Attached files
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| 8-K - MICROMET, INC. | v201463_8k.htm |
Q3 2010
Financial Results
Micromet
Reports Third Quarter 2010 Financial Results
- Company to host conference call
today at 8:30 AM ET to review financial results and recent pipeline
progress -
Bethesda,
MD, November 9, 2010 --Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical
company focused on the development and commercialization of next-generation
antibodies for the treatment of cancer, today announced its financial results
for the third quarter and nine months ended September 30, 2010.
“With
clinical trials of our lead product candidate blinatumomab now underway in
patients with both early and advanced stages of acute lymphoblastic leukemia
(ALL), we are on track to roll out a comprehensive development plan evaluating
blinatumomab across the spectrum of the disease," said Christian Itin, Ph.D.,
President and Chief Executive Officer. “We look forward to reporting
new data from on-going blinatumomab trials at the American Society of Hematology
Annual Meeting in December.”
Recent Events:
|
•
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In
September, the Company initiated a European pivotal clinical trial of
blinatumomab (MT103) in adult patients with minimal residual disease (MRD)
positive B-precursor ALL. This multi-center, single-arm study,
also known as BLAST (Blinatumomab Adult ALL MRD Study of T cell engagement), is
intended to evaluate the efficacy, safety and tolerability of blinatumomab
in up to 130 evaluable adult ALL patients
with MRD after treatment with front-line
chemotherapy.
|
|
•
|
In
September, the Company initiated a phase 2 clinical trial of blinatumomab
in adult patients with relapsed or refractory B-precursor ALL. This
single-arm study is intended to evaluate the efficacy, safety and
tolerability of blinatumomab in 20 adult patients with
B-precursor ALL who are resistant or intolerant to standard
chemotherapy.
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|
•
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In
October, the Company announced that its licensee for MT111, Astra-Zeneca’s
subsidiary MedImmune, plans to initiate a phase 1 clinical trial in
patients with advanced gastrointestinal cancers based on an
investigational new drug application recently accepted by the U.S. Food
and Drug Administration. MedImmune expects to initiate the
study in the first half of 2011.
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|
•
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In
November, the Company announced plans to advance its BiTE antibody MT112
into formal preclinical development in collaboration with its partner
Bayer Schering Pharma AG. Taking this next step toward an
IND filing triggers a 2.5 million euro (approximately $3.5 million)
milestone payment to Micromet.
|
|
•
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In
November, the Company announced that data on two of its BiTE antibody
product candidates will be reported at the 52nd
Annual American Society of Hematology Annual Meeting, to be held December
4 – 7 in Orlando, Florida.
|
Q3 2010
Financial Results
Financial Results for the Three and Nine Months Ended
September 30, 2010
Three
Months Ended September 30, 2010
For the
three months ended September 30, 2010, Micromet recognized total revenues of
$6.7 million, compared to $4.0 million for the same period in 2009. Total
operating expenses were $16.1 million for the three months ended September 30,
2010, compared to $17.1 million for the same period in 2009.
Loss from
operations for the three months ended September 30, 2010 was $9.5 million,
compared to a loss from operations of $13.1 million for the same period in
2009.
For the
three months ended September 30, 2010, Micromet reported a net loss of $10.4
million, or a loss of $0.13 per basic and diluted common share, compared to a
net loss of $19.9 million, or a loss of $0.32 per basic and diluted common
share, for the same period in 2009.
Nine
Months Ended September 30, 2010
For the
nine months ended September 30, 2010, Micromet recognized total revenues of
$19.5 million, compared to $16.4 million for the same period in 2009. Total
operating expenses were $50.9 million for the nine months ended September 30,
2010, compared to $42.1 million for the same period in 2009.
Loss from
operations for the nine months ended September 30, 2010 was $31.4 million,
compared to a loss from operations of $25.7 million for the same period in
2009.
For the
nine months ended September 30, 2010, Micromet reported a net loss of $29.8
million, or a loss of $0.38 per basic and diluted common share, compared to a
net loss of $34.2 million, or $0.62 per basic and diluted common share, for the
same period in 2009.
Micromet's
cash, cash equivalents and investments were $164.3 million as of September 30,
2010.
Webcast
and Conference Call
Micromet
management will host a conference call today at 8:30 AM ET to review the
Company's third quarter 2010 results and recent corporate progress. To
participate in the conference call, please dial 866-713-8395 (domestic) or
617-597-5309 (international) and reference the access code 11269684. The
presentation will be available via webcast in the Investor Relations section of
the Micromet website at www.micromet.com.
A replay
of the call will be available from 11:30 AM ET on November 9, 2010 until
midnight ET on December 9, 2010. To access the replay, please dial 888-286-8010
(domestic) or 617-801-6888 (international) and reference the access code
63331845. The archived webcast will be available for 30 days in the Investor
Relations section of the Micromet website at www.micromet.com.
About Micromet,
Inc.
Micromet,
Inc. is a biopharmaceutical company focused on the discovery, development and
commercialization of innovative antibody-based therapies for the treatment of
cancer. Its product development pipeline includes novel antibodies generated
with its proprietary BiTE® technology, as well as conventional monoclonal
antibodies. The Company’s lead product candidate blinatumomab (MT103) is
currently the subject of a European pivotal trial in patients with minimal
residual disease positive acute lymphoblastic leukemia. Micromet has
collaborations with a number of leading pharmaceutical and biotechnology
companies, including Bayer Schering Pharma, Boehringer Ingelheim, MedImmune,
Merck Serono, Nycomed and sanofi-aventis. Additional information can be found at
www.micromet.com.
Q3 2010
Financial Results
Safe
Harbor Statement
This
release contains certain forward-looking statements that involve risks and
uncertainties that could cause actual results to be materially different from
historical results or from any future results expressed or implied by such
forward-looking statements. These forward-looking statements include statements
regarding the development and commercialization of blinatumomab and other BiTE
antibodies by us and our collaborators, including the development of BiTE
antibodies for the treatment of hematological cancers and the conduct and timing
of ongoing and future clinical trials involving these product candidates, as
well as plans regarding our regulatory strategy and announcements and
publication of clinical data. You are urged to consider statements that include
the words “continues,” "will," "believes," "potential," "plans," "intends,"
“expects” or the negative of those words or other similar words to be uncertain
and forward-looking. Factors that may cause actual results to differ materially
from any future results expressed or implied by any forward-looking statements
include the risk that blinatumomab or our other product candidates do not
demonstrate safety and/or efficacy in future clinical trials, delays in
development and testing, the risk that we will not obtain approval to market
blinatumomab or our other BiTE antibodies, and the risks associated with
reliance on outside financing to meet capital requirements. These factors and
others are more fully discussed in Micromet's Annual Report on Form 10-K for the
fiscal year ended December 31, 2009, filed with the SEC on March 5, 2010, and
Micromet's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010,
filed with the SEC on August 6, 2010, as well as other filings by the Company
with the SEC.
Contact:
Jennifer
Neiman
Director,
Corporate Communications
Micromet,
Inc.
240-235-0246
jennifer.neiman@micromet.com
Q3 2010
Financial Results
Micromet,
Inc.
Condensed
Consolidated Balance Sheets
(In
thousands, except par value)
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Sept.
30, 2010
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Dec.
31, 2009
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|||||||
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(unaudited)
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||||||||
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Assets
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||||||||
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Current
assets:
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Cash
and cash equivalents
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$ | 99,746 | $ | 113,434 | ||||
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Short-term
investments
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61,820 | 4,169 | ||||||
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Accounts
receivable
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2,460 | 464 | ||||||
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Prepaid
expenses and other current assets
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3,284 | 2,156 | ||||||
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Total
current assets
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167,310 | 120,223 | ||||||
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Property
and equipment, net
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5,157 | 3,959 | ||||||
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Goodwill
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6,462 | 6,462 | ||||||
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Patents,
net
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485 | 1,016 | ||||||
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Long-term
investments
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2,751 | - | ||||||
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Restricted
cash
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2,114 | 3,153 | ||||||
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Total
assets
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$ | 184,279 | $ | 134,813 | ||||
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Liabilities
and Stockholders’ Equity
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||||||||
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Current
liabilities:
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Accounts
payable
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$ | 5,479 | $ | 6,053 | ||||
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Accrued
expenses
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9,697 | 16,360 | ||||||
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Common
stock warrants liability
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18,726 | 20,244 | ||||||
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Current
portion of deferred revenue
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8,813 | 9,838 | ||||||
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Total
current liabilities
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42,715 | 52,495 | ||||||
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Deferred
revenue, net of current portion
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21,934 | 13,281 | ||||||
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Other
non-current liabilities
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1,348 | 2,196 | ||||||
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Stockholders’
equity:
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||||||||
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Preferred
stock, $0.00004 par value; 10,000 shares authorized; no shares issued and
outstanding
|
- | - | ||||||
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Common
stock, $0.00004 par value; 150,000 shares authorized; 80,999 shares issued
and outstanding at September 30, 2010 and 69,178 shares issued and
outstanding at December 31, 2009
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3 | 3 | ||||||
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Additional
paid-in capital
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396,865 | 314,627 | ||||||
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Accumulated
other comprehensive income
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7,080 | 8,062 | ||||||
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Accumulated
deficit
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(285,666 | ) | (255,851 | ) | ||||
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Total
stockholders´ equity
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118,282 | 66,841 | ||||||
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Total
liabilities and stockholders’ equity
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$ | 184,279 | $ | 134,813 | ||||
Q3 2010
Financial Results
Micromet,
Inc.
Condensed
Consolidated Statements of Operations
(In
thousands, except per share amounts)
(Unaudited)
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
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2010
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2009
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2010
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2009
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Revenues
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||||||||||||||||
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Collaboration
agreements
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$ | 6,464 | $ | 3,361 | $ | 19,027 | $ | 15,261 | ||||||||
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License
fees and other
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194 | 660 | 490 | 1,153 | ||||||||||||
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Total
revenues
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6,658 | 4,021 | 19,517 | 16,414 | ||||||||||||
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Operating
expenses
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Research
and development
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11,468 | 12,871 | 35,684 | 30,151 | ||||||||||||
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General
and administrative
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4,650 | 4,261 | 15,258 | 11,936 | ||||||||||||
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Total
operating expenses
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16,118 | 17,132 | 50,942 | 42,087 | ||||||||||||
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Loss
from operations
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(9,460 | ) | (13,111 | ) | (31,425 | ) | (25,673 | ) | ||||||||
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Other
income (expense)
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||||||||||||||||
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Interest
expense
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(230 | ) | (52 | ) | (378 | ) | (222 | ) | ||||||||
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Interest
income
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303 | 66 | 533 | 346 | ||||||||||||
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Change
in fair value of warrants
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(753 | ) | (6,354 | ) | 1,518 | (8,183 | ) | |||||||||
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Other
income (expense)
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(278 | ) | (441 | ) | (63 | ) | (437 | ) | ||||||||
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Net
loss
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$ | (10,418 | ) | $ | (19,892 | ) | $ | (29,815 | ) | $ | (34,169 | ) | ||||
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Basic
and diluted net loss per common share
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$ | (0.13 | ) | $ | (0.32 | ) | $ | (0.38 | ) | $ | (0.62 | ) | ||||
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Weighted
average shares used to compute basic and diluted net loss per
share
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80,992 | 62,655 | 77,652 | 55,058 | ||||||||||||