Amphastar Prescribed drugs, Inc. (NASDAQ:AMPH) This fall 2022 Earnings Name Transcript

Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) Q4 2022 Earnings Call Transcript

Amphastar Prescribed drugs, Inc. (NASDAQ:AMPH) This fall 2022 Earnings Name Transcript February 28, 2023

Operator: Greetings, and welcome to the Amphastar Prescribed drugs Fourth Quarter Earnings Name. Right now all contributors are in a listen-only mode. An issue-and-answer session will observe the formal presentation. . Please word that sure statements made throughout this name concerning issues that aren’t historic info, together with, however not restricted to administration’s outlook or predictions for future intervals, are forward-looking statements. These statements are primarily based solely on info that’s now accessible to us. We encourage you to evaluation the part entitled forward-looking statements within the press launch issued as we speak and a presentation on the corporate’s web site. Additionally, please seek advice from our SEC filings, which will be discovered on our web site and the SEC’s web site for a dialogue of quite a few elements which will influence our future efficiency.

We may even talk about sure non-GAAP measures. Necessary info on our launch of those measures and reconciliations to U.S. GAAP could also be present in our earnings launch. Please word that this convention name is being recorded. Our audio system as we speak are Mr. Invoice Peters, CFO; Mr. Dan Dischner, Senior Vice President of Company Communications; and Mr. Tony Marrs, Vice President of Regulatory Affairs and in Medical Operations. I’ll now flip the convention over to your host, Mr. Dan Dischner, Senior Vice President of Company Communications. Dan, you could start.

Dan Dischner: Thanks, Paul. Good afternoon, and thanks all for becoming a member of us as we speak. On the decision with me will probably be Invoice Peters, CFO and Govt Vice President of Finance; and Tony Marrs, Govt Vice President of Regulatory Affairs and Medical Operations. Following Invoice’s monetary updates, we are going to transfer the decision to Q&A the place the workforce will reply your questions. As introduced in our press launch and monetary outcomes revealed earlier as we speak, our web revenues for the fiscal 12 months have reached a brand new excessive at $499 million, reflecting a major 14% enhance with a corresponding 25% enhance in gross revenue. Within the fourth quarter alone, our web revenues hit $135 million. Once more, we attribute the success for our excessive margin merchandise, with Primatene MIST, glucagon and epinephrine sustaining a strong market share and having demonstrated spectacular development all year long.

On a short word about Primatene MIST, we nonetheless anticipated gross sales trending in the direction of $100 million in annualized gross sales by the tip of 2024. We plan to extend our advertising spend by a further $2 million to $3 million, thus bringing our whole to the low double-digit tens of millions for the 12 months. We have now adjusted the retail worth to accommodate greater value inputs. Shifting our focus to glucagon. We have now seen a notable 29% enhance in gross sales in comparison with the earlier quarter and a 20% enhance in comparison with the identical interval. As talked about in our final name, the altering market dynamics of the glucagon market, each within the retail and diagnostic help markets, have offered a development alternative for our generic glucagon. Moreover, I’m happy to announce that the FDA has authorized our considerably elevated glucagon manufacturing capability, permitting us to double our output and meet the extra market demand.

Pharmacy, Medication, Well being

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Shifting on to the subject of different income drivers for the quarter. We’re happy to report that our different completed pharmaceutical merchandise skilled a notable 52% enhance in gross sales in comparison with the identical interval. This vital development additional validates our skill to satisfy the rising demand for these merchandise resulting from competitor shortfalls. We anticipate that this portion of our portfolio will proceed to have residual power all through 2023. Nevertheless, on the similar time, we may count on fluctuation as these merchandise are influenced by competitor capability and unpredictable demand. Nonetheless, we stay optimistic about our development drivers and their potential development trajectory. Having coated our income drivers for the quarter, we are able to now talk about our pipeline and regulatory actions.

To begin, I am going to briefly overview our proprietary merchandise and biosimilars within the pipeline. Our intranasal naloxone NDA obtained a preapproval inspection within the first quarter forward of the PDUFA date. Whereas we acknowledge that public demand persists for this product in a crowded market, we stay inspired because the potential approval will function an revolutionary platform for our intranasal pipeline with our proprietary machine. This revolutionary method coincides with our time-tested technique of using our vertically built-in enterprise mannequin. Turning to a different proprietary product, our intranasal epinephrine. We now anticipate submitting in 2024 following adjustments we’re making to the product. Concerning our first interchangeable biosimilar insulin submitting for insulin aspart or AMP-004, progress or submitting is on monitor, and we count on it to happen this 12 months.

As for our generic pipeline, our AMP-008 product, our first inhalation submitting, I am happy to announce that we’ve got responded to the CRL. With the FDA’s granting precedence evaluation, we’ve got the brand new GDUFA motion date within the third quarter of this 12 months, with a preapproval inspection extending the aim date to the next quarter. Concerning our second inhalation product within the pipeline, AMP-007, we now anticipate this submitting to happen within the second quarter. Likewise, we now anticipate AMP-027 to be filed within the second quarter. Pivoting to our pending refile and refiled ANDAs. AMP-015, or our generic teriparatide, we’re seeing progress in the direction of refiling as we anticipate it to happen within the second quarter of this 12 months. For our AMP-002 refiling that occurred within the third quarter of final 12 months, our deliberate GDUFA motion date stays within the second or third quarter relying on a preapproval inspection, if wanted.

Earlier than I flip the decision to Invoice, I wish to reiterate that 2022 noticed a sustained year-over-year development. Whereas we could expertise some fluctuations, we are able to finally count on annualized development from our whole portfolio to proceed. Sustaining and constructing upon these achievements would require a rise in our funding in R&D, from which we stay on monitor to rising our capability in any respect of our services as we progress nearer to submitting and approval. I wish to flip the decision over now to the CFO and Govt Vice President of Finance, Invoice Peters, to debate the fourth quarter and year-end monetary outcomes.

Invoice Peters: Thanks, Dan. Gross sales for the fourth quarter of 2022 elevated 12% to $135 million from $120.9 million within the earlier 12 months’s interval. Glucagon led the gross sales development with a rise of 19% to $18.3 million from $15.3 million because the discontinuation of the opposite glucagon merchandise on the finish of 2022 positively impacted demand. Primatene MIST continues to point out sturdy gross sales development through the quarter with gross sales up of $22.3 million, up from $21.5 million within the prior 12 months. Epinephrine confirmed sturdy gross sales within the fourth quarter amid continued shortages by our opponents, rising to $21.4 million from $18.9 million within the earlier 12 months’s interval. Different completed pharmaceutical product gross sales totaled $33.1 million, up 52% from 2021 as the corporate recorded stronger gross sales of sodium bicarbonate, dextrose and isoproterenol, whereas benefiting from the 2022 launches of vasopressin and ganirelix.

API gross sales decreased to $2.3 million from $2.9 million because of the timing of orders from MannKind and different prospects. Gross margins elevated considerably to 53% of revenues within the fourth quarter of 2022 from 47% of revenues within the fourth quarter of 2021 resulting from sturdy gross sales of upper margin merchandise like Primatene MIST, glucagon, and epinephrine. Promoting, distribution and advertising bills elevated to $5.5 million from $4.1 million resulting from elevated tv, radio and digital bills for advertising Primatene MIST and elevated freight prices. Common and administrative bills had been primarily unchanged at $10.6 million. Analysis and growth expenditures had been additionally primarily unchanged at $17.2 million as a rise in scientific trial bills for our insulin and inhalation product pipelines was offset by a lower in spending on supplies and provides.

Non-operating earnings within the fourth quarter of 2022 was $3.4 million, primarily associated to the — achieve on overseas foreign money in comparison with the prior quarter’s non-operating earnings of $2.9 million, which was primarily associated to a authorized settlement. The corporate recorded web earnings of $33.9 million or $0.66 per share, which is up 72% and 66% respectively, in comparison with the earlier 12 months’s fourth quarter web earnings of $19.8 million or $0.39 per share. The corporate reported an adjusted web earnings of $37.6 million or $0.73 per share in comparison with an adjusted web earnings of roughly $20.8 million or $0.42 per share within the fourth quarter of the earlier 12 months. Adjusted earnings excludes amortization, fairness compensation, impairments of long-lived property and one-time occasions.

Within the fourth quarter, we had optimistic money move supplied by operations of roughly $15.2 million. And for the full-year, money move from operations was $89.2 million. Through the quarter, the corporate repurchased roughly $18.1 million of inventory to convey the whole repurchases for the 12 months to over $39.9 million. Now let me evaluation a couple of of the monetary assumptions we’re utilizing as we glance to 2023 and past. Glucagon will drive gross sales development in 2023 as we profit from opponents leaving the market. Primatene MIST will proceed to develop and profit from our first worth enhance. We may even have gross sales contributions from two to 4 new product launches. We count on gross margins to stay flat year-over-year as the combo of upper margin merchandise will probably be offset by elevated labor and enter prices.

Our promoting, distribution and advertising bills will rise as we plan to extend our promoting for Primatene MIST however will stay a relentless share of Primatene MIST gross sales. We count on basic and administrative spending to extend however stay an analogous share of gross sales. Turning to analysis and growth. We plan to ramp-up spending on scientific trials and purchases of fabric and provides this 12 months as we enhance spending on our insulin portfolio, two inhalation candidates and our intranasal epinephrine product. We additionally anticipate a major enhance in capital spending this 12 months as we proceed our venture to double capability for inhalation merchandise to align with our pipeline growth. We plan to complete our insulin API manufacturing capability enlargement at our ANP facility in China this 12 months as nicely.

At our Amphastar facility, we’re within the strategy of an enlargement venture that can finally quadruple our capability in Rancho Cucamonga as we glance to main insulin and sophisticated injectable alternatives. We plan to finance this enlargement with money flows from operations. On the similar time, we are going to make the most of our sturdy money place to proceed our inventory buyback program. I’ll now flip the decision again over to the operator for Q&A.

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