BioDelivery Sciences International, Inc.

Greetings. Welcome to Biodelivery Sciences' first quarter 2021 earnings call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I would now like to turn the conference over to Terry Cuio, Executive Vice President and Chief Financial Officer. Thank you. You may begin.

Thank you and good morning, everyone. Welcome to our first quarter 2021 earnings conference call. Leading the call today is Jeff Bailey, Chief Executive Officer. We are joined by Scott Plescia, President and Chief Commercial Officer. Following our prepared remarks, we will conduct a question and answer session. Earlier today, Biodelivery Sciences issued a press release announcing its financial results for the first quarter of 2021. A copy of the release can be found on the investor relations page of the company's website. Before we begin, I would like to remind everyone that certain statements may be made during this call, which may contain forward-looking statements. Such forward-looking statements are based upon current expectations, and there can be no assurances that the results contemplated in these statements will be realized. Actual results may differ materially from such statements due to a number of factors and risks, some of which are identified in our press release and our annual, quarterly, and other reports filed with the SEC. These forward-looking statements are based on information available to BDSI today, May 6, 2021, and the company assumes no obligation to update statements as circumstances change. An audio recording and broadcast replay for today's conference call will also be available online in the Investors section of the company's website. With that, I'd like to turn the call over to Jeff Bailey, our CEO. Jeff?

Thank you very much, Terry, and welcome, everyone, to our company's first quarter 2021 earnings call. I'm happy to report that our business remains healthy and well-positioned as we manage through the pandemic. I would like to focus your attention on three main takeaways from today's call. The first key takeaway, our overall business remains solid in the first quarter with sales growing 7%, including Bell Buca, TRX volume growth of 8.9% year over year, despite two challenges. A notable challenge, like other pharma companies are reporting, COVID is having a market impact in Q1 with patient visits being down across a number of therapeutic areas. This includes a long-acting opioid market that saw prescription volume decline 5.8% compared to Q4. Furthermore, we saw one-time disruptions to our business from the February winter storm URI. The storm had both regional and national impact. Recently, in the south-central area, where we have a strong presence, pharmacies and physician offices were closed for multiple days. More specific to BDSI, we encounter a national impact. as our Tennessee distribution facility was not able to ship product due to the storm for approximately two weeks. We mentioned these headwinds previously in our Q4 2020 earnings call. Despite these challenges, our businesses performed well. With weather-related issues behind us, it's been encouraging to see an increase in sales representatives' face-to-face calls with healthcare providers or HCPs, as well as stronger prescription trends. We're also seeing the highest weekly NBRX market shares on a year-to-date basis in April, along with an all-time record high TRX market share in our most recent data week. Scott will cover this in more detail. These trends give us confidence in our growth going forward. Additionally, we know that much of our lost revenue in Q1 was due to a weather-related disruption to prescription fulfillment rather than decreased customer demand. The second key takeaway, our product portfolio remained strong and profitable as we continued to build our balance sheet ending the quarter with approximately $116 million in cash. In the first quarter, we generated $9.2 million in EBITDA with an attractive 22% EBITDA margin. This is accompanied by approximately $11 million in operating cash flow generation. which enables us to invest in our brands while positioning us well to maximize shareholder value through thoughtful business development at the appropriate time. The third key takeaway, we remain confident about our growth in 2021 as we see three important developments going forward. First, patients are returning to physician offices at a higher rate and weekly shares in April are at all-time highs. Second, we are seeing increasing face-to-face interactions by our sales representatives with HCPs as offices are reopening access, which is critical to promoting clearly differentiated products like Belbuca and Simproic. Third, and most importantly, we are reiterating the financial guidance we issued last quarter. We are still on track to achieve four-year total revenues of $170 to $180 million, including Belbuca net sales of $155 to $165 million, and $40 to $50 million of . I also want to share one additional update about our business. Our three-day bench trial with Allergen related to their paragraph four patent challenge concluded on March the 3rd. Post-trial briefs from the parties are due to the courts by mid-May. We have a strong patent position, and while we remain very confident in the strength of our IP, we can neither predict the decision the court will reach nor the timing of the court's decision. As you would expect, we are not able to comment further regarding the ongoing litigation. With that, I will turn the call over to Scott to provide more details of our performance during the first quarter. Scott?