CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the year ended December 31, 2016.
Mark Perrin, InVivo’s CEO and Chairman, said, “2016 was a year marked by meaningful and significant progress. In 2016, we:
received approval for converting the Neuro-Spinal Scaffold™ pilot study to the pivotal INSPIRE study;
received approval to initiate the INSPIRE study in Canada (1st global step for InVivo);
added 13 new clinical sites, including our first ex-U.S. sites (both in Canada);
enrolled seven new patients, with three of those patients achieving the primary endpoint of conversion to partial paralysis by six months post-injury1;
continued our spinal cord injury (SCI) thought leadership by attending and presenting at international conferences, where we presented 13 scientific abstracts to renowned leaders within the neurosurgical, neuroscience, and SCI communities;
raised $32 million (gross), which is the company’s largest fund raising to date;
successfully developed a preclinical prototype of the TrailMaker™ for the chronic spinal cord injury market and filed two patent applications;
garnered unique media coverage about InVivo and the Neuro-Spinal Scaffold in 18 widely-read outlets resulting in nearly 30 million media impressions;
and continued to make great strides in strengthening our research and intellectual property portfolio.
We ended the year with approximately $33 million in cash, cash equivalents, and marketable securities that we project will fund us into the second quarter of 2018, by which time we expect to be able to submit the HDE application for marketing approval of the Neuro-Spinal Scaffold. Over the coming quarters, we will continue to make progress toward this goal by enrolling more patients, increasing sites, expanding into the U.K., and completing enrollment of the INSPIRE study, which we are now projecting will occur in the third quarter of 2017.
In addition to the progress with INSPIRE, we also plan to initiate our first study in cervical SCI in Canada in the coming months. Cervical SCI represents a higher risk, higher reward indication in which the effects of neural preservation, regeneration or remyelination may be more dramatically demonstrated. I am excited at the prospect of building upon last year’s advances and continuing our journey to redefine the lives of patients with spinal cord injuries.”
Financial Results
For the year ended December 31, 2016, the Company reported a net loss of approximately $23,438,000, or $0.76 per share, compared to a net loss of approximately $33,314,000, or $1.26 per share, for the year ended December 31, 2015. Included in results for the years ended December 31, 2016 and 2015 were non-cash gain of $593,000 and a non-cash loss of $10,804,000, respectively, reflecting changes in the fair market value of the derivative warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the year ended December 31, 2016, was $24,031,000, or $0.78 per share, compared to an adjusted net loss of $22,510,000, or $0.85 per share, for the year ended December 31, 2015. The Company ended the year with $33,041,000 of cash, cash equivalents, and marketable securities as of December 31, 2016.
Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude the impact of the items noted. A reconciliation of these measures to the comparable GAAP measures is included with the tables contained in this release. The Company believes a presentation of these non-GAAP measures provides useful information to investors, enabling them to better understand the Company’s operations, on a period-to-period comparable basis, with financial amounts both including and excluding these identified items.
About the Neuro-Spinal Scaffold™ Implant
Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with thoracic complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffoldreceived the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws.These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,”“will,” “may,” “should,” “expect” and similar expressions, and include statements regarding expected enrollment in its pivotal INSPIRE study in 2017, expansion of clinical sites into the UK and Canada, initiation of a cervical spinal cord injury study, and the benefits of the Neuro-Spinal Scaffold.. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the Company’s ability to obtain FDA approval to commercialize its products; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, and its other filings with the SEC, including the Company’s Form 10-Qs and current reports on Form 8-K. The Company does not undertake to update these forward-looking statements.
InVivo Therapeutics Holdings Corp.
Consolidated Balance Sheets
(In thousands, except share and per-share data)
December 31,
2016
2015
ASSETS:
Current assets:
Cash and cash equivalents
$21,464
$14,920
Restricted cash
361
361
Marketable securities
11,577
5,274
Prepaid expenses and other current assets
451
184
Total current assets
33,853
20,739
Property, equipment and leasehold improvements, net
510
938
Other assets
421
115
Total assets
$34,784
$21,792
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Accounts payable
$1,011
$521
Loan payable, current portion
423
395
Derivative warrant liability
1,314
1,907
Deferred rent, current portion
141
115
Accrued expenses
1,959
374
Total current liabilities
4,848
3,312
Loan payable, net of current portion
852
1,275
Deferred rent, net current portion
135
276
Total liabilities
5,835
4,863
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.00001 par value, authorized—100,000,000 shares, issued and outstanding 32,044,087 shares at December 31, 2016; and authorized 50,000,000 shares, issued and outstanding 27,555,948 shares at December 31, 2015
1
1
Additional paid-in capital
185,955
150,497
Accumulated deficit
(157,007)
(133,569)
Total stockholders’ equity
28,949
16,929
Total liabilities and stockholders’ equity
$34,784
$21,792
InVivo Therapeutics Holdings Corp.
Consolidated Statements of Operations
(In thousands, except share and per-share data)
Years Ended December 31,
2016
2015
2014
Operating expenses:
Research and development
$12,557
$10,058
$10,273
General and administrative
11,506
12,340
7,566
Total operating expenses
24,063
22,398
17,839
Operating loss
(24,063)
(22,398)
(17,839)
Other income (expense):
Interest income
187
60
5
Interest expense
(155)
(172)
(136)
Derivatives gain (loss)
593
(10,804)
(376)
Other income (expense), net
625
(10,916)
(507)
Net loss
$(23,438)
$(33,314)
$(18,346)
Net loss per share, basic and diluted
$(0.76)
$(1.26)
$(0.83)
Weighted average number of common shares outstanding, basic and diluted
31,025,585
26,461,374
22,080,761
Reconciliation of GAAP to non-GAAP measures
InVivo Therapeutics Holdings Corp.
(In thousands, except share and per share data)
Three Months Ended
Year Ended
December 31,
December 31,
2016
2015
2016
2015
Reported GAAP net income (loss)
(5,435
)
(4,733
)
(23,438
)
(33,314
)
Derivative (gain)/loss
(1,381
)
(544
)
(593
)
10,804
Adjusted net loss
(6,816
)
(5,277
)
(24,031
)
(22,510
)
Reported GAAP net loss per diluted share
(0.17
)
(0.17
)
(0.76
)
(1.26
)
Derivative (gain)/loss per diluted share
(0.04
)
(0.02
)
(0.02
)
0.41
Adjusted net loss per diluted share
(0.21
)
(0.19
)
(0.78
)
(0.85
)
1 two patients passed away and one unconverted patient has less than six months of follow-up.
Acumed LLC, a member of the Colson Associates, Inc. group of companies and a global leader of innovative orthopaedic medical solutions, today announced the appointment of Sharon Wolfington as president and chief executive officer, effective immediately. Ms. Wolfington succeeds Robert Johnson, who had served as Acumed’s president since 2013.
“We are extremely pleased that Sharon Wolfington is joining Acumed as president and chief executive officer,” said Louhon Tucker, president and chief executive officer of Colson Associates, Inc. “Acumed is an outstanding and highly respected company in the orthopaedic implant market. Sharon’s deep orthopaedic industry experience and her broad market knowledge—combined with her successful leadership roles, her focused approach to market-based product innovation, quality and customer service, her record of building successful and effective sales and distribution networks, and her demonstrated belief in and adherence to ethics, accountability, and employee support and mentoring—makes her the ideal individual to lead Acumed forward. I am confident that Sharon will achieve the company’s objectives of sustainable above-market profitable growth and increasing the pace of providing innovative new products for Acumed’s existing and new customers within the orthopaedic market. As always, it is our intent to ease the burden on orthopaedic and trauma surgeons and further improve the standard of patient care.”
Wolfington joins Acumed after most recently serving as president of DJO Recovery Sciences, a Blackstone company. Previously, Wolfington held a number of significant leadership positions with Stryker Corporation, including president of Stryker Performance Solutions and vice president and general manager of Stryker Global Trauma and Extremities. Wolfington is a graduate of the Advanced Management Program of the Harvard School of Business with an undergraduate degree from Miami University in Oxford, Ohio. She is an honorary founding member of the Foundation of Orthopaedic Trauma.
“I am honored to join the Acumed organization and continue the legacy of high ethics and integrity, quality manufacturing, and new product innovation with the goal of delivering an outstanding customer experience. Acumed is 100% dedicated to serving the foot and ankle, trauma, sports medicine, and hand and upper extremity health care professionals. Acumed has the ability to achieve market-leading growth as an agile, fast moving innovator with highly engaged employees and a best-in-class distributor network,” said Wolfington.
About Acumed
Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With over two decades of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. Acumed was founded in 1988 by Randy and Mary Huebner and became a member of the Colson Associates group of companies in 1999. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported by offices worldwide.
3-10-2017 – Health & Medicine, Press release from: TMR
Lateral lumbar interbody fusion (LLIF) is a minimally invasive technique and is in demand for surgical spinal fusion procedure. LLIF is an effective and safe surgical procedure that makes post-operative recovery quicker and less painful. The incision is made from the side through psoas muscle that allows surgeons to access more surface area with less damage to the tissue and reduced blood loss.
Lateral lumbar interbody fusion is a surgical procedure used to treat specific types of disorders of lumbar spine, such as degenerative disc disease, low grade spondylolisthesis, degenerative scoliosis (asymmetric disc degeneration) and deformity, and some recurrent lumbar herniated disc and lumbar stenosis. Developments in magnification and illumination associated with surgical instrumentation have led to increased applicability of minimally invasive technique for spinal fusion. High device cost and various procedure levels are likely to boost the growth of the market.
The minimally invasive lateral lumbar interbody fusion has certain advantages such as enhanced spine alignment and easier spine access in several cases such as degenerative diseases and correction in sagittal and coronal deformities. Large number of surgeons prefer this procedure, as it results in less blood loss and lower damage to the tissues around the surgical area. Reduced time for operation and length of hospital stay, greater fusion, and lesser infection rates are the other advantages of this procedure.
Increased incidence of degenerative diseases and rising prevalence of lower back pain in the population above 45 years drive the global lateral lumbar interbody fusion market. Higher visualization resulting in easy and precise operation with less tissue sparing practice are other factors that propel the global lateral lumbar interbody fusion market. However, high cost of operation and risks associated with lateral lumbar interbody fusion such as psoas muscles or neural network injury and bone graft fusion complication restrain the market.
A significant study published in theJAMA Internal Medicine at the beginning of the year demonstrates how a health system effectively reduced episodic expenditures through bundled payments by 20 percent. Notwithstanding the rising national costs of joint replacements, Baptist Health System (BHS) saved $20 million over seven years with bundled payments.
The study, from the Perelman School of Medicine at the University of Pennsylvania, co-authored by Dr. Ezekiel Emanuel, combines hospital and Medicare data to evaluate the costs and care quality for nearly 4,000 hip and knee replacement episodes from July 2008 to June 2015. The five-hospital Baptist Health System in San Antonio, Texas saved more than $5,000 per episode, or $20 million in total savings. BHS also improved outcomes during the study by reducing readmissions, emergency department visits, and inpatient prolonged lengths of stay.
Remedy Partners has achieved similar results in a shorter period of time with engaged, aligned, and motivated provider partners across the country. Our experience has shown that hospitals and physician group practices can replicate this success by developing local, focused networks of cooperating providers and committing to optimized workflows.
March 1, 2017 – By Nick Bluhm, Director of Strategy & Government Policy at Remedy Partners
When Secretary Price said “people have coverage, but they don’t have care,” he underscored his commitment to one of the core values of bundled payments: patient-centered care. Dr. Price believes that “patients and doctors should be in control of healthcare”; which is why he does not support mandatory pilot programs.” He understands that providers need flexibility, not dictations, to accommodate the needs of their patients.
Dr. Price knows that physicians will need Medicare to accommodate their diverse, local needs in designing payment models. Notably, Secretary Price sees value in voluntary pilot programs, especially the Bundled Payments for Care Improvement initiative (BPCI). During his confirmation hearing, Secretary Price expressed support for voluntary bundled payment models and highlighted the role of the CMS Innovation Center in sponsoring pilot programs, saying that “for certain patients, bundled payments make a lot of sense.”
Expansion and extension of the framework of the BPCI initiative could create a more competitive and long-term approach to bundled payments. Voluntary models should be agnostic to the sponsoring provider; physician groups, post-acute providers and third-party risk-bearing entities have proven highly successful in government and private sector bundled payment programs. For instance, Accountable Care Organizations can use voluntary bundled payments to improve relationships with hospital-based physicians and integrate acute care management into their population health strategy.
I first got to know Curt Wiedenhoefer in 1988 when we were both working with Richards Medical, now Smith & Nephew.He was a young salesman working in Southern California selling trauma and hip and knee products. Since that time, Curt was recruited to Depuy in Northern California to manage the sales efforts for one of the largest distributorships at the time in the U.S.While he was working closely with surgeons, he realized there was a need for medical electronics in orthopedics. He founded a company, called Eisenlohr Technologies, Inc. in 1992.They developed a hand held measuring device for radiographs and an X-Ray marker.He bootstrapped the product development by collaborating with the PhD electrical engineering program at Stanford University.Self-funding with a small group of investors, he was able to get the product to market and sold it worldwide. Over the last 12 years he served as the Executive Vice President of Sales and Marketing for Consensus Orthopedics. The past 2 years he has also been the General Manager of the TracPatch division, which focuses on wearable technology in orthopedics.Recently, he was promoted to President of the Consensus Orthopedics.
I sat down with Curt and asked him a few questions about the new technology Consensus is developing.
1. So Curt, tell me about Consensus Orthopedics and its current trajectory.
Thank you Tiger. We are excited to say this year Consensus will celebrate 25 years in orthopedics!Our company headquarters is in El Dorado Hills, CA, about 30 miles east of Sacramento in Northern California.Our primary focus has always been on the hip and knee market and we have been and will continue to be, a high quality and reliable US joint manufacturer. We continued to expand our joint line by launching two new products this year, a Uni Knee and Shoulder. We are a start to finish manufacturing facility from raw materials through sterilization and packaging. We distribute to more than 15 countries worldwide.
Our future is looking bright. In 2015, we founded a medtech division within Consensus named TracPatch. The goal of this division is to use our 25 years of orthopedic experience to create innovative wearable technology for joint replacement rehabilitation and to assist our surgeons through the entire episode of care.
2. Why is Consensus, a traditionally orthopedic implant company, branching out into post-op patient monitoring?
The beginning of TracPatch is an interesting story. I was at a friend’s birthday party and I was talking with an orthopedic surgeon I knew. We were engrossed in the topic of real time post-op patient data. He told me he could “put in the best implant technology, align the joint perfectly, and balance the soft tissues, but if his patient sits on their couch with a pillow under their knee during those critical first six weeks post-operatively, the patient will have a bad result.” The TracPatch spark was lit right then.
From there, we combined our employees’ knowledge of orthopedics and electronics and created the TracPatch Division.
At the same time, CJR was being finalized. So this casual party conversation combined with the market shifting towards a value based model led to our discovering a need for post-op patient monitoring. This was critical to a healthcare providers and/or hospitals success. We leveraged our proximity to Silicon Valley and felt that we could develop products that potentially could improve outcomes, reduce cost and enhance patient satisfaction after total joint surgery. As a result, we created our TracPatch Division, and developed TracPatch, a wearable device for total joint rehabilitation patients.
3. Give me some more details about TracPatch.
TracPatch is a wearable device that can be utilized with any total knee system.It is placed just below the tibia joint line, medial or lateral to the midline, using a disposable adhesive pad. TracPatch is designed to remotely monitor range of motion, ambulation, exercise compliance, and temperature trends during post-surgical rehabilitation. This machine learning technology strategically optimizes the patient’s entire episode of care with a proactive approach. The TracPatch system includes an app and web dashboard. The app features an intuitive interface for easy operation on any smart phone with Bluetooth technology. The device transmits key data points directly to a secure cloud-based platform, where healthcare providers can track individual patient progress anytime on the app or web dashboard.
4. How can this technology scale for all orthopedic stakeholders?
TracPatch can be used by every patient. I am personally convinced that the benefits of the TracPatch wearable device are so significant that it will become the technology of choice for every surgeon/healthcare provider.
For example, a patient with TracPatch is motivated to engage in their rehabilitation program through daily exercise reminders and an interactive episode of care rehab roadmap. The healthcare provider can know every day if the patient is moving, increasing their range of motion, and completing their rehab exercises. This will in turn have the potential to reduce MUA’s (manipulation under anesthesia), readmissions, and physical therapy sessions; meaning increased value of care with decreased cost of care. These improved outcomes will result in higher patient satisfaction.
5. What kind of impact do you foresee the TracPatch technology having on Consensus as a company?
As I mentioned earlier, Consensus is celebrating our 25th year anniversary. Our products are known for their quality, reliability, and surgeon reproducibility in the OR. This innovative technology allows us to provide a groundbreaking new approach to help healthcare providers reduce costs and increase positive outcomes. TracPatch can add tremendous value to the entire episode of care. This technology delivers never-before-seen data into the post-surgical rehabilitation for healthcare providers. Being able to monitor your patients’ range of motion progress and exercise compliance daily is a game changer. TracPatch is making proactive care easy, so every patient has an excellent outcome. In 2018, we will be releasing a version for the hip as well.
The orthopedic industry has never seen anything like this before and we want to be on the forefront in this budding medtech orthopedic space. It not only allows Consensus Orthopedics to expand our current revenue and customer base, TracPatch also will attract new surgeons and hospitals that don’t currently use our total joints. This technology provides a synergistic market strategy we can use to create a streamlined episode of care.
6. Where do you see this technology going next?
Without giving up too much detail on our IP, Orthopedic wearable technology is the future. TracPatch is just the beginning. I envision wearable technology will completely change the orthopedic industry. Just imagine a future where innovative implant technology, wearable technology, and IoT intersect to create a completely connected care environment. Where provider and patient are synced throughout the entire pre, intra, and post-operative episode of care.
WALTHAM, Mass., March 09, 2017 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced the online publication in the Journal of Orthopaedic Research of a peer-reviewed publication entitled Mechanical Properties and Structure-Function Relationships of Human Chondrocyte-Seeded Cartilage Constructs After In Vitro Culture. The publication analyzes mechanical properties of tissue engineered cartilage based on work done as part of a sponsored research agreement between Histogenics and Dr. Lawrence Bonassar at Cornell University (Cornell). The initial data were presented at the Orthopaedic Research Society annual meeting in March 2016 and are based on a long-standing cooperative research agreement between Histogenics and Cornell. The lead author is Jill E. Middendorf (Cornell) with support from: Darvon J. Griffin, PhD, Itai Cohen, PhD and Lawrence J. Bonassar, PhD from Cornell and Sonya Shortkroff, Caroline Dugopolski, Stephen Kennedy and Joseph Siemiatkoski from Histogenics.
The objective of the study was to understand the complex mechanical behavior, function and changes that occur in human chondrocyte seeded collagen constructs during in vitro culture using multiple mechanical tests, which measure the compressive, frictional and shear properties of the constructs. This study was the first to examine the measurement of all three of these properties in human chondrocyte seeded constructs, and is intended to respond to U.S. Food and Drug Administration (FDA) guidance related to the generation of biomechanical or structural data for cartilage implants.
“We are excited to continue building our scientific understanding of the hyaline cartilage like properties of our tissue engineered product, NeoCart, and intend to use the data from these tests to support the Biologics License Application for NeoCart,” said Stephen Kennedy, Chief Technology Officer of Histogenics. “The data generated in this study provide additional evidence of the importance of the combination of cells, engineering and scaffold to produce mechanically competent cartilage tissue implants with additional unique friction and compression properties that allow for proper function in vivo. NeoCart’s unique ability to generate these characteristics prior to implantation is important, and we believe correlates nicely with the recently published clinical pain and functional data from the combined Phase 1 and 2 clinical trials for NeoCart. Taken together, these results may indicate that tissue engineered implants, such as NeoCart, may enable a more rapid recovery and return to function for patients suffering from cartilage defects,” continued Mr. Kennedy.
While all mechanical properties of human, tissue engineered, cartilage constructs nominally improved with time, frictional properties approached native values by three weeks and compressive properties approached native values by seven weeks. The results of the study suggest that in vitro cartilage constructs, or tissue implants, produced using a process that is designed to mimic that of NeoCart® exhibited mechanical properties prior to implantation approaching such properties of native cartilage. Specifically, the results of the study indicate that a combination of cells, scaffold and engineering play an important role in the development of tissue engineered-cartilage implants, such as NeoCart, and the maturation of such implants, leads to improved biological and mechanical properties. Together, these attributes may enable the early response and repair of focal cartilage lesions and the results of this study are consistent with data seen in patients in the Phase 1 and 2 clinical trials of NeoCart.
“Cartilage is a unique and difficult tissue to repair or regenerate. This challenge is evident from the many approaches to cartilage repair that include cells and scaffolds,” stated Dr. Lawrence Bonassar, Professor at Cornell University in the Meinig School of Biomedical Engineering and the Sibley School of Mechanical and Aerospace Engineering. “The data from this study confirm prior observations by scientists and surgeons that different mechanical properties of tissues improve at different rates. For example, frictional properties appear to improve quickly, while shear properties improve more slowly. These data are valuable not only for comparison to the performance of native tissue, but also in directing attention towards the properties that still need improvement,” continued Dr. Bonassar.
The full peer-reviewed publication will be available in the Investor Relations section of the Histogenics website once the final article is released for publication.
About NeoCart
NeoCart is a cartilage-like, tissue engineered implant created from a patient’s own cartilage cells. The patient’s cells are multiplied in Histogenics’ laboratory and then infused into a proprietary scaffold to allow them to organize and function like cartilage cells. Before NeoCart is shipped to the surgeon for implantation, the cell and scaffold construct undergoes a bioengineering process that is designed to mimic a joint so that the implant, upon placement in the knee with a proprietary bioadhesive, is primed to begin functioning like healthy cartilage. NeoCart is currently in a Phase 3 clinical trial that is designed to evaluate the safety and efficacy of NeoCart as a first-line therapy for full thickness knee cartilage defects in skeletally mature adults ages 18 to 59 and to show superiority of NeoCart against the current standard of care, microfracture. Histogenics is conducting the trial under a Special Protocol Assessment with the FDA and expects to complete enrollment in this trial by the end of the second quarter of 2017.
About Histogenics Corporation
Histogenics is a leading regenerative medicine company developing and commercializing products in the musculoskeletal segment of the marketplace. Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions to treat musculoskeletal-related conditions. Histogenics’ first investigational product candidate, NeoCart, is currently in Phase 3 clinical development. NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient’s own cells. Knee cartilage defects represent a significant opportunity in the United States, with an estimated 500,000 or more applicable procedures each year. NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage, characteristics not exhibited in other current treatment options. For more information, please visit www.histogenics.com.
Forward-Looking Statements
Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others: the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, which are on file with the SEC and available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2016, to be filed with the SEC in the first quarter of 2017. In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.
There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Consolidated total revenue increased 9.9% to a record $24.5 million compared to fourth quarter 2015 revenue of $22.3 million
Consolidated gross profit increased 17.4% to $17.5 million compared to fourth quarter 2015 gross profit of $14.9 million
Consolidated gross margins improved to 71.6%, compared to 67.0% reported in the fourth quarter of 2015
Full-Year 2016 Highlights:
Consolidated gross profit increased 10.1% to $62.3 million compared to pro forma 2015 gross profit of $56.6 million
Consolidated gross margins for the year were 69.2%, compared to pro forma 2015 gross margin of 65.4%
BELGRADE, Mont., March 09, 2017 (GLOBE NEWSWIRE) — Xtant™ Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today reported its financial results for the period ended December 31st, 2016. The Company reported annual revenues of approximately $90.0 million and a net loss for the year of approximately $19.5 million.
Revenue
Consolidated fourth quarter 2016 revenue was approximately $24.5 million, an increase of 9.9% compared to revenue of approximately $22.3 million for the same period during 2015.
Consolidated revenue for the full year 2016 was approximately $90.0 million, compared to pro forma 2015 revenue of approximately $86.5 million, representing an increase of 4.0% over the prior year.
Gross Profit
Consolidated gross profit for the fourth quarter of 2016 was $17.5 million or 71.6% of revenues, compared to gross profit of $14.9 million or 67.0% of revenues for the fourth quarter of 2015.
For the year, gross profit was approximately $62.3 million, compared with pro forma 2015 gross profit of $56.6 million. Gross margin for the year was 69.2%, compared to 2015 pro forma gross margin of 65.4%
Sales and Marketing Expenses
Consolidated fourth quarter 2016 sales and marketing expenses increased to $11.9 million, as compared to sales and marketing expenses of $10.6 million during the same period in 2015. For the quarter, sales and marketing as a percentage of revenues increased slightly to 48.8%, compared to 47.6% in the fourth quarter of 2015.
For the year, sales and marketing expenses increased to $44.1 million for 2016, as compared to pro forma 2015 sales and marketing expenses of $39.3 million. As a percentage of revenues, sales and marketing expenses increased to 48.9% compared to 45.5% reported for the pro forma full year 2015.
General and Administrative Expenses
In the fourth quarter, consolidated general and administrative expenses remained flat at $4.5 million as compared to general and administrative expenses of $4.2 million reported for the same period last year. As a percentage of revenues, general and administrative expenses were 18.3% during the period as compared to 18.9% for the same period during 2015.
2016 general and administrative expenses decreased to $15.8 million as compared with $16.6 million reported for the pro forma period last year. As a percentage of revenues, general and administrative expenses were 17.5% as compared to 19.2% for 2015.
Net Income / Loss
The fourth quarter 2016 consolidated net loss was $4.5 million, compared to the same period a year-ago net income of $11.6 million. The decrease was primarily due to a one-time recording of a deferred tax benefit of $17.5 million that occurred during the fourth quarter 2015.
The fourth quarter 2016 consolidated loss per share of $0.31 compared to earnings per share of $0.97 in the fourth quarter of 2015.
For the full-year 2016, the Company had a net loss of $19.5 million compared to a pro forma net loss of $5.8 million for 2015. Net loss per share for the full-year 2016 was $1.54 a share compared to pro forma net loss per share of $0.65 for 2015.
EBITDA
The Company defines earnings before interest, taxes, depreciation and amortization (“EBITDA”) as net income/loss from operations before depreciation, amortization, impairment charges, non-recurring expenses and non-cash stock-based compensation. Consolidated EBITDA for the fourth quarter of 2016 was a gain of $1.2 million compared to a loss of $350,000 for the same period during 2015.
Full year 2016 EBITDA was a gain of $2.0 million compared to a zero pro forma loss in the prior year.
Financial Liquidity
Cash on hand as of December 31, 2016, was $2.6 million, as compared to $6.4 million as of December 31, 2015. Net working capital as of December 31, 2016 decreased $5.7 million to $17.9 million, as compared to $23.6 million as of December 31, 2015.
Outlook for Full Year 2017
The Company plans to have an immediate focus on operational and cash flow efficiencies throughout 2017. As a result, we have reduced revenue guidance while expanding projected EBITDA margins as we get to the latter part of 2017. The Company’s revised full year 2017 revenue and EBITDA guidance is based on the following:
Stated in 000’s
FY ’15*
FY ’16
2017 Guidance
Revenue
$
86,518
$
90,003
$96,000 – $98,000
Growth
4
%
6.7% – 8.9%
EBITDA
$
(33
)
$
2,050
$6,900 – $7,700
*Pro forma results
Conference Call to be Held March 10, 2017
An accompanying listen-only conference call will be hosted by Carl O’Connell, Chief Executive Officer, and John Gandolfo, Chief Financial Officer, to discuss the results. The call will be held at 10:00 AM ET, on March 10, 2017. Please refer to the information below for conference call dial-in information and webcast registration.
Conference date: March 10, 2017, 10:00 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: Xtant Medical’s Fourth Quarter 2016 Results Call Webcast Registration: Click Here
Following the live call, a replay will be available on the Company’s website, www.xtantmedical.com, under “Investor Info.”
Use of Pro Forma Financial Information
On July 31,2015, Bacterin International Holdings, Inc. acquired all of the issued and outstanding stock of X-Spine Systems, Inc. and the combined company was renamed Xtant Medical Holdings, Inc. Except for the financial results for the three months ended December 31, 2015, the results presented for the full 2015 year are on a pro forma basis as if the two companies were combined for the periods shown. Certain pro forma adjustments have been made to reflect the impact of the purchase transaction, primarily consisting of amortization of intangible assets with determinable lives and interest expense on long-term debt. In addition, certain historical expenses, such as warrant expense and interest expense associated with debt that was immediately repaid, were eliminated from these pro-forma results. The pro forma information does not necessarily reflect the actual results of operations had the acquisition been consummated at the beginning of the fiscal reporting period indicated nor is it indicative of future operating results. The pro forma information does not include any adjustment for potential revenue enhancements, cost synergies or other operating efficiencies that could result from the acquisition.
Additional information regarding the business combination and its impact on the Company’s financial position will be set forth in the Company’s Form 10-K for the fiscal year ended December 31, 2016, which will be filed with the Securities and Exchange Commission on or about March 30, 2017 and will include the Company’s audited consolidated financial statements as of and for the years ended December 31, 2016 and December 31, 2015
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 Company’s ability to successfully integrate the acquisition of X-spine; the ability of the Company’s sales force to achieve expected results; the Company’s ability to meet its existing and anticipated contractual obligations, including financial covenant and other obligations contained in the Company’s secured lending facility; the Company’s ability to manage cash flow; the Company’s ability to develop, market, sell and distribute desirable applications, products and services and to protect its intellectual property; the ability of the Company’s customers to pay and the timeliness of such payments; the Company’s ability to obtain financing as and when needed; changes in consumer demands and preferences; the Company’s ability to attract and retain management and employees with appropriate skills and expertise; the impact of changes in market, legal and regulatory conditions and in the applicable business environment, including actions of competitors; and other factors. 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.” 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.
XTANT MEDICAL HOLDINGS, INC.
Condensed Consolidated Statements of Operations
Unaudited Actual and Proforma Results
For the Three Months Ended December 31,
For the Year Ended December 31,
2016 Unaudited
2015 Unaudited
2016 Unaudited
2015 Pro Forma
% of
% of
% of
% of
Amount
Revenue
Amount
Revenue
Amount
Revenue
Amount
Revenue
Orthopedic Product Sales
$
24,362,237
99.6
%
$
21,771,750
97.8
%
$
89,388,145
99.3
%
$
85,235,170
98.5
%
Other
108,621
0.4
%
494,072
2.2
%
614,591
0.7
%
1,282,429
1.5
%
Total Revenue
24,470,858
100.0
%
22,265,822
100.0
%
90,002,736
100.0
%
86,517,599
100.0
%
Cost of sales
6,960,634
28.4
%
7,353,446
33.0
%
27,710,014
30.8
%
29,913,686
34.6
%
Gross Profit
17,510,223
71.6
%
14,912,376
67.0
%
62,292,722
69.2
%
56,603,913
65.4
%
Operating Expenses
General and administrative
4,484,419
18.3
%
4,201,394
18.9
%
15,762,531
17.5
%
16,612,883
19.2
%
Sales and marketing
11,940,049
48.8
%
10,607,475
47.6
%
44,055,813
48.9
%
39,334,250
45.5
%
Research and development
798,198
3.3
%
1,027,166
4.6
%
3,410,600
3.8
%
3,840,958
4.4
%
Depreciation and amortization
1,250,436
5.1
%
2,019,258
9.1
%
4,940,955
5.5
%
6,220,316
7.2
%
Acquisition and Integration related expenses
131,755
0.5
%
1,079,236
4.8
%
1,401,367
1.6
%
4,935,755
5.7
%
Gain from the Extinguishment of Debt
0
0.0
%
0
0.0
%
0
0.0
%
(2,345,019
)
-2.7
%
Impairment of Assets
0
0.0
%
0
0.0
%
0
0.0
%
233,748
0.3
%
Non-cash consulting
0
0.0
%
55,296
0.2
%
266,721
0.3
%
246,165
0.3
%
Total Operating Expenses
18,604,856
76.0
%
18,989,824
85.3
%
69,837,986
77.6
%
69,079,056
79.8
%
Net Gain (Loss) from Operations
(1,094,633
)
-4.5
%
(4,077,448
)
-18.3
%
(7,545,264
)
-8.4
%
(12,475,142
)
-14.4
%
Other Income (Expense)
Interest expense
(3,287,855
)
-13.4
%
(2,802,807
)
-12.6
%
(12,262,750
)
-13.6
%
(10,948,845
)
-12.7
%
Change in warrant derivative liability
0
0.0
%
348,943
1.6
%
716,738
0.8
%
270,020
0.3
%
Non-cash consideration associated with stock purchase agreement
0
0.0
%
0
0.0
%
0
0.0
%
(558,185
)
-0.6
%
Other income (expense)
(103,990
)
-0.4
%
582,123
2.6
%
(351,914
)
-0.4
%
395,006
0.5
%
Total Other Income (Expense)
(3,391,845
)
-13.9
%
(1,871,740
)
-8.4
%
(11,897,926
)
-13.2
%
(10,842,004
)
-12.5
%
Net Gain (Loss) from Operations Before Benefit (Provision) for Income Taxes
(4,486,478
)
-18.3
%
(5,949,188
)
-26.7
%
(19,443,190
)
-21.6
%
(23,317,146
)
-27.0
%
Benefit (Provision) for Income Taxes
Current
(50,362
)
-0.2
%
0
0.0
%
(50,362
)
-0.1
%
(65,387
)
-0.1
%
Deferred
0
0.0
%
17,537,408
78.8
%
0
0.0
%
17,537,408
20.3
%
Net Income (Loss)
$
(4,536,840
)
-18.5
%
$
11,588,220
52.0
%
$
(19,493,552
)
-21.7
%
$
(5,845,125
)
-6.8
%
Net Income (loss) per share:
Basic
$
(0.31
)
$
0.97
$
(1.54
)
$
(0.65
)
Dilutive
$
(0.31
)
$
0.97
$
(1.54
)
$
(0.65
)
Shares used in the computation:
Basic
14,479,201
11,890,104
12,671,685
9,055,483
Dilutive
14,479,201
11,890,104
12,671,685
9,055,483
XTANT MEDICAL HOLDINGS, INC.
Condensed Consolidated Statements of Operations
Audited and Unaudited Actual Results
For the Three Months Ended December 31,
For the Year Ended December 31,
2016 Actual Unaudited
2015 Actual Unaudited
2016 Actual Unaudited
2015 Actual Audited
% of
% of
% of
% of
Amount
Revenue
Amount
Revenue
Amount
Revenue
Amount
Revenue
Orthopedic Product Sales
$
24,362,237
99.6
%
$
21,771,750
97.8
%
$
89,388,145
99.3
%
$
58,194,249
98.1
%
Other
108,621
0.4
%
494,072
2.2
%
614,591
0.7
%
1,151,468
1.9
%
Total Revenue
24,470,858
100.0
%
22,265,822
100.0
%
90,002,736
100.0
%
59,345,717
100.0
%
Cost of sales
6,960,634
28.4
%
7,353,446
33.0
%
27,710,014
30.8
%
20,262,728
34.1
%
Gross Profit
17,510,223
71.6
%
14,912,376
67.0
%
62,292,722
69.2
%
39,082,989
65.9
%
Operating Expenses
General and administrative
4,484,419
18.3
%
4,201,394
18.9
%
15,762,531
17.5
%
12,993,307
21.9
%
Sales and marketing
11,940,049
48.8
%
10,607,475
47.6
%
44,055,813
48.9
%
28,731,184
48.4
%
Research and development
798,198
3.3
%
1,027,166
4.6
%
3,410,600
3.8
%
2,546,362
4.3
%
Depreciation and amortization
1,250,436
5.1
%
2,019,258
9.1
%
4,940,955
5.5
%
3,819,588
6.4
%
Acquisition and Integration related expenses
131,755
21.8
%
1,079,236
4.8
%
1,401,367
1.6
%
4,935,755
8.3
%
Gain from the Extinguishment of Debt
0
0.0
%
0
0.0
%
0
0.0
%
(2,345,019
)
-4.0
%
Impairment of Assets
0
0.0
%
0
0.0
%
0
0.0
%
233,748
0.4
%
Non-cash consulting
0
0.0
%
55,296
0.2
%
266,721
0.3
%
246,165
0.4
%
Total Operating Expenses
18,604,856
76.0
%
18,989,824
85.3
%
69,837,986
77.6
%
51,161,091
86.2
%
Net Gain (Loss) from Operations
(1,094,633
)
-4.5
%
(4,077,448
)
-18.3
%
(7,545,264
)
-8.4
%
(12,078,101
)
-20.4
%
Other Income (Expense)
Interest expense
(3,287,855
)
-13.4
%
(2,802,807
)
-12.6
%
(12,262,750
)
-13.6
%
(7,733,748
)
-13.0
%
Change in warrant derivative liability
0
0.0
%
348,943
1.6
%
716,738
0.8
%
270,020
0.5
%
Non-cash consideration associated with stock purchase agreement
0
0.0
%
0
0.0
%
0
0.0
%
(558,185
)
-0.9
%
Other income (expense)
(103,990
)
-0.4
%
582,123
2.6
%
(351,914
)
-0.4
%
388,177
0.7
%
Total Other Income (Expense)
(3,391,845
)
-13.9
%
(1,871,740
)
-8.4
%
(11,897,926
)
-13.2
%
(7,633,736
)
-12.9
%
Net Gain (Loss) from Operations Before Benefit (Provision) for Income Taxes
(4,486,478
)
-18.3
%
(5,949,188
)
-26.7
%
(19,443,190
)
-21.6
%
(19,711,838
)
-33.2
%
Benefit (Provision) for Income Taxes
Current
(50,362
)
-0.2
%
0
0.0
%
(50,362
)
-0.1
%
0
0.0
%
Deferred
0
0.0
%
17,537,408
78.8
%
0
0.0
%
17,537,408
29.6
%
Net Income (Loss)
$
(4,536,840
)
-18.5
%
$
11,588,220
52.0
%
$
(19,493,552
)
-21.7
%
$
(2,174,430
)
-3.7
%
Net Income (loss) per share:
Basic
$
(0.31
)
$
0.97
$
(1.54
)
$
(0.24
)
Dilutive
$
(0.31
)
$
0.97
$
(1.54
)
$
(0.24
)
Shares used in the computation:
Basic
14,479,201
11,890,104
12,671,685
9,055,483
Dilutive
14,479,201
11,890,104
12,671,685
9,055,483
XTANT MEDICAL HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the twelve months ended December 31,
2016 Unaudited
2015 Audited
Operating activities:
Net loss
$
(19,493,552
)
$
(2,174,430
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
7,241,870
4,889,272
Purchase accounting valuation allowance
0
(17,537,408
)
Non-Cash Interest
6,784,785
4,814,506
Impairment of Assets
0
956,395
Gain (Loss) on sale of fixed assets
25,458
(596,883
)
Non-cash consulting expense/stock option expense
522,987
836,741
Provision for losses on accounts receivable and inventory
223,538
700,234
Change in derivative warrant liability
(716,738
)
(270,020
)
Non-cash consideration associated with stock purchase agreement
0
558,185
Extinguishment of debt
0
(2,345,019
)
Changes in operating assets and liabilities:
Accounts receivable
(2,680,405
)
(5,512,429
)
Inventories
(4,074,086
)
(545,713
)
Prepaid and other assets
(484,061
)
(1,044,962
)
Accounts payable
319,091
644,149
Accrued liabilities
(2,076,183
)
7,527,514
Net cash used in operating activities
(14,407,296
)
(9,099,868
)
Investing activities:
Acquisition of X-spine Systems, Inc.
0
(72,975,200
)
Purchases of property and equipment and intangible assets
(5,832,690
)
(2,263,033
)
Proceeds from sale of fixed assets
16,400
1,667,195
Net cash used in investing activities
(5,816,290
)
(73,571,038
)
Financing activities:
Proceeds from long-term and convertible debt, net of deferred and financing costs
3,238,166
83,897,361
Net proceeds from equity private placement
0
515,395
Payment on royalty obligation
0
(542,905
)
Payments on Long-term debt
0
(1,325,814
)
Payments on capital leases
(144,600
)
(101,760
)
Net proceeds from the issuance of stock
3,087,462
2,116,937
Net Proceeds from the revolving line of credit
10,252,809
0
Proceeds from exercise of options
0
11,500
Net cash provided by financing activities
16,433,837
84,570,714
Net change in cash and cash equivalents
(3,789,749
)
1,899,808
Cash and cash equivalents at beginning of period
6,368,016
4,468,208
Cash and cash equivalents at end of period
$
2,578,267
$
6,368,016
XTANT MEDICAL HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
As of December 31, 2015 and 2016
As of Dec. 31,
As of Dec. 31,
2016 Unaudited
2015 Audited
ASSETS
Current Assets:
Cash and cash equivalents
$
2,578,267
$
6,368,016
Trade accounts receivable, net of allowance for doubtful accounts of $1,635,385 and $2,579,634, respectively
18,991,872
15,385,218
Inventories, net
26,266,457
22,684,716
Prepaid and other current assets
1,149,616
601,697
Total current assets
48,986,211
45,039,647
Non-current inventories
971,854
1,607,915
Property and equipment, net
15,840,730
11,816,629
Goodwill
41,534,626
41,534,626
Intangible assets, net
35,940,810
40,237,289
Other assets
827,372
791,221
Total Assets
$
144,101,605
$
141,027,327
LIABILITIES & STOCKHOLDERS’ (DEFICIT) EQUITY
Current Liabilities:
Accounts payable
$
10,471,944
$
9,386,531
Accounts payable – related party
640,441
1,406,763
Accrued liabilities
8,982,187
9,595,851
Revolving Line of Credit
10,448,283
0
Warrant derivative liability
333,613
1,050,351
Current portion of capital lease obligations
244,847
35,139
Total current liabilities
31,121,316
21,474,635
Long-term Liabilities:
Capital lease obligation, less current portion
832,152
7,800
Long term convertible debt, less current portion
68,937,247
66,436,647
Long-term debt, less current portion
50,284,187
44,231,718
Total Liabilities
151,174,902
132,150,800
Commitments and Contingencies
Stockholders’ Equity
Preferred stock
–
–
Common stock
17
11
Additional paid-in capital
85,461,210
81,917,488
Accumulated deficit
(92,534,524
)
(73,040,973
)
Total Stockholders’ Equity (Deficit)
(7,073,297
)
8,876,527
Total Liabilities & Stockholders’ Equity
$
144,101,605
$
141,027,327
XTANT MEDICAL HOLDINGS, INC.
Calculation of Consolidated EBITDA for the Three and Twelve Months Ended December 31, 2016
and for the Three and Pro Forma Twelve Months Ended December 31, 2015
Unaudited
For the three months ended December 31,
For the twelve months ended December 31,
2016
2015
2016
2015
Net Loss
(4,536,840
)
11,588,220
(19,493,552
)
(5,845,125
)
(Benefit) Provision
50,362
(17,537,408
)
50,362
(17,472,021
)
Other (Income) Expense
103,990
(582,123
)
351,914
(395,006
)
Change in warrant derivative liability
0
(348,943
)
(716,738
)
(270,020
)
Non-cash consideration associated with stock purchase agreement
0
0
0
558,185
Interest expense
3,287,855
2,802,807
12,262,750
10,948,845
Acquisition and Integration related expenses
131,755
0
1,401,367
233,748
Extinguishment of Debt
0
1,079,236
0
4,935,755
Impairment of Assets
0
0
0
(2,345,019
)
Non-Cash Compensation
0
163,124
522,987
794,358
Depreciation & Amortization
1,690,020
2,485,321
7,241,870
8,822,994
One Time Inventory Reserves and Accounts Receivables Allowances
426,355
0
426,355
0
EBITDA Gain (Loss)
1,153,497
(349,767
)
2,047,315
(33,306
)
Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital
Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com
DANIA BEACH, Fla., March 9, 2017 /PRNewswire/ — OrthoSensor, Inc., a leader in sensor-assisted technology for total knee arthroplasty (TKA), will be on the main aisle at booth #5823 during the 2017 American Academy of Orthopedic Surgeons (AAOS) Annual Meeting at the San Diego Convention Center from March 15-17. OrthoSensor will be releasing its three-year multicenter study results, as well as other new studies showing the clinical and economic advantages that may be gained with the use of VERASENSE, the leading intraoperative product for OrthoSensor. OrthoSensor will also host distinguished surgeon speakers at the booth.
VERASENSE for TKA transmits quantitative data from a patient’s knee, enabling a surgeon to customize implant position and achieve better soft tissue balance. The newly released studies show:
Statistically significant improvement in patient-reported outcomes and satisfaction for TKA patients whose knees were balanced using VERASENSE sensors
Improved post-op physical therapy performance and short-term clinical outcomes
Reduced complications and costs over 90-day TKA episode of care (MUA rate)
Cost mitigation when used for revision TKA (implant preservation, improved rehabilitation and other ancillary benefits)
“We are excited to present a new study showing 88% of planned early stage total revisions changed to partial revisions when VERASENSE was used in revision TKA procedures. This reduction represents very meaningful clinical and financial benefits to both patients and providers. This is just one of many studies showing the significant clinical and economic advantages of VERASENSE that have been recently released,” said Ivan Delevic, President and Chief Executive Officer of OrthoSensor, Inc.
The distinguished presenters at the OrthoSensor Booth #5823 are as follows:
Wednesday, March 15, 2017 10:30 am – Gregory J. Golladay, MD – Virginia Commonwealth University 2:00 pm – Michael Mont, MD – Cleveland Clinic
Thursday, March 16, 2017 10:30 am – Jimmy Chow, MD – St. Luke’s Hospital 2:00 pm – Patrick Meere, MD – NYU Hospital for Joint Diseases
Friday, March 17, 2017 11:00 am – David Fabi, MD – Scripps Mercy Hospital San Diego
About OrthoSensor, Inc.
OrthoSensor, Inc., a leader in Sensor-Assisted Total Knee Arthroplasty develops and commercializes intelligent orthopedic devices and data services that provide quantitative feedback to surgeons and hospitals. The company’s intelligent orthopaedic devices utilize advanced proprietary sensor and communications technologies, coupled with the company’s innovative software products, to facilitate evidence-based decisions in orthopaedic surgery – with the goal of improving patient outcomes and potentially reducing the cost of treating musculoskeletal disease.
OrthoSensor®, VERASENSE™, and ORTHOLOGIQ™ are trademarks of OrthoSensor, Inc.
ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that it will demonstrate its Aero-C Cervical Stability System (Aero-C) and Xia 4.5 Cortical Trajectory implants and instruments (Xia CT) at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, March 15–18, 2017, in San Diego (booth No. 3133).
Aero-C, the only straight forward anterior cervical discectomy and fusion (ACDF) device that offers uniform compression across the interbody space, will be displayed at AAOS 2017, highlighting its full commercial launch. Using Aerofoil™ Compression Technology, Aero-C is designed to pull the vertebral bodies toward the implant as it is inserted, creating compressive forces at the implant-to-endplate interface.1 Aerofoil Compression Technology is also available for lateral and anterior lumbar interbody fusion procedures (LLIF and ALIF). Since the initial introduction to the market, over 600 cases have been completed.
Also to be demonstrated at AAOS is Xia CT, which includes implants and instruments used in less invasive LITe LIF posterior lumbar interbody fusion procedures for patients with degenerative disc disease, spondylolisthesis, and trauma. The cortical trajectory procedure facilitates a smaller midline incision to help achieve decompression, fixation, and fusion.2 It also is intended to be more muscle sparing than standard open procedures that require lateral dissection, and its reduced incision may allow for more efficient exposure and closure time.2 The launch of the Xia CT system occurred in 2016, with 575 cases completed to date.
“Since their introduction last year, Aero-C and Xia CT have been well received by our surgeon customers and have achieved rapid adoption in the marketplace,” said Bradley Paddock, President of Stryker’s Spine division. “These unique products reflect our strong commitment to advancing spine health and helping to enhance outcomes for patients by providing physicians with innovative and differentiated technology.”
Aero-C and Xia CT offer advancements that highlight the Spine division’s leadership in pioneering innovative technologies for traditional and minimally invasive surgical techniques. The company offers one of the most comprehensive and diverse product portfolios for the treatment of degenerative and complex spinal disorders. Its suite of leading-edge products includes implants, instruments, and biologics for the cervical, thoracic, and lumbar spine.
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.
Lee GW, Son JH, Ahn MW, Kim HJ, Yeom JS. (2015) The comparison of pedicle screw and cortical screw in posterior lumbar interbody fusion: a prospective randomized noninferiority trial. The Spine Journal 15, 1519-1526.
Indications for Use
The AERO-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. The AERO-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.
The Xia CT implants and instruments are intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; failed previous fusion.
