-- NUZYRA® (omadacycline) Generated Net U.S. Sales of $13.2 Million in the First Quarter 2021; 6% Increase Over the Fourth Quarter 2020
-- BARDA has Initiated the First Procurement of NUZYRA Valued at ~$38 Million in the Second Quarter of 2021
-- NUZYRA Expansion into the Primary Care Setting Underway
BOSTON, May 17, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the quarter ended March 31, 2021.
“Our first quarter 2021 results were consistent with our expectations. We continued to see quarter over quarter growth with NUZYRA, which generated $13.2 million in net sales in the first quarter, reflecting the health of our commercial business,” said Evan Loh, M.D., Chief Executive Officer at Paratek. “We believe that 2021 will be a transformative year for Paratek. We are excited to announce that BARDA has now initiated the first procurement of NUZYRA valued at ~$38 million. We also anticipate a regulatory decision later this month for the oral loading dose regimen for community-acquired bacterial pneumonia (CABP), and the start of our Phase 2b non-tuberculous mycobacteria (NTM) Abscessus study in this rare disease for which no therapies have been approved.”
“With our expansion into the primary care setting now well underway, we anticipate the commercial growth of NUZYRA to continue throughout 2021. We are also encouraged by the initial demand in the primary care setting for a well-tolerated, once daily oral broad-spectrum antibiotic that includes coverage against MRSA for skin infections. We believe the anticipated expansion of the label to include the oral loading dose regimen for CABP will further contribute to the overall primary care growth for the second half of 2021 and beyond,” said Adam Woodrow, President and Chief Commercial Officer at Paratek.
Expansion of NUZYRA into the primary care setting: Initiated promotion of NUZYRA in the primary care setting at the end of the first quarter of 2021. The initial focus is on the estimated $2.2 billion addressable market opportunity for skin infections in this setting of care.
Oral loading dose regimen for CABP: The supplemental New Drug Application (sNDA) for NUZYRA’s oral loading dose regimen for CABP has a PDUFA date in late May 2021. Plans have been established to broaden the Company’s sales effort in primary care to include CABP later this year in anticipation of the 2021/2022 flu season, which represents an estimated potential $1.5 billion addressable market opportunity.
NTM abscessus rare disease opportunity: The Company plans to initiate a Phase 2b study, in June 2021, to explore the potential utility of omadacycline as a treatment for NTM abscessus pulmonary infection, a rare disease with no approved therapies, which the Company estimates is a potential $1.0 billion addressable market opportunity in the U.S.
Continued progress of the BARDA Project BioShield anthrax program: Biomedical Advanced Research and Development Authority (BARDA) has initiated the first procurement of NUZYRA valued at ~$38 million, which is expected to be delivered and the revenue recognized in the second quarter of 2021. The Company continues to execute and deliver on its five-year contract with BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), to develop NUZYRA for the treatment of pulmonary anthrax, a critical bioterrorism threat deemed important to national security by BARDA. These activities include advancing the U.S. onshoring of NUZYRA manufacturing and the continued execution of certain preclinical research activities supporting the pulmonary anthrax development program.
Upcoming Medical Conference Participation
Data from the NUZYRA clinical and microbiology programs will be presented at several upcoming medical conferences including the MAD-ID Annual Meeting (May 27-30), ASM Microbe 2021 (June 20-24) and the Special Operations Medical Association (SOMA) Scientific Assembly (June 28-July 2). Abstracts presented at these meetings will continue to highlight the efficacy and safety profile of NUZYRA including its in vitro activity against key pathogens with known resistance to tetracyclines and other antibiotic drug classes.
First Quarter 2021 Financial Results
Total revenue was $16.4 million for the first quarter of 2021, an increase of 3% over the fourth quarter of 2020 and an increase of 107% over the first quarter of 2020.
NUZYRA generated $13.2 million in net U.S. sales during the first quarter of 2021, an increase of 6% over the fourth quarter of 2020 and an increase of 81% over the first quarter of 2020.
Government contract service and grant revenue earned under the BARDA contract was $2.6 million for the first quarter of 2021 versus $2.8 million in the fourth quarter of 2020 and $0.3 million in the first quarter of 2020.
Research and development (R&D) expenses were $5.5 million for the first quarter of 2021 compared to $6.4 million for same period in the prior year. Included in R&D expenses for the first quarter of 2021 was $2.7 million in costs reimbursed under the BARDA contract for the U.S. onshoring of NUZYRA manufacturing and for FDA post-marketing requirements, or PMRs, associated with the approval of NUZYRA. 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 costs incurred under the BARDA contract.
Selling, general and administrative (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.
Paratek reported a net loss of $18.3 million, or ($0.39) per share, for the first quarter of 2021, compared to a net loss of $27.6 million, or ($0.66) per share, for the same period in 2020.
As of March 31, 2021, Paratek had $103.5 million in cash and cash equivalents. Based upon the Company’s current operating plan, Paratek anticipates its existing cash and cash equivalents will provide for a cash runway through the end of 2023 with a pathway to cash flow break even.
Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance.
Call and Webcast
Paratek’s earnings conference call for the quarter ended March 31, 2021 will be broadcast at 8:30 a.m. EST on May 17, 2021. The live audio webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek’s website at www.ParatekPharma.com.
Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13719040. Investors can also access the call at http://public.viavid.com/index.php?id=144550.
Paratek routinely posts important information for investors on the Investor Relations section of its website at www.ParatekPharma.com. Paratek intends to use this website as a means of disclosing material, non-public information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Paratek’s website, in addition to following its press releases, U.S. Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek’s website is not incorporated by reference into, and is not a part of, this document.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.
The Company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from BARDA, valued at ~$285 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.
Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.
Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall strategy, products, prospects, potential and expected results, including statements about our expectations regarding the Company’s future growth and performance, the exercise and timing of BARDA’s first procurement of NUZYRA for the SNS, the expected timing of certain regulatory decisions, our plans to initiate a Phase 2b NTM abscessus study, the anticipated expansion of the NUZYRA label, our plans to broaden the Company’s sales efforts, our expectation to continue to execute and deliver on our BARDA contract, and our anticipated cash runway. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as “will be,” "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2020 and our other filings with the SEC. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.
PARATEK PHARMACEUTICALS, INC.
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