Melinta Therapeutics Announces Preliminary Second Quarter 2019 Financial Results and Provides Corporate Update
July 16 2019 - 7:30AM
Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage
company focused on the development and commercialization of novel
antibiotics to treat serious bacterial infections, today reported
preliminary and unaudited financial results and provided a
corporate update for the second quarter ended June 30, 2019.
“Melinta’s preliminary second quarter 2019
results demonstrate that the actions taken to improve upon the
Company's operational and financial efficiencies are continuing to
drive progress,” said John H. Johnson, chief executive officer of
Melinta. “As we enter into the third quarter of 2019, we remain
focused on driving sales efforts, preparing for the potential
Baxdela® (delafloxacin) community-acquired bacterial pneumonia
(CABP) approval and launch, while also continuing to identify
additional ways to reduce expenses. We believe in the strength of
our long-term strategy to best position Melinta for future success
and remain committed to delivering upon our mission of leading
the global fight against antimicrobial resistance and providing
antibiotic solutions to patients and healthcare providers.”
Preliminary Second Quarter 2019
Financial ResultsMelinta anticipates that it will report
net product sales of approximately $13.8 million for the
second quarter of 2019, which is an increase of 51 percent1 over
the second quarter of 2018 and an increase of 17 percent over the
first quarter of 2019.
Melinta also expects to report quarter-end cash
and cash equivalents of approximately $90 million, and the
Company is targeting to reduce full-year 2019 operating expenses by
approximately $70 million.
The figures in the foregoing sentences are all
based upon preliminary estimates and remain subject to change as
the Company finalizes its results for the second quarter of
2019.
The Company will announce its full second quarter 2019 financial
results on August 7, 2019 at 8:30 a.m. ET and plans to host a
conference call at that time.
Recent Corporate Updates
- On July 10, The World Health
Organization (WHO) added Vabomere® (meropenem and vaborbactam) to
its Essential Medicines List for its ability to target
multidrug-resistant infections caused by pathogens deemed a
"critical priority" by the WHO, including carbapenem-resistant
Enterobacteriaceae
- The U.S. Food and Drug
Administration (FDA) recently accepted for priority review a
supplemental New Drug Application (sNDA) for Baxdela®
(delafloxacin) seeking to expand the current indication to include
adult patients with community-acquired bacterial pneumonia (CABP);
the FDA has assigned a Prescription Drug User Fee Act (PDUFA)
action date (proposed review deadline) of October 24, 2019
- Sixteen scientific presentations
and posters of portfolio and pipeline data have been accepted for
presentation at the Infectious Diseases Society of America IDWeek
2019 meeting, being held October 1 – 6, 2019 in Washington,
D.C. and at the American College of Chest Physicians (ACCP) CHEST
Meeting, being held October 19 – 23, 2019 in New Orleans, LA
Second Quarter 2019 Conference Call and
WebcastMelinta’s earnings conference call for the second
quarter of 2019 will be broadcast at 8:30 a.m. ET on August 7,
2019. Investors wishing to participate in the call should dial:
877-377-7553 and international investors should dial: 253-237-1151,
using the conference ID# 5166674. A live webcast of the call will
be available online from the Investor Relations section of the
company website at www.melinta.com and will be archived there for
30 days. A telephone replay of the call will be available by
dialing 855-859-2056 for domestic callers or 404-537-3406 for
international callers and entering the conference ID# 5166674.
About Melinta
TherapeuticsMelinta Therapeutics, Inc. is the largest
pure-play antibiotics company, dedicated to saving lives threatened
by the global public health crisis of bacterial infections through
the development and commercialization of novel antibiotics that
provide new therapeutic solutions. Its four marketed products
include Baxdela® (delafloxacin), Vabomere® (meropenem and
vaborbactam), Orbactiv® (oritavancin), and Minocin® (minocycline)
for Injection. This portfolio provides Melinta with the unique
ability to provide providers and patients with a range of solutions
that can meet the tremendous need for novel antibiotics treating
serious infections. Visit www.melinta.com for more information.
Cautionary Note Regarding
Forward-Looking StatementsCertain statements in this
communication constitute “forward-looking statements” within the
meaning of Section 27A of the Securities Act and Section 21E of the
Securities Exchange Act and are usually identified by the use of
words such as “anticipates,” “believes,” “estimates,” “expects,”
“intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,”
and variations of such words or similar expressions, including
statements related to guidance. We intend these forward-looking
statements to be covered by the safe harbor provisions for
forward-looking statements contained in Section 27A of the
Securities Act and Section 21E of the Securities Exchange Act and
are making this statement for purposes of complying with those safe
harbor provisions. These forward-looking statements reflect our
current views about our plans, intentions, expectations, strategies
and prospects, which are based on the information currently
available to us and on assumptions we have made and include
statements regarding: expectations with respect to our financial
position, results and performance. Although we believe that our
plans, intentions, expectations, strategies and prospects as
reflected in or suggested by those forward-looking statements are
reasonable, we can give no assurance that the plans, intentions,
expectations, strategies or prospects will be attained or achieved.
Furthermore, actual results may differ materially from those
described in the forward-looking statements and will be affected by
a variety of risks and factors that are beyond our control.
Risks and uncertainties for Melinta include, but
are not limited to, the fact that we have incurred significant
operating losses since inception and will incur continued losses
for the foreseeable future; our limited operating history; our need
for future capital and risks related to our ability to obtain
additional capital to fund future operations; risks related to our
failure to close on the full amount of the two disbursements under
the Vatera loan financing and risks related to the satisfaction of
the closing conditions for the remaining disbursement amount,
including the inability to close on such disbursement; risks
related to our ability to borrow additional amounts under the
Deerfield facility agreement; risks related to compliance with the
covenants under our facilities with Vatera and Deerfield;
risks related to our future liquidity, including uncertainties of
cash flows and inability to meet working capital needs as well as
other milestone, royalty and payment obligations, including as a
result of the outcome of the pending litigation with respect to,
and any requirement to make, payments potentially due under our
purchase agreement with to The Medicines Company; risks that
may arise from the Vatera loan financing and
the Deerfield facility agreement, including potential
dilution to our stockholders and the fact that Vatera beneficially
owns a substantial portion of our common stock; risks related to
our ability to continue as a going concern unless we can secure
additional sources of liquidity; our substantial indebtedness;
risks related to potential strategic transactions; risks related to
the commercial launches of our products and our inexperience as a
company in marketing drug products; the degree of market acceptance
of our products among physicians, patients, health care payors and
the medical community; the pricing we are able to achieve for our
products; failure to obtain and sustain an adequate level of
reimbursement for our products by third-party payors; inaccuracies
in our estimates of the market for and commercialization potential
of our products; failure to maintain optimal inventory levels to
meet commercial demand for any of our products; risks that our
competitors are able to develop and market products that are
preferred over our products; our dependence upon third parties for
the manufacture and supply of our marketed products; failure to
achieve the benefits of our recently completed transactions
with Cempra and The Medicines Company; failure to establish
and maintain development and commercialization collaborations;
uncertainty in the outcome or timing of clinical trials and/or
receipt of regulatory approvals for our product candidates;
undesirable side effects of our products; failure of third parties
to conduct clinical trials in accordance with their contractual
obligations; our ability to identify, develop, acquire or
in-license products; difficulties in managing the growth of our
company; the effects of recent comprehensive tax reform; risks
related to failure to comply with extensive laws and regulations;
product liability risks related to our products; failure to retain
key personnel; inability to obtain, maintain and enforce patents
and other intellectual property rights or the unexpected costs
associated with such enforcement or litigation; risks relating to
third party infringement of intellectual property rights; our
ability to maintain effective internal control over financial
reporting; unfavorable outcomes in any of the class action and
shareholder derivative lawsuits currently pending against the
Company; and the fact that a substantial number of shares of common
stock may be sold into the public markets by one or more of our
large stockholders in the near future. Many of these factors that
will determine actual results are beyond Melinta’s ability to
control or predict.
Other risks and uncertainties are more fully
described in our Annual Report on Form 10-K for the year
ended December 31, 2018, our Revised Definitive Proxy
Statement filed January 29, 2019, and in other filings that
Melinta makes and will make with the SEC. Existing and
prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. The statements made in this press release speak only as of
the date stated herein, and subsequent events and developments may
cause our expectations and beliefs to change. While we may elect to
update these forward-looking statements publicly at some point in
the future, we specifically disclaim any obligation to do so,
whether as a result of new information, future events or otherwise,
except as required by law. These forward-looking statements should
not be relied upon as representing our views as of any date after
the date stated herein.
For More Information:
Media Inquiries:Lindsay RoccoElixir Health
Public Relations+1 862-596-1304lrocco@elixirhealthpr.com
Investor Inquiries:Susan Blum+1 312-767-0296
ir@melinta.com
_________________________
1 In connection with its second quarter 2018
earnings release, Melinta disclosed that in the second quarter of
2018, net product sales were negatively impacted by approximately
$2.7 million related to the integration of distribution channels in
connection with the acquisition of the infectious disease business
of The Medicines Company. Absent this integration activity in the
second quarter of 2018, net product sales in the second quarter of
2019 would have increased 17 percent year-over-year.
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