Feb 10, 2022
Operator
Good day, ladies and gentlemen, and welcome to the Medexus Pharmaceuticals Third Quarter 2022 Earnings Call. At this time, all participants have been placed on a listen-only mode and the floor will be open for questions and comments after the presentation.
It is now my pleasure to turn the floor over to your host, Victoria Rutherford. Ma'am, the floor is yours.
Victoria Rutherford
Thank you and good morning, everyone. Welcome to the Medexus Pharmaceuticals Third Quarter, Fiscal 2022 Earnings Call.
On the call this morning are Ken d’Entremont, Chief Executive Officer and Marcel Konrad, Chief Financial Officer. If you have any questions after the conference call or would like further information about the company, please contact Adelaide Capital at 480-625-5772.
I would like to remind everyone that this discussion will include forward-looking information that is based on certain material factors or assumptions and is subject to risks and uncertainties that could cause actual results to differ materially from historical results or results anticipated by the forward-looking information. In addition, during the course of this call, there may also be references to certain non-IFRS financial measures, including references to adjusted net loss and adjusted EBITDA, which do not have any standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other companies.
For more information about both forward-looking information and non-IFRS financial measures, including a reconciliation of each adjusted net loss and adjusted EBITDA to net loss, please refer to the company's management discussion and analysis, which along with the financial statements are available on the company's website at www.medexus.com, and the company's corporate filings on SEDAR at www.sedar.com. I would now like to turn the call over to Ken d’Entremont.
Ken d’Entremont
Thank you, Victoria. Good morning, everyone.
Thanks for joining us on the call today. We've got some prepared statements that we'll read and then be happy to take questions at the end.
In the third quarter of fiscal 2022, we achieved revenue of $21.3 million compared to $17.9 million in the second quarter of fiscal 2022, and $24.3 million in the quarter ending December 31, 2020 or the previous year. Revenues during Q3 were positively impacted by stronger IXINITY sales quarter-over-quarter.
As we began to see the results of the channel corrections, we initiated a few quarters ago. This improvement was partially moderated by the typical seasonality we have in our portfolio, specifically with the Rupall sales, which reflected a severe allergy season in Canada and then as expected, return to normal levels in the fall.
Adjusted EBITDA was positive at $1.9 million compared to negative $2 million in Q2, and compares to $3.9 million for Q3 last year. This improvement from Q2 also reflects the improvements we have seen in IXINITY, in particular, in the manufacturing process, which we will touch on later in the call, as well as the reduction of expenses in Q3.
Our Net loss of $1.2 million compared to a Net loss of $12.8 million for the same period last year. Our Q3 figure included a non-cash unrealized gain of $2.2 million on the fair value of the embedded derivatives in our convertible debentures, which is driven by a change in our share price at the end of the applicable periods.
Our adjusted net loss, which adjusts for these unrealized losses or gains, was $3.4 million compared to $0.4 million for the same period last year. Our net cash flow was $1.4 million in the period compared to a use of $2.9 million for the same period last year.
And at December 31, 2021, we had $9.6 million in cash and cash equivalents with $10.1 million of total available liquidity. Turning to our specific product lines, we saw sequential quarter-over-quarter improvement overall in our core business and are excited about the new and potential additions to our product portfolio, which we believe will generate growth momentum over the coming years.
During the quarter, we saw recovery in IXINITY sale that validates our recent initiatives to reset the supply chain and selling process over the last few quarters. And our unit market demand figures suggest a moderate level of patient conversions on top of a stable existing base of patients.
We're also continuing to invest in a Phase 4 pediatric study that if successful, we'll expand the IXINITY product label to include the pediatric population of patients under 12 years of age with hemophilia B. During Q3, we completed enrollment in our trial and the trial is expected to be completed by June of 2022 this year.
Once completed, a successful study could support an expansion of the indicated patient population for IXINITY and we are exploring approaches to address this potentially expanded market. Rupall saw strong and continued unit demand growth of 30% for the trailing 12 months ended December 31, 2021, continuing its trend as one of the fastest-growing anti-histamines in the Canadian prescription market.
Again, this growth reflects a severe allergy season across Canada and physicians increasingly switching patients to Rupall from either the generic prescription anti-histamines or over-the-counter products. Turning to Rasuvo, a once-weekly subcutaneous single-dose auto-injector of methotrexate indicated for the treatment of rheumatoid arthritis, psoriasis, and juvenile idiopathic arthritis.
On a unit sold basis, Rasuvo continued to maintain, and in fact, slightly increased its market share in the United States in the trailing 12 months ended December 31, 2021. However, product revenue was negatively impacted by a decrease in the effective unit level prices we implemented during this period to defend our strong market share in light of increased competition in the branded methotrexate market.
Metoject is a pre -filled syringe of methotrexate, which is indicated for the treatment of rheumatoid arthritis and psoriasis. Even with a generic entry into the Canadian market in 2020, Metoject had a unit demand increase of 8% in the trailing 12 months ended December 31st, 2021.
Again, product revenue was negatively impacted by a similarly motivated decrease in effective unit level prices. As we have discussed in the past, we continue to be excited about treosulfan.
We expect that it will become a leading agent for use in conditioning regimen as part of allogeneic hematopoietic stem cell transplant patient protocols, but thankfully abbreviated allo-HSCT. This is a therapeutic area of great strategic interest for us.
In June of 2021, we received notice of compliance from Health Canada to commercialize Treosulfan which we currently market at Canada on the trade name Trecondyv. We have entered into an exclusive license with medac GmbH to commercialize Treosulfan in Canada and now have fully launched in the Canadian market.
We also entered into an exclusive license with medac in February 2021 to commercialize Treosulfan in the United States. As we have previously discussed, on August 2, 2021, we were notified by medac of a Complete Response Letter from the U.S.
Food and Drug Administration related to the New Drug Application for the use of treosulfan in the United States. We participated in medac Type A meeting with the FDA on November 23, 2021 to review medac 's resubmission plan.
Following that meeting and based on our discussions with medac, our view is that there is a path towards approval, it does not involve completing an additional Phase 3 study, provided that medac delivers to the FDA materials that address the FDA 's outstanding issues set out in the CRL. The NDA resubmission is currently expected to occur in the second quarter of 2022 with a final FDA decision expected two to six months after the NDA resubmission.
Timing that is essentially consistent with our previous estimates. We continue to believe that treosulfan could eventually overtake the current market leading product in the U.S., busulfan, which realized $126 million in the U.S.
sales prior to genericization. In the meantime, we do not expect to make additional milestone payments to medac until we have received FDA approval.
In addition to our current product portfolio, we also have a right of first refusal on current products from medac, the previous owner of Medexus U.S. We believe that several of these products represent a promising commercial opportunity in North America and we are in the process of assessing the licensing of these products.
We are also in discussion with several partners regarding other licensing opportunities that we believe have the potential to material contribute to the revenue over the next few years. A key component of our growth strategy will be to continue to leverage our infrastructure through new products, acquisitions, and partnerships.
We are exploring a number of opportunities, including a portion of the deal pipeline in the negotiation phase in both the U.S. and Canada.
We will continue to look at optimizing our portfolio and leveraging our resources with the goal of exceeding near-term -- of executing near term accretive transactions to achieve our sales growth targets over the coming years. We aim to continue to grow revenue, leverage our North America sales force across products, realize synergies from our predecessor companies, and maintain strict financial discipline.
In summary, we believe we have built a highly scalable business model, which should provide significant incremental earnings potential. I'll now turn the call over to Marcel, who will discuss our financial results in more detail.
Marcel?
Marcel Konrad
Yes. Absolutely.
Thanks, Ken. Total revenue was $21.3 million and $56.4 million for the three and nine months periods ended December 31, 2021, respectively compared to revenue of $24.3 million and $62 million for the three and nine months period ended December 31, 2020.
Revenue for the quarter benefited from end-of-year wholesale buying by approximately $2 million. The competitive revenue period in 2020, similarly benefited from over $2.5 million in IXINITY revenues that was collected in October of 2020 versus September 2020 as expected due to a delay in receipt of finished product from our contract manufacturing partner.
We expect that timing of large orders like these will continue to affect quarter-to-quarter comparisons of our revenues. Gross profit was $11.5 million and $27.8 million for the three and nine months periods ended December 31, 2021 respectively, compared to gross profits of $12.7 million and $33.2 million for the same period last year.
The decline for the nine-month period ended December 31, 2021 was due in part to an increase in cost of goods sold, costs by additional expenses related to failures during the IXINITY manufacturing process in the quarter end of June 30, 2021, as previously disclosed. The gross margin was 54.1% and 49.3% for the three and nine months period, ended December 31, 2021, respectively, compared to 52.2% and 53.5% for the three and nine months periods ended December 31, 2020.
For the most recent quarter, we are encouraged to see initial results of improvements made to IXINITY manufacturing. Investments we made in people and in the process -- in the manufacturing process are beginning to show good results.
Selling and administrative expenses was $10.7 million and $34.1 million for the three and nine months periods ended December 31, 2021 respectively, compared to $9.4 million and $25.9 million for the three and nine months periods ended December 31, 2020 respectively. The increase over the comparative periods reflect important investment in our personnel and infrastructure to support our anticipated growth going forward, including preparation for the commercial launch of treosulfan in the United States will react quickly to defer or cancel any further significant expenditures related to the treosulfan launch after receiving notice of the CRL on August 2, 2021.
However, we believe that the CRL provides a path to review and approval and therefore, have continued to incur some expenses in anticipation of treosulfan 's eventual commercial launch. Recession development was $1 million and $5 million for the three and nine months periods end of December 31st, 2021, respectively.
Compared to $1.2 million and $2.6 million for the 3 and 9 months periods end of December 31st, 2020, respectively. As we continue to fund the IXINITY pediatric adjusted study, which is now 100% in growth.
Adjusted EBITDA for the three and nine months periods ended December 31, 2021 was $1.9 million and minus $5 million respectively, compared to $3.9 million and $9.8 million for the three and nine months period ended December 31st, 2020. Adjusted EBITDA of $1.9 million reflects an increase from the minus $2 million of the second quarter in our fiscal year 2022.
Sequential quarterly improvement was primarily attributable to improved IXINITY net sales in the third quarter and through reduction of expenses. As mentioned earlier, the company's recent inventory management and manufacturing process modernization initiatives have also started to produce positive results.
The three and nine months ' periods ended December 31st, 2021, saw a year-over-year decrease in adjusted EBITDA due to the impact of the IXINITY manufacturing failures during the three months ended June 30, 2021. The large increase in research and development costs over the comparative period and the significant investments we made to improve our capacity for future business development and prepare for the anticipated commercialization of treosulfan in the United States.
Net Income for the three month and nine month period ended December 31, 2021 was minus $1.2 million and $2.4 million, respectively. Compared to net loss of $12.8 million and $17.8 million for the same period last year.
Included in net Income or loss is a non-cash, unrealized gain or loss on fair value of the embedded derivatives in our outstanding convertible debentures, which are sensitive to amongst other these fluctuations of our share price. We believe that adjusted net income or loss, which excludes the impact of unrealized gains or losses on the fair value of derivatives, provides a better representation of performance of our operations because it excludes non-cash fair value adjustments on liabilities, which may be settled for shares.
Our adjusted Net loss for the three and nine months periods ended December 31, 2021 was $3.4 million and $19.4 million respectively, compared to $0.4 million and $2.5 million for the three and nine months periods ended December 31, 2020. Cash and cash equivalents was $9.6 million at December 31, reflecting an increase of $1.4 million during Q3 and a decrease of $9.1 million over the first three quarters of fiscal 2020.
Our available liquidity was $10.1 million at December 31, 2021, which consisted of $9.6 million in cash and cash equivalents and an undrawn credit of $0.5 million available under our ABL Facility. We are continuing to exploring various financing strategies to enhance our liquidity, to support our execution of our business plan that includes an eventual launch of treosulfan in the United States.
We are exploring various options to bolster our liquidity both pre and post FDA decision, including to fund any milestone payment announced that may be comparable as a result of the FDA decision. As mentioned during previous earnings results, no further milestone payments will be owed to medac unless and until FDA approval of treosulfan is obtained.
Furthermore, we want to reiterate to investors that we do not expect this year rail for treosulfan to result in any default on our credit facility.
Ken d’Entremont
Operator, we'll now open the call to questions.
Operator
Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, We ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality.
Please hold while we poll for questions. Your first question for today is coming from Andre Uddin.
Please announce your affiliation, then pose your question.
Andre Uddin
Research Capital. Hi, Ken and Marcel, looks like IXINITY inventory issues are now resolved which is good to see.
Just looking at the pediatric IXINITY trial results, are those going to be coming out this June or when should we expect that data?
Ken d’Entremont
Yeah. Thanks, Andre.
Good question. So the last patient dose will be June of this year.
And then it will likely take about six months to prepare the results for submission.
Andre Uddin
And just obviously, there's lots of stuff going on here in Canada. I'm just wondering if you foresee any supply chain issues with your business given the current border closures?
Maybe you could just talk a little bit about that.
Ken d’Entremont
No, we don't. We -- since the beginning of the pandemic, we've been seeking to hold significant inventory on hand.
Many months, we're trying to shoot for six, and so temporary delays don't affect us. It certainly is much more challenging to move product.
It costs more and it takes more time. But because of the safety stock we've got built-in, it hasn't affected us.
We haven't had any significant backwards.
Andre Uddin
Okay. Okay.
That's great. Thanks, Ken.
Operator
Your next question is coming from Scott Henry. Please announce your affiliation, then pose your question.
Scott Henry
Thank you. Roth Capital.
Couple of questions. First, did you disclose what products had the $2 million order at the end of the quarter?
Ken d’Entremont
I don't believe we did, but it was IXINITY. And as we've been describing, we have been resetting the channel to whatever we think we anticipate the right level is.
We were somewhat surprised that that order came in. We didn't think that that customer wanted to hold that much inventory, but they do.
And so we feel that, so we ended up with a higher quarter than we expected. So we'll see what happens this quarter.
We -- I think the good news is that demand matched that factory revenue this quarter for IXINITY. And if there are no further corrections in the channel, then we would go forward from here, but we thought that we'd go a little bit lower in terms of months on hand in the channel.
So it's a little bit higher than we had anticipated, but that's totally up to the wholesale and retail customers at this point.
Scott Henry
And if we look at the sequential gain in U.S. sales from Q2 to Q3, is the large bulk of that gain all coming from IXINITY?
Ken d’Entremont
Yes, absolutely. Metoject is mature.
We hold very strong market share there. I think we were like 80%.
So it's basically flat on a unit basis, a slight increase and a little bit down in dollars as we protect our share. So yeah, all of the gain that was realized came from IXINITY.
Scott Henry
Okay. And now --
Marcel Konrad
Maybe, Scott, since you asked for the Q2 or the Q3 variant, is that correct? Yeah, that was your question?
Scott Henry
Yes.
Marcel Konrad
Yes, that is the majority of the U.S. kind mentioned is from the strong that it's actually somebody pulp line.
We've also been very consistent in saying that we've produced and we've stop obviously to spend from the launch. So we see, if you look at our operating expenses, for example, Q3 over Q2, which would have also decreased, which is the fact that that contributed to an increase EBITDA this quarter.
Scott Henry
Okay. Now, given that you had this $2 million order in Q3, how should we think about fourth quarter?
I mean, I know the trends are going in the higher direction. But do you think Q4 could be as strong as Q3?
And should we think about positive EBITDA as a continuing event or more of a one-time event? Thank you.
Ken d’Entremont
We're obviously heading in the right direction and we're anticipating that -- I think we kind of thought we'd be break even this quarter and then positive next quarter. It may be the inverse, if the channel further corrects, and we might have a break even quarter.
This quarter maybe a little bit down, little bit up. I mean, it really depends on where the channel settles.
The good news is that there are no incentives, so we're selling all the IXINITY at normal pricing, which is great, helps the margins. We think we're near where the channel should be, but the channel will determine exactly where it wants to be.
It's hard to call this quarter. I think the good news and direction I would give is that the ex-factory sales matched demand this quarter.
Scott Henry
Okay. Great.
And final question on the balance sheet current portion of long-term debt is a sizable number. But I know there's a lot of noise in that.
Do you have any debt that you expect to be due within the next 12 months? And maybe you could give some color around that?
Ken d’Entremont
I'll let Marcel take care of that.
Marcel Konrad
Yes, Scott. Good question.
And it's a bit difficult to decipher footnotes feisty on this particular $18 million. With the huge majority of this is our ABL, the asset-based loan, which is the revolver that that this is going in there that obviously is not within the 12 months, and then we have $4 million or so subject cumulative to true test that we have to repay in the next step.
Scott Henry
Okay, great. Thank you for that color and thank you for taking the questions.
Ken d’Entremont
Okay, Scott.
Operator
You do have an email question from Thomas Newman. And Thomas asks, is Medexus still planning to uplift to a U.S.
national exchange in 2022?
Ken d’Entremont
It's a good question. It depends on the circumstances.
Obviously, we had believed that the FDA approval of treosulfan would've been a good catalyst for upgrading to a major U.S. exchange.
We still believe that's the case and we're evaluating those options.
Operator
Thank you. Your next question is coming from Prasath Pandurangan.
Please announce your affiliation, then pose your question.
Prasath Pandurangan
Good morning, I'm from Bloom Burton. Thanks for taking my questions.
My first one relates to the impact of IXINITY. What's the target gross margin once the channel inventory is completely normalized and the manufacturing process improvements are fully in place?
Ken d’Entremont
Great question, complicated answer. The gross margin obviously improved probably points as a result of withdrawing the discounts.
The improvement in cost of goods is far more difficult to forecast. We're on a very good trajectory.
We're seeing nice improvements and goals will be realized as we go forward. It's a long manufacturing process for IXINITY.
And remember, it's a biologic product so it takes a long time to make it. And so the improvements that we're seeing are as a result of work we've been doing over the last year.
And it's now starting to be realized and will continue to be realized as you go forward. The target is little ambiguous and that we don't know the improvement that each of the steps will make.
We've been pleasantly surprised that the improvements we've made so far have exceeded expectations, the yields have gone up more than we expected. And so we've had very good impact with the money that we spent so far and the work that our U.S.
team has done, which has been excellent so far. It's hard to forecast how much better we'll get, but we're confident that we'll get better.
Prasath Pandurangan
Okay. That sounds good.
And then, have you looked at potential capital raise for milestone payments as well as the eventual launch of treosulfan in the U.S. How do you see the market changing over the past year?
And how do you plan to overcome any potential challenges?
Ken d’Entremont
I think I'll turn that over to Marcel.
Marcel Konrad
Yeah. Thanks for that question.
So we have obviously a lot going on right now with our base business. Ken alluded to business development.
We're looking at launching products. We're did -- the dynamics per se obviously, if you look at the past versus where we are at right now, and it hasn't really fundamentally changed specifically with the share price we had up to now.
Now obviously, we're looking at this a little bit short, mid and long-term now. The short-term whereas you've seen, now we had about $10 million of available liquidity and now we're looking into the next steps, sort of the midterm phase here up to the FDA approval decision ultimately then to say that after the decision point, we have a long-term view on this race as you mentioned on the milestone payments.
So we're looking at various financing strategies within those periods and we'll be tackling them over the next few quarters.
Prasath Pandurangan
Great. Thank you.
Operator
Your next question is coming from Justin Keywood. Please announce your affiliation, then pose your question.
Justin Keywood
Hi, Stifel and thanks for taking my call and nice to see the base business stabilized in the quarter. On the resubmission of treosulfan, what determines the FDA response being two months versus six months?
Ken d’Entremont
Yeah. Good question, Justin.
It's totally up to the FDA and it's dependent on the amount of material that they need to review. We're planning for the worst, which is the six months; and it's either two or six.
It's not really anything in between. Probably, we're assuming it's going to be six that would put us out of October decision point, but it could be two.
We will know 30 days after re-submission, so they will tell us whether it's type one or type two 30 days after re-submission. We will communicate that once we know.
Justin Keywood
Okay. And the re-submission is in Q2, any indication when in Q2 or difficult to say?
Ken d’Entremont
We think it's early Q2. medac is obviously the party responsible for preparing it.
We're reviewing and we've all with it, but they are the party preparing it. We think very early Q2, we had previously said, I think at the very beginning when we first got to CRL, that we're shooting end of Q1.
It looks like it's beginning of Q2, and again, soon as we put it in, we will announce that.
Justin Keywood
And what indicators are you looking for to resume some increased spending in anticipation to launch treosulfan? Would that happen perhaps if it's a two-month or six-month review?
Or how are you planning that?
Ken d’Entremont
Yeah. Again, great question.
First, remind you that we are carrying spending associated with treosulfan now under the medical team, the MSLs, some ITPs investigator initiated trials. So there is trio spending that's in our numbers.
We will initiate the sales force after a decision. That's the big spending.
And we've said previously that we were anticipated about 16 reps, one-six, to support treosulfan commercialization. And so that spending will not happen until we get a decision.
We have some months before commercial product is available. So we have time between the decision and availability of product in order to establish the sales force in and that's the plan.
Justin Keywood
It seems like a prudent strategy and thank you for taking my call.
Ken d’Entremont
Thanks, Justin.
Operator
Your next question is coming from Simon Jarry. Please announce your affiliation, then pose your question.
Simon Jarry
Hi, Ken. This is Simon Jarry from Raymond James.
My question is about regarding the margin you are experiencing with IXINITY. What I understand is that you changed the manufacturing process?
Can you talk a bit about that?
Ken d’Entremont
Sure.
Simon Jarry
What has been done? My question is more -- yeah.
Ken d’Entremont
Yes. Just to be clear, we haven't changed the process.
We're improving the process. So these are all small incremental improvements that when you layer one on top of another, it start to make a difference.
So that's what we're doing. It's really hard to quantify the improvement.
I mean, I will turn it over to Marcel. We're seeing small improvements in some of the skews and we anticipate that to get better as we go forward.
And so there is a percentage improvement, probably single-digit in cost and goods so far, and we expect that to continue to grow as we go forward. Marcel, anymore color you can add to that?
Marcel Konrad
Yeah, maybe. As I mentioned, we've just now seeing this quarter.
For example, initial, it's a long process, obviously, with the biologic products and we've seen initial encouraging results. And maybe the question around gross margin versus improvements versus the overall stability is important one as you had.
Maybe you notice, for example, this quarter and we had earlier this year, we had to put a reserve for batches which now has been turned out to be, because of this project, we seem to be in a more stable environment. So it's not only -- these investments are not only about targeting opposite the gross margins, but stabilizing the product stability.
And hence, we don't want to see these reserves which as you had seen this quarter, we haven't found. So it's a two-sided view on this.
One, obviously a direct impact on the financial statements when you talk about gross margin, but the other one is really targeting on your manufacturing process to make sure that we see these products coming through the manufacturing process. Innovative bump is seen them through and then don't have to assess resource.
Simon Jarry
Thank you.
Operator
Your next question is coming from Alan Ford (ph). Please announce your affiliation, then pose your question.
Alan Ford
Hi. I am private investor and hi, Ken and taking the question.
And I got three questions if that's the case. The first one is on IXINITY.
And are you able to confirm what the NGs at demand growth over the last 12 months? And then I appreciate it's been tricky with COVID, but what also on the prospects of getting back to kind of price levels and then look at what I'm seeing afterwards.
Ken d’Entremont
Yes. So the IXINITY demand is primarily made up of existing customers so we've got a strong base of customers that have been with us for a long time.
So that's very, very stable. The challenging piece is new patient growth, which became more challenging with the initiation of COVID, because the face-to-face visits just aren't happening.
So the growth, I would estimate to be in the high single-digit, low double-digit sort of growth over the period over 12 months. And then quarter-to-quarter it fluctuates, but I think the good news for us is that we've got a very stable base of existing business that is quite easy to project in terms of demand.
Alan Ford
Thank you. That's very helpful.
And then just some receive. I saw the Otrexup being acquired by us.
And I know it's just one of the basic question, but they had 12-month revenue about $15 million, and my understanding was it received I was sudden year, described exactly but they were somewhere around $30 million, right. And that's just can't quite relate the TAVI foresee that has an 80% market share and attract simply those with much smaller.
Say, it's fair, it's a slight more mix level. It's really helpful.
Ken d’Entremont
When we quote the market share, we're quoting prescriptions, so that's demand really units. And so the dollar value shares may be different depending on pricing.
Alan Ford
Okay. So you're but much lower price product is that the right take?
Ken d’Entremont
I think by those measures, yeah, we're a little bit lower. Therefore, we'd have a lower share of dollar volume and much higher share of unit volume.
Alan Ford
Okay. That's that's a good position to be in, I think.
Thanks very much.
Operator
There are no questions in queue at this time.
Ken d’Entremont
Great. Well, thank you everyone for joining us on the call today.
Despite the challenging start to fiscal '22, we are confident medac has now turned the quarter with the IXINITY supply chain process changes we're making and we're back to a positive growth trajectory. We're pleased with the clarity providing the type A meeting on treosulfan resubmission and expect the FDA's decision later this calendar year.
We do anticipate that we will continue to execute our business strategy and are in a good place to do that. Looking forward to future updates.
Thanks very much for tuning in.
Operator
Thank you, ladies and gentlemen. This does conclude today's conference call.
You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.