News ReleaseView printer-friendly version << Back
Paratek Pharmaceuticals Generates Net Revenues of $3.9 Million in the Third Quarter of 2019
-- Third Quarter 2019 NUZYRA® (omadacycline) Net Sales increased 82% versus the Prior Quarter to
-- Oral-only CABP Pharmacokinetics Study Initiated--
“It has been a productive period for Paratek. We saw a significant increase in demand for NUZYRA with third quarter net sales growing 82% versus the prior quarter.” said
Third Quarter 2019 NUZYRA Commercial Highlights
- NUZYRA generated
$3.1 millionin net sales in the U.S. in the third quarter of 2019.
-- Accounting for inventory, NUZYRA gross demand increased from approximately
$1.7 millionin the second quarter of 2019 to approximately $3.3 millionin the third quarter of 2019.
- Expanded the sales force size in time for the 2019 pneumonia season.
- Over 75% of commercial lives in U.S. now have access to NUZYRA.
Other Recent Highlights
- Paratek initiated sites for a pharmacokinetics study intended to obtain oral-only indication in CABP with potential approval of the indication in time for the 2020 pneumonia season.
- Paratek announced topline data from its two exploratory Phase 2 clinical studies evaluating the efficacy and safety of omadacycline in patients with two common forms of urinary tract infections.
- Paratek withdrew European Marketing Authorization application (MAA) for oral and intravenous NUZYRA in skin infections and pneumonia. The EMA deemed the MAA approvable for skin infections but requested a second pneumonia study in order to approve the pneumonia indication.
- Paratek presented new data from NUZYRA development program at IDWeek 2019; highlighting Paratek’s commitment to further understanding safety and efficacy of NUZYRA in unique population subsets.
Third Quarter 2019 Financial Results
Paratek reported a net loss of
Revenue earned during the third 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 now anticipates 2019 NUZYRA U.S. net product sales will come in within the previously communicated range of
We anticipate that continued revenue growth in the fourth quarter will be partially driven by recent initiatives that include the increase in the size of the field force in time for the fall pneumonia season and further expansion of institutional access within the group of approximately 600 targeted hospitals.
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 10008072. Investors can also access the call at http://public.viavid.com/index.php?id=136394.
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 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 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||$||225,637||$||292,838|
|Total current liabilities||25,018||17,709|
|Common stock and additional paid-in-capital||643,139||630,174|
|Total stockholders' equity||(40,606||)||47,578|
Condensed Consolidated Statements of Operations
(in thousands, except loss per share data)
|Three Months Ended
|Nine Months Ended
|Product revenues, net||$||3,053||$||—||$||6,102||$||—|
|Collaboration and royalty revenue||881||50||1,475||101|
|Cost of revenue||958||—||1,731||—|
|Research and development||8,350||16,040||30,421||45,706|
|General and administrative||23,636||13,610||67,874||38,395|
|Impairment of intangibles||—||21||—||107|
|Changes in fair value of contingent consideration||—||(11||)||—||(57||)|
|Total operating expenses||32,944||29,660||100,026||84,151|
|Loss from operations||(29,010||)||(29,610||)||(92,449||)||(84,050||)|
|Other income and expenses:|
|Other loss, net||(36||)||(12||)||(72||)||(14||)|
|Loss before income taxes||$||(32,614||)||$||(32,083||)||$||(101,425||)||$||(89,565||)|
|Provision for income taxes||—||—||—||—|
|Net loss per share - basic and diluted||$||(1.00||)||$||(1.01||)||$||(3.12||)||$||(2.86||)|
|Weighted average common stock outstanding|
|Basic and diluted||32,590,454||31,742,854||32,458,010||31,301,249|
|Investor and Media Relations:|
Source: Paratek Pharmaceuticals