Nabriva Therapeutics plc

and 8K filed with the SEC. Turning to slide three, I would like to briefly run through this afternoon's agenda. Ted Schroeder, Nebreva's CEO, will start with a business update and will present an overview of the commercial highlights from the quarter. Steve Gillone, Nebreva's president and COO, will then give an update on LaFamulin and the prospects for LaFamulin's lifecycle management. Lastly, I will provide a financial review before Ted comes back with some summary comments and leads a Q&A session. I would like to now turn the call over to NEBREVA's Chief Executive Officer, Ted Schroeder.

Thank you, Dan, and thanks to everyone joining our call this afternoon. Before I get started, I would like first to welcome Dr. Christine Guicopabia, who joined NEBREVA as our Chief Medical Officer in October. Dr. Guicopabia brings over 30 years of global biopharmaceutical experience and extensive expertise in every stage of drug development. including pharmacoeconomics and outcomes research and medical affairs. She has previously held leadership positions at small startups and large multinational companies, including McKesson, Merck, Wyeth, Pfizer, and Medigenics. Welcome again, Christine. Let's start on slide five. We are very pleased with our results this quarter and the progress we are making on multiple fronts. Savextro's performance was strong, recording double-digit quarter-over-quarter growth in both net sales and in TRXs. These figures are promising and give us increased confidence that our commercial efforts are having an impact. As mentioned in previous updates, we expect to get Savextro sales back to historical peak sales trends by mid-2022. To help our efforts in increasing awareness of both Zenletta and Cevextro, we recently launched an inside sales representatives program, which has supplemented our field-based team to expand the promotional reach of Cevextro and Zenletta. We believe this additional program will expand our reach by targeting an estimated 2,000 top prescribers in white space geographies through additional personal promotion. Moving to Zenletta, we recently announced an agreement with Vizient, the largest healthcare performance improvement company in the U.S., to expand access to Zenletta in the hospital setting. For those that are not aware, Vizient provides expertise, analytics, and advisory services, as well as a contract portfolio that represents more than $110 billion in annual purchasing volume to improve patient outcomes and lower costs. With approximately 3 million people treated for community acquired bacterial pneumonia, or CAP, in the hospital setting each year, we believe this partnership is a great step toward establishing Zenletta as a treatment option for CAP in the hospital setting. In September, we also announced the approval of Zenletta in Taiwan. As many of you know, Zenletta has received regulatory approval in every country in which we have filed a regulatory application. We continue to see additional opportunity for growth with Zenletta through geographic expansion. We recently renegotiated our agreement with Hovion by extending our strategic partnership with Hovion through 2030. We gained near-term flexibility in cash allocation. We can now deploy additional investments towards growth-driving initiatives such as the increased advertising, non-promotional promotion, and direct-to-patient initiatives as we are entering the cap season. Earlier this month, we published the first data demonstrating the potent anti-inflammatory properties of lefamine. We are encouraged by these data and the potential that an agent-combining antibacterial and anti-inflammatory properties may offer clinicians and patients. Steve will provide additional color on these important data later in the presentation. As a result of accelerating revenue growth and continuing to be prudent with our resource deployment, we have now extended our cash runway to substantially through the second quarter of 2022. Moving to slide seven, This graph shows the TRXs for the oral antibiotic market in the United States. As you can see, the current trajectory is trending positively towards a return to pre-pandemic antibiotic prescribing. The trend is encouraging, and while not back to pre-pandemic levels, we are seeing consistent upward prescription growth overall. This is promising, especially for Zenletta, as we head into the fall and winter season when we typically expect to see a greater incidence of respiratory infections. Looking specifically at Cevextro on slide 8, I am excited to announce that Cevextro hit the 1,000 prescription mark this quarter. The first quarter this has been achieved since the second quarter of 2020. Additionally, we are excited to report the quarter-over-quarter growth demonstrated by Cevextro with a 14% sequential increase. We remain confident that Civextra sales can reach historical peak sales levels by mid-2022. Some of the factors responsible for the strength include the increased product awareness, the rate of MRSA infections in the community, and the productivity of our sales force. The outstanding coverage for Civextra was another factor driving adoption. We currently have approximately 275 million lives in the U.S. covered for Civextro. Our field-based sales representatives continue to see a high level of in-office interactions as we have progressed throughout the year. Not only are these increased office visits good for the current growth of Civextro, but we also believe this is laying the groundwork ahead of the cap season by keeping Zenleta top of mind. Moving to slide nine, let me spend the next few minutes discussing our agreement with Vizient, which we signed in early September to make Senletta available to Vizient's pharmacy network program. Vizient is the largest healthcare performance improvement company in the U.S. Vizient's customer base includes 18 networks and approximately 340 health systems and which represents an opportunity to focus on improving patient outcomes. Our partnership will afford us access to Vizient's expertise, analytics, and advisory services. With approximately 3 million adults treated with CAP in the hospital setting annually, this represents a significant opportunity to efficiently expand the use of Zenletta over time. Slide 10 lays out some of the key benefits that this relationship will bring to Zenletta. Given the recent challenges of getting access to hospitals due to COVID restrictions, we believe that we have created a channel through Vizient to expand the awareness and presence of Zenletta in the hospital setting. As we have previously mentioned, we are optimistic that Zenletta 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. What is also important about the Vizient agreement is the opportunity to expand Xenletta usage in the transition of care scenario when a CAT patient goes from the hospital to the outpatient setting. Last winter, we experienced a season of drastically reduced respiratory infections. But we anticipate that as people continue to resume normal activities, it is reasonable to expect a rise in the number of patients seeking treatment this fall and winter. We are envisioning the patient will start therapy while they are in the hospital and then get an additional prescription to take home upon discharge. Slide 11 highlights some additional efforts we are employing to promote Zenletta and drive increased demand in Q4 to capitalize on the respiratory season. These efforts focus on expanding prescriber reach through brand messaging at the point of cap diagnosis, generating highly qualified leads to sales representatives from non-personal efforts, identifying local and regional medical congresses for the sales representatives to engage with prescribers beyond the office and the introduction of the 10-count oral pack, or XPAC, for improved patient access and convenience. We are also focused on activating targeted patients by developing a Zenletta patient destination and content repository. Doctor discussion guides leave behinds with key messages and leveraging website drivers to reach the most likely CAP patients. As we turn to slide 12, we are excited to announce the launch of our 10-count oral pack, or the XPAC, for Zenletta. The availability of the 10-count oral pack allows for an efficient option for pharmacies to carry Zenletta across their distribution networks. As a result, we believe this will enhance the overall patient experience by improving access and availability of Zenletta across the retail market. Our sales force will actively communicate the availability of the 10-count oral pack, which we believe provides another positive step for Zenletta as we enter the upcoming cap season. With that as the commercial update, I will now pass the call over to Steve Jalone, who can discuss the progress of Lathamulin in cystic fibrosis, and the recent promising data showing lefamulin's anti-inflammatory activity. Steve.

Thank you, Ted, and it's my pleasure to provide a brief update on some of the ongoing Zinleta lifecycle management activities. As we have previously disclosed, Nebreva is evaluating the potential of Zinleta in the management of bacterial exacerbations caused by Staph aureus in patients with cystic fibrosis. As a reminder, and to help frame the unmet medical need, Slide 14 depicts the most recent data from the Cystic Fibrosis Foundation Patient Register Report from 2019, showing that Staph aureus remains the most common respiratory pathogen identified in patients with CF, even after the introduction of CFTR modulator therapy. Importantly, as shown on the right side of the slide, the presence of methicillin-resistant Staph aureus, or MRSA, in a respiratory tract culture negatively impacts the median survival time in CF patients with an observed reduction of 6.2 years as compared to CF patients with a respiratory culture that is negative for MRSA. While clinicians have a number of anti-staphylococcal antibiotics in their treatment armamentarium, they have had to rely upon agents that have either not been demonstrated to be reliably effective for the treatment of MRSA, that require intravenous administration in order to be effective, or have significant safety and tolerability issues limiting their clinical utility. Given that Zynleta is available as both an oral and intravenous formulation, has been shown to be a potent anti-MRSA agent, and is well tolerated, we believe it may provide an attractive treatment option for this difficult to treat patient population. Slide 15 provides an overview of the multifaceted approach we are taking to demonstrate the potential clinical utility of Xenleta in patients with CF. In collaboration with experts in the field, we have identified the most important challenges present in treating exacerbations in patients with CF, including that this patient population is often heavily pretreated with antibiotics, placing them at increased risk for the presence of resistance to many existing antibacterial classes. that these patients have a unique inflammatory environment present in their lung, and that they take concomitant medications that may pose potential drug-drug interactions as we constructed our approach to optimize the key attributes of Xenletta. For example, we have demonstrated the potent anti-staphylococcal activity of Xenletta against strains of Staph aureus isolated from CF patients, and have completed modeling the potential for drug-drug interactions with the most commonly prescribed CFTR modulators. Additional ongoing work will describe the efficacy of lefamilin in CF mouse infection models, and we are on track to dose the first patient in our phase one study evaluating the safety and pharmacokinetics of Xenletta in patients with CF in the first quarter of 2022. We are very excited to be working with many of the world's experts on this program, and are anxious to continue to share our progress with the scientific community over the coming months. In addition to our ongoing work to further describe Zinlet as direct acting antibacterial effects, we have recently published results that demonstrate Zinlet also possesses potent anti-inflammatory and immunomodulatory properties in the journal PLOS ONE. In two different animal models of lung inflammation, one simulating acute respiratory distress similar to that caused by the SARS-CoV-2 virus, and another caused by the H1N1 strain of influenza virus, also known as the swine flu that caused the pandemic in 2009. Xenletta was shown to reduce the number of neutrophils, which are a specific kind of white blood cell that get recruited into the lung of these animals. It inhibited the production of pro-inflammatory cytokines, including TNF-alpha and interleukin-6, that have been associated with poor outcomes in patients with pneumonia. It reduced alveolar inflammation and lung consolidation, and importantly was shown to increase the survival rate in animals infected with the H1N1 influenza virus. Zynletta's activity was notably shown to be similar to that observed with dexamethasone, a known potent anti-inflammatory corticosteroid, and superior to azithromycin, a macrolide antibacterial agent that is commonly used for its anti-inflammatory activity. With grant support from the Austrian Research Promotion Agency, our team is advancing work designed to elucidate the potential mechanism of action of Xenletis anti-inflammatory and immunomodulatory effects, as well as to validate these effects in in vivo disease-specific models that will help guide potential future clinical applications, such as the treatment of acute respiratory tract infections, bacterial exacerbations of cystic fibrosis, autoimmune conditions, and fibrotic diseases. We look forward to the next steps in this important project and to providing updates on our progress. It's now my pleasure to turn the presentation over to my colleague, Dan Dolan, who will provide the brevis corporate financial update. Dan?