BioDelivery Sciences International, Inc. (BDSI) Q4 2020 Results Earnings Conference Call March 10, 2021 8:30 AM ET
Company Participants
Terry Coelho - Executive Vice President & CFO
Jeff Bailey - CEO
Scott Plesha - President and Chief Commercial Officer
Conference Call Participants
Brandon Folkes - Cantor Fitzgerald
Gregg Gilbert - Truist
David Amsellem - Piper Sandler
Scott Henry - ROTH Capital
Tim Lugo - William Blair
Tim Chiang - Northland Securities
Operator
Greetings and welcome to the BioDelivery Sciences Fourth Quarter and Full Year 2020 Earnings Conference Call. [Operator Instructions] As a remainder this conference is being recorded.
It is now my pleasure to introduce your host, Miss. Terry Coelho, Executive Vice President and Chief Financial Officer. Thank you. Please go ahead.
Terry Coelho
Thank you and good morning everyone. Welcome to our fourth quarter 2020 earnings conference call. Leading the call today is Jeff Bailey, Chief Executive Officer. We are joined by Scott Plesha, President and Chief Commercial Officer.
Following our prepared remarks, we will conduct a question-and-answer session. Earlier today, BioDelivery Sciences issued a press release announcing its financial results for the fourth quarter and full year 2020. A copy of the release can be found on the Investor Relations page of the Company's website.
Before we begin, I would like to remind everyone that certain statements may be made during this call, which may contain forward-looking statements. Such forward-looking statements are based upon current expectations and there can be no assurances that the results contemplated in these statements will be realized. Actual results may differ materially from such statements due to a number of factors and risks, some of which are identified in our press release and our annual, quarterly and other reports filed with the SEC. These forward-looking statements are based on information available to BDSI today, March 10, 2021, and the Company assumes no obligation to update statements as circumstances change.
Our 10-K will be filed with the SEC by Friday March 12. An audio recording and broadcast replay for today's conference will also be available online in the Investor Section of the Company's website.
With that, I'd like to turn the call over to Jeff Bailey, our CEO. Jeff?
Jeff Bailey
Thanks very much, Terry and welcome everyone to our company’s fourth quarter 2020 earnings call. I am pleased to report that BDSI finished the year strong to fully both our fourth quarter as well as our full year 2020 results. With 2020 our key focus on responding rapidly to the evolving pandemic selling requirement to develop a number of commercial tools to help prescribers and patients on continuing insured [ph] patient access to the solid formula recoveries.
We also realigned resources to ensure continued prioritization of customer facing resources, pursued operational excellence and further strengthened our balance sheet to a combination of healthy operational cash flow and it’s like to borrowing.
Year-over-year sales for the company grew 40% for full year 2020 inspite of the multiple headwinds we faced. We generated over $40 million of EBITDA or 26% of that sales. Our business was helped with strong cash generation and we are beginning 2021 well positioned for continued growth.
I would like you to share [ph] three main takeaways from today’s call. First, prescription growth trends in the fourth quarter were highly encouraging and momentum for both BELBUCA and Symproic total prescriptions and new to brand prescriptions remained strong.
So far in 2021, we are reassured to see demand and seasonality trends that are aligned with prior years. But there have been no unusual disruptions associated with the pandemic; we did see some impact from the severe winter storms in February in the south central part of the country, an area where we have a strong presence. Both plants continue to achieve all-time highs in market share and volume. Second, our agile commercial team was able to rapidly adapt to pandemic selling environment where patient visits were down by implementing virtual tactics to communicate with physicians in developing a number of creative programs.
As I had mentioned in our prior earnings call, we have rolled out BELBUCA First Start program on a national basis. First Start allows healthcare professionals to easily prescribe BELBUCA to appropriate commercial patients for the first time, providing convenient access to BELBUCA while the health care providers staff with security prior authorization approval. We believe that this program is having a positive impact and we are optimistic that it can generate incremental growth in 2021.
Scott will provide more details. Third, our company has a strong balance sheet, in the end of the year with approximately $112 million in cash. This cash provides us with strategic optionality to maximize shareholder value. As a reminder, BDSI is highly profitable. In the fourth quarter, we generated $14.3 million in EBITDA with 34% EBTIDA margins. This was accompanied by over $11 million in operating cash flow generation.
Taken together, I am highly optimistic in our ability to deliver continued growth in 2021. The COVID pandemic is now one year old, but our performance remains strong. And we are well positioned in our respective markets in both of our high performing brands continue to grow market share. I want to share a few key updates about our business.
BELBUCA generated outstanding growth in the fourth quarter, BELBUCAs TRx volume grew 3.7% sequentially, and 20.6% year-over-year. Additionally, BELBUCA TRx market share ended another all-time high by growing to 4.5% in Q4, as compared to 4.1% in Q3. We are now in the second straight quarter of what appears to be a recovery following the low point in the second quarter of 2020 as a result of pandemic, which led to a reduced number of patient visits to physician offices. Similarly, we also saw Symproic rebound, it hit an all-time high for TRx volume and market share in the PAMORA class, which declined 6%. These results reflect the outstanding execution by our sales team as the product spare role product profile.
Lastly, our balance sheet has never looked better. With $112 million in cash, we focused on prioritizing our investments during this disruptive time with a focus on preserving and growing our customer base and the longer term health of our brands. Our balance sheet is a significant optionality to expand our business organically. We're seeing complimentary opportunities at the right time in investing our business.
2020 was a challenging year for the industry. And I'm proud to see how the BDSI team really pulled together, and also thrived. Our outstanding performance, both in the fourth quarter and for all of 2020 positions us to remain on a strong growth trajectory. We have differentiated in growing products, a strong balance sheet and high performance senior management team. We have united our mission to help patients with chronic diseases while focusing as well and delivering increased shareholder value.
With that, I'll turn the call over to Scott to provide more details about performance during the fourth quarter. Scott?
Scott Plesha
Thank you Jeff. As Jeff mentioned during Q4, BELBUCA prescriptions grew by 4200 to a new high of more than 118,800 retail mail order and long term care TRx’s combined. This represents a 20.6% increase in BELBUCA TRx’s compared to the fourth quarter of 2019 and the 3.7% increase over the third quarter of 2020. This was accomplished despite the continued decline in the overall long acting opioid market. We were pleased with BELBUCA’s continued growth, which led to its Q4 TRx market share increasing to over 4.5% from 4.1% in the third quarter of 2020.
During the fourth quarter BELBUCA’s new-to-brand market share of 7.8% grew from 7.4% in the third quarter, significantly above its TRx share of 4.5%, which means there's still a meaningful opportunity to grow total prescription shares as these metrics historically converge.
New-to-brand prescriptions continue to rebound in the fourth quarter. We believe that to accelerate current and future growth, it is important that we have robust NBRx growth. As Jeff mentioned, we implemented our first start NBRx program on a national basis in October after conducting a successful pilot in select territories during the prior quarter, analysis from the pilot group suggested a 31% lift in NBRx volume and a 20% lift in TRx volume in participating prescribers and provided us with confidence to expand the program across all territories on October 20. We believe that this program contributed to the new quarterly high for NBRx share of 7.8% during Q4 and to the 2% increase in NBRx count from Q3 to Q4 in a LAO market that declined 2%.
We're pleased report that both vehicle prescriber base grew in the fourth quarter after rebounding in Q3, and was up 9% year-over-year. We reached an all-time high over 8000 total unique prescribers in the quarter up from the third quarter. With the introduction of the vaccine, we are optimistic that physician's offices will begin to gradually reopen, and in person promotion may begin to normalize.
Our market access with BELBUCA has improved greatly over time, has been important to our success. BELBUCA currently enjoys strong commercial coverage with over 90% of live coverage, of which almost 59% are covered at a preferred level, while in Medicare BELBUCA is covered in 33% lives, with 10% of them being at the preferred level.
We believe our current level of coverage provides a significant opportunity for growth, which is supported by our consistent TRx growth across all payer types, and we continue to be committed to improving access to BELBUCA while balancing payer coverage and rebate levels, especially in Medicare. Symproic Q4 prescriptions reached a new high of over 18,700, representing a solid 9.6% increase year-over-year compared to Q4 2019 and a 3.4% increase over Q3 2020.
During the fourth quarter, we generated a 13.5% TRx share up from 11.1% in Q4 2019, representing the highest market share today. Additionally, we reached a 14% NRx share up from 12.7% a year ago. We expect continued growth in revenues and total prescriptions for some product, as its new Rx share has consistently exceeded total Rx share since May 2019 when BDSI began active promotion.
In the fourth quarter, our prescriber count for some product increased slightly from Q3 at over 4800 physicians, while also improving the productivity per prescriber. Like BELBUCA, Symproic is well positioned with covered status for 89% of commercial lives with 60% at preferred status. We believe our early 2020 market access wins with Prime Therapeutics and CVS will continue to drive additional growth in 2021. The BDSI sales force has done an outstanding job pulling through these wins, as TRx's have improved within Prime Therapeutics by approximately 152% from Q4 2019 to Q4 2020. We've also seen consistent growth within CVS where TRx's have increased 37% over Q4 2019.
While our 2020 TRx market share growth from 12.4% to 24.1% within these plans has been robust, we believe there remains room for growth in 2021 and beyond. A testament to the focus and effectiveness of our commercial team has how are brands performed in their respective markets.
We know that both BELBUCA and Symproic retail TRx growth outperformed in both the fourth quarter and full year 2020. For example, BELBUCA retail prescriptions grew 30.2% in 2020, versus 2019 and 3.3% sequentially in Q4 compared to declines of 9.7% year-over-year and 5.9% quarter-over-quarter in the long-acting opiate market.
Similarly, some product retail prescriptions grew 13.1% in 2020 versus 2019 and 3.8% sequentially in Q4, compared to declines of 5.9% year-over-year and 3.7% quarter-over-quarter in the PAMORA market.
I'm extremely proud of our team who has persevered and succeeded during the difficult times of the pandemic. As in person access to physician offices continues to improve, and patient visits increase, I believe that our high performing commercial team will build upon our strong growth trajectory.
With that, I will turn the call over to Terry to provide an update on the financials. Terry?
Terry Coelho
Thank you, Scott. As Jeff and Scott discussed, we are excited to report our fourth quarter and full year results which have remained strong despite the continuation of the COVID-19 pandemic. 2020 was a transformational year from a financial perspective as we reached record levels in sales, profitability and operating cash flows culminating in closing the year with an increased cash position and a strong balance sheet.
Total Company net revenue for the full year 2020 was $156.5 million, up 40% when compared to $111.4 million for full year 2019. The increase in 2020 is primarily driven by BELBUCA, which accounted for 87% of total sales for the year and the continued success of Symproic, which was added to our product portfolio in the second quarter of 2019.
Full year 2020 net sales of BELBUCA were $136.1 million up 40% compared to $97.5 million in 2019. Symproic net sales for 2020 were $14.7 million in its first full year of commercialization by BDSI’s team. Royalty revenues for ex U.S. sales of PAINKYL and BREAKYL totaled $1.9 million for 2020, compared to $3.5 million in the prior year.
BUNAVAIL was discontinued in mid-2020, and generated net revenue of $3.7 million, which included a release of $2.4 million of sales returns reserves. Total company gross margin for full year 2020 was 84% compared to 81% for 2019. The increase in gross margins was driven primarily by the favorable gross to net deductions as compared to 2019, largely due to the one time impact of the channel refresh for BELBUCA in Q3 of 2020 along with the non-recurring negative impact of the BUNAVAIL sales returns reserves taken in Q4 of 2019.
Total operating expenses for 2020 were $98.8 million, compared to $86.1 million for 2019, comprising 63% and 77% of total revenues in the respective years. The year-over-year increase in spend is primarily driven by increased legal costs and the one time impact of the CEO transition in Q2 of 2020.
GAAP net income for the full year 2020 was a record $25.7 million, or net income of $0.26 per share, compared to a GAAP net loss of $15.3 million for 2019, or net loss of $0.18 per share. 2020 full year EBITDA was $40.5 million, or 26% of net sales, as compared to EBITDA of $12.5 million, or 11% of net sales in 2019. This marks the second straight year of positive EBITDA for BDSI.
Non-GAAP net income for full year 2020 was $44.2 million, a substantial increase compared to $13.2 million in 2019, and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets, certain warrant discount costs in 2019, one-time expenses related to the CEO transition incurred in the second quarter of 2020, and the non-recurring costs in 2019 related to the discontinuation of marketing of BUNAVAIL.
Let's turn to the fourth quarter of 2020. Total net revenue for the fourth quarter was $42.2 million, an increase of 33% compared to $31.6 million in the fourth quarter of 2019. BELBUCA net sales in the fourth quarter of 2020 were $35.6 million, an increase of 26% compared to $28.3 million in the fourth quarter of 2019 and an increase of $800,000 or 2.3%, compared to $34.8 million in the third quarter of 2020.
Gross to net deductions did increase in the quarter, as expected and discussed on the Q3 call based primarily on typical increases seen in the Medicare coverage gap, often referred to as the Doughnut Hole, along with increased Medicaid costs.
Net sales for Symproic in the fourth quarter of 2020 were $3.7 million, which reflects 35% growth year-over-year and 6% growth compared to the third quarter of 2020. BUNAVAIL net revenue for the fourth quarter was $2.4 million, compared to net revenue of negative $500,000 in the fourth quarter of 2019 and $600,000 in the third quarter of 2020. Total gross margin for the fourth quarter was 80% as compared to 77% in the fourth quarter of 2019 and below the 86% margin during the third quarter of 2020. The primary drivers for the quarter-over-quarter decline included the expected increase in gross net deductions following the favorable channel refresh impact experienced in Q3 and increased BELBUCA inventory reserves.
Total operating expenses in the fourth quarter of 2020 were $21.4 million compared to $23.8 million in Q4 2019 and $22.5 million in Q3 2020. GAAP net income for the fourth quarter was $10.2 million or $0.10 per share compared to a GAAP net loss of $700,000 in the fourth quarter of 2019.
The year-over-year improvement in GAAP net income of approximately $11 million is primarily driven by the continued growth of our top line, improved gross margins and a decrease in overall operating expenses.
EBITDA in Q4 2020 was $14.3 million, or 34% of net sales compared with $4.1 million, or 13% of net sales in Q4 2019. This quarter marks the eighth consecutive quarter of positive EBITDA for BDSI.
Non-GAAP net income for the fourth quarter was $13.7 million, and reflects GAAP net income excluding stock-based compensation and non-cash amortization of intangible assets.
The Company has a strong balance sheet with cash and cash equivalents as of December 31 2020, of $111.6 million as compared to $63.9 million at year end 2019. The combination of continued strong revenue growth and attractive gross margins together with prudent spend management and working capital improvements resulted in positive operating cash flow of $11 million in the fourth quarter, and a total of $25 million over the course of 2020.
$47.7 million increase in the total cash position from 2019 to 2020, reflects our positive operating cash flow, in addition to the net proceeds of $19.6 million from the drawdown in May 2020 of $20 million from our existing debt facility, and $3.4 million in proceeds from the exercise of stock options, partially offset by $200,000 used to repurchase shares in the quarter.
The Company's total long term debt position as of December 31 2020 remains at $80 million. Our share buyback program initiated late in the fourth quarter and resulted in the repurchase of approximately 48,000 shares in 2020. The program has continued to execute purchases in 2021, with close to 660,000 shares repurchased thus far in the quarter. The $2.9 million in share repurchases today represents more than 11% of the authorized amount. This reflects the continued confidence of the board and the management team in the strength and value of our business.
We are very pleased with our year-to-date business and record financial performance having delivered 40% year-over-year revenue growth continuing profitability reflected in our 26% EBITDA margin, $25 million of operating cash flow generation and a strong balance sheet. Despite the impact of the pandemic for almost a full year on patient visits, physician's offices and our limited ability to market in person to healthcare providers, 2020 was a successful year for BDSI. We once again achieved record level sales performance for BELBUCA, providing us with confidence in the sustainability of this growth momentum into 2021 and beyond.
In addition, Symproic has been an attractive adds on for our sales force and fits well with our targeted physician group. Given solid market demand for our products, we expect net sales in 2021 for BELBUCA of $155 million to $165 million and 2021 total company net sales in the range of $170 million to $180 million. These estimates incorporate the expected impact in quarter one from the winter storms, which affected some of our most productive territories, as well as an expectation that there will be a continuing improvement in live access to physician’s offices, and a more gradual increase of in-person patient visits.
We estimate our total operating expenses to be in the range of $115 million to $120 million as we continue to invest to support the growth of our brands, and we expect EBITDA to be in the range of $40 million to $50 million in 2021.
Finally, we anticipate continuing to be operating cash flow positive throughout 2021. On a final note, a three day bench trial against Alvogen was conducted commencing on March 1 2021 related to their Paragraph IV patent challenge.
Court has requested the parties to submit post trial briefs over the coming two months, and a decision from the court is expected subsequent to the filing of the post-trial briefings. As you would expect, we are not in a position to comment any further regarding on-going litigation.
I will now turn the call back to Jeff for some concluding remarks before we open up the call for Q&A. Jeff?
Jeff Bailey
I want to take a moment and thank our employees that really performed when faced with pandemic last year. The spirit of an empowered culture, really delivered the 2020 strong results we highlighted. This would not have been possible if we did not have great people. As a result of their hard work, BDSI and our brands are on solid footing and we are thrilled to introduce our 2021 guidance that reflects our expectation for continued growth of our business.
We're looking forward to greater interaction between our Salesforce and healthcare professionals in 2021, especially in person as the pandemic wanes, and starting with what will hopefully be an even stronger year ahead for our customers, our patients and our employees.
We will now take your questions.
Question-and-Answer Session
Operator
[Operator Instructions] Our first question is coming from Brandon Folkes of Cantor Fitzgerald. Please go ahead.
Brandon Folkes
Hi, thanks for taking my questions, and congratulations on another solid quarter of execution. And Jeff you mentioned the balance sheet has never been stronger. I guess following on, given that we can't speak about the litigation. But I think, with the litigation and really COVID just really highlighting product concentration risk in smaller companies, what is your urgency to expand the portfolio over the coming months, and maybe sort of the rest of the year as well but, kind of prior to this decision in sort of two plus months.
And then secondly, Symproic’s implied guidance if I’m calculating this correctly seems to imply sort of marginal growth to very significant growth. Can you just talk about some of the pushes and pulls around Symproic growth in 2021? Thank you.
Jeff Bailey
Thanks for the question, Brandon, hope you're doing well. First of all, the urgency to expand the portfolio, very consistent with what we talked about before as far as just really making sure that we're looking for the right asset at the right time. We have a very thorough, complete process when it comes to looking at different assets to really focus on bringing home shareholder value. So when you do take a look at this right now, in the spaces we typically look in, and all that stuff that and some really good stuff going on behind the scenes. But it's also one where it's your point, relative to, the litigation and all that that, we want to make sure that we really are in a position to be able to leverage our balance sheet, the cash position, the EBITDA, the continued growth that we see the momentum that we have going on, we're really positioned super well on that end.
But we're also being really careful to make sure that it's one where it's the right deal at the right time as far as making sure that it's one that brings shareholder value home. So I think you're connecting the right thoughts there. And it's one where, we're really looking forward to expanding the portfolio, but it's one where we've been very prudent with that.
So as far as urgency, if that's something that we see that, that’s something we have to do in the next few months, that's for sure. But if there’s right deal at the right time, then we're ready to make that move.
As far as growth of Symproic, I'm going to go ahead and let Scott go ahead and weigh in on that as far as some of the growth drivers on Symproic, but they're very optimistic about what we see there. Scott, which by the way in…
Scott Plesha
Yes, Brandon, thanks for the question. We were actually really happy with where Symproic ended the year, all time high for the quarter, but also December at well over 6600 prescriptions. I think one of the things we wanted to be a little cautious with is the beginning of the year is always soft with the PAMORAs. We traditionally see a pullback in in Q1 and the entire market and then it kind of gains actually business throughout the year.
So we still think we can grow it. I think one of the crucial drivers though, as it will be for BELBUCA is patients getting back into offices. There's like TRx [ph] data suggests that office visits are still down over 20% as we exited 2020 and then the face-to-face visits by our reps. We're encouraged by that. We were seeing about 60% of our call activity through Q3, Q4 just around 60%. And in recent weeks here, we're encouraged to see that rising just below 70%. So I think that's a positive but, until we fully see the impact of the vaccines and patients getting back in offices, that we wanted to make sure that we were conservative what we're putting out there.
Brandon Folkes
Great, thank you very much to both of you.
Jeff Bailey
Thank you, Brandon.
Operator
Thank you. Our next question is coming from Gregg Gilbert of Truist. Please go ahead.
Gregg Gilbert
Thanks. Good morning. As you settled into the permanent CEO role, have you reconsidered the possibility of building a development pipeline? Or is the focus still on commercial assets? As you think about how the company should evolve over the coming years, I think the company's been pretty consistent that it is not in the development game, and as a commercial entity, but just curious to hear your thoughts on that, as you look out a few years.
And secondly, as it relates to capital allocation, notice the share buyback, obviously, should we continue to expect you to be active around these levels? Or at this point are you more focused on deploying that capital in other ways?
And maybe lastly, Terry, you can comment on the gross margin in the fourth quarter and what pressured that? And how you're thinking about gross margin for the coming year? Thanks a lot.
Jeff Bailey
Thanks for the question, Gregg, hope you're doing well. Yes, as far as the types of assets we're looking at are ones that do not push us into being coming in a development stage company as a wonder, want to be consistent with this, that, as we go way back into early stage and building out the complete infrastructure there. That's something that's a significant change from where we've been.
Now, the types of assets that we're looking at are later stage type of assets, or some that could be early stage have already out there, commercialized at this particular point, that is one where the strength of our organization is really been proven as far as with the results in 2020.
As far as the commercial strength that our team brings to the table, as far as across larger functional areas, we like to play the game quite well there to be able to really outperform markets and really go down that road. So we continue to stay focused on those types of assets that, are the mid-to-later stage type assets to bring in but that not one where we view ourselves as a development stage company at this point.
On the capital allocation and the buyback, I'm going to go ahead and let Terry weigh in on that. But I think it's also just one where you're really clear that it's one where we see ourselves as being undervalued. And so that's an important part of why we focus on some things tied to the buyback. But then Terry, I want you to go ahead and weigh with some additional thoughts about capital allocation from your perspective.
Terry Coelho
Thanks, Jeff and hi Greg. So yes, on the capital allocation I think, look we mentioned before, and just talked about how, we feel value of the stock is and we will continue to evaluate the market. We will opportunistically do, as we mentioned before, we don't expect to necessarily, do one large buyback all at once we'll be monitoring it. So, I think you can be thinking about that, right? Now, you can imagine we've been in a quiet period. So there's a plan in place, but that is operating on its own, let's say, with some guidelines from us, that we initially put in place.
In terms of the gross margins as I shared on the call, there were probably two major drivers. One was, if you were comparing it to Q three, you may recall that we had the channel refresh, which had a favorable impact to the gross to net in Q3, and therefore the gross margins in Q3 and what we saw was the typical normal kind of second half of the year impact of higher coverage gap and so on. So we came back in line because of that. And then secondly, the I shared that we had some BELBUCA inventory reserves that we took in the quarter.
Gregg Gilbert
And for the year, the coming year, Terry?
Terry Coelho
For the coming year. So we've talked, I think, in general, we still see ourselves in that kind of mid 80s. Both brands have pretty attractive gross margins, and I would expect that to be able to continue.
Gregg Gilbert
Thanks. If I could just follow up with one last one, Jeff. I know you guys are not looking at the specifics of litigation, but correct me if I'm wrong, but a win or a loss here could be quite transformational for the company. Am I overplaying that thought? Is it something that really helps to find the types of deals you're looking into or the sense of urgency with which you need to do them. Any sort of just philosophical thoughts around the importance of this event would be would be helpful. It seems to be the elephant in the room for a lot of investors at this point.
Jeff Bailey
Yes. That's a good question, Gregg. So it's an important outcome for us. That's clear. We will continue to take a prudent approach to our business development activity and naturally there is a link between the outcome of trial on our BD efforts however, we remain very focused in parallel with our BD efforts, really bringing shareholder value in meantime. So, it's one where the strong balance sheets, really positions us well. What we developed at this particular point where we see the right asset at the right time, we're able to move forward with it, but I think you have the right perspective, Greg. So it's hopefully with some helpful background.
Gregg Gilbert
Thanks a lot. Appreciate it.
Jeff Bailey
Thank you.
Operator
Thank you. Excuse me. Our next question is coming from David Amsellem, of Piper Sandler. Please go ahead.
David Amsellem
Thanks. So just a hypothetical to the extent that you do when in your case versus Alvogen and you've shored up the exclusivity runway for BELBUCA, can you talk about the extent to which you would invest further in the brand, that whether that larger sales organization or other activities? Just give us your sense, philosophically and how you think about further investment, or is this sort of a brand where you just execute on the formulary front but in terms of commercial support, you're pretty much where you want to be for the duration of the exclusivity runway? Thanks.
Jeff Bailey
Yes. David, really good question. As far as the way that we're reviewing at the execution with BELBUCA and Symproic is that, as you can see from some of the numbers, and some of the things that Terry is talking about, as far as, projecting in 2021, we are very focused on investing in our brands as sort of where we see so much more upside for these brands in the coming years. And a lot of this is about marketing and muscle, it's about really funding that, COVID world is one where we reallocate resources to customer facing and we did the right thing, they're really paid off for us there. But investing even more into these brands, that it's really one where that helps drive that upside for us that we see clearly.
You take a look at the size of our Salesforce Scott, and I spend a lot of time with this team talking about this. We really feel strongly we are right sides with that. A lot of the investments that we're talking about is really on the marketing side and the things that are adjacent to the marketing efforts to really drive this. The thing I really like about this, so much that we can for our destiny on this as far as where we take this thing. It's really, really good old fashioned operational excellence, the right block to the right message, the right frequency, and just really our team, just continuing to do what they're doing and continue to this growth trajectory going forward. But what's an additional marketing resource behind it was will be really helpful to really drive that. Scott, do you have anything else you want to add to that as well?
Scott Plesha
That's a great summary. Jeff, the only thing I would add is that, we obviously made a pivot last year, and really built out the digital component of our promotions. And I think importantly, also moved a large part of our dollars from a non-branded promotion, setting to branded. So I do think when you when you look at our performance, year-over-year, compared to the markets we’re in, I think that was a big part of it, obviously, as well as the reps doing a really nice job at a distance virtually as well as the face-to-face interaction. So that would be all I'd add to that, Jeff.
Jeff Bailey
Thank you. David, did we give you the background you needed there?
David Amsellem
Oh, sorry about that. Yes. And if I if I may just make a follow up. I know you talked about formulary access. But, another philosophical question here, just on this time on the on the payer front. I guess how aggressive do you want to get in terms of contract? And again, assuming that you short up the exclusivity runway, here? How aggressive do you want to get in terms of rebating in order to improve formulary positioning, particularly as it relates to Part D?
Jeff Bailey
So I will let Scott wave and let me cover a couple things up front. So you take a look at where we are right now. And the team of Terry, Scott, myself, we have a lot of experience in this area. And you know that we would have the opportunity if we really wanted to, we could go out and sign a ton of contracts right now. And, the point you'd make great headlines as far as your press releases about X number of million more lives that are covered and all this sort of stuff. But when you take a look the math behind them, you're really super prudent behind that makes sure we're doing the math behind that.
So as far as your future contracting, a lot of our work is really about making sure that we're maintaining good contract and good access. We have very good access for our products right now. That really played through and so we're very focused on that. But we're also very opportunistic as far as looking at, give you an example, as for some refill plans, and some things that are very targeted with that. So you take a look at where we are on the product lifecycle that the team has done a really good job as far as, contracting and getting us to a good place. As far as the additional contracting, we’ll remain opportunistic. But the one thing I want to make sure, just from a shareholder standpoint, that we are really prudent about doing the math behind the scenes that what really makes sense or not.
So we can make some great headlines in the short term, because feel really good about like, expanding some things. But I want to make sure there's confidence knowing that we're doing the math behind the scenes about what was really best for our business. And, Scott, do you have anything else to add to that?
Scott Plesha
I think Jeff's just spot on here. David, we're, we're always and I think it was in my prepared remarks. But we're committed to improving access. But we're also trying to balance rebates with that access, and making sure that it makes sense from a business standpoint, and just spot on, we could we could go out and sign a bunch of contracts. Tomorrow, almost, but they wouldn't make sense financially to the company. And so we're trying to be very prudent. I think the other thing that's really important, and I know we've talked about this in the past is that, Medicare, probably when you look at it, that that might look like the opportunity. But we have really high approval rates, they're almost 90%, it's almost identical, identical to commercial. So what that means is if a physician or a midlevel prescribes the product, BELBUCA and they do the proper PA authorization, that about 90% of the time it's going to get approved, which is quite good in the marketplace.
So we feel we have coverage in place that's going to allow future growth, we'll continue to look for some improvement and smaller plans on the commercial side, because that's, that's really about what's left is sub plans. And then on the Medicare again, if it makes sense from a rebate level, we'll, we'll move forward with those, but not until we do extensive analysis on the financial side and financial impact.
David Amsellem
Okay, thanks. That's helpful.
Jeff Bailey
Thanks, David. You're welcome.
Operator
[Operator Instructions] The next question is coming from Scott Henry of ROTH Capital. Please go ahead.
Scott Henry
Thank you. Good morning. Just a couple questions. First, for Terry, just for clarification, the operating expense guidance for 2021 of $115 million to $120 million. Is that inclusive of cost of goods sold?
Terry Coelho
No, that does not include cost of goods sold.
Scott Henry
Okay, so it does….
Terry Coelho
It doesn't include amortization, however.
Scott Henry
Okay, so you should I interpret that to be when I when I look at the model, the second half spending was down pretty significant. 2020 and the first half was higher. So, I mean, should we think of more of first half of being a reflection of operating expenses for 2021?
Terry Coelho
Yes, I think so. So as I shared on the call, with my prepared remarks, I think we see a couple things. One is we want to make sure we're continuing to invest behind our brands and support the growth; we're still looking to grow nicely. And I think the other piece of it is, we are expecting to see a return to more normal market conditions and being able to have the reps out in the field and traveling and everything else. So, we have some of that built into our assumptions as well.
Scott Henry
Okay, thank you for that color. I then just a couple questions for Scott. When I look at the Symproic prescriptions, market share has steadily increased pretty consistently month-over-month, and then it dipped, at least according to the numbers I'm looking at in January. The question is, is that noise or is there anything that could be causing that?
Scott Plesha
Scott, thanks for the question. Yes. So we're what we're watching that carefully. And I think it's just noise at this point. I think we have enough data to conclude there's, a trend there. So and then I think Jeff had mentioned in his remarks also and Terry did that February was pretty disruptive to our business as well. The winter storm that hit in that area, that's where some of our biggest businesses so that that definitely impacted and there's some ITV reports that report that Texas, for example, is down 40% alone in retail prescriptions during that week. So I think it's early. We've actually seen the brand recovering here in recent weeks. So I anticipate us getting back on track there.
Scott Henry
Okay great. And then with regards to BELBUCA, the opioid category continues to decline. How are you thinking about the level of decline in 2021 versus 2020? I don't know if it was 2020, impacted additionally by COVID. So if we don't get that, I'm just wondering if you expect the category to stabilize at lower declines or to continue at the current rate?
Scott Plesha
No, so we've modelled a slower decline going forward. And that's been the case really, year-after year. Here Scott, if you were to go back to 2017, 2018, 2019, the decline has definitely slowed. Matter of fact, last year, it actually as we exited 2019, going into early 2020, especially on the NBRx side, it was really flattened, flattening out and almost completely flat, and then COVID, had pulled it down a little bit. So I do think that we've gotten to the level of more kind of appropriate prescribing of opioids, it appears, everything you look at, it's kind of flattening out. And I think a lot of the different programs put in place have helped kind of get to a more normalized area. And, again, I do we do, we do anticipate a flattening of that curve over time.
Scott Henry
Okay, great….
Jeff Bailey
And then I’ll add to Scott if you…And Scott, just a couple of data points to supplement what Scott just covered is that, the guidance for providing is we've used being conservative and achievable, which is probably hopefully, we're everybody would want us to be in our mind-set. But as far as also the background goes, and this ties back to your market question. We're really paying super close attention to the NBRx market that, last year, the NBRx market was down about 15% compared to 2019. And the real driver, there was patient visits were down in the second quarter of last year were down 45%. And that's a key driver to that part of the market. And also, sales rep face-to-face interactions are down 56% for the year, that's according to a QB [ph] data.
So we take a look at that. That's what we're paying really close attention to about the market. And that's something where, for our view of 2021, we see some trends where that you know, that's coming back. And I think that's favorable for the market, because it's what we're paying super close attention to that as far as how we're viewing the road in front of us. So I just want to provide a little bit more data behind your question as well, Scott.
Scott Henry
Okay, great. Thank you. And then final question, with regards to the litigation and not specific to this trial, but perhaps you can add some color. What would you typically expect for the timeline between a bench trial and a decision? I don't know if there's any guidelines we should be thinking about. But I wanted to hear your thoughts? Thank you.
Jeff Bailey
Got me? No, I think we really comment on there is that just for everybody else on the call as well, that there's a three day bench trial that was conducted commenced on March 1. And it was one where the court has requested the parties to submit post trial briefs over the coming two months, and the decision from the court is expected subsequent to the filing of the post-trial briefing, so there is no real like super clear timeline on that end. But that's really what's out there that's played back from the courts. So if you could imagine that we cannot really comment further on the litigation. But that's really where we stand at this point. So and hopefully I gave everybody a bit on the timeline.
Scott Henry
Yes, that's helpful. I appreciate that. Thank you for taking the questions.
Jeff Bailey
Thank you, Scott.
Scott Plesha
Thanks, Scott.
Operator
Thank you. Our next question is coming from Tim Lugo of William Blair. Please go ahead.
Tim Lugo
Thanks for the question. And I guess given the Alvogen chase timing, do any of that overhang impact pair discussions in Q4? Maybe some parents who were looking at preferred contracts that they wanted to know what the kind of on-going tail end of the contract would look like? And do you expect hopefully, given a favorable outcome was to have a more active payer round in Q4 [ph] 2021.
Jeff Bailey
Scott, you want to go and take that? Yes, I know, the answer is no. Please do you want to provide a more color behind that?
Scott Plesha
No, no, I appreciate that. No Tim, there's really no awareness at a pair level of around the trial at all. And I can honestly say that that it's not come up one time in our discussion. So and, really, it's just been normal contract discussions. So it again, going from the other part of your question I don't really see any impact there as well.
Tim Lugo
Okay. And Scott, I guess given the recent pick up in person call activity, I think you said maybe about 10% or so. Have you seen any of that flow through to I guess, Rx or a prior authorizations, or maybe new the brand growth? And I guess, in general, how happy are you with the script trends in January and February, given the normal seasonality?
Scott Plesha
So I'll take the first question. First, we really don't have enough data yet. Tim, as you know, it lags a good amount, least a few weeks, till we get a full picture. And really, it's been over the only last two to three weeks. And there was a good, there was a week, two weeks in February, where we had a virtual national sales meeting, and then the weather hit. So those weeks were lower on call activities. So it's hard to draw any conclusions where we would have been.
But Jeff mentioned this earlier; I'm a firm believer that it's number of calls on the right physicians with the right message. And, us having additional touchpoints face-to-face while we've enhanced our digital, I still believe, that's synergistic with getting in front of our prescribers. So, the -- that to me that that's, that's kind of crucial for us to see that going forward, and then the return of the patients to the offices like Jeff had mentioned.
Tim Lugo
Okay, understand.
Scott Plesha
I'm sorry, what was your -- what was your other? I'm sorry? The other question.
Tim Lugo
I think your general comfort…
Scott Plesha
Are the trends, yes?
Tim Lugo
February trends.
Scott Plesha
Yes. So when we go back and look at kind of seasonality of BELBUCA. In 2019, we had very similar trend to what we're seeing now. Excluding, again, that week, we can have in February, where we saw very soft and we can go back and trace that directly to the states impacted by winter storm, Uri. And what we will typically see is March being our next kind of inflection point and growth, after a little bit of a tick down, in January and February is always a short month. So that, that's kind of difficult to look at as a monthly basis. But March is usually the rebound month for us. And I think we're positioned well to do that.
Tim Lugo
Great, thanks a lot.
Scott Plesha
Thank you Tim.
Jeff Bailey
Thanks for question.
Operator
Our next question is coming from Tim Chiang of Northland Securities. Please go ahead.
Tim Chiang
Hi, thanks. Jeff, maybe you could just comment on how active you guys have been looking at potential BD transactions. Is there a lot out there that you guys have seen? And you do think that there's complimentary assets that you could bring in near term?
Jeff Bailey
Yes, Tim Hope you're doing well. Yes, no, we're very active as far as keeping our finger on the pulse. That's the best way to phrase it that so just give you from a process standpoint, we have a weekly call based on the different team members in the work that we're doing there that there are some interesting assets, we see a number of attractive assets out there. Neurology, CNS rare disease that we see as being complimentary to our to our focus, more so much focused on products that are focused on unmet medical needs. And that's really something that we will always read also focused Tim on, anything that leverages our core capabilities, our backbone of the commercial team, and really making sure that sufficient operating model as best as possible, looking at some things there.
So its good process in place, if you take a pie chart of where I spend my time, Terry and Scott, as well as it's become a significant part of the pie chart. But also, it's one, make sure that everybody takes away from the call that is a very prudent process to make sure that it's well thought out and really focused on shareholder value, anything we're doing on that. And so there's some interesting stuff out there. But it's also, the diligence and making sure that we're really solid as far as the process goes, is really cool. What's top of mind, so the senior management team is very focused on this, and it's a pretty good thing for that end
Tim Chiang
Okay, great. And maybe just one follow up for Scott. I mean, Scott, I mean, obviously, you guys are doing a valiant effort promoting BELBUCA. What sort of pushback are you still getting on the product here? I mean, obviously, there's no shortage of scheduled to opioids being prescribed in this country. I'm a little surprised that you're not getting more traction. I mean, is there something that's holding BELBUCA back?
Scott Plesha
Tim, I think the number one thing always in getting something prescribe is just changing habits. Obviously, there, there are a lot of health care providers that over the years have gotten very comfortable in prescribing the C2s, and they work very well. So there's a, there's a large base of business in that area. And there are a lot of short acting’s also those same molecules that are short acting's that are very easy to transition to a to, like molecule long acting.
So it's really getting people to change how they practice medicine, and how they treat their patients. So it's really about changing habit. And that's why, earlier I mentioned, being able to be in front of our healthcare providers our customers is so important to us, because I think that's the best way to change habit is face to face visit talk, sharing clinical data, and information. So hopefully, that helps.
Tim Chiang
I mean, do you see anything that the new government can do in terms of increasing awareness of, of non-opioid alternatives to treating pain?
Scott Plesha
Well we've seen some things come out, for example, the HHS Task Force obviously issued some different guidance, chronic pain guidance, a while back, but they really haven't mandated anything. I think we always view, policy as being something that could be additive, but we don't want to count on it to grow our business, it has to be us executing at a high level. So I don't know that we've ever seen the government very often come in and just dictate or practice medicine. So I think it's challenging to rely on that to drive our business, we have to kind of own our destiny going forward.
Tim Chiang
Got it. Thanks.
Scott Plesha
You're welcome. Thanks for questions.
Operator
Thank you. At this time, I'd like to go back over to Mr. Bailey for closing comments.
Jeff Bailey
Thank you very much. And so just real quickly, just today, very much appreciated by participating on the call. Hopefully, we gave you a pretty good snapshot about why we're so pleased about the fourth quarter very strong results also, really, to our employees and the teamwork that's gone on as far as really pleased with the record of the 2020 results that that we just were able to review with you. And also just to reinforce that we're very excited about the road in front of us. We're really teed up well here with a lot of great things for the market dynamics and also with our balance sheet that we've really worked hard to really grow that and improve it over the last year or two. And some really good stuff happening for the company that's in front of us, so we’re really poised for some great growth. And just as we wrap up, just thanks everybody for the time participating today and look forward to some of the follow up and been really focused on delivering a very strong year in 2021. Thanks all, and that's all we have on our ends.
Operator
Ladies and gentlemen, thank you for your participation and interest in BioDelivery Sciences. You may disconnect your lines and log off the webcast at this time, and have a wonderful day.
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