~ Reports Revenue of $96.4 million, Including Net
Product Sales of $46.6 million, for the Full-Year 2018 ~
Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage
company, developing and commercializing novel antibiotics to treat
serious bacterial infections, today reported financial results and
provided a business update for the fourth quarter and full-year
ended December 31, 2018. In 2018, Melinta achieved several key
milestones within its commercial, development and business
development operations critical to positioning the company for
long-term growth.
“We are pleased with the decisive actions we
took in 2018 to realign the business and help position Melinta for
future growth and stockholder value creation. In the past year, the
Company has made significant strides to streamline operations and
strengthen its balance sheet, while at the same time executing
against our sales and clinical goals,” said John H. Johnson, chief
executive officer of Melinta. “As a result, we delivered revenues
of $96.4 million, driven by $46.6 million in net product sales. In
addition, the positive results we reported in 2018 give us
confidence in the commercial potential of our products and
pipeline.”
“We have several upcoming milestones in 2019,
including opportunities to potentially expand product labels and
increase our marketing territory. We believe that the Company’s
efforts over the past year coupled with our strategic initiatives
underway position Melinta to continue leading the global fight
against antimicrobial resistance and delivering anti-infective
solutions to patients,” continued Johnson.
Fourth Quarter and Full-Year
Results
- In the fourth quarter, sales of commercial products increased
32% compared to the third quarter of 2018, driven by strong
Vabomere® (meropenem and vaborbactam) and Orbactiv® (oritavancin)
performance
- Delivered full-year 2018 revenues of $96.4 million, including
$46.6 million in net product sales
- Melinta ended the year with $81.8 million of cash and cash
equivalents
Portfolio Updates
- Vabomere received European Commission approval in November 2018
for the following indications in adult patients: --
Complicated intra-abdominal infections
(cIAI) -- Complicated urinary tract infections
(cUTI) -- Hospital-acquired pneumonia including
ventilator associated pneumonia (HAP/VAP) -- Bacteraemia
that occurs in association with any of these
infections -- Infections due to aerobic Gram-negative
organisms where treatment options are limited
- Reported positive top-line results from the Phase III trial of
Baxdela® (delafloxacin) for the treatment of adult patients with
community-acquired bacterial pneumonia (CABP) in October 2018
- Began preparation of supplemental new drug application (sNDA)
to the U.S. Food and Drug Administration (FDA) for Baxdela in CABP,
which is expected to be filed in the second quarter of 2019
- Entered into a commercial agreement with Menarini Group to
commercialize Vabomere, Orbactiv and Minocin® (minocycline) for
injection in 68 countries outside of the U.S. in October 2018
Business Highlights
- John H. Johnson named permanent chief executive officer
- Closed the initial $75 million disbursement under the
previously announced $135 million convertible loan facility from
Vatera Healthcare Partners, LLC on February 22, 2019
- Implementation of operating cost reduction initiatives expected
to deliver significant cost savings in 2019
- Strengthened Board of Directors and senior leadership team
through new appointments adding beneficial experience and expertise
to Melinta
- Effected a one-for-five reverse stock split of the Company's
common stock on February 22, 2019
“We were pleased to announce the closing and
receipt of the initial $75 million disbursement of the $135 million
convertible loan facility from Vatera in February 2019,” said Peter
Milligan, chief financial officer of Melinta. “We believe this
funding, along with existing cash and cash from future revenue,
will provide valuable liquidity to support the Company's operations
as we continue to take steps to become cash-flow positive. We will
continue to exercise disciplined post-integration stewardship of
cash resources and spending to achieve significant operating
expense savings in 2019.”
2019 GuidanceThe Company
provides guidance for the full-year 2019 as follows:
- Net product sales of approximately $65 million
- Gross margin of approximately 55%, including intangible assets
amortization
- Operating expenses of approximately $140 million
Upcoming Potential
Catalysts
- Expected sNDA submission to FDA for Baxdela for treatment of
CABP
- European Commission approval decision for delafloxacin (to be
marketed under the brand name Quofenix) for acute bacterial skin
and skin structure infections (ABSSSI)
- Country approvals for Baxdela in South America and Central
America
- Execute Latin America commercialization agreement for Vabomere,
Orbactiv and Minocin for injection
Fourth Quarter and Full-Year 2018
Financial ResultsMelinta reported revenue of $35.5 million
and $96.4 million, respectively, for the fourth quarter and
full-year ended December 31, 2018. Revenue from product sales was
$14.6 million for the quarter and $46.6 million for the full-year,
representing the first year of product sales in the Company's
history.
in
USD millions |
Q4 2018 |
Q4 2017 |
Full Year 2018 |
Full Year 2017 |
Product sales,
net |
$14,554 |
|
$— |
|
$46,580 |
|
$— |
|
Contract research |
2,776 |
|
4,231 |
|
11,677 |
|
13,959 |
|
License |
18,159 |
|
— |
|
38,173 |
|
19,905 |
|
Total revenue * |
$35,489 |
|
$4,231 |
|
$96,430 |
|
$33,864 |
|
* Excludes BARDA and Carb-X grant funding included in
Other Income of $0.6 million and $5.8 million, respectively, in Q4
2018 and the full-year 2018 |
Cost of goods sold (“COGS”) was $9.0 million and
$41.1 million, respectively, for the fourth quarter and full-year
ended December 31, 2018, of which $3.9 million and $16.4 million
was comprised of non-cash amortization of intangible assets. In
addition, for the fourth quarter and full-year ended December 31,
2018, we recorded $1.0 million and $8.0 million, respectively, in
charges related to inventory that is approaching shelf life,
primarily driven by product launches. There were no product sales
and therefore no costs of goods sold in the prior year period.
Research and development (“R&D”) expenses
were $10.4 million and $55.4 million, respectively, for the fourth
quarter and full-year ended December 31, 2018, compared to $11.6
million and $49.5 million for the same periods in 2017. Selling,
general and administrative (“SG&A”) expenses were $29.5 million
and $133.3 million for the fourth quarter and full-year ended
December 31, 2018, compared to $37.3 million and $63.3 million for
the same periods in 2017. R&D and SG&A expenses increased
primarily as a result of the additional costs associated with the
acquisition of The Medicines Company infectious disease business
("IDB") and the Cempra merger. In addition, SG&A included
severance-related costs of $8.9 million and $12.3 million,
respectively, for the fourth quarter and full-year ended December
31, 2018, as well as an offsetting gain of $8.8 million from the
remeasurement of contingent consideration associated with the
acquisition of the IDB from The Medicines Company in January 2018.
Also, during the fourth quarter of 2018, we recognized goodwill
impairment charges of $25.1 million related to the acquisition of
the IDB in the first quarter of 2018.
Net loss was $44.1 million, or $3.94 per share,
for the fourth quarter of 2018, compared to a net loss of $20.9
million, or $7.40 per share, for the fourth quarter of 2017. Net
loss was $157.2 million, or $17.12 per share, for the year ended
December 31, 2018, compared to a net loss of $78.2 million, or
$109.28 per share, for 2017. Net loss per share year-over-year was
impacted by changes in share count as a result of the Cempra merger
and financing related to the acquisition of the IDB, as well as a
one-for-five reverse stock split effective on February 22,
2019.
Conference Call and
WebcastMelinta’s earnings conference call for the fourth
quarter and full-year ended December 31, 2018 will be broadcast at
4:30 p.m. ET on March 13, 2019. 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 1698998. Investors can also
access the call at
http://ir.melinta.com/events/event-details/melinta-therapeutics-q4-2018-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 # 1698998.
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.
As more fully described in our Annual Report on
Form 10-K for the year ended December 31, 2017, the former private
company Melinta was determined to be the accounting acquirer in our
November 2017 reverse merger with Cempra and, accordingly,
historical financial information for the fourth quarter and full
year 2017 presented in this press release reflects the standalone
former private company Melinta until November 3, 2017, and,
therefore, period-over-period comparisons may not be
meaningful.
Non-GAAP Financial MeasuresTo
supplement our financial results presented on a U.S. generally
accepted accounting principles, or GAAP, basis, we have included
information about non-GAAP adjusted EBITDA, a non-GAAP financial
measure, as a useful operating metric. We believe that the
presentation of this non-GAAP financial measure, when viewed with
our results under GAAP and the accompanying reconciliation,
provides supplementary information to analysts, investors, lenders,
and our management in assessing the Company’s performance and
results from period to period. This non-GAAP measure closely aligns
with the way management measures and evaluates the Company’s
performance. This non-GAAP financial measure should be considered
in addition to, and not a substitute for, or superior to, net
income or other financial measures calculated in accordance with
GAAP. Non-GAAP Adjusted EBITDA is not based on any standardized
methodology prescribed by GAAP and represents GAAP net income
(loss), which the Company believes is the most directly comparable
GAAP measure, adjusted to exclude interest income, interest
expense, depreciation and amortization, stock based compensation
expense, changes in the fair value of our warrant liability,
impairment charges, bargain purchase gains, gains or losses on
extinguishment of debt, acquisition-related costs, gains on the
reversal of loss contracts, and other adjustments, including the
remeasurement of contingent consideration related to our
acquisition of IDB and launch-related excess and obsolete
inventory. Non-GAAP financial measures used by us may be calculated
differently from, and therefore may not be comparable to, non-GAAP
measures used by other companies.
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 the
satisfaction of the closing conditions for the remaining two
disbursements under the loan agreement with Vatera, including any
consequences of a failure to close on the two disbursements under
the Vatera loan financing; risks related to compliance with the
covenants under our facilities with Vatera and Deerfield;
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
to The Medicines Company; risks that may arise from the
consummation of the Vatera loan financing and the effectiveness of
the amendment to the Deerfield facility agreement, including
potential dilution to our stockholders and the fact that Vatera
will beneficially own a substantial portion of our common stock;
the fact that our independent registered public accounting firm’s
report on the Company’s 2016, 2017, and 2018 financial statements
contains an explanatory paragraph that states that 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 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.
Melinta Therapeutics, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share
amounts)
|
Dec 31, |
|
Dec 31, |
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
Assets |
|
|
|
Cash and cash
equivalents |
$ |
81,808 |
|
|
$ |
128,387 |
|
Receivables |
|
22,485 |
|
|
|
7,564 |
|
Inventory |
|
41,341 |
|
|
|
10,825 |
|
Prepaid expenses and
other current assets |
|
3,848 |
|
|
|
2,988 |
|
Total
current assets |
|
149,482 |
|
|
|
149,764 |
|
Property and equipment,
net |
|
1,586 |
|
|
|
1,596 |
|
Intangible assets,
net |
|
229,196 |
|
|
|
7,500 |
|
Other assets |
|
61,326 |
|
|
|
1,413 |
|
Total assets |
$ |
441,590 |
|
|
$ |
160,273 |
|
|
|
|
|
Liabilities and
Shareholders' Equity |
|
|
|
Accounts payable |
$ |
16,765 |
|
|
$ |
7,405 |
|
Accrued expenses |
|
33,924 |
|
|
|
24,041 |
|
Deferred purchase price
and other liabilities |
|
78,394 |
|
|
|
- |
|
Accrued interest on
notes payable |
|
4,485 |
|
|
|
284 |
|
Warrant liability |
|
38 |
|
|
|
- |
|
Total
current liabilities |
|
133,606 |
|
|
|
31,730 |
|
Notes payable, net of
debt discount |
|
110,476 |
|
|
|
39,555 |
|
Deferred revenue |
|
- |
|
|
|
10,008 |
|
Other long-term
liabilities |
|
7,444 |
|
|
|
6,644 |
|
Total
long-term liabilities |
|
117,920 |
|
|
|
56,207 |
|
Total liabilities |
|
251,526 |
|
|
|
87,937 |
|
|
|
|
|
Shareholders'
equity |
|
|
|
Common stock |
|
11 |
|
|
|
4 |
|
Additional paid-in
capital |
|
909,896 |
|
|
|
644,991 |
|
Accumulated
deficit |
|
(719,843 |
) |
|
|
(572,659 |
) |
Total shareholders' equity |
|
190,064 |
|
|
|
72,336 |
|
Total liabilities and shareholders' equity |
$ |
441,590 |
|
|
$ |
160,273 |
|
|
|
|
|
Melinta Therapeutics, Inc.
Consolidated Statements of
Operations
(In thousands, except per share amounts)
|
|
Quarter Ended December 31, |
|
Year Ended December 31, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
(in
000s) |
|
(in
000s) |
Revenue |
|
|
|
|
|
|
|
|
Product
sales, net |
|
$ |
14,554 |
|
|
$ |
- |
|
|
$ |
46,580 |
|
|
$ |
- |
|
Contract
research |
|
|
2,776 |
|
|
|
4,231 |
|
|
|
11,677 |
|
|
|
13,959 |
|
License |
|
|
18,159 |
|
|
|
- |
|
|
|
38,173 |
|
|
|
19,905 |
|
Total
revenue |
|
|
35,489 |
|
|
|
4,231 |
|
|
|
96,430 |
|
|
|
33,864 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
Cost of
goods sold |
|
|
8,989 |
|
|
|
- |
|
|
|
41,057 |
|
|
|
- |
|
Research
and development |
|
|
10,402 |
|
|
|
11,599 |
|
|
|
55,409 |
|
|
|
49,475 |
|
Goodwill
impairment |
|
|
25,088 |
|
|
|
- |
|
|
|
25,088 |
|
|
|
- |
|
Selling,
general and administrative |
|
|
29,455 |
|
|
|
37,349 |
|
|
|
133,312 |
|
|
|
63,325 |
|
Total
operating expenses |
|
|
73,934 |
|
|
|
48,948 |
|
|
|
254,866 |
|
|
|
112,800 |
|
Loss from
operations |
|
|
(38,445 |
) |
|
|
(44,717 |
) |
|
|
(158,436 |
) |
|
|
(78,936 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest income |
|
|
209 |
|
|
|
130 |
|
|
|
730 |
|
|
|
155 |
|
Interest expense |
|
|
(10,847 |
) |
|
|
(1,859 |
) |
|
|
(43,179 |
) |
|
|
(7,624 |
) |
Change in fair value of
warrant liability |
|
|
2,580 |
|
|
|
- |
|
|
|
33,226 |
|
|
|
335 |
|
Loss on extinguishment
of debt |
|
|
- |
|
|
|
- |
|
|
|
(2,595 |
) |
|
|
(607 |
) |
Grant income |
|
|
577 |
|
|
|
- |
|
|
|
5,828 |
|
|
|
- |
|
Other income |
|
|
1,806 |
|
|
|
3 |
|
|
|
1,904 |
|
|
|
98 |
|
Gain on loss contract
reversal |
|
|
- |
|
|
|
- |
|
|
|
5,330 |
|
|
|
- |
|
Bargain purchase
gain |
|
|
- |
|
|
|
27,663 |
|
|
|
- |
|
|
|
27,663 |
|
Total
other income (expense), net |
|
|
(5,675 |
) |
|
|
25,937 |
|
|
|
1,244 |
|
|
|
20,020 |
|
Net
loss |
|
$ |
(44,120 |
) |
|
$ |
(18,780 |
) |
|
$ |
(157,192 |
) |
|
$ |
(58,916 |
) |
|
|
|
|
|
|
|
|
|
Accretion
of convertible preferred stock dividends |
|
- |
|
|
|
(2,098 |
) |
|
|
- |
|
|
|
(19,259 |
) |
Net
loss available to common shareholders |
$ |
(44,120 |
) |
|
$ |
(20,878 |
) |
|
$ |
(157,192 |
) |
|
$ |
(78,175 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share |
|
$ |
(3.94 |
) |
|
$ |
(7.40 |
) |
|
$ |
(17.12 |
) |
|
$ |
(109.28 |
) |
Basic and diluted
weighted-average shares outstanding |
|
|
11,203,779 |
|
|
|
2,820,937 |
|
|
|
9,181,668 |
|
|
|
715,369 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Melinta Therapeutics, Inc.
Consolidated Statement of Cash
Flows
(In thousands)
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
(in
000s) |
|
(in
000s) |
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(44,120 |
) |
|
$ |
(18,780 |
) |
|
$ |
(157,192 |
) |
|
$ |
(58,916 |
) |
Adjustments to
reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
4,014 |
|
|
|
83 |
|
|
|
16,901 |
|
|
|
451 |
|
Bargain
purchase gain |
|
|
- |
|
|
|
(27,663 |
) |
|
|
- |
|
|
|
(27,663 |
) |
Non-cash
interest expense |
|
|
6,361 |
|
|
|
917 |
|
|
|
25,673 |
|
|
|
5,091 |
|
Share-based compensation |
|
|
(576 |
) |
|
|
4,822 |
|
|
|
3,465 |
|
|
|
6,450 |
|
Change in
fair value of warrant liability |
|
|
(2,580 |
) |
|
|
- |
|
|
|
(33,226 |
) |
|
|
(335 |
) |
Changes
in fair value of IDB contingent consideration |
|
|
(8,817 |
) |
|
|
- |
|
|
|
(8,817 |
) |
|
|
- |
|
Loss on
extinguishment of debt |
|
|
- |
|
|
|
- |
|
|
|
2,595 |
|
|
|
607 |
|
Reversal
of loss contract |
|
|
- |
|
|
|
- |
|
|
|
(5,330 |
) |
|
|
- |
|
Provision
for inventory obsolescence |
|
|
986 |
|
|
|
- |
|
|
|
8,042 |
|
|
|
- |
|
Asset
impairment |
|
|
25,695 |
|
|
|
- |
|
|
|
26,076 |
|
|
|
- |
|
Other |
|
|
- |
|
|
|
56 |
|
|
|
- |
|
|
|
70 |
|
Changes in operating
assets and liabilities: |
|
|
|
|
- |
|
|
|
|
|
Receivables |
|
|
16,419 |
|
|
|
3,931 |
|
|
|
(5,044 |
) |
|
|
(3,140 |
) |
Inventory |
|
|
(6,669 |
) |
|
|
(4,828 |
) |
|
|
(17,541 |
) |
|
|
(10,825 |
) |
Prepaids
expenses and other current assets |
|
|
2,494 |
|
|
|
(322 |
) |
|
|
2,180 |
|
|
|
600 |
|
Accounts
payable |
|
|
503 |
|
|
|
(8,572 |
) |
|
|
8,285 |
|
|
|
(1,269 |
) |
Accrued
expenses |
|
|
8,457 |
|
|
|
7,736 |
|
|
|
1,445 |
|
|
|
12,014 |
|
Accrued
interest on notes payable |
|
|
97 |
|
|
|
9 |
|
|
|
4,202 |
|
|
|
110 |
|
Deferred
revenues |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,000 |
|
Deposits
on future inventory purchases |
|
|
(151 |
) |
|
|
- |
|
|
|
(40,773 |
) |
|
|
- |
|
Other
non-current assets and liabilities |
|
|
(2,947 |
) |
|
|
616 |
|
|
|
(2,486 |
) |
|
|
157 |
|
Net cash used in operating activities |
|
|
(834 |
) |
|
|
(41,995 |
) |
|
|
(171,545 |
) |
|
|
(75,598 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities: |
|
|
|
|
|
|
|
|
Cash
acquired in merger with Cempra, Inc. |
|
|
- |
|
|
|
161,410 |
|
|
|
- |
|
|
|
161,410 |
|
IDB
acquisition |
|
|
- |
|
|
|
- |
|
|
|
(166,382 |
) |
|
|
- |
|
Purchases
of intangible assets |
|
|
- |
|
|
|
(2,000 |
) |
|
|
(2,000 |
) |
|
|
(5,500 |
) |
Purchases
of property, plant and equipment |
|
|
(247 |
) |
|
|
(58 |
) |
|
|
(1,690 |
) |
|
|
(849 |
) |
Net cash provided by (used in) investing
activities |
|
|
(247 |
) |
|
|
159,352 |
|
|
|
(170,072 |
) |
|
|
155,061 |
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities: |
|
|
|
|
|
|
|
|
Proceeds
from financing under Deerfield arrangement: |
|
|
|
|
|
|
|
|
Proceeds
from the issuance of notes payable |
|
|
- |
|
|
|
- |
|
|
|
111,421 |
|
|
|
38,844 |
|
Costs
associated with the issuance of notes payable |
|
|
- |
|
|
|
- |
|
|
|
(6,455 |
) |
|
|
- |
|
Proceeds
from the issuance of warrants |
|
|
- |
|
|
|
- |
|
|
|
33,264 |
|
|
|
- |
|
Proceeds
from the issuance of royalty agreement |
|
|
- |
|
|
|
- |
|
|
|
1,472 |
|
|
|
- |
|
Purchase
of notes payable disbursement option |
|
|
- |
|
|
|
- |
|
|
|
(7,609 |
) |
|
|
- |
|
Proceeds
from issuance of common stock, net, to lender |
|
|
- |
|
|
|
- |
|
|
|
51,452 |
|
|
|
- |
|
Other
financing activities: |
|
|
|
|
|
|
|
|
- |
|
Proceeds
from issuance of common stock, net |
|
|
- |
|
|
|
- |
|
|
|
155,273 |
|
|
|
- |
|
Proceeds
from the issuance of convertible promissory notes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
24,526 |
|
Payment
of debt extinguishment fees |
|
|
- |
|
|
|
- |
|
|
|
(2,150 |
) |
|
|
(1,240 |
) |
IDB
acquisition deferred payments |
|
|
(906 |
) |
|
|
- |
|
|
|
(1,633 |
) |
|
|
- |
|
Proceeds
from the exercise of stock options, net of cancellations |
|
|
- |
|
|
|
- |
|
|
|
3 |
|
|
|
88 |
|
Repayment
of notes payable and other |
|
|
- |
|
|
|
(1,163 |
) |
|
|
(40,000 |
) |
|
|
(24,503 |
) |
Net cash provided by (used in) financing
activities |
|
|
(906 |
) |
|
|
(1,163 |
) |
|
|
295,038 |
|
|
|
37,715 |
|
|
|
|
|
|
|
|
|
|
Net change in
cash and cash equivalents |
|
|
(1,987 |
) |
|
|
116,194 |
|
|
|
(46,579 |
) |
|
|
117,178 |
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents and restricted cash at beginning of period |
|
|
83,995 |
|
|
|
12,393 |
|
|
|
128,587 |
|
|
|
11,409 |
|
Cash and cash
equivalents and restricted cash at end of period |
|
$ |
82,008 |
|
|
$ |
128,587 |
|
|
$ |
82,008 |
|
|
$ |
128,587 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Melinta Therapeutics
GAAP to Non-GAAP Adjustments
for the Quarters and Full-Years Ended
December 31, 2018 and 2017
(In thousands)
Three Months Ended December 31, 2018 |
|
Revenue |
Cost of Product Sales |
R&D |
SG&A |
Goodwill impairment |
Other Income (Expense), Net |
Total |
As reported under
GAAP |
|
$ |
35,489 |
$ |
(8,989 |
) |
$ |
(10,402 |
) |
$ |
(29,455 |
) |
$ |
(25,088 |
) |
$ |
(5,675 |
) |
$ |
(44,120 |
) |
EBITDA
adjustments: |
|
|
|
|
|
|
|
|
Interest
expense |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
10,847 |
|
|
10,847 |
|
Interest
income |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(209 |
) |
|
(209 |
) |
Depreciation and amortization |
|
|
- |
|
3,875 |
|
|
31 |
|
|
108 |
|
|
- |
|
|
- |
|
|
4,014 |
|
Total
EBITDA adjustments |
|
|
- |
|
3,875 |
|
|
31 |
|
|
108 |
|
|
- |
|
|
10,638 |
|
|
14,652 |
|
EBITDA |
|
|
35,489 |
|
(5,114 |
) |
|
(10,371 |
) |
|
(29,347 |
) |
|
(25,088 |
) |
|
4,963 |
|
|
(29,468 |
) |
Other
adjustments: |
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
- |
|
41 |
|
|
110 |
|
|
(727 |
) |
|
- |
|
|
- |
|
|
(576 |
) |
Change in
fair value of warrant liability |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(2,580 |
) |
|
(2,580 |
) |
Impairment charges |
|
|
- |
|
- |
|
|
607 |
|
|
- |
|
|
25,088 |
|
|
- |
|
|
25,695 |
|
Other
* |
|
|
- |
|
- |
|
|
- |
|
|
(8,817 |
) |
|
- |
|
|
- |
|
|
(8,817 |
) |
Total
other adjustments |
|
|
- |
|
41 |
|
|
717 |
|
|
(9,544 |
) |
|
25,088 |
|
|
(2,580 |
) |
|
13,722 |
|
Adjusted
EBITDA |
|
$ |
35,489 |
$ |
(5,073 |
) |
$ |
(9,654 |
) |
$ |
(38,891 |
) |
$ |
- |
|
$ |
2,383 |
|
$ |
(15,746 |
) |
*
Remeasurement of contingent consideration for the acquisition of
the infectious disease business from The Medicines Company in
January 2018. |
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, 2017 |
|
|
|
|
|
|
|
|
As reported under
GAAP |
|
$ |
4,231 |
$ |
- |
|
$ |
(11,599 |
) |
$ |
(37,349 |
) |
$ |
- |
|
$ |
25,937 |
|
$ |
(18,780 |
) |
EBITDA
adjustments: |
|
|
|
|
|
|
|
|
Interest
expense |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
1,859 |
|
|
1,859 |
|
Interest
income |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(130 |
) |
|
(130 |
) |
Depreciation and amortization |
|
|
- |
|
- |
|
|
22 |
|
|
61 |
|
|
- |
|
|
- |
|
|
83 |
|
Total
EBITDA adjustments |
|
|
- |
|
- |
|
|
22 |
|
|
61 |
|
|
- |
|
|
1,729 |
|
|
1,812 |
|
EBITDA |
|
|
4,231 |
|
- |
|
|
(11,577 |
) |
|
(37,288 |
) |
|
- |
|
|
27,666 |
|
|
(16,968 |
) |
Other
adjustments: |
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
- |
|
- |
|
|
276 |
|
|
4,546 |
|
|
- |
|
|
- |
|
|
4,822 |
|
Acquisition-related costs |
|
|
- |
|
- |
|
|
- |
|
|
11,735 |
|
|
- |
|
|
- |
|
|
11,735 |
|
Bargain
purchase gain |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(27,663 |
) |
|
(27,663 |
) |
Total
other adjustments |
|
$ |
- |
$ |
- |
|
$ |
276 |
|
$ |
16,281 |
|
$ |
- |
|
$ |
(27,663 |
) |
$ |
(11,106 |
) |
Adjusted
EBITDA |
|
$ |
4,231 |
$ |
- |
|
$ |
(11,301 |
) |
$ |
(21,007 |
) |
$ |
- |
|
$ |
3 |
|
$ |
(28,074 |
) |
|
|
|
|
|
|
|
|
|
Twelve Months Ended December 31, 2018 |
|
|
|
|
|
|
|
|
As reported under
GAAP |
|
$ |
96,430 |
$ |
(41,057 |
) |
$ |
(55,409 |
) |
$ |
(133,312 |
) |
$ |
(25,088 |
) |
$ |
1,244 |
|
$ |
(157,192 |
) |
EBITDA
adjustments: |
|
|
|
|
|
|
|
|
Interest
expense |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
43,179 |
|
|
43,179 |
|
Interest
income |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(730 |
) |
|
(730 |
) |
Depreciation and amortization |
|
|
- |
|
16,366 |
|
|
183 |
|
|
352 |
|
|
- |
|
|
- |
|
|
16,901 |
|
Total
EBITDA adjustments |
|
|
- |
|
16,366 |
|
|
183 |
|
|
352 |
|
|
- |
|
|
42,449 |
|
|
59,350 |
|
EBITDA |
|
|
96,430 |
|
(24,691 |
) |
|
(55,226 |
) |
|
(132,960 |
) |
|
(25,088 |
) |
|
43,693 |
|
|
(97,842 |
) |
Other
adjustments: |
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
- |
|
80 |
|
|
718 |
|
|
2,667 |
|
|
- |
|
|
- |
|
|
3,465 |
|
Change in
fair value of warrant liability |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(33,226 |
) |
|
(33,226 |
) |
Loss on
extinguishment of debt |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
2,595 |
|
|
2,595 |
|
Gain on
loss contract reversal |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(5,330 |
) |
|
(5,330 |
) |
Acquisition-related costs |
|
|
- |
|
- |
|
|
- |
|
|
2,528 |
|
|
- |
|
|
- |
|
|
2,528 |
|
Impairment charges |
|
|
- |
|
|
988 |
|
|
- |
|
|
25,088 |
|
|
- |
|
|
26,076 |
|
Other
** |
|
|
- |
|
6,119 |
|
|
- |
|
|
(8,817 |
) |
|
- |
|
|
- |
|
|
(2,698 |
) |
Total
adjustments |
|
$ |
- |
$ |
6,199 |
|
$ |
1,706 |
|
$ |
(3,622 |
) |
$ |
25,088 |
|
$ |
(35,961 |
) |
$ |
(6,590 |
) |
Adjusted
EBITDA |
|
$ |
96,430 |
$ |
(18,492 |
) |
$ |
(53,520 |
) |
$ |
(136,582 |
) |
$ |
- |
|
$ |
7,732 |
|
$ |
(104,432 |
) |
**
Remeasurement of contingent consideration for the acquisition of
the infectious disease business from The Medicines Company in
January 2018 |
and
launch-related excess and obsolete inventory. |
|
|
|
|
|
|
Twelve Months Ended December 31, 2017 |
|
|
|
|
|
|
|
|
As reported under
GAAP |
|
$ |
33,864 |
$ |
- |
|
$ |
(49,475 |
) |
$ |
(63,325 |
) |
$ |
- |
|
$ |
20,020 |
|
$ |
(58,916 |
) |
EBITDA
adjustments: |
|
|
|
|
|
|
|
|
Interest
expense |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
7,624 |
|
|
7,624 |
|
Interest
income |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(155 |
) |
|
(155 |
) |
Depreciation and amortization |
|
|
- |
|
- |
|
|
255 |
|
|
196 |
|
|
- |
|
|
- |
|
|
451 |
|
Total
EBITDA adjustments |
|
|
- |
|
- |
|
|
255 |
|
|
196 |
|
|
- |
|
|
7,469 |
|
|
7,920 |
|
EBITDA |
|
|
33,864 |
|
- |
|
|
(49,220 |
) |
|
(63,129 |
) |
|
- |
|
|
27,489 |
|
|
(50,996 |
) |
Other
adjustments: |
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
- |
|
- |
|
|
651 |
|
|
5,799 |
|
|
- |
|
|
- |
|
|
6,450 |
|
Change in
fair value of warrant liability |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(335 |
) |
|
(335 |
) |
Acquisition-related costs |
|
|
- |
|
- |
|
|
- |
|
|
11,735 |
|
|
- |
|
|
- |
|
|
11,735 |
|
Loss on
extinguishment of debt |
|
|
- |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
607 |
|
|
607 |
|
Bargain
purchase gain |
|
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
(27,663 |
) |
|
(27,663 |
) |
Total
adjustments |
|
$ |
- |
$ |
- |
|
$ |
651 |
|
$ |
17,534 |
|
$ |
- |
|
$ |
(27,391 |
) |
$ |
(9,206 |
) |
Adjusted
EBITDA |
|
$ |
33,864 |
$ |
- |
|
$ |
(48,569 |
) |
$ |
(45,595 |
) |
$ |
- |
|
$ |
98 |
|
$ |
(60,202 |
) |
|
|
|
|
|
|
|
|
|
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
Melinta Therapeutics (NASDAQ:MLNT)
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From Apr 2024 to May 2024
Melinta Therapeutics (NASDAQ:MLNT)
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From May 2023 to May 2024