Q1 2021 Antares Pharma Inc Earnings Call

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From Act of 1995 examples of forward looking statements income those related to our future financial and operating results, including our expectations regarding the impact of the ongoing COVID-19 pandemic and mitigation measures implemented in response to the outbreak on our overall business operating result in financial condition or one.

Ability to achieve the 2021 revenue guidance future revenue growth prescription volumes and market share for our products and our partner products, including <unk> attractive knock Donna and tub as generic epipen at da action and other regulatory activities, including actions with respect to makita and approval of tub as pending Anders.

Generic per tail, and Byetta timing and result of ongoing and future development programs and clinical trials, including a Trs 19 O one and 19 O two as well as programs with Pfizer and endorse year and other product development activities and business development efforts.

These forward looking statements are subject to certain risks and uncertainties, an actual results could differ materially they're certified.

Certified in describing today's press release in the accompanying slide presentation on slide too and in the company's filings with the SEC on form 10-K and is updated in on tourist as we said periodic filings on form 10-Q and form 8-K.

On charges, providing this information as of the date of today's conference call and does not undertake any obligation to update any forward looking statements contained in this conference call as a result of new information of future events or circumstances. After the date hereof, except as required by law or otherwise the company cautions investors.

Not to replace undue reliance on these forward looking statements.

Joining me on the call today, or Bob Apple, President and Chief Executive Officer, and Fred Pal Executive Vice President and Chief Financial Officer, Let's review the agenda for today's call on slide three.

I will begin with a review of our overall business, including our commercial achievements and strategy for our port proprietary portfolio as well as provide an update on our partner business. Fred will then go through the detailed financials and Bob will conclude with closing comments before opening up the line from your questions.

Please turn to slide four and I'll hand, the call over to Bob Apple Bob.

Thanks, Sean a good morning, everyone. Thank you for your interest in our first quarter.

<unk> and operations update.

We are pleased to have started the year with strength financial results with record first quarter revenue, increasing 27 per cent to $42 million would be reported net income of three $8 million or two cents per share and.

In the first quarter, we continue to increase the adoption of guys at that drove the 48% revenue increase in their proprietary products to almost $19 million as.

Prescriptions filled particularly in his first quarter.

Notwithstanding according to <unk> data total prescriptions resides that increased 50% year over year with March representing our highest month to date and we expect continued growth throughout the year.

The remains enthusiastic with the opportunity to compete in a growing testosterone market resides day, particularly given the evolving industry dynamics due to the pandemic.

As our sales reps continue to execute a hybrid detailing model of approximately 60% in person and 40% virtual detailing this quarter. We believe the advantages as I said with an easy to use once weekly virtually painless at home testosterone replacement therapy will continue to garner brand recognition an adoption by physicians.

We believe that the pandemic will continue to shift societal norms to see good at home therapies, which are at the core of our platform technology and development portfolio.

During the first quarter, Iowa hybrid detailing model continued to prove effective driving strong brand awareness and profile acceptance by our target audience supporting a growing prescriber base and year over year prescription growth.

We believe these accomplishments when paired with an enhanced targeting strategy and new digital and social media promotional campaign that was recently introduced had the brand poised for continued growth.

And as the year progresses, we also expect our sales force to increase their productivity as they garner more in office visits with a slowdown in the pandemic.

We believe that has successfully that we have achieved thus far <unk> can be leveraged for the relaunch of not Donna.

Total prescriptions for non Durnin remain consistent with our expectations in year one of this relaunch.

We believe this product is uniquely positioned to help patients suffering from nocturia due to nocturnal polyuria.

Our learnings from the soft launch at the end of last year have translated into a new comprehensive marketing campaign illustrated on slide six that we believe will increase awareness trial and adoption of knock Donna with our targeted physicians.

We anticipate continuing to call an existing ZISA targets that will also have the potential to prescribe enough deurne to share reallocate the appropriate selling time to reestablish nocturnal while also remaining focused on as I said.

Furthermore, we also have a select group of new high potential knob turn it targets to our sales force will be able to reach with minimal distraction desires dead.

With that overview of our commercial portfolio I'd like to take this opportunity to welcome Joe rendered to the company as our new senior Vice President of commercial.

Joe brings considerable commercial experienced from large and midsize pharma companies, where his leg commercial organisations with significant revenue.

He has also proved successful across therapeutic areas and we look forward to his contributions to our sales marketing and data analytics that we believe will enhance our strong growth trajectory.

Is broad therapeutic experience also aligns with our initiatives to continue to expand our commercial portfolio through business development.

On that same note. We're also very pleased to have Dr. Peter Richardson joined our leadership team as executive Vice President Research and development and Chief Medical Officer Peter.

Peter joined Us at a very exciting juncture of our internal development with a proven track record of success in managing development programs in clinical trials that have resulted in multiple product approvals.

We look forward to being able to leverage is extensive research and development background as we advance HRS 19, O one and 19 O two and look to continue to expand our internal development pipeline.

Looking at our current internal development programs, we remain on track and expect to file an indie with the FDA for Andrew chronology rescue Peg 19 O two and the first half of this year and 19 O. One a weekly formulation of an auto injector administered product in urology and the second half of this year based on positive.

Feedback from the FDA on both potential products at our pre meetings with them last year.

And as we previously noted once we filed the <unk> in the air accepted by the agency will be able to provide more detail around the app and an opportunity is important to remember that we are pursuing a 500 I'd be too pathway for both assets, helping to potentially provide an abbreviated development timeline.

With a commercial footprint letter lines with where we are today. We believe these assets will only enhance our future growth.

And while we believe that we have a robust proprietary business and development pipeline. We are equally pleased with our partner business, which brings me to slide seven and cabinets generic epipen.

The success of Tevis generic epipen in the first quarter allowed us to garner attractive royalties and strong demand for our devices.

Well as physicians and patients.

With that I'll turn the call over to Fred Fred Thanks, Bob and good morning, everyone.

Believe that our strong first quarter results that we announced earlier today are indicative of the solid foundation, we have built across our diversified business. We believe our first quarter total revenue of $42 1 million sets us on a good path to achieve our 2021 revenue guidance of 175% to $200 million.

With strong contributions again this quarter from our flagship products <unk> and <unk> generic Epipen, which is our primary partner product. We're pleased to be able to report net income of $3 8 million or <unk> <unk> per share.

So now let me provide a more detailed review of the financial results for the first quarter ended March 31, 2021, which brings us to slides eight and nine.

Total revenue generated from product sales license and development activities in royalties was $42 $1 million per three.

Three months ended March 31, 2021, representing.

Representing a 27% increase compared to $33 1 million in the same period in 2020.

Total proprietary revenue per the quarter of $18 7 million accounted for 45% of our total revenue while our partner revenue was $23 4 million and made up 55% of our revenue per the first quarter. We expect during the year. Our proprietary revenue will continue to make up an increasing percentage of our total revenue.

Sales of our proprietary products is outset, otrexup and nocturnal generated revenue of $18 7 million.

For the three months ended March 31, 2021, compared to $12 6 million for the same period in 2020.

The 49% increase in proprietary product sales were mainly attributable to continued growth in sales of <unk>, which increased 60% year over year to $14 4 million.

Product sales development revenue and royalties for our product partnered products increased 14% and totaled $23 4 million for three months ended March 31, 2021, as compared to $25 million from the same period in 2020.

During the first quarter of 2021 tenants Epipen said tremendous growth of the epipen market share as well as the stocking of Etsy devices required a mass vaccination sites.

<unk> of these two factors allowed us to record total revenue related to <unk> of $17 4 million, an increase of $6 1 million over 2020.

The most significant component of <unk> revenue growth was royalties, which grew $3 $6 million.

Offsetting the increase IP revenue was the overall revenue reduction from Amex Makena. Our total revenue for the first quarter of 2021 from Makena was $2 3 million a.

A reduction of $2 8 million from 2020.

Our gross profit was $25 7 million.

Representing a gross margin of 61% for the first quarter of 2021 as compared to $18 1 million or 55% gross margin in the same period in 2020 the increases in gross profit and margin were primarily attributable to the increases in SaaS net sales and <unk> royalty.

Selling general and administrative expenses were $7 $17 6 million for three months ended March 31, 2021, compared to $16 4 million for the comparable period in 2020. The increase in SG&A expenses was primarily due to an increase in sales and marketing costs for our proprietary portfolio and increases in cash.

Compensation and professional expenses.

As a result of our strong operational results net income was $3 8 million or <unk> <unk> per basic and diluted share for the first quarter of 2021 compared to a net loss of $2 4 million or.

<unk> <unk> per basic and diluted share in the same period in 2020.

Finally, our cash balance increased $2 1 million from December 31, 2020 to $55 7 million as of March 31, 2021, I'll now turn the call back to Bob for closing remarks, Bob Thanks, Greg.

In the first quarter, we reported strong comp.