Paratek Pharmaceuticals Announces Total Revenue of $24.4 Million in the Third Quarter 2021
-- NUZYRA® (omadacycline) Generated Net U.S. Sales of $19.4 Million from the Core Commercial Business alone, a 30% Increase over Prior Quarter
-- BARDA Contract Expanded to Include sNDA Anthrax Post-Exposure Prophylaxis Development Program;ContractnowValued at up to $304 Million
-- First Patient Enrolled in Phase 2b Study in Non-Tuberculous Mycobacterium (NTM) Abscessus
BOSTON, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), today reported financial results and provided an update on corporate activities for the quarter ended September 30, 2021.
“We are extremely proud of the 30% quarter-over-quarter growth in the core NUZYRA commercial business despite continued challenges from the ongoing COVID-19 pandemic. Our performance this quarter reflects continued strong execution and momentum,” said Evan Loh, M.D., chief executive officer at Paratek. “Other highlights during this quarter included broadening our promotion of NUZYRA for the treatment of pneumonia in the community setting. In addition, the BARDA contract has now been expanded to include a NUZYRA sNDA program for prophylaxis as well as treatment of anthrax. And finally, we enrolled the first patient in our Phase 2b study evaluating the utility of NUZYRA as a treatment for NTM abscessus. This follows the orphan drug designation for NTM granted by the FDA in August.”
- Both Hospital and Community Prescribers Fueled Growth of NUZYRA: Tablet prescriptions continued to increase in both the outpatient and hospital settings, leading to significant growth in demand for the third quarter of 2021.
- BARDA Expanded Paratek Contract: Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, activated an option under the Company’s Project BioShield contract that provides $31.6 million in committed funding, of which $18.9 million was incremental to the original development program. This funding will fully support the development of NUZYRA® for a supplemental new drug application (sNDA) to the FDA for the post-exposure prophylaxis indication in addition to the development program for the treatment of pulmonary anthrax.
- Orphan Drug Designation for NUZYRA Granted by the FDA for the Treatment of NTM in August 2021
- First Patient Enrolled in NTM abscessus study: First patient enrolled in October in the company’s Phase 2b study evaluating the efficacy and safety of NUZYRA as a treatment for NTM abscessus pulmonary infection, a rare disease with no FDA-approved therapies. The company estimates NTM abscessus is a $1.0 billion addressable market opportunity in the United States.
- NUZYRA Data at IDWeek 2021: Peer-reviewed data deepened the understanding of the utility of NUZYRA for serious community-acquired infections and NTM as well as its potential in treating anthrax infections. Key highlights include real-world health outcomes data for pneumonia and skin infections, data on in vitro activity against B. anthracis, and real-world experience for NTM infections.
Third Quarter 2021 Financial Results
Total revenue was $24.4 million for the third quarter of 2021.
- NUZYRA generated $19.4 million in net U.S. sales from the core commercial business during the third quarter of 2021, a 30% increase over the second quarter of 2021 and a 78% increase over the third quarter of 2020.
- Government contract service and grant revenue earned from cost reimbursement under the BARDA contract was $4.5 million for the third quarter of 2021 compared to $4.2 million in the second quarter of 2021 and $2.7 million in the third quarter of 2020.
Research and development (R&D) expenses were $7.9 million for the third quarter of 2021, of which $4.5 million were costs reimbursed under the BARDA contract, compared to $6.7 million for same period in the prior year. The increase in R&D expenses for the third quarter of 2021 was primarily due to FDA post-marketing requirements associated with the approval of NUZYRA, which are fully reimbursed under the BARDA contract. The remaining increase was mainly the result of costs incurred for the Phase 2b NTM study.
Selling, general and administrative (SG&A) expenses were $26.0 million for the third quarter of 2021, compared to $20.9 million for the same period in the prior year. The increase in SG&A expenses was primarily the result of costs incurred for the NUZYRA community expansion.
Paratek reported a net loss of $18.2 million, or ($0.37) per share, for the third quarter of 2021, compared to a net loss of $20.9 million, or ($0.46) per share, for the same period in the prior year.
- Paratek anticipates net revenue of NUZYRA will be at the higher end of the previously indicated range of $100 to $106 million, which includes the $38 million NUZYRA procurement by BARDA in June 2021. Total Revenue is expected to be within the previously indicated range of $128 to $139 million. Total R&D and SG&A expenses are projected to be within the original guidance range of $150 to $155 million.
- Based upon the company’s current operating plan, Paratek anticipates its existing cash and cash equivalents of $111.0 million as of September 30, 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 quarter ended September 30, 2021, will be broadcast at 4:30 p.m. EDT on Nov. 8, 2021. 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: 855-327-6837 and international investors should dial: 631-891-4304. The conference ID is 10017186. Investors can also access the call at https://viavid.webcasts.com/starthere.jsp?ei=1509402&tp_key=f032c5b8ec.
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 in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex with NUZYRA. 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.
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. 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 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, 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.
PARATEK PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
|September 30, 2021||December 31, 2020|
|Cash, cash equivalents and marketable securities||$||110,999||$||125,162|
|Total current liabilities||29,150||23,953|
|Long-term debt, less current portion||253,269||250,474|
|Common stock and additional paid-in-capital||729,637||705,535|
|Total stockholders' deficit||(104,993||)||(102,260||)|
Condensed Consolidated Income Statements
| Three Months Ended |
| Nine Months Ended |
|Product revenues, net||$||19,432||$||10,895||$||85,441||$||26,330|
|Collaboration and royalty revenue||1,467||785||4,553||1,560|
|Cost of revenue||$||24,447||$||13,659||$||98,365||$||30,903|
|Research and development||-||-||-||-|
|General and administrative||4,289||2,017||16,817||5,724|
|Impairment of intangibles||7,920||6,687||19,977||17,636|
|Changes in fair value of contingent consideration||25,955||20,902||75,420||65,514|
|Total operating expenses||38,164||29,606||112,214||88,874|
|Loss from operations||(13,717||)||(15,947||)||(13,849||)||(57,971||)|
|Other income and expenses:||—||—||—||—|
|Other loss, net||(143||)||(10||)||(24||)||67|