Paratek Pharmaceuticals, Inc.
Q4 2020 Earnings Call Transcript

Published: 24 Feb 2021

[Operator:]

Greetings and welcome to the Paratek Pharmaceuticals Fourth Quarter and Full Year 2020 Earnings Conference Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a remainder this conference is being recorded. I'd now like to turn the conference over to your host Ben Strain, Vice President of Investor Relations. Please go ahead, sir.

[Ben Strain:]

Good afternoon, and welcome to Paratek's fourth quarter and full year 2020 earnings and corporate update conference call. A press release for the company's fourth quarter and full year results was issued earlier today, and we've also posted slides on our website that will be referred to on this call. Both can be found at www.paratekpharma.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 Sarah Higgins, Vice President of Finance, Controller and Principal Accounting Officer, will also be available for questions.

[Evan Loh:]

Thank you, Ben. Good afternoon and thank you all for joining our fourth quarter and full year 2020 earnings and corporate update call. Before I provide an overview of our corporate highlights, I would like to thank all of our Paratek employees who have worked tirelessly and courageously throughout 2020 to ensure the continued commercial success of NUZYRA and the advancement of Paratek's mission to provide lifesaving medicines for patients in need in this challenging pandemic environment. I would also like to acknowledge and thank those selfless and dedicated healthcare professionals who each and every day are putting themselves at risk being at the bedside to save lives for patients in need. The strong quarter-over-quarter revenue growth seen through the first three quarters of 2020 continued into the fourth quarter, as NUZYRA generated net revenue of $12.4 million, a 14% increase over the third quarter. For the full year 2020, NUZYRA generated $38.8 million, which was at the high end of our most recently communicated commercial range, well exceeding our original core business NUZYRA commercial sales guidance of $28 million that we had provided in February of last year. Our belief and confidence in the long-term commercial success of NUZYRA continues unabated based upon the 2020 performance metrics of NUZYRA through continued strong demand in the hospital care settings. Throughout 2020, we continue to execute and deliver against our objectives, targeting our priority hospitals while providing educational scientific exchange to ensure that physicians understand and appreciate NUZYRAs unique profile. NUZYRAs once-daily well tolerated oral and intravenous formulation combined with NUZYRAs broad spectrum profile offers a much-needed new life saving antibiotic for patients with serious community acquired infections. In today's COVID environment NUZYRAs ability to minimize hospital stays with the oral formulation is especially relevant for many prescribers and potentially meaningful benefit for patients. NUZYRAs continued quarter-over-quarter growth in 2020 is not only a significant achievement in a volatile and rapidly evolving healthcare setting, but a reflection of the clinical importance and the positive patient outcomes with NUZYRA in the hands of clinicians. The launch success to date has established NUZYRA as one of the most successful antibiotics launched in the last five years. We've always believed that NUZYRAs product profile makes it a very attractive option for community use, specifically its broad-spectrum profile and once-daily oral formulation.

[Adam Woodrow:]

Thanks Evan. Before I begin, I'd like to welcome our new sales representatives that have joined the Paratek family over the past couple of months. We have a tremendous opportunity ahead of us to provide NUZYRA to patients in need. And I look forward to the journey with each of you. The US launch of NUZYRA continues to progress well with strong quarter-over-quarter growth seen since launch, even in the face of the challenging and ongoing COVID-19 pandemic. As you can see from this slide, NUZYRA net revenue grew 14% in the fourth quarter when compared to the third quarter. We are particularly encouraged by these results in the fourth quarter despite increased COVID related restrictions due to spiking levels of the virus further affected representative access and productivity.

[Randy Brenner:]

Thank you, Adam. I'd like to begin by thanking the Paratek team for their hard work in making significant progress advancing our research, development, manufacturing and medical affairs activities. 2020 was a standout year that included many successes such as advancing the preclinical, clinical and manufacturing work under the BARDA anthrax program, the sharing of new data through publications and at a number of medical conferences, and progressing our pipeline with the submission of the oral loading dose regimen for CABP and startup activities for our Phase 2b study NTM with enrollment to begin as early as the first half of 2021. We believe all these efforts will have the potential to build significant value for physicians, patients and shareholders. As noted earlier, our BARDA partnership continues to progress well. This unique public private partnership is recognition of our jointly shared commitment to advancing NUZYRA in the fight against antimicrobial resistance and to develop NUZYRA as a potential treatment against bioterrorism pathogens including anthrax and the procurement of NUZYRA for the Strategic National Stockpile. Together with BARDA we continue to make important progress advancing our efforts to onshore the manufacturing of NUZYRA that will enable us to secure an additional supply chain for NUZYRA within the US. Paratek along with our US onshoring partners has completed the knowledge transfer of our manufacturing process for the API and we are currently in the development stage of this initiative. The process flow, equipment selection and facility modifications have been planned and the process development engineering are expected to be completed in 2021. The process validation will begin in early '22 with the goal of having commercial supply produced in the United States starting in 2023. To the best of our knowledge NUZYRA will be the first and only antibiotic to be made in the US including API production. This is an important deliverable for the BARDA Paratek partnership, but also fulfils the White House's executive order to onshore production of medicines codified in the FDAs recently published Essential Medicines List, Omadacycline was so designated. We also continue to make significant progress in the anthrax animal roll program. A PK study on rabbits was recently completed, which will lead into the pilot efficacy studies in this species. In addition, Paratek evaluated Omadacycline MICs against 100 additional anthrax strains, which continued to demonstrate potent MICs and was considered effective against all bacteria tested. Of note the collection of isolates had a strain-resistant to Doxycycline and a strain-resistant to Ciprofloxacin the two antibiotics currently in the SNS due to their approval against anthrax many years ago. We're pleased to report that Omadacycline activity was not impacted in either of those resistant strains. These data will be shared at an upcoming Scientific Congress. Based upon very recent dialogue with BARDA, we are aligned and expecting the first procurement in the near-term and the second procurement in the second half of 2021. Importantly, based upon feedback from BARDA, the delay in the first procurement is not expected to have any impact on the timing of our future procurements. Beyond the work with BARDA, we also continue to progress some of our other lifecycle opportunities for NUZYRA. The first of these is the sNDA for our oral loading dose regimen for community acquired bacterial pneumonia. This application was submitted in July of last year with our action date set in May of 2021. We're also pursuing a program for a rare disease non-tuberculous mycobacteria pulmonary disease caused by Mycobacterium abscessus or NTM. As a reminder, non-tuberculous Mycobacterium abscessus is an orphan disease with no FDA approved therapies. Inbound feedback from the KOL community continues to highlight the clinical unmet need for an efficacious and well tolerated oral antibiotic to treat infections caused by Mycobacterium abscessus. Patients with pulmonary Mycobacterium abscessus have many symptoms that include severe fatigue, fever, cough and shortness of breath. Antibiotic therapy durations can often be lifelong in duration. Based upon our internal market analytics, pulmonary Mycobacterium abscessus has a potential $1 billion addressable market in the US alone. We are advanced in the startup activities for our Phase 2b study for this disease with the initiation of the study plan for as early as the first half of 2021. This study is a placebo controlled randomized monotherapy study of NTM abscessus pulmonary disease in patients who are not receiving other treatments. The study size will be approximately 75 subjects randomized in a 1.5 to 1 ratio. Therapy will be for 12 weeks with an efficacy endpoint assessment at that time point. Due to the small numbers of patients with this rare disease we expect overall that this study will take about two years to complete enrollment. We'll provide more details about the safety and efficacy endpoints, which include both symptoms and microbiology assessments at a future meeting. This is an exciting lifecycle opportunity for NUZYRA with significant potential to address important unmet medical needs. 2020 was a great year for data generation and medical affairs activities for Paratek. In addition to progress with the initiation of our 10 non-clinical and clinical studies in our investigator-initiated research program, there were 19 Omadacycline manuscripts that were accepted for publication that addressed the use of NUZYRA in special pathogens, populations, or disease states that will further define its unique therapeutic profile. In parallel, real world evidence from two ongoing observational studies and independent case theories continue to be published in peer reviewed journals, describing the clinical features and outcomes of patients with challenging infections receiving Omadacycline, including non-tuberculous Mycobacterium abscessus and osteomyelitis. The scientific story will continue to expand throughout 2021 with additional evidence from our investigator-initiated research program in areas like diabetic foot and C. difficile infections. In addition, non-clinical research studying the activity of Omadacycline alone and in combination in a rat osteomyelitis model, and studies in Mycobacterium abscessus and Mycobacterium avium complex or MAC will build on the growing scientific data from NUZYRA. The medical field team will also take the learnings over the first two years of the launch to work with institutions to continue to implement skin and pneumonia clinical protocols to optimize treatment algorithms when considering treatment with NUZYRA. Importantly, in time for the launch expansion into the primary care setting, we've also launched a new medical affairs website as a resource for healthcare professionals. Healthcare providers can use this website to request medical information, access our completed bibliography, access product resources on NUZYRA and request funding for investigator-initiated research. It also provides educational tools and resources related to the antimicrobial resistance. Additional disease state resources on skin infections, as well as community acquired bacterial pneumonia will be available soon. Additionally, in order to fully support the community expansion medical affairs will extend resources to provide scientific and medical engagement in the community with thought leaders, primary care physicians and clinical research institutions. More specifically, a community focused field medical team is being deployed to allow face-to-face engagements with primary care providers and deepen mechanisms to educate and ensure access to NUZYRA. Last, with regard to the NDA review in China, the regulatory process continues to make good progress with the approval expected in the first half of this year, triggering a $6 million milestone payment from Zai Lab to Paratek. We believe that the China approval and the additional data generation opportunities will further broaden the potential for NUZYRA to reach into new and clinically important patient populations. At this point, we would now like to open the line for questions. Operator?

[Operator:]

At this time, we'll be conducting the question-and-answer session. And our first question is from Ami Fadia with SVB Leerink.

[Eason Lee:]

Hi, this is Eason Lee on for Ami. Thanks for taking our question. Maybe two if I may, just first, in terms of the first $30 million BARDA procurement, I'm just curious what dialogue have you had recently maybe on the status of the pre-EUA, which I assume is sort of the remaining step to getting this award?

[Randy Brenner:]

Sure. So this is Randy, I'll take that. Based on our recent communications we believe that the scientific review of the mouse PK data, which was the most recent data submitted to the pre-EUA has been completed by FDA. And then based on very recent discussion with BARDA, we're aligned and expecting that the first procurement will be triggered in the near term.

[Eason Lee:]

Great, thank you. Okay, maybe my second question then is I guess just on the $62 million to $68 million guidance for the core commercial business, I guess, it seemed like consensus was estimating maybe a number slightly above this., I guess maybe just relative to the strong performance you did in 2020, how do you sort of - how are you sort of thinking about the growth trajectory in 2021 maybe in terms of like the relative impact from COVID, the community launch and then for the I guess the sales force realignment? Thank you.

[Evan Loh:]

Adam, do you want to take that?

[Adam Woodrow:]

Yeah, I'll check that. Look one of the things first and foremost that we have to be cognizant of is it's very difficult to predict how COVID-19 is going to continue to impact our business. But as we mentioned earlier on, we definitely had a feeling that we're going to see a modest impact in the early part of this year mainly because COVID pandemic is still ongoing. We've got limited face-to-face interactions with our hospital-based physician. We've got a very, very large flu season and obviously reorganized and contracted our sales forces we went into the new year, which is why we provided guidance on the quarters, which essentially is saying that from our perspective, we expect to see the impact of the expansion into the community really kick into gear as we get into the second half of the year.

[Evan Loh:]

Yeah. And what I would build on that is that guidance range that we provided, as you referenced, I think, is what we are comfortable with today, based upon some of the uncertainties vis-à-vis COVID. That being said, I think foundationally we're very strong as you saw in terms of quarter-over-quarter growth, in terms of what our hospital sales team was able to do. We think that'll continue to grow and expand incrementally. And then when you add the expansion with regards to the primary care sales force, I do see that the second half of this year will - that we've got confidence in terms of the acceleration of that growth curve. And we'll come back to you each quarter to give you more fidelity once we see those numbers coming forward.

[Eason Lee:]

Great, thank you very much.

[Operator:]

And our next question is from Ed Arce with H.C. Wainwright. Please state your question.

[Thomas Yip:]

Hello everyone, this is Thomas Yip, asking a couple of questions for Ed. Congratulations on a very strong quarter for NUZYRA. So perhaps first question related to that for the sNDA, for all oral only formulation is there any remaining work that needs to be completed? Or are there any updates from the FDA so far?

[Randy Brenner:]

So as far as remaining work the answer is no. I mean, the study was submitted within the sNDA filing in July of last year. So our PDUFA data is upcoming in May of this year and as of right now no further updates to report on with regard to how the review progressing.

[Thomas Yip:]

Okay, thanks for the update. And then you guys clarified - I believe Randy was the one who said the two BARDA procurements in 2021, one is near-term and one should be expected in the second half. Just curious, is there any - going forward should we expect any spacing and timing for different tranches in procurements?

[Randy Brenner:]

Yeah. Sure. So thank you for the question. This is Randy again. I mean, in general, the way the BARDA contract was structured is the four 2,500 treatment courses were originally spaced about one annually over the first four years of the contract. Because of the initial delays and the reviews of the pre-EUA from FDA due to COVID-19 and other priorities that were focused from FDA. That first procurement is the one that has shifted out a little bit now into 2021. But our anticipation is the timing of the future procurements will remain generally annually over the next three years of contract.

[Evan Loh:]

Yeah, but that being said there will be a compression in having two this year, which we're delighted to be able to anticipate at this point.

[Thomas Yip:]

Okay, that sounds good. Thanks for clarification. And then switching gears to the new NTM study. You gave some details on the Phase 2b. What are some preliminary thoughts regarding study sites? Any specific geographical areas that you guys tend to focus on? And are there any chances to expand to outside of the United States?

[Randy Brenner:]

Yeah, so at the current time the current plan is to conduct a study entirely in the US. As far as specific study sites go. In general, I think people generally know where the NTM Centers of Excellence are and where people ultimately get referred to, to have the final diagnosis of NTM, all species of NTM, but specifically Mycobacterium abscessus. So the sites will generally align around the major academic centers, as well as some of the other NTM specialty centers that exist across the US.

[Thomas Yip:]

Okay, thank you very much for the elegant show. That's it for us for now. We'll be back in the queue. Thanks for the questions and look forward to a very busy 2021.

[Operator:]

And our next question is from Kevin Kedra with G. Research.

[Kevin Kedra:]

Hi, thanks for taking the questions. I want to follow up on NTM. Randy, you went through some of the details of that that study. So I may have missed one or two of them trying to keep track. But I thought you had said that patients in the study will basically be not on any therapy. So they won't be on any sort of background antibiotic cocktail or off label antibiotic use. It's going to be basically washed out and purely placebo patients or kind of what sort of background therapy are these patients going to be able to be on?

[Randy Brenner:]

Yeah, so thanks for the question. These patients will generally be I'll call them newer diagnosed NTM patients. So they will come into the study most likely not on other therapies or had been on previous therapies and stopped for some period of time. And you're right that this is a monotherapy placebo-controlled study looking at the symptom, primarily the symptom relief of NUZYRA monotherapy versus placebo for a three-month period of time.

[Evan Loh:]

Kevin, just to add a little bit more color. In these newly diagnosed patients, when they get referred to these specialty centers, generally the physicians like to recommend a lot of pulmonary toilet therapy to try to move secretions. And they generally do that for almost a three-to-four-month period of time. So over this period of time, it is completely consistent with their care algorithms that the addition of another antibiotic into another placebo-controlled arm is actually in addition to the standard of care. So it's - we're very excited about the ability to look at a monotherapy intervention to improve the symptoms of these chronically ill patients.

[Kevin Kedra:]

Great and as part of the endpoints, have you guys termed out what primary endpoint would be - is it going to be some patient symptom score? Is there going to be diagnostic tool and for the - sorry, I'll stop with that and follow up from there.

[Randy Brenner:]

So as - I think we've shared before. We've had a couple of meetings with FDA over the last 12 months or so that talk about generally about clinical trial endpoints for NTM and NTM Mycobacterium abscessus and as you may know, the FDA is really pushing for more of a symptom relief endpoint rather than the microbiological endpoint. So the symptom endpoint will be the efficacy abscessus that we look at first. And not to say we won't look at microbiological, pure as well. But in a 12-week study, it may be harder to show significant changes in microbiological endpoints. So the symptom endpoint will be the ones we look at primarily.

[Evan Loh:]

Kevin, the FDA a couple of years ago had an advisory panel specifically about NTM where they walked away from a microbiologic endpoint as the primary endpoint because the vagaries of how these individuals respond to combination cocktails of antibiotics. And so symptoms are really the, I think the driver here. And we think that there's an opportunity here for us to create a symptom scale. It's not too different than the symptom improvement scale that was used for our pivotal pneumonia trial. Randy and his team have had lots of dialogue with the FDA. And I think generally, we're aligned here. And we're looking forward to being able to share what that looks like in an upcoming meeting that we are planning to conduct in the near future.

[Kevin Kedra:]

Great and I'll get to two last ones to this, just one any powering assumptions on the sort of efficacy you would expect to see in symptom reduction? And then do you feel that this would be data if you generate and you're able to hit those primary endpoints and possibly show something on the secondaries. Would this be filed with old data or would you have to run - would you anticipate them to run a Phase 3?

[Randy Brenner:]

Yeah, so I think we'll hold off giving too much around the statistics and the power assumptions at this time as Evan mentioned, we're planning to have a more detailed review of the NTM study design in an upcoming meeting that we'll schedule soon and we're still working through some of the specifics around that. So if you don't mind, I'll deflect that question until a future discussion. As far as the study itself goes, I mean, we've - this is a Phase 2b study. We're not calling it a Phase 3 study for a reason. We do believe based on what we've seen from the case series that have been published and what we hear from the KLO community that there's a very clear place for Omadacycline in the treatment of Mycobacterium abscessus where there are no FDA approved therapies and the need for an oral therapy is super high. And so we continue to stand by the fact that if the data from this study is robust enough that there will be an opportunity for us to go back to FDA and have discussions about how best to include this information in the label and a potential indication. But I think we got a little ways to go on that and we'll see how the data comes out. But this study is designed as a Phase 2b study with the ultimate goal should the data support to have future discussions with FDA on how it supports label changes.

[Kevin Kedra:]

Great, thanks.

[Evan Loh:]

There is another aspect to this that Randy you are actively discussing with FDA, which is focused around the long-term safety extension and that component might look like. And I think that they're still yet to be determined how that component will evolve, right?

[Randy Brenner:]

Yeah, that's correct. So if you were listening to my words carefully, you heard that is a 12-week study. Our clinical team is working through the logistics on the opportunity to enable patients as they complete this study to roll into an open label extension, which would allow us to collect longer term safety data on the use of Omadacycline in a controlled setting. And also allow us to study Omadacycline with some of the other combinations that are considered standard of care, so more to come on that in the future.

[Operator:]

And our next and final question is from Bert Hazlett with BTIG.

[Bert Hazlett:]

Thanks. Thanks for taking the question. Congratulations on the progress folks. Just first and - for specific come back to the BARDA reimbursement or the BARDA purchases, excuse me. So just to probe a little bit more, given some of the issues with the first payment, what gives you the confidence that the second payment will actually occur within 2021?

[Evan Loh:]

Bert, we've had ongoing discussions with BARDA not only through the joint development team that we have with them, but we are in contact on a regular basis with senior leadership at BARDA. Very recent phone calls have allowed us to continue to align and feel very comfortable and very confident in our current guidance.

[Bert Hazlett:]

Okay. Thank you. And then just coming to the reimbursement question and kind of coverage, Adam mentioned during his comments that there were some wood left to chop in terms of Medicare. Adam, could you put a little bit more on that subject in terms of things you'd like to accomplish in the not-too-distant future with regard to coverage in Medicare?

[Adam Woodrow:]

Yeah, more happy to. Look, remember, first we've got about 300 million lives covered, which is a huge number. And we have a very small amount left in Medicare that's still a little bit of work to do. Right now, our focus actually has always been on the Medicaid and the commercial, because from a skin perspective that's the most important population. And it enables us the fact that sort of community $2.2 billion addressable market. The Medicare would - which is what you allude to is a couple of the players are still holding out in negotiations, and we're cautiously optimistic that they will come through within the quarters ahead. But as I said before, for the purposes of our commercial approach into the community setting into primary care is actually more of a Medicare patient population that gets skin. It's the pneumonia or oral only dosing regimen, approval later on in the year that would benefit from the rest of the Medicare coverage. But the other thing I should point out is that we get an extremely low rejection or refusal rate. We're in high single digits, which is a remarkable achievement for a new branded agent that's only been on the market for a couple of years. And that's not just on label that's also with off label. So we don't really have a big trouble, big issue with making sure we get through the benefits investigations and the approval for prescribing in either the hospital or the community setting.

[Evan Loh:]

Yeah, and I think that that - and Bert just to add to that. I think Adam and his team have continued to commit to a specialty pharmacy support model. And we've had a great relationship with the vendor that we've created as well as having a very strong internal team that is fully committed to ensuring that everyone who has potential eligibility could have the support, they need to go through the process to get coverage. And we've had success within the Medicare population as well, even in CVS where we do not have a defined contract in the Medicare population, we continue to see that CVS comes forward, but it does take half a day or a day longer in those particular settings, not ideal, but at least it continues to move forward.

[Adam Woodrow:]

It's Adam, we should add that we provide every type of support you can imagine for ensuring that the patients have that including bridging. They have a sampling program we obviously, ensure that it's affordable for patients. So everything's in there and that will continue as we move into the primary care side as well. But so nothing's changed. The only thing that's likely to change actually over the next year is we may well expect the number of sites from a specialty perspective where we actually hold product over time just because we're expanding our geography as we move into primary care side.

[Bert Hazlett:]

That's great. And then just - I actually did have one question with regard to sales force structure. You mentioned I think 45 in the hospital, 40 in primary care, as you look to the traction that you hopefully get in primary care, at what point do you start to assess whether that 40 patient sales force is right sized? Again, there's a lot of variables here with regard to COVID and the access that the primary care reps might get, but is that - do you take a look at six months post approval of the oral loading dose, is at 12 months, at what point do you reassess that 40-person primary care sales force?

[Adam Woodrow:]

Well, first, nothing will be determined based upon the additional add on indication, because far and away the largest indication is actually the skin one actually in the community, 2.2 billion versus 1.5 billion. But we will be on - it'll be an ongoing assessment, somewhat similar to what we did with the hospitals. We know that the primary care side is actually a target rich environment. We could quite considerably put a lot more representatives in there, because there's that number of physicians that potentially could be targets. But if we find that we're tracking to plan based - we use the pilot as - and everything we learned in that pilot to help assist with how projections would be for this field force. And if we find where we're tracking to plan, after the first quarter or two, we'll definitely look to see whether we need to add. It's highly unlikely that we will need to shrink in this side just by virtue of the sheer size of the targets that we're going for, because there's a lot more primary care targets, and there are institutional targets.

[Evan Loh:]

Yeah, Bert I think that one of the things that Adam has done in a really, really, I think, thoughtful and discipline way is to walk before we run. And we did that with our institutional sales force in terms of getting metrics and understanding their performance before expanding and changing territories, et cetera, which he did in the in the - at the end of last year. I think because of the data that I think we're able to - preliminary data that we're able to generate and see from more than six months of a very focused and modest sized community pilot. I think that data plus the data in terms of the expansion in the 40 will give us, I think, a good set of metrics to be gauging on what we want to see from a productivity standard before we actually start adding reps. With that, we're very excited about this expansion because we think that the foundation of the institutional sales force being as effective as it has been characterized by the most talented and most productive individuals that we had from the contract sales relationship. And we think that we know the phenotype of what we're looking for and the talent base that we've now recruited to, I think portends a very auspicious upcoming 2021.

[Bert Hazlett:]

Great, look forward to more progress. Thank you.

[Evan Loh:]

Thank you.

[Adam Woodrow:]

Thank you, Bert.

[Operator:]

And ladies and gentlemen, we have reached the end of the question-and-answer session. And now I would like to turn the call back over to Evan Loh for closing remarks.

[Evan Loh:]

Yeah, thank you, operator. In closing, I'd like to thank you all for your time and attention today. Your continued interest in NUZYRA and Paratek are important to us. The journey of making NUZYRA a commercial success is well underway. As the wealth of microbiological data and clinical outcome studies on NUZYRA continues to expand, we are increasingly confident in the potential of NUZYRA to be an effective and a much-needed addition to the armamentarium of antibiotics available to physicians to save lives, particularly when resistance is of concern. The BARDA collaboration also positions Paratek as a leader, not only with the potential to provide NUZYRA for bioterrorism pathogens, but as a leader in innovation for the broader IV sector in the battle against antimicrobial resistance. We will continue to be focused on being disciplined in our capital allocation, executing and delivering on our commitments, as well as building long-term value for patients, physicians and our shareholders. The opportunities ahead of us to be able to provide a novel lifesaving antibiotic to patients motivates us all at Paratek. We'd like to thank the patients who have participated in our clinical studies and our employees who have worked hard, tirelessly and passionately to provide NUZYRA for patients in need, and those selfless and dedicated healthcare 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 in the quarters ahead. Good bye for now.

[Operator:]

Thank you. This concludes tonight's web conference. You may disconnect your lines at this time. Thank you for your participation and have a great evening. Thanks.