UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): July 18, 2011
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Bacterin International Holdings, Inc.
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(Exact Name of Registrant as Specified in Its Charter)
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Delaware
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(State or Other Jurisdiction of Incorporation)
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001-34951
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20-5313323
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(Commission File Number)
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(IRS Employer Identification No.)
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600 Cruiser Lane
Belgrade, Montana
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59714
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(Address of Principal Executive Offices)
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(Zip Code)
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(406) 388-0480
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(Registrant’s Telephone Number, Including Area Code)
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(Former Name or Former Address, if Changed Since Last Report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 7.01
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Regulation FD Disclosure.
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The Company has issued press releases entitled “Bacterin Acquires Assets of Robinson MedSurg” and “Bacterin Expects Q2 2011 Revenues up 134% to Record $7.5 Million” attached as Exhibits 99.1 & 99.2 respectively, both of which are incorporated herein.
The information in this Item 7.01 and the documents attached as Exhibit 99.1 and 99.2 are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), nor otherwise subject to the liabilities of that section, nor incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
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Item 9.01.
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Financial Statements and Exhibits.
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(d) Exhibits.
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Exhibit No
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Description
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99.1
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Press Release of Bacterin International Holdings, Inc. dated July 18, 2011 entitled “Bacterin Acquires Assets of Robinson MedSurg”
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99.2
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Press Release of Bacterin International Holdings, Inc. dated July 18, 2011 entitled “Bacterin Expects Q2 2011 Revenues up 134% to Record $7.5 Million”
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Dated: July 18, 2011
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BACTERIN INTERNATIONAL HOLDINGS, INC.
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By: /s/ Guy S. Cook
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Name: Guy S. Cook
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Title: President and Chief Executive Officer
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EXHIBIT INDEX
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99.1
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Press Release of Bacterin International Holdings, Inc. dated July 18, 2011 entitled “Bacterin Acquires Assets of Robinson MedSurg”
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99.2
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Press Release of Bacterin International Holdings, Inc. dated July 18, 2011 entitled “Bacterin Expects Q2 2011 Revenues up 134% to Record $7.5 Million”
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Bacterin Acquires Assets of Robinson MedSurg
Company Prepares to Introduce Anti-Microbial Coated Orthopedic Implants
BELGRADE, MT, – July 18, 2011 – Bacterin International Holdings, Inc. (NYSE Amex: BONE), a leader in the development of revolutionary bone graft material and anti-infective coatings for medical applications, has acquired the assets of Robinson MedSurg LLC (RMS), a medical device distribution company focused primarily on maxillofacial and craniofacial surgery devices.
For consideration of $1 million in Bacterin common stock at the closing date, Bacterin acquired approximately $500,000 in inventory, existing commercial agreements and intellectual property, including a number of patents and patent applications. Upon the achievement of certain revenue goals generated by the assets over a two-year period, additional Bacterin common stock valued at $1 million will be paid to RMS.
As part of the transaction, Bacterin has retained certain key employees of RMS, and engaged the president of RMS, Dr. Randolph C. Robinson M.D., D.D.S., F.A.A.C.S., as a consultant to Bacterin’s sales force for RMS products. Dr. Robinson is also a highly accomplished surgeon and thought leader in Cranio Maxillo Facial Reconstruction and trauma to the face.
“We expect this acquisition to leverage our sales force, which will now have additional products to sell into the same call points,” said Guy Cook, Bacterin’s chairman and CEO. “This acquisition also represents our first foray into medical devices that will eventually use our anti-microbial coatings.”
RMS brings to Bacterin a well-established network of independent distributors throughout the United States and internationally. Bacterin plans to expand upon this network with its 60 company sales reps and 450 independent reps, as well as further enhance the RMS product line with its antimicrobial coatings.
“We will leverage our sales force by first selling RMS uncoated orthopedic implants, then by this time next year, we expect to have FDA concurrence use for anti-microbial coating on these implants,” said Cook. “We expect to be the only company in the space that can offer this technology with anti-microbial coatings, which we believe has an estimated $600 million market potential.”
The acquired RMS product line is comprised of implantable medical devices for maxillofacial, craniofacial, and orthopedic uses. It includes a complete compact bone plating systems; patented small bone generator and craniofacial bone generator distraction devices; and the Patent-pending QuickScrew™ system, a unique pre-loaded surgical screw delivery system that provides a new level of speed and convenience during surgery.
RMS products have received approval at various marquee hospitals, with approved vendor status anticipated soon by the VA Hospital system. Bacterin is now pursuing the FDA market approval process to add its anti-microbial coatings to the RMS product line, and plans to submit a 510(k) application before the end of the year. “We believe this will add an additional and important differentiating IP protection to our product line and we hope to receive approval in 2012,” noted Cook.
“We will continue to be opportunistic in terms of our M&A activity, with a focus on orthopedic implants for the extremities, such as foot and ankle, hands, cranial, and maxillofacial,” said Cook, “and we plan to eventually establish a credit facility to fund our M&A program.”
About Bacterin International Holdings
Bacterin International Holdings, Inc. (NYSE Amex: BONE) develops, manufactures and markets biologics products to domestic and international markets. Bacterin's proprietary methods optimize the growth factors in human allografts to create the ideal stem cell scaffold to promote bone, subchondral repair and dermal growth. These products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain, promotion of bone growth in foot and ankle surgery, promotion of cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries.
Bacterin's Medical Device division develops, employs, and licenses bioactive coatings for various medical device applications. Bacterin's strategic coating initiatives include antimicrobial coatings designed to inhibit biofilm formation and microbial contamination. For further information, please visit www.bacterin.com.
Important Cautions Regarding Forward-looking Statements
This news release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as "continue," "efforts," "expects," "anticipates," "intends," "plans," "believes," "estimates," "projects," "forecasts," "strategy," "will," "goal," "target," "prospects," "potential," "optimistic," "confident," "likely," "probable" or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the Company’s ability to obtain FDA concurrence use for anti-microbial coatings in a timely manner; whether RMS products achieve approved vendor status by the VA hospital system; whether we are able to establish a credit facility to fund any additional acquisition; the Company's ability to meet its obligations under existing and anticipated contractual obligations; the Company's ability to develop, market, sell and distribute desirable applications, products and services and to protect its intellectual property; the ability and willingness of third-party manufacturers to timely and cost-effectively fulfill orders from the Company; the ability of the Company's customers to pay and the timeliness of such payments, particularly during recessionary periods; the Company's ability to obtain financing as and when needed; changes in consumer demands and preferences; the Company's ability to attract and retain management and employees with appropriate skills and expertise; the impact of changes in market, legal and regulatory conditions and in the applicable business environment, including actions of competitors; and other factors. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.
Company Contact:
Guy Cook
President & CEO
Bacterin International Holdings, Inc.
Tel 406-388-0480
gcook@bacterin.com
Investor Relations:
Liolios Group, Inc.
Scott Liolios or Ron Both
Tel 949-574-3860
info@liolios.com
Bacterin Expects Q2 2011 Revenue up 134% to Record $7.5 Million
BELGRADE, MT, – July 18, 2011 – Bacterin International Holdings, Inc. (NYSE Amex: BONE), a leader in the development of revolutionary bone graft material and anti-infective coatings for medical applications, expects to report its seventh consecutive quarter of record revenue growth.
Based on preliminary unaudited information, the company expects to report Q2 2011 revenue of approximately $7.5 million, representing an increase of 25% from $6.0 million in the previous quarter, and up 134% from $3.2 million in the same year-ago quarter.
The revenue increase is attributed to continued growth in the number of domestic hospitals and new international accounts using Bacterin products, as driven by the company’s expanding direct and outside sales force.
“Our record revenue reflects the tremendous operational progress we made during the quarter,” said Guy Cook, the company’s chairman and CEO. “This included the launch of our third human acellular biological scaffold during the quarter, hMatrix, which has opened the door to a $2.5 billion market in the U.S. alone.
“We expect this revenue momentum and domestic and international market expansion to continue building throughout the rest of the year, especially with the recent addition of Bacterin’s product line to ROI’s nationwide network of hospitals and medical practices,” said Cook. “We also plan to leverage our direct sales force with new product lines that complement existing ones.”
The company’s successful capital raise during the quarter has increased working capital for continued product development, including enhancing the newly acquired Robinson MedSurg orthopedic implants with Bacterin’s anti-microbial coating technology. Bacterin is pursuing the FDA market approval process to add its anti-microbial coatings to the RMS product line, and plans to submit a 510(k) application before the end of the year.
Bacterin’s management plans to hold a conference call in the second week of August to discuss the second quarter and will announce the details of the call approximately two weeks prior. These preliminary results are subject to a final auditor’s review and filing of its quarterly report in Form 10-Q.
About Bacterin International Holdings
Bacterin International Holdings, Inc. (NYSE Amex: BONE) develops, manufactures and markets biologics products to domestic and international markets. Bacterin's proprietary methods optimize the growth factors in human allografts to create the ideal stem cell scaffold to promote bone, subchondral repair and dermal growth. These products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain, promotion of bone growth in foot and ankle surgery, promotion of cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries.
Bacterin's Medical Device division develops, employs, and licenses bioactive coatings for various medical device applications. Bacterin's strategic coating initiatives include antimicrobial coatings designed to inhibit biofilm formation and microbial contamination. For further information, please visit www.bacterin.com.
Important Cautions Regarding Forward-looking Statements
This news release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as "continue," "efforts," "expects," "anticipates," "intends," "plans," "believes," "estimates," "projects," "forecasts," "strategy," "will," "goal," "target," "prospects," "potential," "optimistic," "confident," "likely," "probable" or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the Company's ability to meet its obligations under existing and anticipated contractual obligations; the Company's ability to develop, market, sell and distribute desirable applications, products and services and to protect its intellectual property; the ability and willingness of third-party manufacturers to timely and cost-effectively fulfill orders from the Company; the ability of the Company's customers to pay and the timeliness of such payments, particularly during recessionary periods; the Company's ability to obtain financing as and when needed; changes in consumer demands and preferences; the Company's ability to attract and retain management and employees with appropriate skills and expertise; the impact of changes in market, legal and regulatory conditions and in the applicable business environment, including actions of competitors; and other factors. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.
Company Contact:
Guy Cook
President & CEO
Bacterin International Holdings, Inc.
406-388-0480
gcook@bacterin.com
Investor Relations:
Liolios Group, Inc.
Scott Liolios or Ron Both
Tel 949-574-3860
info@liolios.com