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 and provided an update on financial,
clinical and regulatory filing activities for the quarter ended
September 30, 2017.
“Following the successful completion of our clinical development
program for omadacycline in skin infections and pneumonia in July,
the third quarter included increased activities around the
preparation of our NDA filing package for submission to the FDA as
well as expanded pre-commercialization activities in anticipation
of product approval,” said Michael Bigham, Chairman and Chief
Executive Officer, Paratek. “In parallel, we continued to advance
plans for our Phase 2 program in urinary tract infections. The
granting of Qualified Infectious Disease Product designation for
omadacycline for the potential treatment of uUTI is an
acknowledgement by the FDA of the important need for new
broad-spectrum oral agents for this indication.”
Recent Highlights
- Granted Qualified Infectious Disease Product (QIDP) Designation
for an additional indication in uUTI by the FDA
- Nine posters and one oral presentation at IDWeek 2017 in San
Diego
- Presented omadacycline clinical profile, market landscape, and
pre-commercial activities at Investor Day on October 17
Upcoming Milestones
- Initiation of rolling NDA submission for omadacycline
- Initiation of Phase 2 program of omadacycline in UTI
Financial ResultsParatek reported a net loss of
$21.3 million, or ($0.77) per share, for the quarter ended
September 30, 2017 compared to a net loss of $23.6 million, or
($1.04) per share, for the same period in 2016.
Research and development expenses were $12.1 million for the
quarter ended September 30, 2017 compared to $17.3 million for the
same period in 2016. The decrease was driven primarily by lower
clinical study costs associated with the completion of our Phase 3
program for omadacycline.
General and administrative expenses were $8.2 million for the
quarter ended September 30, 2017 compared to $5.9 million for the
same period in 2016. The increase was driven primarily by
higher employee compensation costs as we continue to expand our
team and engage in pre-commercial activities.
As of September 30, 2017, Paratek had cash, cash equivalents,
and marketable securities of $163.4 million. Based on current
assumptions, including full commercial buildout and launch of
omadacycline, Paratek’s cash, cash equivalents and marketable
securities, remaining debt capacity, and anticipated regulatory and
commercial milestone payments from our existing collaboration
partners will enable the Company to fund operating expenses and
capital expenditure requirements through the second quarter of
2019.
Conference Call and WebcastParatek’s earnings
conference call for the quarter ended September 30, 2017 will be
broadcast at 8:30 a.m. EDT on November 8, 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: 877-407-0792 and international investors should dial:
201-689-8263. The conference ID is 13671638. Investors can also
access the call at
http://public.viavid.com/index.php?id=126484.
Replays of the call will be available through November 22, 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 13671638.
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. The
Company’s lead product candidate, omadacycline, is a new,
once-daily oral and intravenous broad-spectrum antibiotic being
developed for the treatment of serious community-acquired bacterial
infections, including community-acquired bacterial pneumonia
(CABP), acute bacterial skin and skin structure infections
(ABSSSI), and urinary tract infections. Omadacycline has
been granted Qualified Infectious Disease Product designation and
Fast Track status by the U.S. Food and Drug
Administration for the target indications of ABSSSI, CABP,
uUTI and cUTI. Paratek has completed Phase 3 development activities
for omadacycline in CABP and ABSSSI and is preparing to submit
marketing applications in the United States and European
Union. Paratek has licensed rights for omadacycline to Zai
Lab for 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 Phase 3
product candidate, sarecycline, is being developed
by Allergan in the U.S. as a new once-daily oral therapy
for the treatment of acne. Allergan has completed Phase 3
development activities for sarecycline and is preparing a new drug
application for submission to the U.S. Food and Drug
Administration. Paratek retains all ex-U.S. rights to sarecycline.
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
StatementsThis 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
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
obtain regulatory approval 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, 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 Ended |
|
|
Nine Months Ended |
|
|
September 30, |
September 30, |
|
|
|
2017 |
|
2016 |
|
|
2017 |
|
2016 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and royalty revenue |
|
$ |
12 |
|
$ |
— |
|
|
$ |
7,544 |
|
$ |
— |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
12,112 |
|
|
17,334 |
|
|
|
45,847 |
|
|
63,757 |
|
|
General and administrative |
|
|
8,219 |
|
|
5,949 |
|
|
|
25,299 |
|
|
19,896 |
|
|
Impairment of intangible asset |
|
|
— |
|
|
— |
|
|
|
682 |
|
|
— |
|
|
Changes in fair value of contingent consideration |
|
|
(22 |
) |
|
(170 |
) |
|
|
(571 |
) |
|
(50 |
) |
| Total
operating expenses |
|
|
20,309 |
|
|
23,113 |
|
|
|
71,257 |
|
|
83,603 |
|
| Loss
from operations |
|
|
(20,297 |
) |
|
(23,113 |
) |
|
|
(63,713 |
) |
|
(83,603 |
) |
| Other
income and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(1,408 |
) |
|
(820 |
) |
|
|
(3,666 |
) |
|
(2,368 |
) |
|
Interest income |
|
|
389 |
|
|
309 |
|
|
|
979 |
|
|
788 |
|
|
Other (loss) income, net |
|
|
(8 |
) |
|
(4 |
) |
|
|
(23 |
) |
|
1 |
|
| Loss
before income taxes |
|
$ |
(21,324 |
) |
$ |
(23,628 |
) |
|
$ |
(66,423 |
) |
$ |
(85,182 |
) |
|
Provision for income taxes |
|
|
— |
|
|
— |
|
|
|
753 |
|
|
— |
|
| Net
loss |
|
$ |
(21,324 |
) |
$ |
(23,628 |
) |
|
$ |
(67,176 |
) |
$ |
(85,182 |
) |
|
Net loss per share - basic and diluted |
|
$ |
(0.77 |
) |
$ |
(1.04 |
) |
|
$ |
(2.54 |
) |
$ |
(4.39 |
) |
|
Weighted average common shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
27,776,218 |
|
|
22,627,711 |
|
|
|
26,453,219 |
|
|
19,391,443 |
|
|
|
Condensed Consolidated Balance
Sheets (unaudited) (in
thousands)
| |
|
September 30, |
|
|
December 31, |
|
| 2017 |
2016 |
|
|
|
|
|
|
|
|
|
| Cash,
cash equivalents and marketable securities |
|
$ |
163,440 |
|
|
$ |
128,038 |
|
| Total
assets |
|
|
169,734 |
|
|
|
135,732 |
|
|
Working capital |
|
|
150,409 |
|
|
|
111,688 |
|
| Total
current liabilities |
|
|
15,797 |
|
|
|
20,412 |
|
|
Long-term debt, less current portion |
|
|
49,079 |
|
|
|
38,974 |
|
|
Common stock and additional paid-in-capital |
|
|
548,172 |
|
|
|
451,970 |
|
|
Accumulated deficit |
|
|
(448,220 |
) |
|
|
(380,362 |
) |
| Total stockholders'
equity |
|
|
99,872 |
|
|
|
71,592 |
|
CONTACTS:
| |
|
|
| Media
Relations: |
|
Investor
Relations: |
| Michael Lampe |
|
Hans Vitzthum |
| (484) 575-5040 |
|
LifeSci Advisors,
LLC. |
|
michael@scientpr.com |
|
212-915-2568 |
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