BioMimetic Therapeutics Reports 2009 Third Quarter Earnings Results

http://www.businesswire.com/news/home/20091105006428/en

Company`s Second Orthopedic Product Candidate Enters Pivotal Trial for Foot and
Ankle Fusion Indications
FRANKLIN, Tenn.--(Business Wire)--
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today reported its financial
results as of and for the three and nine months ended September 30, 2009. For
the three months ended September 30, 2009, the Company reported a net loss of
$7.9 million, or $0.36 per diluted share, compared to a net loss of $18.0
million, or $0.97 per diluted share, for the same period in 2008. For the nine
months ended September 30, 2009, the Company reported a net loss of $22.3
million, or $1.11 per diluted share, compared to a net income of $4.2 million,
or $0.22 per diluted share, for the same period in 2008. The Company ended the
third quarter of 2009 with $69.2 million of cash, cash equivalents and
short-term investments. The Company also reported $31.4 million in long term
investments which includes $29.9 million invested in auction rate securities.

Comparatively, the net loss for the three and nine months ended September 30,
2008 included a $10.2 million non-cash impairment charge on the Company`s
investments in auction rate securities. Additionally, the net income for the
nine months ended September 30, 2008 included a $39.3 million gain resulting
from the January 2008 sale of the Company`s orofacial therapeutic business.
Excluding these items, the Company`s net loss for the three and nine months
ended September 30, 2008 would have been $7.8 million, or $0.42 per diluted
share, and $24.9 million, or $1.29 per diluted share, respectively.

The Company initiated patient enrollment in a pivotal study in North America to
assess the safety and efficacy of Augment Injectable Bone Graft as a substitute
for autograft in foot and ankle fusion procedures. This randomized, controlled
study is intended to support Augment Injectable product registration in the
United States and Canada. The study will incorporate approximately 300 patients,
some of whom will be autograft patients that were enrolled in the Company`s
Augment Bone Graft study. The Augment Injectable study protocol is similar to
the Augment Bone Graft study protocol so that certain control (autograft)
patients already enrolled in the Augment study can be used to supplement the
control group in the new study. Up to 20 clinical centers in North America will
be involved, with five sites already approved for enrollment in Canada.

The Company recently reported positive data from its North American pivotal
clinical trial which demonstrated that fusion rates for Augment Bone Graft
treated patients were equivalent to patients treated with autograft taken from
elsewhere in the patient`s own body, but without the donor site pain and
potential complications of harvesting autograft. Additionally, the Company
recently reported approval of Augment Bone Graft in Canada.

"We are gratified that our Augment Bone Graft investigators are enthusiastic
about our second orthopedic product candidate, Augment Injectable, and all of
the top enrolling clinical investigators have agreed to participate in this
study. This is clearly a testament to the strong data and patient benefits we`ve
previously discussed, as well as the Company`s unique and proven platform
technology," said Dr. Samuel E. Lynch, president and CEO of BioMimetic
Therapeutics. "The injectable formulation will allow delivery of the product to
the fusion site through a syringe ensuring controlled and consistent delivery.
We have five clinical centers activated and have already enrolled our first
patients in this trial. We expect to complete enrollment within the coming 12
months. The initiation of this pivotal trial for our second orthopedic product
candidate and the Canadian approval of Augment Bone Graft announced earlier this
week are both major milestones towards the commercialization of our exciting
regenerative technology."

Recent Company Highlights

During the last few months of 2009, the Company made advancements in its product
development programs and other critical business areas:

* In October, the Company announced positive top-line results from its North
American pivotal (Phase III) randomized, controlled trial comparing Augment to
autograft, the historical standard of care, for use in hindfoot and ankle fusion
surgery. The study goal was to establish non-inferiority of Augment compared to
autograft. The primary endpoint of the study is the percentage of patients fused
at 24 weeks, with fusion defined as 50% or greater bone bridging on CT scans, as
evaluated by an independent musculoskeletal radiologist. For the pre-specified
primary endpoint, patients treated with Augment experienced a similar fusion
rate (61.2%) compared with those receiving autograft (62.0%). These data met
statistical non-inferiority (p=0.037; n=397 patients). Since many patients had
multiple joints treated, analysis was also performed on a per joint basis.
Non-inferiority was also established on a per joint basis, with 66.5% of joints
treated with Augment fused on CT scans compared to 62.6% of joints treated with
autograft (p=<0.001; n=597 joints). The Company expects to file the third and
final PMA module, containing the data from the clinical trial, to the FDA around
the end of 2009.
* The Company received approval from Health Canada to begin the marketing of its
lead orthopedic product, Augment Bone Graft, as an alternative to the use of
autograft in foot and ankle fusion indications in Canada. Joint Solutions
Alliance Corporation is the exclusive distributor of BioMimetic`s Augment Bone
Graft product in Canada. BioMimetic will also deploy product specialists in the
Canadian market to work collaboratively with the Joint Solutions Team. The
Company expects the product will be available to customers in Canada within 30
days.
* In November 2008, the Company completed enrollment in the EU clinical study
with Augment for the treatment of foot and ankle fusions with a total enrollment
of 108 patients. The Company expects that the data from the study will be
available in the first half of 2010. The data will be used in conjunction with
data from the North American pivotal trial and other trials to achieve product
registration worldwide.
* The Company has initiated patient enrollment in a pivotal study in North
America to assess the safety and efficacy of Augment Injectable as a substitute
for autograft in foot and ankle fusion procedures.

"During the third quarter we made strong progress towards the goal of achieving
our first orthopedic product approval in the United States," said Dr. Samuel E.
Lynch, president and CEO of BioMimetic Therapeutics. "We released positive,
pivotal data on Augment, our lead orthopedic product candidate, which we believe
demonstrates a clear picture of non-inferiority to autograft. We expect to
submit the third and final PMA module for submission to the FDA around the end
of this year."

Additional Financial Results

As of September 30, 2009, the Company has approximately $14.3 million of cash
and cash equivalents and $86.3 million of investments, which includes a total of
$39.0 million of short-term and long-term investments in auction rate securities
recorded at fair market value. During the nine months ended September 30, 2009,
certain of the Company`s investments in auction rate securities were redeemed or
partially redeemed by the issuer at par, and certain of its auction rate
securities were sold at a discount to a third party, for total proceeds of $12.3
million. These redemption and sale transactions resulted in a $2.1 million
realized gain recorded to investment income during the nine months ended
September 30, 2009. Concurrently with the redemption and sale transactions, the
Company repaid $9.3 million against its note payable to Deutsche Bank, which is
secured by certain of its auction rate securities, resulting in a remaining
balance on the note payable of $29.8 million as of September 30, 2009.

Subsequently, in October 2009, certain of the Company`s auction rate securities
were partially redeemed by the issuer at par value, and certain of its auction
rate securities were sold at a discount to a third party, for total proceeds to
the Company of $9.1 million. Concurrently with these October 2009 transactions,
the Company repaid an additional $4.8 million against its note payable to
Deutsche Bank. As a result, the Company classified $9.1 million of its
investments in auction rate securities, and $4.8 million of its note payable, as
short-term on its condensed consolidated balance sheet as of September 30, 2009.

For the three and nine months ended September 30, 2009, the Company reported
total revenues of $0.4 million and $1.1 million, respectively, consisting of
royalty income and sublicense fee income. This compares to total revenues of
$0.4 million and $1.4 million, respectively, for the same periods in 2008.

Research and development expenses totaled $5.2 million for the three months
ended September 30, 2009, compared to $5.7 million for the same period in 2008.
For the nine months ended September 30, 2009, research and development expenses
totaled $15.5 million, compared to $18.6 million for the same period in 2008.
Research and development expenses result primarily from clinical trials of the
Company`s orthopedic product candidates in the United States, Canada and the
European Union, as well as continuing expenses associated with new and ongoing
pre-clinical studies and regulatory filings. The decrease in 2009 research and
development expenses was partially due to contract manufacturing costs, which
decreased by $0.4 million and $1.7 million for the three and nine months ended
September 30, 2009, respectively, since certain clinical trials came to a close
in 2009. In addition, professional services costs for clinical, validation
consulting, regulatory and outside research and development, milestone expenses,
salary & benefits and recruiting and relocation costs decreased by approximately
$0.1 million and $1.4 million for the three and nine months ended September 30,
2009, respectively.

General and administrative expenses totaled $2.8 million for the three months
ended September 30, 2009, compared to $2.2 million for the same period in 2008.
For the nine months ended September 30, 2009, general and administrative
expenses totaled $7.5 million, compared to $7.1 million for the same period in
2008. The increase resulted primarily from increases in salaries, wages and
related benefits, professional services, rent and utility costs for the
Company`s facilities and minimum royalty payments per the Company`s patent
licensing agreements.

2009 Financial Guidance

Based on current operating plans, forecasted timing and costs of clinical trials
and other product development programs, the Company anticipates its 2009
year-end balance of cash, cash equivalents and investments to range from $88.0
to $95.0 million, and anticipates that its net cash use will be between $2.0 and
$9.0 million. This includes the $4.0 million remaining time-based payment
expected later in 2009 related to the sale of its orofacial therapeutic business
to Luitpold Pharmaceuticals, Inc. Loss before income taxes for the year ending
December 31, 2009 is forecasted to be in the range of $31.0 to $38.0 million.

Conference Call and Webcast

As previously announced, BioMimetic will be hosting a conference call and
webcast on Thursday, November 5, 2009 at 4:30 p.m. EST to discuss the third
quarter 2009 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, 2009 by dialing 888-679-8040
(passcode: 72254521). The international dial in number is 617-213-4851, and the
same passcode applies. Participants should dial in 10 minutes prior to the call
if they have not pre-registered.

About BioMimetic Therapeutics

BioMimetic Therapeutics is a biotechnology company utilizing purified
recombinant human platelet-derived growth factor (rhPDGF-BB) in combination with
tissue specific matrices as its primary technology platform for promotion of
tissue healing and regeneration. rhPDGF-BB is a synthetic copy of one of the
body's principal agents to stimulate and direct healing and regeneration. The
mechanism of action of this platform technology suggests it may be effective in
a broad array of musculoskeletal applications, including the repair of bone,
ligament, tendon and cartilage. Through the commercialization of this
technology, BioMimetic seeks to become the leading company in the field of
orthopedic regenerative medicine. BioMimetic received marketing approval from
the FDA for its first product, GEM 21S, as a grafting material for bone and
periodontal regeneration following completion of human clinical trials, which
demonstrated the safety and efficacy of the rhPDGF-BB platform technology.
Additionally, BioMimetic Therapeutics has completed and ongoing clinical trials
with its product candidates Augment and Augment Injectablein multiple orthopedic
bone healing indications including the treatment of foot and ankle fusions and
the stimulation of healing of fractures of the wrist. In November 2009,
BioMimetic received approval from Health Canada to begin the marketing of
Augment as an alternative to the use of autograft in foot and ankle fusion
indications in Canada.

GEM 21S is a trademark of Luitpold Pharmaceuticals, Inc., who now owns this
dentally related product and markets it through its Osteohealth Company in the
United States and Canada.

For further information, visit www.biomimetics.com or contact Kearstin
Patterson, corporate communications, at 615-236-4419.

Forward-looking Statements

This press release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. These forward-looking
statements are based on the current intent and expectations of the management of
BioMimetic. These statements are not guarantees of future performance and
involve risks and uncertainties that are difficult to predict. There are many
important factors that could cause actual results to differ materially from
those indicated in the forward-looking statements. 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 associated with
the marketing of BioMimetic`s product and product candidates, unproven
preclinical and clinical development activities, regulatory oversight, and other
risks detailed in BioMimetic`s filings with the Securities and Exchange
Commission. 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, or for changes made to this document by wire services or Internet
services.

BIOMIMETIC THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
September 30, December 31,
2009 2008
ASSETS
Current assets:
Cash and cash equivalents $ 14,336,533 $ 17,534,963
Investments - short term 54,915,624 33,218,233
Receivables - trade - 1,084
Receivables - other 4,503,714 11,635,778
Inventory 1,361,334 -
Prepaid expenses 591,126 503,032
Total current assets 75,708,331 62,893,090
Investments - long term 31,378,620 46,624,040
Inventory - 1,261,987
Prepaid expenses - long term 15,663 58,673
Property and equipment, net 6,270,787 7,014,262
Capitalized patent license fees, net 3,329,706 4,983,729
Deposits 2,304,277 2,284,608
Total assets $ 119,007,384 $ 125,120,389

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,646,299 $ 4,325,907
Accrued payroll, employee benefits and payroll taxes 2,009,226 2,304,016
Other accrued expenses 1,085,305 2,392,236
Current portion of capital lease obligations 18,840 18,187
Current portion of note payable 4,760,000 -
Deferred revenue 971,188 971,188
Total current liabilities 10,490,858 10,011,534
Accrued rent - related party 413,542 399,256
Capital lease obligations 20,500 34,713
Deferred revenue 15,794,471 16,520,866
Note payable 25,030,000 39,100,000
Total liabilities 51,749,371 66,066,369

Stockholders` equity:
Preferred stock, $0.001 par value; 15,000,000 shares authorized; no shares issued and outstanding as of September 30, 2009 and December 31, 2008 - -
Common stock, $0.001 par value; 37,500,000 shares authorized; 21,790,787 shares issued and outstanding as of September 30, 2009; 18,714,067 shares issued and outstanding as of December 31, 2008 21,791 18,714
Additional paid-in capital 159,246,371 131,262,570
Accumulated other comprehensive income 2,605,070 135,542
Accumulated deficit (94,615,219 ) (72,362,806 )
Total stockholders` equity 67,258,013 59,054,020
Total liabilities and stockholders` equity $ 119,007,384 $ 125,120,389

BIOMIMETIC THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

Three months ended Nine months ended
September 30, September 30,
2009 2008 2009 2008
Revenues:
Royalty income $ 129,749 $ 169,017 $ 400,111 $ 605,012
Sublicense fee income 244,793 244,792 726,396 729,056
Other revenue - 5,160 - 30,301
Total revenues 374,542 418,969 1,126,507 1,364,369
Costs and expenses:
Research and development 5,191,513 5,665,818 15,538,084 18,631,080
General and administrative 2,755,003 2,198,393 7,534,323 7,056,214
Depreciation and capital lease amortization 333,458 355,235 1,015,424 1,067,209
Patent license fee amortization 549,025 665,825 2,018,444 1,898,268
Total costs and expenses 8,828,999 8,885,271 26,106,275 28,652,771
Loss from operations (8,454,457 ) (8,466,302 ) (24,979,768 ) (27,288,402 )
Interest (expense) income, net (103,919 ) 97,903 (264,299 ) 427,726
Investment income (loss), net 642,243 (9,598,379 ) 2,991,654 (8,150,753 )
Gain on disposal of equipment - - - 5,025
(Loss) gain on disposal of orofacial therapeutic business - (1,875 ) - 39,291,314
(Loss) income before income taxes (7,916,133 ) (17,968,653 ) (22,252,413 ) 4,284,910
Income taxes - - - 122,500
Net (loss) income $ (7,916,133 ) $ (17,968,653 ) $ (22,252,413 ) $ 4,162,410
Net (loss) income per common share:
Basic $ (0.36 ) $ (0.97 ) $ (1.11 ) $ 0.23
Diluted $ (0.36 ) $ (0.97 ) $ (1.11 ) $ 0.22
Weighted average shares used to compute net (loss) income per common share:
Basic 21,751,983 18,566,073 20,074,256 18,481,388
Diluted 21,751,983 18,566,073 20,074,256 19,241,894

BioMimetic Therapeutics, Inc.
Kearstin Patterson, 615-236-4419
Director, Corporate Communications
Mobile: 615-517-6112
kpatterson@biomimetics.com

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