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ENDP - Endo Health Solutions Inc.


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U.S. FDA Approves AVEEDTM (Testosterone Undecanoate) Injectable Testosterone Replacement Therapy For Men Living With Hypogonadism, Or Low-T

 

AVEED offers distinct dosing schedule to increase testosterone levels in hypogonadal men, and underscores Endo's strategy and commitment to addressing health issues facing men

 

DUBLIN, March 6, 2014 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) announced today that its operating company Endo Pharmaceuticals Inc. received U.S. Food and Drug Administration (FDA) approval of AVEEDTM (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. AVEED is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750 mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter.  It is expected to be available in early March.

 

"Today's FDA approval of AVEED is a significant milestone for Endo.  AVEED expands our branded portfolio of men's health products and highlights our passion and commitment to providing high quality therapies that improve patient care," said Rajiv De Silva, president and chief executive officer of Endo.  "With AVEED, Endo can now offer men living with hypogonadism different treatment options to raise testosterone levels.  We are focused on getting AVEED to market to ensure that appropriate patients have access to it."

 

The approval of AVEED is based on data from an 84-week Phase 3 trial of hypogonadal men in the U.S. Men enrolled in the study had an average age of 54 years and a serum total testosterone level of less than 300 ng/dL.  In the Phase 3 study, AVEED increased mean serum testosterone levels, maintaining them for up to 10 weeks at steady state (between weeks 14-24). AVEED is approved with a Risk Evaluation and Mitigation System (REMS) requiring prescriber education and certification as well as restricted product distribution.

 

"Physicians have prescribed FDA-approved testosterone replacement therapies for many years to help treat men diagnosed with testosterone deficiency, or hypogonadism.  AVEED is an important new option that may be suitable for some men given its dosing schedule and administration," said Martin Miner, M.D., co-director of the Men's Health Center at Miriam Hospital and a clinical associate professor of Family Medicine and Urology at Brown University's Warren Alpert School of Medicine, Providence.  "As with any prescription therapy, hypogonadal men should talk to their doctor about the potential risks and benefits of testosterone replacement therapy so they can make an informed treatment decision."

 

"Men's Health Network is pleased to see the FDA approval of a new treatment for hypogonadism as we believe men with this condition should have access to a broad range of treatment options," said Ana Fadich, MPH, vice president of the national non-profit organization Men's Health Network.  "Men diagnosed with hypogonadism and their partners need to have an open discussion, with each other and the man's doctor, about the condition and ways to manage it so they can find the right treatment that best suits their individual needs."

 

http://www.endo.com/news-events/press-releases

 

 

Gio

 

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  • 3 weeks later...

Gio,

 

Is this enough of a pullback in the stock for you to buy more ENDP?

 

Right now I am really concentrating on LRE and ALS. Practically all my new funds get invested in those two businesses as soon as they come in…

Anyway, my target price to pull the trigger and add more ENDP is 15 x 2014 Cash EPS, which is around $55.

 

Gio

 

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  • 3 weeks later...

Gio,

 

I read somewhere that you are adding a little bit of ENDP, don't you think it's strange that you're paying 15.7 - 16.8 for 2014 cash EPS, while at Valeant you're paying between 14 - 14.8 ?

 

Ok, let us see:

Cash EPS at VRX from 2009 to 2013:

2009: $2.29

2010: $2.05

2011: $2.93

2012: $4.51

2013: $6.24

CAGR of 22.2%.

 

ENDP has an outlook for 2014 of $3.5 Cash EPS, therefore I have paid $57.2 / $3.5 = 16.3.

 

On the other hand, VRX has an outlook for 2014 of $8.5 Cash EPS, therefore I have paid $122 / $8.5 = 14.3.

 

Now let’s suppose ENDP for the next 5 years gets results in line with what VRX achieved from 2009 to 2013: ENDP’s Cash EPS in 2019 will be $9.5. If by then ENDP’s stock is trading at the same multiple of VRX today (14.3), it will be worth $9.5 x 14.3 = $135.

 

That would translate into a 18.8% compounded annual return on my investment.

 

To get a 15% compounded annual return on my investment, the stock would have to trade around $115, at a multiple of $115 / $9.5 = 12.

 

Given the size of ENDP today, and given the fact Mr. De Silva was with Mr. Pearson from 2009 to 2012, I think it could replicate VRX’s success.

 

Of course, I have also added a bit to my VRX position. And I waited a lower multiple, simply because I think the opportunities to move the needle at a $41 billion market cap company are less and harder to find, than the opportunities to make a $6.6 billion market cap company grow.

 

Gio

 

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I agree, I think its fair to pay a slightly higher multiple for Endo given that you should see faster earnings growth. I think there are still some levers left to pull to easily grow earnings, such as continuing to lower that tax rate and a chance to work on the gross margin. At Valeant there isn't much room left for margin expansion, tax rate cant get any lower, manufacturing efficiency plan is complete, and SG&A has been cut to the bone.

 

Endo also has so many opportunities for small deals that can still move the needle. <$1b deals where Endo can get a very high ROI. Valeant's highest ROI deals were the small companies that it could take new product revenue without many of the associated costs. Now with Valeant, targeting $10-50b businesses, the ROI is going to be a little lower IMO.

 

Of course there are other concerns with Endo, including its heavy reliance on pain and the mesh litigation liability.

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Endo Acquires Rights to Sumavel® DosePro®

 

 

-- Addition of product to Specialty Pharmaceuticals portfolio expected to be immediately accretive to adjusted diluted earnings per share

 

 

-- Product to be commercialized by current Endo Branded Pharmaceutical team

 

 

-- Expands portfolio of branded products in treatment of pain and migraine management

 

 

DUBLIN, April 24, 2014 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) announced today that affiliates of the company have acquired worldwide rights to Sumavel® DosePro® (sumatriptan injection) for subcutaneous use, a needle-free delivery system for sumatriptan, from Zogenix, Inc.

 

Under the terms of the agreement, Endo is acquiring the product for an upfront payment of $85 million and rights to additional cash payments based on the achievement of certain commercial milestones.  In addition, Endo will assume an existing third party royalty obligation on net sales. 

 

"We are pleased to acquire the worldwide rights to Sumavel DosePro to enhance our branded pharmaceutical portfolio," said Rajiv De Silva, President and CEO of Endo. "We are focused on completing a seamless transition of commercial support for this currently marketed product that will leverage our existing commercial expertise in pain and migraine management and the current infrastructure of our branded pharmaceuticals business overall."

 

Sumavel DosePro is a prescription medicine given with a needle-free delivery system to treat adults who have been diagnosed with acute migraine or cluster headaches. In clinical studies, relief started within 10 minutes for some patients, with most achieving relief within 1 or 2 hours. A burst of air delivers sumatriptan just under the skin in less than a second. Sumavel DosePro is designed to be used in just 3 simple steps: SNAP, FLIP, PINCH & PRESS. In a study evaluating the effectiveness of instructions for use, 51 out of 52 people used Sumavel DosePro correctly the first time with little instruction during a migraine attack.

 

http://www.endo.com/news-events/press-releases

 

 

Gio

 

 

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Endo to Acquire Specialty Pharmaceuticals Company Somar

Tuesday, April 29, 2014

 

DUBLIN, April 29, 2014 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) today announced it has entered into a definitive agreement under which Endo will acquire Grupo Farmaceutico Somar ("Somar"), a leading privately-owned specialty pharmaceuticals company based in Mexico City, Mexico, for cash consideration.  Endo expects the transaction to be immediately accretive to adjusted earnings per share.

 

"The acquisition of Somar is well-aligned with our goal of pursuing accretive acquisitions that enhance Endo's strategic positioning and diversifying our pharmaceutical business beyond the U.S. by accessing attractive emerging markets" said Rajiv De Silva, president and CEO of Endo.  "The transaction provides Endo with a strong growth platform in Mexico that we believe can be further leveraged more broadly in Latin America, a proven sales team, and scalable manufacturing facilities.  This acquisition allows us to fully benefit from the starting point that Paladin Labs established in Mexico.  We look forward to leveraging Endo's global resources to take full advantage of Somar's robust pipeline, which currently includes over 60 products expected to launch over the next 3 years."

 

Jose Miguel Ramos R., chief executive officer of Somar, stated, "We are excited about the combination with Endo, joining a best-in-class global organization with access to valuable resources that will help us realize the full potential of our opportunities across branded, generic, and OTC pharmaceuticals in Mexico and Latin America more broadly.  Our team is dedicated to developing and marketing new and effective treatments that improve patients' lives.  I am confident that Endo's commitment to building sustainable businesses will be invaluable as we continue forward with our mission."

 

Somar is a leading pharmaceutical company focused on the development, manufacturing, marketing and commercialization of high-quality products across all key market segments in Mexico.  Its portfolio targets Mexico's non-patented pharmaceutical market through 3 primary segments: Generics (private label and traditional generics, as well as products for government tender), Branded generics (dermatology and infectious disease platforms), and OTC (women's health and child care products).  The Company generated approximately $100 million of revenue in 2013 and has approximately 1,200 employees.

 

The transaction is subject to customary conditions, including the receipt of applicable antitrust/competition approvals.  It is expected to close in the third quarter of 2014.

 

Skadden, Arps, Slate, Meagher & Flom LLP and Creel, Garcia-Cuellar, Aiza y Enriquez, S.C. acted as advisors to Endo.  Deutsche Bank Securities Inc.and Galicia Abogados, S.C.acted as advisors to Somar.

 

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Endo Reaches Agreements in Principle to Settle a Substantial Majority of AMS Litigation Cases

Wednesday, April 30, 2014

 

 

 

DUBLIN, April 30, 2014 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) today announced that it has reached agreements in principle with several leading plaintiffs' law firms, including Motley Rice LLC, Blasingame, Burch, Garrard & Ashley, P.C., Levin Simes LLP, and Clark, Love & Hutson, G.P., to resolve approximately 20,000 claims relating to vaginal mesh products sold by Endo's AMS subsidiary.  The agreements, which are subject to final documentation, were entered into solely by way of compromise and settlement and are not in any way an admission of liability or fault.  The settlements, once final, will resolve a substantial majority of the AMS vaginal mesh-related claims.

 

Under the terms of the agreements, Endo estimates that it will pay an aggregate pre-tax amount of approximately $830 million in connection with the resolution of these claims. The aggregate amount is expected to be payable over time.  The settlements are subject to a number of requirements that the individual plaintiffs' law firms must fulfill, including verification of the implant of an AMS vaginal mesh product and confirmation of pertinent medical records. 

 

Endo previously established a product liability reserve of approximately $520 million for all then known, pending and estimated future claims primarily related to vaginal mesh products, which the Company believed represented the minimum anticipated loss AMS would sustain with respect to this litigation, including potential liabilities and/or possible settlements.  Based on the settlement agreements described above, the Company will incur an incremental pre-tax, non-cash charge of approximately $625 million in the first quarter of 2014, increasing the product liability accrual to approximately $1.1 billion in total.  Of this $1.1 billion, approximately $830 million is related to the resolution of the approximately 20,000 cases as noted above.  The Company anticipates that the total accrual represents payments through 2016. The Company will announce its first quarter 2014 financial results tomorrow, May 1st.

 

Endo's top priority is the safety and efficacy of its products and supporting the patients and physicians who use them.  The Company continues to support the FDA's recommendations that physicians be well trained and patients fully understand the risks associated with the use of mesh products.  Endo and AMS remain committed to the safety and efficacy of AMS's transvaginal mesh products and will continue developing AMS' Women's Health business and devices product suite so that women have appropriate access to innovative, safe and effective therapies. AMS's commitment to these treatment solutions is demonstrated by its ongoing and significant investments in developing clinical evidence to support the restoration of quality of life AMS's mesh solutions provide. 

 

AMS will also continue to invest in educational activities as part of an overall effort to continue to encourage patients and physicians to discuss the risks and benefits of AMS's surgical mesh.

 

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Title: Endo Reports First Quarter Financial Results

 

Date(s): 1-May-2014 6:00 AM

 

DUBLIN, May 1, 2014 /PRNewswire/ --

 

- Total quarterly revenues of $595 million, reported diluted (GAAP) loss per share of $3.41 and adjusted diluted EPS of $0.92.

- Company raises expected 2014 revenues to a range from $2.55 billion to $2.64 billion and raises expected 2014 adjusted diluted EPS to a range from $3.60 to $3.85.

- Company expects 2014 reported diluted (GAAP) loss per share to be in the range from $1.35 to $1.10.

- Company announced the acquisitions of Grupo Farmaceutico Somar and Sumavel DosePro as it continues to transform into a leading global specialty healthcare company.

- Company entered into agreements to repurchase approximately $240 million aggregate principal amount of its 1.75% Convertible Senior Notes due 2015.

- Company Reaches Agreements in Principle to Settle a Substantial Majority of AMS Litigation Cases.

 

Endo International plc (NASDAQ: ENDP) (TSX: ENL) today reported first quarter 2014 revenues of $595 million, compared to  first quarter 2013 revenues of $658 million. Endo reported a net loss of $437 million in first quarter 2014 compared to net income of $15 million in first quarter of 2013. As detailed in the supplemental financial information below, adjusted net income for the three months ended March 31, 2014 increased by 9 percent to $134 million, compared to adjusted net income of $123 million for the first quarter of 2013.

 

The net loss reported for the period is primarily attributable to a pre-tax, non-cash charge of approximately $625 million, to increase the company's product liability reserve for all known, pending and estimated future claims primarily related to vaginal mesh cases. As announced previously, the change in the accrual for product liability claims is attributable to agreements in principle that the company's AMS subsidiary has reached to resolve approximately 20,000 claims, which represents a substantial majority of the claims relating to vaginal mesh products.

 

Reported diluted loss per share for the first quarter of 2014 was $3.41, compared to first quarter 2013 reported earnings per share of $0.14.  Adjusted diluted EPS decreased by 16 percent to $0.92 for the first quarter of 2014 compared to $1.09 for the same period in 2013. 

 

"We had a solid first quarter delivering strong operating results as we continue to execute against our strategic plans to transform Endo into a leading global specialty healthcare company," said Rajiv De Silva, President and CEO of Endo. "We completed two acquisitions during the first quarter and will continue to actively pursue additional business development opportunities throughout the year. We are focused on building a diversified and sustainable portfolio of product offerings through a combination of disciplined allocation of capital to strategic growth opportunities and investment in organic growth drivers for our existing businesses."

 

 

Gio

 

 

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Just curious is anybody adding at these levels? What is your estimate of intrinsic value? It looks like MorningStar has it at $70

 

No, I am not adding. I added a few days ago at around $57. Now I am fine keeping my investment in ENDP and watching how the business develops. :)

 

Gio

 

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Endo Completes Acquisition of Rights to Sumavel® DosePro®

 

-Addition of product to Specialty Pharmaceuticals portfolio expected to be immediately accretive to adjusted diluted earnings per share

 

-Product to be commercialized by current Endo Branded Pharmaceutical team

 

-Expands portfolio of branded products in treatment of pain and migraine management

 

DUBLIN, May 19, 2014 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) announced today that affiliates of the company have completed the acquisition of worldwide rights to Sumavel® DosePro® (sumatriptan injection), a needle-free delivery system for subcutaneous use, from Zogenix, Inc, for $85 million in cash and rights to additional cash payments based on the achievement of certain commercial milestones.  In addition, Endo will assume an existing third party royalty obligation on net sales.  The transaction will be financed with Endo's current cash on hand.

 

 

Gio

 

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Endo Completes Sale of Early Stage Drug Discovery Portfolio

 

Date(s): 2-Jun-2014 7:30 AM

 

DUBLIN, June 2, 2014 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) today announced that its Endo Pharmaceuticals subsidiary has completed the sale of its branded pharmaceutical drug discovery platform to AsanaBioSciences, LLC, an independent member of the Amneal Alliance of Companies.  The deal includes an upfront payment as well as milestones on the achievement of certain development objectives.  Endo initiated the exploration of strategic alternatives for the portfolio of early stage drug discovery assets in 2013 as part of the company's portfolio optimization process.  The sale includes multiple early-stage drug discovery and development candidates in a variety of therapeutic areas, including oncology, pain and inflammation, among others.

 

"The sale of the early stage discovery platform is another step in the transformation of Endo," said Rajiv De Silva, president and CEO of Endo.  "We continue to make progress against the strategic objectives we set forth in 2013 and remain enthusiastic about what lies ahead for Endo.  We are committed to supporting the organic growth of our existing business segments as we search for attractive acquisition targets to enhance our portfolio of pharmaceutical products."

 

 

Gio

 

 

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Endo to Acquire DAVA Pharmaceuticals

Tuesday, June 24, 2014

 

DUBLIN, June 24, 2014 /PRNewswire/ --

•Adds high-margin marketed generics portfolio, robust near-term ANDA pipeline to Endo's existing generics portfolio

•Ability to leverage Endo's corporate platform and proven commercial expertise to maximize profitable growth

•Clear path to achievable synergies

•Expected to be immediately accretive to Endo's 2014 adjusted EPS

 

Endo International plc (NASDAQ: ENDP) (TSX: ENL) today announced that it has reached a definitive agreement to acquire DAVA Pharmaceuticals, Inc., a privately-held company specializing in marketed, pre-launch and pipeline generic pharmaceuticals, for $575 million in cash, with additional cash consideration of up to $25 million contingent on the achievement of certain sales milestones.  The acquisition enhances Endo's attractive commercialization and development platform and is expected to be immediately accretive to Endo's 2014 adjusted earnings per share (EPS).

 

"The acquisition of DAVA is another step in our pursuit of accretive and strategic external growth opportunities where we see a clear path to meaningful upside and synergies," said Rajiv De Silva, president and CEO of Endo.  "DAVA is well-positioned for continued strong and highly predictable financial performance with its existing commercial portfolio and attractive near-term pipeline, and is a natural fit for our generics business.  With Endo's sharp focus, lean operating model and improved execution within our core businesses, strategic acquisitions will continue to play a key role in maximizing our growth potential and cash flow to drive future value for Endo shareholders."

 

DAVA operates a highly-profitable generics franchise with 2013 revenue of approximately $131 million and 2013 adjusted EBITDA of approximately $100 million.  DAVA's strategically-focused generics portfolio includes 13 on-market products in a variety of therapeutic areas. In addition, DAVA has assembled a promising product pipeline across a multitude of therapeutic categories, including recent launches of generic Doxycycline and Cefdinir.  The Company also expects over 5 products to be launched in 2015, and more than 20 additional products to be launched over the next several years.  Going forward, DAVA will be well-positioned to leverage Endo's extensive relationships with the industry's most important suppliers and customers, commercial expertise, and financial strength to drive continued predictable cash flows and execute its product launch strategy.

 

The transaction is subject to requisite regulatory approvals and customary closing conditions, and is expected to be completed in the second half of 2014.

 

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Endo Delivers A Proposal To Acquire Auxilium Pharmaceuticals For $28.10 Per Share In Cash And Stock

- Endo's Proposal Provides Auxilium Shareholders with Substantial Premium, Immediate Cash Value, and Ongoing Participation in Endo's Global Expansion

- Combination would Accelerate Endo's Transformation to Leading Specialty Healthcare Company, Expand Platform for Future Organic Growth

- Addition of Auxilium's Leading Men's Healthcare Products and Development Portfolio would Significantly Enhance Endo's Branded Pharmaceutical Business

- Expected to be Immediately Accretive to Endo's Adjusted Diluted EPS

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  • 4 months later...

Endo International to join S&P 500 • 7:40 PM

 

Carl Surran, SA News Editor

Endo International (NASDAQ:ENDP) +2.9% AH on news it will join the S&P 500 later this month, replacing Covidien (NYSE:COV) after its acquisition by Medtronic (NYSE:MDT), which is expected to close next week.

Also, Boston Beer (NYSE:SAM) will take ENDP’s spot on the S&P MidCap 400, and Southside Bancshares (NASDAQ:SBSI) is tapped to join the S&P SmallCap 600

 

 

Gio

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Endo Pharmaceuticals (ENDP) confirms proposal to purchase Salix Pharmaceuticals for $175/sh cash and stock

Wednesday, March 11, 2015

 

ENDP today confirmed that it has submitted a proposal to the board of Salix to acquire all of the outstanding shares of common stock of Salix Pharmaceuticals, Ltd. in a negotiated cash and stock transaction.

 

Based on the closing stock price of Endo on 10-Mar-15, the transaction is valued at $175.00 per Salix share.

 

Endo believes that its cash and stock proposal would provide Salix shareholders with a substantial premium and immediate cash value, as well as the opportunity to participate in the significant upside potential of a global leader in specialty pharmaceuticals with a highly diversified platform for future growth, through a material equity component. Endo believes that its proposal constitutes a "Superior Proposal" under the terms of Salix's Merger agreement with Valeant Pharmaceuticals International (VRX)

 

If a negotiated transaction were to be agreed to with Salix, Endo anticipates that the transaction could close in Q2 and is confident that it would obtain any regulatory and shareholder approvals. The proposed transaction would not be subject to any financing condition.

Additional information regarding Endo's proposal, including the full terms and conditions, are included in a letter that Endo provided to the Salix board today, which is filed on Form 8-K with the SEC (see attached PDF). There can be no assurance that any transaction will result from this proposal.

 

BofA Merrill Lynch and Credit Suisse Securities (USA) LLC are serving as financial advisors to Endo

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Endo to Acquire Par Pharmaceutical, Strategically Expanding Generics Business to a Top 5 Industry Leader

 

Date(s): 18-May-2015 6:30 AM

 

For a complete listing of our news releases, please  click here

 

DUBLIN and WOODCLIFF LAKE, N.J., May 18, 2015 /PRNewswire/ --

•Transaction valued at $8.05 billion is transformative for Endo, creating a powerful platform for future growth and further strategic M&A

•Creates specialty pharmaceutical company with one of industry's fastest growing generics businesses and expanded product portfolio, pipeline, technology platform and manufacturing capabilities

•Positions Endo for long-term double-digit organic growth, strong cash flow and financial flexibility

•Accretive to non-GAAP diluted earnings per share within first 12 months with double-digit accretion to non-GAAP diluted earnings per share expected in 2016

•Projected total operational and tax synergies of $175 million while strategically maintaining R&D

•Par CEO Paul Campanelli to join Endo to lead generics business and join Executive Leadership Team

•Closing anticipated in 2H 2015

 

http://www.prnewswire.com/news-releases/endo-to-acquire-par-pharmaceutical-strategically-expanding-generics-business-to-a-top-5-industry-leader-300084670.html

 

 

Gio

 

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