UNITED STATES
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FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On June 2, 2021, Collegium Pharmaceutical, Inc. delivered a corporate presentation at the Jefferies Healthcare Conference. A copy of the presentation is attached hereto as Exhibit 99.1 and is being furnished, not filed, under Item 7.01 of this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| 99.1 | Corporate presentation, dated June 2, 2021. |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: June 2, 2021 | Collegium Pharmaceutical, Inc. | |
| By: | /s/ Colleen Tupper | |
| Name: Colleen Tupper | ||
| Title: Executive Vice President and Chief Financial Officer | ||
Exhibit 99.1
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Collegium Pharmaceutical, Inc. Corporate Overview June 2021 |
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Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this presentation include, among others, statements regarding financial guidance for Xtampza ER and Nucynta Franchise revenues, Adjusted EBITDA, total operating expenses, current and future market opportunities for our products and our assumptions related thereto. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this presentation could also be affected by risks and uncertainties relating to a number of other factors, including the impact of the COVID-19 pandemic on our ability to conduct our business, reach our customers, and supply the market with our products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to obtain and maintain regulatory approval of our products and any product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product; the size of the markets for our products and product candidates, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products and product candidates; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement, opioid-related or other litigation that may be brought by or against us, including litigation with Purdue Pharma, L.P.; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency, or DEA, compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and other filings with the SEC. Any forward-looking statements that we make in this presentation speak only as of the date of this presentation. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this presentation. This company presentation is not for promotional purposes. |
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Our Mission: We are committed to being the leader in responsible pain management We are a mission-driven organization with an unwavering commitment to people living with pain and the communities we serve |
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Integrity is Core to our Mission The core of our mission, and the central tenet of our values, is leading with integrity. As an organization committed to being the leader in responsible pain management, we believe that integrity begins with the equitable, inclusive and dynamic environment we create within our organization, and manifests in all of our corporate activities, which we are committed to conducting at all times in compliance with both the letter and the spirit of the laws, regulations and policies that govern us. |
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Experienced Management Team & Board of Directors Joseph Ciaffoni President, CEO & Board Member Alison Fleming, Ph.D. EVP & Chief Technical Officer Inventor of DETERx® Colleen Tupper EVP & Chief Financial Officer Richard Malamut, M.D. EVP & Chief Medical Officer Scott Dreyer EVP & Chief Commercial Officer Shirley Kuhlmann EVP & General Counsel Bart Dunn EVP, Strategy & Corporate Development Joseph Ciaffoni President & CEO, Collegium Pharmaceutical Michael Heffernan Chairman of the Board & Collegium Founder Collegium Board of Directors Garen Bohlin Former COO, Sirtris, Former CEO, Syntonix John Fallon, M.D. Former SVP & CMO, Blue Cross Blue Shield of MA Gwen Melincoff Former Senior BD roles, BTG International, Shire, Adolor John Freund, M.D. Co-Founder & Partner, Skyline Ventures Gino Santini Former SVP, Corp. Strategy & BD, President, Eli Lilly Rita Balice-Gordon Chief Scientific Officer, Muna Therapeutics 5 |
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Strong Corporate Culture Commitment to our Core Values and DE&I D I E A Uphold Integrity Embrace Differences Encourage Expression Be Accountable External Recognition of our Culture Corporate Social Responsibility Efforts |
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Our Strategy Deliver on our missionICreate value for shareholders Maximize the value of our differentiated portfolio of pain products Achieve our near-term operational and financial goals Invest in our long-term growth |
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Focus on 2021 Objectives Drive revenue growth from Xtampza® ER Achieve stable profit contributions from Nucynta® franchise Leverage current cost structure, generate cash Deploy balance sheet in disciplined manner Seek opportunities to enhance portfolio long-term |
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Addressing a Need for Differentiated Pain Products ~50M Americans experience some form of chronic or severe disabling pain.1 Chronic pain leads to over $560 billion in healthcare and productivity costs each year.2 The FDA has encouraged development of prescription opioids with abuse- deterrent formulations.3 HCPs and regulators are advocating for appropriate opioid prescribing practices that may help mitigate the risk of addiction and other adverse events to patients. Sources: 1. Yong RJ, Mullins PM, Bhattacharyya N. The prevalence of chronic pain among adults in the United States. Pain. 2021; epub ahead of print. April 2021. Gaskin DJ, Richard P. The Economic Costs of Pain in the United States. In: Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Appendix C. Center for Drug Evaluation and Research (CDER). Guidance for industry: abuse-deterrent opioids —evaluation and labeling. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. https://www.fda.gov/files/drugs/published/Abuse-Deterrent-Opioids-Evaluation-and- 9Labeling.pdf Published April 2015. Accessed January 4, 2021. |
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Our Differentiated Pain Portfolio Viewed Favorably by HCPs & Strong Intent to Prescribe1 LABEL & ACCESS DIFFERENTIATIONPRODUCT DIFFERENTIATION Extended-release, oral oxycodone Indicated for pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate; not for PRN use2 Abuse-deterrent label2; proprietary formulation Broad formulary coverage, strong position Extended-release and immediate-release formulations of the opioid tapentadol with different indications ER formulation proven to treat chronic low back pain and neuropathic pain associated with DPN in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate; not for PRN use3 IR formulation is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults4 Boxed Warning: Xtampza® ER, Nucynta® and Nucynta® ER exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death. Serious, life-threatening, or fatal respiratory depression may occur. Accidental ingestion, especially by children, can result in fatal overdose. The Prescribing Information includes information on other Boxed Warnings and serious side effects. Abuse of Xtampza® ER by injection and by the oral and nasal routes of administration is still possible. Note: Xtampza® ER, DETERx®, and Nucynta® are registered trademarks of Collegium Pharmaceutical, Inc. 10 Nucynta® ER [package insert]. Stoughton, MA: Collegium Pharmaceutical Inc.; 2021. 4. Nucynta® [package insert]. Stoughton, MA: Collegium Pharmaceutical Inc.; 2021 |
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Xtampza® ER: Our Core Growth Engine EFFICACY Powerful Pain Relief of ER Oxycodone 12-Hour Dosing DIFFERENTIATED LABEL VS. OXYCONTIN® Comparative PK Data Versus OxyContin®1 Maintains PK Profile Designed to maintain its PK profile even when manipulated1 Abuse-Deterrent Labeling Only ER oxycodone with labelling for abuse- deterrence via all 3 routes: oral, intranasal, and intravenous1,2,3 DETERx® Technology Only opioid w/ unique DETERx® abuse-deterrent technology engineered to resist: crushing, grinding, cutting, chewing and injecting1 Boxed Warning: Xtampza® ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Serious, life-threatening, or fatal respiratory depression may occur. Accidental ingestion, especially by children, can result in fatal overdose. The prescribing Information includes information on other Boxed Warnings and serious side effects.1 Abuse of Xtampza® ER by injection and by the oral and nasal routes of administration is still possible. Additional data, including epidemiological data, may provide further information on the impact of the current formulation of Xtampza® ER on the abuse liability of the drug. Sources: 1. Xtampza® ER [package insert]. Stoughton, MA: Collegium Pharmaceutical Inc.; 2021. 2. OxyContin [package insert]. Stamford, CT: Purdue Pharma LP; 2021. 113. Oxycodone Hydrochloride tablet, film coated, extended release [package insert]. Parsippany, NJ: Teva Pharmaceuticals, USA, Inc.; 2021. OxyContin is a registered trademark of Purdue Pharma LP |
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Xtampza® ER: Immediate Acceleration in 2021 Xtampza® ER has Achieved Q1’21 Growth of 11% Q/Q Growth3%10%3%1%2%11% YTD Share Growth of +5.5 Points Outpaces Early 2020 Share Growth1 175 TRx (000’s) 125 100 75 124137142143145 161 35% OER Share 25% 20% 15% 19.0% 22.6% 25.1% 30.6% Dec-19 Jan-20 Feb-20 Mar-20 Apr-20 May-20 Jun-20 Jul-20 Aug-20 Sep-20 Oct-20 Nov-20 Dec-20 Jan-21 Feb-21 Mar-21 32.3% 21.8% 27.1% 23.5% 25.6% 23.7% 27.8% 24.6% 43.4% 29.3% Xtampza® ER Unique Prescribers Were up 22% in Q1’211,3 50% Exit Share 24.4% 18.5% 30% 20% 10% 0% Q4'19Q1'20Q2'20Q3'20Q4'20Q1'21 NBRx ShareTRx Share 9.39.410.09.79.89.0 HCP Counts (000’s) 22 12 188 1618.06 1414.514.214.714.84 1213.32 100 Q4'19Q1'20Q2'20Q3'20Q4'20Q1'21 Unique HCPsTRx/HCP 12 +Note: All historical data has been updated and is sourced with IQVIA Data Enhancements; Branded ER Market Data |
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2021 Xtampza® ER Growth Supported by Broad Market Access Coverage 2021 Xtampza® ER Coverage: Commercial Plans: 83% of lives covered1 Medicare Part D Plans: 57% of lives covered1 Xtampza® ER is covered through Exclusive & Parity Contracts for ~55% of lives in 20211 Sources: 1: MMIT Xtampza® ER data April 2021; policies applied 13 Note: Total commercial insured population approximately 171 million lives; Total Medicare part D insured population approximately 47.5 million lives |
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Xtampza® ER Positioned for Next Phase of Growth Goal for Xtampza® ER: Secure path for Xtampza® ER market leadership Expect to emerge as #1 branded product in 2023 Strong patent position supports long commercial runway: 19 OB listed patents going out to 2036 TEVA ANDA litigation settled for September 2033 No approved ANDA for Xtampza® ER to date |
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Managing Nucynta® Franchise for Stable Profit Contribution Goal for the Nucynta® Franchise: Contribute stable profits through remaining 5-year lifecycle Leverage our cost structure Five-year commercial runway: IP through mid-2025 Potential pediatric extension would extend exclusivity through end of 2025 |
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Strengthening Our Financial Position Key Highlights Net Revenue ($m)OPEX Excluding SBC1 ($m) $87.7 $76.5 $78.1$79.2 $76.3 $29.0 $27.5 Record Net Revenue of $87.7m in Q1’21 Reduced Operating Expenses, Excluding Stock-Based Comp, by $35.4 $31.5$33.6$32.1$30.8 $45.0$44.5$47.1$45.5$52.3 Q1Q2Q3Q4Q1 20202021 $26.2$23.4$23.1 Q1Q2Q3Q4Q1 20202021 5% in Q1’21 vs. Q1’20 Xtampza Nucynta Franchise Non- GAAP Adjusted EBITDA2 ($m)Cash Balance ($m) GAAP Net Income of $15.7m in Q1’21 Adjusted EBITDA of $45.3m in Q1’21 $20.5 $39.1 $41.8 $38.3 $45.3 Closed Nucynta® Acquisition Q1’20 $116.2 $145.7 $165.4 $174.1 $182.8 Q1Q2Q3Q4Q1 20202021 Q1Q2Q3Q4Q1 20202021 Notes : This financial data, provided by Collegium Pharmaceutical, Inc. in its Quarterly Report on Form 10-Q filed with the SEC on May 6, 2021. OPEX Excluding SBC is defined as Operating Expenses less Stock-Based Compensation Expense Non-GAAP Adjusted EBITDA excludes stock-based compensation, non-cash interest and non-cash amortization of the Nucynta® intangible asset. The company has not provided a 16 without unreasonable efforts, the timing and amount of items that would be included in such a reconciliation. These items are uncertain and depend on various factors that could have a material impact on GAAP net income (loss) for the guidance period. |
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2021: Focused on Growth & Value Creation Maximize the value of ourAchieve our near-term differentiated portfolio ofoperational and pain productsfinancial goals • Drive revenue growth from• Leverage our current cost structure Xtampza® ER‒ Revenue growth • Stable Nucynta® Franchise‒ Profitability profit contributions‒ Cash generation OUR STRATEGY Invest in our long-term growth 2021 FOCUS 17 Deploy balance sheet in a disciplined manner Actively seek opportunities to enhance portfolio long-term |
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Disciplined Approach to Business Development Favorable position with current in-line portfolio Long runway with Xtampza® ER: 19 OB listed patents through 2036 Stable Profit Contributions from the Nucynta® Franchise through 2025 Strong balance sheet creates flexibility $174m cash balance YE2020 $170-180m Non-GAAP Adjusted EBITDA 2021 guidance1,2 Actively pursuing Priority 1Priority 2 opportunities to enhance portfolio long-term Novel non-opioid pain assets Ph 2 assets with potential to generate revenue in 2025-2027 timeframe Peak sales potential of $150m+ Differentiated commercial-stage pain assets Leverage cost structure & accretive within 24 mos or less 1: This financial guidance, provided by Collegium Pharmaceutical, Inc. in its Current Report on Form 8-K filed with the SEC on January 6, 2021, and updated on the Q1 2021 Earnings Press Release issued May 6, 2021, is effective only as of this date. The company expressly disclaims any obligation to update or reaffirm guidance. The company only provides guidance in a Regulation FD compliant manner. 2: Non-GAAP Adjusted EBITDA excludes stock-based compensation, non-cash interest and non-cash amortization of the Nucynta® intangible asset. The company has not provided a reconciliation of its full-year 2021 guidance for non-GAAP adjusted income (loss) to the most directly comparable forward-looking 18 GAAP measure because it is unable to predict, without unreasonable efforts, the timing and amount of items that would be included in such a reconciliation. These items are uncertain and depend on various factors that could have a material impact on GAAP net income (loss) for the guidance period. |
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2021 Financial Guidance1 Xtampza® ER Revenue $155.0 - $165.0 Million Nucynta® Franchise Revenue $185.0 - $195.0 Million Total Operating Expenses $125.0 - $135.0 Million Non-GAAP Adjusted EBITDA2 $170.0 - $180.0 Million Notes 1: This financial guidance, provided by Collegium Pharmaceutical, Inc. in its Current Report on Form 8-K filed with the SEC on January 6, 2021, and updated on the Q1 2021 Earnings Press Release issued May 6, 2021, is effective only as of this date. The company expressly disclaims any obligation to update or reaffirm guidance. The company only provides guidance in a Regulation FD compliant manner. 2: Non-GAAP Adjusted EBITDA excludes stock-based compensation, non-cash interest and non-cash amortization of the Nucynta® intangible asset. The company has not provided a reconciliation of its full-year 2021 guidance for non-GAAP adjusted income (loss) to the most directly comparable forward-looking GAAP measure because it is unable to predict, 19without unreasonable efforts, the timing and amount of items that would be included in such a reconciliation. These items are uncertain and depend on various factors that could have a material impact on GAAP net income (loss) for the guidance period. |
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2021: Focused on Growth & Value Creation Deliver on our missionICreate value for shareholders OUR STRATEGY Maximize the value of our differentiated portfolio of pain products Achieve our near-term operational and financial goals Invest in our long-term growth 2021 FOCUS 20 Drive revenue growth from Xtampza® ER Stable Nucynta® Franchise profit contributions Leverage our current cost structure ‒ Revenue growth ‒ Profitability ‒ Cash generation Deploy balance sheet in a disciplined manner Actively seek opportunities to enhance portfolio long-term |