Nabriva Therapeutics plc

Ladies and gentlemen, thank you for standing by, and welcome to the Nabeva Therapeutics 4th Quarter 2020 Financial Results Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, Please press star zero. Thank you. I would now like to hand the conference over to the speaker today, Mr. Gary Sender, Chief Financial Officer. The floor is yours.

Thank you, and good afternoon, everyone. Welcome to NEBREVA's conference call and webcast to discuss the fourth quarter and full year 2020 earnings and business updates. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. These statements are subject to the 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 three, I'd like to share the agenda for today. Ted Schroeder, NEBREVA's CEO, will start with a review of key business items in 2020. He will provide an overview of our 2021 priorities and will take you through a thorough commercial update. Jennifer Schrands, our Chief Medical Officer, will then discuss an exciting new development project as we explore the potential use of Zenletta in patients with respiratory infections due to cystic fibrosis. 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 me, joining us on the call for the Q&A session is Steve Gillone, our President and Chief Operating Officer. The slides for today's presentation can be found on our website under the Investors section. I would now like to turn the call over to our Chief Executive Officer, Ted Schroeder.

Thank you, Gary. and thanks to everyone joining our call this afternoon. Starting with a review of 2020, there is no doubt that COVID-19 made for a challenging year for the world, the pharmaceutical industry, and for Nebreva. I am so incredibly proud of the perseverance and dedication demonstrated by everyone on the Nebreva team. For 2020, For NEBREVA, 2020 represented a year of making great strides and shifting our focus to serve patients in the community and building positive momentum heading into 2021. One of our major achievements last year was obtaining the U.S. rights from Merck to promote and distribute Cevextro for patients with acute bacterial skin and skin structure infections, also known as ABSI. Gaining the rights to Cevextro provided a complementary product alongside our first marketed drugs, Enleta, which was approved by the FDA in August 2019 for the treatment of adults with community-acquired bacterial pneumonia, or CAP. It's a testament to Merck's confidence in our ability to market innovative antibiotics. We remain keenly focused on business development opportunities as we move forward. At the same time of the Civexta transaction, Nibriva announced a partnership with AmpliTea Health, a leading contract sales organization. Through AmpliTea, we are now pleased to have 60 sales representatives deployed, reaching almost 8,000 community healthcare providers. This effort, coupled with the continued excellent managed care coverage for Zenletta, has positioned us well towards our commercialization goals to expand the awareness and prescription growth for both products in the community setting. Approximately 92% of total commercial lives have access to Zenletta, with most of the coverage still being unrestricted without the requirements for prior authorization or a step edit. Internationally in 2020, Zenletta secured regulatory approvals in Europe and Canada, and a phase three trial completed enrollment in China. A regulatory filing in China is expected by the second half of 2021 by Sinovant, our local partner. And as Gary will comment on later in the presentation, in 2020, we removed risk by paying down debt and recently strengthened our balance sheet with an extended cash runway that now gets us into the fourth quarter of 2021. With that as an overview of how we executed in 2020, let me discuss our key objectives for 2021 on slide six. First and foremost is to build upon the commercial infrastructure we implemented last year to broaden the prescription uptake for both Zenletta and Cevextro. Please keep in mind that three-quarters of our current field force started after Thanksgiving. Early trends remain encouraging, especially our ability to get direct access to medical providers. We also anticipate that Cevextro will be transitioned to a Nebreva-branded product early in the second quarter, and we will begin recording 100% of the net sales on our P&L. More to come on that in Gary's financial section. An important objective for NEBREVA this year is to remain opportunistic in finding ways to expand organically and through synergistic business development initiatives. In this regard, you will hear from Dr. Schrands about our plans to initiate an important phase one study for Zenletta in patients with cystic fibrosis, or CF, who often take antibiotics chronically. Our decision was based on Zenletta's ability to achieve high concentrations in the lung, coverage of resistant organisms, favorable safety profile, and the large unmet medical need. We anticipate having meaningful data readouts to share with you beginning later this year. Additionally, we continue to focus on business development for Zenletta in Europe and other territories as we look to find partners to market the drug outside of the U.S. With regards to Contipo and our new drug application resubmission, the FDA still has not determined how it will conduct international manufacturing inspections during the COVID-19 pandemic. This has negatively impacted many FDA product reviews. It's important to know that we and our manufacturing partners have been in active dialogue with the FDA to ensure that all parties are prepared for a resubmission. As a result, next steps and specific timing of the Contipo NDA resubmission cannot be finalized until the agency issues industry guidance. We in the industry await future communication from the FDA on the matter and how the agency plans to address foreign facility inspections. Recall that no new non-clinical or clinical data were requested, and the FDA did not raise any other concerns with respect to the safety or efficacy of Contipo. Please keep in mind that our eight-year market exclusivity does not begin until Contipo is approved by the FDA. We will provide an update once we have greater clarity. We know that you, our investors, are eager to hear about the path forward, and so are we. And lastly, we will pursue our 2021 objectives while prudently managing our balance sheet and expenses as we have historically done. Now, turning to slide eight, let me walk you through our commercial progress and outlook. You've seen this slide before, but let me use it to reinforce the complementary overlap in our targeted calling markets. I think it's important to reiterate the shared physician specialty is in focus for Cevextro and Abc and for Xenleta in CAP. Strategically, there are considerable similarities in the prescriber base, particularly within primary care, urgent care, and infectious disease. The market is large, with these two products having a combined total in excess of 5 million potential patients in the outpatient setting. On slide 9, We show the updated sales territories with 60 amputee representatives now in the field, 45 of them being added after Thanksgiving of last year. We believe that the footprint of these 60 salespeople will effectively cover our target of 7,800 physicians across the country. We believe our current alignment gives us the ability to reach approximately 61% of the historical Civextro prescribers and roughly 57% of the potential Zenletta prescribers. That gives you some perspective on the healthcare provider side. So let me shift and talk now about what we are currently seeing in the market and how we are systematically approaching our brand awareness and medical education campaign given the COVID-19 dynamics. What we have seen in the market is a meaningful fall-off in non-COVID-related respiratory ailments versus the prior year's level. Looking at total prescriptions for oral levofloxacin, a commonly used quinolone antibiotic to treat bacterial infections as a benchmark, the graph shows a steep 50% drop in total prescriptions year over year. But it's still a big opportunity, and we hope to participate even more as trends return to normal. While the market is challenging, we are getting meaningful interactions with healthcare providers. Starting with slide 11, I am pleased to share that 33,000 total sales calls have occurred since October, over 6,000 in family medicine alone. Other top medical specialties include podiatry, dermatology, infectious disease, and internal medicine. Based on our efforts to date, we have reached approximately 96% of the top two deciles of potential Civextra prescribers and 98 percent of potential top deciles in Leda prescribers, truly a demonstration of our execution and ability to be able to reach our target physician audience. The next slide shows that the majority of the primary care engagements, approximately 56 percent, have been in person, which is a third higher than the industry average. Overall, we are seeing some reassuring signs with improvements in access for certain regions. Our feedback from the sales force shows an increase in physician offices allowing sales professionals to conduct educational lunches, fulfill sample requests, and deliver clinical messages. Admittedly, we are still in the early days as it takes multiple visits with physicians to educate them on a new drug, especially given the fact that there has been a dearth of new antibiotics. However, what we are seeing is directionally positive, and we remain hopeful that our access for face-to-face interactions will improve. We have proceeded cautiously given the dynamics of the COVID-19 environment. But given our current confidence, we are rolling out enhanced marketing materials and medical education programs in the weeks and months ahead as we aim to expand Zenletta's brand recognition in order to drive new prescription growth. Some examples of these new initiatives for Zenletta can be seen on the next slide. Our goal is to optimize resources by focusing on enhanced marketing resources for Zenletta, which include both rep-driven and non-personal promotion materials. A few highlights include virtual education seminars delivered by leading specialists in the pulmonary community, as well as outpatient-focused promotional pieces, highlightings and letters inclusion, and up-to-date recommendations for community-acquired pneumonia outpatient treatment. Additionally, we are focused on a new creative campaign, expanded HCP education, and additional rep-directed resources. In parallel, the managed market team continues to secure excellent managed care coverage for Zenletta. This can be seen on slide 14. Over 248 million lives have coverage with Zenletta, and we expect to further expand formulary coverage in 2021. Unrestricted access has edged over 78% versus 74% in the prior quarter. Major plans are being added. As we conveyed last quarter, Humana, which has nearly 1 million lives, came on board as of January 1, 2021, also with unrestricted coverage. In summary, before I hand the call over to Jennifer, it is important to note that physicians' historic knowledge of and experience with Civextro has initially opened the door for discussing Zenletta. With 60 field personnel now fully trained and deployed, we would expect to see the pull-through of prescriptions to increase as we move through the year. And as Gary will explain in more detail, we are excited to be able to sell Cevextro in the coming months under the NEBREVA label. Now, let me have Jennifer talk more about why we are exploring the uses in LETA in cystic fibrosis. Jennifer?