Emisphere Technologies, Inc. (OTCBB:EMIS) today reported financial
results for the quarter ended March 31, 2016, and provided an
overview of corporate accomplishments and plans.
“During the first quarter 2016, on the commercial side of our
business, we continued to focus on building new, high value
partnerships and securing a strategic transaction or alliance to
realize the full healthcare and economic potential of oral Eligen
B12™,” said Alan L. Rubino, President and Chief Executive Officer
of Emisphere. “Development of our Eligen® Technology carriers also
continued with Novo Nordisk A/S (NYSE:NVO), our most advanced
collaborative partner, having commenced Phase 3a development with
oral semaglutide, a once daily treatment for Type 2 diabetes which
utilizes SNAC, one of our Eligen® Technology carriers. Novo Nordisk
is also continuing to evaluate the feasibility of using the Eligen®
Technology for the development of oral formulations targeting major
metabolic disorders under the new “expansion” license agreement.
Novo Nordisk’s recent progress with oral semaglutide and its
expanded feasibility testing provides important validation for our
Eligen® Technology and its ability to facilitate absorption from
the gastrointestinal tract.”
First Quarter 2016 HIGHLIGHTS
- Novo Nordisk Commenced Global Phase 3a Clinical Trials for Oral
Semaglutide. During the first quarter of 2016, Novo Nordisk
commenced Phase 3a testing for oral semaglutide, which utilizes
Emisphere’s absorption-enhancing monosodium N-[8-(2-hydroxybenzoyl)
amino] caprylate (SNAC) carrier. Novo Nordisk plans to conduct ten
clinical trials enrolling approximately 9,300 patients with Type-2
diabetes in this Phase 3a program. The advancement of oral
semaglutide into Phase 3a development represents a significant
milestone for both Emisphere and the Eligen® Technology platform
and supports the Company’s belief that products developed using
Eligen® carriers have the potential to overcome bioavailability
challenges commonly associated with the oral administration of
peptides and certain other compounds.
- Novo Nordisk Continues Feasibility Studies under our
Development and License Agreement to Develop Oral Formulations
Targeting Metabolic Indications. In October 2015, Emisphere and
Novo Nordisk entered into a new license agreement to develop and
commercialize oral formulations of four classes of Novo Nordisk’s
investigational molecules targeting major metabolic disorders,
including diabetes and obesity, using Emisphere’s oral Eligen®
Technology. Emisphere received a $5.0 million upfront licensing
fee, and is eligible to receive up to $207 million in development
and sales milestone payments in addition to royalties on sales of
each successfully commercialized product under this agreement.
- Exploring Strategic Partnership Opportunities for Oral Eligen
B12™ in the U.S. and Internationally. Eligen B12™ is the first and
only once-daily oral prescription medical food tablet shown to
normalize B12 levels without the need for an injection. Eligen B12™
is indicated for the dietary management of patients who have a
medically-diagnosed vitamin B12 deficiency, associated with a
disease or condition that cannot be managed by a modification of
the normal diet alone. Eligen B12™ utilizes Emisphere's SNAC
carrier to chaperone B12 through the gastric lining and directly
into the bloodstream even in the absence of intrinsic factor, a
protein made in the stomach that normally facilitates B12
absorption.
- Global Eligen® Technology Business Development Initiatives
Continue. During the first quarter 2016, we continued to pursue our
comprehensive business development initiative designed to identify
and secure new Eligen® Technology partnerships. Eligen® Technology
is a proven delivery system technology that is applicable to a
broad range of chemical entities and has been shown to increase the
benefit of the therapy by improving bioavailability or absorption
or by decreasing time to onset of action. The Company currently
owns rights to an extensive portfolio of carriers with strong
patent protection. The current focus of the business development
initiative is on next generation, smaller proteins and peptides,
proven and/or approved drug compounds, and the development of new
oral formulations to replace injectables.
- Grant of Waivers and Extensions Under Debt Facility,
Convertible Notes and Reimbursement Notes. During November 2015,
the creditor under our Loan Agreement, Convertible Notes and
Reimbursement notes agreed to waive any event of default resulting
from our failure to satisfy the net sales milestone for the Eligen
B12™ product for the 2015 fiscal year specified in our Loan and
Royalty Agreements. The creditor has also agreed to extend the date
by which we are required to use 50% of the $14 million received
from Novo Nordisk to pre-pay certain loans and notes (the “Loan
Prepayment”) until June 13, 2016, provided that we deliver to the
creditor a revised proposal (the “Proposal”) regarding potential
amendments and waivers to certain loan agreements and related
matters by May 20, 2016. In the event we do not timely deliver the
Proposal, the Loan Prepayment will be due on May 20, 2016. We
intend to submit the Proposal before May 20, 2016. We believe that
our current cash balance will provide sufficient capital to
continue operations through approximately July 2016. However, if
the pre-payment obligation is further extended or waived, the
Company will have sufficient cash to operate through approximately
July 2017.
FIRST QUARTER 2016 FINANCIAL RESULTS
Emisphere reported a net loss of $1.8 million, or ($0.03) per
basic and diluted share, for the quarter ended March 31, 2016,
compared to a net loss of $33.0 million, or $0.54 per basic and
diluted share, for the quarter ended March 31, 2015.
The Company reported an operating loss of $2.7 million for the
first quarter 2016, compared to an operating loss of $4.7 million
for the same period in 2015.
Total operating expenses were $3.0 million for the first quarter
2016, a decrease of $1.6 million or 35% compared to the same period
in 2015. Total operating expenses include research and development
costs of $0.1 million compared to $0.2 million in 2015, and
selling, general and administrative expenses of $2.9 million, a
decrease of $1.5 million or 34% compared to the same period in
2015. Other income for the first quarter of 2016 was $0.9 million
compared to other expense of $28.3 million for the first quarter
2015.
Weighted average basic and diluted shares outstanding for the
three months ended March 31, 2016, and March 31, 2015,
was 60,687,478.
LIQUIDITY
As of March 31, 2016, Emisphere had approximately $10.4 million
in cash, a net decrease of $2.5 million from December 31,
2015, approximately $8.9 million working capital deficiency, a
stockholders’ deficit of approximately $153.7 million and an
accumulated deficit of approximately $556.3 million. The $7.2
million Loan Prepayment is due and payable on June 13, 2016,
provided that if the Company does not deliver the Proposal to the
creditor by May 20, 2016, the Loan Prepayment will be due and
payable on May 20, 2016, unless a waiver or further extension is
obtained. The Company intends to submit the Proposal to the
creditor before May 20, 2016.
As of March 31, 2016, the Company’s obligations included
approximately $46.5 million (face value) under its Second Amended
and Restated Convertible Notes (the “Convertible Notes”),
approximately $22.8 million (face value) under a loan agreement
dated August 20, 2014 (the “Loan Agreement”), approximately
$0.8 million (face value) under its Second Amended and Restated
Reimbursement Notes (the “Reimbursement Notes”), and approximately
$2.1 million (face value) under its Second Amended and Restated
Bridge Notes (the “Bridge Notes”). The Convertible Notes and the
Loan Agreement are subject to various sales, operating and
manufacturing performance criteria.
On October 26, 2015, we received a total payment of $14 million
from Novo Nordisk pursuant to, and consisting of, $5 million as
payment for entry into the Expansion License Agreement and $9
million as prepayment of a product development milestone and in
exchange for a reduction in certain future royalty payments that
may have become due and payable under the terms of the GLP-1
Development License Agreement.
Under terms of its loan agreements, the Company is obligated to
pre-pay certain loans and notes using 50% of any extraordinary
receipts, such as the $14 million received from Novo Nordisk. The
creditor under our Loan Agreement and Reimbursement Notes has
agreed to extend the date by which we are required to use 50% of
the $14 million received from Novo Nordisk to pre-pay certain loans
and notes until June 13, 2016, provided that the Company delivers
the Proposal to the Creditor by May 20, 2016. In the event that the
Company does not timely deliver the Proposal, the Loan Prepayment
will be due on May 20, 2016. Because the Loan Prepayment deadline
has not been extended beyond one year from March 31, 2016, we have
classified $7.0 million of the loans and notes as a current
liability as of March 31, 2016.
We believe that our current cash balance will provide sufficient
capital to continue operations through approximately July 2016.
However, if the pre-payment obligation is further extended or
waived, the Company will have sufficient cash to operate through
approximately July 2017. The Company’s future capital requirements
beyond July 2016 (or July 2017, in the event the pre-payment
obligation is further extended or waived) and its financial success
depend largely on its ability to raise additional capital,
including by leverage existing and securing new partnering
opportunities for Eligen B12™ and for the Eligen® Technology.
While our plan is to raise capital from commercial operations
and/or product partnering opportunities to address our capital
deficiencies and meet our operating cash requirements, there is no
assurance that our plans will be successful. If we fail to generate
sufficient capital from commercial operations or partnerships, we
will need to seek capital from other sources and risk default under
the terms of our existing loans. We cannot assure you that
financing will be available on favorable terms or at all. If we
fail to generate sufficient additional capital from sales of oral
Eligen B12™ or obtain substantial cash inflows from existing or new
partners or other sources prior to July 2016 (or July 2017, in the
event the prepayment obligation is further extended or waived), we
could be forced to cease operations. Additionally, if additional
capital is raised through the sale of equity or convertible debt
securities, the issuance of such securities would result in
dilution to our existing stockholders. These conditions raise
substantial doubt about our ability to continue as a going concern.
Consequently, the audit reports prepared by our independent
registered public accounting firm relating to our financial
statements for the years ended December 31, 2015, 2014
and 2013 include an explanatory paragraph expressing substantial
doubt about our ability to continue as a going concern.
CONFERENCE CALL AND WEBCAST INFORMATION
The live webcast of the conference call can be accessed through
the Company’s web site at www.emisphere.com. The call can also be
accessed by dialing (877) 303-9483 (United States and Canada)
or (760) 666-3584 (international), and entering Conference ID#
7280403. In addition, an archive of the webcast can be accessed
through the same link and an audio replay of the call will be
available beginning Monday, May 16, 2016 at 11:30 AM ET
through 11:59 PM ET on May 23, 2016, by calling
(855) 859-2056 (United States and Canada) or
(404) 537-3406 (International), and entering Conference ID#
7280403.
ABOUT ELIGEN B12™
Eligen B12™ is indicated for the dietary management of patients
who have a medically-diagnosed vitamin B12 deficiency, associated
with a disease or condition that cannot be managed by a
modification of the normal diet alone. Eligen B12™ is designed so
that patients only need to take a single oral tablet
(cyanocobalamin 1000 mcg/salcaprozate sodium [SNAC] 100 mg) of B12
daily.
Eligen B12™ is the first and only prescription medical food that
has been shown to normalize vitamin B12 levels comparable to an
intramuscular (IM) injection of B12. In a study that compared the
impact of Eligen B12™ and IM B12 on plasma B12 levels in 50
patients with demonstrated B12 deficiency (serum B12 <350
pg/mL), both products normalized B12 levels by Day 15 (first
observation) and maintained normal levels over the duration of the
study (three months). In a study that compared bioavailability in
20 healthy subjects of Eligen B12™ with that of a standard oral B12
supplement, the bioavailability of Eligen B12™ was 5.09 percent
compared with 2.16 percent, which is more than double the
bioavailability of the conventional over-the-counter oral B12
supplement formulation at the same dose.
Eligen B12™ is classified by the U.S. Food and Drug
Administration as a medical food. A medical food is a prescription
product formulated to be consumed or administered orally under
medical supervision for the treatment of a disease or condition
that cannot be managed by a modification of the normal diet
alone.
For more information, visit www.eligenb12.com.
ELIGEN B12™ IMPORTANT SAFETY INFORMATION
Those with an allergy to B12, cobalt or any ingredients of
Eligen B12™ should not take this product. Eligen B12™ should not be
taken by people who have Leber’s disease, which physicians may
refer to as hereditary optic nerve atrophy. Cyanocobalamin (B12)
can lead to optic nerve damage (and possibly blindness) in people
with Leber’s disease. Note that Eligen B12™ has not been studied in
patients below 18 years of age.
ABOUT EMISPHERE
Emisphere Technologies, Inc. (“Emisphere” or the “Company”) is a
pharmaceutical and drug delivery company. The Company launched its
first prescription product, oral Eligen B12™, in the U.S. in March
2015 and we are currently engaged in strategic discussions to
optimize its economic value in the U.S. and global markets. Beyond
Eligen B12™, the Company utilizes its proprietary Eligen®
Technology to create new oral formulations of therapeutic agents.
Emisphere is currently partnered with global pharmaceutical
companies for the development of new orally delivered therapeutics.
For more information, please visit www.emisphere.com.
SAFE HARBOR STATEMENT REGARDING FORWARD-LOOKING
STATEMENTS
The statements in this release or oral statements made by
representatives of Emisphere relating to matters that are not
historical facts are forward-looking statements that involve risks
and uncertainties, including, but not limited to, the sufficiency
of the Company’s cash position, the Company’s ability to enter into
strategic partnerships, the Company’s ability to capture market
share for oral Eligen B12™ or any potential products, the success
of the Company’s commercialization initiatives, the ability if the
Company and/or that of its partners to develop, manufacture and
commercialize products using Emisphere’s drug delivery technology,
and other risks and uncertainties detailed in Emisphere’s filings
with the Securities and Exchange Commission, including those
factors discussed under the caption “Risk Factors” identified in
the documents Emisphere has filed, or will file, with the
Securities and Exchange Commission (“SEC”). Copies of Emisphere’s
filings with the SEC may be obtained from the SEC Internet site at
http://www.sec.gov. Emisphere expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in Emisphere’s expectations with regard thereto or any change in
events, conditions, or circumstances on which any such statements
are based.
|
EMISPHERE TECHNOLOGIES, INC. |
CONDENSED STATEMENT OF OPERATIONS |
For the three months ended March 31, 2016 and
2015 |
(in thousands, except share and per share data) |
(unaudited) |
|
|
|
For the Three Months Ended |
|
|
March 31, |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
Net revenue |
$ |
|
373 |
|
$ |
|
6 |
|
|
|
|
|
|
Cost of goods sold |
|
|
52 |
|
|
|
25 |
|
|
|
|
|
|
Gross profit
(loss) |
|
|
321 |
|
|
|
(19 |
) |
|
|
|
|
|
Costs and
expenses: |
|
|
|
|
Research and development |
|
|
91 |
|
|
|
228 |
|
General and administrative
expenses |
|
|
1,340 |
|
|
|
1,293 |
|
Selling expenses |
|
|
1,595 |
|
|
|
3,125 |
|
Depreciation and amortization |
|
|
4 |
|
|
|
3 |
|
Total costs and expenses |
|
|
3,030 |
|
|
|
4,649 |
|
Operating loss |
|
|
(2,709 |
) |
|
|
(4,668 |
) |
|
|
|
|
|
Other non-operating
income (expense): |
|
|
|
|
Other income |
|
|
5 |
|
|
|
3 |
|
Change in fair value of derivative
instruments |
|
|
|
|
Related party |
|
|
3,449 |
|
|
|
(25,609 |
) |
Other |
|
|
122 |
|
|
|
(853 |
) |
Interest expense, related
party |
|
|
(2,696 |
) |
|
|
(1,841 |
) |
Total other
non-operating income (expense) |
|
|
880 |
|
|
|
(28,300 |
) |
Net loss |
$ |
|
(1,829 |
) |
$ |
|
(32,968 |
) |
Net loss per share,
basic and diluted |
$ |
|
(0.03 |
) |
$ |
|
(0.54 |
) |
Weighted average shares
outstanding, basic and diluted |
|
|
60,687,478 |
|
|
|
60,687,478 |
|
|
|
|
|
|
|
|
|
|
|
EMISPHERE TECHNOLOGIES INC. |
CONDENSED BALANCE SHEETS |
MARCH 31, 2016 AND DECEMBER 31,
2015 |
(in thousands, except share and per share data) |
|
|
|
March 31, 2016 |
|
December 31,2015 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
|
10,360 |
|
$ |
|
12,898 |
|
Accounts Receivable, net |
|
|
297 |
|
|
|
455 |
|
Inventories |
|
|
1,323 |
|
|
|
1,340 |
|
Prepaid expenses and other current
assets |
|
|
769 |
|
|
|
1,081 |
|
|
|
|
|
|
Total Current Assets |
|
|
12,749 |
|
|
|
15,774 |
|
|
|
|
|
|
Equipment and leasehold
improvements, net |
|
|
8 |
|
|
|
12 |
|
Security deposits |
|
|
24 |
|
|
|
24 |
|
|
|
|
|
|
Total assets |
$ |
|
12,781 |
|
$ |
|
15,810 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS DEFICIT |
|
|
|
|
Current
liabilities |
|
|
|
|
Accounts payable and accrued
expenses |
$ |
|
1,649 |
|
$ |
|
2,121 |
|
Notes payable, related party |
|
|
7,000 |
|
|
|
7,000 |
|
Deferred Revenue, current
portion |
|
|
684 |
|
|
|
631 |
|
Royalty Payable – related
party |
|
|
208 |
|
|
|
208 |
|
Derivative instruments |
|
|
|
|
Related party |
|
|
12,067 |
|
|
|
12,690 |
|
Others |
|
|
83 |
|
|
|
205 |
|
|
|
|
|
|
Total current liabilities |
|
|
21,691 |
|
|
|
22,855 |
|
|
|
|
|
|
Notes payable, related
party, net of related discount |
|
|
54,408 |
|
|
|
54,172 |
|
Accrued interest,
related party |
|
|
2,376 |
|
|
|
- |
|
Derivative instruments
– related party |
|
|
32,245 |
|
|
|
35,071 |
|
Deferred revenue |
|
|
55,616 |
|
|
|
55,616 |
|
Royalty payable –
related party |
|
|
86 |
|
|
|
- |
|
Deferred lease
liability and other liabilities |
|
|
11 |
|
|
|
14 |
|
|
|
|
|
|
Total liabilities |
|
|
166,433 |
|
|
|
167,728 |
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
- |
|
|
|
- |
|
Stockholders’
deficit: |
|
|
|
|
Preferred stock, $.01
par value; 4,000,000 shares authorized; none-issued and
outstanding |
|
|
- |
|
|
|
- |
|
Common stock, $.01 par
value; 400,000,000 shares authorized; issued 60,977,210 Shares
(60,687,478 outstanding) as of March 31, 2016 and December 31,
2015 |
|
|
610 |
|
|
|
610 |
|
Additional
paid-in-capital |
|
|
406,039 |
|
|
|
405,944 |
|
Accumulated
deficit |
|
|
(556,349 |
) |
|
|
(554,520 |
) |
Common stock held in
treasury, at cost; 289,732 shares |
|
|
(3,952 |
) |
|
|
(3,952 |
) |
Total stockholders’ deficit |
|
|
(153,652 |
) |
|
|
(151,918 |
) |
Total liabilities and stockholders’
deficit |
$ |
|
12,781 |
|
$ |
|
15,810 |
|
|
COMPANY CONTACTS:
Michael R. Garone, CFO
973.532.8005
mgarone@emisphere.com
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