Conference Call Today at 4:30 p.m. Eastern
Time
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a
biopharmaceutical company focused on developing and commercializing
novel tetracyclines to treat serious and life-threatening
conditions, today reported financial results for the fourth quarter
and year ended December 31, 2018, provided an overview of recent
achievements, and highlighted key milestones for 2019.
“We capped off 2018 with a strong finish, with the regulatory
approvals of XERAVA™ (eravacycline) 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
mid-October,” said Guy Macdonald, President and Chief Executive
Officer of Tetraphase. “With the U.S. launch off to a solid start,
XERAVA is now available for use in U.S. hospitals and healthcare
institutions for the treatment of a range of patients with empiric
and confirmed cIAI. We are encouraged by the progress we have made
during our first few months of launch, with more than 400 formulary
reviews already completed or scheduled to occur by mid-year and a
re-ordering rate for XERAVA above 70 percent. Further, as we look
to the balance of 2019, we have made the decision to delay
launching XERAVA in the EU5 independently and will instead continue
to focus our resources on building momentum and supporting a
successful launch in the U.S.”
Mr. Macdonald continued, “With respect to our pipeline, we
expect to complete our bronchopulmonary disposition study for
TP-6076, targeted against Acinetobacter baumannii and other
multidrug-resistant pathogens, later this year and look forward to
presenting preclinical data on our new acute myeloid leukemia (AML)
pipeline candidate, TP-2846, at the American Association for Cancer
Research (AACR) Annual Meeting in Atlanta.”
Key Milestones for 2019
- Complete 400 formulary reviews for
XERAVA by mid-year
- Present preclinical data on TP-2846 at
the AACR Annual Meeting – 2Q 2019
- Everest Medicines to begin Phase 3
clinical trial of eravacycline in cIAI in China – 2Q 2019
- Complete bronchopulmonary disposition
study for TP-6076 – 2H 2019
Fourth Quarter and Recent Highlights
- Commercially Launched XERAVA for
cIAI in the U.S.The Company commercially launched XERAVA in the
U.S. in mid-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. The salesforce is
focusing on institutions responsible for treating 90 percent of
patients with Gram-negative infections. Currently, three
antimicrobial susceptibility tests (ASTs) have been approved for
commercial use including the Eravacycline Mast Disk by Hardy
Diagnostics; the Eravacycline MIC Strip by Liofilchem, Inc.; and
the Sensititre Plate by Thermo Fisher Scientific, Inc. Previously,
more than 200 healthcare institutions ordered ASTs for
research-use-only purposes.
- 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.
- Entered into Loan and Security
Agreement with Solar Capital LimitedIn November 2018, the
Company entered into a loan agreement with Solar Capital Limited,
providing up to $75 million, with $30 million funded at closing,
which is being used to support the commercial launch of XERAVA and
for general corporate purposes.
- Announced New Preclinical Data on
TP-2846 for AML to be Presented at the 2019 AACR Annual
MeetingIn February 2019, Tetraphase announced it will present
three posters on TP-2846, the Company’s newly revealed pipeline
candidate for AML, at the 2019 AACR Annual Meeting taking place
March 29 – April 3 at the Georgia World Congress Center in Atlanta.
The poster presentations will include in vitro and in vivo data
supporting TP-2846’s potential as a novel tetracycline antileukemia
agent.
- Approval of Everest Medicines’
Investigational New Drug (IND) Application for Eravacycline in cIAI
by the China National Medical Products Administration (NMPA)In
June 2018, Everest Medicines, a C-Bridge Capital-backed
biopharmaceutical company, which has the exclusive license to
develop and commercialize eravacycline in China, Taiwan, Hong Kong,
Macau, South Korea and Singapore, submitted an IND application to
the China NMPA, formerly the China FDA. The IND was approved by
China NMPA, and Everest expects to begin enrolling patients in its
Phase 3 study of eravacycline in cIAI in the second quarter of
2019.
- Presented XERAVA and TP-6076 Data at
the Infectious Disease Society of America’s (IDSA) 2018
IDWeekIn October 2018, 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 and microbiological eradication rates
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
ConferenceAt the ACCP 2018 Global Conference in October, the
Company announced positive data from a post-hoc analysis of two
Phase 3 trials of XERAVA in cIAI in higher-risk populations – obese
patients and those with altered renal function. Similar clinical
cure rates were observed for XERAVA in these populations across all
classifications of renal function, further supporting that the drug
is an effective empiric treatment for cIAI and may provide an
alternative to antibiotics that require dosing modification in
patients with altered renal function. XERAVA was also effective
regardless of body mass index when dosed 1mg/kg IV every 12 hours,
based on total body weight when compared to carbapenems.
Fourth Quarter and Full-Year 2018 Financial Results
As of December 31, 2018, Tetraphase had cash and cash
equivalents of $107.8 million and 53.7 million shares outstanding.
The Company expects that its cash and cash equivalents, as well as
expected revenue, will be sufficient to fund operations into the
third quarter of 2020.
For the fourth quarter of 2018, Tetraphase reported a net loss
of $21.5 million, or $0.40 per share, compared to a net loss of
$23.5 million, or $0.46 per share, for the same period in
2017. For the year ended December 31, 2018, Tetraphase
reported a net loss of $72.2 million, or $1.37 per share, compared
to a net loss of $114.8 million, or $2.63 per share, for the same
period in 2017.
XERAVA product revenue for the fourth quarter and year ended
December 31, 2018 was $178,000, reflecting sales of the product
which was commercially introduced in the U.S. in mid-October
2018.
Total revenues were $4.3 million for the fourth quarter of
2018, compared to $2.5 million for the same period in
2017. Total revenues were $18.9 million for the year
ended December 31, 2018, compared to
$9.7 million for the same period in 2017. Total revenues
for the fourth quarter and year ended December 31, 2018 consisted
of XERAVA product revenue, license and collaboration revenue from
the Company’s relationship with Everest Medicines and government
contract revenue. The increases in total revenues for the fourth
quarter and year ended December 31, 2018 compared to the same
prior-year periods were primarily due to the collaboration and
XERAVA revenue, neither of which existed in 2017.
Research and development (R&D) expenses for the fourth
quarter of 2018 were $10.7 million, compared to $18.5
million for the same period in 2017. R&D expenses for the
year ended December 31, 2018 were $54.9 million, compared
to $101.7 million for the same period in 2017. The decreases
in R&D expenses for the fourth quarter and year ended December
31, 2018 compared to the same prior-year periods were primarily due
to lower clinical trial costs associated with the IGNITE Phase 3
clinical trials, which concluded in the first quarter of 2018, and
a decrease in chemistry, manufacturing and controls (CMC) expenses
for XERAVA.
Selling, general and administrative (SG&A) expenses for the
fourth quarter of 2018 were $14.7 million, compared to $7.9
million for the same period in 2017. SG&A expenses for the year
ended December 31, 2018 were $37.1 million, compared to $23.7
million for the same period in 2017. The increases in SG&A
expenses for the fourth quarter and year ended December 31, 2018
compared to the same prior-year periods were primarily due to an
increase in commercial launch-related expenses for XERAVA and
related G&A infrastructure investments.
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
4187876. To access the live audio webcast, 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, March 14, 2019, through 7:30 p.m. ET on Thursday,
March 21, 2019 and by dialing 855-859-2056 (U.S. and Canada) or
404-537-3406 (international). The conference ID number is 4187876.
A replay of the webcast will be available on 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, tetracycline-class antibacterial
drugs or to any of the excipients. 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 eight 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 eight 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 Pharmaceuticals, Inc., is a biopharmaceutical company
using its proprietary chemistry technology to create novel
tetracyclines for serious and life-threatening conditions,
including bacterial infections 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 XERAVATM is approved for the
treatment of complicated intra-abdominal infections 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, and TP-2846, which is in preclinical
testing for acute myeloid leukemia. 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,
including our key milestones for 2019 and our anticipated cash
runway, 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 our commercial launch of XERAVA in the U.S. will be
successful; our cash resources and the expected revenue will be
sufficient to fund our operations for the period anticipated; our
product candidates will succeed in clinical trials and even if the
clinical trials are successful, we may never achieve regulatory
approval of such product candidates and other clinical, regulatory
and commercial risk factors discussed in the "Risk Factors" section
of our quarterly report on Form 10-Q for the period ended September
30, 2018, filed with the Securities and Exchange Commission on
November 9, 2018. In addition, the forward-looking statements
included in this press release represent our views as of March 14,
2019. 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.
Tetraphase Pharmaceuticals,
Inc.
Condensed Consolidated Statement of Operations (Unaudited)
(In thousands, except per share data)
Three Months Ended
Year Ended
December 31, December 31, 2018
2017 2018 2017 Revenues: Product
revenue, net $ 178 $ - $ 178 $ - License and collaboration revenue
3,177 - 12,677 - Government revenue 928 2,528
6,049 9,666 Total revenue 4,283 2,528 18,904 9,666 Expenses:
Cost of revenue - product 130 - 130 - Cost of revenue - intangible
asset amortization 98 - 98 - Research and development 10,717 18,468
54,879 101,706 Selling, general and administrative 14,727
7,878 37,078 23,675 Total expenses
25,672 26,346 92,185 125,381 Loss from
operations (21,389) (23,818) (73,281)
(115,715) Other income and expenses Interest income 532 343 1,747
963 Interest expense (624) - (624) -
Net loss $ (21,481) $ (23,475) $ (72,158) $ (114,752) Net loss per
share-basic and diluted $ (0.40) $ (0.46) $ (1.37) $ (2.63)
Weighted-average common shares used in net loss per share-basic and
diluted 53,652 51,415 52,514 43,582
Tetraphase Pharmaceuticals, Inc. Condensed
Consolidated Balance Sheets (Unaudited) (In thousands)
December 31,
December 31, 2018 2017 Assets Cash and
cash equivalents $ 107,776 $ 136,411 Accounts receivable, net 2,274
4,653 Contract asset 3,000 - Inventory 748 - Prepaid expenses and
other current assets 2,674 6,382 Property and equipment, net 1,121
1,395 Intangibles assets, net 4,652 - Other assets, noncurrent
699 199 Total assets $ 122,944 $ 149,040
Liabilities and Stockholders' equity Accounts payable and
accrued expenses $ 14,957 $ 17,865 Deferred revenue 6 660 Loan
payable 28,291 - Other liabilities, noncurrent 8 105 Total
stockholders' equity 79,682 130,410 Total liabilities
and stockholders' equity $ 122,944 $ 149,040
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190314005773/en/
Jennifer Vierajviera@tphase.com617-600-7040
Tetraphase Pharmaceuticals (NASDAQ:TTPH)
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