Q2 2022 Acorda Therapeutics Inc Earnings Call

Ladies and gentlemen, and welcome to our quarter Therapeutics second quarter, 2022 financial and business update.

At this time all participants are in a listen only mode and there will be a question and answer session to follow.

Please be advised that this call is being recorded at the company's request.

I will now introduce your host for today's call Tierney Salvino at a quota Jenny. Please go ahead.

Thank you Bobby and good afternoon, everyone. Before we begin let me remind you that our presentation will contain forward looking statements detailed disclosures can be found in our SEC filings, which are public and we encourage you to refer to those filings today during the Q&A, we will take some questions from investors.

I had written and when they registered for the call I will now pass the call over to our CEO Ron Cohen Ron.

Welcome everyone.

We'll go right into the report.

Starting with Embrasure embrasure net revenues for the second quarter of 2022 with $7 $4 million. That's a 16% increase over Q2 of 2021 and this also doubled our net revenue from the first quarter of 2022, which followed the buy in that we saw in Q.

For 2021, and also a challenging Q1 due to the Covid omicron surge at that time.

We were also encouraged to see that new prescription forms increased progressively since the first quarter and in July were 37% greater than in January as the country has opened up even in the face of Covid.

Okay.

Regarding on PURA <unk> net revenue for the second quarter was $18 2 million, that's a 17% decline over Q2, 2021, but a 22% increase over the first quarter of this year as again specialty pharmacy by in the fourth quarter had a rollover.

Factored into Q1.

We are reiterating our guidance for 2022 net sales of <unk> of between $68 $78 million.

Moving to our ex U S revenue.

<unk>.

Launched in Germany, which we were delighted to see in June and we recorded $1 $9 million in revenue from our survey for the initial launch shipments under our supply agreement and an additional $900000 worth of drug was shipped in July .

<unk> is reporting that feedback in the first two months of the launch in Germany has been enthusiastic with excellent uptake.

Stephanie has benefited from our learnings in the U S, which we transferred to them, particularly regarding the importance of training about proper inhalation technique and we believe they are also benefiting by not launching into the onset of the pandemic.

<unk> expects to launch in Spain in the first quarter of 2023 and our other <unk>.

<unk> bio paths is continuing to work toward launches of embrasure and the nine largest Latin American markets, including Mexico and Brazil.

We're also in discussions for commercial embrasure partnerships in additional territories around the world.

Regarding <unk>, which is the X gene I'm, sorry, Sam <unk>, which is the ex U S version of <unk> that is marketed by <unk>.

Biogen our obligation to healthcare royalty partners has been fulfilled and the double digit royalties per fan PURA reverted to a quarter as of late June we expect to see the full benefit of those royalties commencing again in Q3.

And in addition, we're pleased that Biogen has now launched <unk> in China.

Our CFO , Mike Gasser will now review the financials Mike.

Thanks, Ron.

Opex for 2000 $22 million to $5 million lower than our Q2 2021, and we are maintaining our 2022 opex guidance of $110 million to a $120 million.

The amendment to the catalyst supply agreement that was effective from July one 2021 through June 32022 resulted in a $4 $6 million in savings from the minimum commitment.

As of July one 2022, we have reverted back to the original contract conditions.

Although we were aiming to be cash flow neutral by the end of the year. We now anticipate that that will occur in 2023, while we have seen a gratifying bounce back in our business from Q1. The Q1 shortfall had a bigger effect than we originally anticipated based on the buy in in Q4 and the extremely large COVID-19.

Serge during that quarter.

Back to you Ron.

Ron are you there.

Sorry, I had.

I was on mute I have corrected that so we continue to focus on building long term value through execution on the key goals you see here.

First continuing to drive <unk> growth.

We were encouraged to see that new prescription forms grew in the second quarter through July following the dip in Q1, which was associated as you heard with a large fourth quarter buy in as well as the extreme omicron wave at that time, although COVID-19 has not moved past the country.

The country has clearly been moving past COVID-19 and as the effects of the pandemic continued to recede. We believe that people with Parkinson's are anxious to become more active again, especially since activity is an important part of managing their Parkinson's and we expect those trends to continue to positively impact.

And breezes trajectory.

And we've been implementing multiple new commercial programs to take advantage of that.

Those programs include for example, a new electronic or E prescribing option, which reduces friction for positions when prescribing embrasure. We've also added before and after videos to the embryo website embryo dot com. These compellingly demonstrate.

Enbridge has potential benefits and I encourage you all to visit the Enbridge at dotcom site to see them for yourselves.

We're also gratified to have begun to receive initial revenues from our ex U S. Embrasure partnerships and we're looking forward to additional launches from our existing partners as well as additional partnerships for new territories moving forward.

Yes.

Regarding and Purion <unk>.

While we expect the brand to continue to decline against generics over time that decline has been flattening and we've been encouraged by <unk> durability to date, we're continuing to provide our support programs have our field force call on EMS, So offices and we're reiterating our net sales guidance of <unk>.

The 8% to $78 million in 2022.

We're also continuing to exercise and fiscal discipline to control operating expenses and as the Biogen royalties on the ex U S sales of <unk> have reverted to a quarter, we will receive the full value of these royalties commencing in the third quarter.

We're also building on the ARCUS technology platform, which has now been validated by the approval of <unk> in both the U.

<unk> in the EU.

We are in discussions about potential collaborations with other companies who have expressed interest in formulating their novel molecules for pulmonary delivery with ARCUS and we've already been performing feasibility studies for a number of these opportunities.

So with that we will open up the.

Your line for questions.

Have received a couple of questions at per the announcement earlier, so I will.

I will read those.

First question is please provide an update about the timing of breakeven cash flow.

As Mike Gasser, just shared in our presentation, we had been aiming to be cash flow neutral to reach cash flow neutrality on a run rate basis by the end of this year due to the outsized impact in the first quarter of both the fourth quarter by an ads b.

Mendes Omicron Serge.

We are now aiming at for 2023, we believe we will hit that in 2023, we'll narrow that more as we gather more data in the next couple of quarters.

Second question is FDA is slated to release product specific guidance to develop a generic embrasure later this year, how long do you envision a quota can or will retain branded exclusivity on embrasure and two what are your lifecycle plans to blunt the impact of the brand.

<unk> strong enough to hold off generics.

<unk>.

A few points on that first of all FDA was actually scheduled to have issued the guidance last year, they have not yet done so.

We are not aware of any anda filers yet.

But the broader point is we believe we have a strong patent portfolio that extends to 2032.

In addition, the product is based on the ARCUS technology, and we think the complexities of that technology, along with the patent portfolio and the fact that this is an inhaled drug which brings additional obligations for safety and so forth that all of that will be helpful. In defending the frac.

Charge going forward.

Are there any other questions operator.

I have no further questions at this time.

Alright, so with that thank you all for joining us and we look forward to updating you in our third quarter call.

A great evening.

And ladies and gentlemen, this concludes the quarter Therapeutics second quarter 2022 financial and business update we thank you for your participation and you may now disconnect.

Please wait the conference will begin shortly.

Yes.

Sure.

[music].

Okay.

Yes.

[music].

Yes.

Okay.

Yes.

Yes.

Yes.

[music].

Sure.

[music].

Yes.

[music].

Yes.

Yes.

Yes.

Okay.

[music].