Paratek Pharmaceuticals, Inc.
Q4 2019 Earnings Call Transcript

Published: 26 Feb 2020

[Operator:]

Greetings, and welcome to the Paratek Pharmaceuticals Fourth Quarter and Fiscal Year 2019 Earnings Call. [Operator Instructions].It is now my pleasure to introduce your host, Ben Strain, Vice President of Investor Relations and Corporate Communications. Thank you, Mr. Strain. You may begin.

[Ben Strain:]

Good afternoon, and welcome to Paratek's Fourth Quarter and Full Year 2019 Earnings and Corporate Update Conference Call. A press release with the company's fourth 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.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.Before I turn the call over to Evan, I would like to point out that we'll 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 our risk factors discussed in our SEC filings for additional detail. Evan?

[Evan Loh:]

Thank you, Ben. Good afternoon, and thank you all for joining our fourth quarter and full year 2019 earnings call and corporate update. 2019 was a transformative year for Paratek with a number of key achievements that we believe have set the stage for sustained long-term growth and have established Paratek as a leader in the anti-infective space.In early 2019, both NUZYRA and SEYSARA launched in the United States, and we are pleased with the progress of both product launches. These innovative therapies are now providing much needed new therapeutic alternatives for patients in need and in the case of NUZYRA, offering an effective, life-saving antibiotic for serious community-acquired infections.We are pleased by the performance of NUZYRA's launch with significant increases in demand seen quarter-over-quarter throughout 2019, driven predominantly by the oral formulation. This quarter-over-quarter increase in demand was accompanied by continued success in securing access from payers and access within the targeted hospitals. Adam will highlight these successes in greater detail.We generated $9 million in net revenues in the fourth quarter, primarily driven by the sales of NUZYRA. Net sales of NUZYRA increased 74% over the previous quarter to $5.4 million in the fourth quarter. We earned other revenues of approximately $3.6 million, which consisted principally of a $3 million development milestone for the submission of the regulatory filing of omadacycline in China from Zai Lab and royalties earned from SEYSARA sales in the U.S.Looking at the growth trajectory observed in 2019, we believe that NUZYRA is on track to be one of the most successful antibiotic launches in the last decade. We believe that the achievements and sales trajectory seen in 2019 are setting the foundation for future sustained growth in 2020 and beyond.Late last year, we also announced a significant milestone, entering into a broad-based Project BioShield contract with Biomedical Advanced Research and Development Authority, or BARDA, which is part of the United States Department of Health and Human Services and the office of the Assistant Secretary for Preparedness and Response. We would like to thank BARDA for their commitment to the long-term viability of the antibiotics sector. In particular, we appreciate their confidence in Paratek and their significant investment in this innovative, long-term public-private partnership for the development of NUZYRA in the fight against antimicrobial resistance in order to save lives and protect Americans.BARDA awarded Paratek a 5-year contract, which is valued at up to $285 million over the initial 5-year term. And if successful, we believe that there is potential to expand this partnership to 10 years. This contract is unique in scope and designed to support the development of NUZYRA for pulmonary anthrax. Importantly, beyond the support for a pulmonary anthrax development program, this award also provides full cost reimbursement to fund all of the FDA post-marketing requirements associated with NUZYRA's initial approval, including the pneumonia and pediatric studies, which will commence in the coming months and funding for the 5-year post-marketing bacterial surveillance studies, which is required for all newly approved antibiotics.As a reminder, this clinical expense was previously included in our cash runway. However, these activities will now be funded entirely through the BARDA collaboration to an aggregate value of $77 million. This is the first time that an antibiotic will be procured via Project BioShield for the Strategic National Stockpile. Our contract provides procurement -- provides for procurement of up to 10,000 treatment courses of NUZYRA for the Strategic National Stockpile for use against potential anthrax attacks, valued at up to $153 million. Randy will provide an overview of the details of the collaboration and an update on progress to date.The recent news with the coronavirus [indiscernible] '19 further highlights the need for novel therapeutics to treat this devastating and near-pandemic disease. As with influenza, many of the coronavirus fatalities are unfortunately associated with secondary bacterial pneumonia infections, further highlighting the importance of a novel once-daily, well-tolerated oral and IV antibiotic in the treatment paradigm for pandemic preparedness. The rapid global spread of this new virus further highlights the importance of pandemic preparedness including the need for novel therapeutics.Accordingly, we believe that our recently announced broad-based, public-private partnership with BARDA will open up opportunities for Paratek to actively pursue other strategic partnerships via government contracts to further support national pandemic preparedness and help patients in need. We believe NUZYRA is uniquely positioned with its once-daily broad spectrum profile for these opportunities.We're also pleased with the recent progress achieved in expanding the global footprint for both SEYSARA and NUZYRA into China, which I will detail in this slide and the next.Our omadacycline partner, Zai Lab has made significant progress following completion of the Phase III development program. Following the successful submission of the omadacycline NDA in late 2019, Zai Lab recently announced this month that the China National Medical Products Administration has accepted its new drug application for omadacycline for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.Under the terms of the Zai collaboration agreement, we are entitled to receive a milestone payment of $6 million upon regulatory approval, which is anticipated in the first half of 2021 and tiered royalties at low double-digit to mid-teen percentages on omadacycline net sales in China.Now turning to SEYSARA. Almirall's launch of SEYSARA in the U.S. has successfully generated clinical demand, and we are pleased to see its growth trajectory in 2019, which we believe augurs well for continued growth in 2020. To further the global opportunity with SEYSARA, we announced yesterday that we have signed an agreement with Almirall, granting a license for Almirall to develop and commercialize SEYSARA for the Greater China region. Almirall is anticipating a regulatory submission in the 2023 time frame. As part of the agreement, we are entitled to receive high single-digit royalties on net sales.Before I hand the call over to Adam, I would like to provide full year 2019 financial highlights and cover our 2020 guidance. In 2019, we generated total revenues of $16.5 million, of which $11.5 million were attributable to NUZYRA net sales in the United States, driven by a strong finish to the year as NUZYRA generated $5.4 million in net sales in the fourth quarter alone. We also earned collaboration revenues of $5 million in 2019, consisting primarily of a $3 million milestone payment received from Zai Lab, as just highlighted, and royalties earned from SEYSARA sales in the United States.R&D expenses were $39.6 million in 2019 compared to $57.5 million for 2018. The decrease was primarily the result of the capitalization of NUZYRA commercial supply costs, which were classified as an R&D expense until FDA approval of NUZYRA.SG&A expenses were $89.1 million in 2019 compared to $63.7 million in 2018. The increase was primarily the result of investments in support of the U.S. commercial launch of NUZYRA.Now turning to our 2020 financial guidance. Paratek estimates 2020 total revenues to be between $75 million and $80 million compared to $16.5 million in 2019. This revenue guidance consists of the following elements. NUZYRA's net sales in 2020 is expected to be approximately $66 million, with slightly more than half of these revenues coming from the initial BARDA procurement of 2,500 anthrax treatment courses. As a reminder, the initial BARDA procurement is anticipated to be secured in the first half of 2020.Royalty and collaboration revenue combined with BARDA grant revenue is expected to be between $9 million and $14 million. Of note, BARDA grant revenue consists of cost reimbursement associated with 2020 spend on the FDA post-marketing requirement activities, the anthrax development program and the onshoring of U.S. NUZYRA manufacturing.2020 R&D and SG&A expense is expected to be approximately $140 million. We continue to remain disciplined from an OpEx perspective balanced against potential strategic investments in areas we believe will create long-term shareholder value. For example, R&D expense includes approximately $5 million earmarked for the start-up activities in preparation for a potential NTM registrational study. Excluding the BARDA R&D and onshoring reimbursement, R&D and SG&A expenses combined are expected to remain relatively flat when compared to 2019, highlighting our commitment to remain disciplined from an OpEx perspective, including continued investment in our commercial infrastructure and additional value drivers such as pursuing the potential indication in NTM.As many of you are aware, in 2019 we established a $50 million ATM program. As of the close of the market yesterday, we have raised approximately $36 million in net proceeds under this program, of which approximately 3/4 was raised in 2019. While as a matter of corporate policy, we do not comment in advance on our future financing activities, given our recent ATM activity, we feel it appropriate in this circumstance to provide some general guidance, specifically given the current strength of our balance sheet, we have no plans at this time to sell additional equity, including through the ATM.Based on our current operating plan, which includes estimated NUZYRA U.S. product sales and the BARDA expense reimbursement activities related to the Project BioShield contract, we anticipate that our existing cash, cash equivalents and marketable securities of $215.4 million as of December 31, 2019, will extend our cash runway through the end of 2023, providing Paratek with a pathway to cash flow breakeven. This anticipated pathway assumes we will be able to fund all company operating expenses, anticipated capital expenditures and debt service that includes repayment in full of the Hercules loan and security agreement under its existing returns.With that, I will now turn over the call to Adam. Adam?

[Adam Woodrow:]

Thanks, Evan. The U.S. launch of NUZYRA continues to progress well, and we are encouraged by the significant growth seen in the fourth quarter. In fact, the demand seen in the fourth quarter exceeded our expectations. We believe many of the successes and leading indicators such as the particularly strong demand seen in December of 2019 bode well for the future. As the first broad spectrum, once-daily oral and IV antibiotic approved for both pneumonia and skin in nearly 20 years, we believe that NUZYRA is well on its way to addressing important unmet needs in this serious community-acquired infections, while combating antibiotic-resistant pathogens that arise from clinical failures and poor outcomes with older generic antibiotics. We believe NUZYRA's convenient, once-daily oral and IV dosing is providing flexibility in prescribing, resulting in reductions in hospital stays, and in some cases, allowing patients to avoid hospital admissions altogether.In addition, we believe that NUZYRA's safety and tolerability profile along with its lack of dosing modifications for hepatic or renal impairment provides a much needed alternative to many existing antibiotics. For example, the quinolones with their vascular, QTc and neurologic serious adverse events that were recently added to their black box warning.As discussed in prior calls, it does take a sustained effort, education and patience to establish momentum for a new IV antibiotic in the hospital setting, after which adoption in the community setting for a companion once-daily oral like NUZYRA can be accelerated.As Evan mentioned, NUZYRA generated $5.4 million in net sales in the U.S. in the fourth quarter compared to $3.1 million seen in the third quarter. Accounting for inventory, NUZYRA gross demand increased from approximately $3.3 million in the third quarter of 2019 to approximately $6.1 million in the fourth quarter of 2019, an increase of 85% versus the prior quarter. Simply stated, growth in the fourth quarter was driven by demand as inventory in the channel remained essentially flat.For the full year, NUZYRA achieved net sales of $11.5 million, which landed right at the midpoint of our guidance of $10 million to $13 million, driven by the growth in demand.Our initial outreach continues to be directed towards early adopting hospital specialists, including ID doctors, pulmonologists, hospitalists and ER physicians within nearly 600 key U.S. accounts, which are currently being supported by approximately 50 to 60 representatives, which we believe is the appropriate level, given our experience in the market to date. We have taken a measured approach with our hiring process as we balance our return on investment to ensure we have the right sales representatives in place to drive objective value creation.In our key targeted hospitals and integrated delivery networks, we've been focused on gaining institutional access for NUZYRA, while making steady progress in raising awareness. We have achieved institutional access in over 60% of the 600 targeted hospitals and awareness of NUZYRA now exceeds 90% in the ID community and over 60% in the broader physician target base. This is important because awareness serves as the gatekeeper for physicians to consider writing a prescription for NUZYRA.We're extremely pleased with the initial launch and believe we're on the right path with NUZYRA and are well positioned for long-term commercial success, and we look forward to reporting on our progress in the quarters ahead.With that, I'd now like to turn the call over to Randy.

[Randall Brenner:]

Thanks, Adam. We have several important value drivers, which we believe have the potential to add significant value for patients and shareholders. We are excited to be the sole recipient of the first-ever BioShield award from BARDA for antibiotic for the treatment of a biothreat and for addition to the Strategic National Stockpile. This unique public-private partnership with BARDA is a recognition of our shared commitment to studying NUZYRA in the fight against antimicrobial resistance and the treatment -- and bioterrorism pathogens, including anthrax.Let me start with an overview of the BARDA program. The base program is activated and provides funding of approximately $59 million, including approximately $21 million for the development program for NUZYRA for the treatment of pulmonary anthrax. The planning and preparation for these studies are well underway, with plans to initiate the studies this year. The cost of these activities will be reimbursed as work is complete.The balance of the program is $38 million earmarked for the procurement of 2,500, 60-day treatment courses of NUZYRA to be purchased for the Strategic National Stockpile. The $38 million procurement purchase of the initial treatment courses will occur upon FDA's acceptance of the pre-emergency use authorization for NUZYRA, which is targeted for submission to the FDA in the first quarter of this year with projected acceptance occurring in the second quarter of this year.In addition to the base program, the contract also provides support for the following

[Operator:]

[Operator Instructions]. Our first question comes from the line of Ed Arce with H.C. Wainwright.

[Antonio Arce:]

Congrats on a strong finish to the year. First question I have is on NUZYRA on the demand that you discussed, and this question is either for Adam or Evan. Given the strength that you saw in December, could you give us a little more detail around what you think was driving that -- continues to drive that and where do you think perhaps there is still room in 2020 to expand and strengthen the underlying demand? And related to that, in 2020, what kind of seasonality or trajectory would you expect throughout the year?

[Adam Woodrow:]

Thanks, Ed. It's Adam. So look, there's about 2 or 3 things that have continued to drive it. Obviously, there is some seasonality. What we've seen from an indication perspective is we've seen a little bit more CABP as we've moved into the winter season with a corresponding slight decline in the skin indication. But if you also recall, we were granted a J-code towards the back end of the year. We've seen an uptick in our IV utilization. And in addition and in answer to your question about how we're going to continue to increase the demand as we go through 2020, we continue to make progress gaining hospital [indiscernible] and getting committed to accept NUZYRA into the institutions and that will continue to assist us in the growth that we expect to see during 2020.

[Evan Loh:]

I think just to build on that as well, I think Adam has seen effects of the -- having the J-code as it relates to the hospital IV use and another big commitment that his team will continue to have is on the educational front to continue to build awareness throughout all the different physician populations that actually have told us that they see interest and utility in the product.

[Operator:]

Our next question comes from the line of Kevin Kedra with Gabelli & Company.

[Kevin Kedra:]

First, Evan, maybe to get down -- the revenue guidance target that you gave for NUZYRA, very specific. Wondering what gives you the confidence in that target? And why wouldn't should we be looking at something that's more range bound given the early nature of the launch? And then secondly, you mentioned that you're seeing an increased use in the IV. Can you give us a sense -- I don't know if you mentioned this earlier. If you did, I'm sorry I missed it. But kind of what are we seeing in IV versus oral as a percentage of use?

[Evan Loh:]

Adam, do you want to take that question first?

[Adam Woodrow:]

Yes. So I'll answer the question about the IV and oral. About 85% of our utilization is in the IV -- sorry, in the oral with only about 15% in the IV. And if you go back to what I said right at the beginning, before we even launched, the strength of NUZYRA is in the -- is the fact that we have an oral. What physicians tell us, what the research tells us is that the strength is in the oral discharge. And as a consequence, we continue to see more utilization of oral than we do IV.

[Evan Loh:]

And Kevin, getting back to your revenue guidance, as we said, total estimates for 2020 will be somewhere between $75 million and $80 million in terms of total revenue consisting of -- I think the most prominent component of that is NUZYRA net product sales expected to be about $66 million. More than -- approximately $38 million of those sales are going to come from the initial BARDA procurement. And as Randy said, we have high confidence of that component actually moving ahead because it was part of the base award. And we think that, that will be secured in the first half of 2020. We do have some royalty and collaboration revenues with that as well, but I think the confidence that we have is based upon the inbound stories. And I think it's really organic growth. When you look at what the doctors have told us, the demand that we're seeing and the positive patient stories at this point in time, we feel comfortable in the range that we've provided and we still think that this overall implies significant growth over 2019 from $11.5 million. So this is a good place to be, and we'll be updating you on the coming quarters.

[Operator:]

Our next question comes from the line of Robert Hazlett with BTIG.

[Robert Hazlett:]

I have a couple. Adam, just on the sales force of 50 to 60 people that you had mentioned in the call, how do you think about that in the near term? Obviously, it sounds like you're comfortable with it. And how do you think about that in the medium and long term? And are there any plans to expand or at least -- any plans contemplated to expand? And I have a couple of other questions as well.

[Adam Woodrow:]

So look, I mean, at the end of the day -- and I think we've been pretty clear, we want to be judicious in the use of our balance sheet. And so we've taken a very measured approach in the expansion of our field force. Right now, based on the sort of learnings that we've got, we think that 50 to 60 is the right number. Obviously, over time, we will learn more. And as we do so, it's not inconceivable that we may add more representatives. But for now, our view is that we've got the right number to achieve what we're trying to achieve during the course of this year. And in truth, if you recall, we're actually hitting our number with a smaller field force than we originally had planned.

[Robert Hazlett:]

Yes. Good positive progress. With regard to progress in China as well, your partner Zai Lab, it looks like they're making material strides there. Can you talk about the potential timing for approval there? And then is there also a possibility for licensing in other geographies such as Japan?

[Randall Brenner:]

Yes. So this is Randy. I mean, with regards to the approval in China, I think what Zai is anticipating is approval anywhere from a 12- to 18-month review time frame, which gets them approval in the early part of 2021.

[Evan Loh:]

Bert, this is Evan. With regards to other regions, we do, as we've always said, that antibiotic resistance is a global need, and we have explored and will continue to explore the right opportunities for what's best for NUZYRA and what's best for Paratek. That being said, we've actually spent time in Japan. And given the feedback that we've received both from potential partners as well as from regulatory authorities, we see that, that pathway is one that we will not be pursuing in the near term.

[Robert Hazlett:]

Okay. And then you talk about in the press release aggressively pursuing other opportunities within the government to support national pandemic preparedness. Could you just elaborate a little bit more about what types of opportunities exist out there in terms of magnitude, scale and potential timing? I know that -- the last is definitely a challenge to predict, but any additional clarity would be helpful.

[Evan Loh:]

I think these are really initial conversations that we've -- we thought about and have started to contemplate. I think it's too early to really be commenting on them specifically. That being said, there are opportunities in terms of other facets of the HHS as well as Department of Defense, who actually think about the national pandemic preparedness that are looking for the continuum of not only materials for containment as well as prophylaxis on a vaccine basis, but also to think about therapeutic armamentarium, not only therapeutic antibodies, but also antibiotics, which serve an important -- serve as an important addition to that as well. And in our view, given the commitment by BARDA and ASPR to be committed to saving lives and protecting Americans, we think that this is potentially a significant opportunity for us going forward.

[Robert Hazlett:]

Okay. Well, congratulations on the first award. And I hope there's other consideration down the road.

[Evan Loh:]

Thank you, Bert.

[Operator:]

Our next question comes from the line of Ami Fadia from SVB Leerink.

[Xiaozhou Fan:]

This is Sheldon on for Ami. So first, do you have an updated outlook for the long-term potential of NUZYRA in commercial sales? And also, secondly, about the BARDA reimbursement of R&D activities, you mentioned that some of those trials, studies and onshoring activities will start to be activated this year. Could you elaborate more on the following -- the remaining sections of those reimbursements in the following years about what the cadence will look like?

[Randall Brenner:]

Sure. This is Randy. I can take the BARDA question from you. So as we've announced right after the award came out in December and again, on the call today, there are multiple components to the BARDA award

[Evan Loh:]

So just to build on what Randy said, because you specifically asked about the cadence of the R&D reimbursement, it's contemplated that the vast majority of these dollars actually would be invoiced and actually accounted for over the 5-year period of the grant. To give you a specific point of case on this is our commitment through our FDA approval letter for our CABP trial that in fact we have to actually have that data into the FDA during over that period of time in the 2023, 2024 time frame. So it was specifically designed to support those programs and a 5-year microbiologic surveillance program as well.

[Adam Woodrow:]

And your question about whether we're updating our long-term guidance. Right now, we're not updating our long-term guidance at this time. But we do continue to see a really tremendous long-term opportunity for NUZYRA. I mean, given the initial momentum that we've seen and what we've also committed to for 2020, we can connect the dots for our 2024 guidance of $500 million.

[Xiaozhou Fan:]

Maybe if I may -- and I have a follow-up question just regarding your cash runway. I think your cash runway was extended from your last update by another half year through the end of 2023, is that -- that can potentially lead you to cash flow breakeven? And also, you will be able to fully payoff Hercules loan. I noticed that you have another convertible loan of $165 million that's due in Q2 2024. Do you have a plan to pay that off? Or will you have other financing options to pay that?

[Evan Loh:]

Yes. Look, at the end of the day, for us, it's always been maintaining a strong balance sheet as a principal focus for the management team and our Board of Directors and in the best interest of all of our shareholders. And our -- the strength of our current balance sheet remains a core strength of our company for the benefit of all shareholders. But as you alluded to, we do have this convertible debt and it's due in the first half -- at the end, I think -- closer to the end of the first half, May of 2024. Based upon our expected performance for Paratek over this period of time that we see today, we believe that the convert will have been converted on or before that maturity date.

[Operator:]

Our next question is a follow-up question from the line of Ed Arce with H.C. Wainwright.

[Antonio Arce:]

So along the lines of your cash runway through the end of 2023 and now your guidance of a pathway clear to cash flow breakeven, I was just wondering if other than perhaps BARDA as a risk, which seems quite low, are there any potential risks over that period that could change this? And on the flip side, are there any potential opportunities that could even provide for a longer runway?

[Evan Loh:]

Well, I think, as we said, thank you for the question, that this pathway that we looked at is based upon what we see today and based upon the initial momentum and performance that we saw with NUZYRA in 2019, which very much fit within our expectations. I think what we've learned also is that there is tremendous strength in the oral as the majority of our scripts are coming from the oral. And as you know, after the first couple of years of this typical IV and oral product launch is that we'll be exploring what that community setting actually looks like. And we do think that there's expansion and upside opportunity there as well.And as a prior question came by in terms of other opportunities with regards to government contracts or stockpiling, et cetera, we see those as upside to the current forecast. And I think the other piece of growth is what Randy talked about as well, not only adding the oral-only pneumonia indication to our label for the full pneumonia season, I think, will be another boost to the momentum that we've already seen with NUZYRA's launch and as well as having a pathway forward with regards to nontuberculous mycobacteria.At the end of the day, for us, it's heads down on execution, and that is always a risk that we keep right front and center each and every day as we think about our operational deliverables. We have worked hard to live by our commitments and deliver against them, which we have each and every -- either development or commercial milestone to date. And we continue to plan on doing that going forward.

[Antonio Arce:]

Great. And then perhaps just one last question. Around the awareness metrics that you mentioned earlier, obviously, in IV right now quite high at 90%, 60% in sort of the community, which hasn't yet seen a whole lot of direct marketing. I would assume that over time as that gets more -- you see more growth in both markets that, that delta will diminish over time.

[Adam Woodrow:]

Yes. And it will. I mean, obviously, our initial focus is around the ID community and then the associated specialties that we target. There's no direct communication with the community side of the business. But as we've said before, the first couple of years are focused on the hospital setting and then we'll look to address the community base at a later time, and we're definitely starting to consider our approach in that space as we go through this year.

[Operator:]

There are no further questions in the queue. I'd like to hand it back over to Mr. Loh for closing remarks.

[Evan Loh:]

As there are no more questions, we'll conclude today's call. And in closing, I would 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. The unique profile of NUZYRA, specifically our once-daily, well-tolerated oral is positioned well for long-term growth and broad-based commercial success.As the wealth of data on omadacycline continues to expand, we are increasingly confident in the potential of omadacycline 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 development of NUZYRA through its life cycle.We also look forward to working closely and collaboratively with BARDA in this unique public-private partnership. This is a transformative collaboration that 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 ID sector. We fully expect to deliver an important treatment option for pulmonary anthrax that has the potential to save lives and protect Americans.These opportunities motivate us all at Paratek, and we would like to thank the patients who have participated in our clinical studies and our employees who have worked tirelessly to provide NUZYRA for patients in need. We very much appreciate your support and interest. We look forward to keeping you apprised of our continued progress. Goodbye for now.

[Operator:]

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.