Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), (“Paratek” or “the
Company”), a commercial-stage biopharmaceutical company focused on
the development and commercialization of novel life-saving
therapies for life-threatening diseases and other public health
threats for civilian, government and military use, today reported
financial results and provided an update on corporate activities
for the second quarter ended June 30, 2023.
Recent Highlights
- BARDA Contract
Modification: The Company executed a modification to its
Project BioShield contract with the Biomedical Advanced Research
and Development Authority (“BARDA”), part of the Administration for
Strategic Preparedness and Response (“ASPR”) within the U.S.
Department of Health and Human Services, in July 2023.
- BARDA and Paratek have agreed the
next procurement of NUZYRA anthrax treatment courses will be split
into two equal procurements based on the achievement of specific
development milestones toward both treatment and post-exposure
prophylaxis (“PEP”) indications of pulmonary anthrax.
- The first of these procurements will
be triggered by the delivery of positive top-line data from a
dose-ranging efficacy study for PEP of inhalation anthrax in
non-human primates (“NHPs”). The company expects this data to be
available in the first quarter of 2024.
- The second of these procurements
will be triggered by BARDA's receipt of positive top-line data from
a combination of two studies, a dose-ranging efficacy study in NHPs
and a pivotal efficacy study in rabbits for the treatment of
inhalation anthrax, which the company anticipates could be
available as early as the fourth quarter of 2024.
- Non-Tuberculous Mycobacteria
(“NTM”) Rare Disease Program: The Company announced that
the European Medicines Agency (“EMA”) Committee for Orphan
Medicinal Products (“COMP”) recommended a positive opinion for
orphan medicinal product designation for NUZYRA for the treatment
of NTM lung disease in June 2023. The European Commission
officially designated NUZYRA as an orphan medicinal product in July
2023.
Second Quarter 2023 Financial Results
Total revenue for the second quarter of 2023 was $40.0 million
compared to $29.6 million for the same period in the prior year.
Total revenue for the second quarter of 2023 was comprised of the
following:
- NUZYRA net U.S. sales of $33.8
million, which represented a 35% increase from $25.1 million for
the same period in the prior year.
- Government contract service and
grant revenue earned from cost reimbursement under the BARDA
contract of $5.6 million, a 40% increase from $4.0 million for the
same period in the prior year.
- Collaboration and royalty revenue of
$0.6 million, consistent with $0.6 million for the same period in
the prior year, both of which primarily represent 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 $8.8 million
for the second quarter of 2023, compared to $7.6 million for the
same period in the prior year.
Selling, general and administrative (“SG&A”) expenses were
$36.3 million for the second quarter of 2023, compared to $30.3
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 potential acquisition of Paratek by Gurnet Point and Novo
Holdings.
Paratek reported a net loss of $14.6 million, or $(0.25) per
share, for the second quarter of 2023, compared to a net loss of
$17.7 million, or $(0.33) per share, for the same period in the
prior year.
Paratek had cash and cash equivalents of $42.7 million as of
June 30, 2023. Based upon the Company’s current operating plan, if
it is unable to consummate the merger with Gurnet Point and Novo
Holdings, as described below, there is substantial doubt about the
Company’s ability to operate as a going concern.
Proposed Gurnet Point Capital and Novo Holdings A/S
Transaction
On June 6, 2023, Paratek announced it entered into a definitive
agreement to be acquired by Gurnet Point Capital ("Gurnet Point")
and Novo Holdings A/S ("Novo Holdings") in a transaction valued at
approximately $462 million, including the assumption of debt and
assuming full payment of a Contingent Value Right (“CVR”). Debt
financing of $175 million for this transaction will be provided by
funds managed by Oaktree Capital Management, L.P.
Under the terms of the merger agreement, Gurnet Point, a leading
healthcare investment firm, and Novo Holdings, a holding and
investment company responsible for managing the assets and wealth
of the Novo Nordisk Foundation, will acquire all outstanding shares
of Paratek for $2.15 per share in cash at close, plus a CVR of
$0.85 per share payable upon the achievement of $320 million in
U.S. NUZYRA net sales (excluding certain permitted deductions,
payments under Paratek's contract with ASPR-BARDA, certain
government payments and certain royalty revenue) in any calendar
year ending on or prior to December 31, 2026.
The transaction, which the Paratek Board of Directors has
unanimously approved, is expected to close in the third quarter of
2023, subject to customary closing conditions, including approval
by Paratek shareholders and receipt of regulatory approvals.
Following completion, Paratek will become a private company and
will no longer be subject to the reporting requirements of the
Securities Exchange Act of 1934, as amended, nor be traded on
Nasdaq Global Market.
Due to the pending transaction, Paratek will not host a
conference call to discuss its quarterly financial results or
comment on its financial guidance for the year ending December 31,
2023.
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 the expected timing of closing of our sale to
Gurnet Point and Novo Holdings, 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 NTM development program, and our ability to operate
as a going concern.
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 June 30, |
|
|
|
December 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
Cash, cash equivalents and
marketable securities |
|
$ |
42,685 |
|
|
$ |
34,248 |
|
Total assets |
|
|
145,792 |
|
|
|
172,538 |
|
Working capital |
|
|
(97,392 |
) |
|
|
99,454 |
|
Total current liabilities |
|
|
202,619 |
|
|
|
37,388 |
|
Long-term debt |
|
|
94,285 |
|
|
|
256,946 |
|
Common stock and additional
paid-in capital |
|
|
763,780 |
|
|
|
759,407 |
|
Accumulated deficit |
|
|
(965,145 |
) |
|
|
(930,449 |
) |
Total stockholders'
deficit |
|
|
(201,365 |
) |
|
|
(171,042 |
) |
Condensed
Consolidated Statement of Operations(unaudited)(in
thousands, except loss per share data) |
|
Three Months EndedJune 30, |
Six Months EndedJune 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Product revenue, net |
$ |
33,800 |
|
$ |
25,082 |
|
$ |
60,013 |
|
$ |
45,000 |
|
Government contract service revenue |
|
3,620 |
|
|
1,896 |
|
|
5,301 |
|
|
4,068 |
|
Government contract grant revenue |
|
1,931 |
|
|
2,082 |
|
|
4,084 |
|
|
4,182 |
|
Collaboration and royalty revenue |
|
642 |
|
|
577 |
|
|
1,831 |
|
|
1,248 |
|
Net revenue |
$ |
39,993 |
|
$ |
29,637 |
|
$ |
71,229 |
|
$ |
54,498 |
|
Expenses: |
|
|
|
|
Cost of product revenue |
|
4,368 |
|
|
4,878 |
|
|
10,612 |
|
|
8,372 |
|
Research and development |
|
8,772 |
|
|
7,592 |
|
|
16,080 |
|
|
15,069 |
|
Selling, general and administrative |
|
36,264 |
|
|
30,335 |
|
|
69,753 |
|
|
57,937 |
|
Total operating expenses |
|
49,404 |
|
|
42,805 |
|
|
96,445 |
|
|
81,378 |
|
Loss from operations |
|
(9,411 |
) |
|
(13,168 |
) |
|
(25,216 |
) |
|
(26,880 |
) |
Other income and expenses: |
|
|
|
|
Interest income |
|
252 |
|
|
133 |
|
|
473 |
|
|
240 |
|
Interest expense |
|
(5,287 |
) |
|
(4,546 |
) |
|
(9,763 |
) |
|
(9,025 |
) |
Other (losses) gains, net |
|
(56 |
) |
|
(38 |
) |
|
(78 |
) |
|
138 |
|
Net loss before provision for income taxes |
$ |
(14,502 |
) |
$ |
(17,619 |
) |
$ |
(34,584 |
) |
$ |
(35,527 |
) |
Provision for income taxes |
|
(51 |
) |
|
— |
|
|
(111 |
) |
|
— |
|
Net loss |
|
(14,553 |
) |
|
(17,619 |
) |
|
(34,695 |
) |
|
(35,527 |
) |
Other comprehensive (loss) |
|
|
|
|
Unrealized (loss) on available-for-sale securities, net of tax |
|
— |
|
|
(53 |
) |
|
— |
|
|
(224 |
) |
Comprehensive loss |
$ |
(14,553 |
) |
$ |
(17,672 |
) |
$ |
(34,695 |
) |
$ |
(35,751 |
) |
Basic and diluted net loss per common share |
$ |
(0.25 |
) |
$ |
(0.33 |
) |
$ |
(0.61 |
) |
$ |
(0.67 |
) |
Weighted average common stock outstanding |
|
|
|
|
Basic |
|
57,282,239 |
|
|
53,023,350 |
|
|
57,093,876 |
|
|
53,310,091 |
|
Diluted |
|
57,282,239 |
|
|
53,023,350 |
|
|
57,093,876 |
|
|
53,310,091 |
|
|
|
|
|
|
CONTACT:
Investor Relations:PJ KelleherLifeSci
Advisorsir@ParatekPharma.comPhone: 617-430-7579Media:Christine
FanelleScient PRChristine@scientpr.comPhone: 215-595-5211
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