— NUZYRA® (omadacycline) Generated Net U.S. Sales of $98.7 Million from the Core Commercial Business, a 45% Increase Over the Prior Year
— Continued Progress on the Rare Disease Nontuberculous Mycobacteria (NTM) & BARDA Project BioShield Anthrax Programs
BOSTON, March 16, 2023 (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, 2022. Paratek generated total revenue of $160.3 million, primarily as a result of strong growth in NUZYRA® commercial revenue. NUZYRA generated full-year net U.S. sales of $136.8 million in 2022, comprised of $98.7 million from the core commercial business, a 45% increase over the prior year, and $38.1 million from the second procurement of NUZYRA under the BARDA Project BioShield contract.
“We are pleased to report continued robust growth in our core NUZYRA commercial revenue. These results, combined with the efforts we have made to enroll patients in our NTM Phase 2b clinical study, advance regulatory discussions in Japan for NTM, and generate new efficacy data in our Project BioShield anthrax program highlight the broad utility of NUZYRA and the overall strength of our business,” said Evan Loh, M.D., chief executive officer at Paratek.
Non-Tuberculous Mycobacteria (NTM) Rare Disease Program:
- 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.
- Out-license Opportunity in Japan: Formal consultation with the Pharmaceuticals and Medical Device Agency was completed in February 2023 and provided clarity on the elements necessary for a NTM registration program in Japan. With this regulatory guidance in hand, the company is moving to progress a partnership focused on the development and commercialization of NUZYRA for NTM in Japan anticipated to be completed in the second half of 2023.
BARDA Project BioShield Anthrax Program: The company continued to execute and deliver on its contract with BARDA to develop NUZYRA as a novel antibiotic for both the treatment and post-exposure prophylaxis of pulmonary anthrax, a critical bioterrorism threat deemed important to national security by BARDA. In December 2022, the company reported pilot efficacy data in a treatment model of pulmonary anthrax in rabbits with 100% survival in all three NUZYRA treatment groups. These data results triggered the activation of the second procurement of NUZYRA by BARDA.
Fourth Quarter & Full-Year 2022 Financial Results
Total revenue for the fourth quarter of 2022 was $75.6 million compared to $31.8 million for the same period in the prior year. Total revenue for the fourth quarter was comprised of the following:
- NUZYRA net U.S. sales of $66.4 million, a 221% increase from $20.6 million in the prior year, which includes:
- $28.3 million net sales from the core commercial business, a 37% increase year-over-year compared to the same period in the prior year.
- $38.1 million in revenue from the second procurement of NUZYRA under the BARDA contract.
- Government contract service and grant revenue earned from cost reimbursement under the BARDA contract of $8.4 million, an 83% increase from $4.6 million for the same period in the prior year.
- Collaboration and royalty revenue of $0.8 million, which primarily represents royalty revenues earned on sales of SEYSARA® (sarecycline) in the United States.
Total revenue for the year ended December 31, 2022 was $160.3 million compared to $130.2 million for the prior year. Total revenue for the year was comprised of the following:
- NUZYRA net U.S. sales of $136.8 million, a 29% increase from $106.1 million in the prior year, which includes:
- $98.7 million from the core commercial business, a 45% increase compared to $68.2 million for the prior year.
- $38.1 million from the second procurement of NUZYRA under the BARDA contract compared to $37.9 million for the initial procurement in the prior year under the BARDA contract.
- Government contract service and grant revenue earned from cost reimbursement under the BARDA contract of $21.1 million, a 33% increase from $15.9 million in the prior year.
- Collaboration and royalty revenue of $2.4 million, which primarily represents royalty revenues earned on sales of SEYSARA in the United States.
Research and development (R&D) expenses were $14.3 million for the fourth quarter of 2022, compared to $10.4 million for the same period in the prior year. R&D expenses were $37.8 million for the year ended December 31, 2022, compared to $30.4 million in the prior year. The increase in R&D expenses in both periods was primarily due to costs for activities reimbursed under the BARDA contract and costs incurred for the Phase 2b NTM study.
Selling, general and administrative (SG&A) expenses were $53.8 million for the fourth quarter of 2022, compared to $44.0 million for the same period in the prior year. SG&A expenses were $145.6 million for the year ended December 31, 2022, compared to $119.4 million in the prior year. The increase in SG&A expenses in both periods was primarily due to costs incurred in connection with the NUZYRA community expansion and travel costs as a result of the easing of COVID-19 restrictions.
During the fourth quarter of 2022, as a result of NUZYRA’s strong sales since launch combined with projected future sales, we accrued a contingent, non-recurring compensation charge of $21.9 million payable in 2027. Excluding this charge, combined R&D and SG&A expenses were $161.5 million for the year ended December 31, 2022.
Paratek reported a net loss of $7.2 million, or $(0.13) per share, and $63.6 million, or ($1.17) per share, for the quarter and year ended December 31, 2022, respectively, compared to a net loss of $32.3 million, or $(0.66) per share, and $59.1 million, or ($1.22) per share, for the quarter and year ended December 31, 2021, respectively.
2023 Financial Guidance
Paratek also announced its full-year 2023 revenue guidance, which is expected to be in the range of $143.0 to $158.0 million, which includes the following components:
- NUZYRA net U.S. sales of approximately $125.0 to $135.0 million.
- BARDA government contract service and grant revenue between $15.0 to $20.0 million.
- Royalty and collaboration revenue of approximately $3.0 million.
Paratek expects to reduce full-year 2023 R&D and SG&A expense below that incurred in 2022. More detailed operating expense guidance with additional corporate updates will be provided during the company’s first quarter 2023 earnings call.
Paratek had cash and cash equivalents of $34.2 million as of December 31, 2022 which, combined with $36.1 million in cash received from BARDA for the second procurement of NUZYRA, yielded a pro forma cash and cash equivalents balance of $70.3 million as of January 4, 2023. This balance of cash and cash equivalents alone may not be sufficient to fund operations through 12 months from the filing date of the company’s 2022 Annual Report on Form 10-K. The Company expects to address future cash needs 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 and to accelerate its pathway to profitability.
Call and Webcast
Paratek’s earnings conference call for the year ended December 31, 2022, will be broadcast at 8:30 a.m. EST on March 16, 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: 877-407-0792 and international investors should dial: +1-201-689-8263. The conference ID is 13736677.
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.
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, 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 and Japan, the potential for a partnership in Japan 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.
Condensed Consolidated Balance Sheets
|As of December 31,|
|Cash, cash equivalents and marketable securities||$||34,248||$||95,474|
|Total current liabilities||37,388||31,297|
|Common stock and additional paid-in capital||759,407||739,105|
|Total stockholders’ deficit||(171,043||)||(127,787||)|
Condensed Consolidated Statement of Operations
(in thousands, except loss per share data)
|Year Ended December 31,|
|Product revenue, net||$||136,820||$||106,084|
|Government contract service revenue||11,586||6,639|
|Government contract grant revenue||9,480||9,211|
|Collaboration and royalty revenue||2,382||8,228|
|Cost of product revenue||23,056||21,535|
|Research and development||37,823||30,353|
|Selling, general and administrative||145,598||119,404|
|Total operating expenses||206,477||171,292|
|Loss from operations||(46,209||)||(41,130||)|
|Other income and expenses:|
|Other gains (losses), net||67||(12||)|
|Net loss before provision for income taxes||(63,509||)||(58,484||)|
|Provision for income taxes||57||600|
|Other comprehensive loss|
|Unrealized gain (loss) on available-for-sale securities, net of tax||9||(13||)|
|Other comprehensive gain (loss)||9||(13||)|
|Net loss per share:|
|Basic and diluted net loss per common share||$||(1.17||)||$||(1.22||)|
|Weighted average common shares outstanding|
|Basic and diluted||54,387,880||48,415,500|