Paratek Pharmaceuticals, Inc.

Greetings. Welcome to Paratech Pharmaceuticals' 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 from your telephone keypad. Please note, this conference is being recorded. At this time, I'll turn the conference over to Ben Strain, Vice President of Investor Relations. Ben, you may now begin. Thank you.

Good morning and welcome to Paratech's first quarter 2021 earnings and corporate update conference call. A press release with the company's first quarter results was issued earlier today, and we have also posted slides on our website that will be referred to on this call. Both can be found at www.paratechpharma.com. Participants on today's call are Evan Lowe, CEO, Adam Woodrow, President and Chief Commercial Officer, Randy Brenner, Chief Development and Regulatory Officer, Michael Bigham, Executive Chairman, and Sarah Higgins, Vice President of Finance, Controller, and Principal Accounting Officer will also be available for questions. Before I turn the call over to Evan, I would 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, Ben. Good morning, and thank you all for joining our first quarter earnings and corporate update call. We believe 2021 will be a transformative year of continued growth for Paratech. New Cyrus quarter-over-quarter growth in 2020 continued into the first quarter of this year. We believe this is not only a significant achievement in this volatile and rapidly evolving healthcare setting, but also a reflection of the clinical importance of positive patient outcomes with New Zyra in the hands of clinicians. Our first quarter 2021 results were consistent with our expectations as New Zyra generated U.S. net sales of $13.2 million in the first quarter, reflecting the health of our commercial business. Our confidence in the long-term commercial success of New Zyra remains unabated based upon growing demand of New Zyra in the hospital care setting coupled with the recent initial positive signs of new prescriptions and adoption in the primary care commercial expansion. We anticipate that this growth trajectory will continue through the balance of 2021, given the encouraging initial inbound feedback from the primary care-based physicians for a well-tolerated, once daily, oral, broad-spectrum antibiotic that includes coverage against MRSA for skin infections. As seen in this next slide, The commercial success to date has established Neuzira as one of the most successful antibiotics launched in the last five years. Neuzira continues to materially differentiate itself from other IV oral antibiotic launches driven by strong operational execution and Neuzira's many product attributes that include, first, broad spectrum efficacy including resistant pathogens across two common indications, second, a favorable safety profile consistent with New Zyra's tetracycline heritage. And third, convenient, once daily, oral, and IV formulations that enable utility in multiple settings of care. In addition to the commercial business, we are focused on several exciting and potentially transformative catalysts for Paratech. First, we're excited to announce that BARDA has initiated the first procurement of New Zyra valued at approximately $38 million. We expect that this procurement will be delivered and recognized this quarter. Second, an important FDA decision on the Neuzira SNDA for the oral loading dose regimen in pneumonia. If approved, we believe this will be an important catalyst to further expand the commercial opportunities for Neuzira in the primary care setting. Third, the initiation of a Phase IIb study for Nuzira in a rare disease, pulmonary NTM abscessus, for which there are no approved therapies. Fourth, we anticipate the second barter procurement in the second half of this year. Fifth, we anticipate an approval of Nuzira in China, one of the largest potential antibiotic markets, which will trigger a $6 million approval milestone payment from XyLab to Paratech. And finally, in addition to these catalysts, we continue to actively evaluate potential assets to expand our portfolio and leverage our commercial infrastructure. Before I hand the call over to Adam, I would now like to provide Paratech's first quarter 2021 financial highlights. First quarter 2021 total revenue was $16.4 million, an increase in 3% over the prior quarter and 107% over the first quarter of 2020. New Zyra generated $13.2 million in net U.S. sales in the first quarter, an increase of 6% over the prior quarter, and an increase of 81% over the first quarter of 2020. First quarter 2021 government contract service and grant revenue earned under the BARDA contract were $2.6 million for the first quarter versus $2.8 million in the fourth quarter of 2020. We anticipate a modest step-up in contract service and grant revenue earned under the BARDA contract as we move through the year, driven by activities associated with the on-shoring in the U.S. of new thyroid manufacturing, the continued enrollment of the FDA post-marketing required study in pneumonia, and further advancement of the preclinical work in the anthrax program. First quarter R&D expenses were $5.5 million. compared to $6.4 million for the same period in the prior year. Included in R&D expenses for the first quarter were $2.7 million in costs reimbursed under the BARDA contract for the U.S. onshoring of New Zyra manufacturing and for FDA post-marketing requirements. The decrease in R&D expense is primarily the result of lower third-party manufacturing process scale-up and clinical study costs, as well as lower stock-based compensation expense partially offset by an increase in the reimbursable costs incurred under the BARDA contract. SG&A expenses were $22.4 million for the first quarter of 2021, compared to $23.6 million for the same period in the prior year. The decrease in SG&A expense is primarily the result of a continued focus on driving operational efficiencies across the organization, as well as lower stock-based compensation expense. As of March 31st, 2021, we had $103.5 million in cash and cash equivalents. Based upon our current operating plan, we anticipate our existing cash and cash equivalents provides for a cash runway through the end of 2023 with a pathway to cash flow breakeven. I would now like to turn the call over to Adam. Adam?