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spk02: Greetings. Welcome to Paratech Pharmaceuticals' first quarter 2021 earnings call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note, this conference is being recorded. At this time, I'll turn the conference over to Ben Strain, Vice President of Investor Relations. Ben, you may now begin. Thank you.
spk03: Good morning and welcome to Paratech's first quarter 2021 earnings and corporate update conference call. A press release with the company's first quarter results was issued earlier today, and we have also posted slides on our website that will be referred to on this call. Both can be found at www.paratechpharma.com. Participants on today's call are Evan Lowe, 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 will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. Evan?
spk04: Thank you, Ben. Good morning, and thank you all for joining our first quarter earnings and corporate update call. We believe 2021 will be a transformative year of continued growth for Paratech. New Cyrus quarter-over-quarter growth in 2020 continued into the first quarter of this year. We believe this is not only a significant achievement in this volatile and rapidly evolving healthcare setting, but also a reflection of the clinical importance of positive patient outcomes with New Zyra in the hands of clinicians. Our first quarter 2021 results were consistent with our expectations as New Zyra generated U.S. net sales of $13.2 million in the first quarter, reflecting the health of our commercial business. Our confidence in the long-term commercial success of New Zyra remains unabated based upon growing demand of New Zyra in the hospital care setting coupled with the recent initial positive signs of new prescriptions and adoption in the primary care commercial expansion. We anticipate that this growth trajectory will continue through the balance of 2021, given the encouraging initial inbound feedback from the primary care-based physicians for a well-tolerated, once daily, oral, broad-spectrum antibiotic that includes coverage against MRSA for skin infections. As seen in this next slide, The commercial success to date has established Neuzira as one of the most successful antibiotics launched in the last five years. Neuzira continues to materially differentiate itself from other IV oral antibiotic launches driven by strong operational execution and Neuzira's many product attributes that include, first, broad spectrum efficacy including resistant pathogens across two common indications, second, a favorable safety profile consistent with New Zyra's tetracycline heritage. And third, convenient, once daily, oral, and IV formulations that enable utility in multiple settings of care. In addition to the commercial business, we are focused on several exciting and potentially transformative catalysts for Paratech. First, we're excited to announce that BARDA has initiated the first procurement of New Zyra valued at approximately $38 million. We expect that this procurement will be delivered and recognized this quarter. Second, an important FDA decision on the Neuzira SNDA for the oral loading dose regimen in pneumonia. If approved, we believe this will be an important catalyst to further expand the commercial opportunities for Neuzira in the primary care setting. Third, the initiation of a Phase IIb study for Nuzira in a rare disease, pulmonary NTM abscessus, for which there are no approved therapies. Fourth, we anticipate the second barter procurement in the second half of this year. Fifth, we anticipate an approval of Nuzira in China, one of the largest potential antibiotic markets, which will trigger a $6 million approval milestone payment from XyLab to Paratech. And finally, in addition to these catalysts, we continue to actively evaluate potential assets to expand our portfolio and leverage our commercial infrastructure. Before I hand the call over to Adam, I would now like to provide Paratech's first quarter 2021 financial highlights. First quarter 2021 total revenue was $16.4 million, an increase in 3% over the prior quarter and 107% over the first quarter of 2020. New Zyra generated $13.2 million in net U.S. sales in the first quarter, an increase of 6% over the prior quarter, and an increase of 81% over the first quarter of 2020. First quarter 2021 government contract service and grant revenue earned under the BARDA contract were $2.6 million for the first quarter versus $2.8 million in the fourth quarter of 2020. We anticipate a modest step-up in contract service and grant revenue earned under the BARDA contract as we move through the year, driven by activities associated with the on-shoring in the U.S. of new thyroid manufacturing, the continued enrollment of the FDA post-marketing required study in pneumonia, and further advancement of the preclinical work in the anthrax program. First quarter R&D expenses were $5.5 million. compared to $6.4 million for the same period in the prior year. Included in R&D expenses for the first quarter were $2.7 million in costs reimbursed under the BARDA contract for the U.S. onshoring of New Zyra manufacturing and for FDA post-marketing requirements. The decrease in R&D expense is primarily the result of lower third-party manufacturing process scale-up and clinical study costs, as well as lower stock-based compensation expense partially offset by an increase in the reimbursable costs incurred under the BARDA contract. SG&A expenses were $22.4 million for the first quarter of 2021, compared to $23.6 million for the same period in the prior year. The decrease in SG&A expense is primarily the result of a continued focus on driving operational efficiencies across the organization, as well as lower stock-based compensation expense. As of March 31st, 2021, we had $103.5 million in cash and cash equivalents. Based upon our current operating plan, we anticipate our existing cash and cash equivalents provides for a cash runway through the end of 2023 with a pathway to cash flow breakeven. I would now like to turn the call over to Adam. Adam?
spk05: Thanks, Evan. The commercialization of New Zyra continues to progress well with consistent quarter over quarter growth seen since launch, even in the face of the ongoing COVID-19 pandemic. As you can see from slide 11, New Zyra net revenue grew 6% in the first quarter when compared to the fourth quarter of last year. New Zyra gross demand increased from approximately 13.5 million in the fourth quarter of 2020 to approximately 14.6 million in the first quarter of 2021. And thus the growth in the first quarter was driven by demand. In the first quarter, our sales were impacted by the typical new year insurance resets. In addition to recruiting and training a new sales force and the ongoing challenges presented by COVID-19 that we have discussed in the past. Nevertheless, our business grew quarter over quarter as we effectively and efficiently operated within a hybrid sales model that consisted of both face-to-face and virtual interactions. We see COVID and the related access challenges occurring well into the second half of 2021, but with a steady shift to the more impactful face-to-face interactions as the year progresses. Newzira's once-daily, well-tolerated oral and intravenous formulations Combined with New Zyra's broad spectrum profile offers a much needed new life saving antibiotic that is uniquely positioned to be applicable in every setting of care. From the hospital and its potential to minimize hospital stays to the community where there is a tremendous unmet need for a well tolerated once daily oral broad spectrum antibiotic that includes coverage against MRSA for skin infections. Current generic antibiotic options in the community are challenged by either significant bacterial resistance or serious safety concerns limiting their utility. This is verified by our utilization data from our primary care pilot and the initial results from our primary care expansion seen so far this year. The data suggests primary care physicians' first trial of Nuzira occurs quicker and with fewer calls than the hospital-based physicians. This dynamic is playing out as we have seen encouraging signs in prescription numbers driven from our primary care expansion efforts. We anticipate this momentum will continue through 2021 as we maintain our focus on gaining institutional access, continuing to support the primary care expansion, building awareness and trust and credibility with physicians who are saving lives and treating serious community-acquired infections every day. Our SALS team is now near our targeted headcount following significant recruitment efforts that occurred in the first quarter. We now have approximately 80 representatives with half focused on the hospital and half focused on primary care. As described last quarter, our initial launch into primary care will focus on the estimated $2.2 billion addressable market opportunity for skin infections, which represents the largest targeted segment for New Zyra promotion. Later this year, after the anticipated approval of the pneumonia oral-only loading dose regimen, we plan to expand our promotion to include pneumonia in the community, which represents an additional estimated $1.5 billion addressable market opportunity. A recent study published by Pew, also reports and reinforces the potential role Neuzira can play in addressing unmet needs for community acquired infections. The study highlighted the potential risks of toxicity and adverse events associated with fluoroquinolone use, with the panel recommending that alternative and equally effective antibiotic agents should always be favored over fluoroquinolones when available. In this study, 47% of all fluoroquinolone and 27% of all vancomycin prescriptions were deemed inappropriate. As a result, the panel recommended a national target to reduce inappropriate use for each of these antibiotics by some 95%. These data reinforce the unmet clinical need and suggest that Nuzara could provide an important clinical alternative in some circumstances. We believe we're on the right path with New Zyra and are well positioned for long-term commercial success. We look forward to reporting on our continued progress in the quarters ahead. And with that, I'd now like to turn the call over to Randy.
spk10: Thanks. Thanks, Adam. As you heard from Evan a few minutes ago, we are excited to announce that BARDA has initiated the first procurement of New Zyra valued at approximately $38 million that we expect will be delivered this quarter. We also continue to advance the preclinical, clinical, and manufacturing work under the BARDA contract. In addition to BARDA activities, we are progressing our pipeline with the startup activities for our Phase IIb study in the rare disease pulmonary NTM abscessus, with study initiation expected next month and the recent initiation of the pneumonia post-marketing study required by FDA. We continue to actively pursue lifecycle initiatives for New Zyra, Later this month, we are anticipating a decision from the FDA on our SNDA for our oral loading dose regimen for community-acquired bacterial pneumonia. We also continue to advance our clinical development program for a rare disease, non-tuberculous mycobacteria pulmonary disease caused by mycobacteria abscessus, or NTM. As a reminder, pulmonary NTM abscessus is an orphan disease with no FDA-approved therapies. Inbound feedback from the KOL community has continued to highlight the clinical unmet need for an efficacious and well-tolerated, once-daily oral antibiotic to treat infections caused by mycobacterium abscessus. Based upon our internal market analytics, pulmonary mycobacteria abscessus represents an estimated $1 billion addressable market in the U.S. alone. We are in advance in the startup activities for our Phase IIb study for this disease, with the initiation of the study planned in June. We will provide more details about the safety and efficacy endpoints, which include symptom and microbiology assessments, at an upcoming meeting to be announced in the near term. NTM is an exciting lifecycle opportunity for New Zyra with significant potential to address important unmet medical needs. Our BARDA partnership also continues to progress well. This unique public-private partnership is in recognition of our jointly shared commitment to advancing New Zyra in the fight against antimicrobial resistance, and to develop New Zyra as a potential treatment against bioterrorism pathogens, including anthrax, and the procurement of New Zyra for the Strategic National Stockpile. In addition to initiating the first procurement, we, along with BARDA, continue to make important progress advancing our anthrax animal world program, as well as our efforts to onshore manufacturing of New Zyra that will enable us to secure an additional supply chain for New Zyra within the U.S. To the best of our knowledge, Nuzira will be the first and only antibiotic to be made exclusively in the U.S., including API production. With regards to the Anthrax Animal World Program, we have generated data in over 130 bacillus anthracis isolates that continues to confirm the in vitro potency of Nuzira against this potentially life-threatening pathogen. Importantly, this testing also included a strain resistant to ciprofloxacin and and a separate strain resistant to doxycycline. Against both of these strains, imatocycline remained active with its in vitro potency maintained. In addition to that data, we recently received data from work we conducted with the United States Army Research Institute of Infectious Disease, also known as U.S. AMIRID, testing imatocycline in many panels against various resistance strains of bacillus anthracis, including a multidrug resistance strain resistant to all other antibiotic classes. Against this multidrug-resistant strain, Imatocycline retained its activity and in vitro potency, suggesting Nuzira could be the only viable option for multidrug-resistant strains of Bacillus anthracis. These data support the potential utility of Nuzira in pandemic preparedness against antibiotic-resistant bio-threats. In addition, a recent poster from ASPR at the 2021 National Association of City and County Health Officials Preparedness Summit highlighted the challenges with secondary infections resulting from chemical, radiologic, nuclear, and biologic threats. When looking closely at the infection types and or pathogens highlighted in this poster, Nuzira already has either the approved indication or pathogen in its USPI, as shown in green boxes, or the in vitro data for the pathogen, as shown in blue boxes, further confirming that Nuzira has the potential to address several of these key pathogens. Also at this conference, the CDC presented a poster regarding the recommended treatments for plague. In this poster, hematocycline was included on the list of alternatives for pre or post exposure prophylaxis of plague, another bacterial pandemic threat. As a result, we anticipate the CDC to update their guidelines on pneumonic plague to include hematocycline this summer. We believe these two recent posters continue to highlight the potential utility of hematocycline in a growing list of threats and we believe has the potential to open further opportunities with U.S. government for future utilization and procurements. The scientific story will continue to expand throughout 2021 with the continued advancement of our IIR program. The medical affairs team has several activities planned further to support the community launch and the expansion of the scientific education into this new healthcare base. This includes the placement of a small number of targeted community-based education specialists, to further augment the primary care launch. With regards to the NDA review in China, the regulatory process continues to make good progress with the approval expected later this year, triggering a $6 million milestone payment from XyLab to Paratech. We believe that the China approval and the additional data generation opportunities will further broaden the potential for New Zyra to reach into new and clinically important patient populations. At this point, we'd like to open the line for questions.
spk02: Thank you. We'll now be conducting the question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
spk06: One moment, please, while we poll for questions. Thank you. Our first question is from the line of Ed Arce with HC Wainwright. Please proceed with your questions. Mr. Arce, your line is live for questions. Mr. Arce, your line is live. Our next question is coming from the line of Bert Haslett with BTIG.
spk02: Please proceed with your question.
spk08: on a number of levels. It's been quite an effort and terrific results. Just three brief ones. Could you give us some timetable for the enrollment of the 2B study in NTM? Then secondly, your confidence with regard to further government, military, or other procurement. Just love some additional thoughts there. And then last but not least, as you contemplate further portfolio product expansion, as you've mentioned, is that primarily with the amount of cycling or are we thinking more broadly? Thanks and congratulations on all the progress once again.
spk04: Hi, Bert. Thank you very much for the questions. I'll have Randy address the first question around timeline.
spk10: Yep, thanks, Evan. Hey, Bert. So we will be providing a much more detailed update on our NTM study in an upcoming meeting that we'll be announcing soon. We've said that based on the size of the study and the numbers of patients in this population, we expect about a two-year enrollment process for that study.
spk06: Okay. Terrific.
spk08: And then the potential for additional government procurement and your enthusiasm there, and then potential expansion either with or without Ometa Cycling.
spk04: Yeah. We're extremely excited about the procurement being initiated here. We do think that that is tremendously validating to the commitment within our public-private partnership In addition to that, as a reminder, USIRA last year was added to the Joint Deployment Formulary, which I think opens up the possibility for future procurements broader throughout the Department of Defense. Maybe I could have Adam comment on some of the efforts that his team has been exploring.
spk05: Thanks, Evan. Yeah, hi, Bert. Look, we continue to engage with a number of departments within the government about future stockpiling opportunities, especially with the recent stimulus package. Nuzaro could be an ideal choice for a new therapeutic option to add to the strategic national stockpile, and we'll continue to explore other bio threats and departments such as the Department of Defense and military. It's too early to predict how successful we'll be with these efforts, but rest assured, we'll try hard.
spk04: And, Bert, I'll take your third question with regards to potential product expansion with regards to imidacycline or something else. Look, I think that, as you can imagine, we monitor our sector very closely, and having now a commercial presence in both the hospital and the community setting I think gives us greater flexibility to consider opportunities to expand our pipeline. Our first commitment has always been to build around opportunities around our lead asset news. I already heard from Randy today about the expanding lifecycle opportunities, which we're excited about. given our core competencies and our established infrastructure and expertise to ensure that our franchise product news I wrote be successful. Given our position of strength, though, we believe we can potentially bring in additional assets. We continue to look for these assets, but as always, we'll remain disciplined in our approach and carefully monitor our cash runway. Thank you.
spk06: Congratulations again. Thank you, Bert.
spk02: Our next question is from the line of Kevin Kendra with G Research. Please proceed with your question.
spk09: Hi, thanks for taking the questions. Maybe first, congratulations on getting the initial procurement moving from BARDA. Can you remind us of any deliverables needed for that second procurement that you expect later this year?
spk04: Randy, you want to take that one?
spk10: Yeah, sure. So thanks, Kevin. Yeah, so we're excited that we achieved the first procurement. Certainly continue to exemplify BARDA's commitment to advancing the program. We continue to plan for the second procurement in the second half of this year. As we've continued to state, the future procurements are tied to ongoing progress of the program. There's no specific milestone assigned specifically to each of them. So we'll continue to have discussions with BARDA to provide more specifics in the future about the exact timing of that procurement in the second half of the year.
spk09: Great. And then switching over to a mass cycling and cap, we kind of had a bit of an abnormal cap season this year with everything with COVID. How are you guys thinking about the next cap season? Do you expect something closer to normal, or do you anticipate that's still going to feel a lot of this COVID disruption as we start heading into next winter?
spk04: Yeah, I mean, as we look at the success of the vaccination program throughout the U.S., you know, we're You know, very excited about that with regards to our commitment as a company to provide resources for improving health across all populations. And what was interesting was that the public health measures that were instilled during the COVID pandemic that included social distancing, rigorous handwashing, as well as masking, really drove the community-acquired pneumonia rates to, I think, a lower rate than has been seen in many decades. That being said, I think that we're seeing that the vaccination programs have been successful. With the recent CDC guidances, we see an expansion of folks being able to interact on a more pre-pandemic massless interaction basis. And I think we'll start to see trends in the fall for a more normal pneumonia season. That being said, I think that another aspect of our expansion for the New Zyra franchise that I think will play into this quite a bit, given the fact that, you know, because of COVID, I think hospitals have been places where most patients and most doctors are trying to be very cautious about referring patients who are ill there. And as such, I think there'll be a more concentrated effort to keep people out of the hospital and keep them home. And our stay-home strategy with regards to the oral-only potential loading dose for pneumonia I think will play very well into that dynamic come the fall. And if there is continued growth in the community expansion, as we started to see, With the community launch with skin infections, especially those with MRSA considerations, I do think there will be, I think, a growth in opportunity come the fall.
spk09: Great. Appreciate that. Maybe the last one. Can you talk about, you mentioned stockpiling opportunities in the U.S., or at least government opportunities in the U.S. beyond the initial contract with BARDA. Do you see opportunities with international governments as well? Would you need to have approval of New Zyra in those countries before you could have those discussions, or would you be able to have discussions with other governments before you have New Zyra approved in those markets?
spk04: Yeah, thanks for that. I'll have Randy address that one.
spk10: Sure. So, yeah, we are continuing to pay attention to what's going on around the world with regards to antibiotic incentives, which includes some potential for stockpiling. You've probably read some of the European countries are thinking about doing some of those activities now as well. A precursor to many of those does require regulatory approval in those countries. That being said, as we continue to expand our database, particularly on pandemic preparedness and bio-threats, we will continue to share that data and look for ongoing opportunities to look to ways to provide opportunity for ex-U.S. countries to look for stockpiling opportunities for biothreats and antibiotic resistance as well.
spk04: In point of fact, Kevin, just to build on what Randy said, if you look at the – you know, the essential medicines listing of Neuzira in the bioterrorism category, as well as this recent poster that Randy mentioned in his presentation specifically around the CDC moving to add Neuzira as a second line option for plague. You can see that not only are we having a franchise product profile for, I think, more bread and butter skin and pneumonia infections, I do think that the pandemic preparedness portfolio of commitments by the U.S. government is something that I think will be very hard for others to ignore in terms of what we are doing internally from a DOD perspective on preparedness and the commitments of BARDA, et cetera. And I think that it will lead to other opportunities that we can explore outside of the U.S. as appropriate.
spk06: Thank you. Thank you, Kevin.
spk02: Thank you. The next question is from the line of Sujee Jung with Jefferies. Please proceed with your question.
spk01: Hi. Thanks for taking my question. So the first one is about NTM-based 2B trial. I'm sorry I missed it earlier, but when do you expect to share the trial design? And then I have follow-up questions.
spk10: We're planning a meeting in the near future to really review in more detail the NTM study design. So that's coming shortly. And I think Ben will provide more information once we're able to share the date of that meeting.
spk01: I see.
spk04: You know, that all being said, Suji, I think that there's opportunity here for us to really be relatively innovative in terms of that approach, given the fact that there are no approved oral therapies. for this disease, and we are looking forward to being able to share that more broadly in an upcoming meeting that we'll announce shortly.
spk01: Okay, thank you. My next questions are on the expansion of Zara into the community setting for CAVP. How many additional Salesforce do you expect to add to support the indication in the primary care setting? And second question is, when do you expect to see the full impact of the expansion of Salesforce to the community on the sales? Thank you.
spk04: Adam, do you want to take that one?
spk05: Yeah, I'll take that. Thanks, Evan. Well, first and foremost, I'll take those in reverse order, actually. We expect to see the real impact of the expansion in the latter half of this year. This field force was obviously recruited in the first quarter. It's just getting up to speed as we move into the second quarter, and the full impact will be realized in the second half. But early signs are extremely encouraging, and we're really pleased with what we've seen. As regards to whether we need new and additional representatives to support the CAP launch, the answer is simply no. We don't need to expand beyond where we plan to be, which would be at sort of steady state, having about 40, 45 hospital-based representatives and about 40 in the community. And the reason for that simply is that many of the individuals that prescribe the skin also overlap significantly with those that prescribe the community-acquired pneumonia. And so you get a double hit on those individuals that you're targeting. you might shift your focus a little bit. Both of these diseases are a bit seasonal as you can imagine. There's more skin infections in the summer and more pneumonia in the winter. So you might reverse your order of detailing and you may over index on certain positions for one indication rather than the other at some point in time. As we've stated in the past, we're very careful We're putting lots and lots of representatives on the ground until we're sure that we'll realize the benefit. And if we feel that we can benefit from putting more in, we'll look at that at some time in the future.
spk04: I think that the other component of the timing of how we've expanded the community, Suji, I think is an important one to consider, which is that we believe that it was important always to have a solid foundation in the hospital setting. to establish, I think, the credibility of the product in the sickest patients with infectious disease individuals and physicians being the primary prescriber. The other, I think, feature of the predicate for setting the right conditions for a successful community expansion includes the robustness, we believe, of our market access efforts to date. And I do think that those efforts and our operational support here I think we're part of the underlying reasons for, despite the insurance resets and some of the COVID pandemic headwinds, we were still able to see a robust quarter-per-quarter growth in the first quarter of this year.
spk06: Great. Thank you. Thank you, Suji.
spk02: Our next question is from the line of Ed Arce with H.C. Wainwright. Please just use your questions.
spk07: Hi, guys. Thanks for taking my questions and congrats on the first part of procurement this quarter. Apologies for the issue with the phone earlier. First couple of questions is regarding New Zyra. Firstly, I think you had started engagement with the primary care physicians back in February. It's been roughly three months now, and I know that you're expecting hopefully an expansion of the label later this month. Maybe discuss for us a bit what you're hearing as you look to expand for the all oral tap in the community, what you're hearing from physicians. the feedback that you're getting and how you think that will tie into your expectations for the latter half of this year. And then more broadly, I was just wondering, certainly there's early in the year given COVID as well as the cycle of reimbursement, but just wondering if If you can give us a bit more detail of how you think the growth will sort of unfold for New Zyra through the remainder of this year. Thanks.
spk04: Thanks, Ed, for those questions. Maybe, Adam, you can talk a little bit about the inbound that we're hearing about the potential for the oral-only loading dose and how that will help with regards to your projected expansion success in the fall.
spk05: Yeah, so I had asked also about how things are going since February. Look, we're really encouraged with what we're seeing. All signs are good. And we're pleased with the uptake. The feedback that we're getting on the skin side is very simple. Physicians are desperate for a really good once a day oral drug that has MRSA coverage. and we're absolutely sure, based on what we're seeing, that we'll continue to see uptake as we go through the bulk of the skin season, which is in the middle of this year. With regard to pneumonia, slightly different. We've conducted a number of advisory boards and we've done some market research. Here it's slightly different. What they're looking forward to with regard to Neuzira is a drug that can be used in the elderly safely and with good monotherapeutic coverage of the relevant pathogens, and a drug that doesn't cause C. diff. Unfortunately, that's something that affects the older patient population quite a bit, along with the QTC issue that you see with some of the drugs that are on the market. So it's a safety story as much as an efficacy story in community-acquired pneumonia, and in skin, it's all about the efficacy because of the MRSA once-a-day drug. So You know, we'll target those appropriate physicians along with their needs. And based on the once daily dosing, we're sure we're going to get good uptake. The only really efficacious therapies that are out there in oral form for pneumonia today are the quinolones. And we know that they've got some significant limitations from a safety perspective, and we'll take advantage of that.
spk04: So in terms of your question with regards to how the growth might be expanding throughout the balance of the year, as you know, I think that forecasting in the midst of the COVID pandemic really has provided real challenges for us, for every company that's commercial at this point in time. But we continue to believe in the blockbuster potential of New Zyra and I think the continued strong demand that we're seeing as coupled to the start of prescriptions and adoption in the primary care setting, I think continues to fuel our continued belief and confidence in the future growth of New Zyra. We think that continued growth in the second half of this year I think will be an exciting journey for all of us to be on and for us to be part of. I think that there are many other components of contribution to that second half growth that includes a potential second half barter procurement, I think potential for DOD purchases, as we've mentioned, and continued organic growth in our overall institutional commitments, as well as what Adam has said, a further expansion in our primary care estimated market addressable opportunities in the event that we get that FDA approval for our SNDA for the oral loading dose. So we remain confident and excited about all of that.
spk05: And, Evan, I would add that we also anticipate a lifting of some of the restrictions that we see continue in the hospital and a move to the more impactful face-to-face interactions as we go through the year and as we're already seeing.
spk04: Thank you for that, Adam. Thank you, Ed, for the questions.
spk02: Thank you. At this time, we've reached the end of the question and answer session. I'll turn the call over to Evan Lowe for closing remarks.
spk04: As there are no more questions, we will conclude today's call. In closing, I'd like to thank you all for your time and attention today. Your continued interest in USIRA and Paratech are important to us. The journey of making USIRA a commercial success is well underway. As the wealth of microbiological data and clinical outcome studies on USIRA continues to expand, we are increasingly confident in the potential of USIRA to be an effective, and a much-needed addition to the armamentarium of antibiotics available to physicians to save lives, particularly where resistance is of concern. The opportunities ahead of us to be able to provide a novel, life-saving antibiotic to patients motivates us all here at Paratech. We would like to thank the patients who have participated in our clinical studies and our employees who have worked tirelessly and passionately to provide Newsire 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. Goodbye for now.
spk02: This concludes today's conference. Let me disconnect your lines at this time. Thank you for your participation.
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