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Collegium Pharmaceutical price target raised to $42 from $36 at Piper Sandler 06:03 COLL, BDSI Piper Sandler analyst David Amsellem raised the firm's price target on Collegium Pharmaceutical (COLL) to $42 from $36 and keeps an Overweight rating on the shares following the BioDelivery Sciences (BDSI) acquisition announcement. The analyst believes that visibility into EBITDA in excess of $300M by 2023 is relatively high. Show Related Items >>
Read more at:
https://thefly.com/n.php?id=3463057
Since 2016, 1K+ government officials have been affected by persistent, mysterious, neurological incidences.
"Havana Syndrome" stumps investigators as U.S. officials report injuries on White House grounds
60 minutes - Feb. 20, 2022
COLL - buyout of BDSI includes 3 FDA approved drugs. One of which is is new to the market for MIGRAINES.
Dr. Jessica Ailani and Dr. Peter McAllister share their views on ELYXYB™ (celecoxib) oral solution, the first and only FDA-approved treatment of its kind for MIGRAINES.
Watch video -
https://vimeo.com/639176222?embedded=true&source=vimeo_logo&owner=138775481
Also:
https://ir.bdsi.com/news-releases/news-release-details/biodelivery-sciences-international-completes-acquisition
Dr. Jessica Ailani and Dr. Peter McAllister share their views on ELYXYB™ (celecoxib) oral solution, the first and only FDA-approved treatment of its kind for MIGRAINES.
Watch video -
https://vimeo.com/639176222?embedded=true&source=vimeo_logo&owner=138775481
Analysts' Upgrades -
A. Cantor upgrades Collegium on revenue diversification from deal 16:28 COLL, BDSI Cantor Fitzgerald analyst Brandon Folkes upgraded Collegium Pharmaceutical (COLL) to Overweight from Neutral with a price target of $26, up from $18, following the company's acquisition of BioDelivery Sciences (BDSI). The upgrade is driven by the diversification in revenue in which the deal brings, as well as a footprint in the adjacency neurology category, Folkes tells investors in a research note. The analyst believes Collegium's newly diversified revenue streams and therapeutic focus are both "multiple enhancing." Folkes adds that while his overall concerns with the branded Xtampza and OxyContin market decline has not subsided, the start of 2022 offers "some hope that the decline could stabilize this year."
Read more at:
https://thefly.com/n.php?id=3458996
B. Collegium Pharmaceutical price target raised to $29 from $26 at H.C. Wainwright
C. Collegium Pharmaceutical price target raised to $34 from $28 at Needham 07:16 COLL, BDSI
Collegium to Acquire BioDelivery Sciences Broadening Pain Portfolio
February 14, 2022 at 6:30 AM EST
Expected to be Immediately and Highly Accretive Driven by Identified Annual Synergies of at Least $75 Million -
- Will Diversify Revenue Growth and Accelerate Cash Flow Generation -
- Addition of BELBUCA® Provides a Second Growth Driver and ELYXYB™ Establishes Foothold in Neurology -
- Conference Call Scheduled for Today at 8:30 a.m. ET -
STOUGHTON, Mass. and RALEIGH, N.C., Feb. 14, 2022 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) and BioDelivery Sciences International, Inc. (NASDAQ: BDSI) today announced a definitive agreement pursuant to which Collegium will acquire BDSI for $5.60 per share in cash.
BDSI has a portfolio of pain and neurology products that address serious and debilitating conditions. BDSI’s commercial growth driver, BELBUCA, is a meaningfully differentiated schedule III opioid product and is highly complementary to Collegium’s portfolio of pain products. Additional products in the BDSI portfolio include Symproic®, a contributor, and ELYXYB, a neurology product in its early launch phase.
“We are excited to announce this acquisition, which represents a major step forward in our mission to build a leading, diversified specialty pharmaceutical company committed to improving the lives of people suffering from serious medical conditions,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “The BDSI portfolio expands and enhances Collegium’s differentiated pain offerings and establishes a foothold in neurology, a strategic market adjacency. Importantly, we expect this acquisition will be immediately and highly accretive by expanding our revenue scale and generating significant synergies.”
“We are pleased to announce the transaction with Collegium, which we view as a testament to the attractiveness of our portfolio and long-term value of our brands,” said Jeff Bailey, Chief Executive Officer of BDSI. “Our team has worked diligently to grow our differentiated products. We believe that this transaction will deliver benefits to patients and prescribers and create significant value for our shareholders.”
Transaction Rationale
Strategically aligned with Collegium’s mission to build a leading, diversified specialty pharmaceutical company committed to improving the lives of people suffering from serious medical conditions
Diversifies and expands Collegium’s revenues by adding BELBUCA as a second and highly complementary growth driver to Collegium’s highly differentiated pain portfolio, in addition to a contributor with Symproic, and a new product launch opportunity with ELYXYB
Further strengthens Collegium’s financial position through increased revenue scale, immediate and significant earnings accretion, and accelerated cash flow generation, driven by identified annual run rate synergies of at least $75 million expected to be achieved within twelve months post-closing
ELYXYB provides entry into the neurology market, a strategic market adjacency previously identified by Collegium
Additional Transaction Details
Under the terms of the definitive agreement, Collegium will promptly commence a tender offer to acquire all the outstanding shares of BDSI at the price of $5.60 per share
The offer price of $5.60 represents a 54% premium to BDSI closing share price of $3.64 as of Friday, February 11, 2022, and implies a fully diluted equity value of approximately $604 million using the treasury stock method
The all-cash consideration will be funded by a combination of Collegium existing cash on hand and a $650 million secured financing from funds managed by Pharmakon Advisors, LP (“Pharmakon”), with a four-year term, which will bear an interest rate of Libor+750bps and will be amortized over four years
As part of the transaction, Collegium will repay the existing Collegium term loan from Pharmakon and the existing BDSI term loan from Pharmakon
Post-closing, we expect Collegium net leverage to be below 3.0x based on estimated fiscal year 2021 pro forma combined EBITDA including run rate synergies
Collegium expects to achieve annual run rate synergies of at least $75 million, based off of BDSI estimated 2021 operating expenses, within twelve months post-closing
Collegium expects this transaction to be highly accretive to earnings in 2022 and 2023
Timing to Close
The transaction, which has been unanimously approved by the boards of directors of both companies, is expected to close late in the first quarter 2022, subject to customary closing conditions, including receipt of required regulatory approvals and the tender of a majority of outstanding shares of BDSI’s common stock. Following the successful closing of the tender offer, Collegium will acquire any shares of BDSI that are not tendered in the tender offer through a second-step merger at the same consideration as paid in the tender offer.
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-acquire-biodelivery-sciences-broadening-pain-portfolio
Collegium to Acquire BioDelivery Sciences Broadening Pain Portfolio
February 14, 2022 at 6:30 AM EST
- Expected to be Immediately and Highly Accretive Driven by Identified Annual Synergies of at Least $75 Million -
- Will Diversify Revenue Growth and Accelerate Cash Flow Generation
- Addition of BELBUCA® Provides a Second Growth Driver and ELYXYB™ Establishes Foothold in Neurology -
- Conference Call Scheduled for Today at 8:30 a.m. ET -
STOUGHTON, Mass. and RALEIGH, N.C., Feb. 14, 2022 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) and BioDelivery Sciences International, Inc. (NASDAQ: BDSI) today announced a definitive agreement pursuant to which Collegium will acquire BDSI for $5.60 per share in cash.
BDSI has a portfolio of pain and neurology products that address serious and debilitating conditions. BDSI’s commercial growth driver, BELBUCA, is a meaningfully differentiated schedule III opioid product and is highly complementary to Collegium’s portfolio of pain products. Additional products in the BDSI portfolio include Symproic®, a contributor, and ELYXYB, a neurology product in its early launch phase.
“We are excited to announce this acquisition, which represents a major step forward in our mission to build a leading, diversified specialty pharmaceutical company committed to improving the lives of people suffering from serious medical conditions,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “The BDSI portfolio expands and enhances Collegium’s differentiated pain offerings and establishes a foothold in neurology, a strategic market adjacency. Importantly, we expect this acquisition will be immediately and highly accretive by expanding our revenue scale and generating significant synergies.”
“We are pleased to announce the transaction with Collegium, which we view as a testament to the attractiveness of our portfolio and long-term value of our brands,” said Jeff Bailey, Chief Executive Officer of BDSI. “Our team has worked diligently to grow our differentiated products. We believe that this transaction will deliver benefits to patients and prescribers and create significant value for our shareholders.”
Transaction Rationale
Strategically aligned with Collegium’s mission to build a leading, diversified specialty pharmaceutical company committed to improving the lives of people suffering from serious medical conditions
Diversifies and expands Collegium’s revenues by adding BELBUCA as a second and highly complementary growth driver to Collegium’s highly differentiated pain portfolio, in addition to a contributor with Symproic, and a new product launch opportunity with ELYXYB
Further strengthens Collegium’s financial position through increased revenue scale, immediate and significant earnings accretion, and accelerated cash flow generation, driven by identified annual run rate synergies of at least $75 million expected to be achieved within twelve months post-closing
ELYXYB provides entry into the neurology market, a strategic market adjacency previously identified by Collegium
Additional Transaction Details
Under the terms of the definitive agreement, Collegium will promptly commence a tender offer to acquire all the outstanding shares of BDSI at the price of $5.60 per share
The offer price of $5.60 represents a 54% premium to BDSI closing share price of $3.64 as of Friday, February 11, 2022, and implies a fully diluted equity value of approximately $604 million using the treasury stock method
The all-cash consideration will be funded by a combination of Collegium existing cash on hand and a $650 million secured financing from funds managed by Pharmakon Advisors, LP (“Pharmakon”), with a four-year term, which will bear an interest rate of Libor+750bps and will be amortized over four years
As part of the transaction, Collegium will repay the existing Collegium term loan from Pharmakon and the existing BDSI term loan from Pharmakon
Post-closing, we expect Collegium net leverage to be below 3.0x based on estimated fiscal year 2021 pro forma combined EBITDA including run rate synergies
Collegium expects to achieve annual run rate synergies of at least $75 million, based off of BDSI estimated 2021 operating expenses, within twelve months post-closing
Collegium expects this transaction to be highly accretive to earnings in 2022 and 2023.
Timing to Close
The transaction, which has been unanimously approved by the boards of directors of both companies, is expected to close late in the first quarter 2022, subject to customary closing conditions, including receipt of required regulatory approvals and the tender of a majority of outstanding shares of BDSI’s common stock. Following the successful closing of the tender offer, Collegium will acquire any shares of BDSI that are not tendered in the tender offer through a second-step merger at the same consideration as paid in the tender offer.
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-acquire-biodelivery-sciences-broadening-pain-portfolio
From COLL career posts -
We will continue to work hard to position Collegium to usher in a next generation of non-opioid pain solutions in the US market.
FDA NEWS RELEASE
FDA Takes Steps Aimed at Fostering Development of Non-Addictive Alternatives to Opioids for Acute Pain Management
https://www.fda.gov/news-events/press-announcements/fda-takes-steps-aimed-fostering-development-non-addictive-alternatives-opioids-acute-pain-management
___________________________________________
Amended statement of ownership -
Vanguard owns 6.62% of COLL
https://ih.advfn.com/stock-market/NASDAQ/collegium-pharmaceutical-COLL/stock-news/87235991/amended-statement-of-ownership-sc-13g-a
January 28, 2022
A Form SC 13G/A has been filed with the United States Securities and Exchange Commission.
View this filing ?
https://ir.collegiumpharma.com/static-files/a1aa0b3b-4a52-4c4d-92c6-c056887cc664
BlackRock, Inc. now owns 5550301 shares or 16.3% of Collegium
What Can a Schedule 13D Tell an Investor?
A Schedule 13D is a document that must be filed with the Securities and Exchange Commission (SEC) within 10 days of the purchase of more than 5% of the shares of a public company by anyone investor or entity. It is sometimes referred to as a beneficial ownership report.1?
This document, which is publicly available, provides useful information about majority ownership in the company. It reveals the name, ownership amount, and stated intentions of any investor who has purchased a substantial share of a company.2? (The buyer might not intend an outright takeover. It might, for example, be a purchase by an activist investor seeking more management input.)
KEY TAKEOVERS
The Schedule 13D is a required SEC filing for entities acquiring more than 5% of the stock of a public company.
It is seen as a signal of an imminent corporate takeover.
Significant information in the 13D includes the source of the funds used for the purchase.1?
Read more:
https://www.investopedia.com/ask/answers/09/schedule-13d.asp
What does this tell you?
Principal Financial Group Inc. Acquires 25,684 Shares of Collegium Pharmaceutical, Inc.
Collegium Pharmaceutical logoPrincipal Financial Group Inc. grew its holdings in shares of Collegium Pharmaceutical, Inc. (NASDAQ:COLL) by 2.5% in the third quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission (SEC). The firm owned 1,057,611 shares of the specialty pharmaceutical company’s stock after acquiring an additional 25,684 shares during the period. Principal Financial Group Inc. owned about 3.06% of Collegium Pharmaceutical worth $20,878,000 as of its most recent filing with the Securities and Exchange Commission (SEC).
Several other hedge funds have also modified their holdings of COLL. Peregrine Capital Management LLC bought a new stake in shares of Collegium Pharmaceutical during the 3rd quarter valued at $13,464,000. Dimensional Fund Advisors LP grew its position in shares of Collegium Pharmaceutical by 33.2% during the 2nd quarter. Dimensional Fund Advisors LP now owns 775,908 shares of the specialty pharmaceutical company’s stock valued at $18,344,000 after acquiring an additional 193,468 shares during the period. Massachusetts Financial Services Co. MA grew its position in shares of Collegium Pharmaceutical by 29.4% during the 2nd quarter. Massachusetts Financial Services Co. MA now owns 832,554 shares of the specialty pharmaceutical company’s stock valued at $19,682,000 after acquiring an additional 189,232 shares during the period. Federated Hermes Inc. boosted its holdings in Collegium Pharmaceutical by 76,168.4% in the 2nd quarter. Federated Hermes Inc. now owns 171,604 shares of the specialty pharmaceutical company’s stock worth $4,057,000 after buying an additional 171,379 shares during the period. Finally, LSV Asset Management bought a new position in Collegium Pharmaceutical in the 3rd quarter worth $2,899,000.
https://etfdailynews.com/news/principal-financial-group-inc-acquires-25684-shares-of-collegium-pharmaceutical-inc-nasdaqcoll/
Best Value Pharmaceutical Stocks - 12 Jan.
These are the pharmaceutical stocks with the lowest 12-month trailing price-to-earnings (P/E) ratio. Because profits can be returned to shareholders in the form of dividends and buybacks, a low P/E ratio shows you’re paying less for each dollar of profit generated.
https://www.investopedia.com/investing/pharmaceutical-stocks/?utm_campaign=quote-yahoo&utm_source=yahoo&utm_medium=referral
COLL recommendation - January 3
Sonic Automotive And 5 Other Stocks Have High Sales Growth And An Above 3% Return on Equity
https://via.news/markets/sonic-automotive-5-other-stocks-high-sales-growth-an-above-3-return-equity-3/
“We are pleased to be in a position to resolve these cases and move forward. We remain committed to our mission of being the leader in responsible pain management,” said Shirley Kuhlmann, Executive Vice President, General Counsel of Collegium.
Collegium Announces Settlement Framework to Resolve Pending Opioid-Related Litigation
https://ir.collegiumpharma.com/news-releases/news-release-details/collegium-announces-settlement-framework-resolve-pending-opioid
Now - UP!
Three items:
A. Current restructuring is eliminating approximately 50 positions. However, 9 new career listings are now posted -
https://careers-collegiumpharma.icims.com/jobs/search?mobile=false&width=1170&height=500&bga=true&needsRedirect=false&jan1offset=-300&jun1offset=-240
B. Jeffries recommends COLL -
https://www.thestreet.com/investing/jefferies-small-caps-callaway-january
C. Dreyer Scott, EVP & Chief Commercial Officer, sells 5,693 shares at $18.33. Probably to buy holiday gifts for Joe Ciaffoni.
https://ir.collegiumpharma.com/static-files/7482db0d-8b8c-4e7c-9bf8-37969521eab9
Besides the moon & the stars - who reads these posts? LOL
Analysts Expect Collegium Pharmaceutical, Inc. (NASDAQ:COLL) to Announce $1.04 Earnings Per Share 12/9/2021
Collegium Pharmaceutical Wall Street analysts expect that Collegium Pharmaceutical, Inc. (NASDAQ:COLL) will report $1.04 earnings per share (EPS) for the current fiscal quarter, Zacks reports. Four analysts have provided estimates for Collegium Pharmaceutical's earnings, with the lowest EPS estimate coming in at $0.96 and the highest estimate coming in at $1.09. Collegium Pharmaceutical posted earnings per share of $0.20 in the same quarter last year, which indicates a positive year over year growth rate of 420%. The company is expected to issue its next quarterly earnings results on Thursday, February 24th.
https://www.marketbeat.com/instant-alerts/nasdaq-coll-consensus-analyst-rating-2021-12/
10 Growth Stocks Under $20 in Billionaire Ken Fisher’s Portfolio
Mon, December 6, 2021, 1:42 PM
10. Collegium Pharmaceutical, Inc. (NASDAQ:COLL)
Number of Hedge Fund Holders: 13
Price as of December 5, 2021: $17.61 per share
Collegium Pharmaceutical, Inc. (NASDAQ:COLL) is a pharmaceutical company that focuses on developing medicines for pain management. Latest data shows that Fisher Asset Management owned 20,349 shares of the company at the end of the third quarter of 2021 worth $402,000.
HC Wainwright analyst Oren Livnat has a Buy rating on Collegium Pharmaceutical, Inc. (NASDAQ:COLL) stock with a price target of $26. In a recent investor note, the analyst appreciated the potential of pipeline drugs of the firm.
Among the hedge funds being tracked by Insider Monkey, New York-based firm Rubric Capital Management is a leading shareholder in Collegium Pharmaceutical, Inc. (NASDAQ:COLL) with 2.6 million shares worth more than $51 million.
At the end of the third quarter of 2021, 13 hedge funds in the database of Insider Monkey held stakes worth $144 million in Collegium Pharmaceutical, Inc. (NASDAQ:COLL), down from 16 in the preceding quarter worth $209 million.
Just like Apple Inc. (NASDAQ:AAPL), Microsoft Corporation (NASDAQ:MSFT), Amazon.com, Inc. (NASDAQ:AMZN), and Alphabet Inc. (NASDAQ:GOOG), Collegium Pharmaceutical, Inc. (NASDAQ:COLL) is one of the stocks on the radar of growth investors.
https://finance.yahoo.com/news/10-growth-stocks-under-20-184250597.html
10 Growth Stocks Under $20 in Billionaire Ken Fisher’s Portfolio
Mon, December 6, 2021, 1:42 PM
10. Collegium Pharmaceutical, Inc. (NASDAQ:COLL)
Number of Hedge Fund Holders: 13
Price as of December 5, 2021: $17.61 per share
Collegium Pharmaceutical, Inc. (NASDAQ:COLL) is a pharmaceutical company that focuses on developing medicines for pain management. Latest data shows that Fisher Asset Management owned 20,349 shares of the company at the end of the third quarter of 2021 worth $402,000.
HC Wainwright analyst Oren Livnat has a Buy rating on Collegium Pharmaceutical, Inc. (NASDAQ:COLL) stock with a price target of $26. In a recent investor note, the analyst appreciated the potential of pipeline drugs of the firm.
Among the hedge funds being tracked by Insider Monkey, New York-based firm Rubric Capital Management is a leading shareholder in Collegium Pharmaceutical, Inc. (NASDAQ:COLL) with 2.6 million shares worth more than $51 million.
At the end of the third quarter of 2021, 13 hedge funds in the database of Insider Monkey held stakes worth $144 million in Collegium Pharmaceutical, Inc. (NASDAQ:COLL), down from 16 in the preceding quarter worth $209 million.
Just like Apple Inc. (NASDAQ:AAPL), Microsoft Corporation (NASDAQ:MSFT), Amazon.com, Inc. (NASDAQ:AMZN), and Alphabet Inc. (NASDAQ:GOOG), Collegium Pharmaceutical, Inc. (NASDAQ:COLL) is one of the stocks on the radar of growth investors.
https://finance.yahoo.com/news/10-growth-stocks-under-20-184250597.html
Needham Thinks Collegium Pharmaceutical’s Stock is Going to Recover
November 26 2021 - 11:15AM
In a report released today, Serge Belanger from Needham maintained a Buy rating on Collegium Pharmaceutical (COLL – Research Report), with a price target of $28.00. The company's shares closed last Friday at $17.83, close to its 52-week low of $17.67. According to TipRanks.com, Belanger is a 3-star analyst with an average return of 1.8% and a 38.5% success rate. Belanger covers the Healthcare sector, focusing on stocks such as Clarus Therapeutics Holdings, Amphastar Pharmaceuticals, and KalVista Pharmaceuticals. Currently, the analyst consensus on Collegium Pharmaceutical is a Strong Buy with an average price target of $27.00.
https://ih.advfn.com/stock-market/NASDAQ/collegium-pharmaceutical-COLL/stock-news/86665851/needham-thinks-collegium-pharmaceutical-s-stock-i
New Corporate slide show presentation at Jefferies - Nov. 18:
Select Pages 14, 15 & 22
https://ir.collegiumpharma.com/static-files/a38f74ec-ad9f-48d8-b0a2-37766a071619
FWIW -
These 40 Mass. companies made the new Deloitte Fast 500 list https://www.bizjournals.com › boston › news › 2021/11/17
The list, released Wednesday, ranks the fastest-growing technology, media, telecommunications and life sciences companies based in North America.
Collegium Pharmaceutical Inc., No. 138
Realistically, even considering the buyback & the restructuring, they need to fire their PR department. This stock has stagnated for years.
Sell the company for $85 PPS!!
Collegium Pharmaceutical price target lowered to $26 from $28 at H.C. Wainwright
H.C. Wainwright analyst Oren Livnat lowered the firm's price target on Collegium Pharmaceutical to $26 from $28 and keeps a Buy rating on the shares. The analyst sees Xtampza 20022 return to growth likely, with potential 2023 accelerations if contracts improved. Livnat added that COVID-related mix shift worsened in Q3, and that "all eyes" are now on the company's 2022 guidance and execution.
FYI - Seeking Alpha -
Risks and Conclusions
The current valuation that investors are placing on the company is likely more than just disappointment from the CRL. I think management has done a massive disservice to investors and analysts alike by not disclosing the results of the 483 during their August conference call (or sooner). Even after analysts spoke with consultants and the company, we still saw bullish notes expecting approval. With an original PDUFA date of November 25th, 2020 it remains a mystery how management could fall so short on the protocols set forth for their manufacturing processes. Now, I think we will get a lot of color on the conference call next month, and hopefully some tough questions from analysts, but it appears to me that we need to take what management says with a grain of salt until we see changes being made. I think many investors expect CEO Mark Foley to explain his timely disposition of $1m of stock two days before the company announced it had received a CRL. I was shocked by this as well, but after doing some digging it appears Mr. Foley made a similarly sized disposition on the same exact date in 2020.
We also need to take into account the risks posed by AbbVie in its recent patent infringement case filed against Revance. Analysts have largely brushed off the lawsuit's potential to matriculate into anything with substance. However, that doesn't mean that legal costs won't start to mount and eventually damage shareholder value. This is something I'll look to monitor closely.
IMHO - I wouldn't be surprised if TAKEDA bought out COLL.
Rationale:
COLL - is way too cheap! At 7 times earnings plus a $100M buyback - the stock has been going NO-WHERE. If this was a biotech - the stock would be $100+ PPS due to earnings alone.
Most importantly - Colleen Tupper - Prior to joining Collegium [in May 2021], Colleen most recently served as Chief Financial Officer, U.S. Business Unit as well as a member of the U.S. Business Unit Executive Leadership Team and the Global Finance Leadership Team at Takeda.
Prior to that role, Colleen held several roles of increasing responsibility at Shire Pharmaceuticals (acquired by Takeda in 2019) including Vice President, U.S. Commercial Finance, Vice President, Finance Integration Lead, and Vice President, Head of Finance Global Neuroscience and Ophthalmics.
https://www.collegiumpharma.com/people/colleen-tupper/
______________________________________
On April 19, 2018 Takeda made an official bid of about $66.22 (U.S.) per share, which had a value of about $60 billion (U.S.). ... Under the final bid, Shire agreed to be acquired for about $62.2 billion (U.S.), or $66.22 per share, made up of $30.33 per share in cash and 0.839 shares of Takeda stock. Jan 8, 2019
$COLL - Collegium Pharmaceuticals DCF - 20 October 2021
To all my good friends on the RVNC board - I have sold all my RVNC & will concentrate on COLL. Stay well & the best of luck.
FYI -
Our Call,18 October:
While RVNC did not disclose the specifics of the CRL, based on our conversation with a bio manufacturing expert earlier this week, we suspect that the deficiencies in the CRL had to do specifcally with observation #2 (and/or potentially #1). Our expert suggested
that observation #1 was likely fixable in a few weeks, whereas #2 had the potential to be more troublesome given its nature (i.e., using a different manufacturing process than described in the BLA).
FWIW -
Needham reiterated coverage of Revance Therapeutics with a rating of Buy and set a new price target of $25.00 from $45.00 previously
Stifel - $RVNC more optimistic saying possibly 3-6 month delay With RVNC stock set to open after $15 - find this ~ 45% drop from pre-Form-483 levels an overreaction to what could be a relatively marginal delay in light of opportunity as only differentiated, long-duration toxin in market.
Stifel - $RVNC more optimistic saying possibly 3-6 month delay With RVNC stock set to open after $15 - find this ~ 45% drop from pre-Form-483 levels an overreaction to what could be a relatively marginal delay in light of opportunity as only differentiated, long-duration toxin in market.
From your same article - how well I know -
Even more odious to FDA than manufacturing problems are repeat manufacturing problems.
Momenta Pharmaceuticals felt the effects of such repeat problems and took a financial blow when it reported in February that compliance issues at a supplier might delay approval of a high-dose version of its multiple sclerosis drug, Glatopa. After the news, Momenta’s stock price dropped 20%, and it continued to fall further.
Momenta’s development partner, Sandoz, had contracted with Pfizer for filling and finishing the final product. Pfizer, in turn, had received a warning letter in regard to a sterile injectable drug facility in McPherson, Kan. The plant is one of several with cGMP violations that Pfizer acquired when it bought Hospira in 2015.
“These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” FDA wrote in the warning letter. That the letter was also addressed to Pfizer CEO Ian Read is noteworthy, Evercore ISI stock analyst Umer Raffat said. “When FDA addresses the letter to the senior-most person, it is trying to make a statement.”
I had to take several B/P pills after this announcement as MNTA went from a one-time high of 30 to somewhere in the high teens.
MIRACULOUSLY, I held & approximately 2 years later - J&J bought them out for $52.50.
I'm older now, not sure if I have the stamina since my nerves are now - permanently frazzled!
Updated analysts' reports - [excerpts]
Revance issues in Form 483 'must be very addressable,' says Mizuho 07:05 RVNC Mizuho analyst Vamil Divan says that while the Form 483 disclosure yesterday led to many questions and confusion from investors, Revance Therapeutics' comments last night provide comfort. Most importantly, management already responded to the questions raised in the Form 483 later that month, Divan tells investors in a research note. While management was not able to go into detail on the steps they are taking to address FDA's concerns, Divan believes the issues "must be very addressable" for the company to still expect FDA approval by the end of the year. Divan still expects approval for Daxi and keeps a Buy rating on Revance with a $36 price target.
________________________________________
Wells-Fargo
We spoke to RVNC mgmt. tonight after the company issued a PR.
A CRL has not been issued. Mgmt. commented that FDA should now have sufficient information to make an approval decision, and at this stage, does not envision a second inspection to be required.
Revance Therapeutics, Inc.
Equity Research
Price Target Basis and Risk
Price Target for RVNC: $35.00 from NC
Updated analysts' reports - [excerpts]
Revance issues in Form 483 'must be very addressable,' says Mizuho 07:05 RVNC Mizuho analyst Vamil Divan says that while the Form 483 disclosure yesterday led to many questions and confusion from investors, Revance Therapeutics' comments last night provide comfort. Most importantly, management already responded to the questions raised in the Form 483 later that month, Divan tells investors in a research note. While management was not able to go into detail on the steps they are taking to address FDA's concerns, Divan believes the issues "must be very addressable" for the company to still expect FDA approval by the end of the year. Divan still expects approval for Daxi and keeps a Buy rating on Revance with a $36 price target.
________________________________________
Wells-Fargo
We spoke to RVNC mgmt. tonight after the company issued a PR.
A CRL has not been issued. Mgmt. commented that FDA should now have sufficient information to make an approval decision, and at this stage, does not envision a second inspection to be required.
Revance Therapeutics, Inc.
Equity Research
Price Target Basis and Risk
Price Target for RVNC: $35.00 from NC
Revance issues in Form 483 'must be very addressable,' says Mizuho
[Remainder blocked from the FLY.]
Fair recovery, so far, after hours:
Open....$27.30
Block Trade Count....18
Close....$20.45
Bid
/ Ask
$22.50/23.00
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Revance Continues to Anticipate FDA Approval of DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines in 2021
October 12, 2021
PDF Version
- BLA for DaxibotulinumtoxinA for Injection remains under FDA review -
NASHVILLE, Tenn.--(BUSINESS WIRE)--Oct. 12, 2021-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, responds to the public disclosure of its Form 483 pursuant to a Freedom of Information Act (FOIA) request that was directed to the FDA. The Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection remains under FDA review and the company continues to anticipate FDA approval of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines in 2021.
Revance notes that the issuance of a Form 483 following the conclusion of an on-site inspection is not uncommon. A Form 483 lists observations made by FDA representatives during the inspection of a facility. A Form 483 does not constitute a final agency determination.
Revance provided its response to the Form 483 in July 2021 following a pre-approval inspection and is currently awaiting the FDA’s decision on its BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines. The company remains confident in the quality of its BLA submission and continues to anticipate FDA approval in 2021.
https://investors.revance.com/news-releases/news-release-details/revance-continues-anticipate-fda-approval-daxibotulinumtoxina
Time to buy! The FLY -
Revance likely already responded to FDA plant observations, says William Blair 15:35
RVNC
William Blair analyst Tim Lugo noted that Revance shares are trading down by more than 20% following the posting of a Form 483 by the FDA with five observations from an inspection that occurred in late June and early July. While "the public airing of concerns with the manufacturing site is leading to investor anxiety," he notes that Revance's CEO has publicly stated as recently as September that the inspection was "very typical" and that the company was still awaiting a final FDA decision. Lugo believes management's recent commentary, and "the high credibility of management," suggest the company has likely already responded to the agency and dealt with the issues raised, he tells investors. Lugo has an Outperform rating on Revance, which is down about 25% to $20.49 in late day trading.
Time to buy! The Fly -
Revance likely already responded to FDA plant observations, says William Blair 15:35
RVNC
William Blair analyst Tim Lugo noted that Revance shares are trading down by more than 20% following the posting of a Form 483 by the FDA with five observations from an inspection that occurred in late June and early July. While "the public airing of concerns with the manufacturing site is leading to investor anxiety," he notes that Revance's CEO has publicly stated as recently as September that the inspection was "very typical" and that the company was still awaiting a final FDA decision. Lugo believes management's recent commentary, and "the high credibility of management," suggest the company has likely already responded to the agency and dealt with the issues raised, he tells investors. Lugo has an Outperform rating on Revance, which is down about 25% to $20.49 in late day trading.
Basically -
"We believe the alleged patent issues asserted by Allergan in this case are not infringed upon by Revance or our supply source partner Ajinomoto or are invalid," Revance said in a statement. "We are confident in the strength of our intellectual property and have done and will vigorously defend these allegations."
The lawsuit is one of several Allergan has filed against companies threatening to cut in on its aesthetics and therapeutics applications for Botox. Revance said lawsuits are "a frequent tactic" Allergan uses to "distract their competitors."
"If anything, we believe it speaks to Allergan's concern of how impactful our differentiated product will be in the market once approved," Revance said.
https://www.bizjournals.com/sanfrancisco/news/2021/10/04/botox-allergan-revance-daxi-frown-lines-ajinomoto.html?ana=TRUEANTHEMTWT_FR&csrc=6398&taid=615bf7fd76ce460001396e2b&utm_campaign=trueAnthem%3A+Trending+Content&utm_medium=trueAnthem&utm_source=twitter
Two items:
A. Botox war: East Bay challenger sued by maker of blockbuster cosmetic toxin [**follow discussion on Biotech Values board]
Basically -
"We believe the alleged patent issues asserted by Allergan in this case are not infringed upon by Revance or our supply source partner Ajinomoto or are invalid," Revance said in a statement. "We are confident in the strength of our intellectual property and have done and will vigorously defend these allegations."
The lawsuit is one of several Allergan has filed against companies threatening to cut in on its aesthetics and therapeutics applications for Botox. Revance said lawsuits are "a frequent tactic" Allergan uses to "distract their competitors."
"If anything, we believe it speaks to Allergan's concern of how impactful our differentiated product will be in the market once approved," Revance said.
https://www.bizjournals.com/sanfrancisco/news/2021/10/04/botox-allergan-revance-daxi-frown-lines-ajinomoto.html?ana=TRUEANTHEMTWT_FR&csrc=6398&taid=615bf7fd76ce460001396e2b&utm_campaign=trueAnthem%3A+Trending+Content&utm_medium=trueAnthem&utm_source=twitter
B. Fosun concludes patient enrollment for Ph 3
https://twitter.com/medtechmd/status/1445013357044453378/photo/1