EX-99.1 2 file2.htm PRESS RELEASE DATED MAY 8, 2008


Contact:

Kearstin Patterson

Associate Director, Corporate Communications

615-236-4419 (office)

615-517-6112 (mobile)

kpatterson@biomimetics.com

BioMimetic Therapeutics Reports 2008 First Quarter Results

$33.4 Million Cash Received

from the Sale of Orofacial Therapeutic Business

Franklin, Tenn. – May 8, 2008 - BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today reported its financial results as of and for the three months ended March 31, 2008. For the three months ended March 31, 2008, the Company reported net income of $31.3 million, or $1.62 per diluted share, compared to a net loss of $5.7 million, or $(0.34) per diluted share, for the same period in 2007. The Company ended the quarter with $92.8 million of cash and cash equivalents and long-term investments in marketable securities.

During the first part of 2008, the Company made the following significant advancements in its product development programs and other critical business areas:

Clinical Highlights

 

Reported a total of 170 patients have been enrolled, as of May 5, 2008, in the U.S. pivotal trial evaluating the safety and effectiveness of GEM OS1 to stimulate bone healing in foot and ankle fusions. The study design is a randomized, controlled, non-inferiority trial comparing GEM OS1 to autograft and will enroll up to 396 patients.

 

Reported a total of 81 patients have been enrolled, as of May 5, 2008, in the EU registration study with GEM OS1 for the treatment of foot and ankle fusions. This study is an open label trial in which all patients will receive GEM OS1 treatment and will enroll up to 125 patients.

 

Announced today that the Marketing Authorization Application (MAA) for GEM 21S Growth-factor Enhanced Matrix was validated and accepted for review by the European Medicines Agency (EMEA) in March. The MAA submission is required for approval of commercialization and distribution of GEM 21S as a medicinal product in the European Union (EU). As previously announced, BioMimetic will receive a $10 Million milestone payment from Luitpold Pharmaceuticals, Inc., which owns and markets that product through its Osteohealth Company, upon approval of GEM 21S in the EU.

 

 

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Reported that the U.S. Food and Drug Administration (FDA) issued a letter to BioMimetic confirming that its U.S. GEM OS1 pivotal study for the treatment of foot and ankle fusions should continue as designed and that the FDA has taken no action to change the study status. This letter followed a posting on the FDA website of an Early Communication concerning the Agency’s ongoing safety review of Regranex®, a Johnson & Johnson product. Both GEM OS1 and Regranex contain recombinant human platelet-derived growth factor (rhPDGF-BB) (becaplermin) as the active ingredient, though Regranex is approved for up to 140 daily applications, in contrast to GEM OS1 which is applied as a single application at the time of surgery.

Corporate Highlights

 

Generated $33.4 million in cash with the closing of the January 2008 sale of the Company’s remaining orofacial therapeutic business, including the downstream formulation, fill and finish manufacturing rights of GEM 21S, to Luitpold Pharmaceuticals, who markets the product through its Osteohealth Company division. In total, BioMimetic will receive $43.4 million in cash as a result of the transaction, plus ongoing royalty payments based on net sales of GEM 21S and future products in the dental and cranio-maxillofacial fields. The remaining $10 million in milestones from this transaction, as well as an additional $10 million milestone payment associated with a previous research, development and marketing agreement with Luitpold, are payable upon completion of certain milestones anticipated prior to year-end 2009.

 

Entered into a distribution agreement in April with Joint Solutions Alliance Corporation, a sales and distribution company for orthopedic products headquartered in Burlington, Ontario, Canada. As part of this agreement, Joint Solutions will act as the exclusive distributor of BioMimetic’s GEM OS1 Bone Graft and GEM OS2 Injectable Bone Graft products in Canada. The agreement has an initial two-year term expiring in April 2010, and is subsequently renewable for additional one-year terms. BioMimetic will also deploy a product specialist in the Canadian market to work collaboratively with the Joint Solutions Team.

 

Presented nine oral and poster presentations highlighting pre-clinical and clinical data in the orthopedic space at the AAOS/ORS meetings held in San Francisco in March. The Company also hosted an investor and analyst meeting that highlighted pre-clinical and clinical data, and provided guidance on new clinical opportunities and updates on the Company’s clinical pipeline.

 

Received U.S. Patent Office approval of a 2.7 year patent term extension on a key patent that protects GEM 21S, a product approved by the FDA for the treatment of bone loss associated with advanced periodontal disease. Upon issuance of the certificate of extension, the patent’s term will extend to March 8, 2012.

 

Scheduled the Annual Meeting of Stockholders to be held on Thursday, June 12, 2008 at 8:00 a.m. CDT at the Company’s corporate headquarters south of Nashville, Tennessee.

“Over the past quarter we strengthened our balance sheet significantly and continued our focused orthopedic product development efforts, including advancing our pivotal clinical trials for GEM OS1 in the United States and EU,” said Dr. Samuel E. Lynch, president and CEO of BioMimetic

 

 

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Therapeutics. “With our GEM OS1 product registration filing expected to be submitted in Canada in the second quarter, additional data from our GEM OS2 injectable bone graft clinical trial expected in the third quarter, the anticipated completion of enrollment later this year in the U.S. and EU pivotal GEM OS1 clinical trials for foot and ankle fusions and the cash reserves from the sale of GEM 21S, we are well positioned to exploit the large and growing opportunity in orthobiologics and become one of the leading regenerative biologics companies in orthopedics.”

Additional Financial Results

For the three months ended March 31, 2008, the Company reported a gain of $39.3 million resulting from the January 2008 sale of its orofacial therapeutic business. In addition, the Company reported revenues of $0.5 million. This compares to revenues of $0.4 million for the three months ended March 31, 2007.

Research and development expenses totaled $6.1 million for the three months ended March 31, 2008, compared to $3.9 million for the three months ended March 31, 2007. The increase in 2008 research and development expenses was primarily due to new and ongoing clinical trials of the Company’s orthopedic product candidates in the United States, Canada and the EU, as well as continuing expenses associated with pre-clinical studies and regulatory filings. In addition, expenses for salaries, wages, benefits, stock based compensation expenses, supplies and other employee costs have increased as a result of a net increase of 19 new employees in research and development functions.

General and administrative expenses were $2.3 million for the three months ended March 31, 2008, compared to $2.0 million for the three months ended March 31, 2007. These expenses consist of salaries, wages and related benefits for employees in general and administrative functions, professional services, rent and utility costs for the Company’s facilities, minimum royalty payments per the Company’s patent licensing agreements and costs of operating as a public company.

2008 Financial Guidance

The Company had approximately $92.8 million of cash, cash equivalents and long-term investments in marketable securities as of March 31, 2008. Based on current operating plans, forecasted timing and cost of clinical trials and other product development programs, the Company anticipates its 2008 year-end balance of cash, cash equivalents and marketable securities to range from $71 to $78 million, and anticipates that its net cash flow will be between $4 and $11 million, including $10 million in additional milestone payments that the Company anticipates receiving in the fourth quarter of 2008 from Luitpold, its GEM 21S marketing partner. Income before income taxes for the year ending December 31, 2008 is forecasted to be in the range of $2 to $9 million.

Conference Call and Webcast

As previously announced, BioMimetic will be hosting a conference call and webcast on May 9, 2008 at 8:30 a.m. EDT to discuss the first quarter 2008 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.

 

 

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The conference call may be accessed on May 9, 2008 by dialing 888.713.4209 (passcode: 30353831). The international dial in number is 617.213.4863, 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, Inc. is developing and commercializing bio-active recombinant protein-device combination products for the healing of musculoskeletal injuries and disease, including orthopedic, spine and sports injury applications. BioMimetic received marketing approval from the FDA in 2005 for its first product, GEM 21S, for regeneration of bone and periodontal tissue loss resulting from periodontal disease, which was subsequently sold to Luitpold Pharmaceuticals, Inc. Currently, the Company has clinical trials ongoing with its product candidates GEM OS1 and GEM OS2 in multiple orthopedic bone healing indications including the treatment of foot and ankle fusions and the stimulation of healing of fractures of the wrist. The Company’s lead product candidates and GEM 21S all combine recombinant human platelet derived growth factor (rhPDGF-BB) with tissue specific scaffolds to actively stimulate tissue healing and regeneration. 

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.

 

 

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BIOMIMETIC THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

 

 

March 31,
2008

 

December 31,
2007

 

ASSETS

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

35,164,801

 

$

25,482,587

 

Receivables – trade

 

 

13,900

 

 

2,243,318

 

Receivables – other

 

 

425,332

 

 

1,144,755

 

Prepaid expenses

 

 

414,053

 

 

681,189

 

Assets held for sale

 

 

 

 

3,436,911

 

Total current assets

 

 

36,018,086

 

 

32,988,760

 

Marketable securities

 

 

57,600,000

 

 

41,800,000

 

Inventory

 

 

2,008,942

 

 

787,132

 

Receivables – long term

 

 

9,549,080

 

 

 

Property and equipment, net

 

 

5,504,603

 

 

5,559,930

 

Capitalized patent license fees, net

 

 

5,505,475

 

 

6,003,321

 

Deposits

 

 

2,904,000

 

 

2,478,823

 

Total assets

 

$

119,090,186

 

$

89,617,966

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

4,956,359

 

$

4,150,093

 

Accrued payroll, employee benefits and payroll taxes

 

 

1,029,811

 

 

1,665,838

 

Other accrued expenses

 

 

814,435

 

 

1,201,277

 

Current portion of capital lease obligations

 

 

17,557

 

 

17,351

 

Deferred liability

 

 

1,250,000

 

 

1,250,000

 

Deferred revenue

 

 

971,188

 

 

973,849

 

Total current liabilities

 

 

9,039,350

 

 

9,258,408

 

Accrued rent – related party

 

 

371,464

 

 

362,200

 

Capital lease obligations

 

 

48,433

 

 

52,900

 

Deferred revenue

 

 

17,252,584

 

 

17,492,055

 

Total liabilities

 

 

26,711,831

 

 

27,165,563

 

Stockholders’ equity:

 

 

 

 

 

 

 

Preferred stock, $0.001 par value; 15,000,000 shares authorized; no shares issued and outstanding as of March 31, 2008 and December 31, 2007

 

 

 

 

 

Common stock, $0.001 par value; 37,500,000 shares authorized; 18,457,285 shares issued and outstanding as of March 31, 2008; 18,351,312 shares issued and outstanding as of December 31, 2007

 

 

18,457

 

 

18,351

 

Additional paid-in capital

 

 

127,814,492

 

 

126,791,861

 

Accumulated other comprehensive loss

 

 

(2,400,000

)

 

 

Accumulated deficit

 

 

(33,054,594

)

 

(64,357,809

)

Total stockholders’ equity

 

 

92,378,355

 

 

62,452,403

 

Total liabilites and stockholders’ equity

 

$

119,090,186

 

$

89,617,966

 

 

 

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BIOMIMETIC THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

Three months ended
March 31,

 

 

 

2008

 

2007

 

Revenues:

 

 

 

 

 

 

 

Product sales

 

$

 

$

24,548

 

Royalty income

 

 

227,172

 

 

158,615

 

Sublicense fee income

 

 

242,132

 

 

175,029

 

Rental and other income

 

 

18,431

 

 

7,521

 

Total revenues

 

 

487,735

 

 

365,713

 

Costs and expenses:

 

 

 

 

 

 

 

Cost of sales (exclusive of depreciation and amortization shown separately below)

 

 

 

 

19,102

 

Research and development

 

 

6,141,223

 

 

3,943,522

 

General and administrative

 

 

2,344,427

 

 

2,047,689

 

Depreciation and capital lease amortization

 

 

355,793

 

 

244,480

 

Patent license fee amortization

 

 

616,222

 

 

541,109

 

 

 

 

9,457,665

 

 

6,795,902

 

Loss from operations

 

 

(8,969,930

)

 

(6,430,189

)

Interest income, net

 

 

211,664

 

 

563,954

 

Investment income, net

 

 

882,062

 

 

171,936

 

Gain (loss) on disposal of equipment

 

 

5,025

 

 

(15

)

Gain on disposal of orofacial therapeutic business

 

 

39,296,894

 

 

 

Income (loss) before income taxes

 

 

31,425,715

 

 

(5,694,314

)

Income taxes

 

 

122,500

 

 

 

Net income (loss)

 

$

31,303,215

 

$

(5,694,314

)

Net income (loss) per common share:

 

 

 

 

 

 

 

Basic

 

$

1.70

 

$

(0.34

)

Diluted

 

$

1.62

 

$

(0.34

)

Weighted average shares used to compute net income (loss) per common share:

 

 

 

 

 

 

 

Basic

 

 

18,366,814

 

 

16,909,714

 

Diluted

 

 

19,343,224

 

 

16,909,714

 

 

 

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