Loading, Please Wait...
-- Approximately One Third of Commercial Lives in U.S. had Access to NUZYRA by the End of the First Quarter 2019 --
-- Significant Presence at ECCMID 2019 with Nine NUZYRA Presentations --
BOSTON, May 08, 2019 (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 corporate activities for the quarter ended March 31, 2019.
“We are pleased with the results from the first eight weeks of the NUZYRA launch in the United States. We have achieved several of our early benchmarks that we believe are necessary to create a strong foundation for long-term commercial success,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “The organization is motivated and focused on the launch of NUZYRA. We appreciate that it takes sustained effort and patience to establish momentum for any new antibiotic in the hospital setting. To date, our efforts have been focused on establishing a robust supply chain and distribution channel, actively educating and building awareness with the key stakeholders on the potential benefits NUZYRA offers and ensuring patients have access to this potential life-saving therapy.”
“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
Other Recent Highlights
First Quarter 2019 Financial Results
For the first quarter of 2019, Paratek reported a net loss of $35.6 million, or ($1.10) per share, compared to a net loss of $27.8 million, or ($0.91) per share, for the same period in 2018.
Revenue earned during the quarter ended March 31, 2019 was attributable to net U.S. NUZYRA product revenue of $1.3 million and royalty revenue of $0.3 million, which included royalties earned from SEYSARA sales in the U.S.
Research and development expenses were $11.4 million for the quarter ended March 31, 2019 compared to $14.9 million for the same period in 2018. This decrease is primarily the result of the capitalization of NUZYRA commercial supply costs, which were classified as research and development expense until FDA approval of NUZYRA on October 2, 2018, and lower NDA user fees due to timing of our NDA submissions, partially offset by higher clinical study costs associated with our Phase 2 UTI program.
Selling, general and administrative expenses were $23.3 million for the quarter ended March 31, 2019, compared to $11.9 million for the same period in 2018. The increase is primarily the result of the cost of our contract sales force, higher marketing, trade and distribution fees, and increased salaries, benefits and other personnel-related costs in support of the commercialization of NUZYRA.
Based upon Paratek’s current operating plan, the Company anticipates that its existing cash, cash equivalents and marketable securities of $257.9 million as of March 31, 2019, estimated NUZYRA product sales, and SEYSARA royalty-backed loan with HCRP gross proceeds of $32.5 million, which was funded on May 1, 2019, will fund company operating expenses, capital expenditures, and debt service beyond the first quarter of 2021.
Conference Call and Webcast
Paratek’s earnings conference call for the quarter ended March 31, 2019 will be broadcast today at 4:30 p.m. EDT on May 8, 2019. 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 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, U.S. Securities and Exchange Commission (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™ (omadacycline), which has launched and is available in the U.S., is a once-daily oral and intravenous antibiotic for the treatment of adults 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 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 May 1, 2019, the progression of our commercial roll out for NUZYRA™, the prospects of our U.S. launch of NUZYRA™, our ability to shape the future treatment paradigm for community-acquired pneumonia and serious skin infections, our plans to evaluate additional indications for NUZYRA™, including UTI, and to work toward an oral-only indication in CABP, our potential to further drive long-term value for all of our shareholders and our plans to obtain regulatory approval of omadacycline in the European Union . 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," "expect," "look forward," "anticipate," "continue," 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, 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
|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:|