Q1 2020 Earnings Call

Ladies and gentlemen. This is your operator today's conference is scheduled to begin momentarily until that time. Your line will again be placed on music.

Thank you for your patience.

[music].

My name is Michelle and I will take your conference operator today.

Hi, Mike welcome everyone.

Pharmaceuticals first quarter 2020, <unk> earnings call.

All lines have been placed.

Any background.

Sure Mike There would be a question section if he would like to ask questions. During this time.

And then number one on the telephone.

If you just placements draw your question. Please I suppose.

It's now my pleasure to from today's call office, Linda Lennox, Vice President Investor Relations.

I begin your conference.

Thank you Michelle good morning, and welcome to the Amax Pharmaceutical conference call to discuss our first quarter 2020 financial results.

Earlier this morning, we issued a press release.

For those of you don't have a copy you can access in the Investor section of our website at a nice pharma dotcom.

Please be reminded that remarks made during this call may include forward looking statements pursuant to the safe Harbor provisions of the private Security Litigation Reform Act of 1995.

We want to emphasize that these forward looking statements involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward looking statements.

Please refer to our 2019 form 10-K, our form 10-Q, an 8-K as well as statements included in our presentation remarks for full review of the risks and uncertainties associated with our business.

On today's call, we will discuss certain non-GAAP financial measures with respect to work before.

We use these non-GAAP measures for financial and operational decision, making and as a means to evaluate our performance because we believe they better represent the onboarding economics of our business.

The definitions of our non-GAAP measures are set forth in our earnings release, which was filed with the FCC today.

You may be obtained at FCC dot Gov and in the Investor section of our website.

We are conducting todays earning calls with participant in different locations given the coal bed 19 pandemic. So we ask that you. Please bear with us if there any technical issues. We do have a team at a process in place to handle issued should any IRI.

With me on todays call our stock Meyers, our newly appointed President and CEO.

10 miles, our chief operating and Chief Financial Officer, and try to talk to you know our chief commercial officer.

Scott will kick off the call with some introductory remarks, including executing and it cobot 19 environment.

When he will provide a commercial update and Ted will cover our financial results and guidance.

Scott will conclude the call with the status of our 2020 goals and then we'll open up the call for Q1 day would that it's my pleasure to now turn the call over to Scott.

Thanks, Wendy good morning, everyone and thank you for joining us.

I joined the company just about two weeks ago, when I'm very pleased to be fully engage with the executive team and a bag as a whole.

I've been in the pharma biotech in Med Tech space for nearly three decades I served as a chairman and CEO and my last three rolls, leading the companys throughout the development stage and with their commercial assets. Most recently I served as chairman and CEO over in your therapeutics clinical stage oncology company focused in that metastatic bladder cancer.

Previously I served as CEO and Directorate Cascadian Therapeutics, Cascadian fleet asset to cap, which is now two Tyson Seattle genetics.

Combination for treatment of her two positive metastatic breast cancer for patients with and without brain Mets was recently approved by the FDA.

Your next acquired all the assets of Cascadian in 2018.

I also had the opportunity to be seat aircraft Abbey, Swedish Medtech company based in Stockholm, Sweden.

I spent the development portion of my career and management consulting before moving into industry and ticking on increased senior management responsibilities with companies such as Johnson and Johnson dogs and you see before.

And all I lived and worked overseas for approximately nine years I look forward to bringing some of those perspectives and experiences to bear heading back.

Many people have asked me why would you join a back now it's a broader impact of cold and given that its previously announced changes.

The last several companies that I had helped lead also had a myriad of challenges spanning their entire enterprise and we sound solutions I believe that will be the case here as well.

This company has high value products that meet critical unmet needs in the marketplace. We had fully integrated sales marketing sales operations and medical affairs to support the market and with the backdrop is holding our health care providers in their patients really need us at this point.

I'm looking for four to helping a bag become more nimble improve decision making.

Communication engaged even more actively with the shareholders.

I've already spoken to be a few shareholders. We will continue this effort. After this call as well as had discussions with the analysts that provide coverage on a bag.

And my short tenure I brought a few guiding principles are executive team will continue to evolve.

Focus on what is important as the underlying thing.

Yes on our core business manage expenses and head count to be prepared to grow this company utilize business development to bring in non dilutive capital to strengthen our balance sheet and also look for products that can be added to our field teams promotional and medical education efforts.

The ultimate goal is to serve unmet needs for the patients and providers and if we do that efficiently through marketed products and developing the potential our pipeline.

Talking to shareholder values and then begin.

The board of directors and executive leadership team along with the rest of already Mag Associates have welcomed me with open arms. So I'd like to share with you some excellent progress in a very challenging environment.

Turning to page five.

In bag is going through an evolution and as previously announced we are progressing with her plans to divest Intrarosa. Finally see we're in negotiations now and look forward to updating everyone by the end of second quarter.

The transition out of consumer driven women's health products will mark important milestone on our path to increase shareholder value and sharpen our focus on our priorities of maximizing feraheme value retaining patient access to makena.

Continuing to efficiently develop innovative therapies, including seven franchise.

Despite solid first quarter results Amex products are being adversely impacted by the cobot 19 Pendennis is patient visits have declined during this period.

Should not be surprising it was across the country. The Pandemics has led to a decline in medical visits for conditions and illnesses not related to covert 19th.

Given the impacting cobot died gene and the plan Divesture of in a row CNBC eight Magnus made the decision to implement a companywide restructuring of about 30% of our workforce in total we reduced our headcount by about 140 positions.

This was a very difficult decision I'd like to take a moment to recognize the contributions of our colleagues who are leading amax and wish them well.

As we look towards the future. We believe we've taken steps to rightsize. Our organization. We are laser focused on maximizing hematology oncology and maternal health reviewing our existing pipeline and developing innovative therapies. We are currently in the process of exploring additional opportunities to grow our hematology oncology business, both on the business development fraud.

As well as lifecycle management.

Now going to turn it over to Tony to provide a couple commercial update Tony.

Thank you Scott and good morning, everyone.

On slide six I'd like to take this a few minutes to provide an update on our performance in the quarter for both Feraheme and Mckenna.

Well then do my best to provide you with some color on the Kogan in fact, they seem to date.

Starting with Feraheme, yet another strong performance by our team Oxy record revenues of 44.4 million in the first quarter, which was an increase of 11% over the same period last year.

This quarter marks the second full year following Ida label expansion in early 2018.

And then that's fine the same has consistently delivered strong results more than doubling the feraheme taking share in the hematology oncology segment of our business.

18.4 per se in Q1 to 2018, nearly 40% in Q1 2020.

What has been a truly remarkable walk.

Starting from the Tina.

We finished the quarter with 21.8 million in revenue.

Well below the same quarter last year and three point Eightmillion below Q4, 20 I see.

As a reminder, this was our first full quarter following the FDA Advisory Committee meeting last October.

While revenue was down quarter over quarter that seems a nice job stabilizing monthly patient enrollment prior to the tandem.

That's got mentioned declines in medical business for conditions, and Ella's is not related to covert Nike has been widely reported in our products, especially feraheme have not been immune to that effect.

Might be aware feraheme is administered to infusing typically analytic or hospital.

In the patients ability to access the treatment setting.

Has become challenge.

We believe this dynamic will negatively impact feraheme sales in the second floor.

As you've already observed volume declines in the month of April.

Mckenna, we've seen smaller in fact over the same time period.

There are customers are finding alternative ways to get these high risk patients their injections Arnie pandemic.

More recently, we have begun thing leading indicators of recovery what consecutive weeks of increasing outflow for feraheme and patient enrollments for Makena.

Let's be clear, we have not yet returns are pretty cold with others.

And why we believe the underlying patient need for both products remains high with Phoenix that of the recovery largely depends on the Phoenix that on patient visit normalization and health care providers ability to administer treatment for those neat.

Well, we don't yet know the full impact of code on our business, we do believe.

That is policymakers begins to move to stay at home orders and people begin to participate in a normal routine patients will once again had back to doctors offices infusion centers to receive the treatments they need.

We believe the patients will be there when the pandemic is fast.

And we will be there.

Were they have access to our medications.

I'll pass it over to Ted for the financial update.

Thanks, Tony Tony just covered revenue for Feraheme, which were strong and Mckenna, which appears to stabilize after the Q4 AD com eating I'll start with operating expenses here on slide seven.

As you can see from the year over year trends, we have been managing expenses carefully as weve navigated our strategic evolution and the Kogan 19 pandemic.

Had a couple of onetime expenses in the first quarter 2019 related to the acquisition of parish your pharmaceutical and a restructuring charge related to our women's health maternal health Salesforce combination.

Those two items operating expenses decreased by approximately 20% year over year.

<unk> expenses decreased by 29% year over year, a key driver in our Q1 2019 S. units then was the DTC campaign to support Intrarosa.

We reduced our investment that product during the second half through the year driving the favorable trends you see in comparison to the first quarter 20 Twond.

Year over year R&D expenses decreased by approximately 38% by lease. He was approved in June of 2019, so the R&D spending that products significantly decreased in the second half of last year.

These decreases in operating expenses were partially offset by an increase in cost of product sales.

Due to an increase of approximately $6 million in noncash amortization expense driven by the fourth quarter revision of the estimated useful life of the intangible assets related to Mckenna Intrarosa NBC.

Our year over year operating loss decreased significantly to $19.6 million compared to 117 million in last year's first quarter as part of our stated strategy to return to profitability. Our adjusted EBITDA loss decreased significantly to 5.5 million in the first quarter compared to a loss of over 26 million.

The first quarter of last year.

Moving to slide eight.

In January we issued.

2020 financial guidance provided here on the left side of the flight.

I took into account the divestiture of our women's health assets and our goal of becoming adjusted EBITDA positive.

Well that guidance captured a wide range or potential outcomes for our business as we navigated through year of uncertainty it did not account for global pandemic and its impact our business.

Because the severity and duration of the pandemic and the subsequent speed of any recoveries so uncertain.

It is impossible, they're pretty reasonably predict how this recovery will look and how long it will take for patient visits to return to some form of pre pandemic status.

We therefore made the decision to withdraw our 2020 financial guidance at this time.

As Tony mentioned earlier, we have some leading indicators to suggest that the decline may have stabilized. We just don't know indicators. We saw in April a representative of the remainder of the quarter or the remainder of the year.

It's important to note that while there's new risk in our topline we remain committed to the previously stated goal of reducing total operating expenses by more than $100 million in 2020 as compared to 2019.

In returning the company to profitability.

This workforce reduction that we announced this morning is an important step in achieving these objectives and rightsizing the organization for the future.

We will continue to closely monitored the impact of Coca 19, our business and financial and plan to reinstitute financial guidance as soon as we can provide a reasonable range.

Please turn to slide nine.

At AMAG, we're very committed to the health and safety of our employees patient health care providers and business partners. We have taken numerous actions to date to ensure business continuity. These steps have been working very well and we're continuing to call upon our customers interact with government and private pairs.

We continue to focus on these important activities to make sure health care providers can help their patients we gain or maintain access to our central products.

After review with our manufacturing partners at this time, we do not anticipate that coping 19 will materially impact our ability to supply the market in the near term.

We continue to work diligently with our suppliers to maintain continuous supply as the cold in 19 situational evolves.

On the clinical development front, we have experienced delays and our ongoing amec for 23 phase to be three a clinical trial and no plan fill brand techfaith to be trial due to covert 19.

Again, while we cannot estimate the severity and duration of the pandemic and subsequent speed of recovery.

We do expect these delays to continue to impact trial site initiation and patient enrollment for these trials.

We are working with RCR rose to reduce spend on these trials during this period.

While we remain committed to develop to developing products that could create the next leg of growth for the company, we can not going from timing of our development progress.

We do look forward to updating you at the appropriate time.

Ill now hand, it back to Scott to remind you of our goals and wrap up today's call Scott.

Thanks, Ted I'd ask everyone to turn to page.

Chen.

And review our goals in the status, where we stand now we continue to execute on our 2020 goals, which are outlined and we're now making great strides towards those I'm pleased to have joined day Magnus a new CEO and lead the company at this critical juncture in its evolution as we previously mentioned, we're progressing the interests and by Lisi divestitures and wheel pro.

I didn't update by the end of the second quarter, we remain steadfast about driving feraheme growth and despite the challenges, resulting from coven 19, we're keeping our sales sales support medical affairs teams fully engaged we're working to continue our dialogue with the FDA to maintain access to makena for eligible pregnant women as.

As we shared in the press release. This morning, the FDA responded to our request to discuss the future of Makena and indicated it was premature to hold the meeting at this time.

We continue to actively marketing support makena in the marketplace. We're committed to work collaborative Lee with the FDIC to support continued availability to Mckenna and its patients.

As expected Coven 19 has resulted in delays to that in AG for 23 answer for Antech development programs and export <unk>. They made for 23 phase to be entry a clinical trials is a hospital based trial and all sites and pause new patient enrollment and the company has had to pause initiation of new sites do the pandemic that's significantly in.

Packing recruitment enrollment.

And that continues to work with the FDA to initiate the Serra Grande Tech seems to be trial in healthy volunteers in the U.S.. It's called the 19 pandemic has also force the clinical trial sites in the company and expected to conduct a trial to close during the past that Nick.

We continue to explore ex us portfolio partnering opportunities for our established brands and our pipeline.

As we looked towards the future we remain committed to managing our business to further our goal of achieving profitability in 2020.

There's no doubt that we've had some unforeseen heads headwinds with coven 19, However, it will do everything in our control to closely manage our expenses and maximize their portfolio.

Given the challenge all this you're having this remote situation.

Either answer the questions. After the operator opens up the line or director questions to a member of my Executive team. This includes our former landmarks and I now I see operator open the call for questions.

Okay. So at this time, if anybody has a question star one on your telephone keypad okay.

One.

So that's question <unk> and.

That's it.

Your lines.

Hi, Good morning, Thanks for taking my question and Scott Congratulations on the new role.

I why youre kind of view on the company in the trajectory going attendance Oh, what my you know.

Even in a couple of weeks that you've been at the company. How are you thinking about driving shareholder value in the company Litle. Some of the stated set of priorities for the company and then specifically just with regards to say it can tag. We recently saw the Portola acquisition.

And you know some of the features a certified and tygart So to me competitive.

Relative to index up new Kinda talk about Wendy My guess.

Visibility into you know the set of present time to profitability and up how do you plan to be got off the father. Thank you.

Yeah, I mean nice to meet you, albeit virtually thanks to the question. So a couple of things coming in as I said I'd been welcome with open arms by the executive team and we really did start off with some very simple focal points first and foremost stabilizing growing our base business with Feraheme and Mccain and obviously keeping access to Macau.

You know, which I'm continues to this day the second was to focus on expenses.

That's both opt acts and headcount and we announced today you know the reduction of 140 positions.

To rightsize the company for growth in the future. The third area. Obviously is the pipeline focus down on that to look at the highest value assets, which we believe Serra Grande Tech to your question isn't very very very good one to do and given the Portillo acquisition I think that's a that's that's a really nice validation of this this class of drugs.

And then finally using business development.

Both on the I'd say, the sell side and the Buyside to free up some cash flow to improve our balance sheet. And then also coven 19 has impacted a lot of other people Oh, excuse me people and companies and attracting with our great sales team. The sale. So fully integrated sales support and then the medical affairs team that we.

We have versus some of these companies, who also had to either reduce down or don't even have those resources yet were very attractive partner for those people.

And then finally I think it's a it's a ways out but doing anything we can to improve our balance sheet somewhat my vision is to stabilize the company I'm I've shared that with the team.

Focus on our current products make us much more efficient cash efficient and watching expenses and then really turned towards the future and look for other assets to bring in.

And improve our balance sheet. So those are the few very very clear focal points I brought about you know I want to say right the shift, but it's really just get the ship ready to move forward and that's what I'd. That's why I came to the company I really love The foundation, that's here and we're gonna all work hard together to do that so hopefully that answer.

Your your question.

Thank you.

Your next question comes from Douglas Oh from it.

Your line is open.

Hi, good morning, Thanks for taking the questions just Scott maybe to start when you think about business development opportunities given your background.

Do you see sort of pivoting a little bit more of a focus on oncology I mean, certainly with Terry I mean, you have a strong anchor asset. Although obviously, that's not exclusive to to that to talk colleges or you know do you continue to see a lot of promise in many sort of women's health sector. So.

It's a business.

Yeah, Doug nice to meet you. Thanks for the question actually.

I think you're you're actually going into right direction in this and we have but we have a lot to do before we can completely makes a pivot, but I think the discussions have been.

Obviously with the announced divestiture and the progress in negotiations were undertaking right now to move out of the heavy direct to consumer advertising businesses. Mccain is great products serves as an unmet need.

So so we're not giving up on that certainly.

But you know looking more at he mahnken ONGC could be very attractive to us and again as I mentioned, there's companies out there that need help on the commercial side and then yes I'd like to go look for some of those assets that we can add the bad because Tony and.

And credit Flanagan had built and great Great Field force and at our medical Affairs teams that I've met so far I think we can support a he mom and more of an oncotype play, but that's going to take some time dug in wheat, and we have lot of other things to do returning to eat that's a positive is certainly a strong goal for us and and cleaning up the balance sheet, but.

I feel like we have support from the board and that and hopefully shareholders Ah, Yes, and I. We've had some success recently in other companies with the play I think I don't want to say versus spec pharma because there's a lot of very very successful spec farm, but I think with the foundation I see here, we can make that pivot overtime.

Okay, great. Thank you and then just.

Just quickly in terms that Mccain are obviously, you know everybody seeing pressure in Twoq you just curious in terms of Makena if with it really.

Based on geography said it than most impacted by co fit or with it sort of broad based and just trying to parse the sort of.

The reason I'm asking the question is just trying to understand what is nothing what we can figure out just colgate related versus might be just be some additional pressure on the franchise. Thank you yeah, I think actually the young Tony mentioned looking at some leading indicators that brand is actually proven to be other sticky as we would say in the in the jargon, but.

I'm going to turn it over to Tony Tony can you had any more color to doug's question or.

Yeah sure. Good question, Doug So just to be clear on what we saw in the first quarter. It was really.

A full quarter of the post AD com insights on so if you look at.

What we were seeing in November and December I'm, just kind of quarter eyes that.

That's essentially what we saw in the quarter due due to some good work in stabilizing that business and stabilizing our lead indicators in terms of patient enrollment during the quarter.

Not at Nada Thunder cobot impact in the quarter, we thought as we exited the quarter.

And as Scott mentioned.

It's interesting to see it's been a bit more durable and I think one would have anticipated during the pandemic.

And why we believe that anecdotally.

As you know we hear from our because this is all the time you beauty patients at high risk patients and to bleed Mccain is an important part of managing that rest. So we've seen things like alternate sites. So offices are changing the way they operate around the patients.

Sure they get their injections. We also have access to patients can access I'm home nursing for injections.

So they can work that through their insurance company can certainly what we built with a strong team at all care and Makena care connection can help navigate patients to that and thirdly. We've you know really built from a high touch model around these moms and need over the years. So this model was essentially built for a bit of market.

Impact interruptions in patient care I'm. So for all those reasons, we've seen a phone call. It marginal because it definitely have an impact but a much much lighter impact than what we're seeing both with feraheme and really across the industry. As you look at other other products and how they have been impacted during a cogan.

And in terms of Mccain has there been a shift toward towards more commercial versus Medicaid during the last quarter or or so far into Q.

So hard to say in Q2, because we haven't even closed April yet.

I would remind you remind everybody that.

Mckenna is close to 60% Medicaid.

And that was consistent in the first quarter.

And post AD com and its with part of I think the story in the prior earnings and we did see a slight shift in mix overcome Medicaid and again, we believe that those patients are categorized by physicians as the highest risk.

So if you're looking at a you know.

Segmentation of the patients at risk.

For pre term birth, those preterm birth patients that have less means and less ability.

Other otherwise around the cannot have seem to be a bit stickier as well so no no big shifts so far in the quarter, but to be 100% transparent we haven't closed the quarter yet.

So let's see that.

Great. Thank you.

Yep.

Your next question.

Hi.

Your line is open.

Hey, guys. Good morning, Thanks for taking my question, Scott you talked about cleaning up the balance sheet, but also business development.

If we look out a couple of years to 2020, you. How are you thinking about the capital structure as it relates the potential need to pay off or refinance the converts.

Yeah, I think when we talk about business development. Obviously, it's one of the if we do deals sell side deals are out licensing and territories and things like that it brings in a lot of non dilutive capital. So that's one way to look at it and then I would ask Ted to to pick the question up and say like how we plan to do move tactically through toward.

Right.

Yes, Hi, Jeff.

So what that both the convert is on our minds, it's due in a little over two years and it's been part of our our thinking for a long time and and the risk that we implemented. This morning, obviously has been many weeks and months in the planning and we executed we're executing on it now.

An important element of getting us back to profitability.

Which obviously profitability and internal cash flow generation is an important element of.

Managing the convert.

I'd like to say, we don't think we can generate enough cash to fully paid off so there's.

Going to have to be some form of transaction occurring at some point typically in that 18 to 24 month to maturity range is when people typically think about managing a convert.

So stay tuned it could be some form of.

Straight debt or equity linked to debt or equity or some combination of all the above but we're going to have to.

We were focused on it we're gonna have to manage it but first step is get profitable and then bring in some non dilutive capital, we're very focused on mitigating dilution and managing this company.

Okay, Great and maybe just another one on.

On the piano can see how much of the first quarter 2020, Opex was associated with highly seeing intrarosa and kind of related to that and just thinking about the restructuring can you help us understand how much of the opex costs are linked to the.

Feraheme and making a business versus how much are tied to it.

Interest then by Lisi.

Yes, so the trend from Q1 19 to Q1 20 is pretty straightforward as you recall in Q1 19, we merge the sales forces. So we've got about 110 employees out of the workforce by merging the sales forces.

It was a little bit late in Q1. So most of Q1 19 was a full two sales force effort and span and with all the big push thereby we see wasn't get approved the big push was on Intrarosa and our plans had been as we stepped through 2019.

Our DTC investment from Intrarosa to buy we see the support that products launch so in the first quarter, a big chunk of the spending in 19 that went away as you look at 2020 is the decrease in interim suspension.

And in terms of.

Drawing a line between 140 positions that we eliminated this morning.

How much of that was associated with the women's health divestiture and how much was associated with softening topline I can't draw a line there what I can tell you is we had this risk architected since.

Q4 last year, but and so part of that was not hiring we were very deliberate about not hiring a lot of position. So that we would be able to mitigate the impact of a rep. It's certainly easier to eliminate unfilled positions and one that felt.

So we're trying to be mindful of that throughout the quarter and look to covert risk.

And we've made US you know dig deeper in our plans and we executed more heavily.

More substantial reduction.

Opex and positions than we would've otherwise.

I think these are the types of decisions that make.

Companies have to go through and they make management teams stronger as you get through unforeseen crises like that like this pandemic. So we're comfortable with where we landed just about 300 employees and we think that's a good go forward basis to hit all of our key objectives for the remainder of the year and beyond.

Okay. So I think Paul up on that just to make sure I understand the when you talk about the 100 million dollar euro free or Opex reduction I think in the past it kind of alluded to that being.

And the minimum but I just want to make sure I understand is that a reduction off of the.

Feraheme and Mckenna Opex base or just off of the overall cleaning doesn't opex phase.

That that headline the greater than $100 million removed from the operating expense of the company that was really associated with it that's what we kind of the battery flu as we announced the strategic pivot and getting out of these women's health products and he's very very heavy DTC spending. So I was comfortable saying if you look at 2019 total opex versus 2022.

Total opex there'll be a more than $100 million drop.

That was pretty covert that was just associated primarily with but we knew we were going to rightsize. The company. We also knew we were going to decrease DTC spending substantially. So we stick by that we can continue to do that but of course with Colgate evolving in Q1, we dug a little deeper to help mitigate whatever topline softness for share.

Great. Thank you.

Okay and congratulations Jeff.

Thanks again within a pretty good luck ask a question. Please press star one telephone keypad.

I'm sorry, the lunch day from Needham <unk> Company. Your line is okay.

Hi, Good morning, and just a couple of questions for me. The first one I guess for Scott on a under keener from your interactions with the FDA do you have any visibility on.

A timeline on when they can make a decision.

And then secondly on a very heme, you're talking about expanding the market opportunity for that product.

I'd be done might just shifting or expanding the marketing focus or.

Is the way to do that really just by label expansion idea additional clinical trials.

Good questions. Thanks, Nice nice to meet your first on Makena, our regulatory folks had been in touch with the agency and obviously given the world events.

And our interpretation from the follow up to the AD com is that they needed some more time to review the situation.

We are dealing really with a safety signal here a tall.

So they told us to wait and that we would hear from them, which obviously our label hasn't changed. So we continue to actively promote that product. Our plan is to send in a briefing book at some point when it's appropriate and then we will set up a meeting with them to to hear back about.

You know what the plan is we're going to go and proactively with our our own plans and suggestions about what to do post the ad com.

So we're feeling pretty good about that I think.

Silence is a good thing right now because they're very busy doing a lot of great things on covidien.

And we're hearing that from other people in other categories of drugs that if it's not covered related it will take some time, but we will be prepared for that meeting when when they're ready to habit I I have not personally spoken to the agency. It since I've only been here a couple of weeks, but our our head of regulatory affairs and the whole team are working very proactively with regard to Feraheme I think there's two angles with that.

On his business development, so looking for outside the U.S. type out licensing opportunities to grow through territory expansion and possibly some lifecycle management ideas that have come up through the team or it's come in from different investigators and so uses a feraheme in different settings, and that's about all I can.

I'd say on that right now, but that's it's a it's a very trusted brand it's done well in the past than I think we're going to look and see what we can do to just maximize it going forward.

Okay I have no further questions in queue I turn the call back over to Scott lives for closing remarks.

Yes, well, we live in a very interesting and challenging time meeting each ahlberg, beating each other virtually continuing our relationships virtually for the time being I look forward to meeting you in the near future and person hopefully.

But I just wanted to thank you all for the support a day magazine and our team here and really our patients because we do really feel like our patients need us now in the the providers that are treating them, we're doing our best to to help them at all the different ways that we can as a as an organization, but thank you for carrying enough to call. It today and supporting the company I wish.

As you, all well and safety and good health for the future, but bye for now and hopefully season.

Thank you everyone Misspoken today's conference call you may now disconnect.

[music].