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Paratek Pharmaceuticals (PRTK) Q1 2021 Earnings Call Transcript | The Motley Fool

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Paratek Pharmaceuticals (NASDAQ:PRTK)
Q1 2021 Earnings Call
May 17, 2021, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Greetings. Welcome to Paratek Pharmaceuticals first-quarter 2021 earnings call. [Operator instructions] 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.

Ben StrainVice President, Investor Relations

Good morning, and welcome to Paratek’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.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 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?

Evan LohChief Executive Officer

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 Paratek. Nuzyra’s 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 Nuzyra in the hands of clinicians. Our first-quarter 2021 results were consistent with our expectations as Nuzyra 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 Nuzyra remains unabated based upon growing demand of Nuzyra 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 Nuzyra as one of the most successful antibiotics launched in the last five years. Nuzyra continues to materially differentiate itself from other IV oral antibiotic launches driven by strong operational execution and Nuzyra’s many product attributes that include, first, broad-spectrum efficacy including resistant pathogens across two common indications; second, a favorable safety profile consistent with Nuzyra’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 Paratek.

First, we’re excited to announce that BARDA has initiated the first procurement of Nuzyra valued at approximately $38 million. We expect that this procurement will be delivered and recognized this quarter; second, an important FDA decision on the Nuzyra sNDA and 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 Nuzyra in the primary care setting. Third, the initiation of a phase 2b study for Nuzyra in a rare disease, pulmonary NTM abscesses for which there are no approved therapies.

Fourth, we anticipate the second BARDA procurement in the second half of this year. Fifth, we anticipate an approval of Nuzyra in China, one of the largest potential antibiotic markets, which will trigger a $6 million approval milestone payment from Zai Lab to Paratek. 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 Paratek’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. Nuzyra 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 onshoring in the U.S. of Nuzyra 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 cost reimbursed under the BARDA contract for the U.S.

onshoring of Nuzyra 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 31, 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?

Adam WoodrowPresident and Chief Commercial Officer

Thanks, Evan. The commercialization of Nuzyra continued 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, Nuzyra net revenue grew 6% in the first quarter when compared to the fourth quarter of last year. Nuzyra 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 our 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. Nuzyra’s once-daily, well-tolerated oral and intravenous formulations, combined with Nuzyra’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 Nuzyra 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 sales 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 Nuzyra 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 Nuzyra 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 the 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 Nuzyra could provide an important clinical alternative in some circumstances. We believe we’re on the right path with Nuzyra 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.

Randy BrennerChief Development and Regulatory Officer

Thanks, Adam. As you heard from Evan a few minutes ago, we are excited to announce that BARDA has initiated the first procurement of Nuzyra 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 start-up activities for our phase 2b study in the rare disease, pulmonary NTM abscesses with study initiation expected next month and the recent initiation of the pneumonia post-marketing study required by FDA.

We continue to actively pursue life cycle initiatives for Nuzyra. 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 called 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 start-up activities for our phase 2b 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 life cycle opportunity for Nuzyra 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 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.

In addition to initiating the first procurement, we, along with BARDA, continue to make important progress advancing our anthrax Animal Rule program, as well as our efforts to onshore manufacturing of Nuzyra that will enable us to secure an additional supply chain for Nuzyra within the U.S. To the best of our knowledge, Nuzyra will be the first and only antibiotic to be made exclusively in the U.S., including API production. With regards to the anthrax Animal Rule program. We have generated data in over 130 Bacillus anthracis isolates that continues to confirm the in vitro potency of Nuzyra against this potentially life-threatening pathogen.

Importantly, this testing also included a strain resistant to ciprofloxacin and a separate strain resistant to doxycycline. Against both of these strains, omadacycline 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 USAMRIID, testing omadacycline in mini panels against various resistance strains of Bacillus anthracis, including a multidrug-resistant strain, resistant to all other antibiotic classes. Against this multidrug-resistant strain, omadacycline retained its activity and in vitro potency, suggesting Nuzyra could be the only viable option for multidrug-resistant strains of Bacillus anthracis.

These data support the potential utility of Nuzyra in pandemic preparedness against antibiotic-resistant biothreats. In addition, a recent poster from ASPR at the 2021 National Association of City and County Health Officials Preparedness Summit highlighted the challenges of the secondary infections resulting from chemical, radiologic, nuclear, and biologic threats. When looking closely at the infection types and/or pathogens highlighted in this poster, Nuzyra 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 Nuzyra 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, omadacycline 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 omadacycline this summer. We believe these two recent posters continue to highlight the potential utility of omadacycline in a growing list of threats, and we believe had 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 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 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’d like to open the line for questions.

Questions & Answers:

Operator

Thank you. [Operator instructions] Our first question is from the line of Ed Arce with H.C. Wainright. 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 Hazlett with BTIG. Please proceed with your question.

Bert HazlettBTIG — Analyst

Congratulations on a number of levels. It’s been quite an effort and terrific result. Just three brief ones. Could you give us some timetable for the enrollment of the IIb study in NTM? And then secondly, your confidence with regard to further government, military, or other procurement, I’d 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 omadacycline or are we thinking more broadly? Thanks, and congratulations on all the progress once again.

Evan LohChief Executive Officer

Hi, Bert. Thank you very much for the questions. I’ll have Randy address the first question around timeline.

Randy BrennerChief Development and Regulatory Officer

Yes. Thanks, Evan. 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, Robert.

Evan LohChief Executive Officer

OK. And then the —

Bert HazlettBTIG — Analyst

Terrific. And then the potential for additional government procurement and your enthusiasm there and then potential expansion, either with or without omadacycline.

Evan LohChief Executive Officer

Yes. We are 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, Nuzyra 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.

Adam WoodrowPresident and Chief Commercial Officer

Thanks, Evan. Yes. 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.

Look, Nuzyra could be an ideal choice for a new therapeutic option to add to the strategic national stockpile, and we’ll continue to explore other biothreats 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.

Evan LohChief Executive Officer

And, Bert, I’ll take your third question with regards to potential product expansion with regards to omadacycline or something else. Look, I think that as you can imagine, we monitor our sector very closely. And having now a commercial presence in both the hospital and the community setting, I think, gives us greater flexibility to consider opportunities to expand our pipeline. Our first commitment has always been to build around opportunities around our lead asset Nuzyra.

And you heard from Randy today about the expanding life cycle opportunities, which we’re excited about given our core competencies and our established infrastructure and expertise to ensure that our franchise product, Nuzyra, will 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.

Bert HazlettBTIG — Analyst

Thank you. Congratulations again.

Evan LohChief Executive Officer

Thank you, Bert.

Operator

Our next question is from the line of Kevin Kedra with G.research. Please proceed with your question.

Kevin KedraG.research — Analyst

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?

Evan LohChief Executive Officer

Randy, do you want to take that one?

Randy BrennerChief Development and Regulatory Officer

Yes, sure. So thanks, Kevin. Yes. 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 this 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 to sign 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.

Kevin KedraG.research — Analyst

OK. Great. And then switching over to omadacycline in 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 it’s still going to feel a lot of this COVID disruption as we start heading into next winter?

Evan LohChief Executive Officer

Yes. I mean, as we look at the success of the vaccination program throughout the U.S., we’re 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 hand washing, 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 mask-less 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 Nuzyra franchise that I think will play into this quite a bit given the fact that 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 in 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 opportunity come the fall.

Kevin KedraG.research — Analyst

Great. Appreciate that. Maybe 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 Nuzyra in those countries before you could have those discussions? Or would you be able to have discussions with other governments before you have Nuzyra approved in those markets?

Evan LohChief Executive Officer

Yes. Thanks for that. I’ll have Randy address that one.

Randy BrennerChief Development and Regulatory Officer

Sure. So yes, we are continuing to pay attention to what’s going on around the world with regards to antibiotic incentives and — 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 biothreats, 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.

Evan LohChief Executive Officer

And point of fact, Kevin, just to build on what Randy said, if you look at the essential medicines listing of Nuzyra in the bioterrorism category, as well as this recent poster that Randy mentioned in his presentation, specifically around the CDC moving to add Nuzyra 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 ammonia 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, etc.

And I think that it will lead to other opportunities that we can explore outside of the U.S. as appropriate.

Kevin KedraG.research — Analyst

Thank you.

Evan LohChief Executive Officer

Thank you, Kevin.

Operator

Thank you. The next question is from the line of Suji Jeong with Jefferies. Please proceed with your question.

Suji JeongJefferies — Analyst

Hi. Thanks for taking my question. So the first one is about NTM phase 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.

Randy BrennerChief Development and Regulatory Officer

So yes, so 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.

Suji JeongJefferies — Analyst

Thank you.

Evan LohChief Executive Officer

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.

Suji JeongJefferies — Analyst

OK. Thank you. My next questions are on the expansion of Nuzyra into the community setting for CABP. How many additional sales force 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 sales force to the community on the sales? Thank you.

Evan LohChief Executive Officer

Adam, do you want to take that one?

Adam WoodrowPresident and Chief Commercial Officer

Yes, I’ll take that. Thanks, Evan. Well, first of all, 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 for skin also overlap significantly with those that prescribed 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.

Evan LohChief Executive Officer

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 individual if 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 insurance resets and some of the COVID pandemic headwinds, we were still able to see a robust quarter-over-quarter growth in the first quarter of this year.

Suji JeongJefferies — Analyst

OK. Great. Thank you.

Evan LohChief Executive Officer

Thank you, Suji.

Operator

Our next question is from the line of Ed Arce with H.C. Wainwright. Please proceed with your question.

Ed ArceH.C. Wainwright — Analyst

Hi, guys. Thanks for taking my questions, and congrats on the first BARDA procurement this quarter. Apologies for the issue with the phone earlier. First couple of questions is regarding Nuzyra.

Firstly, with — 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 in the expansion of the label later this month. Maybe discuss for us a bit what you’re hearing as you look to expand for the all-oral cap 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 you can give us a bit more detail of how you think the growth will sort of unfold for Nuzyra through the remainder of this year. Thanks.

Evan LohChief Executive Officer

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.

Adam WoodrowPresident and Chief Commercial Officer

Yes. So, Ed, you asked also about how it’s going in 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 will 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 Nuzyra is a drug that can be used in the elderly, safely, and with good monotherapy — 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’d 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 community-acquired — in skin, it’s all about the efficacy because of the MRSA once-a-day drug. So 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.

Evan LohChief Executive Officer

So, Ed, 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 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 Nuzyra. 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 Nuzyra.

We think that continued growth in the second half of this year, I think, will be an exciting journey for all of us to be on and for us to be part of. I think there are many other components of contribution to that second-half growth that includes a potential second BARDA procurement. I think potential for DoD purchases, as we’ve mentioned, and continued organic growth in our overall institutional commitments, as well as 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.

Adam WoodrowPresident and Chief Commercial Officer

And, Evan, I would add that we also anticipate a lifting of some of the restrictions that we see out 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.

Evan LohChief Executive Officer

Thank you for that, Adam. Thank you, Ed, for the questions.

Operator

Thank you. At this time, we have reached the end of the question-and-answer session. I’ll turn the call over to Evan Loh for closing remarks.

Evan LohChief Executive Officer

As there are no more questions, we will continue — we will conclude today’s call. In closing, I’d like to thank you all for your time and attention today. Your continued interest in Nuzyra and Paratek are important to us. The journey of making Nuzyra a commercial success is well under way.

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 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 Paratek. 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 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. Goodbye for now.

Operator

[Operator signoff]

Duration: 41 minutes

Call participants:

Ben StrainVice President, Investor Relations

Evan LohChief Executive Officer

Adam WoodrowPresident and Chief Commercial Officer

Randy BrennerChief Development and Regulatory Officer

Bert HazlettBTIG — Analyst

Kevin KedraG.research — Analyst

Suji JeongJefferies — Analyst

Ed ArceH.C. Wainwright — Analyst

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