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Paratek Pharmaceuticals Reports Second Quarter 2018 Financial Results

1112 Days ago

-- Antimicrobial Drugs Advisory Committee of FDA scheduled for August 8, 2018 to review the Company's NDAs for omadacycline --

-- Omadacycline PDUFA action date scheduled for October 2018 --

-- Company on track for a first quarter 2019 omadacycline U.S. launch --

BOSTON, Aug. 02, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based on tetracycline chemistry, today reported financial results and provided an update on financial, clinical, commercial and regulatory filing activities for the quarter ended June 30, 2018.

“With the omadacyline regulatory applications accepted for review by the FDA, and an early October FDA decision date, 2018 is shaping up to be a transformative year for Paratek.  Our clinical and regulatory teams are actively preparing for the upcoming advisory committee meeting, while in parallel, our commercial team has accelerated activities for an anticipated product launch in the first quarter 2019,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “We also continue to educate the medical community about the efficacy and safety profile of omadacycline against a number of important resistant pathogens, in a variety of infection types and across the range of disease severity studied, with a number of presentations from omadacycline development programs at two medical conferences this quarter.”

Recent Highlights

  • New drug applications (NDAs) for the once-daily oral and intravenous formulations of omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI) accepted for priority review by U.S. Food and Drug Administration (FDA).
  • Significant presence at ASM Microbe 2018 and American Thoracic Society 2018 International Conferences:
    • At ASM Microbe 2018, highlights included a new analysis of combined data from the Company’s two, pivotal Phase 3 clinical studies of omadacycline in ABSSSI, which demonstrated high clinical success rates for omadacycline in skin infections caused by S. aureus even when MDR or Panton–Valentine leucocidin positive (PVL+) isolates were present.
    • At American Thoracic Society 2018 International Conference, the Company presented a new analysis of the Phase 3 OPTIC study of omadacycline versus moxifloxacin, a fluoroquinolone, for the treatment of CABP. The data showed similar, high rates of response for the early clinical response and post therapy evaluation endpoints in both the omadacycline and moxifloxacin treatment groups, regardless of the severity of disease.
  • Pre-commercialization activities have included advancement of manufacturing validation, market access team outreach to key payers, and the completion of building out the sales management team.
  • Strengthened balance sheet:
    • Raised $159.0 million in net proceeds through the issuance of convertible senior subordinated notes in April that will mature on May 1, 2024.
    • Amended the financial terms of the Hercules Loan Agreement.  On August 1, 2018, the Company increased the principal drawn down by $10.0 million with an option to borrow an additional $20 million.

Upcoming Milestones 

  • Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration has been scheduled for August 8, 2018 to review the Company's NDAs for once-daily, oral and intravenous omadacycline. Omadacycline is under review for the treatment of CABP and ABSSSI. 
  • Omadacycline Prescription Drug User Fee Act (PDUFA) Action Date in early October 2018.
  • U.S. launch of omadacycline in the first quarter of 2019.
  • Submission of the marketing authorization for omadacycline in Europe in the second half of 2018.
  • Initiate second Phase 2 study with omadacycline for complicated urinary tract infections in the second half of 2018.
    • Phase 2 UTI data expected in the second half of 2019.
  • SEYSARATM (sarecycline) PDUFA action date expected in the second half of 2018.

Second Quarter 2018 Financial Results
For the second quarter of 2018, Paratek reported a net loss of $29.7 million, or $0.94 per share, compared to a net loss of $18.2 million, or $0.66 per share, for the same period in 2017.

Research and development expenses were $14.8 million for the second quarter of 2018, compared to $15.1 million for the second quarter of 2017.  The decrease was primarily driven by lower clinical study costs, offset by an increase in manufacturing production costs for omadacycline.

General and administrative expenses were $12.9 million for the second quarter of 2018 compared to $8.7 million for the second quarter of 2017.  The increase was primarily due to additional headcount, higher marketing, market access and other commercial costs related to commercial launch preparation activities.

As of June 30, 2018, Paratek had cash, cash equivalents, and marketable securities of $321.1 million. Based on current operating assumptions, including commercial buildout and launch of omadacycline, Paratek’s existing capital, future contingent regulatory and commercial milestone payments from collaborations with Allergan and Zai Lab, and estimated omadacycline product sales will enable Paratek to fund operating expenses and capital expenditure requirements through the first quarter of 2021.

Conference Call and Webcast
Paratek’s earnings conference call for the quarter ended June 30, 2018 will be broadcast today at 4:30 p.m. EDT on August 2, 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: 866-575-6539 and international investors should dial: 323-994-2082. The conference ID is 7693255. Investors can also access the call at http://public.viavid.com/index.php?id=130195.

Replays of the call will be available through August 16, 2018. Domestic investors can access the replay by dialing 844-512-2921 and international investors can access the replay by dialing 412-317-6671. The PIN code to access the replay is 7693255.

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, 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 biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. The Company’s lead product candidate, omadacycline, is a new, once-daily oral and intravenous broad-spectrum antibiotic being developed for the treatment of serious community-acquired bacterial infections, including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and urinary tract infections (UTI). Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications of ABSSSI, CABP, and UTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI, and its New Drug Applications to the U.S. FDA have been accepted for priority review. The Company plans to submit a marketing authorization in the European Union in the second half of this year. 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 product candidate, SEYSARA™ (sarecycline), is being developed by Allergan in the U.S. as a new once-daily oral therapy for the treatment of acne. Allergan has completed Phase 3 development activities for Seysara and its new drug application was accepted for review by the U.S. FDA in December 2017. Paratek retains all ex-U.S. rights to sarecycline.

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 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 obtain regulatory approval 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, 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)
  June   30,     December   31,  
  2018     2017  
Cash, cash equivalents and marketable securities $ 321,145     $ 151,723  
Total assets   327,828       163,698  
Working capital   233,901       143,697  
Total current liabilities   33,995       16,789  
Long-term debt, less current portion   202,717       59,186  
Common stock and additional paid-in-capital   613,311       552,748  
Accumulated deficit   (527,593 )     (470,112 )
Total stockholders' equity   85,492       82,478  

Condensed Consolidated Statements of Operations
(in thousands, except loss per share data)
  Three Months Ended     Six Months Ended  
  June 30,     June 30,  
  2018     2017     2018     2017  
License and royalty revenue $ 40     $ 7,514     $ 50     $ 7,532  
Operating expenses:                              
Research and development   14,802       15,079       29,665       33,735  
General and administrative   12,912       8,716       24,785       17,080  
Impairment   86       682       86       682  
Changes in fair value of contingent consideration   (31 )     (318 )     (46 )     (549 )
Total operating expenses   27,769       24,159       54,490       50,948  
Loss from operations   (27,729 )     (16,645 )     (54,440 )     (43,416 )
Other income and expenses:                              
Interest expense   (2,904 )     (1,126 )     (4,410 )     (2,258 )
Interest income   894       349       1,369       590  
Other (loss) income, net   6       (8 )     (1 )     (15 )
Loss before income taxes $ (29,733 )   $ (17,430 )   $ (57,482 )   $ (45,099 )
Provision for income taxes         753             753  
Net loss $ (29,733 )   $ (18,183 )   $ (57,482 )   $ (45,852 )
Net loss per share - basic and diluted $ (0.94 )   $ (0.66 )   $ (1.85 )   $ (1.78 )
Weighted average common shares outstanding                              
Basic and diluted   31,581,275       27,347,941       31,076,788       25,780,756  


Investor and Media Relations:
Ben Strain

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