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Paratek Pharmaceuticals Announces Second Quarter 2020 Total Revenue of $9.3 Million including NUZYRA® (omadacycline) Net Revenue of $8.1 Million
-- Paratek Raises Full Year 2020 Revenue Guidance; Total Revenue guidance expected to be Between $78 and $83 Million Driven by Strong NUZYRA Net Revenue
-- Company Lowering 2020 R&D and SG&A Expense Guidance to approximately
-- FDA Pre-EUA Review Remains Ongoing; NUZYRA Procurement by BARDA for the Strategic National Stockpile Anticipated by year-end 2020
-- Company Strengthens Long-term Cash Position through Amendment to Hercules Loan Agreement
“Demand for NUZYRA was strong in the first half of 2020 with the momentum continuing into the third quarter,” said
“BARDA and Paratek continue to effectively execute on the anthrax development program and
Recent NUZYRA Commercial Highlights
- NUZYRA generated
$8.1 millionin net revenue in the second quarter of 2020, an 11% increase over the prior quarter and 378% increase over the second quarter of 2019. NUZYRA revenue growth continues to validate the Company’s initial launch strategy with 90% of demand being generated from hospitals and adjacent sites of care.
- The initial NUZYRA procurement by
Biomedical Advanced Research and Development Authority(BARDA) for the Strategic National Stockpile (SNS) valued at approximately $38 millionis now anticipated to be secured by year end 2020.
July 2020, the supplemental NDA to support an oral-only dosing label for Community-Acquired Bacterial Pneumonia (CABP) was submitted to FDA with an approval expected during the 2020-2021 pneumonia season.
August 2020, Paratek modified its outstanding loan agreement with Hercules Capital.
° Under the terms of the agreement, Paratek repaid
° The interest-only period under the new loan agreement is now extended through
Second Quarter 2020 Financial Results
Paratek reported a net loss of
Total revenue was
U.S.NUZYRA net revenue of $8.1 millionfor the second quarter of 2020 grew 11% versus the prior quarter and 378% versus the same quarter in the prior year.
- Government contract service and grant revenue was
$0.9 millionfor the second quarter of 2020 versus $0.3 millionin the prior quarter. No revenue was generated from the BARDA contract in 2019.
- Second quarter 2020 collaboration and royalty revenue was
$0.3 million, which is consistent with both the prior quarter and the same quarter in prior year.
Research and development (R&D) expenses were
Selling, general and administrative (SG&A) expenses were
Paratek is raising its full year 2020 revenue guidance primarily based on the stronger than anticipated
- Paratek now estimates 2020 total revenue to be between $78 and $83 million, an increase from our prior guidance of $75 and $80 million.
° The Company now anticipates the initial BARDA procurement of 2,500 anthrax treatment courses valued at approximately
- 2020 R&D and SG&A expense is now expected to be approximately
$135 millioncompared to the prior guidance of $140 million, driven by an increased focus on operational efficiencies and other favorability driven by the COVID-19 pandemic. Excluding the BARDA R&D and onshoring cost reimbursement, R&D and SG&A expense is expected to be modestly lower when compared to 2019.
° Based upon our current operating plan, which includes estimated NUZYRA
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: 888-256-1007 and international investors should dial: 323-994-2093. The conference ID is 8856661. Investors can also access the call at http://public.viavid.com/index.php?id=141013.
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 to support the development of NUZYRA for the treatment of pulmonary anthrax.
For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.
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 the impact of the COVID-19 pandemic on our revenue projections, supply chain and clinical trials, projected awareness, payor coverage, net product revenues, total revenues including assumptions related to our financial guidance, the financial impact of our BARDA contract including the status of the FDA review of the pre-EUA application, the status of our supplemental mouse pharmacokinetic data to support the human dose recommendation, the timing and exercise of BARDA’s procurement of NUZYRA for the SNS, BARDA exercising full contract line items, including for
Condensed Consolidated Balance Sheets
|Cash, cash equivalents and marketable securities||$||186,818||$||215,379|
|Total current liabilities||33,925||24,200|
|Long-term debt, less current portion||251,586||260,728|
|Common stock and additional paid-in capital||698,222||671,537|
|Total stockholders’ deficit||(63,458||)||(39,647||)|
Condensed Consolidated Statements of Operations
(in thousands, except loss per share data)
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Product revenue, net||$||8,133||$||1,702||$||15,436||$||3,049|
|Government contract service revenue||439||—||775||—|
|Government contract grant revenue||437||—||437||—|
|Collaboration and royalty revenue||317||343||597||594|
|Cost of product revenue||2,236||567||3,707||773|
|Research and development||4,561||10,679||10,949||22,071|
|Selling, general and administrative||20,975||20,920||44,613||44,238|
|Total operating expenses||27,772||32,166||59,269||67,082|
|Loss from operations||(18,446||)||(30,121||)||(42,024||)||(63,439||)|
|Other income and expenses:|
|Other gains (losses), net||(5||)||(24||)||78||(36||)|
|Other comprehensive loss|
|Unrealized gain (loss) on available-for-sale securities, net of tax||(217||)||144||180||344|
|Basic and diluted net loss per common share||$||(0.53||)||$||(1.02||)||$||(1.19||)||$||(2.12||)|
|Weighted average common stock outstanding|
|Basic and diluted||43,629,836||32,446,202||42,635,520||32,390,691|
Investor and Media Relations:
Source: Paratek Pharmaceuticals