CombinatoRx, Incorporated (NASDAQ: CRXX) today reported
financial results for the first quarter ended March 31, 2010.
“In the last month our commercial partner Covidien launched
Exalgo™ into the U.S. market, providing many patients with
moderate-to-severe pain with access to this new therapy and
providing us with the potential for future royalty revenue,”
commented Mark H.N. Corrigan, MD, President and CEO of CombinatoRx.
“In addition, we published and presented data on our cell-based
drug discovery platforms, further validating our capability to
identify novel drug candidates.”
First Quarter 2010 and Recent Accomplishments:
- Covidien launched Exalgo™
(hydromorphone HCl) extended-release tablets, (CII), the only
extended-release hydromorphone treatment available in the United
States. Exalgo provides opioid-tolerant patients suffering from
moderate-to-severe chronic pain, relief for 24 hours per dose.
CombinatoRx is eligible to receive tiered royalties on net sales of
Exalgo by Covidien.
- Powerful and unexpected
synergistic interactions of A2A Agonist and PDE Inhibitors as
potential adjunctive therapy in the treatment of multiple myeloma
and other B-cell malignancies were published in BLOOD, The Journal
of the American Society of Hematology, and highlighted at the
American Association for Cancer Research 2010 annual meeting. These
preclinical studies demonstrated that both agonists synergize with
standard of care, even after chronic exposure, and highlight the
Company’s ability to rapidly screen large numbers of drug
combinations in many cell lines to identify novel synergistic
pairings, which can provide new insights into disease biology and
new drug combinations that can be further evaluated as potential
clinical candidates.
- CombinatoRx continued to
leverage the power of its proprietary cHTS combination drug
discovery platform by entering into a pilot discovery research
collaboration with Amgen in which they have
licensed access to our cHTS drug discovery platform for a
limited period of nine months with the option of extending the term
and scope of the collaboration beyond the third quarter
of 2010. CombinatoRx has received a license fee for this trial
period. This collaboration represents a step towards our stated
2010 goal of continuing to seek additional revenue-generating
research and technology collaborations for our cHTS combination
drug discovery platform.
- Preclinical progress was also
made with the CombinatoRx Ion Channel drug discovery and
development program, as our research team in Vancouver presented
key data reinforcing our leadership position in the identification
of novel ion channel blockers aimed at selected pain targets. At
the Spring Pain Research Conference on April 21st in a presentation
entitled “A Novel Small Organic Compound Attenuates Neuropathic
Pain by Stabilizing the Slow Inactivated State of Sodium and
Calcium Channels,” Michael Hildebrand, Ph.D., described the
successful reversal of neuropathic pain in preclinical models with
a proprietary, novel ion channel blocker candidate.
First Quarter 2010 Financial Results (Unaudited):
As of March 31, 2010, CombinatoRx had cash, cash equivalents,
restricted cash and short-term investments of $55.3 million
compared to $25.9 million on December 31, 2009.
Total revenue was $41.3 million in the first quarter of 2010
compared to $2.6 million reported in the first quarter of 2009.
Revenue increased from the first quarter of 2009 to the first
quarter of 2010 due to a $40.0 million milestone payment from
Covidien related to the FDA approval of Exalgo on March 1,
2010.
Net loss from continuing operations for the quarter ended March
31, 2010 was $3.1 million, or ($0.05) per share, as compared to
$8.5 million, or ($0.24) per share, in the first quarter of 2009.
The first quarter of 2010 included a one-time, non-cash charge of
$29.3 million related to the settlement of the contingent
consideration issued in the Neuromed merger. Stock-based
compensation expense was approximately $1.6 million in the first
quarter of 2010 as compared to $1.3 million in the first quarter of
2009.
Research and development expenses totaled $7.4 million in the
first quarter of 2010 compared to $7.1 million in the first quarter
of 2009.
General and administrative expenses were $3.9 million in the
first quarter of 2010 compared to $3.6 million in the first quarter
of 2009.
About CombinatoRx:
CombinatoRx, Incorporated (CRXX) develops novel drug candidates
with a focus on the treatment of pain and inflammation. The company
applies its combination drug discovery capabilities and its
selective ion-channel modulation platform to generate innovative
therapeutics. To learn more about CombinatoRx, please visit
www.combinatorx.com.
Forward-Looking Statement:
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
concerning CombinatoRx, the product Exalgo™ and its ability to
generate future royalty revenue for CombinatoRx, the CombinatoRx
selective ion channel modulation platform, its combination drug
discovery technology, its B-cell malignancy program and its
potential, and CombinatoRx’s financial condition, results of
operations, cash position and business plans. These forward-looking
statements about future expectations, plans, objectives and
prospects of CombinatoRx may be identified by words like "believe,"
"expect," "may," "will," "should," "seek," or “could” and similar
expressions and involve significant risks, uncertainties and
assumptions, including risks related to the sale and marketing of
Exalgo by Covidien, risks related to the development and regulatory
approval of CombinatoRx’s product candidates, the unproven nature
of the CombinatoRx drug discovery technologies, the ability of
Covidien to perform its obligations under its agreement with
CombinatoRx relating to Exalgo, the ability of the Company or its
collaboration partners to initiate and successfully complete
clinical trials of its product candidates, the Company's ability to
obtain additional financing or funding for its research and
development and those other risks that can be found in the "Risk
Factors" section of CombinatoRx's annual report on Form 10-K on
file with the Securities and Exchange Commission and the other
reports that CombinatoRx periodically files with the Securities and
Exchange Commission. Actual results may differ materially from
those CombinatoRx contemplated by these forward-looking statements.
These forward looking statements reflect management’s current views
and CombinatoRx does not undertake to update any of these
forward-looking statements to reflect a change in its views or
events or circumstances that occur after the date of this release
except as required by law.
(c) 2010 CombinatoRx, Incorporated. All rights reserved.
CombinatoRx, Incorporated Condensed Consolidated
Statements of Operations
(in thousands, except share and
per share amounts)
(Unaudited)
Three months ended March 31 2010
2009as Adjusted
Revenue: Collaborations $ 41,065 $ 2,329 Government contracts and
grants 265 304 Total revenue
41,330 2,633 Operating expenses:
Research and development 7,381 7,137 General and administrative
3,862 3,647 Amortization of intangible asset 4,684 — Restructuring
— 441 Total operating expenses
15,927 11,225 Income (loss) from
operations 25,403 (8,592 ) Interest income 7 128 Interest expense —
(16 ) Loss on revaluation of contingent consideration (29,286 ) —
Other (expense) income (142 ) 4 Net
loss before provision for income taxes (4,018 ) (8,476 ) Income tax
benefit 910 — Net loss from
continuing operations (3,108 ) (8,476 )
Discontinued operations: Loss from operations of discontinued
subsidiary — (1,007 ) Loss on
discontinued operations — (1,007 ) Net
loss $ (3,108 ) $ (9,483 ) Net loss per share—basic and
diluted: From continuing operations $ (0.05 ) $ (0.24 ) From
discontinued operations — (0.03 ) Net
loss per share—basic and diluted $ (0.05 ) $ (0.27 )
Weighted average number of common shares used in net loss per share
calculation – basic and diluted 63,310,675
35,013,381
Note: The Statements of
Operations for the three months ended March 31, 2009 reflect the
financial results of CombinatoRx Singapore as a discontinued
operation.
CombinatoRx, Incorporated Condensed Consolidated Balance
Sheets
(in thousands except per share
data)
(Unaudited)
March 31, December 31, 2010
2009 Assets Current assets: Cash
and cash equivalents $ 3,585 $ 8,779 Restricted cash 750 750
Short-term investments 49,133 14,551 Accounts receivable 1,415
2,927 Prepaid expenses and other current assets 2,341
5,415 Total current assets 57,224 32,422
Property and equipment, net 7,677 8,380 Intangible asset, net
40,738 45,423 Restricted cash and other assets 1,820
1,927 Total assets $ 107,459 $ 88,152
Liabilities and stockholders’ equity Current
liabilities: Accounts payable $ 994 $ 4,269 Accrued expenses 2,343
5,495 Accrued restructuring 597 1,274 Deferred revenue 2,500 2,750
Current portion of lease incentive obligation 284
284 Total current liabilities 6,718 14,072
Deferred revenue, net of current portion 2,917 2,667
Deferred rent, net of current portion 767 775 Lease incentive
obligation, net of current portion 1,655 1,726 Other long-term
liabilities 2,137 3,235 Contingent consideration — 12,764
Stockholders’ equity: Preferred stock, $0.001 par value; 5,000
shares authorized; no shares issued and outstanding — — Common
stock, $0.001 par value; 200,000 shares authorized; 88,862 and
117,828 shares issued and outstanding at March 31, 2010 and
December 31, 2009, respectively 89 118 Additional paid-in capital
315,892 272,405 Accumulated other comprehensive loss — (2 )
Accumulated deficit (222,716 ) (219,608 )
Stockholders’ equity 93,265 52,913
Total liabilities and stockholders’ equity $ 107,459
$ 88,152
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