BOTHELL, WA, May 14, 2009 (MARKETWIRE via COMTEX) -- MDRNA, Inc. (NASDAQ: MRNA) today reported financial results for the
first quarter ended March 31, 2009.
"The first quarter of 2009 was a period of significant accomplishment
for the Company," stated J. Michael French, President and Chief
Executive Officer. "With the sale of our intranasal contract
manufacturing operations in Hauppauge, N.Y. on March 31st, we
completed our transition from a clinical stage delivery company to a
pre-clinical RNAi drug discovery company, having reduced or
eliminated all of our legacy liabilities within the last nine months.
In addition, during the quarter, we generated over $12 million in
revenue solely from our RNAi technologies. More importantly, we
believe the agreements with Roche and Novartis have validated the key
aspects of our RNAi drug discovery engine: siRNA constructs and siRNA
delivery. We expect to leverage the validation of our platform into
multiple target and therapeutic-based research and development
collaborations with additional pharmaceutical companies. Having
completed our transition to an RNAi drug discovery company, we feel
we have emerged as a true leader in the field."
Revenue for the three months ended March 31, 2009 was $14.2 million,
compared to $1.3 million for the quarter ended March 31, 2008. The
2008 period included $0.7 million in license and research fee revenue,
$0.5 million in Nascobal(R) product sales and $0.1 million in
government grants. Revenue in 2009 primarily included upfront
licensing fees of $7.25 million from Novartis, upfront licensing fees
of $5.0 million from Roche, recognition of $1.0 million in milestone
revenue from Amylin Pharmaceuticals, Inc. related to the amendment to
our 2006 License Agreement and recognition of the remaining $0.7
million of deferred revenue from the $2.0 million payment received in
2005 from QOL due to the Asset Purchase Agreement with Par
Pharmaceutical Companies, Inc. entered into during the first quarter
2009.
Net income for the current quarter was approximately $7.3 million or
$0.23 per share, compared to a net loss of $16.5 million or $0.63 loss
per share for the prior year quarter. This positive net income,
compared to the loss in the 2008 period, reflects in large part
revenue from licensing transactions in the RNA interference space
enabled by our broad RNAi intellectual property estate and drug
discovery platform. These license agreements, as well as target and
therapeutic-based research and development collaborations, represent
the types of periodic transactions contemplated as part of our
business strategy.
Research and development ("R&D") expenses for the current quarter
decreased $6.7 million to $4.2 million compared to the prior year
quarter. In the current quarter, the decrease in our R&D expenses was
associated with our transition from a clinical-stage intranasal drug
delivery company to a pre-clinical RNAi drug discovery company.
Selling, general and administrative expenses for the current quarter
decreased by $2.7 million compared to the prior year quarter to $2.1
million due to our cost containment efforts.
We recorded a net restructuring charge in the first quarter of 2009
of $0.1 million, comprised of facilities related charges. Total
restructuring charges were $1.9 million for the prior year quarter
primarily comprised of employee severance and related costs of
approximately $1.6 million and $0.3 million in net clinical trial
termination fees related to the termination of the clinical trial for
intranasal PTH(1-34) for osteoporosis.
We recorded an expense of $1.0 million during the current quarter
related to the change in fair value of price adjustable warrants, and
a net gain on settlement of liabilities $0.7 million related to our
efforts during early 2009 to restructure our outstanding liabilities,
including our capital lease obligations with GE capital, severance
compensation and other accounts payable.
We ended the first quarter of 2009 with approximately $7.7 million in
cash and cash equivalents, including $2.2 million in restricted cash,
compared to approximately $3.4 million in cash and cash equivalents,
including $2.3 million in restricted cash at December 31, 2008. We
received a "going concern" opinion from KPMG, LLP, our independent
registered accountants, in our 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 presented its plan to regain compliance before
the NASDAQ Listing Qualifications Panel on April 23, 2009, and is
currently waiting for the Panel's response, which is expected by the
end of May 2009.
FIRST QUARTER AND 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.
Advanced the RNAi Drug Discovery Platform and RNAi Pipeline
- 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;
- 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.
Restructured Key Elements of the Company
- 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
- Sold the Company's manufacturing facilities in Hauppauge, New York as
well as the Company's Abbreviated New Drug Application (ANDA) for generic
calcitonin-salmon nasal spray to Par Pharmaceuticals. Under the terms of
the Agreement, MDRNA received upfront cash and will receive profit sharing
on commercial sales of calcitonin. In addition, Par assumed MDRNA's supply
and manufacturing obligations as well as all operating costs associated
with the facilities;
- 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.
Conference Call and Webcast Information
Management will host a conference call to review financial results
for the quarter ended March 31, 2009 and recent business
developments. The call is scheduled for Friday, May 15, 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 866-761-0748 and
international callers should dial 617-614-2706. The participant
passcode for the live conference call is 95089155. 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
passcode for the replay is 40891910. 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.
Financial Tables Follow
MDRNA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Data)
Three Months Ended
March 31,
2008 2009
--------- ---------
(Unaudited)
Revenue
License and research fees $ 682 $ 14,068
Product revenue 488 70
Government grants 93 13
--------- ---------
Total revenue 1,263 14,151
--------- ---------
Operating expenses:
Cost of product revenue 164 ---
Research and development 10,926 4,116
Selling, general and administrative 4,802 2,107
Restructuring 1,917 133
--------- ---------
Total operating expenses 17,809 6,356
--------- ---------
Income (loss) from operations (16,546) 7,795
Other income (expense):
Interest income 293 2
Interest expense (265) (143)
Net gain on settlement of liabilities --- 654
Change in fair value of price adjustable warrants --- (1,027)
--------- ---------
Net income (loss) $ (16,518) $ 7,281
========= =========
Basic and diluted net loss per share:
Net income (loss) per common share -- basic and
diluted $ (0.63) $ 0.23
========= =========
Shares used in computing net loss per share - basic
and diluted 26,211 32,243
========= =========
December 31, March 31,
Selected Balance Sheet Data (In Thousands) 2008 2009
(Unaudited)
Cash and cash equivalents
(includes restricted cash of $2,268
and $2,155, respectively) $ 3,352 $ 7,687
Accounts receivable, net 32 13
Property and equipment, inventories and
other assets 9,753 7,670
Total assets 13,137 15,370
Total liabilities 16,396 11,256
Accumulated deficit (254,085) (247,690)
Contacts:
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.