Q1 2021 Paratek Pharmaceuticals Inc Earnings Call
Yeah.
[music].
Greetings welcome to protect Pharmaceuticals first quarter 2021 earnings call.
At this time all participants are in a listen only mode.
<unk> and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero from your telephone keypad. Please note. This conference is being recorded.
At this time I'll turn the conference over to Ben strain Vice President of Investor Relations you May now begin.
Good morning, and welcome to <unk> first quarter 2021 earnings and corporate update conference call a press release with the company's first quarter results was issued earlier today and we have also posted slides on our website that will be referred to on this call. Both can be found at www Dot <unk> pharma.
<unk> com.
Participants on today's call are Evan Loh CEO.
Adam Woodrow President and Chief Commercial Officer, Randy Brenner, Chief Development, and regulatory Officer, Michael Bigham, Executive Chairman and Sara Higgins, Vice President of Finance controller, and principal accounting officer will also be available for questions before I turn the call over to over to Evan I would like to point out that we will be making forward.
Looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially I encourage you to consult the risk factors discussed in our SEC filings for additional detail Evan.
Thank you Ben good morning, and thank you all for joining our first quarter earnings and corporate update call.
We believe 2021 will be a transformative year of continued growth for per day.
These iris quarter over quarter growth in 2020.
Continue into the first quarter of this year.
We believe this is not only a significant achievement in this volatile and rapidly evolving health care setting, but also a reflection of the clinical importance of positive patient outcomes with new xyrem in the hands of clinicians.
Our first quarter 2021 results were consistent with our expectations as new XI regenerated U S net sales of $13 two.
In the first quarter, reflecting the health of our commercial business.
Our confidence in the long term commercial success of new Xyrem remains unabated based upon growing demand of new Xyrem in the hospital care setting coupled with the recent initial positive signs of new prescriptions and adoption in the primary care commercial expansion.
We anticipate that this growth trajectory will continue through the balance of 2021, given the encouraging initial inbound feedback from the primary care base positions for a well tolerated once daily.
Oral broad spectrum antibiotic that includes coverage against MSA for skin infections.
As seen in this next slide the commercial success to date has established new Xyrem as one of the most successful antibiotics launched in the last five years.
As IRA continues to materially differentiate itself from other IV oral antibiotic launches driven by strong operational execution and new Xyrem many product attributes that include.
First.
Broad spectrum efficacy, including resistant pathogen across two common indications.
Second a favorable safety profile consistent with news Iris Tetracycline heritage.
And third convene.
Convenient once daily oral and IV formulations that enable utility in multiple settings of care.
In addition to the commercial business, we are focused on several exciting and potentially transformative catalyst prepare tech.
First we're excited to announce that BARDA has initiated the first procurement of new Zara valued at approximately $38 million.
We expect that this procurement will be delivered and recognized this quarter.
Second.
An important FDA decision on the new Xyrem NDA for the oral loading dose regimen and pneumonia.
If approved we believe this will be an important catalyst to further expand the commercial opportunities for news IRA in the primary care setting.
Third the initial the initiation of a phase <unk> study for new Xyrem and our rare disease pulmonary MTM obsesses for which there are no approved therapies.
Fourth we anticipate the second BARDA procurement in the second half of this year.
Fifth we anticipate an approval of new Xyrem China.
One of the largest potential antibiotic markets, which will trigger a $6 million approval milestone payment from <unk> lab to pair tech.
And finally in addition to these catalysts, we continue to actively evaluate potential assets to expand our portfolio and leverage our commercial infrastructure.
Before I hand, the call over to Adam I would now like to provide <unk> first quarter 2021 financial highlights.
First quarter 2021, total revenue was $16 4 million, an increase of 3% over the prior quarter and 107% over the first quarter of 2020.
<unk> IRA generated $13 2 million and net U S sales in the first quarter.
An increase of 6% over the prior quarter and an increase of 81% over the first quarter of 2020.
First quarter 2021 government contract service and grant revenue earned under the BARDA contract were $2 6 million for the first quarter versus $2 $8 million in the fourth quarter of 2020, we.
We anticipate a modest step up in contract service and grant revenue earned under the BARDA contract as we move through the year driven by activities associated with the onshoring in.
In the U S of new Xyrem manufacturing, the continuing enrollment of the FDA post marketing required studies pneumonia and further advancement of the preclinical work in the Anthrax program.
First quarter R&D expenses were $5 5 million compared.
Compared to $6 4 million for the same period in the prior year <unk>.
Included in R&D expenses for the first quarter were $2 7 million in cost reimbursed under the BARDA contract for the U S onshoring of Xyrem manufacturing and for FDA post marketing requirements.
The decrease in R&D expense is primarily the result of lower third party manufacturing process scale up and clinical study costs as well as lower stock based compensation expense, partially offset by an increase in the reimbursable costs incurred under the BARDA contract.
SG&A expenses were $22 4 million for the first quarter of 2021 compared to $23 $6 million from the same period in the prior year.
The decrease in SG&A expenses, primarily the result of a continued focus on driving operational efficiencies across the organization as well as lower stock based compensation expense.
As of March 31, 2021, we had $103 $5 million on cash and cash equivalents.
Based upon our current operating plan, we anticipate our existing cash and cash equivalents provides for a cash runway through the end of 2023 with a pathway to cash flow breakeven.
I would now like to turn the call over to Adam.
Adam.
Thanks, Kevin.
The commercialization of new Zara continues to progress well with consistent quarter over quarter growth sales since launch even in the face of the ongoing COVID-19 pandemic.
As you can see from slide 11, New Xyrem net revenue grew 6% in the first quarter when compared to the fourth quarter of last year.
<unk> gross demand increased from approximately $13 5 million in the fourth quarter of 2020 to approximately $14 6 million in the first quarter of 2021, and thus the growth in the first quarter was driven by demand.
In the first quarter, our sales were impacted by the typical new year insurance resets. In addition to recruiting and training of new sales force and the ongoing challenges presented by COVID-19 that we have discussed in the past.
Nevertheless.
Our business grew quarter over quarter, as we effectively and efficiently operated within a hybrid sales model that consisted of both face to face and virtual interactions.
We see COVID-19 and the related access challenges occurring well into the second half of 2021.
But with a steady ship the more impactful face to face interactions as the year progresses.
Nissan was once daily well tolerated oral and intravenous formulations combined with news on his broad spectrum profile offers a much needed new lifesaving antibiotic that is uniquely positioned to be applicable in every setting of care.
From the hospital and its potential to minimize hospital stays to the community where there was a tremendous unmet need for a well tolerated once daily oral broad spectrum antibiotic that includes coverage against the MLR site skin infections.
Current generic antibiotic options in the community are challenged by either significant bacterial resistance or serious safety concerns limiting their utility.
This is verified by our utilization data from a primary care pilots and the initial results from our primary care expansion seen so far this year.
The data suggests primary care physicians first trial of news IRA occurred quicker and with fewer calls than the hospital based physicians.
This dynamic is playing out as we have seen encouraging signs in prescription numbers driven from a primary care expansion efforts.
We anticipate this momentum will continue through 2021, as we maintain our focus on gaining institutional access continuing to support the primary care expansion building awareness from trust and credibility with physicians, who are saving lives from treating serious community acquired infections every day.
Our sales team is now near our targeted head count following significant recruitment efforts that occurred in the first quarter.
We now have approximately eight representatives with half focused on the hospital and Hawk focused on primary care.
As described last quarter, our initial launch into primary care, we will focus on the estimated $3 2 billion dollar addressable market opportunity with skin infections, which represents the largest targeted segment for news on a promotion.
Later this year after the anticipated approval of the pneumonia overlay on the loading dose regimen, we plan to expand on promotion to include pneumonia in the community, which represents an additional estimated one 5 billion dollar addressable market opportunity.
A recent study published by Pew also reports and reinforces the potential role <unk> can play in addressing unmet needs for community acquired infections.
The study highlighted the potential risks of toxicity and adverse events associated with Florida quinolone use with the panel recommending the alternative and equally effective antibiotic agents should always be favorite over fluoroquinolones when available.
In this study.
47% of all Florida, Quinolone, and 27% of all bank commodity and prescriptions were deemed inappropriate.
As a result, the panel recommended a national target to reduce inappropriate use for each of these antibiotics by some 95%.
These data reinforce the unmet clinical need and suggest that you use on a could provide an important clinical alternative in some circumstances.
We believe we're on the right path with news on IRA and are well positioned for long term commercial success.
Look forward to reporting on our continued progress in the quarters ahead.
And with that I'd now like to turn the call over to Randy.
Thanks, Thanks, Adam as you heard from even a few minutes ago. We are excited to announce that BARDA has initiated the first procurement of news IRA valued at approximately $38 million that we expect will be delivered this quarter.
We also continue to advance the preclinical clinical and manufacturing work under the BARDA contract.
In addition to BARDA activities, we are progressing our pipeline with the startup activities for our phase II study in the rare disease pulmonary LTM obsesses with study initiation expected next month and the recent initiation of the pneumonia post marketing study required by FDA.
We continue to actively pursue lifecycle initiatives for news IRA later this month, we are anticipating a decision from the FDA on our NDA for oral loading dose regimen for community acquired bacterial pneumonia.
We also continue to advance our clinical development program for our rare disease non tuberculosis mycobacteria pulmonary disease caused by mycobacterium abscesses or MTM.
As a reminder, pulmonary <unk> is an orphan disease with no FDA approved therapies.
Inbound feedback from the Kols community has continued to highlight the clinical unmet need for an efficacious and well tolerated once daily oral antibiotic to treat infections caused by Mycobacterium abscesses based.
Based upon our internal market analytics pulmonary Michael bacteria Obsesses represents an estimated $1 billion addressable market in the U S alone.
We are in advanced in the startup activities for our phase <unk> study for this disease with the initiation of the study planned in June.
We will provide more details about the safety and efficacy endpoints, which include symptom and microbiology assessments at an upcoming meeting to be announced in the near term.
<unk> is an exciting lifecycle opportunity for new Zara with significant potential to address important unmet medical needs.
Our BARDA partnership also continues to progress well this unique public private partnership is in recognition of our jointly share commitment to advancing new xyrem in the fight against antimicrobial resistance and to develop new Saar as a potential treatment against bioterrorism pathogens, including anthrax and the procurement of desire for the strategic national stockpile.
In addition to initiating the first procurement.
<unk>, along with BARDA continued to make important progress advancing our anthrax animal rule program as well as our efforts to onshore manufacturing revenues IRA that will enable us to secure additional supply chain for new xyrem within the U S to the best of our knowledge no zero will be the first and only antibiotic to be made exclusively in the U.
The us including API production.
With regards to the Anthrax animal World program, we have generated data in over 130 facilities answer Acos isolates that continues to confirm the in vitro potency of news IRA against this potentially life threatening pathogen <unk>.
Importantly, this testing also included a strain resistant to ciprofloxacin and a separate straight resistant to doxycycline.
Against both of these strains in matter of cyclic remained active with its in vitro potency maintained.
In addition to that data. We've recently received data from work, we conducted with the United States Army Research Institute of infectious disease also known as U S average testing omadacycline in many panels against various resistance range of bacillus <unk>, including a multi drug resistant strain resistant to all other antibiotic classes.
Against this multi drug resistant strain matters cyclic retained its activity in in vitro potency, suggesting news IRA could be the only viable option for multi drug resistant strains of the silica embraces these data support the potential utility of news IRA pandemic preparedness against antibiotic resistant bio threats.
In addition, a recent poster from asper at the 2021 National Association of City and County Health officials preparedness summit highlighted the challenges with secondary infections, resulting from chemical radiological nuclear and biologic threats. We're looking closely at the infection types <unk> pathogens highlighted in his poster.
These are already has either the approved indication or pathogen and at USPI is shown in green boxes or the in vitro data for the pathogen is shown in blue boxes further confirming that news IRA has the potential to address several of these key pathogens.
Also at this conference the CDC presented a poster regarding the recommended treatment for plague.
And this poster Omadacycline was included on our list of alternatives for pre or post exposure prophylaxis of plague another bacterial pandemic threat.
As a result, we anticipate the CDC to update their guidelines on pneumonic plague to include Omadacycline. This summer.
We believe these two recent posters continue to highlight the potential utility of Omadacycline and a growing list of threats and we believe has the potential to open further opportunities with U S government for future utilization and procurements.
The scientific story will continue to expand throughout 2021 with the continued advancement of our IR program.
The medical Affairs team has several activities plan further support the community launch and the expansion of the scientific education into this new health care base.
This includes the placement of a small number of targeted community based education specialists to further augment the primary care launch.
With regards to the NDA review in China. The regulatory process continues to make good progress with the approval expected later this year, triggering a $6 million milestone payment from <unk> lab to power Tech.
We believe that the China approval and the additional data generation opportunities will further broaden the potential for new Zara to reach into new and clinically important patient populations.
At this point, we'd like to open the line for questions.
Thank you well now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad and a confirmation tone will indicate your line is on the question queue you.
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Thank you.
Our first question is from the line of Ed Arce with H C. Wainwright. Please proceed with your questions.
Mr. <unk>. Your line is the line for questions.
Mr. <unk> your line is live.
Our next question is coming from the line of Bert Hazlett with BTG. Please proceed with your question.
Operations on a number of levels.
It's been quite an effort and.
Terrific terrific result.
Just three.
Three brief ones could.
Could you give us some timetable for the enrollment.
The <unk> study in MTM, then secondly.
Your confidence with regard to further government military or other procurement just love some additional thoughts there and then last but not least as you contemplate further portfolio of product expansion as you've mentioned is that primarily with omadacycline or are we thinking more broadly.
Thanks, and congratulations on all the progress once again.
Hi, Bert Thank you very much for the questions ill have Randy addressed the first question around timeline.
Yes, Thanks, Kevin Hey, Bert So we will be providing at a much more detailed update on our MTM study at an upcoming meeting that we'll be announcing soon.
We've said that based on the size of the study.
The numbers of patients in this population, we expect about a two year enrollment process for that study.
Okay terrific and then.
Potential for additional government procurement and your enthusiasm there and then potential expansion.
Either with or without Omadacycline. Yeah. We are we're extremely excited about the procurement.
<unk> initiated here, we do think that that is tremendously validating.
On to the commitment.
Within our public private partnership in addition to that as a reminder.
<unk> last year was added to the joint deployment formulary, which I think opens up the possibility for future procurements broader throughout the department of defense, maybe I could have add on comment on some of the efforts that his team has been <unk>.
Flooring.
Thanks, Kevin, Yes, Hi, Bert.
We continue to engage with a number of departments within the government about future stockpiling opportunities, especially with the recent stimulus package.
The news on it could be an ideal choice for a new therapeutic option to add to the strategic national stockpile and we will continue to explore.
Although part of threats.
<unk> such as the department of Defense and military.
It's too early to predict how successful we'll be with these efforts, but rest assured we'll try hard.
And Bert I'll take your third question with regards to potential product expansion with regards to omadacycline or something else look I think that.
As you can imagine we monitor our sector very closely and.
Having now a commercial presence in both the hospital and the community setting I think gives us greater flexibility to consider opportunities to expand our pipeline. Our first commitment has always been to build around opportunities around our lead asset <unk> iron you heard from Randy today about the expanding lifecycle.
On opportunities, which we're excited about.
Given our core competencies and our established infrastructure and expertise to ensure that our franchise product xyrem be successful.
Given our position of strength, though we believe we can potentially bring in additional assets. We continue to look.
For these assets, but as always we will remain disciplined in our approach and carefully monitor our cash runway.
Okay.
Congratulations again, thank you Bert.
Our next question is from the line of Kevin <unk> with G. Research. Please proceed with your question.
Hi, Thanks for taking the questions maybe.
Maybe first.
Congratulations on getting the initial procurement moving from from BARDA can you remind us of any deliverables needed for that second procurement that you expect later this year.
Randy you want to take that sure. So thanks, Kevin Yeah. So we're excited that we achieved the first procurement certainly continue to exemplify <unk> commitment to advancing the program that we continue to plan for this second procurement in the second half of this year.
We've continued to state the future procurements are tied to ongoing progress of the program. There is no specific milestone assigned specifically to each of them. So we're we will continue to have discussions with BARDA.
To provide more specifics in the future about the exact timing of that procurement the second half of the year.
Okay great.
And then switching over to a minocycline and cap, we kind of had a bit of a.
Abnormal cap season, this year with everything with COVID-19.
Are you guys thinking about the next cap season, do you expect something closer to normal.
You anticipate that's still going to feel a lot of this COVID-19 disruption as we start heading into next winter.
As we look at the success of the vaccination program throughout the U S.
Sure.
Very.
We're excited about that with regards to our commitment as a company too.
<unk>.
To provide resources for improving.
Health across all populations and what was interesting was that the public health measures that were instilled.
During the COVID-19 pandemic that included social distancing.
Rigorous hand washing as well is masking.
Really drove the community acquired pneumonia of rates too.
I think a lower rate than has been seen in many decades.
That being said I think that we're seeing that the vaccination programs have been successful with.
With the recent CDC guidance as we see an expansion of.
Folks being able to interact on a.
More pre pandemic massless.
Interaction basis, and I think we'll start to see trends in the fall.
For a more normal pneumonia season.
That being said.
I think that another aspect of our expansion for the new Xyrem franchise debt debt I think will play into this quite a bit given the fact that because of COVID-19 I think hospitals have been places where most patients and those doctors are trying to be very cautious about referring patients who are ill there and.
As such I think there'll be more concentrated effort to keep people out of the hospital and keep them home and our stay home strategy.
Strategy with regards to the oral only and potential loading dose for pneumonia I think will play very well.
Into that dynamic come the fall.
If we if there is continued.
Growth.
In the community expansion as we started to see with the community launch with us skin infections.
Especially those with the MSA considerations I do think there'll be I think our growth in opportunity come this fall.
Okay I appreciate that maybe last one.
Can you talk about the.
Mentioned stockpiling opportunities.
Or at least government opportunities in the U S. B on the initial contract from Florida do you see opportunities with international governments as well would you need to have approval of news already in those countries.
Before you go to others discussions or would you be able to.
Have discussions with other governments, but.
<unk> you have new cyber.
Approved in those markets.
Thanks for that I'll have Randy addressed that one sure. So yes, we are continuing to pay attention to what's going on around the world with regards to antibiotics.
Antibiotic incentives in which include some potential for stockpiling on you.
Probably read some of the European countries or are thinking about doing some of those activities now as well.
A precursor to many of those does require regulatory approval in those countries that being said as we continue to expand our database, particularly on pandemic preparedness and bio threats.
We will continue to share that data and look for ongoing opportunities to look to ways to provide opportunity for ex U S countries to to look for a stockpiling opportunities for bio threats and antibiotic resistance as well.
In point of fact, Kevin just to build on what Randy said, if you look at the.
The essential medicines listing of unused IRA in the bioterrorism category as well as this recent poster that Randy mentioned in his presentation, specifically around the CDC moving to add on.
On <unk> Zara as a second line option.
For plague you can see that not only are we having a franchise product profile for I think more bread and butter skin and pneumonia infections I do think that the pandemic preparedness portfolio of commitments by the U S government.
Is something that I think will be very hard for others to ignore in terms of what we are doing internally from a Dod perspective on on preparedness and the commitments of BARDA et cetera, and I think that it will lead to other opportunities that we can explore outside of the U S as appropriate.
Okay. Thank you.
Thank you Ken.
Okay.
Thank you. The next question is from the line of Susan Zhang with Jefferies. Please proceed with your question.
Hi, Thanks for taking my question.
The first one is about MTN ATB trial, I'm, sorry, I missed it earlier on when do you expect to share the trial design and then I have follow up questions.
So yes, so we.
We are planning a meeting in the near future to really review in more detail. The MTM study design. So that's coming shortly and I think Ben will provide more information. Once you are able to share the date of that meeting.
Okay. Thank you.
That all being said synergy I think that there's opportunity here for us to.
B.
Relatively innovative in terms of that approach given the fact that there are no no approved oral therapies for.
For this disease, and we are looking forward to being able to share that.
More broadly in an upcoming meeting that we'll announce shortly.
Okay. Thank you my next questions are on the expansion on the day alright into the community setting <unk> EVP.
Any additional sales force do you expect to add to support the indication in debt primary care setting.
And second question is when do you expect to see the full impact I think expansion of sales force.
E on.
On net sales.
Thank you.
Adam do you want to take that one yes, okay. Thanks, Kevin.
Well first one force I'll take those in reverse order actually.
We expect.
See the real impact of the expansion in the latter half of this year.
This field force was obviously recruited in the first quarter is just getting up to speed as we move into the second quarter on the.
Full impact will be realized in the second half, but early signs are extremely encouraging and we're really pleased with what we've seen on.
With regards to whether we need new on additional representatives to support the capital on she ounces simply no.
Don't need to expand.
On where we plan to be which would be.
Sort of steady state, having about 40 45 hospital base represents sales from about 40 in the community.
And the reason for that simply is that many of the individuals the prescribed the skin also overlap significantly with those.
Prescribed for community acquired pneumonia, and so you get a day.
I will hit on those individuals that you were targeting you might shift your focus a little bit both of these diseases are a bit seasonal as you can imagine there's more skin infections in the summer on more pneumonia in the winter. So you might reverse your order of day tightly and you may over index on pause.
<unk> for one indication rather than the other at some point in time.
As we've stated in the past, we're very careful with putting lots and lots of representatives on the ground until we're sure that we will realize the benefit I think we feel that we can benefit from putting more and we'll look at that at some time in the future.
I think that the.
Other components of the.
The timing of how we are expanding the community <unk> I think is an important one to consider which is that we believe that it was important always to have a solid foundation in the hospital setting.
To establish I think the credibility of the product in the sickest patients with infectious disease individuals and physicians being being the primary prescriber. The other the other I think feature of of the predicate for setting the right conditions for a successful community expansion includes the robustness, we believe of our market access.
Efforts to date and I do think that those efforts and our operational support here I think we're part of the underlying reasons for despite the insurance resets in some of the COVID-19 pandemic headwinds, we were still able to see a robust quarter over quarter growth in the first quarter of <unk>.
This year.
Okay. Thank you.
Thank you Susan.
Our next question is from the line of Ed Arce with H C. Wainwright. Please proceed with your questions.
Okay.
Hi, guys. Thanks for taking my questions and congrats on the first.
BARDA procurement this quarter apologies for the issue with the phone earlier.
First couple of questions.
As regarding new Zara.
Firstly.
I think you started you had started engagement.
With the primary care.
Physicians back in.
In February.
It's been roughly three months now on I know that you are expecting.
Hopefully on the expansion of the label later this month.
Maybe.
Discuss.
For us a bit.
What you're hearing.
As you.
Look to expand for the oral cap and the community what youre hearing from physicians.
<unk>.
The feedback that you're getting and how you think that will.
Tie into your your expectations for the latter half of this year and then.
More broadly I was just wondering.
Certainly there is.
Yes.
Right.
Early in the year, given COVID-19 as well as.
The cycle of reimbursement, but just wondering.
If you can give us a bit more detail on how you think the growth will sort of unfold for us IRA through the remainder of this year.
Thanks, Ed for those questions, maybe Adam you can talk a little bit about the <unk>.
Inbound that were hearing about the potential for the oral only loading dose and how that will help with regards to your projected expansion.
Success in the fall.
Yes so.
So hi, Ed.
Oster.
So about going in since February look, we're really encouraged with what we've seen <unk>.
All signs are good.
And.
We are pleased with.
On the uptake.
The.
On the feedback that we're getting on the skin side is very simple.
Physicians are desperate for a really good once a day oral drug that has MRO site coverage.
And we are absolutely sure.
Based on what we're seeing that we will continue to see uptake as we go through the bulk of the skin season, which is in the middle of this year.
With regards to pneumonia slightly different we've conducted a number of advisory boards and we've done some market research.
Slightly different.
<unk> forward to with regard to use or is it is a drug that can be used in the elderly safely.
Good morning, Pete mono therapeutic coverage of the relevant pathogens and on drug that doesn't cause C. Diff. Unfortunately, that's something that affects the older patient population quite a bit.
Along with the <unk> issue that you see with some of the drugs that are on the market.
It's a safety story as much as on efficacy story in community acquired pneumonia community acquired.
It's all about the efficacy because of the MRO side once a day drug.
Yes.
We will target those.
<unk> along with their needs.
And based on the once daily dosing.
We're sure we're going to get good uptake the only really efficacious therapies that are out there in oral form for pneumonia today on the quinolone and we know that <unk> got some significant limitations from a safety perspective, and we will take advantage of that.
So in terms of your quest.
Question with regards to how the growth might be expanding.
Throughout the balance of the year.
<unk>.
As you know I think hit.
Forecasting in the midst of the COVID-19 pandemic really has provided real challenges for us for for every company that that's commercial at this.
Point in time, but we continue to believe in the blockbuster potential of our new Zara and I think the continued strong demand that we're seeing.
Coupled to the <unk>.
Dart of prescriptions and adoption in the primary care setting I think continues to fuel our continued belief and confidence in the future growth.
<unk>, we think that continued growth in the second half of this year I think will be an exciting journey for all of us to be on and for us to be part of I think there are many other components of of contribution to that second half growth that includes a potential second.
BARDA procurement I think potential for Dod purchases as we've mentioned and continued organic growth in our overall institutional commitments as well as as what Adam has said.
A further expansion in our primary care.
Estimated market addressable opportunities.
In the in the event that we get that FDA approval for our NDA for the oral loading dose. So we remain confident and excited about all of that.
David I would add that we anticipate.
I think of some of the restrictions that we see continuing in the hospital and the move to the more impactful face to face interaction as we go through the year and at least from already seeing.
Thank you for that Adam Thank you Ed for the questions.
Thank you at this time, we have reached the end of the question and answer session I will turn the call over to Evan Loh for closing remarks.
As there are no more questions. We will continue we will conclude today's call in closing I'd like to thank you all for your time and attention today. Your continued interest in use iron Powertech are important to us the journey of making use IRA commercial success is well underway.
As the wealth of microbiological data and clinical outcome studies on <unk> continues to expand we are increasingly confident in the potential and desire to be an effective and a much needed addition to the armamentarium of antibiotics available to physicians to save lives, particularly where resistance is of concern.
The opportunities ahead of us to be able to provide a novel life saving antibiotic to patients motivates us all here at <unk>.
We would like to thank the patients who have participated in our clinical studies and our employees, who have worked tirelessly and passionately to provide us higher for patients in need and those selfless and dedicated health care professionals, who are at the bedside each and every day, we very much. Appreciate your continued support and interest we look forward to keeping you apprised of our continued progress.
Goodbye for now.
This concludes today's conference you may disconnect your lines at this time and thank you for your participation.