Collegium Pharmaceutical, Inc. (COLL)
NASDAQ: COLL · Real-Time Price · USD
22.38
+0.19 (0.86%)
Sep 17, 2026, 4:00 PM EDT - Market closed
← View all transcripts

H.C. Wainwright 28th Annual Global Investment Conference

Sep 16, 2026

Summary

A diversified biopharma company projects $840 million in 2026 revenue, driven by strong ADHD portfolio growth and stable pain management revenues. Recent acquisitions, disciplined capital allocation, and robust cash flow support ongoing expansion and shareholder returns.

Brandon Folkes
Equity Research Analyst, H.C. Wainwright

Good morning, everyone. Thank you very much for joining us at the H.C. Wainwright Global Investment Conference. My name is Brandon Folkes, and I am one of the Equity Research Analysts here at H.C. Wainwright. Next up, we have a presentation from Collegium Pharmaceutical, and joining us from Collegium is CEO Vikram Karnani. Vikram, thanks very much for joining us.

Vikram Karnani
CEO, Collegium Pharmaceutical

Thank you for having me. Good morning, everyone. Before I start with the presentation, I would like to remind everyone that during this presentation, I will be making forward-looking statements and discussing non-GAAP metrics. Please refer to the risk factors and non-GAAP reconciliations discussed in our latest SEC filings. Thank you for the opportunity to introduce you to Collegium. I started at Collegium just under two years ago in late 2024, with the goal to lead the organization in its next phase of growth following our acquisition JORNAY PM for ADHD, our first medicine diversifying from the pain market. Collegium is on a mission to building a leading diversified biopharmaceutical company. We are committed to patients with complex CNS conditions as well as in pain management. Our current focus is chronic pain management and ADHD with six differentiated marketed products.

We have significant revenue and cash generation and a very strong growth profile. We expect to do approximately $840 million in revenues this year, representing 8% growth compared to 2025. Our near-term growth is expected to be driven by our franchise of ADHD JORNAY PM and AZSTARYS. Our business continues to be highly profitable, with adjusted EBITDA expected to be nearly $460 million this year. Collegium has a very proud history of serving patient needs. The company was founded in 2002, with the goal to help address the opioid epidemic. We became a leader in responsible pain management by developing Xtampza ER and then acquiring three additional differentiated chronic pain medicines. In 2024, the Ironshore acquisition was our first step as we diversified into ADHD and CNS conditions.

We subsequently continued to grow our pain and ADHD businesses while also evaluating potential new commercial products to add to our portfolio. In 2026, just a couple of months ago, we added a second differentiated ADHD medicine into our portfolio called AZSTARYS. Today, ADHD represents our core growth driver with two medicines serving different and distinct patient needs and with patent protection out to 2032 and 2037 respectively JORNAY PM and for AZSTARYS. As we look ahead to Collegium's vision for our next phase of growth, with a long history in responsible pain management, we believe that our pain portfolio serves as an important foundation for our business. While part of this franchise, specifically our NUCYNTA products, began to see some initial generic competition this year, we expect overall pain revenues to remain meaningful and durable well into the future.

We expect that this business will play a significant role in funding our expansion into new medicines and therapeutic areas. Our current growth engine, which is driven by our ADHD portfolio with two highly differentiated medicines, continues to perform well. We have broader aspirations for the future, and we plan to continue to grow and diversify our portfolio with future business development, and I'll get to that a little bit later. 2026 is expected to represent another year of revenue growth for the company, where we project approximately 8% year-over-year growth. Much of this will be driven JORNAY PM, which is expected to grow by more than 30% this year, as well as an initial contribution from a partial year of sales from AZSTARYS. Despite this revenue growth, we do expect adjusted EBITDA to remain generally flat this year.

This is primarily driven by increased investment to further grow our ADHD business, as well as some initial declines in our NUCYNTA revenues, which is experiencing for the first time, some competition from generic products. We have a clear set of strategic priorities we believe will create long-term value for our shareholders, which include driving further growth and accelerating that growth for our ADHD portfolio, continuing to maximize the durability of our pain business, and strategically deploying capital as we generate significant amount of cash from our base business. Our capital allocation priorities include business development, as we did earlier this year in acquiring AZSTARYS, debt repayment and strengthening the balance sheet, and opportunistically buying back shares. We also announced a new $50 million ASR in August.

Turning to our most recent quarterly results, we generated 41% year-over-year growth JORNAY PM revenues, nearly $141 million in total pain revenue, and total revenues were up 6%, and adjusted EBITDA was up 8% year-over-year. Importantly, we closed on the acquisition of AZSTARYS in Q2 and raised our expectations to $65 million-$75 million of revenue this year. As a reminder, that's a partial year of sales. Finally, in August, as part of our broader capital allocation strategy, we announced a new $50 million accelerated share repurchase program, reflecting our confidence in the strength of our ongoing business. Let's now take a deeper dive into our ADHD business. Taking a step back and looking at the market, the total market in the U.S. is large and growing, with about 111 million annual prescriptions increasing more than 8% a year.

Majority of these prescriptions, about 90%, are for stimulants, which include methylphenidates as well as amphetamines. JORNAY PM and AZSTARYS are in the methylphenidate category and have unique and differentiated profiles which drive usage. Despite the availability of multiple generic ADHD medicines, many patients are not fully satisfied with their options. In fact, on average, patients try three different ADHD medicines before they find the right treatment that works for them. Often influenced by level of efficacy, onset of action, duration of effect or side effect profile. We believe that there is a significant opportunity for JORNAY PM and AZSTARYS to grow share from generic stimulants both this year and into the JORNAY PM is a highly differentiated medicine. Specifically, it is a CNS stimulant, prescribed by both psychiatrists as well as pediatricians.

It is the only stimulant ADHD medicine with once-daily evening dosing that provides symptom control upon awakening, eliminating the need to dose in the morning and waiting for its onset of action. This is particularly important for those patients whose ADHD symptoms are especially challenging first thing in the JORNAY PM can provide smooth symptom control throughout the day, which may eliminate the need for short-acting stimulant add-ons later in the day as well. It is slowly absorbed in the colon, providing smooth onset and offset of effect. Based on recent market JORNAY PM is now the number one highest-rated branded ADHD medicine in terms of product differentiation. 70% of HCPs surveyed plan to increase prescribing. This was the highest among all other branded ADHD medicines. More than 70% of HCPs will honor a patient or caregiver request to try JORNAY PM.

Collegium was the highest-rated company in terms of reputation in ADHD. We have experienced significant growth in JORNAY since it was acquired by Collegium in 2024. Scripts grew significantly in the most recent quarter, up 13% year-over-year. We have a broad and a growing prescriber base. More than 30,000 prescribers in Q2, which was up almost 18% year-over-year. Our branded long-acting methylphenidate market share is up 6 percentage points to 29% overall. More importantly, the back-to-school season, which is now well underway, we are already beginning to see some positive signals JORNAY PM usage continues to tick up. For new-to-brand prescriptions, which is a very good leading indicator often in this category, we are very encouraged by more recent trends, as we were at the same time last year, and we observe that JORNAY is also growing share in new-to-brand RXs.

Moving over to AZSTARYS. We acquired AZSTARYS in May of this year. We're well-positioned for future growth as it is highly also complementary to JORNAY as part of our ADHD portfolio. It is the first and only ADHD treatment with both fast and long-acting medicines in one capsule. It's an ideal treatment option for patients in need of rapid onset of efficacy and duration throughout the day. Often with variable daily schedules, such patients may not always be an ideal candidate JORNAY PM, but they are an ideal candidate for AZSTARYS. It is viewed as highly differentiated and highly favorable among HCPs, and as I said earlier, we have IP protection through 2037. This brings significant cost synergies for Collegium. It is an immediately accretive transaction with greater impact in 2027 and beyond.

As I said earlier, we raised expectations recently to $65 million-$75 million in revenues in its first partial year of sales. Moving on to our 2026 priorities, for the ADHD portfolio, our priorities JORNAY PM are pretty straightforward. Increase awareness and adoption with an expanded set of prescribers. Raise caregiver and patient awareness to drive HCP requests, and increase depth of prescribing with targeted physicians. Moving over to AZSTARYS, successfully integrate into our portfolio, which we're well underway on that priority already. Accelerate the growth trajectory by leveraging established commercial infrastructure that is already in place, and evaluate opportunities to continue to drive operational efficiencies within this portfolio. Let's now switch gears for a moment and talk about our pain portfolio and the durability of that business. Our two core pain products include BELBUCA and Xtampza.

BELBUCA is the only long-acting opioid pain medicine that uses buprenorphine buccal film technology. It is the number one highest-rated branded ER opioid in terms of product differentiation and favorability. Xtampza is the only extended-release oxycodone pain medicine that uses best-in-class abuse-deterrent technology, also known as DETERx. It is the number one highest-rated ER oxycodone in terms of product differentiation and favorability among physicians. In total, our pain portfolio had revenues of $630 million last year, with about $420 million coming from BELBUCA and Xtampza combined. We expect sales from these two products combined to generally be flat this year, with lower RX volumes largely offset by improved profitability. As I mentioned previously, the NUCYNTA franchise is expected to begin to decline this year due to initial generic competition, which began earlier in 2026.

With that said, we still expect to generate meaningful revenues and cash flows from our pain portfolio both this year and in the coming years. This slide shows our patent expectations across the entire portfolio. The top portion is fairly straightforward, showing our ADHD medicines, which have patent protection out to March 2032 and December 2037 respectively JORNAY PM and AZSTARYS. To date, we have seen no generic ANDA filers for either product. Our pain portfolio is a bit more nuanced, which is where I will focus my time. Xtampza has projected exclusivity until 2033, which provides us with the longest exclusivity within this portfolio. For BELBUCA, there is a single generic company, Teva, that could potentially launch a generic version in January 2027 based on a settlement they made with BDSI back in 2018.

However, we believe they have also not received tentative approval and have relinquished their first filer status. It remains unclear whether Teva will even want to re-enter the generic opioid space, given their change in strategy to focus on innovative branded medicines and only the highest-selling generics. They have also stopped distributing other generic opioids and have opted not to launch additional generic opioids whose IP has expired, including our own NUCYNTA. Thus, we continue to believe that we will maintain exclusivity for BELBUCA until 2032, when key IP expires for the product. Finally, I have already mentioned our NUCYNTA franchise, which now has some competition from authorized generic products for both NUCYNTA and NUCYNTA ER, as well as from a separate third-party generic manufacturer for the immediate-release form. I would like to now highlight how we are strategically deploying our capital to create long-term shareholder value.

We have a long history of successfully acquiring products and companies to drive revenue and adjusted EBITDA growth. Since 2020, we have acquired five different products and have been able to grow our annual revenues from $446 million in 2022 to an expected $840 million this year. Importantly, we also continue to increase our profitability with these acquisitions. We have seen our adjusted EBITDA grow from $266 million in 2022 to roughly $460 million last year, and we expect a similar amount this year. We continue to take a very disciplined approach to business development, with a focus on both the quality and the strategic fit of the products we acquire, as well as the economics of each transaction. In terms of the target therapeutic areas we are looking for, we continue to prioritize psychiatry and pediatrics and other specialty conditions, including rare diseases, on a case-by-case basis.

In terms of key features we are looking for in potential new medicines, they are commercial or near commercial, have cost-effective sales and marketing requirements, and have LOEs into the 2030s and beyond. Finally, given the strong profitability of our business and our confidence in the opportunities ahead, we have a track record of opportunistically returning capital to shareholders through share repurchases. Since 2021, we have returned $272 million of value to shareholders through share repurchases, including a $50 million ASR we announced last month. Looking ahead, we will continue to evaluate share repurchases as part of our broader capital allocation strategy. In summary, Collegium is well positioned to positively impact the lives of patients with ADHD and pain conditions, and in return, we expect to create long-term value for our shareholders. Following the AZSTARYS acquisition, our ADHD portfolio is on an exciting trajectory.

Our business fundamentals remain strong, with significant cash flow and profitability, providing financial flexibility to invest in our growth drivers, strengthen our portfolio, and return capital to shareholders. We have an experienced and committed management team and board of directors that are helping guide our success. I remain confident in our journey to building a leading diversified biopharmaceutical company. We have a clear strategy, a differentiated portfolio, and the financial discipline to create long-term value. I look forward to updating you on our continued progress. Thank you for joining us today.