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Xtant Medical Holdings, Inc. (XTNT)

Q4 2011 Earnings Call· Thu, Mar 22, 2012

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the Bacterin International Holdings Incorporated Fourth Quarter and Year End 2011 Conference Call. [Operator instructions] I would now like to turn the conference over to Guy Cook, Chief Executive Officer of Bacterin International Holdings. Please go ahead.

Guy Cook

Analyst · Caroline Corner with MLV & Company

Thank you, Douglas, and good afternoon, everyone. Thank you for joining us today to discuss our fourth quarter and year ended 2011 results. We issued a press release this afternoon announcing our earnings results. We increased our revenue sequentially quarter-over-quarter and year over year, 21%, 72%, and 96% respectively, which shows accelerating progress. In the fourth quarter, we achieved important data and acquired additional product to sell into existing call points. We are growing revenue rapidly, with strong gross margins and established, leverageable infrastructure that positions Bacterin to have excellent top line growth and future profitably. Now, before we go much further, I’d like to turn the call over to our CFO, John Gandolfo, who will walk us through a summary of the quarter and year’s financial results. When he’s finished, I’ll return to review our operational progress and how the first quarter’s been shaping up. Then we’ll open the call up to your questions. John?

John Gandolfo

Analyst · Caroline Corner with MLV & Company

Thank you Guy, and thanks everyone for joining us today. Now, turning to our results in the fourth quarter of 2011, as Guy mentioned, revenues for the quarter were up 72% to a record $9.1 million from $5.3 million in the same year-ago quarter, and up 21% from $7.5 million in the third quarter of 2011. For the full year 2011, revenues totaled a record $30.1 million, up 96% versus $15.4 million in the same period of 2010. The increase in revenue was primarily attributed to the company’s continued market penetration, driven by unique product benefits for both the patient and medical care provider, combined with the continued expansion of the company’s direct sales force. Gross profit margin for the quarter was 44% as compared to 83% in the previous quarter and 82% in the year ago quarter. Excluding adjustments mentioned in today’s release, which I will discuss in a moment, fourth quarter 2011 gross margin would have been 61% of sales. The decrease in Q4 2011 gross margin, excluding adjustments compared to prior quarters, is due to an increased sales price discount on a $1.4 million stocking order sale made during the quarter. Gross profit margin for the year was 70%, compared to 78% in 2010. Excluding the cost of sales adjustments, our full year 2011 gross margin would have been 75% of sales. Going forward, we believe gross margins will be 70-75% of revenues due to the increased allocation of our corporate overhead to cost of sales. Correspondingly, G&A expenses will be lower due to the increased allocation. Operating expenses for the quarter totaled $6.7 million, as compared to $7.8 million in the previous quarter and $7.1 million in the fourth quarter of 2010. Operating expenses for the year totaled $27.5 million compared to $20.7 million in the…

Guy Cook

Analyst · Caroline Corner with MLV & Company

Thank you, John. As reflected in our nearly doubling of revenue in 2011 from one year ago, we’ve made a lot of progress across our entire business. Focusing on the fourth quarter, we reported results of a two-year study for OsteoSponge. For anyone unfamiliar on the call today, OsteoSponge, used in conjunction with the patient’s own bone marrow aspirate, is a highly effective osteoinductive and osteoconductive bone scaffold that aids in spinal fusion. The study was conducted in collaboration with researchers at the Salt Lake Orthopedic Clinic Spine Surgery of Salt Lake City. The two-year postoperative clinical data showed OsteoSponge to be equivalent to rhBMP-2 in achieving an interbody fusion based upon radiographic assessment, CT scans, and quality of life outcomes. Additionally, patients receiving the OsteoSponge graft reported statistically significant less leg pain at one year relative to the rhBMP-2 group. Since OsteoSponge has been released, surgeons have used our implants more than 100,000 times, and this latest study further validates OsteoSponge’s effectiveness in spinal fusion surgery. Surgeons noted our products unique handling properties, ability to irrigate the site without graft migration, and quick insertion of the OsteoSponge scaffold into an interbody cage. In November of 2011, we signed an exclusive agreement with Jeil Medical Corporation for distribution in the U.S. and Canada of Jeil’s LeForte system. The LeForte system is composed of orthopedic implants used in craniomaxillofacial procedures, including trauma and reconstruction, and complements Bacterin’s existing expertise and product offerings in the tissue grafting arena. We are planning a full product release during the second quarter of 2012. The introduction of these products will expand Bacterin’s capabilities to include surgical procedures in the facial arena, such as craniomaxillofacial trauma, orthognathic surgery of the mid-face and mandible, mandibular reconstruction, reconstruction of the chin, and fracture fixation. We intend to develop…

Operator

Operator

[Operator instructions] Our first question is from the line of Caroline Corner with MLV & Company.

Caroline V. Corner

Analyst · Caroline Corner with MLV & Company

First of all, did you break out the royalty revenues at all for the quarter?

Guy Cook

Analyst · Caroline Corner with MLV & Company

No, we have not.

John Gandolfo

Analyst · Caroline Corner with MLV & Company

It’s an immaterial amount for the quarter.

Caroline V. Corner

Analyst · Caroline Corner with MLV & Company

Okay, and then going forward, can you give any guidance toward tissue sales revenues versus the royalty revenue?

Guy Cook

Analyst · Caroline Corner with MLV & Company

I think we expect the tissue sales to be probably 96-97% of the revenues as we look through 2012.

Caroline V. Corner

Analyst · Caroline Corner with MLV & Company

The gross margin going forward, thanks for breaking out all that detail for us. As we look forward, then, if I pull a G&A amount down, or put it back into COGS, are we looking at gross margins going forward in mid- to high-70s for product sales?

Guy Cook

Analyst · Caroline Corner with MLV & Company

I think we mentioned we expect it to be between 70% and 75%, so if I was modeling, I would probably do 72-73%.

Caroline V. Corner

Analyst · Caroline Corner with MLV & Company

And the hMatrix product, before when we’ve talked about it and in some of your comments, looked at a number for 2012 for that product in the $8-10 million range. Is that still a ballpark estimate for that product? How is the initial launch going? And what kind of surgeries are you seeing that one being used in right now?

Guy Cook

Analyst · Caroline Corner with MLV & Company

That remains on track. We still expect revenues in that product to be approximately in that range. We are seeing more interest in the breast reconstruction market than we originally anticipated. It uses a much-larger graft size. So we are still in the process of stocking the appropriate hospitals and establishing the distributor base for that particular product. We still continue to have sales for dermal repair and breast reconstruction, trauma, and in foot and ankle.

Caroline V. Corner

Analyst · Caroline Corner with MLV & Company

And around that comment on stocking orders, the gross margin got hit this quarter because of stocking orders. Going forward, as you move into new medical facilities, should we expect more of those large stocking orders? Is that something that you’re going to do typically when you go into a new facility?

Guy Cook

Analyst · Caroline Corner with MLV & Company

No, we’re not. We’re actually pulling back away from the stocking orders. We feel that we can establish the distributor channels ourselves as well as anyone we can partner with at this point. So I’d say in 2012 we don’t have any plans to do any large stocking orders.

Caroline V. Corner

Analyst · Caroline Corner with MLV & Company

And then last question for me, and then I’ll get back in queue, for the cartilage trial, with the SC, you said that has recently begun enrolling. I think I missed it. How many patients are you expecting this one to encompass?

Guy Cook

Analyst · Caroline Corner with MLV & Company

This will have 75 patients in the trial.

Caroline V. Corner

Analyst · Caroline Corner with MLV & Company

Okay, and it’s currently enrolling now?

Guy Cook

Analyst · Caroline Corner with MLV & Company

Yes.

Operator

Operator

Our next question is from the line of Matthew O’Brien with William Blair.

Matthew O'Brien

Analyst

I was just curious about the stocking order in the quarter. Was that fully recognized revenue in the quarter?

John Gandolfo

Analyst · Caroline Corner with MLV & Company

Yes, it met the criteria for revenue recognition during the quarter. Basically risk of loss, passage of title, and shipment passed to the entity during the quarter.

Matthew O'Brien

Analyst

Okay, so excluding that order in the quarter, it looks like revenue was roughly flat versus Q3. Is that a fair characterization? And can you just talk a little bit about reorder rates among your surgeon base from maybe six to nine months at this point?

Guy Cook

Analyst · Caroline Corner with MLV & Company

Well, the third quarter also had a stocking order, although not at that size, so I think probably on a comparison basis it was probably $6.8 million in the third quarter of revenues going up to $7.7 million quarter to quarter.

Matthew O'Brien

Analyst

So something along the lines of around maybe 16-17% sequential growth excluding the stocking orders?

Guy Cook

Analyst · Caroline Corner with MLV & Company

Correct.

Matthew O'Brien

Analyst

And then on the charges side, those are a bit surprising, the number in the quarter. Should we expect more in Q1 and Q2? Or should this be something from the tissue donor perspective that we expect on an annual basis?

John Gandolfo

Analyst · Caroline Corner with MLV & Company

Well, in terms of the adjustment that you’re talking about, are you talking about the West Coast Tissue related adjustment?

Matthew O'Brien

Analyst

Specifically just all the adjustments in the quarter and their impact going forward. Are there going to be more of those in Q1-Q2? And then on the tissue donor side, in terms of the adjustments, I understand it’s a four-year agreement, but you secure donors from different companies. Should we expect something along the line of every one or two years?

John Gandolfo

Analyst · Caroline Corner with MLV & Company

No, not at all. We don’t expect these adjustments going forward into the first and second quarter relating to COGS. And in terms of the donor, this relationship with this donor started out probably four or five years ago. And this was more of a receivable that built up over time that we felt from a business standpoint it was more important to extend the relationship and get a right of first refusal, and that’s why we agreed to write off the receivable. But going forward, you will not see any type of agreement like that.

Matthew O'Brien

Analyst

Okay, and then just getting to guidance, you know, $53-56 million for the year, that’s something you’ve said before. What gives you the confidence in this environment that you can get to those numbers. If $8 million is really the adjusted revenue number in the quarter, that’s assuming a pretty material sequential increase as you get up to that $53-56 million range. What gives you that confidence on the OsteoSponge side, and then on the hMatrix side, that you can go from -- not even sure what the revenue was in the quarter -- $8-10 million in a pretty competitive market? Is it simply guys that have been trialing it for a while now and are saying hey, I’m going to use this a lot more frequently? Just any kind of color around your confidence in hitting those numbers would be helpful.

Guy Cook

Analyst · Caroline Corner with MLV & Company

And also, one thing too is we are expanding our production capability significantly through 2012. We expect to add an additional nine clean rooms in our current facilities. So that will help. There are still products that are backward. We still have extremely high demand for our core OsteoSponge products. We are signing up new facilities, larger facilities, that we expect to significantly add to the demand that we already have. But we continue to have our existing accounts. The information that’s coming back from the sales force is that there’s still a lot of untapped demand that we have not gotten to yet because of our production limitations.

Matthew O'Brien

Analyst

And then one last one from me, and this is all very helpful. Your coatings submissions, any update there? Are we still expecting Q2 or Q3 for those?

Guy Cook

Analyst · Caroline Corner with MLV & Company

I think Q2 or Q3 is still reasonable. We’re still within the first 90-day window on the original submission.

Matthew O'Brien

Analyst

Any irregular questions back from the agencies?

Guy Cook

Analyst · Caroline Corner with MLV & Company

Nothing yet. We’re still within the 90 days. We would expect to get a letter at the end of that 90-day period.

Operator

Operator

Our next question is from the line of Nathan Cali with Noble Financial.

Nathan Cali

Analyst · Nathan Cali with Noble Financial

Just can you help us understand what happened in the quarter, why you guys were toward the low end of the range on the revenue?

Guy Cook

Analyst · Nathan Cali with Noble Financial

We still had some production limitations. Again, we have certain sizes that are in high demand and so if we would have had that excess production or excess capability we felt we would have been higher than we currently were.

Nathan Cali

Analyst · Nathan Cali with Noble Financial

And then as far as on the production side of things, will that be an order as far as what you need to get done to increase the capabilities there to provide the demand? When do you expect that to be sort of underway and completed?

Guy Cook

Analyst · Nathan Cali with Noble Financial

We are significantly increasing our donor queues, and as those are allowed to be processed and cleared for processing, that will help us. The actual infrastructure in the clean rooms that are expected to be completed are in the September and October window. And so the full benefit of that increased production capacity and donor queue would be expected later this year in Q4.

Nathan Cali

Analyst · Nathan Cali with Noble Financial

Could you give us any guidance for the first quarter of 2012, how that quarter’s coming along, and what the expectations for revenue are for that quarter?

Guy Cook

Analyst · Nathan Cali with Noble Financial

I’d say January started out a little bit slower than we expected. We had some infrastructure issues with implementing some new accounting systems, which slowed us down a little bit in January. But we did reiterate the guidance of $53-56 million for the year.

Nathan Cali

Analyst · Nathan Cali with Noble Financial

And then just one question on the reps. Where do you guys stand with the direct sales reps and the move toward 100 reps in 2012? Where do you guys expect to end that balance. So in other words, when will all the reps be hired to get you to 100 on your estimates?

Guy Cook

Analyst · Nathan Cali with Noble Financial

We’re still expecting to get up to 100 by the end of the year. We’re trying to balance it out with the current capacity constraints that we have. But our turnover is significantly lower than it has been in the past. We are spending more time on training. We’re spending more time on training our mid-level managers to give them the appropriate tools to manage the new hires that are coming in. We’ve also given them a longer runway. They have approximately six months to a year. But the new hires that we have we feel are excellent candidates, and we remain hopeful that they will achieve the goals we have for them quite quickly.

Operator

Operator

Our next question is from the line of Bruce Jackson with Northland Securities.

Bruce Jackson

Analyst · Bruce Jackson with Northland Securities

Looking at the revenue, can you talk on the biologics side the split between the direct revenue and the distributor revenue?

John Gandolfo

Analyst · Bruce Jackson with Northland Securities

I think the breakout was roughly 55% coming from distributors, 45% from the direct sales force.

Bruce Jackson

Analyst · Bruce Jackson with Northland Securities

And then do you still anticipate that the direct sales force is going to become a larger proportion of revenue?

John Gandolfo

Analyst · Bruce Jackson with Northland Securities

Yes, certainly as we look out over the next year to two, and one of the key drivers in us gaining leverage and increasing the contribution margin from the sales, is to get a higher percentage of our revenues coming from direct sales force, because that will lower our sales and marketing expenses. So yes, we continue to expect that.

Bruce Jackson

Analyst · Bruce Jackson with Northland Securities

And then moving over to the sales force expansion, is that something that’s going to be a little bit more back-end loaded in 2012?

John Gandolfo

Analyst · Bruce Jackson with Northland Securities

I think in January we’ve already hired roughly 10 new reps. I think that will probably be done after January more evenly throughout each quarter.

Bruce Jackson

Analyst · Bruce Jackson with Northland Securities

Okay. And moving over to manufacturing, so you’re going to be expanding the clean rooms and you’re also expanding the procurement. How do you feel about your current procurement pipeline and manufacturing capacity in terms of your revenue guidance for the year?

John Gandolfo

Analyst · Bruce Jackson with Northland Securities

In terms of the donor supply coming in? I think that when we looked at the model we needed roughly, on average, 50 donors per month in order to meet the guidance of $53-56 million in revenues. We’re currently already at roughly 45-50 per month, so we don’t see that as an issue at all with respect to 2012.

Operator

Operator

Ladies and gentlemen, that is all the time we have for questions. I’d like to turn the conference back over for closing remarks.

Guy Cook

Analyst · Caroline Corner with MLV & Company

Thank you, operator. I’d like to thank each of you for joining us this evening. And I especially want to thank you for your insightful questions and comments. As we advance through 2012, our overriding priority will continue to be delivering the best quality medical devices in biologic products for our clients and sustaining Bacterin’s position as the provider of choice in the areas that we serve. I hope you all will continue to be interested in Bacterin as we continue to make progress, and I’m looking forward to speaking with you again in the near future. Thank you very much.

Operator

Operator

Thank you, ladies and gentlemen. That does conclude our conference for today. We’d like to thank you for your participation.