Q1 2021 Amryt Pharma Holdings Ltd Earnings and to Discuss Acquisition of Chiasma Inc Call

Good afternoon, ladies and gentlemen, and welcome to the farmer on the kiosk my analyst call and.

Webcast during the conference all participants will be on a listen only if you wish to ask a question during the Q&A session.

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I'll now hand, the call over to him right pharma. Please go ahead.

Hello, everyone and thank you for joining us for the call to discuss the proposed acquisition of Geos and not by average before we begin from a little marks.

And you that some of the information and state news release and on this conference call contains forward looking statements related to among other things the anticipated benefits of the proposed transaction the anticipated impact of the proposed transaction and the combined company's business and future financial and operating results and your expected amounts and timing of synergies from the proposed transaction and the anticipated closing.

For the proposed transaction and other aspects of our operations core operating results. These forward looking statements involve risks uncertainties and assumptions that are difficult to predict and which may be outside of the cartons control, including among other things risks that the merger disrupts current plans and operations of the business.

The outcome of any legal proceedings related to the merger.

Parties to consummate the proposed transaction on a timely basis or at all.

And I respect some of the conditions precedent to consummation of the proposed transaction and the development of families and businesses trends and their operating industry, changing economic and financial or other market conditions.

And license these risks uncertainties and assumptions the events or circumstances referred to on the forward looking statements may differ materially from those indicated in these statements words and expressions, reflecting optimism satisfaction with current progress prospects or projections as well as words, such as believes intends estimates expect plans projects anticipates and other similar hurting.

Jason identify forward looking statements, but their absence does not mean that the statement is not forward looking and such.

Forward looking statements are not a guarantee of performance and the Companys actual results.

What could differ materially from those contained and such statements.

Any forward looking statements speak only as of today's press release and conference call Wednesday May fear.

21, and the company undertakes no obligation to publicly update any forward looking statements or supply new information regarding the circumstances. After the day of this call.

I want to draw your attention to two press releases that we used to earlier today.

Earlier today Amherst from government published a joint press release announcing the proposed acquisition of kiosks, and if I average copies of which can be found on the respective farmers and CASM on corporate website separately.

Issued a press release this morning announcing financial results for Q1, 2021.

Today's call will happen in two segments.

And then with Dr. Joe Wild and.

<unk> will present the details of the proposed transaction and then we'll be joined by senior management from both companies for a Q&A session regarding that transaction at the conclusion of the formal remark.

And we'll then turn the call back to Joe Woody and lower yield on the CFO and COO to discuss Q1 2021.

And this will be followed by a second Q&A session, specifically focused on questions around Q1 there.

There are slides accompanying today's call and can access these two arms and kiosks and the corporate web site. At this time I will turn the call over to Dr. Joe Why Joe. Please go ahead.

Thank you, Scott and I and now on slide five and good afternoon, everyone and good morning to those joining from the U S.

Day and importance day for Atlas, we are very excited to be announcing that we've entered into a definitive agreement to acquire key asthma and and all stock transaction.

I'm pleased to be joined on the call by Raj Kannan CEO. He asthma, along with other members of the gas and that management team.

Before getting into the details of the transaction along with the deal rationale and more let me first say thank you to the teams from both companies are working very hard over these last few weeks to get to this point.

And does the deal, which further strengthens <unk> position as a global leader and treating rare and orphan conditions and the combined company will have three on Mark just commercial products and <unk> Metro left and on my top set.

As well as a significant development pipeline.

This portfolio will be supported by a global commercial and operational footprint.

<unk> is the first and only approved oral somatostatin analog for appropriate patients with acromegaly.

Significant revenue growth opportunities from my top set and acromegaly, while we estimate the global market is worth $800 million.

We are also very excited to further develop the potential from <unk> and patients with carcinoid symptoms stemming from neuro endocrine tumors are and where.

For the total market opportunity is even larger estimates it at $1.9 billion.

This transaction is expected to accelerate and diversify and thats growing revenues and we.

Believe this combined portfolio of products offered the pathway to a potential $1 billion and peak revenue.

Moving on to slide six.

Our average fleet development tonnes, a day audio gel S. 10, we have made regulatory submissions and both the U S and EU.

If approved this will bring the combined company's portfolio of commercial products before.

Very importantly, this transaction will leverage our track record of successful integration.

And it already has in place the infrastructure expertise and the financial flexibility to realize the full potential of my accounts there.

We intend to deploy this infrastructure to further accelerate the launch of <unk> and the U S and also leverage our regulatory affairs experience and global commercial infrastructure to seek approval and launch internationally.

The acquisition is expected to deliver annual cost synergies from approximately $50 million.

And we expect that it will be revenue and EBITDA accretive and cash generative and the first full calendar year of combined operations and substantially accretive thereafter.

Yes.

<unk> royalty interest financing improvement is expected to be fully repaid upon closing of this transaction, allowing us to add a high margin unencumbered assets to our portfolio.

This is an all stock transaction with Amherst shareholders to own approximately 60% of the combined company and <unk> shareholders to own approximately 40%.

The deal has been unanimously approved and recommended by the boards of both <unk> and PFS map.

And also have voting agreements with the shareholders both businesses theory on capital management Highbridge capital.

And MTN Council.

Slide seven.

And just help explain exactly why we're so excited about this transaction and how we can leverage our combined infrastructure to really get the most out of our assets and create shareholder value.

The addition of my confidence on what's existing commercial products means the combined company will have a total of three products on the market with strong IP protection.

I was already has existing global infrastructure and addition to our commercial and medical teams. We also have strong capabilities and R&D and regulatory and the addition of key asthma will further strengthen our existing footprint and the U S.

And a capsule has recently been launched and the U S and given the significant degree of customer call points overlap. We believe the combined business will potentially accelerate the adoption of my cash with endocrinologists.

Our strong existing relationships with them to come on let's just and by combining and scaling.

Scaling sales forces.

We believe that this will both drive my test adoption and also potentially enable further metro left and revenue growth.

On the R&D from a lead development pipeline products <unk> S. 10 is under regulatory review and the U S and EU.

And we intend to advance our gene therapy assets AP 103 into the clinic and 2022.

With this transaction. We are also excited by the opportunities from a cutback in NTT and post FDA discussion and it's our intention to start a phase III study and this indication and the first half of 2022.

We believe there is also a potential to leverage the asthma technology delivery platform with our other products.

I already mentioned the financial benefits just to reiterate the transaction will be revenue accretive immediately we expect approximately $50 million and annual cost synergies and expect to be EBITDA positive and cash generative and the first full calendar year.

Turning to slide eight this is an overview of AMR and I'm presenting this mainly for the benefit of kiosk, Ms shareholders, and others, who might be EBIT less familiar with us.

As a growing commercial business with two commercial products Metro left on the metal price and a significant development pipeline.

Our business and EBITDA positive and cash generative.

Global hate Skus and built in Ireland, or USA to Us and Boston Company was founded in 2015.

On the right you can see financial metrics, including some highlights from our Q1 2021 numbers that we reported this morning.

Slide nine.

Presents a financial snapshot of AMR and.

Chuck gave you a sense of how well the business is currently performing well.

And what you are seeing here are the 2020 versus 2019 numbers as well as some highlights from our Q1 2021 financial results.

Want to emphasize here is that these numbers on to a large expense estimates to the success of the jewelry and acquisition, we acquired a jewelry and in September 2019, and it was <unk>.

<unk> integrated turning to combined business EBITDA positive and Q1 2020.

Acquiring businesses and products as an integral part of <unk> growth strategy and success to date, we have a proven track record of doing it successfully and I'm fully confident that we can repeat the success with asthma.

Today, We announced Q1 2021 revenues of $48 4 million, that's up eight 7% over the same period last year and up 13, 9% sequentially over Q4 2020.

Metro left and revenues from Q1 increased by 11, 3% year over year to $30 million and <unk> revenues increased four four percentage year over year to $18 2 billion.

EBITDA in Q1 was $9 9 million.

And that compares with $4 6 million and Q1 2020.

We have a strong balance sheet with cash of $118 6 million.

And as of March 31st.

To date, we have announced that we are raising our full year 2021 revenue guidance from a previous range of.

$200 million to $205 million to now 205 million to $210 million on it.

It's of course reflects the strength of <unk> existing business and excludes the expected uplift from my cost of revenues post transaction close.

Moving on to Amex approved products and now on slide 10.

I'll start with match left and which is our product for the treatment of <unk>. This.

This is a chronic condition that results in less and efficiency, which in turn causes metabolic abnormalities, including severe insulin resistance diabetes, hyperdrive dyslipidemia and start to deliver.

And that should lessen as an analog of the hormone leptin and has been shown to improve these metabolic parameters without from a lower triglyceride levels lower blood sugar levels and lower H B C.

The size of the opportunity and the major markets and summarized here.

Estimate that the global market from Astro lesson is what $530 million. So we believe the product still has significant potential for further market penetration on slide 11.

Our other product limited pipe is approved as an adjunct to a low fat diet on other lipid lowering medicinal treatments for adults.

And with a rare cholesterol disorder, known as homozygous familial hypercholesterolemia or hateful effect.

Thank you.

<unk> life threatening disorder that impairs, the body's ability to remove LDL cholesterol from the floods.

The result is extremely high blood LDL cholesterol levels.

Left untreated can lead to blocking of arterial blood vessels and.

<unk> patients are experiencing.

Experiencing life, threatening cardiovascular events and aren't treated have a substantially reduced life expectancy.

Estimates that the global market for them its price and Patriot is approximately $250 million.

On slide 12.

And it's most advanced development stage comp based on on potentially a very significant growth driver is all of the hotel and Ted.

If approved this product will be known on to the brands and sales to that.

Successful completion of our phase III trial, and EP with one of our major accomplishments last year.

<unk> known as he's met its primary endpoint with 41, 3% of patients and the audio Joe S 10 group achieved and first complete closure.

And the EBIT target wound with a 45 day treatment versus 28, 9% and the control group.

Results were statistically significant P value was 0.01 and three.

This was the largest phase III trial ever conducted in EP and also the first to show a positive readout.

Our plans to seek approval for audio gel and <unk>.

And our ready for us on and we have made regulatory submissions and both the U S and EU.

And our NDA submission to the FDA includes a request for priority review, which could potentially expedite the review process to six months.

Following acceptance policy NDA submission.

And as Brian says, we could potentially be looking on the U S approval and the fourth quarter this year.

Previously <unk> has been granted orphan fast track and pediatric rare disease designation by the FDA. It means that if and NDA approved under priority review, we will be eligible to apply for a priority review voucher, which can be used so a transfer.

Turning to slide 13.

And you can see the combined portfolio of products and our pipeline post transaction flows will be significant.

For the two commercial products <unk> and Metro left and you can see the approved indications on the upper section of the chart.

And acromegaly will be our third market caught us and as I mentioned. This also has the potential to be developed for neuroendocrine tumors.

I have already discussed audio gel and 10 and we'd like to highlight our exciting gene therapy assets AP on all three.

Is it expected to enter the clinic next year.

And this thing to note here is both the breadth and.

Our portfolio and also that these products will generate meaningful news flow this year into 2022 and beyond.

Slide 14.

<unk> expense of Commerce global infrastructure.

For the U S and major markets and the EU, we have our own direct sales team.

And the Middle East, we operate a hybrid model with our own teams working together with local distributors and we have a similar model and Latin America.

And thus, we have distributors and calendar central and eastern Europe and in Russia.

We plan to leverage this infrastructure to drive the launch my concept internationally.

At this point I will hand over to Raj Kannan talked about key assets.

The opportunity from a top on the potential for this transaction to deliver significant value for shareholders.

Thank you Joe.

And good morning, and good afternoon, everyone, depending on where you are.

Let me start by saying I'm equally excited about the combination.

And the potential for the combined company to deliver value for both the patients we serve and for our shareholders.

For the average shareholders and for those of you who.

And maybe less familiar with key asthma, we're a commercial stage company that is focused on developing and commercializing oral formulations for patients who face significant challenges with their deductibles.

We were pleased to see you might catch there.

As the first and only oral somatostatin analog approved for patients with acromegaly.

In June of 2020.

The U S. Adult acromegaly market is a commercially attractive space and which we estimate approximately 8000 patients to be on chronic somatostatin injectable therapy.

We believe given the robust clinical data that we have generated for my cash flow and the patient preference for oral.

<unk> has the potential to become the new standard of pharmacological care.

And the maintenance treatment of patients with acromegaly.

We believe we have strong patent protection for my cash flow in the U S and and the EU.

Through 2029.

And with method of use coverage and the U S to 2036.

And would the EU patents pending.

And lastly, our company's Genesis was the technology platform, we call TBE or transient permeability enhancer.

And would be approval if my taxes. We believe we now have a validated platform to explore other development opportunities and the conversion of burdens on injectables and therapeutic areas.

Unmet need and put an oral option.

Moving on to slide 16, acromegaly as many of you may know is a rare disease. Most often caused by a benign pituitary tumor and characterized by an excess of growth hormone and insulin like growth factor. One also called IGF one.

It is a serious life altering and life threatening disease.

The first line treatment choice is surgery. However, we estimate that four out of 10 patients are either ineligible for surgery or.

<unk> are not cured and will lead to lifelong pharmacological treatment.

So somatostatin.

Analog or SFA class is the preferred dominant first line therapeutic choice for these patients.

Prior to the introduction of my cancer.

The current SSA injectables.

While offering a life altering treatment option for patients with acromegaly.

And with them significant challenges.

And with Injectables are administered via large board needles, 18 to 19 gates injections.

Many patients experience considerable pain, even days after administration and a significant percentage of patients experienced modest to severe injection site reactions.

Importantly, more than half experienced breakthrough symptoms towards the end of the monthly dosing cycle when the level of the monthly depot injections begins to taper off.

Patients May also Miss working day in scheduling visits with their doctors and.

These injections often have to be administered by a healthcare provider.

Given the significant challenges patients with acromegaly phase, we believe my cancer offers an attractive alternative and providing consistent biochemical control.

And a positive patient experience with a simple daily dose regimen of and oral pill.

Turning to slide 17.

We launched my Captor in September of 2020.

And given the launch was during a pandemic, we adopted a hybrid and a fee.

<unk> approach and our go to market launch plan with my cash flow.

We're pleased with our launch progress to date.

We've significantly increased the number of covered lives with access to my caps are now over 185 million lives.

And also significantly increased our reach into pituitary centers and high volume and endocrinologists.

Who are most likely to be early adopters of the potential paradigm shift.

Importantly, based on our market research, the leading indicators on physicians and intend to prescribe <unk>.

Patients' willingness to try and oral option.

And the increasing payer coverage.

Nice and accept the value proposition of the knee.

Needed oral option.

Patients with acromegaly.

Support our belief that my cash flow is well positioned to become the new standard pharmacological care and the maintenance treatment of patients with acromegaly.

Moving on to slide 18.

Net sales of somatostatin analogs in 2019 were estimated at $2 $8 billion globally.

Of which acromegaly represents approximately $800 million.

In addition to this opportunity the dominant utilization of assets eight is in any case.

Potentially expanding the benefits of my cash to patients with neuroendocrine tumors or <unk> is a logical next step.

Any teeth represent the single largest segment of the U S SFA market accounting for approximately $1 $3 billion.

This could represent a significant.

Market opportunity for my cash flow.

Moving on to slide 19.

Any teeth on.

For neuroendocrine tumors or <unk>.

Normal growth of neuroendocrine cells occurring and what's the body, most commonly found and the gastrointestinal tract.

And it is can metastasize and produce hormones that cause significant symptoms termed as carcinoid syndrome.

It includes diarrhea, and Flushing episodes.

Treatment and surgery, and somatostatin analogs to limit tumor progression and.

Carcinoid symptoms.

Octreotide L. A R and landscape depot injections are broadly used as first line pharmacological treatments and the potential addressable market with somatostatin analogs in any team is estimated at approximately 24000 patients and the U S.

We believe there is a high unmet need and put an oral option and neuroendocrine tumors and similar to the acromegaly market.

As we noted in the joint press release today.

Following feedback from the FDA, we believe we have a modified five or five <unk> regulatory pathway for marketing approval that could potentially enable my cancer to become the first approved oral somatostatin analog indicated for the treatment of carcinoid symptoms and <unk>.

Patients with anything.

Moving on to slide 20.

And finally, my caps emerged from our proprietary oral technology platform, which we called CPE.

This is now a validated platform that allows us to further explore additional new development opportunities and therapeutic areas dominated by burdens on injectables with high unmet need.

I'm now on slide 21.

I hope that gives you a good overview of key asthma and why we are confident and establishing a successful commercial company with a meaningful pipeline.

I now want to articulate why do they want to join with Amyris.

And why this is the right time and kiosk much evolution to enter into this transaction.

As you heard from Joe.

And where it is and established successful company focused on rare and orphan diseases with a consistent track record of commercial success.

Average global presence.

A key factor for us and joining forces with them.

He asthma is a U S focused organization today, so there'll be clear benefits to leveraging and reduced global commercial presence and success and key markets outside the United States.

This will be critical we believe the continued growth of my caps are globally.

Importantly, we believe this combination allows us to accelerate the commercialization of my cancer and.

And the United States, while extracting significant operational synergies of approximately $50 million and annual savings.

We believe the combination allows our business to get to profitability and positive cash flows faster than doing this alone.

Lastly, capitalizing on and its financial strength and cash flows we expect the combined company to further expand the development opportunities, where my cash flow beyond acromegaly and.

And by leveraging our technology delivery platform.

Importantly, I believe that average and key asthma.

Shared values and that both companies are passionate about delivering innovative treatments that can help improve the lives of patients with rare and orphan diseases.

And meeting with Joe and many members of his management team I believe theres a good cultural fit and this is going to be a key factor and making this combination a success.

Finally, I can say that I'm impressed by the management team at average.

We have a clear vision for the company and I'm confident that they have the passion drive and the resources to maximize the value of my cash flow and the CPE.

Create long term value.

Both for our patients and for our shareholders.

I will now turn the call back over to Joe for closing remarks.

Thank you Raj I'm turning to slide 22, let me conclude by reiterating why we think this transaction makes sense strategically and.

And while we have strong conviction of the value that this combination will bring to our patients and our shareholders.

This transaction strengthens our position as a leading global commercial stage orphan disease company. The combined business will have three marketed products each of them growing on addressing large attractive markets.

In addition, we have an exciting pipeline of development stage assets with the potential to drive near and long term growth overall.

Overall, the combination represents a compelling operational and strategic fit supported by global commercial medical and regulatory rare disease infrastructure and very importantly, we believe we will have the financial strength to deliver on our future growth plan.

That concludes our prepared remarks, I will now hand over to our operator, and we will open the call to questions from the.

Interest of time, I would ask that everyone limit themselves to a maximum of two questions. Each please operator.

Thank you.

And ladies and gentlemen, if you wish to ask a question. Please press star one on your telephone keypad.

And that we have a second and kind of attendees online today, and we will be limiting questions to a maximum of 10 analyst.

Our first question today is from London and fixed income.

And so Fitzgerald. Please go ahead.

Hi, and thanks for taking my question and congratulations to both teams on this so oh.

Alright.

Lots of questions, but I think it's pretty good but and.

The two on kind of August <unk>.

Maybe just on only a gel as 10 and.

And let's get Emirates updated thoughts on gene therapy, we've obviously seen some safety concerns and general and are on gene therapy, and how do we think about what we've seen and how this could play out from <unk>.

If you could point, just given and even more.

Could this make it more compelling visit perhaps and viral vector and then any implications and thank for all their Joe S tend to net.

Meantime.

And then you covered a lot on.

He has done but maybe if I can ask for and just.

And before Raj and.

Any color on your access to physicians at the moment and.

The number of patients on therapy, just sort of even if it's just.

Qualitative Lee and with and that sort of broader channel how should we think about the synergies and are they going to be reinvested back into the combined business or drop to the bottom line. Thank you.

And I think you smoke and third question and there Brandon.

[laughter] MBS.

Let me, let me address the AR.

A question on the gene therapies first time I find that that over and we have a number of both management teams on the call today, so and.

Our Chief Medical Officer, Mark summaries on AR, and ask him to speak as well and.

So I think youre right.

People are three products and we didn't get a chance to speak passes and our <unk>.

Remarks, but is it is a.

Talk to gene therapy, delivering the gene called seven day, one and in patients with dystrophy can be so we're also focused on on <unk>.

However, the delivery vector is enough and virus.

It is a polymer based delivery vector based on a platform technology H P.

And in our preclinical work, it's giving the same degree of collagen production and a.

And our models that you see with cash.

And with viral vectors. So we're very excited by that because in a situation where you have the likely need for chronic therapy with a gene therapy with the skin turning over and how.

A.

And just a gene therapy that does not how they.

The viral vector we believe.

Could confer some significant benefits and.

Mark maybe I'll hand, it over to you and you could give us a little more color.

Yeah. Thanks, Joe So just very quickly to add to what she said.

More specifically with a viral vector and.

One is the way, it's going to be concerned about the risk of and immune response from them.

Patient.

And that could potentially have consequences and.

In terms of anti <unk> antibodies, which would interfere with efficacy over time.

As well as potential safety concerns as well with adverse.

Immune responses and.

And inflammation, and causing symptoms, which are on pleasant to the patients and potentially even dangerous so avoiding a virus and.

And even a virus that might have been modified to try to mitigate those potential adverse effects is always going to pay and attractive potential. So we believe that the platform behind <unk> three is attractive so.

Those reasons.

In addition of course, it's also attractive because the manufacturing process simpler.

And both biological material the supply chain and frozen.

On the application of the product is more straightforward.

And it doesn't have the potential to be limited to a situation, where and health care provider might be applying the product. So.

As Jo has already mentioned, there's plenty of non clinical data. So far that suggests it's feasible to deliver the gene using.

Polymer technology as the VAT instead of the virus and we think that's very appealing potential you did ask briefly about how it fits in with earlier, Joe as 10.

We think that there's some attractive complementarity to these two approaches Olivia gel as tenants you know them.

And is a product that's also applied topically.

Which accelerates the healing process and we've seen evidence of clinical.

Benefits in terms of number of endpoints that we've measured and a phase III program.

Which are associated with that acceleration of healing process and.

But there are definitely wounds and particular chronic wounds that are very difficult to heal and one would envisage that actually the most likely opportunity to benefit the patient by treating those chronic non healing wounds would be to apply a gene therapy approach, so and conversations with.

Kols, we certainly of the view debt that we see on basi.

And opportunity for these products to be used alongside each other.

Thanks Mark.

Raj and I'll hand over to you and they see access to Kols question, and then maybe you've already should speak about synergies.

Sure.

So Brandon Great question.

I'd say that our access to customers continues to improve as COVID-19 restrictions have begun to ease and many of the states.

And the country and we continue to believe that that access will improve further in the months to come.

As we stated and our <unk> earnings release. This morning, Grand and you clearly saw and increased momentum with our launch where we doubled on net sales and the first quarter and as I noted before I think I'm waiting for at least a couple of normal quarters without COVID-19 to be able to start talking about weighted.

We are netting out and what the.

And the future guidance, but at this time I will say that I remain confident that we are on our way and.

And our belief and our intent to make my cash to the new standard of pharmacological care.

And non before and we're already jumps on to add any other color from his perspective on the lunch.

And thanks Raj I appreciate it so.

Brandon and then in addition to what Raj said the what we are seeing is that the accounts that are open to calls are more productive in terms of prescription generation and those that arent. So that's another positive leading indicator for ongoing momentum because obviously and our expectation is that these accounts will continue to real.

Reopened to face to face sales calls as the pandemic recedes more people are vaccinated and then theres more general reopening and we have seen that in the pockets of the country, where there is a greater level of reopening as well that those accounts are are more productive in terms of prescription. So thats I think for us up positively.

Leading indicators.

Thanks and on.

Before we go to Rory and answered on synergy question and we also have our president of the Americas Sheila frame on on this call Sheila maybe you could.

Give some color as to why we're so excited about the opportunity for my comfort zone.

Sure. Thanks, Joe and I think the combination of the two sales organizations as it relates to endocrinologists and especially now as the country starts to open up is really and opportunity for us. So we've seen significant momentum in Q1 with respect to <unk>.

My left and I think that that combined with the open access and value that my caps I can bring to patients I think is really what will demonstrate the value of these two companies and these two teams and particular coming together, so I think having debt.

Upon close of course, it's new products together on the face of endocrinology and really enhances the value that we can bring to the marketplace and then as well I think payers are demonstrating that they are certainly supportive of what these two products can continue to bring to patients overall so we're.

Certainly very optimistic about what we can do together.

Thanks Sheila.

Rory and coastal road.

Yeah, I'll hand over to you on that on the Sneaky third question and there from that product and I think Brendan is getting lots of value for money, but its two questions but anyway.

I draw your attention focused on slide I think it was Turkey, and which is the pipeline slide I believe your question on as to what extent are we investing the synergies back into the business random and if you look through that slide you'll note that we are investing in and their models and our plans and any T and the partial U S. A partial lipodystrophy opportunity from Metro left and the United States.

Which could potentially double the market opportunity and the states. We're also doing a pediatric study and the <unk>.

Also as you all are as Joe alluded to and pushing through hopefully to conclusion, and <unk> 10 study and EBIT and as well spoken on a short while ago went on three so we are investing back into the business to answer your question and we're also planning to pull out the $50 million of synergies that we alluded to and the press release.

I think you mean, the other HR strength.

Regulatory group of process, rather than discrete thanks Laurence.

Thank you very much everyone and I appreciate that that was great color.

Thanks, Brian.

Our next question is from the line of Michelle Gilson from <unk>. Please go ahead.

Hi, Thank you so much for and for taking my question.

I was hoping you could get a little bit more into the specifics here in terms of.

Why.

And the theme I guess.

You know what.

Some of them.

And that you think that you need to execute on and to accelerate the launch of my cap Star and maybe you can point to your experience and a little bit more I guess specifics day that gives you confidence that you can execute on those parameters and the value that the I guess and <unk>.

And experience adds to deny capsule launch.

And then I do have a follow up.

And absolutely Michelle.

Maybe I'll hand that one to you Sheila if you could give a little bit of color on your background as well from Michelle.

Sure and I think Michelle and the most important thing to look at is the quarter over quarter six SaaS net ameren and he's demonstrated with respect to endocrinology and particular about certainly on both products in the.

The U S. Since the integration of a Jerry on and so we have been able to demonstrate.

And this notion of bringing the companies together and leveraging the synergies that debt came available from a generic from near jewelry on acquisition.

And I think what really excites us now is that with the access and relationships that we have in particular and endocrinology.

<unk>.

Instead of starting from scratch, we actually have those relationships and have had pretty consistent access throughout.

I think were you know my cats, I think has an opportunity to enhance our value proposition with respect to what we bring to the endocrinology total office call.

Will really accelerate that I think trying to launch a product in endocrinology, which I think was very hard hit.

By the pandemic I think just need the launch that much more difficult for them for the team at key asthma, although from what we've seen every one of the fundamentals have been in place in order to do that so as the marketplace opens up.

Binding the deep relationships and experience that we have with my left and particular with the value that my caps it brings to patients and we think.

Raj spoke.

A while ago about on.

Stable patients your ear and launching into a market place, where you're asking physicians to switch and not that in the context of this pandemic and particular is is a big hurdle. So as the marketplace opens up we have a value proposition that will provide sustained.

Troll.

And for patients at the same time, this way and leveraging the relationships that we have and a track record from a business perspective.

And sustained quarter over quarter growth.

Sheila I would also say I think we have invested quite heavily to that question and a digital and virtual platform during the pandemic and I think increasing our focus on senior just debt rate between two companies.

Really and serving our endocrinologist better.

With the continued strength of relationships that we have with our kols and increasing payer coverage that we're getting from my cash.

And our patient support services system that is in place we remain confident to your question that this combined company can further accelerate the.

The adoption and utilization of my caps and a bit.

And and much more efficient way than we've been able to do on our own.

And thanks Raj and before.

You go to your second question Michelle.

The other thing that we shouldn't forget here is that there is a huge opportunity internationally and I'm. It brings the the infrastructure to the table, we are already a global commercial business.

So and on the slides, where we showed our net.

And our infrastructure, including our own folks on the ground or on teams on the ground medical and on commercial and our distributor network. We do have our chief business officer, Dave all of them and to on the line as well so Dave maybe you could give a little bit of color as to how we see the opportunity from my comps and beyond the U S.

Yeah, Thanks, Joe so on and.

Pending the work that the cash the team are doing in Europe from a from a clinical and regulatory.

Good wishes on going.

You know we are in the midst of assessing market by market, where the opportunity lies for my cap so to serve patients across the Europe Middle East Africa region and that would be on on to two levels. One is the formal reimbursement approach for.

Full launch in a given market, where we see attractive opportunity and there's a number of those markets. We've done a whole bunch of research now as to whether those markets and most beats countries like Germany. For example would be want to consider.

As an example, we've also done a research and Japan. So we are considering each market.

Round the world for that full full approach and of course, we as we see and rare diseases.

Because patients frankly don't choose where they are born.

And.

They can access these therapies, perhaps when physicians.

Seeking treatments for them we expect.

And also some named patient.

On demand, which is on solicited, but we see that in the middle East we see that in Latin America.

And beyond.

And where patients are dissatisfied with current standards of care.

And physicians are seeking alternatives on their own volition will be ready and able to support those those requests. In addition to those sort of formal reimbursement approaches once we've done also market assessments.

Thanks, Dave and.

And I think you said you had a second question.

Yes, I do.

Thank you so much for the comprehensive answer.

Also I wanted to ask you know.

That you mentioned and the slides that the GPU technology could be expanded.

Into more of a pipeline.

I just was wondering about metro Lufkin Marsh, specifically, besides metro lapped and fits within.

And the constraints that GE technology.

From my memory I think the size was a constraint.

And in a while.

But then the other question that I had is just in terms of I guess, the altra and PK profile. The daily oral could sort of provides from metro Atkins and.

In terms of on.

Hey, guys.

C Max and more specifically.

Could that also has an effect on neutralizing antibodies.

Yeah.

Thanks Michelle.

Yes, we are.

I'm not the expert and TPS, while I'm, certainly going to hand that over to Russia and have seen growth.

But in terms of the overall strategy.

We believe that we can invest and and the CPE technology and leverage that for other products you alluded to metro left and.

Metro left and this is an obvious choice and.

There's a lot of work left to do before.

Before we could.

I understand that better and.

And Raj, maybe you want and take a little bit.

Talk a little bit about TEP and then Mark you might answer the question on the on that.

And to get the sooner.

Yes.

Yes sure.

Look I think it's important to kind of focus on the.

And the comments that Joe and I made during our call today.

Got three.

Very strong commercially growing marketed products, we have and exciting product and registration and earlier Joe <unk>.

And we've got a midterm opportunity with any team and certainly we're starting to explore how we can leverage our CPE. So theres a quite a lot of exciting things within the company and we certainly have.

Our eyes on certain therapeutic areas, where there's a high unmet need but as we progress right.

We certainly feel there was and there are opportunities to potentially explore and leveraging PPE to start.

Further supporting the robust pipeline that Joe pointed out during this presentation.

I think Joe you wanted to mark to take over from there or I wanted to see and Phil also have any comments to make from my team.

Okay.

No Raj I completely agree with that we brought on a very exciting opportunities that we're going to be looking at carefully as we move ahead.

And with this this merger together really opens up a lot of new possibilities for us.

Yeah, the only thing I'd add that throughout that for mark to answer and it is that because.

We believe that this.

And we'll be we'll be EBITDA positive and.

And cash generative accretive in the first full calendar year, we have the financial strength not only to invest in that and see opportunity as we stand, but also to invest in and Tpa, which which.

We would definitely wants to do and will do mark.

Yeah. Thanks Chuck.

So just like everybody else I'm also excited about the possibilities for Tpa.

And it probably Wouldnt surprise, you and Michelle to know that I've already looked at the size of Metro leptin.

<unk> kill adult and molecular weight them.

Molecules so.

And of course, it's important to caveat, we have not looked and any detail whatsoever and to the feasibility of combining metro left and with the T. P. Technology approach. However, I can say that at least on the face of it the size of the molecule does not appear to be a barrier based on how T. P.

And is able to facilitate entry of molecules of that size across the small intestine and so at least in that sense. It doesn't fall at the first first hurdle and regarding your question about.

The potential to have an impact on the incidence of neutralizing antibodies.

And how that might relate to the PK profile.

And it's a it's a very good point and me.

Maybe it would have a beneficial impact in terms of avoidance of those neutralizing antibodies.

We don't fully understand.

On the mechanisms behind neutralizing antibody formation with injected Metro leptin.

Over I think it's actually quite likely rather than it being a PK issue and it may well be a routes of administration issue and.

By which I mean, when you inject it and.

It may well be debt and.

The molecule the.

Mitch, let and drug substance comes out of solution and precipitate under the skin.

And that something that can cause and immune response, because it gets taken up by antigen presenting cells and then that triggers.

A series of events that lead to antibody production so.

It could be that administering this differently would avoid that and but we just don't know certainly very excited to explore it.

Okay.

Thanks, Mark Thank you for taking my questions and congratulations on the merger.

Thanks, Michelle Thank you.

Okay.

Our next question is from Max Herrmann from Stifel. Please go ahead.

Great. Thanks for taking my question and congratulations on on the deal.

And as you know that.

And when it was looking at acromegaly from and it's very early day. So.

It's interesting to see moving into that now and in terms of Ah My cap. So I had one question which is.

In terms of what.

You expect and attempt to the market penetration do you see it really being and alternative for patients with acromegaly.

Currently on Sandoz stat on that at.

Or do you see it potentially for a larger market and other words patients who are also perhaps on so.

I'm actually and as well.

And with other treatments for acromegaly.

Okay.

And I shall hand, the question over to you and you got another tour product.

Yeah absolutely.

Thanks for asking that question.

Always.

<unk> consistently stated that our intent is to make my caps are the new standard of care and you know.

What I presented during the call with Joe is that if you look at all of the leading indicators and the feedback that we've had from patients physicians and.

Opinion leaders patient advocacy organizations and payers, we continue to see a clear unmet need for an oral option and for all the problems that I stated during my call that the monthly injectables bring with them clearly.

Clearly patients have a very good preference a clear preference for overall options one of the most tangible points that I can point to you is are.

Optimal study where in the open label extension you saw 90% of the patients who stayed on my caps I remember these were patients who were stabilized.

Stabilized on Injectables and and the open label extension, 90% of them chose to stay on the oral therapy and we continue to see the same kind of feedback every time, we do market surveys and what we hear from patients. So we continue to remain very confidence that this could become the new standard of pharmacological care I don't know if I can give you a specific.

Share what what is standard of care it means but usually and.

And our estimation that means it's the preferred.

Agent for physicians to go to versus the current standard of care.

So just as a follow up in terms of I know it's early days.

<unk> patients that you're seeing now.

Switch will move to my caps are all day and you patients like patients that have previously been on sends a statin or are they a combination of patients who've been on the I understand and then.

And you mean.

Yes, great question.

Remember our label right now and our clinical trials were done and patients who were controlled on somatostatin injectables. So.

This is also by the way the largest.

And market opportunity that we have as we stayed at 8000 patients.

Our.

At any given point in time on any given day, they're on chronic SSA injectables. So that's the market to go after and that's our label the new patient flows per se is not as attractive.

I think about the incidence and prevalence of.

And the new diagnosis for acromegaly, so going after the patients who are on SSA, injectables, and we will face challenges and and everyday basis is the right target to go after to be able to realize the intent of making this a new standard of care.

Great. Thank you.

Our next question is from the line of Douglas Tsao from H C. Wainwright. Please go ahead.

Hi, good morning, Thanks for taking my questions and congratulations on the deal obviously.

And you highlighted.

And the opportunity and net for my caps just curious how quickly you can when you start to see development and that indication. Thank you.

Yes.

Hi, guys, sorry, I didn't catch that last part of that question and sorry.

Oh, sorry, I was just curious how quickly in terms of the net opportunity do you think you can start to see some actual clinical development work.

Uh huh.

So.

And Joe if I could answer that question.

Please go ahead.

Thanks, Joe as we noted in our press release and in our.

I'm joined presentation as well.

We have an IND submitted for a phase one healthy volunteer PK study.

Followed by a single Phase III study.

And we stayed at expected to be initiated and the first half of 2022, obviously this needs and final alignment with the FDA, which we hope to do in the middle of this year and once we have that final along alignment and the expectation is to kick up that study and the first half of 2022 and so all of this is designed to support.

And a modified <unk> pathway. So our intent is to get to the market as efficiently as possible to be able to expand the benefits of my GAAP. So.

Two patients in any T. Doug.

Okay.

And I guess just in terms of sort of the theory and accelerated path. How do you feel your comfort level in terms of not meeting sort of a dose ranging study or do you feel that given what you've got and acromegaly and you have.

Sufficient understanding.

I think if you look at the my caps a submission on acromegaly writes a lot of the preclinical and CMC talks and the dose capitalization has been well substantiated and so I think that's what gave us the.

In pet is to stick with the FDA and really work with them to be able to what I call a modified five btu pathway.

And again I think there was a final alignment is still pending.

Post that we'll be able to update you dug in and what that timeline looks like and what the feasibility study it looks like.

Okay, great. Thanks.

Okay.

Yes.

Our next question is from.

Ross and draw from Shah. Please go ahead.

Hi, Good morning, guys. Congratulations on the on the acquisition side.

Two questions from me, please I guess, firstly for it and show and and Raj How How's. He arrived at your 1 billion peak sales from the combined entity. So if I look at consensus.

Consensus on going back as far as pathmark and seen revenues and 240 million by 2024, and so are you comfortable with ethane and house made up of the document and the only.

U S and EU and then secondly, if you can.

And just give us a bit more color on the.

Total net trial.

And then if you're thinking of doing.

Just in terms of design and timelines and Kim.

Hey, tariff hike and thanks for your questions.

Yes so.

On the announced potential and constantly $2 billion and revenues.

We havent given any specifics on.

On that and.

But when you look to this.

So we have and we have three marketed products we have.

And if the opportunities for Metro Leptin, and we've stated that the market for that product is 500 and currency.

We've got the <unk> go to market opportunities $250 million.

You then look at and after.

<unk> you.

And given some numbers there the addressable market is $800 million, but any T.

The addressable market is $1 9 billion.

And the addressable market for <unk> B is north of a billion dollars. So.

And when you when you look at as you can see and that's before we start thinking about eight people on our three coming to market as well.

You can see that there is a significant opportunity here with <unk>.

Combined group and.

Raj and I'll hand over to you on that on the MDT question.

Yeah.

Joe.

And as I stated before on.

We still have a type C meeting scheduled with the FDA.

And our intent is to conduct a phase one healthy volunteer study.

By a single Phase III study I think as soon as we have that alignment we should be able to provide you.

Details at an appropriate time in the second half of this year in terms of what that phase III study design looks like and potentially the timeline on the costs for that.

Yeah.

Okay, great. Thanks, and congratulations again guys.

Alright. Thanks.

And our next question is from it and all this woman from Maxim Group. Please go ahead.

Hi, guys congrats on the deal.

I have a question on my caps and there's national market. What are your thoughts on timeline for regulatory submissions potential approvals and potential launches.

And my apologies I agreed on cash you cut your first name.

<unk>.

Not probably going on and.

Yeah. So.

And.

I'll pass.

A question on on the regulatory timelines and.

On the used to and tomorrow.

Tomorrow.

And then maybe day, if you could speak a little bit more capable and.

A little more color on the international markets that we're.

And we're looking at there are a number of those were.

And I'll leave it to Dave.

Give some color on that.

Yeah. Thanks, Joe So I, let me start the answer on <unk>.

Going to ask Bill who has been obviously much more involved with the.

Our implementation of the European filing from like hubs to comment.

But based on the information.

And the exchange between the two companies so far.

My understanding is that.

Chasma progress discussions with the European Medicines agency, and the rapporteur and co rapporteur countries over the last few months.

And expecting fairly soon to be and are positioned to file a marketing authorization application and the ear.

And but I'll ask bill to comment with a little bit more specificity.

Thanks Mark.

And what you said is exactly right. We started our initial interactions we've had a rapid tour meetings and is as Raj said earlier, we'll be submitting our MAA mid this year. So we are well on our way.

To that application.

Process.

Thanks.

And I've got another question on the Phase one study any T I know.

You said the phase one study is mostly a healthy volunteer safety study, but are there any biomarkers, you're going to be looking at or any like specific endpoints and want to look out on top of safety.

Bill do you want to answer that question.

Sure Yes, so so as you pointed out this is a.

On a small healthy volunteer study.

In acromegaly, our dosing went up to eight.

80 milligrams total a day.

And neuroendocrine tumors, often higher doses used and those patients as compared to patients with acromegaly. So we'll be looking at some higher doses for that safety.

And and get a.

Sensitive peaks.

PK.

Analysis and and that studies.

And it's enabling us to launch into our phase III study. That's the primary purpose of that phase one study.

Alright, thank you.

And that on no further questions at this time, we went and I'll hand back to pharma for the second part of today's call.

No to this growth beyond the Q1 results are Dr. Joel Wallach, and Rory Nealon, the company's CFO and COO and <unk>.

And Dr. Mark <unk>, Chief Medical Officer, moving available to answer questions. During the Q&A session. Joe will provide enough vision of the business and memorial and drove through the financials in detail.

Before I turn it back to Joe for his formal remarks, let me remind you that this conference call contains forward looking statements and involve risks uncertainties and assumptions that are difficult to predict and which may be outside the company's control, including among other things the development of its business trends and what's operating industry, changing economic financial and market conditions and long.

These risks uncertainties and assumptions the events or circumstances referred to and the forward looking statements may differ materially from those indicated and these statements words or expressions, reflecting optimism satisfaction with current progress prospects or projections as well as words, such as believes intends estimate expect plans projects anticipates and other similar variations.

Forward looking statements, but their absence does not mean for the statement is not forward looking such forward looking statements and north of Denver to your performance and the company's actual results could differ materially from those contained in such statements any from Forwardlooking statements made speaks only as of the data on today's press release and conference call Wednesday may 5th Thanks.

21, and the company undertakes no obligation to publicly update any forward looking statements or supply new information regarding the circumstances. After the date of this call.

For more information and we'd refer you to the forward looking statements section of the quarterly press release issued earlier today as well as the company's filings with the SEC.

This time I will turn the call back to Dr. Joe What Joe. Please go ahead.

Thank you Simon and I will now go through our earnings for the quarter ended March 31, and 2021 and recent business highlights and I'll.

I'll begin on slide 28 of the presentation that's on.

Actual results. We released this morning demonstrates the continued positive momentum and growth and our commercial business. We generated overall double digit organic revenue growth on our raising our guidance for 2021 more on this later.

And we made progress on our label expansion plans for both of our commercial products on.

On the regulatory funds, we have made submissions to both the FDA and EMA for our lead pipeline assets all the old U S 10, and if we are successful we could potentially be looking at approval in the U S. Before year end 2020, but overall, a busy and exciting quarter for amarin.

And a really fantastic start to the year.

Let me now run you through some more specific highlights for Q1 and I'm now on slide 29 first quarter total revenues grew by eight 7% year over year to $48.4 million.

Exclude periodically block time orders and the underlying year over year revenue growth was 16, 5% on a sequential basis revenues increased 13, 9% quarter on quarter.

We generated $9 $9 million of EBITDA in the quarter. This represents the fifth consecutive quarter of positive EBITDA generation.

Total cash as of March 31, 2021 was $118 $6 million, which is about flat versus year end 2020.

Today, we are raising guidance for 2021, given the strong performance of the business year to date, we are now increasing our revenue guidance for 2021 from a previous range of 200 million to $205 million to a new guidance today of between $205 million to two hubs and <unk>.

$10 million, which represents growth of between 12% to 15% on 2020.

For clarity the new guidance excludes any potential revenue contribution from the chaos and the acquisition.

Moving now to our two commercial products and now on slide 13.

Global sales of Metro left and the first quarter were $30 million up 11% year over year underlying sales, which excludes periodic latam orders increased by 25%.

A significant order has now been received and will be booked in Q2 2021 from that town. The U S accounted for 54% of much left and sales and EMEA accounts for 43% EMEA.

EMEA and Bachelor lapse and sales growth.

50% in the quarter.

This was driven by the ongoing rollout natural left and the EMEA and previously announced positive reimbursement decisions in Q1, we announced a new multi reach and distribution partnership with Medicine Pharma Medicine will work with Airbus to distribute metro leptin and limits Pride and Canada and is.

Medicine has a significant presence in each of these geographies and we are pleased to leverage their distribution strength to expand our commercial access.

We have previously shared our lifecycle plan and the U S to seek a label expansion from X relapse and to include the treatment of partial Lipodystrophy and addition to the current day approved label for the treatment of generalized lipodystrophy.

We received feedback from the FDA on the path forward for this initiative, which will require a phase III study.

And our discussion with the FDA, we are planning a global AC patients 12 month randomized placebo controlled phase III trial to evaluate the safety and efficacy of daily subcutaneous much left and treatments and patients with <unk>. Our goal is to initiate the study by the end of 2021.

And as we've discussed on prior calls we estimate the market opportunity in the U S. With a current G O label to be approximately $140 billion, unless we are successful and adding P. L. We believe it would be approximately double the size of the festival bonkers to $280 million.

Let's move to limit price on slide 31.

First quarter sales were $18.2 million, a 4% year over year increase.

And the U S made up 46% of sales and EMEA sales were 41% EMEA sales increased by 42% year over year.

We are conducting a pediatric study and hate to its age and we expect to have data in early 2022, assuming positive data we will seek license variation in both Europe and the U S to include the treatment of children with him to a page.

We are also testing the use of <unk> and familial cause and micro anemia syndrome or Fcs.

This is a severe rare genetic liver disease characterized by extremely elevated levels of triglycerides are hyper triglyceride EMEA.

We recently announced positive clinical results from an investigator led proof of concept study and Italy.

And the open label study patients were administered ex escalation doses of <unk> for 26 weeks. The medians fasting triglyceride levels at 26 weeks was 672 milligrams per deciliter, representing a 17.5% median reduction versus baseline <unk>.

And of the 18 enroll those patients.

<unk> achieved.

And I'm sorry, you got 14 of the 18 and rose adult patients.

<unk> a reduction in triglycerides to less than one pilots and two milligrams per deciliter on 13 of these achieved triglycerides of 750 milligrams per deciliter or below at 26 weeks.

The reduction and triglyceride levels is consistent with <unk> mechanism of action and the small intestine, where it inhibits the assembly of kind of micron's reduction in triglycerides to these levels or below is generally considered adequate to substantially reduce the risk of acute pancreatitis.

We are encouraged by these data and we plan to discuss the potential development path forward with the FDA and EMA and we will provide further updates in the coming quarters.

Finally, let me provide and update on audio Joe S. 10, I'm now on slide 32, we completed the rolling submission of an NDA to the FDA for the potential treatment of the cutaneous manifestations of jokes, though on the stroke with German license, but also the NDA submission includes a request for priority.

And with you, which if granted kind of expedite the review process to six months following the acceptance of the NDA submission.

Previously on the hotel as 10 Hudson.

And has been granted orphan fast track and pediatric rare disease designation by the FDA.

Submission of the NDA began on June 29, 2020 based on FDA timelines and must expects to receive notification. If priority review has been granted and if the NDA and it's been accepted for filing sometime this quarter.

We also announced the validation of the marketing authorization application for all your job as Ted by the European Medicines Agency for E D.

The army a validation confirms that the application is sufficiently complete to begin the formal review process.

And the timeline for an opinion of the Timothy from medicinal products for human use is within 210 active days.

We look forward to working with the respective agencies as they review our applications.

And we prepare for potential launch.

We have the commercial and medical teams systems and infrastructure in place to launch all Youll Joe <unk>.

And now I'll turn the call over to our CFO and COO, Rory Nealon, who will provide more details on the Q1 financials.

Thanks, Joe and I will keep my comments relatively short today as it has been a long call already so let's just briefly start with our revenues Joe has already covered the revenue performance by product and by geography, just to remind you of the headline numbers, we've seen on overall eight 7% improvement and our year on year revenues, which represents a 16 points.

Per cent increase if the impact of that 3 million periodic net flipped and lifetime order from Q1 2020 is removed and as Joe noted there were no such periodic periodic orders in Q1, and a significant order from Metro left and a lot of time was received and will be booked in Q2.

Finally, before concluding on the revenues as noted on the press release and reiterated a reiteration of what Joe has said, we're issuing revenue guidance for the full year.

2021 from 205 $210 million and please note that this guidance excludes the impact of the incremental revenues from the <unk> if that deal concludes as planned in Q3.

Our annual revenues have grown from $136 million in 2018 to $1 $54 million and 2019 with both 2018 and 2019 being pro forma combined numbers and how much Nigeria and what emerged from January 2018.

So $182 6 billion and for 2020, and finally to that guidance of $205 million to $210 million from 2021.

The next item I would like to touch on is our gross margin performance, excluding the impact of the non cash items, which is up 75, 8% for the quarter. This compares to 73, 5% for the year as a whole and 2021.

At this stage a lot of the heavy lifting and improving our gross margin has been done in particular, we have effected the savings we saw and inventory storage costs a reduction on the number of skus or stock keeping units with an associated reduction and regulatory fees. We've renegotiated our minimum annual purchase commitments with a number of suppliers, which has reduced the potential for inventory obsolescence and.

Finally, we have brought in house and <unk> logistics coordinating function for EMEA, which was completed in late Q4.

Moving on to our SG&A and R&D spend our R&D spend increased to $8 9 million for the quarter from the average for last year of $6 9 million per quarter.

And in part due to the timing of spend associated with the recent submissions to the FDA and DMA for audio gel as tenant ebay and.

And also the ongoing spend on the pediatric study from <unk> and our development efforts and <unk> III, our gene therapy assets focused on ebay.

Our SG&A spend before the impact of the non cash depreciation and amortization has been very consistent for the last quarter three quarters. During the quarter, we spent $17 $9 million, which also and facts the average from quarter three and four it's also marginally lower on the average quarterly spend for the year as a whole last year of $18 $8 million.

We're particularly happy to have managed to contain the spend while our underlying revenues have been increasing.

And we move later into the year and 2021 I'll remind you that this spend will increase as we can start to incur prelaunch costs and anticipation of the potential approval of <unk> 10 for EBIT.

The next key metric I would like to focus on is EBITDA before I come back and touch on some of its constituent components EBITDA as a key metric for us given it was a good proxy for our cash from operations and 2020.

And I draw your attention to slide 30, Threep already and we adjusted our Q1 operating loss for noncash items and get to adjusted EBITDA of $9 $9 million for the quarter. This compares to $4 6 million for the same quarter, one and 2020 or 115% increase year on year and represents our fifth.

A quarter of positive EBITDA.

I'll remind you that when we closed the merger and acquisition in September 2019.

And we stated that our objective was to turn the business into and EBITDA positive business to a significant reduction and the pro forma combined operating cost base of both legacy and Chilean and legacy Amyris and particular, we transitioned a sizeable number of non customer facing functions and roles from Boston to Dublin, which resulted in significant economies of scale.

We also leveraged off the significant previous experience with the management team of average amortized from acquisitions integration and processes and extracting synergies the outcome of the engineering and integration was that we not only achieved but exceeded our objectives and expectations. We converted the combined business into and EBITDA positive business and quarter, one 2020 a quarter.

Ahead of schedule, which was just six months after the deal completed.

When it comes to the proposed scheme. That's about transaction. We believe we can leverage off this experience and our expertise and seeking to extract the expected synergies from the chiasma integration.

Before moving on to EBITDA would just like to note that the $10 $7 million intangible amortization and the EBITDA calculation is consistent with previous quarters and also that the adjustment for amortization of inventory fair value step up associated with the Algerian acquisition inventory is almost finished we booked approximately 1 billion and quarter, one and the final amount.

There are approximately $250000 will be released and quarter two.

Beneath the operating loss line and our income statement you will note that the noncash change and the fair value of the contingent consideration and the noncash contingent value rights expense are broadly consistent with the same quarter in 2020.

And finally in that section of and our income statements and you will note a $7 9 million charge for net finance expense of which $4 8 million is noncash and $3 1 million as the cash interest payable in the quarter on our convertible bonds and term debt.

Before concluding I'd like to summarize our current net debt position, excluding the convertible we have net cash of 28 $29 $8 million at the end of March being cash of $118 $6 million and term debt of $88 $8 million on top of this we do have a convertible loan with a principal value of $125 million.

Albeit the conversion price on this is $12 95 per <unk> or $2 59 per ordinary share, which is and the money currently.

The strong operating cash.

Operational performance of the business and the recent phase III data and <unk>. We believe it is likely that this will get converted to equity before because otherwise you for payments and April 2025, as a result, we view this as more akin to equity and debt.

Finally, I'd like to discuss the impact of the payments, we made to the department of Justice and the U S. During the period, we paid $3 9 million and legacy science during the quarter, which were fine that we inherited when we acquired the jewelry and whatnot.

These payments our operating cash flow was would've been $3 $9 million higher on our cash balances would have increased accordingly.

Good news is that this payment of $3 $9 million and Q1 was the final payments and as of today, we have no other amounts due to the Doj.

And that is the end of my remarks, and I'll now hand, you back to Joe.

Thank you Laurie.

Now on slide 34 and <unk>.

In conclusion I'm very pleased with today's very strong results for Q1, which demonstrates the continued positive momentum and growth we are experiencing and our business across our two commercial products globally.

Q1 was extremely busy and we delivered a number of commercial and regulatory successes during the quarter.

Our two commercial products Metro left and unlimited price continue to deliver solid growth across a host of metrics, including revenue EBITDA growth cash generation and market expansion.

This performance year to date gives us confidence to increase our previous revenue guidance for the full year.

Announcement earlier today of our proposed acquisition of kiosks mapped we believe will pave a path to a combined potential 1 billion peak revenue for Amyris.

I will now hand over to our operator for Q&A and given that that she asthma team have dropped off the call and I would ask that you limit your questions. Please at this time to our Q1 results only.

Thank you very much.

Ladies and gentlemen.

If you wish to ask a question. Please press star one on your telephone keypad.

Thank you from waiting our first question is from Colorado and joined from Shore cap. Please go ahead.

And again I didn't think I'd get squeezed and my extra question. So I'm glad for the opportunity. So thank you.

First question is from Joe So I know, it's early days, but I was wondering if you could give us any color on what's going on and the H O MH market and the U S, particularly with the temporary and approval of cancer.

Jack and therapy.

And then secondly for me please.

The press release related to the acquisition there was a line about financial obligations related to the chiasma and royalty financing agreement. So can you just remind us how much is due to repay debt repaid and five and thank you.

Thanks, and thanks.

Sheila are you still on the on the line.

I am.

Uh huh.

But can you I'm going on.

Question for you so.

Okay.

Sure and thanks for the question.

And we've obviously been working with anticipation and anticipating and.

Launch and have Keith and the U S and <unk>.

And we expect that they may actually expand the market and help us find additional patients as you know it's a pretty.

Pretty rare disease, and being able to identify and find those patients and then secure access to treatment. It is a significant challenge and this marketplace. So we haven't seen any specific impact yet in the U S on our business and.

And expect that we will continue to see and.

Additional activity in the marketplace overall, but the patients that we have are well controlled and certainly.

And tend to be quite sustainable and so I think what we expect to see is really that the market may.

Grow and in terms of the total number of patients that are treated and the U S.

Yeah.

Thanks, Sheila and Rory you want to take.

So two questions.

Sure Tyra, so it's a.

And like a quasi debt facility, it's a royalty arrangement from healthcare royalty partners and on a change of control that accelerates and will result in a payment to healthcare royalty partners or a little over $116 million and.

And obviously at that point and time all royalty stuff.

Okay, great. Thank you.

Thanks, Sir.

Our next question is from that and as a woman from Maxim Group. Please go ahead.

Hey, guys. Thanks for taking the question two now.

Now that your NDA is filed for our gel.

Have you guys had a manufacturing plant inspection that produces a product or are you guys expecting one and the near term.

Thanks, Matt.

And you want to take that one.

Sure. So we bear bear in mind. This this.

<unk> product was approved back in 2016 to Trieste partial thickness wounds and adults by the EMA and now obviously <unk> is a partial thickness wounds, but obviously since that point and time, we amyris I've gone on and on a phase III study specifically in <unk> and so that facility has been affected and on a number of occasions within the within Europe either.

On the people, who do so far on their behalf. So if there's somebody asked me and inspected in relation to the FDA has not been inspected at this point and time and we watch with interest what the ft are doing in terms of new submissions.

And for new products and facilities that havent been inspected I read about on occasions. They rely on local inspections that are being done here to four so at this point is a little bit already to say now split that I believe may be the direction that we would see them go, but we just need to wait and see.

Just to add a little bit more color on that we have actually had.

And that got query from the FDA and <unk>.

Provided them with.

The local and spectrum and inspection findings.

Alright, thank you.

Thank you very much that on no further questions at this time on.

On the call back to <unk>.

Thank you. So thank you all for joining us today, hopefully we will seek to speak with you and hopefully see you again soon thanks everybody.

Thank you very much that ladies and gentlemen, thank you for joining today's call you may now disconnect your lines.

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