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Edited Transcript of NBRV.OQ earnings conference call or presentation 11-May-20 8:30pm GMT

DUBLIN May 12, 2020 (Thomson StreetEvents) — Edited Transcript of Nabriva Therapeutics PLC earnings conference call or presentation Monday, May 11, 2020 at 8:30:00pm GMT

* Gary L. Sender

* Steven P. Gelone

* Theodore R. Schroeder

Morgan Group Holding Co. – Research Analyst

Ladies and gentlemen, thank you for standing by, and welcome to the Nabriva Therapeutics First Quarter 2020 Financial Results Conference Call. (Operator Instructions)

I would now like to turn the conference over to Mr. Gary Sender, Chief Financial Officer of Nabriva. Thank you, sir. Please go ahead.

Gary L. Sender, Nabriva Therapeutics plc – CFO [2]

Thank you, Lisa, and good afternoon, everyone. Welcome to Nabriva’s conference call and webcast to discuss the first quarter 2020 earnings and business highlights. Different from previous earnings calls, the slides for today’s presentation are posted on the company’s website and can be found under the Investors tab in the Events and Presentations section. We recommend that you refer to the presentation, as we will be using those slides for today’s discussion.

Before we begin on Slide 2, I’d like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. These statements are subject to risks and uncertainties that could cause actual results to differ. Please note that these forward-looking statements reflect our opinions only as of the date of this call. We will undertake no obligation to revise or publicly release the results of any revisions to these forward-looking statements in light of new information or future events. Factors that could cause actual results or outcomes to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our most recent filings on Form 10-K and our other periodic reports on Forms 10-Q and 8-K filed with the SEC.

Moving to Slide 3, I’d like to share the agenda for today. Ted Schroeder, Nabriva’s CEO, will start with a business update. Dr. Jennifer Schranz, our Chief Medical Officer, will discuss how XENLETA’s profile connects with the current pandemic, and she will also review our further areas of research. Francesco Maria Lavino, Nabriva’s Chief Commercial Officer, will then present an update on the commercial highlights and then let a strategy for the community. I will provide a financial review, and Ted will wrap up the discussion and lead a Q&A session. In addition to Ted, Jennifer and Francesco, joining us on the call for the Q&A session is Steve Gelone, our President and Chief Operating Officer.

I would now like to turn the call over to our Chief Executive Officer, Ted Schroeder.

Theodore R. Schroeder, Nabriva Therapeutics plc – CEO & Director [3]

Thank you, Gary, and thanks to everyone joining our call this afternoon.

Let’s start on Slide 5. Following the approval of XENLETA in August and through today, we continue to gain traction with managed care coverage and patient reimbursement. Our team has had to be flexible and adapt to not only the historically challenging hospital environment for launching new anti-infective products, but also to the evolving COVID-19 pandemic, which has changed the way promoting pharmaceuticals can be done for us and for everyone.

As we discussed on our last earnings call, we at Nabriva adjusted our efforts to focus on where we saw the greatest opportunity to drive product awareness in the near term and made a strategic decision that focusing on the community is our best opportunity. The top priority for 2020 is to build upon the shift of our commercialization efforts in the community, which we started at the beginning of the year. Recall that this decision was based upon the positive managed care coverage that we were able to establish early on for XENLETA. The message about XENLETA’s short-course oral indication was beginning to resonate well with physicians and health care providers, and we were starting to gain momentum. Looking ahead, our plan is to advance along this path, while carefully managing our balance sheet and expenses.

As we continue our mission during 2020, we expect to come out of the COVID-19 situation with a strong foundation to capitalize on our community outreach. We are opportunistically pursuing business development and lightening opportunities for assets that would complement our focus on community-based products, and we are continuing to seek international partners for XENLETA.

Additionally, we are working on obtaining XENLETA approvals in Europe and Canada. We are planning for the launch of our second product, CONTEPO, a potentially first-in-class intravenous antibiotic in the U.S. for the treatment of complicated urinary tract infections, which has an upcoming PDUFA date in late June.

Turning to Slide 6. Let me spend a little more time on how we expect to modify and deploy our resources to get the greatest return, with a focus on transitioning to the community. Managed care coverage on both commercial and Medicare plans continues to exceed our expectations and has increased from last quarter. Plans representing approximately 70% of all covered lives in the U.S. have XENLETA on formulary, representing greater than 200 million people. Patients with prescription coverage offered by well-known plans, such as Express Scripts, UnitedHealthcare and Cigna, now have access to XENLETA. What is most significant is that the majority of the formularies have no utilization management, meaning that there are no prior authorization or step edit requirements before a patient is prescribed XENLETA.

The market dynamics, coupled with the excellent payer coverage, is what dictated Nabriva’s shift to the community, an approach we initiated several months ago. We are encouraged by the early traction our sales representatives gained by making multiple visits to targeted physicians. Unfortunately, the world changed rapidly through the first quarter, with the ongoing impact from the COVID-19 pandemic. Direct interaction with providers was suspended. This halt in providing medical education is particularly difficult for antibiotics, which are known to be promotionally sensitive. Prior launches have shown that physicians require multiple interactions with company representatives to fully capture a new antibiotics profile. These frequent reminders are particularly relevant for antibiotics because there are typically no refills. Each new prescription for an antibiotic is usually for one course of treatment. Like all pharmaceutical companies, Nabriva was forced to move to a remote working model, which included leveraging digital and nonpersonal promotion. Our intent is to utilize the sales force with community-based expertise when the operational restrictions related to COVID-19 are lifted, when access to health care providers can be reestablished and, most importantly, when it is safe to be directly calling on doctors. While I can’t tell you exactly when that will be, I can reassure you that when we relaunch our community sales effort, the company will be well positioned with a strong foundation of patient access.

Let me turn to a brief update on CONTEPO or fosfomycin for injection for the treatment of complicated urinary tract infections. As you know, we resubmitted the NDA for CONTEPO in December,and have a PDUFA action date of June 19, 2020. Due to COVID-19, the FDA has restricted travel for FDA inspections. It’s unknown if this will delay the FDA’s review of the CONTEPO suppliers who were subject — who were the subject of the CRL. Nabriva continues to work with the agency to identify the most expeditious manner to complete the NDA, and we will provide any material updates in the future. There are a number of science-driven activities we are pursuing to help patients with COVID-19 and other serious infections. Jennifer will review these in more depth.

We are thoughtfully managing our resources, while appropriately allowing us to fully capture the value of our assets. The savings from our sales force restructuring is an example of this, and our cash runway has been extended into the fourth quarter of this year. Being flexible and being able to adapt to the changing scenarios is an undeniable strength of the Nabriva team. As a company, we are committed to getting XENLETA to the patients that need it most. We have implemented a strategy that we believe will appropriately bring XENLETA to the millions of patients that suffer from community-acquired bacterial pneumonia.

Let me hand off the call to Jennifer, who will review some of the interesting areas of medical research. Jennifer?


Jennifer Schranz, Nabriva Therapeutics plc – Chief Medical Officer [4]


Thank you, Ted.

Let’s turn to Slide 8. There has been incredible focus on the diagnosis and treatment of acute respiratory tract infection in patients with COVID-19, and it is more important than ever to have safe and effective treatment options for patients with community-acquired bacterial pneumonia that enable them to stay at home or get home from the hospital as soon as possible.

In adult patients of CABP, XENLETA has been shown to be a generally well tolerated and highly effective stay at home treatment option. In the LEAP 2 study, a 5-day course of oral XENLETA was highly efficacious, including in those patients with multiple comorbidities or more severe disease. Importantly, outpatients receiving XENLETA in the study did not have any serious adverse events or require a subsequent hospitalization. This is especially critical during the COVID-19 pandemic, where minimizing contact with the hospital not only decreases the patient’s chance of being exposed to SARS-CoV-2 and assist in flattening the curve, but also ensures valuable hospital resources are preserved to those who need it most.

For those patients who require initial treatment for CABP in the hospital, the sooner they can reach clinical criteria to be considered for discharge home, the better. Based on pool data from the LEAP 1 and LEAP 2 trials, patients treated with XENLETA meet these discharge readiness criteria in 3 to 4 days, opening the door for them to get home quickly, again, decreasing potential exposure to SARS-CoV-2 and preserving valuable hospital resources.

Turning to Slide 9. A number of case theories have been published describing the clinical presentation and outcomes in COVID-19 patients. It is well recognized that viral respiratory retract infection, such as influenza, can be complicated by secondary bacterial pneumonia. In the largest published autopsy series of patients dying from COVID-19, up to 50% had superimposed bacterial pneumonia. Of note, in this cohort, 70% of patients did not receive mechanical ventilation and, therefore, do not have ventilator-associated pneumonia, or VAP. In addition, data from a China cohort indicate that 50% of patients who die from COVID-19 had a superimposed bacterial infection in contrast to COVID-19 survivors, where only 1% had a secondary bacterial infection.

In response to the increased morbidity and mortality associated with the superimposed bacterial pneumonia in COVID-19 patients, the current World Health Organization guidance on the clinical management of severe acute respiratory infection, also known as SARI, when COVID-19 disease is suspected, recommends empiric antimicrobials to be given as soon as possible to treat all likely pathogens causing SARI and sepsis. They further recommend that treatment be based on the clinical diagnosis, in other words, community-acquired versus health care-associated pneumonia, local epidemiology and susceptibility data, national treatment guidelines, and that appropriate deescalations guided by microbiology results and clinical judgment be implemented.

Just last week, the co-Chairs of the American Thoracic Society and Infectious Disease Society of America CAP guidelines published principles of management of pneumonia in patients with COVID-19. They state that since serologic evidence of bacterial co-infections are common in fatal cases of COVID-19 pneumonia and relevant bacterial pathogens, such as Streptococcus pneumoniae, Staphylococcus aureus and atypicals are the same with or without concurrent COVID-19. Empiric antibiotic coverage for CAP is recommended in patients being revoked for COVID-19.

In summary, the COVID-19 pandemic reinforces the need for new antibacterial classes with a novel mechanism of action. XENLETA provides a safe and effective treatment options for COVID-19 patients when they develop a superimposed bacterial pneumonia.

Turning to Slide 10. Given the unique properties of XENLETA, our team is working on several important potential value-creating life cycle management opportunities for XENLETA. Post-immunologic responses play a critical role in the significant inflammatory reaction and lung damage seen in COVID-19 patients. Initial in vivo investigations of XENLETA’s anti-inflammatory activity in a mouse model of lipopolysaccharide-induced lung neutrophilia demonstrate a significant reduction in inflammation, as measured by total cell and neutrophil count in the brochoalveolar lavage fluid,that is comparable to dexamethasone, a known potent anti-inflammatory drug.

In addition, XENLETA, like other fluorometholone, exhibits in vitro activity against selected viruses, including some human coronaviruses. Based on preliminary positive in vitro results, we are evaluating XENLETA’s activity against SARS-CoV-2.

We also continued to make significant progress in China with our partner, Sinovant. In recognition of the high rate of bacterial resistance in China and that bacterial pneumonia has been found to be a common complication in COVID-19 patients, Sinovant is in active discussions with the China’s National Medical Product Administration to accelerate development activities and regulatory filings for XENLETA.

While tremendous resources have been mobilized to control COVID-19, antimicrobial resistance quietly continues to increase and has been dubbed the silent threat by several experts during the pandemic. As it relates to respiratory tract infection, resistance in Streptococcus pneumoniae in the U.S. is increasing. Recently, published data indicate that a shift in pneumococcal serotypes recovered from the upper respiratory tract of patients to those not covered by the pneumococcal conjugate vaccine has occurred since the introduction of the 7- and 13-valent versions of pneumococcal conjugate vaccines. As depicted in the figure on the right, these nonvaccine serotypes are largely responsible for decreased in vitro susceptibility to the most commonly prescribed antibiotic classes, resulting in the V-shape distribution of MICs for penicillin, ceftriaxone, levofloxacin and meropenem. Because of XENLETA’s novel mechanism of action, its in vitro activity is not affected by the observed serotype shifting.

Another important unmet medical need being evaluated utilizing grant funding is the role of XENLETA in the treatment of multidrug-resistant sexually transmitted infections, or STI, specifically those caused by Neisseria gonorrhoeae and Mycoplasma genitalium. We have been actively collaborating with a global team of STI experts and have an ongoing collaboration with the Global Antibiotic Research & Development Partnership, referred to GARD-P, and the WHO Collaborating Center for Gonorrhoea and Other STI to evaluate XENLETA’s potential in the treatment of this important public health threat. It is noteworthy that both Neisseria gonorrhoeae and Mycoplasma genitalium have become increasingly difficult to treat due to increasing rates of resistance and, as a result, have been recognized by the Centers for Disease Control and Prevention as urgent and emerging threat pathogen, respectively, in their 2019 Antimicrobial Resistance Threats Report. XENLETA has been shown to possess potent in vitro bactericidal activity against both Neisseria gonorrhoeae and Mycoplasma genitalium that is maintained in the presence of resistance to all standard of care treatment options.

And finally, the COVID-19 pandemic is a stark reminder of the importance of preparedness for infectious disease threats. Due to the predominant role of bacterial pneumonia as a cause of death in pandemic influenza, we believe XENLETA has the potential to be an important addition to the U.S. government’s Strategic National Stockpile for pandemic influenza.

In closing, as an infections disease physician who was on the front lines during the early days of the HIV epidemic and now living in a multigeneration family with an immunocompromised elder, I sincerely express my gratitude to our frontline responders. This is an important time for Nabriva, and we are committed to making our scientific resources available to improve health outcomes in patients fighting this global public health pandemic.

I would now like to hand over to my colleague, Francesco.


Francesco Maria Lavino, Nabriva Therapeutics plc – Chief Commercial Officer [5]


Thanks, Jennifer, and good afternoon to everyone on the call. Building on Ted’s opening, I’m going to share more details about the shift in our strategy to address the community opportunity for XENLETA.

Before going into the list of our strategy, Slide 12 is an important reminder of how XENLETA represents a promising treatment option for CABP, appropriate for a wide variety of treatment settings, a new class for IV and oral use with a new mechanism of action that overcomes existing mechanism of resistance and has proven low propensity for the development of bacterial resistance.

XENLETA’s complete spectrum of coverage of the main CABP pathogen, including the resistance strain, has shown to provide as monotherapy, the appropriate coverage with a low risk of C. difficile infection. XENLETA has a very favorable PK/PD profile with no need for a loading dose, no dose adjustments for renal insufficiency and an excellent lung penetration. In each large clinical trial, it was shown to be generally well tolerated with low rates of discontinuation due to adverse events. The flexible IV and oral bioequivalent formulation and the short course of monotherapy make XENLETA convenient for patient in the hospital, in the transition of care and particularly in the community.

Turning to Slide 13. As Ted commented, we have made the strategic choice of expanding our focus in the community, focusing our efforts on the right patient in the outpatient setting for XENLETA. Yearly, more than 2 million adult patients with community-acquired bacterial pneumonia are treated in the outpatient setting, generating more than 15 million days of antibiotic therapy. They are generally diagnosed and treated for CABP in a primary care office, in an urgent care center or in an outpatient pulmonology clinic. They are generally older, but still working age with common comorbidities, like hypertension or diabetes, with or without the previous antibiotic exposure, with a PORT score suggesting that the patient can be treated at home. And about 80% of these patients are covered by commercial or Medicare Part D plans. XENLETA’s broad and growing managed care coverage is one of the key reason for a resource shift to the community.

Moving on to Slide 14. Let me talk about the great progress we’ve made with the managed care coverage for XENLETA. Our market access team has continued to do a tremendous job, and we are pleased to say that our managed care coverage continues to exceed our expectation and is still better at this point in XENLETA’s life cycle than other recently launched antibiotics, in particular when it comes to the Medicare coverage. As of April 2020, more than $200 million or about 70% of all United States covered lives have access to XENLETA, and most of the access is unrestricted, with no utilization management, such as step edit or prior authorization. XENLETA has achieved around 75% of commercial health plan coverage and about 30% of Medicare Part D plan coverage. About 120 million commercial and Medicare Part D lives are under contract, with more than 90% unrestricted, with no utilization management. As a result of this contract, we expect XENLETA Medicare Part D and commercial coverage to further increase in Q2, as we see more plans adding XENLETA to their formularies. In addition, XENLETA IV was granted a J Code effective on July 1, 2020, that allows outpatient and emergency department to bill Medicare and commercial plan at ASP+6%.

Turning to Slide 15. I’d like to share a few more details about XENLETA’s managed care coverage and the major formulary wins today. 74% of total commercial lives in the U.S. have access to XENLETA, and 70% of their access is unrestricted with no utilization management. Coverage is primarily driven by major plans, Express Script, UnitedHealth Group, OptumRx, Aetna and TRICARE, who have headed XENLETA to their commercial formularies, again, with no utilization management.

Our market access team will continue to focus on expanding XENLETA Medicare Part D and commercial coverage in the near term, and this is going to be a key success factor and a strong differentiator when we are able to go back in the field and promote XENLETA in the community.

Moving on to Slide 16. I’d like to discuss how, in addition to the focus on the right patient for XENLETA and other critical element of our strategic approach to the community, is going to be targeting the right prescribers. Starting anew, allow us to think about who we will call. Primary care physician, pulmonologist and urgent care physician, along with nurse practitioners and physician assistant, are the key prescribers of antibiotics for CABP in the community. And it’s a fairly concentrated prescriber base, with around 5% of the prescribers accounting for about 50% of the total prescription. We will effectively and efficiently target those prescribers with the highest volume on prescription.

Finally, on Slide 17, I’d like to summarize the XENLETA action plan for the community. Nabriva’s strategic transition started in late 2019, with a targeted outreach to 6,000 community health care professionals in close proximity to our target hospital. And we further increased focus starting in January when we also launched a direct XENLETA shipment to patient option and made samples available to sales reps. As frequency of calls increased on the right target, we were experiencing early signals of success in 2020, with a positive trend in prescription. In response to the COVID-19 pandemic, we moved to a remote working model, we off-boarded the hospital sales force and leveraged digital and nonpersonal promotion. We will relaunch with a community-based sales effort as soon as access to health care providers is reestablished. We will revise our customer segmentation and targeting, and we will evaluate new personnel as well as remote customer engagement models in order to accelerate our execution for XENLETA. We’ll roll out resource based on customers’ access, potentially partnering with contract sales organization to ensure flexibility as well as community-based skill set to deliver optimal total office calls. We will also leverage effective digital and nonpersonal promotion element of the marketing mix to maximize our customer engagement. With more than 2 million patients and broad and grow managed care coverage, the outpatient population represent a substantial opportunity for XENLETA.

I would now like to turn the presentation over to Gary for the financial review.


Gary L. Sender, Nabriva Therapeutics plc – CFO [6]


Thanks, Francesco.

On Slide 19, I’ve listed some key highlights that are relevant to our financial position. These highlights include XENLETA’s revenue profile and the active management of our balance sheet. Nabriva generated total revenue of approximately $800,000 in the first quarter. As expected and disclosed in our prior financial updates, wholesalers continue to fill XENLETA orders, primarily from their existing initial strong stocking.

We recorded net product sales of approximately $150,000. Other sales is comprised of collaboration revenue and grant income from the Austrian government.

Like with all companies, the COVID-19 pandemic has made it difficult to predict future sales. There are a variety of scenarios which could evolve for the rest of the year, depending on demand. We are poised to assist physicians and the U.S. government with XENLETA supply, if needed. And we’ll continue to advance our science related to its potential benefits to COVID-19 patients, but sales in subsequent quarters in 2020 are difficult to forecast and, therefore, remain uncertain.

We previously announced the proactive management of our balance sheet through the paydown of $30 million of the $35 million of our Hercules debt. While our original disclosure said that we would pay down the debt in early April, we continue to work collaboratively with Hercules and have the opportunity to save on interest expense and, therefore, reduce our debt balances in mid-March versus in early April.

There are typically some cash needs, which occur early in the year, including payments for insurance and incentive compensation, and these were incurred in the first quarter. They will not materially impact the remaining quarters in 2020. We ended the first quarter with cash of approximately $27 million, we are actively managing our resource allocation and have identified significant savings throughout the organization.

As Ted and Francesco stated, we are poised to resume our promotion and medical education once we believe that these investments will provide their intended benefit. In the meantime, we believe it’s in our shareholders’ best interest to preserve cash in the near term. This exercise has allowed us to extend our cash runway, and we expect that our current balances will allow us to fund operations into the fourth quarter.

Let’s now look at the details of our P&L and balance sheet. Please advance to Slide 20. Slide 20 provides details of our P&L, and I ask that you look at the notes on the right side. The product sales generated in the first quarter were predominantly for the oral version of XENLETA, which carries a higher gross to net than the IV formulation. We therefore booked a 35% gross to net reserve in the first quarter.

As previously disclosed, our cost of goods are low, as we are utilizing inventory, which had previously been expensed when it was used for stability testing.

R&D expense is significantly lower year-over-year due to a decrease in activities, and the increase in SG&A was driven by the investments in the commercial organization. We expect that number to be lower in the quarters ahead, as we pause investments in light of the COVID-19 pandemic.

Interest expense is expected to fall significantly since our debt balances have been reduced to $5 million, and this reduction in our debt resulted in a noncash charge of about $2.8 million in the first quarter.

Turning to Slide 21, which has our March 31 balance sheet. We previously discussed our cash balances. And as was disclosed in the 10-Q we just filed, we raised over $3 million in cash from our ATM facility from the end of March until today, and that helps our current cash position. Accounts receivable increased due to product sales and the research grant from the Austrian government, and you can see the significant fall in our debt balances.

With that, I will ask Ted to make some closing remarks, and then we will head into a Q&A session.


Theodore R. Schroeder, Nabriva Therapeutics plc – CEO & Director [7]


Thanks, Gary.

In conclusion on Slide 23, let me go back and focus on our priorities for the year. The patient is at the center of what we do, and our primary goal is to make sure XENLETA is available to patients suffering from CABP. Our community action plan is designed to do this to expand coverage, both commercial and Medicare.

As Francesco stated, approximately 80% of CABP patients fall into 1 of these 2 categories. On relaunch of a community-based sales effort, we will have an increase in the frequency of face-to-face interactions with targeted physicians, meaning we will be able to restart in-person physician education. The message is clear. A novel antibiotic, such as XENLETA, provide a new treatment option for CABP, particularly for high-risk patients.

In the meantime, the company will manage expenses and conserve resources until we can realize the benefits of a new community-based sales initiative.

Also in 2020, we will continue to look for business development and in-licensing opportunities to find assets that fit Nabriva’s realigned infrastructure. And we anticipate obtaining approval of XENLETA in Europe and working with our partner, Sunovion, for approval in Canada.

No doubt, there is a lot to accomplish this year, but we have a vision of what needs to be done and a way to execute it.

I would now like to ask the operator to open up the line for questions. Operator?


Questions and Answers


Operator [1]


(Operator Instructions) Your first question comes from the line of Alan Carr with Needham & Company.


Joseph Robert Stringer, Needham & Company, LLC, Research Division – Associate [2]


This is actually Joey on for Alan. So first, on XENLETA, and then I just have a quick follow-up on CONTEPO. For XENLETA, I understand that the timing of this community-based sales force is still TBD, but maybe you could talk about what type — what size of sales force. And is there opportunities or options to do some initial sort of virtual with a smaller community-based sales force or maybe some additional color around that?

And then the second one on CONTEPO, I understand that it’s a matter of — is it just a matter of FDA physically inspecting the facilities? Or is there — you mentioned that you were in discussion with FDA, but is there something on your end or something that can sort of expedite that process? Or is it not really the gating — only gating factors, just the physical inspection?


Theodore R. Schroeder, Nabriva Therapeutics plc – CEO & Director [3]


Thanks for the question. I’ll handle the first question, and then I’m going to actually turn it over to Steve Gelone to talk about the CONTEPO NDA. So regarding the sales force, we’re looking at a variety of options. And you’re right, I don’t think any of us really know when face-to-face promotion will be available to a direct sales force. I think the kind of the common thinking is that, whenever that happens, it will likely occur in a phased way across the country, as different regions and states and maybe even cities become more relaxed. And we as a company,feel comfortable that it’s safe for our employees to be having those kind of interactions. And so there’s a fair amount of disruption that’s occurred in the physician practice setting, particularly in the community. And so we will take a flexible approach. Francesco mentioned the potential to use of contract sales organization and that may give us the optimum flexibility. So not having a standing sales force at the moment actually allows us now to deploy the sales force where we can utilize into the greatest efficiency and efficacy to deploy them in the right areas, aligned in — to an alignment that’s community focused, not based on the old institutional alignment, but truly focused on where the best community opportunity is and then with a sales force whose skill set is aligned to the — aligned to promoting in a community-based environment.

I would say that our plan is to start with the sales force about the same size that we had previously. And as the business grows to expand from there. But at the moment, we’re really looking at a flexible deployment model that will include both in-person selling as well as support for the brand with other nonpersonal and kind of semi-personal sales approaches.

So with that, why don’t I turn it over to Steve to talk about the CONTEPO NDA?


Steven P. Gelone, Nabriva Therapeutics plc – President & COO [4]


Thanks, Ted, and thanks for the question. So I think, as we communicated previously, the clinical and nonclinical review of the CONTEPO NDA have been completed. The remaining items left are for review of the manufacturing partners that we utilize. Obviously, with the travel ban, that’s created a challenge for the agency to be able to physically go on site and complete those activities. So we’re working collaboratively with the agency to try and see what alternate means they may be able to utilize in order to complete those manufacturing site reviews. The agency has certainly put out in the public domain that they’re considering utilizing previous compliance history or information sharing with other governments as part of mutual recognition as potential ways they can navigate around, not being able to physically go on site to complete some of this work. So — but as of now, the CONTEPO NDA is still set for June 19, and we continue to work collaboratively with them to find the most expeditious manner to successfully complete the NDA review and obtain approval for CONTEPO.


Operator [5]


(Operator Instructions) Our next question comes from the line of Kevin Kedra with G. Research.


Kevin Kedra, Morgan Group Holding Co. – Research Analyst [6]


Just a couple around CONTEPO. First, has the FDA given any sense of how they would handle the CONTEPO filing if, let’s say, they’re not able to figure out a work around to the travel ban? Should we be — should we expect something like a CRL, a 3-month delay, and indefinite delay? Any sense on kind of how the FDA would basically treat the filing in that situation?

And then secondly, just wanted to get a bit more sense of how you think about the sales force relative to the uncertainty with CONTEPO. I know the shift to the community focus is what you’ve talked about, that CONTEPO being more of a hospital-based product. How does that figure into the way that you think about the sales force, either if you do get CONTEPO in June or if we see a meaningful delay? Is there any difference in how you think about that?


Theodore R. Schroeder, Nabriva Therapeutics plc – CEO & Director [7]


Sure. So the first question, consistent with, I think, what Steve just reviewed with the FDA, to date, the FDA has not indicated one way or the other, anything other than a June 19 PDUFA date. And we still have some time for them to think about other ways to move forward with the NDA. I would say that they recognize the value of CONTEPO, particularly with the backdrop of a global pandemic and increased infections in the hospital and increase in resistance. So we’re working collaboratively with them. There’s nothing to really speculate on at this time, but we’re expecting further guidance from FDA and working towards that June 19 date.

As far as the sales force in CONTEPO, one of the realities, I think, in the current situation is that I don’t think there are many people in the industry who believe that hospitals will be the first place that sales representatives will be able to make calls. And in fact, hospitals will likely be the last place that will allow outside vendors of any company into their institutions to — that are not kind of required personnel. As you know, in some hospitals, family members can’t even visit. And so we think that, that restriction is going to stay.

I think the good news for CONTEPO is IV fosfomycin is a well-known, well-established antibiotic. It’s extensively written on their extensive library of clinical publications, and physicians know the product. And in our market research, nearly every physician we talk to has a sense of where they would use IV fosfomycin in their practice. So I think, with our medical affairs team being able to field questions and some other support with nonpersonal means and with the publications that are available, that we’ll be able to support the brand as it rolls out. That also doesn’t say that we won’t seek partners for the hospital as well. And I think there are a number of opportunities where we may be able to find a combination of a partner promoting and us supporting the brand with the tactics I just outlined.


Operator [8]


At this time, there are no further questions. This does conclude today’s conference. You may now disconnect.

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