Monogram Biosciences, Inc. (Nasdaq:MGRM) today reported
financial results for the quarter ended March 31, 2009.
The Company reported revenues of $14.2 million for the first
quarter of 2009, compared to $14.8 million in the first quarter of
2008.
Including deferred revenue from sales of Trofile� related to
Pfizer of $1.1 million, total revenue for the quarter on this
non-GAAP basis was $15.3 million, compared to Non-GAAP total
revenue of $15.6 million in the first quarter of 2008. In addition
to the reported revenue, Monogram records as deferred revenue on
its balance sheet, the sale of Trofile assays related to Pfizer for
patient testing outside of the U.S. and for use in Pfizer�s
clinical trials. This revenue was recorded as deferred revenue due
to the accounting treatment for the Company�s collaboration with
Pfizer. �With Trofile now available in over 30 countries around the
world, total revenue, including assay revenue that is deferred for
accounting purposes, along with our reported revenue provides a
more complete reflection of the progress in our business,� said
William Young, Monogram Chief Executive Officer.
Monogram had $13.7 million in cash at March 31, 2009. �We
continue to be tightly focused on those key programs and
deliverables that we believe will drive the most significant
stockholder value,� added Young. �The steps taken to reduce our
costs have been effective and our overall use of cash was $2.2
million in the first quarter. We are making good progress toward
our goal of achieving cash flow breakeven by the fourth quarter of
2009.�
Outlook
�We continue to look to three separate sources of revenue growth
in 2009,� continued Young. These are:
- Increased sales of Trofile due
to its clinically proven high level of sensitivity for selecting
appropriate patients for CCR5 therapy and an increasingly positive
profile for Selzentry�, Pfizer�s CCR5 antagonist, as a treatment
option for a broad group of treatment-experienced HIV
patients.
- Sales of HERmark� for assessment
of breast cancer patients� HER2 status, and later in 2009, for
assessment of Herceptin� resistance pathways for HER2 positive
patients.
- Use of VeraTag� assays for our
expanded portfolio in drug development programs focused on EGFR/HER
targets.
�The general economic environment is challenging,� continued
Young. �While this may continue to affect us during 2009, we
believe that our products are well positioned. We expect to
capitalize on the proven strong clinical utility of Trofile and a
strong and improving long term outlook for Selzentry to increase
Trofile revenue over the remainder of the year. Our oncology
programs, too, are building momentum.�
HIV Update
�Trofile continues to be the clinically accepted method for
assessment of tropism,� said William Welch, Monogram Chief
Commercial Officer. �Our interactions with HIV physicians, together
with our market research, suggests that the CCR5 class of HIV drugs
is gaining in interest as an option for treatment-experienced HIV
patients, and that greater use of Trofile for patient selection can
be expected.�
�Looking to the future, we see several additional positive
factors for the CCR5 class, for Selzentry and for Trofile,� added
Welch. �Pfizer�s submission for a treatment-na�ve indication for
Selzentry is now under review by the FDA and after regulatory
review and approval, Selzentry may receive this expanded
indication. Schering Plough�s CCR5 antagonist, vicriviroc, is also
expected to enter regulatory review and the addition of a second
drug in the class will generate increased attention on the CCR5
class by physicians.�
Also, Pfizer has recently announced the intention to create a
joint venture with GlaxoSmithKline in which the two companies will
pool their HIV drugs and drugs in development in a new entity that
will be focused exclusively on HIV. This more focused organization
is expected to have a sales force substantially larger than that
currently deployed by Pfizer alone.
�All of these factors can be expected to bring increased
attention on the strong safety profile and on the effectiveness of
the CCR5 class of HIV drugs,� added Welch. �Trofile has a strong
position as the only clinically validated way to determine tropism
and we look forward to these developments generating increased use
of Trofile to select patients.�
Oncology Update
�In the first few months of 2009, we have continued to build on
the ability of our VeraTag assays, including our first
CLIA-validated product, the HERmark Breast Cancer Assay, to make
reliable, accurate and quantitative measurements of a number of
proteins and protein complexes in the EGFR/HER family,� commented
Young. �As many of these markers are believed to be important to
the progress of multiple cancers, this positions the VeraTag
platform for an important role in patient selection and clinical
development across a broad spectrum of cancer therapy.�
�We are pleased with the progress of our commercialization of
the HERmark Breast Cancer Assay as a tool for physicians to
identify markers of response to HER2 targeted drugs in metastatic
breast cancer,� commented Young. �Our goal in 2009 is to supplement
the current HER2 measurements in HERmark by incorporating at least
one additional marker of potential resistance to HER2 antagonists
such as trastuzumab.� Key elements of Monogram�s programs related
to this goal are:
- Publication in a peer reviewed
journal of the data previously presented at the San Antonio Breast
Cancer Symposium in December 2008. This study (the �Lipton Study�)
provided clinical evidence for the superiority of HERmark over
conventional FISH and IHC testing for predicting patient response
to trastuzumab. This data has been submitted for publication.
- Conducting studies to confirm
the results of the Lipton Study in an additional patient cohort to
further validate the clinical utility of HERmark as a predictor of
response to trastuzumab for patients with metastatic breast cancer.
Initial samples have been received related to two such studies and
further studies are under discussion. Our goal is to receive
samples and to complete the analyses to enable presentation of
validating clinical results in 2009.
- Extending the Lipton Study in
metastatic breast cancer by making additional VeraTag measurements,
such as those for p95, HER3 and HER heterodimers, in existing
patient samples to investigate the relationship between those
biomarkers and clinical outcomes, and subsequently submitting study
results for presentation in 2009 and for subsequent
publication.
We are introducing HERmark and its clinical utility in
metastatic breast cancer to oncologists, through our direct sales
and education team to educate the physician community about the
clinical utility of HERmark and to drive additional adoption of
HERmark by oncologists. We will also be presenting HERmark and its
clinical utility to payers to obtain reimbursement. �Physicians are
reacting well to HERmark and several have not only ordered HERmark
but have done so on a repeat basis,� said William Welch, Monogram
Chief Commercial Officer. �Additionally, we are receiving payments
for assays and, as clinical utility is published, we will be
communicating this to payers to optimize reimbursement policies and
payment levels.�
In addition to the development and commercialization of the
HERmark Breast Cancer Assay, Monogram is also working with
biopharmaceutical companies to incorporate VeraTag assays into
their preclinical and clinical development programs for cancer
therapies that target markers in the EGFR/HER family. These
activities are leveraging Monogram�s portfolio of VeraTag assays
that includes research assays for measurement of the levels of HER1
and HER3 total protein, HER1:HER1 homodimers, HER1:HER2 and
HER2:HER3 heterodimers, as well as the HER3:PI3K complex (a key
downstream signaling complex in the Akt pathway) and p95 (a
proteolytically truncated form of the HER2 protein).
�The initial clinical data correlating measurements using these
new assays with clinical outcomes in breast cancer has been very
important in gaining increased interest from biopharmaceutical
companies and in several cases, joint experiments are under way to
further evaluate the VeraTag technology,� added Welch. �We will be
continuing these activities with the goal of achieving adoption of
VeraTag assays in drug development programs.�
GAAP and Non-GAAP
Results
Net Loss and Net Loss Per Share are shown below in accordance
with GAAP and also on a Non-GAAP basis. The Company is reporting
Non-GAAP results which provide a clearer view of ongoing results by
excluding the impact of non-cash valuation adjustments related to
our convertible debt. Such adjustments have been and could continue
to be significant and unpredictable in future quarters depending on
several factors, including the level of the Company�s common stock
price.
The following table sets out Net Loss and Net Loss Per Share on
both GAAP and Non-GAAP basis. A reconciliation of these Non-GAAP
results to GAAP results is included with the Statement of
Operations data attached to this release.
�
Three Months Ended March 31, 2009 �
2008 � Net Loss ($ Millions) GAAP Net Loss
$
(11.4 ) $ (1.7 ) Non-GAAP Proforma Net Loss
$
(6.0 ) (6.5 ) � Net Loss Per Share ($) GAAP Net Loss
Per Share
$ (0.50 ) $ (0.08 ) Non-GAAP
Proforma Net Loss Per Share
$ (0.26 ) $ (0.29
)
We believe that the foregoing presentation of these Non-GAAP
financial measures will enable investors, analysts and readers of
our financial statements to compare Non-GAAP measures with relevant
GAAP measures in all periods presented. Any Non-GAAP financial
measure used by us should not be considered in isolation or as a
substitute for measures of performance prepared in accordance with
GAAP.
Capital
Structure
At March 31, 2009, a total of 23.0 million shares of common
stock were outstanding and stock options were outstanding on 4.8
million shares of common stock. The principal amount of Pfizer�s
$25 million convertible note, issued in May 2006, is convertible
into approximately 1.5 million shares of common stock. The $30
million principal amount of our 0% Convertible Senior Unsecured
Notes, issued in January 2007, is convertible into approximately
2.0 million shares of common stock. The conversion ratios of the
respective convertible notes were automatically adjusted to reflect
the reverse stock split implemented by the Company in November
2008.
Conference Call
Details
Monogram will host a conference call today at 4:30 p.m. Eastern
Time. To participate in the live teleconference please call (877)
545-1407, or (719) 325-4847 for international callers, fifteen
minutes before the conference begins. Live audio of the call will
be simultaneously broadcast over the Internet and will be available
to members of the news media, investors and the general public.
Access to live and archived audio of the conference call will be
available by following the appropriate links at www.monogrambio.com
and clicking on the Investor Relations link. Following the live
broadcast, a replay of the call will also be available at (888)
203-1112, or (719) 457-0820 for international callers. The replay
passcode is 8727141. The information provided on the teleconference
is only accurate at the time of the conference call, and Monogram
assumes no obligation to provide updated information except as
required by law.
About Monogram
Monogram is advancing individualized medicine by discovering,
developing and marketing innovative products to guide and improve
treatment of serious infectious diseases and cancer. The Company's
products are designed to help doctors optimize treatment regimens
for their patients that lead to better outcomes and reduced costs.
The Company's technology is also being used by numerous
biopharmaceutical companies to develop new and improved anti-viral
therapeutics and vaccines as well as targeted cancer therapeutics.
More information about the Company and its technology can be found
on its web site at www.monogrambio.com.
Forward Looking
Statements
Certain statements in this press release are forward-looking,
including statements regarding the demand and outlook for our
products, including our Trofile and HERmark assays, the impact of
the planned joint venture between Pfizer and GlaxoSmithKline, our
projected use of cash, our projected revenues, our plans for
further developing our oncology franchise, including the conduct
and outcome of planned clinical studies and the possible launch of
an assay to measure resistance to Her2 targeted drugs such as
Herceptin. These forward-looking statements are subject to risks
and uncertainties and other factors, which may cause actual results
to differ materially from the anticipated results or other
expectations expressed in such forward-looking statements. These
risks and uncertainties include, but are not limited to: risks and
uncertainties relating to the performance and acceptance of our
products; the growth in revenues from all products, including
Trofile, growth in deferred revenues; the size, timing and success
or failure of any clinical trials for CCR5 inhibitors, entry
inhibitors or integrase inhibitors; the risk that our VeraTag
assays, including HERmark, may not predict response to particular
therapeutic agents; the risk that we may not be able to obtain
additional cohorts of patient samples for additional VeraTag
studies, our ability to successfully conduct clinical studies on
our expected timelines and the results obtained from those studies;
whether larger confirmatory clinical studies will confirm the
results of initial studies; whether we will be able to develop,
validate and launch assays which measure resistance to Her2
targeted drugs; expected reliance on a few customers for the
majority of our revenues; the renewal of certain customer
agreements, including the Pfizer collaboration for the ex-US
distribution of Trofile; the impact of our expense reduction
programs; our ability to retain and hire key employees; the impact
of competition; whether payers will authorize reimbursement for our
products and services and the amount of such reimbursement that may
be allowed; whether the FDA or any other agency will decide to
further regulate our products or services, including Trofile and
HERmark; whether the draft guidance on Multivariate Index Assays
issued by the FDA will be subsequently determined to apply to our
current or planned products; whether we will encounter problems or
delays in automating our processes; the ultimate validity and
enforceability of our patent applications and patents; the possible
infringement of the intellectual property of others; whether
licenses to third party technology will be available; whether we
are able to build brand loyalty and expand revenues; restrictions
on the conduct of our business imposed by the Pfizer, G.E. and
other debt agreements; the impact of additional dilution if our
convertible debt is converted to equity; and whether we will be
able to raise sufficient capital in the future to repay our
convertible debt in the event it is not converted to equity and/or
to maintain operations, if required. For a discussion of other
factors that may cause actual events to differ from those
projected, please refer to our most recent annual report on Form
10-K and quarterly reports on Form 10-Q, as well as other
subsequent filings with the Securities and Exchange Commission. We
do not undertake, and specifically disclaim any obligation, to
revise any forward-looking statements to reflect the occurrence of
anticipated or unanticipated events or circumstances after the date
of such statements.
PhenoSense, PhenoSenseGT, Trofile, HERmark and VeraTag are
trademarks of Monogram Biosciences, Inc. Herceptin is a registered
trademark of Genentech, Inc. Selzentry is a trademark of Pfizer
Inc.
MONOGRAM BIOSCIENCES,
INC.
SELECTED CONSOLIDATED STATEMENT
OF OPERATIONS DATA
(In thousands, except per share
amounts)
(Unaudited)
� �
Three Months Ended March 31, 2009 2008 �
Revenue: Product revenue
$ 13,586 $ 14,007
Contract revenue
605 820 License Revenue
15 10 � �
Total revenue
14,206 14,837 �
Operating costs and
expenses: Cost of product revenue
6,640 6,364 Research
and development
5,909 6,024 Sales and marketing
3,969
4,352 General and administrative
3,519 4,566 � � Total
operating costs and expenses
20,037 21,306 � �
Operating
loss (5,831) (6,469) � Convertible debt valuation
adjustment
(5,400) 4,736 Interest (expense) income, net
(204) 6 � �
Net loss $ (11,435) $
(1,727) � Basic and diluted net loss per common share
$
(0.50) $ (0.08) � Weighted-average shares used in computing
basic Net loss per common share �
22,962 � 22,365 � �
Reconciliation of Non-GAAP Proforma Results to GAAP Net loss
$ (11,435) $ (1,727) Convertible debt valuation
adjustment �
5,400 � (4,736)
Non-GAAP Proforma net
loss �
(6,035) � (6,463) � Non-GAAP Proforma net loss
per common share, basic
$ (0.26) $ (0.29) �
Management believes that this
non-GAAP financial data supplements the Company�s GAAP consolidated
financial statements by providing investors with additional
information which allows them to have a clearer picture of the
Company's operations, financial performance and the comparability
of the Company's operating results from period to period as they
exclude the effects of revaluation of the Company�s convertible
debt that management believes are not indicative of the Company�s
ongoing operations. The presentation of this additional information
is not meant to be considered in isolation or as a substitute for
results prepared in accordance with GAAP. Above, management has
provided a reconciliation of the non-GAAP financial information
with the comparable consolidated financial information reported in
accordance with GAAP.
MONOGRAM BIOSCIENCES,
INC.
SELECTED CONSOLIDATED BALANCE
SHEET DATA
(In thousands)
(Unaudited)
�
�
March 31, �
December 31, 2009 2008
(1) ASSETS Current assets: Cash and cash equivalents $
13,740 $ 15,965 Accounts receivable, net 16,332 15,883 Prepaid
expenses 627 1,123 Inventory 1,462 1,623 Other current assets � 388
� � 324 � Total current assets 32,549 34,918 Property and
equipment, net 7,507 7,874 Goodwill 9,927 9,927 Deferred costs
19,092
17,275 Other assets �
14
� � 38 �
Total assets $
69,089
� $ 70,032 � �
LIABILITIES AND STOCKHOLDERS' DEFICIT Current
liabilities: Accounts payable $ 2,404 $ 2,637 Accrued compensation
3,181 2,911 Accrued liabilities 4,113 4,015 Contingent value rights
1,935 1,935 Current portion of loans payable and capital lease
obligations 10,118 9,704 Other current liabilities � 730 � � 660 �
Total current liabilities 22,481 21,862 Long-term 3% convertible
promissory note 20,579 18,594 Long-term 0% convertible promissory
note 13,883 10,468 Long-term deferred revenue 28,171 24,769 Other
long-term liabilities � 1,211 � � 1,025 �
Total liabilities
� 86,325 � � 76,718 � � Stockholders' deficit: Common stock 23 23
Additional paid-in capital 293,378 292,493 Accumulated deficit �
(310,637 ) � (299,202 )
Total stockholders' deficit �
(17,236 ) � (6,686 ) �
Total liabilities and stockholders'
deficit $ 69,089 � $ 70,032 � �
(1) The consolidated balance sheet
data at December 31, 2008 is derived from audited financial
statements included in the Company�s Annual Report on Form 10-K for
the year ended December 31, 2008 filed with the Securities and
Exchange Commission.
Reconciliation of Revenue on
GAAP to Non-GAAP Basis
Total revenue is shown below in accordance with GAAP and also on
a Non-GAAP basis to include deferred revenue from the sale of the
Company�s assays related to Pfizer of $1.1 million and $0.8 million
for the three months ended March 31, 2009 and 2008, respectively.
The Company is reporting total revenue on a Non-GAAP basis to
provide a matching of revenue and expenses for product sales.
� �
Three Months Ended December 31, 2009
2008 �
Revenue ($ millions) GAAP Product
Revenue
$ 13.6 $ 14.0 Add: Deferred Revenue
$
1.1 $ 0.8 Non-GAAP Product Revenue
$ 14.7 $
14.8 Contract Revenue
$ 0.6 $ 0.8 Non-GAAP Total
Revenue
$ 15.3 $ 15.6
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