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Paratek Pharmaceuticals Generates Net Revenues of $2.0 Million in the Second Quarter of 2019
-- NUZYRA® (omadacycline) Net Sales increased 26% to
-- Over 50% of Commercial Lives in U.S. now have Access to NUZYRA --
-- Paratek Promotes Evan Loh, M.D. to Chief Executive Officer --
“We are encouraged with the second quarter performance of NUZYRA in the United States. We saw a significant increase in demand, continued success in obtaining access and positive momentum in building awareness across our target prescribers.” said
Second Quarter 2019 NUZYRA Commercial Highlights
- NUZYRA generated
$1.7 millionin net sales in the U.S. in the second quarter of 2019.
-- Accounting for inventory, NUZYRA gross revenue demand increased from approximately
$250 thousandin the first quarter of 2019 to approximately $1.7 millionin the second quarter of 2019.
- Over 50% of commercial lives in U.S. now have access to NUZYRA.
- Aided awareness with target prescribers conducted through market research has increased to over 50% compared to 27% at launch.
Other Second Quarter 2019 Highlights
- Announced the promotion of Evan Loh, M.D., to Chief Executive Officer. Michael Bigham, who has served as Paratek’s Chairman and CEO since 2014, will remain active with the Company in the newly created role of Executive Chairman.
- Adam Woodrow was promoted to President and will retain his current Chief Commercial Officer title.
- Randy Brenner has been promoted to Chief Development & Regulatory Officer.
Second Quarter 2019 Financial Results
Paratek reported a net loss of
Revenue earned during the second quarter of 2019 was attributable to net U.S. NUZYRA product sales of
Research and development expenses were
Selling, general and administrative expenses were
Based upon our current operating plan, we anticipate that our existing cash, cash equivalents and marketable securities of
The company maintained its previously provided range of $10.0 to $13.0 million for 2019 NUZYRA U.S. net product sales.
This guidance assumes appreciable acceleration in net product revenue growth in the second half of 2019. The Company anticipates that this acceleration will be partially driven by recent initiatives that include increasing the size of the field force to approximately 60 representatives in time for the fall flu season, further expanding institutional access within our group of the approximately 400 targeted hospitals and securing one or more contracts specific to certain governmental organizations. The Company expects the full impact of these initiatives to be evident in the latter half of this year and extend into 2020 and beyond.
The timing of and results from these initiatives could cause actual results to vary from this guidance.
- Topline data from both Phase 2 studies in urinary tract infections expected in the fourth quarter of 2019.
- Decision in the EU regarding the Marketing Authorization Application for omadacycline expected in the second half of 2019.
- J-Code established for
October 1, 2019.
- Additional clarity regarding contracts specific to certain governmental organizations expected by the end of 2019.
- Initiate study in the second half of this year to obtain oral-only indication in CABP with potential approval of the indication in time for the 2020 influenza-pneumonia season.
Call and Webcast
Paratek’s earnings conference call for the quarter ended
Domestic investors wishing to participate in the call should dial: 855-327-6838 and international investors should dial: 604-235-2082. The conference ID is 10007405. Investors can also access the call at http://public.viavid.com/index.php?id=135649.
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,
Paratek has submitted a marketing authorization application of omadacycline in the European Union. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.
SEYSARA™ (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.
Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.
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 projected net product revenues of NUZYRA® including assumptions related to our financial guidance, our anticipated cash runway, our SEYSARA royalty-backed loan funded on
Condensed Consolidated Balance Sheets
|Cash, cash equivalents and marketable securities||$||252,347||$||292,838|
|Total current liabilities||22,080||17,709|
|Long-term debt, less current portion||260,097||228,959|
|Common stock and additional paid-in-capital||637,386||630,174|
|Total stockholders' equity (deficit)||(13,677||)||47,578|
Condensed Consolidated Statements of Operations
(in thousands, except loss per share data)
|Three Months Ended
|Six Months Ended
|Product revenue, net||$||1,702||$||—||$||3,049||$||—|
|Collaboration and royalty revenue||343||40||594||50|
|Cost of product revenue||567||—||773||—|
|Research and development||10,679||14,802||22,071||29,665|
|Selling, general and administrative||20,920||12,912||44,238||24,785|
|Impairment of intangible asset||—||86||—||86|
|Changes in fair value of contingent consideration||—||(31||)||—||(46||)|
|Total operating expenses||32,166||27,769||67,082||54,490|
|Loss from operations||(30,121||)||(27,729||)||(63,439||)||(54,440||)|
|Other income and expenses:|
|Other gains (losses), net||(24||)||6||(36||)||(1||)|
|Basic and diluted net loss per share||$||(1.02||)||$||(0.94||)||$||(2.12||)||$||(1.85||)|
|Weighted average common stock outstanding|
|Basic and diluted||32,446,202||31,581,275||32,390,691||31,076,788|
|Investor and Media Relations:|
Source: Paratek Pharmaceuticals