"2020美国生物科技展望：新年以清晰的愿景迈进--102页.pdf"

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《JP 摩根-美股-生物科技行业-美国生物科技展望：以的愿景迎接新的一年--102页.pdf》是一份关于2020年美国生物科技展望的研究报告，共102页。该报告由J.P.摩根的美国生物科技研究团队撰写，针对美国大型生物科技公司和中小型生物科技公司展开研究。报告中包含了2020年的美国生物科技行业展望，并将召开电话会议进行解读。该报告中提供了J.P.摩根的美国生物科技研究团队的联系方式，包括Anupam Rama、Cory Kasimov、Jessica Fye、Eric Joseph等人，以方便读者获取更多详细信息。此外，报告还提供了12月18日举行电话会议的具体时间和联系方式，欢迎对此感兴趣的人参与会议。该报告意在帮助投资者对2020年美国生物科技行业有更清晰的认识，以便制定投资策略。报告作者具备丰富的行业知识和经验，值得投资者关注和借鉴。

A Quick Look Back at 2019 – Snapshot of Binary Events

On average, business development and financial events gave maximum returns followed by clinical events

Of note, average returns post +ve clinical events were higher than +ve regulatory events, improving over prior years

 In 2019, positive clinical events returned more than positive regulatory events, reversing 2018’s trend of positive regulatory

events paying out more than positive clinical events

 The magnitude of upside in 2019 on positive clinical / regulatory events was also meaningfully higher relative to 2018

Source: J.P. Morgan Research; Bloomberg as of 12/10/2019.

Return profiles by type of event

In 2019, clinical events on average returned more than the regulatory events; while IP and corporate events yielded negative

returns

 BD and financial events carried more upside, on average, than clinical and regulatory events

*Detailed list of Binary Events can be found in subsequent slides

Return profiles by type of event

-11%

-1%

-3%

-4%

-5%

-7%

-2%

-3%

-1%

-2%

-1%

12%

-20%

-10%

10%

20%

Regulatory Clinical IP Corporate Financial BD

-1 Month -5 Days -1 Day Day 0 1 Day 5 Days 1 Month

-10%

-7%

-3%

-1%

11%

19%

-4%

14%

32%

10%

22%

-3%

17%

10%

34%

11%

24%

-3%

24%

16%

36%

15%

22%

-2%

13%

40%

-20%

-10%

10%

20%

30%

40%

50%

Regulatory +ve Clinical +ve IP +ve Corporate +ve Financial +ve BD +ve

-1 Month -5 Days -1 Day Day 0 1 Day 5 Days 1 Month

Based on an analysis of key binary events in our universe, the average upside post binary events was lower in 1H19 vs. 2H19

 Downside after negative events was higher in 1H compared to 2H

A Quick Look Back at 2019 – Select 1H19 Binary Events

On average, upside after positive events was lower in 1H19 vs. 2H19 whereas downside after negative events was higher

Source: J.P. Morgan Research; Bloomberg as of 12/10/2019.

% Return

Ticker

Event

Type of

Event

Good or

Bad

update?

Date of

Event

-1 Month

5 Days

-1 Day Day 0 1 Day 5 Days

1 Month

MYOK

Regaining Global Rights to Mavacamten from Sanofi

IP +

01/02/19

-21% 4% -2% -14% -17% -13% -15%

CELG

Announced acquistion by BMY for $74B

BD +

01/03/19

-8% 7% 4% 21% 27% 31% 35%

NBIX

Pre

-Announced Ingrezza 4Q Revs

Financial

01/06/19

-13% 9% 8% 10% 13% 16% 18%

SAGE

Report randomized Phase 3 data in PPD with SAGE

-217 Clinical +

01/07/19

-8% 10% 9% 33% 23% 28% 52%

APTX

NYX

-2925 phase II topline data in DPN Clinical -

01/16/19

-19% -6% 2% -66% -70% -68% -68%

LXRX

Ad com for sotagliflozin in T1D

Regulatory

01/17/19

5% 3% 0% -23% -25% -41% -31%

EDIT

Announced departure of CEO

Corporate

01/22/19

44% 5% 0% -23% -18% -21% -25%

ZLAB

Zejula Granted Priority Review

Regulatory

01/28/19

20% -1% 1% 1% 6% 6% 13%

SLDB

Preliminary Micro

-Dystrophin DMD Update for IGNITE-DMD Clinical -

02/07/19

-25% -12% -3% -68% -67% -63% -56%

SRPT

Preliminary Micro

-Dystrophin DMD Update for IGNITE-DMD (read-through) Clinical +

02/07/19

23% 9% 0% -3% -10% -5% -7%

SGMO

In vivo gene editing data in MPS I & II

Clinical -

02/07/19

1% 4% 2% -31% -36% -27% -20%

KPTI

Release of ODAC panel briefing documents for

selinexor in penta-refractory

Regulatory

02/21/19

-9% 2% -4% -43% -44% -54% -35%

ONCE

Announced acquistion by Roche for $4.3B

BD +

02/25/19

22% -2% 2% 120% 120% 120% 119%

ATRA

Delay of Topline Phase 3 tab

-cel EBV+ PTLD data to 2H19 (prior 1H19) Clinical -

02/26/19

16% 3% 8% -11% -13% -7% -13%

KPTI

ODAC panel for selinexor in penta

-refractory MM (STORM)

Regulatory

02/26/19

-46% -47% -4% -10% -15% -11% 13%

EIDX

AG10 Phase 3 ATTRibute

-CM Trial Design Update in ATTR-CM

Regulatory

02/27/19

46% 21% 1% 10% 5% 5% 27%

SRPT

Initial MYO

-101 Phase 1/2 LGMD2E Data Clinical +

02/27/19

14% 0% -2% 8% 3% 6% -13%

NVAX

Topline phase 3 PREPARE data (ResVax for infant RSV)

Clinical -

02/28/19

-3% 6% 4% -67% -67% -73% -75%

IMGN

Topline phase III FORWARD I results

Clinical -

03/01/19

-10% -15% 3% -47% -45% -45% -43%

ASND

Topline TransCon GH phase III heiGHt results

Clinical +

03/04/19

-1% -4% -5% 74% 81% 74% 63%

MYOK

Phase 2 PIONEER

-OLE Topline 24-Week Data in Obstructive HCM Clinical +

03/04/19

16% 10% 6% 7% 10% 4% 11%

BIIB

Negative

futility analysis for aducanumab Ph3 in AD; program discontinued Clinical -

03/21/19

-4% 0% -1% -29% -32% -28% -29%

LXRX

CRL for sotagliflozin in T1D

Regulatory

03/22/19

49% 8% 3% -22% -29% -34% -30%

JAZZ

JZP

-258 topline phase III results Clinical +

03/26/19

7% 1% 0% 1% 3% 3% -4%

A Quick Look Back at 2019 – Select 1H19 Binary Events (Cont’d)

Source: J.P. Morgan Research; Bloomberg as of 12/10/2019.

% Return

Ticker

Event

Type of

Event

Good or

Bad

update?

Date of

Event

-1 Month

5 Days

-1 Day Day 0 1 Day 5 Days

1 Month

TCDA

Topline TCDA

-301E results Clinical +

03/28/19

5% -5% -1% 57% 60% 52% 40%

SGMO

Debut phase 1/2 ALTA data (SB

-525 Hem A gene therapy) Clinical +

04/02/19

-5% 4% 0% 29% 37% 32% 19%

AGLE

Pegzilarginase Updated Phase 1/2 Data at SIMD

Clinical +

04/07/19

4% 9% 0% -8% -11% -17% -21%

CLVS

Discontinued Ph2 ATLAS study in urothelial carcinoma with Rubraca

Clinical -

04/12/19

-16% -9% -1% -12% -10% -11% -18%

UROV

Topline phase 3 EMPOWUR data (vibegron for OAB)

Clinical +

04/18/19

-42% -17% -3% 2% 7% 4% -8%

GTHX

Trilaciclib Regulatory Update (NDA Planned for 2020)

Regulatory

04/29/19

12% 0% 0% 15% 10% 21% 17%

AGIO

Tibsovo

Approval in IDH1 Newly Diagnosed AML

Regulatory

05/01/19

-17% -5% -2% -5% -8% -10% -17%

IONS

mos RG6042 phase I/IIa OLE presentation Clinical -

05/06/19

-13% -2% 2% -1% -8% -6% -12%

PTCT

Risidiplam FIREFISH and SUNFISH updates at AAN

Clinical +

05/07/19

-4% -4% 0% -2% 6% 9% 10%

AKBA

AZ/FGEN roxadustat topline MACE safety data

Clinical -

05/09/19

-21% -5% 1% 1% -1% -5% -27%

STML

1Q Elzonris Revs

Financial +

05/10/19

15% 7% 2% 0% -10% -9% -10%

PTCT

Topline phase 2 part 2 randomized SUNFISH data

Clinical +

05/11/19

6% 11% 1% -2% -4% -5% 0%

MYOV

Phase 3 relugolix in UF topline data (LIBERTY1)

Clinical +

05/14/19

-16% -7% -3% -25% -22% -27% -48%

BCRX

Topline APeX

-2 results Clinical +/-

05/21/19

-7% -3% 1% -53% -53% -55% -51%

NVCR

FDA

approval of TTF in mesothelioma

Regulatory

05/23/19

10% -2% -4% 7% 9% 9% 22%

BMRN

Topline

Ph1/2 ext data for valrox (3 yrs for high dose) & initial Ph3 data Clinical +

05/28/19

5% 3% 2% -7% -6% -8% -6%

FPRX

Phase 1a FPA150 monotherapy data in solid tumors

Clinical -

06/01/19

-24% -7% -1% -19% -21% -27% -28%

MRTX

Initial Phase 1 AMG 510 at ASCO (read

-through) Clinical +

06/03/19

14% -12% -3% 32% 45% 47% 52%

IFRX

Phase 2b SHINE Study Fails in HS

Clinical -

06/05/19

-17% 2% 2% -92% -91% -92% -91%

ENTA

Phase 2 human challenge RSV readout

Clinical +

06/14/19

16% 7% 2% -12% -8% -8% -13%

GBT

Top line results for Phase 3 HOPE study with vox in adults SCD (at EHA)

Clinical +

06/14/19

5% -3% 5% -6% -6% 3% -1%

GTHX

Trilaciclib Phase 2 TNBC Update

Clinical +

06/18/19

-13% 6% 6% 24% 33% 38% 20%

IRWD

Linaclotide phase 3b abdominal sx claims data

Clinical +

06/18/19

2% 3% 8% 1% -2% -10% -7%

ANAB

REGN3500 Topline Phase 2 Results in Asthma (read

-through) Clinical -

06/21/19

-2% -6% 1% -12% -20% -19% -19%

SRPT

Initial Phase 1b data for PF

-06939926 (a microdystrophin-

AAV9 gene therapy)

in DMD (read

-through)

Clinical +

06/28/19

7% 0% 1% 17% 21% 17% 15%

All Events

0% 0% 1% -5% -5% -6% -6%

All +ve Events

3% 2% 1% 13% 14% 14% 12%

All

-ve Events

-5% -4% 1% -32% -34% -35% -34%

Upside after positive events was higher in 2H19 vs. 1H19 while downside after negative events lessened, potentially reflecting the increased

appetite for playing binary events

A Quick Look Back at 2019 – Select 2H19 Binary Events

On average, upside after positive events was higher in 2H19 vs. 1H19 whereas downside after negative events was lower

Source: J.P. Morgan Research; Bloomberg as of 12/10/2019.

% Return

Ticker

Event

Type of

Event

Good or

Bad

update?

Date of

Event

-1 Month

5 Days

-1 Day Day 0 1 Day 5 Days

1 Month

KPTI

Xpovio (selinexor) approval for triple

-class refractory MM

Regulatory

07/03/19

16% 11% 16% 36% 35% 22% 27%

SGMO

Phase 1/2 ALTA update at ISTH

Clinical +

07/05/19

23% 6% -2% 1% 0% 3% -1%

ITCI

Topline lumateperone ph III bipolar depression data

Clinical +/-

07/08/19

11% 4% -1% -13% -15% -17% -34%

ACAD

Topline data from Phase 3 ENHANCE

-1 study with Nuplazid in schizophrenia

(adj

)

Clinical -

07/22/19

0% -3% 1% -14% -11% -7% 12%

ITCI

Ad com cancellation for lumateperone in schizophrenia

Regulatory

+/-

07/23/19

-10% 5% 1% -32% -32% -32% -28%

JNCE

Announced renegotiated strategic collab with CELG

Corporate

07/23/19

-14% -5% -2% 11% 12% 19% -11%

AGLE

Pegzilarginase Receives BTD in Arginase 1 Deficiency

Regulatory

07/24/19

12% 0% 3% 20% 17% 25% 4%

LXRX

Sanofi ends collaboration agreement

BD -

07/26/19

0% 8% 1% -70% -71% -79% -77%

NBIX

Ingrezza 2Q Revs

Financial

07/29/19

3% 0% -1% 10% 11% 7% 13%

ALKS

Topline data for EVOLVE

-MS-2 safety/tolerability study with Vumerity Clinical +

07/30/19

-3% -4% 6% 6% 6% -2% -4%

VRTX

Updates from Phase 1 AAT study and announcement of plans to move VX

814

into Phase 2

Clinical +

07/31/19

-9% -4% -2% 8% 7% 5% 8%

FOLD

CLN6 Gene Therapy Initial Phase 1/2 Update in Batten's Disease

Clinical +

08/01/19

-1% -2% -4% 0% -6% -5% -20%

STML

2Q Elzonris Revs

Financial

08/02/19

-12% 0% -2% 14% 10% 27% -9%

NKTR

Bempeg manufacturing issues / narrower BMS collab

BD -

08/08/19

-13% -5% 3% -29% -37% -38% -42%

MRTX

Updated Phase 1 AMG 510 at World Lung (read

-through) Clinical +

08/08/19

-9% -8% 1% -2% -6% -7% -10%

AMGN

Enbrel litigation with NVS

IP +

08/09/19

2% 0% 1% 6% 11% 8% 12%

DCPH

Topline ripretinib phase III INVICTUS results

Clinical +

08/13/19

-8% -13% -15% 80% 90% 84% 83%

SRPT

CRL Announced for Golodirsen in exon 53 DMD

Regulatory

08/20/19

-32% -19% -15% -1% -7% -10% -19%

MDCO

Topline ORION

-11 results Clinical +

08/26/19

-4% 7% -2% 14% 18% 20% 36%

ALNY

Inclisiran Phase 3 Topline ORION

-11 Data in ASCVD + elevated LDL-C (read-

through)

Clinical +

08/26/19

6% 1% 0% 0% 0% -1% 3%

ALXN

IPR institution decision (IPR filed by AMGN)

IP -

08/30/19

-12% -13% -10% -6% -3% 3% -3%

MDCO

ORION

-11 presentation at ESC Clinical +

09/02/19

15% 20% -2% 10% 13% 13% 19%

EBS

ACAM2000 Contract

Financial

09/03/19

-2% 7% 3% 28% 29% 29% 21%

RARE

Data from DTX401 Phase 1/2 second dose cohort

Clinical -

09/04/19

-8% 1% -6% -12% -9% -16% -15%

GBT

NDA filing acceptance for accelerated approval (hemolytic anemia endpoints)

Regulatory

09/05/19

-9% 1% 3% 11% 6% 14% 1%

ACAD

Interim data from Phase 3 HARMONY study

Clinical +

09/09/19

-19% -14% -3% 73% 74% 70% 64%

XLRN

ACE

-083 in FSHD phase 2 topline data Clinical -

09/16/19

-3% -2% 2% 0% -3% -4% -7%

URGN

UGN

-102 for LG UTUC interim analysis Clinical -

09/24/19

5% -10% -1% -16% -23% -28% -34%

MDCO

Topline ORION

-9 and ORION-10 results Clinical +

09/25/19

35% -1% -1% 6% 7% 4% 19%

ENTA

ARGON

-1 phase 2a data (EDP-305 for NASH) Clinical -

09/25/19

2% 1% -1% -15% -15% -11% -16%

GTHX

Pipeline Updates at ESMO

Clinical -

09/28/19

2% 1% 1% -33% -32% -31% -36%

FOLD

Multiple Pipeline / Commercial Updates at Analyst Day

Clinical +

10/10/19

-21% -9% -3% 2% 5% 9% 20%

REPL

RP1 CSCC Phase 1 Update

Clinical +

10/15/19

-2% -2% -2% 15% 18% 21% 12%

SGEN

Topline data in Ph2 study with

tucatinib in metastatic breast cancer (3L+) Clinical +

10/21/19

18% 6% 2% 13% 14% 17% 38%

A Quick Look Back at 2019 – Select 2H19 Binary Events (Cont’d)

Source: J.P. Morgan Research; Bloomberg as of 12/10/2019.

% Return

Ticker

Event

Type of

Event

Good or

Bad

update?

Date of

Event

-1 Month

5 Days

-1 Day Day 0 1 Day 5 Days

1 Month

BIIB

Updated

aducanumab data in AD; announced intention to file w/ FDA

Regulatory

10/22/19

-6% -1% 2% 26% 25% 32% 29%

RIGL

Pipeline Business Updates

Clinical/Corp

10/23/19

0% 0% 1% 4% 21% 28% 36%

ACOR

Restructuring announcement and 3Q revenue pre

-announcement Corporate -

10/23/19

-24% 6% 12% -26% -27% -32% -30%

MRTX

Initial Phase 1/2 MRTX849 Data at The Triple Meeting

Clinical +

10/28/19

-3% 7% 1% 17% 16% 19% 22%

AMAG

Ad com for PROLONG

Regulatory

10/29/19

10% 14% 0% -22% -27% -30% -20%

IDYA

IDE196 Regulatory Update in MUM

Regulatory

10/31/19

-37% 0% -5% 8% 4% 1% 35%

HALO

Topline phase III HALO

301 results / announcement to discontinue PEGPH20

development

Clinical/Corp

+/-

11/04/19

1% 3% 2% -1% 10% 8% 25%

NBIX

Ingrezza 3Q Revs

Financial +

11/04/19

14% 4% -1% 0% 0% 8% 16%

XLRN

Phase 2 luspatercept for myelofibrosis data

Clinical -

11/05/19

18% 9% 1% -15% -15% -6% 2%

CNST

CPI

-0610 Phase 2 MANIFEST Data in MF (initial data within ASH Abstract) Clinical +

11/06/19

78% 9% 5% 90% 115% 119% 189%

DTIL

Phase 1/2a PBCAR0191 DL1 data

- abstract Clinical +

11/06/19

-9% 6% 4% 18% 24% 31% 169%

STML

3Q Elzonris Revs

Financial -

11/07/19

16% 4% 2% -11% -7% -9% -1%

OBSV

Nolasiban phase 3 IMPLANT4 data

Clinical -

11/07/19

8% 4% 1% -65% -62% -66% -42%

ANAB

Etokimab Phase 3 ATLAS Failure in AD

Clinical -

11/08/19

7% -4% -3% -72% -71% -70% -61%

REPL

RP1 Phase 1 Update in Solid Tumors at SITC

Clinical +

11/08/19

36% -1% -1% 0% 2% -19% -18%

AKBA

AZ/FGEN roxadustat full MACE safety data

Clinical +

11/08/19

-10% -1% -2% 10% -1% -13% 60%

XLRN

FDA approval of

luspatercept for TD β-thal

Regulatory

11/08/19

-2% -9% 1% 7% 10% 6% 23%

MYOK

Mavacamten Phase 2 MAVERICK Data in Non

-Obstructive HCM Clinical -

11/11/19

18% 1% 2% -8% -9% -8% NA

SLDB

SGT

-001 Clinical Hold Clinical -

11/12/19

6% -3% 0% -74% -72% -68% NA

SRPT

SGT

-001 Clinical Hold (read-through) Clinical +

11/12/19

14% 4% -2% 5% 7% 3% NA

MDCO

ORION

-10 presentation at AHA Clinical +

11/16/19

-2% -6% 2% 13% 35% 32% NA

EIDX

AG10 Phase 2 OLE Update in ATTR

-CM at AHA Clinical +

11/16/19

28% 3% 3% 18% 24% 18% NA

BBIO

AG10 Phase 2 OLE Update in ATTR

-CM at AHA Clinical +

11/16/19

52% 4% 3% 3% 7% 20% NA

KNSA

Final Phase 2 Data for Rilonacept in Recurrent Pericarditis

Clinical +

11/16/19

11% -11% 1% -1% 6% 47% NA

MYOV

Phase 3 relugolix in advanced prostate cancer topline data (HERO)

Clinical +

11/19/19

20% 10% -2% 113% 112% 148% NA

ALNY

Givlaari

(Givosiran) Approval in Acute Hepatic Porphyria

Regulatory

11/20/19

16% 8% 6% 10% 14% 22% NA

CCXI

Phase 3 ADVOCATE Results in AAV

Clinical +

11/25/19

2% -7% 2% 281% 269% 261% NA

ACAD

Data presentation for Nuplazid's Phase 3 HARMONY study in DRP at CTAD

Clinical +

12/04/19

4% -6% -1% 14% 16% 4% NA

SAGE

Topline data for MOUNTAIN Phase 3 MDD study

Clinical -

12/05/19

4% -1% 0% -60% -57% NA NA

BIIB

Data presentation for aducanumab's ENGAGE and EMERGE studies at CTAD

Clinical +/-

12/05/19

-1% -5% 0% 3% 4% NA NA

BLUE

Topline results for pivotal KarMMa study

Clinical +

12/06/19

1% -2% -2% -4% 8% NA NA

MGTA

145 data at ASH

Clinical +

12/07/19

24% 0% 2% -4% 5% NA NA

APRE

Updated APR

-246 phase Ib/II at ASH Clinical +

12/09/19

4% 3% 8% 5% 18% NA NA

AGIO

Pipeline Updates at ASH

Clinical +

12/09/19

21% 5% 2% 3% 8% NA NA

CNST

CPI

-0610 Phase 2 MANIFEST Data in MF at ASH Clinical +

12/09/19

56% -6% 2% -17% -19% NA NA

DTIL

Phase 1/2a PBCAR0191 DL 2 data

- poster presentation Clinical -

12/09/19

142% 11% 6% -52% -51% NA NA

OBSV

Phase 3 linzagolix in UF topline data (PRIMROSE2)

Clinical +/-

12/09/19

-42% 0% 6% -29% -20% NA NA

All Events

6% 0% 0% 4% 6% 10% 9%

All +ve Events

7% 0% 0% 21% 24% 28% 28%

All

-ve Events

7% 0% 0% -30% -31% -28% -24%

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