BOTHELL, WA, Mar 24, 2009 (MARKET WIRE via COMTEX) -- MDRNA, Inc. (NASDAQ: MRNA) today reported financial results for the
fourth quarter and year ended December 31, 2008.
"Since July 2008, MDRNA has made significant strides in its
transition from a clinical stage intranasal drug delivery company to
an RNAi drug discovery company," stated J. Michael French, President
& CEO of MDRNA. "In the second half of 2008, we reduced headcount,
terminated all legacy intranasal clinical programs; closed down idle
facilities and began to sell excess assets. In 2009, we have
renegotiated terms with our landlord, converted our capital leases
into a venture loan, significantly reduced certain employee severance
payments and successfully settled certain trade payables via
negotiated discounts and stock issuances. We expect that the above
restructuring, renegotiation and cost containment efforts will result
in cash utilization of approximately $5.5 million beginning in the
second quarter of 2009, a greater than 25% reduction compared to the
fourth quarter of 2008. Additionally, we have entered into two
non-exclusive license agreements with major international
pharmaceutical companies -- Novartis and Roche -- which we believe
validates our science, our unique intellectual property portfolio and
our outstanding team. MDRNA is now poised to emerge as a solid drug
discovery company focused in the cutting-edge area of RNAi-based
therapeutics."
Revenue for the three months ended December 31, 2008 was $0.2
million, compared to $6.4 million for the quarter ended December 31,
2007. The 2007 period included recognition of approximately $5.5
million in previously deferred revenue related to our collaboration
with Procter & Gamble Pharmaceuticals, Inc. ("P&G"). Revenue for the
year ended December 31, 2008 was $2.6 million, compared to $18.1
million for the year ended December 31, 2007. Revenue in 2008
included Nascobal(R) product sales, amortization of deferred revenue
from a $2.0 million payment received in 2005 from QOL Medical LLC
("QOL"), revenue from feasibility program partners and our government
grant. The 2007 period included revenue from a $2.0 million payment
from QOL related to the June 2007 issuance of a patent for
Nascobal(R) nasal spray, which was received and recognized in June
2007, revenue from P&G as well as revenue from other pharmaceutical
company research and development collaborations.
Net loss for the current quarter was approximately $12.3 million or
$0.39 per share, compared to a net loss of $12.0 million or $0.47 per
share for the prior year quarter. The 2008 period net loss included
the following non-recurring items totaling $5.5 million: noncash
stock compensation, accrued severance for the Company's former CSO
and accrual of a legacy intranasal patent milestone settlement. Net
loss for the year ended December 31, 2008 was $59.2 million or $2.01
per share, compared to $52.4 million or $2.10 per share for the prior
year period. The per-share decrease resulted from the current year's
loss being spread over a greater number of shares outstanding. The
2008 annual period included $8.3 million in restructuring charges,
compared to zero during 2007.
Cost of product revenue increased $2.8 million for the year ended
December 31, 2008, compared to the prior year due to a non-cash
inventory write-down of approximately $2.6 million recorded in the
second quarter of 2008.
Research and development expenses for the current quarter decreased
$3.1 million to $9.7 million, compared to the prior year quarter, and
decreased $15.5 million to $36.8 million for the year ended December
31, 2008, compared to the prior year. In the current quarter and
year, MDRNA's decrease in R&D expenses were largely associated with
its restructuring plan to transition from a clinical-stage intranasal
drug delivery company to a pre-clinical RNAi drug discovery company.
Lower R&D expenses related to this transition were offset by
restructuring charges. In 2007, MDRNA initiated four clinical trials
to evaluate nasal sprays for the treatment of osteoporosis, obesity,
Type 2 diabetes and autism, which contributed to the higher research
and development spending in 2007. Some of these legacy clinical
trials continued into mid-2008.
Selling, general and administrative expenses for the current quarter
decreased by $3.3 million to $2.5 million, compared to the prior year
quarter, and decreased $6.7 million to $13.6 million for the year
ended December 31, 2008, compared to the prior year, due primarily to
lower headcount from the Company's restructuring plan, cost
containment efforts, and lower legal and consulting fees in 2008.
MDRNA recorded a net restructuring charge in the fourth quarter of
2008 of $0.2 million, comprised of property and equipment and
facilities related charges. Total restructuring charges were $8.3
million for the year ended December 31, 2008.
The Company ended 2008 with approximately $3.4 million in cash and
cash equivalents, including $2.3 million in restricted cash, compared
to $41.6 million at the end of 2007, including $2.2 million in
restricted cash. As a result of its low cash position, the Company
anticipates receiving a "going concern" opinion from KPMG, LLP, its
independent registered public accountants, to be included in the
Company's 10-K for the 2008 fiscal year.
As previously disclosed, the Company received a Staff Determination
from The NASDAQ Stock Market arising out of its non-compliance with
NASDAQ Marketplace Rule 3340(a)(3), which requires a minimum of $10
million in stockholders' equity for continued listing on the NASDAQ
Global Market. MDRNA has scheduled a hearing before a NASDAQ Listing
Qualifications Panel in April 2009 to review the Staff Determination,
at which time MDRNA will present its plan to regain compliance with
this requirement.
RECENT CORPORATE ACCOMPLISHMENTS
Strengthened Management Team and Scientific Leadership
-- Hired Barry Polisky, Ph.D., as Chief Scientific Officer. Dr. Polisky
previously served as Research Vice President at Merck & Co. and Chief
Scientific Officer at Sirna Therapeutics where he led the research and
development of RNAi-based therapeutics.
Validated RNAi Drug Discovery Platform through multiple Pharma
Licensing
Deals
-- Entered into a worldwide, non-exclusive sublicense agreement with
Roche for MDRNA's siRNA constructs and chemistry platform;
-- Entered into a worldwide, non-exclusive licensing agreement with
Novartis for MDRNA's liposomal technology platform for siRNA delivery.
Additionally, the companies have entered into a separate agreement, which
provides Novartis with an exclusive period to negotiate a research and
development collaboration and broader licensing rights related to MDRNA's
RNAi drug delivery platform.
Corporate Restructuring Accomplishments
-- Eliminated rent obligations from January 2009 until July 2010 on the
Company's excess facility in Bothell, Washington through a previously
disclosed lease amendment;
-- Significantly reduced previously disclosed employee-related cash
severance payments for both a one-time cash payment due in June 2009 as
well as continuing severance payments through September 2009;
-- Significantly reduced the Company's ongoing monthly payments to
General Electric Capital Corporation on leased equipment and leasehold
improvements by restructuring the debt into a Loan and Security Agreement;
-- Our restructuring, renegotiation and cost containment efforts will
result in cash utilization of approximately $5.5 million beginning in the
second quarter of 2009, a greater than 25% reduction compared to the fourth
quarter of 2008.
Monetized Legacy Nasal Assets
-- Received tentative approval by the FDA for generic calcitonin-salmon
nasal spray for osteoporosis and are preparing for commercial launch in mid-
2009. The Company will receive profits related to the commercial sale of
the product through the Company's partner Par Pharmaceutical;
-- Received an accelerated $1.0 million milestone payment from Amylin
Pharmaceuticals for advancement of the intranasal exenatide program by
amending a 2006 Development and Licensing Agreement. Under terms of the
amended agreement, MDRNA could receive up to an additional $79 million in
future milestones and royalties;
-- Engaged Adjuvant Global Advisors, LLC to identify potential licensing
opportunities for MDRNA's intranasal delivery clinical programs in Asia and
Europe.
SCIENTIFIC ACCOMPLISHMENTS IN THE COMPANY'S RNAI DRUG DISCOVERY
PROGRAM
-- Reported positive in vivo data on the Company's proprietary RNAi drug
discovery engine at multiple international meetings and conferences.
The Company reported:
-- Systemically delivered meroduplex siRNAs were: (1) well tolerated;
(2) effective against multiple liver targets when delivered
systemically, and (3) inhibited tumor growth when applied topically
for bladder cancer. Keystone Symposia's RNAi, MicroRNA, and
Non-coding RNA Meeting;
-- Robust activity in a mouse model following a single IV
administration of MDRNA's meroduplexes targeting apolipoprotein B
(ApoB) mRNA formulated in a DiLA(2) delivery vehicle. The meroduplex
siRNA decreased both ApoB mRNA and serum cholesterol levels. In
addition, the formulated, chemically modified siRNA resulted in
minimal body weight loss in mice while showing reduced levels of
cytokine stimulation. "RNA 2008," the 13th Annual Meeting of the
RNA Society;
-- Positive efficacy data demonstrating a 100 to 1000-fold (99%)
reduction in viral titers of influenza A virus in animal models
with the Company's proprietary RNAi-based therapeutic for the
treatment of multiple strains of influenza. XIV International
Congress of Virology;
-- Positive efficacy data demonstrating up to 90% knockdown of ApoB
and reduced serum cholesterol with the Company's proprietary
unlocked nucleobase analogs siRNAs (UsiRNA) in animal models.
Informa Life Sciences 9th Annual Conference, EuroTIDES;
-- Positive data demonstrating a dose response, which resulted in up
to 90% knockdown of ApoB message in a rodent model using UsiRNAs
targeting multiple metabolic targets. Informa Life Sciences TIDES
Oligonucleotide and Peptide, Research, Technology and Product
Development Conference.
-- Refocused the Company's pipeline efforts on a single indication --
hepatocellular carcinoma (liver cancer) -- to maximize the use of
capital and increase the potential success of pre-clinical studies
and early stage human clinical trials.
BROADENED AND ENHANCED THE COMPANY'S INTELLECTUAL PROPERTY ESTATE
-- Filed multiple patent applications, including intellectual property
rights, that:
-- expanded protection for the Company's DiLA(2) delivery platform;
-- added novel chemistries to MDRNA's growing patent portfolio; and
-- further expanded the Company's target IP for siRNA therapeutics;
-- Acquired the intellectual property related to Unlocked Nucleobase
Analog (UNA) technology from RiboTask ApS thereby increasing the
breadth of the Company's technology platform by providing additional,
novel RNA chemistries;
-- Terminated the Company's 2006 license agreement with City of Hope for
technology and intellectual property related to Dicer substrates and
will focus on the development of the Company's proprietary and solely
owned UsiRNA and meroduplex constructs.
Conference Call and Webcast Information
Management will host a conference call to review financial results
for the period ended December 31, 2008, and recent business
developments. The call is scheduled for Tuesday, March 24, 2009, at
8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). To participate in
the live conference call, U.S. residents should dial 866-356-4441 and
international callers should dial 617-597-5396. The participant code
for the live conference call is 88132749. To access the 24-hour
telephone replay, U.S. residents should dial 888-286-8010 and
international callers should dial 617-801-6888. The participant code
for the replay is 27372871. Alternatively, to access the live audio
webcast for this conference call, please go to MDRNA's Web site at
http://www.mdrnainc.com approximately 15 minutes prior to the
conference call in order to register and download any necessary
software. A replay of the webcast will be available for 30 days
following the event.
About MDRNA, Inc.
MDRNA is a biotechnology company focused on the development and
commercialization of therapeutic products based on RNA interference
(RNAi). The Company's goal is to improve human health by combining
novel RNAi-based compounds and proprietary peptide- and
liposomal-based drug delivery technologies to provide superior
therapeutic options. MDRNA's multi-disciplinary portfolio of
capabilities includes molecular biology, cellular biology,
formulation expertise, peptide and alkylated amino acid chemistry,
pharmacology, toxicology and bioinformatics. The Company is applying
this expertise to a single, integrated drug discovery platform that
will be the engine for its clinical pipeline and a versatile platform
for establishing broad therapeutic partnerships. MDRNA is also
building on new technologies, such as UsiRNAs that incorporate the
non-nucleotide moiety Unlocked Nucleobase Analog (UNA) within the
siRNA molecule, that it expects to lead to safer and more effective
RNAi-based therapeutics. By combining broad expertise in siRNA
science with proven delivery platforms and a strong and growing IP
position, MDRNA is well positioned as a leading RNAi therapeutics
company and value-added collaborator for our research partners.
Additional information about MDRNA, Inc. is available at
http://www.mdrnainc.com.
MDRNA Forward-Looking Statement
Statements made in this news release may be forward-looking
statements within the meaning of Federal Securities laws that are
subject to certain risks and uncertainties and involve factors that
may cause actual results to differ materially from those projected or
suggested. Factors that could cause actual results to differ
materially from those in forward-looking statements include, but are
not limited to: (i) the ability of MDRNA to obtain additional
funding; (ii) the ability of MDRNA to attract and/or maintain
manufacturing, research, development and commercialization partners;
(iii) the ability of MDRNA and/or a partner to successfully complete
product research and development, including preclinical and clinical
studies and commercialization; (iv) the ability of MDRNA and/or a
partner to obtain required governmental approvals; and (v) the
ability of MDRNA and/or a partner to develop and commercialize
products that can compete favorably with those of competitors.
Additional factors that could cause actual results to differ
materially from those projected or suggested in any forward-looking
statements are contained in MDRNA's most recent periodic reports on
Form 10-K and Form 10-Q that are filed with the Securities and
Exchange Commission. MDRNA assumes no obligation to update and
supplement forward-looking statements because of subsequent events.
MDRNA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Data)
Three Months Ended Years Ended
December 31, December 31,
2007 2008 2007 2008
--------- --------- --------- ---------
(Unaudited)
Revenue
License and research fees $ 6,152 $ 147 $ 17,349 $ 1,360
Government grants 126 40 433 277
Product revenue 110 -- 355 972
--------- --------- --------- ---------
Total revenue 6,388 187 18,137 2,609
--------- --------- --------- ---------
Operating expenses:
Cost of product revenue,
including non-cash inventory
write-down of $0 and $2,579
in the three and twelve
months ended December 31,
2008, respectively 32 -- 100 2,906
Research and development 12,842 9,749 52,254 36,771
Selling, general and
administrative 5,824 2,488 20,314 13,617
Restructuring -- 173 -- 8,257
--------- --------- --------- ---------
Total operating expenses 18,698 12,410 72,668 61,551
--------- --------- --------- ---------
Loss from operations (12,310) (12,223) (54,531) (58,942)
Other income (expense):
Interest income 586 22 3,308 519
Interest and other expense (291) (100) (1,149) (797)
--------- --------- --------- ---------
Net Loss $ (12,015) $ (12,301) $ (52,372) $ (59,220)
========= ========= ========= =========
Basic and diluted net loss per
share:
Net loss per common share --
basic and diluted $ (0.47) $ (0.39) $ (2.10) $ (2.01)
========= ========= ========= =========
Shares used in computing net
loss per share - basic and
diluted 25,444 31,147 24,995 29,529
========= ========= ========= =========
December 31, December 31,
Selected Balance Sheet Data (In Thousands) 2007 2008
(Unaudited) (Unaudited)
Cash, cash equivalents and investments
(includes restricted cash of $2,155 and $2,268,
respectively) $ 41,573 $ 3,352
Accounts receivable, net 324 32
Property and equipment, inventories and other
assets 19,719 9,753
Total assets 61,616 13,137
Total liabilities 22,396 16,396
Accumulated deficit (194,865) (254,085)
Matthew D. Haines
Senior Director, Investor Relations and Corporate Communications
(212) 209-3874
Email Contact
McKinney|Chicago (Media)
Alan Zachary
(312) 944-6784 x 316 or
(708) 707-6834
Email Contact
SOURCE: MDRNA, Inc.
http://www2.marketwire.com/mw/emailprcntct?id=288288A7F21D13FF
http://www2.marketwire.com/mw/emailprcntct?id=B6762A542790DFDA