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 quarter ended June 30, 2020.
“Demand for NUZYRA was strong in the first half of
2020 with the momentum continuing into the third quarter,” said
Evan Loh, M.D., Chief Executive Officer. “I am particularly pleased
that these results were achieved despite a healthcare environment
where the unprecedented global pandemic temporarily closed many
healthcare practices and eliminated essentially all face to face
access for our sales representatives. Our results reinforce our
continued belief and confidence that NUZYRA is well-positioned to
help address current and future unmet medical needs at a time when
antibiotic resistance is a growing global threat.”
“BARDA and Paratek continue to effectively execute
on the anthrax development program and U.S. onshoring activities
for NUZYRA,” Dr. Loh continued. “The FDA review of the
pre-EUA application remains ongoing and BARDA continues to be fully
committed to procuring NUZYRA for the Strategic National Stockpile
once the FDA review process is completed. We
appreciate BARDA’s confidence in Paratek and their
significant investment in this innovative, long-term public-private
partnership for the development of NUZYRA in the fight
against bioterrorism and antimicrobial resistance in
order to save lives and protect Americans.”
Recent NUZYRA Commercial
Highlights
- NUZYRA generated $8.1 million in net revenue in the second
quarter of 2020, an 11% increase over the prior quarter and 378%
increase over the second quarter of 2019. NUZYRA revenue
growth continues to validate the Company’s initial launch strategy
with 90% of demand being generated from hospitals and adjacent
sites of care.
Other Highlights
- The initial NUZYRA procurement by Biomedical Advanced Research
and Development Authority (BARDA) for the Strategic National
Stockpile (SNS) valued at approximately $38 million is now
anticipated to be secured by year end 2020.
° The Food and Drug
Administration (FDA) review of the pre-Emergency Use Authorization
(pre-EUA) application, which was submitted in February, remains
ongoing. The Company believes the review was delayed due to
internal resourcing at FDA caused by the COVID-19 pandemic and
other review priorities at FDA unrelated to NUZYRA. As part
of the ongoing review, FDA has requested supplemental mouse
pharmacokinetic data to support the human dose recommendation in
case of an immediate anthrax outbreak. This work has been initiated
and expected to be completed in 8 to 10 weeks.
- In July 2020, the supplemental NDA to support an oral-only
dosing label for Community-Acquired Bacterial Pneumonia (CABP) was
submitted to FDA with an approval expected during the 2020-2021
pneumonia season.
- In August 2020, Paratek modified its outstanding loan agreement
with Hercules Capital.
° Under the terms of the
agreement, Paratek repaid $10 million of the principal $70 million
loan balance reducing the outstanding loan to $60
million. ° The interest-only period under the new loan
agreement is now extended through December 2021, with further
extension of the interest-only period of up to an additional 12
months, contingent on Paratek achieving certain performance-based
milestones.
Second
Quarter 2020 Financial Results Paratek reported a
net loss of $23.1 million, or ($0.53) per share, for the
second quarter of 2020, compared to a net loss of
$33.2 million, or ($1.02) per share, for the same period in
2019.
Total revenue was $9.3 million for the second
quarter of 2020, an increase of 18% versus the prior quarter and
356% versus the same quarter in the prior year.
- U.S. NUZYRA net revenue of $8.1 million for the second quarter
of 2020 grew 11% versus the prior quarter and 378% versus the same
quarter in the prior year.
- Government contract service and grant revenue was $0.9 million
for the second quarter of 2020 versus $0.3 million in the prior
quarter. No revenue was generated from the BARDA contract in
2019.
- Second quarter 2020 collaboration and royalty revenue was $0.3
million, which is consistent with both the prior quarter and the
same quarter in prior year.
Research and development (R&D) expenses were
$4.6 million for the second quarter of 2020, compared to $10.7
million for the second quarter of 2019. The $6.1 million decrease
is primarily the result of lower personnel-related costs, lower
clinical study costs associated with our Phase 2 UTI program and
other operational efficiencies.
Selling, general and administrative (SG&A)
expenses were $21.0 million for the second quarter of 2020,
compared to $20.9 million for the second quarter of
2019.
As of June 30, 2020, Paratek had $186.8 million in
cash, cash equivalents and marketable securities.
Financial GuidanceParatek is
raising its full year 2020 revenue guidance primarily based on the
stronger than anticipated U.S. NUZYRA net product revenue modestly
offset by lower than anticipated royalty revenue from SEYSARA.
- Paratek now estimates 2020 total revenue to
be between $78 and $83 million, an increase
from our prior guidance of $75 and $80
million.
° The Company now
anticipates the initial BARDA procurement of 2,500 anthrax
treatment courses valued at approximately $38 million to occur by
the end of 2020 contingent on the completion of the pre-EUA
application review by FDA.
- 2020 R&D and SG&A expense is now expected to be
approximately $135 million compared to the prior guidance of $140
million, driven by an increased focus on operational efficiencies
and other favorability driven by the COVID-19 pandemic.
Excluding the BARDA R&D and onshoring cost reimbursement,
R&D and SG&A expense is expected to be modestly lower when
compared to 2019.
° Based upon our current
operating plan, which includes estimated NUZYRA U.S. product
revenue and cost reimbursement under the BARDA contract, we
anticipate that our existing cash, cash equivalents and marketable
securities of $186.8 million, as of June 30, 2020, provide for a
cash runway through the end of 2023 with a pathway to cash flow
break even. This anticipated pathway assumes the Company will be
able to fund all company operating expenses, anticipated
capital expenditures, and debt service, including repayment in full
of the Hercules Loan and Security Agreement.
Company performance and unanticipated events could
cause actual results to vary from this forward-looking
guidance.
Call and WebcastParatek’s earnings
conference call for the quarter ended June 30, 2020 will be
broadcast at 8:30 a.m. EDT on August 10, 2020. The live 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: 888-256-1007 and international investors should
dial: 323-994-2093. The conference ID is 8856661. Investors can
also access the call at
http://public.viavid.com/index.php?id=141013.
Website InformationParatek
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 U.S. for the treatment of
adults with community-acquired bacterial pneumonia and acute
bacterial skin and skin structure infections. 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 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 (Almirall). Paratek
retains the development and commercialization rights for
sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from
BARDA to support the development of NUZYRA for the treatment
of pulmonary anthrax.
For more information,
visit www.ParatekPharma.com or follow
@ParatekPharma on Twitter.
Forward Looking StatementsThis
press release contains forward-looking statements including
statements related to our overall strategy, products, prospects,
potential and expected results, including statements about the
impact of the COVID-19 pandemic on our revenue projections, supply
chain and clinical trials, projected awareness, payor coverage, net
product revenues, total revenues including assumptions related to
our financial guidance, the financial impact of our BARDA contract
including the status of the FDA review of the pre-EUA application,
the status of our supplemental mouse pharmacokinetic data to
support the human dose recommendation, the timing and exercise of
BARDA’s procurement of NUZYRA for the SNS, BARDA exercising full
contract line items, including for U.S. onshoring and PMR
reimbursement, our anticipated cash runway, our operating expenses,
our SEYSARA royalties and SEYSARA -backed loan funded on May 1,
2019, the strategy, execution and progression of our commercial
launch of NUZYRA, our ability to shape the future treatment
paradigm for community-acquired pneumonia and serious skin
infections, our plans to evaluate additional indications for
NUZYRA, including NTM, and to work toward an oral-only indication
in CABP, future governmental stockpiling opportunities, and our
potential to further drive long-term value for all of our
shareholders. 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, 2019 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)
|
|
June 30, 2020 |
|
|
December 31, 2019 |
|
Cash, cash equivalents and marketable securities |
|
$ |
186,818 |
|
|
$ |
215,379 |
|
Total assets |
|
|
227,126 |
|
|
|
251,079 |
|
Working capital |
|
|
188,278 |
|
|
|
219,154 |
|
Total current liabilities |
|
|
33,925 |
|
|
|
24,200 |
|
Long-term debt, less current
portion |
|
|
251,586 |
|
|
|
260,728 |
|
Common stock and additional
paid-in capital |
|
|
698,222 |
|
|
|
671,537 |
|
Accumulated deficit |
|
|
(761,934 |
) |
|
|
(711,258 |
) |
Total stockholders’
deficit |
|
|
(63,458 |
) |
|
|
(39,647 |
) |
Condensed Consolidated Statements of
Operations (unaudited) (in
thousands, except loss per share data)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
June 30, |
June 30, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Product revenue, net |
|
$ |
8,133 |
|
|
$ |
1,702 |
|
|
$ |
15,436 |
|
|
$ |
3,049 |
|
Government contract service
revenue |
|
|
439 |
|
|
|
— |
|
|
|
775 |
|
|
|
— |
|
Government contract grant
revenue |
|
|
437 |
|
|
|
— |
|
|
|
437 |
|
|
|
— |
|
Collaboration and royalty
revenue |
|
|
317 |
|
|
|
343 |
|
|
|
597 |
|
|
|
594 |
|
Net revenue |
|
$ |
9,326 |
|
|
$ |
2,045 |
|
|
$ |
17,245 |
|
|
$ |
3,643 |
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue |
|
|
2,236 |
|
|
|
567 |
|
|
|
3,707 |
|
|
|
773 |
|
Research and development |
|
|
4,561 |
|
|
|
10,679 |
|
|
|
10,949 |
|
|
|
22,071 |
|
Selling, general and administrative |
|
|
20,975 |
|
|
|
20,920 |
|
|
|
44,613 |
|
|
|
44,238 |
|
Total operating expenses |
|
|
27,772 |
|
|
|
32,166 |
|
|
|
59,269 |
|
|
|
67,082 |
|
Loss from operations |
|
|
(18,446 |
) |
|
|
(30,121 |
) |
|
|
(42,024 |
) |
|
|
(63,439 |
) |
Other income and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
363 |
|
|
|
935 |
|
|
|
1,067 |
|
|
|
1,881 |
|
Interest expense |
|
|
(4,971 |
) |
|
|
(3,991 |
) |
|
|
(9,797 |
) |
|
|
(7,217 |
) |
Other gains (losses), net |
|
|
(5 |
) |
|
|
(24 |
) |
|
|
78 |
|
|
|
(36 |
) |
Net loss |
|
$ |
(23,059 |
) |
|
$ |
(33,201 |
) |
|
$ |
(50,676 |
) |
|
$ |
(68,811 |
) |
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale securities, net of
tax |
|
|
(217 |
) |
|
|
144 |
|
|
|
180 |
|
|
|
344 |
|
Comprehensive loss |
|
$ |
(23,276 |
) |
|
$ |
(33,057 |
) |
|
$ |
(50,496 |
) |
|
$ |
(68,467 |
) |
Basic and diluted net loss per common share |
|
$ |
(0.53 |
) |
|
$ |
(1.02 |
) |
|
$ |
(1.19 |
) |
|
$ |
(2.12 |
) |
Weighted average common stock
outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
43,629,836 |
|
|
|
32,446,202 |
|
|
|
42,635,520 |
|
|
|
32,390,691 |
|
Investor and Media Relations: Ben Strain
617-807-6688 ir@ParatekPharma.com
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