XERAVA™ Carton Sales Grew over 30% Compared
with Second Quarter of 2019
Increased Formulary Uptake, with a 99% 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 XERAVA™ (eravacycline for injection) to treat serious
and life-threatening infections, today reported financial results
for the third quarter ended September 30, 2019.
“XERAVA has now been on the market for just over a year, and
during that time we have made significant progress, particularly in
the third quarter, with 30% carton growth over last quarter,
leading to a 23% increase in net XERAVA revenue compared with the
previous quarter,” said Larry Edwards, President and Chief
Executive Officer of Tetraphase. “We are squarely focused on
continuing to increase formulary uptake and pull-through, as we
believe XERAVA is a critically important new addition to the
hospital antibiotic armamentarium, and that increased formulary
uptake and pull through will result in increased sales. With our
recent equity offering and payoff of debt, we are now in a stronger
financial position to execute on these goals.”
Third Quarter and Recent Highlights
- Continued to Progress Launch of XERAVA in U.S. Hospitals
The Company continues to see increased formulary uptake, with a 99%
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 very strong with the reorder rates as high as 57%
for all accounts and approximately 70% within the tier 1 account
segment. XERAVA is available at more than 1,000 accounts and
approximately 154 formulary reviews are pending or planned to take
place by the end of the fourth quarter of 2019.
- Completed $7M Equity Financing (Net of Fees and
Expenses) In November 2019, the Company completed a registered
direct offering with a healthcare-focused institutional investor
for the purchase of (i) 300,000 shares of common stock and
accompanying warrants to purchase an aggregate of 300,000 shares of
common stock, and (ii) pre-funded warrants to purchase up to an
aggregate of 1,830,493 shares of common stock and accompanying
warrants to purchase an aggregate of 1,830,493 shares of common
stock. The net proceeds to the Company from the offering, after
deducting the placement agent's fees and other estimated offering
expenses payable by the Company, were approximately $7.0 million.
The Company intends to use the net proceeds from the offering for
the commercialization of XERAVA as well as for working capital and
other general corporate purposes.
- Presented XERAVA Data at the Infectious Disease Society of
America’s (IDSA) Infectious Disease Week (IDWeek) 2019 In
October 2019, XERAVA was featured in seven poster presentations at
IDWeek 2019, which was held October 2-6 in Washington, D.C. The
data lend additional support for the continued use of XERAVA in the
hospital setting to treat serious, life-threating multidrug
resistant infections, including complicated intra-abdominal
infections (cIAI).
- Effected a Reverse Stock Split In September 2019, the
Company effected a 1-for-20 reverse stock split of its common
stock, bringing the Company into compliance with the minimum bid
price requirement for maintaining its listing on the Nasdaq Global
Select Market.
- Completed Payment of Debt to Solar Capital Limited In
August 2019, the Company paid off its remaining debt to Solar
Capital Limited. The Company had previously entered into a loan
agreement with Solar Capital in November 2018 to support the
commercial launch of XERAVA and general corporate purposes. The
payoff of this debt provides the Company with long term financial
flexibility.
Third Quarter 2019 Financial Results
As of September 30, 2019, Tetraphase had cash and cash
equivalents of $24.5 million and 2.7 million shares outstanding.
Subsequent to the end of the third quarter, the Company raised an
additional $7 million, net of expenses, in an equity offering. The
Company expects that its cash and cash equivalents including the
equity proceeds, as well as expected revenue, will be sufficient to
fund operations into the third quarter of 2020.
For the third quarter of 2019, Tetraphase reported a net loss of
$16.3 million, or $6.00 per share, compared to a net loss of $19.6
million, or $7.39 per share, for the same period in 2018, driven by
both increased revenues and lower operating expenses.
Revenues from sales of XERAVA were $1.0 million in the third
quarter of 2019. Total revenues, including License and
Collaboration Revenue and Government Revenue, were $3.3 million for
the third quarter of 2019, compared to $1.2 million for the same
period in 2018. Total revenues for the third quarter of 2019
consisted of XERAVA product revenue of $1.0 million, a territory
expansion payment from Everest Medicines of $2.0 million and
government contract revenue of $0.4 million.
Research and development (R&D) expenses for the third
quarter of 2019 were $5.3 million, compared to $11.7 million for
the same period in 2018. This decrease was primarily due to a
decrease in activity across all of our pipeline programs as
compared to the prior year period.
Selling, general and administrative (SG&A) expenses for the
third quarter of 2019 were $11.4 million, compared to $9.5 million
for the same period in 2018. This increase in SG&A expenses for
the third 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
2362909. 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 Tuesday, November 12, 2019, through 7:30 p.m. ET on Tuesday,
November 19, 2019 by dialing and dialing 855-859-2056 (U.S. and
Canada) and 404-537-3406 for (international) callers. The
conference ID number is 2362909. A replay of the webcast will be
available by visiting Tetraphase’s website.
About XERAVA™
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.
XERAVA™ 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 anticipated sales revenue, 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 runway
and the expected revenue will be sufficient to fund our operations
in the future and other commercial risk factors discussed in the
"Risk Factors" section of our quarterly report on Form 10-Q for the
period ended June 30, 2019, filed with the Securities and Exchange
Commission on August 8, 2019. In addition, the forward-looking
statements included in this press release represent our views as of
November 12, 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) September
30,2019 December 31,2018 Assets
Cash and cash equivalents
$
24,508
$
107,776
Accounts receivable, net
1,710
2,274
Contract asset
-
3,000
Assets held for sale
544
-
Inventory
2,434
748
Prepaid expenses and other current assets
2,718
2,674
Property and equipment, net
113
1,121
Intangibles assets, net
4,357
4,652
Operating lease right-of-use assets
5,197
-
Restricted cash
699
699
Total assets
$
42,280
$
122,944
Liabilities and Stockholders' equity Accounts payable
and accrued expenses
$
10,320
$
14,971
Operating lease liabilities
5,347
-
Loan payable, long term
-
28,291
Total stockholders' equity
26,613
79,682
Total liabilities and stockholders' equity
$
42,280
$
122,944
Tetraphase Pharmaceuticals, Inc.Condensed Consolidated
Statement of Operations (Unaudited) (In thousands, except
per share data)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2019
2018
2019
2018
Revenues: Product revenue, net
$
978
$
-
$
2,115
$
-
License and collaboration revenue
2,000
-
2,000
9,500
Government revenue
362
1,151
1,571
5,120
Total revenue
3,340
1,151
5,686
14,620
Expenses: Cost of revenue - product sales
882
-
1,353
-
Cost of revenue - intangible asset amortization
98
-
295
-
Research and development
5,348
11,665
20,252
44,162
Selling, general and administrative
11,350
9,481
39,776
22,350
Total expenses
17,678
21,146
61,676
66,512
Loss from operations
(14,338
)
(19,995
)
(55,990
)
(51,892
)
Other income and expenses
(1,966
)
437
(2,723
)
1,215
Net loss
$
(16,304
)
$
(19,558
)
$
(58,713
)
$
(50,677
)
Net loss per share-basic and diluted
$
(6.00
)
$
(7.39
)
$
(21.70
)
$
(19.44
)
Weighted-average number of common shares used in net loss per
share-basic and diluted
2,716
2,647
2,706
2,607
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191112005929/en/
Media and Investor Contact: Argot Partners Maeve
Conneighton 212-600-1902 maeve@argotpartners.com
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