Leerink Equity Research provides a catalyst tracker previewing top upcoming catalysts over the next 3-6 months for various healthcare stocks. Key events include data readouts from clinical trials that could significantly move stock prices depending on the results. The report lists dozens of stocks and their associated drug or product, indication, type of event, timeline, and estimated stock price impact. Upcoming catalysts highlighted include data presentations, regulatory decisions, product launches, and business development deals.
Top Upcoming Healthcare Catalysts Previewed by Leerink Equity Research
1. January 23, 2016
Reason for report:
CATALYST TRACKER
Leerink Equity Research
Alice C. Avanian, CFA
(617) 918-4544
alice.avanian@Leerink.com
HEALTHCARE
Catalyst Tracker Previews Top Upcoming Catalysts - 1/23/2016
• Bottom Line: Binary Events in healthcare can be key determinants
of stock price performance. During volatile times, these are very
relevant, as these events are non-correlated to the overall market.
Also, investors may focus on later-stage assets for the time being.
Our top upcoming catalysts for the next 3-6 months are ALDR, ALNY,
CBYL, CLDX, DERM*, ESRX, EXEL, FOLD, GWPH, INCY*, MDCO,
MRTX, QURE, SHPG*, STJ*, TEVA*, TSRO. (*Among top stock picks for
2016). For Managed Care, key upcoming catalysts are 2017 Medicare
Advantage rates (preliminary release, Feb.) and regulatory approvals for
mega-mergers (CNC-HNT Feb., and AET-HUM and ANTM-CI in 2H16).
We are bullish on MCOs in 2016 and our top picks are HUM, AET, UNH,
and MOH. Our sortable Excel sheet (calendar) has timelines and stock
impacts, Up/down.
• ALDR – In 1Q16, Ph IIb I.V. Chronic Migraine data, Up/down
+40%/-30%, and Ph I SC healthy volunteer data, Up/down +/-10%.
• ALNY: Multiple pipeline updates in mid- and late-2016 (ALN-CC5,
revusiran, patisiran, ALN-AS1, ALN-AT3); combined Up/down
+30%/-10%.
• CBYL – Positive Ph III top-line data for Hydros-TA (knee
osteoarthritis) in 1Q16 would significantly de-risk the asset and raise
probability of success to 85% from 65%, adding $5/share to our PT.
• CLDX – Rintega GBM 2nd interim analysis in 1H16 offers chance for
early trial stop for success, Up/down +100%/-15-20%.
• DERM – Three high-probability data readouts in the next 6-12
mos. (Up/down +30%/-20%). If one or more of its 3 programs read out
positively, we view it as a compelling M&A target (Up/down +30-50%).
• ESRX – Uncertainty over the pending renewal of its contract with
ANTM sometime in the next 6 mos. is an overhang on the stock,
while the fundamental model for ESRX is challenged; Up/down +/-7%.
• EXEL – Our recent upgrade was driven by potential for accelerated
FDA approval (before June PDUFA), positive OS data and ROW
partnership with good terms in 2016; combined Up/down +60%/-20%.
• FOLD – We est. 75% probability of success (POS) for Galafold EU
CHMP opinion 1Q16; Up/down +20%/-30%. For Zorblisa pivotal data in
2H16, we est. 65% POS; Up/down +40%/-25%.
• GWPH – The next 12 months are catalyst-rich; Next up is top-line
Ph III Epidiolex (Dravet) data in 1Q16; Up/down +60%/-85%.
• INCY – Key drivers of upside in 2016, in our view, are Ph II and Ph III
data readouts expected from Jakafi in three solid tumor indications
and updated IDO data; 3 catalysts combined, Up/down +40%/0%.
• MDCO – Ph II data for Apo-A Milano in 1Q16; Up/down +30%/-10%.
S&P 500 Health Care Index: 776.63
Companies Highlighted:
AET, ALDR, ALNY, CBYL, CI, CLDX, CNC, DERM,
EXEL, FOLD, HUM, INCY, LLY, MDCO, MOH, MRTX,
QURE, SHPG, STJ, TEVA, TSRO, UNH
Please refer to Pages 56 - 58 for Analyst Certification and important disclosures. Price charts and disclosures specific to
covered companies and statements of valuation and risk are available at
https://leerink2.bluematrix.com/bluematrix/Disclosure2 or by contacting Leerink Partners Editorial Department, One
Federal Street, 37th Floor, Boston, MA 02110.
2. HEALTHCARE January 23, 2016
• MRTX –Ph Ib data for MGCD265 (non-small cell lung cancer),
possibly at AACR (4/16-20) or ASCO (6/3-7), Up/down +50%/-25%.
• QURE – Full Hemophilia B Gene Therapy (AMT-060) Ph I/II data in
2Q16, +50%/-20%.
• SHPG – In addition to the BXLT merger (expected to close
mid-2016), there are several catalysts. Ph II data for intrathecal
Elaprase (Hunter’s CNS) in 1H16 (+~5%/-2%) and Premiplex Ph IIb data
(retinopathy) in mid-2016, worth a risk adj. $11/shr (POS to 75% after
positive data). In 3Q16, we expect lifitegrast (dry eye) approval (+5%).
• STJ – Analyst mtg. on 2/5/16 to provide pipeline and product
updates in a catalyst-rich year. Also expect updated dividend policy,
usually +9% annually, adding to stock’s appeal in a tough market.
• TEVA – If TEVA gets a surprise victory in its Copaxone 40mg patent
case in Aug. '16, Up/down +10-12%/-2-3%.
• TSRO – Niraparib Ph III data in ovarian cancer expected 2Q16, Up/
down +100/-35%.
2
3. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
ABMD Balloon pump
Percutaneous Coronary
Intervention
OUS Approval
Approval in Japan, greenfield
opportunity
- Mid-2016 7/1/16 - - Outperform Danielle Antalffy
ABMD Impella
Percutaneous Coronary
Intervention
PDUFA Potential PMA approval in shock - Mid-2016 7/1/16 - - Outperform Danielle Antalffy
ABT - Nutritionals Product Launch
New product launches. ABT
launching new products to gain
share in pediatric nutritionals in
- 2016 12/29/16 L - Market Perform Danielle Antalffy
ABT ABSORB GT1
Bioresorbable vascular
scaffold
FDA AdCom
Circulatory System Devices
Panel to review, make
recommendation and vote;
Briefing documents likely
- 3/15/16 3/15/16 - - Market Perform Danielle Antalffy
ABT ABSORB III & IV Angina Data Presentation
Data presentation. Post-TCT,
the focus will shift to claims
around reduction in Angina in
- 1H16 6/29/16 L - Market Perform Danielle Antalffy
ABUS ARB-1467
Chronic Hepatitis B Virus
(HBV)
Data Presentation Ph IIa data: SAD and MAD -
3Q16
(SAD);
4Q16
12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
ACAD
NUPLAZID
(pimavanserin)
Alzheimer's Disease
Psychosis (ADP)
Data Presentation Phase II proof-of-concept. - 2H16 12/30/16 H - Outperform Paul Matteis
ACAD
NUPLAZID
(pimavanserin)
Parkinson's Disease PDUFA Potential FDA approval - 5/1/16 5/1/16 H - Outperform Paul Matteis
ACHC
Business
Development
- P&A
ACHC to acquire Priory Health,
a UK behavioral halth provider.
Acquisition to be financed with a
combo of debt & equity. Deal
- 2/16/16 2/16/16 H - Outperform Ana Gupte, Ph.D.
ACOR Amprya Stroke Data Presentation
Interim analysis may present an
inflection point
- 2016 12/29/16 H - Market Perform Paul Matteis
ACOR Ampyra
Walking in multiple
sclerosis
Legal / Regulatory Markman hearing -
3/1/16 -
3/30/16
3/1/16 H - Market Perform Paul Matteis
ACOR CVT-301 Parkinson's Disease Data Presentation Phase III data - 2H16 12/30/16 - - Market Perform Paul Matteis
ADAP - - P&A Potential partnerships KITE, JUNO 2016 12/29/16 H +30%/0% Outperform
Michael Schmidt,
Ph.D.
ADAP MAGE A-10 TCR
Non-small cell lung
cancer (NSCLC)
Data Presentation
Ph I data from 2 initial cohorts.
Proprietary asset.
- 2016 12/29/16 H +200%/-20% Outperform
Michael Schmidt,
Ph.D.
ADAP NY-ESO TCR
Non-small cell lung
cancer (NSCLC)
Data Presentation
Phase I/II data. Multiple trials.
High response rate (60%)
observed so far in synovial
sarcoma. Partner GSK.
GSK, JUNO, KITE,
BLCM, IMDZ
2016 12/29/16 H +100%/-20% Outperform
Michael Schmidt,
Ph.D.
ADOC.FP
BC glargine/lispro
combo
Type 1 / Type 2 Diabetes P&A
Partnership with one of the
leading diabetes players; deal
similar to the LLY deal on BC
lispro
LLY, NVO, SNY 2016 6/29/16 H
+20-30% if attractive deal
signed
Outperform Seamus Fernandez
ADOC.FP BC Lispro Type 1 / Type 2 Diabetes Trial Initiation
Ph III study. Expect ADOC/ LLY
to complete Ph I/II study with
mixed meals before entering Ph.
LLY, NVO, SNY 2016 6/29/16 H +10-20% if initiating PhIII Outperform Seamus Fernandez
ADOC.FP BC Lispro Type 1 Diabetes Data Presentation
Ph I study results. Release
further details at EASD (9/12-
9/16/16 or ADA 2016). Topline
LLY, NVO, SNY
2Q16 -
3Q16
9/30/16 L - Outperform Seamus Fernandez
ADRO
CRS-207 (live
Listeria-based
cancer vaccine
Malignant Pleural
Mesothelioma
Data Presentation
Top-line data from Ph1b
mesothelioma study including
OS
- 1H16 6/29/16 H +15% / -15% Outperform Seamus Fernandez
3
HEALTHCARE January 23, 2016
4. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
ADRO
CRS-207 (live
Listeria-based
cancer vaccine
expressing
mesothelin)
Malignant Pleural
Mesothelioma
Trial Initiation
Initiate Ph III trial in combination
with SoC chemo in malignant
pleural mesothelioma
- 2Q16 6/30/16 L +5% / -5% Outperform Seamus Fernandez
ADRO
CRS-207 (live
Listeria-based
cancer vaccine
Pancreatic cancer Data Presentation
Top-line data from Ph IIb
ECLIPSE study
- Late 2Q16 6/30/16 H
+100% / -50% (this is the
key catalyst for the firm)
Outperform Seamus Fernandez
ADRO
CRS-207 (live
Listeria-based
cancer vaccine
Pancreatic cancer Data Presentation
Interim data from Ph2b
STELLAR study
- 2H16 12/31/16 H
+ 100% / -30% (will
depend on exact outcome
of ECLIPSE study)
Outperform Seamus Fernandez
AEGR Myalept
Generalized
Lipodystrophy (GL)
Legal / Regulatory EU MAA filing. - YE2016 1/1/17 L - Outperform Joseph P. Schwartz
AET - - Other Event 4Q15 Results. Scheduled Date. - 2/1/16 2/1/16 - - Outperform Ana Gupte, Ph.D.
AET
Business
Development
- P&A
Potential Deal. AET announced
deal for HUM at $230/share, with
8-K filed 9/18/15. FL Office of
AET, CI, HNT, MOH,
UNH, WCG
7/2/15 -
2H16
12/30/16 H - Outperform Ana Gupte, Ph.D.
AFMD AFM11 non Hodgkin's lymphoma Data Presentation Phase I interim data. - YE2016 1/1/17 H - Outperform
Michael Schmidt,
Ph.D.
AFMD AFM13 Hodgkin's lymphoma Trial Initiation
Ph I/II Combo trial could form the
basis for a partnership near-term
- 1H16 6/29/16 H - Outperform
Michael Schmidt,
Ph.D.
AFMD AFM13 Hodgkin's lymphoma Data Presentation
Phase IIa interim monotherapy
data
- 2Q16 6/30/16 H - Outperform
Michael Schmidt,
Ph.D.
AGIO AG-120 AML Trial Initiation Initiate Ph 3 registration study CELG 2H16 12/30/16 L - Market Perform Seamus Fernandez
AGIO AG-348
Pyruvate Kinase R
deficiency
Data Presentation
First data from Ph 2 DRIVE-PK
study in PKD pts
- 1H16 6/29/16 H +50%/-20% Market Perform Seamus Fernandez
AGIO AG-519
Pyruvate Kinase R
deficiency
Data Presentation
First data from healthy
volunteers
- 1H16 6/29/16 H +20%/-10% Market Perform Seamus Fernandez
AGN
Business
Development
- Other Event
Close of AGN Generics sale to
TEVA
TEVA 1Q16 3/31/16 L - Outperform Jason Gerberry, JD
AGN
Business
Development
- P&A
Merger with PFE, expected to
close in 2H16
- 2H16 12/30/16 H - Outperform Jason Gerberry, JD
AGN Esmya
Chronic treatment of
uterine fibroids
Data Presentation
Phase III. High unmet need.
Peak sales est. $365M
- 1H16 6/29/16 L - Outperform Jason Gerberry, JD
AGN GLYX-13 Depression Data Presentation Phase III - 2016 12/29/16 H - Outperform Jason Gerberry, JD
AGN Kybella Chin fat reduction Product Launch Product launch. - 2016 12/29/16 L - Outperform Jason Gerberry, JD
AGN
Relamorelin (RM-
131)
Diabetic gastroparesis Data Presentation Phase IIb - Mid-2016 7/1/16 L - Outperform Jason Gerberry, JD
AGN Botox Depression Data Presentation Phase II - 1Q16 3/31/16 L - Outperform Jason Gerberry, JD
AKRX - - Legal / Regulatory
Filing of restated financials, to be
in compliance with NASDAQ
requirements or face de-listing
- 1H16 5/9/16 H - Market Perform Jason Gerberry, JD
ALDR ALD403
Migraine and Other
Headaches
Data Presentation
Ph IIb IV chronic migraine data.
We model 60% probability of
approval.
LLY, AMGN, TEVA 1Q16 3/31/16 H +40%/-30% Outperform Joseph P. Schwartz
4
HEALTHCARE January 23, 2016
5. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
ALDR ALD403
Migraine and Other
Headaches
Trial Initiation
Ph III trial initiation
(450 chronic migraine patients)
(PROMISE-2) & SC once-
quarterly formulation
(Ph. 2b, 240 episodic pts). 60%
probability of approval
LLY, AMGN, TEVA
1Q16 -
1H16
3/31/16 L - Outperform Joseph P. Schwartz
ALDR ALD403
Migraine and Other
Headaches
Data Presentation
Ph I multi-+single-dose healthy
volunteer data in capsaicin-
induced vasodilation study may
confirm whether 300mg is a
promising dose to be given SC
Q3M for the Ph.2b EM+CM trial.
LLY, AMGN, TEVA 1Q16 3/31/16 H +10%/-10% Outperform Joseph P. Schwartz
ALDR ALD403
Migraine and Other
Headaches
Trial Initiation
Ph II/IIb EM+CM trial for
quarterly self-administration
(Q3M) of ALD403.
LLY, AMGN, TEVA 2016 12/29/16 L - Outperform Joseph P. Schwartz
ALGN - - Other Event
Multiple patents set to expire in
2017-2018. These patents do
not cover subsequent
innovations / IP protection
associated with advanced
materials.
- 2017-2018 12/29/18 - - Outperform Richard Newitter
ALNY ALN-AAT
Alpha-1 antitrypsin (AAT)
deficiency-associated
liver disease
Data Presentation Phase I data - Mid-2016 7/1/16 L - Outperform
Michael Schmidt,
Ph.D.
ALNY ALN-AS1 porphyria Data Presentation Ph I data from patients SNY/GENZ Late 2016 12/29/16 H
Multiple pipeline updates
(ALN-CC5, revusiran,
patisiran, ALN-AS1, ALN-
AT3); combined Up/down
+30%/-10%.
Outperform
Michael Schmidt,
Ph.D.
ALNY ALN-AT3 Hemophilia Data Presentation Ph I data update SNY/GENZ Mid-2016 7/1/16 L
Multiple pipeline updates
(ALN-CC5, revusiran,
patisiran, ALN-AS1, ALN-
AT3); combined Up/down
+30%/-10%.
Outperform
Michael Schmidt,
Ph.D.
ALNY ALN-CC5
Paroxysmal nocturnal
hemoglobinuria
Data Presentation PNH Patient data -
mid 2016
and late
2016
12/29/16 H
Multiple pipeline updates
(ALN-CC5, revusiran,
patisiran, ALN-AS1, ALN-
AT3); combined Up/down
+30%/-10%.
Outperform
Michael Schmidt,
Ph.D.
ALNY ALN-GO1
Primary hyperoxaluria
type I
Data Presentation Ph I data SNY/GENZ 2H16 12/29/16 L - Outperform
Michael Schmidt,
Ph.D.
ALNY ALN-TTR-sc02 TTR (FAP/FAC) Data Presentation Ph I data SNY/GENZ Late 2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
ALNY Patisiran
TTR-mediated
amyloidosis (FAP)
Data Presentation
Updates from the Ph II OLE 24
month (Open Label Extension)
SNY/GENZ Mid-2016 7/1/16 H
Multiple pipeline updates
(ALN-CC5, revusiran,
patisiran, ALN-AS1, ALN-
AT3); combined Up/down
+30%/-10%.
Outperform
Michael Schmidt,
Ph.D.
5
HEALTHCARE January 23, 2016
6. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
ALNY Revusiran
TTR-mediated
cardiomyopathy (FAC)
Data Presentation
Updates from the Ph II OLE 12
month (Open Label Extension)
SNY/GENZ Mid-2016 7/1/16 H
Multiple pipeline updates
(ALN-CC5, revusiran,
patisiran, ALN-AS1, ALN-
AT3); combined Up/down
+30%/-10%.
Outperform
Michael Schmidt,
Ph.D.
AMAG Feraheme
Iron Deficiency Anemia
(IDA)
Legal / Regulatory
Clarity from FDA on amount of
additional data required for
broader label.
- 1Q16 3/31/16 H - Outperform Joseph P. Schwartz
AMAG Makena Preterm Birth Legal / Regulatory
FDA's final decision on response
to complete response letter
(CRL) for a second source
manufacturer of 1 mL vial; may
also supplement with further
clarity on lifecycle mgmt. We
assume a modest 50%
probability that LOE extends
beyond orphan drug expiration in
2018 (until 2023) and
conservative sales from EU
market entry in 2016.
- 1Q16 3/31/16 H +15%/-20% Outperform Joseph P. Schwartz
AMAG Makena Preterm Birth Submit Application sNDA filing for SQ formulation -
YE16 -
1/1/17
1/1/17 H - Outperform Joseph P. Schwartz
ANTM - - Other Event 4Q15 Results. Scheduled Date. - 1/27/16 1/27/16 - - Outperform Ana Gupte, Ph.D.
ANTM
Business
Development
- P&A
ANTM to acquire CI for $188 per
share in 55% cash / 45% stock
deal. FL Office of Insurance
Regulations held public hearings
12/8; FL expected to approve
merger. Expected close in 2H16.
- 2H16 12/30/16 H - Outperform Ana Gupte, Ph.D.
ANTM
ESRX Re-Pricing
Negotiations
- Other Event
ESRX in re-pricing negotiations
with ANTM; contract came up for
market check Dec 2015. ANTM
expects it is entitled to ~$3B in
gross annual savings.
- 2016 12/29/16 H - Outperform Ana Gupte, Ph.D.
AQXP AQX-1125
Bladder Pain
Syndrome/Interstitial
Cystitis (BPS/IC)
Legal / Regulatory
Similar to End-of-Phase II
meeting with FDA, AQXP wll
meet with EMA to discuss trial
design and registrational
pathway in EU.
- 1H16 6/29/16 - - Outperform Paul Matteis
ARDX Tenapanor
ESRD
hyperphosphatemia
Data Presentation
2nd Phase IIb. Top-line data for
2nd Phase IIb study for
tenapanor in ESRD
hyperphosphatemia
- 2H16 12/30/16 H
$6/shr upside on
increased POS for ESRD
Outperform Jason Gerberry, JD
ARDX Tenapanor
Irritable Bowel Syndrome
with Constipation (IBS-C)
Data Presentation Phase III data from two trials - 1H17 6/29/17 H
$8 upside/$15 downside to
valuation on POS impact
Outperform Jason Gerberry, JD
ARQL ARQ-087 FGFR2-driver tumors Data Presentation Ph II data - 2H16 12/29/16 H - Market Perform
Michael Schmidt,
Ph.D.
ARQL ARQ-092 AKT-driver tumors Data Presentation Ph Ib data - Mid-2016 7/1/16 - - Market Perform
Michael Schmidt,
Ph.D.
ARQL Tivantinib
2nd line Hepatocellular
Carcinoma (HCC)
Data Presentation Ph III interim data - 1H16 6/29/16 H +50-70% / -~25% Market Perform
Michael Schmidt,
Ph.D.
6
HEALTHCARE January 23, 2016
7. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
ARRY
Binimetinib (MEK
inhibitor)
BRAF+ melanoma Data Presentation
Phase III data, COLUMBUS trial.
Based on promising Ph I/II data,
we est. 90% POS.
- 1H16 6/29/16 H
25%; We assume a 90%
PoS
Outperform
Michael Schmidt,
Ph.D.
ARRY
Binimetinib (MEK
inhibitor)
NRAS+ melanoma,
BRAF+ melanoma
Submit Application
Binimetinib for NRAS+ in 1H16
and for BRAF+ in 2016
- 2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
ARRY
Selumetinib (MEK
inhibitor)
KRAS+ NSCLC, Thyroid
cancer
Data Presentation
Phase III data in KRAS+
NSCLC,. Pivotal ASTRA trial ( in
Thyroid cancer)
- 2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
ASND TransCon hGH
Short Stature/Growth
hormone deficiency
Trial Initiation
Ph III Is planned to enroll 130-
150 patients.
- Mid-2016 7/1/16 L - Outperform Joseph P. Schwartz
ATHN
athenaClinical
Enterprise for
Hospitals
Enterprise Solution for
Hospitals
Other Event
Ongoing Enterprise
Implementation. Will likely gain
incremental traction with
Enterprise accounts now that it
has a roadmap for development
of hospital software.
- 2016 12/29/16 - - Market Perform David Larsen, CFA
ATRC
AtriCure Bipolar
System
Non-paroxysmal forms of
atrial fibrillation
Data Presentation
Data presentation. ABLATE post-
approval study enrolled 365
patients across 40 US centers,
with data release expected in
early 2016, possibly at ACC.
- 1Q16 3/31/16 L - Outperform Danielle Antalffy
AUPH Voclosporin Lupus Nephritis (LN) Data Presentation
Ph IIb AURA-LV top-line results.
We model 65% probability of
success. Enrollment completion
announced 1/19/16
- 3Q16 9/30/16 H - Outperform Joseph P. Schwartz
AZN - - P&A
Capital Allocation. Either cost
restructuring or mid-scale M&A
would reduce the depth of the
earnings trough and/or advance
the return to growth. Visibility is
low but the oppt'y is substantial
& would be upside to our model.
- 2016 12/29/16 H - Market Perform Seamus Fernandez
AZN durvalumab
PD L1 -positive non
small cell lung cancer
Data Presentation ATLANTIC trial BMY, MRK, RHHBY 2016 12/29/16 H +/-5% Market Perform Seamus Fernandez
AZN
Olaparib (PARP
inhibitor)
Ovarian cancer Data Presentation SOLO-2 (Ph III) TSRO, CLVS 2H16 12/29/16 H +/-5% Market Perform Seamus Fernandez
BCR Tridyne Vascular sealant Submit Application
PMA submission. IDE study.
Approval and launch expected
2H16.
- 2H16 12/30/16 - - Market Perform Richard Newitter
BIIB Anti-Lingo (BIIB) Multiple Sclerosis (MS) Data Presentation
Ph II SYNERGY data. We
assume 33% probability of
success.
DYAX Mid-2016 7/1/16 H - Outperform Joseph P. Schwartz
BIIB
BAN-2401 (anti-
Aβ mAB)
Alzheimer's Disease
(AD)
Data Presentation
Ph II topline results in 1H16 in
the ongoing 700 pt. early AD
trial.
- 1H16 6/29/16 H +10%/-5% Outperform Joseph P. Schwartz
BIIB
E2609 (oral
BACE1 inhibitor)
Alzheimer's Disease
(AD)
Data Presentation Ph II topline results likely. - 2H16 12/30/16 H +5%/0% Outperform Joseph P. Schwartz
BLPH INOpulse PH-COPD P&A Potential partnership - 2016 12/29/16 H - Outperform Jason Gerberry, JD
BLPH INOpulse PH-COPD Data Presentation
Phase II proof of concept study
data
- 2H16 12/30/16 H - Outperform Jason Gerberry, JD
7
HEALTHCARE January 23, 2016
8. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
BLPH INOpulse PH-IPF Data Presentation
Phase II proof of concept study
data
- 2H16 12/30/16 H - Outperform Jason Gerberry, JD
BMRN BMN-190 Batten's Disease Data Presentation
Ph I/II/III data at the World
Symposium conference in Feb
'16 (1-yr. full data set in 24
patients), including regulatory
clarity
-
2/29/16 -
3/4/16
2/29/16 H +15%/-5% Outperform Joseph P. Schwartz
BMRN BMN-270 Hemophilia A Data Presentation
Expect updates at R&D day in
Apr '16: Ph.1 proof-of-biology
data
- 4/20/16 4/20/16 L - Outperform Joseph P. Schwartz
BMRN BMN-701 Pompe Disease Data Presentation
Expect updates at R&D day in
Apr '16:
1) regulatory pathway and Ph. III
trial design
2) full Ph.II efficacy/safety data.
We model 60% probability of
approval
- 4/20/16 4/20/16 H +5%/-5% Outperform Joseph P. Schwartz
BMRN
Kyndrisa
(Drisapersen)
Duchenne Muscular
Dystrophy (DMD)
Legal / Regulatory CHMP opinion. SRPT 2Q16 6/30/16 L +5%/-5% Outperform Joseph P. Schwartz
BMRN
Kyndrisa
(Drisapersen)
Duchenne Muscular
Dystrophy (DMD)
Legal / Regulatory
EMA approval. We model 70%
probability of a EU 2016 launch
SRPT 3Q16 9/30/16 L 10%/-5% Outperform Joseph P. Schwartz
BMRN PEG-PAL Phenyketonuria (PKU) Data Presentation
Phase III data. BLA filing also
expected in 2H16. We model
60% probability of approval
-
Mar-Apr
2016
3/31/16 H +5%/-5% Outperform Joseph P. Schwartz
BMY - - Other Event
More business development
activity (“top priority” in 2016,
according to mgmt)
- 2016 12/29/16 H +/-5% Outperform Seamus Fernandez
BMY
Combo Studies
LAG3, CD137
(aka 4-1BB,
urelumab), and
KIR (lirilumab)
Multiple Oncology
Indications
Data Presentation
Large Ph I/II dose escalation
studies. Data likely after ASCO
2016.
MRK, Roche, AZN Mid-2016 7/1/16 H - Outperform Seamus Fernandez
BMY Daklinza HCV PDUFA
potential FDA approval for pts
with HCV coinfected with HIV,
with advanced cirrhosis, or with
post transplant recurrence of
HCV
- 1Q16 3/31/16 L - Outperform Seamus Fernandez
BMY Opdivo Lung cancer Data Presentation
Checkmate-026 study of Opdivo
vs. chemo in PD-L1+ NSCLC on
PFS endpoint.
MRK, Roche, AZN 2H16 12/30/16 H +/-5% Outperform Seamus Fernandez
BMY Opdivo + Yervoy melanoma PDUFA
sBLA based on CheckMate-067
data
CELG, MRK 1/23/16 1/22/16 L - Outperform Seamus Fernandez
BSX
Brady MRI-Safe
Platform
- Product Launch
Launch. Expected in 1Q16. Also
launch of full quad system in
1H16.
- 1Q16 3/31/16 L - Outperform Danielle Antalffy
BSX Watchman
Left Atrial Appendage
(LAA) Closure system for
AF (atrial fibrillation)
Other Event
CMS issue final NCD (National
Coverage Determination). We
expect CMS to ease restrictions
on usage. We conservatively est
$300M by 2020.
- 2/8/16 2/8/16 H +/-5% Outperform Danielle Antalffy
CALA CB-1158 Immuno-oncology Submit Application IND filing - 1H16 6/29/16 - - Outperform Paul Matteis
8
HEALTHCARE January 23, 2016
9. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
CALA CB-839
MM, NHL, ALL, AML,
kidney cancer
Data Presentation
Updates at medical meetings,
especially for combinations in
kidney cancer
- 1H16 6/29/16 - - Outperform Paul Matteis
CBYL Hydros-TA Knee Osteoarthritis Data Presentation Phase III Top-line COR 1.1 Data - 1Q16 3/31/16 H
On positive data POS
goes to 85% (from 65%);
equals +$5/share to our
price target
Outperform Jason Gerberry, JD
CBYL Hydros-TA Knee Osteoarthritis P&A
OUS partnership assuming
positive Phase III COR 1.1 data
- 2016 12/29/16 H
We believe a theoretical
partnership agreement
consisting of ~$100m in
commercial milestones
and mid-teen royalties
could be worth ~$3/share
in upside to our current
Outperform Jason Gerberry, JD
CDTX CD101 topical Anti-fungal Data Presentation Phase I/II safety/efficacy study. - 4Q16 12/31/16 H - Outperform Paul Matteis
CEMP Solithromycin
Chronic Obstructive
Pulmonary Disease
(COPD) and Non-
Alcoholic Steatohepatitis
(NASH)
Data Presentation Phase II studies. - 2016 12/29/16 - - Market Perform Paul Matteis
CERU CRLX101
Neoadjuvant rectal
cancer
Data Presentation Phase Ib CRT/Xeloda combo - 2H16 12/30/16 H - Outperform
Michael Schmidt,
Ph.D.
CERU CRLX101
Platinum-resistant
ovarian cancer
Data Presentation
Phase Ib data with weekly
paclitaxel
- 1H16 6/29/16 L - Outperform
Michael Schmidt,
Ph.D.
CERU CRLX101 Renal cell carcinoma Data Presentation
Phase II data, combo with
Avastin
- 1H16 6/29/16 H - Outperform
Michael Schmidt,
Ph.D.
CERU CRLX301 Solid tumors Data Presentation Phase I interim data (MTD) - 1H16 6/29/16 L - Outperform
Michael Schmidt,
Ph.D.
CI - - Other Event 4Q15 Results. Scheduled Date. - 2/4/16 2/4/16 - - Outperform Ana Gupte, Ph.D.
CLDX Glembatumumab
Triple-negative gpNMB-
positive breast cancer
Data Presentation
Mgmt. stated that it now expects
enrollment in the pivotal
METRIC study of glemba in
metastatic triple-negative breast
cancer to complete in 2H16. Per
prior firm estimates, top line
results are expected
approximately 6 months after
completion of enrollment.
- 1H17 6/29/17 H +50%/-20% Outperform Seamus Fernandez
CLDX
Rindopepumut
(Rintega)
newly diagnosed
glioblastoma
Data Presentation
ACT IV 2nd interim analysis.
Offers chance for early trial stop
for success.
- 1H16 6/29/16 H
+100%/-15-20% (this is
the key catalyst for the
firm)
Outperform Seamus Fernandez
CLDX
Rindopepumut
(Rintega)
newly diagnosed
glioblastoma
Data Presentation
ACT IV final data. We currently
model market entry in 2017
following the final analysis.
- 2016 12/29/16 H
+100%/-50% (this
becomes the key catalyst
for the firm if ACT IV does
NOT stop for success at
the 2nd interim analysis)
Outperform Seamus Fernandez
9
HEALTHCARE January 23, 2016
10. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
CLDX Varlilumab Immuno-oncology Data Presentation
Several combination studies are
expected to complete in 2016,
although release of data in
combination with either BMY's
(OP) Opdivo or Roche's anti-
PDL1 antibodies will be
controlled by the collaborators.
- YE2016 1/1/17 H +50%/-20% Outperform Seamus Fernandez
CLVS
Rociletinib (CO-
1686)
Non-Small Cell Lung
Cancer (NSCLC)
Legal / Regulatory
CHMP opinion (expected: 150
days from submission date)
AZN, ARIA, Hanmi,
Astellas, NVS
Mid-2016 7/1/16 H -
Suspended
Coverage
Michael Schmidt,
Ph.D.
CNC - - Other Event 4Q15 Results. Scheduled Date. - 2/9/16 2/9/16 - - Outperform Ana Gupte, Ph.D.
CNC
Business
Development
- P&A
Acquisition. CNC to acquire HNT
at $78.57/share. S-4 filed on
8/18/15. Merger expected to
complete 2/1/16.
AET, CI, HNT, MOH,
UNH, WCG
Feb-2016 2/1/16 H - Outperform Ana Gupte, Ph.D.
CNMD
SurgiQuest
acquisition
- P&A Deal close expected 1Q16. - 1Q16 3/31/16 - - Outperform Richard Newitter
CORI Donepezil
Alzheimer's Disease
(AD)
Data Presentation
Phase I Data. Donepezil is
transdermal version of Aricept
(AGN)
-
January
2016
1/31/16 H
~$2 upside/$1.50
downside on POS impact
Outperform Jason Gerberry, JD
CORI Memantine
Alzheimer's Disease
(AD)
Data Presentation
Phase I Data. Memantine is
transdermal version of Namenda
(AGN)
-
January
2016
1/31/16 H
~$2 upside/$1.50
downside on POS impact
Outperform Jason Gerberry, JD
CORI
Potential
Partnerships
- Other Event
Phase II assets. Phase II assets
– Corplex-tamsulosin for BPH
and MicroCor-PTH for
osteoporosis – which receive
little or no credit, could drive
- 2016 12/29/16 H +5% on partnership Outperform Jason Gerberry, JD
CORI Twirla (patch)
Low-dose hormone
Contraceptive
Data Presentation
Phase III data. We see Twirla as
low development risk (75% prob.
of success) with est $400M in
peak US sales, or 3-5% share
based on physician feedback &
need for a low-dose hormone
patch. Trial began mid-2014.
Launch est late 2016.
- 2H16 12/29/16 H +/-5% Outperform Jason Gerberry, JD
CSII Micro Cown 360
CAD (Coronary Artery
Disease)
Data Presentation
COAST 30-day top-line trial
results, likely to pave the way for
approval in '17
- 2016 12/31/16 L +5% Market Perform Danielle Antalffy
CSII Stealth 360
PAD (Pulmonary Artery
Disease)
Data Presentation
Trial protocol presentation at
CRT16.
-
2/20/16 -
2/23/16
2/20/16 L - Market Perform Danielle Antalffy
CSII Stealth 360
PAD (Pulmonary Artery
Disease)
Product Launch
EU launch. Sales likely to begin
in the EU in late 2015-early
2016.
- 1H16 6/29/16 L - Market Perform Danielle Antalffy
CSLT - - Other Event
4Q15 Earnings. Scheduled
Date.
- 2/17/16 2/17/16 - - Market Perform Steven Wardell
CSLT
Consumer Digital
Tools
- Other Event
Employers Shifting to Exchange.
A greater shift by US employers
of employees onto public and
private exchanges would be a
negative catalyst for CSLT as
CSLT has built product and
sales force around selling to
employers.
- 2016 12/29/16 - - Market Perform Steven Wardell
CYH - - Other Event 4Q15 Results. Scheduled Date. - 2/17/16 2/17/16 - - Market Perform Ana Gupte, Ph.D.
10
HEALTHCARE January 23, 2016
11. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
CYH
Business
Development
- P&A
Spin-off of Quorum Health
Corporation (QHC), announced
8/3/15. Form-10 Registration
Statement filed 9/11/15. Spin-off
expected to boost CYH revenue
per adjusted admission, EBITDA
margin and FCF as a proportion
of net revenue.
- 1Q16 3/31/16 - - Market Perform Ana Gupte, Ph.D.
CYNO SculpSure Non-invasive fat Data Presentation
Clinical presentations at
American Academy of
Dermatology (AAD) and
(American Society for Laser
Medicine and Surgery) ASLMS
-
3/4/16-
4/3/16
3/4/16 - - Outperform Richard Newitter
CYNO SculpSure Non-invasive fat Product Launch
The full launch will focus on
broader rollout in US. Also
EMEA roll out in key direct OUS
markets beginning in 1Q16.
- 1H16 6/29/16 H +/-10-15% Outperform Richard Newitter
DBVT Viaskin Peanut Peanut allergy Data Presentation
Ph.2 VIPES 2-yr. follow up data
and possibly COFAR6 IIT trial
results at AAAAI'16
AIMT 3/31/16 3/31/16 L - Outperform Joseph P. Schwartz
DERM - - P&A
We believe DERM is a
compelling M&A target when
one or more of its 3 programs
read out positively.
- 2016 12/29/16 H
+30-50% if deal
announced
Outperform Seamus Fernandez
DERM
Cimzia (injectable
TNF-alpha
inhibitor)
psoriasis Data Presentation 3 Ph III trials data readout AMGN, ABBV 1Q17 3/31/17 H +10-20% Outperform Seamus Fernandez
DERM DRM01 Acne Data Presentation
Ph IIb . A critical valuation
inflection point. We assign a
70% POS.
- 2Q16 6/30/16 H +30%/-20% Outperform Seamus Fernandez
DERM DRM04
Hyperhidrosis (excessive
underarm
sweating)
Data Presentation
Topline results from two Ph3
trials (ATMOS-1 and -2). We
assign a 75% POS.
AGN Mid-2016 7/1/16 H +30%/-20% Outperform Seamus Fernandez
Digital Health - - Other Event
Employer Risk Shifting. Look for
news stories on employers
shifting healthcare benefit costs
onto employees. Benefits cos.
providing consumer tools to
manage their healthcare costs.
CSLT, WAGE Ongoing 12/29/16 - - - Steven Wardell
Digital Health - - Other Event
Pharma Brands Shift to Online
Ad Spend. Watch: (1) signs of
ad spend shifting to online
channels, (2) pharma R&D
spend on targeted therapeutics,
which lend themselves better to
targeted online advertising, and
(3) regulatory changes that make
conventional pharma promotion
more challenging (ex. Sunshine
Act).
EVDY, WBMD Ongoing 12/29/16 - - - Steven Wardell
11
HEALTHCARE January 23, 2016
12. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
Digital Health - - Other Event
Pharma Ad Spend. New
molecular entity (NME) launches
in 2015-17 period will drive
pharma spend, benefitting
companies whose revenue is
tied to advertising spend.
EVDY, WBMD
Ongoing -
2017
12/29/17 - - - Steven Wardell
Digital Health - - Other Event
Meaningful Use Program
Deadlines. Meaningful use /
HITECH Act: we expect single
sign-on services will be a useful
tool for health system CIOs to
achieve Meaningful Use goals.
Varying deadlines for each
provider organization.
IMPR
Ongoing -
2020
12/29/20 - - - Steven Wardell
DRNA - - Other Event
Platform update at American
Assoc of Cancer Research
- 4/16 - 4/20 4/20/16 L - Outperform
Michael Schmidt,
Ph.D.
DRNA DCR PH1
Primary hyperoxaluria
type I
Data Presentation
Phase I data could partially de-
risk this asset.
ALNY 4Q16 12/31/16 H - Outperform
Michael Schmidt,
Ph.D.
DRNA DCR-MYC
P-NET, Hepatocellular
Carcinoma (HCC)
patients
Data Presentation Ph I point of care (POC) data - YE2016 1/1/17 H - Outperform
Michael Schmidt,
Ph.D.
EARS AM-101 Tinnitus Data Presentation
Ph III TACTT data. Top-line Ph
III TACTT2 (US) & TACTT3 (EU)
data. We model 60% probability
of approval
-
2Q16 -
2H16
6/30/16 H - Outperform Joseph P. Schwartz
EDGE EG-1962
Aneurysmal
subarachnoid
hemorrhage (aSAH)
Trial Initiation
Single global Phase 3 study.
We estimate 80% and 60%
probabilities of success for
approval and commercialization
in US and EU.
-
2Q16 -
3Q16
6/30/16 L - Outperform Joseph P. Schwartz
ENDP Belbuca Chronic Pain Product Launch US Launch - Feb-2016 2/1/16 H - Outperform Jason Gerberry, JD
ENDP
Business
Development
- P&A
However, deal capacity is limited
in 2016.
- 2016 12/29/16 M - Outperform Jason Gerberry, JD
ENDP Xiaflex Frozen Shoulder Data Presentation Phase II data - 4Q16 12/31/16 H - Outperform Jason Gerberry, JD
ENDP Xiaflex Peyronie's Disease Other Event DTC (web-based) ad campaign - 1H16 6/29/16 M - Outperform Jason Gerberry, JD
EPRS Biosimilars - P&A
Marketing filings and
partnerships
- 1Q16 3/31/16 L - Outperform Jason Gerberry, JD
EPZM
Tazemetostat,
EPZ-6438
non Hodgkin's lymphoma Data Presentation
Initial results from first arms of
Phase II trial. Could be ASCO,
EHA, or less likely ESMO/
ECCO in Oct.
Eisai Mid-2016 7/1/16 H - Outperform Seamus Fernandez
EPZM
Tazemetostat,
EPZ-6438
Genetically Defined Solid
Tumors
Data Presentation
Data could be at ESMO/ECCO
in Oct. or triple meeting in Nov.
- 4Q16 12/31/16 H - Outperform Seamus Fernandez
ESRX
ANTM Re-Pricing
Negotiations
- Other Event
ESRX in re-pricing negotiations
with ANTM. ANTM asking for
~$3B in gross annual savings.
ANTM 2016 12/29/16 H +/- 7% Market Perform David Larsen, CFA
EVDY - - Other Event 4Q15 Earnings. Estimated Date. - 2/29/16 2/29/16 - - Outperform Steven Wardell
12
HEALTHCARE January 23, 2016
13. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
EW RESILIA ZETA
Resilient Tissue
Technology for In-Valve
Delivery
Other Event
PMA and CE Mark Submission.
Expected in 2015, after
completion of COMMENCE trial
enrollment.
- 2016 12/29/16 L - Outperform Danielle Antalffy
EW Sapien 3 Cardiac Valve Data Presentation
1 Year intermediate risk data
likely at ACC
-
4/2/16-
4/4/16
4/2/16 - - Outperform Danielle Antalffy
EXEL - - P&A
Near-term ROW Cabo
partnership represents a source
of upside.
- 2016 12/29/16 H
Potential for accelerated
FDA approval (before
PDUFA), positive OS data
and ROW partnership with
good terms in 2016;
combined Up/down +60%/-
20%.
Outperform
Michael Schmidt,
Ph.D.
EXEL
Cometriq
(Cabozantinib)
1st Line Renal Cell
Carcinoma
Data Presentation Ph II data vs. sunitinib BMY, GSK, SOBI.SS 1H16 6/29/16 H - Outperform
Michael Schmidt,
Ph.D.
EXEL
Cometriq
(Cabozantinib)
2nd/3rd Line Renal Cell
Carcinoma
PDUFA
Expect FDA approval around
mid-year or earlier. EXEL will be
launch-ready by 4/1/16.
BMY, GSK, SOBI.SS 6/23/2016 6/23/2016 H
Potential for accelerated
FDA approval (before
PDUFA), positive OS data
and ROW partnership with
good terms in 2016;
combined Up/down +60%/-
20%.
Outperform
Michael Schmidt,
Ph.D.
EXEL
Cometriq
(Cabozantinib)
2nd/3rd Line Renal Cell
Carcinoma
Data Presentation
METEOR trial OS (Overall
Survival) data could drive faster
adoption.
BMY, GSK, SOBI.SS 2016 12/29/16 H
Potential for accelerated
FDA approval (before
PDUFA), positive OS data
and ROW partnership with
good terms in 2016;
combined Up/down +60%/-
20%.
Outperform
Michael Schmidt,
Ph.D.
FGEN
FG-3019 (anti-
CTGF antibody)
Idiopathic pulmonary
fibrosis (IPF)
Data Presentation
Phase II data. Not currently in
our model but this indication
could add $3-4B alone.
- 1H17 6/29/17 - - Outperform Seamus Fernandez
FGEN Roxadustat chronic kidney disease Data Presentation
Results from Phase III study in
China.
AZN, Astellas, GSK,
AKBA
2H16 12/30/16 H - Outperform Seamus Fernandez
FGEN Roxadustat chronic kidney disease Data Presentation
Results from US/ROW Phase III
studies.
AZN, Astellas, GSK,
AKBA
1H17 6/29/17 H
Bull case: upside to $83;
Base case: $49; Bear
Case: downside to $10
Outperform Seamus Fernandez
FIT - - Other Event
IPO lockup set to expire on
about 165M shares.
- 2/11/16 2/11/16 H - Outperform Steven Wardell
FIT - - Other Event
Potential Apple Watch 2
announcement
-
Mar-Apr
2016
3/1/16 H - Outperform Steven Wardell
FLML
Micropump
sodium oxybate
Sleep Disorders Data Presentation
Phase III data; accounts for 65%
of FLML valuation
- 1H17 6/29/17 H - Outperform Jason Gerberry, JD
FLML UMD product #3 - PDUFA
PDUFA date; we think the end
market is injectable epinephrine
sulfate
AKRX 4/30/16 4/30/16 L - Outperform Jason Gerberry, JD
13
HEALTHCARE January 23, 2016
14. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
FMI
Comprehensive
genomic
profiling panels
Non-small cell lung
cancer
Other Event
In late December, comment
period ended for reimbursement
proposal from National
Government Services, FMI's
Medicare administrative
contractor. Expect finalization
1H16.
- 1H16 6/29/16 L - Market Perform Dan Leonard
FOLD
ATB200 +
chaperone combo
Pompe Disease Data Presentation
Ph I/II data anticipated.
Additional study details will be
disclosed in early ’16
- 1H16 6/29/16 H +20%/-10% Outperform Joseph P. Schwartz
FOLD Galafold Fabry Disease Legal / Regulatory
EU CHMP opinion. We assume
75% probability of success
- 1Q16 3/31/16 H +20%/-30% Outperform Joseph P. Schwartz
FOLD Zorblisa
Epidermolysis bullosa
(EB)
Data Presentation
Ph III pivotal data. We ascribe a
65% probability of success for
both US and EU
- 2H16 12/30/16 H +40%/-25% Outperform Joseph P. Schwartz
FOLD Zorblisa
Epidermolysis bullosa
(EB)
Submit Application Complete NDA submission. -
2H16 -
early-2017
12/30/16 L - Outperform Joseph P. Schwartz
FPRX FP-1039 Solid tumors Data Presentation
Ph Ib with Paclitaxel/Carboplatin
or Coectaxel at ASCO.
GSK, 6/3/16 6/7/16 H - Outperform
Michael Schmidt,
Ph.D.
FPRX
FPA008 (CSF1R
mAB)
Solid tumors, Opdivo
combination
Data Presentation
Main value driver. Ph I/IIb data
on safety, pharmacokinetics,
biomarkers.
BMY 2H16 12/30/16 H - Outperform
Michael Schmidt,
Ph.D.
FWP FP187 - Legal / Regulatory
Estimated patent interference
ruling. FP187 has same API as
BIIB's Tecfidera. PTO to rule on
patent inference. FWP would
receive royalties on WW
Tecfidera sales if FWP prevails.
A settlement is the most likely
outcome.
BIIB 1Q17 3/31/17 H
Stock most likely trades at
psoriasis opportunity
($10/shr) + net cash
Outperform Jason Gerberry, JD
GMED - Trauma products Submit Application
FDA submissions beginning in
2H16 for 6 trauma products
currently under development.
- 2H16 12/30/16 - - Outperform Richard Newitter
GMED
Excelsius robotics
system
Spine Legal / Regulatory
FDA 510k submission in 1H16,
launch expected in 2017.
- 1H16 6/29/16 - - Outperform Richard Newitter
GSK - - Other Event Special Dividend to be declared. - 2/3/16 2/3/16 L - Market Perform Seamus Fernandez
GSK Benlysta SC Lupus Legal / Regulatory Regulatory filing AZN 2016 12/31/16 L - Market Perform Seamus Fernandez
GSK
Closed Triple
(LAMA/LABA/ICS
)
respiratory Product Launch
Nucala US/EU launch trajectory
key to GSK's long term
respiratory portfolio
AZN 2016 12/31/16 L - Market Perform Seamus Fernandez
GSK Nucala Asthma Legal / Regulatory Regulatory filing AZN 2016 12/31/16 L - Market Perform Seamus Fernandez
GWPH CBDV Adult epilepsy Data Presentation
Phase II data. Currently not in
our model, but could provide
meaningful upside to how the
street models the life cycle of
GW's seizure franchise
- 2016 12/29/16 H - Outperform Paul Matteis
GWPH Epidiolex Dravet Syndrome Data Presentation
Phase III pivotal data. From at
least one of its Phase III Dravet
studies
ZGNX 1Q16 3/31/16 H +60%/-85% Outperform Paul Matteis
14
HEALTHCARE January 23, 2016
15. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
GWPH Epidiolex Dravet, Lennox Gastaut Data presentation
Phase III pivotal data. From
other three trials (1 Dravet, 2
Lennox Gastaut)
- 2Q16 6/30/16 H - Outperform Paul Matteis
GWPH Epidiolex Dravet, Lennox Gastaut Submit Application File NDA - 4Q16 12/31/16 - - Outperform Paul Matteis
GWPH Epidiolex
Tuberous Sclerosis
Complex (TSC)
Data Presentation Phase III data - 2017 12/29/17 H - Outperform Paul Matteis
GWPH GWP42004 Brain Cancer Data Presentation - - 2016 12/29/16 - - Outperform Paul Matteis
HCA - - Other Event 4Q15 Results. Scheduled Date. - 1/28/16 1/28/16 - - Market Perform Ana Gupte, Ph.D.
Healthcare
Services
Medicaid - Other Event
Medicaid Expansion. Additional
Expansion states pose upside
potential for MCO margins and
hospitals' reductions in bad debt
and uninsured volumes.
However, additional State
Medicaid expansions unlikely
until after 2016 election.
AET, ANTM, CI, CNC,
CYH, HCA, HUM,
LPNT, MGLN, MOH,
THC, UAM, UHS,
UNH, WCG
2016 12/29/16 - - - Ana Gupte, Ph.D.
HNT - - Other Event 4Q15 Results. Estimated Date. - 2/22/16 2/22/16 - - Market Perform Ana Gupte, Ph.D.
HQY - - Other Event
Possible press release on HSA
account stats
- early Feb 2/1/16 H - Outperform Steven Wardell
HQY - - Other Event 4Q16 Earnings. Estimated Date. - 3/22/16 3/22/16 - - Outperform Steven Wardell
HRTX HTX-011b Post-operative pain Data Presentation Phase II data (hernia) PCRX 1H16 6/29/16 H - Outperform Jason Gerberry, JD
HRTX HTX-011b Post-operative pain Data Presentation Phase IIb data (bunionectomy) PCRX Mid-2016 7/1/16 H - Outperform Jason Gerberry, JD
HRTX Sustol
Chemo induced nausea
(CINV)
PDUFA
FDA PDUFA date; potential
launch in 2Q16
- Feb-2016 2/1/16 H - Outperform Jason Gerberry, JD
HTWR - - P&A
Valtech Acquisition Deal Close -
Cardioband (differentiated
transcatheter annuloplasty
system) to secure CE mark by
year end and commercial launch
2016; Cardinal (surgical
annuloplasty repair system)
commercial launch 2016
- Early-2016 1/1/16 L - Outperform Danielle Antalffy
HTWR HVAD - Submit Application
Bridge to Transplant filing in
Japan
- 2016 12/29/16 L - Outperform Danielle Antalffy
HUM - - Other Event 4Q15 Results. Scheduled Date. - 2/10/16 2/10/16 - - Outperform Ana Gupte, Ph.D.
ICPT
Obeticholic acid
(OCA)
Primary Biliary Cirrhosis
(PBC)
FDA AdCom
PDUFA date delayed until
5/29/16 (previously 2/19/16).
Approval anticipated.
- 4/7/16 4/7/16 H +10%/-10% Market Perform Joseph P. Schwartz
ICPT
Obeticholic acid
(OCA)
Primary Biliary Cirrhosis
(PBC)
Data Presentation
4 planned abstracts for EASL '16
focused on OCA-induced
pruritus, pruritus, pruritus
management, and impact on
efficacy/safety.
-
4/13/16 -
4/16/16
4/13/16 L - Market Perform Joseph P. Schwartz
ICPT
Obeticholic acid
(OCA)
Primary Biliary Cirrhosis
(PBC)
PDUFA
PDUFA date delayed until
5/29/16 (previously 2/19/16).
Approval anticipated.
- 5/29/16 5/29/16 H +5%/-5% Market Perform Joseph P. Schwartz
ICPT
Obeticholic acid
(OCA)
Primary Biliary Cirrhosis
(PBC)
Legal / Regulatory CHMP opinion. - Mid-2016 7/1/16 L +5%/-5% Market Perform Joseph P. Schwartz
15
HEALTHCARE January 23, 2016
16. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
IMDZ CMB305
sarcomas, melanoma,
ovarian and lung cancer
Data Presentation
First data from Phase I dose
escalation and expansion phase.
- 1Q16 3/31/16 H
+100% (if clear single-
agent activity, though
unlikely) /-10%
Outperform Seamus Fernandez
IMDZ CMB305 soft tissue sarcoma Data Presentation
Initial data from randomized
Phase II in soft-tissue sarcomas
in combination with
atezolizumab; expect to see
efficacy here
RHHBY 2H16 6/30/16 H
+100%/-50% (this is the
key catalyst for the firm)
Outperform Seamus Fernandez
IMDZ G100 Merkel Cell carcinoma Data Presentation
First data from all 10 pts on
Phase I study in combination
with radiation therapy
- 1Q16 3/31/16 L - Outperform Seamus Fernandez
IMDZ G100 Merkel Cell carcinoma Data Presentation
Full dataset from phase I study
in combination with radiation
therapy
- 2H16 12/31/16 L - Outperform Seamus Fernandez
IMDZ G100 non Hodgkin's lymphoma Data Presentation
first data from Phase I NHL
study in combination with
Keytruda
MRK 2H16 12/31/16 H +100%/-30% Outperform Seamus Fernandez
IMDZ LV305 Solid tumors Data Presentation
Initial data from Phase I
expansion cohort
- 1Q16 3/31/16 H +20%/-10% Outperform Seamus Fernandez
IMGN IMGN853 Ovarian cancer Data Presentation
Full data set Ph I 40 pts., likely at
ASCO.
- 2Q16 6/30/16 H - Market Perform
Michael Schmidt,
Ph.D.
IMGN Kadcyla eBC neoadjuvant Data Presentation Phase III data. KRISTINE trial RHHBY, ENDP, PDLI 2016 12/29/16 L - Market Perform
Michael Schmidt,
Ph.D.
IMPR - - Other Event
4Q15 Earnings. Scheduled
Date.
- 2/16/16 2/16/16 - - Outperform Steven Wardell
INCY Baricitinib Rheumatoid Arthritis Other Event
US and EU regulatory
submissions
LLY 1Q16 3/31/16 L - Outperform
Michael Schmidt,
Ph.D.
INCY epacadostat Immuno-oncology Data Presentation
Combo studies provide add'l
insight into the magnitude of the
IDO1 oppt'y beyond melanoma.
BMY, MRK, RHHBY,
AZN
2016 12/29/16 H
Ph II and Ph III data
readouts from Jakafi in
three solid tumor
indications and updated
IDO data; 3 catalysts
combined, Up/down
+40%/ 0%.
Outperform
Michael Schmidt,
Ph.D.
INCY INCB50465 B-cell malignancies Data Presentation Phase I data - 2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
INCY INCB54329 Advanced Malignancies Data Presentation Phase I data - 2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
INCY INCB54828 Advanced Malignancies Data Presentation Phase I data - 2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
INCY Jakafi Pancreatic Cancer Data Presentation
Phase III JANUS-1 could
validate solid tumor oppt'y.
- 2016 12/29/16 H
Ph II and Ph III data
readouts from Jakafi in
three solid tumor
indications and updated
IDO data; 3 catalysts
combined, Up/down
+40%/ 0%.
Outperform
Michael Schmidt,
Ph.D.
INCY Jakafi Solid Tumors Data Presentation
Ph II data in breast & colorectal
cancers
- 2016 12/29/16 H
Ph II and Ph III data
readouts from Jakafi in
three solid tumor
indications and updated
IDO data; 3 catalysts
combined, Up/down
+40%/ 0%.
Outperform
Michael Schmidt,
Ph.D.
INSM Arikayce
Non-Tuberculous
Mycobacteria
OUS Approval EU approval anticipated. - 1Q16 3/31/16 H -20%/+20% Outperform Joseph P. Schwartz
INSM Arikayce
Non-Tuberculous
Mycobacteria
Submit Application Rolling NDA submission. - YE2016 1/1/17 L - Outperform Joseph P. Schwartz
16
HEALTHCARE January 23, 2016
17. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
IONS IONIS-FXI anti-coagulant Data Presentation Ph II - 4Q16 12/30/16 H - Market Perform
Michael Schmidt,
Ph.D.
IONS
ISIS-SMNRx
(Nusinersen)
spinal muscular atrophy Data Presentation Phase III data BIIB
Early/ Mid
2017
7/1/17 H - Market Perform
Michael Schmidt,
Ph.D.
IONS ISIS-TTR FAP Data Presentation Ph III - 1H17 6/29/17 H - Market Perform
Michael Schmidt,
Ph.D.
IONS Volanesorsen familial chylomicronemia Data Presentation Ph III data - 1H17 6/29/17 L - Market Perform
Michael Schmidt,
Ph.D.
IPH FP
IPH2201 (anti-
NKG2A)
Solid tumors Data Presentation Multiple solid tumor trials AZN 2017 12/31/17 H - Outperform
Michael Schmidt,
Ph.D.
IPH FP
Lirilumab (anti-
KIR)
Acute Myeloid Leukemia
(AML)
Data Presentation Phase II data . BMY 2Q16 6/30/16 H - Outperform
Michael Schmidt,
Ph.D.
IPH FP
Lirilumab (anti-
KIR)
Hematological Cancer
Trials
Data Presentation Ph II trials in MM and Lymphona BMY 2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
IPH FP
Lirilumab (anti-
KIR)
solid tumors Data Presentation Ph I/II combo data with Opdivo BMY 2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
IPXL
Business
Development
- P&A Potentially accretive M&A - 2016 12/29/16 H
We believe transactions in
the $500-$700M range
are feasible and could add
~50c-60c EPS accretion.
Market Perform Jason Gerberry, JD
IPXL
Business
Development
Product Launches Product Launch
Potential high-value launches
including OxyContin TR,
Welchol, Renvela and AXR
- 2016 12/29/16 H - Market Perform Jason Gerberry, JD
IRWD IW-9179 Diabetic gastroparesis Data Presentation Phase IIa data - 1H16 6/29/16 L - Market Perform Jason Gerberry, JD
IRWD Linzess
Opioid-induced
constipation
Data Presentation
Linaclotide colonic release Ph.
2b data to inform decision on
OIC program
AGN 2H16 12/29/16 L - Market Perform Jason Gerberry, JD
ISRG
Sp Surgical
System
- Product Launch
Full launch. FDA Approval 4/22,
with expanded approvals likely in
'16 and launch possible in 1H16.
- 1H16 6/29/16 - - Outperform Richard Newitter
ITCI ITI-007 Bipolar Depression Data Presentation
Top-line readouts from two Ph III
trials as monotherapy and as
adjunctive therapy. We est. 70%
POS.
- 2017 12/29/17 H +20-30% / -10-15% Outperform Seamus Fernandez
ITCI ITI-007 schizophrenia Data Presentation
Results from second Phase III
schizophrenia trial. We est. 90%
POS.
- Mid-2016 7/1/16 H
+$15-20/shr
-$10-15/shr
Outperform Seamus Fernandez
ITCI ITI-007 schizophrenia Submit Application
FDA filing expected if the 2nd Ph
III study is pos.
-
YE2016-
1H2017
1/1/17 L - Outperform Seamus Fernandez
JAZZ
Business
Development
- P&A
Potential M&A. Conservatively,
we estimate JAZZ has $3-4B
available for M&A.
- 2016 12/29/16 H
$5B M&A transaction
drives ~35-40% EPS
accretion, assuming spec
pharma multiples on a
synergy focused deal,
paying 5x sales multiple, &
achieving R&D and SGA
Outperform Jason Gerberry, JD
JAZZ
Defitelio
(Defibrotide)
Veno-occlusive disease
(VOD)
PDUFA
Estimated US approval by
3/31/16. We model sales of
$300M in '20E.
- 3/31/16 3/31/16 H +/- 5% Outperform Jason Gerberry, JD
JAZZ JZP-110 Sleep Disorders Data Presentation Phase III data - 2H16 12/30/16 H +/- 5% Outperform Jason Gerberry, JD
17
HEALTHCARE January 23, 2016
18. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
JAZZ Xyrem Narcolepsy Legal / Regulatory
Patent Trial (Roxane). We
believe Xyrem is protected by a
strong formulation patent to
2019, REMS patent expiring
2024 is a wildcard.
- 1Q16 3/31/16 H +/- 5% Outperform Jason Gerberry, JD
JNJ Imbruvica - Other Event
Extension of Imbruvica line.
Extension of the Imbruvica
product to DLBCL and relapsed
MCL expected in 2016
- 2016 12/29/16 L - Outperform Danielle Antalffy
JNJ Imbruvica
Chronic lymphocytic
leukemal small cell
lymphocytic lymphoma,
Non Hodgkins lymphona
PDUFA
potential approval based on
RESONATE-2 data
- 7/14/16 7/14/16 - - Outperform Danielle Antalffy
JUNO
JCAR023
(L1CAM)
Neuroblastoma Data Presentation
Proof of concept data. First
JUNO CAR in solid tumors.
Likely to be of high investor
interest
KITE, NVS, ADAP,
CLLS
2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
JUNO JTCR016 (WT-1)
NSCLS, Acute Myeloid
Leukemia (AML)
Data Presentation
Phase I/II top line results
results.
KITE, NVS, ADAP,
CLLS
2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
JUNO Multiple CARs
hematological
malignancies
Data Presentation Multiple programs - AACR
KITE, NVS, ADAP,
CLLS
4/16 - 4/20 4/20/16 H - Outperform
Michael Schmidt,
Ph.D.
JUNO Multiple CARs
hematological
malignancies
Data Presentation Multiple programs - ASCO
KITE, NVS, ADAP,
CLLS
6/3-6/7 6/7/16 H - Outperform
Michael Schmidt,
Ph.D.
KPTI Selinexor
Diffused Large B-Cell
Lymphoma (DLBCL)
Data Presentation Ph II SADAL trial data. - 1Q17 3/31/17 H - Outperform
Michael Schmidt,
Ph.D.
KPTI Selinexor Multiple Myeloma Data Presentation
Ph II STORM and SCORE trial
interim data
-
mid-16
(STORM) /
2H16
6/30/16 H - Outperform
Michael Schmidt,
Ph.D.
KPTI Selinexor
r/r Acute Myeloid
Leukemia (AML)
Data Presentation Ph II SOPRA top line trial data - Mid-2016 7/1/16 H - Outperform
Michael Schmidt,
Ph.D.
KURA Tipifarnib
HRAS mutated cancers
and Peripheral T-cell
Lymphoma (PTCL)
Data Presentation
Top-line data from Phase II trial
in HRAS mutated tumors in
2H16. Top-line data from Phase
II trial in PTCL in 1H17. We
assume a 25% probability of
success in all indications.
-
2H16 -
1H17
12/30/16 - - Outperform Paul Matteis
LLY
abemaciclib (CDK
4/6 inhibitor)
Breast cancer Data Presentation
Interim look at MONARCH 2 and
3 results.
- 2H16 12/30/16 H 3%-5% Outperform Seamus Fernandez
LLY
AZD3293 (BACE
inhibitor)
Alzheimer's Data Presentation
AMARANTH study safety interim
analysis.
AZN 2Q16 6/30/16 H
+3%-5% if continues to
Ph3 after safety interim
analysis
Outperform Seamus Fernandez
LLY
Ixekizumab (IL-17
mAb)
Plaque Psoriasis PDUFA We. Est. $1.85B 2026 rev. - 1Q16 3/31/16 L +2%-3% Outperform Seamus Fernandez
LLY Lantus Diabetes (T2DM) Legal / Regulatory
Earliest potential Basaglar
(insulin Lantus biosimilar) US
launch according to
LLY/SNY settlement
SNY Dec. 2016 12/1/16 L - Outperform Seamus Fernandez
LLY solanezumab mild Alzheimer's Data Presentation
EXPEDITION 3 trial top-line
results. Bull case $5B+ sales
potential.
- YE2016 1/1/17 H +/-10-20% Outperform Seamus Fernandez
18
HEALTHCARE January 23, 2016
19. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
LPNT - - Other Event 4Q15 Results. Estimated Date. - 2/12/16 2/12/16 - - Market Perform Ana Gupte, Ph.D.
Managed Care
Affordable Care
Act
- Other Event
December 2015 omnibus
spending bill delayed Cadillac
tax implementation 2 years, to
2020. Funding shortfalls
extended on 3R Risk Corridors.
Expected to slow down adoption
of Private & Public Exchanges.
- Ongoing 12/29/20 - - - Ana Gupte, Ph.D.
Managed Care Contract re-award - Other Event
Re-procurement. Anticipated
reward date of TriCare North
contract (HNT to face
competition from HUM)
HUM, HNT 2016 12/29/16 - - - Ana Gupte, Ph.D.
Managed Care
Health Insurance
Exchange (HIX)
- Other Event
CMS-proposed modifications to
HIX regulations. UNH guide-
down and Public Exchange
pressures top issues. Rules
involve puts and takes for MCO,
and aim to make the
marketplaces more consumer
friendly.
AET, ANTM, CI, CNC,
HNT, HUM, MOH,
UNH
2016 12/29/16 - - - Ana Gupte, Ph.D.
Managed Care Medicaid - Other Event
Implementation of new contracts
for Georgia Families and
Georgia Families 360°
programs. Awards announced
9/9/15, with GA Families bids
retained by AGP/ANTM, CNC,
and WCG. ANTM retained its
Georgia Families 360° contract.
ANTM, CNC, WCG 7/1/16 7/1/16 - - - Ana Gupte, Ph.D.
Managed Care Medicaid - Other Event
CMS Monthly Medicaid
Enrollment Reports. First week
of every month; provide insight
into the pace of Medicaid uptake
in both expansion and non-
Medicaid expansion states.
- 2016 12/29/16 - - - Ana Gupte, Ph.D.
Managed Care Medicaid - Other Event
TX Re-procurement. Presents
binary risks for incumbents;
enrolling all eligible children and
young adults who are currently in
or formerly were in the foster
care system into Managed
Medicaid.
CNC 2016 12/29/16 - - - Ana Gupte, Ph.D.
19
HEALTHCARE January 23, 2016
20. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
Managed Care Medicare - Other Event
CMS Data. CMS Medicare data
released every month around
the 17th
AET, ANTM, CI, CNC,
HNT, HUM, MGLN,
MOH, UAM, UNH,
WCG
2016 12/29/16 - - - Ana Gupte, Ph.D.
Managed Care
Medicare
Advantage
- Other Event
2017 MA Rate figures to be
published in 2016. MA all-in rate
preliminary estimate expected
2/19/16. Final numbers
expected 4/4/16.
AET, CI, HUM, UAM,
UNH, WCG
Feb-Apr
2016
2/1/16 H - - Ana Gupte, Ph.D.
MCRB SER-109
Recurrent
C. difficile infection (CDI)
Data Presentation
Ph II data readout anticipated.
We model an 80% probability of
success.
- Mid-2016 7/1/16 H +10%/-30% Outperform Joseph P. Schwartz
MDAS
Pamplona Capital
Management deal
close
- P&A
Pamplona Capital Management
proposal to buy MDAS deal
closing. No additional bids
expected to emerge.
- 1Q16 3/31/16 - - Market Perform David Larsen, CFA
MDCO ALN-PSCsc anti-PCSK9 Trial Initiation
Ph II ORION trial data for once-
quarterly or semi-annual dosing
in ASCVD pts
- 4Q16 12/31/16 H +25%/-40% Outperform Joseph P. Schwartz
MDCO Carbavance
Gram-negative targeting
antibiotic
Data Presentation
Ph III data (TANGO 1 & 2
studies).
- 2H16 12/30/16 H +20%/-10% Outperform Joseph P. Schwartz
MDCO MDCO-216 Apo-A Milano Data Presentation Ph II data. - 1Q16 3/31/16 H +30%/-10% Outperform Joseph P. Schwartz
MGLN - - Other Event 4Q15 Results. Scheduled Date. - 2/29/16 2/29/16 - - Market Perform Ana Gupte, Ph.D.
MGNX MGD006
Acute Myeloid Leukemia
(AML)
Data Presentation Phase I data. - 2016 12/30/16 H - Outperform
Michael Schmidt,
Ph.D.
MGNX MGD007 Colorectal Cancer Data Presentation Phase I data. - 2016 12/30/16 H - Outperform
Michael Schmidt,
Ph.D.
MGNX MGD271 Solid Tumors Data Presentation
Combo studies with BMY's
Yervoy and MRK's Keytruda
BMY, MRK 2016 12/30/16 H - Outperform
Michael Schmidt,
Ph.D.
MNK Acthar
Amyotrophic Lateral
Sclerosis (ALS)
Data Presentation Phase II data - 2016 12/29/16 L - Outperform Jason Gerberry, JD
MNK Acthar Nephrotic Syndrome Data Presentation Phase II data - 2016 12/29/16 L - Outperform Jason Gerberry, JD
MNK
Business
Development
- P&A
Potential M&A. MNK expected to
be active in M&A in CY16.
- 2016 12/29/16 M - Outperform Jason Gerberry, JD
MNK INOmax
Hypoxic respiratory
failure
Legal / Regulatory
IPR rulings on Method Patents
'284, '112
- 3Q16 9/30/16 L - Outperform Jason Gerberry, JD
20
HEALTHCARE January 23, 2016
21. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
MNTA Copaxone RR Multiple Sclerosis Legal / Regulatory
Inter partes review (IPR) case
invalidating Copaxone 40mg
patents. We expect a favorable
ruling for generics; possible
launch in early- to mid-2017.
TEVA, MYL Aug-16 8/1/16 H +5% on ruling Outperform Jason Gerberry, JD
MNTA Necuparanib Pancreatic Cancer Data Presentation Phase II data - 1H17 6/29/17 M - Outperform Jason Gerberry, JD
MOH - - Other Event 4Q15 Results. Scheduled Date. - 2/8/16 2/8/16 - - Outperform Ana Gupte, Ph.D.
MRK - - P&A
Business Development focused
on restocking and reshaping the
pipeline.
- 2016 12/29/16 L - Market Perform Seamus Fernandez
MRK anacetrapib hypercholesterolemia Data Presentation Phase III CV outcome study - 2017 12/29/17 H +5%/-2%-4% Market Perform Seamus Fernandez
MRK Biosimilars - Submit Application
US Filing. MRK's collaboration
with Samsung Bioepsis has 5
programs in Phase III (Humira,
Remicade, Enbrel, Lantus,
Herceptin) expected to file in
2015-16.
Roche, SNY, JNJ,
ABBV
2016 12/29/16 L - Market Perform Seamus Fernandez
MRK GITR compound Immuno-oncology Data Presentation Initial data - 2016 12/29/16 H +/-5% Market Perform Seamus Fernandez
MRK
Grazoprevir/Elbas
vir (MK-5172/MK-
8742) 2DAA
combo
Hepatitis C PDUFA
US Approval. With BTD status,
expect priority review & YE
approval. Under the FDA and
EMA review, with an FDA
PDUFA date of Jan. 28, 2016.
We est. rev. $485M in 2016.
ABBV, GILD 1/28/16 1/28/16 H +1-2%/-5% Market Perform Seamus Fernandez
MRK
MK-8931 (BACE
inhibitor)
mild to moderate
Alzheimer's
Data Presentation Phase III - 2017 12/29/17 H +5%/-3%-5% Market Perform Seamus Fernandez
MRTX MGCD265
Non-small cell lung
cancer (NSCLC)
Data Presentation
Ph Ib dose expansion update,
possibly at AACR (4/16-20) or
ASCO.
- 1H16 6/29/16 H +50%/-25% Outperform
Michael Schmidt,
Ph.D.
MRTX MGCD516
Non small cell lung
cancer
Data Presentation Ph Ib LOXO, RXDX 2016 12/30/16 H - Outperform
Michael Schmidt,
Ph.D.
MYGN
myRisk hereditary
cancer testing
panel
Hereditary cancer testing
panels
Other Event
CMS to establish gapfill pricing
for hereditary breast cancer-
related panels of 14+ genes
NVTA Sep 2016 9/30/16 H - Market Perform Dan Leonard
MYL
Business
Development
- P&A - - 2016 12/29/16 H - Outperform Jason Gerberry, JD
MYL g-Copaxone RR Multiple Sclerosis PDUFA
Potential g-Copaxone 20mg
approval
TEVA 2016 12/29/16 H - Outperform Jason Gerberry, JD
NBIX Elagolix Endometriosis Data Presentation
Phase III data. We assume an
85% probability-of-success.
- 1Q16 3/31/16 H +5%/-20% Outperform Paul Matteis
21
HEALTHCARE January 23, 2016
22. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
NBIX NBI-98854 Tardive Dyskinesia (TD) Data Presentation
Full KINECT3 data will likely be
presented at medical meetings
in '16 starting with AAN (4/15-21)
but rate limiting step to filing
NDA is one year safety data
from KINECT4
- 2016 12/29/16 L +10%/-5% Outperform Paul Matteis
NBIX NBI-98854 Tourette's Data Presentation Phase II data - 2H16 12/30/16 L - Outperform Paul Matteis
NBRV Lefamulin
Community Acquired
Bacterial Pneumonia
(CABP)
Data Presentation
Phase III interim analysis. We
model 60% probability of
success.
- 2H16 12/30/16 H - Outperform Paul Matteis
NUAN - - Other Event 1Q16 Earnings. Estimated Date. - 2/4/16 2/4/16 - - Outperform Steven Wardell
NUVA - - Other Event
OUS expansion. Entering
Benelux, Nordic countries;
Indonesia and Peru in 2015.
Continued expansion in 2016.
- 2016 12/29/16 - - Outperform Richard Newitter
NUVA - - Legal / Regulatory
Phase 2 MDT litigation. Absent
further proceedings on appeal,
the case will be returned to the
District Court for further
proceedings to determine a
proper damage award based
solely on a reasonable royalty.
Could occur later in 2015.
- 2016 12/29/16 - - Outperform Richard Newitter
NUVA Attrax
Orthobiologic (calcium
phosphate synthetic)
Product Launch Product launch. - 2016 12/29/16 - - Outperform Richard Newitter
NUVA
Ellipse
Technologies
acquisition
- P&A Deal close expected Feb. 2016. - Feb-2016 2/1/16 - - Outperform Richard Newitter
NVCN Reducer Refractory angina Trial Initiation Initiate IDE Study by mid 2016. - Mid-2016 7/1/16 L - Outperform Danielle Antalffy
NVO Semaglutide
Type 2 Diabetes
(cardiovascular outcome
trial)
Data Presentation
Topline result for SUSTAIN 6 for
once weekly GLP-1
LLY, AZN 2Q16 8/31/16 H +/- 3%-5% Market Perform Seamus Fernandez
NVO Victoza
Type 2 Diabetes
(cardiovascular outcome
trial)
Data Presentation
Top Line LEADER
cardiovascular outcome trial is
important for the outlook for
Victoza in light of Jardiance's
successful OUTCOME study
LLY 1Q16 3/31/16 H + 5-10%/-5% Market Perform Seamus Fernandez
NVO Xultophy Type 2 Diabetes PDUFA potential FDA approval - 7/25/16 7/25/16 H + 2%/ -5% Market Perform Seamus Fernandez
NVS CTL019 (CAR-T)
Pediatric r/r ALL
(Leukemia)
Submit Application
US Filing. Has breakthrough
therapy status. We est. rev. of
$2.1B in 2026.
JUNO, KITE 2016 12/29/16 - - Outperform Seamus Fernandez
NVS
Fovista (anti-
PDGF)
Wet Age-related Macular
Degeneration (AMD)
Submit Application
US Filing. We est. $490M rev. in
2026.
OPHT 2016 12/29/16 - - Outperform Seamus Fernandez
NVS
LEE011 (CDK4/6
inhibitor)
Breast Cancer Data Presentation
MONALEESA. Interim data in
mid-2016, final data 4Q16, triple
combo data no later than ASCO
2016.
- 2016 12/29/16 H +/- 5% Outperform Seamus Fernandez
22
HEALTHCARE January 23, 2016
23. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
NVS Serelaxin
Acute Heart Failure
(AHF)
Data Presentation
Top-line results are expected in
2016
- Mid-2016 7/1/16 H +/- 5% Outperform Seamus Fernandez
NVS Strategic review - P&A
Strategic review. Details on
restructuring of Alcon and
pharma R&D spending geared
toward sustained margin
improvements
- 2016 12/29/16 L - Outperform Seamus Fernandez
NVTA
Hereditary cancer
testing panels
Hereditary cancer testing
panels
Other Event
CMS to establish gapfill pricing
for hereditary breast cancer-
related panels of 14+ genes
MYGN Sep 2016 9/30/16 H - Outperform Dan Leonard
NXTM -
Next Generation
Hemodyalisis
Product Launch
For home and in-center care.
Expected to launch in late 2016.
BAX 4Q16 12/31/16 L - Outperform Danielle Antalffy
NXTM
Home
Hemodyalisis
(BAX)
Home Hemodyalisis Product Launch
Potential Launch. Competitor to
NXTM's NxStage One
BAX 2016 12/29/16 L - Outperform Danielle Antalffy
OMED Demicizumab Pancreatic cancer Data Presentation
Ph Ib survival data for
Demicizumab + abraxane +
gemcitabine; at ASCO-GI
CELG 1/22/16 1/22/16 - - Outperform Paul Matteis
OMED Tarextumab Pancreatic cancer Data Presentation
ALPINE 2 1st randomized phase
2 seeking OS benefit; bar may
not be just stat sig as Abraxane
was previously approved and
generated uptake. May be
looking for validation of the
biomarker in order to move into
phase 3
GSK 2H16 12/30/16 H - Outperform Paul Matteis
OMED Tarextumab Small cell lung cancer Data Presentation
Phase Ib data, at IASLC
Targeted Therapies annual
meeting
GSK
2/17/16-
2/21/16
2/17/16 - - Outperform Paul Matteis
OMED Tarextumab Small cell lung cancer Data Presentation PINNACLE Phase Ib data. - 2H16 12/30/16 - - Outperform Paul Matteis
OPHT Fovista
Wet Age-related Macular
Degeneration (AMD)
Trial Initiation
Ph III Fovista + Eylea trial
enrollment completion.
REGN 1Q16 3/31/16 L - Outperform Joseph P. Schwartz
OPHT Fovista
Wet Age-related Macular
Degeneration (AMD)
Data Presentation
Ph III Fovista + Lucentis topline
results from two fully-enrolled
trials, followed by Ph III Fovista +
Eylea trial readout in 1H17
REGN 4Q16 12/31/16 H 50%/-50% Outperform Joseph P. Schwartz
OREX Contrave Obesity Data Presentation
LIGHT study data to be
published in scientific journal.
ARNA, VVUS 1Q16 3/31/16 L - Outperform Paul Matteis
OREX Contrave Obesity Product Launch
As Mysimba, through co-
marketing partnerships, in
country-specific launches in EU
ARNA, VVUS 2H16 12/30/16 - - Outperform Paul Matteis
PBYI Neratinib
3rd line metatastic breast
cancer
Data Presentation Ph III data - 4Q16 12/31/16 H -
Suspended
Coverage
Michael Schmidt,
Ph.D.
PBYI Neratinib
Extended adjuvant
breast cancer
Submit Application
Filing for extended adjuvant
breast cancer.
- 1Q16 3/31/16 L -
Suspended
Coverage
Michael Schmidt,
Ph.D.
PBYI Neratinib
Extended adjuvant
breast cancer
Data Presentation with loperamide prophylaxis - 1H16 6/29/16 L -
Suspended
Coverage
Michael Schmidt,
Ph.D.
PBYI Neratinib
Metastatic breast cancer
w/ brain mets
Data Presentation Phase II data. - 4Q16 12/31/16 L -
Suspended
Coverage
Michael Schmidt,
Ph.D.
PBYI Neratinib
neoadjuvant breast
cancer
Data Presentation Ph II data update - 1H16 6/29/16 L -
Suspended
Coverage
Michael Schmidt,
Ph.D.
PCRX Exparel Nerve Block Data Presentation
Phase III Top-line data. From 3
nerve block studies
HRTX 1Q17 3/31/17 H - Market Perform Jason Gerberry, JD
23
HEALTHCARE January 23, 2016
24. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
PCRX Exparel Oral surgery pain Data Presentation
Phase III data. Wisdom teeth
removal
HRTX 1Q16 3/31/16 L - Market Perform Jason Gerberry, JD
PCRX Exparel Oral surgery pain Product Launch
Potential launch; for Wisdom
teeth removal
HRTX 4Q16 12/31/16 L - Market Perform Jason Gerberry, JD
PCRX Exparel Post-operative pain P&A OUS partnership - 2016 12/29/16 L - Market Perform Jason Gerberry, JD
PFE - - P&A
AGN deal completion and any
regulatory changes that might
interfere with the transaction
AGN 2H16 12/30/16 H - Market Perform Seamus Fernandez
PFE Ibrance Metastatic Breast Cancer PDUFA
2nd / 3rd line therapy approval
based on PALOMA-3 study.
Already seeing significant off-
label use here.
- Apr-2016 4/1/16 L +/- 2%-3% Market Perform Seamus Fernandez
PODD
OmniPod/Humulin
U-500
Diabetes Submit Application
Submit 510(k) for approval of
combination product. Market
opportunity to be ~10% of Type II
diabetics - ~2M patients - and
can double their addressable
market. FDA prefers trial to be
completed prior to 510 (k)
submission.
LLY 2016 12/29/16 L - Outperform Danielle Antalffy
PRGO
Business
Development
- P&A
Estimated close of Matawan's
Retin-A
- 1Q16 3/31/16 L - Market Perform Jason Gerberry, JD
PRGO Tysabri - P&A
Possible sale of Tysabri royalty,
or M&A event
- 2016 12/29/16 H - Market Perform Jason Gerberry, JD
PRQR QR-010 Cystic fibrosis (CF) Data Presentation
Proof-of-concept NPD data
readout.
-
mid-to-late
2016
7/1/16 H +5%/-5% Outperform Joseph P. Schwartz
PRQR QR-010 Cystic fibrosis (CF) Data Presentation
Ph Ib safety and efficacy data.
We assume 20% and 10%
probabilities of success in
PARI Pharma GmbH 2H16 12/30/16 H +10%/-10% Outperform Joseph P. Schwartz
PRQR QR-110
Leber's Congenital
Amaurosis (LCA)
Trial Initiation Ph I trial initiation.
QLTI, APHB, AGTC,
ONCE
1H16 6/29/16 L - Outperform Joseph P. Schwartz
PRTK Omadacycline
Acute Bacterial Skin and
Skin Structure Infections
(ABSSSI)
Data Presentation Phase III data. - 2H16 12/30/16 H - Outperform Paul Matteis
PRTK Omadacycline
Community Acquired
Bacterial Pneumonia
(CABP)
Data Presentation Phase III data. - 2H17 12/30/17 H - Outperform Paul Matteis
PRTK Omadacycline
Sinusitus and Urinary
Tract Infection (UTI)
Trial Initiation Initiation of Phase I study - 1H16 6/29/16 - - Outperform Paul Matteis
PRTK Omadacycline Urinary Tract Infection Data Presentation
Phase I PK/PD. With 16M
inpatient/outpatient cases in UTI
this indication would provide
significant upside to our model.
- 2H16 12/30/16 H - Outperform Paul Matteis
QSII NextGen Now Cloud based platform Other Event
Potential launch of new platform.
New cloud based EHR platform
will target small doc practices.
- 2017 12/29/17 - - Market Perform David Larsen, CFA
QURE
AMT Hemophilia
B Gene Therapy
(AMT-060)
Hemophilia-B Data Presentation Cohort 1 data in Ph I/II Chiesi (EU) 2Q16 6/30/16 H +50%/-20% Outperform
Michael Schmidt,
Ph.D.
QURE
AMT Sanfilippo B
Gene Therapy
(AMT-110)
Sanfilippo B Data Presentation 30-month follow-up data - YE2016 1/1/17 H - Outperform
Michael Schmidt,
Ph.D.
24
HEALTHCARE January 23, 2016
25. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
REGN Dupilumab Atopic Dermatitis Data Presentation Ph III top-line data. SNY 1H16 3/30/16 H +10%/-15% Outperform Joseph P. Schwartz
REGN
I/O (REGN2810
[PD-1], REGN
1979
[CD20XCD3]
Hematologic
malignancies
Data Presentation Ph.1 proof-of-concept data - 1H16 7/1/16 L - Outperform Joseph P. Schwartz
REGN
Praluent
(Alirocumab,
PCSK9 antibody)
LDL Lowering Legal / Regulatory 7-day jury trial. SNY partner 3/7/16 3/7/16 L - Outperform Joseph P. Schwartz
REGN
Praluent
(Alirocumab,
PCSK9 antibody)
LDL Lowering Data Presentation
Interim analysis of CV Outcomes
trial, Odyssey.
SNY partner Mid-2016 7/1/16 H +15%/-25% Outperform Joseph P. Schwartz
REGN
REGN2176-3
(anti-PDGF/VEGF
mAb)
Wet Age-related Macular
Degeneration (AMD)
Data Presentation Ph.II vision outcome/acuity data Bayer partner, OPHT 4Q16 6/30/16 H +10%/-5% Outperform Joseph P. Schwartz
REGN Sarilumab
Rheumatoid Arthritis
(RA)
PDUFA PDUFA 10/30/16. - 10/30/16 10/30/16 L - Outperform Joseph P. Schwartz
REGN Sarilumab
Rheumatoid Arthritis
(RA)
Data Presentation
MONARCH data (head-to-head
study results of sarilumab vs.
adalimumab (Humira)
- 2H16 12/30/16 H +5%/-5% Outperform Joseph P. Schwartz
REGN REGN2222
Respiratory Syncitial
Virus (RSV)
Data Presentation
Ph III pivotal interim data from
one of two trials.
AZN 2016 12/29/16 L - Outperform Joseph P. Schwartz
RPTP
Procysbi (DR
Cysteamine
[RP103])
Huntington's Disease
(HD)
Legal / Regulatory
Feedback from the FDA/EMA on
CYST-HD data, including design
of Ph.3
- 1Q16 3/1/16 H +15%/-10% Outperform Joseph P. Schwartz
RPTP
Procysbi (DR
Cysteamine)
(RP103)
Leigh's Disease Data Presentation Ph IIb interim data. - 1Q16 3/31/16 H - Outperform Joseph P. Schwartz
RPTP Quinsair
Chronic pulmonary
infections in adults with
cystic fibrosis due to
Pseudomonas
aeruginosa
Product Launch EU/Canada launch. - 1H16 6/29/16 H - Outperform Joseph P. Schwartz
RTRX RE-024
Pantothenate kinase-
associated
neurodegeneration
(PKAN)
Data Presentation
Full data from Ph. 1 study in
adult healthy volunteers will be
presented at ACMG. Ph. 2
expected to begin in 1H16.
-
3/8/16 -
3/12/16
3/8/16 L - Outperform Joseph P. Schwartz
RTRX Sparsentan
Focal segmental
glomerulosclerosis
(FSGS)
Data Presentation
Ph II/III data. Enrollment for Ph. 2
DUET trial to complete by 1Q16
with data readout by 3Q16.
Could lead to NDA filing for
accelerated approval in mid-
- 3Q16 9/30/16 H +40%/-25% Outperform Joseph P. Schwartz
RXDX Entrectinib
ROS, ALK, NTRK
rearranged tumors
Data Presentation
Interim data from ongoing Phase
II studies
- 1H16 6/29/16 - - Outperform Paul Matteis
RXDX RXDX-105 Solid tumors Data Presentation Phase Ib expansion cohort data - 2016 12/29/16 - - Outperform Paul Matteis
SAGE SAGE-217 Healthy volunteers Data Presentation Phase I study - 1H16 6/29/16 - - Outperform Paul Matteis
SAGE SAGE-547
Post-partum depression
(PPD)
Data Presentation
Phase II placebo-controlled
study
- 1H16 6/29/16 H - Outperform Paul Matteis
SAGE SAGE-547
Super Refractory Status
Epilepticus
Data Presentation Phase III data - 2H16 12/30/16 H - Outperform Paul Matteis
SCMP Amitiza
Chronic Idiopathic
Constipation (CIC)
Data Presentation
Phase III data for pediatric
indication (6-17 years old).
Would be the only approved
drug for pediatric CIC.
- 2H16 12/30/16 L - Market Perform Jason Gerberry, JD
SCMP Amitiza Constipation Legal / Regulatory
Potential Markman Hearing for
RDY PIV case
- 1Q16 3/31/16 L - Market Perform Jason Gerberry, JD
SCMP Amitiza Constipation Data Presentation
Phase IIb data in adults using
the alternative formulation of
Amitiza
- 1H16 6/29/16 L - Market Perform Jason Gerberry, JD
25
HEALTHCARE January 23, 2016
26. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
SCMP
Business
Development
- P&A - - 2016 12/29/16 H - Market Perform Jason Gerberry, JD
SCMP Cobiprostone Oral Mucositis Data Presentation Phase II top-line data - 1H17 6/29/17 H - Market Perform Jason Gerberry, JD
SCMP Cobiprostone rGERD/rNERD Data Presentation Phase II top-line data - 1H16 6/29/16 H - Market Perform Jason Gerberry, JD
SGEN Adcetris CTCL (lymphoma) Data Presentation ALCANZA Trial - 2H16 12/30/16 L - Outperform Seamus Fernandez
SGEN Adcetris DLBCL (lymphoma) Data Presentation
Phase II data and define next
steps in front-line and relapsed
DLBCL
- 2016 12/29/16 L - Outperform Seamus Fernandez
SGEN Adcetris Hodgkin's lymphoma Data Presentation
OS update from AETHERA trial;
company noted that front line HL
could be a $2B market opp'y
- 2016 12/29/16 - - Outperform Seamus Fernandez
SGEN
ASG-15ME/ASG-
22ME
Solid tumors Data Presentation Report Phase I data Astellas 1H16 6/29/16 L - Outperform Seamus Fernandez
SGEN SGN CD33A - Data Presentation
Phase I trial in combination with
cytarabine and daunorubicin
(7+3 chemotherapy)
- 2016 12/29/16 H +/-5% Outperform Seamus Fernandez
SGEN SGN CD33A AML Data Presentation
Additional Phase I data in AML
(in combo with hypomethylating
agents)
ABBV, RHHBY 2016 12/29/16 L - Outperform Seamus Fernandez
SHPG
Business
Development
- P&A
Close of BXLT merger; needs
favorable shareholder votes,
regulatory approval
- Mid-2016 7/1/16 L - Outperform Jason Gerberry, JD
SHPG
Intrathecal
Elaprase
Hunter's CNS Data Presentation Phase II proof-of-concept data - 1H16 6/29/16 H
Positive Ph. 2 data for
intrathecal programs (~5%
upside on positive data/-
2% down on negative
data)
Outperform Jason Gerberry, JD
SHPG Lifitegrast Dry Eye Disease (DED) PDUFA Potential FDA approval AGN 3Q16 9/30/16 H +5% Outperform Jason Gerberry, JD
SHPG Natpara Hypoparathyroidism OUS Approval In EU - 2016 12/29/16 H +5% Outperform Jason Gerberry, JD
SHPG Premiplex
Retinopathy of
prematurity
Data Presentation Phase IIb proof-of-concept data - Mid-2016 7/1/16 H
Positive Premiplex data:
worth a risk adj. $11/shr
(POS to 75% after positive
data)
Outperform Jason Gerberry, JD
SHPG SHP610 Sanfilippo A Data Presentation Phase IIb proof-of-concept data - 2016 12/29/16 L - Outperform Jason Gerberry, JD
SHPG SHP'620
Refractory
Cytomegalovirus (CMV)
Infections
Data Presentation Phase II data - 2H16 12/30/16 L - Outperform Jason Gerberry, JD
SHPG SHP'626
Non-alcoholic
Steatohepatitis
Data Presentation Phase I data - 1H16 6/29/16 L - Outperform Jason Gerberry, JD
SNY SAR342434 Type I and II Diabetes Data Presentation
Topline results from Ph3 studies
(SORELLA 1 and SORELLA 2)
LLY, NVO 2Q16 6/30/16 L +2%/-4% Outperform Seamus Fernandez
26
HEALTHCARE January 23, 2016
27. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
SNY dupilumab Atopic Dematitis Data Presentation
Ph III topline readout (SOLO1
and SOLO2). KOLs estimate AD
may be 3x as prevalent as
psoriasis, a $4B ww mkt. Similar
pathway for resistant asthma,
eusinophilic diseases provide
upside to model.
AZN, Roche
competitors, REGN
partner
1Q16 3/31/16 H +/-5% Outperform Seamus Fernandez
SNY LixiLan Type II Diabetes Legal / Regulatory
FDA decision; NDA to the FDA
filed in Dec 2015 with a priority
review voucher (PRV) for an
expedited 6-month review
LLY, AZN, NVO Mid-2016 7/1/16 H +2%/-5% Outperform Seamus Fernandez
SNY Lyxumia Type II Diabetes Legal / Regulatory FDA decision LLY, AZN, NVO 3Q16 9/3/16 H +2%/-5% Outperform Seamus Fernandez
SNY
Praluent
(alirocumab)
hypercholesterolemia Data Presentation
Efficacy/safety interim analysis
of the CV outcome study
(ODYSSEY OUTCOME)
AMGN, REGN, PFE 2H 2016 12/31/16 H
+3%-5% if stop early for
overwhelming efficacy
-1%-3% if trial continues
Outperform Seamus Fernandez
SNY Sarilumab anti-IL6 antibody PDUFA FDA decision REGN 3Q16 9/30/16 L - Outperform Seamus Fernandez
SRPT Eteplirsen
Duchenne Muscular
Dystrophy (DMD)
PDUFA PDUFA 2/26/16 BMRN 2/26/16 2/26/16 H +70%/-30% Market Perform Joseph P. Schwartz
SRPT Eteplirsen
Duchenne Muscular
Dystrophy (DMD)
Data Presentation
Pivotal Ph. III data readout in
4Q16/early 2017
BMRN 4Q16-1H17 12/31/16 H +50%/-50%% Market Perform Joseph P. Schwartz
SYK
Cementless Uni
Knee
Knee Other Event Evaluations begin in early-2015. - 1Q16 3/31/16 - - Outperform Richard Newitter
SYK
Otismed
(ShapeMatch)
patient specific
knee
Custom cutting block/jig
for knee surgery
Legal / Regulatory
FDA 510k clearance/ Re-
Launch.
ZMH, JNJ, SNN 1Q16 3/31/16 L - Outperform Richard Newitter
SYK Robotic total knee - Product Launch
Initial launch phase in late 2015
targeting small group of KOLs,
full market launch in 2H16.
- 2H16 12/30/16 - - Outperform Richard Newitter
TBRA
Cenicriviroc
(CVC)
Non-alcoholic
steatohepatitis (NASH)
Data Presentation
Interim 12-wk study data from
Phase 2a trial in diabetes/
prediabetes patients with
suspected NAFLD which aims to
show improvements in insulin
sensitivity and inflammatory
biomarkers
- 2Q16 6/30/16 L - Outperform Joseph P. Schwartz
TBRA
Cenicriviroc
(CVC)
Non-alcoholic
steatohepatitis (NASH)
Data Presentation
Ph IIb CENTAUR trial data (289-
patient 52-wk data).
- 3Q16 9/30/16 H +70%/-20% Outperform Joseph P. Schwartz
TEVA Austedo (SD-809)
Chorea with Huntington's
(cHD)
PDUFA Estimated FDA Approval VRX May-16 5/1/16 H
+1.5% on approval; +5%
on approval with no black
box warning
Outperform Jason Gerberry, JD
TEVA Austedo (SD-809) Tardive Dyskinesia Data Presentation Phase III AIM-TD data - Mid-2016 7/1/16 H
+5% on positive data; -3%
to -4% on study failure
Outperform Jason Gerberry, JD
TEVA
Business
Development
Generics P&A
Close of AGN Generics
business deal
- 1Q16 3/31/16 L - Outperform Jason Gerberry, JD
TEVA Copaxone RR Multiple Sclerosis Legal / Regulatory
Inter partes review (IPR) case
invalidating Copaxone 40mg
patents. We expect a favorable
MNTA, MYL Aug-16 8/1/16 H
+10% to +12% on
favorable ruling; -2% to -
3% on negative
Outperform Jason Gerberry, JD
TEVA g-EpiPen Anaphylaxis PDUFA
Estimated approval date range.
We estimate 40% odds of
approval. TEVA received a CRL
MYL 2H16 12/30/16 H +5% Outperform Jason Gerberry, JD
TEVA Reslizumab Asthma PDUFA Potential FDA approval - March-16 3/1/16 L - Outperform Jason Gerberry, JD
27
HEALTHCARE January 23, 2016
28. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
THC - - Other Event 4Q15 Results. Estimated Date. - 2/23/16 2/23/16 - - Market Perform Ana Gupte, Ph.D.
THC
Hospital
Divestiture
- Other Event
THC to divest 5 hospitals in
Atlanta, GA. Expected net sales
receipt of $575MM in cash. Deal
will help with THC re-alignment
plan.
- 1Q16 3/31/16 - - Market Perform Ana Gupte, Ph.D.
TMH - - Other Event 4Q15 Results. Estimated Date. - 2/9/16 2/9/16 - - Outperform Ana Gupte, Ph.D.
TRIL SIRP αFc
Relapsed/ refractory
lymphoma
Data Presentation Phase I data at ASH 2016 - 4Q16 12/31/16 H - Outperform
Michael Schmidt,
Ph.D.
TSRO IV Rolapitant Chemo induced nausea Submit Application Submit NDA. - 1Q16 3/31/16 L - Outperform Seamus Fernandez
TSRO Niraparib Ovarian cancer Data Presentation
ORR and DOR data from Ph III
QUADRA study.
AZN, CLVS, MDVN,
ABBV
2Q16 6/30/16 H - Outperform Seamus Fernandez
TSRO Niraparib Ovarian cancer Data Presentation
PFS data from Ph III NOVA in
gBRCA and non-gBRCA
(including HRD+) cohorts.
AZN, CLVS, MDVN,
ABBV
2Q16 6/30/16 H +100/-35% Outperform Seamus Fernandez
TSRO Niraparib Ovarian cancer Submit Application
niraparib NDA filing for ovarian
cancer
AZN, CLVS, MDVN,
ABBV
2H16 12/30/16 - - Outperform Seamus Fernandez
UAM - - Other Event 4Q15 Results. Estimated Date. - 2/22/16 2/22/16 - - Market Perform Ana Gupte, Ph.D.
UAM
Business
Development
- P&A
UAM announced 10/8/15 sale of
Traditional Insurance business
by Nassau Reinsurance Group
for $43M. Deal close expected
early 2016.
- 1Q16 3/31/16 - - Market Perform Ana Gupte, Ph.D.
UHS - - Other Event 4Q15 Results. Estimated Date. - 2/25/16 2/25/16 - - Outperform Ana Gupte, Ph.D.
UNH - - Other Event 4Q15 Results. Scheduled Date. - 1/19/16 1/19/16 - - Outperform Ana Gupte, Ph.D.
UTHR Treprostinil PAH Data Presentation
Ph III FREEMDOM-EV
(Treprostinil in Combination w/
PDE5-I / ERA vs PDE5-I / ERA
alone) topline data expected in
1H16.
- 1H16 6/29/16 H +20%/-20% Market Perform Joseph P. Schwartz
VEEV - - Other Event 4Q16 Earnings. Estimated Date. - 3/1/16 3/1/16 - - Market Perform Steven Wardell
VEEV Veeva Vault
Content Management for
Life Sciences
Other Event
Press and Earnings Releases.
Vault traction through sales to
pharma and CROs may give a
better indication of market size
and act as a catalyst for the
stock.
- Ongoing 12/29/16 - - Market Perform Steven Wardell
WAGE - - Other Event 4Q15 Earnings. Estimated Date. - 2/11/16 2/11/16 - - Outperform Steven Wardell
WBA
Rite Aid
Acquisition
- P&A
Deal close - FTC review is
underway. Up to ~$0.80E of
accretion eventually possible
with $1B+ in synergies.
MCK 2H16 12/30/16 - - Outperform David Larsen, CFA
WBMD - - Other Event 4Q15 Earnings. Estimated Date. - 2/18/16 2/18/16 - - Outperform Steven Wardell
WCG - - Other Event 4Q15 Results. Scheduled Date. - 2/9/16 2/9/16 - - Outperform Ana Gupte, Ph.D.
XENT Propel Mini CS - Frontal Sinus Legal / Regulatory
Frontal sinus indication on track
for approval by 2H16.
- 2H16 12/30/16 - - Outperform Richard Newitter
28
HEALTHCARE January 23, 2016
29. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
XENT S8
In-office steroid-eluting
implant
Other Event
Complete RESOLVE II
Enrollment. Currently enrolling
(and commercial launch
expected in 1H18).
- Ongoing 6/30/18 - - Outperform Richard Newitter
XLRN
Dalantercept
(ACE-041)
Renal cell carcinoma Data Presentation
Enrollment ongoing in Part2 of
Ph II study in RCC; expect
preliminary data by end of 2016
- YE2016 1/1/17 H +50%/-20% pls update Outperform Seamus Fernandez
XLRN
Luspatercept
(ACE-536)
Myelodysplastic
Syndrome (MDS) and
beta-thalassemia
Data Presentation
Additional updates from the two
phase II long-term extension
studies at EHA and ASH
CELG 2016 12/29/16 L - Outperform Seamus Fernandez
XNCR XmAb5871 IgG4-RD (Autoimmune) Data Presentation Phase II data. - YE2016 1/1/17 H
We model 20% POS.
'5871 ~20% of our PT.
Outperform
Michael Schmidt,
Ph.D.
XNCR XmAb7195 Asthma Data Presentation
Phase Ia. We model 15%
probability of success. '7195
~25% of our PT.
- 1H16 6/29/16 H - Outperform
Michael Schmidt,
Ph.D.
ZFGN Beloranib
Severe Obesity
complicated by Type 2
Diabetes
Data Presentation Phase IIb 6-mo. full data. - YE2016 1/1/17 H +20%/-20% Market Perform Joseph P. Schwartz
ZFGN Beloranib
Prader-Willi Syndrome
(PWS)
Legal / Regulatory
FDA's feedback on clinical hold
based on assessment of
risk/benefit profile derived from
Ph.3 bestPWS trial and ZFGN's
proposed risk mitigation strategy.
We model 40% probability of
approval in PWS.
- 2016 6/30/16 H - Market Perform Joseph P. Schwartz
ZGNX Relday schizophrenia P&A Find Partner - 1H16 6/29/16 H - Outperform Paul Matteis
ZGNX ZX008 Dravet Syndrome Data Presentation
Phase III studies. The Phase III
program includes two
efficacy/safety studies in the US,
EU.
GWPH Late 2016 12/31/16 H - Outperform Paul Matteis
ZLTQ - Cellulite Other Event
Expect to see new cellulite
device in 2017.
- 2017 12/29/17 - - Outperform Richard Newitter
ZLTQ - New applicators Product Launch
Likely to roll out the technology
in most commonly used
applicators
first, followed by converting the
remainder of the handpieces
through early 2017.
- 2016 - 2017 12/29/16 - - Outperform Richard Newitter
Source: Company information, Leerink estimates
29
HEALTHCARE January 23, 2016
30. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
ABMD Balloon pump
Percutaneous Coronary
Intervention
OUS Approval
Approval in Japan, greenfield
opportunity
- Mid-2016 7/1/16 - - Outperform Danielle Antalffy
ABMD Impella
Percutaneous Coronary
Intervention
PDUFA Potential PMA approval in shock - Mid-2016 7/1/16 - - Outperform Danielle Antalffy
ABT - Nutritionals Product Launch
New product launches. ABT
launching new products to gain
share in pediatric nutritionals in
- 2016 12/29/16 L - Market Perform Danielle Antalffy
ABT ABSORB GT1
Bioresorbable vascular
scaffold
FDA AdCom
Circulatory System Devices
Panel to review, make
recommendation and vote;
Briefing documents likely
- 3/15/16 3/15/16 - - Market Perform Danielle Antalffy
ABT ABSORB III & IV Angina Data Presentation
Data presentation. Post-TCT,
the focus will shift to claims
around reduction in Angina in
- 1H16 6/29/16 L - Market Perform Danielle Antalffy
ABUS ARB-1467
Chronic Hepatitis B Virus
(HBV)
Data Presentation Ph IIa data: SAD and MAD -
3Q16
(SAD);
4Q16
12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
ACAD
NUPLAZID
(pimavanserin)
Alzheimer's Disease
Psychosis (ADP)
Data Presentation Phase II proof-of-concept. - 2H16 12/30/16 H - Outperform Paul Matteis
ACAD
NUPLAZID
(pimavanserin)
Parkinson's Disease PDUFA Potential FDA approval - 5/1/16 5/1/16 H - Outperform Paul Matteis
ACHC
Business
Development
- P&A
ACHC to acquire Priory Health,
a UK behavioral halth provider.
Acquisition to be financed with a
combo of debt & equity. Deal
- 2/16/16 2/16/16 H - Outperform Ana Gupte, Ph.D.
ACOR Amprya Stroke Data Presentation
Interim analysis may present an
inflection point
- 2016 12/29/16 H - Market Perform Paul Matteis
ACOR Ampyra
Walking in multiple
sclerosis
Legal / Regulatory Markman hearing -
3/1/16 -
3/30/16
3/1/16 H - Market Perform Paul Matteis
ACOR CVT-301 Parkinson's Disease Data Presentation Phase III data - 2H16 12/30/16 - - Market Perform Paul Matteis
ADAP - - P&A Potential partnerships KITE, JUNO 2016 12/29/16 H +30%/0% Outperform
Michael Schmidt,
Ph.D.
ADAP MAGE A-10 TCR
Non-small cell lung
cancer (NSCLC)
Data Presentation
Ph I data from 2 initial cohorts.
Proprietary asset.
- 2016 12/29/16 H +200%/-20% Outperform
Michael Schmidt,
Ph.D.
ADAP NY-ESO TCR
Non-small cell lung
cancer (NSCLC)
Data Presentation
Phase I/II data. Multiple trials.
High response rate (60%)
observed so far in synovial
sarcoma. Partner GSK.
GSK, JUNO, KITE,
BLCM, IMDZ
2016 12/29/16 H +100%/-20% Outperform
Michael Schmidt,
Ph.D.
ADOC.FP
BC glargine/lispro
combo
Type 1 / Type 2 Diabetes P&A
Partnership with one of the
leading diabetes players; deal
similar to the LLY deal on BC
lispro
LLY, NVO, SNY 2016 6/29/16 H
+20-30% if attractive deal
signed
Outperform Seamus Fernandez
ADOC.FP BC Lispro Type 1 / Type 2 Diabetes Trial Initiation
Ph III study. Expect ADOC/ LLY
to complete Ph I/II study with
mixed meals before entering Ph.
LLY, NVO, SNY 2016 6/29/16 H +10-20% if initiating PhIII Outperform Seamus Fernandez
ADOC.FP BC Lispro Type 1 Diabetes Data Presentation
Ph I study results. Release
further details at EASD (9/12-
9/16/16 or ADA 2016). Topline
LLY, NVO, SNY
2Q16 -
3Q16
9/30/16 L - Outperform Seamus Fernandez
ADRO
CRS-207 (live
Listeria-based
cancer vaccine
Malignant Pleural
Mesothelioma
Data Presentation
Top-line data from Ph1b
mesothelioma study including
OS
- 1H16 6/29/16 H +15% / -15% Outperform Seamus Fernandez
30
HEALTHCARE January 23, 2016
31. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
ADRO
CRS-207 (live
Listeria-based
cancer vaccine
expressing
mesothelin)
Malignant Pleural
Mesothelioma
Trial Initiation
Initiate Ph III trial in combination
with SoC chemo in malignant
pleural mesothelioma
- 2Q16 6/30/16 L +5% / -5% Outperform Seamus Fernandez
ADRO
CRS-207 (live
Listeria-based
cancer vaccine
Pancreatic cancer Data Presentation
Top-line data from Ph IIb
ECLIPSE study
- Late 2Q16 6/30/16 H
+100% / -50% (this is the
key catalyst for the firm)
Outperform Seamus Fernandez
ADRO
CRS-207 (live
Listeria-based
cancer vaccine
Pancreatic cancer Data Presentation
Interim data from Ph2b
STELLAR study
- 2H16 12/31/16 H
+ 100% / -30% (will
depend on exact outcome
of ECLIPSE study)
Outperform Seamus Fernandez
AEGR Myalept
Generalized
Lipodystrophy (GL)
Legal / Regulatory EU MAA filing. - YE2016 1/1/17 L - Outperform Joseph P. Schwartz
AET - - Other Event 4Q15 Results. Scheduled Date. - 2/1/16 2/1/16 - - Outperform Ana Gupte, Ph.D.
AET
Business
Development
- P&A
Potential Deal. AET announced
deal for HUM at $230/share, with
8-K filed 9/18/15. FL Office of
AET, CI, HNT, MOH,
UNH, WCG
7/2/15 -
2H16
12/30/16 H - Outperform Ana Gupte, Ph.D.
AFMD AFM11 non Hodgkin's lymphoma Data Presentation Phase I interim data. - YE2016 1/1/17 H - Outperform
Michael Schmidt,
Ph.D.
AFMD AFM13 Hodgkin's lymphoma Trial Initiation
Ph I/II Combo trial could form the
basis for a partnership near-term
- 1H16 6/29/16 H - Outperform
Michael Schmidt,
Ph.D.
AFMD AFM13 Hodgkin's lymphoma Data Presentation
Phase IIa interim monotherapy
data
- 2Q16 6/30/16 H - Outperform
Michael Schmidt,
Ph.D.
AGIO AG-120 AML Trial Initiation Initiate Ph 3 registration study CELG 2H16 12/30/16 L - Market Perform Seamus Fernandez
AGIO AG-348
Pyruvate Kinase R
deficiency
Data Presentation
First data from Ph 2 DRIVE-PK
study in PKD pts
- 1H16 6/29/16 H +50%/-20% Market Perform Seamus Fernandez
AGIO AG-519
Pyruvate Kinase R
deficiency
Data Presentation
First data from healthy
volunteers
- 1H16 6/29/16 H +20%/-10% Market Perform Seamus Fernandez
AGN
Business
Development
- Other Event
Close of AGN Generics sale to
TEVA
TEVA 1Q16 3/31/16 L - Outperform Jason Gerberry, JD
AGN
Business
Development
- P&A
Merger with PFE, expected to
close in 2H16
- 2H16 12/30/16 H - Outperform Jason Gerberry, JD
AGN Esmya
Chronic treatment of
uterine fibroids
Data Presentation
Phase III. High unmet need.
Peak sales est. $365M
- 1H16 6/29/16 L - Outperform Jason Gerberry, JD
AGN GLYX-13 Depression Data Presentation Phase III - 2016 12/29/16 H - Outperform Jason Gerberry, JD
AGN Kybella Chin fat reduction Product Launch Product launch. - 2016 12/29/16 L - Outperform Jason Gerberry, JD
AGN
Relamorelin (RM-
131)
Diabetic gastroparesis Data Presentation Phase IIb - Mid-2016 7/1/16 L - Outperform Jason Gerberry, JD
AGN Botox Depression Data Presentation Phase II - 1Q16 3/31/16 L - Outperform Jason Gerberry, JD
AKRX - - Legal / Regulatory
Filing of restated financials, to be
in compliance with NASDAQ
requirements or face de-listing
- 1H16 5/9/16 H - Market Perform Jason Gerberry, JD
ALDR ALD403
Migraine and Other
Headaches
Data Presentation
Ph IIb IV chronic migraine data.
We model 60% probability of
approval.
LLY, AMGN, TEVA 1Q16 3/31/16 H +40%/-30% Outperform Joseph P. Schwartz
ALDR ALD403
Migraine and Other
Headaches
Trial Initiation
Ph III trial initiation
(450 chronic migraine patients)
(PROMISE-2) & SC once-
quarterly formulation
(Ph. 2b, 240 episodic pts). 60%
probability of approval
LLY, AMGN, TEVA
1Q16 -
1H16
3/31/16 L - Outperform Joseph P. Schwartz
ALDR ALD403
Migraine and Other
Headaches
Data Presentation
Ph I multi-+single-dose healthy
volunteer data in capsaicin-
induced vasodilation study may
LLY, AMGN, TEVA 1Q16 3/31/16 H +10%/-10% Outperform Joseph P. Schwartz
31
HEALTHCARE January 23, 2016
32. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
ALDR ALD403
Migraine and Other
Headaches
Trial Initiation
Ph II/IIb EM+CM trial for
quarterly self-administration
(Q3M) of ALD403.
LLY, AMGN, TEVA 2016 12/29/16 L - Outperform Joseph P. Schwartz
ALGN - - Other Event
Multiple patents set to expire in
2017-2018. These patents do
not cover subsequent
- 2017-2018 12/29/18 - - Outperform Richard Newitter
ALNY ALN-AAT
Alpha-1 antitrypsin (AAT)
deficiency-associated
liver disease
Data Presentation Phase I data - Mid-2016 7/1/16 L - Outperform
Michael Schmidt,
Ph.D.
ALNY ALN-AS1 porphyria Data Presentation Ph I data from patients SNY/GENZ Late 2016 12/29/16 H
Multiple pipeline updates
(ALN-CC5, revusiran,
patisiran, ALN-AS1, ALN-
AT3); combined Up/down
Outperform
Michael Schmidt,
Ph.D.
ALNY ALN-AT3 Hemophilia Data Presentation Ph I data update SNY/GENZ Mid-2016 7/1/16 L
Multiple pipeline updates
(ALN-CC5, revusiran,
patisiran, ALN-AS1, ALN-
Outperform
Michael Schmidt,
Ph.D.
ALNY ALN-CC5
Paroxysmal nocturnal
hemoglobinuria
Data Presentation PNH Patient data -
mid 2016
and late
2016
12/29/16 H
Multiple pipeline updates
(ALN-CC5, revusiran,
patisiran, ALN-AS1, ALN-
Outperform
Michael Schmidt,
Ph.D.
ALNY ALN-GO1
Primary hyperoxaluria
type I
Data Presentation Ph I data SNY/GENZ 2H16 12/29/16 L - Outperform
Michael Schmidt,
Ph.D.
ALNY ALN-TTR-sc02 TTR (FAP/FAC) Data Presentation Ph I data SNY/GENZ Late 2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
ALNY Patisiran
TTR-mediated
amyloidosis (FAP)
Data Presentation
Updates from the Ph II OLE 24
month (Open Label Extension)
SNY/GENZ Mid-2016 7/1/16 H
Multiple pipeline updates
(ALN-CC5, revusiran,
patisiran, ALN-AS1, ALN-
AT3); combined Up/down
+30%/-10%.
Outperform
Michael Schmidt,
Ph.D.
ALNY Revusiran
TTR-mediated
cardiomyopathy (FAC)
Data Presentation
Updates from the Ph II OLE 12
month (Open Label Extension)
SNY/GENZ Mid-2016 7/1/16 H
Multiple pipeline updates
(ALN-CC5, revusiran,
patisiran, ALN-AS1, ALN-
AT3); combined Up/down
+30%/-10%.
Outperform
Michael Schmidt,
Ph.D.
AMAG Feraheme
Iron Deficiency Anemia
(IDA)
Legal / Regulatory
Clarity from FDA on amount of
additional data required for
broader label.
- 1Q16 3/31/16 H - Outperform Joseph P. Schwartz
AMAG Makena Preterm Birth Legal / Regulatory
FDA's final decision on response
to complete response letter
(CRL) for a second source
- 1Q16 3/31/16 H +15%/-20% Outperform Joseph P. Schwartz
AMAG Makena Preterm Birth Submit Application sNDA filing for SQ formulation -
YE16 -
1/1/17
1/1/17 H - Outperform Joseph P. Schwartz
ANTM - - Other Event 4Q15 Results. Scheduled Date. - 1/27/16 1/27/16 - - Outperform Ana Gupte, Ph.D.
ANTM
Business
Development
- P&A
ANTM to acquire CI for $188 per
share in 55% cash / 45% stock
deal. FL Office of Insurance
Regulations held public hearings
- 2H16 12/30/16 H - Outperform Ana Gupte, Ph.D.
ANTM
ESRX Re-Pricing
Negotiations
- Other Event
ESRX in re-pricing negotiations
with ANTM; contract came up for
market check Dec 2015. ANTM
expects it is entitled to ~$3B in
gross annual savings.
- 2016 12/29/16 H - Outperform Ana Gupte, Ph.D.
AQXP AQX-1125
Bladder Pain
Syndrome/Interstitial
Cystitis (BPS/IC)
Legal / Regulatory
Similar to End-of-Phase II
meeting with FDA, AQXP wll
meet with EMA to discuss trial
design and registrational
pathway in EU.
- 1H16 6/29/16 - - Outperform Paul Matteis
32
HEALTHCARE January 23, 2016
33. 1/22/16
Stock Drug / Product Topic / Indication Event Type Event Details Lateral Impact
Date
Range
Sort Date
Impact:
H(igh)/
L(ow)
Up/Down Leerink Rated Analyst
ARDX Tenapanor
ESRD
hyperphosphatemia
Data Presentation
2nd Phase IIb. Top-line data for
2nd Phase IIb study for
tenapanor in ESRD
hyperphosphatemia
- 2H16 12/30/16 H
$6/shr upside on
increased POS for ESRD
Outperform Jason Gerberry, JD
ARDX Tenapanor
Irritable Bowel Syndrome
with Constipation (IBS-C)
Data Presentation Phase III data from two trials - 1H17 6/29/17 H
$8 upside/$15 downside to
valuation on POS impact
Outperform Jason Gerberry, JD
ARQL ARQ-087 FGFR2-driver tumors Data Presentation Ph II data - 2H16 12/29/16 H - Market Perform
Michael Schmidt,
Ph.D.
ARQL ARQ-092 AKT-driver tumors Data Presentation Ph Ib data - Mid-2016 7/1/16 - - Market Perform
Michael Schmidt,
Ph.D.
ARQL Tivantinib
2nd line Hepatocellular
Carcinoma (HCC)
Data Presentation Ph III interim data - 1H16 6/29/16 H +50-70% / -~25% Market Perform
Michael Schmidt,
Ph.D.
ARRY
Binimetinib (MEK
inhibitor)
BRAF+ melanoma Data Presentation
Phase III data, COLUMBUS trial.
Based on promising Ph I/II data,
we est. 90% POS.
- 1H16 6/29/16 H
25%; We assume a 90%
PoS
Outperform
Michael Schmidt,
Ph.D.
ARRY
Binimetinib (MEK
inhibitor)
NRAS+ melanoma,
BRAF+ melanoma
Submit Application
Binimetinib for NRAS+ in 1H16
and for BRAF+ in 2016
- 2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
ARRY
Selumetinib (MEK
inhibitor)
KRAS+ NSCLC, Thyroid
cancer
Data Presentation
Phase III data in KRAS+
NSCLC,. Pivotal ASTRA trial ( in
Thyroid cancer)
- 2016 12/29/16 H - Outperform
Michael Schmidt,
Ph.D.
ASND TransCon hGH
Short Stature/Growth
hormone deficiency
Trial Initiation
Ph III Is planned to enroll 130-
150 patients.
- Mid-2016 7/1/16 L - Outperform Joseph P. Schwartz
ATHN
athenaClinical
Enterprise for
Hospitals
Enterprise Solution for
Hospitals
Other Event
Ongoing Enterprise
Implementation. Will likely gain
incremental traction with
Enterprise accounts now that it
- 2016 12/29/16 - - Market Perform David Larsen, CFA
ATRC
AtriCure Bipolar
System
Non-paroxysmal forms of
atrial fibrillation
Data Presentation
Data presentation. ABLATE post-
approval study enrolled 365
patients across 40 US centers,
- 1Q16 3/31/16 L - Outperform Danielle Antalffy
AUPH Voclosporin Lupus Nephritis (LN) Data Presentation
Ph IIb AURA-LV top-line results.
We model 65% probability of
success. Enrollment completion
announced 1/19/16
- 3Q16 9/30/16 H - Outperform Joseph P. Schwartz
33
HEALTHCARE January 23, 2016