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Paratek Pharmaceuticals Reports Third Quarter 2018 Financial Results
--NUZYRA™ (omadacycline) approved by
-- SEYSARA™ (sarecycline) approved by FDA for the treatment of moderate to severe acne vulgaris --
-- Company planning for a
“It has been an exciting and productive period for Paratek during which we achieved two significant milestones with the approval of NUZYRA and SEYSARA. NUZYRA was approved by the
- The FDA approved NUZYRA (omadacycline) in
October 2018for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI).
- The company is planning for a
February 2019launch. Pre-commercialization activities for NUZYRA are proceeding to plan. The Company’s manufacturing of launch product is near completion; the market access team outreach to key payers is ongoing; the build out of the sales management team is complete; and the Company is commencing the initial hiring of its sales team.
- The company is planning for a
FDAapproved SEYSARA (sarecycline) in October 2018for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
- Paratek has exclusively licensed U.S. development and commercialization rights of SEYSARA to Almirall S.A. and is now entitled to receive tiered royalties at rates ranging from high-single to low double digits on net sales of SEYSARA.
- The European Marketing Authorization Application for oral and Intravenous omadacycline was submitted in
October 2018and the review has been initiated.
- The Company is seeking approval for the treatment of community-acquired bacterial and acute bacterial skin and skin structure infections.
- During IDWeek 2018, the Company presented additional data demonstrating the continued importance of omadacycline in acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia highlighted by an analysis of the clinical efficacy of omadacycline against a broad collection of clinical isolates with known tetracycline resistance and improvement in quality of life in patients with ABSSSI.
- Strengthened balance sheet:
FDAapproval of NUZYRA extended the interest-only period and maturity date for $60 millionof the total $70 millionin principal of the Hercules term loan by one year to January 1, 2021and September 1, 2021, respectively.
- Paratek earned a
$12.0 millionmilestone payment from Almirall S.A.upon FDAapproval of SEYSARA, which will be recognized as revenue in the fourth quarter of 2018.
- The company earned a
$5.0 millionmilestone from Zai Labupon FDAapproval of NUZYRA, which will be recognized as revenue in the fourth quarter of 2018.
Third Quarter 2018 Financial Results
For the third quarter of 2018, Paratek reported a net loss of
Research and development expenses were
General and administrative expenses were
Based upon our current operating plan, we anticipate that our 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 13683977. Investors can also access the call at http://public.viavid.com/index.php?id=131722.
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,
AboutParatek Pharmaceuticals, Inc.
Paratek has submitted a marketing authorization applicationforomadacyclinein the
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.
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, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of commercializing NUZYRA, advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to make and sell NUZYRA, obtain certain regulatory approvals of omadacycline. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended
Condensed Consolidated Balance Sheets
|Cash, cash equivalents and marketable securities||$||310,915||$||151,723|
|Total current liabilities||25.696||16,789|
|Long-term debt, less current portion||228,680||59,186|
|Common stock and additional paid-in-capital||617,636||552,748|
|Total stockholders' equity||57,630||82,478|
Condensed Consolidated Statements of Operations
(in thousands, except loss per share data)
|Three Months Ended
|Nine Months Ended
|License and royalty revenue||$||50||$||12||$||101||$||7,544|
|Research and development||16,040||12,112||45,706||45,847|
|General and administrative||13,610||8,219||38,395||25,299|
|Changes in fair value of
|Total operating expenses||29,660||20,309||84,151||71,257|
|Loss from operations||(29,610||)||(20,297||)||(84,050||)||(63,713||)|
|Other income and expenses:|
|Other (loss) income, net||(12||)||(8||)||(14||)||(23||)|
|Loss before income taxes||$||(32,083||)||$||(21,324||)||$||(89,565||)||$||(66,423||)|
|Provision for income taxes||—||—||—||753|
|Net loss per share - basic
|Weighted average common
|Basic and diluted||31,742,854||27,776,218||31,301,249||26,453,219|
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