Paratek Pharmaceuticals, Inc.

Good afternoon, and welcome to Paratech Pharmaceuticals' first quarter 2022 earnings call. All participants will be in 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 a question, please press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to Sarah Higgins, Vice President of Finance. Please go ahead.

Good afternoon and welcome to Paratech's first 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 Brenner, Chief Development and Regulatory Officer. Michael Bigham, 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, and thank you all for joining our first quarter 2022 earnings and corporate update call. We believe that the strength of Paratech's commercial business is driven by disciplined operational execution combined with New Zyra's 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. As you can see on this next slide, our U.S. commercial launch performance over the first three years continues to differentiate Nuzira as one of the most successful IV oral antibiotics launched in the last decade. Having both formulations enables Nuzira to have clinical utility in every setting of care. Strong demand, coupled with disciplined execution, resulted in a significant year-over-year first quarter growth in Uzaira's core commercial business. We believe this growth would have been even stronger were it not for the Omicron wave in January and February. As the surge receded, Uzaira demand accelerated through the balance of the first quarter and into the second quarter. This momentum is being driven by improved access to physicians in both the hospital and community settings, a resurgence of elective surgeries, and satisfaction of annual insurance deductible resets. On the left panel of this next slide, you can see that net sales from our core New Zyra commercial business increased from $7 million in the first quarter of 2020 to $13 million in the first quarter of 2021, and landed at nearly $20 million this past quarter, which represents a 51% growth over the first quarter of 2021. Importantly, on the right panel, New Zyra's trailing 12-month core commercial revenue performance demonstrates a significant upward trajectory, suggesting strong continued growth to the balance of this year. Based on our performance to date, we are reiterating our full year guidance. We continue to prioritize our 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. Adam will provide more details in his prepared remarks. Second, non-tuberculous mycobacterial disease. NTM represents a promising future growth opportunity in the orphan disease space. More specifically, NTM of the M-obsessive subtype is a rare disease with currently no FDA-approved therapies. In the U.S. alone, Paratek estimates that NTM-obsessives represents a potential $1 billion addressable market opportunity. Third, U.S. government opportunities. We believe that Neuzira'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 New Zyra include performance under our BARDA BioShield contract, other stockpiling initiatives for pandemic preparedness, and contracting within the Department of Defense. Now I would like to review Paratech's first quarter 2022 financial highlights. Total revenue was $24.9 million for the first quarter of 2022, a 51% increase from $16.4 million for the same period in the prior year. Total revenue for the first quarter of 2022 was comprised of the following. New Zyra generated net U.S. sales of $19.9 million, a 51% increase from $13.2 million for the same period in the prior year. Government contract service and grant revenue earned from cost reimbursement under the BARDA contract was $4.3 million, a 65% increase from $2.6 million for the same period in the prior year. Collaboration in royalty revenue of $0.7 million, which primarily represents royalty revenues earned on sales of Cicera in the United States and on the initiation of sales of Nuzaira in China. Research and development expenses were $7.5 million for the first quarter of 2022 compared to $5.5 million for the same period in the prior year. The increase in R&D expenses was primarily due to costs for activities reimbursed under the BARDA contract and costs incurred for the Phase 2b NTM study. Selling, general, and administrative expenses were $27.6 million for the first quarter of 2022 compared to $22.4 million for the same period in the prior year. The increase in SG&A expenses was primarily the result of compensation expense and costs incurred for the New Zyra Community expansion. Fairtech reported a net loss of $17.9 million, or 35 cents per share, and $18.3 million, or 39 cents per share, for the first quarters of 2022 and 2021, respectively. In this last slide for me, We note that Paratech ended the quarter with $79.1 million in cash, cash equivalents, and marketable securities. I would now like to turn the call over to Adam. Adam?