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Paratek Pharmaceuticals Announces Third Quarter 2020 Total Revenue of $13.7 Million
-- NUZYRA® (omadacycline) Generated Net Product Revenue of
-- Paratek now Anticipates Full Year 2020 Total Revenue to be at the Higher End of the Previously Communicated Range of $78 to $83 Million
-- Company Lowering 2020 R&D and SG&A Expense Guidance to Approximately $120 million
-- Omadacycline Added to the FDA’s Essential Medicines List as a Medical Counter Measure Against Biological Threats
“We continue to execute against our plan for NUZYRA, which is reflected in the third quarter net revenue growth of 35% over the prior quarter,” said
Third Quarter 2020 NUZYRA Commercial Highlights and Update
- NUZYRA generated
$10.9 millionin net revenue in the third quarter of 2020, a 35% increase over the prior quarter and a 252% increase over the third quarter of 2019.
- NUZYRA revenue growth reflects continued commitment to strong execution and NUZYRA’s attributes that address unmet needs in the marketplace despite the reductions in patient traffic to physician offices and institutions of approximately 25% compared to pre-COVID-19 levels. In today’s COVID-19 environment, NUZYRA’s ability to minimize hospital stays with the oral formulation is especially relevant for many prescribers and a potentially meaningful benefit for patients.
Other Recent Highlights
The Food and Drug Administration(FDA) review of the pre-Emergency Use Authorization (pre-EUA) application, which was submitted in February, remains ongoing. As part of the ongoing review, the supplemental mouse pharmacokinetic data requested by FDA are in the final stages of publishing at BARDA and will be submitted to FDA imminently. Based on agency discussions, we believe FDA will complete their review in a timely fashion.
- Seven posters from the NUZYRA clinical and microbiology programs were presented at the IDWeek 2020 virtual meeting in
° In a multicenter real-world study evaluating NUZYRA, the authors concluded that NUZYRA was effective and well-tolerated in this small sample for a variety of infections, including pulmonary M. abscessus (11 patients; average treatment duration 6.4 months) and MDR/XDR A. baumannii and Enterobacteriaceae (7 patients; average duration 14 days). These data continue to reinforce the importance of additional studies to expand these encouraging clinical findings.
° Additional data presented also highlighted that the substitution of NUZYRA in place of standard of care, such as quinolones, for the treatment of patients with Community-Acquired Bacterial Pneumonia (CABP), has the potential to reduce Clostridioides difficile infection and deliver cost savings in the acute care setting.
Third Quarter 2020 Financial Results
Total revenue was
U.S.NUZYRA net revenue of $10.9 millionfor the third quarter of 2020 grew 35% versus the prior quarter and 252% versus the same quarter in the prior year.
- Government contract service and grant revenue was
$2.7 millionfor the third quarter of 2020 versus $0.9 millionin the prior quarter. No revenue was generated from the BARDA contract in 2019.
Research and development (R&D) expenses were
Selling, general and administrative (SG&A) expenses were
Paratek reported a net loss of
Paratek now anticipates its full year 2020 total revenue to be at the higher end of the previously communicated range of $78 to $83 million driven by strong NUZYRA net revenue trends.
- This revenue guidance assumes that the initial BARDA procurement of NUZYRA, valued at approximately
$38 million, will occur by the end of 2020. The FDA review could be completed as early as the end of this year but may slip into the first quarter of 2021. The first procurement is expected soon after completion of the FDA review. Accordingly, revenue from the first procurement will be recognized as early as late 2020 or in the first quarter of 2021.
- 2020 R&D and SG&A expenses are now expected to be approximately $120 million compared to the prior guidance of
$135 million, driven by a continued focus on operational efficiencies, and the timing of certain expenses driven by the COVID-19 pandemic, some of which will now occur in 2021.
- Based upon our current operating plan, which includes estimated NUZYRA
U.S.product revenue, BARDA procurements of NUZYRA for the SNS, and cost reimbursement under the BARDA contract, we anticipate that our existing cash, cash equivalents and marketable securities of $149.5 million, as of September 30, 2020, will provide for a cash runway through the end of 2023 with a pathway to cash flow break even. This anticipated pathway assumes the Company will be able to fund all company operating expenses, anticipated capital expenditures, and debt service, including repayment in full of the Hercules Loan and Security Agreement.
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: 888-204-4368 and international investors should dial: 323-994-2093. The conference ID is 9510788. Investors can also access the call at http://public.viavid.com/index.php?id=142174.
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, access to hospital institutions, 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||$||149,498||$||215,379|
|Total current liabilities||22,899||24,200|
|Long-term debt, less current portion||250,631||260,728|
|Common stock and additional paid-in capital||702,805||671,537|
|Total stockholders’ deficit||(79,884||)||(39,647||)|
Condensed Consolidated Statements of Operations
(in thousands, except loss per share data)
|Three Months Ended
|Nine Months Ended
|Product revenue, net||$||10,895||$||3,053||$||26,330||$||6,102|
|Government contract service revenue||785||—||1,560||—|
|Government contract grant revenue||1,866||—||2,303||—|
|Collaboration and royalty revenue||113||881||710||1,475|
|Cost of product revenue||2,017||958||5,724||1,731|
|Research and development||6,687||8,350||17,636||30,421|
|Selling, general and administrative||20,902||23,636||65,514||67,874|
|Total operating expenses||29,606||32,944||88,874||100,026|
|Loss from operations||(15,947||)||(29,010||)||(57,971||)||(92,449||)|
|Other income and expenses:|
|Other gains (losses), net||(10||)||(36||)||67||(72||)|
|Other comprehensive loss|
|Unrealized gain (loss) on available-for-sale securities, net of tax||(154||)||(68||)||26||276|
|Basic and diluted net loss per common share||$||(0.46||)||$||(1.00||)||$||(1.64||)||$||(3.12||)|
|Weighted average common stock outstanding|
|Basic and diluted||45,483,346||32,590,454||43,591,724||32,458,010|
|Investor and Media Relations:|
Source: Paratek Pharmaceuticals