Nabriva Therapeutics plc

Good day and welcome to the Nebreva Therapeutics fourth quarter 2021 financial results and business update call. At this time, all participants are in 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 then one on your touchtone telephone. If anyone should require assistance during the call, please press star then zero to reach an operator. As a reminder, this call may be recorded. I would like to turn the call over to Dan Dolan, Nebreva's Chief Financial Officer. You may begin.

Thank you, and good afternoon, everyone. Welcome to Nebreva's conference call and webcast, where we'll be discussing the fourth quarter 2021 earnings and providing 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 sections. We recommend that you refer to the presentation as we'll be using those slides for today's discussion. 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. Turning to slide three, let's briefly run through this afternoon's agenda. Ted Schroeder, NEBREVA's CEO, will start with a business update and present an overview of the commercial highlights from the quarter. Dr. Steve Gillone, our President and Chief Operating Officer, will provide an overview of our regulatory strategy related to Contipo, and then I will provide a financial review before Ted comes back with some final commentary and leads our Q&A session. I will 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. Let's start on slide five. We are pleased with the progress we made in the fourth quarter and how we exited the year. Last year, the team continued to lay the groundwork on key operational drivers focused on creating sustainable long-term value. Let me start with the launch of our own NDC for Civextro in April 2021. As you recall, this allowed us to recognize 100% of net product sales for Cevextro, which has provided a positive impact to our P&L. We continue to see ongoing momentum for Cevextro and are happy to report another quarter of sequential prescription growth. Next, we transitioned development and commercialization rights of Lathamulin in Greater China to Sumitomo Pharmaceuticals. Sumitomo opted to pursue lefamulin to complement their existing anti-infective product portfolio in China. Sumitomo is already a dominant player in the anti-infective space in the Greater China region, putting them in a solid position to launch lefamulin once approved. We announced in November that the NDA for lefamulin in Greater China has been accepted by the regulatory authorities, and we look forward to providing updates when available. As a reminder, we are entitled to low double-digit royalties on net sales, as well as payments of up to $86 million upon the achievement of certain sales and regulatory milestones, the first milestone of which is due upon approval in the region. As previously mentioned, We'd expect this approval to be within 18 to 24 months from when the regulatory authorities accepted the new drug application in November 2021. Moving to our second commercial product, Zenletta, we continue to make progress in making the product more accessible and convenient for patients in the U.S. In November of last year, we launched the 10-count oral pack, or XPAC, which allows for improved patient access and the opportunity to further broaden availability in retail channels. Next, we partnered with Vizient's pharmacy network to expand visibility of the IV formulation of Zenletta in hospitals. This agreement affords Zenletta the support of the Vizient network through their hospital systems by increasing awareness of Zenletta as an alternative antibiotic treatment option for community-acquired pneumonia. We believe this could be a good opportunity for Zenletta as a transition of care alternative given its IV and oral formulations. We continue to explore additional uses of Zenletta and have advanced the cystic fibrosis program. We are making good progress with the CF trial and anticipate the first patient dose within the next month. The Phase I safety and PK data are expected in 2023. Our optimism for this program is based on the potent anti-staphylococcal activity of Xenleta against strains of Staph aureus isolated from CF patients. In October, we published data in a peer-reviewed journal, PLOS One, demonstrating lefamulin has anti-inflammatory properties in in vivo and in vitro models. The anti-inflammatory aspects of Lathamulin has potential wide-ranging applications to various infections including CAP and CF. The combination of the potent antimicrobial and potent anti-inflammatory properties of Lathamulin is very encouraging for the cystic fibrosis patient population in particular. We continue to strengthen our financial position with negotiations on our contracts with Oveon, our third-party manufacturer for Zenletta, and our debt agreement with Hercules. These amended agreements, along with the strong performance from Civextro, extended our cash runway well into the fourth quarter of 2022. Moving to slide seven, we are excited with the accomplishments to date. but more importantly, with what we see as the key value drivers that lie ahead for the company. We believe we have multiple significant catalysts over the near term that can benefit patients and enhance shareholder value as we maximize each of our core franchises. With roughly $48 million of cash on hand as of December 31, 2021, we have now extended our cash runway well into the fourth quarter of 2022. Our strategy is based on the strong Savextra Foundation, which continues to show solid growth in the U.S. This progress gives us confidence to reaffirm our guidance that Savextra sales will reach historical peak sales levels by mid-2022. Fully funding our commercial efforts, and a portion of our G&A costs while helping to further reduce our overall cash burn. As for Zenletta, we are continually seeking ways to optimize access for patients and healthcare practitioners. As we have said before, the cap market is large with approximately 2 million potential adult patients in the outpatient setting. We recently held a positive interaction with an advisory board of pulmonologists, who understand and see the value in a product like Zenletta. The advisory board provided significant insights as we continue to evaluate and assess the value proposition for Zenletta in the antibiotic market. It's important to remember that we have an extensive patent runway out until 2033 to giving us time to raise awareness and create value with Zenletta for patients and for healthcare practitioners. Additional opportunities for Zenletta include potential use in cystic fibrosis, which we estimated could potentially generate $100 million of incremental sales. The phase one trial is a small investment to determine if the non-clinical data translate clinically, and if so, we believe this could be a major catalyst for the company. Lastly, with Zenletta, we continue to explore partnership opportunities outside the United States. This is another resource which has the potential to provide the company with additional non-dilutive funding. We have existing partnerships in Canada and China and are actively negotiating in other regions, including Europe. Moving on, We remain committed to bring Contipo to the market. We believe there is still a large unmet need in the United States for treating patients with infections caused by multidrug-resistant or MDR organisms. An estimated 3 million people in the United States are treated for suspected or confirmed MDR. Turning to slide eight. Civextro posted another quarter of sequential growth and the second straight quarter where we saw more than 1,000 Civextro TRXs. In addition to executing commercially with our experienced sales team, we are demonstrating the ability to grow Civextro back towards historical peak sales. With our commercial infrastructure now well-established, the organization has shown the capability to drive patient access and utilization for established brands like Cevextro. Shifting to Zenletta on slide nine, we continue to see a lot of potential for the product with its novel mechanism and broad coverage. We held an advisory board with pulmonologists earlier this year, which reinforced Zenletta's positive characteristics and differentiated positionings. One of the main takeaways was the ongoing need for CAP treatment options. The availability of IV and oral formulations allows for the efficient transition of care from hospital to community. More importantly, the availability of an oral option may allow for treatment in the community to help avoid hospitalizations. The short five-day course of therapy is another positive attribute. Feedback from the advisory board also supports interest in the potent anti-inflammatory properties of Xenletta. We continue to learn more about Xenletta from ongoing interactions with community-based HCPs, gaining insights from providers about how they view the drug and its utility as a first-line empiric agent. This is especially important as we plan a framework to explore expanded usage for Xenletta in areas such as cystic fibrosis. Switching to Contipo on slide 10, our optimism for the prospects of Contipo continue to be bolstered by the reality that the silent pandemic of antimicrobial resistance is becoming more prevalent and negative patient outcomes continue to be more common. Based on a recent publication in Lancet, it was estimated that a staggering 1.27 million deaths were attributed to AMR in 2019 globally. To put that into perspective, deaths attributable to AMR now outnumber the annual deaths from HIV, breast cancer, or malaria globally. The six leading pathogens for deaths associated with resistance were E. coli, followed by Staph aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Acinetobacter baumannii, and Pseudomonas aeruginosa. And these pathogens accounted for just under 1 million deaths attributable to AMR. As you are most likely aware, Contipo has a novel mechanism of action and has been shown to be highly active in vitro against several of these commonly resistant pathogens. Contipo has been demonstrated to be well tolerated and effective against E. coli and Klebsiella pneumoniae in our pivotal trial for complicated UTI and pyelonephritis. In addition, IV phosphomycin is approved for multiple indications and used extensively outside the United States for many years now. As a result, many U.S. physicians are already aware of the drug's potential benefits, and we believe there is a unique opportunity for Contipo as a potential treatment option for patients with suspected or confirmed multi-drug resistant infections in the United States. For the next part of the presentation, I'd like to turn it over to Dr. Steve Gillone, our president and chief operating officer, for a brief update on the status of the Contipo NDA. Steve?