo removal and basal cell carcinoma.
We have nothing to report with regard to these feasibility studies at this time, except to say that they are progressing on schedule and we will provide updates as data dictates.
I will now turn the call over to Brian to discuss our financial results from the third quarter.
Thanks Darren.
Shortly before todays call, we announced the financial results for our third quarter ended September 32019.
Our financial results for the quarter reflect the progress achieved in our development and clinical programs accompanied by the requisite support infrastructure for those endeavor.
Cash and investments at the end of the third quarter totaled $34.5 million compared to $42.6 million at the ended the second quarter and $52.8 million at the end of the first quarter, reflecting third quarter cash use of $8.1 billion compared to 10.2 million.
Dollars for the second quarter of 2019.
Net cash used year to date totaled $25 million.
A reminder, our cash used during the second quarter was elevated as we incurred $2 million of cash use relating to the annual renewal of our corporate insurance policies for the 2019 2020 policies.
The expense associated with the Q2 policy renewals are being recognized over the next several quarters.
Excluding the timing associated with our insurance renewals cash use was comparable on a quarter over quarter basis.
Net loss for the quarter totaled $11.7 million, reflecting a 1 million dollar or 9% increase compared to the net loss of $10.8 million for the third quarter of 2018.
Net losses for the quarter include charges for non cash stock based compensation totaling $2.7 million and $3.4 million for the third quarters of 2019 and 2018, respectively.
The increase in net loss during the quarter represents research and development expenses, which increased to $6.2 million for the third quarter of 2019, an increase of $1.2 million were 30% compared to the $5 million for the third quarter 2018.
A significant portion of the increase reported reflects the increase in R&D personnel and development work related to our cell effects system.
R&D headcount increased to 52 as of September 32019 from 36 at September 32018.
Also contributing to increased R&D expenses and consistent with my comments last quarter, our increases in engineering and prototyping expenses reflect into the design development and manufacturer and deployment of our teleflex systems to our clinical study sites.
Late stage prototypes and acquisition of inventory components in preparation for commercial launch.
Ongoing clinical studies and support expenses relating to the increase in breadth of R&D.
We expect that R&D expenses will continue at approximately the current levels for the remainder of 2019 as we continue to focus on refinements to our fellow Opex system and preparation for planned commercial introduction, our current clinical studies and feasibility work our future applications.
Turning now to general and administrative expenses GNS expenses remain consistent year over year totaling $5.6 million for the third quarter of 2019 compared to $5.7 million reported for the same quarter last year.
Reflected in the numbers for the current quarter.
DNA expenses, our compensation increases from increased headcount, which increased to 29 from 12 with growth primarily in our sales and marketing organization that has increased to 14 in the current period.
This compares to two in the prior period.
The increase in cash compensation expense was mitigated our year over year basis by decreases and stock based compensation accompanied by reduced legal costs associated with prior year corporate matters, including our reincorporation and Delaware.
As we continue to prepare for our plant commercial introduction of the Celebrex system maintain public company infrastructure and continue to maintain our IP estate. We expect that DNA expenses will also continue at approximately the current levels for the remainder of 2019.
Finally on a personal note this will be my last investor call with both bio Sciences.
Im incredibly proud of the many contributions made to launch and build pulls bio sciences from a small development company to what is now is strong and growing publicly funded company on a cost of securing clearance to introduce the cell effects system.
I am confident that the foundation, we have established over the past four years will serve the company well for many years to call.
I look forward to working with sandy to effectively transition my role and completely confident in her ability to take the company forward.
Darren and Ed.
It's really enjoyed working with both of you on the rest of the team here post bio sciences, and I'm looking forward to your future success.
That concludes my comments I would like to turn call back to Darrin.
Thanks, Brian .
We continue to make progress towards our goal of commercializing or sell effects system and aesthetic dermatology, we've had very productive and collaborative conversations with the FDA as we work through the review process and continue to believe the review is likely to be completed this quarter by the end of the year and we're planning for a five 10-K clearance and commercialization.
We're thrilled to announce the appointment of an experienced leader in Sandy Gardner as our CFO starting on November 18, and again I. Appreciate all the significant contributions from Brian Dow and wish him the best of luck going forward.
We continue to make progress in developing our pipeline of applications. The recent presentations at Ssds and publications and the journal of Dermatologic surgery reflect our multiple applications strategy and the growing acceptance from the scientific community regarding our novel Nanopore stimulation technology and its a non thermal cells to sit.
Mechanism.
We're on track with our investigational clinical studies, including our awards Multicenter pivotal study and our multi center study in macular S. case and look forward to completing enrollment for both studies by the end of the year.
We believe our cell effects system will offer unique treatment capabilities to our aesthetic dermatology partners through the delivery of needed and wanted applications that enable finance physicians to provide safe and effective treatments to patients. We believe we will achieve our mission is building a viable company.
That concludes our prepared remarks, we would now like to open the call for questions.
Ladies and gentlemen, if you have a question at this time please press the star.
One key on your Touchstone telephone if your question. It spans search will you wish to me yourself from the Q. Please press the pound key.
[noise].
[noise] and you do you have your first question.
First question comes from Arthroscopy H.C. Wainwright.
Hey, guys couldn't garden, congratulations and I would say.
Brian .
Nice working with you and though we I wish you all the best.
And.
So for the.
Five Oh on key submission.
You mean, we get at Carowinds and by the end of this year how soon.
I think to the launch the sales effects is getting approvals.
Yeah. Thanks Arthur.
Yeah, It's a it's a it's a five 10-K submission and.
If we receive a clearance before the end of the year, we're ready to go so I think if.
Those view that new listening to our updates over the over the last several quarters, you'll know that Ed has developed.
Were very strong team are the foundation of a very strong team.
We have plans for a controlled launch program that we believe will be extremely effective in getting this technology into the market and.
And our operations team is ready to go with systems. Once we get the go ahead.
So we're well poised.
To go as soon as we work through this five 10-K submission.
That's great. Thanks for that and Oh, two follow up on that could you guys give us a bit more color on the come the jendro the commercial strategy.
To launch the sales tax.
Yes.
I think our strategy is pretty straightforward.
Our clinical application study program has focused on.
Difficult to treat lesions, such as some basis hyperplasia, and escapades, which are two of the most common leaves and some counterpart customer. These are primarily cash paying procedures. So our ability to capitalize on the market opportunity with cash paying customers fits into the sweet spot of the customers who typically buy.
These devices. So many of our studies are focused on this customer and this this growing market niche. So thats steps. Our general strategy. We are hiring a sales force that is well connected with this customer base and has experienced and our utilization utilization based business.
Model in which each use of the device is a revenue event for both us and the physician. So the most successful companies in this sector mortality have been.
Focused on this type of utilization based model and our model represents an improved version of built utilization based models that we believe will be a very attractive for both customers and for us.
I see that's great. Thanks, Thanks for the for the quarter ER and the just to for US for the fall off the awards pivotal study.
You mentioned you guys expect to completing enrollment by the end of this year of when we could expect the topline data from that study.
Yes, so we.
We'll continue to follow patients into Q1, and so likely towards the end of quarter, one we'll have that data.
Okay, and Oh, so I would assuming.
If we want to get approved for awards.
One pivotal study would be.
For the clearance.
Yes so.
That would be our expectation.
I think as we work through.
The current process with the FDA, yes, it's going to help us understand that as we go forward, but that would be our current assumption yes.
Okay, great. Thank you. Thank you for for the ads and that's all my question. Thank you Greg. Thanks, Thanks, a lot Arthur.
And your next question comes on line of proper Lufkin medical hold <unk>.
Well.
Yes, Hi, Bob Hi.
The conference in.
Here are the beginning of.
Yes.
And I wondered if you had.
Yeah.
Any.
Highlights.
I know that.
There.
Then over anybody out there.
Let me highlight.
No.
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The Oh of your process.
And.
Good.
Are you still feel comfortable with the a proprietary advantage you have.
With your Youre.
Over the University.
By the way there was a paper Republic.
Hey woman named.
Uh huh.
Who was I believe Italian.
And in fact, you.
That paper.
Yeah, Yeah Bob.
Yeah. So let me try to let me try to go through your question. So first yes, we had two people from our company at the at the World Congress earlier. This year that you mentioned on bio electrics.
Both.
Dr Neuchatel, Who's our Chief Science Officer, and another person from the company and I think always that those meetings and I think you maybe bend to one or more of those meetings. There's always a lot of very good information that comes out of them I think a lot of it in those those types of comp.
France's are pretty early on the research side. So I think our participation in those oftentimes, we're presenting a rent doctrine each telly isn't invited speaker many of the times he's been as you know in this field for very long time.
And so gets invited to speak on these and the podium into session. So.
You know I think we're always gleaning a lot of good information and a lot about the research that's going on around the world and.
And I think.
Dr New Shelly and the other gentleman, who is there from our company.
Both brought back a lot of interesting information I think the upshot is that bio electrics I'm using nanosecond pulsing and other pulsing modalities. It's certainly active as you know and so we're I.
I think.
An important part of that community and we as far as we know where the only.
Company that is pursuing a commercial product in that space in the life Sciences. So.
We stay very close to two what's going on as you know and part of that is our relationship with old Dominion University, which.
No.
As you know was the foundational a lot of the foundational IP.
At this company licensed in order to launch the company. So we certainly continue to be a part of that community.
From a research perspective, and a basic science perspective and we.
We utilize our internal resources to continue to advance a lot of that research as well, including as you mentioned.
In the basic biology, and immunology side.
So hopefully I was hoping that was responsive to your questions there.
Thank you.
Thanks, Bob.
And your next question comes on of James Hung swimmer retired.
Yes.
Daring ad.
Brian .
I've a couple of questions.
Couple of areas.
Great Holly Hunt.
Yeah.
Hello.
Huh.
Yeah. We're here, it's good to hear from it.
Okay.
Well. The first question I have is in regard to these.
Language.
The FDA.
Position or the progress with the FDA and that is you're going to put.
You agreed.
Good day.
The review on the temporary holds.
While sufficient time for the FDA review.
Well it seems to me that FDA review is just part of the process.
Why is it necessary to put something on hold why isn't that active while their review.
Yeah. So that's a that's a very good question and.
You know, we're trying to and in this in that language.
Our goal is to be as transparent as possible and I think some of the.
Some of these regulatory processes can be a little maybe overly complicated but basically.
You know the F.D.A. has it reveals a review clock they keep track of so its time that there.
Officially actives in a review and so it's important to FDA to manage that time and they have had they have a goal of a 90 day review time on that clock. After we went through the the teleconference with them on these couple of questions.
Some of the discussion on their side was that it may take them a little bit longer to do an appropriate review and of course, we're interested in than doing whatever review. They believe is necessary and so the best way for them to do that and manage their review clock is to put it on hold so that they can.
And take the time to do that review.
And then ultimately we would expect it would come off of hold and that they would finalize.
The review process. So it's a it's maybe a little bit of a technicality in terms of how Sta manages their review time.
But again, we're probably.
Our goal is to provide as much detail as we can.
You also that you can understand where we're at.
You don't see that has a negative.
Yeah, absolutely not yeah, not at all so I think what it means is.
FDA wants to spend the time that they need to do the the appropriate review, we want them to do that and and we want to work with and in that process. So it's just really about being collaborative with them to to get to the best result.
Okay. Thank you know the next question I have this is regarding Brian's resignation.
And I really enjoyed working with you and.
I've just appointed.
I'd rather have you around.
And I got to come but trust you and I think that your is a straight shooter I know it gives me a feeling of uneasiness shared by though the stock market.
All the gains we've made the last 10 days or so given that could one day. So they don't like it either.
Sure.
In the announcement it said that Brian will be.
Handing over November 18th, but staying with the company and advisory role until December 31st.
And just kind of reminds me of the.
Surprised.
Now it's meant that the April conference call.
Investors are looking forward to some good news and then you know we get a bombshell.
So.
Why not wait.
For this announcement Brian's resignation, then until you have an approval.
So this is this put some questions in there and then down.
Seems like an unusual.
Aiming for this announcement.
Yeah, Holly I'll address and then I didn't know what I'll, let Brian jump in as well you know I think the way I would.
Described this to you is that.
Companies evolve and they grow and as they do that roles and responsibilities.
Can change and so this is a company you know that when Brian joined.
With me it was.
Four years ago, the company was much smaller and in a much different situation and over those four years, we've grown and we find ourselves.
In a in a new situation in different situation and I think you know this is reflective of that and sort of changes related to that.
The timing of something like this we don't predicate on.
These other events I think from a communication perspective, they're completely.
Asynchronous and so this is something that that we announced and and we're moving forward on and the FDA events continue and you know we think.
That's all in good stead as well.
That I'll, let Brian chime in.
Thanks for calling in hallway and thank you for the kind words that has been great getting to know you in the rest of our investors and it it's nice to hear that I've been able to earn your trust along the way with that I think when you have a chance to get to know Sandy who is going to becoming inherent taking over the rule I feel that you're going to be able to find the same level.
Candor and professionalism that you've come to know post bio sciences for obviously I have poor four years into doing everything I can to help build this company I think it's been incredibly successful us we've come from a very small company to what is now a a growing and thriving.
As a company on the customer commercialization I think sandy is definitely got the background and it's going to be able to come in and really drive forward with the company and I invite you and the rest of the investors to reach out and to get to know Sandy and I think you'll find a she's is impressive those what the management team in the Bay.
Board has found her to be but with that I'm grateful to you and the rest of the investors for your support over the last several years and look forward to watching a little bit from the stands ensuring on from the sidelines, but I think we're putting you in good hands with sandy.
[noise].
And Lee with that operator, we do we have another color. Yes, we do have I. Another question and his questions from the line of Thomas I'll turn private investor.
Actually I found what are the several of them that's showing a this previous versus questions I've actually covered all the issues that I was concerned with so I. Thank you for your clarification on that mainly on the.
But there.
What the FDA is.
Aspect of having a dumb quote on Holden Lewis.
Appears to be merely to.
Spend should or their official timeline.
More for there.
Benefit of keeping their their own.
Well 90 day.
Program led to date.
The schedule more than anything else it related really to two pulse or.
The situation that exists there. So I think that's question spit answered.
Thank you guys for your answer.
Thanks, a lot of Thomas you're exactly right.
Okay.
Okay and that was our last question I'll now turn the call over to daring you're correct.
Thank you operator, and thank you everyone for joining our call. We're very much appreciate everybody, calling and listening. We're excited about the progress we've made and continue to make and we look forward to the year and conference call and updating you again have a great day everybody.
This concludes our conference call you may now disconnect.
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