Paratek Pharmaceuticals, Inc., reported financial results and provided an update on corporate activities for the quarter ended September 30, 2022.
- NUZYRA® (omadacycline) Generated Net U.S. Sales of $25.5 Million from the Core Commercial Business, a 31% increase from $19.4 Million in Third Quarter 2021
- Initiated Rabbit Pilot Efficacy Study for the Treatment of Pulmonary Anthrax
- Announced Commercial Availability of U.S.-manufactured NUZYRA Tablets
BOSTON, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), today reported financial results and provided an update on corporate activities for the quarter ended September 30, 2022.
“We are pleased to report another strong quarter of growth in NUZYRA’s core commercial business, as evidenced by the 31% increase in net U.S. sales compared to the same period in 2021. NUZYRA’s core commercial business achieved a 52% increase in trailing 12-month net U.S. sales as a result of accelerating product demand and the disciplined execution of our community sales force expansion,” said Evan Loh, M.D., chief executive officer at Paratek. “Based on our results to date, we continue to reiterate our full-year 2022 financial guidance.”
Recent Highlights
- Completed Second Wave of Expansion in Primary Care: This wave of the company’s commercial and medical expansion into the community setting was completed during the third quarter of 2022. These efforts included an increase in the number of sales representatives, medical science liaisons, and territories covered in the primary care setting. Early leading indicators of the performance of the new community sales cohort are promising, including prescription data aligning with the initial wave of community expansion completed in the first quarter of 2021.
- Hosted an Investor Day on the Global Opportunity for NUZYRA in Non-Tuberculous Mycobacteria (NTM): The company hosted an Investor Day event on October 3 to update investors on the global market opportunity for NTM in both M. abscessus and M. avium complex (MAC). This event highlighted the significant global unmet medical need for patients suffering from this chronic, rare and life-threatening pulmonary disease and the potential clinical utility of NUZYRA based on data generated to date. These data and efforts further support ex-U.S. partnering discussions for the treatment of NTM in key global markets. A replay of the event can be accessed via the following link: NTM Investor Day Webcast Replay.
- Continued Progress of the BARDA Project BioShield Program: The company has continued to execute on its contractual deliverables on the BARDA contract. The Animal Rule program for both the treatment and post-exposure prophylaxis of pulmonary anthrax continues to progress with the initiation of the rabbit pilot efficacy study for the treatment indication. We anticipate that positive top line data from this study will trigger BARDA’s second procurement of 2,500 NUZYRA anthrax treatment courses. In addition, the onshoring program continues to progress with tablet validation and manufacturing now complete. As a result, U.S.-manufactured NUZYRA tablets are now commercially available.
- Scientific Congresses: The company has recently participated in several important in-person scientific congresses, including the Military Health System Research Symposium (MHSRS), the Academy of Managed Care Pharmacy (AMCP) Nexus, the American College of Chest Physicians (CHEST), and IDWeek. Peer-reviewed data presented at these conferences furthers the understanding of NUZYRA’s utility for serious community-acquired and combat-associated infections.
Financial Results
Total revenue for the third quarter of 2022 was $30.2 million, a 24% increase from $24.4 million for the same period in the prior year. Revenue earned in the third quarter of 2022 was comprised of $25.5 million in net U.S. sales from the NUZYRA core commercial business, a 31% increase from $19.4 million for the same period in the prior year; $4.4 million in revenue earned under the BARDA contract; and $0.3 million in royalty revenue.
Research and development (R&D) expenses were $8.5 million for the third quarter of 2022, compared to $7.9 million for the same period in the prior year. The increase in R&D expenses was primarily the result of costs incurred under our BARDA contract, including the timing of activities for the U.S. onshoring of NUZYRA manufacturing and additional work completed under the anthrax development program, partially offset by lower clinical study costs associated with our post-marketing required clinical study for adult patients with community-acquired bacterial pneumonia (CABP).
Selling, general and administrative (SG&A) expenses were $33.8 million for the third quarter of 2022, compared to $26.0 million for the same period in the prior year. The increase in SG&A expenses was primarily the result of compensation expense and costs incurred for the expansion of NUZYRA promotion into the primary care setting.
Paratek reported a net loss of $20.9 million, or ($0.38) per share, and $18.2 million, or ($0.37) per share, for the third quarters of 2022 and 2021, respectively.
Based upon the company’s current operating plan, Paratek anticipates its existing cash, cash equivalents and marketable securities of $57.0 million as of September 30, 2022, 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, 2022, will be broadcast at 4:30 p.m. ET on November 3, 2022. 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: 800-458-4121 and international investors should dial: +1-646-828-8193. The conference ID is 7165992. Investors can also access the call at https://viavid.webcasts.com/starthere.jsp?ei=1577240&tp_key=22e88571f9.
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, non-tuberculous 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, our expectation to continue to execute and deliver on our BARDA contract, the exercise and timing of BARDA’s future procurements of NUZYRA for the SNS, , the status of our Phase 2b NTM abscessus study and the potential market opportunity of NTM, and our anticipated cash runway.
This press release contains forward-looking statements. 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.
Contact
Investor Relations:
Hans Vitzthum
LifeSci Advisors
ir@ParatekPharma.com
Phone: 617-430-7578
Media:
Christine Fanelle
Scient PR
Christine@scientpr.com
Phone: 215-595-5211
Paratek Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except for share and par value amounts)
(unaudited)
| September 30, 2022 | December 31, 2021 | ||||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 27,087 | $ | 80,367 | |||
| Marketable securities | 29,922 | 15,107 | |||||
| Restricted cash | 125 | 125 | |||||
| Accounts receivable, net | 29,407 | 29,438 | |||||
| Inventories | 20,750 | 11,020 | |||||
| Other receivables | 3,332 | 3,679 | |||||
| Prepaid and other current assets | 10,718 | 12,364 | |||||
| Total current assets | 121,341 | 152,100 | |||||
| Long-term restricted cash | — | 125 | |||||
| Fixed assets, net | 663 | 794 | |||||
| Goodwill | 829 | 829 | |||||
| Right-of-use assets | 1,128 | 1,757 | |||||
| Long-term inventories | 33,117 | 27,767 | |||||
| Other long-term assets | 243 | 497 | |||||
| Total assets | $ | 157,321 | $ | 183,869 | |||
| Liabilities and Stockholders’ Deficit | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 8,107 | $ | 5,394 | |||
| Accrued expenses | 28,520 | 23,446 | |||||
| Other current liabilities | 2,349 | 2,457 | |||||
| Total current liabilities | 38,976 | 31,297 | |||||
| Long-term debt | 258,482 | 254,428 | |||||
| Long-term lease liabilities | 621 | 1,308 | |||||
| Accrued long-term compensation | 22,874 | 21,846 | |||||
| Other liabilities | 2,520 | 2,777 | |||||
| Total liabilities | $ | 323,473 | $ | 311,656 | |||
| Stockholders’ deficit | |||||||
| Preferred stock: | |||||||
| Undesignated preferred stock: $0.001 par value, 5,000,000 shares authorized; no shares issued and outstanding | — | — | |||||
| Common stock, $0.001 par value; 200,000,000 shares authorized; 55,438,716 shares issued and outstanding as of September 30, 2022; and 200,000,000 shares authorized; 51,711,809 shares issued and outstanding as of December 31, 2021 | 55 | 52 | |||||
| Additional paid-in capital | 757,202 | 739,053 | |||||
| Accumulated other comprehensive income | (117 | ) | (9 | ) | |||
| Accumulated deficit | (923,292 | ) | (866,883 | ) | |||
| Total stockholders’ deficit | (166,152 | ) | (127,787 | ) | |||
| Total liabilities and stockholders’ deficit | $ | 157,321 | $ | 183,869 | |||
Paratek Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Product revenue, net | $ | 25,455 | $ | 19,432 | $ | 70,455 | $ | 85,441 | |||||||
| Government contract service revenue | 2,060 | 1,467 | 6,128 | 4,553 | |||||||||||
| Government contract grant revenue | 2,368 | 3,011 | 6,550 | 6,712 | |||||||||||
| Collaboration and royalty revenue | 330 | 537 | 1,578 | 1,659 | |||||||||||
| Net revenue | $ | 30,213 | $ | 24,447 | $ | 84,711 | $ | 98,365 | |||||||
| Expenses: | |||||||||||||||
| Cost of product revenue | 4,372 | 4,289 | 12,744 | 16,817 | |||||||||||
| Research and development | 8,486 | 7,920 | 23,555 | 19,977 | |||||||||||
| Selling, general and administrative | 33,846 | 25,955 | 91,784 | 75,420 | |||||||||||
| Total operating expenses | 46,704 | 38,164 | 128,083 | 112,214 | |||||||||||
| Income (loss) from operations | (16,491 | ) | (13,717 | ) | (43,372 | ) | (13,849 | ) | |||||||
| Other income and expenses: | |||||||||||||||
| Interest income | 186 | 25 | 425 | 61 | |||||||||||
| Interest expense | (4,536 | ) | (4,367 | ) | (13,561 | ) | (13,019 | ) | |||||||
| Other gains (losses), net | (39 | ) | (143 | ) | 99 | (24 | ) | ||||||||
| Net income (loss) | $ | (20,880 | ) | $ | (18,202 | ) | $ | (56,409 | ) | $ | (26,831 | ) | |||
| Other comprehensive income (loss) | |||||||||||||||
| Unrealized gain (loss) on available-for-sale securities, net of tax | 116 | — | (108 | ) | (4 | ) | |||||||||
| Comprehensive income (loss) | $ | (20,764 | ) | $ | (18,202 | ) | $ | (56,517 | ) | $ | (26,835 | ) | |||
| Basic and diluted net loss per common share | $ | (0.38 | ) | $ | (0.37 | ) | $ | (1.05 | ) | $ | (0.56 | ) | |||
| Weighted average common stock outstanding | |||||||||||||||
| Basic | 55,166,491 | 49,213,986 | 53,933,408 | 47,676,365 | |||||||||||
