-- Announced Initiation of Funding from BARDA for All FDA Required Post-Marketing Studies and Security Requirements and U.S. Onshoring of an Additional Manufacturing Supply Chain for NUZYRA

BOSTON, May 11, 2020 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today reported financial results and provided an update on corporate activities for the quarter ended March 31, 2020. 
“Demand for NUZYRA continued to increase in the first quarter of 2020 with net revenue growing 35% versus the fourth quarter of 2019, with particular strength seen with the oral formulation.  NUZYRA is well-positioned to help address current and future public health emergencies at a time when antibiotic resistance is a growing global threat,” said Evan Loh, M.D., Chief Executive Officer.  “I would like to thank the entire Paratek team for their dedication and efforts during the COVID-19 pandemic and continuing to drive the business forward, ensuring patients continue to have access to NUZYRA, with its once-daily oral and intravenous formulations, approved for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.” 
Recent NUZYRA Commercial Highlights

• NUZYRA generated $7.3 million in net revenue in the first quarter of 2020.
• The Company transitioned efficiently to a fully virtual model including the sales and marketing organization.
• Over 80% of commercial lives, greater than 50% of Medicaid lives and over one third of Medicare lives in the U.S. now have access to NUZYRA with limited or no restrictions.
  • Secured multi-year agreement with Humana Medicare Part D and Commercial lines of business to place NUZYRA on their formulary with no restrictions.

Other Highlights

• Biomedical Advanced Research and Development Authority (BARDA) has initiated funding to support all of the U.S. Food and Drug Administration (FDA) post-marketing requirements associated with the approval of NUZYRA including pneumonia and pediatric studies as well as the five-year post-marketing bacterial surveillance study.
  • The cost reimbursement for these post-marketing commitments is projected to total approximately $77 million.
• BARDA initiated funding to support the onshoring of Paratek manufacturing activities for NUZYRA.
  • The cost reimbursement for the onshoring and security requirement activities is projected to total approximately $20 million over the next couple of years.
  • Helps to further secure NUZYRA’s overall supply chain, adding a comprehensive additional supply chain to our existing infrastructure, and over the projected collaboration timeframe, will provide for a secure, United States based manufacturing supply chain.
• The Company’s partner for the greater China region, Zai Lab Limited (Zai Lab), announced its New Drug Application (NDA) for omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) has been accepted with priority review in China. 
  • Paratek earned $3.0 million upon this regulatory submission in the fourth quarter of 2019. 
  • Paratek is eligible to receive $6.0 million upon regulatory approval and royalties on net sales.
• Data from the NUZYRA clinical and microbiology programs were made available through the 30^th European Congress of Clinical Microbiology & Infectious Diseases, ECCMID 2020.  Four abstracts from the congresses abstract book released last week continued to highlight the efficacy and safety profile of NUZYRA, highlighting omadacycline’s in vitro activity for a number of key pathogens, quality of life outcomes in the Phase 3 program and the epidemiology and potential advantages omadacycline with regards to Clostridioides difficile infections.

• Paratek granted a license to Almirall, S.A. (Almirall, BME ticker: ALM) for SEYSARA® (sarecycline) in the greater China region, which includes the Peoples Republic of China, Hong Kong, and Macau.  Almirall plans to develop sarecycline for acne in China, with a submission to the China National Medical Products Administration expected in 2023.  Under the terms of the agreement, Paratek will earn high single-digit royalties on net sales. 
  

Anticipated Near-Term 2020 Milestones

• The initial NUZYRA procurement by BARDA for the Strategic National Stockpile (SNS) valued at approximately $38 million remains on track and is anticipated to be secured in the second quarter of 2020.
• The supplemental NDA to support an oral-only dosing label for CABP is anticipated to be filed with the FDA mid-year with potential approval during the 2020-2021 pneumonia season.   

First Quarter 2020 Financial Results
Paratek reported a net loss of $27.6 million, or ($0.66) per share, for the first quarter of 2020, compared to a net loss of $35.6 million, or ($1.10) per share, for the same period in 2019.    
Revenue earned during the first quarter of 2020 of $7.9 million was attributable to U.S. NUZYRA net sales of $7.3 million, government contract service revenue of $0.3 million and collaboration and royalty revenue of $0.3 million.  Revenue earned during the first quarter of 2019 was attributable to net U.S. NUZYRA product revenue of $1.3 million and royalty and collaboration revenue of $0.3 million. 
Research and development (R&D) expenses were $6.4 million for the first quarter of 2020, compared to $11.4 million for the first quarter of 2019. The $5.0 million decrease is primarily the result of lower clinical study costs associated with our Phase 2 UTI program completed in 2019 and other operational efficiencies as Paratek continues to focus on streamlining operations. 
Selling, general and administrative (SG&A) expenses were $23.6 million for the first quarter of 2020, compared to $23.3 million for the first quarter of 2019.  The modest increase is primarily the result of personnel-related costs in support of the commercialization of NUZYRA, additional contract sales force costs, and higher trade and distribution fees, partially offset by lower sales and marketing costs due to COVID-19-related travel restrictions that prohibited in-person training events and sales meetings from taking place during a portion of the first quarter. 
As of March 31, 2020, Paratek had $194.8 million in cash, cash equivalents and marketable securities.   
Financial Guidance
In evaluating the 2020 financial guidance, the Company balanced its strong first quarter results against the forecasting challenges related to the COVID-19 pandemic.  As a result, Paratek is currently maintaining its full year 2020 financial guidance and will not be making any adjustments at this time. 
The 2020 financial guidance issued in conjunction with the 2019 fourth quarter earnings call consisted of the following components:

• Paratek estimates 2020 total revenues to be between $75 and $80 million.  This revenue consists of the following elements:
  • 2020 NUZYRA U.S. net product sales is expected to be approximately $66 million with approximately $38 million of these sales coming from the initial BARDA procurement of 2,500 anthrax treatment courses.
    • The initial NUZYRA BARDA procurement is anticipated to be secured in the second quarter of 2020.
  • Royalty and collaboration revenue combined with government contract service revenue earned under the BARDA contract are expected to be approximately $9 to $14 million.
    • Of note, government contract service revenue consists of cost reimbursement by BARDA for 2020 spend on the Company’s post-marketing requirement clinical development activities, anthrax development program and onshoring of U.S. NUZYRA manufacturing.
• 2020 R&D and SG&A expense is expected to be approximately $140 million.
  • R&D expense includes approximately $5 million earmarked for start-up activities in preparation for potential nontuberculous mycobacteria (NTM) studies.
  • Excluding the BARDA R&D and onshoring cost reimbursement, R&D and SG&A expense is expected to remain relatively flat when compared to 2019.
• Based upon the Company’s current operating plan, which includes estimated NUZYRA product sales, and the BARDA cost reimbursement of activities related to the Project BioShield contract, the Company anticipates that its existing cash, cash equivalents and marketable securities of $194.8 million as of March 31, 2020, provide for a cash runway through the end of 2023 with a pathway to cash flow break even. 
  • This anticipated pathway assumes the Company will be able to fund all company operating expenses, anticipated capital expenditures, and debt service, including repayment in full of the Hercules Loan and Security Agreement under its existing terms.   

Company performance and unanticipated events could cause actual results to vary from this forward-looking guidance. 
Call and Webcast
Paratek’s earnings conference call for the quarter ended March 31, 2020 will be broadcast at 8:30 a.m. EDT on May 11, 2020. The live webcast can be accessed under "Events and Presentations" in the Investor Relations section of Paratek’s website at .   
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 13703077. Investors can also access the call at . 
Website Information
Paratek routinely posts important information for investors on the Investor Relations section of its website at . 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 novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.  
The Company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. 
Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world. 
In 2019, Paratek was awarded a contract from BARDA to support the development of NUZYRA for the treatment of pulmonary anthrax. 
For more information, visit  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 impact of the COVID-19 pandemic on our revenue projections, supply chain and clinical trials, projected awareness, payor coverage, net product revenues, total revenues including assumptions related to our financial guidance, the financial impact of our BARDA contract including BARDA exercising full contract line items for procurement and PMR reimbursement, our anticipated cash runway, our operating expenses, our SEYSARA royalty-backed loan funded on May 1, 2019, the progression of our commercial roll out for 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 NTM, and to work toward an oral-only indication in CABP, future governmental stockpiling opportunities, and our potential to further drive long-term value for all of our shareholders.  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, 2019 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.

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