Paratek Pharmaceuticals Announces First BARDA Project BioShield Procurement of NUZYRA® (omadacycline) Valued at ~$38 Million

Rhea-AI Summary

Paratek Pharmaceuticals has successfully delivered its first procurement of NUZYRA to the Biomedical Advanced Research and Development Authority (BARDA) valued at approximately $38 million, which will be recorded in Q2 2021 net sales. This achievement marks a significant step in their partnership with BARDA to develop NUZYRA for pulmonary anthrax, a critical public health threat. The five-year contract awarded in December 2019 potentially totals $284.5 million and includes various support for NUZYRA's development and manufacturing.

Positive

• First BARDA procurement of NUZYRA delivered, worth ~$38 million.
• Recognition of revenue from BARDA contract will boost Q2 2021 net sales.
• Partnership with BARDA validates commitment to public health initiatives.
• Potential $1.0 billion addressable market in Nontuberculous Mycobacterial Pulmonary Disease.

Negative

• None.

-- First BARDA Procurement has been Delivered and Revenue will be Recognized in Second Quarter 2021

BOSTON, June 29, 2021 (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 and for other public health threats for civilian, government and military use, today announced Paratek has delivered the first procurement of NUZYRA to the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), and BARDA has taken title of the product. This procurement is valued at ~$38 million and will be recognized in the Company’s second quarter 2021 net sales of NUZYRA.

“This is an important milestone and validation of the continued commitment by BARDA to our ongoing partnership,” said Evan Loh, MD, CEO, Paratek. “Paratek continues to execute and deliver on all aspects of this unique public-private partnership with BARDA to develop NUZYRA for the treatment of pulmonary anthrax, a bioterrorism threat deemed critical to develop novel treatments to address for national security by BARDA. We believe that NUZYRA, with its once-daily oral and intravenous formulations, approved for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, is well-positioned to help address potential public health emergencies, including pandemics, at a time when antibiotic resistance is a growing global threat.”

In December 2019, BARDA awarded Paratek a five-year contract, valued at up to $284.5 million, to support: 1) the development of NUZYRA for the treatment of pulmonary anthrax; 2) U.S. Food and Drug Administration post-marketing requirements associated with the initial NUZYRA approval; 3) U.S. onshoring of NUZYRA and manufacturing security requirements, and 4) up to four procurements of NUZYRA. As described above, BARDA has taken title of the first procurement under the contract.

This Project BioShield project has been funded in whole or in part with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract number 75A50120C00001.

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 is also conducting a Phase 2b Study in a rare disease, Nontuberculous Mycobacterial (NTM) Pulmonary Disease, caused by Mycobacterium abscessus Complex (MABc) with NUZYRA. Paratek estimates this opportunity represents a potential $1.0 billion addressable market in the U.S.

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, valued up to $284.5 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.

For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

About NUZYRA^®
NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.

Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.

Forward Looking Statements
This press release contains forward-looking statements including statements related to our overall BARDA contract, our execution under the contract, and potential utility of NUZYRA to address potential health emergencies, including pandemics. 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, 2020 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.

CONTACT:

Investor and Media Relations:
Ben Strain
617-807-6688
ir@ParatekPharma.com

FAQ

What is the value of the first BARDA procurement for Paratek Pharmaceuticals?

The first BARDA procurement of NUZYRA is valued at approximately $38 million.

When will the revenue from the BARDA contract be recognized by Paratek?

The revenue will be recognized in the second quarter of 2021.

What is the purpose of the BARDA contract awarded to Paratek?

The BARDA contract supports the development of NUZYRA for the treatment of pulmonary anthrax and includes up to four procurements.

What is NUZYRA, and what diseases does it treat?

NUZYRA (omadacycline) is an antibiotic that treats community-acquired bacterial pneumonia and acute bacterial skin infections.

What are the potential financial implications of the BARDA contract for Paratek?

The BARDA contract could total up to $284.5 million, significantly impacting Paratek's revenue and market position.