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Paratek Pharmaceuticals Announces First Quarter 2021 Total Revenue of $16.4 Million and Initiation of First BARDA Procurement
-- NUZYRA® (omadacycline) Generated Net
-- BARDA has Initiated the First Procurement of NUZYRA Valued at
-- NUZYRA Expansion into the Primary Care Setting Underway
“Our first quarter 2021 results were consistent with our expectations. We continued to see quarter over quarter growth with NUZYRA, which generated
“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
- 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 billionaddressable 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 billionaddressable 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 AssistantSecretary 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 millionin 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 millionin the first quarter of 2020.
Research and development (R&D) expenses were
Selling, general and administrative (SG&A) expenses were
Paratek reported a net loss of
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
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,
The Company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the
Paratek exclusively licensed
In 2019, Paratek was awarded a contract from BARDA, valued at
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
Condensed Consolidated Balance Sheets
|Cash, cash equivalents and marketable securities||$||103,450||$||125,162|
|Total current liabilities||22,957||23,953|
|Long-term debt, less current portion||250,809||250,474|
|Common stock and additional paid-in-capital||707,137||705,535|
|Total stockholders' deficit||(119,008||)||(102,260||)|
Condensed Consolidated Statements of Operations
(in thousands, except loss per share data)
|Three Months Ended
|Product revenue, net||$||13,207||$||7,303|
|Government contract service revenue||973||337|
|Government contract grant revenue||1,613||—|
|Collaboration and royalty revenue||634||280|
|Cost of product revenue||2,751||1,471|
|Research and development||5,538||6,389|
|Selling, general and administrative||22,359||23,638|
|Total operating expenses||30,648||31,498|
|Loss from operations||(14,221||)||(23,578||)|
|Other income and expenses:|
|Other gains (losses), net||157||82|
|Other comprehensive loss|
|Unrealized gain (loss) on available-for-sale
securities, net of tax
|Basic and diluted net loss per common share||$||(0.39||)||$||(0.66||)|
|Weighted average common stock outstanding|
|Basic and diluted||46,664,374||41,641,203|
|Investor and Media Relations:|
Source: Paratek Pharmaceuticals