Conference Call Today at 4:30 p.m. Eastern Time
WATERTOWN, Mass.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24TTPH&src=ctag" target="_blank"gt;$TTPHlt;/agt; lt;a href="https://twitter.com/hashtag/antibioticresistance?src=hash" target="_blank"gt;#antibioticresistancelt;/agt;–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 Limited
In
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 Meeting
In 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 IDWeek
In 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 Conference
At 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 | |||||
Contacts
Jennifer Viera
jviera@tphase.com
617-600-7040