De-Risk: Another Step in Preparation for Acquisition

First quarter 2016, CEO Dr. Bal laid out 4 major objectives he has for the company and 3 of them are oriented around de-risking the company.

In 2016, we have focused on four key areas that I want to cover. First and foremost we have improved our financial position. Specifically since my joining the company about 18 months ago, our debt is lower by almost 50%. Operational cash burn is lower by 52% and we have a stable capitalization structure and that’s remarkable. These changes will undoubtedly prove their value for the company and the years to come.

Second, we have focused on expanding sales in the healthcare market that is changing and challenging and evolving. Toward the last part of the year in 2015, we adjusted and expanded our sales forces in key geographic areas throughout the United States, some of those personnel changes impacted of our revenues for the quarter, but I’m absolutely confident that going forward once our enhanced sales strategy is fully implemented revenues will stabilize and grow with new distributors.

We are bringing on additional sales professionals to expand and diversify a surgeon and hospital base and we have new data and messaging to support our direct and private label sales going forward.

Point number three, we have advanced and validated our science at worldwide forums thereby increasing the visibility, success and outcomes of silicon nitride. This portfolio publication and science have been instrumental in gaining the attention of other large companies in healthcare and outside, who are now starting to explore our material for their own specific needs. These scientific advancements and visibility will continue this year complemented by clinical reports that we are publishing now that further validate our material claims.

Point number four, we have shown as have others that our material is equally advantageous in non-medical i.e. industrial applications. It’s just as strong as any other industrial material if not better. This expansion into the larger space of non-medical users of our material such as the aerospace industry and electronics industry has just begun, and it’s a very promising development for our future.

Amedica Q1 2016 Transcript

Point number 2 concerns sales and it wasn’t until 2017 that sales seem to have “stabilized”. Point 2 is more of a sideshow for Amedica as what really matters is point 3, validating the science, showing Silicon Nitride really does what was once theorized to do.


Point Number 3 & 4: Validating the Science & Material

Dr. Sonny Bal, Giuseppe Pezzotti, & Brian McEntire have been painstakingly working to prove that Silicon Nitride is truly Antimicrobial, Ostoeconductive, Osteoinductive, prevents Osteolysis, reduces corrosion, & has minimal affect on the bodies ecosystem; silicon nitride is water soluble allowing the body to evacuate excess silicon nitride. All biomaterials corrode to some extent, so you want an implant material that will have the least impact systematically. The fact that our bodies can evacuate potential buildup prevents issues of toxic buildup that people with metal implants can suffer from.

Proving these things makes Silicon Nitride the leading biomaterial on market in terms of benefits it can offer patients. No other company currently has a product that can do all these things despite competitors trying to modify their materials to provide some of the above benefits. Fortunately Amedica has a solution for them as well, a Si3N4 coating or Si3N4 brazing for metal implants made from second generation Si3N4. Second generation is an enhanced version of Si3N4 that, with a tweak to the surface makeup, can increase the bodies response to the material potentially reducing healing time further.

Dr. Bal, et al have proven the core concepts of Amedica’s material. Now its testing the material with major partners to apply the material to various medical & non-medical applications.

Si3N4 has been proven in-vitro, in-vivo, & clincally. The only thing missing is long-term retrospective studies which was announced earlier this year. I contend that Dr. Bal, et al. have done all they can do to mitigate risk a large company like Zimmer would take on upon M&A with Amedica. This is especially important for a company like Zimmer which may have acquired Trabecular Metal too soon, bitting them in the behind when the recalls and lawsuits began to occur. Given Dr. Bal’s experience with Zimmer & Trabecular Metal I’m sure he’s well aware of this and that may have been what prompted this statement:

Now keep this in mind in every instance we have expressed concerns not that the testing conditions are too harsh but rather that they are not harsh enough. Our material is very competitive and it has been used in industry, in extreme applications where other materials fail. We are keen to put it to the test in every which way, we are open to the most intense testing of our material against any other material in the world by any partner.

Amedica 2015 Q4 Transcript


Point Number 1: First & Foremost Improved Financials.

Financials.jpg

(In thousands)

Dr Bal became CEO of Amedica September 30, 2014. Immediately Dr. Bal began evaluating ways to cut costs. The first round of layoffs occurred Q1 2015 reducing workforce 28%, cutting overhead costs 35%, & reducing manufacturing costs 25%.

We are committed to our shareholders to improving the focus and profitability of Amedica, as these initiatives will strengthen our financial position, and allow us to execute on the development of our core silicon nitride technology,” chairman & CEO Dr. Sonny Bal

Amedica slumps on layoffs, restructuring plan

You can see the results in the above graphs of Dr. Bal’s agenda. During his 3 years as CEO the companies debt dropped from about 24 million to current 3.6m. Amedica’s cash burn has dropped from ~15 million in 2014 to ~ 4.5m for first 9months of 2017. EBITDA has dropped from 28 million to 5.6m so far 2017. Those are staggering financial changes all done with falling revenue. Revenue is not as important as proving the material. Zimmer can handle unlocking revenue with its huge sales staff.

As someone that works in the accounting world I do like seeing these metrics improving the way they do. I’m pleased with seeing the company running with greater efficiency, squeezing every cost point possible to minimize their impact. That said, what’s confusing to me is, why continue to cut costs while not investing in sales? Why not obtain a new loan for expansion to increase sales & marketing? Is that not what a typical CEO does? Try to grow his business? Why then is Dr. Bal doing the opposite?

Well this is where de-risking the companies financial position comes into play. The purpose is the minimize the companies potential dilutive financial impact on an acquirer and to maximize potential accretive potential in the future.

Earnings Per Share

Analysts, investors and journalists who follow stocks have an obsessive focus on earnings per share, what it is now and what it will be in the future, as can be seen in the earnings announcement game every that takes up so much of Wall Street’s time and resources. Not surprisingly, acquiring firms, considering new deals, put their accountants to work on what they believe is a central question, “Will the earnings per share for the company (acquirer) go up or down after the acquisition?” A deal that will result in higher earnings per share, post-deal, is classified as accretive, whereas one that will cause a drop in earnings per share is viewed as dilutive.

This is what it all boils down to and how management of a company is evaluated, EPS. It should be noted that, after factoring in 2 reverse splits, the initial loss per share was ~$480 per share. So far, in 2017, that loss is just $2.42 per share. That’s a bit flawed comparison but when you factor in both reverse splits, 2014 OS was only 68,000 shares. A better comparison though is 2016 loss of $4.38, a 45% improvement in EPS; does not include a dividend paid out 2016 and is based on current weighted OS.

Consider this for a moment:

If you are buying a company with a lower PE ratio than yours, there is usually a good reason why that company has the lower PE. It could be that the firm is riskier than average, has lower or no growth or is in a business with sub-standard returns. If any or all of these reasons hold, acquiring this company will bring those problems into the combined company and cause the PE ratio for the combined company to fall. If that drop exceeds the increase in EPS, the stock price of the combined company will also fall, notwithstanding the accretive nature of the deal.

Acquisition Accounting I: Accretive (Dilutive) Deals can be bad (good) deals

Amedica has a lower PE ratio than Zimmer. To reduce potential negative impact of a merger between companies, especially since Zimmer is struggling, minimal financial risk is called for.

Debt

Heavily indebted companies rarely represent good takeover targets. Stocks that trade at low multiples and that look cheap, are usually cheap because the company is facing some issues. By buying this kind of company, an acquirer places a bet on its ability to unlock the target’s performance, taking advantage of the low valuation. Acquirers know that they could be overestimating their ability to unlock the target’s performance, that integration between the two companies could be more difficult than expected and that the issues the company is facing could be worse that they appear. Debt, on the other hand, is certain. The higher the indebtedness, the higher the loss if something goes wrong. Acquirers don’t want to risk buying an asset that they can’t take advantage of and that ends up being a drag on cash flows.

As i already stated Amedica’s debt is down to 3.6m and 1.1m of that will be paid off by January 1st 2018. It’s also possible the 2.5m debt is a backdoor payment from Zimmer to North Stadium Investments for Amedica, as confusing as this seems to me. Recall that Zimmer paid $2.5m to an unknown company Q2’17 & North Stadium Investments, owned by Amedica’s CEO Dr. Bal, loaned Amedica an identical amount. A backdoor payment is possible but i certainly do not understand how it works. Anyways, its possible that there is only $1.1m in real debt.

I would like to add, that its odd that Amedica has not been able to or has not tried to obtain a loan to expand operation, as i mentioned earlier. I wonder if this is why:

Another common deal protection is a standstill agreement. A standstill agreement prevents a party from making business changes outside of the ordinary course, during the negotiation period. Examples include prohibitions against selling off major assets, incurring extraordinary debts or liabilities, spinning of subsidiaries, hiring or firing management teams and the like.

As i pointed out in my blog post, Zimmer & Amedica Connections via Personnel, Amedica has hired members to its management team but those members are former Zimmer employees.

Capital Structure

The first thing I look at is capital structure. Good takeover targets usually have a clean capital structure. If a company has large amounts of convertible bonds, several classes of common or preferred stocks or is exposed to “overhang,” the risk of share dilution is much higher, making the stock a less attractive target.

Is Kate Spade A Good Takeover Target?

Amedica has no convertible debt, it paid of its senior notes last year, & issued preferred shares from an offering in 2016 have been converted. There are about 1.5 million warrants outstanding with various strike prices however. In the scheme of things these shares will not impact EPS as badly, especially now after the reverse split. The warrants will provide a small injection of capital into Amedica’s coffers, ~$15 million, which would allow Amedica to retire all debts after announcement of M&A; this assumes of course funds exercise after announcement. Amedica’s small, fully diluted, share count would minimize the initial dilutive impact upon closing of M&A and increase potential accretive impact in the future as compared to before the reverse split.


Conclusion

Based on the evidence i’ve collected, i am confident in saying that Dr. Bal’s modus operandi is simply to de-risk Amedica to the fullest extent of his ability. Dr. Bal et al have worked extensively to run medical grade silicon nitride through the ringers to ensure that the material not only does what is expected but that there is are no negative surprises. While de-risking the material, Dr. Bal has spent his 3 years as CEO insuring that Amedica’s financials are as pristine as possible before M&A. I can see no other purpose of his pursuits outside of preparation for acquisition.

For years they’ve leased 56,000 sq ft building only occupying 30,000 sq ft of it. In 2017 that changed and now they are leasing sub-sections they do not use. Almost as if they do not plan to occupy it much longer.

 

For more research on this check the following links:

Accretion/dilution

proforma EPS

For some outstanding research on lack of annual meetings & executive compensation:

DEF 14 or DEFM 14

 

Pertinent Filings & Press Releases

Zimmer Biomet Spine Opens New Headquarters in Westminster Colorado

Zimmer Biomet Spine had a recent grand opening of its new HQ in Westminster, CO. According to Colorado Real Estate Journal as of August 31st, 2016, Zimmer Spine had leased 104,000 sq ft of space and planned to invest $6.3 million in facility renovations & improvements. This culminated in a grand opening approximately 1 year later, September 28th, 2017. Oddly enough this was shortly after Zimmer Spine president stepped down, September 1st, 2017. Conveniently timed for someone to takeover the new office.

Zimmer Biomet, a medical device company, recently celebrated the grand opening of their newest facilities in Westminster, Colorado. Zimmer Biomet is a global company that manufactures orthopedic medical devices to help those with disorders of, or injuries to,  bones, joints, or supporting soft tissues. The Westminster location is the newest headquarters for their Spinal division.  This new facility combines research, marketing, development, and administrative functions that had previously been dispersed between Austin, Minneapolis, and Broomfield.

OZ transformed the interiors of a former call center in the Westmoor office park into cutting-edge research laboratories, development facilities, and high-end office space with sweeping views of the Front Range. The research labs include simulation rooms where implants are placed in simulated spines and tested using machines that mimic the human forces of standing, sitting, walking and lifting. With the new facilities, the company hopes to delve further into the research of new robotic tools and devices that would provide minimally-invasive spinal surgery.

It should be noted that a move of this magnitude suggests pre-planning that predates the acquisition of LDR; just a little over a year from the signing of a certain letter of intent. We know from the blog post “Who’s Next” that Zimmer had been considering buying LDR back in 2011 along with Biomet, K2M, & Amedica. Zimmer has acquired two of the four obviously while seemingly gearing up to acquire Amedica. I wonder if Zimmer’s acquisition of LDR was in part for acquiring LDR’s global sales presence in spine? Zimmer spine was primarily geared toward the Americas. LDR’s global sales force/connections would allow for quicker execution of spine sales on the global front, once cleared. Obviously Zimmer’s sales partnership with JMDM in Japan would provide similar synergy once Si3N4 is cleared in Japan.

I’m sure i don’t need to point out that this is a significant move by Zimmer, relocating its Spine division and expending the resources to  establish a Spine HQ that is similar in size to that of the companies main HQ in Indiana. Seems like a significant investment for a division that is its weakest. Maybe has something to do with this goal: Zimmer Biomet Rides on Spine Business, Knee Challenges Stay

This is in line with the strategy to grow through inorganic means by focusing on mega acquisitions.

Management is also striving to develop spine portfolio in order to cash in on the opportunities.

Zimmer currently has only 6% market share in spine & 10% in dental according to its 10k. Spine represents a major untapped global market with its $10+ billion annual sales potential. Dental adds another 4 Billion. (Dental is under the Spine division). Smart move for Zimmer is to invest in Spine. What better investment than a product that fuses as well as Autograft, kills bacteria, prevents osteolysis, & is bioactive thus body can remove excess buildup from normal implant degradation.


 

KYOCERA Expands Industrial Ceramic Manufacturing Operations in Washington State

Kyocera, currently a partner with Amedica, had a grand opening of a new building of their manufacturing facility in Vancouver, WA April 20th 2017.

Kyocera International, Inc. conducted a grand opening ceremony today for a $10 million expansion of its manufacturing operations here.

The newly constructed building on the Kyocera site at 5713 N.E. Fourth Plain Boulevard expands the company’s local 40,000-square-foot manufacturing presence by more than 50 percent, to 63,000 square feet

Originally conceived as a R&D based facility, Kyocera’s Vancouver location has now been converted to full manufacturing facility specializing in “custom-order manufacturing site specializing in high-added-value components made from advanced ceramic materials”.

Amedica first signed its partnership with Kyocera on November 26th 2013 to take on the role as a backup manufacturing partner  It always struck me as odd that the 6th largest ceramic company in the world signed up as a contract manufacturer for Amedica when Amedica’s sales were so small. However if this was done because Kyocera would one day produce for Zimmer, well that seems more likely; unless of course Kyocera wanted to buy Amedica one day.

The story of Kyocera’s Vancouver plant is interesting. First part obviously it being a R&D based location that converted to custom order shop. Second though is the fact the new building, first announce June 2014, was only supposed to be 13,000 sq ft.

How so many random events line up so well with Amedica is something i find interesting. One year after the announcement that Kyocera was contemplating expansion in Vancouver, it was revealed that the new building would increase 5000 sq ft (~28%) over first planned. This isnt the part thats interesting however, what is interesting is this was revealed July 21st, 2015 just 2 days before Amedica announced the letter of intent with an unknown ortho company (linked above). So many coincidences.

The story doesn’t end there though. No, Kyocera breaks ground on its new building just 1 week after Amedica revealed its 10 year distribution agreement with Weigao Orthopedics in China, April 25th, 2016. Not only that, but at some point during construction Kyocera added another 5,000 sq ft to the new building which brings our total to the 23,000 sq ft announced above.

Is it possible im reading into this? Certainly. That said i see too many coincidences to ignore this. I leave it for you to decide.

Might mean nothing but Westminster, CO is sort of the middle point between Vancouver, WA & Austin, TX.

 


Zimmer Biomet to Present at Jefferies 2017 London Healthcare Conference

Nov 08, 2017

WARSAW, Ind., Nov. 8, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that it will be participating in the Jefferies 2017 London Healthcare Conference on November 16, 2017, at 11:20 a.m. GMT (6:20 a.m. ET) (4:20 a.m. MT)

 

Nuvasive announced their acquisition of Vertera Spine just before Morgan Stanley HealthCare conference in September. Stryker announced their acquisition at NASS. Will Zimmer follow suit at Jefferies?

Why announce at investment conferences such as Jefferies Healthcare conference or major Orthopedic events? I’ll let Zimmer explain:

Zimmer Holdings, Inc. (NYSE: ZMH)(SWX: ZMH) announced today that it will conduct a meeting for investors and investment analysts on March 10, 2004, during the American Academy of Orthopaedic Surgeons meeting. The meeting will be held at the San Francisco Hilton, beginning at 5pm (PST), in the Imperial A Ballroom.

The meeting will be hosted by Ray Elliott, Chairman, President and CEO, and Sam Leno, Executive Vice President, Corporate Finance and Operations and Chief Financial Officer.

The investor meeting will include both presentations and a technology exhibit featuring products from Zimmer as well as products acquired through the Centerpulse transaction. These include Minimally Invasive Solutions(TM) (MIS(TM)) Procedures and Technologies, spinal systems, advanced bearing surfaces, orthobiologics, and Trabecular Metal(TM) Technology.

Zimmer Holdings, Inc. to Meet with Investment Analysts at American Academy of Orthopaedic Surgeons Meeting

Essentially it gives the companies a chance to sell their investors on technology they are acquiring or intend on acquiring & showcase their future in process products line.

Zimmer’s goal is to see year over year growth of 2-4%. As I’ve pointed out before, they need help to achieve this through acquisition of new differentiated technology like Silicon Nitride. Silicon Nitride can help in areas Zimmer’s weakest in, Spine & Dental, as well as potentially boost sales in Knee & Hip in the future but at the very least save on cost of goods sold (3D printed porous Silicon  Nitride will provide significant reductions to cogs in future).


Zimmer GK obtains new loan worth $189 million US.

On September 22, 2017, Zimmer Biomet G.K. (the “Borrower”), a wholly-owned subsidiary of Zimmer Biomet Holdings, Inc. (the “Company”), entered into (i) a Term Loan Agreement (the “New Term Loan Agreement”) with Sumitomo Mitsui Banking Corporation (“SMBC”), for a new ¥21.3 billion term loan, and (ii) an Amended and Restated Term Loan Agreement (the “Restated Term Loan Agreement,” and together with the New Term Loan Agreement, the “Loan Agreements”) with SMBC, which amends and restates that certain ¥11.7 billion Term Loan Agreement between the Borrower and SMBC dated as of May 24, 2012, as amended by the First Amendment dated as of October 31, 2014, and which Restated Term Loan Agreement further extends the maturity date of the ¥11.7 billion term loan, reflects name changes and makes certain other changes. The term loans under the Loan Agreements will mature on September 27, 2022 and bear interest at a fixed rate of 0.635% per annum.

Zimmer GK formally Zimmer KK, is a Zimmer subsidiary in Japan with offices in Tokyo. The same company that provided the liners for testing used with Amedica’s femoral heads; Amedica Announces Results of Independent Femoral Head Wear Testing Zimmer GK also has a Joint Sales Agreement with JMDM. Amedica’s Valeo implants are due for clearance in Japan “very soon” according to Dr. Bal.

In November 2009, we concluded a joint sales agreement with Zimmer K.K. to further strengthen our product lineup and promote joint sales, thus expanding our market share at the same time.

 

Comparable Company Analysis

Medtronic merges with Spinal Dynamics Corporation

According to above source, Medtronic merged with SDC for $269.5 million in cash and stock. This represented a 54x premium over revenue, around $5 million annual.

Snap928.jpg

What is it about Spinal Dynamic that made Medtronic pay that level of premium. From what i can gather, SDC’s BRYAN Cervical Disc was a truly unique product. They only had CE clearance in Europe, but had ~1,000 devices  implanted at the time. SDC was in the midst of putting together its trial and it looks like Medtronic bought them out to inject the capital needed.

Now you could ask, if Si3N4 is so special why didn’t Zimmer do the same thing? Well i believe Zimmer was a little gun shy to take on the risk given the issues shown in its clinical study for Cervical Trabecular Metal device which failed to fuse at acceptable levels. What gives us clues is the fact that Zimmer consulting surgeons ran Amedica’s Cascade/SNAP trials & that a leading orthopedic firm signed the letter of intent development agreement with Amedica in 2015 as Cascade trial came to a close. This suggests that Zimmer wanted people it could trust running the trial and that once results showed Si3n4’s success, Zimmer immediately  entered into the letter of intent. Of course we do not know for a fact Zimmer signed the letter of intent with Amedica but there is sufficient circumstantial evidence to suggest it; one might even say “there is a prima facie case there”.

I cover Zimmer’s surgeons involvement in my blog post, Zimmer & Amedica Connections via Personnel. I also cover Zimmer’s trial issues and letter of intent in this blog post,  Exposè on the failure of Zimmer’s Trabecular Metal, how Si3N4 can fill the void, & the future


Zimmer Acquires Implex

While Zimmer’s upfront acquisition costs was $108 million, earn out payments increased the total acquisition amount to $225.3 million

The aggregate cash consideration paid by us through December 31, 2006 was $225.3 million, consisting of a $98.6 million payment at closing, $2.6 million of direct acquisition costs and $124.1 million of earn-out payments made pursuant to the merger agreement.

Zimmer’s 2006 10k page 52

I have mentioned Implex before on previous posts, but I wanted to go into the company in more detail especially as its very similar type of acquisition as any company would of Amedica.

Implex produces a porous version of Tantalum which Zimmer eventually marketed under the trademark, Trabecular Metal. Zimmer believed that Trabecular Metal would mark the next evolution in orthopedics due to its similar nature to trabecular bone.

“We call Trabecular Metal ‘the best thing next to bone’ because we believe it is the most exciting new porous material platform the orthopaedics industry has seen in decades,” said Ray Elliott, Zimmer Chairman, President and CEO. “We look forward to applying our extensive development resources to the application of the technology in new areas. We intend to expand the existing Implex line of spinal products that incorporate Trabecular Metal Technology, which have already been implanted in Europe and the United States, into our new Zimmer Spine division. We believe Trabecular Metal has the potential to give us opportunities in the fusion and non-fusion spinal categories that other competitors cannot match.”

As i previously discussed in my blog post, Exposè on the failure of Zimmer’s Trabecular Metal, how Si3N4 can fill the void, & the future, Trabecular Metal did not reach the level of fusion success that Zimmer had hoped, particularly in spine. Other applications like hip and knee seemed to fuse well but the products did experience recalls. I believe trabecular metal dental implant ran into similar fusion issues and did have issues with bacteria.

While Trabecular Metal (TM) did not reach the clinical results later on, Zimmer was very successful in marketing TM. In fact when Zimmer signed the exclusive distribution and development deal with Implex in 2000, Implex’s revenue was in the $15-30 million dollar range; not unlike Amedica. I ‘m guesstimating here, but it seems likely that at the time of acquisition, Implex revenue was around the $40 million dollar level; this assumes Zimmer took 30% off the top. Watch how quickly revenue grows just 2 years after acquisition of Implex.

2004 10k pg 21

Prior to the acquisition, over 90 percent of Implex sales were Trabecular Metal Technology sales to the Company. Therefore, the acquisition did not result in the immediate addition of significant new customers or sales for the Company.

2005 10k pg 24

For example, during the year ended December 31, 2005, sales of products incorporating Trabecular Metal Technology were over $100 million, an increase of nearly 40 percent over 2004.

2006 10k pg 24

For example, during 2006, sales of products incorporating Trabecular Metal Technology were over $165 million, a year-over-year increase of over 40 percent.

2007 10k pg 23

For example, during 2007, sales of products incorporating Trabecular Metal Technology were over $210 million, a year-over-year increase of over 26 percent

By 2008, despite TM being used in many products, revenues for TM were negatively impacted due to a product recall of Zimmer’s Durom Cup. Zimmer began experiencing customer attrition due to this recall.

This would be the first of many recalls TM based products would face. Despite the problems, TM has still performed fairly well for Zimmer in the Hip & knee arenas. However if you look at Zimmer’s Spinal & Dental revenues, they fall way behind the leaders at just 6 & 10% of market. Its not the issues I wish to focus on at this time, its the growth of sales of TM out of the gate.

90% of Implex’s revenue was generated by Zimmer. Despite that fact, Zimmer was able to increase revenues of TM based products an average of 44% a year for the first 3 years.

 


 

How Amedica compares to Spinal Dynamics & Implex

 

Right out of the gate, it should be noted that neither Implex nor Spinal Dynamics had clinical studies documenting results. Scientifically the technologies were sound but did not have the supporting clinical data. Amedica’s Si3N4 however has two trials proving how well Si3N4 fuses with bone along with numerous scientific studies. Think about that for a minute, Si3N4 risk factor is significantly lower than both SDC & Implex’s technologies were at the time their companies were acquired.

Spinal Dynamics had little revenue, however, Medtronic did not seem to care because it wanted the technology. Implex’s revenue was likely worse if you take Zimmer out of the equation.  At least TM was FDA approved while SDC’s Bryan Cervical Disc was awaiting its trial to start; cleared 2007 after trial completed December 2006.

Revenue was not a driver of either acquisition. In both cases it was about what the acquiring company could do with the technology.  Both SDC & Implex had 1 customer in their acquirers. Amedica however has several customers & potential customers.

Amedica has several distributors, hospitals, & surgeons in its current customer pool. However, Amedica also has several very large partners that could be potential customers outside of Zimmer.

In the US, Amedica has DENTSPLY, a multi-billion dollar company that groses approximately 1 billion a year in dental implant sales.

In Japan, a market still pending, Amedica has 2 major partners. Kyocera another billion dollar company,  aids in manufacturing of Si3N4 is also a major testing partner of its products. It should be noted that Kyocera does not currently sell spinal based products; could Kyocera be a distribution partner in Japan after clearance? NGK is the other partner in Japan which develops and sells ceramic based products primarily non-medical. According to CEO Dr. Bal, NGK is very interested in getting into the Si3N4 market. In my blog post, Six Degrees of Zimmer-Biomet, I touch on the subject of NGK’s current objectives. It should also be noted that NGK owns 30% of Japan’s MDM which functions as its distribution arm for medical devices; JMDM has a joint sales agreement with Zimmer GK.

In China, Amedica has a purchase agreement in place with Weigao Orthopedics for 425,000 units over the span of 10 years with the option for an 11th year. Starting year 1, its 25,000 units and it rises from there until it reaches 50,000 units a year. If the numbers are correct here: Spinal fusion market value in China to grow to $665m by 2020, then the avg cost per surgery for the interbody device & pedicle screw system is about $4,500. Without knowing the cost of pedicle screw system versus interbody device lets say 50/50, then remove Weigao’s cut of say 35%, means average ~$1500 a unit or about $37.5million year 1. (These numbers are not to be consider hard numbers but for visual purposes). Of course this particular revenue source is pending CFDA clearance and that is on hold atm as Amedica looks for a way to obtain clearance without exposing it’s IP. The good news is this delay has allowed CFDA to enact some new policies this year allowing for foreign trial data & increasing IP protection. I am not sure if the changes are sufficient. Imagine a deal of comparable size in Japan (fewer units but higher cost per unit). Also Weigao isn’t just interested in Si3n4 for Spine products but also intends to purchase Hip/Knee when available. Weigao alone represents a large future revenue source after M&A.

Lastly there is Morgan Advanced Materials which is currently working with Amedica on developing Si3N4 metal brazed products for Spine & Hip. What does Morgan get out of this relationship? Well Morgan is also using this same technique for aerospace applications, possible for NASA. Apparently there is something different about Amedica’s formulation/manufacturing process that yields differentiated results from standard Si3N4 in the non-medical industry. I assume results are superior or I doubt Morgan would be co-developing this.


 

Summary

Any product that represents a true leap in evolution in technology will always get a major premium over me too companies. Revenues are not a major concern when dealing with leaps in technology especially in the medical field. Instead proving product, aka De-risking it (like superior Phase 3 results), is more important and in my opinion increases the potential premium.

That said, Amedica brings with it addition pending markets in China, Japan, & Australia as compared with Implex & Spinal Dynamics. Not only that Amedica brings with it major players in both ceramics & orthopedics including 1 very lucrative deal already in place. All this increased Amedica’s valuation immensely over Implex & Spinal Dynamics.

Let me leave you with a statement from CEO Dr. Bal and a basic valuation formula:

Our presentations will demonstrate the rationale for using our proprietary silicon nitride composition in a variety of medical applications within the $15 billion surgical spine, dental, hip and knee replacement markets,” said Dr. Sonny Bal, Chairman and CEO of Amedica Corporation. “This scientific data will convincingly demonstrate the serious limitations of other existing biomaterials, while highlighting the advantages of silicon nitride, even as we continue further testing on an improved second generation silicon nitride composition. I’m very proud of our continued innovation and robust science, which will be presented at this important orthopedic forum.”

Amedica to Present Research Supporting Favorable Silicon Nitride Findings at the Orthopaedic Research Society Annual Meeting

PV = (Worldwide implant market X 0.30 (penetration rate)) x 2.0 (sales multiple for tech leader)
all discounted back 5 years using a 15% time/risk discount rate…

PV = Present Value in todays dollars

Implant Market figures are gross sales numbers…
(take current figures and add 25% to allow for growth with 2nd gen and 3D printing and aging of population etc)
Assumes 5 years to penetrate market

Stealthways

Certain R&D Agreements Part 2: Natural Bone Regeneration

In my previous post, Certain R&D Related Expenses, i indicated that I believed that Zimmer had paid Amedica $2.5 million as a milestone payment, likely upfront, for one of three potential products in development. The product that seemed most likely to warrant a payment is the Si3N4 version of Ardis. It has been my belief that Zimmer signed the letter of intent in 2015, discussed in my blog post Exposè on the failure of Zimmer’s Trabecular Metal, how Si3N4 can fill the void, & the future, to develop a Si3n4 version of Ardis. It is also possible that the payment was in relation to a co-developed hip implant that recently tested Amedica’s femoral head against Zimmer’s liners; which Zimmer GK (Tokyo Office) so graciously provided for testing. The third possible payment was in relation to a dental implant. While i still believe they are developing a Si3n4 dental implant with  Zimmer, we have recently found out that the dental implant Dr. Bal has mentioned during conference calls, is for DENTSPLY. That fact reduces the likelihood of the payment being dental related. That said, just like Zimmer’s development deal that begin with Implex in 2000, i would expect Zimmer to have several projects in development with Amedica (Zimmer had 7 products in development with Implex) . Of course this is all speculation but if you read through my blog, you’ll find many pieces of evidence connecting Amedica & Zimmer.

Whats the purpose of this blog post? Well I wanted to take a moment to highlight the fact that when Zimmer pays out Certain R&D related payments, Zimmer acquires a company. It should be noted that Zimmer does not make these payments often. Payments took place in Q2’17, Q1’14, Q2’13 & I believe the next previous payment occurred 2006-2008 timeframe. I mention this only to point out that these payments are not part of Zimmers regular R&D operations.


NORMED Medizin-Technik GmbH

2013CertainR&D.jpg

Q2’2013 Zimmer paid $800,000 to an undisclosed company for a project under development. June 4th, 2013 Zimmer announced acquisition of NORMED Medizin-Technik GmbH. In the press release it stated the following:

The acquisition of NORMED will strengthen Zimmer’s Extremities and Trauma product portfolios and new product development capabilities in the fast growing foot and ankle and hand and wrist segments.

There is no groundbreaking piece of information contained in this quote, but it does indicate that the addition of NORMED increases Zimmer’s extremities and Trauma portfolio as well as provides opportunities for additional product development. This is very important distinction compared to Zimmer’s other acquisitions, like its acquisition of Knee Creations:

“The acquisition of Knee Creations’ revolutionary Subchondroplasty treatment provides Zimmer with another clinically differentiated offering that addresses an unmet clinical need.”

Knee Creations was acquired by Zimmer May 2013, 1 month before Zimmer’s NORMED acquisition. Unlike NORMED, Knee creations seems to be an acquisition to simply fill the gap in Zimmer’s product portfolio instead of providing future product development opportunities. This also can be seen in Zimmer’s merger with Biomet and acquisition with LDR. Zimmer did not pay out Certain R&D related payments in relation to these M&A transactions because there was no joint development opportunities. Instead, Biomet & LDR simply fill the gaps of Zimmer’s portfolio and business operations.


 

Zimmer Acquires ETEX Holdings, Inc.

2014CertainR&D.jpg

Q1 2014, Zimmer paid $4,500,000 to an undisclosed company for a project under development. Zimmer’s only acquisition in 2014 was its acquisition of ETEX Holdings, Inc in October 2014. Unlike NORMED acquisition, the press release about Zimmer’s acquisition of ETEX Holdings did not mention future product development. However, at the time of the $4.5 million dollar payment, ETEX had a FDA pending application for ETEX CarriCell® Bone Substitute Material.FDA did not clear this product until after Zimmer’s acquisition of ETEX, February 20th, 2015.

I believe Carricell is exactly what Zimmer was after!

Since 1989, ETEX has been focused on Dosuk Lee’s vision of providing clinical solutions that advance the orthopaedic standard of care. His breakthrough technology in biomimetic calcium phosphate, which mimics the chemical and structural features of human bone, promotes natural bone regeneration that positively impacts patients’ lives.

Read this quote and really let it sink in. Carricell is a calcium phosphate product that minics chemical and structural features of human bone! It promotes natural bone regeneration that positively impacts patients lives. Well so does Amedica’s Silicon Nitride!


 

Why Material Matters!

Snap852.jpg

 

Implex, ETEX, & now Amedica. What do all three of these companies have in common? All three companies were developing products that enhanced bone fusion naturally by mimicking trabecular bone. Implex’s tantalum material did find some level of success in this arena but did fall short in other applications. ETEX’s calcium phosphate is used a bonegraft substitute. I havent done the research to see how well it performs. Amedica’s Silicon Nitride has successfully been found to experience bone ingrowth similar to that of autograft, the current gold standard. Porous Si3N4 not only mimics trabecular bone, but its surface chemistry encourages and enhances bone growth onto and into the implant. This is just Amedica’s first generation formulation. They have since developed an enhanced formulation that increases osteoblast activity & Hydroxyapatite formation.

Zimmer’s modus operandi is pretty clear, they desire to find materials that can truly provide natural fusion similar to that of a patient’s own bone. Not only that, Zimmer always acquires companies after it pays out Certain R&D related payments. There has been no acquisition so far in 2017 to follow Q2’s payment but you can better believe its coming soon. Amedica can’t M&A until its loan is paid off; due to be paid off by Jan 1st 2018 or sooner.

On a slightly different note, its curious that Zimmer still hasn’t disclosed anything about its open CEO & President of Spine positions.

Porous Fusion Device

For sometime i have been trying to determine what 510k application Amedica submitted December 2016. I had thought it was a modified version of their Valeo C + CsC with a hole drilled in the middle of CsC. How silly of me. What Amedica in fact submitted was a porous version of their Valeo C implant. Think of Zimmer’s Ardis TM Cervical implant.

Zimmer’s Ardis Cervical Implant

Amedica’s Valeo C Implant

Now try to picture a porous version of Valeo C. Based on the description in the PR about the 510k, i believe that is what Amedica submitted December 2016.

application with the FDA, with a modified CsC-based cervical implant that is comparable to Amedica’s own commercially-available Valeo®C cervical implants.

Amedica Announces Positive Scientific Data and Re-files FDA Submission

The description is CsC based cervical implant similar to their Valeo C cervical implant. CsC stands for Cancellous Structured Ceramic, essentialy Si3N4 with porousity similar to that of bone. The description indicates Valeo C so the implant may look more like their first model instead of second.

Amedica recently filed its 10k in late September which had the same language, suggesting the 510k was still under review:

We have since re-filed a 510(k) premarket application with the FDA, for a modified CsC-based cervical implant that is comparable to our own commercially-available Valeo®C cervical implants.

Amedica 2016 10k pg 12

UPDATE


Above quote mentions a CsC-based implant. Now lets look at the other device mentioned in the 10K

In December 2016, we re-filed an FDA 510(k) submission for clearance in the United States of a modified novel composite spinal fusion device that combines porous and solid silicon nitride, and obviates the need for bone grafts that is comparable to our commercially-available Valeo®C cervical implants.

As you can plainly see, there are in fact 2 different submission made to the FDA December 2016. One is the novel composite device mentioned above quote the other is the CsC-based device similar to Valeo C. Yesterday we saw clearance of the Novel composite. Still pending is the CsC-based device.

Just to add more credence to my evidence, i stumbled unto this quote today while searching for where Dr. Bal mentions their addressable market would be 4 billion after clearance. During D1’16 CC, Dr. Bal said this:

We have prepared to launch porous silicon nitride and specifically our composite device shortly after receiving clearance from the FDA.

Unfortunately, Seeking Alpha requires PRO subscription for this particular transcript, linked here, but fortunately I did manage to get a screenshot linked here.

As you can see Dr. Bal mentions launching porous Silicon Nitride, also referred to as CsC, along with their composite device.

For extra measure i am attaching screenshot of the various forms of silicon nitride:


Finally, CEO Dr. Sonny Bal gave a presentation at the Ladenburg Thalmann Healthcare conference with the following milestones:

In the upcoming milestones for 2017, is the following: “FDA Clearance: porous fusion device from spinal fusion surgery”

Not only is FDA still reviewing this submission, it would appear they expect it this year; of course you never know with the FDA. Thats what we are waiting on folks a porous version of Valeo C. I suspect that this clearance will happen before NASS (Review this post about my theory on NASS).

Obviously my thoughts that CsC based implant would clear October last year was off. Its possible that the novel composite device has to clear first to open up clearance for a porous fusion device. That particular application ran into a road block in 2017 and they resubmitted it Oct.

Note: Below is all material covered in previous blog posts.


The Letter of Intent

If you recall from my post Exposè on the failure of Zimmer’s Trabecular Metal, how Si3N4 can fill the void, & the future Zimmer’s TM Ardis implant did not fair well in its trial at all. In fact they had to cut off enrollment after 39 patients due to non-fusion issues. During the same month it was published, December 2011, about TM Ardics cervical trial failure, Amedica’s trial, Cascade, began recruiting. It has been my belief that Zimmer reached out to Amedica to say they were interested in Si3N4 but that they wanted to make sure your product can do what TM can’t. Sure enough, Cascade trial showed that Amedica’s CsC allowed for fusion at clinically the same rate as that of bonegraft; Cascade trial completed September 2015. July 2015 Amedica filed a Change of Control Agreement & released the following PR. (linked above under title Letter of Intent)

SALT LAKE CITY, July 23, 2015 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq:AMDA), a biomaterial company that has developed silicon nitride ceramics as a material platform to manufacture and commercialize orthopedic implants, is pleased to announce that it has signed an original equipment manufacturer (OEM) letter of intent supply agreement with a leading orthopedic device design and manufacturing company.

Under the proposed agreement, Amedica will assist this company with their proprietary design, development, manufacture and supply of silicon nitride spinal implants. The two companies will begin negotiating the definitive agreement once it is satisfied that all necessary and appropriate regulatory approvals can be obtained without significant expense. The agreement underscores Amedica’s continued focus to provide superior and innovative solutions to the market.

The day prior an anonymous person posted this on cafepharma:

Word on the street is a merger/buyout with Amedica….any info or thoughts?

Zimmer M&A Amedica?


What is a Letter of Intent?

A letter of intent or LOI is a document outlining an agreement between two or more parties before the agreement is finalized. A LOI may also be referred to as a memorandum of understanding (MOU), or term sheet. Although the terms refer to different documents, the differences are often formal in nature, reflecting different drafting styles or business customs, not a substantive difference in what these various documents accomplish. The term sheet, LOI, or MOU can be used for mergers, acquisitions, and joint ventures (also commonly referred to as business sale, business purchase, and business alliance). Further below on this page, we provide specific templates for each type of transaction.

The term sheet is the first step in the process leading to definitive agreements that will reflect the terms of the venture capital or other private equity transaction.

Term Sheet and Letter of Intent


What is Zimmer’s Stategy?

This is in line with the strategy to grow through inorganic means by focusing on mega acquisitions.

Management is also striving to develop spine portfolio in order to cash in on the opportunities.

Zimmer Biomet has been of late working to strengthen its foothold in the emerging markets that provide long-term opportunities. The company’s strategic investments in these regions over several quarters with a view to enhance operational and sales performance are yielding results.

Zimmer Biomet Rides on Spine Business, Knee Challenges Stay

Zimmer’s strategy is simple, acquire new technologies through the process of M&A and its focus is on 2 fronts, Spine & Dental.

Not only is it focused on acquiring new technologies, it is also trying to capture emerging markets of the Asian Pacific & in South America.

Amedica has clearance in Brazil, partial clearance in Australia, & is pending in Japan (clearance due very soon) & China; China is on hold for now until they can be assured that Amedica’s IP is adaquately protected.

Six Degrees of Zimmer-Biomet

For those of you unfamiliar with the game Six Degrees of Kevin Bacon, I’ll let wikipedia explain:

The Bacon number of an actor or actress is the number of degrees of separation he or she has from Bacon, as defined by the game. This is an application of the Erdős number concept to the Hollywood movie industry. The higher the Bacon number, the farther away from Kevin Bacon the actor is.

The computation of a Bacon number for actor X is a “shortest path” algorithm, applied to the co-stardom network:

  • Kevin Bacon himself has a Bacon number of 0.
  • Those actors who have worked directly with Kevin Bacon have a Bacon number of 1.
  • If the lowest Bacon number of any actor with whom X has appeared in any movie is N, X’s Bacon number is N+1.

Six Degrees of Kevin Bacon

The rules of Six Degrees of Zimmer-Biomet are a bit different in that we start with companies or personnel that have worked with Amedica and see if we can connect them back to Zimmer. Skip to corporate connections section of this blog post if you’re overly familiar with the personnel connections.

So far the results are:

  1. CEO Dr. Sonny Bal, MD, JD, MBA, PHD was a member of Zimmer’s Surgeon Panel from 2002-2014 (?). Dr. Bal has a score of 1.
  2. Former Amedica Chairman of the Board Dr. Max Link, PHD was CEO of Centerpulse when Zimmer merged acquired them in 2003. Dr. Link would have a score of 2. His interactions with Zimmer during the acquisition and afterwards could easily be seen as consulting position which would qualify him as having a score of 1.
  3. Vice President of Sales & Marketing Dana Lyons left his Area vice president position at Zimmer. His score is 1.
  4. Area Vice President of Sales & Director of Strategic Development, Ryan Long also left a regional VP position at Zimmer for Amedica. His score is 1.
  5. Dr. Mark P Arts, MD & Dr. Jasper Wolf, MD both are paid consultants of Zimmer. Score: 1
  6. Dr. Paul Saiz, MD consultant for Zimmer specializing in Trabecular Metal. Score 1
  7. Dr. Paul Suh, MD consultant for Zimmer & Amedica.
  8. Dr. Michael P Bolognesi MD Zimmer Prinicple Investigator, Amedica Advisory Board in 2011. Score 1.

All except Dr. Bolognesi, who will be added soon, are talked about in Zimmer & Amedica Connections via Personnel. Since they are human resources, their score only makes sense if its a 1; with exception of Dr. Link because of his interactions with Zimmer upper management. This has been discussed already. Time to move onto something new.


Corporate Connections

On Tuesday September 26th, 2017 , Dr. Bal gave a presentation at the Ladenburg Thalmann Healthcare Conference in New York. During the presentation, Dr. Bal disclosed a new partner in Japan, NGK-NTK Spark Plugs. This is what he had to say:

NGK-NTK wants to enter the Silicon Nitride biomedical implant industry and market and we are talking to them.

Notice of Capital and Business Alliance with Japan Medical Dynamic Marketing Inc. and Acquisition of Stock Shares

Take note that in parenthesis is the company Japan MDM. The reason for this is on April 20th, 2016 NGK-NTK acquired a 30% stake in Japan MDM.

Nagoya, April 20, 2016― NGK SPARK PLUG CO.,LTD.(Securities Code 5334, hereafter
referred to as “ NGK SPARK PLUG”, “Us”, or “We”) announced today that the company has decided to conclude a capital and business alliance agreement with Japan Medical Dynamic Marketing Inc. ( Securities Code 7600, hereafter “MDM”)
and stock transfer agreement with ITOCHU Corporation (Securities Code 8001, hereafter “ ITOCHU”) to acquire stock shares of MDM (both transactions collectively referred to as “the Alliance” or “Alliance”).

NGK Manifesto

In the 7th Mid-Term Management Plan’s “Evolving 3 years ’’ that started from April 2016, We announced the plan to “Develop existing and new business at an
accelerated rate” and are investing our management resources to apply core technologies to product development in the three market areas “environment and
energy”, “next generation vehicles” and “medical applications ” that are expected to grow.
Specifically, in the implant business of the medical applications , we continue to operate only in domestic production and sales of the various artificial bone products that are applied to ceramics technology. However, through the Alliance, we will expand our business domain to the production and sales of orthopedic implants products and promote the expansion of the ceramics products to the global market. NGK SPARK PLUG will also nurture the medical-related business as a new pillar of revenue and embark upon growing as a global manufacturer of comprehensive orthopedic implants.

Good news for Amedica is that NGK seems to be aggressively investing in the medical implant market and obviously believe it can do that using Amedica’s Si3N4.

If you look into the product offerings that JMDM has, their orthopedic product portfolio is rather barren if you ask me. However, you’ll come across the following quote:

In November 2009, we concluded a joint sales agreement with Zimmer K.K. to further strengthen our product lineup and promote joint sales, thus expanding our market share at the same time.

There we have it, Amedica is 3 degrees separated from Zimmer via its partnership with NGK. NGK is 1, JMDM is 2, Zimmer KK is 3. JMDM will be handling all of the medical device distribution so its really JMDM that would be handling Amedica’s products and possible Zimmers & Zimmer KK could sell Amedica’s products.

This leads me to one last interesting coincidence. September 28, 2017, Zimmer filed a 8k with the SEC indicating that it had changed the name of its Japanese Subsidiary Zimmer KK to Zimmer GK & that Zimmer GK had received a new loan in the amount of ~$189 million US. Other than the fact that the new name is oddly similar to NGK, there is no real connection based on this information. I bring it up only because i asked myself why is Zimmer maneuvering in Japan? Does it have any connection to Amedica’s current application for clearance of Valeo in Japan? Dr. Bal said of Japan PMDA approval during the conference, “he hoped for clearance very soon”. Very soon is subjective to the person however, but if you look at the bottom of my blog post Exposè on the failure of Zimmer’s Trabecular Metal, how Si3N4 can fill the void, & the future you’ll see that Amedica recently received ISO 13485:2016 certification. This certification is a big part of the final step in the PMDA process QMS conformity.  This suggests that Amedica is indeed very close to clearance as that was received almost 2 months ago. Zimmer’s rumblings in Japan in oddly timed with said approval. Only time will tell if the two points intersect.

I’ll be adding to this post as i find more connections like this.


UPDATE

As posted on cafepharma, this researcher found a link to a former(?) partner of Amedica and former employee of Zimmer Guy Mayer (currently on OSI board). This partner helped Amedica redesign its hip & knee implants.

May 2013, Zimmer President of the Orthopedics Implant Division joined Orthopaedic Synergy, Inc. as a BOD

The Board of Directors of Orthopaedic Synergy, Inc. (“OSI”) whose subsidiary companies include OMNIlife science®, Inc., Enztec, Ltd., and Praxim, SA, have elected two experienced directors to their Board. Guy Mayer,

https://www.prnewswire.com/news-rel…ions-to-the-board-of-directors-208198531.html

President of the Orthopedics Implant Division – Zimmer Inc

https://www.zoominfo.com/p/Guy-Mayer/382663

Late December 2013 – Early 2014, OSI helped them to design prototype of femoral heads to initiate the biomechanical testing with a strategic partner.

Our Total Hip Implant Product Candidates

We have developed two designs of femoral heads for use in our total hip replacement product candidates. Our first design is a silicon nitride-coated metal femoral head, for total joint replacement, which we plan to develop with a medical device partner. The second design is a femoral head that is made from our solid MC2 silicon nitride and we are collaborating with Orthopaedic Synergy, Inc. to develop a total hip replacement product candidate using this design. These femoral heads are expected to articulate against a cross-linked polyethylene liner, fixed into a metal acetabular cup. We intend to initially advance our process to develop silicon nitride-coated femoral heads and then, together with a strategic partner, initiate biomechanical testing with our silicon nitride-coated femoral head for use in total hip replacement procedures to support a 510(k) submission to the FDA. If clearance is obtained, we intend to commercially launch products for use in total hip replacement by the second half of 2015. Although we have designs for solid silicon nitride components, we have not yet determined if we will pursue the development of these components.​

 

In order to succeed in our joint commercialization efforts, we and OSI, and any future partners must execute effectively on all elements of a combined business plan, including continuing to establish sales and marketing capabilities, manage certified, validated and effective commercial-scale manufacturing operations, conduct product development and testing, and obtain regulatory clearances and approvals for our product candidate.​

https://www.sec.gov/Archives/edgar/data/1269026/000119312514124269/d698775d10k.htm

Who was/is that hidden strategic partner??? Look like they postponed the acquisition (as originally planned) to further testing the Si3N4 tech in other components like Spine, Dental, Knees, etc…

Index Page

This blog post will hold direct links to each of my pertinent posts. I’ll update it with with links to new posts and i’ll indicate when a post has been updated. This way you’ll know when there is something new to look at. If you are going to bookmark my blog, this is the page to do so.

Zimmer and Amedica

        1. Exposè on the failure of Zimmer’s Trabecular Metal, how Si3N4 can fill the void, & the future (Posted: September 11, 2017. Last Update: None)
        2. Certain R&D Related Expenses (Posted: September 12, 2017. Last Update: September 29nd, 2017)
        3. Zimmer & Amedica Connections via Personnel (Posted: September 12, 2017. Last Update: September 13th, 2017)
        4. Steps Taken in Preparation for Acquisition (Posted: September 13, 2017. Last Update: None)
        5. CNS & NASS 2017 Collaboration or Union? (Posted: September 14, 2017. Last Update: None)
        6. Six Degrees of Zimmer-Biomet (Posted: September 29th, 2017. Last Update: February 24th, 2018)
        7. Certain R&D Agreements Part 2: Natural Bone Regeneration (Posted: October 30th, 2017. Last Update: None)
        8. Comparable Company Analysis (Posted: November 6th, 2017. Last Update: None)
        9. Pertinent Filings & Press Releases (Posted:November 9th, 2017.Last Update: November 21st, 2017) Updated as relevant news is released.
        10. De-Risk: Another Step in Preparation for Acquisition(Posted: November 27th, 2017. Last Update: None)
        11. Conclusion Part 1: Timeline of Events  (Posted: December 3rd, 2017. Last Update: 1/21/2018)
        12. Conclusion Part 2: Inside Men, a Commentary (Posted: December 7th, 2017. Last Update: None)
        13. Amedica’s Three Year Audit (Posted: December 24th, 2017. Last Update: 1/21/2018)
        14. Zimmer’s Q4 Conference Call(Posted: February 3rd, 2018. Last Update: February 26th, 2018)
        15. Q4 & 2017 Revenue (Posted: February 22nd, 2018. Last Update: March 30th, 2018)
        16. Five Year Joint R&D Agreement (signed 2015) (Posted: April 2nd, 2018)
        17. Amedica’s Corporate Strategy, Need I Say More? (Posted: May 22nd, 2018)

Most Recent Update: Q4 & 2017 Revenue(Updated: March 30, 2018)

 

Silicon Nitride (Si3N4)

        1. Why Material Matters! (Posted: September 18, 2017. Last Update: None)
        2. Porous Fusion Device (Posted: October 13, 2017. Last Update: None)
        3. Amedica’s Silicon Nitride: Current and Potential Markets (Posted: December 10, 2017. Last Update: None)

Not Zimmer & Amedica related

Outside the Z&A box

Why Material Matters!

I have seen it said on numerous occasions that material doesn’t matter and that all materials work relatively the same. The context of this was in reference to spine where the main biomaterials have improved many of lives over the years.

From my research however i have seen sufficient evidence to indicate that material really does matter. So this post is going to explore the main biomaterials on market and it will show you why Silicon Nitride is simply the best material in terms of bio-compatibility.


PEEK

Enter a caption

One of the main drawbacks to PEEK in regards to osseointegration stems from its hydrophobic nature. As such the surface doesn’t promote cellular attachment which contributes to the body responding by encapsulating it in fibrous tissue.

However, the hydrophobic surface of PEEK implants induces fibrous encapsulation which is unfavorable for stable implant anchorage.

However, as with many other polymers, the relatively low surface energy of PEEK can limit osseointegration [4,5], potentially leading to fibrous encapsulation, implant loosening and reduced wound healing in applications requiring integration. Furthermore, the formation of a fibrous capsule around an implant can also provide a niche for contaminating bacteria to grow, isolated from the host vasculature and protected from the full extent of the immune system. Bacteria on the implant surface may then multiply, potentially forming a biofilm and causing infection of the surrounding tissue [6,7]. If the subsequent biomaterial associated infection (BAI) cannot be remediated by antibiotic therapy, often the only effective treatment is implant removal and tissue debridement [8]. However, in the case of spinal instrumentation, the requirement for vertebral stability means that these load-bearing implants cannot always be removed, making BAI, which occurs in 2–6% of these patients [9–11], difficult to fully eliminate [12].

Bacterial adhesion to orthopaedic implant materials and a novel oxygen plasma modified PEEK surface

One of the solutions to this problem is recently acquired Vertera Spine’s Roughened Porous PEEK implant. Vertera has shown pre-clinical trial osteogenises compared to smooth surface PEEK. Anyways, roughening the surface & creating cavities for bone & tissue to grow into does seem to be the direction the industry is going in for all materials. However, roughening the surface actually increases surface area and potential for greater bacteria adhesion.

In the above image, the rougher machined PEEK (PA) had a significantly greater number of adherent bacteria compared to injection moulded PEEK.

Implant-related infections are a serious complication in prosthetic surgery, substantially jeopardizing implant fixation. As porous coatings for improved osseointegration typically present an increased surface roughness, their resulting large surface area (sometimes increasing with over 700% compared to an ideal plane) renders the implant extremely susceptible to bacterial colonization and subsequent biofilm formation. Therefore, there is particular interest in orthopaedic implantology to engineer surfaces that combine both the ability to improve osseointegration and at the same time reduce the infection risk.

Staphylococcal biofilm growth on smooth and porous titanium coatings for biomedical applications.

The solution to increase osseointegration works but at a cost as it also means increased risk for bacteria adhesion. Notice the above quote said that its of particular interest for the orthopaedic implantology to engineer a surface that increases Osseointegration while reducing risk of infection. Silicon Nitride does exactly that! Surface chemistry modifications have only worked to improve that in what is currently being dubbed second generation Silicon Nitride.


Titanium and other metal implant materials

 

Titanium certainly does not have the level of issues of PEEK does in regards to osseointegration. Titanium is not hydrophobic like PEEK which allows greater osteoblast proliferation and attachment. Thus the body does not encapsulate it with fiborous tissue. A smooth surface titanium implant still shows a level of hydrophobic behavior which led to roughening the surface of Titanium to improve osseointegration. Also, as seen in the image above, a level of bacteria still adheres to the surface. As with PEEK, roughened & porous implants only work to increase the potential contact area for bacteria proliferation. Also like PEEK, orthopedic industry is looking for way to reduce bacteria adherence.

The main drawback of Titanium, or really any metal implant, is corrosion & degradation over time. This leads to metallic debris build up in the body.

It has recently been shown that titanium-based implants both corrode and degrade, generating metallic debris. There is some concern over the increased concentrations of circulating metal-degradation products derived from these implants, and their potential harmful biological effects over a period of time, including hepatic injury and renal lesions.
They found that control individuals had very low levels of titanium in the blood whereas titanium concentrations were significantly higher for all the patients with implants. The sensitivity of the method was such that the researchers were also able to show significant differences in titanium levels for different types of bone fixation devices.
Heavy metal: Titanium implant safety under scrutiny
Metal debris in the body can cause multiple different issues from allergic reations
Patients with an oral allergy demonstrate various clinical features such as burning or tingling sensations, generally associated with swelling, oral dryness, or loss of taste,27 or occasionally more common signs and symptoms (eg, headache, dyspepsia, asthenia, arthralgia, myalgia, etc).23,27 Allergy in the oral cavity manifests as erythema of the oral mucosa, labial edema, or purpuric patches on the palate, mouth ulcers, hyperplastic gingivitis, depapillation on the tongue, angular cheilitis, perioral eczematous eruption, or lichenoid reactions.23 Type I allergy may appear clinically in the orofacial region, in the acute form as swelling, may involve the upper respiratory tract, and be dangerous for the patient. In serious conditions, it may convert to urticarial reactions with or without tingling sensations confined to a small area in the oral or pharyngeal cavity.22
to possibly cell death as it damages proteins and protein expression.
Metal cytotoxicity, which may ultimately lead to cell death, can cause significant morphological changes, damage to proteins, and modified protein expression. Morphological changes have been observed after osteoblasts have been exposed to Co particles at concentrations of 100 μg/L or higher with the development of cytoplasmic vacuolations (4446). Proteins from the extracellular matrix such as bone sialoprotein, osteocalcin, and osteopontin are important for calcification of the bone matrix and can be used as markers of osteoblastic activity. These proteins are synthesized by osteoblasts and released into the extracellular matrix.
 Ultimately this leads to osteolysis & can lead to aseptic loosening.
Titanium discs with machined, sandblasted/acid-etched and sandblasted surfaces were subjected to ultrasonic scaling and we physically and chemically characterized the released particles. These particles induced a severe inflammatory response in macrophages and stimulated osteoclastogenesis. The number of released particles and their chemical composition and nanotopography had a significant effect on the inflammatory response. Sandblasted surfaces released the highest number of particles with the greatest nanoroughness properties. Particles from sandblasted/acid-etched discs induced a milder inflammatory response than those from sandblasted discs but a stronger inflammatory response than those from machined discs. Titanium particles were then embedded in fibrin membranes placed on mouse calvariae for 5 weeks. Using micro-CT, we observed that particles from sandblasted discs induced more osteolysis than those from sandblasted/acid-etched discs. In summary, ultrasonic scaling of titanium implants releases particles in a surface type-dependent manner and may aggravate peri-implantitis. Future studies should assess whether surface roughening affects the extent of released wear particles and aseptic loosening of orthopedic implants.
Total joint replacement, although considered an excellent surgical procedure, can be complicated by osteolysis induced by implant particles and subsequent aseptic loosening of the implant. The pathogenesis of implant-associated osteolysis includes inflammatory and osteolytic processes. The sustained chronic inflammatory response initiated by particulate debris at the implant-bone interface is manifested by recruitment of a wide array of cell types. These cells include macrophages, fibroblasts, giant cells, neutrophils, lymphocytes, and – most importantly – osteoclasts, which are the principal bone resorbing cells. The ‘cellular response’ entails secretion of osteoclastogenic and inflammatory cytokines that favor exacerbated osteoclast activity and enhanced osteolysis.

In summary, metal implants corrode and degrade over time, a process all biomaterials go through within the body. Titanium is insoluble and so collects within the blood causing allergic responses, heavy metal buildup/toxicity, & titanium debris induces greater osteocalogic response thus causing the body to essentially eat its own bone. A balance must be maintained between osteoblast & osteoclast activity. While the articles i chose focused more on Titanium this is generally true for all metallic implants.


ZTA (Zirconia toughened Alumina)

ZTA, a ceramic, primarily used for hip implants is actually bacteria resistant unlike the other materials covered so far. Bacteria resistance also known as bacteriostatic does not stop bacteria growth on the surface just reduces the likelihood of biofilm proliferation on its surface.  It has the best wear properties of any femoral head material currently on market and seems to be considered the golden standard in hip. I have not been able to find much in the way of negatives about ZTA in hip implants.

ZTA can shatter, so surgeons need to be careful in placement. Patients with these implants that fall could run into a situation where the impact of the fall causes the femoral head to shatter. These types of situations are rare as they are disastrous.

Research conducted in 2015 reviewed five high-qualities studies investigating the clinical outcome of persons receiving an all-ceramic hip implant. In total, 897 patients were included. The mean duration of the combined studies was 8.4 years, while the mean age of the participants was 54.5 years.

Based on the analysis, the investigators were able to conclude that the persons offered an all-ceramic implant had lower rates of revision surgery, bone deterioration, and the loosening and/or dislocation of the device compared to metal-and-plastic implants.

The two major drawbacks, by comparison, were a greater likelihood of squeaking and a higher risk of damage to the device during the operation (such as cracks or chips caused when the device was accidentally dropped).

In addition, there is a small risk of a so-called “catastrophic failure,” wherein a serious fall or impact could potentially shatter the ceramic.  Fortunately, newer composites have proven far more resilient and impact-resistant than earlier generation ceramics. Facts About Ceramic Hip Replacements

Where the above article is incorrect is ZTA femoral head articulating against a poly liner still can cause osteolysis.

My guess is this has more to do with the poly liner debris & metal portions of the implant causing an inflammatory response than it did ZTA debris. Poly liner debris is not used in a ceramic and ceramic (C-o-C) hip implant so there is no issue here. That said, C-o-C hip implants have the unfortunate side effect of squeaking. Ultimately though I think the real drawback for these types of implants are in fact their metal shells & metal femoral stems. This is because polished ZTA is not osseointegrative limiting the shells and stems to manufactured out of some sort of metallic material.

This is where things get a little darker in the world of ZTA because it appears that someone is trying to increase ZTA ossoeintegration by a process known as nano-etching.

In the present work, we propose an innovative strategy to provide both osseointegrative and antibacterial properties to ZTA surfaces: we demonstrate that injection molding allows a flexible design of surface micro-topography and can be combined with selective etching, a novel process that induces nano-roughness and surface interconnected porosity without the need for coating, avoiding reliability issues. These surface modifications have the potential to improve osseointegration. Furthermore, our results show that the porosity can be used for drug delivery and suggest that the etched surface could reduce bacterial adhesion.

Selective etching of injection molded zirconia-toughened alumina: Towards osseointegrated and antibacterial ceramic implants.

Sounds promising so far right? Well there will be an unintended consequence of this process. The problem arises when you switch to nano level of ZTA. It appears micro sized debris is rather benign, but nano particles are not. I’m not sure why micro particles are safer but particle size does seem to matter across all materials.

Nanoparticles In addition to the positive aspects of tending to its toxicity in the environment is unavoidable. This research studies the effects of ZrO2 NPs on the liver and kidney tissues as well as the activities in liver and kidney enzymes in the male rats. This study is done on 40 Wistar rat race, in 4 groups which includes on control and 3 experimental groups that are monitored daily, for the control group we give a Saline Solution and 3 other with 1ml/day nanoparticle by different
doses (50,25,100 ppm) intra-peritoneally. After a 1 week period, samples were unconscious, blood sample were collected from the heart and the ALT, AST, ALP and creatinine were measured. Post-treatment tissue level of malondialdehyde as well as the activities of catalase, glutathione peroxidase and superoxide dismutase were measured in the liver. The statistical raw data was analyzed by SPSS statistical software. The significant difference (p<0.05) in the levels of foregoing factors was obtained by the application of the maximum density of ZrO2NPs (100ppm) in comparison with the control groups. The rats when exposed to a high dosage of nanoparticles reported a significant increase in MDA concentration level while significant decreases were observed in GPX , CAT and SOD activities (P<0.001). In the rats which were exposed to high dosage of nanoparticles, the liver enzyme concentration was significantly increased (p<0.05). The obtained
results revealed the significant role of ZrO2 as an increasing ROS generation agent and the ROS have induced the development of free radicals.

Potential toxic effects of Zirconia Oxide nanoparticles on liver and kidney factors.

Manufactured nanoparticles of aluminum oxide (nano-alumina) have been widely used in the environment; however, their potential toxicity provides a growing concern for human health. The present study focuses on the hypothesis that nano-alumina can affect the blood-brain barrier and induce endothelial toxicity. In the first series of experiments, human brain microvascular endothelial cells (HBMEC) were exposed to alumina and control nanoparticles in dose- and time-responsive manners. Treatment with nano-alumina markedly reduced HBMEC viability, altered mitochondrial potential, increased cellular oxidation, and decreased tight junction protein expression as compared to control nanoparticles. Alterations of tight junction protein levels were prevented by cellular enrichment with glutathione. In the second series of experiments, rats were infused with nano-alumina at the dose of 29 mg/kg and the brains were stained for expression of tight junction proteins. Treatment with nano-alumina resulted in a marked fragmentation and disruption of integrity of claudin-5 and occludin. These results indicate that cerebral vasculature can be affected by nano-alumina. In addition, our data indicate that alterations of mitochondrial functions may be the underlying mechanism of nano-alumina toxicity.

Manufactured Aluminum Oxide Nanoparticles Decrease Expression of Tight Junction Proteins in Brain Vasculature

The technique that they want to use to increase osseointegration would allow nano-sized debris to get into the bloodstream potentially causing issues with both the liver/kidneys and blood brain barrier.

In summary, ZTA may work well in the C-o-C setting but it may not the best material for C-o-P due to buildup of oxygen on the poly liner. ZTA has issues with infection like all the biomaterials explored so far and has phase stability issues, but ZTA is by far the the best material for bearing like workloads. That said, since ZTA is not osseoinductive at this juncture, ZTA is still dependent on metal cups and femoral stems which do induce inflammatory responses in the body and this contribute to osteolysis limiting the lifespan of the hip implant.


Si3N4 (Silicon Nitride)

 

In the materials we have explored so far, bacteria infection is an issue for all of them. Inflammation leading to osteoclast activation & osteolysis seems to follow both the metal materials & PEEK. I bring this up because this is where Si3N4 comes in.

Silicon nitride has the right combination of strength, toughness, wear resistance, biocompatibility, bioactivity, bone integration, structural stability, corrosion resistance, and easier imaging, all of which are desirable in medical implants.

Not only does it do all the the above, Silicon Nitride is also bacteriostatic like ZTA, resisting bacteria production on its surface.  Not just bacteriostatic, Silicon Nitride is also antibacterial. It actually kills bacteria over time.

Organisms of Gram-negative phylum bacteroidetes, Porphyromonas gingivalis, underwent lysis on polished surfaces of silicon nitride (Si3N4) bioceramics. The antibacterial activity of Si3N4 was mainly the result of chemically driven principles. The lytic activity, although not osmotic in nature, was related to the peculiar pH-dependent surface chemistry of Si3N4. A buffering effect via the formation of ammonium ions (NH4+) (and their modifications) was experimentally observed by pH microscopy. Lysis was confirmed by conventional fluorescence spectroscopy, and the bacteria’s metabolism was traced with the aid of in situ Raman microprobe spectroscopy. This latter technique revealed the formation of peroxynitrite within the bacterium itself. Degradation of the bacteria’s nucleic acid, drastic reduction in phenilalanine, and reduction of lipid concentration were observed due to short-term exposure (6 days) to Si3N4. Altering the surface chemistry of Si3N4 by either chemical etching or thermal oxidation influenced peroxynitrite formation and affected bacteria metabolism in different ways. Exploiting the peculiar surface chemistry of Si3N4 bioceramics could be helpful in counteracting Porphyromonas gingivalis in an alkaline pH environment.

Silicon Nitride Bioceramics Induce Chemically Driven Lysis in Porphyromonas gingivalis

Silicon Nitride isn’t only unique because it naturally fights bacteria, it also aids in bone growth.

Considerable research has demonstrated that silicon has several biological functions in the human body, and many of these can be exploited therapeutically to improve bone health and accelerate healing. The many biomaterials that contain silicon all share the same fundamental property of providing a localized source of bio- available silicon in the form of silicic acid, which both directly affects cell molecular biology and has numerous direct and indirect effects on the extracellular matrix. As regenerative medicine strategies are now becoming more common in the clinic, tissue engineering via appropriate biomaterials will play a key role in optimizing approaches for optimum healing of the tissues and restoring function. Silicon has a proven record in being able to increase the bioactivity of various materials without adversely affecting their mechanical properties or inducing cytotoxicity, and so the future for carefully designed biomaterials containing silicon appears to be promising.

Silicon: The evolution of its use in biomaterials

As you can see the surface chemistry of Si3N4 reacts with the bodily fluid forming orthosilicic acid, calcium, phosphate, & carbonate ions. orthosilic acid forms  a silica gel on the surface layer which acts as a bed for apatite formation. Macrophages and osteoblasts attach to this silicia & apatite bed where they begin forming osteocytes and then actual bone.

No other implant material on market reacts with the body naturally forming the right environment for natural bone growth. This is what makes Si3N4 so special compared to the other materials.

Not only does Si3N4 stimulates osteoblasts, bone forming cells, it also inhibits osteoclasts.

By using different analytical techniques, the resulting data clearly indicate that biochemical reactions occurring at the Si3N4 surface provided silicic acid (H4SiO4) and ammonia (NH3), both of which were active in regulating cellular metabolism. It is postulated that osteoblast cells actually scavenged Si from silicic acid and used part of it to build (SiO4)4− tetrahedra while endocytotically internalizing Si-QDs. In turn, the newly formed Si-apatite and the Si-QDs affected the morphogenetic activity of the osteoblasts through expressing osteoprotegerin (OPG) and the bone morphogenetic protein 2 (BMP2); and while strongly stimulating osteoblasts, they also inhibited formation of osteoclasts.

Bioactive silicon nitride: A new therapeutic material for osteoarthropathy

PEEK, titanium, other metals, all cause inflammatory response in the body which stimulates osteoclast production. Mostly this is in response to implant debris from either wear or degradation that happens over time. Si3N4 doesn’t cause this response. In fact, because Si3N4 is soluble, the body can evacuate to prevent buildup in the bloodstream like the other materials.


In Conclusion

 

Material absolutely does matter. PEEK & Titanium cause inflammatory responses in the body while also being insoluble so particulate debris collects in the body. Both implant types are breeding grounds for bacteria especially when the surface is roughened to promote osseintegration.  ZTA is insoluble as well, but the micro debris does not seem to cause the level of harm of ZTA’s nano particles do. ZTA also suffers from infection issues despite showing bacteriostatic tendencies. Still if I had to choose i would choose a product which my body can naturally remove itself and can naturally fight bacteria which gets into every surgical site.

Si3N4 is soluble, it inhibits osteoclast cells that’s function is to reabsorb bone while promoting an environment that osteoblasts thrive in. Si3n4 doesn’t cause the inflammatory response and it fights against bacteria without the need of antibiotics.  Si3N4 has excellent imaging properties so doctors can monitor patient progress,

To me there is no debate here. Si3N4 is superior in pretty much every facet and is the most bio-compatible material. Look for more in-depth information in future blog posts.

CNS & NASS 2017 Collaboration or Union?

North American Spine Society

(October 25th-28th)


NASS 2017

First thing to note is that Amedica & Zimmer’s booths are right next to each other, side by side down the main aisleway. At the very least having Amedicas booth next to Zimmer will help draw more attention to Amedica. In addition to that Zimmer Spine has 2 suites, one of which is 50 x 10 & one of which is 15 x 10.  No other company currently has a session booth that exceeds 15×10 and only Orthofix has 2 suites.

NASS 2016

NASS 2016 Amedica & Zimmer-Biomet were on opposite sides of the exhibition but they did have their suites right next to each other. Amedica was soft launching their new Taurus screws plus showcasing CsC (not currently available in US market) and that was one of the reasons they have a booth 2016. More interesting is the lack of presence that Zimmer has 2016 compared to 2017. Zimmer acquired LDR July 2016 so why the lack of investment in 2016? What is Zimmer planning on showcasing at a Spine exhibit this year that needs a large session booth?


Congress of Neurological Surgeons (October 7th -11th)

 

CNS 2017

CNS 2017 doesnt put Zimmer and Amedica together like NASS, in fact they are on opposite sides of the conference from each other. What is interesting about CNS this year is the fact that Zimmer has 3 meeting suites. Examining 2016 you’ll see why its intriguing.

CNS 2016

CNS 2016 features a similar layout with Amedica on the opposite side but does have Zimmer & its recently acquired subsidiary LDR near each other. The part that matters is Zimmer had 0 suites despite acquiring LDR just 3 months earlier. As you can see, there was sufficient open space to add more suites.


 

Union of Partners

So the big question about CNS & NASS is why is Zimmer spine anteing up on their spinal presence this year? CNS seems less telling than NASS, but NASS seems to indicate a joint venture with Amedica by how their booths are next to each other along the main aisleway.

By itself this doesn’t indicate much but when you factor in the evidence from my previous blog posts it certainly seems to indicate that we may be hearing an announcement of something between the companies very soon. It could just be FDA clearance of Si3N4 Ardis or it could be merger announcement I’ve been anticipating for some time. Either way i believe Amedica’s & Zimmer’s long “secret” courtship is about to come into the light.

Steps Taken in Preparation for Acquisition

Golden Parachute

One day before announcing the signature of the letter of intent July 23, 2015, Amedica filed this change in control agreement:

On July 17, 2015, Amedica Corporation (“we,” “us” or the “Company”) entered into Change of Control Agreements (the “Change of Control Agreements”) with certain executives of the Company, including B. Sonny Bal, MD, the Company’s Chief Executive Officer and Ty Lombardi, the Company’s Vice President Finance and Principal Accounting Officer.
Among other things, the Change in Control Agreements provide that upon the consummation of a change in control, all outstanding options, restricted stock and other such rights held by the executives will fully vest. Additionally, if a change in control occurs and at any time during the one-year period following the change in control (i) we or our successor terminate the executive’s employment other than for cause (but not including termination due to the executive’s death or disability) or (ii) the executive terminates his employment for good reason, then such executive has the right to receive payment consisting of a lump sum payment equal to one-half his highest annual salary with us during the preceding three-year period, including the year of such termination and including bonus payments (measured on a fiscal year basis), but not including any reimbursements and amounts attributable to stock options and other non-cash compensation. Change of Control Agreements


2016 Annual Shareholders Meeting

During the 2016 Annual Shareholders Meeting, the board of directors asked for an increase in its equity incentive plan by 800,000.

The 2012 Plan currently authorizes the issuance of up to 342,425 shares of common stock (or 3.0% of outstanding shares at March 28, 2016) pursuant to awards granted under the Plan. Of those shares, 221,177 have been issued or are subject to outstanding awards, leaving only 121,248 shares available for future awards. The Board of Directors does not believe that the number of shares available for issuance under the 2012 Plan is sufficient in light of our compensation strategy and objectives. Accordingly, the Board is proposing to increase the number of shares available under the 2012 Plan by 800,000 shares, from 342,425 to 1,142,425, increasing the percentage ratio of the amount of shares available under the Plan to 10.0% of outstanding shares as of March 28, 2016. 2016 Annual Shareholders Meeting pg 16

10% of OS represents 2 x the percent of outstanding shares they wished to have available in 2015. Please note that a 15:1 reverse split was executed January 2015 so the amount of shares mention in the 2016 annual meeting represents 1/15th that of 2015.

The 2012 Plan currently authorizes the issuance of up to 3,568,181 shares of common stock (or 12% of outstanding shares at March 31, 2015) pursuant to awards granted under the Plan. Of those shares, 3,202,106 have been issued or are subject to outstanding awards, leaving only 366,875 shares available for future awards. The Board of Directors does not believe that the number of shares available for issuance under the 2012 Plan is sufficient in light of our compensation strategy and objectives. Accordingly, the Board is proposing to increase the number of shares available under the 2012 Plan by 1,000,000 shares, from 3,568,181 to 4,568,181, increasing the percentage ratio of the amount of shares available under the Plan to 5% of outstanding shares as of March 31, 2015. 2015 Annual Shareholders Meeting pg 16


BDO acquires Amedica’s Independent Auditing Firm Mantyla McReynolds, LLC

Chicago, IL – BDO USA, LLP, one of the nation’s leading professional service organizations, today announced an expansion into the Utah market through the addition of 64 staff, including 10 partners, from Mantyla McReynolds, LLC.  Founded in 1989, Mantyla McReynolds provides a full range of accounting and consulting services to a diversified client base of public and private businesses.  The firm has significant strength in the technology and life sciences, real estate, hospitality and entertainment, equipment leasing, outdoor recreation and ski resorts, auto dealerships, and manufacturing and distribution industries. Based in Salt Lake City, the firm has been a member of BDO Alliance USA since 2008.  The combination of BDO and Mantyla McReynolds is subject to customary closing conditions and is expected to be completed on July 1, 2016.

BDO USA, LLP Announces Expansion into Utah Through Addition of Mantyla McReynolds, LLC

One of the many services BDO provides, is Mergers and Acquisitions.

Sell-side Services

Providing focused, value-added approaches for sellers

Our M&A team offer a full spectrum of sell-side advisory services often working with entrepreneurs, private equity backed businesses and public companies amongst others.

Services include identifying key strategic buyers, negotiation to maintain competitive tension between potential buyers, general project management and deal execution.

We also assist private equity firms and corporate development teams to source acquisition opportunities.

Our sell-side services include:

  • Indicative Valuation
  • Preparation of Information Memorandum
  • Identifying and approaching potential acquirers/investors
  • Negotiation of indicative offers
  • Management of the due diligence process
  • Contractual negotiations through to completion
  • Taxation advice
 I cannot find this document, but this pertains to the acquisition of Centerpulse AG by Zimmer in 2003. Just so happens that the CEO of Centerpulse was also Chairman of the Board of Amedica after Centerpulse’s acquisition October 2003 until his passing in 2014. More on that can be found at Zimmer & Amedica Connections via Personnel.
 

BDO Visura is the Swiss branch of BDO Global. BDO USA, LLP is obviously the USA branch.


Staff Reductions including CFO & Investor Relations

On October 3, 2016, the Board of Directors of Amedica Corporation authorized the implementation of certain cost saving measures which included a reduction in staff of 21 employees, or approximately 38% of the company’s workforce as the result of a comprehensive business review to improve financial performance, increase operational efficiencies and strengthen the Company’s value proposition. The implementation of the staff reduction was started on October 3, 2016 and completed on October 4, 2016.

In connection with Amedica’s staff reduction, Ty Lombardi, the company’s Chief Financial Officer and Principal Financial Officer, left the employ of the company.

Layoffs are generally not a good sign but also can be a sign of acquisition particularly letting go of CFO, head of Investor Relations, & Controller (left Jan 2017). Those positions are redundant in a M&A scenario. Instead of paying employees to do these fuctions, Amedica has opted to use third party consultants to handle accounting & IR. I am not sure if BDO provides some of the CFO & Controller services or if another company is providing the services. Investor Relations however is being handled by a securities lawyer with M&A experience; former Chief Legal Counsel for Amedica 2015.

Kevin Ontiveros

Possess 20+ years of experience as in-house corporate counsel for publicly traded and privately held companies. Provide effective and strategic counseling and direction to public and private company boards’ of directors, C-level executives, other members of corporate management and business leaders. Excel in leading and motivating talented, dynamic legal teams. Advise the board and senior personnel regarding legal/legislative developments, laws, and regulations impacting company operations. Offer proven strengths in working with and supporting business units in commercialization and joint venture agreements, sales and distribution matters, merger and acquisition activities, and supply, manufacturing, and development agreements. Set internal governance policies and manage the impact of external factors. Anticipate issues and estimate risks strategically. Identify proactive solutions that will eliminate or mitigate risks. Create associations of trust and respect with key stakeholders. Deal with external parties (regulators, external counsel, politicians, and clients). Manage complex, significant matters that cut across legal and related areas.

Dana Lyons

Covered in my previous blog post, Mr. Lyons seemingly left his regional VP position at Zimmer to take over the role of VP of Sales & Marketing at Amedica. With it, Mr. Lyons brings his experience integrating  sales teams during the Zimmer Biomet merger and push sales growth before merger.

Ryan Long

Mr. Long is also mentioned in the previous post,  but his position of Director of Strategic Development is intriguing. While the actual post for the position was never made available, here are some common job functions of this type of position:

A note on the job description below: the numbers in { } are the number of times I came across that responsibility, in one turn of phrase or another.  I’m presenting the description in decreasing order of this number, assuming my sampling is a good reflection of what the market expects of VPCD’s.

  1. Develop strategic business plan and roadmaps for inorganic growth. {11}  Thinking of how to grow a company inorganically is likely to fill my waking moments and dreams very soon…and will be the topic of many blogs I suspect.
  2. Mergers and acquisitions, including setting objectives {7}, sourcing {4}, funding {2}, negotiation {4}, and post-deal integration {4}
  3. Oranization and management of due diligence projects (not necessarily all related to M&A activity) {7}
  4. Partner management, including alliances, joint ventures, and distribution partnerships {7}
  5. Revenue modeling and financial risk analysis of business opportunities {4}
  6. Development and monitoring of business performance metrics {3}
  7. Analyzing trends, including competitive {3}, market {2}, and regulatory/compliance {1}
  8. Optimize the company’s use of resources to achieve profitability, particularly reorganizations {2}
  9. Coordinate new market development, including new verticals and geographic expansion (particularly international) {2} VP of Corporate Development Position Description

The Seemingly Never-Ending Audit.

Amedica has been a public company for just over 3 years now from February 2014 – September 2017. For large corporate acquisitions, audits of the previous 3 years are generally required. Just so happens Amedica’s audit by BDO was officially disclosed in April and is still ongoing according to official accounts.

On March 31, 2017, Amedica filed a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission (the “SEC”) regarding its delayed Form 10-K. At that time, Amedica expected that it would be able to file the Form 10-K within the 15-day extension period provided by Form 12b-25. Amedica has subsequently determined that the Company will be unable to do so. The Company requires additional time to fully consider whether there is any potential impairment in relation to certain of its long-lived assets.

Amedica Announces Delayed Filing of Annual Report on Form 10-K and Receipt of Nasdaq Letter

From my research there are 2 main triggering events for an audit to Long-Lived Assets. The most common reason is drop in market value stemming from a downturn in market & or sales. The other major cause is done in preparation in selling asset/company.

It is hard to rationally believe that there has been a drop in market value when the orthopedic industry continues to grow each year. Sales did drop in 2016, but gross profit for Amedica’s Assets far exceed its booked value. It does not seem likely that this is the cause of the audit.

However an audit of long-lived assets due to preparation for M&A with Zimmer, based on preponderance of evidence, does explain the need for the audit.

For posterity sake, lets examine the other main causes.

  1. A significant decrease in the market price of a long-lived asset (asset group)
  2. A significant adverse change in the extent or manner in which a long-lived asset (asset group) is being used or in its physical condition
  3. A significant adverse change in legal factors or in the business climate that could affect the value of a long-lived asset (asset group), including an adverse action or assessment by a regulator
  4. An accumulation of costs significantly in excess of the amount originally expected for the acquisition or construction of a long-lived asset (asset group)
  5. A current-period operating or cash flow loss combined with a history of operating or cash flow losses or a projection or forecast that demonstrates continuing losses associated with the use of a long-lived asset (asset group)
  6. A current expectation that, more likely than not, a long-lived asset (asset group) will be sold or otherwise disposed of significantly before the end of its previously estimated useful life (the term “more likely than not” refers to a level of likelihood that is more than 50 percent)

    ASC 360 Impairment Testing: Long-Lived Assets Classified as Held and Used

We have already gone over 1 & 6. Number 2 does not apply as Amedica’s main two products are Silicon Nitride (Si3N4) & metal screws (pedicle screw system). Both product lines are still seeing value added to them as Amedica obtains government approval & tweaks its current designs.

Number 3: does not apply because there is no pending legal factors that Amedica is currently facing. In fact their only legal case pending 2016 was settled; lawsuit was over insufficient issuance of shares from warrant conversion and nothing to do with Amedica’s products.

Number 4: Does not seem to apply to Amedica.

Number 5: While Amedica does have operational losses, this is not incur losses from the production and sales of its long-lived assets. Like most orthopedic companies, Amedica enjoys healthy margins from each sale which helps cover the cost of SG&A. Amedica’s operating losses mostly stem from Research & Development costs as well as interest expenses to cover its debt obligations.

This is why Number 6, especially when combined with all the other evidence, is my logical reason for the audit.