Nabriva Therapeutics plc

Good morning, and welcome to the Nebreva Therapeutics Second Quarter 2022 Financial Results Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, and then two. Please note that this event is being recorded today. I would now like to turn the conference over to Dan Dolan. Please go ahead, sir.

Thank you, and good afternoon, everyone. Welcome to NEBREVA's conference call and webcast, where we'll be discussing the second quarter 2022 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 section. 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 3, let's briefly run through today's agenda. Ted Schroeder, NEBREVA's CEO, will start with a business update and present an overview of the commercial highlights from the quarter. I will then provide a financial review before Ted comes back with some final commentary and leads our Q&A session. I will now like to turn the call over to NEBREVA's Chief Executive Officer, Ted Schroeder.

Thank you, Dan, and thank you, everyone, for joining our call this afternoon. Our theme of accelerated performance from prior quarters continued in the second quarter. Vextro's strong demand growth performance in the quarter continues to position the business well. We continue to move the business forward across all three key areas, commercial, clinical development, and business development. I will get into more detail about each of these areas later in the presentation. In parallel, we also continue to improve our financial position. We saw significant double-digit top-line growth versus the prior year, driven by Cevextro's 28% prescription demand growth. We achieved this growth efficiently with our SG&A expenses declining 14% versus the same quarter in 2021. This resulted in further improvements in operating burn, which Dan will highlight later in the presentation. It is very encouraging to see all the hard work and focused efforts creating momentum as we move forward. Turning to slide six, I believe it's important to remind everyone of the changes we've made this year and the positive impact they have had on the business. As you recall, we extended our agreement with Merck to distribute and promote Civextro in the U.S. through at least 2026. This extension provides us with an established revenue stream for at least three and a half more years. Civextro will continue to serve as the foundation of our commercial focus and extend the runway we have built from our commercial execution to date. With this in mind, we realigned our efforts on Civextro, adding over 3,000 additional targets beginning April 1st, bringing our total target universe to nearly 8,000. We have experienced immediate benefits from this realignment here in the second quarter, and I will expand upon that later. We also brought our district sales managers in-house, which we believe provides enhanced line of sight and a streamlined communication so we can be more nimble in responding to evolving dynamics in the field. A year ago, we piloted an inside sales representative program, and based upon its success, we have extended the program and expanded the role of the inside sales representatives to help further accelerate the Vextra's uptake with expanded targets. Our strategy is simple. Expand our Civextro targets with a more focused approach, keep frequency high with the use of the inside sales representatives, and generate increased prescribing from both current and new targets. As you can see on slide seven, the strategy I outlined has had an immediate impact on performance. Civextro posted 28% year-over-year prescription demand growth surpassing the year-on-year growth in the prior three quarters. This is even more encouraging as we continue to work through what has historically been peak season for acute bacterial skin and skin structure infections, or ABSI. And we are poised to continue to take advantage of the momentum with our refocused efforts on the brand. The realignment that we put in place earlier this year has had significant impacts from the very beginning. This reaffirms our confidence in our strategy, commercial execution, and promotional sensitivity of the brand, demonstrated by the consistent growth of Civextro demand since we reengaged with promotion. The over 1,100 retail prescriptions in Q2-22 were another high for the brand since Nebreva took over promotional efforts. Turning to slide eight. First, let me briefly discuss the new alignment we implemented for Civextro. Specifically, we already are seeing early returns on our Civextro refocus with our key targets, demonstrated by the impressive demand growth in Q2 driven by our increased reach to target prescribers, including podiatrists, dermatologists, nurse practitioners, PAs, and primary care physicians. In the second quarter, We saw over 100 new Civextra writers, with 30% of those prescribers writing for two or more prescriptions in the quarter. In Q2-22, our reach of targets more than doubled versus Q1-22. We are encouraged by the early results and expect the increased reach and frequency to drive growth over time. We are confident that we are well-positioned for continued growth with Civextra. On slide 9, our Civextra promotion has been further supported by the work of inside sales representatives. A pilot program we initiated a year ago, which initially focused on potential white space geographies targeting approximately 2,000 additional potential prescribers. We have been encouraged by the activity of the inside sales representatives to date and plan to expand their utility in a number of ways. When you consider the nearly 8,000 potential prescribers the field-based representatives are now calling on, combined with the white space reach of inside sales reps, we are effectively covering close to 10,000 potential Sevextro prescribers. In addition to driving demand in white space geographies, the inside sales reps will now provide support in assigned districts for vacancy coverage. They will also help to increase the frequency with high-volume writers by making additional calls in between calls made by our field-based representatives. As the field-based reps continue to increase their reach in the expanded universe, the ISRs will provide additional calls to keep frequency high so Civextra remains top of mind for prescribers. Moving to slide 10, Two weeks ago, we announced we had entered into an exclusive distribution agreement with ERKIM, a leading partner for biotech companies in international markets, for the oral and intravenous formulations of Venleta. Under the terms of the agreement, ERKIM gained exclusive rights to distribute Venleta in nine countries. ERKIM also may distribute Venleta to an additional five countries through a named patient usage program. Nebreva will be the exclusive supplier of Zenleta to Erkin. This agreement highlights the execution of just one part of our business development goals for 2022 and expands our geographic presence for Zenleta. This provides yet another opportunity for Nebreva to generate passive income with a significant double-digit royalty on sales in these territories. We've taken large steps to unlock value for this asset, and I'm especially pleased with our team for executing a transaction in such a tough macro environment. I will now hand it over to Dan for a financial update.