BioMimetic Therapeutics, Inc. Reports Third Quarter 2012 Financial Results

  BioMimetic Therapeutics, Inc. Reports Third Quarter 2012 Financial Results

Business Wire

FRANKLIN, Tenn. -- November 05, 2012

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today reported its corporate
highlights and financial results as of and for the three and nine months ended
September 30, 2012. For the three months ended September 30, 2012, the Company
reported a net loss of $4.6 million, or $0.16 per diluted share, compared to a
net loss of $7.1 million, or $0.25 per diluted share, for the same period in
2011. For the nine months ended September 30, 2012, the Company reported a net
loss of $17.1 million, or $0.61 per diluted share, compared to a net loss of
$23.3 million, or $0.83 per diluted share, for the same period in 2011. The
Company ended the quarter with $44.3 million of cash, cash equivalents and
investments.

Corporate Development Highlights

The following are some of the recent key Company highlights:

  *The Company continues to focus on advancing its Augment^® Bone Graft
    Pre-Market Approval (PMA) application through the FDA review process. In
    September 2012, the Company amended its PMA to include the results of a
    study conducted on becaplermin (Regranex^®) to evaluate cancer mortality.
    The results of the study, presented at the Second Annual Meeting of The
    American College of Wound & Tissue Repair, indicated no difference in
    either cancer incidence or cancer mortality in 12,858 matched patients
    (Regranex vs. no Regranex) who were recorded in the Veterans Affairs and
    Medicare patient records and followed for up to 11 years to identify new
    malignancies and cancer-related deaths. Regranex contains the same
    synthetic protein that is found in Augment, but is topically administered
    onto open skin sores daily for weeks to months compared to the one-time
    implantation of Augment during foot and ankle fusion surgery. Given that
    the same protein therapeutic is used in both Regranex and Augment, the
    Company believes these data strengthen the case for approval of Augment.
  *In June 2012, the Company submitted to the FDA an amendment to its PMA
    application for Augment Bone Graft for its use as an alternative to
    autograft in hindfoot and ankle fusion procedures. The amendment provided
    supplemental information requested by the FDA in a post-panel response
    letter announced by the Company earlier this year. The FDA is actively
    reviewing the amendment and has 180 days from the date of the filing to
    respond, although there can be no assurance that this timeline will not be
    extended. The Company reiterates guidance for a complete response letter
    from FDA around year-end and a final approvability decision between April
    2013 and January 2014.
  *Augment Bone Graft was recently listed on the Australian Private Health
    Insurance Prostheses List, enabling a full launch into this market in
    September.
  *Following the June release of top-line data from the Canadian registration
    study comparing Augment^® Injectable Bone Graft to autograft in foot and
    ankle fusion surgery, the Company recently filed a Device License
    Application (DLA) with Health Canada for approval to market the product
    candidate in Canada. The Company also intends to file for approval of
    Augment Injectable in other countries in the coming months. Additionally,
    all 105 patients enrolled in the North American randomized controlled
    clinical trial have completed six months follow-up, the time of the
    primary endpoint for the study. The patients will continue to be followed
    to assess safety. If the Company determines it won’t re-initiate
    enrollment, it expects results of the trial will be unblinded and
    available in the first half of next year.
  *The Company has elected to proceed with its Augment^® Chronic Tendinopathy
    100 patient dose ranging Phase II clinical trial. A contract research
    organization has been retained to assist in managing the trial. Patient
    enrollment is expected to begin in the first half of next year.

“We remain focused on gaining U.S. FDA marketing approval of Augment and
accordingly amended our PMA to include compelling findings supporting the
safety of rhPDGF-BB which we believe further strengthen the benefit: risk
profile of Augment and offer another supporting factor for approval. The FDA
is reviewing our submission, and we continue to anticipate additional feedback
from the Agency in the coming weeks and a formal letter around year-end,” said
Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. “While we
await the FDA’s complete response, we believe we are in a position to continue
to advance regulatory approvals and subsequent commercialization of Augment in
other parts of the world, the commercialization of Augmatrix in the U.S. and
our other product development programs such as Augment ^ Injectable Bone Graft
and Augment Chronic Tendinopathy in the sports medicine area. If approved by
the appropriate regulatory authorities, we believe our deep product pipeline
will provide new, effective and less invasive treatment options for the repair
of bone, tendons and ligaments, thus helping patients recover from their
injuries and improving their quality of life.”

Additional Financial Results

As of September 30, 2012, the Company had approximately $15.5 million in cash
and cash equivalents and $28.8 million in short-term investments.

For the three and nine months ended September 30, 2012, the Company reported
total revenues of $0.7 million and $1.6 million, respectively, consisting of
product sales, sublicense fee income and royalty income. This compares to
total revenues of $0.4 million and $1.3 million, respectively, recorded for
the same periods in 2011.

Research and development expenses totaled $1.9 million for the three months
ended September 30, 2012, compared to $3.6 million for the same period in
2011. For the nine months ended September 30, 2012, research and development
expenses totaled $7.5 million, compared to $11.5 million for the same period
in 2011. Research and development expenses include outside professional
services expenses, as well as salaries, wages, benefits, payroll taxes and
stock-based compensation expense for internal research and development
personnel, and relate to clinical trials of our product candidates in the
United States, Canada and the European Union, as well as continuing expenses
associated with pre-clinical studies and regulatory filings. The 2012 expenses
for manufacturing costs and outside professional services associated with
clinical trials, which decreased by a combined $0.6 million and $1.1 million
for the three and nine months ended September 30, 2012, respectively, were
lower as certain clinical trials and pre-clinical studies have been delayed to
allow the Company to conserve resources and focus attention on addressing the
Augment PMA. For example, clinical trial expenditures for Augment Injectable
have decreased since the Company voluntarily suspended additional screening
and enrollment of patients. Salaries, benefits, payroll taxes and stock-based
compensation expense in the research and development function decreased by a
combined $0.9 million and $2.3 million for the three and nine months ended
September 30, 2012, respectively, due to a reduction in staffing. In addition,
expenses for general business activities in the research and development
function, such as travel, recruiting and relocation and lab supplies,
decreased by a combined $0.2 million and $0.6 million for the three and nine
months ended September 30, 2012, respectively.

Selling, general and administrative expenses totaled $3.0 million for the
three months ended September 30, 2012, compared to $3.6 million for the same
period in 2011. For the nine months ended September 30, 2012, selling, general
and administrative expenses totaled $10.2 million, compared to $12.3 million
for the same period in 2011. The 2012 expenses for selling, general and
administrative activities decreased primarily from the Company’s efforts to
carefully manage expenses and conserve resources given the uncertainty
surrounding the FDA review process of its Augment PMA application, offset
partially by the Company’s sales, marketing and customer service efforts,
particularly in connection with the commercial activities for Augment and
Augmatrix. The $0.6 million decrease for the three months ended September 30,
2012 resulted from a $0.3 million decrease in salaries, benefits, payroll
taxes and stock-based compensation expense due to a reduction in staffing, and
a $0.4 million decrease in general business activities in the selling, general
and administrative function, such as outside professional services, rent and
utilities, dues and subscriptions, recruiting and relocation, repairs and
maintenance, and taxes and licenses. These decreases are partially offset by
an increase of $0.1 million in sales commissions and milestone expenses during
the quarter. The $2.1 million decrease for the nine months ended September 30,
2012 resulted from a $0.5 million decrease in royalty expense, a $0.7 million
decrease in outside professional fees, a $0.7 million decrease in salaries,
benefits, payroll taxes and stock-based compensation expense due to a
reduction in staffing, and a $0.4 million decrease in general business
activities in the selling, general and administrative function, such as
travel, conferences and seminars, charitable contributions, office supplies,
and rent and utilities. These decreases are partially offset by an increase of
$0.2 million in sales commissions and milestone expenses during the year.

2012 Financial Guidance

Based on current operating plans, forecasted timing and costs of clinical
trials and other product development programs, the Company anticipates its
2012 year-end balance of cash, cash equivalents and investments to range from
$32 to $39 million, and anticipates its net cash use for the year will be
between $22 and $29 million. Net loss for the year ending December 31, 2012 is
forecasted to be in the range of $23 to $30 million.

Conference Call and Webcast

As previously announced, BioMimetic will be hosting a conference call and
webcast on Monday, November 5, 2012 at 4:30 p.m. EST to discuss the third
quarter financial results. A live webcast of the conference call will be
available on the Investor Relations section of BioMimetic’s website at
www.biomimetics.com. The webcast will be archived on the website for at least
30 days.

The conference call may be accessed on November 5, 2012, by dialing (877)
224-4059 for U.S. and Canadian callers (passcode: 56458053). The international
dial in number is (706) 902-2069, and the same passcode applies. Participants
should dial in 10 minutes prior to the call.

About BioMimetic Therapeutics

BioMimetic Therapeutics (NASDAQ: BMTI) is a biotechnology company specializing
in the development and commercialization of clinically proven products to
promote the healing of musculoskeletal injuries and diseases, including
therapies for orthopedics, sports medicine and spine applications. All
Augment^® branded products are based upon recombinant human platelet-derived
growth factor (rhPDGF-BB), which is an engineered form of PDGF, one of the
body's principal agents to stimulate and direct healing and regeneration.
Through the commercialization of this patented technology, BioMimetic seeks to
become the leading company in the field of regenerative medicine by providing
new treatment options for the repair of bone, cartilage, tendons and
ligaments.

BioMimetic has received regulatory approvals to market Augment^® Bone Graft in
Canada, Australia and New Zealand for use in hindfoot and ankle fusion
indications. Augment is pending regulatory decisions in the U.S. and European
Union for similar indications. The Company also markets a bone graft
substitute line of products for orthopedic indications called Augmatrix^TM
Biocomposite Bone Graft.

For further information contact Kearstin Patterson, senior director of
corporate communications, at 615-236-4419.

Forward-looking Statements

This press release contains forward-looking statements about our future
results of operations and financial position, product development programs,
business strategy, plans and objectives of management for future operations
that are not historical facts. The words “may,” “continue,” “estimate,”
“intend,” “plan,” “will,” “believe,” “project,” “expect,” “anticipate,”
“optimistic” and similar expressions may identify forward-looking statements,
but the absence of these words does not necessarily mean that a statement is
not forward-looking. There are many important factors that could cause actual
results to differ materially from those indicated in the forward-looking
statements, including that: (i) the FDA may not be satisfied with the
Company’s amendment to its PMA and may determine such PMA is not approvable or
require additional clinical trials and (ii) despite the Company’s future
marketing and commercialization efforts, Augment and Augmatrix may not achieve
broad market acceptance. Further, BioMimetic’s actual results and the timing
and outcome of events may differ materially from those expressed in or implied
by the forward-looking statements because of risks detailed in BioMimetic’s
recent annual and quarterly reports filed with the Securities and Exchange
Commission, including those factors discussed under the caption "Risk Factors"
in the Company’s Annual Report on Form 10-K filed with the SEC on March 13,
2012, which are incorporated in this press release by this reference. Except
as required by law, BioMimetic undertakes no responsibility for updating the
information contained in this press release beyond the published date, whether
as a result of new information, future events or otherwise, and has no policy
of doing so.

                                                            
BIOMIMETIC THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
                                          September 30,     December 31,
                                           2012               2011
ASSETS
Current assets:
Cash and cash equivalents                  $ 15,494,488       $ 18,503,061
Investments - short term                     28,771,322         42,950,397
Receivables - trade, net                     347,688            85,759
Receivables - other                          263,530            1,121,596
Inventory, net                               4,057,139          3,528,771
Prepaid expenses                            568,351          485,385      
Total current assets                         49,502,518         66,674,969
Receivables - long term                      168,999            73,801
Prepaid expenses - long term                 1,287              4,577
Property and equipment, net                  4,369,802          5,304,565
Capitalized patent license fees, net         2,662,512          2,443,590
Deposits                                    385,000          385,000      
Total assets                               $ 57,090,118      $ 74,886,502   
                                                              
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable                           $ 830,379          $ 2,392,910
Accrued payroll, employee benefits and       2,027,754          2,430,701
payroll taxes
Other accrued expenses                       344,170            634,216
Current portion of capital lease             88,735             83,921
obligations
Deferred revenue                            971,188          973,849      
Total current liabilities                    4,262,226          6,515,597
Accrued rent - related party                 585,170            622,950
Capital lease obligations                    67,639             131,724
Deferred revenue                            12,880,245       13,604,641   
Total liabilities                            17,795,280         20,874,912
                                                              
Stockholders’ equity:
Preferred stock, $0.001 par value;
15,000,000 shares authorized; no shares      -                  -
issued and outstanding as of September
30, 2012 and December 31, 2011
Common stock, $0.001 par value;
100,000,000 shares authorized;
28,225,241 shares issued and outstanding     28,225             28,128
as of September 30, 2012; 28,128,280
shares issued and outstanding as of
December 31, 2011
Additional paid-in capital                   217,035,682        214,626,320
Accumulated other comprehensive loss         9,845              4,490
Accumulated deficit                         (177,778,914 )    (160,647,348 )
Total stockholders’ equity                  39,294,838       54,011,590   
Total liabilities and stockholders’        $ 57,090,118      $ 74,886,502   
equity
                                                              


BIOMIMETIC THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(Unaudited)
                Three months ended               Nine months ended
                 September 30,                     September 30,
                 2012            2011             2012             2011
Revenues:
Product sales    $ 359,561        $ 63,311         $ 601,694         $ 212,223
Royalty income     72,506           120,523          232,777           327,974
Sublicense fee     244,792          244,793          729,056           726,396
income
Other income      11,805         -              28,605          -           
Total revenues     688,664          428,627          1,592,132         1,266,593
Costs and
expenses:
Cost of sales
(exclusive of
depreciation
and                129,343          12,362           183,662           34,196
amortization
shown
separately
below)
Research and       1,929,659        3,604,994        7,451,535         11,453,229
development
Selling,
general and        2,998,032        3,585,505        10,158,854        12,260,820
administrative
Depreciation
and capital        233,352          359,632          952,244           893,982
lease
amortization
Patent license
fee               11,227         9,626          32,233          27,235      
amortization
Total costs       5,301,613      7,572,119      18,778,528      24,669,462  
and expenses
Loss from          (4,612,949 )     (7,143,492 )     (17,186,396 )     (23,402,869 )
operations
                                                                                   
Interest           (702       )     (1,054     )     (2,228      )     (3,396      )
expense, net
Investment         15,784           25,400           56,864            91,570
income, net
Gain (loss) on
foreign
currency          (782       )    (3,253     )    194             (2,055      )
translation
and other
transactions
Loss before        (4,598,649 )     (7,122,399 )     (17,131,566 )     (23,316,750 )
income taxes
Income taxes      -              -              -               -           
Net loss         $ (4,598,649 )   $ (7,122,399 )   $ (17,131,566 )   $ (23,316,750 )
                                                                                   
Basic and
diluted net      $ (0.16      )   $ (0.25      )   $ (0.61       )   $ (0.83       )
loss per share
Comprehensive    $ (4,592,076 )   $ (7,140,091 )   $ (17,126,211 )   $ (23,316,378 )
loss
Weighted
average shares
used to
compute basic     28,216,493     28,035,339     28,187,186      27,983,839  
and diluted
net loss per
share

Contact:

BioMimetic Therapeutics, Inc.
Kearstin Patterson
Senior Director of Corporate Communications
615-236-4419 (office)
615-517-6112 (mobile)
kpatterson@biomimetics.com
 
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