--NUZYRA™ (omadacycline) approved by FDA for the
treatment of CABP and ABSSSI --
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 financial, clinical,
commercial and regulatory filing activities for the quarter ended
September 30, 2018.
“It has been an exciting and productive period for Paratek
during which we achieved two significant milestones with the
approval of NUZYRA and SEYSARA. NUZYRA was approved by the
FDA as the first once-daily IV and oral antibiotic to treat both
CABP and ABSSSI in nearly 20 years while the FDA approved SEYSARA
for the treatment of inflammatory lesions of non-nodular
moderate to severe acne vulgaris,” said Michael Bigham, Chairman
and Chief Executive Officer, Paratek. “These regulatory
achievements are transformative for Paratek. Our commercial
team is actively preparing for a NUZYRA launch in the
U.S. in February, and we are looking forward to the
opportunity to help shape the future treatment paradigm
for community-acquired pneumonia and
skin infections.”
Recent Highlights
- The FDA approved NUZYRA (omadacycline) in October 2018 for
the treatment of adults with community-acquired bacterial pneumonia
(CABP) and acute skin and skin structure infections (ABSSSI).
- The company is planning for a February 2019 launch.
Pre-commercialization activities for NUZYRA are proceeding to plan.
The Company’s manufacturing of launch product is near completion;
the market access team outreach to key payers is ongoing; the build
out of the sales management team is complete; and the Company is
commencing the initial hiring of its sales team.
- The FDA approved SEYSARA (sarecycline) in October 2018 for the
treatment of inflammatory lesions of non-nodular moderate to severe
acne vulgaris in patients 9 years of age and older.
- Paratek has exclusively licensed U.S. development and
commercialization rights of SEYSARA to Almirall S.A. and
is now entitled to receive tiered royalties at rates ranging from
high-single to low double digits on net sales of
SEYSARA.
- The European Marketing Authorization Application for oral and
Intravenous omadacycline was submitted in October 2018 and the
review has been initiated.
- The Company is seeking approval for the treatment of
community-acquired bacterial and acute bacterial skin and skin
structure infections.
- During IDWeek 2018, the Company presented additional data
demonstrating the continued importance of omadacycline in acute
bacterial skin and skin structure infections and community-acquired
bacterial pneumonia highlighted by an analysis of the clinical
efficacy of omadacycline against a broad collection of clinical
isolates with known tetracycline resistance and improvement in
quality of life in patients with ABSSSI.
- Strengthened balance sheet:
- The FDA approval of NUZYRA extended the interest-only period
and maturity date for $60 million of the total $70 million in
principal of the Hercules term loan by one year to January 1, 2021
and September 1, 2021, respectively.
- Paratek earned a $12.0 million milestone payment from Almirall
S.A. upon FDA approval of SEYSARA, which will be recognized as
revenue in the fourth quarter of 2018.
- The company earned a $5.0 million milestone from Zai Lab upon
FDA approval of NUZYRA, which will be recognized as revenue in the
fourth quarter of 2018.
Third Quarter 2018 Financial Results For the
third quarter of 2018, Paratek reported a net loss of $32.1
million, or $1.01 per share, compared to a net loss of $21.3
million, or $0.77 per share, for the same period in 2017.
Research and development expenses were $16.0 million for the
third quarter of 2018, compared to $12.1 million for the third
quarter of 2017. The increase was driven primarily by
manufacturing production costs for NUZYRA, higher salaries,
benefits and recruiting fees, and costs associated with regulatory
activities.
General and administrative expenses were $13.6 million for the
third quarter of 2018, compared to $8.2 million for the third
quarter of 2017. The increase was primarily due to additional
headcount and higher marketing, market access and other commercial
consulting costs.
Based upon our current operating plan, we anticipate that our
existing cash, cash equivalents and marketable securities of $310.9
million as of September 30, 2018, estimated NUZYRA product sales,
and estimated royalty payments from our collaboration with
Almirall, LLC will enable us to fund our operating expenses,
capital expenditures, and debt service through the first quarter of
2021.
Conference Call and WebcastParatek’s earnings
conference call for the quarter ended September 30, 2018 will be
broadcast today at 4:30 p.m. EST on November 6, 2018. 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 13683977.
Investors can also access the call
at http://public.viavid.com/index.php?id=131722.
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, 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, is a once-daily intravenous and oral antibiotic for the
treatment of adult patients 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 for 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.
Paratek’s second FDA approved product, SEYSARA™
(sarecycline), will be marketed by Almirall, LLC 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 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, product candidates, clinical
studies, prospects, potential and expected results, including
statements about the timing of commercializing NUZYRA, advancing
omadacycline and otherwise preparing for
clinical studies, the timing of enrollment in our
clinical studies and our reporting of the results of such
studies, the potential for omadacycline to serve as an empiric
monotherapy treatment option for patients suffering from ABSSSI,
CABP, UTI, and other bacterial infections when resistance is of
concern, the prospect of omadacycline providing broad-spectrum
activity, and our ability to make and sell NUZYRA,
obtain certain regulatory
approvals of omadacycline. 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," "believe," "expect," "well
positioned," "look forward," "anticipated," "continued," 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, 2017, our Form 10-Q filed
for the quarter ended September 30, 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)
|
|
|
September 30,
2018 |
|
|
December 31,2017 |
|
|
|
|
(unaudited) |
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
310,915 |
|
|
$ |
151,723 |
|
|
Total assets |
|
|
317,847 |
|
|
|
163,698 |
|
|
Working capital |
|
|
266,834 |
|
|
|
143,697 |
|
|
Total current liabilities |
|
|
25.696 |
|
|
|
16,789 |
|
|
Long-term debt, less current portion |
|
|
228,680 |
|
|
|
59,186 |
|
|
Common stock and additional paid-in-capital |
|
|
617,636 |
|
|
|
552,748 |
|
|
Accumulated deficit |
|
|
(559,677 |
) |
|
|
(470,112 |
) |
|
Total stockholders' equity |
|
|
57,630 |
|
|
|
82,478 |
|
Condensed Consolidated Statements of
Operations (unaudited) (in
thousands, except loss per share data)
|
|
Three Months
EndedSeptember 30, |
|
|
Nine Months
EndedSeptember 30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and royalty
revenue |
|
$ |
50 |
|
|
$ |
12 |
|
|
$ |
101 |
|
|
$ |
7,544 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
16,040 |
|
|
|
12,112 |
|
|
|
45,706 |
|
|
|
45,847 |
|
General and administrative |
|
|
13,610 |
|
|
|
8,219 |
|
|
|
38,395 |
|
|
|
25,299 |
|
Impairment |
|
|
21 |
|
|
|
— |
|
|
|
107 |
|
|
|
682 |
|
Changes in fair value ofcontingent
consideration |
|
|
(11 |
) |
|
|
(22 |
) |
|
|
(57 |
) |
|
|
(571 |
) |
Total operating expenses |
|
|
29,660 |
|
|
|
20,309 |
|
|
|
84,151 |
|
|
|
71,257 |
|
Loss from operations |
|
|
(29,610 |
) |
|
|
(20,297 |
) |
|
|
(84,050 |
) |
|
|
(63,713 |
) |
Other income and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(3,383 |
) |
|
|
(1,408 |
) |
|
|
(7,793 |
) |
|
|
(3,666 |
) |
Interest income |
|
|
922 |
|
|
|
389 |
|
|
|
2,292 |
|
|
|
979 |
|
Other (loss) income, net |
|
|
(12 |
) |
|
|
(8 |
) |
|
|
(14 |
) |
|
|
(23 |
) |
Loss before income taxes |
|
$ |
(32,083 |
) |
|
$ |
(21,324 |
) |
|
$ |
(89,565 |
) |
|
$ |
(66,423 |
) |
Provision for income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
753 |
|
Net loss |
|
$ |
(32,083 |
) |
|
$ |
(21,324 |
) |
|
$ |
(89,565 |
) |
|
$ |
(67,176 |
) |
Net loss per share - basicand diluted |
|
$ |
(1.01 |
) |
|
$ |
(0.77 |
) |
|
$ |
(2.86 |
) |
|
$ |
(2.54 |
) |
Weighted average commonshares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
31,742,854 |
|
|
|
27,776,218 |
|
|
|
31,301,249 |
|
|
|
26,453,219 |
|
CONTACT:
Investor and Media Relations:Ben
Strain617-807-6688ir@ParatekPharma.com
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