DGAP-News: Curasan starts dynamically into the new year

Kleinostheim, 18 May 2017 – curasan AG (ISIN DE0005494538), a leading specialist for medical products in the field of orthobiologics, has continued to grow dynamically at the start of the year. Gross sales increased by 15.9 percent to EUR 1.89 million (Q1 2016: EUR 1.62 million). Earnings before interest, taxes, depreciation and amortization (EBITDA) improved by 3.4 percent (Q1 2016: -0.45 m EUR), while earnings before interest and taxes (EBIT) remained virtually unchanged at -0.45 million euros (Q1 2016: -0.45 m euros). However, due to lower interest expense, the net result rose slightly as well by 8.7 percent to -0.46 million euros (Q1 2016: -0.50 m euros).

The consideration of the sales performance according to regional aspects shows that the clear growth of almost all regions was dynamically supported. In Europe, sales rose by 10.6 percent to EUR 0.66 million, in MENA sales more than doubled, rising by 128.6 percent to EUR 0.26 million. In Asia, growth was 7.6 percent, with sales of a total of EUR 0.40 million, while the US markets increased by 7.7 percent to EUR 0.46 million.

Cash and cash equivalents decreased by 78.7 percent to EUR 0.21 million (31.12.16: 1.01 EUR) as of the balance sheet date, whereas trade receivables increased by 11.6 percent to 2.35 million Euro (31.12.16: 2.11 mEUR). At the same time, trade payables rose by 22.2 percent to EUR 1.05 million (31.12.16: 0.86 mEUR). Shareholders’ equity fell by 4.8 per cent to EUR 8.52 million, compared to EUR 8.95 million as of the end of 2016.

“We have shown a strong first quarter and our sales are growing across the board in all regions,” explains Michael Schlenk, CEO of curasan AG. “As projected, we will continue to invest heavily in marketing and registrations for this growth. Since the beginning of the second quarter and under the direction of the Finance Department by our new CFO, Christine Uekert, we are also taking a new approach in terms of our receivables management as well as the working capital and achieving good success here.” In addition, the company announced, with the publication of the 2016 Annual Report, that a capital increase would be implemented in the current financial year. “Our dynamic and sustainable growth is well recognized by institutional investors as well as strategic ones. A good basis for a further growth financing”, Schlenk adds.

Further details on the quarterly figures published today as well as current developments in the second quarter will be discussed by the CEO today at 2.00 pm in the course of an open telephone conference for analysts, qualified investors and journalists. You can register by e-mail via the Investor Relations and Corporate Communications departments (IR@curasan.com).

The complete report on the first quarter of 2017 has been made available by curasan on the Company’s website at the following link:

www.curasan.de/investoren/publikationen/finanzberichte

Contact curasan AG:
Ingo Middelmenne
Head of Investor Relations
+49 6027 40 900-45
+49 174 90 911 90

ingo.middelmenne@curasan.com

Andrea Weidner
Head of Corporate Communications
+49 6027 40 900-51
andrea.weidner@curasan.com

About curasan AG:

curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, curasan, Inc., in the Research Triangle Park area, near Raleigh, N.C., USA. curasan’s innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide. curasan AG is a public company listed in the General Standard at the Frankfurt Stock Exchange.


18.05.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.

The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.

Archive at www.dgap.de


Language: English
Company: curasan AG
Lindigstraße 4
63801 Kleinostheim
Germany
Phone: 06027/40 900 0
Fax: 06027/40 900 29
E-mail: info@curasan.de
Internet: www.curasan.de
ISIN: DE0005494538
WKN: 549453
Listed: Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange

 

End of News DGAP News Service

Florida Institute Funds Alachua-based Amend Surgical

GAINESVILLE, Fla. and BOCA RATON, Fla., May 18, 2017 /PRNewswire-USNewswire/ — The Florida Institute for the Commercialization of Public Research (the Florida Institute) announced today that it has finalized a funding agreement with Amend Surgical, an Alachua-based medical device company with newly licensed technology developed at the University of Florida. The Florida Institute supports new company development and expansion based on publicly-funded research, and bridges early funding gaps for companies licensing technology out of Florida-based universities and research institutions.

Amend Surgical is a specialty medical device company focused on enhancing the healing and regenerative capacity of bone grafts, including allograft, xenograft tissues and synthetic materials. The company’s pipeline includes novel, osteoinductive bone extracts, and will expand in the future to disruptive products based on discovery and development of novel therapeutic additives with tissue-specific regenerative characteristics.

“We are committed to advancing the science of orthobiologics by improving the healing capacity of bone grafts.  The new funding agreement with the Florida Institute will allow Amend to rapidly expand our research and commercialization efforts on Biomimetic Bone which was licensed from the University of Florida in March 2017,” said Robby Lane, Chief Executive Officer of Amend Surgical.

“Amend Surgical provides surgeons and their patients access to innovative bone grafting options,” said Jackson Streeter, MD, Florida Institute Chief Executive Officer. “By developing and advancing bone grafts and other orthobiologics with enhanced regenerative capacity, surgery patients can identify, with guidance from their physicians, new options that can help them achieve the best possible surgical outcomes.”

About the Florida Institute

Formed by the Florida Legislature in 2007, the Florida Institute for the Commercialization of Public Research is a non-profit organization that works collaboratively with the technology licensing and commercialization offices of Florida’s state universities and private research institutions to leverage a $2.5B+ research base and form investable companies that create clean jobs in new industries that are driving the global economy. With funding from the State of Florida through the Department of Economic Opportunity, and through the generosity of mentors, advisors and donors, the Florida Institute provides company building services, and seed funding through the Florida Technology Seed Capital Fund, to promising Florida startups. Sixty-nine companies have been funded to date, and the Florida Institute’s economic impact through June 30, 2016 in the State of Florida was $630 million.

About Amend Surgical

Amend Surgical is a product development company offering differentiated biologic solutions for surgeons, medical device manufacturers and distributors globally.  Amend is targeting the bone graft substitute market with licensed, patented, technology and is focused on spine, orthopedic and dental indications.  The R&D pipeline includes products loaded with antibiotics and natural bone morphogenic proteins. Additionally, Amend is commercializing a novel Biomimetic Bone technology licensed from the University of Florida that offers the hope for a synthetic graft with load bearing capability and osteostimulative properties.  Amend currently manufactures and distributes the only demineralized bone-bioactive glass combination product approved by the FDA. NanoFUSE® Bioactive Matrix uniquely combines the osteoinductive capabilities of demineralized allograft bone with the osteostimulative properties of 45S5 bioactive glass.

CONTACT:
Jane Teague
Chief Operating Officer
Institute for the Commercialization of Public Research
561-368-8889
jane.teague@florida-institute.com

 

SOURCE Florida Institute for the Commercialization of Public Research

Related Links

http://www.florida-institute.com

10 orthopedic device company CEOs: Who is paid the most?

Written by  Laura Dyrda – Becker’s Spine Review, 09 May 2017

Orthopedic and spine device company leader compensation varies across the board based on the company’s size and market share. While some have a larger base salary, others have higher bonus and stock option value.

Here is the compensation for 10 orthopedic and spine device company leaders based on data from Salary.com. The information is reported according to the proxy statements filed for the 2015 fiscal year.

1. Alex Gorsky. Chairman and CEO of Johnson & Johnson: $21.2 million

2. Omar Ishrak. Chairman and CEO of Medtronic PLC: $15 million

3. Kevin Lobo, Chairman, President and CEO of Stryker: $12.8 million

 

 

READ THE REST HERE

VEXIM in Facts, Five Years after the Stock Market Listing on the Alternext Market

May 17, 2017

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces its fifth-year anniversary on the Alternext market.

“After five years of quotation on the Alternext market, VEXIM has made tremendous progress on all fronts. VEXIM has successfully implemented its direct go to market strategy in Europe reaching 10% market share in 2016 and reached profitability on the second half of 2016. VEXIM also attracted and recruited more than 30 talented and experienced employees supporting the growth of VEXIM’s business and serving our customers every day. We also generated value for our shareholders by tripling our market capitalization in 5 years. With the US market, EU market, international expansion and our product portfolio extension projects, VEXIM has a great potential of growth for the next coming years. We would like to thank all VEXIM’s shareholders from the first days and the ones who have joined recently for their trust and support“, said Vincent Gardès, CEO of VEXIM.

EUROPE, A GREAT SUCCESS IN 5 YEARS

In 2012, we launched our Go-to-market strategy in Europe that was to address 90% of the market through a direct sales force organization. After 5 years, VEXIM results are impressive with a compounded average growth rate of our sales of 74% since 2011. We now have reached a 10% market share position1 as of end of 2016 and a leading market position in France2, VEXIM’s domestic market. We aim to continue to gain market share in the coming years in Europe by focusing mainly in Germany and all other countries.

EXPANDING OUR PRODUCT PORTFOLIO

The SpineJack® remains VEXIM’s main product representing close to 90% of our sales but in the past 5 years we also launched new products to extend our portfolio. The Interface™ launched in 2014, a cement with 50% of Hydroxyapatite to be used in younger patients. The Masterflow™ launched in 2015, is a sophisticated solution providing a controlled high viscosity cement injection, at a safe distance3from the radiation field for multi-level procedures. And more recently the Masterflow™ PLUS launched in March 2017 in Germany that allows a Controlled Cement Augmentation Procedure first through vertebral body height elevation, and second by stabilizing the fracture using Cohesion® Bone Cement injection. We have also other projects in the pipeline to extend our portfolio into high energy vertebral fractures and tumor. This promising portfolio will strenghthen our Spine trauma positioning and expertize.

BUILDING CLINICAL EVIDENCE

We have successfully conducted 7 international clinical studies and 4 biomechanical studies to support the efficacy and safety of our SpineJack® product. These studies have led to 14 publications in renowned medical journals4. VEXIM is continuously looking and investing to build more clinical evidence. VEXIM’s US FDA 510K clinical study, the clinical and health economic study comparing the SpineJack® vs conservative treatments and the future clinical study in Germany where the SpineJack® will be more evidence based towards a wider range of indications to follow, are demonstrating VEXIM’s commitment to build clinical evidence and demonstrate benefits of its technology.

HIGH PERFORMING ORGANIZATION

VEXIM’s culture of execution, passion and customer focus are key strengths that supported the development of the company on the past 5 years. Vexim more than doubled its number of employees in 5 years reaching 66 employees across all entities with diverse and experienced talents across the company. VEXIM will continue to recruit talents across the globe to sustain its objectives and projects.

STRATEGIC INTERNATIONAL EXPANSION

There has been a growing interest in the SpineJack® across the world. The SpineJack® is today available in more than 15 countries across the world from Central & Latin America to Eastern Europe, Middle East, South Africa and South East Asia. We will continue to expand our footprint by opening new markets such as Brazil, Australia, South Korea, China.

OPERATIONAL AND FINANCIAL EXCELLENCE

VEXIM successfully achieved to turn profitable on a full semester in the second half of 2016 and generated positive cash flows. VEXIM also increased its Gross Margin on sales from 59% to 72% in average by optimizing its production costs and inventory processes. VEXIM aims at reaching profitability on a full year basis in 2017 and future cash flows should allow VEXIM to self-finance, in line with its ambitions.

Click here to consult VEXIM’s 2016 results presentation

Financial reporting schedule:
2nd quarter sales: July 11th, 20175

About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital6, and from OSEO public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 66 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on NYSE Alternext Paris since May 3rd 2012. For further information, please visit www.vexim.com

SpineJack®7, an innovative implant for treating Vertebral Compression Fractures
The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

1 Internal Vexim source.
2 Internal Vexim source.
3 Mehlman, Charles T., DiPasquale, Thomas G. Journal of Orthopaedic Trauma: August 1997 – Volume 11 – Issue 6 – pp 392-398 Radiation Exposure to the Orthopaedic Surgical Team During Fluoroscopy: “How Far Away Is Far Enough?”
4 http://en.vexim.com/professionals/scientific-and-clinical-communication/
5 Indicative date, subject to changes.
6 Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.
7 This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tel.: +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tel.: +33 1 44 54 36 66
Tel.: +33 6 48 82 18 94
vexim@alizerp.com

SANUWAVE Health Reports First Quarter Financial Results and Provides a Business Update

SUWANEE, GA–(Marketwired – May 16, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV), today reported financial results for the three months ended March 31, 2017 and provided a business update. The Company will host a conference call at 9AM Eastern Time on Tuesday, May 16, 2017.

Highlights of the first quarter and recent weeks:

  • The Company hired André Mouton to head the Company’s international sales and relations. André’s focus is on adding additional countries and regions to our portfolio and centralize the management of SANUWAVE’s existing distributor and customer base.
  • SANUWAVE launched a blog entitled “SHOCK THIS” to bring together in one setting various information about the Company, the products and the science behind the technology in a useful and entertaining way. Two blogs have been published to date, with a third coming shortly. Please visit our website at www.sanuwave.com to view the blogs.
  • SANUWAVE has appointed LOK North America to act as Territory Sales Manager for sourcing and screening of potential distributors for the Company’s products in Canada. LOK North America will give SANUWAVE an extended reach and establish rigorous evaluation methods of the regional distribution options in Canada to ensure the development of a strong distribution network.
  • SANUWAVE exhibited, in conjunction with Ortho-Medico, a member of B&Co, at EWMA in Amsterdam, The Netherlands on May 3 -5, 2017.

“The first quarter came in as we had expected and announced on our most recent conference call. The weakness was due to economic concerns in South Korea. The good news is since the recent election in South Korea and a successful Korea Diabetic Conference, held in BEXCO from May 11th to 13th orders have returned and the outlook in South Korea for 2017 remains very robust. We also remain on track to add 3 new countries in the second quarter and 7-10 during the full year, as we had indicated on our year end conference call. Lastly, we have submitted our response to the FDA’s questions and are hopeful of a positive response by year end,” stated Kevin Richardson, CEO and Chairman.

First Quarter Financial Results

Revenues for the three months ended March 31, 2017 were $149,569, compared to $269,324 for the same period in 2016, a decrease of $119,755, or 44%. Revenues resulted primarily from sales in Europe, Asia and Asia/Pacific of our orthoPACE device and related applicators. The decrease in revenues for 2017 was due to lower sales of new orthoPACE devices and applicators, lower applicator refurbishments and lower wound kit sales in Europe and Asia/Pacific in 2017.

Research and development expenses for the three months ended March 31, 2017 were $260,338, compared to $309,955 for the same period in 2016, a decrease of $49,617, or 16%. Research and development expenses decreased in 2017 due to lower payments to consultants related to the de novo petition submission to the FDA in July 2016.

General and administrative expenses for the three months ended March 31, 2017 were $448,606, as compared to $499,132 for the same period in 2016, a decrease of $50,526, or 10%. The decrease in general and administrative expenses is primarily due to reduced salary and related costs due to reduction in headcount in June 2016, lower rent expense due to move to new facility and lower travel expenses.

Net loss for the three months ended March 31, 2017 was $493,532, or ($0.00) per basic and diluted share, compared to a net loss of $1,724,576, or ($0.02) per basic and diluted share, for the same period in 2016, a decrease in the net loss of $1,231,044, or 71%. The decrease in the net loss for 2017 was primarily due to a gain on warrant valuations and lower operating expenses as noted above.

Conference Call
The Company will also host a conference call on Tuesday, May 16, 2017, beginning at 9AM Eastern Time to discuss the first quarter financial results, provide a business update and answer questions. Shareholders and other interested parties can participate in the conference call by dialing 866-682-6100 (U.S.) or 862-255-5401 (international) or via webcast at http://www.investorcalendar.com/IC/CEPage.asp?ID=175965.

A replay of the conference call will be available beginning two hours after its completion through May 30, 2017, by dialing 877-481-4010 (U.S.) or 919-882-2331 (international) and entering Conference ID 10400.

About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
March 31, December 31,
2017 2016
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 97,538 $ 133,571
Accounts receivable, net of allowance for doubtful accounts 451,369 460,799
Inventory 202,879 231,953
Prepaid expenses 115,377 87,823
TOTAL CURRENT ASSETS 867,163 914,146
PROPERTY AND EQUIPMENT, at cost, less accumulated depreciation 70,818 76,938
OTHER ASSETS 13,841 13,786
TOTAL ASSETS $ 951,822 $ 1,004,870
LIABILITIES
CURRENT LIABILITIES
Accounts payable $ 1,033,341 $ 712,964
Accrued expenses 546,829 375,088
Accrued employee compensation 64,860 64,860
Interest payable, related parties 246,264 109,426
Short term loan, net 100,000 47,440
Warrant liability 861,525 1,242,120
Notes payable, related parties, net 5,367,912 5,364,572
TOTAL LIABILITIES 8,220,731 7,916,470
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ DEFICIT
PREFERRED STOCK, SERIES A CONVERTIBLE, par value $0.001,
6,175 authorized; 6,175 shares issued and 0 shares outstanding
in 2017 and 2016
PREFERRED STOCK, SERIES B CONVERTIBLE, par value $0.001,
293 authorized; 293 shares issued and 0 shares outstanding
in 2017 and 2016, respectively
PREFERRED STOCK – UNDESIGNATED, par value $0.001, 4,993,532
shares authorized; no shares issued and outstanding
COMMON STOCK, par value $0.001, 350,000,000 shares authorized;
138,815,329 and 137,219,968 issued and outstanding in 2017 and
2016, respectively 138,815 137,220
ADDITIONAL PAID-IN CAPITAL 92,569,540 92,436,697
ACCUMULATED DEFICIT (99,926,980 ) (99,433,448 )
ACCUMULATED OTHER COMPREHENSIVE LOSS (50,284 ) (52,069 )
TOTAL STOCKHOLDERS’ DEFICIT (7,268,909 ) (6,911,600 )
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT $ 951,822 $ 1,004,870
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
Three Months Ended Three Months Ended
March 31, March 31,
2017 2016
REVENUES $ 149,569 $ 269,324
COST OF REVENUES (exclusive of depreciation and amortization shown below) 55,144 73,181
OPERATING EXPENSES
Research and development 260,338 309,955
General and administrative 448,606 499,132
Depreciation 6,120 836
Amortization 76,689
Gain of sale of assets, property and equipment (1,000 )
TOTAL OPERATING EXPENSES 715,064 885,612
OPERATING LOSS (620,639 ) (689,469 )
OTHER INCOME (EXPENSE)
Gain (loss) on warrant valuation adjustment and conversion 323,223 (797,697 )
Interest expense, net (192,738 ) (234,430 )
Loss on foreign currency exchange (3,378 ) (2,980 )
TOTAL OTHER INCOME (EXPENSE), NET 127,107 (1,035,107 )
NET LOSS (493,532 ) (1,724,576 )
OTHER COMPREHENSIVE LOSS
Foreign currency translation adjustments 1,785 2,972
TOTAL COMPREHENSIVE LOSS $ (491,747 ) $ (1,721,604 )
LOSS PER SHARE:
Net loss – basic and diluted $ 0.00 $ (0.02 )
Weighted average shares outstanding – basic and diluted 138,042,070 75,220,485
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
Three Months Ended Three Months Ended
March 31, March 31,
2017 2016
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (493,532 ) $ (1,724,576 )
Adjustments to reconcile net loss to net cash used by operating activities to net cash used by operating activities
Depreciation 6,120 836
Change in allowance for doubtful accounts 5,152 1,052
Amortization 76,689
Stock-based compensation – employees, directors and advisors 4,500
(Gain) loss on warrant valuation adjustment (323,223 ) 873,118
Amortization of debt discount 55,900 5,694
Amortization of debt issuance costs 74,549
Gain on sale of asset, property and equipment (1,000 )
Changes in assets – (increase)/decrease
Accounts receivable – trade 4,278 27,370
Inventory 29,074 26,413
Prepaid expenses (27,554 ) (23,530 )
Other (55 ) (94 )
Changes in liabilities – increase/(decrease)
Accounts payable 320,377 (153,022 )
Accrued expenses 171,741 (107,371 )
Accrued employee compensation 44,613
Interest payable, related parties 136,838 (56,835 )
Promissory notes, accrued interest (79,948 )
NET CASH USED BY OPERATING ACTIVITIES (114,884 ) (1,011,542 )
CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds from sale of property and equipment 1,000
NET CASH PROVIDED BY INVESTING ACTIVITIES 1,000
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from warrant exercise 77,066
Proceeds from 2016 Public Offering, net 1,352,775
Proceeds from convertible promissory notes, net 106,000
NET CASH PROVIDED BY FINANCING ACTIVITIES 77,066 1,458,775
EFFECT OF EXCHANGE RATES ON CASH 1,785 2,972
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS (36,033 ) 451,205
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 133,571 152,930
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 97,538 $ 604,135
SUPPLEMENTAL INFORMATION
Cash paid for interest, related parties $ $ 209,549

CONTACT INFORMATION

Orthonika accelerates development of total meniscus replacement and secures additional funding

London, UK, 15th May 2017 / Orthonika Limited, a spin-out from Imperial College London, is pleased to announce success in securing funding for development of its novel synthetic total knee meniscus replacement. The company has closed a second round of investment of £675,000 from a group of angel investors alongside a Biomedical Catalyst award and an Industrial Challenge award. The funding is being used to accelerate progress on biomechanical testing and carry out a pre-clinical pilot trial.

Dr Mario Alberto Accardi, Co-Founder and Chief Executive Officer, commented “We are delighted to have raised the funds to bring this revolutionary treatment for meniscus injury into a pre-clinical pilot trial. We are very grateful to our angel investors and Innovate UK for their support.”

Dominique Kleyn, Co-Founder and Chief Operating Officer, added “This investment demonstrates a strong endorsement of our progress in developing a novel solution for meniscus injury and allows us to cement our network of collaborators and suppliers.”

Orthonika brings design and development expertise to exploit a novel approach for the replacement of a damaged meniscus, restoring knee biomechanics and allowing patients to return to an active lifestyle. The goal is to advance the meniscus replacement into a product and obtain regulatory approval for its clinical application.

Ends

For further information, contact:

Orthonika

Dr Mario Alberto Accardi
CEO and Co-Founder
E: ma.accardi@orthonika.com

Dominique Kleyn
COO and Co-Founder
E: d.kleyn@orthonika.com

Media Relations, Sciad Communications

Deborah Cockerill
Managing Partner
E: deborah@sciad.com
T: +44 (0)20 7470 8801

Notes to Editors

About Orthonika Limited:
Orthonika is a spin-out from Imperial College London founded in 2015, developing an anatomical total meniscus replacement for the knee joint. Orthonika’s revolutionary meniscus implant accurately mimics the natural structure of meniscal tissue replicating its ‘structure-function’ relationship. It is designed to restore knee biomechanics and allow patients to return to an active lifestyle, an option currently not available to patients with severe meniscus injury hence fulfilling a gap of high unmet clinical need. For further information visit www.orthonika.com.

About Innovate UK:
Innovate UK is the UK’s innovation agency. It works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. For further information visit www.innovateuk.gov.uk.

About meniscus injury:
Meniscus injury is the most frequent orthopaedic surgical intervention with meniscus-related operations accounting for up to 50% of all knee surgeries with an average of 1.7m total surgeries performed each year in the EU and U.S. Despite this prevalence, today’s standard of care for a severely damaged meniscus is partial or total meniscectomy (removal) with no total meniscus replacement currently available on the market. Removal of the meniscus is well understood to be a major risk factor for osteoarthritis (OA) a chronic and debilitating condition, with an estimated 50% of partial meniscectomy patients being diagnosed with OA as a result.

Category:

Vericel Reports First-Quarter 2017 Financial Results

CAMBRIDGE, Mass., May 10, 2017 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leading developer of autologous expanded cell therapies for the treatment of patients with serious diseases and conditions, today reported financial results for the first quarter ended March 31, 2017.

Total net revenues for the quarter ended March 31, 2017 were approximately $9.4 million, net of a $2.8 million revenue reserve related to an unresolved contractual dispute between one of the Company’s pharmacy providers and a payer.  Net revenue included approximately $5.0 million of Carticel® (autologous cultured chondrocytes) and MACI® (autologous cultured chondrocytes on porcine collage membrane) net revenues and approximately $4.4 million of Epicel® (cultured epidermal autografts) net revenues, compared to $8.8 million of Carticel revenues and $5.3 million of Epicel revenues, respectively, in the first quarter of 2016.

Carticel and MACI net revenues reflect a change in estimate for revenue reserves of $2.1 million related to 2016 sales and $0.7 million related to 2017 sales.  The company engages pharmacies to contract with insurance providers and recently received notification of a dispute between one contracted pharmacy and a payer.  Since the company retains credit and collection risk from the end customer, we revised our estimate by assuming cases processed by that pharmacy will be paid at a lower out-of-network rate.  The earlier estimates were based on claims being paid on an in-network basis consistent with the actual payment history and the pharmacy’s interpretation of its contract with the payer.

Gross profit for the quarter ended March 31, 2017 was $2.3 million, or 24% of net revenues, compared to $7.5 million, or 54% of net product revenues, for the first quarter of 2016.

Research and development expenses for the quarters ended March 31, 2017 and March 31, 2016 were $3.5 million.  Clinical trial expenses for the ixCELL-DCM clinical trial and research and development expenses related to Epicel were consistent for both periods.  Research and development expenses related to Carticel decreased, offset by an increase in research and development expenses related to MACI.

Selling, general and administrative expenses for the quarter ended March 31, 2017 were $8.4 million compared to $6.0 million for the same period in 2016.  The increase in SG&A expenses is primarily due to an increase in consulting expenses of $0.8 million for marketing initiatives related to the launch of MACI, an increase in personnel costs of $0.8 million primarily related to an increase in the MACI sales force, costs associated with reimbursement and patient support services for Carticel and MACI of $0.5 million, and an increase in professional fees of $0.3 million.

Loss from operations for the quarter ended March 31, 2017 was $9.6 million, compared to $2.0 million for the first quarter of 2016.  Material non-cash items impacting the operating loss for the quarter included $0.5 million of stock-based compensation expense and $0.4 million in depreciation expense.

Other expense for the quarter ended March 31, 2017 was $0.2 million compared to $1.7 million for the same period in 2016.  The change in other expense for the quarter is primarily due to the change in the fair value of warrants in the first quarter of 2017 compared to the same period in 2016.

Vericel’s net loss for the quarter ended March 31, 2017 was $9.8 million, or $0.31 per share, compared to a net loss of $3.7 million, or $0.24 per share, for the same period in 2016.

As of March 31, 2017, the company had $19.8 million in cash compared to $23.0 million in cash at December 31, 2016.

Recent Business Highlights
During and since the first quarter of 2017, the company:

  • Commenced MACI launch activities and announced treatment of the first patient with MACI on February 1, 2017;
  • Increased the number of sales representatives and expanded the marketing, market access and medical affairs teams to support the MACI launch;
  • Trained more than 200 surgeons on MACI, with nearly half of trained surgeons coming from former Carticel user and non-Carticel user segments;
  • Increased MACI biopsies 17% in Q1 2017 compared to Q1 2016;
  • Medical benefit policies updated to include MACI at several commercial plans, including four of the top ten commercial plans for MACI/Carticel;
  • Announced the presentation of outcomes data from over 950 severe burn patients treated with Epicel demonstrating a probable survival benefit at the 49th annual meeting of the American Burn Association;
  • Received FDA Fast Track designation for the investigation of ixmyelocel‑T for the  reduction in the risk of death and cardiovascular hospitalization in patients with chronic advanced heart failure due to ischemic dilated cardiomyopathy;
  • Received the FDA Regenerative Medicine Advanced Therapy (RMAT) designation for ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy; and
  • Completed treatment of eligible patients in the open-label crossover extension portion of the ixCELL-DCM study.

“The first quarter of 2017 was challenging due to a number of factors, but we are very pleased with the customer response to MACI,” said Nick Colangelo, president and CEO of Vericel.  “Moreover, while our focus remains on our core commercial business, we are very pleased with to have received the RMAT designation for ixmyelocel-T and to have signed the license agreement with ICT, which we believe have the potential to create shareholder value moving forward.”

Conference Call Information
Today’s conference call will be available live at 8:00am Eastern time in the Investors section of the Vericel website at http://investors.vcel.com/events.cfm.  Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary.  To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s first-quarter 2017 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.

If you are unable to participate in the live call, the webcast will be available at http://investors.vcel.com/events.cfm until May 14, 2018. A replay of the call will also be available until 11:00 am (EST) on May 14, 2017 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406.  The conference ID is 11385924.

About Vericel Corporation
Vericel develops, manufactures, and markets autologous expanded cell therapies for the treatment of patients with serious diseases and conditions.  The company markets three cell therapy products in the United States.  Vericel is marketing MACI® (autologous cultured chondrocytes on porcine collagen membrane), an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  Carticel® (autologous cultured chondrocytes) is an autologous chondrocyte implant for the treatment of cartilage defects in the knee in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure.  Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.  Vericel is also developing ixmyelocel‑T, an autologous multicellular therapy intended to treat advanced heart failure due to ischemic dilated cardiomyopathy (DCM).  For more information, please visit the company’s website at www.vcel.com.

Epicel®, Carticel®, and MACI® are registered trademarks of Vericel Corporation. © 2017 Vericel Corporation. All rights reserved.

This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of our products and growth in revenues, intended product development, clinical activity timing, regulatory progress, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements, estimating the commercial growth potential of our products and product candidates and growth in revenues and improvement in costs, market demand for our products, our ability to secure consistent reimbursement for our products, and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission (“SEC”) on March 13, 2017, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management’s current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

VERICEL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, amounts in thousands)
March 31, December 31,
2017 2016
ASSETS
Current assets:
Cash $ 19,847 $ 22,978
Accounts receivable (net of allowance for doubtful accounts of $249 and $225, respectively) 12,127 17,093
Inventory 3,958 3,488
Other current assets 1,018 1,164
Total current assets 36,950 44,723
Property and equipment, net 3,638 3,875
Total assets $ 40,588 $ 48,598
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 6,335 $ 6,535
Accrued expenses 6,030 4,523
Current portion of term loan credit agreement, net of deferred costs of $110 1,446 779
Warrant liabilities 650 757
Other 291 259
Total current liabilities 14,752 12,853
Revolving and term loan credit agreement, net of deferred costs of $265 and $293, respectively 8,679 9,318
Long term deferred rent 1,632 1,687
Other long term debt 21 32
Total liabilities 25,084 23,890
COMMITMENTS AND CONTINGENCIES
Shareholders’ equity:
Series B-2 voting convertible preferred stock, no par value: shares authorized and reserved — 39, shares issued and outstanding —  0 and12, respectively 38,389
Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 32,724 and 31,595, respectively 368,683 329,720
Warrants 190 190
Accumulated deficit (353,369 ) (343,591 )
Total shareholders’ equity 15,504 24,708
Total liabilities and shareholders’ equity $ 40,588 $ 48,598
VERICEL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, amounts in thousands except per share amounts)
Three Months Ended March 31,
2017 2016
Product sales, net $ 9,361 $ 14,108
Cost of product sales 7,109 6,560
Gross profit 2,252 7,548
Research and development 3,467 3,536
Selling, general and administrative 8,408 6,004
Total operating expenses 11,875 9,540
Loss from operations (9,623 ) (1,992 )
Other income (expense):
Decrease (increase) in fair value of warrants 107 (1,640 )
Foreign currency translation loss (1 ) (10 )
Interest income 1 5
Interest expense (262 ) (3 )
Other expense (10 )
Total other income (expense) (155 ) (1,658 )
Net loss $ (9,778 ) $ (3,650 )
Net loss per share attributable to common shareholders (Basic and Diluted) $ (0.31 ) $ (0.24 )
Weighted average number of common shares outstanding (Basic and Diluted) 31,896 22,604
CONTACT:    
Chad Rubin
The Trout Group
crubin@troutgroup.com
(646) 378-2947
or
Lee Stern
The Trout Group
lstern@troutgroup.com
(646) 378-2922

Xtant Medical Announces OrbiMed Financing and Engagement of Aurora Management Partners

BELGRADE, Mont., May 12, 2017 (GLOBE NEWSWIRE) — Xtant™ Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced it has entered into an amendment to its senior credit facility with affiliates of OrbiMed Advisors (“OrbiMed”) for a financing of up to $15 million with the proceeds being used to pay off its outstanding balance of approximately $9 million under its accounts receivable credit facility with Silicon Valley Bank (“SVB”) with the remainder for general working capital purposes.  Additionally, OrbiMed has deferred the interest originally due under the senior credit facility January 2, 2017 and March 31, 2017 to June 30, 2017.

Xtant Medical also announced it has entered into an agreement on May 8, 2017 with Aurora Management Partners Inc. to engage David Baker and Wayne Tanner as restructuring officers to assist with day-to-day operations of the company and implementation of an operating business plan. The restructuring officers will report to the special restructuring committee of Xtant Medical’s Board of Directors.

About Xtant Medical Holdings, Inc.

Xtant Medical Holdings, Inc. (NYSE MKT:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press 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 ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. 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. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

 

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

ConforMIS Reports First Quarter 2017 Financial Results

BILLERICA, Mass., May 10, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are customized to fit each patient’s unique anatomy, announced today financial results for the first quarter ended March 31, 2017.

Q1 Summary:

  • Total revenue of $20.5 million, up 1% year-over-year on a reported basis and up 2% on a constant currency basis
  • Product revenue of $20.4 million, up 2% year-over-year on a reported basis and up 3% on a constant currency basis
    –  U.S. product revenue increased 9% year-over-year
    –  Rest of World product revenue decreased 16% year-over-year on a reported basis and decreased 12% year-over-year on a constant currency basis

“We reported better than expected revenue results in the first quarter of 2017,” said Mark Augusti, President and Chief Executive Officer of ConforMIS, Inc. “Revenue exceeded the mid-point of the first quarter 2017 guidance range in excess of $2 million. Our full year guidance remains unchanged as we work through this year of transition.”

First Quarter 2017 Financial Results

Three months ended March 31, Increase/decrease
($, in thousands) 2017 2016 $
Change
%
Change
%
Change
(as reported) (constant
currency)
United States $   15,964 $   14,708 $   1,256 9 % 9 %
Rest of world   4,415   5,274   (859 ) -16 % -12 %
Product revenue   20,379   19,982   397 2 % 3 %
Royalty revenue   76   268   (192 ) -72 % -72 %
Total revenue $   20,455 $   20,250 $   205 1 % 2 %

Total revenue increased $0.2 million to $20.5 million, or 1% year-over-year on a reported basis and increased 2% on a constant currency basis. Total revenue in the first quarter of 2017 included royalty revenue related to patent license agreements of $0.1 million as compared to $0.3 million in the first quarter of 2016.

Product revenue increased $0.4 million to $20.4 million, or 2% year-over-year on a reported basis and increased 3% on a constant currency basis. U.S. product revenue increased $1.3 million to $16.0 million, or 9% year-over-year, and Rest of World product revenue decreased $0.9 million to $4.4 million, or 16% year-over-year on a reported basis and decreased 12% on a constant currency basis. Product revenue from sales of iTotal CR, iDuo and iUni was $15.3 million for the three months ended March 31, 2017 compared to $17.6 million for the three months ended March 31, 2016, a decrease of $2.3 million, or 13% year-over-year, on a reported basis and 12% on a constant currency basis.  Product revenue from sales of iTotal PS was $5.1 million for the three months ended March 31, 2017 compared to $2.4 million for the three months ended March 31, 2016, an increase of $2.7 million, or 113% year-over-year, on a reported and constant currency basis.

Total gross profit decreased $0.2 million to $6.5 million, or 32% of revenue, in the first quarter of 2017, compared to $6.7 million, or 33% of revenue, in the first quarter of 2016. The decrease in gross margin year-over-year was driven primarily by the impact of foreign currency exchange rate changes and the timing of royalty payments received.

Total operating expenses increased $2.0 million to $23.8 million, or 9% year-over-year. The increase in operating expenses was driven primarily by higher general and administrative expense, including a $1.4 million increase in patent litigation expense and a $0.7 million increase in personnel costs compared to last year.

Net loss was $17.2 million, or $0.40 per basic share, in the first quarter of 2017, compared to a net loss of $15.0 million, or $0.37 per basic share, for the same period last year. The change in first quarter net loss was driven primarily by higher general and administrative expense year-over-year.

As of March 31, 2017, the Company’s cash and cash equivalents and investments totaled $68.5 million, compared to $65.5 million as of December 31, 2016.  As previously announced, in January 2017 the Company secured up to $50 million in term debt financing from Oxford Finance, of which $15 million was borrowed in January.

2017 Financial Guidance

ConforMIS reaffirms the financial guidance provided on February 15, 2017. For the full year 2017, the Company continues to expect total revenue in a range of $80 to $84 million and total gross margin in a range of 36% to 38%.

Note on Non-GAAP Financial Measures

In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain information regarding the Company’s financial results or projected financial results on a non-GAAP “constant currency basis.” This information estimates the impact of changes in foreign currency rates on the translation of the Company’s current or projected future period financial results as compared to the applicable comparable period. This impact is derived by taking the adjusted current or projected local currency results and translating them into U.S. Dollars based upon the foreign currency exchange rates for the applicable comparable period. It does not include any other effect of changes in foreign currency rates on the Company’s results or business. Non-GAAP information is not a substitute for, and is not superior to, information presented on a GAAP basis.

Conference Call

As previously announced, ConforMIS will conduct a conference call and webcast today at 4:30 PM Eastern Time. Management will discuss financial results and strategic matters. To participate in the conference call, please call 877-809-6331 (or 615-247-0224 for international) and use conference ID number 5263799 or listen to the webcast in the investor relations section of the company’s website at ir.conformis.com. The online archive of the webcast will be available on the company’s website for 30 days.

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about our strategy, future operations, future financial position and results, market growth, total revenue and revenue mix by product and geography, gross margin, operating trends, the potential impact and advantages of using customized implants, and potential transition at the Company as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our revenue, gross margin, expenses, revenue growth, transition and other results of operations, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

CONFORMIS, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
Three Months Ended
March 31
2017 2016
Revenue
Product $   20,379 $   19,982
Royalty   76   268
Total revenue   20,455   20,250
Cost of revenue   13,960   13,586
Gross profit   6,495   6,664
Operating expenses
Sales and marketing   10,816   11,115
Research and development   4,560   4,398
General and administrative   8,458   6,295
Total operating expenses   23,834   21,808
Loss from operations   (17,339 )   (15,144 )
Other income and expenses
Interest income   103   139
Interest expense   (307 )   (25 )
Foreign currency exchange transaction income   390   —
Total other expenses   186   114
Loss before income taxes   (17,153 )   (15,030 )
Income tax provision   7   4
Net loss $   (17,160 ) $   (15,034 )
Net loss per share – basic and diluted $   (0.40 ) $   (0.37 )
Weighted average common shares outstanding – basic and diluted   42,874,743 40,993,485
CONFORMIS, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands, except share and per share data)
March 31, 2017 December 31, 2016
 
Assets  (unaudited) 
Current Assets
Cash and cash equivalents $ 36,392 $ 37,257
Investments 27,910 28,242
Accounts receivable, net 13,052 14,675
Inventories 11,383 11,720
Prepaid expenses and other current assets 2,910 3,954
Total current assets 91,647 95,848
Property and equipment, net 15,760 15,084
Other Assets
Restricted cash 762 300
Investments 4,192
Intangible assets, net 684 746
Goodwill 753 753
Other long-term assets 29 79
Total assets $ 113,827 $ 112,810
Liabilities and stockholder’s equity
Current liabilities
Accounts payable $ 5,768 $ 5,474
Accrued expenses 8,875 8,492
Deferred revenue 305 305
Total current liabilities 14,948 14,271
Other long-term liabilities 161 164
Deferred revenue 4,243 4,320
Long-term debt,less debt issuance costs 14,718
Total liabilities 34,070 18,755
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.00001 par value:
Authorized: 5,000,000 shares authorized at March 31, 2017 and December 31, 2016, respectively, no shares outstanding as of March 31,2017 and December 31, 2016.
Common stock, $0.00001 par value:
Authorized: 200,000,000 shares at March 31, 2017 and December 31, 2016; 43,840,318 and 43,399,547 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively
Additional paid-in capital 480,022 476,486
Accumulated deficit (400,401 ) (382,930 )
Accumulated other comprehensive loss 136 (499 )
Total stockholders’ equity 79,757 94,055
Total liabilities and stockholders’ equity $ 113,827 $ 112,810
CONTACT:    

Investor contact
Oksana Bradley
ir@conformis.com
(781) 374-5598

Alphatec Holdings Reports First Quarter 2017 Financial Results

CARLSBAD, Calif., May 11, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today recent corporate highlights and financial results for first quarter ended March 31, 2017.

First Quarter 2017 Highlights and Recent Accomplishments

Financial Highlights

  • Total net revenues of $28.0 million; revenue from the Company’s U.S. commercial business of $23.4 million
  • U.S. commercial gross margin of 68%
  • Gross proceeds of $18.9 million from private placement
  • Cash balance of $25.5 million at March 31, 2017

Organizational and Product Highlights

  • Completed its seven-person senior leadership team with appointments of Chief Financial Officer and Executive Vice President of Strategic Marketing and Product Development.
  • Initiated transition of sales organization from non-exclusive to dedicated.
  • Added three new Area Vice Presidents with a history of building strong, dedicated distribution channels in spine.
  • Reduced headcount from 195 in September 2016 to approximately 140 today, and implemented cost-control measures, including consolidating the Company’s operations into one building.
  • Completed a limited user release of Arsenal™ Deformity Adolescent Idiopathic Scoliosis (AIS) System, and introduced a limited user release of Battalion™ Lateral System, both which have  been well-received by surgeons.

“We are very pleased with our progress in evolving the Alphatec organization over the past few months,” said Terry Rich, CEO of Alphatec.  “Our strategy for the Company centers on combining our broad product portfolio with new leadership, dedicated distribution partners, and a high-performance culture in order to significantly re-position the Alphatec brand to customers, investors, employees, and business partners. In the short time that our new team has been together, we have taken many important steps to provide a solid base to return Alphatec to a growth organization.”

Financial Results for the First Quarter Ended March 31, 2017

As a result of the sale of the Company’s international business in September 2016, the financial results and related assets and liabilities of the former international business have been excluded from continuing operations for all periods herein and reported as discontinued operations.

U.S. commercial revenues for the first quarter of 2017 were $23.4 million, down 19.8%, compared to $29.2 million reported for the first quarter of 2016. On a sequential basis, U.S. commercial revenues in the first quarter of 2017 were down $1.1 million, or 4.3%, compared to $24.5 million in the fourth quarter of 2016.

These decreases are largely the result of financial and operational challenges the Company faced in 2016, which led to the sale of the Company’s international business in order to sustain operations.  This resulted in a reduction in volume from several distributors and surgeons. Revenue was also impacted by the Company’s decision to exit the stocking distributor and terminate distributor relationships that are not representative of the Company’s long-term business and rebranding strategy.

U.S. gross profit and gross margin for the first quarter of 2017 were $16.0 million and 68.3%, respectively, compared to $23.5 million and 80.6%, respectively, for the first quarter of 2016. Gross margins declined primarily as a result of increased supply costs from reduced sourcing and manufacturing volumes, and an increase in inventory kit write-offs due to distributor turnover.

On a sequential basis, U.S. gross margin of 68.3% in the first quarter of 2017 increased from 62.2% in the fourth quarter of 2016.

Total operating expenses for the first quarter of 2017 were $20.2 million, reflecting a decrease of $7.8 million, an approximate 28% improvement over the first quarter of 2016. On a non-GAAP basis, excluding restructuring charges, total operating expenses in the first quarter of 2017 decreased $8.9 million, or approximately 32%, compared to the first quarter of 2016.  These decreases reflect the impact of cost reduction initiatives, including the workforce reductions the Company implemented in October 2016 and February 2017.

On a sequential basis, total operating expenses in the first quarter of 2017 were down $1.5 million, or approximately 7%, compared to $21.7 million in the fourth quarter of 2016.  On a non-GAAP basis, excluding restructuring charges, total operating expenses in the first quarter of 2017 decreased $2.2 million, or approximately 11%, compared to the fourth quarter of 2016.

GAAP loss from continuing operations for the first quarter of 2017 was $5.4 million, compared to a loss of $4.2 million for the first quarter of 2016, and a loss of $10.2 million for the fourth quarter of 2016.

Adjusted EBITDA in the first quarter of 2017 was $0.5 million, compared to $71,000 in for the first quarter of 2016 and a loss of $2.2 million for the fourth quarter of 2016. Please refer to the table, “Alphatec Holdings, Inc. Reconciliation of Non-GAAP Financial Measures” that follows for more detailed information.

Total Current and Long-term debt, includes $34.2 million in term debt and $10.3 million outstanding under the Company’s revolving credit facility at March 31, 2017. This compares to $34.8 million in term debt and $12.5 million outstanding under the Company’s revolving credit facility at December 31, 2016.

Cash and cash equivalents were $25.5 million at March 31, 2017, compared to $19.6 million reported at December 31, 2016. In March, the Company raised gross proceeds of $18.9 million in a private placement of common stock, Series A Convertible Preferred Stock and warrants exercisable for common stock.

Non-GAAP Information

To supplement the Company’s financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company reports certain non-GAAP financial measures such as Adjusted EBITDA.  Adjusted EBITDA included in this press release is a non-GAAP financial measure that represents net income (loss), excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation expenses, and other non-recurring income or expense items, such as impairments, restructuring expenses, severance expenses and transaction-related expenses.  The Company believes that non-GAAP Adjusted EBITDA provides investors with an additional tool for evaluating the Company’s core performance, which management uses in its own evaluation of continuing operating performance, and a baseline for assessing the future earnings potential of the Company.  For completeness, management uses non-GAAP Adjusted EBITDA in conjunction with GAAP earnings and earnings per common share measures.  The Company’s Adjusted EBITDA measure may not provide information that is directly comparable to that provided by other companies in the Company’s industry, as other companies in the industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. Adjusted EBITDA should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.  Included below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly-owned subsidiary Alphatec Spine, Inc., is a medical device company that designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies.  The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward looking statements include the references to the Company’s strategy in significantly re-positioning the Alphatec brand and turning the Company into a growth organization.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA clearance or approval or international regulatory approvals for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and periodic reports, filed with the  Securities and Exchange Commission. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

 

ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
  (in thousands, except per share amounts – unaudited)
Three Months Ended
March 31,
2017 2016
Revenues $ 27,978 $ 34,206
Cost of revenues 11,199 9,719
Gross profit 16,779 24,487
60.0 % 71.6 %
Operating expenses:
Research and development 1,449 3,641
Sales and marketing 11,103 14,940
General and administrative 6,223 9,004
Amortization of intangible assets 172 255
Restructuring expenses 1,231 89
Total operating expenses 20,178 27,929
Operating loss (3,399 ) (3,442 )
Interest and other expense, net (1,976 ) (783 )
Loss from continuing operations before taxes (5,375 ) (4,225 )
Income tax provision 49 23
Loss from continuing operations (5,424 ) (4,248 )
Loss from discontinued operations (91 ) (2,369 )
Net loss $ (5,515 ) $ (6,617 )
Net loss per share continuing operations $ (0.60 ) $ (0.50 )
Net loss per share discontinued operations (0.01 ) (0.28 )
Net loss per share  – basic and diluted $ (0.61 ) $ (0.78 )
Weighted-average shares – basic and diluted 9,005 8,466

 

ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
March 31, December 31,
2017 2016
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 25,485 $ 19,593
Accounts receivable, net 14,212 18,512
Inventories, net 30,088 30,093
Prepaid expenses and other current assets 2,451 4,262
Current assets of discontinued operations 170 364
Total current assets 72,406 72,824
Property and equipment, net 15,408 15,076
Intangibles, net 5,477 5,711
Other assets 222 516
Noncurrent assets of discontinued operations 58 61
Total assets $ 93,571 $ 94,188
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable $ 4,245 $ 8,701
Accrued expenses 26,173 27,589
Current portion of long-term debt 2,616 3,113
Current liabilities of discontinued operations 293 732
Total current liabilities 33,327 40,135
Total long term liabilities 65,774 71,954
Redeemable preferred stock 23,603 23,603
Stockholders’ deficit (29,133 ) (41,504 )
Total liabilities and stockholders’ deficit $ 93,571 $ 94,188

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
(in thousands, except per share amounts – unaudited)
Three Months Ended
March 31,
2017 2016
Operating loss, as reported $ (3,399 ) $ (3,442 )
Add back:
Depreciation 1,634 2,254
Amortization of intangible assets 234 306
Total EBITDA (1,531 ) (882 )
Add back significant items:
Stock-based compensation 516 58
Stock price guarantee 292 806
Restructuring and other charges 1,231 89
EBITDA, as adjusted for significant items $ 508 $ 71

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF GEOGRAPHIC SEGMENT REVENUES AND GROSS PROFIT
(in thousands, except percentages – unaudited)
Three Months Ended
March 31, % Change
2017 2016
Revenues by source
U.S. commercial revenue $ 23,437 $ 29,233 (19.8 %)
Other 4,541 4,973 (8.7 %)
Total revenues $ 27,978 $ 34,206 (18.2 %)
Gross profit by source
U.S. $ 16,015 $ 23,548
Other 764 939
Total gross profit $ 16,779 $ 24,487
Gross profit margin by source
U.S. 68.3 % 80.6 %
Other 16.8 % 18.9 %
Total gross profit margin 60.0 % 71.6 %

Investor/Media Contact: Nick Laudico or Zack KubowThe Ruth Group (646) 536-7000 alphatec@theruthgroup.com Company Contact: Jeff Black Executive Vice President and Chief Financial Officer Alphatec Holdings, Inc. (760) 431-9286

Source: Alphatec Holdings, Inc.

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