Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of innovative therapeutics, today reported
financial results and provided an update on corporate activities
for the quarter ended March 31, 2019.
“We are pleased with the results from the first eight weeks of
the NUZYRA launch in the United States. We have achieved several of
our early benchmarks that we believe are necessary to create a
strong foundation for long-term commercial success,” said Michael
Bigham, Chairman and Chief Executive Officer, Paratek. “The
organization is motivated and focused on the launch of NUZYRA. We
appreciate that it takes sustained effort and patience to establish
momentum for any new antibiotic in the hospital setting. To date,
our efforts have been focused on establishing a robust supply chain
and distribution channel, actively educating and building awareness
with the key stakeholders on the potential benefits NUZYRA offers
and ensuring patients have access to this potential life-saving
therapy.”
“With the U.S. launch of NUZYRA successfully underway, we
continue to pursue a number of compelling life-cycle opportunities
for NUZYRA. These include executing two phase 2 studies in UTI, for
which we expect topline data in the second half of 2019 and
exploring the potential avenues to achieve an oral-only indication
in CABP,” said Evan Loh, M.D., President, Chief Operating
Officer and Chief Medical Officer. “We believe these potential
value drivers provide opportunity to both accelerate commercial
success as well as significantly expand the accessible market. We
look forward to keeping you apprised of our progress on these
promising opportunities in the months ahead.”
First Quarter 2019 NUZYRA Commercial
Highlights
- After an early February launch, NUZYRA generated $1.3 million
in net revenues in the U.S. in its first approximately eight weeks
on the market.
- The Company estimates approximately 85% of NUZYRA revenues were
related to the initial inventory build of the oral formulation in
the channel.
- Approximately 1/3 of commercial lives in U.S. had access to
NUZYRA by the end of the first quarter 2019.
- Aided awareness with target prescribers conducted through
market research increased from 27% to 48% since launch.
- Institutional access achieved in over 50% of approximately 400
targeted institutions.
Other Recent Highlights
- Data from the NUZYRA clinical and microbiology programs were
presented at the 29th European Congress of Clinical Microbiology
& Infectious Diseases, ECCMID 2019. Nine presentations at the
congress continued to highlight the efficacy and safety profile of
NUZYRA, adding to the growing body of evidence of the therapy’s
utility against relevant pathogens and life-threatening infections
such as CABP and ABSSSI.
- Scientific team who worked on the chemistry and clinical
development programs for NUZYRA and SEYSARA™ were awarded the
American Chemical Society’s (ACS) 2019 Heroes of Chemistry
Award.
- New England Journal of Medicine (NEJM) published two
manuscripts with detailed results from the Company’s Phase 3
clinical trials (OPTIC and OASIS-1) of NUZYRA™ (omadacycline)
highlighting the potential clinical impact that NUZYRA can have on
the practice of medicine in an era of growing resistance to older
antibiotic agents.
- NUZYRA launched in the United States in February 2019 as a
once-daily oral and intravenous antibiotic for the treatment of
adults with community-acquired bacterial pneumonia (CABP) and acute
skin and skin structure infections (ABSSSI).
- In concert with the U.S. launch, three antimicrobial
susceptibility tests are now available for use with NUZYRA.
Paratek has also launched the KEYSTONE™ surveillance
program to monitor omadacycline susceptibility.
- Company received gross proceeds of $32.5 million on May 1, 2019
related to recently executed royalty-backed loan agreement with
Healthcare Royalty Partners III, L.P. (HCRP). This royalty-backed
loan agreement will be secured by and repaid from royalties
received by Paratek from the net sales of SEYSARA in the United
States by Almirall, LLC.
- The Company’s partner, Almirall, launched SEYSARA in the U.S.,
in January 2019.
First Quarter 2019 Financial Results For the
first quarter of 2019, Paratek reported a net loss of
$35.6 million, or ($1.10) per share, compared to a net loss of
$27.8 million, or ($0.91) per share, for the same period in
2018.
Revenue earned during the quarter ended March 31, 2019 was
attributable to net U.S. NUZYRA product revenue of $1.3 million and
royalty revenue of $0.3 million, which included royalties earned
from SEYSARA sales in the U.S.
Research and development expenses were $11.4 million for
the quarter ended March 31, 2019 compared to $14.9 million for
the same period in 2018. This decrease is primarily the result of
the capitalization of NUZYRA commercial supply costs, which were
classified as research and development expense until FDA approval
of NUZYRA on October 2, 2018, and lower NDA user fees due to timing
of our NDA submissions, partially offset by higher clinical study
costs associated with our Phase 2 UTI program.
Selling, general and administrative expenses were
$23.3 million for the quarter ended March 31, 2019, compared
to $11.9 million for the same period in 2018. The increase is
primarily the result of the cost of our contract sales force,
higher marketing, trade and distribution fees, and increased
salaries, benefits and other personnel-related costs in support of
the commercialization of NUZYRA.
Based upon Paratek’s current operating plan, the Company
anticipates that its existing cash, cash equivalents and marketable
securities of $257.9 million as of March 31, 2019, estimated
NUZYRA product sales, and SEYSARA royalty-backed loan with
HCRP gross proceeds of $32.5 million, which was funded on May 1,
2019, will fund company operating expenses, capital
expenditures, and debt service beyond the first quarter of
2021.
Conference Call and WebcastParatek’s earnings
conference call for the quarter ended March 31, 2019 will be
broadcast today at 4:30 p.m. EDT on May 8, 2019. 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: 877-407-0792 and international investors should
dial: 201-689-8263. The conference ID is 13690427.
Investors can also access the call
at http://public.viavid.com/index.php?id=134405.
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
innovative therapeutics. The company’s lead commercial product,
NUZYRA™ (omadacycline), which has launched and is available in the
U.S., is a once-daily oral and intravenous antibiotic for the
treatment of adults with community-acquired bacterial pneumonia and
acute bacterial skin and skin structure infections. Paratek is also
studying NUZYRA for the treatment of urinary tract infections
(UTI).
Paratek has submitted a marketing authorization application of
omadacycline in the European Union. Paratek has entered into a
collaboration agreement with Zai Lab for the development
and commercialization of omadacycline in the
greater China region and retains all remaining global
rights.
Under a research agreement with the U.S. Department of
Defense, omadacycline also is being studied against pathogenic
agents causing infectious diseases of public health and biodefense
importance, including plague and anthrax.
SEYSARA™ (sarecycline) is an FDA-approved product with
respect to which we have exclusively licensed certain rights
in the United States to Almirall, LLC,
or Almirall. SEYSARA is currently being marketed
by Almirall in the U.S. as a new once-daily oral therapy
for the treatment of moderate to severe acne vulgaris. Paratek
retains development and commercialization rights with respect to
sarecycline in the rest of the world.
Recognizing the serious threat of bacterial infections,
Paratek is dedicated to providing solutions that enable
positive outcomes and lead to better patient stories.
For more information, visit www.ParatekPharma.com or
follow @ParatekPharma on Twitter.
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 the
projected net product revenues of NUZYRA™, our anticipated cash
runway, our SEYSARA royalty-backed loan funded on May 1, 2019, the
progression of our commercial roll out for NUZYRA™, the prospects
of our U.S. 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 UTI, and to work toward an oral-only indication
in CABP, our potential to further drive long-term value for all of
our shareholders and our plans to obtain regulatory approval of
omadacycline in the European Union . 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, 2018 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)
|
|
|
March 31, 2019 |
December 31, 2018 |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
$ |
257,902 |
|
$ |
292,838 |
|
|
Total assets |
|
|
|
272,444 |
|
|
300,192 |
|
|
Working capital |
|
|
|
247,862 |
|
|
237,534 |
|
|
Total current liabilities |
|
|
|
18,985 |
|
|
17,709 |
|
|
Long-term debt, less current
portion |
|
|
|
229,241 |
|
|
228,959 |
|
|
Common stock and additional
paid-in-capital |
|
|
|
634,037 |
|
|
630,174 |
|
|
Accumulated deficit |
|
|
|
(618,078 |
) |
|
(582,468 |
) |
|
Total stockholders'
equity |
|
|
|
16,031 |
|
|
47,578 |
|
Condensed Consolidated Statements of
Operations (unaudited) (in
thousands, except loss per share data)
|
|
Three Months Ended March 31, |
|
|
|
|
2019 |
|
|
2018 |
|
|
Product revenues, net |
|
$1,347 |
|
|
$ - |
|
|
Collaboration and royalty
revenue |
|
|
251 |
|
|
10 |
|
|
Total revenue |
|
|
1,598 |
|
|
10 |
|
|
Expenses: |
|
|
|
|
Cost of product revenue |
|
|
206 |
|
|
- |
|
|
Research and development |
|
|
11,392 |
|
|
14,864 |
|
|
Selling, general and administrative |
|
|
23,316 |
|
|
11,873 |
|
|
Changes in fair value of contingent consideration |
|
|
- |
|
|
(15 |
) |
|
Total operating expenses |
|
|
34,914 |
|
|
26,722 |
|
|
Loss from operations |
|
|
(33,316 |
) |
|
(26,712 |
) |
|
Other income and
expenses: |
|
|
|
|
Interest income |
|
|
946 |
|
|
475 |
|
|
Interest expense |
|
|
(3,226 |
) |
|
(1,507 |
) |
|
Other losses |
|
|
(14 |
) |
|
(6 |
) |
|
Net loss |
|
|
(35,610 |
) |
|
(27,750 |
) |
|
Net loss per share - basic and
diluted |
|
$(1.10 |
) |
$(0.91 |
) |
|
Weighted average common stock outstanding |
|
|
|
|
Basic and diluted |
|
|
32,334,563 |
|
|
30,566,694 |
|
|
CONTACT:
Investor and Media
Relations: |
Ben Strain |
617-807-6688 |
ir@ParatekPharma.com |
Paratek Pharmaceuticals (NASDAQ:PRTK)
Historical Stock Chart
From Apr 2024 to May 2024
Paratek Pharmaceuticals (NASDAQ:PRTK)
Historical Stock Chart
From May 2023 to May 2024