-- NUZYRA® (omadacycline) Generated Net U.S. Sales of $14.9 Million from the Core Commercial Business, a 13% Increase over the Prior Quarter
-- Reported $37.9 Million in Revenue from the Delivery of the First BARDA Procurement of NUZYRA
-- Received FDA Approval of NUZYRA Oral Only Loading-Dose Regimen for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)
-- Initiated Phase 2b Study in Non-Tuberculous Mycobacterium Abscessus
BOSTON, Aug. 09, 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 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 June 30, 2021.
“We continued to deliver consistent growth and progress in the second quarter with the core NUZYRA commercial business seeing quarter over quarter growth, as net sales increased 13% to $14.9 million versus the first quarter,” said Evan Loh, M.D., Chief Executive Officer at Paratek. “We were also excited to announce that the first BARDA procurement valued at $37.9 million was delivered and accepted in the second quarter as we continued to execute on all aspects of this unique contract with BARDA. NUZYRA’s label was expanded in the second quarter with the FDA approval of the oral loading dose regimen for community-acquired bacterial pneumonia. Importantly, we continued to advance our pipeline for NUZYRA with the initiation of a Phase 2b non-tuberculous mycobacteria (NTM) abscessus study, a rare disease for which there are no approved therapies.”
Highlights
- Oral loading dose regimen for CABP: Received FDA approval for NUZYRA’s oral loading dose regimen for CABP in late May 2021. Plans have been established to broaden the Company’s community-based sales effort in the primary care setting to include CABP later this year in anticipation of the 2021/2022 flu season. The Company estimates that CABP in the primary care setting has a $1.5 billion addressable market opportunity in the U.S.
- NTM abscessus rare disease opportunity: Initiated a Phase 2b study in June 2021 to explore the potential utility of omadacycline as a treatment for NTM abscessus pulmonary infection, a rare disease with no approved therapies, which the Company estimates is a $1.0 billion addressable market opportunity in the U.S.
- Continued progress of the BARDA Project BioShield anthrax program: Biomedical Advanced Research and Development Authority (BARDA) accepted the first procurement of NUZYRA valued at $37.9 million. The Company continues to execute and deliver on its five-year contract with 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), to develop NUZYRA for the treatment 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 and the continued execution of certain preclinical research activities supporting the pulmonary anthrax development program.
- NUZYRA added to the Center for Disease Control and Prevention’s (CDC) Plague Guideline: The Company’s novel, once-daily oral and intravenous antibiotic NUZYRA has recently been added to the CDC’s updated guideline, Antimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response. The addition of NUZYRA provides further validation of the potential utility of the drug against pathogens that cause health security threats such as plague.
- Nuzyra included in CHEST, “Treatment of Mycobacterium abscessus Pulmonary Disease”: Two recognized NTM experts, who are NTM treatment guideline authors, collaborated on a recently published review article that expands on the current guidelines for the treatment of pulmonary M. abscessus infections. The authors included omadacycline in their recommended treatment options based on its potent in vitro activity and reports of clinical success in real-world NTM abscessus case series. In particular, the authors highlighted the importance of NUZYRA’s oral formulation given the lack of currently available oral treatment options.
Second Quarter 2021 Financial Results
Total revenue was $57.5 million for the second quarter of 2021.
- NUZYRA generated $52.8 million in net U.S. sales during the second quarter of 2021. This revenue includes $14.9 million from the core commercial business, a 13% increase over the first quarter of 2021 and an 84% increase over the second quarter of 2020, and $37.9 million from the first BARDA procurement.
- Government contract service and grant revenue earned from costs incurred under the BARDA contract was $4.2 million for the second quarter of 2021 versus $2.6 million in the first quarter of 2021 and $0.9 million in the second quarter of 2020.
Research and development (R&D) expenses were $6.5 million for the second quarter of 2021, compared to $4.6 million for same period in the prior year. The increase in R&D expenses for the second quarter of 2021 was primarily due to $4.2 million in costs reimbursed under the BARDA contract, which included costs for the U.S. onshoring of NUZYRA manufacturing and for FDA post-marketing requirements, or PMRs, associated with the approval of NUZYRA. The remaining increase is mainly the result of start-up costs incurred for the Phase 2b NTM study.
Selling, general and administrative (SG&A) expenses were $27.1 million for the second quarter of 2021, compared to $21.0 million for the same period in the prior year. The increase in SG&A expenses is primarily the result of costs incurred for the NUZYRA community expansion and an increase in stock-based compensation expense due to the probability and timing of the achievement of performance-based vesting milestones.
Paratek reported net income of $9.7 million, or $0.20 per share, for the second quarter of 2021, compared to a net loss of $23.1 million, or ($0.53) per share, for the same period in 2020.
Financial Guidance
- Paratek is maintaining its previously disclosed financial guidance, which moved approximately $38 million associated with the second procurement of NUZYRA by BARDA from its 2021 revenue expectations.
- Based upon the Company's current operating plan, Paratek anticipates its existing cash and cash equivalents of $75.3 million as of June 30, 2021, plus the $37.9 million received from BARDA in July 2021 for the first procurement of NUZYRA, provides for a cash runway through the end of 2023 with a pathway to cash flow break even.
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 June 30, 2021 will be broadcast at 4:30 p.m. EDT on August 9, 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 10016029. Investors can also access the call at http://public.viavid.com/index.php?id=146149.
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 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 strategy, products, prospects, potential and expected results, including statements about our expectations regarding the Company’s future growth and performance, the impact of COVID-19 on our revenue projections, the exercise and timing of BARDA’s future procurements of NUZYRA for the SNS, the expected timing of certain regulatory decisions,, the benefits of our initiation of a 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, our expectation to continue to execute and deliver on our BARDA contract, and our anticipated cash runway. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as “will be,” "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 SEC. 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)
| June 30, 2021 | December 31, 2020 | |||||||
| Cash, cash equivalents and marketable securities | $ | 75,298 | $ | 125,162 | ||||
| Total assets | 179,588 | 176,853 | ||||||
| Working capital | 132,527 | 140,164 | ||||||
| Total current liabilities | 20,977 | 23,953 | ||||||
| Long-term debt | 252,759 | 250,474 | ||||||
| Common stock and additional paid-in-capital | 717,137 | 705,535 | ||||||
| Accumulated deficit | (816,428 | ) | (807,799 | ) | ||||
| Total stockholders' deficit | (99,291 | ) | (102,260 | ) | ||||
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Product revenue, net | $ | 52,803 | $ | 8,133 | $ | 66,009 | $ | 15,436 | ||||||||
| Government contract service revenue | 2,113 | 439 | 3,086 | 775 | ||||||||||||
| Government contract grant revenue | 2,087 | 437 | 3,701 | 437 | ||||||||||||
| Collaboration and royalty revenue | 489 | 317 | 1,123 | 597 | ||||||||||||
| Net revenue | $ | 57,492 | $ | 9,326 | $ | 73,919 | $ | 17,245 | ||||||||
| Expenses: | ||||||||||||||||
| Cost of product revenue | 9,778 | 2,236 | 12,529 | 3,707 | ||||||||||||
| Research and development | 6,519 | 4,561 | 12,057 | 10,949 | ||||||||||||
| Selling, general and administrative | 27,106 | 20,975 | 49,465 | 44,613 | ||||||||||||
| Total operating expenses | 43,403 | 27,772 | 74,051 | 59,269 | ||||||||||||
| Income (loss) from operations | 14,089 | (18,446 | ) | (132 | ) | (42,024 | ) | |||||||||
| Other income and expenses: | ||||||||||||||||
| Interest income | 11 | 363 | 36 | 1,067 | ||||||||||||
| Interest expense | (4,344 | ) | (4,971 | ) | (8,651 | ) | (9,797 | ) | ||||||||
| Other gains (losses), net | (39 | ) | (5 | ) | 118 | 78 | ||||||||||
| Net income (loss) | $ | 9,717 | $ | (23,059 | ) | $ | (8,629 | ) | $ | (50,676 | ) | |||||
| Other comprehensive income (loss) | ||||||||||||||||
| Unrealized gain (loss) on available-for-sale securities, net of tax | — | (217 | ) | (4 | ) | 180 | ||||||||||
| Comprehensive income (loss) | $ | 9,717 | $ | (23,276 | ) | $ | (8,633 | ) | $ | (50,496 | ) | |||||
| Earnings (loss) per common share | ||||||||||||||||
| Basic | $ | 0.20 | $ | (0.53 | ) | $ | (0.18 | ) | $ | (1.19 | ) | |||||
| Diluted | $ | 0.20 | $ | (0.53 | ) | $ | (0.18 | ) | $ | (1.19 | ) | |||||
| Weighted average common stock outstanding | ||||||||||||||||
| Basic | 47,122,717 | 43,629,836 | 46,894,812 | 42,635,520 | ||||||||||||
| Diluted | 48,945,736 | 43,629,836 | 46,894,812 | 42,635,520 | ||||||||||||
CONTACT:
Investor Relations:
Hans Vitzthum
LifeSci Advisors
Phone: 617-430-7578
ir@ParatekPharma.com
Media:
Beth Kramli
Scient PR
Phone: 908-568-9721
beth@scientpr.com
