Paratek Pharmaceuticals, Inc.

Good day and welcome to Paratech Pharmaceutical's second quarter 2022 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please sign our 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 the star then one on your touchtone phone. To withdraw your question, please press star then 2. Please note, this event is being recorded. I would now like to turn the conference over to Sarah Higgins, Vice President Finance and Principal Accounting Officer. Please go ahead.

Good afternoon and welcome to Paratech's second quarter 2022 earnings and corporate update conference call. A press release with the company's financial results was issued earlier today, and we have also posted slides on our website to which we will refer on this call. Both can be found at www.paratechpharma.com. Participants on today's call are Evan Lowe, MD, Chief Executive Officer, Adam Woodrow, President and Chief Commercial Officer, and Randy Brunner, Chief Development and Regulatory Officer. Michael Bigum, Executive Chairman, and I will also be available for questions. Before I turn the call over to Evan, I would also like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. Evan?

Thank you, Sarah. Good afternoon. Thank you all for joining our second quarter 2022 earnings and corporate update call. The strength and continued growth of Paratech's core commercial business in the second quarter of 2022 was driven by our unwavering commitment to disciplined operational execution combined with Nuziris' many clinically important product attributes. These include once daily oral and IV formulations, proven clinical efficacy against resistant pathogens in two approved indications, and a favorable safety and tolerability profile. Our U.S. commercial launch performance continues to differentiate Neusira as one of the most successful IV oral antibiotics launched in the last decade. Having both formulations enables Neusira to have clinical utility in every setting of care. Strong demand, coupled with disciplined execution, resulted in a significant year-over-year, second-quarter growth in Neusira's core commercial business. This momentum is being driven by our ongoing expansion in the community setting, improved access to physicians in both the hospital and community, a growing number of successful formulary reviews, and a significant increase in USIRA prescription access. Net sales from our core USIRA commercial business increased from approximately $14.9 million in the second quarter of 2021 to $25.1 million this past quarter, which represents a 68% year-over-year growth. As you'll hear from Adam, this growth and net sales continues to be driven by strong demand for New Zyra. Importantly, as you can see on the right side of this slide, New Zyra's trailing 12-month core commercial revenue performance continues to demonstrate a consistent and significant upward growth trajectory that we expect to continue through the balance of this year. We continue to prioritize three principal pathways to New Zyra revenue generation. First, Uzaira's core commercial business. This continues to be the main driver of our current revenue growth performance. Second, non-tuberculous mycobacterial disease, or NTM, represents a promising future growth opportunity in the orphan disease space. NTM of the M. abscessus subtype is a rare disease with currently no approved therapies. In the U.S. alone, Paratech estimates that NTM abscessus represents a potential $1 billion addressable market opportunity. We believe that the ongoing data generation and the results from the Phase 2B study will provide the potential to support future NTM treatment guideline inclusion and or New Zyra label changes. Third, U.S. government opportunities. We believe that New Zyra's broad utility against antimicrobial resistance, wound infections, and bioterrorism pathogens should make it an important lifesaving component of the U.S. government strategy and tactics being formulated to address today's emerging threats. These opportunities with New Zyra include procurement deliverables under the BARDA Bioshield Contract and other stockpiling initiatives for pandemic preparedness under both HHS and within the Department of Defense. Now, I would like to review Paratech's second quarter 2022 financial highlights. Total revenue for the second quarter of 2022 was $29.6 million, compared to $19.6 million for the same period in the prior year, when excluding the first procurement of New Zyra under the BARDA contract of $37.9 million. Revenue in the second quarter of 2022 was comprised of $25.1 million in net U.S. sales from the New Zyra core business, a 68% increase from $14.9 million for the same period in the prior year, $4 million in revenue earned under the BARDA contract, and $0.6 million in royalty revenue. Research and development expenses were $7.6 million for the second quarter of 2022 compared to $6.5 million for the same period in the prior year. This increase was primarily due to costs incurred for drug manufacturing and other non-clinical studies. Selling general administrative expenses were $30.3 million for the second quarter of 2022 compared to $27.1 million for the same period in the prior year. This increase was primarily the result of costs incurred for the desired community expansion. Paratech reported a net loss of $17.6 million, or $0.33 per share, and net income of $9.7 million, or $0.20 per share, for the second quarter of 2022 and 2021, respectively. Paratech ended the quarter with $69.4 million in cash, cash equivalents, and marketable securities. Based on commercial revenue performance and operational expenditures, we remain confident in reiterating our full year 2022 financial guidance. I would now like to turn the call over to Adam. Adam?