Micromet, Inc. Reports Third Quarter 2007 Financial Results
Bethesda, MD -November 8, 2007 - Micromet, Inc. (NASDAQ: MITI)
("Micromet" or the "Company"), a biopharmaceutical company developing
novel, proprietary antibodies for the treatment of cancer,
inflammation and autoimmune diseases, today announced its financial
results for the third quarter and nine months ended September 30,
2007.
Summarizing the quarter, Christian Itin, Ph.D., President and Chief
Executive Officer of Micromet said: "We have made significant
clinical progress during the last quarter. Building on the observed
clearance of tumor cells from the bone marrow of patients treated
with our BiTE antibody MT103, we have now initiated a phase 2
clinical trial in acute lymphoblastic leukemia, a very aggressive
form of B-cell leukemia. This disease is routinely treated with
chemotherapy to kill tumor cells in the blood, but tumor cells often
remain in the bone marrow, ultimately leading to the relapse of
patients." Dr. Itin continued, "We have also recently presented a
further analysis of a previously reported phase 2 clinical trial in
metastatic breast cancer patients treated with adecatumumab. This
analysis showed that the improved time to progression observed in
that trial was due to a significant reduction of new metastatic
lesions. These new findings support the development of adecatumumab
in earlier stage disease and in adjuvant settings, which is further
supported by the overall good tolerability and low immunogenicity of
this human antibody."
Recent Highlights:
* In October, at the AACR/NCI/EORTC conference in San Francisco,
Micromet presented a new sub-analysis of a previously reported
phase 2 clinical trial in metastatic breast cancer patients
treated with adecatumumab (MT201). Based on the available data
from the previously conducted clinical trials, Micromet, with its
strategic collaborator Merck Serono, has decided not to initiate
a previously anticipated dose-finding phase 1 clinical trial, but
in its place, is developing clinical trial designs to evaluate
the efficacy of adecatumumab in adjuvant or adjuvant-like disease
settings.
* Micromet also presented data at the AACR/NCI/EORTC conference on
two BiTE therapeutic antibodies: MT110, a BiTE antibody for the
treatment of carcinoma, expected to be in a phase 1 clinical
trial by the end of this year, and a new BiTE antibody for the
treatment of melanoma.
* In October, Micromet announced that the Paul-Ehrlich Institute
approved an Investigational Medicinal Product Dossier (IMPD) for
the conduct of a phase 2 clinical trial testing MT103 in patients
with acute lymphoblastic leukemia (ALL). ALL is a highly
aggressive form of B-cell leukemia. Currently, patients are
initially treated with complex and toxic chemotherapy regimens
that may be followed by bone marrow stem cell transplantation. If
patients have low amounts of residual tumor cells after
chemotherapy (also known as "minimal residual disease" or MRD)
they are at a very high risk of relapse. This phase 2 clinical
trial will test whether MT103 can remove residual tumor cells and
thereby convert patients from a MRD-positive to a MRD-negative
status with an improved time to relapse.
* In September, Micromet announced the appointment of Mark
Reisenauer as Senior Vice President and Chief Commercial Officer.
Mark joined Micromet from Abbott, where he was the General
Manager of the Oncology Franchise from 2002 to 2006 and most
recently Divisional Vice President and General Manager of the
Neuroscience franchise. Before joining Abbott, Mark's career
included marketing positions at Pharmacia, Bristol-Myers Squibb
and Zeneca.
Financial Results:
Quarter Ended September 30, 2007
For the quarter ended September 30, 2007, Micromet recognized total
revenues of $5.6 million, compared to $4.6 million for the same
period in 2006. Revenue was recorded under our TRACON collaboration
of $2.1 million and from our Nycomed collaboration of $0.8 million in
the quarter, both new agreements executed during the first half of
2007. Partially offsetting these increases were decreases in
revenues under our collaborations with Merck Serono of $0.8 million
and with MedImmune of $1.0 million, where we recorded a non-recurring
milestone of $1.7 million during 2006.
Total operating expenses were $9.2 million for the quarter ended
September 30, 2007, compared to $10.2 million for the same period in
2006. Spending in R&D decreased by $0.6 million due to a reduction in
manufacturing and preclinical toxicology expenses for our MT110
program that were ongoing during 2006, and from lower G&A expenses of
$0.4 million due to lower stock-based compensation expenses and lower
legal expenses during the third quarter of 2007.
We reported $1.2 million of non-cash income during the three months
ending September 30, 2007 related to the decrease in fair value of
the warrant liability during the third quarter of 2007 related to
warrants issued in connection with the June 2007 private placement of
common stock. We revalue these warrants at each reporting period
using a Black-Scholes option-pricing model until they are exercised
or expire. Changes in the fair value of the warrants are reported in
the statements of operations as non-operating income or expense.
For the quarter ended September 30, 2007, Micromet reported a net
loss of $2.3 million, or $0.06 per basic and diluted share, compared
to a net loss of $5.8 million, or $0.19 per basic and diluted share,
for the same period in 2006.
Nine Months Ended September 30, 2007
For the nine months ended September 30, 2007, Micromet recognized
total revenues of $11.4 million, compared to $13.8 million for the
same period in 2006. Revenue recognized under collaboration
agreements decreased by $2.4 million resulting from lower
collaboration revenues of $3.6 million related to reimbursement for
the adecatumumab phase 2a clinical trials that were completed in
mid-2006 and from certain nonrecurring revenue received in 2006 from
Cell Therapeutics of $1.9 million relating to a previously terminated
collaboration. These decreases were partially offset by increases
under our collaborations with TRACON of $2.1 million and from Nycomed
of $1.1 million, both new collaborations during the first half of
2007.
Total operating expenses were $30.6 million for the nine months ended
September 30, 2007, compared to $50.3 million for the same period in
2006. The majority of the decrease from the 2006 period relates to a
one-time in-process research and development charge of $20.9 million
taken in 2006 in connection with the CancerVax merger. After
considering this unusual charge, recurring R&D expenses for the nine
months ended September 30, 2007 decreased by $1.1 million over the
same period in the prior year. A decrease in R&D stock-based
compensation charges of $1.1 million, and a decrease of $0.5 million
in clinical expenses related to the adecatumumab phase 2 clinical
trials that were ongoing during 2006, were partially offset by the
payment of a license fee of $0.5 million to AME that was triggered by
our MT293 license granted to TRACON. General and administrative
expenses for the nine months ended September 30, 2007 were $10.8
million as compared to $8.5 million for the same period in 2006.
This increase results from an increase in U.S. based personnel salary
and travel charges of $1.5 million, an increase in facility costs of
$1.0 million stemming from the finalization of our lease exit
liability related to the former CancerVax headquarters and $1.0
million from the increased costs of being a public company
post-merger, including legal, investor relations and auditing and tax
services. This increase was partially offset by a decrease in G&A
stock-based compensation expense of $1.1 million.
Interest expense of $0.6 million for the nine months ended September
30, 2007 was $1.0 million lower than the same period in the prior
year due to the repayment of bank loans and conversion of convertible
notes in 2006, and from the repayment of a significant portion of our
silent partnership debt during 2007.
We reported $1.7 million of non-cash income during the nine months
ending September 30, 2007 related to the decrease in fair value of
the warrant liability from original issuance date related to warrants
issued in connection with the June 2007 private placement of common
stock.
Other income of $1.1 million for the nine months ended September 30,
2006 includes an $0.8million benefit resulting from the collection
of the withholding tax duty owed on past royalty payments made to
collaborators who reside outside of Germany.
For the nine months ended September 30, 2007, Micromet reported a net
loss of $16.3 million, or $0.47 per basic and diluted share, compared
to a net loss of $37.4 million, or $1.52 per basic and diluted share,
for the same period in 2006.
Note on 2006 Merger
As a result of the reverse merger between Micromet AG and CancerVax
Corporation that was completed on May 5, 2006, the financial
information included herein for the third quarter and nine months
ended September 30, 2006 is based solely on Micromet AG's historical
financial statements through May 5, 2006 and thereafter is combined
with the financial results of CancerVax Corporation (renamed
Micromet, Inc. following the merger).
2007 Outlook and Beyond:
- Micromet and its collaborator MedImmune plan to initiate shortly
the first U.S. clinical trial with MT103 (MEDI-538), in patients with
non-Hodgkin's lymphoma.
- Micromet will provide a full update on the phase 1 clinical trial
conducted in Europe with MT103 in patients with relapsed/refractory
non-Hodgkin's lymphoma patients at ASH in December.
- Micromet plans to initiate a clinical trial for MT110, a BiTE
antibody targeting EpCAM, by the end of 2007.
- Micromet will continue its research and development programs for
the discovery of new BiTE product candidates.
Conference Call and Audio Webcast Today, November 8, 2007, at 9:00am
Eastern Time
Micromet will host a conference call and audio webcast today to
discuss these financial results at 9:00 am Eastern Time (3:00 pm
Central European Time). To participate in this conference call, dial
800-260-8140 (U.S.) or 617-614-3672 (international), passcode:
Micromet. The audio webcast can be accessed via our website at:
www.micromet-inc.com.
A replay of the call will be available from 11:00 am Eastern Time on
November 8, 2007 (5:00 pm Central European Time) through Thursday,
November 15, 2007. The replay number is 888-286-8010 (U.S.) or
617-801-6888 (international), passcode: 31354110.
About Micromet, Inc. (www.micromet-inc.com)
Micromet, Inc. is a biopharmaceutical company developing novel,
proprietary antibodies for the treatment of cancer, inflammation and
autoimmune diseases. Three of its antibodies are in clinical
development. MT103 (MEDI-538), the first antibody in Micromet's
product pipeline developed utilizing the BiTE® antibody technology
platform, is being evaluated in a phase 2 clinical trial for the
treatment of patients with acute lymphoblastic leukemia, and in a
phase 1 clinical trial for the treatment of patients with
non-Hodgkin's lymphoma. BiTE antibodies represent a new class of
therapeutic antibodies that activate a patient's own cytotoxic T
cells to eliminate cancer cells. Micromet is developing MT103 in
collaboration with MedImmune, a subsidiary of Astra Zeneca plc. The
second clinical stage antibody is adecatumumab (MT201), a human
monoclonal antibody targeting EpCAM expressing tumors. Adecatumumab
is being developed by Micromet in collaboration with Merck Serono in
a phase 1b clinical trial evaluating adecatumumab in combination with
docetaxel for the treatment of patients with metastatic breast
cancer. The third clinical stage antibody is MT293 (formerly D93),
also known as TRC093, a first-in-class humanized monoclonal antibody
that inhibits angiogenesis and tumor cell growth by binding cleaved
collagen. MT293, which is currently being tested in a phase 1
clinical trial, is licensed to TRACON Pharmaceuticals, Inc. and is
being developed for the treatment of patients with cancer and
age-related macular degeneration. In addition, Micromet has
established a collaboration with Nycomed for the development and
commercialization of MT203, Micromet's human antibody neutralizing
the activity of granulocyte/macrophage colony stimulating factor
(GM-CSF), which has potential applications in the treatment of
various inflammatory and autoimmune diseases, such as rheumatoid
arthritis, psoriasis, or multiple sclerosis.
Forward-Looking Statements
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.
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 product candidates that appeared promising in
early research, preclinical studies or clinical trials do not
demonstrate safety and/or efficacy in subsequent clinical trials, the
risk that encouraging results from early research, preclinical
studies or clinical trials may not be confirmed upon further analysis
of the detailed results of such research, preclinical study or
clinical trial, the risk that additional information relating to the
safety, efficacy or tolerability of our product candidates may be
discovered upon further analysis of preclinical or clinical trial
data, the risk that we or our collaborators will not obtain approval
to market our product candidates, the risks associated with reliance
on outside financing to meet capital requirements, and the risks
associated with reliance on collaborators, including MedImmune, Merck
Serono, TRACON and Nycomed, for the funding or conduct of further
development and commercialization activities relating to our product
candidates. You are urged to consider statements that include the
words "ongoing", "may", "will", "would", "could", "should",
"believes", "estimates", "projects", "potential", "expects",
"suggests", "plans", "anticipates", "intends", "continues",
"forecast", "designed", "goal", or the negative of those words or
other comparable words to be uncertain and forward-looking. These
factors and others are more fully discussed in our periodic reports
and other filings with the SEC.
Any forward-looking statements are made pursuant to Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, and, as such, speak only
as of the date made. Micromet, Inc. undertakes no obligation to
publicly update any forward-looking statements, whether as a result
of new information, future events or otherwise.
(Tables Follow)
Micromet, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except par value)
September 30, 2007 December 31, 2006
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 30,976 $ 24,301
Accounts receivable 3,495 2,319
Prepaid expenses and other
current assets 2,210 2,048
Total current assets 36,681 28,668
Property and equipment, net 4,407 3,357
Goodwill 6,917 6,917
Patents, net 7,972 8,850
Deposits and other assets 437 321
Restricted cash 3,149 3,059
Total assets $ 59,563 $ 51,172
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable $ 1,706 $ 1,680
Accrued expenses 5,990 10,153
Warrant liabilities 5,260 -
Other liabilities 507 366
Short-term note 78 1,320
Current portion of long-term
debt obligations 34 599
Current portion of deferred
revenue 3,515 2,972
Total current liabilities 17,090 17,090
Deferred revenue, net of
current portion 7,762 195
Other non-current liabilities 2,333 1,961
Long-term debt obligations,
net of current portion 4,464 7,408
Commitments
Stockholders' equity:
Preferred stock, $0.00004
par value; 10,000 shares
authorized; no shares issued
and outstanding - -
Common stock, $0.00004 par
value; 150,000 shares
authorized; 40,739 and
31,419 shares issued and
outstanding at September 30,
2007 and December 31, 2006,
respectively 2 1
Additional paid-in capital 183,077 163,482
Stock subscription
receivables - (27)
Accumulated other
comprehensive income 5,969 5,869
Accumulated deficit (161,134) (144,807)
Total stockholders' equity 27,914 24,518
Total liabilities and
stockholders' equity $ 59,563 $ 51,172
Micromet, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2007 2006 2007 2006
Revenues
Collaboration 5,522 $ 4,466 $ 10,615 $ 12,853
agreements
License fees and 41 170 784 923
other
Total revenues 5,563 4,636 11,399 13,776
Operating expenses
Research and 6,296 6,835 19,720 20,866
development
In-process
research and
development - - - 20,890
General and 2,908 3,317 10,840 8,517
administrative
Total operating 9,204 10,152 30,560 50,273
expenses
Loss from operations (3,641) (5,516) (19,161) (36,497)
Other income
(expense)
Interest expense (146) (508) (580) (1,532)
Interest income 365 272 590 581
Change in fair 1,187 - 1,709 -
value of warrants
Other income (33) (14) 1,115 61
(expense)
Net loss $ (2,26) $ (5,766) $ (16,327) $ (37,387)
Basic and diluted
net loss per common
share $ (0.06) $ (0.19) $ (0.47) $ (1.52)
Weighted average
shares used to
compute basic and
diluted net loss per
share 40,727 30,833 34,880 24,665
###
Contact Information
Company:
Christopher Schnittker, SVP & CFO
(240) 752-1421
christopher.schnittker@micromet-inc.com
Investors:
Susan Noonan
(212) 966-3650
susan@sanoonan.com
Media:
Andrea tenBroek
(781) 684-0770
micromet@schwartz-pr.com