-- NUZYRA® (omadacycline) Generated Net U.S. Sales of $19.9 Million from the Core Commercial Business, a 51% Increase over First Quarter 2021
-- Omadacycline Demonstrated Potent In Vitro Efficacy Against Mycobacterium Avium Complex (MAC) in a Hollow Fiber Model
BOSTON, May 04, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today reported financial results and provided an update on corporate activities for the quarter ended March 31, 2022.
“Our commercial execution continues to be strong, as demonstrated by the 51% year-over-year first quarter growth from the core NUZYRA commercial business. As the Omicron wave receded, we experienced accelerated product demand through the end of the first quarter that has continued into the second quarter. This growing momentum is being driven by improved access to physicians in the hospital and community settings, a resurgence of elective surgeries, and satisfaction of annual insurance deductible resets. Based on current performance, we are reiterating our full year 2022 guidance,” said Evan Loh, M.D., chief executive officer at Paratek. “We remain excited about the progress of our NTM development program, including the hollow fiber efficacy data demonstrated in MAC, as it supports further study of NUZYRA in this important chronic, rare and life-threatening pulmonary disease.”
Recent Highlights
- Further Expansion of NUZYRA into Primary Care: Based on the continued success and progress of the company’s community expansion, Paratek has begun to increase the number of sales representatives, medical science liaisons and territories covered in the primary care setting in 2022.
- Significant Increase in NUZYRA Access for Patients: NUZYRA was recently added to three national Medicare formularies, which significantly increases the number of Medicare beneficiaries covered to nearly 60% nationwide. We now believe NUZYRA to be one of the most accessible branded, oral antibiotics with limited or no restrictions, across both commercially insured and Medicare patient populations.
- NTM Rare Disease Development Program: Enrollment in a Phase 2b study is progressing as planned. This study explores the potential utility of omadacycline as a treatment for non-tuberculous mycobacteria (NTM) pulmonary infections due to Mycobacterium abscessus, a rare disease with currently no approved therapies, that the company estimates represent a potential $1 billion addressable market opportunity in the United States. Important to NTM clinicians, an investigator-initiated study has demonstrated potent in vitro activity of omadacycline in a hollow fiber model against MAC, which represents a larger segment of NTM pulmonary disease.
- Continued Progress of the Expanded BARDA Project BioShield Anthrax Program: The company continued to execute and deliver on its contract with BARDA to develop NUZYRA for both the treatment and post-exposure prophylaxis 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, with commercial tablets being available by the end of 2022, and planning for animal pharmacokinetic and pilot efficacy studies to support the pulmonary anthrax development program.
Financial Results
Total revenue was $24.9 million for the first quarter of 2022, a 51% increase from $16.4 million for the same period in the prior year. Total revenue for the first quarter of 2022 was comprised of the following:
- NUZYRA generated net U.S. sales of $19.9 million, a 51% increase from $13.2 million for the same period in the prior year.
- Government contract service and grant revenue earned from cost reimbursement under the BARDA contract was $4.3 million, a 65% increase from $2.6 million for the same period in the prior year.
- Collaboration and royalty revenue of $0.7 million, which primarily represents royalty revenues earned on sales of SEYSARA® (sarecycline) in the United States and the initiation of sales of NUZYRA in China.
Research and development (R&D) expenses were $7.5 million for the first quarter of 2022, compared to $5.5 million for same period in the prior year. The increase in R&D expenses 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 $27.6 million for the first quarter of 2022, compared to $22.4 million for same period in the prior year. The increase in SG&A expenses was primarily the result of compensation expense and costs incurred for the NUZYRA community expansion.
Paratek reported a net loss of $17.9 million, or $(0.35) per share, and $18.4 million, or $(0.39) per share, for the first 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 $79.1 million as of March 31, 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 March 31, 2022, will be broadcast at 4:30 p.m. ET on May 4. The live audio webcast can be accessed under "Events and Presentations" on 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 10166263. Investors can also access the call at https://viavid.webcasts.com/starthere.jsp?ei=1544521&tp_key=032cf0cb7c.
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, the exercise and timing of BARDA's future procurements of NUZYRA for the SNS, the expected timing of certain regulatory decisions, the status of our 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 including into the community, our expectation to continue to execute and deliver on our BARDA contract including the expansion of our anthrax development program for prophylaxis, 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:
For Investors:
Hans Vitzthum
LifeSci Advisors
ir@ParatekPharma.com
Phone: 617-430-7578
For 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)
|
March 31,
2022 |
|
December 31,
2021 |
| Assets |
|
|
|
| Current assets |
|
|
|
| Cash and cash equivalents |
$ |
49,033 |
|
|
$ |
80,367 |
|
| Marketable securities |
|
30,020 |
|
|
|
15,107 |
|
| Restricted cash |
|
250 |
|
|
|
125 |
|
| Accounts receivable, net |
|
24,739 |
|
|
|
29,438 |
|
| Inventories |
|
12,732 |
|
|
|
11,020 |
|
| Other receivables |
|
3,520 |
|
|
|
3,679 |
|
| Prepaid and other current assets |
|
12,988 |
|
|
|
12,364 |
|
| Total current assets |
|
133,282 |
|
|
|
152,100 |
|
| Long-term restricted cash |
|
125 |
|
|
|
125 |
|
| Fixed assets, net |
|
762 |
|
|
|
794 |
|
| Goodwill |
|
829 |
|
|
|
829 |
|
| Right-of-use assets |
|
1,536 |
|
|
|
1,757 |
|
| Long-term inventories |
|
32,955 |
|
|
|
27,767 |
|
| Other long-term assets |
|
668 |
|
|
|
497 |
|
| Total assets |
$ |
170,157 |
|
|
$ |
183,869 |
|
| Liabilities and Stockholders’ Deficit |
|
|
|
| Current liabilities |
|
|
|
| Accounts payable |
$ |
4,697 |
|
|
$ |
5,394 |
|
| Accrued expenses |
|
22,133 |
|
|
|
23,446 |
|
| Other current liabilities |
|
2,007 |
|
|
|
2,457 |
|
| Total current liabilities |
|
28,837 |
|
|
|
31,297 |
|
| Long-term debt |
|
255,949 |
|
|
|
254,428 |
|
| Long-term lease liabilities |
|
1,063 |
|
|
|
1,308 |
|
| Accrued long-term compensation |
|
21,893 |
|
|
|
21,846 |
|
| Other liabilities |
|
2,717 |
|
|
|
2,777 |
|
| Total liabilities |
$ |
310,459 |
|
|
$ |
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; 53,023,350 shares issued and outstanding as of March 31, 2022; and 200,000,000 shares authorized; 51,711,809 shares issued and outstanding as of December 31, 2021 |
|
53 |
|
|
|
52 |
|
| Additional paid-in capital |
|
744,618 |
|
|
|
739,053 |
|
| Accumulated other comprehensive income |
|
(180 |
) |
|
|
(9 |
) |
| Accumulated deficit |
|
(884,793 |
) |
|
|
(866,883 |
) |
| Total stockholders’ deficit |
|
(140,302 |
) |
|
|
(127,787 |
) |
| Total liabilities and stockholders’ deficit |
$ |
170,157 |
|
|
$ |
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
March 31, |
|
2022
|
|
2021
|
| Product revenue, net |
$ |
19,918 |
|
|
$ |
13,207 |
|
| Government contract service revenue |
|
2,172 |
|
|
|
973 |
|
| Government contract grant revenue |
|
2,099 |
|
|
|
1,613 |
|
| Collaboration and royalty revenue |
|
672 |
|
|
|
634 |
|
| Net revenue |
$ |
24,861 |
|
|
$ |
16,427 |
|
| Expenses: |
|
|
|
| Cost of product revenue |
|
3,494 |
|
|
|
2,751 |
|
| Research and development |
|
7,478 |
|
|
|
5,538 |
|
| Selling, general and administrative |
|
27,602 |
|
|
|
22,359 |
|
| Total operating expenses |
|
38,574 |
|
|
|
30,648 |
|
| Loss from operations |
|
(13,713 |
) |
|
|
(14,221 |
) |
| Other income and expenses: |
|
|
|
| Interest income |
|
107 |
|
|
|
25 |
|
| Interest expense |
|
(4,479 |
) |
|
|
(4,307 |
) |
| Other gains (losses), net |
|
175 |
|
|
|
157 |
|
| Net loss |
$ |
(17,910 |
) |
|
$ |
(18,346 |
) |
| Other comprehensive income (loss) |
|
|
|
| Unrealized gain (loss) on available-for-sale securities, net of tax |
|
(171 |
) |
|
|
(4 |
) |
| Comprehensive loss |
$ |
(18,081 |
) |
|
$ |
(18,350 |
) |
| Basic and diluted net loss per common share |
$ |
(0.35 |
) |
|
$ |
(0.39 |
) |
| Weighted average common stock outstanding |
|
|
|
| Basic and diluted |
|
52,149,538 |
|
|
|
46,664,374 |
|
