throbber
12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`
`Ticker or Keyword
`
`(cid:205) MENU
`
`(cid:30)
`
`Momenta Slowed
`(Temporarily)
`Momenta Pharmaceuticals, Inc. reports a quarter-
`over-quarter decrease in revenue from sales of
`Glatopa.
`Brian Orelli (TMFBiologyFool)
`Nov 7, 2015 at 1:40PM
`
`On Wednesday, Momenta Pharmaceuticals (NASDAQ:MNTA)
`reported third-quarter earnings, including sales of Glatopa, its
`genetic version of Teva Pharmaceutical's Copaxone, which
`weren't nearly as good as the second quarter. The issue seems
`to be temporary though, allowing investors to focus on the
`future.
`Momenta Pharmaceuticals results: The raw numbers
`
` Metric
`Revenue
`Cash and
`marketable
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`Q3 2015 Actuals
`$13.8 million
`$375 million
`
`Q3 2014 Actuals
`$9.3 million
`$176 million
`
`Growth (YOY)
`48%
`$113%
`
`1/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 1
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`
`securities
`(Loss) per
`share
`
`($0.44)
`
`($0.56)
`
`N/A
`
`SOURCE: COMPANY PRESS RELEASE.
`What happened with Momenta Pharmaceuticals this quarter?
`Momenta's half of its profit-sharing deal with Novartis
`(NYSE:NVS) for Glatopa tallied $8.7 million in the third quarter,
`considerably lower than the second quarter's $28.2 million in
`profits -- excluding a deduction of $9 million for the
`reimbursement of legal expenses -- but the previous quarter
`had an inventory build that was worked through during the
`third quarter. Revenue from the profit share should pickup and
`stabilize in future quarters.
`Momenta and Novartis' generic version of three-times-a-week
`Copaxone is under review at the FDA.
`Momenta recorded no profit on enoxoparin -- generic Lovenox
`-- in the third quarter because the partnership with Novartis
`didn't make any profit because of competition from other
`generic drugs.
`On the biosimilar front, Baxalta (NYSE:BXLT) has started a
`clinical trial testing M923, a biosimilar version of Abbott Labs'
`Humira. Baxalta is shooting for filing an application for
`approval in 2017. Assuming patent litigation works out, Baxalta
`and Momenta could launch in 2018.
`Momenta spent a measly $2 million of the $377 million of cash
`it started the third quarter with. The company isn't quite cash
`flow positive though since, in addition to the Glatopa profit-
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`2/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 2
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`sharing revenue, Momenta spent all of a milestone payment
`that won't be seen in future quarters.
`What management had to say
`Richard Shea, Momenta's chief financial officer, senior vice
`president, and treasurer, discussed how much of Teva's market
`share Glatopa is taking, stressing how data from third-party
`providers might not tell the full story: "We believe Glatopa's
`market share to be approximately 25% to 30% of the 20-mg
`Copaxone market. The percentage range is based on Symphony
`Health Solutions' data plus internal estimates that include the
`payers' close plans that IMS and Symphony do not track and
`where Glatopa penetration is strong."
`CEO and President Craig Wheeler, talked about the un-partnered
`part of the comapany's biosimilar pipeline: "We continue to
`engage in active discussions with multiple potential biosimilar
`collaborative partners and believe we are still on track to reach
`our goal of having a broad biosimilar collaboration in place by the
`end of this year."
`Finally, a comment from Shea, who recently announced his
`retirement, on finding his replacement: "I'm not running for the
`exit. We'll take our time on this one."
`Looking forward
`Overall, Momenta Pharmaceuticals looks like it's in good shape.
`It would be great if the trajectory of Glatopa's sales were a
`steady move higher, but drug launches rarely work out that way.
`Investors should take the bumps in stride with the hopes that the
`kinks in the system will eventually work out.
`A stock for greedy investors
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`3/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 3
`
`

`
`12/28/2015
`Momenta Slowed (Temporarily) -- The Motley Fool
`The world's biggest tech company forgot to show you
`something, but a few Wall Street analysts and the Fool didn't
`miss a beat: There's a small company that's powering their
`brand-new gadgets and the coming revolution in technology.
`And we think its stock price has nearly unlimited room to run for
`early-in-the-know investors! To be one of them, just click here.
`A secret billion-dollar stock opportunity
`The world's biggest tech company forgot to show you
`something, but a few Wall Street analysts and the Fool didn't
`miss a beat: There's a small company that's powering their
`brand-new gadgets and the coming revolution in technology.
`And we think its stock price has nearly unlimited room to run for
`early-in-the-know investors! To be one of them, just click here.
`Brian Orelli has no position in any stocks mentioned. The Motley Fool
`recommends Momenta Pharmaceuticals and Teva Pharmaceutical. Try any
`of our Foolish newsletter services free for 30 days. We Fools may not all hold
`the same opinions, but we all believe that considering a diverse range of
`insights makes us better investors. The Motley Fool has a disclosure policy.
`
`Forget the iPhone 6. Next Apple
`Sensation Leaked
`Forget the iPhone and the Apple Watch. Another revolutionary
`Apple technology is booming. According to Gartner Research, the
`market for this technology will soon be worth a whopping $721
`billion!
`But you won't hear about this game-changer in front page
`headlines. Peeking under the hood reveals a more intriguing story
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`4/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 4
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`about a little-known company that has cornered the market for the
`technology hidden in Apple's devices. Simply click here to learn
`its name.
`
`Brian Orelli
`
`(cid:50) Nov 7, 2015 at 1:40PM
`(cid:251) Health Care
`
`AUTHOR
`
`ARTICLE INFO
`
`STOCKS
`
`Novartis
`NYSE:NVS
`$87.03
`$0.56 (0.65%)
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`5/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 5
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`
`Momenta Phar…
`NASDAQ:MNTA
`$14.91
`$0.40 (-2.61%)
`
`Baxalta Incorp…
`NYSE:BXLT
`$39.25
`$0.02 (-0.05%)
`
`READ MORE
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`6/23
`
`Follow
`
`Share
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 6
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`
`A Straightforward
`Guide to What Stocks
`Do When Interest
`Rates Rise
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`7/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 7
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`
`Maybe we should all ignore the news, focus on
`what's in our control, and look forward to the
`holidays.
`Morgan Housel (TMFHousel)
`Dec 16, 2015 at 2:08PM
`
`The Federal Reserve raised interests rates today. It was the first
`time in almost a decade. 
`What's this mean for stocks? Well, let's think it through. 
`Higher interest rates makes bonds more attractive. That's bad for
`stocks. 
`But the Fed is raising rates because the economy is strong.
`That's good for stocks. 
`Higher rates could mean higher inflation is anticipated. That's
`bad for stocks. 
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`8/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 8
`
`

`
`12/28/2015
`Momenta Slowed (Temporarily) -- The Motley Fool
`But higher inflation could increase revenue growth. That's good
`for stocks. 
`Higher rates could curtail lending. That's bad for stocks. 
`But less lending reduces the odds of a credit crisis. That's good
`for stocks. 
`Higher rates could hurt leveraged companies. That's bad for
`stocks. 
`But higher rates increase the interest income for companies with
`lots of cash. That's good for stocks. 
`Higher interest rates mean the Fed is taking away the
`punchbowl. That's bad for stocks. 
`But higher rates mean the Fed has room to cut interest rates
`when it needs to. That's good for stocks. 
`So, who knows. 
`Maybe we should all ignore the news, focus on what's in our
`control, and look forward to Christmas. 
`For more: 
`You would have never believed it ...
`If you only know five things about investing, make it these 
`Keep in mind, stocks rose 1,100-fold during this period 
`
`This article is part of Motley Fool Mindset, an exclusive
`behavioral-finance service in Motley Fool One. Click here for
`more. 
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`9/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 9
`
`

`
`12/28/2015
` 
`Contact Morgan Housel at mhousel@fool.com. The Motley Fool has
`a disclosure policy.
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`
`34%
`off
`
`24%
`off
`
`Deco 79 Wood Buoy Table …
`$82.50 $54.15
`
`Deco 79 Wood Buoy …
`$83.10 $62.97
`
`Morgan Housel
`
`(cid:50) Dec 16, 2015 at 2:08PM
`(cid:217) Financials
`
`AUTHOR
`
`ARTICLE INFO
`
`READ MORE
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`10/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 10
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`
`Great News: This
`Government Agency
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`11/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 11
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`
`Government Agency
`Just Received a Big
`Raise
`The $1.1 trillion spending bill passed by Congress
`and signed into law by President Obama gave this
`agency a lot more money.
`Sean Williams (TMFUltraLong)
`Dec 26, 2015 at 9:12AM
`
`IMAGE SOURCE: WHITE HOUSE ON FLICKR.
`Disaster has once again been averted. Despite going down to the
`wire (as it has with each and every spending bill or budget that
`needs to be finalized), Congress came together and, along with
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`12/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 12
`
`

`
`12/28/2015
`Momenta Slowed (Temporarily) -- The Motley Fool
`President Obama, passed a new spending and tax bill into law
`on Dec. 18.
`The bill President Obama signed includes roughly $1.1 trillion in
`spending and approximately $622 billion in tax breaks.
`Businesses are going to be thrilled that a provision allowing them
`to depreciate newly purchased equipment more rapidly is now
`available through 2019, while consumers can rejoice that the
`earned income tax credit isn't going anywhere. 
`This agency just received a big raise
`However, there's perhaps an even bigger winner from the
`passage of this federal spending bill: the National Institutes of
`Health.
`The National Institutes of Health, or NIH, is a government-funded
`medical research facility at the forefront of multiple aspects of
`patient care. It's comprised of 27 institutes and centers,
`including the National Cancer Institute, National Institute on Drug
`Abuse, and National Institute of Allergy and Infectious Diseases,
`to name a few. Each institute or center focuses on particular
`diseases or body systems to help improve our medical
`understanding and potentially even assist in the development of
`cures to chronic and/or terminal diseases.
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`13/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 13
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`
`IMAGE SOURCE: NATIONAL CANCER INSTITUTE. 
`According to details from the recently signed federal spending
`bill, the NIH received the maximum allowable increase in funding
`of $2 billion -- its largest increase in 12 years. Instead of the $30
`billion it currently receives, the NIH will begin receiving $32 billion
`in federal funding in 2016.
`Within the federal spending bill, a portion of the extra funding will
`be funneled toward specific goals. The bill gives $200 million to
`the Precision Medicine Initiative, which aims to improve the effort
`to find personalized treatment options for sick patients by
`targeting their genetic makeup. Another $350 million is to be
`spent on Alzheimer's research. The BRAIN initiative, which is an
`ongoing project to map the human brain, is earmarked to receive
`$85 million. Researchers will receive $303 million to further their
`efforts in the fight against antibiotic-resistant bacteria, and finally,
`$91 million is being set aside for research to examine how opioid
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`14/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 14
`
`

`
`12/28/2015
`Momenta Slowed (Temporarily) -- The Motley Fool
`abuse can be reduced. This is a nearly 300% increase from the
`amount set aside last year to analyze ways to reduce opioid
`abuse.
`The end result is pretty clear: more money at the NIH's disposal
`could mean a better understanding of certain diseases and lead
`to more effective ways to combat them. Of course, we already
`have some intriguing therapies on pharmacy shelves, or working
`their way through clinical trials, in many of the aforementioned
`disease categories above.
`A major advance in Alzheimer's in the offing
`One of the biggest budgetary increases went to researching
`Alzheimer's disease -- and with good reason. Right now more
`than 5 million people in the U.S. have Alzheimer's disease, based
`on estimates from the Alzheimer's Association, but by 2050
`almost 14 million people are expected to be living with some
`degree of Alzheimer's. It's also quite an expensive disease to
`treat. Between 2020 and 2040 the cost to treat Alzheimer's as a
`percentage of Medicare's annual budget is projected to rise from
`just 2% to as much as 24%.
`Thus, a lot could be riding on
`Biogen's (NASDAQ:BIIB)
`aducanumab, arguably its most
`important pipeline product.
`Aducanumab is being studied in
`two global phase 3 studies
`known as ENGAGE and EMERGE
`in early-stage Alzheimer's patients. In a phase 1b study, patients
`taking the 3 mg and 10 mg doses of aducanumab demonstrated
`a statistically significant improvement in the 30-point mental
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`IMAGE SOURCE: ALZHEIMER'S ASSOCIATION.
`
`15/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 15
`
`

`
`12/28/2015
`Momenta Slowed (Temporarily) -- The Motley Fool
`acuity test compared to the placebo. A statistically significant
`improvement over the placebo was also seen in the 10 mg dose
`cohort in the 18-pointClinical Dementia Rating. The 3 mg cohort
`did not reach statistical significance over the placebo.
`We've witnessed a lot of promising early-stage Alzheimer's
`compounds fizzle out in late-stage studies, but the results from
`Biogen's phase 1b study were so demonstrably strong that
`there's certainly some buzz that aducanumab could be a major
`step forward in Alzheimer's disease treatment.
`Explosive growth in personalized treatments
`The $200 million earmarked to examine the ways a patient's
`genetic makeup can be used to help treat certain diseases is a
`great move -- but it's also a move that's been under way for
`years with drug and device developers.
`For instance, some drug
`developers are using certain
`biomarkers as targets for their
`cancer drugs. Merck
`(NYSE:MRK) and Bristol-Myers
`Squibb (NYSE:BMY) have each
`developed a cancer
`immunotherapy drug -- Keytruda for Merck, Opdivo for Bristol-
`Myers -- that works by subduing the immunosuppressant quality
`of cancer cells and exposing them to the patient's immune
`system. Specifically, Merck's Keytruda and Bristol-Myers'
`Opdivo have shown the most promise in tumors expressing PD-
`L1. This biomarker often yields average response rates of
`50%-60% in advanced non-small cell lung cancer patients,
`which is substantially higher than the average response rate for
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`IMAGE SOURCE: BRISTOL-MYERS SQUIBB.
`
`16/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 16
`
`

`
`12/28/2015
`Momenta Slowed (Temporarily) -- The Motley Fool
`prior standards of care for advanced NSCLC.
`Myriad Genetics' (NASDAQ:MYGN) BracAnalysis tests are
`another prime example of how personalized medicine has
`already arrived. Myriad's BracAnalysis test analyzes whether or
`not a woman is a carrier of the mutant BRCA1 or BRCA2 gene. A
`carrier of these mutations is considered to be at a far higher risk
`than a non-carrier to develop breast or ovarian cancer. A positive
`test of this gene mutation is what prompted Hollywood actress
`Angelina Jolie to undergo a preventative mastectomy. Jolie also
`had her ovaries and fallopian tubes removed in a separate
`surgery after tests showed she had markers that may have
`represented signs of early cancer. Jolie's mother, grandmother,
`and aunt have all died from cancer.
`Tests like Myriad Genetics' BracAnalysis could very well become
`the norm as the push to personalize treatment pathways gains
`traction.
`Collaborations galore?
`The increased funding could also mean that drug developers
`could be privy to fully sponsored, or partially sponsored, trials, as
`well as collaborative efforts between drug developers and NIH
`researchers.
`A good example here is the formation of the Accelerating
`Medicines Partnership (AMP) in 2014 between the NIH, Food and
`Drug Administration, and 10 drug developers, including Bristol-
`Myers Squibb, Merck, Biogen, and seven other industry giants.
`With the assistance of multiple non-profit organizations, these
`AMP partners work toward identifying biomarkers that could
`allow more effective treatment options to emerge. Best of all, all
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`17/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 17
`
`

`
`12/28/2015
`Momenta Slowed (Temporarily) -- The Motley Fool
`AMP partners are making their discovery findings public for the
`entire medical community to see (and presumably target).
`Personally, I'm pleased to see the NIH receiving such a large
`increase in its annual budget, and I fully expect we'll begin to see
`the fruits of this budgetary increase in the not-so-distant future.
`The next billion-dollar iSecret
`The world's biggest tech company forgot to show you something
`at its recent event, but a few Wall Street analysts and the Fool
`didn't miss a beat: There's a small company that's powering their
`brand-new gadgets and the coming revolution in technology.
`And we think its stock price has nearly unlimited room to run for
`early in-the-know investors! To be one of them, just click here.
`Sean Williams has no material interest in any companies mentioned in this
`article. You can follow him on CAPS under the screen name TMFUltraLong,
`track every pick he makes under the screen name TrackUltraLong, and
`check him out on Twitter, where he goes by the handle @TMFUltraLong.
`The Motley Fool recommends Biogen. Try any of our Foolish newsletter
`services free for 30 days. We Fools may not all hold the same opinions, but
`we all believe that considering a diverse range of insights makes us better
`investors. The Motley Fool has a disclosure policy.
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`18/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 18
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`
`AUTHOR
`
`Sean Williams
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`19/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 19
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`ARTICLE INFO
`
`(cid:50) Dec 26, 2015 at 9:12AM
`(cid:251) Health Care
`
`STOCKS
`
`Merck & Co., I…
`NYSE:MRK
`$52.74
`$0.11 (-0.21%)
`
`Bristol-Myers …
`NYSE:BMY
`$68.73
`$0.24 (-0.35%)
`
`Biogen
`NASDAQ:BIIB
`$302.75
`$0.46 (0.15%)
`
`Myriad Genetics
`NASDAQ:MYGN
`$43.08 (0.00%)
`
`READ MORE
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`20/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 20
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
`
`http://www.fool.com/investing/general/2015/11/07/momenta-slowed-temporarily.aspx
`
`21/23
`
`MYLAN PHARMS. INC. EXHIBIT 1114 PAGE 21
`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
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`22/23
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`
`

`
`12/28/2015
`
`Momenta Slowed (Temporarily) -- The Motley Fool
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