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
June 30, 2017.
"The successful completion of our planned clinical program for
omadacycline and our recent pre-NDA meetings with the FDA represent
important strategic milestones on our pathway to approval,” said
Michael Bigham, Chairman and Chief Executive Officer, Paratek. “We
believe that omadacycline represents a much-needed new antibiotic
treatment option in an era of rising bacterial resistance.
With the data generated to date in all three Phase 3 studies, we
remain confident in the path to regulatory approval in both the
U.S. and EU. Based on our recent pre-NDA meetings with FDA,
we will initiate our rolling submission in December of this
year.”
Recent Highlights
- Reported positive top-line efficacy, safety, and tolerability
data in the OPTIC study, a Phase 3 registration study of IV to
once-daily oral omadacycline in community-acquired bacterial
pneumonia (CABP)
- Reported positive top-line efficacy, safety, and tolerability
data in the OASIS-2 study, a Phase 3 registration study of
once-daily oral-only omadacycline in acute bacterial skin and skin
structure infections (ABSSSI)
- Completed two pre-NDA meetings, focused on
clinical/non-clinical and CMC topics, with the U.S. Food and Drug
Administration confirming our plans for NDA submission
- Received endorsement of the Pediatric Investigation Plan from
the European Medicines Agency
- Presented 10 posters and oral presentations at American Society
of Microbiology’s ASM Microbe 2017 conference in New Orleans
- Expanded our commercial, medical and drug supply teams
- Strengthened balance sheet, extending runway through Q2 2019,
including full cost of product launch
Upcoming Events
- Presentation of omadacycline data at the ID Week conference,
October 4-8 in San Diego
- Investor Day on October 17, 2017 in New York City
Financial Results Paratek
reported a net loss of $18.2 million, or $0.66 per share, for the
quarter ended June 30, 2017 compared to a net loss of $30.3
million, or $1.69 per share, for the same period in 2016.
Revenue during the quarter ended June 30, 2017 reflects a $7.5
million upfront license fee earned under a License and
Collaboration Agreement with Zai Lab (Shanghai) Co., Ltd., or Zai
Collaboration Agreement as well as fifty percent of net royalties
received pursuant to a separate royalty sharing agreement. The
Company did not record revenue during the quarter ended June 30,
2016.
Research and development expenses were $15.1 million for the
quarter ended June 30, 2017 compared to $22.1 million for the same
period in 2016. The decrease was driven primarily by lower clinical
study costs as the Company neared completion of its planned Phase 3
omadacycline program.
General and administrative expenses were $8.7 million for the
quarter ended June 30, 2017 compared to $7.6 million for the same
period in 2016. The increase was driven primarily by higher
employee compensation costs as the Company continued to expand its
team.
As of June 30, 2017, Paratek had cash, cash equivalents, and
marketable securities of $175.3 million. During the quarter ended
June 30, 2017, the company raised proceeds of $58.5 million.
These include $41.8 million raised through sales of common stock
under controlled equity offering agreements through May 1, 2017, as
previously announced in the Company’s Form 10-Q for the quarter
ended March 31, 2017.
Additionally, the Company amended its loan agreement with
Hercules to extend the interest-only period for one year, through
December 2019, contingent on successful NDA approval and to make an
additional $10.0 million in principal available, bringing the total
amount available to $60.0 million. Concurrent with the
amendment, the Company drew $10.0 million of principal to bring its
outstanding debt balance to $49.0 million, which is presented net
of debt issuance costs.
Finally, the Company also received $6.7 million, which is net of
applicable taxes paid, for the upfront license fee earned under the
Zai Collaboration Agreement.
Based on current assumptions, including full commercial buildout
and launch of omadacycline, Paratek’s cash, cash equivalents and
marketable securities 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 June 30, 2017 will be broadcast at 8:30 a.m. EDT on
August 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: 877-407-0792 and international investors should dial:
201-689-8263. The conference ID is 13665445. Investors can also
access the call at
http://public.viavid.com/index.php?id=125152.
Replays of the call will be available through August 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 13665445.
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. 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 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 endedJune
30, |
|
|
Six months endedJune
30, |
|
|
|
2017 |
|
2016 |
|
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and royalty
revenue |
|
$ |
7,514 |
|
$ |
— |
|
|
$ |
7,532 |
|
$ |
— |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
15,079 |
|
|
22,135 |
|
|
|
33,735 |
|
|
46,423 |
|
General
and administrative |
|
|
8,716 |
|
|
7,602 |
|
|
|
17,080 |
|
|
13,941 |
|
Impairment of intangible asset |
|
|
682 |
|
|
— |
|
|
|
682 |
|
|
— |
|
Changes
in fair value of contingent consideration |
|
|
(318 |
) |
|
15 |
|
|
|
(549 |
) |
|
120 |
|
Total operating
expenses |
|
|
24,159 |
|
|
29,752 |
|
|
|
50,948 |
|
|
60,484 |
|
Loss from
operations |
|
|
(16,645 |
) |
|
(29,752 |
) |
|
|
(43,416 |
) |
|
(60,484 |
) |
Other income and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense |
|
|
(1,126 |
) |
|
(818 |
) |
|
|
(2,258 |
) |
|
(1,548 |
) |
Interest
income |
|
|
349 |
|
|
288 |
|
|
|
590 |
|
|
479 |
|
Other
(loss) income, net |
|
|
(8 |
) |
|
(1 |
) |
|
|
(15 |
) |
|
(1 |
) |
Loss before income
taxes |
|
$ |
(17,430 |
) |
$ |
(30,283 |
) |
|
$ |
(45,099 |
) |
$ |
(61,554 |
) |
Provision for income
taxes |
|
|
753 |
|
|
— |
|
|
|
753 |
|
|
— |
|
Net loss |
|
$ |
(18,183 |
) |
$ |
(30,283 |
) |
|
$ |
(45,852 |
) |
$ |
(61,554 |
) |
Net loss
per share - basic and diluted |
|
$ |
(0.66 |
) |
$ |
(1.69 |
) |
|
$ |
(1.78 |
) |
$ |
(3.47 |
) |
Weighted average common
shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
27,347,941 |
|
|
17,895,301 |
|
|
|
25,780,756 |
|
|
17,755,528 |
|
Condensed Consolidated Balance
Sheets(unaudited)(in
thousands) |
|
|
|
|
June 30,2017 |
|
December 31,2016 |
|
|
|
|
(unaudited) |
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
175,338 |
|
|
$ |
128,038 |
|
|
Total assets |
|
|
182,129 |
|
|
|
135,732 |
|
|
Working capital |
|
|
163,418 |
|
|
|
111,688 |
|
|
Total current
liabilities |
|
|
15,025 |
|
|
|
20,412 |
|
|
Long-term debt, less
current portion |
|
|
48,975 |
|
|
|
38,974 |
|
|
Common stock and
additional paid-in-capital |
|
|
540,375 |
|
|
|
451,970 |
|
|
Accumulated
deficit |
|
|
(426,895 |
) |
|
|
(380,362 |
) |
|
Total stockholders'
equity |
|
|
113,384 |
|
|
|
71,592 |
|
CONTACTS:
Media:
Michael Lampe
Scient Public Relations
(484) 575-5040
michael@scientpr.com
Investors:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
Paratek Pharmaceuticals (NASDAQ:PRTK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Paratek Pharmaceuticals (NASDAQ:PRTK)
Historical Stock Chart
From Apr 2023 to Apr 2024