Paratek Pharmaceuticals, Inc.

Welcome to the Paratex Armisteadville Third Quarter 2022 Earnings Call. Today's conference is being recorded. At this time, I'd like to turn the conference over to Sarah Higgins, Vice President of Finance and Principal Accounting Officer. Please go ahead.

Good afternoon and welcome to Paratex Third Quarter 2022 Earnings and Corporate Update Conference Call. The press release of 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 Brenner, 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 that 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 filing for additional details. Evan?

Thank you, Sarah. Good afternoon, and thank you all for joining our third quarter 2022 earnings and corporate update call. The strength and continued growth of Paratech's core commercial business in the third quarter of 2022 was driven by our unwavering commitment to disciplined operational execution and combined with Neuzira's many clinically important product attributes. These include once daily oral and IV formulations, which enables use in every setting of care, proven clinical efficacy against resistant pathogens in two FDA-approved indications, and a favorable safety and tolerability profile. Our U.S. commercial launch performance continues to materially differentiate Neuzira as one of the most successful oral IV antibiotics launched in the last decade. Having both once-daily oral and IV formulations has enabled Uzaira to have potential clinical utility in multiple settings of care. Strong demand, coupled with disciplined execution, continues to generate year-over-year growth in Uzaira's core commercial business. Sales from our core business increased from approximately $19.4 million in the third quarter of 2021 to $25.5 million this past quarter. which represents a 31% year-over-year growth. As you'll hear from Adam, this growth in net sales of Musaira continues to be driven by strong demand, which we believe is the most important predictor of long-term product growth. Importantly, Musaira's trailing 12-month core commercial revenue performance, as seen in the figure on the right, demonstrates an upward growth trajectory that we expect to continue for the remainder of the year and into 2023 as the community and institutional sales teams broaden and deepen their access points and connections to physicians. We continue to prioritize three principal pathways to New Zyra revenue generation. First, New Zyra's core commercial business. This continues to be the main driver of our current revenue growth performance, and we remain on track to deliver between $95 to $105 million in net sales this year. Operationally, we have completed the second wave of our commercial business and medical expansion into the primary care setting. Adam will tell you a bit more about the impact of these newly deployed resources on our business during his prepared remarks. Second, we believe New Zyra has global potential with a promising future growth opportunity in the orphan disease space with non-tuberculous mycobacteria, or NTM. Veritech hosted a well-received investor day on October 3rd to update investors on the global market opportunity for both NTM obsessives and Mycobacterium avium complex, or MAC, and to lay the foundation for future ex-U.S. partnering discussions. 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 life-saving component of the U.S. government's strategy and tactics being formulated to address today's emerging threats. These opportunities with Newzira include procurement deliverables under the BARDA BioShield contract and other stockpiling initiatives for pandemic preparedness under both HHS and within the Department of Defense. As a first step in that journey, we are very proud to have recently announced that U.S.-manufactured Newzira tablets are now commercially available. Before I turn the call over to Adam, I would like to review Paratech's third quarter 2022 financial highlights. Total revenue for the third quarter of 2022 was $30.2 million, a 24% increase from $24.4 million for the same period in the prior year. Revenue earned in the third quarter of 2022 was comprised of $25.5 million in net U.S. sales from the Uzaira core commercial business, a 31% increase from $19.4 million for the same period in the prior year. $4.4 million in revenue earned under the BARDA contract and $0.3 million in royalty revenue. Research and development expenses were $8.5 million for the third quarter of 2022 compared to $7.9 million for the same period in the prior year. The increase in R&D expenses was primarily the result of costs incurred under our BARDA contract. Selling, general, and administrative expenses were $33.8 million for the third quarter of 2022 compared to $26 million for the same period in the prior year. The increase in SG&A expenses were primarily the result of costs incurred for the expansion of USIRO promotion into the primary care setting. Paratech reported a net loss of $20.9 million, or 38 cents per share, and $18.2 million, or 37 cents per share, for the third quarters of 2022 and 2021, respectively. Paratech ended the quarter with $57 million in cash, cash equivalents, and marketable securities. Based upon 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.