XERAVATM (eravacycline) Now Available to
Hospitals in the United States
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical
company focused on developing and commercializing novel antibiotics
to treat life-threatening multidrug-resistant (MDR) infections,
today reported financial results for the quarter ended September
30, 2018 and provided a corporate update.
“During the third quarter of 2018, we reached our most
significant milestones as a company to date – the regulatory
approvals of XERAVA for the treatment of complicated
intra-abdominal infections (cIAI) in both the U.S. and Europe,
followed by the commercial launch of XERAVA in the U.S. in October.
We are thrilled to have accomplished these extraordinary
achievements and to have made this important new antibiotic
treatment available to patients in need. XERAVA is now available
for use in hospitals and healthcare institutions for the treatment
of a range of patients with empiric and confirmed cIAI infections,”
said Chief Executive Officer, Guy Macdonald.
Mr. Macdonald added, “We are also pleased to have entered into a
loan agreement for up to $75 million, the first $30 million tranche
of which extends our cash runway into the second quarter of 2020
and provides us with additional flexibility to support a strong
launch of XERAVA in the U.S. Beyond XERAVA, we look forward to
milestones for our earlier-stage programs, including completion of
our Phase 1 multiple ascending-dose study for oral TP-271, in
development to target respiratory infections, and initiation of a
bronchopulmonary disposition study for TP-6076, targeted against
Acinetobacter baumannii and other MDR pathogens. As a commercial
company with a focus on delivering XERAVA to patients in need, we
are also continuing our pipeline efforts to develop additional
antibiotic options to fight MDR infections.”
Key Upcoming Milestones
- Commence Phase 1 bronchopulmonary disposition study for TP-6076
– 1Q 2019
- Complete Phase 1 multiple ascending-dose study for oral TP-271
– 2Q 2019
- Begin phased launch of XERAVA in Europe – 1H 2019
Third Quarter and Recent Highlights
- Announced Commercial Launch of XERAVA
for cIAI Following the U.S. Food and Drug
Administration (FDA) Approval in AugustThe Company
commercially launched XERAVA in the U.S. in October 2018. XERAVA is
now available for use in hospitals and healthcare institutions for
the treatment of a range of patients with empiric and confirmed
cIAI infections. The salesforce will be focusing on institutions
responsible for treating patients in 90% of the Gram-negative
marketplace. XERAVA’s launch followed FDA approval of XERAVA in
August for the treatment of cIAI in patients 18 years of age and
older. Supporting XERAVA’s approval were results from two Phase 3
clinical studies that showed the therapy was well-tolerated and
achieved high clinical cure rates in patients with cIAI, thus
demonstrating statistical non-inferiority to two widely used
carbapenems – ertapenem and meropenem.
- Received Marketing Authorization from the European
Commission (EC) for XERAVA in the European Union (EU)In
September, the EC adopted the July 2018 positive opinion issued by
the Committee for Medicinal Products for Human Use of the European
Medicines Agency (EMA) to grant marketing authorization for XERAVA
for the treatment of cIAI in adults in all EU member states as well
as Iceland, Liechtenstein and Norway. Following this approval, the
Company is on track for a phased European launch of XERAVA,
beginning with Germany and the UK in the first half of 2019.
- Presented XERAVA and TP-6076 Data at the
Infectious Disease Society of America’s (IDSA) 2018
IDWeekIn October, the Company presented data related to
XERAVA and TP-6076 at IDSA’s IDWeek. Among the data presented were
results from a post-hoc analysis of XERAVA Phase 3 data, which
showed high clinical cure rates and microbiological eradication
with XERAVA among patients with cIAI and concurrent bacteremia.
Data from a Phase 1 randomized, placebo-controlled, double-blind,
multiple-ascending-dose study demonstrating positive safety,
tolerability and pharmacokinetic results for the Company’s novel,
fully synthetic tetracycline, TP-6076 were also presented.
- Presented XERAVA Data at the American College of
Clinical Pharmacy (ACCP) 2018 Global ConferenceIn October,
the Company announced positive data from a post-hoc analysis of two
Phase 3 trials of XERAVA in higher risk populations – obese
patients and those with altered renal function. Similar clinical
cure rates were observed for XERAVA across all classifications of
renal function, further supporting that the drug is an effective
empiric treatment for cIAI comparable to carbapenems which may
provide an alternative to antibiotics that require dosing
modification in patients with altered renal function. XERAVA was
also effective in treating patients with cIAI regardless of body
mass index when dosed 1mg/kg IV every 12 hours, based on total body
weight when compared to carbapenems.
- Entered into Loan and Security Agreement with Solar
Capital LimitedIn November 2018, the Company entered into
a loan agreement with Solar Capital Limited providing us up to $75
million with $30 million funded at closing, to be used to support
the commercial launch of XERAVA and general corporate purposes.
Armentum Partners acted as advisor to the Company on the
transaction.
Third Quarter 2018 Financial ResultsAs of
September 30, 2018, Tetraphase’s cash and cash equivalents were $97
million, and there were approximately 53.5 million shares
outstanding. The Company expects that its cash and cash
equivalents, including the initial funding of $30 million from the
debt facility, as well as expected revenue from its U.S. government
awards and commercial sales of XERAVA in the U.S. and Europe, will
be sufficient to fund operations into the second quarter of
2020.
Revenues during the third quarter of 2018 were $1.2 million
compared to $4.1 million for the same period in 2017. Revenues for
each period consisted of contract and grant revenue under the
Company's U.S. government awards for the development of
Tetraphase compounds. The decrease was primarily due to the timing
of activities under these awards.
Research and development (R&D) expenses for the third
quarter of 2018 were $11.7 million compared to $28.8 million for
the same period in 2017. The decrease in R&D expenses was
primarily due to the completion of the IGNITE Phase 3 clinical
studies for XERAVA.
Sales, general and administrative expenses for the third quarter
of 2018 were $9.5 million compared to $5.6 million for the same
period in 2017. This increase was primarily due to
commercialization expenses to support the U.S. launch of
XERAVA.
For the third quarter of 2018, Tetraphase reported a net loss of
$19.6 million, or a loss of $0.37 per share, compared to a net loss
of $30.0 million, or a loss of $0.63 per share, for the same period
in 2017.
Conference Call and Webcast Information
Tetraphase will host a conference call today at 4:30 p.m. ET to
discuss its financial results and provide an update on the Company.
The call can be accessed by dialing 844-831-4023 (U.S. and Canada)
or 731-256-5215 (international) and entering conference ID number
3997765. To access the live audio webcast, or the subsequent
archived recording, visit the "Investors — Events &
Presentations" section of the Tetraphase website at
www.tphase.com.
A replay of the conference call will be available from 7:30 p.m.
ET on Thursday, November 8, 2018, through 7:30 p.m. ET on Thursday,
November 15, 2018 and by dialing 855-859-2056 (U.S. and Canada) and
404-537-3406 for (international) callers. The conference ID number
is 3997765. A replay of the webcast is available by visiting
Tetraphase’s website for 90 days.
About XERAVATM
XERAVA (eravacycline) for injection is a tetracycline class
antibacterial indicated for the treatment of complicated
intra-abdominal infections (cIAI) in patients 18 years of age and
older. It is approved for use in the U.S. and Europe. XERAVA was
investigated for the treatment of cIAI as part of the Company's
IGNITE (Investigating
Gram-Negative
Infections Treated with
Eravacycline) Phase 3 program. In the first
pivotal Phase 3 trial in patients with cIAI, twice-daily
intravenous (IV) eravacycline met the primary endpoint by
demonstrating statistical non-inferiority of clinical response
compared to ertapenem and was well-tolerated. In the second Phase 3
clinical trial in patients with cIAI, twice-daily IV eravacycline
met the primary endpoint by demonstrating statistical
non-inferiority of clinical response compared to meropenem and was
well-tolerated. In both trials, XERAVA achieved high cure rates in
patients with Gram-negative pathogens, including resistant
isolates.
XERAVATM Important Safety Information
XERAVA is a tetracycline class antibacterial indicated for the
treatment of complicated intra‑abdominal infections in patients 18
years of age and older.
XERAVA is not indicated for the treatment of complicated urinary
tract infections.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of XERAVA and other antibacterial drugs,
XERAVA should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by susceptible
bacteria.
XERAVA is contraindicated for use in patients with known
hypersensitivity to eravacycline or to tetracycline-class
antibacterial drugs. Life-threatening hypersensitivity
(anaphylactic) reactions have been reported with XERAVA.
The use of XERAVA during tooth development (last half of
pregnancy, infancy and childhood to the age of 8 years) may cause
permanent discoloration of the teeth (yellow-gray-brown) and enamel
hypoplasia.
The use of XERAVA during the second and third trimester of
pregnancy, infancy and childhood up to the age of 8 years may cause
reversible inhibition of bone growth.
Clostridium difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
in severity from mild diarrhea to fatal colitis.
The most common adverse reactions observed in clinical trials
(incidence ≥ 3%) were infusion site reactions, nausea, and
vomiting.
XERAVA is structurally similar to tetracycline-class
antibacterial drugs and may have similar adverse reactions. Adverse
reactions including photosensitivity, pseudotumor cerebri, and
anti‑anabolic action which has led to increased blood urea
nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and
abnormal liver function tests, have been reported for other
tetracycline-class antibacterial drugs, and may occur with XERAVA.
Discontinue XERAVA if any of these adverse reactions are
suspected.
To report SUSPECTED ADVERSE REACTIONS, contact
Tetraphase Pharmaceuticals Inc., at 1-833- 7-XERAVA
(1-833-793-7282) or FDA at 1‑800‑FDA-1088 or
www.fda.gov/medwatch.
Please see full prescribing information for XERAVA.
About Tetraphase Pharmaceuticals, Inc.
Tetraphase is a biopharmaceutical company using its proprietary
chemistry technology to create novel antibiotics for serious and
life-threatening bacterial infections, including those caused by
many of the multidrug-resistant bacteria highlighted as urgent
public health threats by the World Health Organization and the
Centers for Disease Control and Prevention. The Company has created
more than 3,000 novel tetracycline compounds using its proprietary
technology platform. Tetraphase's lead product XERAVA is approved
for the treatment of complicated intra-abdominal infections (cIAI)
by the U.S. Food and Drug Administration and the European Medicines
Agency. The Company’s pipeline also includes TP-271 and TP-6076,
which are in Phase 1 clinical trials. Please visit www.tphase.com
for more company information.
Forward-Looking Statements
Any statements in this press release about our future
expectations, plans and prospects, including statements regarding
our strategy, future operations, prospects, plans and objectives,
and other statements containing the words "anticipates,"
"believes," "expects," "plans," "will" and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including
whether eravacycline will be successfully distributed and marketed
and other regulatory and commercial risk factors discussed in the
"Risk Factors" section of our quarterly report on Form 10-Q for the
period ended June 30, 2018, filed with the Securities and Exchange
Commission on August 2, 2018. In addition, the forward-looking
statements included in this press release represent our views as of
November 8, 2018. We anticipate that subsequent events and
developments will cause our views to change. However, while we may
elect to update these forward-looking statements at some point in
the future, we specifically disclaim any obligation to do so.
Media and Investor Contact: Jennifer Viera
jviera@tphase.com 617-600-7040
(tables follow)
|
Tetraphase Pharmaceuticals, Inc. |
Condensed Consolidated Statements of
Operations (Unaudited) |
(In thousands, except per share
data) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
License revenue |
$ |
- |
|
|
$ |
- |
|
|
$ |
9,500 |
|
|
$ |
- |
|
Government revenue |
|
1,151 |
|
|
|
4,067 |
|
|
|
5,120 |
|
|
|
7,138 |
|
Total
revenue |
|
1,151 |
|
|
|
4,067 |
|
|
|
14,620 |
|
|
|
7,138 |
|
Operating expenses |
|
|
|
|
|
|
|
Research
and development |
|
11,665 |
|
|
|
28,777 |
|
|
|
44,162 |
|
|
|
83,237 |
|
Selling,
general and administrative |
|
9,481 |
|
|
|
5,600 |
|
|
|
22,350 |
|
|
|
15,797 |
|
Total
operating expenses |
|
21,146 |
|
|
|
34,377 |
|
|
|
66,512 |
|
|
|
99,034 |
|
Loss from
operations |
|
(19,995 |
) |
|
|
(30,310 |
) |
|
|
(51,892 |
) |
|
|
(91,896 |
) |
Other income
(expense) |
|
|
|
|
|
|
|
Other
income (expense), net |
|
437 |
|
|
|
302 |
|
|
|
1,215 |
|
|
|
620 |
|
Net loss |
$ |
(19,558 |
) |
|
$ |
(30,008 |
) |
|
$ |
(50,677 |
) |
|
$ |
(91,276 |
) |
Net loss per
share-basic and diluted |
$ |
(0.37 |
) |
|
$ |
(0.63 |
) |
|
$ |
(0.97 |
) |
|
$ |
(2.23 |
) |
Weighted-average number
of common shares used in net loss per share applicable to common
stockholders-basic and diluted |
|
52,937 |
|
|
|
47,347 |
|
|
|
52,131 |
|
|
|
40,942 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tetraphase Pharmaceuticals, Inc. |
Condensed Consolidated Balance Sheets
(unaudited) |
(In thousands) |
|
|
September 30, |
|
December 31, |
|
2018 |
|
2017 |
Assets |
|
|
|
Cash and cash
equivalents |
$ |
96,959 |
|
$ |
136,411 |
Accounts receivable |
|
2,597 |
|
|
4,653 |
Prepaid expenses and other current assets |
|
5,302 |
|
|
6,382 |
Property and equipment, net |
|
1,142 |
|
|
1,395 |
Restricted cash |
|
699 |
|
|
199 |
Intangible assets |
|
4,750 |
|
|
- |
Total assets |
$ |
111,449 |
|
$ |
149,040 |
|
|
|
|
Liabilities and Stockholders'
equity |
|
|
|
Accounts payable and accrued expenses |
$ |
14,391 |
|
$ |
17,865 |
Total deferred revenue |
|
9 |
|
|
660 |
Other liabilities, noncurrent |
|
79 |
|
|
105 |
Total stockholders' equity |
|
96,970 |
|
|
130,410 |
Total
liabilities and stockholders' equity |
$ |
111,449 |
|
$ |
149,040 |
|
|
|
|
|
|
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