Thank you very much, operator. Good morning to everyone, and welcome to the Acerus 2021 fourth quarter and year end conference Call.

I’m 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 would 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 this 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 the call, and 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 factors 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 conference call. Today, I’ll review our recent operational progress, after which Bob will provide a detailed overview of the financial results.

First of all, I hope that many of you were able to join our call last week that discussed in that our acquisition of Serenity Pharmaceuticals LLC. I won’t repeat everything that we said at that time but encourage all participants to review the materials on our website including the transcripts of the call and associated presentation.

There is a lot of information there that clearly lays out the strategic rationale and anticipated events benefits of this transformative acquisition. We expect the transaction to open up new markets for Acerus, accelerate our growth profile and strengthen the company’s future at North America and beyond.

Aside from this exciting development and the SWK debt retirement which Bob will discuss, our existing U.S. business operations continue to show promise in the fourth quarter and the set the stage for a great year to come.

While HCT access in patient volumes at the end of 2021 were still negatively impacted by the pandemic, particularly omicron variant, we made solid strides in a slow market environment. Although total testosterone replacement prescription volume in the U.S.

rose only 4%, versus the prior year Natesto prescriptions grew 20% versus the fourth quarter of 2021 and the for the year in total were up approximately 28% over 2020. Growth was again driven by the urology segment where our total prescriptions rose 30% in the quarter and were up 41% for the full year.

In addition new Natesto prescriptions rose by 24% in Q4, led by urology segment growing up 36% year-over-year. In fact, this performance took place during a slow quarter impacted by the pandemic speaks volumes about the expected growth in 2022.

We are excited by the early trends in the first quarter of 2022 helped by the fact that nearly 100% of HCP interactions in the U.S. are now back to face-to-face given that the pandemic has greatly subsided.

In addition, over 75% of Natesto scripts are now being written for commercially insured patients, driven by best-in-class formulary positioning among major PBMs. The number of healthcare providers writing Natesto prescriptions increased 20% in the fourth quarter of 2021 versus the prior year period and this momentum again has continued into 2022.

The urology segment representing nearly 40% of overall Natesto prescriptions continues to be our largest growth driver. However, we’ve seen increased traction in both the primary care and endocrinology segments as well.

Specific to endocrinology, our co-promotion agreement with Amneal Pharmaceuticals continues to evolve in 2022 and we look forward to accelerate growth in endocrinology as the year progresses. As I said a moment ago, we believe that everything is coming together for a very productive 2022 with the pandemic largely behind us, allowing us to return to in-person interaction with physicians, mid-level providers and pharmacists, we are beginning to see strong results being generated from the platform for commercial execution that we’ve built in the U.S.

market. With a well-differentiated product offering, increased prescriber breadth and depth, and increasing market growth and a motivated commercial team, we are optimistic about the quarters to come.

Now I’ll switch focus to our Canadian commercial business. The timing of Natesto being available in Canada is I regret to say still being impacted by supply chain disruptions and delays.

And we do not anticipate having product to sell until the second half of 2022. It goes without saying that we are working diligently with our manufacturing partners to resolve all remaining issues and we will be back in the market as soon as possible.

With regard to avanafil, we’ve been working with Petros Pharmaceuticals, the licensor, and Sanofi to update the regulatory dossier for resubmission. You may recall that last year Health Canada said that the new drug submission can be withdrawn due to the failure of Sanofi, the active ingredient manufacturer to address specific questions noted in the prior notice of efficiency.

The regulatory dossier has been updated and a resubmission is now expected to be made to Health Canada in the near future with the anticipated introduction of avanafil to the Canadian market taking place in 2023. Before I turn the call over to Bob, let me just reiterate how pleased we are with the outlook for Acerus after successfully building a commercial and medical organization in the U.S.

that has shown that it can drive product growth even during the pandemic and other challenging conditions. The execution shown by our leadership team and staff in the field was outstanding last year for which I couldn’t be more proud.

Facing an environment that changed monthly or even weekly, our U.S. sales force adapted, made inroads and kept winning over new customers, physicians and pharmacies.

Their performance in the phase of such obstacles was nothing less than outstanding and this is just a tip of the iceberg. Given accelerating demand for Natesto, and less pandemic restrictions, expected prescription growth this year looks like it could be even greater than last year’s growth.

Indeed, we have seen that the early weeks of 2022 seem to bring new record highs in terms of total Natesto prescriptions. At the same time, our acquisition of Serenity should lay the path for a broader, stronger company positioned to address and alleviate multiple conditions impacting the health of millions in North America and elsewhere.

We’ve never before had so many opportunities ahead of us and we look forward to re-launch of Noctiva in the US in the second half of this year. Overall, I am confident the company is positioned for a much higher performance going forward.

I believe in our products, our people and our mission while appreciating the steadfast support provided by our investors. It’s been a long journey, but I believe our shareholders will be rewarded with faster growth and improve results in the quarters and years to come.

We are dedicated to providing not only unique pharmaceutical products that significantly improve the patients’ experience and outcomes, but also solid returns to our investors. That concludes my remarks of the operational highlights for the quarter and full year.

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

Thanks, Ed, and good morning, everyone. In the comments that follow, please note that all dollar amounts are expressed in U.S.

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 or future debt obligations, capital expenditures and working capital requirements.

Now moving on to the results. We reported revenue of $738,000 for the three months ended December 31, 2021, compared with $271,000 in the prior year period.

We are pleased with the strong growth over 2020 which reflects both the success of our U.S. marketing efforts, as well as the assumption of full Natesto revenue recognition in 2021.

As a reminder, we repurchased all remaining rights from Natesto in the U.S. from AYTU Biopharma on April 1, 2021, prior to which revenue recognition reflected the value of shipments to AYTU, plus an estimate of the associated co-promotion revenue.

Going forward, as Ed mentioned, we are encouraged by the sales momentum in the U.S., which has accelerated as the pandemic has subsided. Cost of goods sold for the three months ended December 31, 2021 was approximately $393,000 versus $846,000 in the prior year period and the company posted a gross profit of $345,000 in the fourth quarter of 2021, compared to a gross loss of $575,000 in 2020.

Note that the 2020 fourth quarter included a charge of approximately $0.5 million for spoilage of slow moving raw materials. Research and development costs in the fourth quarter were approximately $3.3 million versus $744,000 in the comparative quarter a year ago.

The 2021 results included a $1.7 million non-cash impairment charge that reduced the carrying value of the company’s TriVair intangible assets to nil. As we received notice in December that our TriVair application to extend the patent protection from 2024 to 2037 for the U.S.

market was rejected as currently written, which is now leading to continuations and divisionals being filed. The delays in extending the patent for the U.S.

market has hindered business development opportunities identified by our U.S. partner for the technology and as such we reflected the impairment charge to the asset.

The remaining increase in R&D expense reflects clinical trials for Natesto for the U.S. states ambulatory blood pressure study previously announced which is expected to be completed by mid-2022.

Selling, general, and administrative expenses were $5.2 million in this year’s fourth quarter, compared to $5.6 million in the prior year period. Note that the 2020 fourth quarter included a $1.6 million non-cash charge related to the sale of our Estrace business.

Excluding this, SG&A increased by $1.2 million year-over-year, of which $0.8 million reflects investments in the Company’s US sales operations and related staffing to support our Natesto growth strategy. We posted a loss of $9.0 million, or $0.01 per share, for the three months ended December 31, 2021, compared to a loss of $7 million, also $0.01 a share in the same period in 2020.

Adjusted EBITDA, a key metric we use to assess our business performance for the fourth quarter of 2021, was a loss of $6.2 million compared to $4.8 million in the fourth quarter of 2020. Calculations of EBITDA and adjusted EBITDA are in our MD&A and in the press release issued earlier today.

On December 31, 2021, the company had cash of $2.2 million compared to cash of $9.2 million as of December 31, 2020. This change reflects cash used year-to-date offset by proceeds of $20 million drawn on the first generation subordinated loan facility and the $2.3 million Recipharm settlement we received in the third quarter of 2021.

We also had principal and interest repayments totaling $3.2 million on our senior debt with SWK. Our long-term debt was approximately $26 million as of December 31, 2021 versus $8.25 million at the beginning of the year.

On February 28, 2022, Acerus announced that it entered into a definitive agreement to acquire Serenity and its global rights to Noctiva, a transaction which subsequently closed on March 7, 2022. In order to fund the upfront fees, sales force expansion, marketing investments and growth of the existing Natesto business, as well as the resumption of Noctiva production, Acerus expects to raise an estimated $60 million in capital over the next two years.

As of March 15, 2022, the company has fully drawn on the existing first-generation facility and will need to raise the first tranche of the $60 million in capital within the second quarter of 2022 to execute on this strategy. Before turning the call over to questions, please note that the financial information provided on today’s call and in the press release this morning are issued 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 discussions and analysis, as well as the annual information Form dated March 14, 2022. You can also find these documents posted on the Investor page of our corporate website as well as on SEDAR.

This concludes my prepared comments. We’d like to now turn the call over to the operator and open up for questions.

Operator, can we open up for Q&A, please?

Thank you very much, Paul. This concludes today’s call.

We encourage you to return for our second – our first quarter 2022 call, which will tentatively be scheduled for May 10 of this year. Thank you all.

Have a great day. We look forward to speaking with you again later.

Take care. Bye, bye.