--NUZYRA™ (omadacycline) approved by FDA for the treatment of CABP and ABSSSI --
-- SEYSARA™ (sarecycline) approved by FDA for the treatment of moderate to severe acne vulgaris --
-- Company planning for a February 2019 NUZYRA U.S. launch –
BOSTON, Nov. 06, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, today reported financial results and provided an update on financial, clinical, commercial and regulatory filing activities for the quarter ended September 30, 2018.
“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 FDA as the first once-daily IV and oral antibiotic to treat both CABP and ABSSSI in nearly 20 years while the FDA approved SEYSARA for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “These regulatory achievements are transformative for Paratek. Our commercial team is actively preparing for a NUZYRA launch in the U.S. in February, and we are looking forward to the opportunity to help shape the future treatment paradigm for community-acquired pneumonia and skin infections.”
- The FDA approved NUZYRA (omadacycline) in October 2018 for 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 2019 launch. 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 FDA approved SEYSARA (sarecycline) in October 2018 for 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 2018 and 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:
- The FDA approval of NUZYRA extended the interest-only period and maturity date for $60 million of the total $70 million in principal of the Hercules term loan by one year to January 1, 2021 and September 1, 2021, respectively.
- Paratek earned a $12.0 million milestone payment from Almirall S.A. upon FDA approval of SEYSARA, which will be recognized as revenue in the fourth quarter of 2018.
- The company earned a $5.0 million milestone from Zai Lab upon FDA approval 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 $32.1 million, or $1.01 per share, compared to a net loss of $21.3 million, or $0.77 per share, for the same period in 2017.
Research and development expenses were $16.0 million for the third quarter of 2018, compared to $12.1 million for the third quarter of 2017. The increase was driven primarily by manufacturing production costs for NUZYRA, higher salaries, benefits and recruiting fees, and costs associated with regulatory activities.
General and administrative expenses were $13.6 million for the third quarter of 2018, compared to $8.2 million for the third quarter of 2017. The increase was primarily due to additional headcount and higher marketing, market access and other commercial consulting costs.
Based upon our current operating plan, we anticipate that our existing cash, cash equivalents and marketable securities of $310.9 million as of September 30, 2018, estimated NUZYRA product sales, and estimated royalty payments from our collaboration with Almirall, LLC will enable us to fund our operating expenses, capital expenditures, and debt service through the first quarter of 2021.
Conference Call and Webcast
Paratek’s earnings conference call for the quarter ended September 30, 2018 will be broadcast today at 4:30 p.m. EST on November 6, 2018. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek’s website at www.ParatekPharma.com.
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, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Paratek’s website is not incorporated by reference into, and is not a part of, this document.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The company’s lead commercial product, NUZYRA, is a once-daily intravenous and oral antibiotic for the treatment of adult patients with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek is also studying NUZYRA for the treatment of urinary tract infections (UTI).
Paratek has submitted a marketing authorization application for 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.
Paratek’s second FDA approved product, SEYSARA™ (sarecycline), will be marketed by Almirall, LLC 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 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, 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 December 31, 2017, our Form 10-Q filed for the quarter ended September 30, 2018 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.
PARATEK PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
|September 30, |
|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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