Paratek Pharmaceuticals, Inc., reported financial results and provided an update on corporate activities for the quarter ended June 30, 2022.
- NUZYRA® (omadacycline) Generated Net U.S. Sales of $25.1 Million from the Core Commercial Business, a 68% increase over Second Quarter 2021
- Company Reiterates Full Year 2022 Financial Guidance
BOSTON, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), today reported financial results and provided an update on corporate activities for the quarter ended June 30, 2022.
“The strong year-over-year growth of NUZYRA’s core commercial business is a result of accelerating product demand and the disciplined execution of our community sales force expansion, which was initiated in the first quarter of 2021,” said Evan Loh, M.D., chief executive officer at Paratek. “We expect demand trends for NUZYRA will continue through the end of the year. We are pleased with the improved access to physicians and the breadth of NUZYRA’s commercial and government payer access, resulting in strong performance in both the hospital and community settings. Based on our results to date, we reiterate our full-year 2022 financial guidance.”
Recent Highlights
- Expansion of NUZYRA’s Core Commercial Business in the Primary Care Setting: The second wave of expansion into the community, which includes an increase in the number of sales representatives, medical science liaisons, and territories covered in the primary care setting, is ongoing and anticipated to be completed by the end of 2022.
- FDA Grants Fast Track Designation for the Treatment of Non-Tuberculous Mycobacteria (NTM), including both Mycobacterium abscessus and Mycobacteriumavium Complex: The Fast Track designation further validates the unmet need, allows for more frequent dialogue with the FDA and creates the opportunity to expedite development of NUZYRA as an option to help patients with NTM.
- Progress of the BARDA Project BioShield Anthrax Program: The company has continued to execute on its contractual deliverables to develop NUZYRA through the animal rule for both the treatment and post-exposure prophylaxis of pulmonary anthrax. In addition, the onshoring of tablet manufacturing and validation are complete, with commercial availability of U.S.-based NUZYRA tablets anticipated in the second half of this year.
- Expansion of NUZYRA Scientific Exchange to Primary Care Providers: A supplement to the Journal of Family Practice, focused on NUZYRA’s role in the treatment of serious skin infections and pneumonia, was published in June and delivered to over 100,000 primary care and family medicine providers. The supplement, funded by Paratek, is also available electronically and can be accessed through the following link: https://cdn.mdedge.com/files/s3fs-public/sf322107_mdedge_jfp_paretek_v6kb.pdf.
Financial Results
Total revenue for the second quarter of 2022 was $29.6 million compared to $19.6 million for the same period in the prior year when excluding the first procurement of NUZYRA under the BARDA contract of $37.9 million. Revenue earned in the second quarter of 2022 was comprised of $25.1 million in net U.S. sales from the NUZYRA core commercial business, a 68% increase from $14.9 million for the same period in the prior year, $4.0 million in revenue earned under the BARDA contract, and $0.6 million in royalty revenue.
Research and development (R&D) expenses were $7.6 million for the second quarter of 2022, compared to $6.5 million for the same period in the prior year. The increase in R&D expenses was primarily the result of costs incurred for analytical testing and other non-clinical studies.
Selling, general and administrative (SG&A) expenses were $30.3 million for the second quarter of 2022, compared to $27.1 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 $17.6 million, or $(0.33) per share, and net income of $9.7 million, or $0.20 per share, for the second quarter of 2022 and 2021, respectively.
Based upon the company’s current operating plan, Paratek anticipates its existing cash, cash equivalents and marketable securities of $69.4 million as of June 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 June 30, 2022, will be broadcast at 4:30 p.m. ET on August 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 877-300-8521 and international investors should dial +1-412-317-6026. The conference ID is 10169245. Investors can also access the call at https://viavid.webcasts.com/starthere.jsp?ei=1559934&tp_key=28146cfe9f
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 of omadacycline for pulmonary anthrax and the U.S.-based commercial manufacturing of NUZYRA.
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, full year financial and revenue projections, expected demand trends for NUZYRA, the status of our Phase 2b NTM abscessus study and the potential market opportunity of NTM, 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 expected timing of U.S. based tablet production, 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)
| June 30, 2022 |
December 31, 2021 |
||||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 39,505 | $ | 80,367 | |||
| Marketable securities | 29,886 | 15,107 | |||||
| Restricted cash | — | 125 | |||||
| Accounts receivable, net | 28,521 | 29,438 | |||||
| Inventories | 13,083 | 11,020 | |||||
| Other receivables | 3,297 | 3,679 | |||||
| Prepaid and other current assets | 13,476 | 12,364 | |||||
| Total current assets | 127,768 | 152,100 | |||||
| Long-term restricted cash | 125 | 125 | |||||
| Fixed assets, net | 712 | 794 | |||||
| Goodwill | 829 | 829 | |||||
| Right-of-use assets | 1,352 | 1,757 | |||||
| Long-term inventories | 32,662 | 27,767 | |||||
| Other long-term assets | 247 | 497 | |||||
| Total assets | $ | 163,695 | $ | 183,869 | |||
| Liabilities and Stockholders’ Deficit | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 2,257 | $ | 5,394 | |||
| Accrued expenses | 25,661 | 23,446 | |||||
| Other current liabilities | 2,182 | 2,457 | |||||
| Total current liabilities | 30,100 | 31,297 | |||||
| Long-term debt | 257,153 | 254,428 | |||||
| Long-term lease liabilities | 854 | 1,308 | |||||
| Accrued long-term compensation | 22,339 | 21,846 | |||||
| Other liabilities | 2,616 | 2,777 | |||||
| Total liabilities | $ | 313,062 | $ | 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; 54,778,638 shares issued and outstanding as of June 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 | 753,223 | 739,053 | |||||
| Accumulated other comprehensive income | (233 | ) | (9 | ) | |||
| Accumulated deficit | (902,412 | ) | (866,883 | ) | |||
| Total stockholders’ deficit | (149,367 | ) | (127,787 | ) | |||
| Total liabilities and stockholders’ deficit | $ | 163,695 | $ | 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 June 30, |
Six Months Ended June 30, |
||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Product revenue, net | $ | 25,082 | $ | 52,803 | $ | 45,000 | $ | 66,009 | |||||||
| Government contract service revenue | 1,896 | 2,113 | 4,068 | 3,086 | |||||||||||
| Government contract grant revenue | 2,082 | 2,087 | 4,182 | 3,701 | |||||||||||
| Collaboration and royalty revenue | 577 | 489 | 1,248 | 1,123 | |||||||||||
| Net revenue | $ | 29,637 | $ | 57,492 | $ | 54,498 | $ | 73,919 | |||||||
| Expenses: | |||||||||||||||
| Cost of product revenue | 4,878 | 9,778 | 8,372 | 12,529 | |||||||||||
| Research and development | 7,592 | 6,519 | 15,069 | 12,057 | |||||||||||
| Selling, general and administrative | 30,335 | 27,106 | 57,937 | 49,465 | |||||||||||
| Total operating expenses | 42,805 | 43,403 | 81,378 | 74,051 | |||||||||||
| Income (loss) from operations | (13,168 | ) | 14,089 | (26,880 | ) | (132 | ) | ||||||||
| Other income and expenses: | |||||||||||||||
| Interest income | 133 | 11 | 240 | 36 | |||||||||||
| Interest expense | (4,546 | ) | (4,344 | ) | (9,025 | ) | (8,651 | ) | |||||||
| Other gains (losses), net | (38 | ) | (39 | ) | 138 | 118 | |||||||||
| Net income (loss) | $ | (17,619 | ) | $ | 9,717 | $ | (35,527 | ) | $ | (8,629 | ) | ||||
| Other comprehensive income (loss) | |||||||||||||||
| Unrealized gain (loss) on available-for-sale securities, net of tax | (53 | ) | — | (224 | ) | (4 | ) | ||||||||
| Comprehensive income (loss) | $ | (17,672 | ) | $ | 9,717 | $ | (35,751 | ) | $ | (8,633 | ) | ||||
| Basic and diluted net loss per common share | $ | (0.33 | ) | $ | 0.20 | $ | (0.67 | ) | $ | (0.18 | ) | ||||
| Weighted average common stock outstanding | |||||||||||||||
| Basic | 53,023,350 | 47,122,717 | 53,310,091 | 46,894,812 | |||||||||||
| Diluted | 53,023,350 | 48,945,736 | 53,310,091 | 46,894,812 | |||||||||||
