Q3 2019 Earnings Call

Thank you for standing by this is the conference operator, welcome to the Paratek Pharmaceuticals third quarter 2019 earnings call.

As a reminder, all participants are in listen only mode and the conference is being recorded.

After the presentation, there will be an opportunity to ask questions.

To join the question Q you May press Star one on your telephone keypad should you need assistance during the conference call you may signal operator by pressing star zero.

I would now like to turn the conference over to Bend strain Vice President of Investor Relations and corporate Communications. Please go ahead Sir.

Good afternoon, and welcome to Parateks third quarter, 2019 earnings and corporate update conference call a press release with the Companys third 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 Paratek pharma dot com.

Participants on today's call, our Evan Loh CEO .

Adam Woodrow President and Chief Commercial Officer, Randy Brenner, Chief Development, and regulatory officer, and Michael Brigham Executive Chairman and Sarah Huggins, Vice President Finance controller, and principal accounting officer will also be available for questions.

I would like to know that Adam will be participating in the call from a separate location.

Before I turn the call over the Evan I would like to point out that we'll be making forward looking statements, which are based in our current expectations and believes these statements are subject to certain risks and uncertainties actual results may differ materially I encourage you to consult the risk factors disgusted out at the SEC filings for additional detail Evan.

Thank you Ben.

Good afternoon, and thank you all for joining our third quarter 2019 earnings call in corporate update.

Has been extremely busy and productive past three months with a number of important events for paratek.

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We generated 3.9 million a net revenues in the third quarter, primarily driven by the U.S. launch of news IRA.

Net sales for needs IRA increased 82% to 3.1 million in the third quarter over the previous quarter and we also earned royalty revenues of approximately 900000, primarily from say Sarah sales in the U.S.

We are encouraged by the performance of news I was long so far this year.

Characterized by significant quarter over quarter increases in demand.

Particularly driven by the oral formulation.

As well its continued progress in securing institutional and payer access.

As of the ended the quarter over 75% of commercial lives in the U.S. now have access to new Xyrem.

We've also continued to increase the size of our salesforce in a disciplined manner with geographic expansion as we target opportunities in locations, where we're seeing the greatest level of success in trial and access.

We believe that these launch achievements. So far this year are setting the foundation for future growth.

Early this month, we released topline exploratory phase two results into urinary tract infections studies, which Randy will cover in greater detail.

We're pleased that the innovative design and high quality conduct of these exploratory and adaptive phase two studies provided us data that has built identified a potential dose regimen for further investigation and ruled out ineffective once.

This is exactly what drug development is designed to accomplish provide driven data driven guidance to facilitate sound decisions.

Well both studies may have identified a potential does they could warrant further exploratory investigation. We currently are not planning for any additional clinical development activities and yutai.

As always we remain committed to sharing our findings with the medical community at an upcoming scientific Congress.

That all said, we see more compelling investments and other lifecycle opportunities for desirable.

One of the most important these other opportunities is our pursuit of an oral only indication for community acquired bacterial pneumonia or CABP.

As we mentioned last quarter, we have agreed on a path forward with the FDA to evaluate an oral only dosing regimen for news, Iran cap.

This pharmacokinetic study is designed to show that an oral only dosing regimen will have a comparable pharmacokinetic profile to the approved Ivy to oral dosing regimen in patients with cap that was established in the phase three optics study.

We're pleased to report that we have and that we have initiated sites and plans to begin dosing patients in the fourth quarter of this year.

Based upon a small size of this study once completed.

We anticipate a supplemental NDA submission followed by potential approval for this dosing regimen in time for that 2020 pneumonia season.

We have identified another promising lifecycle opportunity for news IRA with significant potential.

It's called or referred to as non tuberculosis mycobacteria or NTM.

NTM lung disease is a rare type of infection caused by several naturally occurring michael bacterium species, including might go back to your M. abscessus.

Patients that are susceptible to developing NTM, so just patients with underlying pulmonary diseases, including CLP D rocky emphasis and cystic fibrosis.

NTM infections can become resident in these damage lungs, often becoming chronic.

Debilitating.

And requiring prolonged treatment courses with antibiotics for periods ranging from six months to several years.

Oh, sorry, NTM carries a five year mortality rate of approximately 40%.

Today, there are no FDA approved therapies to treat NTM when caused by mycobacteria M. abscessus.

In these cases antibiotics are used off label.

In various combinations of oral and intravenous antibiotics with their attendant and myriad safety concerns tolerability limitations and low rates of treatments success.

Intravenous antibiotic regimens also khan with complications such as a poor quality of life, requiring daily clinic visit sprint fusions risks of Ivy Catherine infections and risk of upper extremity deep venous thrombosis.

Safety Tolerability quality of life issues combined with poor clinical outcomes speak to important unmet needs that well tolerated oral antibiotics could potentially address when treating NTM infections caused by Mechel mycobacteria abscessus.

We're pleased that many of our key opinion leaders have offered to work with Paratek to study news IRA in this disease.

Randy will provide more details during his prepared remarks.

Before I hand, the call over to Adam I would like to provide some financial highlights for the third quarter and an update to our guide.

We generated revenues of 3.9 million of which 3.1 million was attributable to news I read net sales.

Our partner Albuterol also continues to see success in their U.S. launch of say Sarah.

We recorded royalty revenues of approximately 900000, consisting primarily of royalties earned from say Sarah sales in the United States.

<unk> expenses were 23.6 million, but the third quarter of 2019 compared to 13.6 million for the same period in 2018.

The increase was prime Minister is primarily the result of the cost of our contracts Salesforce and other commercialization costs in support of the U.S. launch of use our.

R&D expenses were 8.4 million to the third quarter of 2019 compared to 16 million for the same period in 2018.

The decrease was primarily the result of the capitalization of use IRA commercial supply costs, which were classified as research and development costs until FDA approval of news IRA.

This decrease was partially offset by higher clinical study costs associated with our phase II Your T.I. program.

We continue to remain disciplined from an opex perspective balanced against potential investments in areas. We believe will create long term shareholder value.

We ended the quarter with 225.6 million in cash cash equivalents and marketable securities.

We expect our cash position will fund the company's operating expenses capital expenditures and debt service beyond the first quarter of 2021.

Now turning to our revenue guidance.

We now anticipate 2019 use IRA U.S. net product sales will come in within the previously communicated range of 10 to 13 million.

Likely at the lower end of the rate.

We anticipate that continued revenue growth in the fourth quarter will be partially driven by recent initiatives that include an increase in the size of the field force in time for the fall pneumonia season.

And further expansion of institutional access within the group of approximately 600 targeted hospitals.

With that I'll now turn the call over to Adam.

Hi, Thanks, Adam.

The U.S. launch news <unk> continues to progress well, we encouraged by the continued growth seen in the third quarter.

Particularly strong demand and that once daily oral formulation.

We believe many of the successes and leading indicators seem to date.

Well for the future.

As the first broad spectrum once daily oral antibiotic approved for both pneumonia and skin and maybe 20 years.

He believed that news on that has begun to address important unmet medical needs and we see this community acquired infections. Whilst also combating antibiotic resistant pathogens that are resulting in clinical five years I'm pull outcomes with older generic antibiotics.

Yes, I was convenient once daily oral and I'd hate dosing auction is providing flexibility in prescribing, resulting in minimizing hospital stays and in some cases, allowing patients to avoid hospital admissions altogether.

In addition.

We believe that Miyazato safety and Tolerability profile provides a much needed alternative so many existing antibiotics, such the quinolones sort of expanding safety concerns as highlighted in that black box warnings.

[noise] history tells us, but it takes a sustained efforts in education and patients to establish momentum for new Ivy onto boxes in the hospital setting.

Optiswitch adoption in the community setting <unk> companion once daily oral like news, Iowa CAD accelerate.

So that's when you saw this key attributes are resonating with the medical community and provide support for our commercial strategy, which is tracking favorably in recent market research.

In the in the market research.

The physicians the dollar where you saw that approximately 95% stated and then tend to use news either a significant <unk> and this is significantly more HCP is now consider themselves like you. Let me use our users compared to the research that was conducted earlier in the launch.

As I mentioned USADA generated 3.1 million in net sales in the U.S. and the third quarter compared to 1.7 million seeing in the second quarter.

The increase of 82%.

Accounting for inventory USADA gross demolished nearly doubled from approximately 1.7 billion in the second quarter of 2019, So approximately 3.3 million in the third quarter of 2019.

Representing a significant increase quarter over quarter.

Our initial outreach continues to be directed towards albeit docking hospital specialist, including I'd DOCSIS Pulmonologists Hospitalists and the oppositions, we didn't the nearly 600 key accounts we target.

During the quarter, we expanded the south full size to approximately 50 representatives and we'll continue to just give since may add represents teams throughout the balance of the year toward our target 60 by yearend.

We've taken a measured approach without hiring process as we balance outside on investments to ensure we have to write represents teams in place to drop.

The value creation.

Accordingly, these additional representatives that if folks reagents, showing trial and adoption as well as to newly established regions, where we have received inbound clinical interest or significant access wins.

In our key topics hospitals and integrated delivery networks, we've been focused on gaining institutional access from USADA, while making steady progress in raising awareness.

We have achieved institutional access at approximately 60% of the 600 to topic at hospitals have several significant hobby, formerly decisions in the coming months, which if successful will continue to provide further adoption momentum.

We also also continued to make progress with commercial pious.

Oh, the 75% commercial lives in the U.S. now have access Juniors, Iowa.

We've also started to its strong improvements with the government sector.

Such that the majority it was state Medicaid programs top and use our law, including many of the biggest studies such as New York, New Jersey, Texas, Florida, Illinois.

We are energized by our progress to date, we believe we're on the Black Hawk USADA I would also well positioned for long time commercial success.

We look forward to reporting on our progress in the quarters ahead.

I'll now turn the call over to Randy.

Thanks, Adam as we look towards the balance of this year, we have several important potential value drivers, which we believe should enhance value for shareholders. We continue to pursue several compelling lifecycle opportunities for new zira, including initiation of the oral only cap PK study and taking steps to explore a path forward and NTM caused by my.

How about carrying obsess us.

I believe that these opportunities will broaden the potential news Iraq to reach into new and clinically important patient populations.

Has there been mentioned, we released topline results for our phase two studies in acute pyelonephritis and uncomplicated urinary tract infections.

Both studies were adaptive studies, which included multiple dose regimens of a modest cyclean, but the objective to identify a dose regimen for further investigation that would be clinically and micro biologically effective in the indication.

The first phase two study enrolled 225 subjects and with designed to evaluate the efficacy safety Tolerability and pharmacokinetics of oral only regimens of modest cyclean compared to an oral only regimen I'm not sure if you're a talent and female patients with cystitis or uncomplicated urinary tract infections.

In this study we also evaluated the impact of a light meal two hours prior to dosing on day one only.

We did see a modest improvement in Gi tolerability with generally lower rates than what we've seen in prior studies at similar doses.

In this study maddest cycling showed generally comparable levels of clinical success. However, the microbiological responses and us the composite clinical and micro biologic endpoints are generally lower than comparator.

The 450 milligram be I'd dose demonstrated numerically higher outcomes, but due to the small numbers of patients in this group. This dose regimen would require significant further clinical investment.

The second Phase two study was designed to evaluate the efficacy safety Tolerability and pharmacokinetics of once daily Ivy or Ivy to oral amount of cycling compared to once daily regimen of Ivy to oral leave a flocks ascena in patients with acute pyelonephritis accommodate clinical subset of complicated UTI.

In this study 201 patients were randomized into one a format of cycling dosing regimens or leave a Flokser center.

In the study a matter of cycling again show generally comparable levels of clinical success to leave a flocks ascend however, the microbiological responses and thus the composite clinical and micro biologic endpoint or generally lower and then comparator.

Both studies Mattersight than was generally safe and well tolerated had consistent with states results from previously completed pivotal phase three clinical trials.

Additional analysis of the phase two studies are ongoing including pathogen specific level efficacy and relationships at both clinical and microbiological responses to urinary pharmacokinetic data, we will present data from both these studies at a future Medical conference call. Both studies may have identified a potential does that could warrant further exploratory.

Investigation, we currently we're not planning for any additional clinical development activities and urinary tract infections.

As we previously noted we've agreed on a path forward with the FDA to evaluate and all the dosing regimen for his IRA community acquired bacterial pneumonia or CABP.

Previously mentioned the FDA has requested PK profiles for approximately 20 cap patience to support the approval this labeling language.

We have initiated sites for this study and anticipate dosing to initiate by the end of this year.

Based upon the small size of the required trial, we anticipate a submission and potential approval for this pathology in time for the 2020 pneumonia season.

We're also exploring additional indications to further augment the value for amount of cycling and address critical unmet clinical needs specifically, we're exploring a path forward and not tuberculosis mycobacteria lung disease also known as NTM lung disease in the United States, the incidence of pulmonary NTM as rising.

The annual frequency of NTM as approximately 70, 80000 cases with recent research, indicating a yearly increase of about 5% to 10%.

NTM is broken into two major groups slowly growing slow growing mycobacteria, such as mycobacteria Avium complex also known as Mac and rapidly growing mycobacteria, which includes mycobacteria obsess.

No matter cycling has demonstrated potent in vitro activity against might go back carry much sss.

As we have published also choose very high pulmonary penetration levels in humans.

Michael bacterium Abscessus infection is an orphan disease and accounts for approximately 10% of all NTM cases here in the U.S.

There are currently no FDA approved therapies for NTM caused by mycobacteria processes.

These patients are treated with complex two to four drug combination regimens that I've tolerability challenges and often require patience to return for daily Ivy infusions for months of treatment, which can significantly impact quality of life.

Effective oral option would be a clinically important and welcome addition to the limited list a therapeutic option is being used today.

We're currently considering options for the appropriate development pathway for the treatment of NTM with a matter cycling.

This summer we submitted a response to an RFP issue from project Bioshield from BARDA intends to project Bioshield is to provide government funding to support the required late stage development activities data for FDA approval of a buyer threat indication and for the purchase of the selected therapeutic for the strategic national stockpile in it.

Advance of achieving that indication.

Based upon the approved label for news, Iran, pneumonia, including both oral and I'd be formulations combined with the promising in vitro and then vivo animal data against the like Biotrue, our pathogens already in hand, we believe the desire is well positioned to compete for funding from this program. We continue to expect a decision regarding any such award will be made by the end.

This year.

With that we will open the floor to questions.

Thank you Sir we will now begin the question and answer session to join the question Q You May Press Star one on your telephone keypad, you'll hear a tone acknowledging your request.

Using a speakerphone please pick up your handset before pricing any key to withdraw your question. Please press star too.

We will pause for a moment as colors join the queue.

Our first question comes from Robert Hazlett with BTG.

Please go ahead.

Hi, guys. This is Jack on the line for Bert Thanks for the question.

Ah So I guess, maybe just to start off if you could just kinda talk about the qualification on guidance for the lower end as the pneumonia season is just getting started and maybe some of that the trends you're seeing.

So as you as you look at what we've been seeing over the last several quarters. We continue to see I think progressive growth in our overall utilization specifically in the trial and.

Trial phase and what we've been pleased about is actually we've been seeing more and more repeat prescribers.

As we said before also that the majority of our ER.

Prescriptions today or in the world.

Warm.

More than the Ivy and we think that this trend will continue over that over the pneumonia season that being said given the fact that this pneumonia season is just getting started.

Plus I think some other changes in our.

Overall reimbursement profile, including obtaining the J code and the beginning of October I think portends I think for potential positive acceleration in our overall uptake in the upcoming ammonia season.

Okay. Thank you and I guess, what I can just follow up on the Big cap PK study. Yeah are you looking at multiple doses. There is or are you looking at the loading dose we saw for first scan or some of the other dosing regimens that maybe we looked at a new T.I. in any learnings from the U.T.I. studying in terms of an oil.

Oral.

Dosing regimen for cat. Thank you.

Sure. So this is Randy. So so this study is really designed to show comparable PK from an oral start pathology compared to a ivy to oral pathology pneumonia population. So.

It's not a typical study where we are evaluating multiple doses to try and see one that works. So on the design is really quite simple we're looking at.

You know a loading post allergy that will match. The first two days from a PK you see perspective compared to our IP to oral study.

Got it thank you.

Our next question is from Amy.

CB Leerink. Please go ahead.

Hi, Thank you for the question.

Can you talk to just sort of your.

Neatest expectations for the peak that any potential for new genre has that changed at all.

You know you, obviously need probably isn't going to product, but I was just curious if your thoughts on sort of the BP beak seems prevention of change at all.

Secondly, just on the bond or.

What gives you confidence that we will in fact to get to eat decision before the end of the calendar yeah.

And.

You know last time, you had indicated that.

Once you receive a kind of the allotment.

It might take a couple of months to finalize some of the Thompson the RFP.

It's like me be some time before you can actually publicly announced that.

Since you've non.

It sounds like you've not be seem to decision from from them yet.

Could we anticipate still getting that decision by the year end, you didnt see that but I just wanted to understand sort of some of the details around that thank you.

Yeah.

So iommi its Evan Thank you for your thank you for your questions in terms of our expectations are currently I think we continue to be positively a you know it's continued to see positive signals in terms of a patient experiences as well as feedback from our physicians, it's still relatively early and but at this point of time, we don't see.

The see any changes in terms of the way we.

Look at the potential for this product and for the BARDA question I'll, let Randy.

Address that question yeah. Thanks, Evan.

So we've been.

Continually assuming that a decision from BARDA would be a made by the end of this year.

I don't really have any new information from what we've had in the past.

Other than a there, but a number of recent meetings that have taken place in Washington, D.C.M. I'd week, there was a BARDA industry day by then the World AMR Conference that took place in Washington last week as well, but all of those reading BARDA Rep meetings BARDA representative the Spokane had a consistent message around the importance of project bioshield too to them as well as to the sector.

And that their expectations, where that it award would be coming shortly.

So so we feel comfortable that.

We ended the year seems reasonable of course.

It's a government project is totally out of antibodies the industry industries control, but.

We'll be continuing watching any of the public statements around any further updates for timing.

Our next question comes from Jason Gerberry with Bank of America. Please go ahead.

Hi, This is Ashwin mall on for Jason So couple of questions. So on news that can you help us understand the fact that you saw from the October implementation of J code and just as a follow up as you go towards 2020 or do you expect to see any kind of saw meaningful step up.

No coverage than the current 75% lies and what are the typical coverage policy to quite a good news that I in terms of price step edits.

Yes. Thank you for the question I'll have Adam actually handle those three questions.

Thanks, often look.

We got a.

J code at the beginning of October .

You know what I say that we do still very early in terms of the.

And then pipes, but we do anticipate we're going to see.

Seamless reimbursement when individuals prescribed the idea in the outpatient setting. So it is part of all the all.

Consideration from an acceleration perspective will be called suits, all all while growth in the last quarter.

Last question also about.

We expect to see some additional coverage beyond simple bodies, yes, we continue to work on gaining additional coverage with the paez. Some just take longer than others. It's just the fact and every time, we work with them.

On the one by one basis, they genuinely up relatively favorable which leads me to the last part of your question, which is you know what toppled fall hurdles in place from a from a step that it will probably legislation perspective.

So we're not seeing a great deal of prior authorization all step edits involved in fact, we're seeing.

Now I'll step edits whatever clubs will show up to some genetic dropped before they always see news article.

Yes.

We do see it occasionally causal realizations will most probably localizations really just asked the question is.

In the strong label or sometimes there's a quantity limit fall they.

We will follow who is actually causal the prescription is limited to.

You know mumbled 14 values over the last announced.

Even then depending on what we indication is awesome, sometimes physicians will.

Let me to the payers and.

Change that.

But we're very very pleased with the exception that result from the past summer fall.

In terms of all the tough which is our and we do anticipate continued to see really good.

Couple of each insight will talk with toppling, sometimes one commodity hopeful by the end of the yet.

Great. Thanks, and I just had a quick follow up do you have any metrics for.

What proportion of cap Pete men, all constituting the pneumonia season was off season.

I didn't catch that question could you put into place.

You have any metrics on what proportion of thought he'd be treatment August getting that pneumonia season, what's this off season.

[noise] well with both both skin and pneumonia with seasonal and you know we got both those indications suite, we change our promotional focus some skating to pneumonia as we move into the winter season, then back to skin the summer season.

Remember one of the one of the challenges we are faced with them on the we're working on through Randy and the team is to get the oral only indications.

Ladies and for that is because you know the vast majority values is clearly coming in the oral formulation and that's where we expect to see the growth which is one of the reasons with focused on the will oney indication.

The pneumonia.

We all the factors from our perspective, we're seeing.

Still seeing the majority of our utilization on label between skin and pneumonia, but we obviously like most empty Bossier city, a significant part of that business, which is an off label utilization.

The other than the other thing that I would just at the other thing I would add to Adams response that Thats really important as we think about the world.

Yeah, we receive consistent feedback is one is the once a day oral formulation, it's a companion to the Ivy. It has a safety profile that mimics the more than eight decades of tetracycline safety and.

When you put that altogether in the absence of cardiovascular risk and the the unmet needs with regards to the broadening.

Safety concerns with Quinolones.

We continue to feel very very positive about some of the reflections that we're getting back from both patients and physicians.

Our next question comes from Ed Arce with H.C. Wainwright and company. Please go ahead.

Hi, Thanks for taking my questions. So first on the PK study or all oral top.

I know you just Ah you just recently announced.

Initiation starts out before the end of the year, but what are the what's the timeline you were thinking when do you think ultimately you get this.

Study wrapped up submitted and.

You know the change to the label.

Second.

On.

The NTM study.

[noise] clearly, it's still early days, you're looking at a regulatory path.

Meeting with the agency, but what specifically about.

This syndication is attractive to you given given the profile of from out of cycling a and then lastly.

The 3.3 million in gross demand that you mentioned the quarter what exactly is involved with the 2.2 million Delta there from the sales is that stocking or something else and if you could just help explain to us. Thanks.

Okay.

Hi. This is this is Randy I'll start with your question around the cap study. So our expectation is the cap study will initiate enrollment in the guys. As we've we've stated in the fourth quarter. This year due to the small number of patients. We expect enrollment will complete in the first quarter of next year.

To give us some time to get the data together and have the regulatory submission and the second quarter of next year, how with approximately a six month review, which would get approval late third quarter early fourth quarter just in time for the 2020 pneumonia season.

With regards to NTM I'm in the profile for a modest likely in I think theres a couple of clear things first off is the.

Data that we've seen with regards to the in vitro potency and we know that amassed cyclean has.

Very potent am I see is against mycobacteria abscessus.

The community isn't a huge need for an oral well tolerated once daily formulation. These patients are on therapies.

612, 18 months home, so the ability to minimize Ivy therapies for these patients and their impact on the quality of life. This is quite meaningful and impactful to to patients and providers.

So we think feed the profile the product is.

Well fit for the needs of the NTM community, particularly around mycobacteria processes.

Yeah.

And what was your third question could you just clarify that question for him.

Yeah, just the a that the difference between the net sales and use IRA and the not gross demand of 3.3 in the quarter.

What's driving that so.

It's it's really a.

And Hey, a difference in inventory at the 3.1 in net sales is actually what ultimately goes to our customers in terms of our specialty providers et cetera. So it's really as a small differences in terms of demand in terms of inventory.

Yeah, it's out of them.

It's Adam I think the quick easiest way to explain it.

Just the we tried to give you the gross to bomb. So you can pick quarter on quarter.

Takes out inventory that takes out gross to net.

Oh I see Okay, and then perhaps a squeeze one last question in here.

Given that we now have three quarters in the year I just want to make sure I I've got the number straight year.

Looks like about 6.1 or 6.2, so far this year in terms of.

Net sales so you're looking at.

If you do.

Hey, good low end of your guidance about 3.8 or 3.9.

For the fourth quarter is that right.

To get us.

Yeah, I think that that to get us to 10 million, which is the exact bottom of our of our range Ed but as we've said I think we're going to fall within our.

Previously provided guidance of 10 to 13 likely in the low end of the range.

Understood. Thanks appreciate it.

Right. Thank you Ed.

Once again, if you have a question please press star one.

Our next question comes from Kevin Kedra with GE Research. Please go ahead.

Okay. Thanks for taking my questions Oh meat NTM opportunity first just wanted to ask if you've been seeing anecdotally any use off label for that indication and what you've been hearing back on that and then secondly on that indication. The FDA has kinda notoriously tough.

On on new indications, where they don't already have a guidelines kind of set up for approval. So what gives you confidence that you'll be able to find a path forward with the FDA. That's something that we should think about falling under kind of the l. pad pathway and then finally, if you could just give us sense of.

Well its current or if you look like in the in that indication now is it its combination therapy used as a single agent therapy and.

Would you look at kind of mono or combo therapy in any sort of study.

Yeah, Yeah, Hi, Kevin it's a it's a evan thank you for your questions.

I think when we when we think about the NTM opportunity I.

I think that we have.

Add some anecdotal inbound from clinicians in terms of the market asking for whether we would consider it because of our world. They have agents multiple agents a intravenous as well as a a few orals that are relatively poorly tolerated some involve quinolones.

Tom involve other agents that have bone marrow suppressive effects that you can't take up for the long term and some of the Ivys are as you know just are not practical from from a daily infusion.

Perspective, and so as we think about the path forward I I do think we're exploring multiple different development pathways and maybe I'll, let a randy talk a little bit more about those [noise].

Sure. So yes, so the.

As you noted we have not had discussions with after you add on this this pathway, although it's part of our thinking process and we'll certainly would be part of our plans to do early part of next year.

Well pad is certainly out there and something that we are thinking very heavily about with regard to how best to use that haven't really is designed specifically for this type of situation, where you have a rare disease, you know, particularly around mycobacteria missteps, that's where you have given the bar ballpark of five to 7000 cases in the U.S.

So you're thinking about the orphan status and the rare disease potential pathways Telpad certainly falls into one of those so.

Well be working closely over the next couple of months internally and with our K a wells to design to study that we think's makes sense. Following many of the pathways that had been previously established through the rare disease activity as many of which I participated quite closely and in my previous roles and I think you know with the right discussions and the right Kale wells.

Port that will come we would be able to come to some I agree with F.D.A. There was such a small patient population. The U.S. that study wouldn't be overly conversation, but those discussions are yet to be had yeah and I would just add to that Kevin that you know as we think about the potential development pathways as well they the most important focus for us is to provide.

Adding information that clinicians can use and today they are clamoring for they're asking us for it as well we want to be in a time time efficient as well as capital efficient.

Process in order to actually provide that data and there are other pathways that are available to us that we're also exploring outside of a strict FDA approval process.

Great. Thanks for the color and then if I could just ask about the Utica indication.

It sounds like that you guys aren't going to pursue that.

Any further I know that wasn't part of your long term guidance, but.

It was certainly significant opportunity and differentiation factor for news Iris so.

When you think about the company and the structure of having a single product company does that change at all.

When you take.

Out of the equation.

You know when we when we when we consider and use our or one of the reasons that we're excited about news IRA and continue to be is the fact that it is a franchise product and how do we define a franchise product what we define a franchise product by first of all having a once daily.

Companion, Ivy and oral product that is safe and well tolerated and Weve clearly established that through our.

Broad based safety database and from what we're hearing from clinicians I think the high levels of efficacy that we had seen in our clinical trials today are being a are being seen in replicated in the in the in the clinical setting a in addition to that tetracycline gains have historically known to have a very broad based opportunity in terms of.

Exploring other indications from a lifecycle management perspective, you know that from a Deo de perspective that we've initiated a early animal PK studies to look at.

Bioterrorism organisms, we've applied for the RFP for bio shield as as Randy said in his prepared commentary in addition to US having an approved gnomonic indication with both an oral eni. The indication. We also have in vivo and in vitro animal data, which I think positions us well competitive.

For that particular award and as we look at NTM, we have micro biologic preliminary data that looks very favorable with regards to non tuberculosis mycobacteria us as it relates to those rare cases.

Treated I mean, oh precipitated by mycobacteria.

Abscessus and you know at the yet at the end of the day.

No we realize that a single product affords.

More risks than we would like to take as as a single product company and so as we said before in addition to the multiple indications they get to start with a franchise product, but after that I think once a week continued to build a further forward momentum that we that we're always open to adding other products at the right terms.

To expand our portfolio.

[noise].

Our next question comes from Robert Driscoll with Wedbush Securities. Please go ahead.

Oh, Hi, this is oh sure Mubarak on for Rob.

During my question.

I'm sorry, if I missed this in the prepared remarks, but did you mentioned.

Any thoughts on a timeline for for Europe first is on a given them a withdrawal and I was also curious about how oh the.

Oral only labeling in the U.S. might affect.

Oh, your clinical program going forward for Europe . Thanks.

Randy you want to take that sure. So so so for Europe . Our plan is to go back to Europe . Following the completion of our second.

I viewed oral pneumonia study that was.

We're required to do as part of the approval in the U.S.

We currently have timelines laid out.

With that study with the FDA.

Which is essentially a study completion and data submitted to FDA in April of 2023.

So shortly after that we will just turned around and update our European M&A and submit the product in Europe around the same timeline. So some sometime around the first half of 2023, and we would assume a one year review process again for that application, which gets us at approval somewhere around the middle of 2024.

Just remember in Europe , we went through the application intentionally to maintain our market exclusivity.

So the market exclusivity provisions in Europe wouldn't begin until the approval in 2024, so that exclusivity has been a preserved with regards to the oral only study the PK study and the impact on that study or our plans for Europe , there really very separate studies, how the oral only pneumonia study as we said as a small study looking at.

You get about 20, or so patients for the PK perspective to compare the PK of an oral initiation compared to the Ivy to oral initiation. So I decided it really two very independent in one will have no effect on the other yeah and I you know I would also add a one other thought here to consider as well I think that given the a broad base.

Broad spectrum nature of tetracycline isn't as we continue to explore lifecycle opportunities like non tuberculosis mycobacteria nonproduct not to break those mycobacteria caused by.

Abscessus is not a disease that just limited to the United States and so depending on what that path looks like in the data that we generate I can imagine that from an orphan disease and rare disease perspective that that might be pathway that may be a pathway that could a further be considered in parallel to the pneumonia indication.

For Europe for Europe , Yes.

Okay that makes sense. Thanks.

This concludes the question and answer session I would like to turn the conference back over to Evan Loh for any closing remark.

As there are no more questions, we will conclude todays call and in closing I'd like to thank you all for your time and attention today. Your continued interest in U.S, Iran. Paratek are important to us the journey of making these IRA commercial success is underway.

Profile. These iris specifically, our once daily well tolerated or less positioned well for long term commercial success.

As a wealth of date on them as I can continues to grow we are increasingly confident in the potential them as of a mattersight going to be an effective and much needed addition to the armamentarium of antibiotics available to physicians to save lives, particularly when resistance is of concern.

We remain committed to the continued professional development of these IRA through its lifecycle.

These opportunities motivated motivate us all at Paratek, and we would like to thank the patience and our employees who have worked together to make us all the reality for patients we very much appreciate your support interest.

We look forward to keeping you apprised of our continued progress goodbye for now.

This concludes today's conference call you may disconnect. Your lines. Thank you for participating and have a pleasant day.

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