XERAVA Sales Grew 133% Compared with First
Quarter of 2019
Increased Formulary Uptake, with a 99.7%
Success Rate for all Formulary Reviews to Date
-Company to Hold Conference Call Today at 4:30
PM ET-
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) a
biopharmaceutical company focused on commercializing its novel
tetracycline XERAVATM (eravacycline for injection) to treat serious
and life-threatening infections, today reported financial results
for the second quarter ended June 30, 2019.
“In the second quarter, we continued to work diligently to
increase formulary uptake for XERAVA and are excited to report that
strong month over month sales growth resulted in a 133% increase in
XERAVA revenue compared with the previous quarter, with 154 new
ordering customers in the second quarter,” said Larry Edwards,
President and Chief Executive Officer of Tetraphase. “During the
quarter, we also undertook a corporate reorganization aimed at
maximizing the commercial opportunity of our lead asset, XERAVA.
XERAVA is a critically important new addition to the hospital
antibiotic armamentarium, and as a newly streamlined organization,
we are concentrating our efforts entirely on ensuring its
commercial success. We believe the growth rate in XERAVA revenues
will continue to be strong for the foreseeable future.”
Second Quarter and Recent Highlights
- Continued to Progress Launch of XERAVA in U.S. Hospitals
With High Antibiotic Usage The Company continues to see
increased formulary uptake, with a 99.7% success rate for all
formulary reviews to date. Tetraphase’s salesforce is now focusing
on bringing XERAVA to both Tier 1 as well as Tier 2 institutions,
which are the highest users of antibiotics defined by days of
therapy. The reorder rate for XERAVA continues to be greater than
50%, with the reorder rates as high as 65% within the tier 1
account segment. XERAVA is available at over 500 accounts and
approximately 300 formulary reviews are pending or planned to take
place by the end of the fourth quarter of 2019.
- Implemented Corporate Reorganization Aimed at Maximizing
XERAVA Commercial Opportunity In June, the Company announced a
corporate reorganization, which included the elimination of the
Company’s internal research function and an exploration of
out-licensing opportunities for the Company’s pipeline of
innovative early-stage antibiotic and oncology product candidates.
As part of the reorganization, Larry Edwards, who previously served
as Chief Operating Officer, was appointed President and Chief
Executive Officer, effective August 1st. Mr. Edwards also joined
the Board of Directors. Former President and CEO Guy Macdonald
remains on the Board and will serve as a consultant to the Company
into December 2019. The Company expects that the reorganization and
other cost-saving efforts will result in an approximate $8.0
million reduction in net cash required for operating activities on
an annualized basis.
- Presented New Studies Highlighting Activity of XERAVA at the
2019 Surgical Infection Society (SIS) Congress and at the American
Society for Microbiology (ASM) Microbe 2019 Annual Meeting In
June at the SIS Congress in Coronado, California, the Company
presented positive data from three studies further evaluating
XERAVA in complicated intra-abdominal infections (cIAI), as well as
data from a retrospective study of hospital-based outcomes in cIAI,
underscoring XERAVA’s role as an empiric treatment option for
patients with this type of infection. Also in June, the Company
presented new data from several studies at the American Society for
Microbiology (ASM) Microbe 2019 Annual Meeting in San Francisco,
highlighting the activity of XERAVA against gram-negative and
gram-positive clinical isolates, including multidrug resistant
pathogens.
- First Patient Dosed in Phase 3 Clinical Trial of
Eravacycline for cIAI in China Everest Medicines Limited, which
has the exclusive license to develop and commercialize eravacycline
in China, dosed the first patient in its Phase 3 clinical trial of
eravacycline for cIAI in China. The Phase 3, randomized,
multicenter, double-blind, double-dummy, parallel-group, controlled
study is designed to evaluate the efficacy, safety and tolerability
of eravacycline versus ertapenem for the treatment of cIAI in
hospitalized adult patients.
- Expansion of Territories under the Everest Medicines License
Agreement In July 2019, the Company and Everest Medicines
Limited entered into an amendment to the license agreement to
extend Everest Medicines’ exclusive license to develop and
commercialize eravacycline for cIAI to the jurisdictions of the
Malaysian Federation, the Kingdom of Thailand, the Republic of
Indonesia, the Socialist Republic of Vietnam and the Republic of
the Philippines.
Second Quarter 2019 Financial Results
As of June 30, 2019, Tetraphase had cash and cash equivalents of
$71.0 million and 54.3 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 middle of
the third quarter of 2020.
For the second quarter of 2019, Tetraphase reported a net loss
of $22.9 million, or $0.42 per share, compared to a net loss of
$9.5 million, or $0.18 per share, for the same period in 2018. The
increased loss was largely due to a decrease in license and
collaboration revenue and government revenue of $11.3 million in
the second quarter of 2019 compared with the second quarter of
2018.
Revenues from sales of XERAVA were $0.8 million in the second
quarter of 2019 compared with $0.3 million in the first quarter of
2019. Total revenues, including License and Collaboration Revenue
and Government Revenue, were $1.1 million for the second quarter of
2019, compared to $11.6 million for the same period in 2018. Total
revenues for the second quarter of 2019 consisted of XERAVA product
revenue of $0.8 million as well government contract revenue of $0.3
million. The decrease in total revenues for the second quarter of
2019 compared to the same prior-year period was due to a decrease
in both revenue from our collaboration with Everest Medicines and
government revenue, offset in part by XERAVA revenue.
Research and development (R&D) expenses for the second
quarter of 2019 were $8.2 million, compared to $14.4 million for
the same period in 2018. The decrease in R&D expenses for the
second quarter of 2019 compared to the same prior-year period was
primarily due to a decrease in activity across all of our pipeline
programs vs. the prior year, and lower license and milestone
payments to Harvard University that occurred in the second quarter
of 2018.
Selling, general and administrative (SG&A) expenses for the
second quarter of 2019 were $15.1 million, compared to $7.2 million
for the same period in 2018. This increase in SG&A expenses for
the second quarter of 2019 compared to the same prior-year period
was primarily due to an increase in commercial-related expenses for
XERAVA.
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 844-831-4023 (U.S. and Canada) or
731-256-5215 (international) and entering conference ID number
2336585. 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, August 8, 2019, through 7:30 p.m. ET on Thursday,
August 15, 2019 by dialing and dialing 855-859-2056 (U.S. and
Canada) and 404-537-3406 for (international) callers. The
conference ID number is 2336585. A replay of the webcast will be
available by visiting Tetraphase’s website.
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. 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)
XERAVA 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 XERAVA 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 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 XERAVA™ 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 antibiotics TP-271 and TP-6076, which are
Phase 2 ready, and TP-2846, which is in preclinical testing for
acute myeloid leukemia. The Company intends to out license its
pipeline candidates. 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 our
cash resources and the expected revenue will be sufficient to fund
our operations in the future 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 March 31,
2019, filed with the Securities and Exchange Commission on May 8,
2019. In addition, the forward-looking statements included in this
press release represent our views as of August 8, 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 Balance
Sheets (unaudited)
(In thousands)
June 30,
December 31,
2019
2018
Assets Cash and cash equivalents
$
70,954
$
107,776
Accounts receivable, net
1,728
2,274
Contract asset
-
3,000
Inventory
2,964
748
Prepaid expenses and other current assets
3,047
2,674
Property and equipment, net
683
1,121
Right-of-use operating lease assets
5,549
-
Intangibles assets, net
4,455
4,652
Other assets, noncurrent
699
699
Total assets
$
90,079
$
122,944
Liabilities and Stockholders' equity Accounts payable
and accrued expenses
$
13,900
$
14,971
Lease liabilities
5,686
-
Loan payable
28,748
28,291
Total stockholders' equity
41,745
79,682
Total liabilities and stockholders' equity
$
90,079
$
122,944
Tetraphase Pharmaceuticals, Inc. Condensed
Consolidated Statement of Operations (Unaudited) (In
thousands, except per share data)
Three Months Ended
Six Months Ended
June 30,
June 30,
2019
2018
2019
2018
Revenues: Product revenue, net
$
796
$
-
$
1,137
$
-
License and collaboration revenue
-
9,500
-
9,500
Government revenue
277
2,079
1,209
3,969
Total revenue
1,073
11,579
2,346
13,469
Expenses: Cost of revenue - product
307
-
471
-
Cost of revenue - intangible asset amortization
99
-
197
-
Research and development
8,166
14,370
14,903
32,497
Selling, general and administrative
15,113
7,165
28,427
12,869
Total expenses
23,685
21,535
43,998
45,366
Loss from operations
(22,612)
(9,956)
(41,652)
(31,897)
Other income and expenses
(309)
413
(757)
778
Net loss
$
(22,921)
$
(9,543)
$
(42,409)
$
(31,119)
Net loss per share-basic and diluted
$
(0.42)
$
(0.18)
$
(0.79)
$
(0.60)
Weighted-average common shares used in net loss per share-basic and
diluted
54,274
51,839
54,009
51,721
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Media and Investor Contact: Argot Partners Maeve
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