AbbVie Reports First-Quarter 2023 Financial Results

  • Reports First-Quarter Diluted EPS of $0.13 on a GAAP Basis, a Decrease of 94.8 Percent; Adjusted Diluted EPS of $2.46 , a Decrease of 22.2 Percent; These Results Include an Unfavorable Impact of $0.08 Per Share related to Acquired IPR&D and Milestones Expense
  • Delivers First-Quarter Net Revenues of $12.225 Billion , a Decrease of 9.7 Percent on a Reported Basis and 8.3 Percent on an Operational Basis
  • First   -Quarter Global Net Revenues from the Immunology Portfolio Were $5.587 Billion , a Decrease of 9.0 Percent on a Reported Basis, or 7.8 Percent on an Operational Basis; Global Humira Net Revenues Were $3.541 Billion ; Global Skyrizi Net Revenues Were $1.360 Billion ; Global Rinvoq Net Revenues Were $686 Million
  • First   -Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.416 Billion , a Decrease of 14.0 Percent on a Reported Basis, or 12.9 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $878 Million ; Global Venclexta Net Revenues Were $538 Million
  • First   -Quarter Global Net Revenues from the Neuroscience Portfolio Were $1.695 Billion , an Increase of 13.9 Percent on a Reported Basis, or 15.0 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $719 Million ; Global Vraylar Net Revenues Were $561 Million
  • First   -Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.300 Billion , a Decrease of 5.4 Percent on a Reported Basis, or 2.0 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $659 Million ; Global Juvederm Net Revenues Were $355 Million
  • Raises 2023 Adjusted Diluted EPS Guidance Range from $10.62 - $11.02 to $10.72 - $11.12 , which Includes an Unfavorable Impact of $0.08 Per Share Related to Acquired IPR&D and Milestones Expense Incurred During the First Quarter 2023

AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2023 .

"This year is off to an excellent start, with first-quarter revenues and EPS ahead of our expectations, driven by strong commercial execution across all areas of our diversified portfolio," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "These balanced results give us confidence to increase our full-year guidance and we see numerous opportunities for key assets to drive compelling long-term growth."

First   -Quarter Results

  • Worldwide net revenues were $12.225 billion , a decrease of 9.7 percent on a reported basis, or 8.3 percent on an operational basis.
  • Global net revenues from the immunology portfolio were $5.587 billion , a decrease of 9.0 percent on a reported basis, or 7.8 percent on an operational basis.
    • Global Humira net revenues of $3.541 billion decreased 25.2 percent on a reported basis, or 24.3 percent on an operational basis. U.S. Humira net revenues were $2.948 billion , a decrease of 26.1 percent. Internationally, Humira net revenues were $593 million , a decrease of 20.3 percent on a reported basis, or 14.8 percent on an operational basis.
    • Global Skyrizi net revenues were $1.360 billion , an increase of 44.7 percent on a reported basis, or 46.3 percent on an operational basis.
    • Global Rinvoq net revenues were $686 million , an increase of 47.5 percent on a reported basis, or 51.2 percent on an operational basis.

  • Global net revenues from the hematologic oncology portfolio were $1.416 billion , a decrease of 14.0 percent on a reported basis, or 12.9 percent on an operational basis.
    • Global Imbruvica net revenues were $878 million , a decrease of 25.2 percent, with U.S. net revenues of $638 million and international profit sharing of $240 million .
    • Global Venclexta net revenues were $538 million , an increase of 13.7 percent on a reported basis, or 17.5 percent on an operational basis.

  • Global net revenues from the neuroscience portfolio were $1.695 billion , an increase of 13.9 percent on a reported basis, or 15.0 percent on an operational basis.
    • Global Botox Therapeutic net revenues were $719 million , an increase of 17.1 percent on a reported basis, or 18.7 percent on an operational basis.
    • Global Vraylar net revenues were $561 million , an increase of 31.3 percent.
    • Global Ubrelvy net revenues were $152 million , an increase of 10.0 percent.

  • Global net revenues from the aesthetics portfolio were $1.300 billion , a decrease of 5.4 percent on a reported basis, or 2.0 percent on an operational basis.
    • Global Botox Cosmetic net revenues were $659 million , an increase of 2.9 percent on a reported basis, or 5.8 percent on an operational basis.
    • Global Juvederm net revenues were $355 million , a decrease of 13.4 percent on a reported basis, or 7.4 percent on an operational basis.

  • On a GAAP basis, the gross margin ratio in the first quarter was 67.4 percent. The adjusted gross margin ratio was 84.2 percent.
  • On a GAAP basis, selling, general and administrative (SG&A) expense was 24.9 percent of net revenues. The adjusted SG&A expense was 24.4 percent of net revenues.
  • On a GAAP basis, research and development (R&D) expense was 18.8 percent of net revenues. The adjusted R&D expense was 13.6 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
  • Acquired IPR&D and milestones expense was 1.2 percent of net revenues.
  • On a GAAP basis, the operating margin in the first quarter was 22.6 percent. The adjusted operating margin was 45.0 percent.
  • Net interest expense was $454 million .
  • On a GAAP basis, the tax rate in the quarter was 49.3 percent. The adjusted tax rate was 13.7 percent.
  • Diluted EPS in the first quarter was $0.13 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.46 . These results include an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense.

Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.

Recent Events

  • AbbVie announced the European Commission (EC) approved Rinvoq (upadacitinib, 45 mg induction dose, 15 mg and 30 mg maintenance doses) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. The approval is based on results from three studies in which Rinvoq achieved the co-primary endpoints of clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. This is the seventh approved indication for Rinvoq in the European Union (EU).
  • AbbVie announced positive top-line results from INSPIRE, a Phase 3 induction study, showing Skyrizi (risankizumab, 1200 mg intravenous (IV), at weeks 0, 4 and 8) met the primary endpoint of clinical remission at week 12, as well as all secondary endpoints in adult patients with moderately to severely active ulcerative colitis (UC). Safety results in this study were consistent with the known safety profile of Skyrizi, with no new safety risks observed. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
  • AbbVie announced positive top-line results from a Phase 2 study of Rinvoq (30 mg, once daily), given alone or as combination therapy (ABBV-599) with a Bruton's Tyrosine Kinase inhibitor (elsubrutinib, 60 mg), in patients with moderately to severely active systemic lupus erythematosus (SLE). The study met the primary endpoint of SLE Responder Index (SRI-4) with a steroid dose of less than or equal to 10 mg per day at week 24 in patients with moderately to severely active SLE. Based on these results, AbbVie intends to advance its clinical program of Rinvoq in SLE to Phase 3.
  • At the Congress of European Crohn's and Colitis Organisation (ECCO), AbbVie presented 24 abstracts, including four oral presentations, two digital oral presentations and 18 posters from a broad range of studies across its inflammatory bowel disease (IBD) portfolio. Highlights included data from the ADVANCE, MOTIVATE and FORTIFY studies highlighting efficacy outcomes and clinical response in patients receiving Skyrizi for treatment of moderately to severely active CD, sub-analyses from the U-EXCEL, U-EXCEED and U-ENDURE studies evaluating Rinvoq for the treatment of moderately to severely active CD and analyses evaluating Rinvoq for the treatment of UC.
  • At the 2023 American Academy of Dermatology (AAD) Annual Meeting, AbbVie presented more than 20 abstracts showcasing the strength of its dermatology portfolio. Notable presentations included late-breaking data that demonstrated Skyrizi improved plaque psoriasis (PsO) signs and symptoms among moderate to severe PsO patients that previously had a suboptimal response to IL-17 inhibitor therapy; abstracts assessing long-term outcomes of Skyrizi in patients with active psoriatic arthritis (PsA); subgroup analyses of outcomes in adults and adolescents with atopic dermatitis (AD) from three Phase 3 trials assessing the efficacy and safety of Rinvoq across 52 weeks; and results from a Phase 2 study evaluating the efficacy and safety of Rinvoq in moderate-to-severe hidradenitis suppurativa (HS).
  • AbbVie announced that it intends to voluntarily withdraw the U.S. accelerated Imbruvica (ibrutinib) approvals for patients with mantle cell lymphoma (MCL) who received at least one prior therapy and patients with marginal zone lymphoma (MZL) who require systemic therapy and received at least one prior anti-CD20-based therapy. This voluntary action was due to requirements related to the accelerated approval status granted by the U.S. Food and Drug Administration (FDA) for MCL and MZL. Other approved indications for Imbruvica in the U.S. were not affected by this withdrawal and Imbruvica's established clinical profile in other approved indications is unchanged. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc.

Recent Events (Continued)

  • AbbVie announced that the FDA approved expanding the indication of Qulipta (atogepant) for the preventive treatment of migraine in adults. The approval makes Qulipta the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. The expanded indication provides an additional treatment option for those with chronic migraine whose frequent disabling attacks negatively impact performance of daily activities. Approval is based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
  • AbbVie announced it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). In its letter, the FDA requested additional information about the device (pump) as part of the NDA review. The CRL did not request that AbbVie conduct additional efficacy and safety trials related to the drug. AbbVie plans to resubmit the NDA as soon as possible.
  • AbbVie and Capsida Biotherapeutics Inc. (Capsida) announced an expanded strategic collaboration to develop genetic medicines for eye diseases with high unmet need. The collaboration builds on the partnership announced in 2021. Under the expanded collaboration, AbbVie's extensive capabilities will be paired with Capsida's novel adeno-associated virus (AAV) engineering platform and manufacturing capability to identify and advance three programs.

Full-Year 2023 Outlook

AbbVie is raising its adjusted diluted EPS guidance for the full year 2023 from $10.62 - $11.02 to $10.72 - $11.12 , which includes an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense incurred during the first quarter 2023. The company's 2023 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2023, as both cannot be reliably forecasted.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter, Facebook or LinkedIn .

Conference Call

AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our first-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com . An archived edition of the call will be available after 11:00 a.m. Central time .

Non-GAAP Financial Results

Financial results for 2023 and 2022 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

AbbVie Inc.

Key Product Revenues

Quarter Ended March 31, 2023

(Unaudited)









% Change vs. 1Q22


Net Revenues (in millions)


Reported


Operational a


U.S.


Int'l.


Total


U.S.


Int'l.


Total


Int'l.


Total

NET REVENUES

$9,201


$3,024


$12,225


(11.1) %


(5.2) %


(9.7) %


0.9 %


(8.3) %

















Immunology

4,536


1,051


5,587


(10.8)


(0.6)


(9.0)


6.3


(7.8)

Humira

2,948


593


3,541


(26.1)


(20.3)


(25.2)


(14.8)


(24.3)

Skyrizi

1,139


221


1,360


45.9


38.5


44.7


47.7


46.3

Rinvoq

449


237


686


44.4


53.7


47.5


64.9


51.2

















Hematologic Oncology

903


513


1,416


(18.2)


(5.5)


(14.0)


(2.2)


(12.9)

Imbruvica b

638


240


878


(27.0)


(19.7)


(25.2)


(19.7)


(25.2)

Venclexta

265


273


538


15.7


11.8


13.7


19.2


17.5

















Aesthetics

777


523


1,300


(8.1)


(1.1)


(5.4)


7.8


(2.0)

Botox Cosmetic

409


250


659


(0.7)


9.4


2.9


17.5


5.8

Juvederm Collection

122


233


355


(17.9)


(10.9)


(13.4)


(1.4)


(7.4)

Other Aesthetics

246


40


286


(13.6)


3.6


(11.5)


12.7


(10.4)

















Neuroscience

1,463


232


1,695


15.0


7.5


13.9


15.0


15.0

Botox Therapeutic

587


132


719


17.5


15.5


17.1


24.2


18.7

Vraylar

560


1


561


31.2


n/m


31.3


n/m


31.3

Duodopa

25


93


118


6.5


(4.3)


(2.2)


1.7


2.6

Ubrelvy

150


2


152


9.0


n/m


10.0


n/m


10.0

Qulipta

66



66


>100.0


n/m


>100.0


n/m


>100.0

Other Neuroscience

75


4


79


(56.7)


6.9


(55.2)


12.6


(55.1)

















Eye Care

319


289


608


(35.7)


5.0


(21.2)


11.0


(19.0)

Ozurdex

39


76


115


16.1


3.2


7.3


10.3


12.2

Lumigan/Ganfort

63


67


130


(6.8)


(7.2)


(7.0)


(2.7)


(4.7)

Alphagan/Combigan

28


43


71


(59.4)


16.9


(33.3)


24.2


(30.8)

Restasis

79


13


92


(66.5)


20.4


(62.8)


25.1


(62.6)

Other Eye Care

110


90


200


22.9


10.3


16.9


16.3


19.8

















Other Key Products

727


201


928


5.5


(7.4)


2.4


(1.1)


3.9

Mavyret

171


193


364


1.2


(8.1)


(4.0)


(1.8)


(0.5)

Creon

305



305


6.3


n/m


6.3


n/m


6.3

Linzess/Constella

251


8


259


7.7


11.9


7.8


17.8


8.0



a

"Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues
at the prior year's foreign exchange rates.

b

Reflects profit sharing for Imbruvica international revenues.

n/m = not meaningful

AbbVie Inc.

Consolidated Statements of Earnings

(Unaudited)


(in millions, except per share data)

First Quarter

Ended March 31


2023


2022

Net revenues

$       12,225


$        13,538

Cost of products sold

3,986


4,052

Selling, general and administrative

3,039


3,127

Research and development

2,292


1,497

Acquired IPR&D and milestones

150


145

Other operating income

(10)


Total operating costs and expenses

9,457


8,821





Operating earnings

2,768


4,717





Interest expense, net

454


539

Net foreign exchange loss

35


25

Other expense (income), net

1,804


(776)

Earnings before income tax expense

475


4,929

Income tax expense

234


436

Net earnings

241


4,493

Net earnings attributable to noncontrolling interest

2


3

Net earnings attributable to AbbVie Inc.

$             239


$          4,490





Diluted earnings per share attributable to AbbVie Inc.

$            0.13


$            2.51





Adjusted diluted earnings per share a

$            2.46


$            3.16





Weighted-average diluted shares outstanding

1,776


1,778


a Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details.

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited)


1.     Specified items impacted results as follows:







Quarter Ended March 31, 2023

(in millions, except per share data)





Earnings


Diluted






Pre-tax


After-tax a


EPS

As reported (GAAP)





$                 475


$                239


$                0.13

Adjusted for specified items:










Intangible asset amortization





1,948


1,646


0.93

Intangible asset impairment





710


629


0.35

Acquisition and integration costs





61


55


0.03

Change in fair value of contingent consideration





1,872


1,822


1.02

Other





17


(6)


As adjusted (non-GAAP)





$              5,083


$             4,385


$                2.46


a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs primarily reflect integration costs related to the Allergan acquisition.


Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended March 31, 2023 included acquired IPR &D and milestones
expense of $150 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.08 to both diluted EPS and adjusted diluted EPS.


2.     The impact of the specified items by line item was as follows:



Quarter Ended March 31, 2023

(in millions)

Cost of
products
sold


SG&A


R&D


Other
operating
income


Other
expense
(income),
net

As reported (GAAP)

$      3,986


$      3,039


$               2,292


$                 (10)


$             1,804

Adjusted for specified items:










Intangible asset amortization

(1,948)





Intangible asset impairment

(80)



(630)



Acquisition and integration costs

(15)


(44)


(2)



Change in fair value of contingent consideration





(1,872)

Other

(12)


(11)


(3)


10


(1)

As adjusted   (non-GAAP)

$      1,931


$      2,984


$               1,657


$                  —


$                (69)



3.     The adjusted tax rate for the first quarter of 2023 was 13.7 percent, as detailed below:







Quarter Ended March 31, 2023

(dollars in millions)





Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)





$                 475


$                234


49.3 %

Specified items





4,608


462


10.0 %

As adjusted   (non-GAAP)





$              5,083


$                696


13.7 %

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited)


1.     Specified items impacted results as follows:





Quarter Ended March 31, 2022

(in millions, except per share data)



Earnings


Diluted




Pre-tax


After-tax a


EPS

As reported (GAAP)



$              4,929


$              4,490


$                2.51

Adjusted for specified items:








Intangible asset amortization



1,855


1,565


0.88

Acquisition and integration costs



138


121


0.07

Change in fair value of contingent consideration



(748)


(746)


(0.42)

Litigation matters



184


148


0.08

Other



64


63


0.04

As adjusted (non-GAAP)



$              6,422


$              5,641


$                3.16


a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs reflect integration costs related to the Allergan acquisition. Other primarily includes restructuring charges associated
with streamlining global operations.


Reported GAAP earnings and adjusted non-GAAP earnings for the first quarter of 2022 included acquired IPR&D and milestones expense
of $145 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.08 to both diluted EPS and adjusted diluted EPS.


2.     The impact of the specified items by line item was as follows:



Quarter Ended March 31, 2022

(in millions)

Cost of
products
sold


SG&A


R&D


Other
expense
(income),
net

As reported (GAAP)

$          4,052


$             3,127


$              1,497


$                (776)

Adjusted for specified items:








Intangible asset amortization

(1,855)




Acquisition and integration costs

(34)


(93)


(11)


Change in fair value of contingent consideration




748

Litigation matters


(184)



Other

(60)


2


(6)


As adjusted   (non-GAAP)

$          2,103


$             2,852


$              1,480


$                  (28)



3.     The adjusted tax rate for the first quarter of 2022 was 12.1 percent, as detailed below:





Quarter Ended March 31, 2022

(dollars in millions)



Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)



$             4,929


$                 436


8.8 %

Specified items



1,493


342


22.9 %

As adjusted   (non-GAAP)



$             6,422


$                 778


12.1 %

Cision View original content: https://www.prnewswire.com/news-releases/abbvie-reports-first-quarter-2023-financial-results-301808989.html

SOURCE AbbVie

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Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of 1995.
The words “believe,” “expect,” “anticipate,” “project” and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations is
set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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BLINCYTO® ADDED TO CHEMOTHERAPY SIGNIFICANTLY IMPROVES SURVIVAL IN NEWLY DIAGNOSED PEDIATRIC PATIENTS WITH B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA

Phase 3 Study Results Demonstrated Three Year, Disease-Free Survival of 96%

Amgen (NASDAQ:AMGN) today announced new data demonstrating that adding BLINCYTO ® (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse. The data are from a Phase 3 study (AALL1731) conducted by the Children's Oncology Group. The results were simultaneously published in the New England Journal of Medicine and will be presented during the plenary session on Sunday, Dec. 8 at 2 p.m. PT at the 66 th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego .

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AMGEN ANNOUNCES $1 BILLION MANUFACTURING EXPANSION IN NORTH CAROLINA

Investment Establishes Second Facility in Holly Springs ; Builds on Previous $550M Commitment

Amgen (NASDAQ: AMGN) today announced a $1 billion expansion to establish a second drug substance manufacturing facility in North Carolina . This brings the company's total planned investment in Holly Springs to more than $1.5 billion building on its previously announced $550 million commitment.

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AMGEN TO PRESENT AT CITI'S 2024 GLOBAL HEALTHCARE CONFERENCE

Amgen (NASDAQ:AMGN) will present at Citi's 2024 Global Healthcare Conference at 9:30 a.m. ET on Thursday Dec. 5, 2024. Peter Griffith executive vice president and chief financial officer at Amgen, Jay Bradner executive vice president of Research and Development and chief scientific officer at Amgen, and Susan Sweeney executive vice president of Obesity and Related Conditions at Amgen, will participate in a fireside chat at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

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