Momenta Pharmaceuticals (MNTA) Q4:2009 Earnings; Raising Fair Value to $20 in Anticipation of M-Enoxaparin Approval
•MNTA reported Q4:2009 earnings roughly in line with our estimates. MNTA reported Q4:2009 revenues and EPS of $5.6 million and ($0.34), slightly above our estimates of $4.8 million and ($0.38). MNTA ended FY:2009 with $95.7 million in cash and marketable securities. We predict cash runway for at least 2 years and likely into profitability, provided M-Enoxaparin approval is not unduly delayed by the FDA. •Key focus on M-Enoxaparin approval scenarios. While we fully expect M-Enoxaparin to be approved in the near-term (Q1 or early Q2), the approval of TEVA’s generic remains a key uncertainty. Should both ANDAs be approved simultaneously, we calculate MNTA’s fair value at $20 per share. We think there is considerable upside potential if MNTA is approved alone due to the improved economics from its partner Sandoz. However, the potential launch of an authorized generic provides further uncertainty here. Finally, we note that the outcome of TEVA’s ANDA also has implications for M356 (generic Copaxone). •Outcome in Copaxone lawsuit approaching. A motion seeking summary judgment for invalidity of the Copaxone patents was filed by Sandoz/Momenta in late December. Moreover, a Markman Hearing for the ongoing lawsuit between TEVA and Sandoz/Momenta was held in late January, and Momenta recently guided that it expects a ruling by the court in 60-90 days. However, we expect a ruling on the Markman Hearing could occur in late February or early March, which should provide a strong indication of the ultimate outcome of the trial. Finally, earlier this week, Momenta/Sandoz proactively provided the court with additional details of their inequitable conduct arguments, although many of these details were filed under seal. •Our new fair value of $20 per share is calculated using a sum-of-parts analysis, applying a 30% annual discount to our peak annual sales estimate for M-Enoxaparin in DVT and ACS, M356 in Relapse-Remitting MS, and M118 in ACS, incorporating a 1-10 multiple for each based on stage of clinical risk. Our fair value has increased from $16 due to our increased confidence in near-term M-Enoxaparin approval (we have increased our multiple from 8x to 9x). We note that our estimate for M-Enoxaparin revenues assumes co-approval with TEVA’s generic Lovenox; therefore we believe additional upside to our fair value exists should MNTA receive sole approval. However, the amount of this additional upside would depend on how long Sandoz/MNTA market the sole generic, an issue which is currently difficult to handicap. We reiterate our OUTPERFORM rating. •Risks to the attainment of our fair value include risks that: Momenta’s product candidates obtain disappointing clinical trial results and or fail to obtain regulatory approval in a timely fashion; physician prescribers are not be impressed with the products’ clinical profiles; Sandoz or another partner fails to effectively commercialize Momenta’s drug candidates; third-party patents prevent the timely commercialization; superior clinical results are obtained by a third-party competitor.