Anika Reports Fourth Quarter and Full Year 2016 Financial Results

Posted On February 16, 2017 By OrthoSpineNews In Financial /

February 15, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the fourth quarter and full year ended December 31, 2016, along with business progress in the periods.

“Anika delivered another year of very strong growth, with 17% product revenue growth for the full year of 2016,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “We also submitted an IND application to the FDA to initiate an additional Phase III clinical trial of CINGAL, and we received CE Mark approval for ORTHOVISC-T in the fourth quarter, paving the way for our next generation of growth drivers. We expect to commence the CINGAL Phase III trial and launch ORTHOVISC-T in Europe in the first half of 2017. Our strategic objectives in 2017 are focused on global commercial expansion, pipeline advancement, infrastructure enhancements and strategic M&A to drive sustained growth and create value for patients and shareholders.”

Fourth Quarter and Full Year Financial Results

Product revenue increased 11% for the fourth quarter of 2016, and 17% for the full year of 2016, as compared to the same periods in 2015.
Total revenue for the fourth quarter of 2016 was $28.7 million, compared to $30.9 million for the fourth quarter of 2015. The decline was due to the achievement of $5 million of contractual milestone revenue in the fourth quarter of 2015 for reaching a targeted MONOVISC U.S. end user sales threshold. Total revenue for the full year of 2016 grew 11% to $103.4 million, compared to $93.0 million for the full year of 2015.
Worldwide Orthobiologics revenue increased 13% year-over-year in the fourth quarter of 2016. For the full year of 2016, worldwide Orthobiologics revenue increased 22% and MONOVISC revenue grew 54%, which was the main overall revenue growth driver.
International Orthobiologics revenue increased 24% for the full year of 2016, due primarily to the global expansion of MONOVISC. Domestically, ORTHOVISC and MONOVISC continue to maintain a market leading position.
Total operating expenses for the fourth quarter of 2016 were $16.0 million, compared to $13.8 million for the fourth quarter of 2015, commensurate with the growth in product revenue, expanded commercial efforts and active pipeline development. Total operating expenses for the full year of 2016 were $52.8 million, compared to $44.9 million for the full year of 2015.
Net income for the fourth quarter of 2016 was $8.1 million, or $0.54 per diluted share, compared to $11.0 million, or $0.72 per diluted share, for the fourth quarter of 2015. Fourth quarter 2015 results reflected the favorable impact of the $5 million of licensing, milestone and contract revenue previously discussed. Net income for the full year of 2016 increased $1.8 million to $32.5 million, or $2.15 per diluted share, compared to $30.8 million, or $2.01 per diluted share, for the full year of 2015.

Recent Business Highlights
The Company made key commercial, operational, pipeline, and financial advancements, including:

Submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate an additional Phase III clinical trial of CINGAL.
Receiving CE Mark approval for a treatment, which will be marketed internationally as ORTHOVISC-T, indicated to relieve pain and restore function in tendons affected by chronic lateral epicondylosis.
Advancing its product pipeline with continued progress on enrolling patients in the FastTRACK Phase III HYALOFAST Study for cartilage repair, as well as the Phase III MONOVISC study for the treatment of osteoarthritis pain in the hip.
Progressing with the consolidation of the Company’s global manufacturing operations at Anika’s Bedford, Massachusetts corporate headquarters.

Full Year 2017 Corporate Outlook
Looking forward to 2017, the Company expects total revenue growth to be in the mid-teen percentage range for the full year of 2017. Licensing, milestone and contract revenue is expected to be $5 million for the year. The Company also anticipates continued headway on several key initiatives including:

Commencement of the Phase III clinical trial of CINGAL, to supplement the strong stable of existing pivotal data.
Launch of ORTHOVISC-T in Europe, and the initiation of a Phase III clinical trial for U.S. approval of the treatment.
International expansion of MONOVISC and CINGAL.
Continued progress toward full patient enrollment in the FastTRACK Phase III HYALOFAST study, with over 50% of the total patient population enrolled by the end of 2017.
Completion of the consolidation of the Company’s global manufacturing operations at Anika’s Bedford, Massachusetts corporate headquarters.
Continued progress toward the development of a direct commercialization capability in the U.S.

Conference Call Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights tomorrow, Thursday, February 16^th at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the “Investor Relations” section of Anika’s website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika’s website approximately two hours after the completion of the event.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC^®, MONOVISC^®, and CINGAL^®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST^®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements
The statements made in the third and fourth sentences of the second paragraph, as well as all of the information in the section captioned “Full Year 2017 Corporate Outlook” of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s expectations regarding 2017 revenue growth, 2017 contractual milestone revenue, total 2017 operating expenses, product launches and territorial expansion for existing products, commencement of the CINGAL clinical trial, strategic objectives, including the Company’s focus on strategic M&A, progression of the HYALOFAST FastTRACK clinical trial enrollment, consolidation of manufacturing operations, and progress in the development of its direct commercialization capability. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.


Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)

	For the Three Months Ended December 31,				For the Year Ended December 31,
	2016		2015		2016		2015
Product revenue	$	28,296	$	25,607	$	102,932	$	87,696
Licensing, milestone and contract revenue		430		5,287		447		5,303
Total revenue		28,726		30,894		103,379		92,999

Operating expenses:
Cost of product revenue		7,539		6,290		24,027		21,053
Research & development		2,959		3,016		10,732		8,987
Selling, general & administrative		5,488		4,524		18,013		14,825
Total operating expenses		15,986		13,830		52,772		44,865
Income from operations		12,740		17,064		50,607		48,134
Interest income, net		49		39		263		120
Income before income taxes		12,789		17,103		50,870		48,254
Provision for income taxes		4,704		6,061		18,323		17,496
Net income	$	8,085	$	11,042	$	32,547	$	30,758

Basic net income per share:
Net income	$	0.56	$	0.74	$	2.22	$	2.06
Basic weighted average common shares outstanding		14,538		14,965		14,682		14,934
Diluted net income per share:
Net income	$	0.54	$	0.72	$	2.15	$	2.01
Diluted weighted average common shares outstanding		14,979		15,353		15,116		15,321


Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)

	December 31,			December 31,
ASSETS	2016			2015
Current assets:
Cash and cash equivalents	$	104,261		$	110,707
Investments		20,500			27,751
Accounts receivable, net of reserves of $194 and $167 at December 31, 2016 and December 31, 2015, respectively		27,598			21,652
Inventories		15,983			14,938
Prepaid expenses and other current assets		2,098			1,385
Total current assets		170,440			176,433
Property and equipment, at cost		79,079			64,648
Less: accumulated depreciation		(26,783	)		(24,540	)
Property and equipment, net		52,296			40,108
Long-term deposits and other		69			69
Intangible assets, net		10,227			11,656
Goodwill		7,214			7,482
Total Assets	$	240,246		$	235,748

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	2,303		$	8,302
Accrued expenses and other current liabilities		6,496			4,778
Current portion of long-term debt
Income taxes payable		–			4,198
Total current liabilities		8,799			17,278
Other long-term liabilities		2,078			781
Long-term deferred revenue		48			66
Deferred tax liability		6,548			6,775
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $.01 par value; 1,250 shares authorized, no shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively		–			–
Common stock, $.01 par value; 60,000 and 30,000 shares authorized, 14,627 and 15,037 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively		146			150
Additional paid-in-capital		61,735			81,685
Accumulated other comprehensive loss		(7,317	)		(6,649	)
Retained earnings		168,209			135,662
Total stockholders’ equity		222,773			210,848
Total Liabilities and Stockholders’ Equity	$	240,246		$	235,748


Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data


Revenue by Product Line and Product Gross Margin
(in thousands, except percentages)
(unaudited)

	For the Three Months Ended December 31,										For the Year Ended December 31,
	2016			%		2015			%		2016			%		2015			%
Orthobiologics	$	24,376		86	%	$	21,530		84	%	$	89,695		87	%	$	73,247		84	%
Surgical		1,590		6	%		1,363		5	%		5,427		5	%		5,812		7	%
Dermal		1,114		4	%		1,134		5	%		2,759		3	%		2,266		2	%
Other		1,216		4	%		1,580		6	%		5,051		5	%		6,371		7	%
Product Revenue	$	28,296		100	%	$	25,607		100	%	$	102,932		100	%	$	87,696		100	%

Product Gross Profit	$	20,757				$	19,317				$	78,905				$	66,643
Product Gross Margin		73	%				75	%				77	%				76	%


Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)

	For the Three Months Ended December 31,										For the Year Ended December 31,
	2016			%		2015			%		2016			%		2015			%
Geographic Region:
United States	$	22,940		81	%	$	20,574		80	%	$	83,972		82	%	$	71,621		82	%
Europe		2,696		10	%		2,462		10	%		10,953		10	%		8,756		10	%
Other		2,660		9	%		2,571		10	%		8,007		8	%		7,319		8	%
Product Revenue	$	28,296		100	%	$	25,607		100	%	$	102,932		100	%	$	87,696		100	%

Contacts

Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., 781-457-9000
President and CEO
or
Sylvia Cheung, 781-457-9000
CFO

Invuity Reports 2016 Fourth Quarter, Annual Financial Results

Posted On February 16, 2017 By OrthoSpineNews In Financial /

SAN FRANCISCO, Feb. 14, 2017 (GLOBE NEWSWIRE) — Invuity, Inc. (NASDAQ:IVTY), a leading medical technology company focused on minimal access surgery, today reported financial results for the three months and year ended December 31, 2016.

Q4 2016 Highlights

Revenue grew 50% to $9.4 million compared to revenue of $6.2 million in the 2015 fourth quarter.
Gross margin expansion continued to 74.3% compared to 65.9% in the 2015 fourth quarter.
Approximately 745 hospitals purchased Invuity devices in the fourth quarter of 2016, up from 530 hospitals in the fourth quarter of 2015.
Approximately 240,000 procedures have been performed using Invuity devices.

“We finished 2016 on a strong note, delivering 50% year-over-year growth in the fourth quarter,” said President and CEO Philip Sawyer. “In 2017, we will continue to drive toward our goal of leadership in minimal access surgery through consistent execution of our commercial strategies coupled with the introduction of innovative, disruptive products.”

Financial Results

Revenue was $9.4 million in the fourth quarter of 2016, up 50% from revenue of $6.2 million in the fourth quarter of 2015 driven by an increase in active accounts and an increase in revenue per account. For the 2016 full year, revenue was $32.5 million, an increase of 54% over revenue of $21.0 million in 2015.

Gross margin for the fourth quarter and full-year 2016 was 74.3% and 72.8%, respectively, compared to 65.9% and 63.2% for the same periods in 2015. Gross margin expansion has been helped by the introduction of our non-conductive polymer based retractors, and by overhead efficiencies created as a result of increased sales volumes.

Total operating expenses for the fourth quarter and full-year 2016 were $16.0 million and $62.3 million, respectively, compared to $13.7 million and $48.5 million in the prior year periods. The increase in operating expenses is due to continued investment in our commercial platform, new product development costs and related increases in corporate infrastructure.

The net loss for the fourth quarter of 2016 was $9.6 million, or $0.56 loss per share, compared to a net loss of $10.1 million, or $0.76 loss per share, for the fourth quarter of 2015. The net loss for full-year 2016 was $40.6 million, or $2.73 loss per share, compared to $37.6 million, or $4.94 loss per share, for 2015.

The Company’s balance sheet as of December 31, 2016, included total cash, cash equivalents and short term investments of $39.0 million.

Business Outlook

Invuity is reiterating its revenue guidance for 2017 in the range of $42 million to $44 million.

Conference Call

Invuity’s management will discuss the Company’s financial results for the fourth quarter ended December 31, 2016, and provide a general business update during a conference call beginning at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time today, February 14, 2017. To join the live call, participants may dial 1-877-556-8638 (U.S.) or 1-615-247-0174 (International), Conference ID: 59656880. To listen to the live call via Invuity’s website, go to www.invuity.com, in the Events & Presentations section. A webcast replay of the call will be available following the conclusion of the call for a period of 90 days in the Events & Presentations section of the website.

About Invuity®

Invuity, Inc. is a leading medical technology company focused on developing and marketing advanced surgical devices to improve the ability of physicians to perform minimal access surgery through smaller and hidden incisions. The company’s patented Intelligent Photonics™ technology delivers enhanced visualization which facilitates surgical precision, efficiency and safety. In addition, the company utilizes comprehensive strategic marketing programs to create stronger institutional partnerships. Clinical applications include women’s health, encompassing breast cancer and breast reconstruction surgery, gynecology and thyroid surgery. Additional applications include procedures for electrophysiology, spine, orthopedic, cardiothoracic, and general surgery. Invuity is headquartered in San Francisco, CA. For more information, visit www.invuity.com.

Forward-Looking Statements

This announcement contains forward-looking statements that involve risks and uncertainties, including statements regarding financial projections for 2017, future product introductions, future sales and marketing initiatives, and market opportunities. Actual results could differ materially from those projected in the forward-looking statements as a result of certain risk factors, including, but not limited to: fluctuations in demand or failure to gain market acceptance for the Company’s devices; the Company’s ability to demonstrate to and gain approval from hospitals to use the Company’s devices; the highly competitive business environment for surgical medical devices; the Company’s ability to sell its devices at prices that support its current business strategies; difficulty forecasting future financial performance; protection of the Company’s intellectual property; and compliance with necessary regulatory clearances or approvals. The Company undertakes no obligation to update the forward-looking information in this release. More information about potential factors that could affect the Company’s business and financial results is included in its filings with the Securities and Exchange Commission, including, without limitation, under the captions: “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and “Risk Factors,” which are on file with the Securities and Exchange Commission.


INVUITY, INC.
Condensed Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)

	Three Months Ended December 31,						Year Ended December 31,
	2016			2015			2016			2015

Revenue	$	9,356		$	6,246		$	32,461		$	21,031
Cost of goods sold		2,409			2,127			8,824			7,733
Gross profit		6,947			4,119			23,637			13,298
Operating expenses:
Research and development		2,496			2,069			9,908			7,869
Selling, general and administrative		13,524			11,617			52,409			40,636
Total operating expenses		16,020			13,686			62,317			48,505
Loss from operations		(9,073	)		(9,567	)		(38,680	)		(35,207	)
Interest expense		(505	)		(505	)		(2,018	)		(1,881	)
Interest and other income (expense), net		28			17			89			(482	)
Net loss	$	(9,550	)	$	(10,055	)	$	(40,609	)	$	(37,570	)
Net loss per common share, basic and diluted	$	(0.56	)	$	(0.76	)	$	(2.73	)	$	(4.94	)
Weighted-average shares used to compute net loss per common share, basic and diluted		16,930,612			13,307,031			14,868,501			7,606,172

Condensed Balance Sheets
as of December 31, 2016 and December 31, 2015
(In thousands, except share and per share amounts)
(Unaudited)

	December 31,
	2016			2015
Assets
Current assets:
Cash and cash equivalents	$	28,300		$	46,296
Short-Term Investments		10,737			—
Restricted cash – Current		181			—
Accounts receivable, net		5,782			3,619
Inventory		5,052			5,182
Prepaid expenses and other current assets		1,088			923
Total current assets		51,140			56,020
Restricted cash		909			1,090
Property and equipment, net		8,286			9,195
Other non-current assets		—			—
Total assets	$	60,335		$	66,305
Liabilities, Stock and Stockholders’ Equity
Current liabilities:
Accounts payable	$	2,192		$	2,458
Accrued and other current liabilities		6,351			4,214
Short-term debt—related party		1,362			—
Total current liabilities		9,905			6,672
Deferred rent		2,721			2,810
Long-term debt—related party		13,261			14,480
Total liabilities		25,887			23,962
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value—10,000,000 shares authorized at December 31, 2016 and December 31, 2015, respectively; no shares issued and outstanding at December 31, 2016 and December 31, 2015		—			—
Common stock, $0.001 par value—200,000,000 shares authorized at December 31, 2016 and December 31, 2015 respectively; 16,950,940 and 13,392,358 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively		17			13
Additional paid-in capital		180,647			147,937
Accumulated deficit		(146,216	)		(105,607	)
Total stockholders’ equity		34,448			42,343
Total liabilities and stockholders’ equity	$	60,335		$	66,305

CONTACT:

Company Contact:
Jim Mackaness
Chief Financial Officer
Invuity, Inc.
415-655-2129

Investors:
Mark KlausnerWestwicke Partners
443-213-0501
irdept@invuity.com

Source: Invuity

Osteosynthesis Devices Market is Expected to Reach a Value of USD 9.9 Billion by 2024

Posted On February 15, 2017 By OrthoSpineNews In Extremities, Financial, Spine /

FEBRUARY 15, 2017 – BY RAHUL JADHAV

The osteosynthesis devices market size is expected to reach a value of USD 9.9 billion by 2024, according to a new report by Grand View Research, Inc. The worldwide prevalence of conditions like osteoporosis and osteomalacia, coupled with heavily occurring road traffic injuries/accidents and sporting injuries support the demand for osteosynthesis devices worldwide.

Osteoporosis, a disease resulting in weakening of bones is responsible for causing more than 8.9 million fractures annually. Forearm, humerus, hip and spine are the most commonly affected areas in patients suffering from the disease. The incidence and economic burden of osteoporosis is increasing worldwide, and patients 65 years old or over are at maximum risk of getting affected.

The geriatric population accounted for 46.2 million in 2014, and is increasingly rising. It is projected that by the year 2060, the number of older population will be twice than that of 2014. The rising incidence of osteoporosis and increasing count of the geriatric population is expected to drive demand for osteosynthesis devices in the coming years.

On the other hand, road traffic deaths are at the focal point of a crisis facing public health and development. The WHO reported that accidents/injuries majorly affect the low- and middle-income countries. Road accidents can cause severe injuries such as broken bones and fractures and requires immediate orthopediccare and attention.

READ THE REST HERE

Integra offers to buy J&J’s Codman business for $1.05 billion

Posted On February 15, 2017 By OrthoSpineNews In Financial /

Wed Feb 15, 2017

Medical device maker Integra LifeSciences Holdings Corp said on Wednesday it has offered to buy Johnson & Johnson’s Codman neurosurgery business for $1.05 billion in cash.

Integra, which makes products used in neurosurgery, reconstruction, wound and dental care, said Codman’s devices would bolster its pipeline of offerings for tissue ablation, spinal cord repair and cranial stabilization.

If the bid is accepted, it will add to Integra’s adjusted earnings per share by at least 22 cents in the first full year after closing and increase thereafter.

READ THE REST HERE

AAEAAQAAAAAAAAlmAAAAJDVlMjZhNjg4LThiMzQtNDY1Zi04OWIyLTM3OTFhMjU4OGVhNA.png

Life Spine Achieved 38% Revenue Growth over Previous Year and Launched 27 Products in 2016 Including the Broadest Expandable Offering in Market

Posted On February 14, 2017 By OrthoSpineNews In Financial, Spine /

February 14, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that revenues for 2016 grew by 38% as compared to 2015. Additionally, Life Spine launched 27 products in 2016 including four best-in-class products and one product that was first-to-market.

In 2016 Life Spine launched multiple expandable interbodies including the LONGBOW^® Lateral Expandable A/P Spacer System and the PROLIFT® PLIF/TILF Expandable Spacer System. LONGBOW is the first-to-market product that offers controlled in-situ expansion for maximum endplate coverage, minimal anatomical disruption, and post packing capabilities. Additionally, LONGBOW was selected by Orthopedics this Week for the prestigious Spine Technology award because of its game changing innovation. PROLIFT features an all titanium implant that restores disc height, in-situ, for minimally invasive PLIF and TLIF. Furthermore, the implant is provided pre-sterile for safety and convenience. With these new additions, Life Spine has the broadest, fastest growing suite of expandable products in the market.

In addition to the rapidly growing expandable product offering, Life Spine added three new retractor systems with independently angulating blades to round out its procedural product offering. The CALYPSO™ Midline Retractor System offers snap on quick release blades with anatomically shaped teeth to conform to the facets for improved retraction. The MIS TLIF Retractor system features modular taps that anchor to the pedicles and allow for optimal disc space distraction. Finally, the CENTRIC Lateral Expandable Retractor System boasts an open frame design that increases visibility of patient anatomy accommodating both the plier style and traditional style knob expansion.

Some of the other key milestones that attributed to the 2016 growth include:

Six 510K approvals for a total of 61 since inception.
Expanded the sales footprint to over 27 countries outside of the US.
Continued the commitment to education by conducting 77 PULSE^™ (Physician Ultimate Life Spine Experience) labs at the Huntley, IL facility.
The only company of their size to offer a full line of procedural product solutions including access instrumentation, implants, neuro monitoring, and biologics.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Misonix Reports Receipt of Deficiency Letter from The Nasdaq Stock Market LLC

Posted On February 13, 2017 By OrthoSpineNews In Financial /

FARMINGDALE, N.Y., Feb. 13, 2017 /PRNewswire/ — Misonix, Inc. (MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced that it received a deficiency letter from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, as a result of not filing its Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2016 (the “Q2 10-Q”) by February 9, 2017 and disclosing that the Company will not be able to file the Q2 10-Q within the five-day extension period provided in Rule 12b-25(b) under the Securities Exchange Act of 1934, as amended, together with its prior and ongoing failure to timely file its Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2016, was not in compliance with Listing Rule 5250(c)(1) of the Nasdaq Listing Rules (the “Rules”) for continued listing.

The Company has previously submitted a plan to Nasdaq to regain compliance with the Rules and Nasdaq has granted the Company an exception until March 13, 2017 to regain compliance. The Company is required to submit to Nasdaq an update to the original compliance plan not later than February 27, 2017.

As previously disclosed, on February 9, 2017 the Company filed its Form 10-K for the fiscal year ended June 30, 2016, and management currently believes that the Company will be in a position to file the aforementioned delinquent Quarterly Reports on Form 10-Q not later than March 13, 2017.

At this time, this notification has no effect on the listing of the Company’s common stock on The Nasdaq Global Market.

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s website at www.misonix.com

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s most recent Annual Report on Form 10-K, and any subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking statements.

Intuitive Surgical Reports New Employee Option Grants for February 2017

Posted On February 13, 2017 By OrthoSpineNews In Financial /

SUNNYVALE, Calif., Feb. 13, 2017 (GLOBE NEWSWIRE) — Intuitive Surgical, Inc. (ISRG) today reported that equity awards, approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 92 new employees. Pursuant to NASDAQ Marketplace Rule 5635(c)(4), the equity awards were granted under the Intuitive Surgical, Inc. 2009 Commencement Incentive Plan, which the Board of Directors of Intuitive Surgical, Inc. adopted for the granting of equity awards to new employees. In accordance with NASDAQ rules, these grants were made under an equity incentive plan without shareholder approval. NASDAQ rules require a public announcement of equity awards to be made under this type of plan. 92 employees were granted a combination of Restricted Stock Units (RSUs) and Stock Options to purchase an aggregate of 12,456 shares of the Company’s common stock; 6,273 of the shares granted were Stock Options and 6,183 of the shares granted were RSUs. Both the RSUs and Stock Options vest over four years. The Stock Options expire in 10 years assuming continued employment. No officers received any award under this plan. The exercise price for the Stock Options granted is $704.24 which was the closing price of Intuitive Surgical, Inc.’s common stock on the NASDAQ Global Market as such price was reported by NASDAQ on February 7, 2017. The Company’s policy is to issue RSUs and Stock Option grants to new employees, where equity makes sense, on the fifth business day of every calendar month.

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. (ISRG), headquartered in Sunnyvale, California, is the global technology leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets robotic technologies designed to improve clinical outcomes and help patients return more quickly to active and productive lives. The Company’s mission is to extend the benefits of minimally invasive surgery to the broadest possible base of patients. Intuitive Surgical – Taking surgery beyond the limits of the human hand™.

About the da Vinci® Surgical System

The da Vinci® System is a breakthrough surgical platform designed to enable complex surgery using a minimally invasive approach. The da Vinci® System consists of an ergonomic surgeon console, a patient-side cart with four interactive robotic arms, a high-performance vision system and proprietary EndoWrist® instruments. Powered by state-of-the-art robotic and computer technology, the da Vinci® System is designed to scale, filter and seamlessly translate the surgeon’s hand movements into more precise movements of the EndoWrist® instruments. The net result is an intuitive interface with breakthrough surgical capabilities. By providing surgeons with superior visualization, enhanced dexterity, greater precision and ergonomic comfort, the da Vinci® Surgical System makes it possible for more surgeons to perform minimally invasive procedures involving complex dissection or reconstruction. This ultimately has the potential to raise the standard of care for complex surgeries, translating into numerous potential patient benefits, including less pain, a shorter recovery and quicker return to normal daily activities.

Intuitive®, da Vinci®, da Vinci S®, da Vinci® Si™, InSite® and EndoWrist® are trademarks or registered trademarks of Intuitive Surgical, Inc.

For more information, please visit the company’s web site at www.intuitivesurgical.com.

Exactech Schedules Fourth Quarter and Year-End 2016 Earnings Release and Conference Call

Posted On February 13, 2017 By OrthoSpineNews In Financial /

February 13, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic materials for extremities, hip and knee will release its fourth quarter and year-end 2016 financial results before the market opens on Tuesday, February 21, 2017. A copy of the earnings release will be available at http://www.hawkassociates.com.

The company will hold a conference call with CEO David Petty and key members of the management team on the same day, Tuesday, February 21 at 10:00 a.m. Eastern Time. The call will cover Exactech’s fourth quarter and year-end 2016 results. Petty will open the conference call and a question-and-answer session will follow.

To participate in the call, dial 1-888-471-3836 any time after 9:50 a.m. Eastern on February 21. International and local callers should dial 1-719-325-2475. A live webcast of the call will be available at http://www.hawkassociates.com/profile/exac.cfm or http://public.viavid.com/index.php?id=122940. This call will be archived for approximately 90 days.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

A current investment profile on Exactech (Nasdaq: EXAC) is available online at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

Contacts

Exactech Inc.
Investor contacts
Jody Phillips, 352-377-1140
Executive Vice President of Finance & Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
EXAC@hawkassociates.com
or
Exactech Inc.
Media contacts
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

Jeff_Acuff_Senior_Vice_President_US_Sales_Bioventus_Presents_Check_for__10000_to_Gregory_Gudenkauf_and_Blankmeyer_of_Opportunity_Village_2.11.17.jpg

Bioventus Raises $10,000 for Opportunity Village

Posted On February 13, 2017 By OrthoSpineNews In Financial /

February 13, 2017

LAS VEGAS–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, announced it raised $10,000 for Opportunity Village. More than 240 Bioventus employees, most of whom make up the Bioventus US sales force, took part in a team building exercise in Las Vegas on February 10 and donated the money directly to the non-profit organization. This marks the third consecutive year that the Bioventus US sales force has used its annual team-building event to generate awareness and funds for charitable causes.

Opportunity Village serves adults in the Southern Nevada community with intellectual and related disabilities and works to enhance their lives and the lives of their families. The organization accomplishes this through vocational training, community employment, day services, advocacy, arts and social recreation. Citizens with intellectual disabilities are able to find new friends, realize future career paths, seek independence and community integration and unleash creative passions.

The organization also operates four employment training center campuses and a Thrift Store in Southern Nevada, providing vocational training and placement for hundreds of adults in jobs throughout the community. Ultimately, Opportunity Village’s goal is to help these individuals find independent employment in jobs within the Las Vegas Valley.

“Parents always want the best for their children and the founders of Opportunity Village simply wanted a place their children could grow, make friends, and develop life skills,” said Jeff Acuff, Senior Vice President of Sales – US, Bioventus. “Today, no matter where they fall on the disability spectrum, Opportunity Village helps children and adults to go as far as possible as they try new jobs and learn new skills. Our team at Bioventus is deeply moved by the experience of supporting such a worthwhile organization.”

“For more than 60 years we’ve been enriching the lives of individuals with intellectual and developmental disabilities in Southern Nevada through employment training and job placement, along with other programs and services for people with more severe disabilities. We assess each person to learn their specific goals, interests and passions, and strive to place them in a safe environment that will allow them to thrive and flourish,” said Bob Brown, Opportunity Village President and CEO. “This donation from Bioventus will help us continue to provide these important programs and services to the wonderful folks we serve.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN^® Ultrasound Bone Healing System is the #1 prescribed bone healing system in the US and is the only FDA-approved bone healing device that uses safe, effective ultrasound to stimulate the body’s natural healing process. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, and EXOGEN are registered trademarks of Bioventus LLC.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

Misonix Files Form 10-K Announcing Fiscal 2016 Financial Results

Posted On February 10, 2017 By OrthoSpineNews In Financial /

FARMINGDALE, N.Y., Feb. 9, 2017 /PRNewswire/ — Misonix, Inc. (Nasdaq: MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today the filing of Form 10-K with the Securities and Exchange Commission for the fiscal year ended June 30, 2016 and provided preliminary results for its second fiscal quarter ended December 31, 2016.

The Company has recently completed a voluntary internal investigation, assisted by outside legal counsel and accounting resources, into the business practices of the independent Chinese entity that previously distributed its products in China and the Company’s knowledge of those business practices, which may have implications under the Foreign Corrupt Practices Act, as well as into various internal control issues identified during the investigation. While the internal investigation is now complete, as previously reported, the Company reported to the SEC and the Department of Justice the business practices that were the subject of the Company’s investigation and the government’s investigation of these matters is on-going. The Company has no information derived from the internal investigation or otherwise to suggest that its previously reported financial statements and results were incorrect. A restatement of prior financial results was not required.

Sales and net loss for fiscal year 2016 were consistent with the Company’s previous disclosure. The Company reported net sales of $23.1 million, an increase of 4.1% over the prior year and a net loss of $1.2 million, or $(0.15) per diluted share, compared with net income of $5.6 million, or $0.69 per diluted share, in the prior fiscal year. The Company’s cash balance at January 31, 2017 was $12.0 million.

Stavros Vizirgianakis, president and chief executive officer of Misonix, Inc., stated, “After an exhaustive internal investigation we are pleased to file Form 10-K for the year ended June 30, 2016. An important conclusion of the investigation is that our financial statements were accurate in all material respects and that a restatement was not necessary. Although the investigation uncovered material weaknesses in our internal control over financial reporting and our disclosure controls and procedures, the Form 10-K describes in detail the remediation measures that we have already taken to address these matters.”

“We are currently working diligently to complete our Form 10-Qs for the quarters ended September 30, 2016 and December 31, 2016, which we intend to file not later than March 13, 2017. While our second quarter 10-Q filing will be delayed, upon the filing of those two Form 10-Qs with the Securities and Exchange Commission, we will conduct a conference call to provide a comprehensive business update and review our vision for the Company in the coming years.”

Preliminary results for the second fiscal quarter ended December 31, 2016 are net sales of $6.0 million, compared with net sales of $6.0 million for the second fiscal quarter ended December 31, 2015. For the six months ended December 31, 2016, preliminary sales are $12.2 million, or 8.0% higher than for the first six months of the prior year of $11.3 million. Due to the delay and internal resource allocation associated with the filing of the Company’s 10-K, the Company is not in a position to provide preliminary net income data for the second fiscal quarter and the six months ended December 31, 2016.

Form 10-K for the fiscal year ended June 30, 2016 can be found on the Investor Relations section of the Misonix website at www.misonix.com.

About Misonix Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s website at www.misonix.com

Safe Harbor Statement With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Financial Tables to Follow

MISONIX, INC. and Subsidiaries Consolidated Balance Sheets (unaudited)

				June 30,	June 30,
				2016	2015
Assets
Current assets:
Cash and cash equivalents				$ 9,049,327	$ 9,623,749

Accounts receivable, less allowance for doubtful accounts of $96,868 and$126,868, respectively				3,869,427	4,481,247
Inventories, net				5,822,935	4,303,163
Prepaid expenses and other current assets				530,564	441,562
Deferred income tax					2,118,716
Total current assets				19,272,253	20,968,437

Property, plant and equipment, net of accumulated amortization and depreciation of $6,976,282 and $5,672,287, respectively
				2,492,815	2,056,600
Patents, net of accumulated amortization of $885,394 and $791,551, respectively				604,916	566,028
Goodwill				1,701,094	1,701,094
Intangible and other assets				266,603	388,377
Deferred income tax				3,394,690	773,712
Total assets				$ 27,732,371	$ 26,454,248

Liabilities and shareholders’ equity
Current liabilities:
Accounts payable				$ 1,402,797	$ 1,147,414
Accrued expenses and other current liabilities				1,887,337	1,532,094
Total current liabilities				3,290,134	2,679,508

Deferred lease liability				9,262	–
Deferred income				31,685	20,395
Total liabilities				3,331,081	2,699,903

Commitments and contingencies

Shareholders’ equity:
Common stock, $.01 par value-shares authorized 20,000,000; 7,948,234 and 7,869,095 shares issued and 7,809,385 and 7,744,113 shares outstanding, respectively
				79,482	78,691
Additional paid-in capital				32,502,521	30,531,129
Accumulated deficit				(7,081,361)	(5,909,215)
Treasury stock, at cost, 138,849 and 124,982 shares, respectively				(1,099,352)	(946,260)
Total shareholders’ equity				24,401,290	23,754,345
Total liabilities and shareholders’ equity				$ 27,732,371	$ 26,454,248
MISONIX, INC. and Subsidiaries Consolidated Statements of Operations (unaudited)

	For the years ended
	June 30,
	2016	2015	2014

Net sales	$ 23,113,194	$ 22,204,578	$ 17,060,435
Cost of goods sold, exclusive of depreciation from consigned product	7,611,240	7,280,276	5,933,867
Gross profit	15,501,954	14,924,302	11,126,568

Operating expenses:
Selling expenses	12,296,085	9,062,695	7,272,726
General and administrative expenses	7,364,910	5,983,623	4,691,055
Research and development expenses	1,670,347	1,592,923	1,711,751
Total operating expenses	21,331,342	16,639,241	13,675,532
Loss from operations	(5,829,388)	(1,714,939)	(2,548,964)

Other income (expense):
Interest income	81	75	69
Royalty income and license fees	3,948,757	4,256,321	3,725,436
Other	(21,878)	(22,033)	(19,331)
Total other income	3,926,960	4,234,363	3,706,174

(Loss)/income from continuing operations before income taxes	(1,902,428)	2,519,424	1,157,210

Income tax (benefit)/expense	(573,351)	(2,784,632)	30,630

Net (loss)/income from continuing operations	(1,329,077)	5,304,056	1,126,580
Discontinued operations:
Income from discontinued operations net of tax expense of $0, $1,127 and $235, respectively
	–	17,115	19,666
Gain from sale of discontinued operations net of tax expense of $93,069, $0 and $2,947, respectively
	156,931	250,000	247,053
Net income from discontinued operations	156,931	267,115	266,719
Net (loss)/income	$ (1,172,146)	$ 5,571,171	$ 1,393,299

Net (loss)/income per share from continuing operations – Basic	$ (0.17)	$ 0.70	$ 0.15
Net income per share from discontinued operations – Basic	0.02	0.04	0.04
Net (loss)/income per share – Basic	$ (0.15)	$ 0.74	$ 0.19

Net (loss)/income per share from continuing operations – Diluted	$ (0.17)	$ 0.66	$ 0.15
Net income per share from discontinued operations – Diluted	0.02	0.03	0.04
Net (loss)/income per share – Diluted	$ (0.15)	$ 0.69	$ 0.19

Weighted average shares – Basic	7,776,949	7,580,450	7,232,004
Weighted average shares – Diluted	7,776,949	8,094,119	7,467,592

Corporate Contact	Investor Contact
Joe Dwyer	Joe Diaz
Misonix, Inc.	Lytham Partners
631-927-9113	602-889-9700
jdwyer@misonix.com	mson@lythampartners.com

SOURCE Misonix, Inc.

Financial

Contacts

Contacts

Contacts

Contacts

Related Links