Paratek Pharmaceuticals Announces Full-Year 2021 Revenue of $130.2 Million

-- NUZYRA^® (omadacycline) Generated Net U.S. Sales of $106.1 Million Comprised of $68.2 Million from the Core Commercial Business, a 76% increase over Prior Year, and $37.9 Million from the Initial Procurement of NUZYRA under the BARDA Bioshield Contract

-- Approval of NUZYRA in China for treatment of ABSSSI and CABP in December 2021; Triggered a $6 Million Milestone Payment from Zai Lab

BOSTON, March 14, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), today reported financial results and provided an update on corporate activities for the fourth quarter and full-year ended December 31, 2021.

“We are extremely proud of the 76% year-over-year growth in the core NUZYRA commercial business despite continued challenges from the ongoing COVID-19 pandemic. Our performance this year reflects the important clinical unmet needs that NUZYRA addresses in addition to the consistent strong execution and growth momentum for our business,” said Evan Loh, M.D., chief executive officer at Paratek.

Recent Highlights 

• Expansion of NUZYRA into Primary Care Setting: Based on the continued success and progress of the company’s NUZYRA community expansion, Paratek plans to increase the number of U.S. sales representatives and territories covered in the primary care setting in 2022. The company expects to execute this expansion within its previously communicated cash runway guidance.

• NTM Rare Disease Development Program:
  • Enrollment in a Phase 2b study began in October 2021 to explore the potential utility of omadacycline as a treatment for non-tuberculous mycobacteria (NTM) pulmonary infections due to Mycobacterium abscessus (M. abscessus), a rare disease with currently no approved therapies, that the company estimates represent a potential $1 billion addressable market opportunity in the United States.
  • The results of an investigator-initiated study demonstrating potent activity of NUZYRA in a dynamic hollow fiber model of Mycobacterium avium complex (MAC) pulmonary infection was published in the Journal of Antimicrobial Chemotherapy on March 8, 2022. Efficacy and tolerability challenges associated with certain existing standard of care antibiotics used to treat MAC pulmonary infections further highlight the need for the development of novel antibiotic treatments for the estimated 100,000 cases of NTM pulmonary disease caused by MAC in the United States.

• Continued Progress of the Expanded BARDA Project BioShield Anthrax Program: The company continued to execute and deliver on its contract with BARDA to develop NUZYRA for both the treatment and post-exposure prophylaxis of pulmonary anthrax, a critical bioterrorism threat deemed important to national security by BARDA. These activities include advancing the U.S. onshoring of NUZYRA manufacturing, with commercial tablets being available by the end of 2022, and the execution of animal pharmacokinetic studies to support the pulmonary anthrax development program.

• Approval of NUZYRA in China: The company’s partner in China, Zai Lab Limited, received approval for NUZYRA from the National Medical Products Administration (NMPA) of China for the treatment of adults with CABP and ABSSSI and launched the product in December 2021. Upon approval, Paratek earned a $6 million milestone payment that was recognized as collaboration and royalty revenue during the fourth quarter of 2021.

Fourth-Quarter and Full-Year 2021 Financial Results

Total revenue was $31.8 million for the fourth quarter of 2021, compared to $16.0 million for the same period in the prior year. Total revenue for the fourth quarter was comprised of the following: 

• NUZYRA generated net U.S. sales of $20.6 million, a 66% increase from $12.4 million for the same period in the prior year.
• Government contract service and grant revenue earned from cost reimbursement under the BARDA contract was $4.6 million, a 64% increase from $2.8 million for the same period in the prior year.
• Collaboration and royalty revenue of $6.6 million included a $6.0 million milestone payment earned from Zai Lab upon the NMPA approval of NUZYRA in China for the treatment of CABP and ABSSSI. The balance primarily represents royalty revenues earned on sales of SEYSARA^® (sarecycline) in the United States.

Total revenue was $130.2 million for the year ended December 31, 2021, compared to $46.9 million for the prior year. Total revenue for the year was comprised of the following: 

• NUZYRA generated net U.S. sales of $106.1 million, a 173% increase from $38.8 million in the prior year, which includes $68.2 million from the core commercial business and $37.9 million from the initial procurement of NUZYRA under the BARDA contract.
• Government contract service and grant revenue earned from cost reimbursement under the BARDA contract was $15.9 million, a 137% increase from $6.7 million in the prior year.
• Collaboration and royalty revenue of $8.2 million included a $6.0 million milestone payment earned from Zai Lab upon the NMPA approval of NUZYRA in China for the treatment of adults with CABP and ABSSSI. The balance primarily represents royalty revenues earned on sales of SEYSARA in the United States.

Research and development (R&D) expenses were $10.4 million for the fourth quarter of 2021, compared to $6.3 million for same period in the prior year. R&D expenses were $30.4 million for the year ended December 31, 2021, compared to $23.9 million in the prior year. The increase in R&D expenses for both periods was primarily due to costs for activities reimbursed under the BARDA contract, compensation expense, and costs incurred for the Phase 2b NTM study.

Selling, general and administrative (SG&A) expenses were $44.0 million for the fourth quarter of 2021, compared to $24.3 million for same period in the prior year. SG&A expenses were $119.4 million in the year ended December 31, 2021, compared to $89.9 million in the prior year. The increase in SG&A expenses for both periods is primarily the result of compensation expense and costs incurred for the NUZYRA community expansion.

Paratek reported a net loss of $32.3 million, or ($0.64) per share, and $59.1 million, or ($1.22) per share, for the fourth quarter and year ended December 31, 2021, compared to a net loss of $25.0 million, or ($0.54) per share, and $96.5 million, or ($2.19) per share, for the fourth quarter and year ended December 31, 2020.

Financial Guidance

Paratek also announced its full year 2022 financial guidance. 

• The company estimates 2022 total revenue in the range of $155 to $170 million. This range includes the following components:
  • 2022 NUZYRA net U.S. product sales are expected to be approximately $133 to $143 million, which includes:
    • Net U.S. product sales between $95 to $105 million from NUZYRA’s core commercial business.
    • A second procurement by BARDA valued at approximately $38 million.
  • Royalty and collaboration revenue of approximately $2 million.
  • BARDA government contract service and grant revenue between $20 to $25 million.

• The company estimates 2022 R&D and SG&A expense to be approximately $160 to $170 million. This range includes the following components:
  • Core business R&D and SG&A expense of $140 to $145 million.
  • BARDA R&D and U.S. onshoring cost reimbursements between $20 to $25 million.

• Based upon the company’s current operating plan as described above, Paratek anticipates its existing cash and cash equivalents of $95.5 million as of December 31, 2021, provides for a cash runway through the end of 2023 with a pathway to cash flow break-even.

Call and Webcast

Paratek’s earnings conference call for the year ended December 31, 2021, will be broadcast at 8:30 a.m. EDT on March 14. The live audio 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: +1-201-689-8263. The conference ID is 13727320. Investors can also access the call at https://viavid.webcasts.com/starthere.jsp?ei=1531023&tp_key=373482f150.

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 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 United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). 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 with NUZYRA in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States.

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. Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

In 2019, Paratek was awarded a contract from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), now valued at up to $304 million, to support the development and U.S.-based manufacturing of NUZYRA for pulmonary anthrax.

For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter.

About NUZYRA^®

NUZYRA^® (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) 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. 

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 our expectations regarding the Company's future growth and performance, revenue projections, the exercise and timing of BARDA's future procurements of NUZYRA for the SNS, the expected timing of certain regulatory decisions, the status of our Phase 2b NTM abscessus study and the potential market opportunity of NTM, the benefit of the expansion of the NUZYRA label, our plans to broaden the Company's sales efforts including into the community, our expectation to continue to execute and deliver on our BARDA contract including the expansion of our anthrax development program for prophylaxis, and our anticipated cash runway.

This press release contains forward-looking statements including statements related to our clinical studies for NTM and the potential for NUZYRA to fill an unmet medical need for NTM patients. 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, 2021 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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