floblu14
2年前
Collegium to Acquire Ironshore Therapeutics, Expanding into Neurology
July 29, 2024
– Adds Commercial Product Jornay PM®, Establishing Collegium’s Presence in Neurology (ADHD) –
– H1’24 Jornay PM Prescriptions Grew 32% Year-over-Year –
– Transaction Expected to be Immediately Accretive to Adjusted EBITDA –
– Acquisition Funded by Collegium’s Cash on Hand and New Five-Year Financing with Significantly Improved
Terms –
– Collegium Estimates Q2’24 Pain Portfolio Net Revenue of $145 Million, Up 7% Year-over-Year; Reaffirms 2024
Financial Guidance for the Current Business –
– Conference Call Scheduled for Today at 8:30 a.m. ET –
STOUGHTON, Mass. and GEORGE TOWN, Cayman Islands, July 29, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) and Ironshore Therapeutics Inc. today announced a definitive agreement pursuant to which Collegium will acquire Ironshore for $525 million in cash with the potential for an additional $25 million commercial milestone payment.
Ironshore is a privately held, pharmaceutical company that markets and distributes Jornay PM (methylphenidate HCl), a central nervous system (CNS) stimulant prescription medicine for the treatment of attention deficit hyperactivity disorder (ADHD) in people six years of age and older and the only stimulant medication that is dosed in the evening. The acquisition of Ironshore will represent a significant milestone in advancing Collegium’s mission of building a leading, diversified specialty pharmaceutical company by expanding the Company’s business beyond pain management and establishing a commercial presence in a new and growing market.
“The Ironshore acquisition is a unique opportunity to deliver a transaction that is immediately accretive to Collegium while meeting all of our strategic objectives through the addition of a growing commercial asset that diversifies our portfolio, has significant revenue potential and exclusivity into the 2030s,” said Michael Heffernan, Chairman and Interim President and Chief Executive Officer of Collegium. “The addition of Jornay PM will establish a new presence for Collegium in ADHD, a large and growing market, where we can leverage our core commercial competencies and proven commercial execution capabilities to maximize the brand’s potential. Our healthy balance sheet and strong financial position enabled us to secure attractive financing for the transaction with terms that reduce our cost of capital and enhance our flexibility in the management of our debt.”
“We are pleased to announce this transaction with Collegium, which recognizes the value of Jornay PM and the success of Ironshore’s talented team in the delivery of an important and differentiated treatment option for patients with ADHD and their caregivers,” said Stephanie Read, Chief Executive Officer of Ironshore. “Our team has worked tirelessly to bring Jornay PM to the ADHD community and we are excited that Collegium recognizes Jornay PM’s long-term potential and is committed to supporting its continued growth.”
Transaction Rationale
Strategically aligns with Collegium’s mission of building a leading, diversified specialty pharmaceutical company by broadening the commercial portfolio beyond pain management and establishing a commercial presence in neurology via the large and growing ADHD market.
Jornay PM is poised to become Collegium’s leading growth driver. Net revenue for Jornay PM is expected to be in excess of $100 million in 2024. In the first half of 2024, Jornay PM prescriptions grew 32% year-over-year. For the full-year 2023, the product generated approximately 490,000 prescriptions, a 58% increase compared to 2022. Jornay PM is a highly differentiated treatment for ADHD due to its evening dosing, smooth therapeutic effect and dose-dependent duration.
Jornay PM is supported by 16 Orange Book-listed patents, with expiries in 2032.
Further strengthens Collegium’s financial position through an increased revenue base, expected immediate accretion to adjusted EBITDA and accelerated cash flow generation.
Additional Transaction Details
Under the terms of the agreement, Collegium will acquire all the outstanding shares of Ironshore for $525 million in cash at closing. Collegium will also pay Ironshore shareholders $25 million in additional consideration if Jornay PM net revenue exceeds a defined threshold in 2025.
The all-cash consideration will be funded by a combination of Collegium’s existing cash on hand and a $646 million secured financing from funds managed by Pharmakon Advisors, LP (Pharmakon). The new five-year term loan will replace the existing Collegium term loan from Pharmakon and reduce the interest rate by 300 basis points.
At year-end 2024, Collegium expects net leverage to be less than two times based on estimated 2024 pro forma combined adjusted EBITDA.
Collegium expects this transaction to be immediately accretive to adjusted EBITDA, excluding transaction costs.
Timing to Close
The transaction, which has been unanimously approved by the boards of directors of both companies, is expected to close in the third quarter of 2024, subject to customary closing conditions, including receipt of required regulatory approvals.
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-acquire-ironshore-therapeutics-expanding-neurology
floblu14
2年前
Collegium to Report Second Quarter 2024 Financial Results on August 8, 2024
July 25, 2024
STOUGHTON, Mass., July 25, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced that it will report second quarter 2024 financial results after the market closes on Thursday, August 8, 2024. Following the release of the financials, the Company will host a live conference call and webcast at 4:30 p.m. ET.
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-report-second-quarter-2024-financial-results-august-8
floblu14
2年前
Collegium Obtains Six Month Extension of U.S. Pediatric Exclusivity for Nucynta Franchise
June 13, 2024
STOUGHTON, Mass., June 13, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for Nucynta® and Nucynta® ER (“the Nucynta Franchise”). In 2023, FDA granted New Patient Population exclusivity for Nucynta in pediatrics, extending the period of U.S. exclusivity from June 27, 2025, to July 3, 2026. FDA’s grant of pediatric exclusivity now extends exclusivity of the Nucynta Franchise an additional six months, to January 3, 2027, for Nucynta and December 27, 2025, for Nucynta ER.
“We are pleased with FDA’s grant of pediatric exclusivity for the Nucynta Franchise,” said Thomas Smith, M.D., Collegium’s Chief Medical Officer. “This grant of pediatric exclusivity enhances the value of the Nucynta franchise and bolsters our near-term outlook. Collegium is proud to lead with science in support of people living with serious medical conditions and the communities we serve.”
Nucynta is currently approved in the U.S. for the management of acute pain severe enough to require an opioid analgesic, in light of the known risks associated with opioid analgesic use, and for which alternative treatments are inadequate in adults and pediatric patients aged six years and older with a body weight of at least 40 kg.
Nucynta ER is currently approved in the U.S. for the management of severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic, in light of the known risks associated with opioid analgesic use, and for which alternative treatment options are inadequate, and severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-obtains-six-month-extension-us-pediatric-exclusivity
floblu14
2年前
Collegium to Participate in Jefferies Global Healthcare Conference
May 29, 2024
STOUGHTON, Mass., May 29, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced that management will participate in a fireside chat at the Jefferies Global Healthcare Conference being held in New York, NY from June 5-6, 2024.
Details of the event are as follows:
Fireside Chat Date and Time: Wednesday, June 5, 2024, at 9:30 a.m. ET
The fireside chat will be webcast live and can be accessed from the Investors section of the Company's website: https://ir.collegiumpharma.com. A replay of the webcast will be archived on the Company's website for 90 days following the presentation.
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-participate-jefferies-global-healthcare-conference
floblu14
2年前
Collegium Announces $35 Million Accelerated Share Repurchase Program
May 13, 2024
STOUGHTON, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced that it has entered into an Accelerated Share Repurchase ("ASR") agreement with Jefferies LLC to repurchase $35 million of the Company’s common stock. Collegium will execute the ASR as part of the $150 million share repurchase program authorized by its Board of Directors in January 2024. Upon completion of this ASR, Collegium will have $115 million remaining under the program.
“Our financial and strategic execution bolster the strength of our business today and in the future. Collegium’s strong start to 2024 was supported by robust cash generation, momentum in Belbuca® prescriptions, improved Xtampza® ER gross-to-net and the Nucynta Franchise authorized generic agreement, all of which put us on track to meet our 2024 financial guidance and improve our outlook in 2025 and beyond,” said Colleen Tupper, Chief Financial Officer of Collegium. “This $35 million ASR program reinforces our belief that the value of Collegium is underappreciated. We remain committed to leveraging our $150 million share repurchase program, which is authorized through the second quarter of 2025, to create value for our shareholders through our capital deployment strategy.”
Under terms of the agreement, Collegium will pay $35 million to Jefferies LLC and will receive an initial delivery of 888,889 shares, based on the $31.50 closing stock price of Collegium’s common stock on May 10, 2024, representing approximately 80% of the total shares the Company expects to repurchase under the ASR agreement. The final number of shares repurchased will be based on the volume-weighted average prices of Collegium’s common stock during the term of the ASR and subject to adjustments related to the terms and conditions of the ASR agreement. The final settlement of the ASR is expected to be completed in the third quarter of 2024. As of March 31, 2024, Collegium had approximately 32.7 million shares outstanding.
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-announces-35-million-accelerated-share-repurchase
floblu14
2年前
Collegium Announces Authorized Generic Agreement with Hikma Pharmaceuticals USA Inc. for Nucynta® and Nucynta® ER
April 29, 2024
STOUGHTON, Mass., April 29, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced it has entered into an authorized generic agreement with Hikma Pharmaceuticals USA Inc. (“Hikma”), pursuant to which Hikma will have the exclusive right to sell the authorized generic versions of Nucynta® and Nucynta® ER (“the Nucynta Franchise”) in the United States.
“Our agreement with Hikma bolsters the value of the Nucynta Franchise through 2025 and beyond,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “Collegium is pleased to work with Hikma, an industry leader, to ensure that these important products continue to be manufactured to the highest quality standards and remain broadly and consistently accessible to appropriate patients.”
Under the terms of the agreement:
Collegium will manufacture and supply Hikma with all authorized generic product for sale on an exclusive basis during the term of the agreement.
Hikma will sell the authorized generic forms of the Nucynta Franchise in the United States, commencing 30 days prior to the anticipated loss of exclusivity for each product, or earlier under certain circumstances.
Collegium will receive a meaningful share of net profits of the authorized generic products, that declines based on the number of generic entrants, if any. [NO TEVA, HOPEFULLY.]
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-announces-authorized-generic-agreement-hikma
floblu14
2年前
Collegium to Participate in 23rd Annual Needham Virtual Healthcare Conference - Wed, April 3, 2024 at 8:00 AM EDT
STOUGHTON, Mass., April 03, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced that management will participate in a fireside chat at the 23rd Annual Needham Healthcare Conference being held virtually from April 8-11, 2024.
Details of the event are as follows:
Fireside Chat Date and Time: Wednesday, April 10, 2024, at 3:45 p.m. ET
https://finance.yahoo.com/news/collegium-participate-23rd-annual-needham-120000163.html
floblu14
2年前
Are You Looking for a Top Momentum Pick? Why Collegium Pharmaceutical (COLL) is a Great Choice
March 01, 2024 — 12:00 pm EST
For COLL, shares are up 11.57% over the past week while the Zacks Medical - Drugs industry is down 0.48% over the same time period. Shares are looking quite well from a longer time frame too, as the monthly price change of 9.68% compares favorably with the industry's 1.54% performance as well.
While any stock can see a spike in price, it takes a real winner to consistently outperform the market. Over the past quarter, shares of Collegium Pharmaceutical have risen 35.06%, and are up 34.86% in the last year. In comparison, the S&P 500 has only moved 11.77% and 30%, respectively.
Investors should also pay attention to COLL's average 20-day trading volume. Volume is a useful item in many ways, and the 20-day average establishes a good price-to-volume baseline; a rising stock with above average volume is generally a bullish sign, whereas a declining stock on above average volume is typically bearish. COLL is currently averaging 407,425 shares for the last 20 days.
Earnings Outlook
The Zacks Momentum Style Score encompasses many things, including estimate revisions and a stock's price movement. Investors should note that earnings estimates are also significant to the Zacks Rank, and a nice path here can be promising. We have recently been noticing this with COLL.
Over the past two months, 4 earnings estimates moved higher compared to 1 lower for the full year. These revisions helped boost COLL's consensus estimate, increasing from $6.02 to $6.29 in the past 60 days. Looking at the next fiscal year, 3 estimates have moved upwards while there have been no downward revisions in the same time period.
Read more:
https://www.nasdaq.com/articles/are-you-looking-for-a-top-momentum-pick-why-collegium-pharmaceutical-coll-is-a-great
floblu14
2年前
On February 22, 2024, Collegium Pharmaceutical Inc (NASDAQ:COLL) released its 8-K filing, announcing record financial results for the fourth quarter and the full year ended December 31, 2023. The specialty pharmaceutical company, known for its abuse-deterrent products and patented DETERx platform technology, reported significant growth in revenue and earnings, surpassing its operational objectives and enhancing shareholder value.
Collegium Pharmaceutical Inc's President and CEO, Joe Ciaffoni, expressed satisfaction with the company's performance, stating,
2023 was a banner year for Collegium Pharmaceutical. We delivered record financial results, achieved our operational objectives and delivered value to shareholders through our share repurchase program."
The company's focus for 2024 is on operational execution, aiming to meet financial guidance and create shareholder value.
Colleen Tupper, Chief Financial Officer, highlighted the company's financial achievements, including record revenue, adjusted EBITDA, and free cash flow. She emphasized the strategic financial management that led to a stronger balance sheet and capital return to shareholders. Tupper anticipates continued growth in 2024, driven by product sales and cost structure leverage.
Financial Performance Analysis
Collegium Pharmaceutical Inc's financial results reflect a robust performance in a competitive industry. The company's record net revenue of $149.7 million for the fourth quarter and $566.8 million for the full year signifies a strong market demand for its products, particularly Belbuca and Xtampza ER. The GAAP net income figures of $31.9 million for the quarter and $48.2 million for the year demonstrate effective cost management and operational efficiency.
The adjusted EBITDA of $104.2 million for the quarter and $367.0 million for the year is a critical metric for investors, as it illustrates the company's profitability and ability to generate cash from operations. The substantial reduction in debt and the successful refinancing of convertible debt are indicative of prudent financial stewardship, which is essential for sustaining growth and weathering market volatility.
Collegium Pharmaceutical Inc's commitment to shareholder returns, as evidenced by the $75.0 million share repurchase, is a testament to the company's confidence in its financial health and long-term prospects. The projected financial guidance for 2024, with net revenue expected to be between $580.0 to $595.0 million and adjusted EBITDA between $380.0 to $395.0 million, sets an optimistic tone for the company's future performance.
In conclusion, Collegium Pharmaceutical Inc's record earnings for the fourth quarter and full year of 2023 reflect a company that is not only thriving in its market niche but is also strategically positioned for continued growth. The company's financial discipline and commitment to shareholder value are likely to appeal to value investors....
Read more:
https://finance.yahoo.com/news/heres-key-metrics-tell-us-000009621.html
CC: Coleen Tupper - Our stock is undervalued. ....Repurchase program of an additional $150M in the next 18 months.
floblu14
2年前
Collegium to Report Fourth Quarter and Full-Year 2023 Financial Results on February 22, 2024
February 8, 2024
STOUGHTON, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced that it will report fourth quarter and full-year 2023 financial results after the market closes on Thursday, February 22, 2024. Following the release of the financials, the Company will host a live conference call and webcast at 4:30 p.m. ET.
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-report-fourth-quarter-and-full-year-2023-financial
floblu14
2年前
Third Avenue Management, an investment management company based in New York City, released its “Small-Cap Value Fund” fourth quarter 2023 investor letter. A copy of the same can be downloaded here. In 2023 the fund returned 21.88% compared to a 14.65% return for the Russell 2000 Value Index. In Q4 the fund returned 9.38% versus 15.26% for the index. The returns, both absolute and relative, for the entire year were satisfactory. The past two years have seen rapid changes in equity prices due to varying interest rate outlooks. In addition, you can check the top 5 holdings of the fund to know its best picks in 2023.
Third Avenue Management Small-Cap Value Fund featured stocks such as Collegium Pharmaceutical, Inc. (NASDAQ:COLL) in the fourth quarter 2023 investor letter. Headquartered in Stoughton, Massachusetts, Collegium Pharmaceutical, Inc. (NASDAQ:COLL) is a specialty pharmaceutical company. On January 30, 2024, Collegium Pharmaceutical, Inc. (NASDAQ:COLL) stock closed at $33.45 per share. One-month return of Collegium Pharmaceutical, Inc. (NASDAQ:COLL) was -1.21%, and its shares gained 14.09% of their value over the last 52 weeks. Collegium Pharmaceutical, Inc. (NASDAQ:COLL) has a market capitalization of $1.091 billion.
Third Avenue Management Small-Cap Value Fund stated the following regarding Collegium Pharmaceutical, Inc. (NASDAQ:COLL) in its fourth quarter 2023 investor letter:
"Collegium Pharmaceutical, Inc. (NASDAQ:COLL) was added to the portfolio this past quarter, and the thesis is outlined below.
COLL is an abuse-deterrent opioid company. Since entering its commercialization phase in 2019, the company has benefitted by offering a competitive product to OxyContin. COLL’s lead drug (Xtampza) does not have a black box warning from the F.D.A. for pain management, which illustrates its lower abuse potential in this critical patient segment. COLL is a company we have been following for years since it announced the acquisition of its #2 competitor, BioDelivery Sciences in 2021. During that time, we have built conviction on the durability and continued growth of COLL’s future cash flows. COLL’s valuation has remained depressed, along with the broader healthcare sector. This presented a compelling entry point now that COLL has secured significantly higher margin, multi-year payer contracts because of its responsible pain management (as payers move away from Oxycontin). These contract renewals should help COLL build scale and margins and provide a well-defined path to improve its balance sheet.
The Fund initiated the investment when COLL was trading for a mere 3.2x free cash flow3, or 5.25x trailing enterprise value to trailing EBITDA4. In addition to a low absolute valuation, this investment appears to be misunderstood by investors focused purely on earnings who have not taken the time to sift through one-time items (such as settlement agreements and costs related to the extinguishment of debt) that understate the strength of its operating performance. The company has now completed a majority of its multi-year payer contracts at significantly higher margins to COLL. To underscore this development and what the market is missing, if COLL were to run its business as-is and retire its debt, we estimate it could have a $1 billion net cash position by 2027. Furthermore, if their largest potential competitor (Teva Pharmaceuticals) stays out of the market, it could produce another $1 billion of free cash flow over the next three years. The current market capitalization is roughly $1 billion…” (Click here to read the full text)
https://finance.yahoo.com/news/reasons-invest-collegium-pharmaceutical-coll-130310364.html
floblu14
2年前
FWIW -
Why Collegium Pharmaceutical (COLL) Could Beat Earnings Estimates Again
Zacks Equity Research
Wed, January 24, 2024 at 12:10 PM EST
COLL
+0.55%
Have you been searching for a stock that might be well-positioned to maintain its earnings-beat streak in its upcoming report? It is worth considering Collegium Pharmaceutical (COLL), which belongs to the Zacks Medical - Drugs industry.
This specialty pharmaceutical company has an established record of topping earnings estimates, especially when looking at the previous two reports. The company boasts an average surprise for the past two quarters of 5.67%.
For the last reported quarter, Collegium Pharmaceutical came out with earnings of $1.34 per share versus the Zacks Consensus Estimate of $1.24 per share, representing a surprise of 8.06%. For the previous quarter, the company was expected to post earnings of $1.22 per share and it actually produced earnings of $1.26 per share, delivering a surprise of 3.28%.
Thanks in part to this history, there has been a favorable change in earnings estimates for Collegium Pharmaceutical lately. In fact, the Zacks Earnings ESP (Expected Surprise Prediction) for the stock is positive, which is a great indicator of an earnings beat, particularly when combined with its solid Zacks Rank.
https://finance.yahoo.com/news/why-collegium-pharmaceutical-coll-could-171009011.html
floblu14
2年前
YES!!!!!!!!!
Collegium Provides 2024 Financial Guidance
January 3, 2024
– Product Revenues, Net Expected in the Range of $580.0 Million to $595.0 Million –
– Adjusted Operating Expenses* Expected in the Range of $120.0 Million to $125.0 Million –
– Adjusted EBITDA* Expected in the Range of $380.0 Million to $395.0 Million –
– $150.0 Million Share Repurchase Program Authorized by the Board of Directors –
STOUGHTON, Mass., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company, today announced its 2024 full-year financial guidance and provided a business update.
“2023 was a banner year for Collegium. We are on track to grow revenue over 20% and adjusted EBITDA over 35% in 2023 compared to 2022, leading to strong cash flow generation that enabled us to rapidly pay down debt and opportunistically repurchase shares. Our operational accomplishments position the Company to deliver top- and bottom-line growth in 2024 and strengthen our outlook for 2025 and 2026,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “In 2024, we are focused on operational execution, which includes achieving our financial commitments and deploying capital to create value for shareholders.”
“We expect record revenue, driven by Belbuca® and Xtampza® ER growth, and disciplined operating spend, to result in record adjusted EBITDA in 2024,” said Colleen Tupper, Chief Financial Officer of Collegium. “We plan to deploy capital to rapidly pay down debt and opportunistically utilize our new $150 million share repurchase program to return value to our shareholders.”
Recent Business Highlights
Collegium’s board of directors authorized a new share repurchase program to repurchase up to $150.0 million in common stock over 18 months.
Returned $75.0 million in capital to shareholders in 2023 under the share repurchase program authorized by Collegium’s board of directors in January 2023, including $25.0 million repurchased through an accelerated share repurchase program since November 9, 2023.
Successfully completed Xtampza ER contract renegotiations with payors that represent 30% of Xtampza ER total prescriptions in 2023. As a result, Xtampza ER gross-to-net is expected to be in the range of 56% to 58% in 2024.
Renegotiated a major Medicare Part D contract for Belbuca, maintaining its access position and materially reducing the rebate, and won a new Medicare Part D plan for Belbuca representing approximately one million covered lives.
Financial Guidance for 2024
Product revenues, net are expected in the range of $580.0 million to $595.0 million.
Adjusted operating expenses (excluding stock-based compensation) are expected in the range of $120.0 million to $125.0 million.
Adjusted EBITDA (excluding stock-based compensation) is expected in the range of $380.0 million to $395.0 million.
* Non-GAAP financial measure. Please refer to the “Non-GAAP Financial Measures” section for details regarding these measures.
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-provides-2024-financial-guidance
floblu14
3年前
Official COLLEGIUM PHARMACEUTICAL, INC. press release
Purdue v. Collegium: Upholding The Board's Authority To Issue A Final Written Decision Even After The Statutory Deadline Has Passed
December 08, 2023 at 05:11 am EST
On November 21, 2023, the Federal Circuit in Purdue Pharma L.P et al. v. Collegium Pharm., Inc. (i) affirmed that the Patent Trial and Appeal Board (“Board”) has authority to issue a Final Written Decision after the statutory deadline has passed, and (ii) affirmed the Board's determination that claims 1-17 of U.S. Patent No. 9,693,961 (“'961 patent”) are unpatentable for lack of written description.1 Regarding the Board's authority, the Federal Circuit concluded that the Board's failure to comply with the statutory deadline does not deprive it of authority to render a final determination.2 On the merits, the Federal Circuit determined that neither the specification of the '961 patent nor its priority application provide adequate written description support.3
I. BACKGROUND
Purdue Pharma L.P. (“Purdue) owns the '961 patent, titled “Pharmaceutical Formulation Containing Gelling Agent,” issued on July 4, 2017.4 The '961 patent is directed to preventing or deterring “the abuse of opioid analgesics by the inclusion of at least one aversive agent in the dosage form.”5 The aversive agent “helps to prevent injection, inhalation, and/or oral abuse by decreasing the attractiveness of the dosage form to a potential abuser.”6 Representative claim 1, in relevant part, recites:
A method of preparing an abuse deterrent controlled release dosage form comprising:
combining oxycodone or a pharmaceutically acceptable salt thereof as active agent, polyglycolyzed glycerides, a C12 to C40 fatty acid or a mixture thereof, carnauba wax and beeswax, to form a homogenous mixture, wherein the oxycodone or pharmaceutically acceptable salt thereof is the sole active agent in the dosage form; . . . .7
In September 2017, Purdue sued Collegium Pharmaceutical, Inc. (“Collegium”) for infringement of the '961 patent.8 In March 2018, Collegium petitioned the Board for post grant review (“PGR”) of claims 1-17 of the '961 patent.9 Purdue argued that the '961 patent was not subject to PGR because it claimed priority to an application filed before March 16, 2013, i.e., a pre- America Invents Act (“AIA”) application.10 The Board found that the '961 patent was eligible for PGR because the pre-AIA application “did not contain sufficient written description support for the claimed invention, and the effective filing date was therefore after March 16, 2013.” 11The Board also found that the '961 patent specification likely lacked written description.12 Accordingly, the Board instituted PGR.13 Under 35 US.C. § 326(a)(11), the Board had one year to issue a Final Written Decision subject to a six-month extension for good cause.14
Upon Purdue filing a Notice of Bankruptcy and Imposition of Automatic Stay, the Board stayed the PGR proceeding.15 The parallel district court infringement case was also stayed.16 As the one-year deadline for the Board to issue a Final Written Decision approached, the Board found good cause to extend the stay “so the bankruptcy court could assess whether the automatic stay applied to PGRs.”17 After the six-month extended deadline had passed, the bankruptcy court lifted the stay for both the district court case and the PGR proceeding.18
Purdue moved to terminate the PGR proceeding, arguing that “the Board no longer had the authority to issue a Final Written Decision as the 18-month deadline had passed.”19
The Board denied Purdue's motion and held that “under the circumstances of this case, the AIA's silence as to a consequence for timely issuing a final written decision does not divest us of our authority to issue our final written decision.”20 The Board issued its Final Written Decision, finding all claims unpatentable for lack of written description and anticipation.21 Purdue Appealed.22
II. FEDERAL CIRCUIT DECISION
A. THE BOARD'S AUTHORITY
As “a matter of first impression,” the Federal Circuit held that “following the Supreme Court's rule, the Board has authority to issue a Final Written Decision even after the deadline proscribed in the statute has passed absent any contrary indication in the language, structure, or legislative history of the statute.”23 35 US.C. § 326(a)(11) provides:
(a) Regulations—The Director shall prescribe regulations—
(11) requiring that the final determination in any post-grant review be issued not later than 1 year after the date on which the Director notices the institution of a proceeding under this chapter, except that the Director may, for good cause shown, extend the 1-year period by not more than 6 months, and may adjust the time periods in this paragraph in the case of joinder under section 325(c)24
1. STATUTORY LANGUAGE AND STRUCTURE
Purdue advanced several arguments based on the language and structure of section 326(a)(11). Each was rejected by the Federal Circuit.
First, Purdue argued that the use of the terms “shall” and “requiring” in the statute “deprives the Board of authority to issue a Final Written Decision after the deadline.” The Federal Circuit rejected Purdue's argument as contrary to Supreme Court precedent.25 The Federal Circuit explained that the words “shall” and “requiring” in section 326(a)(11) are “equivalent” and, under Supreme Court precedent, do not divest the Board of authority to issue a final determination after the statutory deadline.26
Second, Purdue contended that “the 'negative words' of 'not later than 1 year' and 'by not more than 6 months' in the section 326(a)(11) show 'the acts required shall not be done in any other manner or time than that designated.'”27 The Federal Circuit dismissed Purdue's contention because “the Supreme Court has held that similar statutory language as that involved here does not result in a loss of authority.”28 Likewise, the Federal Circuit has also “held that a statute containing 'not later than' 'created timing provisions that are at best precatory rather than mandatory.'”29
Third, Purdue asserted that the Board lacked jurisdiction after the statutory deadline because section 326(a)(11) is linked to the Board's jurisdictional grant in section 6 of Section 326(c).30 The Federal Circuit disagreed with Purdue, finding that the statute did not include a “clear statement” that the procedural rule violation would deprive the Board of jurisdiction, as required by Supreme Court precedent.31
Fourth, Purdue argued that “the exceptions in section 326(a)(11) for 'good cause' and 'joinder' show those are the only two limited circumstances under which the Board may issue a Final Written Decision after the one-year deadline.”32 But the Federal Circuit disagreed, explaining that “'enunciation of two exceptions does not imply an exclusion of a third.'”33
Finally, the Federal Circuit emphasized that “section 328(a) mandates that the Board issue a Final Written Decision,” whereas other provisions of AIA, such as sections 315(b) and 321(c), “use quite different language to bar action after deadlines pass.”34 The Federal Circuit stated that “[h]ad Congress meant to deprive the agency of power in section 326(a)(11), it knew how to do it, and, significantly, it did not use language in section 326(a)(11) similar to that used in other sections.”35
2. LEGISLATIVE HISTORY
The Federal Circuit also rejected Purdue's argument that the legislative history deprives the Board of authority to act after the statutory deadline passes.36
The Federal Circuit noted that “Congress enacted the AIA in part to replace inter partes reexaminations,” which “were lengthy and inefficient, often lasting three to five years,” with PGRs and IPRs “to make patent review expeditious[.]”37 The Federal Circuit explained that
[F]orbidding the Board to issue a Final Written Decision after the deadline has passed would go against Congressional intent. If the Board could not issue a Final Written Decision, the parties would be forced to pursue the issue in district court litigation. This is the exact opposite of the purpose of the AIA, which is meant to create a more efficient alternative to district court litigation.38
The Federal Circuit also explained that the Board may not ignore statutory deadlines because a party may seek a petition for a writ of mandamus from the court immediately upon the deadline's expiration to compel the agency to act.39
Thus, the Federal Circuit concluded that “the Board's failure to comply with the statutory deadline does not deprive it of authority thereafter to issue a final written decision.” 40
* * *
Upon assessing “whether the '961 specification adequately discloses the claimed polyglycolyzed glycerides ('PGGs') as an aversive agent,” the Federal Circuit upheld the Board's finding that “the claimed formulation was not disclosed,” and therefore, affirmed the Board's determination that the claims were invalid for lack of written description.41 Having affirmed the Board's invalidation of the claims under section 112, the panel declined to reach the issue of anticipation.42
III. CONCLUSION
If the Board fails to comply with the statutory deadline, the appropriate remedy for a party seeking issuance of a Final Written Decision is to petition for mandamus to compel a decision from the Board.
Footnotes
1. Purdue Pharma L.P et al. v. Collegium Pharm., Inc., No. 22-1482, at 2, 15 (Fed. Cir. Nov. 21, 2023) (“Slip Op.”) available at https://cafc.uscourts.gov/opinions-orders/22-1482.OPINION.11-21-2023_2225603.pdf
floblu14
3年前
3 Pharma Stocks Flashing 'Buy' Signals in December - Dec. 8
The pharmaceutical industry is well-positioned for robust growth, driven by growing healthcare expenditure globally and the rapid adoption of digital technologies. Given the industry’s tailwinds, fundamentally strong pharma stocks, Collegium Pharmaceutical (COLL), Eton Pharmaceuticals (ETON), and GSK plc (GSK) could be ideal buys this month
COLL is a specialty pharmaceutical company that develops and commercializes pain management medicines. The company’s portfolio includes Xtampza ER, an abuse-deterrent and oil formulation of oxycodone; Nucynta ER and Nucynta IR, which are formulations of tapentadol; Belbuca, a buccal film that contains buprenorphin; and Symproic.
On November 9, COLL entered into an Accelerated Share Repurchase (ASR) agreement with Jefferies LLC to repurchase $25 million of the company’s common stock. The company is executing the ASR as part of the $100 million share repurchase program authorized by its Board of Directors in January 2023.
“Our record financial performance in 2023 year-to-date puts Collegium on track to deliver a banner year. Our financial strength, underscored by robust cash generation, enables us to execute on our capital deployment strategy,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium.
On August 24, COLL was granted New Patient Population exclusivity for Nucynta®, an immediate-release formulation of tapentadol, by the U.S. Food and Drug Administration (FDA). This grant extends the period of U.S. exclusivity for Nucynta from June 27, 2025, to July 3, 2026.
The grant of additional exclusivity recognizes the importance of Nucynta in treating acute, severe pain.
COLL’s net product revenues increased 7.6% year-over-year to $136.71 million in the third quarter that ended September 30, 2023. Its gross profit grew 36.5% from the year-ago value to $80.31 million. Its income from operations rose 119.9% year-over-year to $45.01 million. Its adjusted EBITDA was $89.40 million, up 19.4% from the prior year’s quarter.
In addition, COLL’s adjusted net income rose 29.3% from the prior year’s quarter to $55 million, and its adjusted EPS came in at $1.34, an increase of 21.9% year-over-year.
The company updated its full-year 2023 guidance. COLL reaffirmed net product revenues to $565.0 million-$570.0 million, and it expects its adjusted EBITDA to be in the range of $360 million and $365 million.
Street expects COLL’s revenue for the fourth quarter (ending December 2023) to increase 14% year-over-year to $147.80 million. Further, the consensus EPS estimate for the current quarter of $1.40 indicates an improvement of 28.8% year-over-year.
Shares of COLL have gained 27.1% over the past six months and 24.3% over the past year to close the last trading session at $27.18.
COLL’s solid prospects are reflected in its POWR Ratings. The stock has an overall rating of B, which translates to a Buy in our proprietary rating system. The POWR Ratings are calculated by considering 118 different factors, each weighted to an optimal degree.
The stock has an A grade for Quality and B for Growth and Value. COLL is ranked #14 out of 157 stocks in the Medical – Pharmaceuticals industry.
https://stocknews.com/news/gsk-coll-eton-arwr-srra-3-pharma-stocks-flashing-buy-signals-in-december/
floblu14
3年前
Appeals Court Upholds PTAB’s Finding of Invalidity of Purdue’s 961 Patent
November 27, 2023
STOUGHTON, Mass., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company, today announced that the U.S. Court of Appeals for the Federal Circuit has upheld the judgment of the Patent Trial and Appeal Board (PTAB) in its final decision that Purdue’s ‘961 patent, which Purdue has claimed is infringed by Xtampza® ER, is invalid.
The Federal Circuit’s decision affirming the invalidity of Purdue’s ‘961 patent confirms both that the PTAB had statutory authority to issue its final decision, and that the PTAB did correctly conclude that the '961 patent was invalid.
“We applaud the Federal Circuit’s decision to confirm the authority of the PTAB and uphold its finding of invalidity of Purdue’s patent,” said Shirley Kuhlmann, Chief Administrative Officer and General Counsel of Collegium. “We will continue to vigorously defend Collegium's intellectual property against claims of infringement.”
About Collegium Pharmaceutical, Inc.
Collegium is a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com.
https://finance.yahoo.com/news/appeals-court-upholds-ptab-finding-130000732.html
floblu14
3年前
Form 8-K November 9
On November 9, 2023, Collegium Pharmaceutical, Inc. (“Collegium” or the “Company”) announced the execution of an accelerated share repurchase agreement (the “ASR Agreement”) with Jefferies LLC to repurchase $25 million of the Company’s common stock. The ASR Agreement was undertaken as part of the $100 million share repurchase program authorized by its Board of Directors in January 2023.
Under terms of the ASR Agreement, the Company will pay $25 million to Jefferies LLC and will receive an initial delivery of approximately 865,426 shares, based on the $23.11 closing stock price of Collegium’s common stock on November 8, 2023, representing approximately 80% of the total shares the Company expects to repurchase under the ASR Agreement. The final number of shares repurchased will be based on the volume-weighted average prices of Collegium’s common stock during the term of the ASR Agreement and subject to adjustments related to the terms and conditions of the ASR Agreement. The final settlement of the ASR Agreement is expected to be completed in the fourth quarter of 2023. As of September 30, 2023, Collegium had approximately 33.1 million shares outstanding.
https://ir.collegiumpharma.com/node/11611/html
“Our record financial performance in 2023 year-to-date puts Collegium on track to deliver a banner year. Our financial strength, underscored by robust cash generation, enables us to execute on our capital deployment strategy,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “We are committed to opportunistically returning value to our shareholders through our share repurchase program. Since 2021, we have returned $112 million of capital to our shareholders through share repurchases. This additional $25 million ASR program is a productive use of our capital with the potential to generate high returns for our shareholders.”
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-announces-25-million-accelerated-share-repurchase-0
floblu14
3年前
Collegium Pharmaceutical, Inc. (NASDAQ:COLL) Q3 2023 Earnings Call Transcript
Excerpts:
Xtampza ER will maintain its current formulary position and accounts representing 57% of the opportunity at an overall lower rebate level, and plans were Xtampza ER will move to non-formulary, it will be at parity with OxyContin.
We ended the quarter with over $300 million in cash and marketable securities,
For full-year 2023, we expect to grow revenue greater than 20% year-over-year and adjusted EBITDA at 1.5x that rate. Our accomplishments renegotiating of Belbuca and Xtampza ER payor contracts position both products for improved gross-to-nets to support revenue growth in 2024.
As we have demonstrated through our completed $50 million accelerated share repurchase program, and now our additional $25 million accelerated share repurchase program, we are committed to opportunistically returning value to our shareholders.
We believe that our stock continues to be significantly undervalued and we will continue to leverage our share repurchase program to return capital to our shareholders.
Over the last two years, we have successfully renegotiated contracts that represented 84% of all Xtampza ER prescriptions. In 77% of the renegotiation opportunity, we were able to maintain Xtampza ER's formulary position and materially roll back the overall rebate level.
As you know we are locked into the paying down of our debt and as we’ve been very clear, we think there is a significant disconnect between the intrinsic value of the company and where our share price has been.
Further reinforcing our commitment to deliver value to our shareholders through effective capital deployment, today we announced as part of our $100 million share repurchase program, our Board has authorized us to enter into a new $25 million accelerated share repurchase program. We believe that our stock continues to be significantly undervalued and we view our share repurchase program as productive use of our capital to generate high returns for our shareholders.
Q: One more from me on the BD front. What’s your funnel essentially look like now. Are there any opportunities essentially in other non-abuse-deterrent options available in the market now, and then, if not other opportunities out there and what does the competitive landscape essentially look like and also valuations in the current market environment.
A: ....we’re open to anything that really hits the profile of a differentiated commercial stage asset with $150 million plus peak sales potential with exclusivity into the 2030s. Whatever acquisition, we’re able to achieve, we will not be like the ones we’ve done in the past where we’re leveraging our PAIN infrastructure, we’ll be setting a second commercial beachhead. So these will be a lower synergy, more strategically oriented deal for Collegium and that’s our focus. In terms of valuations, what I would say, Les, is right now, what we’ve seen is a lot of receptivity in willingness to engage.
And whilst the financial strength of our company and the fact that we don’t have to do a deal, we aspire to do one will continue to engage and work with urgency. But we won’t strike until we get to a price that we’re comfortable with and believe creates value for our shareholders.
Read more:
https://www.insidermonkey.com/blog/collegium-pharmaceutical-inc-nasdaqcoll-q3-2023-earnings-call-transcript-1219623/#q-and-a-session
floblu14
3年前
Collegium to Participate in Upcoming Investor Conferences
November 8, 2023
STOUGHTON, Mass., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced that management will participate in the following investor conferences:
Jefferies 14th Annual Global Healthcare Conference
Fireside Chat Date and Time: Tuesday, November 14, 2023, at 9:30 a.m. GMT
Piper Sandler 35th Annual Healthcare Conference
Fireside Chat Date and Time: Tuesday, November 28, 2023, at 4:00 p.m. ET
The fireside chat will be webcast live and can be accessed from the Investors section of the Company's website: https://ir.collegiumpharma.com. A replay of the webcast will be archived on the Company's website for 90 days following the presentation.
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-participate-upcoming-investor-conferences-3
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