-- 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
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:
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:
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.
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.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
As of December 31, | ||||||||
2021 | 2020 | |||||||
Cash, cash equivalents and marketable securities | $ | 95,474 | $ | 125,162 | ||||
Total assets | 183,869 | 176,853 | ||||||
Working capital | 120,803 | 140,164 | ||||||
Total current liabilities | 31,297 | 23,953 | ||||||
Long-term debt | 254,428 | 250,474 | ||||||
Common stock and additional paid-in capital | 739,105 | 705,535 | ||||||
Accumulated deficit | (866,883 | ) | (807,799 | ) | ||||
Total stockholders' deficit | (127,787 | ) | (102,260 | ) | ||||
Condensed Consolidated Statement of Operations
(unaudited)
(in thousands, except loss per share data)
Year Ended December 31, | ||||||||
2021 | 2020 | |||||||
Product revenue, net | $ | 106,084 | $ | 38,753 | ||||
Government contract service revenue | 6,639 | 3,299 | ||||||
Government contract grant revenue | 9,211 | 3,407 | ||||||
Collaboration and royalty revenue | 8,228 | 1,465 | ||||||
Net revenue | 130,162 | 46,924 | ||||||
Expenses: | ||||||||
Cost of product revenue | 21,535 | 8,651 | ||||||
Research and development | 30,353 | 23,922 | ||||||
Selling, general and administrative | 119,404 | 89,855 | ||||||
Total operating expenses | 171,292 | 122,428 | ||||||
Loss from operations | (41,130 | ) | (75,504 | ) | ||||
Other income and expenses: | ||||||||
Interest income | 66 | 1,515 | ||||||
Interest expense | (17,408 | ) | (20,240 | ) | ||||
Loss on extinguishment of debt | - | (2,368 | ) | |||||
Other gains (losses), net | (12 | ) | 56 | |||||
Net loss before provision for income taxes | (58,484 | ) | (96,541 | ) | ||||
Provision for income taxes | 600 | — | ||||||
Net loss | $ | (59,084 | ) | $ | (96,541 | ) | ||
Other comprehensive loss | ||||||||
Unrealized gain (loss) on available-for-sale securities, net of tax | (13 | ) | (70 | ) | ||||
Other comprehensive gain (loss) | (13 | ) | (70 | ) | ||||
Comprehensive loss | $ | (59,097 | ) | $ | (96,611 | ) | ||
Net loss per share: | ||||||||
Basic and diluted net loss per common share | $ | (1.22 | ) | $ | (2.19 | ) | ||
Weighted average common shares outstanding | ||||||||
Basic and diluted | 48,415,500 | 44,174,765 |
CONTACT:
Investor Relations: Hans Vitzthum LifeSci Advisors [email protected] Phone: 617-430-7578 Media: Christine Fanelle Scient PR [email protected] Phone: 215-595-5211 | ||
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