On this page of StockholderLetter.com we present the latest annual shareholder letter from NEUROCRINE BIOSCIENCES INC — ticker symbol NBIX. Reading current and past NBIX letters to shareholders can bring important insights into the investment thesis.
2023
Annual Report
Neurocrine Biosciences
has four commercial,
FDA-approved treatments
in the United States and
a robust pipeline with
multiple mid-to-latestage programs focused
on diseases and disorders
across neurology,
neuroendocrinology,
and neuropsychiatry.
COMMERCIALLY AVAILABLE MEDICINES INCLUDE:
IN THE U.S.
IN THE U.S. AND EU
ENDOMETRIOSIS
ADRENAL INSUFFICIENCY
IN EUROPE
TARDIVE DYSKINESIA
CHOREA-HUNTINGTON   S
DISEASE
UTERINE
FIBROIDS
CONGENITAL ADRENAL
HYPERPLASIA
PIPELINE OF INVESTIGATIONAL THERAPIES INCLUDE 6 :
Phase 1
Phase 2
Phase 3
NEUROLOGY
valbenazine1 Dyskinetic Cerebral Palsy
NBI-8271042 Rare Pediatric Epilepsy: Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep
NBI-9213523 Rare Pediatric Epilepsy: SCN8A Development and Epileptic Encephalopathy Syndrome
NBI-1076986 Movement Disorders
NEUROENDOCRINOLOGY
crinecerfont Congenital Adrenal Hyperplasia in Adults
crinecerfont Congenital Adrenal Hyperplasia in Children & Adolescents
                                                            Congenital Adrenal Hyperplasia

NEUROPSYCHIATRY
valbenazine1 Adjunctive Treatment of Schizophrenia
NBI-10658454 Inadequate Response to Treatment in Major Depressive Disorder
                        4 Cognitive Impairment Associated with Schizophrenia
NBI-11175685 Schizophrenia
NBI-10707704 Major Depressive Disorder
NBI-11175675 CNS Indications
NBI-11175695 CNS Indications
NBI-11175705 CNS Indications
NBI-1065890 CNS Indications
* Mitsubishi Tanabe Pharma Corporation (MTPC) has commercialization rights in
Japan and other select Asian markets
    AbbVie has global commercialization rights
Neurocrine Biosciences has global rights unless otherwise noted. Neurocrine
Company Limited.
Mitsubishi Tanabe Pharma Corporation (MTPC) has commercialization rights in
Japan and other select Asian markets.
1
2
Licensed from Idorsia Ltd.
3
Licensed from Xenon Pharmaceuticals, Inc.
4
Licensed from Takeda Pharmaceutical Company Limited.
5
Licensed from Sosei Heptares.
6
Investigational therapies are not approved for use in any country
Dear Fellow Shareholders,
Kevin C. Gorman, Ph.D.
Chief Executive Officer
Neurocrine Biosciences is a company dedicated
to brave science     because the people we
serve need and deserve it. Since our founding
in 1993, we   ve focused in areas that lacked
recent innovation or, in some cases, had no
treatment options. With that focus, we have built
a leading neuroscience company dedicated to
treatments across neurology, neuropsychiatry,
neuroendocrinology and someday,
neuroimmunology. As we look to the future,
we remain focused on optimizing INGREZZA  ,
gaining approval for crinecerfont in congenital
adrenal hyperplasia (CAH), advancing our
growing and diverse pipeline, and improving
the lives of our patients.
In October 2023, we reported strong results
in two Phase 3 studies in adult and pediatric
CAH patients reflecting the potential of a
much-needed new treatment paradigm.
Following these results, the U.S. Food and Drug
Administration (FDA) granted crinecerfont
Breakthrough Therapy designation which serves
as an acknowledgement of the serious and
life-threatening nature of CAH, highlighting
the significant unmet need that exists and
identifying the product as a potentially valuable
treatment. The New Drug Application submission
is anticipated to occur in the second quarter of
2024, and we look forward to potentially bringing
crinecerfont to CAH patients next year.
We are proud of the continued success of
INGREZZA   and remain optimistic about its
untapped potential. While we   ve made good
progress improving the diagnosis and treatment
rates of the estimated 600,000 people in the U.S.
who have tardive dyskinesia (TD), we estimate
only 20% of people living with TD have been
offered treatment with a VMAT2 inhibitor like
INGREZZA. INGREZZA continues to be the #1
prescribed treatment for patients with TD and
we expect to generate sales of over $2 billion
in 2024. Last year, we expanded the label to
include the treatment of the chorea movements
associated with Huntington   s disease (HD).
With patent protection to 2038, we have a
meaningful opportunity to help even more
patients with TD and HD.
While crinecerfont represents the most advanced
potential new therapy in our pipeline, there are
several other exciting programs underway. We
have a number of pipeline candidates that will
be reporting out Phase 2 proof-of-concept data
throughout 2024. In the first half of this year,
we expect a data readout for NBI-   845, an AMPA
potentiator for the treatment of inadequate
response in major depressive disorder. We also
expect data in the second half of this year for
luvadaxistat, a DAAO inhibitor, for cognitive
impairment associated with schizophrenia.
Our muscarinic portfolio represents the most
broad and diverse number of compounds with
what has been a validated asset class.

Our lead asset, NBI-   568, is a highly selective
orthosteric agonist of the M4 receptor, and we
expect a Phase 2 data readout in the second half of
2024. If successful, we will rapidly move NBI-   568 into
registrational studies in schizophrenia and potentially
into other neurological conditions.
At our 2023 Analyst Day, we shared insight into our
R&D Organization   s transformational progression.
As our clinical programs advance, we   ve been hard
at work revamping our pre-clinical research and
development efforts. Over the last few years, we   ve
built and transformed Neurocrine   s R&D Organization
for scale, sustainability, and competitiveness.
Our vision is to be a true global leader in
neuroscience and advance a steady flow of
innovative molecules from the clinic all the way to
commercialization. In the near term, we   ve built a
robust R&D innovation engine designed to rapidly
deliver four to six development candidates a
year. In the long-term, we expect to produce one
commercial launch product every other year. This
will be accomplished through both internal and
external innovation across a range of modalities
including biologics and will be focused on higher
probability, best-in-class and next-in-class
opportunities where we can win.
It has been a humbling journey to grow Neurocrine
to the leader it is today. On behalf of our Board,
management team, and roughly 1,500 team
members around the world, I thank our investors,
clinical partners and especially patients for the trust
you put in us. Seven years ago, Neurocrine was a
clinical stage company with no sales and a limited
pipeline. Today, Neurocrine is a fully integrated
biopharmaceutical enterprise with a broad pipeline,
a strong financial position, a growing blockbuster
in INGREZZA and a potential second blockbuster
in crinecerfont. Now more than ever before, the
Neurocrine team is confident we have the right
foundation, the right strategy and the right mission
to weather the unavoidable setbacks of drug
development and to drive our success in helping
more patients.
Thank you for your unwavering support.
Sincerely,
Kevin C. Gorman, PH.D.
Chief Executive Officer
NEUROCRINE BIOSCIENCES, INC.
6027 Edgewood Bend Court
San Diego, CA 92130
Notice of Annual Meeting of Stockholders
To Be Held on May 22, 2024
TO THE STOCKHOLDERS:
NOTICE IS HEREBY GIVEN that the 2024 Annual Meeting of Stockholders of Neurocrine Biosciences, Inc., a Delaware
corporation (the    Company   ), will be held on May 22, 2024, at 10:30 a.m., local time, at the Company   s corporate offices located at
6027 Edgewood Bend Court, San Diego, California 92130, for the following purposes as more fully described in the Proxy Statement
accompanying this Notice:
1.
The election of the four nominees for Class I directors named herein to the Board of Directors to serve for a term of
three years;
2.
An advisory vote on the compensation paid to the Company   s named executive officers;
3.
To approve an amendment to the Company   s 2020 Equity Incentive Plan to increase the number of shares of common
stock reserved for issuance thereunder by 3,635,000 shares;
4.
The ratification of the appointment of Ernst & Young LLP as the Company   s independent registered public accounting
firm for the fiscal year ending December 31, 2024; and
5.
To transact such other business as may properly come before the Annual Meeting of Stockholders or any continuation,
adjournment or postponement thereof.
Only stockholders of record at the close of business on March 25, 2024 are entitled to receive notice of and to vote at the
Annual Meeting of Stockholders.
All stockholders are invited to attend the Annual Meeting of Stockholders in person. However, we strongly urge our
stockholders not to attend the Annual Meeting in person and to instead submit proxy votes. Our Annual Meeting will be purely
functional in format to comply with the relevant legal requirements. There will be no presentations or exhibitions. No refreshments
will be provided. Your vote is important. Whether or not you plan to attend the Annual Meeting, we encourage you to submit
your proxy or voting instructions as soon as possible to vote your shares. You may vote over the Internet, as well as by telephone
or by mailing a proxy or voting instruction form. Please review the instructions on each of your voting options described in these
proxy materials. Stockholders attending the Annual Meeting may vote in person even if they have returned a proxy. If you hold shares
through an account with a brokerage firm, bank or other nominee, please follow the instructions you receive from such firm, bank or
other nominee to vote your shares.
By Order of the Board of Directors,
Darin Lippoldt
Chief Legal Officer and Corporate Secretary
San Diego, California
April 10, 2024
 • shareholder letter icon 4/10/2024 Letter Continued (Full PDF)
 • stockholder letter icon 4/6/2023 NBIX Stockholder Letter
 • stockholder letter icon More "Biotechnology" Category Stockholder Letters
 • Benford's Law Stocks icon NBIX Benford's Law Stock Score = 64


NBIX Shareholder/Stockholder Letter Transcript:

2023
Annual Report

Neurocrine Biosciences
has four commercial,
FDA-approved treatments
in the United States and
a robust pipeline with
multiple mid-to-latestage programs focused
on diseases and disorders
across neurology,
neuroendocrinology,
and neuropsychiatry.
COMMERCIALLY AVAILABLE MEDICINES INCLUDE:
IN THE U.S.
IN THE U.S. AND EU
ENDOMETRIOSIS
ADRENAL INSUFFICIENCY
IN EUROPE
TARDIVE DYSKINESIA
CHOREA-HUNTINGTON   S
DISEASE
UTERINE
FIBROIDS
CONGENITAL ADRENAL
HYPERPLASIA
PIPELINE OF INVESTIGATIONAL THERAPIES INCLUDE 6 :
Phase 1
Phase 2
Phase 3
NEUROLOGY
valbenazine1 Dyskinetic Cerebral Palsy
NBI-8271042 Rare Pediatric Epilepsy: Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep
NBI-9213523 Rare Pediatric Epilepsy: SCN8A Development and Epileptic Encephalopathy Syndrome
NBI-1076986 Movement Disorders
NEUROENDOCRINOLOGY
crinecerfont Congenital Adrenal Hyperplasia in Adults
crinecerfont Congenital Adrenal Hyperplasia in Children & Adolescents
                                                            Congenital Adrenal Hyperplasia

NEUROPSYCHIATRY
valbenazine1 Adjunctive Treatment of Schizophrenia
NBI-10658454 Inadequate Response to Treatment in Major Depressive Disorder
                        4 Cognitive Impairment Associated with Schizophrenia
NBI-11175685 Schizophrenia
NBI-10707704 Major Depressive Disorder
NBI-11175675 CNS Indications
NBI-11175695 CNS Indications
NBI-11175705 CNS Indications
NBI-1065890 CNS Indications
* Mitsubishi Tanabe Pharma Corporation (MTPC) has commercialization rights in
Japan and other select Asian markets
    AbbVie has global commercialization rights
Neurocrine Biosciences has global rights unless otherwise noted. Neurocrine
Company Limited.
Mitsubishi Tanabe Pharma Corporation (MTPC) has commercialization rights in
Japan and other select Asian markets.
1
2
Licensed from Idorsia Ltd.
3
Licensed from Xenon Pharmaceuticals, Inc.
4
Licensed from Takeda Pharmaceutical Company Limited.
5
Licensed from Sosei Heptares.
6
Investigational therapies are not approved for use in any country

Dear Fellow Shareholders,
Kevin C. Gorman, Ph.D.
Chief Executive Officer
Neurocrine Biosciences is a company dedicated
to brave science     because the people we
serve need and deserve it. Since our founding
in 1993, we   ve focused in areas that lacked
recent innovation or, in some cases, had no
treatment options. With that focus, we have built
a leading neuroscience company dedicated to
treatments across neurology, neuropsychiatry,
neuroendocrinology and someday,
neuroimmunology. As we look to the future,
we remain focused on optimizing INGREZZA  ,
gaining approval for crinecerfont in congenital
adrenal hyperplasia (CAH), advancing our
growing and diverse pipeline, and improving
the lives of our patients.
In October 2023, we reported strong results
in two Phase 3 studies in adult and pediatric
CAH patients reflecting the potential of a
much-needed new treatment paradigm.
Following these results, the U.S. Food and Drug
Administration (FDA) granted crinecerfont
Breakthrough Therapy designation which serves
as an acknowledgement of the serious and
life-threatening nature of CAH, highlighting
the significant unmet need that exists and
identifying the product as a potentially valuable
treatment. The New Drug Application submission
is anticipated to occur in the second quarter of
2024, and we look forward to potentially bringing
crinecerfont to CAH patients next year.
We are proud of the continued success of
INGREZZA   and remain optimistic about its
untapped potential. While we   ve made good
progress improving the diagnosis and treatment
rates of the estimated 600,000 people in the U.S.
who have tardive dyskinesia (TD), we estimate
only 20% of people living with TD have been
offered treatment with a VMAT2 inhibitor like
INGREZZA. INGREZZA continues to be the #1
prescribed treatment for patients with TD and
we expect to generate sales of over $2 billion
in 2024. Last year, we expanded the label to
include the treatment of the chorea movements
associated with Huntington   s disease (HD).
With patent protection to 2038, we have a
meaningful opportunity to help even more
patients with TD and HD.
While crinecerfont represents the most advanced
potential new therapy in our pipeline, there are
several other exciting programs underway. We
have a number of pipeline candidates that will
be reporting out Phase 2 proof-of-concept data
throughout 2024. In the first half of this year,
we expect a data readout for NBI-   845, an AMPA
potentiator for the treatment of inadequate
response in major depressive disorder. We also
expect data in the second half of this year for
luvadaxistat, a DAAO inhibitor, for cognitive
impairment associated with schizophrenia.
Our muscarinic portfolio represents the most
broad and diverse number of compounds with
what has been a validated asset class.


Our lead asset, NBI-   568, is a highly selective
orthosteric agonist of the M4 receptor, and we
expect a Phase 2 data readout in the second half of
2024. If successful, we will rapidly move NBI-   568 into
registrational studies in schizophrenia and potentially
into other neurological conditions.
At our 2023 Analyst Day, we shared insight into our
R&D Organization   s transformational progression.
As our clinical programs advance, we   ve been hard
at work revamping our pre-clinical research and
development efforts. Over the last few years, we   ve
built and transformed Neurocrine   s R&D Organization
for scale, sustainability, and competitiveness.
Our vision is to be a true global leader in
neuroscience and advance a steady flow of
innovative molecules from the clinic all the way to
commercialization. In the near term, we   ve built a
robust R&D innovation engine designed to rapidly
deliver four to six development candidates a
year. In the long-term, we expect to produce one
commercial launch product every other year. This
will be accomplished through both internal and
external innovation across a range of modalities
including biologics and will be focused on higher
probability, best-in-class and next-in-class
opportunities where we can win.
It has been a humbling journey to grow Neurocrine
to the leader it is today. On behalf of our Board,
management team, and roughly 1,500 team
members around the world, I thank our investors,
clinical partners and especially patients for the trust
you put in us. Seven years ago, Neurocrine was a
clinical stage company with no sales and a limited
pipeline. Today, Neurocrine is a fully integrated
biopharmaceutical enterprise with a broad pipeline,
a strong financial position, a growing blockbuster
in INGREZZA and a potential second blockbuster
in crinecerfont. Now more than ever before, the
Neurocrine team is confident we have the right
foundation, the right strategy and the right mission
to weather the unavoidable setbacks of drug
development and to drive our success in helping
more patients.
Thank you for your unwavering support.
Sincerely,
Kevin C. Gorman, PH.D.
Chief Executive Officer

NEUROCRINE BIOSCIENCES, INC.
6027 Edgewood Bend Court
San Diego, CA 92130
Notice of Annual Meeting of Stockholders
To Be Held on May 22, 2024
TO THE STOCKHOLDERS:
NOTICE IS HEREBY GIVEN that the 2024 Annual Meeting of Stockholders of Neurocrine Biosciences, Inc., a Delaware
corporation (the    Company   ), will be held on May 22, 2024, at 10:30 a.m., local time, at the Company   s corporate offices located at
6027 Edgewood Bend Court, San Diego, California 92130, for the following purposes as more fully described in the Proxy Statement
accompanying this Notice:
1.
The election of the four nominees for Class I directors named herein to the Board of Directors to serve for a term of
three years;
2.
An advisory vote on the compensation paid to the Company   s named executive officers;
3.
To approve an amendment to the Company   s 2020 Equity Incentive Plan to increase the number of shares of common
stock reserved for issuance thereunder by 3,635,000 shares;
4.
The ratification of the appointment of Ernst & Young LLP as the Company   s independent registered public accounting
firm for the fiscal year ending December 31, 2024; and
5.
To transact such other business as may properly come before the Annual Meeting of Stockholders or any continuation,
adjournment or postponement thereof.
Only stockholders of record at the close of business on March 25, 2024 are entitled to receive notice of and to vote at the
Annual Meeting of Stockholders.
All stockholders are invited to attend the Annual Meeting of Stockholders in person. However, we strongly urge our
stockholders not to attend the Annual Meeting in person and to instead submit proxy votes. Our Annual Meeting will be purely
functional in format to comply with the relevant legal requirements. There will be no presentations or exhibitions. No refreshments
will be provided. Your vote is important. Whether or not you plan to attend the Annual Meeting, we encourage you to submit
your proxy or voting instructions as soon as possible to vote your shares. You may vote over the Internet, as well as by telephone
or by mailing a proxy or voting instruction form. Please review the instructions on each of your voting options described in these
proxy materials. Stockholders attending the Annual Meeting may vote in person even if they have returned a proxy. If you hold shares
through an account with a brokerage firm, bank or other nominee, please follow the instructions you receive from such firm, bank or
other nominee to vote your shares.
By Order of the Board of Directors,
Darin Lippoldt
Chief Legal Officer and Corporate Secretary
San Diego, California
April 10, 2024



shareholder letter icon 4/10/2024 Letter Continued (Full PDF)
 

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