Tetraphase Pharmaceuticals Reports Fourth Quarter and Full-Year 2018 Financial Results and Highlights Achievements and Key 2019 Milestones

March 14, 2019 Off By BusinessWire

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
[email protected]
617-600-7040