Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical
company focused on the development and commercialization of
innovative therapies based upon tetracycline chemistry, today
reported financial results for the full year and quarter ended
December 31, 2016.
"We made excellent progress with the clinical development
program of omadacycline in the fourth quarter and continued our
work to prepare for a potential NDA submission in the first half of
2018,” said Michael Bigham, Chairman and Chief Executive Officer,
Paratek. “With the enrollment of the pneumonia study now complete,
we expect to release top-line data early in the second quarter. Our
Phase 3 study of an oral-only dosing regimen in skin infections is
progressing well. We continue to expect top-line data as
early as the second quarter of this year from this study.”
Recent Highlights
- Announced completion of enrollment of CABP study and data
readout planned for early second quarter 2017
- Hosted Company’s first R&D day – highlighting new data for
omadacycline in UTI and lung concentrations
- Completed three successive registration batches of omadacycline
IV and oral drug product and placed these batches on stability
testing
- Continued to progress Phase 3 study of oral-only omadacycline
in acute bacterial skin and skin structure infections (ABSSSI) with
top-line data expected as early as the second quarter of 2017
- Announced a new cooperative research effort with the U.S. Army
Medical Research Institute of Infectious Diseases (USAMRIID) to
study omadacycline against biodefense pathogens
- Promoted Evan Loh to Chief Operating Officer
- Drew an additional $20 million from existing debt line with
Hercules Technology Growth Capital and signed an amendment
extending the interest only period of the loan until December 2018
and establishing an additional tranche of $10 million available on
clinical success in either of two ongoing omadacycline Phase 3
studies
Upcoming Milestones
- Presentation of omadacycline IV-to oral ABSSSI clinical study
results at ECCMID, April 22-25 in Vienna, Austria
- Readout of top-line data from the IV-to-oral CABP study
- Readout of top-line data presentation from the oral-only ABSSSI
study
- Readout of top-line data from Allergan’s Phase 3 program of
sarecycline for the treatment of acne vulgaris
Fourth Quarter and Full Year 2016 Financial
Results For the fourth quarter of 2016, Paratek reported a
net loss of $26.5 million, or $1.16 per share, compared to a net
loss of $21.1 million, or $1.20 per share, for the same period in
2015. For the year ended December 31, 2016, Paratek reported
a net loss of $111.6 million, or $5.51 per share, compared to a net
loss of $70.9 million, or $4.29 per share, for the same period in
2015.
Research and development expenses were $19.7 million and $83.5
million for the quarter and year ended December 31, 2016,
respectively, compared to $15.2 million and $50.8 million for the
same periods in 2015. The increase in research and development
expense for the year ended December 31, 2016 was primarily the
result of ongoing development of omadacycline, including costs
associated with clinical studies for the treatment of ABSSSI, CABP
and UTI, production of omadacycline registration batches and
manufacturing process validation work, other research and
development activities, and employee compensation.
General and administrative expenses were $6.5 million and $26.4
million for the quarter and year ended December 31, 2016,
respectively, compared to $5.6 million and $20.0 million for the
same periods in 2015. The increase in general and
administrative costs was primarily the result of employee
compensation.
As of December 31, 2016, Paratek had cash, cash equivalents, and
marketable securities of $128.0 million. Based on current
assumptions, Paratek’s cash, cash equivalents and marketable
securities will enable the Company to fund operating expenses and
capital expenditure requirements through the first half of
2018.
Paratek initiated sales of shares under a Controlled Equity
Offering Sales Agreement with Cantor Fitzgerald & Co. in March
2016, and sold an aggregate of 860,014 shares of common stock
through December 31, 2016, resulting in net proceeds of $11.6
million. As of February 24, 2017, an additional 870,078
shares were sold under the Sales Agreement subsequent to December
31, 2016, resulting in net proceeds of $13.1 million, which will be
recognized during the first quarter of 2017.
Conference Call and WebcastParatek’s earnings
conference call for the quarter ended December 31, 2016, will be
broadcast at 8:30 a.m. EST on March 2, 2017. 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 877-407-9039 and international investors should dial
201-689-8470. The conference ID is 13656270. Investors can also
access the call at
http://public.viavid.com/index.php?=123110.
Replays of the call will be available through March 16, 2017.
Domestic investors can access the replay by dialing 844-512-2921
and international investors can access the replay by dialing
412-317-6671. The PIN code to access the replay is 13656270.
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 biopharmaceutical company focused on the
development and commercialization of innovative therapies based
upon its expertise in novel tetracycline chemistry. Paratek's lead
product candidate, omadacycline, is the first in a new class of
tetracyclines known as aminomethylcyclines, with broad-spectrum
activity against Gram-positive, Gram-negative and atypical
bacteria. In June 2016, Paratek announced positive efficacy data in
a Phase 3 registration study in acute bacterial skin and skin
structure infections (ABSSSI) demonstrating the efficacy and safety
of intravenous (IV) to once-daily oral omadacycline compared to
linezolid. A Phase 3 registration study for
community-acquired bacterial pneumonia (CABP) comparing
IV-to-once-daily oral omadacycline to IV-to-oral moxifloxacin was
initiated in November 2015 and completed enrollment in January
2017. Paratek will report top-line data from this study early in
the second quarter of 2017. A Phase 3 registration study in ABSSSI
comparing once-daily oral-only dosing of omadacycline to
twice-daily oral-only dosing of linezolid was initiated in August
2016. Top-line data from this study are expected as early as
the second quarter of 2017. A Phase 1B study in uncomplicated
urinary tract infections (UTI) was initiated in May 2016 and
positive top-line PK proof-of-principle data were reported in
November 2016. The company plans to begin enrolling patients
in a proof-of-concept Phase 2 study in complicated UTI as early as
the fourth quarter of 2017. Omadacycline has been granted Qualified
Infectious Disease Product designation and Fast Track status by the
U.S. Food and Drug Administration for several indications.
In October 2016, Paratek announced a new cooperative research
effort with the U.S. Army Medical Research Institute of Infectious
Diseases (USAMRIID) to study omadacycline against pathogenic agents
causing infectious diseases of public health and biodefense
importance. These studies are designed to confirm dosing regimens
and assess efficacy of omadacycline against biodefense pathogens,
including Yersinia pestis (plague) and Bacillus anthracis
(anthrax).
Omadacycline is a new once-daily oral and IV, well-tolerated
broad spectrum antibiotic being developed for use as empiric
monotherapy for patients suffering from serious community-acquired
bacterial infections, such as acute bacterial skin and skin
structure infections, community-acquired bacterial pneumonia,
urinary tract infections and other community-acquired bacterial
infections, particularly when antibiotic resistance is of concern
to prescribing physicians.
Paratek's second Phase 3 product candidate, sarecycline, is a
well-tolerated, once-daily, oral, narrow spectrum
tetracycline-derived antibiotic with potent anti-inflammatory
properties for the potential treatment of acne and rosacea in the
community setting. Allergan owns the U.S. rights for the
development and commercialization of sarecycline. Paratek retains
all ex-U.S. rights. Allergan initiated two identical Phase 3
registration studies in December 2014 for sarecycline for the
treatment of moderate to severe acne vulgaris. Top-line Phase 3
data are expected in the first half of 2017.
For more information, visit www.paratekpharma.com.
Forward Looking StatementsThis press release
contains forward-looking statements including statements related to
our overall strategy, product candidates, clinical studies, cash
resources, prospects and expected results, including statements
about the timing of advancing omadacycline and otherwise preparing
for clinical 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 having the resources to execute on
our clinical studies. 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, which include, without limitation, risks related to
(i) our need for substantial additional funding to complete the
development and commercialization of our product candidates, (ii)
our ability to raise the capital to do so, (iii) our ability to
develop and manufacture our drug candidates for potential
commercialization, (iv) the advancement of omadacycline Phase 3
studies for ABSSSI, (v) the potential for omadacycline to be
successfully developed for use as an empiric monotherapy for
patients suffering from serious community-acquired bacterial
infections, (vi) the potential of omadacycline to become the
primary antibiotic choice of physicians for the treatment of
serious community-acquired bacterial infections, (vii) the
potential use and effectiveness of sarecycline for the treatment of
acne and rosacea in the community setting, and (viii) the timing of
the Phase 3 program in moderate-severe acne for sarecycline, risks
that data to date and trends may not be predictive of future
results, risks related to the conduct of our clinical studies, and
risks that our clinical studies and product candidates do not
receive regulatory approval. 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, 2016, 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 Statements of
Operations |
(unaudited) |
(in thousands, except loss per share
data) |
|
|
|
Three months endedDecember
31, |
|
|
Year endedDecember
31, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty
revenue |
|
|
29 |
|
|
|
— |
|
|
|
29 |
|
|
|
— |
|
Total revenue |
|
|
29 |
|
|
|
— |
|
|
|
29 |
|
|
|
— |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
19,703 |
|
|
|
15,209 |
|
|
|
83,460 |
|
|
|
50,765 |
|
General
and administrative |
|
|
6,504 |
|
|
|
5,641 |
|
|
|
26,400 |
|
|
|
19,988 |
|
Impairment of intangible assets |
|
|
— |
|
|
|
99 |
|
|
|
— |
|
|
|
2,860 |
|
Changes
in fair value of contingent consideration |
|
|
(289 |
) |
|
|
(580 |
) |
|
|
(345 |
) |
|
|
(3,560 |
) |
Total operating
expenses |
|
|
25,918 |
|
|
|
20,369 |
|
|
|
109,515 |
|
|
|
70,053 |
|
Loss from
operations |
|
|
(25,889 |
) |
|
|
(20,369 |
) |
|
|
(109,486 |
) |
|
|
(70,053 |
) |
Other income and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
287 |
|
|
|
— |
|
|
|
1,069 |
|
|
|
— |
|
Interest
expense |
|
|
(855 |
) |
|
|
(697 |
) |
|
|
(3,223 |
) |
|
|
(770 |
) |
Other
gains (and losses), net |
|
|
3 |
|
|
|
(40 |
) |
|
|
4 |
|
|
|
(37 |
) |
Net loss |
|
$ |
(26,454 |
) |
|
$ |
(21,106 |
) |
|
$ |
(111,636 |
) |
|
$ |
(70,860 |
) |
Basic and
diluted net loss per common share |
|
$ |
(1.16 |
) |
|
$ |
(1.20 |
) |
|
$ |
(5.51 |
) |
|
$ |
(4.29 |
) |
Weighted average common
shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
22,819,268 |
|
|
|
17,608,615 |
|
|
|
20,253,082 |
|
|
|
16,501,912 |
|
Condensed Consolidated Balance
Sheets |
(unaudited) |
(in thousands) |
|
|
|
As of December 31, |
|
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
128,038 |
|
|
$ |
131,302 |
|
Total assets |
|
|
135,732 |
|
|
|
145,918 |
|
Working capital |
|
|
111,688 |
|
|
|
121,915 |
|
Current
liabilities |
|
|
20,412 |
|
|
|
20,502 |
|
Long-term obligations,
less current portion |
|
|
43,728 |
|
|
|
24,176 |
|
Common stock and
additional paid-in capital |
|
|
451,970 |
|
|
|
369,966 |
|
Accumulated
deficit |
|
|
(380,362 |
) |
|
|
(268,726 |
) |
Total stockholders’
equity |
|
|
71,592 |
|
|
|
101,240 |
|
CONTACTS:
Media:
Michael Lampe
Scient Public Relations
(484) 575-5040
michael@scientpr.com
Investors:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
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