Thank you very much, operator and good morning to everyone and welcome to the Acerus 2021 second quarter conference Call. I’m very pleased to be joined today virtually by Ed Gudaitis, our President and Chief Executive Officer; along with other senior members of the Acerus team.

Before we begin, I’d like to comment on the forward-looking statements in this call. On behalf of the speakers who follow, investors are cautioned that the presentations and responses to questions on the call may contain forward-looking statements.

Such statements may contain forward-looking information within the meaning of applicable securities laws. Forward-looking statements are given as of the date of this call, may involve risks and uncertainty and may include, but are not limited to, the company’s goals, targets, strategies, intentions, plans, beliefs, estimates, expectations, outlook and other statements which contain language such as, believe, anticipate, expect, intend, plan, will, may and other similar expressions.

Certain material factors or assumptions are applied in the formulation of forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. For additional information about the statements, the material facts or assumptions underlying such statements and about the material factors or assumptions that may cause actual results to vary from those expressed or implied in such statements, please consult the press release issued today and the company’s other filings, which are available on SEDAR at www.sedar.com.

I would like to now turn the call over to Mr. Ed Gudaitis, President and Chief Executive Officer, for his remarks.

Ed?

Thanks Bob. And welcome everyone to our 2021 second quarter conference call.

Today I'll review our operational progress this past quarter after which Bob will provide a detailed overview of the financial results. Let me start by saying, how proud I am of the results we posted this quarter with revenue roughly triple that at the same quarter last year.

These results reflect the strength of our strategic plan, increasing demand for our key product NATESTO and the dedication and effort of our staff across North America. We continue to complete the transformation of Acerus into a company with accelerating growth, improving operating results.

At the same time, we're building a company that is easier to understand and appreciate by investors and customers alike. Our repurchasing of NATESTO its US marketing rights from Aytu, we've been able to take direct control of our growth trajectory in the US, as report sales in a more normal manner.

In addition, our co-promotion agreement with Amneal, have opened new opportunities to win business with endocrinologists, dominating prescription growth and strengthening our path to profitability. Acerus also announced a new pharmacy benefit manager contract for NATESTO in the US, increasing commercial insurance access to approximately 85% of commercial lives.

We are successfully building a company that can demonstrate a competency for commercial and medical execution in the American market, which is a key to our future performance. Now let me talk about NATESTO specifically, starting with the US market.

As I just mentioned, we've been pleased with the impact that our commercialization efforts have been making on overall prescription growth, particularly since we amended our relationship with Aytu BioPharma. As captured by Symfony healthcare data that testosterone replacement therapy market has shown a moderate recovery from the pandemic with total prescription volume in the second quarter of 2021, up 5% year-over-year.

In comparison to the total market, Q2 2021 total NATESTO prescriptions grew by 45% year-over-year, and nearly 20% sequentially versus the first quarter of 2021, reflecting improved HCP access, increasing demand and improved insurance pull-through. Looking specifically within the Urology segment, Q2 2021 total NATESTO prescriptions grew 63% year-over-year and 22% sequentially, as we continue to make headway in this important HCP segment.

Changing our focus to new prescription growth in Q2 2021 new NATESTO prescriptions grew 43% year-over-year, driven by growth within the urology arena where new prescriptions climbed 49% year-over-year. In addition to these noteworthy increases in prescription productivity from existing prescribers of NATESTO, we've also seen a growth in the number of physicians prescribing NATESTO, specifically the number of healthcare professionals writing prescriptions for the product is up 27% year-over-year, as in the second quarter of 2021.

With respect to insurance coverage for NATESTO, we've seen coverage for the product move to what could be considered best-in-class for a branded product. Approximately 85% of commercial lives now have access in NATESTO in the United States, boosted by the recent decision by a major pharmacy benefits manager to add NATESTO as a preferred brand to its national preferred brand drug list.

Going forward, we're excited about the opportunities created through our three-year co-promotion partnership with Amneal. Amneal is a leader in endocrinology, and as such, their commercial team will significantly increase the visibility of NATESTO in this important HCP segment.

The combined sales force of Acerus and Amneal is now nearly 75 strong of competitive position that effectively leverages the talents of both organizations. It allows Acerus to focus on the urology segment and high prescribing primary care providers, which we've been actively targeting since the Ayty buyback went into effect.

Amneal has initiated it's promotion of NATESTO after the end of Q2 2021. The initial feedback from the team shas been positive, and we will provide updates as we go forward.

Overall, we put the pieces in place that we believe will lead to accelerated growth in NATESTO during the second half of 2021 and beyond. There are nearly 75 individuals calling on over 8,000 targets.

A big change from earlier in the year, we had just 22 reps calling on around 2,500 physicians. Indicative of the wider audience and increased demand, we've seen strong interest in our sample program and in our copay cards, which typically lead to higher prescriptions over future quarters.

We're very confident about where we stand with regard to our strategic vision for NATESTO and its US positioning. Within the Canadian market, we continue to lay the groundwork for the reintroduction of NATESTO.

We currently expect to reintroduce the product in Canada, early in the fourth quarter of this year. We're gearing up our sales personnel and other staff in Canada.

We're making good progress and are excited to bring NATESTO back to our home market before the year end. I also would like to provide an update regarding ESTRACE, Canada territory only Legacy product.

Much like last quarter, we continue to work on transferring our technology to a new contract manufacture, which will facilitate Acerus’s returned to the market in Canada. Our previously announced agreement to sell the rights to Acerus to an unnamed Canadian pharmaceutical company will come into effect once the after mentioned technology transfer is completed, anticipated to take place in the near future.

We look forward to providing additional updates on Acerus in subsequent quarters this year. Before turning the call over to Bob, let me just say once again how I am very pleased where we are and with what we are doing as a company.

We've accomplished a lot up to this point in 2021. We believe the future looks bright.

Our strategic plans have laid the foundation for a much stronger and broader presence in the United States, and we anticipate accelerated growth going forward. We continue to work on various new business development initiatives to further build out our product portfolio.

We continue to work with Korea partners to identify potential strategic assets in North America that may strengthen and expand our pharmaceutical portfolio. The objective of our business development activities is to find organizations or products that would be accretive to our existing US operations and that would leverage our commercial team as much as possible.

We will deploy capital wisely and we will safeguard the company's future development, with an eye towards much higher growth, improved profitability and increased shareholder returns. That concludes my review of the operational highlights for the quarter.

I would now like to turn the call over to Bob for the financial review. Bob?

Thanks. Thanks Ed, and good morning, everyone.

In the comments that follow, please note that all dollar amounts are expressed in US dollars unless otherwise stated. The results are reported under both standard IFRS and certain non-IFRS measures.

Such non-IFRS measures do not have a standardized meaning prescribed by IFRS and may not be comparable to similar measures presented by other issuers. These measures are provided as additional information to supplement those IFRS measures set out in financial statements.

They provide further understanding of the company’s results of operations from management’s perspective. Accordingly, they should not be considered in isolation nor as a substitute for analysis of the company’s financial information reported under IFRS.

Management believes that securities, analysts, investors and other interested parties frequently use these non-IFRS metrics to value issuers. We use non-IFRS measures to facilitate operating performance comparisons from period-to-period to prepare annual operating budgets and to assess our ability to service any current and future debt obligations, capital expenditures and working capital requirements.

Now moving on to the results. Reported product revenue, excluding some $50,000 in termination fees rose to $562,000 for the three months ended June 30, 2021 compared with roughly $176,000 in the prior year period.

This significant year-over-year growth reflects the positive impact from our buyback of NATESTO rights from Aytu, as previously discussed, allowing us to leverage our marketing efforts and book revenue when realized. As Ed mentioned, we anticipate continued sales growth this year given our strength in North American presence pent-up demand and an improved economic environment.

Cost of goods sold for the three months ended June 30, 2021, was approximately $45,000 versus $224,000 in the prior year period. Excluding the impact from the aforementioned termination fees, gross margin rose to 92% this year from a negative 27.3% in 2020.

Research and development costs were approximately $928,000 in 2021 versus $400,000 in the comparable quarter a year ago. This year-over-year increase reflects expenses tied in NATESTO clinical trials in the US.

Selling, general and admin expenses were $6.3 million in the 2021 second quarter, compared to $4.6 million in the comparable prior year period. The increase primarily reflects investments in the company's US organization, which we continued to expand this year.

In addition, we booked the charge of approximately $700,000 to write out the accrued receivables related to the present value of the expected royalty stream from the sale of ESTRACE recorded in the fourth quarter of 2020. We incurred a net loss of $7.1 million, or $0.00 per share for the three months ended June 30, 2021, compared to a net loss of $5.6 million or $0.01 per share for the same period in 2020.

Adjusted EBITDA, a key metric we use to assess our business performance for the second quarter of 2021, was a loss of $6.5 million, compared with $4.9 million in the second quarter of 2020. Calculations of EBITDA and adjusted EBITDA are in our MD&A and in our press release issued earlier today.

As of June 30, 2021, the company had cash of $2.6 million, compared to cash of $9.2 million as of December 31, 2020. This year-over-year change reflect cash used in the first six months of 2021 for operating purposes, as well as $1.6 million of principal and interest payments and our senior debt, offset by $7 million drawn on our $15 million subordinated demand loan facility with first generation capital.

And as a reminder, the company did announce in April that it did enter into a secured loan agreement with First Generation, a company affiliated with our Chairman of the Board. Total long-term debt was approximately $14.15 million as of June 30, 2021, compared to $8.25 million at the beginning of 2021.

Before turning the call over to questions, please note the financial information provided on today's call, and in the press release issued this morning are in summary form. Interested parties are encouraged to review the company's quarterly and year-end SEDAR filings as they will include the financial statements, the accompanying notes and management's discussion and analysis, as well as the annual information Form dated March 10, 2021.

You can also find these documents posted on the investor page of our corporate website as well as on the SEDAR. This concludes my prepared comments.

We'd like to now turn the call over to the operator and open it up to questions. Operator, can we open it up for Q&A, please?

Hello. Good morning, thank you for taking my call.

I just wanted to see if you could provide any more color on the Amneal business and how it's performing, how they're doing the relationship and maybe any results so far? Thank you.

Great question Colin, thank you for that question. I mean, we kicked off the Amneal promotion, beginning of July, subsequent to the to the second quarter, but I can give you a sense of where we are so far.

The anecdotal feedback from the team has been quite positive. Amneal’s strength being a leader in endocrinology certainly has them in front of the endocrinologist so the access has been quite good.

There's definitely an interest in hearing and learning about NATESTO, that’s been reported back. The team has been added for, I would say, about 30 days now and has delivered more than 2,000 direct healthcare provider interactions over that period of time and that's really 30 calendar days not necessarily business days.

So, on track with what we're expecting on track with Amneal is expecting. And I don't necessarily put too much stock in weekly prescription data, but certainly for the last week, we have data from Symphony in July.

Within the urology segment, we did see a near doubling of the total prescriptions for an NATESTO. So, it is one week it's still early.

I wouldn't necessarily put much stock in that necessarily going forward, but certainly a positive impact from a very professional, well-managed, and commercially strong team, being seen already and I think it bodes well for what we anticipate in the second half of the year and bodes well for the quality of the relationship we'll have with them. So, stay tuned, we'll have more updates as information comes in, but so far so good.

Great. Thank you and congrats on a nice quarter.

Thank you.

Thank you very much operator. This concludes today's call.

Thank you. Have a wonderful day.

We look forward to speaking you -- with you again in early November when we announced our third quarter results. Thank you very much.