Here is the introductory text from the UBS report. Forgive the formatting. Note the upcoming milestones does not mention the possibility of cert and indeed, while they discuss the Copaxone litigation with TEVA in some detail, I see no mention at all of the Amphastar litigation:
Risk Reward Looks Compelling
? What’s new? Upgrading Momenta to Buy with a $17 price target (was $13) Based on recent mgt.
comments we are incrementally more confident that Momenta can get approval for generic
Copaxone in time for launch in Sept. 2015 which is when the patents expire. Further, an appeals
court decision in the Copaxone case vs. Teva is due in Aug-Oct. 2013, and if positive, it would
allow Momenta to launch earlier in May 2014 vs. Sept. 2015. Based on this and our improved
outlook on the pipeline, we are raising our EPS ests. in the outer years.
? Investment thesis is four-fold
(1) Erosion of the generic Lovenox revenue stream is well understood by investors. (2) We also
believe that Momenta has a good chance of getting approval for generic Copaxone in time for launch
by September 2015. Additionally, if it wins the appeal in the litigation vs. Teva it may be able
to launch earlier in May 2014. (3) Momenta’s strong analytical platform positions it well to be one
of the key players in the biosimilars space and this is underappreciated. (4) Momenta has enough
cash to support R&D for the next few years without additional financing.
? Thoughts on the stock: We see favorable risk-reward at current levels
At current levels we see ~10% downside if Copaxone’s launch gets delayed beyond Sept 2015
and upside of ~30% if Momenta can launch Copaxone in mid-
2014. Also, improved pipeline visibility could drive further upside in the LT.
? Valuation: The stock reflects minimal expectations for the pipeline
Our DCF valuation uses a WACC of 12% and a 3% terminal growth. This incl.
~$5 of cash, ~$5 for generic Copaxone, $2 for Lovenox and ~$5 for the pipeline.
~$5 of cash, ~$5 for generic Copaxone, $2 for Lovenox and ~$5 for the pipeline.
UBS 2
Rationale for the Upgrade
We have always believed that Momenta is uniquely positioned to leverage its technology platform to
be a key player in biosimilars. We had downgraded the stock about a year back due to lack of near
term catalysts and the stock has generally traded in the $13 range for the past several months.
Based on management’s comments about its interactions with FDA and its confidence in its
application, we are incrementally more confident of an approval and believe that there is a
good chance that Momenta gets approval for generic Copaxone in time for launch in September
2015 which is when the patents expire.
Additionally, we note that in early May oral arguments were made at the appeal hearing in the
Copaxone case vs. Teva wherein the judges expressed concerns around inconsistency of statements
made by Teva during its patent prosecution history. The Court decision is expected in the
August- October 2013 timeframe and if Momenta wins the appeal it may be able to launch about 16
months early (in May 2014 instead of September 2015).
We believe that these two catalysts could drive the stock up to the high teens.
Table 1: Momenta – Upcoming milestones
Date Drug Milestone
2013
2H13 Generic Copaxone (Multiple sclerosis) Appeals Court decision in the patent case
against Teva
2013 Sialylated IVIG (autoimmune/inflammatory disease)
Initial data to help determine development approach (plasma derived vs recombinant)
2014
1H14 M402 (pancreatic cancer) Expected result from Part A of
Phase 1/2 proof-of-concept study in advanced metastatic pancreatic cancer and initiation of Part B
2014 M923 (autoimmune/inflammatory biosimilar) Submit IND
2014 M511(Oncology antibody biosimilar) Achieve development criteria
2014 M834 (autoimmune/inflammatory biosimilar) Achieve development criteria
Market Data 
Markets 
AI
