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.
Recent Highlights
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
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, 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.
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 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.
Condensed Consolidated Balance
Sheets(unaudited)(in
thousands)
|
|
As of March 31, |
|
|
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Cash, cash equivalents and
marketable securities |
$ |
45,026 |
|
|
$ |
34,248 |
|
Total assets |
|
150,828 |
|
|
|
172,538 |
|
Working capital |
|
78,269 |
|
|
|
99,454 |
|
Total current liabilities |
|
32,745 |
|
|
|
37,388 |
|
Long-term debt |
|
257,695 |
|
|
|
256,946 |
|
Common stock and additional
paid-in capital |
|
761,554 |
|
|
|
759,407 |
|
Accumulated deficit |
|
(950,592 |
) |
|
|
(930,449 |
) |
Total stockholders'
deficit |
|
(189,038 |
) |
|
|
(171,042 |
) |
|
|
|
|
Condensed Consolidated Statement of
Operations(unaudited)(in
thousands, except loss per share data)
|
Three Months EndedMarch 31, |
|
|
2023 |
|
|
|
2022 |
|
Product revenue, net |
$ |
26,213 |
|
|
$ |
19,918 |
|
Government contract service
revenue |
|
1,806 |
|
|
|
2,172 |
|
Government contract grant
revenue |
|
2,028 |
|
|
|
2,099 |
|
Collaboration and royalty
revenue |
|
1,189 |
|
|
|
672 |
|
Net revenue |
$ |
31,236 |
|
|
$ |
24,861 |
|
Expenses: |
|
|
|
|
|
|
|
Cost of product revenue |
|
6,244 |
|
|
|
3,494 |
|
Research and development |
|
7,308 |
|
|
|
7,478 |
|
Selling, general and administrative |
|
33,489 |
|
|
|
27,602 |
|
Total operating expenses |
|
47,041 |
|
|
|
38,574 |
|
Loss from operations |
|
(15,805 |
) |
|
|
(13,713 |
) |
Other income and
expenses: |
|
|
|
|
|
|
|
Interest income |
|
221 |
|
|
|
107 |
|
Interest expense |
|
(4,476 |
) |
|
|
(4,479 |
) |
Other (losses) gains, net |
|
(22 |
) |
|
|
175 |
|
Net loss before provision for
income taxes |
$ |
(20,082 |
) |
|
$ |
(17,910 |
) |
Provision for income taxes |
|
(61 |
) |
|
|
— |
|
Net loss |
|
(20,143 |
) |
|
|
(17,910 |
) |
Other comprehensive
(loss) |
|
|
|
|
|
|
|
Unrealized (loss) on available-for-sale securities, net of tax |
|
— |
|
|
|
(171 |
) |
Comprehensive loss |
$ |
(20,143 |
) |
|
$ |
(18,081 |
) |
Basic and diluted net loss per common share |
$ |
(0.35 |
) |
|
$ |
(0.35 |
) |
Weighted average common stock
outstanding |
|
|
|
|
|
|
|
Basic |
|
56,903,420 |
|
|
|
52,149,538 |
|
Diluted |
|
56,903,420 |
|
|
|
52,149,538 |
|
|
|
|
|
|
|
|
|
CONTACT:
Investor Relations:Hans
VitzthumLifeSci
Advisorsir@ParatekPharma.comPhone: 617-430-7578
Media:Christine FanelleScient
PRChristine@scientpr.comPhone: 215-595-5211
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