ANIP

ANI Pharmaceuticals’ second quarter was marked by strong year-on-year growth in its rare disease and generics businesses, but the market reacted negatively to the results. Management highlighted the rapid scale-up of its sales force for Cortrophin Gel and robust demand across existing specialties. CEO Nikhil Lalwani noted, “We are seeing significant momentum in demand in the third quarter with July representing the highest month for new cases initiated,” attributing quarterly performance to persistent execution and expansion efforts. Is now the time to buy ANIP? Find out in our full research report (it’s free). Revenue: $266 million vs analyst estimates of $259.8 million (25.9% year-on-year growth, 2.4% beat) Adjusted EPS: $2.21 vs analyst estimates of $2.04 (8.2% beat) Adjusted EBITDA: $71.6 million vs analyst estimates of $63.7 million (26.9% margin, 12.4% beat) The company reconfirmed its revenue guidance for the full year of $1.11 billion at the midpoint Management reiterated its full-year Adjusted EPS guidance of $9.44 at the midpoint EBITDA guidance for the full year is $292.5 million at the midpoint, in line with analyst expectations Operating Margin: 15.2%, up from 6.6% in the same quarter last year Market Capitalization: $1.60 billion While we enjoy listening to the management’s commentary, our favorite part of earnings calls is the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Vamil Divan (Guggenheim Partners) asked about the early results and confidence in the gout expansion’s ability to drive the projected ramp in the second half. CEO Nikhil Lalwani emphasized strong leading indicators, with most new sales reps already generating multiple cases and a significant runway remaining in underpenetrated segments. Glen Santangelo (Barclays) questioned the disconnect between prescription data and actual revenue, and whether insurance reverification issues persisted. Lalwani clarified that insurance reverification was no longer an issue in Q2 and that quarterly guidance factored in diverse metrics beyond just prescription data. Yuchen Ding (Jefferies) probed the rationale behind lowering Cortrophin guidance despite positive demand metrics, and the anticipated Q4 step-up. Lalwani attributed the revision to first-half performance, not to deteriorating trends, and cited the scale and timing of the sales force expansion for the expected Q4 ramp. David Amsellem (Piper Sandler) inquired about the conversion of new cases to prescriptions and the time lag to fulfillment. Lalwani explained that “new cases initiated” equates to prescriptions written, with timing to fulfillment varying by payer and prescriber but no notable headwinds were seen. Ekaterina Knyazkova (JPMorgan) asked about the impact of insurance reverification issues on patient volumes and shifts in per-patient Cortrophin usage. Management responded that most patients were retained through the reverification process, with no material change in usage patterns across indications. In the coming quarters, our team will be closely monitoring (1) the pace of Cortrophin Gel uptake in primary care and podiatry following the sales force expansion, (2) sustained growth in established specialty areas such as ophthalmology and nephrology, and (3) execution against the target for new generics launches. Additional attention will be paid to early signs of operating leverage and updates on M&A activity in rare diseases. ANI Pharmaceuticals currently trades at $74.77, down from $82.63 just before the earnings. At this price, is it a buy or sell? Find out in our full research report (it’s free for active Edge members). WHILE YOU’RE HERE: Top 9 Market-Beating Stocks. The best stocks don’t just beat the market once. They do it again. And again. Robust revenue growth, rising free cash flow, returns on capital that leave their competition in the dust. The market has already rewarded these businesses. But our AI platform says the party isn’t over. Find out which 9 stocks made the cut this week — FREE. Get Our Top 9 Market-Beating Stocks for Free HERE. Stocks that have made our list include now familiar names such as Nvidia (+1,460% between June 2020 and June 2025) as well as under-the-radar businesses like the once-small-cap company Exlservice (+271% between June 2020 and June 2025). Find your next big winner with StockStory today.

Image source: The Motley Fool. Friday, Aug. 7, 2026 at 8:00 a.m. ET Investor Relations - Irina Koffler President and Chief Executive Officer - Nikhil Lalwani Senior Vice President and Chief Financial Officer - Stephen Carey Senior Vice President and Head of ANI's Rare Disease Business - Chris Mutz Operator: Good day, everyone, and welcome to today's ANI Pharmaceuticals, Inc. Second Quarter 2026 Earnings Results Call. Please note this call is being recorded. [Operator Instructions] It is now my pleasure to turn the conference over to Irina Koffler. Please go ahead. Irina Koffler: Thank you, Daniel. Welcome to ANI Pharmaceuticals' Second Quarter 2026 Earnings Results Call. This is Irina Koffler, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer; Stephen Carey, Senior Vice President and Chief Financial Officer; and Chris Mutz, Senior Vice President and Head of ANI's Rare Disease Business. Earlier this morning on August 7, 2026, we released our results for the second quarter 2026 via a press release that is available on our website. This call is also available via webcast and is accompanied by a slide deck that can be accessed by going to the Events section of the Investors page of our website. Before we begin, I would like to remind you that we will be making forward-looking statements and discussing certain non-GAAP measures. Forward-looking statements are subject to substantial risks and uncertainties, speak only to the call's original date, and we take no obligation to update or revise any of the statements. During this call, we will also refer to certain non-GAAP financial measures to describe our performance and have provided a reconciliation to the most directly comparable GAAP financial measures within the materials that accompany this call. The archived webcast will be available for 30 days on our website, anipharmaceuticals.com. And with that, I'll turn the call over to Nikhil Lalwani. Nikhil Lalwani: Thank you, Irina. Good morning, everyone, and thank you for joining us for ANI's second quarter of 2026 earnings call. Starting on Slide 5, our entire organization demonstrated outstanding focus during the second quarter as we continued to transform ANI into a leading rare disease company. We reported record second quarter 2026 revenues of $266 million for the overall business, record Cortrophin revenues of $117.1 million and record adjusted EBITDA of $71.6 million. In the second quarter, we grew total net revenues 26% year-over-year, driven by persistent execution across our Rare Disease and Generics businesses with incremental contribution from the Harmony intellectual property out-licensing deal we announced last quarter. We also grew adjusted EBITDA 32% year-over-year to an all-time high and above our prior expectations. Furthermore, we achieved all of this while executing the single largest rare disease sales force expansion in our history, where we increased our sales force by 50% to approximately 180 reps. Our strategic plan is on track and we are well positioned to drive meaningful growth in 2026 and beyond. Turning to Slide 6. Our first area of focus in our transformation into a rare disease company is delivering organic growth for our 2 durable branded rare disease medicines, Cortrophin Gel and ILUVIEN. We delivered $117.1 million in Cortrophin Gel net revenues for the second quarter, up 43% year-over-year and 56% over quarter 1, 2026, consistent with the expectations we outlined during our last quarterly call. Second quarter revenues from our existing specialties of rheumatology, nephrology, neurology, ophthalmology and pulmonology was healthy and we are seeing significant momentum in demand in the third quarter with July representing the highest month for new cases initiated. We expect our existing specialty sales force to continue its strong trajectory in the second half of 2026. We completed our gout-focused organization expansion, and the team was fully operational at the end of June, as expected. We are pleased that we have seen strong demand driven by the high unmet need for patients who are most severely impacted by acute gouty arthritis flares and who need an additional treatment option. Our leading indicators are very positive, such as total new cases initiated, cases initiated per sales rep, and a number of prescribers with multiple new cases. We believe we are at the start of a sizable inflection for this business and look forward to updating you on our progress. Taking a step back, our conviction in the growth and durability of Cortrophin Gel have only increased over time since our 2022 launch. Cortrophin has grown at a compound annual growth rate of 103% to $348 million in sales in 2025, and we're just getting started. We believe Cortrophin will serve as the key building block catalyzing our transformation into a rare disease company. Now that we are midway through the year, we are modestly revising our Cortrophin Gel revenue guidance to $520 million to $540 million, primarily to account for results in the first half of 2026. Our expectations for the back half remain largely intact with what we had expected at the start of the year. Importantly, this still represents 50% to 55% growth for Cortrophin compared to 2025, and the addition of the gout expansion creates a strong new growth trajectory for Cortrophin. We believe we are well-positioned to achieve our revised 2026 guidance based on the continued momentum in existing specialties, as evidenced by the highest [ new cases ] in July, and the strong demand generation from the gout expansion. For ILUVIEN, we delivered $18.7 million of revenue in the second quarter. We announced the top line results from the Phase IV open-label SYNCHRONICITY trial in NIU-PS and plan to unveil detailed results and additional analysis at a medical conference in the fourth quarter of 2026. These results are particularly relevant for retina specialists who see a large population of uveitis patients. Uveitis remains a category in which steroids is a standard of care and where we see an opportunity to build an increasing share of voice over time. Over the long term, we continue to believe the addressable patient populations in DME and NIU-PS represent at least 10x the number of patients treated with ILUVIEN today, a significant and durable opportunity for value creation. Turning to Slide 7, our strategic priority -- our second strategic priority is continued execution in Generics. To date, we have launched 12 generics in 2026 and are on track to launch at least 15 in the full year. We also continue to hold our position as the #2 player in overall CGT filings. Driven by our superior R&D capabilities and operational execution, we delivered another strong quarter with Generics revenue of $99.1 million, up 10% year-over-year. As a reminder, ANI is uniquely positioned to capitalize on opportunities in the evolving tariff landscape that may arise with approximately 95% of our revenues coming from finished goods manufactured in the U.S. Bringing high-quality Generics and Rare Disease products made in the U.S. to our patients plays an important role in our success. Third, we remain focused on executing a disciplined capital allocation strategy. We are investing in organic growth and have expanded our Cortrophin commercial footprint in acute gouty arthritis flares. We continue to deploy a high single-digit percentage of generics revenue into generics R&D programs. We are also evaluating attractive inorganic growth opportunities to expand the scope and scale of our Rare Disease business. Turning to Slide 8, our strong second quarter performance demonstrates the steadfast execution of our strategic priorities as we deploy the cash created by Generics and Brands in our virtuous cycle towards our transformation to becoming a leading rare disease company. We are confident in delivering 50% to 55% Cortrophin revenue growth in 2026 and are pleased that our gout expansion is off to a strong start. Taken together, these initiatives are expected to create operational leverage in 2027 and beyond as we maximize the Cortrophin growth opportunity. In 2026, we expect to deliver $1.1 billion in revenue, representing 26% growth over 2025 at the midpoint of our guidance range, with Rare Disease as the primary driver of that growth. We also expect to expand the bottom line with adjusted EBITDA, forecasted to grow 27% year-over-year to $285 million to $300 million. Our balance sheet is healthy with the capacity to support for future potential business development opportunities to expand the scope and scale of our Rare Disease business. I'll now turn the call to Chris to discuss our Rare Disease business and provide color from the ongoing launch in acute gouty arthritis flares. Chris? Christopher Mutz: Thank you, Nikhil, and good morning, everyone. In the second quarter, Cortrophin grew 43% year-over-year to $117.1 million, in line with our expectations. This growth originated primarily from our existing specialties, such as nephrology, neurology, ophthalmology, pulmonology, and rheumatology, which represent the base Cortrophin business before the recent gout expansion. Momentum in our existing specialties has continued into the third quarter with a record number of new cases initiated in July. We also continue to realize meaningful revenue synergies in ophthalmology with second quarter Cortrophin volumes in ophthalmology again doubling over the same period a year ago. Moving now to Slide 11. The overall ACTH market is quite healthy and expected to grow nearly 30% in 2026 to reach over $1.3 billion in sales, with Cortrophin expected to grow 50% to 55% year-over-year in 2026. This market expansion is driven by growth in key underpenetrated specialties that have significant upside potential. There are a large number of prescribers and patients who are naive to the ACTH category across all therapeutic areas, ANI is steadily reaching this segment including as part of our gout expansion now reaching podiatrists and primary care physicians. Approximately half of Cortrophin Gel prescribers in our core specialties are naive to ACTH. Here on Slide 12, we return to the size of the overall opportunity for Cortrophin Gel. Across indications, we estimate there are almost 1 million addressable patients, and yet, to date, ACTH therapies are vastly underpenetrated. With ANI's demonstrated ability to educate health care providers to help identify new patients who are appropriate candidates for Cortrophin treatment, we have confidence that there is significant runway for continued strong multi-year Cortrophin growth and market expansion. Turning to Slide 13, we have made our largest commercial expansion in the first half of 2026, increasing our sales headcount by 50% to approximately 180 sales representatives based on what we view as a transformational multi-year growth opportunity for our business in the podiatry and primary care settings. Our team was fully onboarded and trained by the end of June and have been out in the field engaging with their new prescribers. Gout is a condition with significant patient burden, and our market research, as well as our early experience, shows us that people view their disease as disruptive, anxiety-provoking, and frustrating. Pain from acute gouty arthritis flares has been described by some as unbearable and can come on quickly and unexpectedly, especially in the middle of the night or the early morning. We believe podiatrists and primary care physicians are actively managing a much larger volume of acute gouty arthritis flares than specialists, and most often earlier in the patient journey either due to referral gaps or access limitations. Our sales representatives are educating podiatrists and primary care providers about Cortrophin Gel and the identification of appropriate patients. We're focused on the most severe patients who experienced multiple flares a year who have previously been treated with injectable medicines like steroids or pain relieving medications. These patients may benefit from an additional treatment option. Our patient support team is helping patients request access to Cortrophin Gel to treat the current flare and to have drug readily available for when the next flare hits. Turning to Slide 14, we feel confident about the opportunity in the podiatry and primary care settings because of the insights and results generated by both the pilots conducted in 10 territories as well as the strong momentum we are seeing today from the gout expansion. While it is early days, we are pleased to see encouraging trends in our leading indicators. To date, we have been generating very strong demand with meaningful breadth and depth of prescribing. Over 95% of our new sales representatives have generated multiple new cases and momentum in demand persists with record new cases achieved by the team week over week. We've seen traction with both primary care and podiatry offices with initial and repeat prescribing. Over 1/3 of our prescribers have initiated 2 or more patient cases. Our patient support team has been successful in helping these patients get access to therapy. ANI's entire organization is dedicated to making this new commercial expansion successful. We're excited that this weekend our marketing, medical, and sales teams will be engaging with customers at the American Podiatric Medical Association Scientific Meeting, or APMA, being held in Nashville, and we intend to be increasingly visible to this key prescriber audience going forward. I want to thank the entire Cortrophin team for their superior focus and execution. Our new gout expansion is off to a very encouraging start, and we look forward to their contribution in the second half of 2026 and beyond. On Slide 15, turning to our retina franchise, we continue to make progress to support a return to growth for ILUVIEN. We recently reported top-line results from the SYNCHRONICITY Phase IV open-label trial in non-infectious uveitis of the posterior segment and plan to present the detailed results and additional analysis at a medical meeting in fourth quarter 2026. These data will support increased engagement with retina specialists who treat NIU-PS as we continue sharing insights and new findings from the SYNCHRONICITY study. The second quarter reflects strong execution across our team as we continue to accelerate into a leading rare disease company. With that, I will now turn the call over to Steve to detail our financials. Stephen Carey: Thanks, Chris, and good morning to everyone on the call. Now I'll review our second quarter results and 2026 guidance in more detail. Starting with Slide 17, ANI total net revenues were $266 million in the second quarter, up 26% over the prior year period. Revenues from Cortrophin Gel in the second quarter were $117.1 million, up 43% from the prior year period, driven by increased volume and performing in line with our expectations. ILUVIEN net revenues were $18.7 million in the second quarter, down 16% from the prior year primarily based on timing of international shipments. We remain on track to meet our full year guidance for this product. In January, we entered into a licensing transaction with Harmony Biosciences. We recognized $17.7 million of associated revenues in the second quarter, consisting of $9.7 million of royalty income on sales of WAKIX and $8 million of revenue based upon work completed in the quarter toward the achievement of certain development milestones. We expect to recognize the remaining $2 million from the development milestone in the third quarter of 2026. Revenues for Generics in the second quarter were $99.1 million, an increase of 10% over the prior year, driven by continued strength in the partner generic launch that commenced in the third quarter of 2025, contribution from new product launches, and commercial and operational outperformance. Turning to Slide 18, non-GAAP cost of sales increased 34% to $99.6 million in the second quarter of 2026 compared to the prior year period. Non-GAAP gross margin in the second quarter was 62.6%, a decrease of approximately 230 basis points from the prior year driven by product mix. Non-GAAP research and development expenses decreased 11% to $14.1 million in the second quarter, primarily due to phasing of generic R&D spend. Non-GAAP selling, general, and administrative expenses increased 20% to $80.7 million in the second quarter, driven by our gout expansion for Cortrophin, as well as an overall increase in activities to support the ongoing growth of our business. Adjusted non-GAAP diluted earnings per share was $2.21 for the second quarter, compared to $1.80 per share in the prior year period. Adjusted non-GAAP EBITDA for the second quarter was $71.6 million, up 32% compared to the prior year period. We ended the second quarter with $360.2 million in unrestricted cash, up $74.6 million as compared to the December 31, 2025 balance sheet. Cash flow from operations was $56.7 million in the second quarter and $115 million on a year-to-date basis. As of June 30, 2026, we had $620.9 million in principal value of outstanding debt, inclusive of our senior convertible notes and term loan. At the end of the second quarter, our gross leverage was 2.4x, and our net leverage was 1x our trailing 12-month adjusted non-GAAP EBITDA of $259.6 million. Turning to Slide 19, we are reaffirming our 2026 financial guidance for total net revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP EPS, which reflects significant top and bottom line growth, and modestly revising our guidance for Cortrophin Gel. Our guidance outlined on Slide 19 is as follows: we expect 2026 total company net revenue of $1.08 billion to $1.14 billion, representing 26% year-over-year growth. From a quarterly cadence perspective, we expect the third quarter total company revenues to be modestly higher as compared to second quarter and accelerating sequential growth in the fourth quarter. We are revising our guidance for Cortrophin Gel net revenue to $520 million to $540 million, primarily to account for results in the first half of the year. Our expectations for the back half of the year remain largely intact. From a quarterly cadence perspective, we expect third quarter Cortrophin revenues to be in the range of $143 million to $153 million, with further sequential gains in the fourth quarter driven by continued performance of our existing specialties team, in addition to the full deployment of our gout expansion sales force. We are reaffirming our ILUVIEN net revenue guidance of $78 million to $83 million, which reflects stronger ILUVIEN revenue in the back half of the year compared to the first half. This guidance assumes no meaningful contribution from third-party patient assistance foundations in line with our prior expectations. We expect adjusted non-GAAP EBITDA of $285 million to $300 million. From a quarterly cadence perspective, we expect third quarter non-GAAP EBITDA to be down sequentially, however higher than the first quarter of 2026 non-GAAP EBITDA. This will be driven by 2 factors. First, we expect to recognize the final $2 million Harmony development milestone in the third quarter as compared to the $8 million recognized in the second quarter. And, secondly, the third quarter will be the first fully loaded quarter of the gout expansion and associated operating expense. We continue to expect fourth quarter EBITDA to be the highest of the year as we begin to achieve leverage on the gout expansion with increasing Cortrophin Gel revenues. We continue to expect adjusted non-GAAP earnings per share between $9.19 and $9.69. We continue to expect adjusted gross margin to be between 59.9% and 60.9% in 2026. We continue to anticipate between 21.5 million and 21.8 million shares outstanding for the purpose of calculating full-year non-GAAP diluted EPS and a full-year U.S. GAAP effective tax rate of approximately 26% to 28%. With that, I'll turn the call back to Nikhil. Nikhil Lalwani: Thank you, Steve. Turning to Slide 21, in closing, we are making meaningful progress against our strategic priorities to accelerate our transformation into a leading rare disease company to continue executing in generics and to deploy capital in a disciplined manner. We are very encouraged by the initial demand that our Cortrophin sales force expansion in gout is driving and the momentum of our existing specialties. Overall, we expect to deliver over $1 billion in revenue in 2026, with Rare Disease approaching 60% of total revenues. We are confident in achieving our 2026 financial guidance, which reflects significant top and bottom line growth. Operator, please open the line for questions. Operator: [Operator Instructions] Our first question comes from Vamil Divan with Guggenheim Partners. Vamil Divan: Just focusing on Cortrophin here. Can you give a little bit more detail in terms of what you've been seeing so far in terms of the gout uptake? I appreciate the comments you made. I'm just sort of thinking about the way you structured the guidance here. You're going to get about $143 million, $153 million in the third quarter. It's a pretty meaningful step up from there into the fourth quarter. So just trying to see what you've seen so far in gout and kind of the confidence it gives you to see the further uptake through the course of the year. And then sort of tied to that also, obviously, a lot of potential patients that Cortrophin can hit across the current indications as you showed on the 1 slide here. Can you maybe just give us a sense of how penetrated you think some of these current indications are? Again, just trying to get a sense in terms of obviously there's a big runway ahead of you, but trying to get a sense of how far you've penetrated them to get a sense of what maybe is left to penetrate them. Nikhil Lalwani: Vamil, thank you for your questions. I think your first question is on the gout expansion. So as we said, the leading indicators from the gout expansion are very positive, right? What we're seeing is the, you know, so first of all, our gout-focused organization expansion was fully operational by the end of June as expected. And then the leading indicators of demand that we've pointed out are, which we're pleased with, is the breadth and the depth of the prescribing, right? So over 95% of the reps generated multiple new patient cases. Over 1/3 of the prescribers have initiated 2 or more cases. And we also saw balanced demand between primary care and podiatrists. We also see continued success and growth in the territories that were the 10 pilot territories that we had, which based on whose success we actually thought about the gout expansion. So I think all of those very pleased with the progress and the leading indicators of demand that we've pointed out for the gout expansion. Now, when it comes to guidance, Steve pointed out that our Q3 guidance for Cortrophin is $143 million to $153 million, and then, your question was around the step-up from there. So when you think about the gout expansion, right, we've executed our largest rare disease sales force expansion and we've increased our reps by 50%. This expansion from 120 to 180 reps, right? So that's a meaningful expansion. That expansion was operational by the end of June. I already spoke about the leading indicators of demand. So we expect Q3 to keep building on this momentum and therefore Q4 will have significantly higher impact from the gout expansion. In parallel, our existing specialties, which were the primary drivers of growth for the 56% quarter-on-quarter growth in 2Q, and have continued the momentum in 3Q with the highest number of new cases initiated in July, so that also has continued momentum. And then lastly, that Q4 also benefits from the typical channel and insurance dynamics acting as tailwinds. So finally, as a reference point in 2025, too, where we did a sales force expansion, revenue contribution from H2 was 61% of the total. And then, just again, as the reference point, the expansion in 2026 is 3x the expansion in 2025 in terms of number of reps and was completed in the second quarter versus the first quarter in 2025. And then lastly, your question was on penetration across the addressable market. It's very low, very, very low, and so there is a huge opportunity, and we continue to believe in the strong multi-year growth opportunity for Cortrophin and are investing in multiple ways to capture that opportunity and to most importantly, be true to our purpose of serving patients, improving lives. Operator: Our next question comes from Glen Santangelo with Barclays. Glen Santangelo: Nikhil, at the beginning of the year, you called out all these prior authorization reverification issues that would impact 1Q. But then on May 8, when you reported 1Q, you said that this was kind of behind the company. This quarter, you're talking about the early progress of your sales force expansion, the early success in gout, but yet you come in light and you sort of trimming the guide for the year. And so I just want to try to get your sense for how the months have progressed and how the insurance reverification issues have progressed and is that playing a role here in the second quarter because you know what we find a little perplexing is the disconnect between the IQVIA data and what you're reporting. And so I'm kind of curious if we have a situation where scripts are getting written but not approved. Any sort of details around sort of how the first half played out from 1Q to 2Q would be helpful. Nikhil Lalwani: Yes, thank you for your question. So first is on the insurance reverification, which drove -- impacted the performance in the first quarter. That issue is behind us and there's no impact from insurance reverifications in the Q2 number. And then to level set here, we did make our guidance range for the quarter, achieving the 56% quarter-on-quarter and 43% year-over-year growth in Q2 and are proud of the progress we made. And there are a diverse range of inputs that drives our guidance, right? Such as number of cases initiated, the indication mix, patient pull-through, payer type, and other such factors. And then, in terms of momentum, right, going into Q2 and -- obviously we're sharing Q3 data too, the growth came in Q2 came primarily from existing specialties and the momentum has continued into the third quarter from existing specialties itself, we have the highest month of new patient cases initiated in July. As expected and as previously discussed, given the timing of operationalizing our gout expansion, it did not have a meaningful impact on Q2 reported revenues, but we continue to expect measurable revenues in the third quarter and robust growth in the fourth quarter, and we're giving, metrics on the indicators of demand, right? That are already laid out. And so our expectation for Q3 and Q4 hinges on both the continued momentum in the existing [indiscernible] talked about as well as the very positive early feedback from the gout launch where we have over 95% of our team has generated multiple new cases and over 1/3 of our prescribers have initiated 2 or more cases. And we continue to have success going to prescribers who are naive to ACTH, right? We have over the history of us commercializing Cortrophin, over half of our prescribers were naive to ACTH and began using ACTH to serve patients. With the linkage to IQVIA and the question around that, while the IQVIA data has historically provided directional insights on revenues, we also know that there is a lot of volatility in the data, and it has over or understated quarterly revenues in the past. That's really all we have to say about the IQVIA data. But we understand that and to be helpful to investors, we have been providing to investors many of our key internal metrics, such as next quarter's revenue guidance or various demand metrics from July in the first month of the current quarter. Operator: Our next question comes from Dennis Ding with Jefferies. Yuchen Ding: We have 2 on the Cortrophin guidance. So number one, what factors didn't play out to your expectations that has driven the guidance revision? Because you guys landed within your Q1 and Q2 soft guidance, but then lowered 2026 by about $30 million. So I'm just curious, did early Q3 demand perhaps not meet your expectations or maybe you're seeing incremental headwinds on access as we've seen a couple of other spec pharma companies flag additional step edits and things even though they're in other therapeutic areas. So that's question number one. And then question number two, is that, your guidance also assumes a pretty big step-up in Q4. But if I look at last year, that was actually the slowest sequential step-up that Cortrophin had. So I'm just wondering, what gives you the confidence that Q4 would play out as expected, appreciating that the gout expansion is happening and is accelerating. Nikhil Lalwani: Thank you for your questions, Dennis. So, our revised guidance, principally accounts for the actual performance in the first half and largely maintains our expectations for both the existing specialties and the gout expansion in the back half. We expect to deliver 50% to 55% year-over-year growth, right? For Cortrophin to $520 million to $540 million in Cortrophin revenue for the full year. And importantly, Cortrophin has a strong multi-year growth opportunity driven by the large significantly underpenetrated almost 1 million patients that we estimate as our addressable market. And we continue to see momentum across both our existing specialties and from the gout expansion. You asked about Q3 metrics, right? In existing specialties, highest number of new cases initiated in July. In the gout expansion, 95% of the reps, right, an expansion that was operational at the end of June, 95% of reps fully operational at the end of June. 95% of reps have initiated 2 or more cases. 1/3 of our prescribers have written 2 or more cases. So we are seeing very strong demand generation and very positive demand generation, which is on track or ahead on metrics that we have, week on week, we're continuing to see that momentum. We do not see any additional headwinds in the back half of the year. And our, very importantly, our expectations for the back half of the year are largely intact with what we had originally anticipated at the start of the year, right? So the revised guidance is simply taking into account the actual results from the first half. And then you asked about the question on the step-up in Q4. I think the big difference with last year is, we have an expansion that's 3x the previous year's expansion, right? That's fully operational at the end of June. So these reps will have been out, 3 months in Q3, but then you'll have a full quarter and most reps will be out between 3 to 5 months when you get to the fourth quarter. So you'll see a much bigger impact from the gout expansion in the fourth quarter. Yuchen Ding: Okay, got it. And if I can have a quick follow-up. So on the dedicated gout expansion, can you comment on how many flares have been treated so far? Because based on some of your comments, I mean, you guys had 65 dedicated gout reps. You said 95% of them had multiple new cases. So if you have conservatively assumed 2 cases each, maybe that's 125 patients or flares from the end of June to the end of July. So that's about a month. And that's going to ramp up through the year. Do you think those are fair assumptions? Nikhil Lalwani: Yes. Thank you, Dennis, for your question. Look, we're trying to give as many internal metrics to be helpful to investors, but we are not at this point sharing flares per rep or number of cases per rep, because as I said, there are many factors that drive our guidance, and so I'll keep it at that. Operator: Our next question comes from David Amsellem with Piper Sandler. David Amsellem: So just a couple for me. First, just wanted to clarify, Nikhil, are cases the same as prescriptions written? And if they're not, can you talk about how many of those cases that you referred to, a percentage of those cases, are actually becoming active prescriptions? That's number one. Number two, as you think about the ramp in the back half of the year. How long does it take on average to get a script filled from when it was written? Are you seeing any significant lags there that could be or have been problematic just beyond the authorization issues that you cited earlier this year? And then lastly, operating leverage. With the expansion in place, how are you thinking about operating leverage beyond this year? Do you think you're going to need further sales force expansion to support the gout indication or other indications? Just generally speaking, if you can talk about that as well that would be helpful. Nikhil Lalwani: Thank you, David. So when we say new cases initiated, we mean prescriptions, we mean the same thing as enrollments, enrollment forms. So when we say number -- highest number of new cases initiated for existing specialties in the month of July, then that means the highest number of enrollment forms or prescriptions that were written in July. And the same thing when we talked about, from the gout expansion, the leading indicators of demand. There are 1/3 of our prescribers have written more than 2 prescriptions, meaning intend to treat more than 2 enrollment forms and initiated -- new cases initiated. So new cases initiated is the terminology we use so that's one. The second on time to -- from the time of the enrollment or the new case initiation to fulfillment that time varies. It varies on a number of different factors. It can be in a matter of a couple of days into weeks, and it depends on the payer type, the patient, the physician's office. I think it's a number of different factors that drives it. I think importantly, we're in year 5 of our launch, right? And we have consistently across the 5 years kept improving this process to support prescribers and prescriber offices and patients who are appropriate for ACTH and Cortrophin therapy to get the medication that they need in time. So there is no lag or any new headwind that we're facing on that front. We continue to work with the prescriber's office in the appropriate fashion to ensure that these enrollments end up with patients on therapy. And then the last question was on -- third question was on operating leverage. Absolutely, David. The investment that we've made in this year by expanding our rare disease sales force by about 50% from 120 reps to 180 reps, we'll see impact in the back half, but we'll see the full year impact on operating leverage in 2027. And so you can expect higher sales in 2027 and operating leverage from the investment made this year. Operator: Our next question comes from Ekaterina Knyazkova with JPMorgan. Ekaterina Knyazkova: So first, I just wanted to go back to the patient reverification issue. Just what percent of the volumes that you lost in Q1 were you eventually able to recover in Q2 versus how much of those -- that volume was permanently lost? And similar kind of line of questioning, but should we expect a similar issue as we kind of think about '27? And then the next topic I wanted to talk about is just also Cortrophin Gel trends that you're seeing in terms of vial per patient. Just any big shifts in terms of the number of vials you're kind of seeing each patient use. Nikhil Lalwani: Got it. Thank you, Ekaterina, for your questions. First question is on, I'll take your second question first, which is on the vials or the usage per patient. The usage per patient varies across indications and prescribers. So we are not seeing any significant shift. The mix of indications, right, we have is there are some indications for which there's a higher usage per patient and there are some indications where there's a lower usage per patient, whatever the prescriber feels is appropriate for the patient. So we're not seeing any specific change in any indication, right, of the usage per patient. And then going back to your reverification question. Look, we worked through the reverification issues, and again, just to remind investors, there was a large bolus of patients that needed to be reverified, that patients who were on therapy on December 31, 2025 and needed to be reverified in 2026 early as part of their insurance process. And because of the large bolus as well as weather-related issues, it took a bit more time. Now, we were able to convert many or most of those patients through the reverification process, right? And there was some shifting of that in the timing of that, that happened. Did we lose some patients? Yes, but that's also, patient pull-through, this is also consistent with what has happened the previous year. So there's not an additional impact that we're seeing from that. Operator: Our next question comes from Gary Nachman with Canaccord Genuity. Gary Nachman: A few more on Cortrophin for me. So what portion of Cortrophin volume was from gouty arthritis flares in 2Q versus 1Q? If you could quantify that, it would be helpful. And maybe where do you see that going by the end of the year? And then just following up on the last usage question, within gouty flares, is the revenue per patient a bit lower? So assuming you need a lot more of those patients on a relative basis, I'm curious if that's a dynamic to consider with the revenue as the mix is going to shift going forward. And then any anticipated pressure in gross to net at all that might be impacting the revenue based on the dynamics that you're seeing in the space, including with your competitor? And then I have one follow-up. Nikhil Lalwani: Got it. Thank you for your questions, Gary. I think your first question on what contribution of gout. So, I'll speak to existing specialties where you remember that even we've spoken about gout being about 18% of our sales as we were reporting in the past, right? So, that's what that gout was giving from existing specialty rheumatology and nephrology and from the pilot territories. That's the last sort of number that we've shared. In Q2, from the gout expansion, where we've had this expanded sales force that goes into primary care and podiatry, we had limited impact in the second quarter in revenues, and this was as expected. We obviously will expect to see a ramp in Q3 and then a much bigger ramp in Q4 on sales from that. So gout as a percentage of sales across existing specialty and from the gout expansion will increase from that 18%. But as I've said, there's 750,000 patients in the other specialties, right, which we believe is the underpenetrated and that are significantly underpenetrated, right? So this is ex-gout, so 1 million patients including gout, but 750,000 patients ex-gout, and there is a significant growth opportunity there. So that will keep growing, right, and we'll keep investing to capture that growth in the non-gout areas too. So at this point, we're not projecting, what's the gout mix of the business going to be going forward. Your second question was on the gout number of vials per patient. Yes, the gout number of vials per patient is lower, or number of PFS per patient is, or mLs per patient is lower, but then there's a lot more gout patients. And even when you think of the prescribers that we go to, the number of patients that each prescriber are seeing, our experience has been through the 10 territories where we did the pilots as well as in the expansion that we've, in the first few weeks of the expansion, that the number of patients that are suffering from acute gouty arthritis flares and who the prescribers believe are appropriate to consider for a new treatment option such as Cortrophin, is a larger number, right, just on a per office basis. So we'll see more patients and there'll be less usage per patient. So we think of it that way. And then the third question on the gross to net. There is no -- nothing to highlight here. We obviously try to strike a balance with, as you refer to our competitor, between sharing information that is competitively sensitive with information that is helpful to investors. So nothing new to share at this time. Gary Nachman: Okay, great. Just a follow-up on David's operating leverage question. So, just how aggressive are you at this point, looking to expand the Rare Disease business through M&A and what kind of assets are you looking for? So, I guess, how important is to further leverage the increased sales force, I guess, particularly in podiatry and primary care? Is that going to be a focus, or do you not want to mess with that because you need to focus on the Cortrophin growth? So just your latest thoughts on the importance of M&A at this point in Rare Disease. Nikhil Lalwani: Yes. So, disciplined capital allocation is a critical path of our success story and plans going forward. And executing M&A to expand the scope and scale of our Rare Disease business is a top priority from a capital allocation perspective and where do we plan to invest or where we've been evaluating opportunities very much 2 sets of opportunities. So commercial or near commercial assets that are synergistic either with our call points, right? So, when we have the benefit with Cortrophin having multiple call points. So synergistic with the call points from a sales force perspective, or leveraging the rest of our infrastructure, right, which is the market access, medical affairs, patient support, a lot of the, which is also a critical part in the rare disease space. So those are the 2 sets of sort of core capabilities that we want to add assets that are synergistic with that. Operator: Our next question comes from Thomas Smith with Leerink Partners. Thomas Smith: Also 2 on the Cortrophin gout launch, if I may, are there any differences you're seeing in payer mix between these podiatrists and primary care settings versus the base business specialties? And can you just elaborate a little bit on how you're engaging with these new specialties to help them navigate the reimbursement process? And then separately, you also -- you called out success and growth coming from these 10 initial pilot categories -- excuse me, territories. Just wondering if you could elaborate and maybe quantify how much of the demand in the quarter came from those territories, and how broadly do you expect the experience within those pilot centers to play out now that you have the sales force expansion fully in place? Nikhil Lalwani: Yes, great. Thank you for your question. I think that, to your question on supporting the podiatrists or engaging with the podiatrists and PCP offices, we've taken, we're in year 5 of Cortrophin, and we've engaged with new prescribers along the way, right? Over half of our prescribers are new, or were naive to ACTH, and then we obviously have the learnings from the pilots that we did in the middle of last year for the podiatry and PCP. So we've taken all those learnings as we have engaged with the podiatrist and PCP offices, and we have found that on both fronts, both in terms of the engagement and the discussions with the podiatrist and PCPs, as well as in the support that's needed for them, our experiences in the gout expansion to date has been pretty consistent. And then to your -- and so we're continuing to build on that, right? So very positive and very consistent. I think the second question on contribution from the pilot territories, I mean, remember there were 10 territories roughly, and then as we've gone into the expansion, we've had about 64 reps, right? And 95% of them are seeing, have initiated 2 or more cases. So the impact is beyond the -- the demand generation is beyond the 10 pilot territories, the momentum is across the entire team. Operator: Our next question comes from Brandon Folkes with H.C. Wainwright. Brandon Folkes: Staying on the Cortrophin guidance, can you just elaborate on the growth of Cortrophin outside of gout, especially those specialties which use a higher number of vials per script, is Cortrophin use declining in any of those specialties? Secondly, you reiterated Cortrophin guidance in May, but flagged in the first half of the year as the driver of the change in guidance. So can you just elaborate if those drivers of the guidance change arose in May and June of this year? And if so, are they resolved? If it is just timing on the sales force expansion, why don't we see that bump in 3Q? And then just lastly, outside of the gout sales force expansion, what are the other drivers of the 4Q's Cortrophin revenue inflection? Nikhil Lalwani: Thank you for your questions. So the first question is on the existing specialties. Look, we see strong multi-year growth potential across the existing specialties. And as I mentioned, there's 750,000 addressable patient population outside of the gout specialty, right? So across the key existing specialties, there are 750,000 patients, and we're just -- they're significantly underpenetrated. And there continues to be robust momentum across these existing specialties. The Q2 to Q1 growth of 56% quarter-on-quarter and the 43% year-over-year growth was essentially achieved by the existing specialties and then the -- are you're seeing, you asked, is there a slowdown? We are not seeing a slowdown across specialties. In fact, I think one of the things we highlighted is there's a doubling of the ophthalmology volumes year-over-year to give you an example. Obviously we're trying to find a balance between sharing information that is helpful with information that is competitively sensitive. So we gave that as an example. And -- but as far as 3Q goes, the momentum is strong, right. We gave multiple metrics for July. And especially for existing specialties, we said that there's the highest number of new patient cases initiated in July, right. And obviously, new patient cases initiated translates to new patient starts, translates to volumes dispensed. Yes, so thank you for your questions, Brandon. Operator: Thank you. I'm showing no further questions at this time. This concludes today's conference call. Thank you for participating. You may now disconnect. 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This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. ANI Pharmaceuticals (ANIP) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

ANI Pharmaceuticals ANIP reported second-quarter 2026 adjusted EPS of $2.21, beating the Zacks Consensus Estimate of $2.01. The reported figure rose 23% year over year, driven by higher sales during the quarter. Quarterly revenues totaled $266 million, up 26% from the year-ago period. The metric also beat the Zacks Consensus Estimate of $262.7 million. The quarter reflected solid execution across the portfolio, led by continued momentum for Purified Cortrophin Gel and contributions from a newly monetized intellectual property licensing arrangement. Rare Disease revenues totaled $135.8 million, up 31% year over year but below the Zacks Consensus Estimate of $141 million. Cortrophin Gel revenues of $117.1 million missed the Zacks Consensus Estimate of $120.4 million. Still, the metric rose 43.5%, primarily driven by existing specialties, including nephrology, neurology, ophthalmology, pulmonology and rheumatology. ANIP shares fell more than 5% on Friday following the results announcement, likely reflecting investor concerns over lower-than-expected Cortrophin sales despite the broader earnings and revenue beat. These concerns were further amplified after management lowered its full-year outlook for the drug. Year to date, the stock has lost 1% against the industry’s 5% growth. Image Source: Zacks Investment Research Iluvien revenues declined 16% year over year to $18.7 million, missing the Zacks Consensus Estimate of $20.7 million, mainly due to the timing of international shipments. The company also reported $17.7 million in brand royalties and other revenues during the second quarter, comprising $9.7 million in royalties on sales of pitolisant-based products and $8 million tied to work completed toward certain development milestones under its Harmony Biosciences HRMY licensing agreement. By contrast, Brands' revenues declined 10.5% year over year to $11.8 million as demand normalized for certain products. In January, the company’s Novitium subsidiary entered into an agreement with Harmony Biosciences, under which ANIP out-licensed intellectual property related to pitolisant, marketed by HRMY under the brand name Wakix. The agreement generated a $15 million upfront license fee and includes low single-digit royalties on sales of pitolisant-based products. It provides for an additional $10 million in development milestones that management expects to be achieved in the second and third quarters of 2026. Generic pharmaceutical product revenues increased 10% year over year to $99.1 million, exceeding the Zacks Consensus Estimate of $96.9 million. Growth reflected new product launches, continued strength from a partnered generic introduced in the third quarter of 2025 and commercial and operational outperformance. ANIP has launched 12 generic products so far in 2026 and expects to launch at least 15 during the full year. The company also maintained its position as the second-ranked player in overall Competitive Generic Therapy (CGT) filings. Adjusted gross margin contracted to 62.6% from 64.9% in the year-ago quarter. The decline primarily reflected higher sales of royalty-bearing products, including Cortrophin Gel and a partnered generic, along with the non-recurrence of prior-year Prucalopride revenues. Adjusted selling, general and administrative expenses increased 20% to $80.7 million, reflecting spending on the Cortrophin gout expansion and broader investments supporting business growth. Adjusted research and development expenses declined 11% to $14.1 million. The company reaffirmed its 2026 total revenue guidance of $1.08-$1.14 billion and adjusted EBITDA outlook of $285-$300 million. Adjusted earnings are still projected between $9.19 and $9.69 per share. However, ANIP lowered its full-year 2026 Cortrophin Gel revenue outlook to $520-$540 million from the previous guidance of $540-$575 million. Management said the revision principally accounts for first-half results, while expectations for the second half remain largely intact. The new range still represents 50-55% growth from 2025. Despite the lowered guidance, management remained optimistic about Cortrophin sales for the remainder of the year. It expects third-quarter revenues of $143-$153 million, followed by further sequential growth in the fourth quarter as the gout sales force contributes more meaningfully. The company maintained the outlook for Iluvien revenues in the range of $78-$83 million. ANIP's gout-focused Cortrophin commercial expansion was fully operational by the end of June. More than 95% of the new sales representatives generated multiple patient cases, while more than a third of prescribers initiated at least two cases. Demand was balanced between primary care physicians and podiatrists. Management said momentum in existing specialties continued into the third quarter, with July recording the highest number of new patient cases initiated. Ophthalmology volumes also doubled year over year during the second quarter. The stock currently has a Zacks Rank #4 (Sell). ANI Pharmaceuticals, Inc. price | ANI Pharmaceuticals, Inc. Quote A better-ranked stock in the biotech sector is Liquidia Corporation LQDA, currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen from $4.81 to $5.31. LQDA shares have skyrocketed 162% so far this year. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Make better investment decisions with Simply Wall St's easy, visual tools that give you a competitive edge. ANI Pharmaceuticals (ANIP) reported better than expected Q2 2026 results and reaffirmed full year revenue guidance, while trimming its Cortrophin Gel outlook, a mix that appears to have driven recent stock volatility. See our latest analysis for ANI Pharmaceuticals. Despite the strong Q2 update, ANI Pharmaceuticals' share price fell 5.3% over the past day and is down 7.7% over the past month. However, the 5 year total shareholder return of 160.4% and 3 year total shareholder return of 24.9% show that longer term investors have still seen substantial gains, suggesting recent volatility is more about recalibrating expectations around Cortrophin Gel than a wholesale shift in the broader story. If earnings resets and guidance changes have you reassessing your watchlist, this can be a useful moment to look at other healthcare names using the 43 healthcare AI stocks The recent drop in ANI Pharmaceuticals shares sits against record Q2 results and reaffirmed full year revenue guidance. Is this move saying more about the Cortrophin Gel reset, or a shift in sentiment around the stock overall? At a last close of $78.25 versus an estimated fair value of $112.71, the most followed narrative on ANI Pharmaceuticals frames the recent share pullback against a much higher long term earnings power story. Read the complete narrative. Want to see what justifies that higher fair value for ANI Pharmaceuticals? The narrative focuses on expanding rare disease exposure, richer margins, and a future profit base that could look very different to today. Result: Fair Value of $112.71 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this ANI Pharmaceuticals narrative still hinges on Cortrophin Gel exposure and key generic exclusivities, where tighter payer controls or faster competition could quickly challenge those fair value assumptions. Find out about the key risks to this ANI Pharmaceuticals narrative. The most followed ANI Pharmaceuticals narrative leans on a discounted cash flow style fair value of $112.71, which implies the stock is undervalued at $78.25. Yet the current P/E of 19.8x sits above both peers at 12.8x and the US Pharmaceuticals industry at 15.1x, and above a 17x fair ratio estimate. That richer multiple suggests less room for error if earnings or Cortrophin Gel expectations are challenged. Which lens you give more weight to will likely shape how you see the recent share pullback. For a closer look at what the numbers imply for valuation risk, See what the numbers say about this price — find out in our valuation breakdown. If the mixed messages around ANI Pharmaceuticals leave you unsure, use this as a prompt to move quickly and review the underlying data yourself. To balance the 4 key rewards against the 3 important warning signs, check the 4 key rewards and 3 important warning signs If ANI Pharmaceuticals has sharpened your focus, do not stop here. Use this moment to widen your watchlist with stocks that match different risk and reward profiles. Target potential value opportunities before others notice by scanning companies highlighted in the screener containing 19 high quality undiscovered gems. Strengthen your core holdings by assessing companies flagged in the solid balance sheet and fundamentals stocks screener (49 results). Reduce portfolio swings by checking stocks featured in the 79 resilient stocks with low risk scores. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include ANIP. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

ANI Pharmaceuticals (ANIP) came out with quarterly earnings of $2.21 per share, beating the Zacks Consensus Estimate of $2.01 per share. This compares to earnings of $1.8 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +9.95%. A quarter ago, it was expected that this drugmaker would post earnings of $1.28 per share when it actually produced earnings of $2.05, delivering a surprise of +60.16%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. ANI, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $266.04 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 1.26%. This compares to year-ago revenues of $211.37 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. ANI shares have added about 4.7% since the beginning of the year versus the S&P 500's gain of 12.6%. While ANI has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for ANI was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.41 on $293.28 million in revenues for the coming quarter and $9.40 on $1.11 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 45% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Codexis (CDXS), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 11. This producer of custom industrial enzymes is expected to post quarterly loss of $0.17 per share in its upcoming report, which represents a year-over-year change of -6.3%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Codexis' revenues are expected to be $12.73 million, down 17% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report Codexis, Inc. (CDXS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

ANI Pharmaceuticals Inc. (NASDAQ:ANIP) reported stronger-than-expected second-quarter results on Friday, but shares fell in pre-market trading after the company lowered its sales forecast for its flagship Cortrophin Gel treatment. The stock declined around 7.6% as investors focused on the weaker product outlook despite better-than-expected earnings and revenue. ANI reported adjusted earnings of $2.21 per share for the second quarter, comfortably ahead of analysts’ consensus estimate of $2.03. Revenue rose 25.9% year over year to $266.0 million from $211.4 million, also surpassing Wall Street’s expectation of $262.14 million. The strong quarterly performance was supported by continued growth across the company’s branded and generic pharmaceutical portfolio. Despite robust quarterly growth, management lowered its full-year revenue outlook for Cortrophin Gel, its largest product. The company now expects Cortrophin Gel sales of between $520 million and $540 million in 2026, compared with its previous forecast of $540 million to $575 million. Second-quarter Cortrophin Gel revenue increased 43.5% year over year to $117.1 million. President and Chief Executive Officer Nikhil Lalwani said, “In the second quarter, we delivered outstanding financial results, while we implemented the largest Rare Disease sales force expansion in our history.” He added, “Leading indicators from our gout expansion for Cortrophin Gel are very positive, with the team rapidly delivering a large funnel of new patient cases, with significant breadth and depth of prescribing.” ANI reaffirmed its overall 2026 revenue guidance of between $1.08 billion and $1.14 billion, although the midpoint of $1.11 billion sits slightly below analysts’ expectations of $1.12 billion. The company also maintained its adjusted EBITDA forecast of $285 million to $300 million. Adjusted earnings per share guidance remained unchanged at $9.19 to $9.69, with the midpoint of $9.44 marginally above the market consensus. Generics revenue increased 9.7% to $99.1 million during the quarter. Revenue from ILUVIEN declined 16.1% to $18.7 million, reflecting the timing of international product shipments. ANI also recognised $17.7 million in brand royalties and other revenue under its Harmony Agreement. Adjusted EBITDA rose 32.4% year over year to $71.6 million. The company generated $115.0 million in operating cash flow during the first six months of 2026 and finished the quarter with cash and cash equivalents of $360.2 million. ANI Pharmaceuticals stock price

This article first appeared on GuruFocus. Release Date: August 07, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Record Q2 2026 revenues of $266 million, up 26% year-over-year, driven by strong performance in rare disease and generics. Record Cortrophin Gel revenues of $117.1 million, up 43% year-over-year and 56% sequentially, with continued momentum in existing specialties. Record adjusted EBITDA of $71.6 million, up 32% year-over-year, exceeding prior expectations. Successful execution of the largest rare disease sales force expansion, increasing headcount by 50% to ~180 reps, with strong early demand from the gout launch (95% of new reps generated multiple new cases). Generics business delivered $99.1 million in Q2, up 10% year-over-year, with 12 product launches in 2026 and a strong pipeline. Healthy balance sheet with $360.2 million in cash and net leverage of 1.0x, providing capacity for future M&A. Reaffirmed full-year 2026 guidance for total revenue ($1.08B-$1.14B) and adjusted EBITDA ($285M-$300M), reflecting 26% and 27% growth, respectively. Cortrophin Gel guidance revised to $520M-$540M, still representing 50-55% growth over 2025, with back-half expectations largely intact. Strong demand indicators for gout expansion: over 95% of new reps have multiple new cases, and over a third of prescribers have initiated 2+ cases. Positive early results from the Phase 4 synchronicity trial for Eluvian, with detailed data to be presented in Q4 2026. Cortrophin Gel full-year guidance was modestly revised downward to $520M-$540M, primarily due to first-half results, which were below initial expectations. Eluvian revenues declined 16% year-over-year in Q2 to $18.7 million, due to timing of international shipments. Non-GAAP gross margin decreased 230 basis points to 62.6% in Q2, driven by product mix. SG&A expenses increased 20% year-over-year to $80.7 million, driven by the gout expansion and higher support costs. Q3 2026 adjusted EBITDA is expected to be down sequentially due to the first fully loaded quarter of gout expansion expenses and lower Harmony milestone revenue. The company faced insurance re-verification issues in Q1 that impacted volumes, and while resolved, some patients were permanently lost. Gout expansion had limited revenue impact in Q2, with meaningful contribution only expected in Q3 and Q4, creating execution risk. The company did not provide specific metrics on gout flare treatments or revenue per patient, limiting visibility into the launch's early performance. IQVIA data shows a disconnect with reported revenues, raising concerns about script-to-revenue conversion. The company faces potential competitive pressures and gross-to-net dynamics, though no specific issues were disclosed. Warning! GuruFocus has detected 2 Warning Sign with TTWO. Is ANIP fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide more detail on the early uptake of Cortrophin Gel in the gout expansion, and what gives you confidence in the significant step-up in revenue from Q3 to Q4? Also, how penetrated are the current non-gout indications? A: Nikhil Alwani, President and CEO, stated that the leading indicators from the gout expansion are very positive. The sales force expansion from 120 to 180 reps was fully operational by the end of June. Over 95% of new reps have generated multiple new patient cases, and over a third of prescribers have initiated 2 or more cases, with balanced demand between primary care and podiatrists. The Q4 step-up is driven by the gout expansion reps having a full quarter of field time (3-5 months) versus just 3 months in Q3, plus continued momentum in existing specialties and typical Q4 channel/insurance tailwinds. Regarding penetration, he noted that the addressable market of almost 1 million patients is "very low" penetrated, with 750,000 patients outside of gout, indicating a huge multi-year growth runway. Q: The company trimmed full-year Cortrophin guidance despite hitting Q2 targets and saying the Q1 re-verification issue was behind it. What factors drove the revision, and is there a disconnect between IQVIA data and reported revenue? A: Nikhil Alwani, President and CEO, clarified that the revised guidance to $520-$540 million principally accounts for actual first-half performance, while expectations for the back half remain largely intact. He confirmed the insurance re-verification issue is behind the company with no impact on Q2. He attributed the guidance revision to a diverse range of inputs beyond just case counts, such as indication mix and patient pull-through. Regarding IQVIA data, he stated it has historically been volatile and has both overstated and understated quarterly revenues in the past, emphasizing that the company prefers to guide investors using its own internal metrics like new case initiations. Q: What specific factors did not play out to expectations that caused the ~$30 million guidance cut, and why should we expect a bigger Q4 step-up than last year, which was the slowest sequential quarter? A: Nikhil Alwani, President and CEO, reiterated that the revised guidance is simply a reflection of actual first-half results and does not imply a change in back-half expectations. He confirmed there are no additional headwinds like step edits. For the Q4 confidence, he highlighted that the 2026 sales force expansion is 3x the size of the 2025 expansion and was completed in Q2 versus Q1 last year. This means the new reps will have 3-5 months of field experience by Q4, leading to a much larger impact from the gout expansion compared to the prior year's trajectory. Q: Can you clarify if "new cases initiated" is the same as prescriptions written, and how long does it take for a script to be filled? Also, how should we think about operating leverage beyond this year? A: Nikhil Alwani, President and CEO, confirmed that "new cases initiated" is synonymous with prescriptions written or enrollment forms. The time from enrollment to fulfillment varies from a couple of days to two weeks, depending on payer type and physician office factors. He noted the company is in year 5 of the launch and has consistently improved this process, with no new lags or headwinds. Regarding operating leverage, he stated that the 50% sales force expansion investment will have a full-year impact and drive significant operating leverage in 2027, expecting higher sales and improved margins from the investment made in 2026. Q: Regarding the Q1 patient re-verification issue, what percentage of lost volume was recovered in Q2 versus permanently lost, and should we expect a similar issue in 2027? Also, are there any shifts in vials per patient? A: Nikhil Alwani, President and CEO, explained that the re-verification issue involved a large bolus of patients needing re-verification at the start of 2026, which took longer due to volume and weather. While some patients were lost, this is consistent with normal patient pull-through seen in previous years, and there is no additional impact. He does not expect a similar issue to be a major factor going forward. On vials per patient, he stated there has been no significant shift in usage per patient by indication, with usage varying based on prescriber judgment and indication type. Q: What portion of Cortrophin volume came from gouty arthritis flares in Q2 versus Q1, and is the revenue per patient lower for gout, impacting the mix? Also, any pressure on gross-to-nets? A: Nikhil Alwani, President and CEO, noted that gout was approximately 18% of sales from existing specialties and pilot territories. The expanded gout sales force had limited revenue impact in Q2 as expected, with a ramp expected in Q3 and a much bigger ramp in Q4. He confirmed that the number of vials (or mLs) per patient is lower for gout, but the volume of patients is significantly higher, creating a larger overall opportunity. On gross-to-nets, he stated there was nothing new to highlight, balancing competitive sensitivity with investor information. Q: Are there differences in payer mix between podiatrists/primary care and the base business specialties, and how are you supporting these new prescribers with reimbursement? Also, can you quantify the demand from the 10 pilot territories? A: Chris Motz, SVP and Head of Rare Disease, explained that the company has leveraged 5 years of experience engaging with new prescribers, including learnings from the 10 pilot territories, to support podiatrists and PCPs. The engagement and support needed have been consistent with expectations. Regarding the pilot territories, he clarified that the momentum is not limited to those 10 territories; with 64 new reps, over 95% have initiated 2 or more cases, indicating the demand generation is broad across the entire expanded team, not just the original pilots. Q: Can you elaborate on the growth of Cortrophin outside of gout, and are there any specialties where use is declining? Also, what are the other drivers of the Q4 revenue inflection besides the gout sales force? A: Nikhil Alwani, President and CEO, stated there is strong multi-year growth potential across existing specialties, with 750,000 addressable patients outside of gout that remain significantly underpenetrated. He confirmed there is no slowdown across specialties, citing ophthalmology volumes doubling year-over-year as an example. The Q2 to Q For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved record quarterly revenue and adjusted EBITDA, driven by a 43% year-over-year increase in Cortrophin Gel sales and persistent execution in the Generics segment. Completed the single largest rare disease sales force expansion in company history, increasing headcount by 50% to approximately 180 representatives to target the acute gouty arthritis market. Attributed strong Cortrophin growth to existing specialties like ophthalmology, where volumes doubled year-over-year, and rheumatology, despite early-year insurance reverification headwinds. Maintained a dominant position in the Generics market as the #2 player in Competitive Generic Therapy (CGT) filings, utilizing cash flow to fund rare disease R&D and commercial infrastructure. Emphasized the strategic advantage of U.S.-based manufacturing, with 95% of revenues derived from domestic finished goods, providing insulation from evolving global tariff landscapes. Reported that the ACTH market remains significantly underpenetrated, with an estimated 1 million addressable patients across all indications compared to current treatment volumes. Revised Cortrophin Gel annual guidance to $520 million to $540 million to reflect first-half results while maintaining expectations for a robust second-half ramp. Anticipates significant sequential revenue and EBITDA growth in Q4 2026 as the gout-focused sales force reaches full operational maturity and seasonal insurance tailwinds take effect. Projects Rare Disease revenues will approach 60% of total company turnover by year-end 2026, marking a critical milestone in the corporate transformation. Expects the gout expansion to drive meaningful operational leverage in 2027 as the initial investment in sales headcount translates into sustained prescribing depth. Assumes no meaningful contribution from third-party patient assistance foundations in the reaffirmed ILUVIEN revenue guidance of $78 million to $83 million. Recognized $17.7 million in revenue from the Harmony intellectual property out-licensing deal, including $9.7 million in royalties and $8 million in development milestones. Confirmed that Q1 2026 insurance reverification issues are fully resolved, with no material impact on Q2 performance or the forward-looking trajectory. Flagged a 230 basis point decrease in non-GAAP gross margin to 62.6%, primarily driven by shifts in product mix toward lower-margin generic launches. Highlighted the Phase IV SYNCHRONICITY trial for ILUVIEN as a key clinical catalyst, with detailed results expected at a medical conference in Q4 2026. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management reported that 95% of new sales representatives have already generated multiple new patient cases since becoming operational in late June. Over one-third of prescribers in the gout segment have initiated two or more patient cases, indicating strong repeat prescribing behavior in primary care and podiatry. The company noted that July represented the highest month for new cases initiated in existing specialties, signaling continued momentum into Q3. The $30 million revision to Cortrophin guidance primarily accounts for actual H1 performance rather than a change in H2 outlook or market headwinds. Confidence in the Q4 revenue inflection is based on the sales force expansion being 3x larger than the 2025 expansion and having more time to mature in the field. Management clarified that the Q4 step-up is also supported by typical year-end channel dynamics and insurance cycle tailwinds. ANI is actively evaluating commercial or near-commercial assets that are synergistic with current call points in podiatry, primary care, and existing rare disease specialties. The company intends to leverage its established market access, medical affairs, and patient support infrastructure to integrate future inorganic acquisitions. Management emphasized a disciplined approach, focusing on assets that can benefit from the recently expanded 180-person commercial footprint.

For the quarter ended June 2026, ANI Pharmaceuticals (ANIP) reported revenue of $266.04 million, up 25.9% over the same period last year. EPS came in at $2.21, compared to $1.80 in the year-ago quarter. The reported revenue compares to the Zacks Consensus Estimate of $262.73 million, representing a surprise of +1.26%. The company delivered an EPS surprise of +9.95%, with the consensus EPS estimate being $2.01. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance. Here is how ANI performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Net Revenues- Generic pharmaceutical products: $99.05 million compared to the $96.93 million average estimate based on three analysts. The reported number represents a change of +9.7% year over year. Total Net Revenues- Rare Disease: $135.84 million versus $141.01 million estimated by three analysts on average. Compared to the year-ago quarter, this number represents a +30.7% change. Net Revenues- Rare Disease and Brands- ILUVIEN and YUTIQ: $18.72 million versus the three-analyst average estimate of $20.69 million. The reported number represents a year-over-year change of -16.1%. Net Revenues- Rare Disease and Brands- Cortrophin Gel: $117.13 million versus the three-analyst average estimate of $120.35 million. The reported number represents a year-over-year change of +43.5%. View all Key Company Metrics for ANI here>>> Shares of ANI have returned -1.4% over the past month versus the Zacks S&P 500 composite's +2.3% change. The stock currently has a Zacks Rank #4 (Sell), indicating that it could underperform the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Interested in ANI Pharmaceuticals, Inc.? Here are five stocks we like better. Record Q2 performance: Revenue rose 26% year over year to $266 million, adjusted EBITDA increased 32% to $71.6 million, and adjusted EPS reached $2.21, driven by Cortrophin Gel and generics growth. Cortrophin momentum continues: Cortrophin revenue climbed 43% to $117.1 million, while ANI completed a 50% expansion of its rare-disease sales force focused partly on gout. The company lowered 2026 Cortrophin guidance to $520 million–$540 million based on first-half results but expects the gout initiative to contribute more meaningfully in the second half. Full-year outlook reaffirmed: ANI maintained total revenue guidance of $1.08 billion–$1.14 billion and adjusted EBITDA guidance of $285 million–$300 million. Cash reached $360.2 million, supported by $115 million in first-half operating cash flow, while ILUVIEN revenue declined 16% in Q2 and generics revenue rose 10%. ANI Pharmaceuticals (NASDAQ:ANIP) reported record second-quarter revenue and adjusted EBITDA as growth in its Cortrophin Gel rare-disease franchise and generics business lifted results, while the company modestly reduced its full-year Cortrophin revenue outlook to reflect first-half performance. Total net revenue rose 26% year over year to $266 million in the second quarter of 2026. Adjusted EBITDA increased 32% to a record $71.6 million, while adjusted diluted earnings per share were $2.21, compared with $1.80 in the prior-year quarter. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth President and CEO Nikhil Lalwani said the company’s performance came as ANI executed its largest rare-disease sales force expansion, increasing its commercial team by 50% to about 180 representatives. The expansion includes a gout-focused organization targeting podiatrists and primary-care providers. Cortrophin Gel generated $117.1 million in second-quarter revenue, up 43% from a year earlier and 56% from the first quarter. Lalwani said growth during the quarter was primarily driven by the company’s existing specialties, including rheumatology, nephrology, neurology, ophthalmology and pulmonology. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Chris Mutz, senior vice president and head of ANI’s rare disease business, said July produced the highest monthly number of new cases initiated in the company’s existing specialty business. He also said Cortrophin volumes in ophthalmology doubled year over year during the second quarter. The company completed the rollout of its gout-focused sales organization by the end of June. ANI said more than 95% of the new representatives had generated multiple new cases, while more than one-third of prescribers had initiated two or more patient cases. The company said it has seen initial and repeat prescribing from both primary-care and podiatry offices. → Sandisk Just Delivered a Blowout Quarter—Here's Why the Stock Is Falling During the question-and-answer session, Lalwani said the gout expansion had a limited contribution to reported second-quarter revenue because of the timing of its deployment. ANI expects measurable revenue from the initiative in the third quarter and a larger contribution in the fourth quarter, when the representatives will have been in the field longer. ANI reduced its 2026 Cortrophin Gel revenue guidance to $520 million to $540 million, saying the revision primarily reflected actual first-half results. Management said its expectations for the second half remain largely intact and that the new range still represents 50% to 55% growth over 2025. For the third quarter, ANI expects Cortrophin revenue of $143 million to $153 million, followed by further sequential growth in the fourth quarter. Lalwani cited ongoing momentum in existing specialties, the expected ramp from the gout sales force and seasonal channel and insurance dynamics as factors supporting the fourth-quarter outlook. Management said it sees nearly 1 million addressable patients across Cortrophin indications and described ACTH therapies as underpenetrated. Lalwani said penetration remains “very, very low” across the addressable market. ILUVIEN net revenue was $18.7 million, down 16% from the prior-year period, which Chief Financial Officer Stephen Carey attributed primarily to the timing of international shipments. ANI maintained its full-year ILUVIEN revenue guidance of $78 million to $83 million and expects stronger revenue in the second half than in the first half. The company said it reported top-line results from the Phase IV open-label SYNCHRONICITY trial in non-infectious uveitis of the posterior segment, or NIU-PS. ANI plans to present detailed results and additional analyses at a medical conference in the fourth quarter. Mutz said the findings are expected to support engagement with retina specialists treating NIU-PS. Generics revenue increased 10% year over year to $99.1 million. The company said the increase reflected a partner generic launch that began in the third quarter of 2025, new product launches, and commercial and operational performance. ANI has launched 12 generics so far in 2026 and remains on track to launch at least 15 for the full year, according to Lalwani. ANI also recognized $17.7 million in second-quarter revenue associated with its licensing transaction with Harmony Biosciences. That figure included $9.7 million in royalty income on WAKIX sales and $8 million tied to development-milestone work completed during the quarter. Carey said ANI expects to recognize the remaining $2 million related to that development milestone in the third quarter. Non-GAAP gross margin was 62.6%, down about 230 basis points year over year due to product mix. Non-GAAP research and development expense declined 11% to $14.1 million, primarily because of the timing of generic R&D spending. Non-GAAP selling, general and administrative expense increased 20% to $80.7 million, reflecting the gout expansion and increased activity supporting the business. ANI ended the quarter with $360.2 million of unrestricted cash, up $74.6 million from Dec. 31, 2025. Operating cash flow totaled $56.7 million in the quarter and $115 million for the first six months of the year. The company had $620.9 million in outstanding principal debt as of June 30, with gross leverage of 2.4 times and net leverage of one times trailing-12-month adjusted EBITDA. Total 2026 net revenue guidance was reaffirmed at $1.08 billion to $1.14 billion. Adjusted EBITDA guidance was maintained at $285 million to $300 million. Adjusted diluted EPS guidance was maintained at $9.19 to $9.69. Adjusted gross-margin guidance remained 59.9% to 60.9%. Carey said ANI expects third-quarter company revenue to be modestly higher than the second quarter, with sequential growth accelerating in the fourth quarter. Third-quarter adjusted EBITDA is expected to decline sequentially due in part to lower Harmony milestone revenue and the first fully loaded quarter of expenses from the gout expansion. The company expects fourth-quarter EBITDA to be its highest of the year as Cortrophin revenue grows. Lalwani said ANI continues to evaluate business-development opportunities to expand the scope and scale of its rare-disease business, focusing on commercial or near-commercial assets that could be supported by its sales force, market-access capabilities, medical affairs organization and patient-support infrastructure. ANI Pharmaceuticals, Inc is a United States–based specialty pharmaceutical company focused on the development, manufacturing and commercialization of generic and branded prescription drugs. The company operates as an end-to-end provider, offering services that range from active pharmaceutical ingredient (API) production and formulation development to finished dosage form manufacturing and packaging. ANI's product portfolio encompasses injectable and oral therapies across several therapeutic areas, including endocrinology, oncology, pain management and respiratory care. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "ANI Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Ovid Therapeutics (OVID) is expected to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.10 per share in its upcoming report, which represents a year-over-year change of -66.7%. Revenues are expected to be $0.15 million, down 97.6% from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Ovid Therapeutics, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -6.94%. On the other hand, the stock currently carries a Zacks Rank of #2. So, this combination makes it difficult to conclusively predict that Ovid Therapeutics will beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Ovid Therapeutics would post a loss of$0.12 per share when it actually produced a loss of -$0.12, delivering no surprise. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Ovid Therapeutics doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Another stock from the Zacks Medical - Biomedical and Genetics industry, ANI Pharmaceuticals (ANIP), is soon expected to post earnings of $2.01 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of +11.7%. Revenues for the quarter are expected to be $262.73 million, up 24.3% from the year-ago quarter. The consensus EPS estimate for ANI has been revised 0.3% lower over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +1.33%. When combined with a Zacks Rank of #4 (Sell), this Earnings ESP makes it difficult to conclusively predict that ANI will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Ovid Therapeutics (OVID) : Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research