News ReleaseView printer-friendly version << Back
Paratek’s NUZYRA™ (omadacycline) Generates Net Sales of $1.3 Million in the First Eight Weeks on the U.S. Market
-- Significant Presence at ECCMID 2019 with Nine NUZYRA Presentations --
“We are pleased with the results from the first eight weeks of the NUZYRA launch in
“With the U.S. launch of NUZYRA successfully underway, we continue to pursue a number of compelling life-cycle opportunities for NUZYRA. These include executing two phase 2 studies in UTI, for which we expect topline data in the second half of 2019 and exploring the potential avenues to achieve an oral-only indication in CABP,” said Evan Loh, M.D., President, Chief Operating Officer and Chief Medical Officer. “We believe these potential value drivers provide opportunity to both accelerate commercial success as well as significantly expand the accessible market. We look forward to keeping you apprised of our progress on these promising opportunities in the months ahead.”
First Quarter 2019 NUZYRA Commercial Highlights
- After an early February launch, NUZYRA generated
$1.3 millionin net revenues in the U.S. in its first approximately eight weeks on the market.
- The Company estimates approximately 85% of NUZYRA revenues were related to the initial inventory build of the oral formulation in the channel.
- Approximately 1/3 of commercial lives in U.S. had access to NUZYRA by the end of the first quarter 2019.
- Aided awareness with target prescribers conducted through market research increased from 27% to 48% since launch.
- Institutional access achieved in over 50% of approximately 400 targeted institutions.
Other Recent Highlights
- Data from the NUZYRA clinical and microbiology programs were presented at the 29th
European Congress of Clinical Microbiology & Infectious Diseases, ECCMID 2019. Nine presentations at the congress continued to highlight the efficacy and safety profile of NUZYRA, adding to the growing body of evidence of the therapy’s utility against relevant pathogens and life-threatening infections such as CABP and ABSSSI.
- Scientific team who worked on the chemistry and clinical development programs for NUZYRA and SEYSARA™ were awarded the American Chemical Society’s (ACS) 2019 Heroes of Chemistry Award.
New England Journalof Medicine (NEJM) published two manuscripts with detailed results from the Company’s Phase 3 clinical trials (OPTIC and OASIS-1) of NUZYRA™ (omadacycline) highlighting the potential clinical impact that NUZYRA can have on the practice of medicine in an era of growing resistance to older antibiotic agents.
- NUZYRA launched in
the United Statesin February 2019as a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI).
- In concert with the U.S. launch, three antimicrobial susceptibility tests are now available for use with NUZYRA. Paratek has also launched the KEYSTONE™ surveillance program to monitor omadacycline susceptibility.
- Company received gross proceeds of
$32.5 millionon May 1, 2019related to recently executed royalty-backed loan agreement with Healthcare Royalty Partners III, L.P.(HCRP). This royalty-backed loan agreement will be secured by and repaid from royalties received by Paratek from the net sales of SEYSARA in the United Statesby Almirall, LLC.
- The Company’s partner,
Almirall, launched SEYSARA in the U.S., in January 2019.
First Quarter 2019 Financial Results
For the first quarter of 2019, Paratek reported a net loss of
Revenue earned during the quarter ended
Research and development expenses were
Selling, general and administrative expenses were
Based upon Paratek’s current operating plan, the Company anticipates that its existing cash, cash equivalents and marketable securities of
Conference 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 13690427. Investors can also access the call at http://public.viavid.com/index.php?id=134405.
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™, our anticipated cash runway, our SEYSARA royalty-backed loan funded on
Condensed Consolidated Balance Sheets
|March 31, 2019||December 31, 2018|
|Cash, cash equivalents and marketable securities||$||257,902||$||292,838|
|Total current liabilities||18,985||17,709|
|Long-term debt, less current portion||229,241||228,959|
|Common stock and additional paid-in-capital||634,037||630,174|
|Total stockholders' equity||16,031||47,578|
Condensed Consolidated Statements of Operations
(in thousands, except loss per share data)
|Three Months Ended March 31,|
|Product revenues, net||$1,347||$ -|
|Collaboration and royalty revenue||251||10|
|Cost of product revenue||206||-|
|Research and development||11,392||14,864|
|Selling, general and administrative||23,316||11,873|
|Changes in fair value of contingent consideration||-||(15||)|
|Total operating expenses||34,914||26,722|
|Loss from operations||(33,316||)||(26,712||)|
|Other income and expenses:|
|Net loss per share - basic and diluted||$(1.10||)||$(0.91||)|
|Weighted average common stock outstanding|
|Basic and diluted||32,334,563||30,566,694|
|Investor and Media Relations:|