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Paratek’s NUZYRA™ (omadacycline) Generates Net Sales of $1.3 Million in the First Eight Weeks on the U.S. Market

1147 Days ago

-- 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

  • After an early February launch, NUZYRA generated $1.3 million in 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 Journal of 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 States in February 2019 as 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 million on May 1, 2019 related 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 States by 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 $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.

Website Information
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.


Condensed Consolidated Balance Sheets
(in thousands)

      March 31, 2019   December 31, 2018    
  Cash, cash equivalents and marketable securities     $   257,902   $   292,838  
  Total assets         272,444       300,192  
  Working capital         247,862       237,534  
  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  
  Accumulated deficit         (618,078 )     (582,468 )
  Total stockholders' equity         16,031       47,578  

Condensed Consolidated Statements of Operations
(in thousands, except loss per share data)

    Three Months Ended March 31,  
      2019     2018    
Product revenues, net   $1,347      $ -    
Collaboration and royalty revenue      251       10    
Total revenue     1,598       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:        
Interest income     946       475    
Interest expense     (3,226 )     (1,507 )  
Other losses     (14 )     (6 )  
Net loss     (35,610 )    (27,750 )  
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:
Ben Strain


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