Baxdela™(delafloxacin) Launched February 6, 2018,
in U.S. for Adults with ABSSSI
Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage
company discovering, developing and commercializing novel
antibiotics to treat serious bacterial infections, today reported
financial results and provided an update on commercial and
regulatory activities for the quarter ended December 31, 2017.
During the quarter, the Company completed its reverse merger with
Cempra, Inc. (Cempra) to become a publicly traded company. Fourth
quarter and full year 2017 results include the addition of the
Cempra business as of the merger date of November 3, 2017.
Immediately following the quarter, the Company acquired the
infectious disease business of The Medicines Company, including
products Vabomere™ (meropenem and vaborbactam), Orbactiv®
(oritavancin) and Minocin® (minocycline) for Injection. This press
release includes highlights from The Medicines Company infectious
disease business as of acquisition close on January 5, 2018.
“Following Melinta becoming a public company on November 3, we
swiftly acquired the infectious disease business from The Medicines
Company, transforming Melinta into the largest global, pure-play
antibiotics company. Today, we have a strong portfolio of products
including Vabomere, Orbactiv and Minocin for Injection, together
with our first drug Baxdela that we launched just this quarter,”
said Dan Wechsler, president and CEO of Melinta.
“We have a strong combined team, including the addition of over
150 seasoned professionals at the time of The Medicines Company
transaction, and a leading pipeline of development and discovery
assets including those from our own Nobel Prize-winning discovery
platform. 2018 will be an exciting year for Melinta, and we look
forward to launching our products, furthering our pipeline and
telling our story focused on bringing life-saving anti-infective
products to areas of unmet need and, in turn, building strong
shareholder value over the long-term,” Mr. Wechsler concluded.
Full Year 2017 and Recent Business
Highlights
- March 2, 2017 - entered into commercial and co-development
agreement with Menarini Group for delafloxacin in 68 countries
outside of the United States
- >$100 million of upfront and potential milestone payments
and double-digit royalties on sales in partnered territories
- Menarini pays 50% of future
delafloxacin indication-expansion efforts
- June 19, 2017 - the U.S. Food and Drug Administration (FDA)
approved Baxdela indicated in adults for treatment of acute
bacterial skin and skin structure infections (ABSSSI) caused by
susceptible bacteria
- A fluoroquinolone that exhibits activity against both
Gram-positive and Gram-negative pathogens, including the
distinction of being the only approved drug in its class that
covers methicillin-resistant Staphylococcus aureus (MRSA)
- A fixed-dose therapy with limited disease or drug interactions
and is available in interchangeable intravenous and oral
formulations
- September 26, 2017 - announced the expansion of agreement with
Eurofarma Laboratorios S.A. (Eurofarma) to include 19 countries in
South and Central America and the Caribbean
- Eurofarma has submitted a marketing authorization for
delafloxacin in Argentina
- November 3, 2017 - completed the reverse merger with Cempra to
become a publicly traded company
- January 5, 2018 - acquired the infectious disease business of
The Medicines Company, including approved products Vabomere,
Orbactiv and Minocin for Injection
- Added a well-experienced commercial, medical affairs and
commercial support organization
- Integration nearing completion
- Minimal disruption to product launches or performance,
including Vabomere, which was recently launched
- February 6, 2018 - launched Baxdela in the United States
- March 8, 2018 - partner Menarini submitted a marketing
authorization application (MAA) to the European Medicines Agency
(EMA) for delafloxacin for treatment of adults with ABSSSI
Q4 and Full Year 2017 Financial Results
Melinta reported a net loss available to shareholders of $20.9
million, or $1.48 per share, for the quarter ended December 31,
2017 compared to a net loss of $27.7 million for the same period in
2016. For the full year ended December 31, 2017, the Company
reported net loss available to shareholders of $78.2 million.
Research and development expenses were $11.6 million for the
quarter ended December 31, 2017, compared to $16.3 million for the
same period in 2016. The decrease was driven primarily by fourth
quarter 2016 New Drug Application (NDA)-related fees and milestone
payments and lower manufacturing costs. For the full year ended
December 31, 2017, the Company reported R&D expenses of $49.5
million.
Selling, general and administrative expenses were $37.3 million
for the quarter ended December 31, 2017, compared to $4.6 million
for the same period in 2016. The increase was driven primarily by
commercial launch preparation activities for Baxdela and
transaction- and integration-related costs, including severance and
stock-based compensation, due to the merger. For the full year
ended December 31, 2017, the Company reported selling, general and
administrative expenses of $63.3 million.
As of December 31, 2017, Melinta had cash and cash equivalents
of $128.4 million. In addition, the Company has available debt
capacity under the Deerfield agreement. It is anticipated that
Melinta may strengthen its cash position through the completion of
business development activities, similar to the transaction
completed with Menarini. The Company also recently filed a
universal shelf registration statement on Form S-3 with the SEC,
which will allow the Company to provide more timely and efficient
access to the capital markets should the Company decide to issue
securities in the future, subject to market conditions.
2017 and Recent Pipeline and Publication
Highlights
Includes highlights from The Medicines Company infectious
disease business as of acquisition close on January 5, 2018.
- Publication of Baxdela Outcomes in ABSSSI Patients with
Fluoroquinolone-resistant S. aureus Isolates
- Presented Outcomes of Baxdela Treatment of Gram-Positive and
Gram-Negative Pathogens at IDWeek 2017
- Announced Topical Radezolid (partnered product) Well Tolerated
in Phase 1 Study for Treatment of Acne, Initiation of Program in
Patients with Bacterial Vaginosis, and Qualified Infectious Disease
Product (QIDP) Designation for Bacterial Vaginosis
- Publication in Journal of Antimicrobial Chemotherapy of 1st
Pivotal Phase 3 Baxdela Trial Data in ABSSSI
- Complete Results from the Phase 3 TANGO-1 Data for Vabomere
Published in The Journal of the American Medical Association
(JAMA)
- 2nd Pivotal Phase 3 Baxdela ABSSSI Trial Data Published in
Clinical Infectious Diseases
- Discovery Platform Oral Presentations at European Congress of
Clinical Microbiology and Infectious Diseases (ECCMID) and American
Society for Microbiology (ASM Microbe) Highlighting Progress
Towards Leads for Drug-resistant Neisseria gonorrhoeae and
Multidrug- and Extremely Drug-resistant ESKAPE Pathogens
2018 Upcoming Potential Catalysts
- Pivotal Phase 3 data for Baxdela in community-acquired
bacterial pneumonia (CABP)
- Vabomere EMA regulatory approval decision
- TANGO-2 additional data and potential publications
- Additional ex-US approvals for Baxdela in Central and South
America
- Ex-US partnership opportunities for Vabomere, Orbactiv and
Minocin for Injection
- IND-enabling studies for lead ESKAPE compound
Conference Call and Webcast
Melinta’s earnings conference call for the quarter ended
December 31, 2017 will be broadcast at 8:30am EDT on March 13,
2018. The live webcast can be accessed under "Events and
Presentations" in the Investor Relations section of Melinta’s
website at www.melinta.com.
Investors wishing to participate in the call should dial:
877-377-7553 and international investors should dial: 253-237-1151.
The conference ID is 7787858. Investors can also access the call at
http://ir.melinta.com/events/event-details/melinta-therapeutics-q4-2017-earnings-call.
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 # 7787858.
About Melinta Therapeutics Melinta
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 and better
therapeutic solutions. Its four marketed products include Baxdela™
(delafloxacin); Vabomere™ (meropenem and vaborbactam), Orbactiv®
(oritavancin), and Minocin® (minocycline) for Injection. It also
has an extensive pipeline of preclinical and clinical-stage
products representing many important classes of antibiotics, each
targeted at a different segment of the anti-infective market.
Together, 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.
About Baxdela (delafloxacin)
For more information about Baxdela, including the Medication
Guide and important safety information, including the Boxed
Warning, see www.baxdela.com.
Cautionary Note Regarding Forward-Looking
Statements
Certain 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. 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. 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 or strategies 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;
uncertainties of cash flows and inability to meet working capital
needs as well as other milestone, royalty and payment obligations;
the fact that our independent registered public accounting firm’s
report on the Company’s 2016 and 2017 financial statements contains
an explanatory paragraph that states that the our recurring losses
from operations and our need to obtain additional capital raises
substantial doubt about our ability to continue as a going concern;
our substantial indebtedness; risks related to our 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 amount of shares of common stock may be
sold into the public markets by one or more of our large
shareholders 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, 2017,
which we expect to file promptly with the SEC, 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.
|
|
December 31, |
|
December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
(in 000s) |
|
|
Assets |
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
128,387 |
|
|
$ |
11,409 |
|
|
Receivables |
|
|
7,564 |
|
|
|
454 |
|
|
Inventory |
|
|
10,825 |
|
|
|
- |
|
|
Prepaid expenses and
other current assets |
|
|
2,988 |
|
|
|
3,226 |
|
|
Total
current assets |
|
|
149,764 |
|
|
|
15,089 |
|
|
Property and equipment,
net |
|
|
1,596 |
|
|
|
1,101 |
|
|
Intangible assets |
|
|
7,500 |
|
|
|
- |
|
|
Other assets |
|
|
1,413 |
|
|
|
444 |
|
|
Total assets |
|
$ |
160,273 |
|
|
$ |
16,634 |
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
31,446 |
|
|
$ |
11,496 |
|
|
Notes payable, net |
|
|
- |
|
|
|
11,075 |
|
|
Other current
liabilities |
|
|
284 |
|
|
|
848 |
|
|
Total
current liabilities |
|
|
31,730 |
|
|
|
23,419 |
|
|
Notes payable, net of
current and debt discount |
|
|
39,555 |
|
|
|
12,647 |
|
|
Convertible promissory
notes |
|
|
- |
|
|
|
45,127 |
|
|
Deferred revenue |
|
|
10,008 |
|
|
|
9,008 |
|
|
Other long-term
liabilities |
|
|
6,644 |
|
|
|
1,541 |
|
|
Total liabilities |
|
|
87,937 |
|
|
|
91,742 |
|
|
|
|
|
|
|
|
Convertible preferred
stock |
|
|
- |
|
|
|
218,343 |
|
|
|
|
|
|
|
|
Stockholders'
equity |
|
|
|
|
|
Common stock |
|
|
22 |
|
|
|
- |
|
|
Additional paid in
capital |
|
|
644,973 |
|
|
|
220,292 |
|
|
Accumulated
deficit |
|
|
(572,659 |
) |
|
|
(513,743 |
) |
|
Total stockholders'
equity |
|
|
72,336 |
|
|
|
(293,451 |
) |
|
Total liabilities and stockholders' equity |
|
$ |
160,273 |
|
|
$ |
16,634 |
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
(in 000s) |
|
|
Revenue |
|
|
|
|
|
|
|
|
|
Contract
revenue |
|
$ |
4,231 |
|
|
$ |
- |
|
|
$ |
13,959 |
|
|
$ |
- |
|
|
License |
|
|
- |
|
|
|
- |
|
|
|
19,905 |
|
|
|
- |
|
|
Total
revenue |
|
|
4,231 |
|
|
|
- |
|
|
|
33,864 |
|
|
|
- |
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
11,599 |
|
|
|
16,302 |
|
|
|
49,475 |
|
|
|
49,791 |
|
|
Selling,
general and administrative |
|
|
37,349 |
|
|
|
4,586 |
|
|
|
63,325 |
|
|
|
19,410 |
|
|
Total
operating expenses |
|
|
48,948 |
|
|
|
20,888 |
|
|
|
112,800 |
|
|
|
69,201 |
|
|
Loss from
operations |
|
|
(44,717 |
) |
|
|
(20,888 |
) |
|
|
(78,936 |
) |
|
|
(69,201 |
) |
|
Other income
(expense), net |
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
130 |
|
|
|
6 |
|
|
|
155 |
|
|
|
30 |
|
|
Interest
expense |
|
|
(1,859 |
) |
|
|
(1,478 |
) |
|
|
(7,624 |
) |
|
|
(4,406 |
) |
|
Change
in fair value of tranche assets and liabilities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,313 |
) |
|
Change
in fair value of warrant liability |
|
|
- |
|
|
|
(64 |
) |
|
|
335 |
|
|
|
781 |
|
|
Loss on
extinguishment of debt |
|
|
- |
|
|
|
- |
|
|
|
(607 |
) |
|
|
- |
|
|
Other
income |
|
|
3 |
|
|
|
42 |
|
|
|
98 |
|
|
|
177 |
|
|
Bargain purchase
gain |
|
|
27,663 |
|
|
|
|
|
27,663 |
|
|
|
- |
|
|
Total
other income (expense), net |
|
|
25,937 |
|
|
|
(1,494 |
) |
|
|
20,020 |
|
|
|
(4,731 |
) |
|
Net
loss |
|
$ |
(18,780 |
) |
|
$ |
(22,382 |
) |
|
$ |
(58,916 |
) |
|
$ |
(73,932 |
) |
|
Accretion of
convertible preferred stock dividends |
|
|
(2,098 |
) |
|
|
(5,334 |
) |
|
|
(19,259 |
) |
|
|
(21,117 |
) |
|
Net loss
available to common shareholders |
|
$ |
(20,878 |
) |
|
$ |
(27,716 |
) |
|
$ |
(78,175 |
) |
|
$ |
(95,049 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share |
|
$ |
(1.48 |
) |
|
$ |
(1,186.17 |
) |
|
$ |
(21.86 |
) |
|
$ |
(4,119.67 |
) |
|
Basic and diluted
weighted-average shares outstanding |
|
|
14,105 |
|
|
|
23 |
|
|
|
3,577 |
|
|
|
23 |
|
|
|
|
|
|
|
|
|
|
|
|
For More Information:
Media Inquiries:Amra Maynard(917)
302-2702Amra.maynard@inventivhealth.com
Investor Inquiries:Lisa DeFrancesco(847)
681-3217ldefrancesco@melinta.com
Raj Mistry(312) 801-2051rmistry@melinta.com
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