Nabriva Therapeutics plc
Q1 2021 Earnings Call Transcript

Published: 9 May 2021

[Operator:]

Thank you for all for standing by and welcome to Nabriva Therapeutics First Quarter 2021 Financial Results Call. All lines have been placed in a listen-only mode until the question-and-answer session of today's conference. I'll now turn the call over to your host, Dan Dolan. Sir, you may begin.

[Dan Dolan:]

Thank you and good afternoon, everyone. Welcome to Nabriva's conference call and webcast where we will discuss the first quarter 2021 earnings and also provide the business update. The slides for today's presentation are posted on the company's website, www.nabriva.com and can be found under the Investors tab in the Events & Presentation section. We recommend that you refer to the presentation as we will be using those slides for today's discussion.

[Ted Schroeder:]

Thank you, Dan and thanks to everyone joining our call this afternoon. Let's start on Slide 5. The progress we made in 2020 to build our infrastructure and to correctly position our commercial efforts in the community are continuing to advance in 2021. Let me begin by revealing our key objectives for this year. Increasing awareness and prescription growth for both XENLETA and SIVEXTRO 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 Nabriva, 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 CABP and acute bacterial skin and skin structure infections or ABSSSI.

[Dan Dolan:]

Thank you, Ted. As we turn to Slide 18, I'd like to touch on some key highlights for the first quarter of 2021. We recognized $2 million of revenue in the quarter, including $1 million of collaboration revenue from our agreement to promote SIVEXTRO with Merck, as well as the achievement of milestones with our partner in China for lefamulin. We exited the quarter with cash and cash equivalents of approximately $55 million, providing us cash runway into the fourth quarter of this year.

[Ted Schroeder:]

Thanks, Dan. Finishing up on Slide 23, which takes us back to the 2021 key objectives slide. As we went through today's presentation, I hope you can see that our near-term focus is all about execution of the commercial growth of SIVEXTRO and XENLETA, the most critical goal this year. Completing the transition of SIVEXTRO to being a Nabriva branded product is a major step in successfully marketing this product. As Dan discussed, it not only allows for a positive financial impact, but additionally, it provides us visibility on material new data to help inform a more strategic approach. Information such as which payers are paying - covering the drug and what the copays are by payer, which wholesalers are purchasing and which pharmacy stocks SIVEXTRO. We see access to physicians' office is improving with more patients returning to see their doctors. We believe that the incidence of skin infections will be on the rise as we return to normal activity and into the summer months when there are higher rates of ABSSSI. All the work our sales representatives are doing now should also solidly position us for the fall with XENLETA when pneumonia becomes more prevalent. Our field force has now been into the doctor's offices for several sales cycles, and are beginning to conduct more face-to-face interactions with healthcare providers. They are reestablishing personal dialogues at medical education, which should lead to a greater pool throw of prescriptions. In parallel, we are continuing to evaluate our pipeline for longer-term potential upside opportunities. We think CF is an interesting area that we have decided to initially pursue internally through grant funding. We are committed to get through at least the Phase 1 program in cystic fibrosis for XENLETA. Discussions are ongoing as we aggressively seek partners in Europe and other unpartnered territories outside of those that are already partnered, which are China and Canada. We plan to resubmit the NDA for CONTEPO when we have clarity, that the FDA will be able to meet their PDUFA obligations. And finally, we will do all this while closely monitoring and managing our expenses as we move through the rest of the year. I would now like to ask the operator to open up the line for questions. Jesse?

[Operator:]

Our first question is from the line of Ed Arce of H.C. Wainwright. Your line is now open.

[Ed Arce:]

Great. Hanks for taking my questions. And congrats on you know getting the NDC for SIVEXTRO few weeks ago.

[Ted Schroeder:]

Yeah. Thanks, Ed.

[Ed Arce:]

I also appreciate the slide on the impact of that on your P&L and sort of the line items and how that flows through that. That's helpful. I'm just wondering now, it's been just a few weeks, I realize it's quite early still. And the summer months will definitely help to kick in more interest. But if you could, you know, since the transition, what kind of commentary are you hearing on the ground with the new branding? You know, what kind of feedback are you getting that perhaps can help you feel more confident about your guidance of reaching that run rate, previous run rate by the middle of next year?

[Ted Schroeder:]

Yeah, no. Thanks, Ed. Good questions. Always appreciate those. So we're hearing a lot on the ground. Certainly, earlier in the year, we were hearing that, you know, I'm just not seen as many patients, I'm not seen even in the winter months, as many skin infections that I used to, I don't think that that's really surprising. People weren't out and about doing the sorts of things where they get bumps and scrapes and inevitably infections follow, you know, people not working you know on their feet all day and those sorts of things. So, as we see, what we're hearing from physicians now is that, we're seeing more people in the office. One of the other things that came with the switch to the Nabriva NDC, is, we're also now hand carrying samples into the physician's office. And that actually makes the close of the sale a much closer to the communication that the rep has with the physician. So the sample acts as a good reminder, we're able to deliver it when a product educational message is delivered and we're hearing from physicians that that's important, it makes a big difference in their prescribing decision. So we're looking forward to that. And then the other thing I would say is that, we've seen good orders from wholesalers, we'll talk about what those orders are in our next quarterly call, but we've been pleased with the initial orders from wholesalers. And so it doesn't and it doesn't look like they're necessarily stocking in, but that they're stocking more or less to meet their anticipated demand, which is good news. So, you know, I think all the factors are moving together for an increase in, you know, kind of a natural increase for the summer, but also a return of patients to the office and that will continue to drive sales upward.

[Ed Arce:]

Okay, great. And then just continuing to think about how this, you know, new structure will impact the P&L going forward as you continue to see prescription growth and utilization. What kind of level of gross to net would you expect? At least, you know, as a steady state, perhaps later in the year? Thank you.

[Ted Schroeder:]

Yeah. Dan, why don't you go ahead and answer that?

[Dan Dolan:]

Yeah, sure. Thanks, Ted and thanks for the question, Ed. And I think I mean in terms of SIVEXTRO, we haven't really provided any guidance, we're still kind of getting our arms around the growth to net in the contract. So I think, give us a quarter or two as to kind of wrap our head around that. I think on the - then led in the past, we'd given a mid 30% range as a guidance. So, you know, you might want to use that for a landmark right now. But give us a few more quarters and we can tighten up the SIVEXTRO side.

[Ed Arce:]

Okay, fair enough. Thank you, both. Appreciate it.

[Ted Schroeder:]

Thanks, Ed.

[Operator:]

No further questions on queue. And that concludes today's conference. Thank you all for participating. You may now disconnect.