SeaSpine Reports First Quarter 2018 Financial Results

CARLSBAD, Calif., May 03, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the quarter ended March 31, 2018.

Summary First Quarter 2018 Financial Results and Recent Accomplishments

  • Revenue of $33.2 million, an increase of 4.0% year-over-year
  • U.S. revenue of $29.5 million, an increase of 3.2% year-over-year
    • U.S. Orthobiologics revenue of $15.8 million, a 4.9% increase year-over-year
    • U.S. Spinal Implants revenue of $13.7 million, a 1.4% increase year-over-year
  • International revenue of $3.6 million, an increase of 10.8% year-over-year
  • Transitioned OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh to full commercial launch

“We are pleased with our first quarter results, which reflect solid revenue growth in both our Orthobiologics and Spinal Implants portfolios, as well as operational efficiencies,” said Keith Valentine, President and Chief Executive Officer. “As we continue to upgrade our distribution footprint, we are well positioned to leverage our recently launched products and development pipeline across both franchises to deliver clinical value to surgeons, hospitals, and patients.”

First Quarter 2018 Financial Results
Total revenue for the first quarter of 2018 was $33.2 million, a 4.0% increase compared to the same period of the prior year. Total U.S. revenue was $29.5 million, a 3.2% increase compared to the same period of the prior year.

Orthobiologics revenue totaled $18.0 million, a 5.2% increase compared to the first quarter of 2017, and was led by growth in our DBM franchise. Spinal Implants revenue totaled $15.2 million, a 2.6% increase compared to the first quarter of 2017, and was driven by growth in the Shoreline and Mariner systems.

Gross margin for the first quarter of 2018 was 63.3%, compared to 58.7% for the same period in 2017. The increase was primarily driven by lower raw material and manufacturing costs for orthobiologics products manufactured at the Company’s Irvine, California facility.

Operating expenses for the first quarter of 2018 totaled $28.0 million, compared to $27.8 million for the same period of the prior year. The $0.2 million increase in operating expenses was driven by higher selling and marketing expenses, partially offset by lower R&D and general and administrative expenses.

Net loss for the first quarter of 2018 was $7.1 million, compared to a net loss of $9.1 million for the same period of the prior year.

Cash and cash equivalents at March 31, 2018 totaled $12.5 million and the Company had no outstanding borrowings against its $30 million credit facility.  The Company realized $8.5 million in net proceeds in the first quarter of 2018 through the sale of its common stock under its “at the market” equity offering program.

2018 Financial Outlook
SeaSpine reiterates expectations for full-year 2018 revenue to be in the range of $135 to $139 million, reflecting growth of 2.5% to 5.5% over full-year 2017 revenue.

Webcast and Conference Call Information
The Company’s management team will host a conference call beginning today at 1:30pm PT/4:30pm ET to discuss the financial results and recent business developments. Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 8167947.  To listen to the webcast, please visit the Investors section of the SeaSpine website at: www.seaspine.com.

The call will be archived until Thursday May 17, 2018. The audio archive can be accessed by calling (855) 859-2056 in the U.S. or (404) 537-3406 from outside the U.S. The passcode for the audio replay is 8167947.

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the Company’s expectations to leverage recently launched products and development pipeline to deliver clinical value; and the Company’s expectations for full-year 2018 revenue.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; the Company’s ability to attract new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages and the associated, potentially long-term disruption to product sales, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; unexpected expense and delay, including as a result of developing and supporting the launch of new products, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of obtaining regulatory clearances; the Company’s ability to continue to invest in medical education and training, product development, and/or sales and marketing initiatives at levels sufficient to drive future revenue growth, including as a result of its inability to obtain funding on a timely basis on acceptable terms, or at all; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact
Lynn Pieper
(415) 937-5405
ir@seaspine.com

SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)

Three Months Ended March 31,
2018 2017
Total revenue, net $ 33,175 $ 31,894
Cost of goods sold 12,179 13,172
Gross profit 20,996 18,722
Operating expenses:
Selling, general and administrative 24,467 23,970
Research and development 2,789 3,050
Intangible amortization 792 792
Total operating expenses 28,048 27,812
Operating loss (7,052 ) (9,090 )
Other income (expense), net 20 (13 )
Loss before income taxes (7,032 ) (9,103 )
Provision for income taxes 73
Net loss $ (7,105 ) $ (9,103 )
Net loss per share, basic and diluted $ (0.50 ) $ (0.79 )
Weighted average shares used to compute basic and diluted net loss per share 14,085 11,586

SEASPINE HOLDINGS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(In thousands)

March 31,
2018
December 31,
2017
(unaudited)
Cash and cash equivalents $           12,470 $ 10,788
Trade accounts receivable, net of allowances of $492 and $466 20,639 21,872
Inventories 43,285 41,721
Short-term debt
Total current liabilities 21,445 23,157
Long-term borrowings under credit facility
Total stockholders’ equity 107,625 105,653

RTI Surgical Announces First Quarter 2018 Results

May 03, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq:RTIX), a global surgical implant company, reported operating results for the first quarter of 2018.

“2018 is off to a positive start with the acquisition of Zyga at the very beginning of the year and a solid financial performance this quarter,” said Camille Farhat, chief executive officer. “The continued strength of our OEM and International franchises demonstrates the importance of our overall portfolio toward the achievement of our long-term strategic goals. With our senior team in place for the first full quarter, our strategic transformation is accelerating and we continue to deliver on our commitments.”

Farhat added, “Thanks to the hard work of numerous people across the Company, we successfully completed the acquisition of Zyga Technology and are well ahead of plan on the integration. The Zyga team hit the ground running, are a strong cultural fit with RTI and have maintained their focus and positive procedural momentum. In addition to differentiated product technology supported by strong clinical evidence, we gained a tremendous team with many individuals taking broader leadership roles at RTI.”

First Quarter 2018

RTI’s worldwide revenues for the first quarter of 2018 were $69.9 million, comparable with the prior year first quarter. First quarter revenues were driven by growth in the OEM and International lines of business, which were partially offset by declines in Sports and Spine and a $3.2 million reduction from the sale of substantially all the assets of the cardiothoracic closure business completed in August 2017. Gross profit for the first quarter of 2018 was $33.7 million, or 48.2% of revenues, compared to $35.8 million, or 51.2% of revenues, in the first quarter of 2017. Gross profit for the first quarter of 2018 was impacted by an inventory charge of $1.0 million from the write-off of inventory related to our international restructuring and $0.2 million due to the purchase accounting step-up of Zyga inventory.

During the first quarter of 2018, RTI incurred non-recurring pre-tax charges to support the ongoing strategic transformation of the business. The company incurred $0.9 million in severance and restructuring charges primarily in support of initiatives to reduce the complexity of its international organizational structure; $0.1 million related to asset impairment and abandonments of certain long-term assets as part of efforts to reduce complexity and improve operational excellence; and $0.8 million in expenses related to the January 2018 acquisition of Zyga Technology to support the acceleration of growth. During the first quarter of 2017, the company incurred $4.4 million of non-recurring pre-tax charges.

Net loss applicable to common shares was $1.9 million, or $0.03 per fully diluted common share in the first quarter of 2018, compared to a net loss applicable to common shares of $2.8 million, or $0.05 per fully diluted common share in the first quarter of 2017. As outlined in the reconciliation tables that follow, excluding the impact of the various non-recurring charges, adjusted net income applicable to common shares was $0.5 million, or $0.01 per fully diluted common share in the first quarter of 2018.

Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA), for the first quarter of 2018 was $7.8 million, or 11% of revenues compared with $6.5 million, or 9% of revenues for the first quarter of 2017. The increase in Adjusted EBITDA is primarily driven by the reduction in operating expenses associated with efforts to reduce complexity and increase operational excellence implemented during 2017.

Fiscal 2018 Outlook

Based on our recent financial results and current business outlook, the Company is reiterating financial guidance for 2018, originally issued on January 5, 2018:

  • The Company expects full year revenues in the range of $280 million and $290 million.
  • The Company expects full year Adjusted EBITDA to be in the range of $32 million to $38 million.

Farhat explained, “As we continue to reduce the complexity of our operations, we remain committed to evaluating our portfolio and exploring partnership opportunities with organizations that are well positioned to be better stewards of selected assets. Our efforts to drive operational excellence focus on implementing lean manufacturing across facilities, as we continue to strengthen the organization and invest in the company. With our senior team in place and now operating efficiently, I am shifting more of my energy towards accelerating growth, by starting to rebuild the R&D pipeline and actively seeking attractive M&A opportunities at logical valuations.”

The Company noted the following assumptions are included in its guidance:

  • Relatively stable market conditions and regulatory environment;
  • Positive revenue contribution from the acquisition of Zyga Technology – announced January 4, 2018;
  • Ongoing positive impact of efforts to reduce complexity and implement operational excellence; and
  • Continued marketing of map3® cellular allogeneic bone graft and minimal negative revenue impact related to recent FDA warning letter.

Conference Call

RTI will host a conference call and audio webcast at 9:00 a.m. ET today. The conference call can be accessed by dialing (877) 383-7419 (U.S.) or (760) 666-3754 (International). The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on RTI’s website for one month following the call.

 

About RTI Surgical, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic and trauma procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

 

RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
Three months ended
March 31,
2018 2017
Revenues $ 69,890 $ 69,939
Costs of processing and distribution 36,208 34,160
Gross profit 33,682 35,779
Expenses:
Marketing, general and administrative 28,389 29,671
Research and development 3,421 3,688
Severance and restructuring costs 884 4,403
Asset impairment and abandonments 129
Acquisition and integration expenses 800
Total operating expenses 33,623 37,762
Operating income (loss) 59 (1,983 )
Total other expense – net (775 ) (799 )
Loss before income tax (provision) benefit (716 ) (2,782 )
Income tax (provision) benefit (249 ) 910
Net loss (965 ) (1,872 )
Convertible preferred dividend (966 ) (910 )
Net loss applicable to common shares $ (1,931 ) $ (2,782 )
Net loss per common share – basic $ (0.03 ) $ (0.05 )
Net loss per common share – diluted $ (0.03 ) $ (0.05 )
Weighted average shares outstanding – basic 63,150,009 58,495,796
Weighted average shares outstanding – diluted 63,150,009 58,495,796

 

READ THE REST HERE

Anika Reports First Quarter 2018 Financial Results

May 02, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the first quarter ended March 31, 2018, along with business progress in the period.

“In the first quarter, Anika saw strong growth in its most prominent product categories and continued to take the steps necessary to transform the Company into a fully integrated, global commercial organization,” said Joseph Darling, President and Chief Executive Officer of Anika Therapeutics. “Global MONOVISC revenue increased 29% year-over-year, and end-user demand for CINGAL in Europe and Canada remained strong in the first quarter. Together, MONOVISC and CINGAL global revenue grew 38% year-over-year. However, that growth was countered by soft ORTHOVISC revenue, non-recurring charges related to the planned CEO transition, and a voluntary recall of three HYAFF-based products.”

Mr. Darling continued, “We are rapidly advancing the CINGAL Phase III trial, with the completion of the 6-month patient follow-up in April. Our entire leadership team is energized and focused on delivering our new and innovative solutions to the market, accelerating our revenue and earnings growth in the years ahead, and creating sustained value for our shareholders.”

First Quarter Financial Results

  • Total revenue for the first quarter of 2018 was $21.3 million, compared to $23.4 million for the first quarter of 2017. The year-over-year decline was due in part to $1.1 million related to the voluntary, non-safety related recall of HYALOFAST, HYALOGRAFT-C, and HYALOMATRIX.
  • Worldwide Orthobiologics revenue decreased $0.7 million year-over-year in the first quarter of 2018, due primarily to lower ORTHOVISC revenue. Global MONOVISC revenue increased 29% year-over-year in the first quarter of 2018, resulting from our international expansion efforts and the industry shift from multi- to single-injection therapies.
  • International Viscosupplementation revenue increased 17% for the first quarter of 2018, due primarily to the global expansion of MONOVISC, as well as the growth of CINGAL in the international markets. Domestically, ORTHOVISC and MONOVISC achieved the number one position in the combined multi- and single-injection segments in the first quarter of 2018.
  • Total operating expenses for the first quarter of 2018 were $29.1 million, compared to $15.4 million for the first quarter of 2017. The increase in total operating expenses was due primarily to a one-time charge of $8.4 million, which consisted mainly of non-cash stock-based compensation expense associated with the retirement of our former CEO.
  • Net loss for the first quarter of 2018 was $6.7 million, or ($0.46) per diluted share, compared to net income of $5.5 million, or $0.37 per diluted share, for the first quarter of 2017. The decline in net income was due primarily to the increase in operating expenses previously discussed.

Recent Business Highlights

The Company made key commercial, pipeline and operational advancements, including:

  • Appointing Joseph Darling as Chief Executive Officer and as a Director to succeed Dr. Charles Sherwood, who retired as Chief Executive Officer and a Director in March 2018. Mr. Darling joined Anika as President in late July 2017, bringing more than 20 years of extensive experience in executive management and leadership skills from publicly-traded, commercial-stage companies, including Abbott Laboratories, Baxter Healthcare, Smith & Nephew, CONMED, and Wyeth-Ayerst.
  • Advancing its product pipeline with the completion of 6-month patient follow-up in the CINGAL Phase III study for the treatment of osteoarthritis pain in the knee, continued progress in the CINGAL 3-month extension study and 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.
  • Continuing the development of a direct commercial capability in the United States to support the planned U.S. launch of CINGAL in 2019 and other new therapies in the years ahead.

Voluntary Recall of HYALOFAST, HYALOGRAFT-C and HYALOMATRIX

The Company is undertaking a voluntary recall of certain lots of its HYALOFAST, HYALOGRAFT-C, and HYALOMATRIX products. While there is no indication of any safety or efficacy issue related to the affected products at this time, the Company remains committed to the highest standards of quality and is removing the products from the field as a precautionary measure. The recall is being initiated by the Company following internal quality testing which indicated that the products were at risk of not maintaining certain measures throughout their entire shelf life. All impacted distributors have been notified of the recall, and the Company is taking all appropriate actions with respect to applicable regulatory authorities. The Company is in the process of identifying and implementing the appropriate operational resolution of the underlying issue, and it expects to fully resolve the matter and resume production and shipping by the end of 2018. The HYALOFAST product being used to conduct the ongoing Phase III clinical trial was not impacted by the recall.

The voluntary recall negatively impacted the Company’s financial results for the first quarter of 2018 by $1.1 million in product revenue, $0.6 million in inventory reserves, and $0.4 million in administration costs related to the recall. HYALOFAST, HYALOGRAFT-C, and HYALOMATRIX revenue totaled approximately 3% of total revenue for the full year of 2017.

“This voluntary recall is based on the Company’s commitment to the highest standards of quality for which we are known around the globe,” continued Joseph Darling. “While there is no indication of any impact on the safety or efficacy of the product at this time, we cannot accept any deviation from our stringent quality measures. Our quality and engineering staff are working diligently to resolve the issue in order to bring these products back into the hands of surgeons who have used the products to treat patients in need.”

Full Year 2018 Revised Corporate Outlook

Based on Anika’s first quarter 2018 results and currently available information, the Company revised its guidance for the full year of 2018. Anika now expects total revenue growth to be flat for the full year of 2018. Total operating expenses are expected to be in the high $90 million range for the full year of 2018, including the one-time charge associated with the retirement of our former CEO in the first quarter of 2018 and the expenses associated with CINGAL pre-launch activities required to support a successful direct commercialization 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, May 3 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 and regenerative 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 first sentence of the third paragraph, the second and third bullet points under the caption “Recent Business Highlights,” the fifth sentence of the first paragraph under the caption “Voluntary Recall of HYALOFAST, HYALOGRAFT-C, and HYALOMATRIX,” and the disclosure under the caption “Full Year 2018 Revised 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 timing for completion of the Company’s CINGAL clinical trial and the product’s commercial launch, the Company’s expectations with respect to timeline for its HYALOFAST clinical trial, the timing associated with the resolution of the Company’s voluntary product recall, and the Company’s expectations regarding its 2018 financial performance. 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
Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)

For the Three Months Ended March 31,

2018 2017
Product revenue $ 21,258 $ 23,381
Licensing, milestone and contract revenue 6 5
Total revenue 21,264 23,386
Operating expenses:
Cost of product revenue 7,845 6,083
Research and development 5,161 4,230
Selling, general and administrative 16,090 5,067
Total operating expenses 29,096 15,380
Income (loss) from operations (7,832 ) 8,006
Interest and other income, net 95 58
Income (loss) before income taxes (7,737 ) 8,064
Provision for (benefit from) income taxes (1,051 ) 2,571
Net income (loss) $ (6,686 ) $ 5,493
Basic net income (loss) per share:
Net income (loss) $ (0.46 ) $ 0.38
Basic weighted average common shares outstanding 14,679 14,576
Diluted net income (loss) per share:
Net income (loss) $ (0.46 ) $ 0.37
Diluted weighted average common shares outstanding 14,679 15,043

 

READ THE REST HERE

Globus Medical Reports First Quarter 2018 Results

AUDUBON, Pa., May 02, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced its financial results for the first quarter ended March 31, 2018.

  • Worldwide sales were $174.4 million, an increase of 11.9% as reported, or 10.8% in constant currency
  • First quarter net income was $39.5 million, or 22.7% of sales
  • Diluted earnings per share (EPS) were $0.39
  • Non-GAAP diluted EPS were $0.41
  • Non-GAAP adjusted EBITDA was 35.4% of sales

“We had a strong first quarter with worldwide sales up 11.9% over the first quarter of 2017 at $174 million,” said CEO Dave Demski.  “We also realized $0.41 in non-GAAP diluted EPS in the first quarter, an increase of 31%.  We had $12.8 million in revenue from Emerging Technologies, primarily due to robust demand for our ExcelsiusGPS® robotics and navigation system.  On a day-adjusted basis, our U.S. Spine business grew at 4.0% over last year.”

“We are pleased with our first quarter performance – not only the continued excitement among surgeons and hospitals about ExcelsiusGPS®, but also the above market growth we achieved in the U.S. with our core spine business and the solid operational improvements we saw in several important International markets.  I’m very proud of our team’s ability to capitalize on our growth opportunities while maintaining fiscal discipline, as our bottom line grew as fast as our top line, even though we continue to invest heavily in Imaging, Navigation and Robotics as well as Trauma.”

First quarter sales in the U.S. increased by 12.3% compared to the first quarter of 2017.  International sales increased by 10.1% over the first quarter of 2017 on an as-reported basis and 3.5% on a constant currency basis.

First quarter GAAP net income was $39.5 million, an increase of 37.7% over the same period last year.  Diluted EPS for the first quarter was $0.39, as compared to $0.30 for the first quarter 2017.  Non-GAAP diluted EPS for the first quarter was $0.41, compared to $0.32 in the first quarter of 2017.

The company generated net cash provided by operating activities of $52.3 million and non-GAAP free cash flow of $39.9 million in the first quarter.  Cash, cash equivalents and marketable securities ended the quarter at $473.6 million.  The company remains debt free.

2018 Annual Guidance
The company increased guidance for full year 2018 sales to $695 million from $690 million and non-GAAP fully diluted earnings per share to $1.52 from $1.50.

Conference Call Information
Globus Medical will hold a teleconference to discuss its 2018 first quarter results with the investment community at 4:30 p.m. Eastern Time today.  Globus invites all interested parties to join the call by dialing:

1-855-533-7141          United States Participants
1-216-562-0037          International Participants
There is no pass code for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at investors.globusmedical.com.

The call will be archived until Wednesday, May 9, 2018.  The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 1012-6349.

About Globus Medical, Inc.
Based in Audubon, Pennsylvania, Globus Medical, Inc. was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at www.globusmedical.com.

Non-GAAP Financial Measures
To supplement our financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), management uses certain non-GAAP financial measures.  For example, non-GAAP adjusted EBITDA, which represents net income before interest income, net and other non-operating expenses, provision for income taxes, depreciation and amortization, stock-based compensation, provisions for litigation, technology in-licensing fee, and acquisition related costs, is useful as an additional measure of operating performance, and particularly as a measure of comparative operating performance from period to period, as it is reflective of changes in pricing decisions, cost controls and other factors that affect operating performance, and it removes the effect of our capital structure, asset base, income taxes and interest income and expense.  Our management also uses non-GAAP adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections.  Provision for litigation represents costs incurred for litigation settlements or unfavorable verdicts when the loss is known or considered probable and the amount can be reasonably estimated, or in the case of a favorable settlement, when income is realized.  Acquisition related costs/licensing represents the change in fair value of business acquisition related contingent consideration; costs related to integrating recently acquired businesses including but not limited to costs to exit or convert contractual obligations, severance, and information system conversion; and specific costs related to the consummation of the acquisition process such as banker fees, legal fees, and other acquisition related professional fees, as well as one time licensing fees.

In addition, for the period ended March 31, 2018 and for other comparative periods, we are presenting non-GAAP net income and non-GAAP diluted earnings per share, which represents net income and diluted earnings per share excluding the provision for litigation, amortization of intangibles, acquisition related costs/licensing, prior period adjustment and the tax effects of such adjustments.  Prior period adjustments represent the cumulative impact of prior year adjustments related to depreciation, scrap and provision for excess and obsolete inventory, none of which were individually material to the related year’s financial position or results of operations.  We believe these non-GAAP measures are also useful indicators of our operating performance, and particularly as additional measures of comparative operating performance from period to period as they remove the effects of litigation, amortization of intangibles, acquisition related costs/licensing, prior period adjustments and the tax effects of such adjustments, which we believe are not reflective of underlying business trends.  Additionally, for the periods ended March 31, 2018 and for other comparative periods, we also define the non-GAAP measure of free cash flow as the net cash provided by operating activities, adjusted for the impact of restricted cash, less the cash impact of purchases of property and equipment.  We believe that this financial measure provides meaningful information for evaluating our overall financial performance for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions.  Furthermore, the non-GAAP measure of constant currency sales growth is calculated by translating current year sales at the same average exchange rates in effect during the applicable prior year period.  We believe constant currency sales growth provides insight to the comparative increase or decrease in period sales, in dollar and percentage terms, excluding the effects of fluctuations in foreign currency exchange rates.

Non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth are not calculated in conformity with U.S. GAAP.  Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for financial measures prepared in accordance with U.S. GAAP.  These measures do not include certain expenses that may be necessary to evaluate our liquidity or operating results.  Our definitions of non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth may differ from that of other companies and therefore may not be comparable.  Additionally, we have recast prior periods for non-GAAP net income and non-GAAP diluted earnings per share.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms.  These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends.  Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted.  These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks.  For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission.  These documents are available at www.sec.gov.  Moreover, we operate in an evolving environment.  New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.  Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements.  Forward-looking statements contained in this press release speak only as of the date of this press release.  We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
Three Months Ended
(In thousands, except per share amounts) March 31,
2018
March 31,
2017
Sales $ 174,411 $ 155,809
Cost of goods sold 37,970 35,600
Gross profit 136,441 120,209
Operating expenses:
Research and development 12,689 10,666
Selling, general and administrative 75,694 67,059
Amortization of intangibles 2,187 1,782
Acquisition related costs 238 388
Total operating expenses 90,808 79,895
Operating income 45,633 40,314
Other income, net 2,444 2,100
Income before income taxes 48,077 42,414
Income tax provision 8,539 13,700
Net income $ 39,538 $ 28,714
Earnings per share:
Basic $ 0.41 $ 0.30
Diluted $ 0.39 $ 0.30
Weighted average shares outstanding:
Basic 96,840 95,996
Diluted 100,496 97,148

 

READ THE REST HERE

K2M Group Holdings, Inc. Reports First Quarter 2018 Financial Results and Updates Fiscal Year 2018 Outlook

LEESBURG, Va., May 01, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today reported financial results for its first quarter ended March 31, 2018.

First Quarter 2018 Financial Summary:

  • Total first quarter revenue of $67.9 million, up 10% year-over-year on a reported basis and 8% on a constant currency basis.
  • Domestic first quarter revenue of $49.9 million, up 8% year-over-year, comprised of:
    • U.S. Complex Spine growth of 8% year-over-year
    • U.S. Minimally Invasive Surgery (MIS) growth of 6% year-over-year
    • U.S. Degenerative growth of 9% year-over-year
  • International first quarter revenue of $18.0 million, up 15% year-over-year, and 9% on a constant currency basis.
  • Net loss of $11.4 million for the first quarter, compared to a net loss of $10.9 million in the comparable quarter last year.
  • Adjusted EBITDA loss of $3.0 million for the first quarter, compared to Adjusted EBITDA loss of $336,000 in the comparable quarter last year.

First Quarter Product Introductions and Strategic Highlights:

  • On February 26, 2018, the Company announced the licensure of its BACS® Data Management tool to the International Spine Study Group Foundation (ISSGF) for collecting spine patient data, including patient reported outcome measures (PROMs), as part of the ISSGF’s globally recognized research studies.
  • On March 14, 2018, the Company announced the commercial launch of the YUKON  OCT Spinal System at the 34th Annual Meeting of the American Association of Neurological Surgeons/Congress of Neurological Surgeons Section on Disorders of the Spine and Peripheral Nerves (AANS/CNS). At the meeting, the Company also showcased Balance ACS® or (BACS), a comprehensive platform that applies three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes for spine patients.
  • On March 29, 2018, the Company announced the appointment of Lane Major as Chief Operating Officer, a new position within K2M.

Highlights Subsequent to Quarter-End:

  • On April 27, 2018, the Company executed an exclusive agency and services agreement to replace its existing exclusive distribution agreement with its partner in Spain and Portugal, Medcomtech, S.A., whereby Medcomtech and K2M extended their partnership through 2024.  Pursuant to the agreement, K2M acquired Medcomtech’s spine customer contracts and relationships and its existing K2M product inventory and instrumentation in exchange for certain outstanding receivables from Medcomtech.

    In addition, Medcomtech will transition from a stocking-based distributor to a commission-based independent sales agency, and K2M will become responsible for and assume risk of billing, collections and inventory management for Medcomtech’s business related to K2M products while Medcomtech will remain focused on sales, marketing and market development activities for these products.  Beginning in May, revenue generated by K2M in Spain and Portugal will reflect its supplier relationships at the hospital level as opposed to its prior wholesale relationship with Medcomtech.  We believe this revised relationship with Medcomtech represents an opportunity to improve the growth and gross margin profile for Spain and Portugal going forward.

“Our first quarter total revenue growth of approximately 10% year-over-year reflect solid trends in the U.S. and stronger-than-expected demand in international markets,” said Chairman, President, and Chief Executive Officer, Eric Major. “We delivered approximately 8% growth in the United States in Q1—at the high-end of our growth expectations—driven by solid execution against our strategic goal of increasing market share by introducing new and innovative spinal implant solutions like our first-of-its-kind MOJAVE PL 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology and our YUKON OCT Spinal System that can be used with the PALO ALTO Cervical Static Corpectomy Cage System, the first and only static corpectomy cage in the world to receive a cervical 510(k) clearance.”

Mr. Major continued, “We have increased our fiscal year 2018 revenue guidance expectations to a new range of $283 million to $287 million based on our improved revenue outlook for Spain.  We remain confident in our ability to drive above-market growth in the U.S., fueled by our continued focus on leading the spine market by introducing new and innovative spinal implant solutions to help surgeons care for patients around the world who suffer from debilitating spinal pathologies.”

 

READ THE REST HERE

NuVasive Announces First Quarter 2018 Financial Results

SAN DIEGOMay 1, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced financial results for the quarter ended March 31, 2018.

First Quarter 2018 Highlights

  • Revenue increased 4.6% to $260.5 million, or 3.4% on a constant currency basis;
  • GAAP operating profit margin of (7.0%); Non-GAAP operating profit margin of 12.3%; and
  • GAAP diluted loss per share of ($0.53); Non-GAAP diluted earnings per share increase of 5.4% to $0.39.

“In the first quarter 2018, NuVasive’s International business continued its momentum of 20% growth year over year on a constant currency basis, with our core U.S. hardware business showing solid case volume growth,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “As we look forward to the remainder of the year, we expect our continued innovation—including the expansion of our lateral procedural solutions with the integration of Lateral Single-Position Surgery, further build out of our Advanced Materials Science portfolio and the initial launch of our Surgical Intelligence platform—to drive further differentiation of NuVasive technologies with surgeon partners. We also anticipate our Ohio manufacturing facility production ramping up in the second half of the year and we begin to realize the 400 basis point improvement in gross margins through this in-sourcing manufacturing effort.”

A full reconciliation of non-GAAP to GAAP measures can be found in the tables of this news release.

First Quarter 2018 Results
NuVasive reported first quarter 2018 total revenue of $260.5 million, a 4.6% increase compared to $249.0 million for the first quarter 2017. On a constant currency basis, first quarter 2018 total revenue increased 3.4% compared to the same period last year.

For the first quarter 2018, GAAP and non-GAAP gross profit was $186.7 million and $187.1 million, respectively, and GAAP and non-GAAP gross margin was 71.7% and 71.8%, respectively. These results compared to both GAAP and non-GAAP gross profit of $187.6 million, and both GAAP and non-GAAP gross margin of 75.3% for the first quarter 2017.

The Company reported a GAAP net loss of ($27.1) million, or ($0.53) per share, for the first quarter 2018 compared to a GAAP net income of $12.4 million, or $0.22 per share, for the first quarter 2017. On a non-GAAP basis, the Company reported net income of $20.2 million, or $0.39 per share, for the first quarter 2018 compared to net income of $19.7 million, or $0.37 per share, for the first quarter 2017. The GAAP net loss for the quarter was driven primarily by an increase in litigation liability of $29.0 million related to the Company’s previously disclosed lawsuit with a former sales agent, which has been ongoing since 2013.

During the quarter ended March 31, 2018, the Company obtained a favorable tax ruling with respect to its operations in Tennessee. The Company modified its local operations to obtain the ruling, which provides for tax exemptions for property, sales and use taxes specific to the state. With the Company’s primary distribution facility based in Memphis, the Company expects this tax ruling to yield in excess of $100 million in tax savings over the next 15 years. The Company engaged a specialized tax consultant to assist with these efforts and the Company recorded a non-recurring, success-based fee of $6.1 million in its first quarter 2018 financials.

Annual Financial Guidance for 2018
The Company reiterated its full-year 2018 guidance, and assumes a full-year benefit of U.S. tax reform, suspension of the medical device tax and the recent acquisition of SafePassage.

2018 Guidance Range 1

Prior

Current

(in Million’s; except %’s and EPS)

 GAAP 

 Non-GAAP 

 GAAP 

 Non-GAAP 

Revenue

$    1,095

$    1,105

$    1,095

$    1,105

$    1,095

$    1,105

$    1,095

$    1,105

  % Growth – Reported 2

6.4%

7.3%

6.4%

7.3%

6.7%

7.6%

6.7%

7.6%

% Growth – Constant Currency 2, 3

5.9%

6.9%

5.7%

6.6%

Operating margin

13.0%

13.0%

17.6%

17.6%

9.6%

9.7%

17.6%

17.6%

Earnings per share

$      1.56

$      1.59

$      2.44

$      2.47

$      0.71

$      0.74

$      2.44

$2.47

EBITDA

23.4%

23.4%

26.9%

26.9%

19.5%

19.5%

26.9%

26.9%

Tax Rate

~19%

~19%

~24%

~24%

~31%

~31%

~23%

~23%

 1

Prior guidance reflects the range provided February 26, 2018. Current guidance reflects the range provided May 1, 2018.

2

2017 has been recasted and presented based on our full retrospective method of adoption of ASC 606.

3

Constant currency is a measure that adjusts US GAAP revenue for the impact of currency over the same period in the prior year.

 

  • Full-year 2018 revenue in the range of $1,095 million to $1,105 million reflecting organic growth in the range of 4.7% to 5.7% and reported growth of 6.7% to 7.6%, inclusive of the recent acquisition of SafePassage;
  • Non-GAAP diluted earnings per share in a range of $2.44 to $2.47;
  • Non-GAAP operating profit margin of approximately 17.6%;
  • Adjusted EBITDA margin of approximately 26.9%;
  • Non-GAAP effective tax expense rate of approximately 23%, compared with the prior expectation of approximately 24%;
  • The Company now expects currency to have a positive impact in 2018 of approximately $10 million, compared with the prior expectation of approximately $5 million; and
  • The Company continues to expect to drive at least 100 basis points in non-GAAP operating margin expansion and adjusted EBITDA of approximately $295 million to $305 million.

 

READ THE REST HERE

 

Orthofix Reports First Quarter 2018 Financial Results

April 30, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX) today reported its financial results for the first quarter ended March 31, 2018. Net sales were $108.7 million, diluted earnings per share from continuing operations was $0.27 and adjusted earnings per share from continuing operations was $0.39. The Company also closed the acquisition of Spinal Kinetics Inc., a privately held developer and manufacturer of artificial cervical and lumbar discs.

“Overall, we had another solid quarter in both top and bottom line performance, including a 290 basis point improvement in adjusted EBITDA margin and a 44% increase in adjusted earnings per share compared to the first quarter of 2017,” said Orthofix President and Chief Executive Officer, Brad Mason. “Since announcing our agreement to acquire Spinal Kinetics, we have received very positive feedback from physicians and our sales force about the M6® artificial discs and the strategic value this brings to Orthofix, which further validates our enthusiasm for this transaction. This deal delivers upon our stated strategy of accelerating top-line growth through the acquisition of products, technologies and companies in our core businesses. The Spinal Kinetics M6 artificial discs enters Orthofix into a fast-growing market with a proven technology and further demonstrates our commitment to providing innovative spine treatment solutions to surgeons and patients.”

Financial Results Overview

The following table provides net sales by strategic business unit (“SBU”):

Three Months Ended March 31,
(Unaudited, U.S. Dollars, in thousands) 2018 2017 Change Constant

Currency

Change

BioStim $ 46,163 $ 44,539 3.6 % 3.6 %
Extremity Fixation 27,504 23,945 14.9 % 4.3 %
Spine Fixation 20,707 19,267 7.5 % 7.2 %
Biologics 14,335 14,987 (4.4 %) (4.4 %)
Net sales $ 108,709 $ 102,738 5.8 % 3.3 %

Gross profit increased $4.4 million to $84.6 million. Gross margin decreased slightly to 77.8% compared to 78.0% in the prior year period due primarily to an unfavorable impact from sales mix this quarter. Non-GAAP net margin, an internal metric that the Company defines as gross profit less sales and marketing expenses, was $34.3 million compared to $31.6 million in the prior year period. The increase in non-GAAP net margin was primarily due to lower marketing expenses and decreased commission rates.

Net income from continuing operations was $5.2 million, or $0.27 per share, compared to a loss of $2.3 million, or ($0.13) per share in the prior year period. Adjusted net income from continuing operations was $7.3 million, or $0.39 per share, compared to adjusted net income of $4.9 million, or $0.27 per share in the prior year period.

EBITDA was $15.2 million, compared to $6.6 million in the prior year period. Adjusted EBITDA was $19.7 million, or 18.1% of net sales, for the first quarter, compared to $15.7 million, or 15.3% of net sales, in the prior year period.

Liquidity

As of March 31, 2018, cash and cash equivalents were $77.1 million compared to $81.2 million as of December 31, 2017. As of March 31, 2018, the Company had no outstanding indebtedness and borrowing capacity of $125 million under its existing credit facility. Cash flow from operations was ($3.6) million, an increase of $7.3 million, and free cash flow was ($7.0) million, an increase of $7.8 million when compared to the prior year period.

2018 Outlook

For the year ending December 31, 2018, the Company expects the following results, assuming exchange rates are the same as those currently prevailing.

(Unaudited, U.S. Dollars, in millions, except per share data) Low High
Full Year 2018 Outlook
Net sales $ 458.0 1 $ 464.0 1
Net income from continuing operations $ 24.8 2 $ 27.1 2
Adjusted EBITDA $ 85.5 3 $ 88.0 3
EPS from continuing operations $ 1.31 4 $ 1.43 4
Adjusted EPS from continuing operations $ 1.58 5 $ 1.68 5
2nd Quarter of 2018 Outlook
Net sales $ 113.0 6 $ 115.0 6
EPS from continuing operations $ 0.28 7 $ 0.30 7
Adjusted EPS from continuing operations $ 0.35 8 $ 0.37 8
1 Represents a year-over-year increase of 5.6% to 7.0% on a reported basis
2 Represents a year-over-year increase of 240.1% to 271.7%
3 Represents a year-over-year increase of 4.8% to 7.9%
4 Represents a year-over-year increase of 235.9% to 266.7%
5 Represents a year-over-year decrease of 2.5% to a year-over-year increase of 3.7%
6 Represents a year-over-year increase of 3.7% to 5.6% on a reported basis
7 Represents a year-over-year increase of 7.7% to 15.4%
8 Represents a year-over-year decrease of 11.9% to 16.7%

Acquisition of Spinal Kinetics

On April 30, 2018, the Company completed the acquisition of Spinal Kinetics, Inc., a privately held developer and manufacturer of artificial cervical and lumbar discs. Terms of the transaction included $45 million in cash plus up to an additional $60 million in future contingent milestone payments related to U.S. Food and Drug Administration approval of the M6-C® cervical disc and the achievement of certain future sales targets. These contingent milestones payments must be achieved within five years of closing.

Inducement Grants Related to Acquisition of Spinal Kinetics

As inducements to enter into employment with Orthofix, Mr. Afzal was granted 8,194 restricted shares of Orthofix common stock and options to purchase 28,624 shares of Orthofix common stock, and 67 additional employees joining from Spinal Kinetics were granted an aggregate of 14,887 restricted shares of Orthofix common stock. All awards vest in one-fourth annual increments beginning on the first anniversary of grant. The grants, which were approved by the Compensation Committee of Orthofix’s Board of Directors, were made under a standalone inducement plan approved pursuant to NASDAQ Marketplace Rule 5635(c)(4), but on terms substantially the same as grants made in the ordinary course under the Company’s 2012 Long Term Incentive Plan.

Domestication to Delaware

As previously announced in February, the Company has been considering a redomicile from Curacao to Delaware. As a result of further analysis during the quarter, the Company has determined to pursue such a redomicile. The redomicile will be subject to approval by shareholders. If approved, the Company expects that the redomicile would be completed by the end of the year.

Conference Call

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company’s financial results for the first quarter of 2018 and the acquisition of Spinal Kinetics. Interested parties may access the conference call by dialing (844) 809-1992 in the U.S. and (612) 979-9886 outside the U.S., and referencing the conference ID 5288605. A replay of the call will be available for two weeks by dialing (855) 859-2056 in the U.S. and (404) 537-3406 outside the U.S., and entering the conference ID 5288605. A webcast of the conference call may be accessed by going to the Company’s website at www.orthofix.com, by clicking on the Investors link and then the Events and Presentations page.

 

READ THE REST HERE

 

Kuros Biosciences Reports Full-Year 2017 Results

Financial highlights

  • CHF 17.0 million cash at year-end
  • CHF 16.9 million equity raise in June 2017
  • Standby equity facility established in November 2017 to increase financial flexibility

Operational highlights

  • Successful completion of merger with Xpand Biotechnology creating a leader in orthobiologics
  • FDA approvals for MagnetOs Granules & Putty
  • Prepared for U.S. launch of MagnetOs by end of June 2018
  • Clinical development of Fibrin-PTH for spinal fusion on track

SCHLIEREN (Zurich), Switzerland, April 30, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX:KURN) reported today its Full-Year 2017 Results, and the publication of its annual report.

2017 has been a transformative year for Kuros Biosciences, which successfully transitioned into a full-fledged orthobiologics company with scientific, clinical, and commercial excellence in bone regeneration. MagnetOs Granules and MagnetOs Putty have been cleared by the U.S. Food and Drug Administration, and the Company is gearing up for their U.S. commercial launch in 2018.

As a technology leader in synthetic and drug-based bone regeneration, Kuros is well-positioned to capture the commercial opportunity in the orthobiologics market, which is estimated to grow to more than $3 billion by 2030. Kuros intends to initially focus on spinal fusion, which represents 50% of the total orthobiologics market.

Joost de Bruijn, Chief Executive Officer, said: “During 2017 we successfully set Kuros on a new course – one that is focused on cutting-edge orthobiologics, an important commercial opportunity. Our international team has responded with verve to our ongoing commercial transition, embracing their new challenges. As a result, we are well-positioned to execute on the commercial roll-out plan for MagnetOs in the U.S. and drive forward our exciting clinical program with Fibrin-PTH in spinal fusion, which represents a huge opportunity.”

Financial position
Cash and cash equivalents (including financial assets and trade and other receivables) as per December 31, 2017, amounted to CHF 17.0 million, compared with CHF 13.0 million as per December 31, 2016. The increase is mainly due to capital increases which off-set net operating cash. In 2017, Kuros received a milestone payment of TCHF 534 (TCHF 997 in 2016) from a collaboration partner. Operating costs for 2017 amounted to CHF 16.8 million, compared with CHF 22.4 million in the previous year. Research and development expenses decreased from CHF 7.9 million in 2016 to CHF 4.5 million in 2017. General and administrative expenses decreased from CHF 17.1 million in 2016 to CHF 15.2 million in 2017.

During 2017, Kuros raised CHF 16.9 million in equity, and put a CHF 30 million equity financing facility in place to provide the Company with more financial flexibility.

Key figures   2017 2016
In TCHF, IFRS      
Revenue   534 1,061
Research and development   (4,470) (7,909)
General and administration   (15,242) (17,070)
Other income   2,935 2,572
Net operating costs   (16,777) (22,407)
Operating income/(loss)   (16,243) (21,346)
Net financial income/(loss)   (350) 1,069
Net income/(loss)   (16,484) (19,744)
Net income/(loss) per share (in CHF)   (2.32) (3.95)
Cash and cash equivalents, financial assets
and trade and other receivables
  17,024 13,034

Outlook
In 2018, the Company aims to capitalize on the restructuring as it executes on its renewed focus on orthobiologics. This includes setting-up a U.S. commercial infrastructure to support the U.S. launch of MagnetOs, as well as the preparation of a Phase 2 clinical study for our drug-based Fibrin-PTH product candidate KUR-113 for spinal indications.

Annual report
The annual report of Kuros Biosciences is available online at
www.kuros.ch/investors/reports-presentations.html.

For further information, please contact:

Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47
michael.grau@kurosbio.com
Media & Investors
Hans Herklots
LifeSci Advisors
+41 79 598 7149
hherklots@lifesciadvisors.com

About Kuros Biosciences AG
Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

Forward-Looking Statements
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors. Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

Zimmer Biomet Announces First Quarter 2018 Financial Results

WARSAW, Ind.April 26, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today reported financial results for the quarter ended March 31, 2018.  The Company reported first quarter net sales of $2.018 billion, an increase of 2.3% over the prior year period, and a decrease of 1.5% on a constant currency basis.  Diluted earnings per share for the first quarter were $0.85, a decrease of 42.2% from the prior year period.  First quarter adjusted diluted earnings per share were $1.91, a decrease of 10.3% from the prior year period.

“As expected, in the first quarter our performance continued to reflect supply headwinds associated with key brands within our Knee, Hip and S.E.T. portfolios, as well as the ongoing quality remediation work at our Warsaw North Campus facility,” said Bryan Hanson, President and CEO of Zimmer Biomet.  “As we look out over the course of the next 18 to 24 months, we will stay laser-focused on taking the necessary actions to narrow our gap to market and drive sustained shareholder value.  These actions include successfully driving our ongoing quality remediation program, restoring supply, and scaling up the commercial launch of compelling new technologies, all of which remain on track.”

Net earnings for the first quarter were $174.7 million, and $390.9 million on an adjusted basis.  Operating cash flow for the first quarter was $490.5 million.  Free cash flow in the quarter was $403.4 million.

In the quarter, the Company paid $48.6 million in dividends and declared a first quarter dividend of $0.24 per share.

Guidance

The Company provided the following full-year 2018 financial guidance:

Projected Year Ending December 31, 2018

2018 Sales Growth vs Prior Year(1)

1.5% – 3.5%

Adjusted Operating Profit Margin(2)

27.5% – 28.5%

Adjusted Tax Rate(2)

18.5% – 19.5%

Adjusted Diluted EPS(2)

$7.60 – $7.80

Free Cash Flow(3)

$1.1 billion – $1.3 billion

(1)

2018 sales growth vs prior year is provided on an as reported basis and includes 200 to 300 basis points of positive foreign exchange impact

(2)

These measures are non-GAAP financial measures for which a reconciliation to the most directly comparable GAAP financial measure is not available without unreasonable efforts.  See “Forward-Looking Non-GAAP Financial Measures.”

(3)

Projected Year Ending December 31, 2018

(in millions)

Low

High

Net Cash Provided by Operating Activities

$1,585

$1,755

Additions to Instruments and Other Property, Plant and Equipment

(485)

(455)

Free Cash Flow

$1,100

$1,300

Conference Call

The Company will conduct its first quarter 2018 investor conference call today, April 26, 2018, at 8:30 a.m. Eastern Time. The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com.  It will be archived for replay following the conference call.

Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985. For a complete listing of international toll-free and local numbers, please visit http://investor.zimmerbiomet.com.  A digital recording will be available 24 hours after the completion of the conference call, from April 27, 2018 to May 26, 2018. To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820 and enter the Access Code ID 7278985.

Sales Table

The following first quarter sales table provides results by geography and product category, as well as the percentage change compared to the prior year quarter on a reported basis and a constant currency basis.

NET SALES – THREE MONTHS ENDED MARCH 31, 2018

(in millions, unaudited)

Constant

Net

Currency

Sales

% Change

% Change

Geographic Results

Americas

$

1,208

(1.8)

%

(2.0)

%

EMEA

497

9.6

(3.0)

Asia Pacific

313

8.2

2.6

Total

$

2,018

2.3

%

(1.5)

%

Product Categories

Knees

Americas

$

417

(2.5)

%

(2.7)

%

EMEA

189

12.4

(0.1)

Asia Pacific

107

2.3

(3.0)

Total

713

1.8

(2.1)

Hips

Americas

248

1.3

1.0

EMEA

142

4.5

(7.6)

Asia Pacific

102

9.5

3.6

Total

492

3.8

(0.9)

S.E.T *

443

4.4

1.1

Dental

108

(0.2)

(4.8)

Spine & CMF

183

(1.7)

(3.8)

Other

79

(1.1)

(4.0)

Total

$

2,018

2.3

%

(1.5)

%

* Surgical, Sports Medicine, Foot and Ankle, Extremities and Trauma

About the Company

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Website Information

We routinely post important information for investors on our website, www.zimmerbiomet.com, in the “Investor Relations” section.  We use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD.  Accordingly, investors should monitor the Investor Relations section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts.  The information contained on, or that may be accessed through, our website is not incorporated by reference into, and is not a part of, this document.

 

READ THE REST HERE

 

SPINEWAY : 2017 annual results and first quarter 2018 activity

2017 annual results

  • Strong revenue growth
  • Improved results

Mixed activity for the 1st quarter of 2018: €1.8M

  In thousands of euros
  Consolidated accounts
2017* 2016
Revenue 9 138 4 643
Gross margin
% Revenue
6 151
67%
3 074
66%
Gross operating surplus 150 – 1 227
Operating income – 845 – 2 257
Current income before taxes – 1 013 – 2 432
Net income – 965 – 2 690

* Audited accounts

Spineway’s Board of Directors, chaired by Stéphane Le Roux, met on 24 April 2018 and closed the 2017 annual accounts. The Group’s Statutory Auditors performed their auditing duties on these accounts and their reports are being prepared.

Improved results

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), confirms the strong growth of its consolidated revenue for the 2017 financial year, at €9.1M (+97%). This increase in activity logically resulted in the all-around improvement of the Group’s results.
Spineway’s consolidated accounts, which include those of the US subsidiary, showed a gross margin of 67.3% compared with 66.2% the previous year. Thanks to dynamic sales, the gross operating surplus was once more in the black at €150k, compared with a loss of -€1 227k at the end of 2016.

Operating income was of – €845k, showing an improvement of €1.4M compared with 31 December 2016. As announced, during the second half of the year the Group required heavier costs in order to strengthen teams in both France and the United States to accompany this strong growth. The operating income takes into account the increases in purchases and changes in inventory (+€1 419k), other purchases and external expenses (+€501k) and personnel expenses (+€1 190k).

The net income reaped the benefits of a positive extraordinary income of €47k (-€258k in 2016) and amounted to -€965k compared with a loss of €2 690k the previous year.

The WCR expressed as days of revenue also improved greatly, at 143 days compared with 221 days as at the end of 2016. This improvement is due, in particular, to a decrease in inventory and trade receivables while revenue increased sharply.

The Group’s financial structure was strengthened during the second half of 2017 thanks to the reserved issue of ORNANE (tranche warrants for notes) with warrants representing €1M and the exercise of €1.6M in warrants by the Chinese company Tinavi Medical Technologies.

These events brought the shareholders’ equity to €1 773k at the end of December 2017 compared with €1 300k at the end of December 2016. Available cash at the end of December amounted to €2.4M, allowing for a gearing (net debt/equity) of 174% compared with 207% the previous year.

A mixed start to 2018

As per its strategy, the Group will be reinforcing its R&D investments in order to offer surgeons implants and instruments that meet their needs. For the first quarter of 2018, the Group posted revenue of €1.8M, down 41% from Q1 2017, with, in particular, an unfavorable comparison base in the US (a $2M order initially scheduled for 2016 was delayed until Q1 2017).

Without this basis, the Group showed a 17% increase in its consolidated activity.

The US activity represented €105k for the period, with poor visibility following the replacement of its main US distributor’s CEO.

In the rest of the world (outside the US), Spineway continued its commercial growth, particularly in Latin America where, at the end of March, it posted €914k in activity, up 14%. This growth is driven by the success of the Mont-Blanc product lines. The Middle-East sector remains on the right track, with revenue of €234k, up 80%, and Europe generated €303k compared with €340k in Q1 2017, with the drop due mainly to Spain, where Spineway recently closed its subsidiary.

Asia continues its climb with a 63% growth in activity, representing revenue of €277k. While awaiting approval Spineway’s products in China, which is expected by the end of 2018, the Group is working on developing implants and instruments for the surgical robot developed by its Chinese partner, Tinavi.

Current sales in the United States, which could affect the 2018 roadmap and goals, are pushing Spineway to study possible changes to its strategic plan in order to accelerate profitable development.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME
Find out all about Spineway at www.spineway.com

This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its revenue comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), has received the OSEO Excellence award since 2011 and has won the Deloitte Fast 50 award (2011). Rhône Alpes INPI Patent Innovation Award (2013) -INPI Talent award (2015). 
ISIN code: FR0011398874 – ALSPW              

Contacts:

Investor relations
David Siegrist – Finance Director
+33 (0)4 72 77 01 52
finance.dsg@spineway.com
  Financial communication
Jérôme Gacoin / Solène Kennis
+33 (0)1 75 77 54 68
skennis@aelium.fr

Attachment