-- NUZYRA® (omadacycline) Generated Net U.S. Sales of $26.2 Million from the Core Commercial Business, a 32% Increase Over First Quarter 2022
-- Company Reiterates Full-Year Revenue Guidance of $143 to $158 Million
-- Announces Full-Year R&D and SG&A Expense Guidance of $160 to $170 Million, Approximately $20 Million in Savings Over Annualized Fourth Quarter 2022 Spend Rate1, Enabled by Operational Efficiencies
BOSTON, May 09, 2023 (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 first quarter ended March 31, 2023.
“The continued and robust year-over-year growth in our NUZYRA core commercial revenue combined with the sales momentum seen in the latter half of the first quarter, which has continued through April, supporting our confidence in our commercial strategy,” said Evan Loh, M.D., chief executive officer at Paratek. “The strong demand we have seen in our commercial business to date, along with the progress we are making in our BARDA contract, allows us to reiterate 2023 revenue guidance of $143 to $158 million. Consistent with our commitment to accelerate our pathway to profitability, 2023 R&D and SG&A expense guidance is $160 to $170 million, which represents a significant reduction from our annualized fourth quarter 2022 spend rate1 that will be achieved through operational efficiencies.”
1 R&D and SG&A expense in the fourth quarter of 2022 was $68.1 million, which included a contingent non-recurring charge of $21.9 million. Excluding this charge, R&D and SG&A expense in the fourth quarter of 2022 was $46.2 million, which incorporated the full cost burden of the community sales expansion completed in the second half of 2022.
Non-Tuberculous Mycobacteria (NTM) Rare Disease Program:
Real World Evidence Presentation: In a poster presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in April 2023 entitled, “A Multicenter Evaluation of Treatment Durability and Safety of Omadacycline for Mycobacterium abscessus Infections,” omadacycline demonstrated a high degree of clinical durability and safety at three, six, and 12 months in 63 patients with NTM infections.
Ex-US Outlicensing Opportunities: Following the receipt of formal guidance on a NTM registration program in Japan during the first quarter, the company has initiated regulatory activities in Europe focused on establishing orphan disease designation and a development pathway for approval of NUZYRA for NTM caused by Mycobacterium abscessus. Progress on partnerships focused on the development and commercialization of NUZYRA for NTM in both Japan and Europe continues. The company anticipates a formal partnership in Japan to be announced in the second half of 2023.
Development Program: Enrollment continues in an ongoing Phase 2b study designed to explore the potential utility of omadacycline as a treatment for NTM pulmonary infections due to Mycobacterium abscessus. The company anticipates that enrollment will be complete by the end of 2023.
First Quarter 2023 Financial Results
Total revenue for the first quarter of 2023 was $31.2 million compared to $24.9 million for the same period in the prior year. Total revenue for the first quarter of 2023 was comprised of the following:
NUZYRA net U.S. sales of $26.2 million, which represented a 32% increase from $19.9 million for the same period in the prior year.
Government contract service and grant revenue earned from cost reimbursement under the BARDA contract of $3.8 million, a 12% decrease from $4.3 million for the same period in the prior year.
Collaboration and royalty revenue of $1.2 million, a 71% increase from $0.7 million for the same period in the prior year, which primarily represents royalty revenues earned on sales of NUZYRA in China and on sales of SEYSARA® (sarecycline) in the United States.
Research and development (R&D) expenses were $7.3 million for the first quarter of 2023, compared to $7.5 million for the same period in the prior year.
Selling, general and administrative (SG&A) expenses were $33.5 million for the first quarter of 2023, compared to $27.6 million for the same period in the year. The increase in SG&A expenses is primarily the result of costs incurred in connection with the NUZYRA community expansion.
Paratek reported a net loss of $20.1 million, or $(0.35) per share, for the first quarter of 2023, compared to a net loss of $17.9 million, or $(0.35) per share, for the same period in the prior year.
Paratek had cash and cash equivalents of $45.0 million as of March 31, 2023. Based upon the Company’s current operating plan, this balance of cash and cash equivalents may not be sufficient to fund operations through the first quarter of 2024. The Company expects to address future cash needs, including the maturity of its outstanding convertible senior subordinated notes due May 2024, primarily through a combination of product sales, royalties, public or private equity offerings, debt or other structured financings, strategic partnership opportunities, government procurements and active management of cash and expenses through operational efficiencies. If these activities are successful, the Company expects to be able to fund operations beyond the first quarter of 2024.
2023 Financial Guidance
Paratek reiterated its full-year 2023 revenue guidance announced earlier this year, which is expected to be in the range of $143 to $158 million, which includes the following components:
NUZYRA net U.S. sales of approximately $125 to $135 million.
BARDA government contract service and grant revenue between $15 to $20 million.
Royalty and collaboration revenue of approximately $3 million.
Paratek also announced its full-year 2023 R&D and SG&A expense guidance, which is expected to be in the range of $160 to $170 million, and include the following components:
Core business R&D and SG&A expenses of $145 to $150 million.
Reimbursable BARDA R&D and U.S. onshoring expenses of $15 to $20 million.
Call and Webcast
Paratek’s earnings conference call for the quarter ended March 31, 2023, will be broadcast at 4:30 p.m. EST on May 9, 2023. 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: 1-800-920-3371 and international investors should dial: 1-212-231-2909. The conference ID is 22026760.
Investors can also access the call at: https://viavid.webcasts.com/starthere.jsp?ei=1611304&tp_key=5fe62a51b9
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.
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 and operating expense projections, our ability to continue to execute and deliver on our BARDA contract, the status of our Phase 2b NTM abscessus study, the potential market opportunity for NTM in the United States, Japan and Europe, the potential for a partnership in Japan and Europe for the development and commercialization of NUZYRA for NTM, 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 “expect,” “anticipate,” “continue,” “will” 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, 2022 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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