Nabriva Therapeutics plc

Thank you all for standing by, and welcome to the Nebreva Therapeutics first quarter 2021 financial results call. All lines have been placed in listen-only mode until the question and answer session of today's conference. To ask a question over the phone by that time, you may press the star key followed by the number one. I'll now turn the call over to your host, Dan Dolan. Sir, you may begin.

Thank you, and good afternoon, everyone. Welcome to NEBREVA's conference call and webcast where we will discuss the first quarter 2021 earnings and also provide a business update. The slides for today's presentation are posted on the company's website, www.nebreva.com, 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 discussions. Before we begin, on slide two, 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 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. Ted Schroeder, Nabriva's CEO, will start with a business update and will present an overview of the commercial highlights from the quarter. Then, I will provide a financial review, and Ted will come back with some summary comments and lead a Q&A session. In addition to Ted and me, joining us on the call for the Q&A session is Dr. Steve Gillone, our President and Chief Operating Officer. I would now like to turn the call over to our Chief Executive Officer, Ted Schroeder.

Thank you, Dan, and thanks to everyone joining our call this afternoon. Let's start on slide five. The progress we made in 2020 to build our infrastructure and to correctly position our commercial efforts in the community is are continuing to advance in 2021. Let me begin by reviewing our key objectives for this year. Increasing awareness and prescription growth for both Zenletta and Cevextro in the community remains our primary focus, and we are seeing ongoing positive momentum. Through our partnership with Amplity Health, a leading contract sales organization, 60 sales representatives were deployed in the field late last year, targeting almost 8,000 healthcare providers. As COVID restrictions are beginning to be lifted and access to doctors' offices is improving, these sales reps are now able to have more in-person visits and are having more face-to-face interactions with HCPs. During the pandemic, according to data from the CDC, influenza-like illnesses, showed a dramatic decline versus the prior flu season, and widely prescribed antibiotic products, such as levofloxacin, declined approximately 50%. The decline in respiratory infections and the associated decrease in antibiotic prescriptions created headwinds in the near term for the broader industry, and specifically for nebreva, as respiratory infections declined due to social distancing and other preventative measures. As we see a return to normal activity post-pandemic, we are continuing our efforts toward keeping our products front of mind with healthcare providers for appropriate patients with community-acquired bacterial pneumonia, or CAP, and acute bacterial skin and skin structure infections, or ABSI. According to acquiring the U.S. rights to Cevextro from Merck, was an important milestone for Nebreva, given that physicians are already familiar with Cevextro for abc. It was also a testament to Nebreva's commercial capabilities. Importantly, as of April 12th of this year, Cevextro is now available under Nebreva's National Drug Code, or NDC, and Nebreva has begun exclusive distribution of Cevextro in the United States and certain of its territories as part of an agreement signed in July 2020. We'll discuss the positive financial impact of this later in the presentation, but it means that 100% of SavextroNet sales are now being recorded by NEBREVA. One should therefore expect our product revenue to significantly increase. Beyond the successful marketing execution of our two products, as we discussed last quarter, We are expanding our pipeline organically, and we are opportunistically looking for complementary business development opportunities. Cystic fibrosis is an area we have highlighted, given Zenlet's therapeutic and safety profile and the significant unmet medical need. We plan to initiate a Phase I trial in the second half of the year for patients with cystic fibrosis who often use antibiotics chronically. Additionally, business development for Zenletta outside the U.S. remains active with ongoing efforts to partner the drug in Europe and other territories. We continue to have multiple parties interested and are moving forward through the process. We want to ensure that we have a transaction that is in the best interest of patients and the bereaved shareholders. Regarding Contipo, Despite the FDA recently issuing some additional guidance, we don't have a lot more clarity at this point. We continue working with our consultants to understand the agency's guidance and the implications for resubmission of the Contipo NDA. We're encouraged that the FDA is thinking beyond just live, in-person inspections and that they're looking for alternatives to those inspections. We do not intend to file Contipo's NDA until we have confidence that the FDA can complete any required inspections within the six-month PDUFA clock. Finally, as we have done in the past, we are carefully deploying our resources to support our existing infrastructure and to drive sustainable growth. Slide six speaks to the depth of our pipeline across serious and rare infectious diseases. Let me talk a little bit more about our work in CF. So what have we done so far? We convened a scientific advisory board, and they were enthusiastic about Zenletta as an option for cystic fibrosis patients, and we believe could provide incremental peak sales in the $100 to $200 million range. The expert panel encouraged us to complete a Phase I safety and PK study in CF patients, so we are planning to start that study in the second half of this year. We expect to have some non-clinical data in the second half of this year with clinical data to follow in 2022. It's important to mention that much of this work is being supported through grants. In addition to the CF trial, I would also like to point out that our partner in China completed their phase 3 Zenletta trial and is planning for an NDA submission in the second half of this year for the treatment of community-acquired bacterial pneumonia. Now, turning to slide 8, I would like to provide a commercial update, starting with Civextro. Our marketing approach to Civextro is clear and focused. We know the drug is promotionally sensitive and that there is a significant prescriber base of physicians who have experience with Cevextro. Therefore, our sales force has been hard at work reengaging with doctors who are already familiar with Cevextro. We know who these healthcare providers are, and we are currently focusing on them to reemphasize the key benefits of Cevextro, a once-daily, short-course monotherapy for abscess. with potent activity against a broad range of pathogens, including MRSA. Given that skin infections tend to be seasonal, with the summer season being the high point for physician treatment of patients, we are pushing hard to capitalize on the opportunity in the coming months. In addition to focusing on previous prescribers, we are overcoming patient barriers by offering copay assistance, indigent patient assistance, and sampling of physicians to offer bridge doses while the patient fills prescriptions at the pharmacy. On slide nine, let me walk you through some of the market research findings and discuss in more detail why we're excited about the Civextro opportunity. Safety and convenience are key attributes that favorably position Civextro with physicians. The message is about potency. six-day course of therapy and no drug-to-drug interactions with other classes of drugs, such as SSRIs, are all benefits important to prescribers. As we increase call frequency and continue to communicate these points, we believe that we will begin to see a rise in prescription growth. Again, our view is that as the summer activity begins to rebound to normal levels, there will be a higher number of infections driving patients back into medical offices. Slide 10 summarizes the execution strategy that I've laid out for Civextro by focusing on identifying the patient, delivering an impactful message, and supporting healthcare providers by making the product more readily available. Civextro is indicated for a broad range of AbbC infections for both adults and adolescents. the drug has excellent managed care coverage. 269 million, or 91% of all insured lives, have coverage for Cevextro. A majority of those lives are unrestricted, which means no step edits or prior authorizations, and the market access team continues to work to expand this coverage. One thing that I think is worth calling out on the right-hand side of this slide is is the number of face-to-face visits we are conducting, which is running at 64 percent. That is up quarter over quarter versus 56 percent at our year-end update, and is well above the industry average for primary care visits. It's a metric that we think is important, is an important component to the strategy, and also demonstrates how the experience of the amputee sales representatives is an advantage to getting into physicians' offices. Slide 11 goes back to what I said at the beginning, that a major achievement this quarter was completing the transaction of Cevextro to a Nebreva branded, the transition of Cevextro to a Nebreva branded product, realizing 100% of net sales. In addition to the financial benefit, this is also important because it allows us to have greater information around the product. Information such as inventory levels, and which wholesalers are buying and when. I can tell you that as of today, the Nebreva brand of Savextro has been purchased by the three largest wholesalers. Nebreva anticipates seeing the return of historical peak sales trends for Savextro by mid-2022. Now, I would like to turn your attention to Zenletta. We have previously discussed how the brand recognition of Savextro has actually helped to get added time with physicians to educate them about Zenletta. We continue to lay the groundwork for Zenletta ahead of the fall season when we typically see an increase in pneumonia. We just exited a winter season of drastically reduced upper respiratory infections, and as people resume normal activities, it's reasonable to expect a future rise in the number of patients seeking treatment. Moving to slide 13, The takeaway from this slide is the rising rate of resistance to the leading cause of community-acquired pneumonia, streptococcus pneumoniae, which is why the CDC has deemed drug-resistant strep pneumoniae a serious public health threat. In fact, resistance to common macrolides like the Z-Pak, which are widely prescribed for treating community-acquired pneumonia, are becoming increasingly less effective as a treatment option. In fact, the Community Acquired Pneumonia Guidelines published by the Infectious Disease Society of America and American Thoracic Society stated that in any region of the country where resistance to strep pneumoniae is greater than 25%, pneumonotherapy with a macrolide is not appropriate. As you can see from the map, all regions across the U.S. have resistance to community respiratory strep isolates above 25%, validating the need for alternative treatment options. And so macrolides are quickly becoming an inadequate choice for treating pneumonia, particularly in more complicated patients. Physicians are looking for alternatives where they can be sure that the first five-day course of therapy will cure their patients and potentially avoid hospitalizations. We are confident that Xenletta will be recognized as a promising therapeutic for CAP with its novel mechanism of action, short course of therapy, low propensity to develop bacterial resistance, and favorable safety profile. Slide 14 is an example of our planned marketing campaign. Designed to increase awareness of Xenletta and establish it as the optimal choice for the appropriate patient in the community. Those with more complicated medical histories, such as older CAT patients who have recently been on antibiotics, and thus are at increased risk for resistance with traditional antibiotics. This patient profile is demonstrated more clearly on slide 15. The opportunity for Zenletta is the patient that has comorbidities, such as diabetes or COPD, which complicates achieving a positive outcome. It's the patient at risk for resistance to other classes of antibiotics like macrolides, tetracyclines, and penicillins. Add in the safety concerns with fluoroquinolones, and I think you can understand why we see a unique opportunity for Zenletta. With outpatient CAP cases estimated to cost $9.3 billion annually, with the largest driver cost for outpatient care is subsequent hospital admission, We believe that Zenletta fills a gap in the treatment of CAP. Slide 16 summarizes Zenletta's value proposition. These are the messages the field force is conveying to physicians about Zenletta that we think differentiate the product. Zenletta can be used as a reliable monotherapy. Zenletta has microbiologic activity against a broad spectrum of pathogens that are most often associated with CAP. Xenletta is a new class of antibiotic with a novel mechanism of action. Xenletta has a low rate of discontinuation due to adverse events, and Xenletta has a short five-day course of therapy. Collectively, these attributes differentiate Xenletta and we believe make it a compelling treatment option for physicians. As the sales reps are able to increasingly interact with doctors and lay the groundwork, ahead of the fall cap season, we would anticipate seeing an uptick in leaded prescriptions as we move throughout the year. I would now like to turn the presentation over to Dan for the financial review. Dan?